Certain Microfluidic Systems and Components Thereof and Products Containing Same, Inv. 337-TA-1100

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In the Matter of

CERTAIN MICROFLUIDIC SYSTEMS AND
COMPONENTS THEREOF AND PRODUCTS
CONTAINING SAME

337-TA-1100

Publication 5077 June 2020

U.S. International Trade Commission

Washington, DC 20436

U.S. International Trade Commission
COMMISSIONERS
David S. Johanson, Chairman
Rhonda K. Schmidtlein, Commissioner
Jason E. Kearns, Commissioner
Randolph J. Stayin, Commissioner
Amy A. Karpel, Commissioner
Address all communications to
Secretary to the Commission
United States International Trade Commission
Washington, DC 20436

U.S. International Trade Commission
Washington, DC 20436
www.usitc.gov
Publication 5077 	June 2020
In the Matter of
337-TA-1100
CERTAIN MICROFLUIDIC SYSTEMS AND
COMPONENTS THEREOF AND PRODUCTS
CONTAINING SAME

UNITED STATES INTERNATIONAL TRADE COMMISSION
Washington, D.C.
In the Matter of
CERTAIN MICROFLUIDIC SYSTEMS 	I“”°s“g*'“°“ N°- 337'TA'11“"
AND COMPONENTS THEREOF AND 	_
PRODUCTS CONTAINING SAME
NOTICE OF THE COMMISSION’S FINAL DETERMINATION FINDING A
VIOLATION OF SECTION 337; ISSUANCE OF A LIMITED EXCLUSION ORDER
AND CEASE AND DESIST ORDER; AND TERMINATION OF THE INVESTIGATION.
AGENCY: U.S. Intemational Trade Commission.
ACTION: Notice.
SUMMARY: Notice is hereby given that the U.S. International Trade Commission has
determined that there is a violation of 19 U.S.C. 1337, as amended (“section 337”), in the above
captioned investigation. The Commission has further determined to issue a limited exclusion
order and cease and desist order and to set a bond rate on the entered value of covered products
imported during the period of Presidential review.
FOR FURTHER INFORMATION CONTACT: Benjamin S. Richards, Esq., Office of the
General Counsel, U.S. Intemational Trade Commission, 500 E Street SW, Washington, DC
20436, telephone (202) 708-5453. Copies of non-confidential documents filed in connection
with this investigation are or will be available for inspection during official business hours (8:45
a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. Intemational Trade Commission, 500 E
Street SW, Washington, DC 20436, telephone (202) 205-2000. General information conceming
the Commission may also be obtained by accessing its Intemet server at httgs."//www.usitc.gov.
The public record for this investigation may be viewed on the Commission’s electronic docket
(EDIS) at httgs://edis. usitc.gov. Hearing-impaired persons are advised that information on this
matter can be obtained by contacting the Commission’s TDD terminal on (202) 205-1810.
SUPPLEMENTARY INFORMATION: On February 21, 2018, the Commission instituted
this investigation based on a complaint filed by 10X Genomics, Inc. of Pleasanton, CA. 83 Fed.
Reg. 7491 (Feb. 21, 2018). The complaint alleges violations of section 337 of the Tariff Act of
1930, as amended, 19 U.S.C. 1337, in the importation into the United States, the sale for
importation, or the sale within the United States after importation of certain microfluidic systems
and components thereof and products containing same by reason of infringement of one or more
claims of U.S. Patent Nos. 9,644,204 (“the ’204 patent”); 9,689,024 (“the ’024 patent”);
9,695,468 (“the ’468 patent”); and 9,856,530 (“the ’530 patent”). Id. The Comrnission’s

notice of investigation named as the sole respondent Bio-Rad Laboratories, Inc. of Hercules, CA.
Id. The Office of Unfair Import Investigations (“OUII”) is participating in this investigation.
1d.
On July 12, 2019, the administrative law judge (“ALJ”) issued the final initial
determination (“ID”). The ID found a violation of section 337 by virtue of Bio-Rad’s indirect
infringement of the ’024, the ’468, and the ’530 patents. The ID found that 10X had not
established a violation with respect to the ’204 patent. The ID also found that Bio-Rad failed to
establish invalidity of any of the asserted claims of any patent. The ID further formd that the
domestic industry requirement was satisfied for each of the asserted patents. Finally, the ID
found that Bio-Rad had not carried its burden with respect to various additional affirmative
defenses, including improper inventorship and ownership. '
u On July 25, 2019, the ALJ issued her recommended determination on remedy and
bonding. The ALJ recommended, upon a finding of violation, that the Commission issue a
limited exclusion order, issue a cease and desist order, and impose a bond in the amount of
twenty-five percent of the entered value of any covered products imported during the period of
Presidential review. _
’ On July 29, 2019, 10X, Bio-Rad, and OUII submitted petitions seeking review of the ID.
On August 6, 2019, 10X, Bio-Rad, and OUII submitted responses to the others’ petitions. On
August 26, 2019, 10X and Bio-Rad submitted comments on the public interest pursuant to
Commission Rule 2l0.50(a)(4).
On October 17, 2019, the Commission issued a notice indicating its determination to
review the ID with respect to (1) all findings related to a violation based on the ’024 patent; (2)
all findings related to a violation based on the ’468 patent; (3) noninfringement of the ’204
patent; (4) all findings related to a violation based on the ’530 patent; (5) Bio-Rad’s inventorship
and ownership defenses; and (6) a typographical error on page 91. The same notice also
requested briefing from the parties on certain of those issues, and on remedy, bonding, and the
public interest. The notice also included an extension of the target date to December 19, 2019.
The parties filed their initial responses to the Co1nrnission’s questions on October 31,
2019, and their replies on November 7, 2019.
Upon review of the parties’ submissions, the ID, RD, and evidence of record, the
Commission has determined that Bio-Rad violated section 337 by reason of infringement of
asserted claims 1, 5, 17, 19, and 22 of the ’024 patent, claims 1, 6, 7, 9, and 21 of the ’468 patent,
and claims 1, 4, 11, 14, 19, 26, and 28 of the ’530 patent. The Commission found no violation
with respect to the ’240 patent. The Commission has further determined to issue a limited
exclusion order prohibiting further importation of Bio-Rad’s infringing microfluidic systems and
a cease and desist order against Bio-Rad. The Commission will set a bond of twenty-five
percent of entered value on Bio-Rad’s infringing microfluidic systems imported during the
period of Presidential review.
2

The authority for the C0mmission’s determination is contained in section 337 of the
TariffAct of 1930, as amended (19 U.S.C. 1337), and in part 210 ofthe Commission’s Rules of
Practice and Procedure (19 CFR 210). 	i
Lisa R. Barton
Secretary to the Commission
By order of the Commission.
Issued: February 12, 2020
/
3

CERTAIN MICROFLUIDIC SYSTEMS AND 	Inv. N0. 337-TA-1100
COMPONENTS THEREOF AND PRODUCTS
CONTAINING SAME '
I 	PUBLIC CERTIFICATE OF SERVICE
I, Lisa R. Barton, hereby certify that the attached NOTICE has been served by hand
upon the Commission Investigative Attorney, Monica Bhattacharyya, Esq., and the following
parties as indicated, on February 12, 2020.
Lisa R. Barton, Secretary
U.S, International Trade Commission
500 E Street, SW, Room 112
Washington, DC 20436
On Behalf of Complainants 10X Genomics, Inc.:
Paul T. Ehrlich ' 	El Via Hand Delivery
TENSEGRITY LAW GROUP LLP 	E vie Express Delivery "
555 Twin Dolphin Dr., Suite 650 I 	|:| Via First Class Mai]
Redwood Shores, CA 94061 	U Other:
On Behalf of Respondents Bio-Rad Laboratories. Inc.:
S. Alex Lasher 	' 	Cl Via Hand Delivery
QUINN EMANUEL URQUHART & SULLIVAN, LLP 	Q Via Express Delivery '
l300 I SIICCINW, Suite 900 	U Via First Class Mai]
Washington, DC 20005 	U other

UNITED STATES INTERNATIONAL TRADE COMMISSION
Washington, D.C.
In the Matter of
Investigation No. 337-TA-1100
CERTAIN MICROFLUIDIC SYSTEMS
AND COMPONENTS THEREOF AND
PRODUCTS CONTAINING SAME
LIMITED EXCLUSION ORDER
The Commission has determined that there is a violation of section 337 of the Tariff Act
of 1930, as amended (19 U.S.C. 1337), in the unlawful importation, sale for importation, and/or
sale within the United States after importation by Bio-Rad Laboratories, Inc. of Hercules,
Califomia (“Bio-Rad” or “Respondent”) of certain microfluidic systems and components thereof
and products containing same that infringe one or more of claims 1, 5, 17, 19, and 22 of U.S.
Patent No. 9,689,024 (“the ’024 patent”); claims 1, 6, 7, 9, and 21 of U.S. Patent No. 9,695,468
(“the ’468 patent”); and claims 1, 4, ll, 14, 19, 26, and 28 ofU.S. Patent No. 9,856,530 (“the
’530 patent”).
Having reviewed the record of this investigation, including the written submissions of the
parties, the Commission has made its detennination on the issues of remedy, the public interest,
and bonding. The Commission has determined that the appropriate form of relief includes a
limited exclusion order prohibiting the tmlicensed entry of covered microfluidic systems and
components thereof and products containing same manufactured by or on behalf of, or imported
by or on behalf of, Respondent or any of its aftiliated companies, parents, subsidiaries, or other

related business entities, or its successors or assigns. This Exclusion Order does not apply to
microfluidic consumablesl imported into the United States for use by researchers who are using
such consumables in the United States as of the date of issuance of this Order, and who have a
documented need to continue receiving the consumables for a specific current ongoing research
project for which that need cannot be met by any alternative product.
The Commission has also determined that the public interest factors enumerated in 19
U.S.C. § l337(d)(l) do not preclude the issuance of this limited exclusion order. Finally, the
Commission has determined that the bond during the Presidential review period shall be in the
amount of twenty-five (2i5)percent of the entered value for all covered products.
Accordingly, the Commission hereby ORDERS that:
l. Microfluidic systems and components thereof and products containing same that
infringe one or more of claims 1, 5, 17, 19, and 22 of the ’024 patent; claims l, 6, 7,
9, and 21 of the ’468 patent; and claims l, 4, 11, 14, 19, 26, and 28 ofthe ’530 patent,
and that are manufactured by or on behalf of, or imported by or on behalf of,
Respondent or any of its affiliated companies, parents, subsidiaries, or other related
business entities, or their successors or assigns (“covered products”), are excluded
from entry for consumption into the United States, entry for consumption from a
foreign trade zone, or withdrawal from a warehouse for consumption, for the
remaining terms of the patents, except under license of the patent owner or as
provided by law.
“Consumable” means any otherwise covered Bio-Rad part or material that is purchased for use
with Bio-Rad’s droplet generation instruments and which is consumed during the use of those
instruments. For example, Bio-Rad’s microfluidic chips are constunables.
1.
2

2. The provisions of this Order shall not apply to covered consumables imported into the
United States for use by researchers who are using such consumables in the United
States as of the date of issuance of this Order, and who have a documented needz to
continue receiving the consumables for a specific current ongoing research project for
_ which that need camiot be met by any alternative product. The provisions of this
Order shall also not apply to service or repair articles imported for use in servicing or
repairing microfluidic systems that were imported as of the date of this Order and are
under a warranty that existed as of the date of this Order, if such servicing or
repairing is provided for in terms of the warranty.
3. Notwithstanding paragraph 1 of this Order, the covered products are entitled to entry
into the United States for consumption, entry for consumption from a foreign-trade
zone, or withdrawal from a warehouse for consumption under bond in the amount of
twenty-five (25) percent of the entered value of such articles pursuant to subsection
(j) of Section 337 (19 U.S.C. § l337(j)) and the Presidential Memorandum for the
United States Trade Representative of July 21, 2005 (70 Fed. Reg. 43,251), from the
day after this Order is received by the United States Trade Representative until such
time as the United States Trade Representative notifies the Commission that this
Order is approved or disapproved but, in any event, not later than sixty (60) days after
the date of receipt of this Order. All entries of covered products made pursuant to
this paragraph are to be reported to U.S. Customs and Border Protection (“CBP”), in
2This “documented need” is to be satisfied by the questionnaire attached to this Order, as discussed
at pages 84-86 of the Commission Opinion issued in this investigation on the date of this Order.
Bio-Rad is not required to maintain the individual researchers’ records supporting the
questionnaire. Commission Opinion, at 85-86. 	'
3

advance of the date of the entry, pursuant to procedures CBP establishes.
At the discretion of CBP and pursuant to procedures that it establishes, persons
seeking to import microfluidic systems and components thereof and products
containing same that are potentially subject to this Order may be required to certify
that they are familiar with the terms of this Order, that they have made appropriate
inquiry, and thereupon state that, to the best of their knowledge and belief, the
products being imported are not excluded from entry under paragraph 1 of this Order.
At its discretion, CBP may require persons who have provided the certification
described in this paragraph to furnish such records or analyses as are necessary to
substantiate the certification.
In accordance with 19 U.S.C. § 1337(1), the provisions of this Order shall not apply
to covered products that are imported byand for the use of the United States, or
imported for, and to be used for, the United States with the authorization or consent
of the Govermnent.
The Commission may modify this Order in_accordancewith the procedures described
in Rule 210.76 of the Commissi0n’s Rules of Practice and Procedure (19 C.F.R.
§ 210.76).
The Secretary shall serve copies of this Order upon each party of record in this
4

Investigation and upon CBP.
8. Notice of this Order shall be published in the Federal Register.
By order of the Commission.
Issued: February 12, 2020
Lisa R. Barton
Secretary to the Commission

ATTACHMENT
.

Name:
Institution: .
If you were conducting research using Bio-Rad’s ddSEQ consumables as of February 12,
2020, in the United States and you need to continue to receive the ddSEQ consumables for that
research, answer the following questions:
1. What is the subject matter of your research that uses Bio-Rad’s ddSEQ system and
consumables?
2. On what date (mm/dd/yyyy) did your research using these Bio-Rad systems begin?
3. What is the expected completion date (mm/dd/yyyy) of your research that uses these Bio
Rad systems?
4. What other competing products did you consider for your research, and why did you
. reject these products? 	"

I certify that all information provided as part of this questionnaire is accurate and
complete to the best of my knowledge. I am aware that U.S. law (including, but not limited to,
18 U.S.C. § 1001) imposes criminal sanctions on individuals who knowingly and willfully make
material false statements to the U.S. Government.
I acknowledge that I am to maintain records supporting the above declarations and am
not to provide those supporting records to Bio-Rad. If the facts change conceming‘my research,
which began on or before February 12, 2020, l understand that I am to provide an updated
questionnaire response to Bio-Rad.
Date: 	Signature:
2

Additional Bio-Rad comments [to be completed by Bio-Rad]:
1
I certify that all infonnation provided as part of this questionnaire is accurate and
complete to the best of my knowledge. I am aware that U.S. law (including, but not limited to, 18
U.S.C. 1001) imposes criminal sanctions on individuals who knowingly and willfully make
material false statements to the U.S. Government. 	"
Date: 	Signature:
3

CERTAIN MICROFLUIDIC SYSTEMS AND 	Inv. No. 337-TA-1100
COMPONENTS THEREOF AND PRODUCTS
CONTAINING SAME
PUBLIC CERTIFICATE OF SERVICE
I, Lisa R. Barton, hereby certify that the attached COMMISSION ORDER has been
served by hand upon the Commission Investigative Attorney, Monica Bhattacharyya, Esq., and
the following parties as indicated, on February 12, 2020.
Lisa R. Barton, Secretary
U.S. International Trade Commission
500 E Street, SW, Room 112
Washington, DC 20436
On Behalf of Complainants 10X Genomics. Inc.:_
Paul T. Ehrlich 	[:1Via Hand Delivery
TENSEGRITY LAW GROUP LLP 	Via Express Delivery
555 TWIII DOlpl1ll'1DI‘., Suite 650 	U Via First Class
Redwood Shores, CA 94061 	E] ‘Other:
On Behalf of Respondents Bio-Rad Laboratories. Inc.:
S. Alex Lasher 	II] Via Hand Delivery
QUINN EMANUEL URQUHART & SULLIVAN, LLP 	Via Express Delivery
I300 I S1166!NW, SLIIIC900 	E] Via First Class
Washington, DC 20005 	_	El Other.

UNITED STATES INTERNATIONAL TRADE COMMISSION
Washington, D.C.
In the Matter of
Investigation No. 337-TA-1100
CERTAIN MICROFLUIDIC SYSTEMS
AND COMPONENTS THEREOF AND
PRODUCTS CONTAINING SAME
CEASE AND DESIST ORDER
IT IS HEREBY ORDERED THAT Bio-Rad Laboratories, Inc. of Hercules, California
cease and desist from conducting any of the following activities in the United States: importing,
selling, marketing, advertising, distributing, transferring (except for exportation), and soliciting
U.S. agents or distributors for, or aiding and abetting other entities in the importation, sale for
importation, sale after importation, transfer (except for exportation), or distribution of
microfluidic systems and components thereof and products containing same covered by one or
more of claims 1, 5, 17, 19, and 22 of U.S. Patent No. 9,689,024 (“the ’024 patent”); claims 1, 6,
7, 9, and 21 of U.S. Patent No. 9,695,468 (“the ’468 patent”); and claims 1, 4, 11, 14, 19, 26, and
28 of U.S. Patent No. 9,856,530 (“the ’530 patent”) in violation of Section 337 of the Tariff Act
of 1930, as amended (19 U.S.C. § 1337).
I.
Definitions _
As used in this order:
(A) “Commission” shall mean the United States International Trade Commission.
(B) “Complainant” shall mean 10X Genomics, Inc. of Pleasanton, California. .

(C) “Respondent” shall mean Bio-Rad Laboratories, Inc., of Hercules, Califomia.
_ (D) “Person” shall mean an individual, or any non-governmental partnership, firm,
association, corporation, or other legal or business entity other than Respondent or
its majority owned or controlled subsidiaries, successors, or assigns.
(E) “United States” shall mean the fifty States, the District of Columbia, and Puerto
/
Rico.
(F) The terms “import” and “importation” refer to importation for entry for
consumption under the Customs laws of the United States.
(G) The term “covered products” shall mean microfluidic systems and components
thereof and products containing same that infringe one or more of claims 1, 5, 17,
19, and 22 of the ’024 patent; claims 1, 6, 7, 9, and 21 of the ’468 patent; and
3
claims 1, 4, 11, 14, 19, 26, and 28 of the ’530 patent.‘ “Covered products” shall
not include articles for which a provision of law or license avoids liability for
infringement of all asserted claims of the Asserted Patents.
(H) The tenn “consumable” means any otherwise covered Bio-Rad part or material
that is purchased for use with Bio-Rad’s droplet generation instruments and which
is consumed during the use of those instruments. For example, Bio-Rad’s
microfluidic chips are consumables.
11- 	,
Applicability
The provisions of this Cease and Desist Order shall apply to Respondent and to any of its
principals, stockholders, officers, directors, employees, agents, distributors, controlled (whether
' For purposes of this Order, “covered products” includes products for which associated conduct
and/or inventory is pennitted based on a documented need.
2

by stock ownership or otherwise) and majority-owned business entities, successors, and assigns,
and to each of them, insofar as they are engaging in conduct prohibited by section III, infia, for,
with, or otherwise on behalf of, Respondent.
III.
Conduct Prohibited
The following conduct of Respondent in the United States is prohibited by this Order. For
the remaining term of one of the ’024, ’468, and ’530 patents, Respondent shall not:
(A) import, sell for importation into the United States, or sell after importation covered
products;
(B) market, distribute, offer to sell, or otherwise transfer (except for exportation) in the
United States imported covered products;
(C) advertise imported covered products;
(D) solicit U.S. agents or distributors for imported covered products; or
(E) aid or abet other entities in the importation, sale for importation, sale after
importation, transfer, or distribution of imported covered products.
IV.
Conduct Permitted
Notwithstanding any other provision of this Order, specific conduct otherwise prohibited
by the terms of this order shall be permitted if: (1) in a written instrument, the owner of the ’024,
’468, and ’530 patents licenses or authorizes such specific conduct; (2) the conduct is limited to
service or repair articles imported for use in servicing or repairing microfluidic systems that were
imported as of the date of this Order and are under a warranty that existed as of the date of this
Order, if such servicing or repairing is provided for in terms of the warranty; or (3) such specific
conduct is related to the importation or sale of covered products by or for the United States. This
Order does not prohibit the importation or sale of covered microfluidic consumables for use by
3

researchers who are using such consumables in the United States as of the date of the issuance of
this Order, and who have a documented needz to continue receiving the consumables for a
specific current ongoing research project for which that need cannot be met by any altemative
product.
V.
Reporting
For purposes of this requirement, the reporting periods shall commence on the first day of
each calendar month and shall end on the last day of each calendar month. The first report
required under this section shall cover the period from the date of issuance of this order through
the last day of that calendar month.
Within five (5) days of the last day of each month’s reporting period, Respondentshall
report to the Commission: (a) the quantity in units and the value in dollars of covered products
that it has (i) imported and/or (ii) sold in the United States after importation during the reporting
period, (b) the quantity in units and the value in dollars of covered products imported and/or sold
for use in each research project for which there is a documented need pursuant to Section IV and
the identity of each spch purchaser, (c) questiormaires3 from each such purchaser supporting the
documented need pursuant to Section IV, and (d) the quantity in units and value in dollars of
reported covered products that remain in inventory in the United States at the end of the
reporting period.
When filing written submissions, Respondent must file the original document
1This “documented need” is to be satisfied by the questionnaire attached to this Order, as discussed
at pages 84-86 of the Commission Opinion issued in this investigation on the date of this Order.
Bio-Rad is not required to maintain the individual researchers’ records supporting the
questionnaire. Commission Opinion, at 85-86.
3 See Footnote 2.
4

1
electronically on or before the deadlines stated above and submit eight (8) true paper copies to
the Office of the Secretary by noon the next day pursuant to section 2l0.4(t) of the
Commission’s Rules of Practice and Procedure (19 C.F.R. § 21O.4(f)). Submissions should refer
to the investigation number (“Inv. No. 337-TA-1100”) in a prominent place on the cover pages
and/or the first page. (See Handbook for Electronic Filing Procedures, 	_
https://www.usitc.gov/documenls/handbo0k_0njilingJ2rocedures.paf). Persons with questions
regarding filing should contact the Office of the Secretary (202-205-2000). If Respondent
desiresto submit a document to the Commission in confidence, it must file the original and a
public version of the original with the Office of the Secretary and must serve a copy of the
confidential version on Complainant’s counse1.4‘
Any failure to make the required report or the filing of any false or inaccurate report shall
constitute a violation of this Order, and the submission of a false or inaccurate report may be
referred to the U.S. Department of Justice as a possible criminal violation of 18 U.S.C. § 1001.
' 	VI.
Recordkeeping and Inspection
(A) For the purpose of securing compliance with this Order, Respondent shall retain any
and all records relating to the sale, offer for sale, marketing, or distribution in the
United States of covered products, made and received in the usual and ordinary
course of business (including docmnents related to the documented need to continue
receiving consumables for a specific current ongoing research project provided in
Section IV), whether in detail or in summary form, for a period of three (3) years
4 Complainant must file a letter with the Secretary identifying the attorney to receive reports
associated with this order. The designated attorney must be on the protective order entered in the
investigation. ‘ V
5

from the close of the fiscal year to which they pertain. "
(B) For the purposes of determining or securing compliance with this Order and for no
other purpose, subject to any privilege recognized by the federal courts of the United
States, and upon reasonable written notice by the Commission or its staff, duly
authorized representatives of the Commission shall be permitted access and the right
to inspect and copy, in Respondent’s principal office during office hours, and in the
presence of counsel or other representatives if Respondent so chooses, all books,
ledgers, accounts, correspondence, memoranda, and other records and documents, in
detail and in smnmary fonn, that must be retained under subparagraph VI(A) of this
Order.
VII.
Service of Cease and Desist Order
Respondent is ordered and directed to: _
(A) Serve, within fifteen days after the effective date of this Order, a copy of this Order
upon each of its respective officers, directors, managing agents, agents, and
employees who have any responsibility for the importation, marketing, distribution,
sale of imported covered products in the United States;
(B) Serve, within fifteen days after the succession of any persons referred to in
subparagraph VIl(A) of this order, a copy of the order upon each successor; and
(C) Maintain such records as will show the name, title, and address of each person upon
whom the order has been served, as described in subparagraphs VII(A) and VII(B)
of this order, together with the date on which service was made.
The obligations set forth in subparagraphs VII(B) and VII(C) shall remain in effect until
the expiration dates of the ’O24,’468, and ’530 patents.
6

VIII.
Confidentiality
\
Any request for confidential treatment of information obtained by the Commission
pursuant to section V—VIof this order should be made in accordance with section 201.6 of the
Commission’s Rules of Practice and Procedure (19 C.F.R. § 201.6). For all reports for which
confidential treatment is sought, Respondent must provide a public version of such report with
confidential information redacted.
V IX.
Enforcement
Violation of this order may result in any of the actions specified in section 210.75 of the
Commission’s_Rules of Practice and Procedure (19 C.F.R. § 210.75), including an action for
civil penalties under section 337(f) of the Tariff Act of 1930 (19 U.S.C. § 1337(f)), as well as
any other action that the Connnission deems appropriate. In determining whether Respondent is
in violation of this order, the Commission may infer facts adverse to Respondent if it fails to
provide adequate or timely information.
X.
Modification
r The Commission may amend this order on its own motion or in accordancewith the
procedure described in section 210.76 of the Commission’s Rules of Practice and Procedure (19
C.F.R. § 210.76).
XI.
Bonding
The conduct prohibited by Section III of this Order may be continued during the sixty
day period in which this Order is under review by the United States Trade Representative, as
delegated by the President (70 Fed. Reg. 43,251 (Jul. 21, 2005)) subject to the Respondent’s
posting of a bond in the amount of twenty-five (25) percent of the entered value of the covered
7

products. This bond provision does not apply to conduct that is otherwise pennitted by section
IV of this order. Covered products imported on or after the date of issuance of this order are
subject to the entry bond set forth in the exclusion order issued by the Commission, and are not
subject to this bond provision. 	.
The bond is to be posted in accordance with the procedures established by the
Commission for the posting of bonds by complainants in connection with the issuance of
temporary exclusion orders. See 19 C.F.R. § 210.68. The bond and any accompanying
documentation are to be provided to and approved by the Commission prior to the
commencement of conductthat is otherwise prohibited by section Ill of this Order. Upon the
Secreta1y’s acceptance of the bond, (a) the Secretary will serve an acceptance letter on all
parties, and (b) Respondent must serve a copy of the bond and any accompanying documentation
on Complainanfs counsel.5 	'
The bond is to be forfeited in the event that the United States Trade Representative
approves this Order (or does not disapprove it within the review period), unless the U.S. Court of
Appeals for the Federal Circuit, in a final judgment, reverses any Commission final
determination and order as to Respondent on appeal, or unless Respondent exports or destroys
the products subject to this bond and provides certification to that effect that is satisfactory to the
Commission.
5See Footnote 4.
8

The bond is to be released in the event the United States Trade Representative
disapproves this order and no subsequent order is issued by the Commission and approved (or
not disapproved) by the United States Trade Representative, upon service on Respondent of an
order issued by the Commission based upon application therefore made by Respondent to the
Commission.
By order of the Commission.
Lisa R. Barton
Secretary to the Commission
Issued: February 12, 2020
I
I
9

ATTACHMENT

Name:
Institution:
If you were conducting research using Bio-Rad’s ddSEQ consumables as of February 12,
2020, in the United States and you need to continue to receive the ddSEQ constunables for that
research, answer the following questions:
1. What is the subject matter of your research that uses Bio-Rad’s ddSEQ system and
consumables?
2. On what date (mm/dd/yyyy) did your research using these Bio-Rad systems begin?
3. What is the expected completion date (mm/dd/yyyy) of your research that uses these Bio
Rad systems?
4. What other competing products did you consider for your research, and why did you
reject these products?

I certify that all infomiation provided as part of this questionnaire is accurate and
complete to the best of my knowledge. I am aware that U.S. law (including, but not limited to,
18 U.S.C. 1001) imposes criminal sanctions on individuals who knowingly and willfully make
material false statements to the U.S. Govemment.
I acknowledge that I am to maintain records supporting the above declarations and am
not to provide those supporting records to Bio-Rad. If the facts change concerning my research
which began on or before February I2, 2020, I understand that I am to provide an updated V
questionnaire response to Bio-Rad.
Date: 	Signature:
2

Additional Bio-Rad comments [to be completed by Bio-Rad]:
I certify that all information provided as part of this questionnaire is accurate and
complete to the best of my knowledge. I am aware that U.S. law (including, but not limited to, 18
U.S.C. 1001) imposes criminal sanctions on individuals who knowingly and willfully make
material false statements to the U.S. Government.
Date: 	Signature:
3

CERTAIN MICROFLUIDIC SYSTEMS AND 	Inv. N0. 337-TA-1100
COMPONENTS THEREOF AND PRODUCTS
CONTAINING SAME
PUBLIC CERTIFICATE OF SERVICE
I, Lisa R. Barton, hereby certify that the attached COMMISSION ORDER has been
served by hand upon the Commission Investigative Attomey, Monica Bhattacharyya, Esq., and
the following parties as indicated, on February 12, 2020.
7%Lisa R. Barton, Secretary
U.S. Intemational Trade Commission
500 E Street, SW, Room 112
Washington, DC 20436
On Behalf of Complainants 10X Genomics. Inc.:
Paul T. Ehrlich 	El Via Hand Delivery
TENSEGRITY LAW GROUP LLP 	Vie Express Delivery
555 Twin Dolphin Dr., Suite 650 	U Via First Class Mail
Redwood Shores, CA 94061 	U other
On Behalf of Respondents Bio-Rad Laboratories. Inc.:
5- AIBXLasher 	El Via Hand Delivery
QUINN EMANUEL URQUHART & SULLIVAN, LLP 	Via Express Delivery O
I SllffifitNW, Suite 	U First Class
Washington, DC 20005 	U other _

PUBLIC VERSION
UNITED STATES INTERNATIONAL TRADE COMMISSION
Washington, D.C.
In the Matter of
CERTAIN MICROFLUIDIC SYSTEMS
AND COMPONENTS THEREOF AND
PRODUCTS CONTAINING SAME
Investigation No. 337-TA-1100
COMMISSION O PINION
I. 	Introduction ....................................................................................................................... 1
II. 	Background ....................................................................................................................... 1
A. 	Procedural History ...................................................................................................1
B. 	Overview of the Technology ...................................................................................4
C. 	Products at Issue ......................................................................................................5
III. 	The ’024 Patent ................................................................................................................. 7
A. 	Construction of “Amplification” and the Effect on
Infringement .............................................................................................................8
B. 	Validity: Disclosure of “Porous Gel Beads” in the Prior Art ................................17
IV. 	The ’468 Patent ............................................................................................................... 21
A. 	Construction of “Amplification” and the Effect on
Infringement and Domestic Industry .....................................................................22
B. 	Validity ..................................................................................................................22
V. 	The ’204 Patent ............................................................................................................... 23
A. 	Literal Infringement ...............................................................................................24
B. 	Doctrine of Equivalents .........................................................................................35
VI. 	The ’530 Patent ............................................................................................................... 42
A. 	Background ............................................................................................................42
B. 	“wherein said barcode molecules become detached from
said gel bead.” ........................................................................................................44
C. 	Infringement of Dependent Claim 26 ....................................................................58
D. 	Contributory Infringement .....................................................................................59
E. 	Indefiniteness .........................................................................................................59
VII. 	Inventorship..................................................................................................................... 70

PUBLIC VERSION
ii
VIII. 	Ownership........................................................................................................................ 71
IX. 	Clerical Error .................................................................................................................. 78
X. 	Remedy............................................................................................................................. 79
A. 	Limited Exclusion Order........................................................................................80
B. 	Cease and Desist Order ..........................................................................................89
XI. 	Bond ................................................................................................................................. 91
XII. 	Public Interest ................................................................................................................. 95
A. 	Public Health and Welfare .....................................................................................97
B. 	Competitive Conditions in the United States Economy ........................................99
C. 	Production of Like or Directly Competitive Articles in the
United States ........................................................................................................100
D. 	United States Consumers .....................................................................................105
E. 	Commission Determination on Public Interest ....................................................106
XIII. 	Conclusion ..................................................................................................................... 106

PUBLIC VERSION
I. 	I NTRODUCTION
On October 17, 2019, the Commission determined to review portions of the Administrative
Law Judge’s (“ALJ”) final initial determination, which issued on July 12, 2019. 	84 Fed. Reg.
56835 (Oct. 23, 2019). 	On review, the Commission has determined that respondent Bio-Rad
Laboratories, Inc. of Hercules, CA (“Bio-Rad” or “Respondent”) violated section 337 of the Tariff
Act of 1930, 19 U.S.C. § 1337, as amended (“Section 337”), by way of infringement of certain
claims of U.S. Patent No. 9,689,024 (“the ’024 patent”), U.S. Patent No. 9,695,468 (“the ’468
patent”), and U.S. Patent No. 9,856,530 (“the ’530 patent”). The Commission has also determined
that there is no violation with respect to U.S. Patent No. 9,644,204 (“the ’204 patent”). The
Commission has determined to issue a limited exclusion order (“LEO”) and a cease and desist
order (“CDO”) against Bio-Rad. The Commission has further determined that during the period of
Presidential review, a bond in the amount of twenty-five (25) percent of entered value shall be
applied to Bio-Rad’s covered products.
II. 	B ACKGROUND
A. 	Procedural History
On February 21, 2018, the Commission instituted this investigation based on a complaint
filed by 10X Genomics, Inc. of Pleasanton, California (“10X” or “Complainant”). 83 Fed. Reg.
7491 (Feb. 21, 2018). The complaint, as supplemented, alleges violations of Section 337, in the
importation into the United States, the sale for importation, or the sale within the United States
after importation of certain microfluidic systems and components thereof and products containing
same by reason of infringement of one or more claims of the ’204 patent; the ’024 patent; the ’468
patent; and the ’530 patent. Id. The Commission’s notice of investigation named Bio-Rad as the
sole respondent. 	Id. 	The Office of Unfair Import Investigations (“OUII”) participated in this
investigation. Id.

PUBLIC VERSION

The ALJ granted 10X’s unopposed motion for summary determination that it has satisfied
the economic prong of the domestic industry requirement. Order No. 19 at 5 (Oct. 5, 2018),
unreviewed, Notice (Nov. 6, 2018). The ALJ also terminated the investigation with respect to
several patent claims. Order No. 26 at 2 (Nov. 30, 2018), unreviewed, Notice (Dec. 20, 2018):
Order No. 27 at 2 (Dec. 10, 2018), unreviewed, Notice (Dec. 21, 2018).

From March 25 to 29, 2019, an evidentiary hearing was held in this investigation. At the

hearing, 10X asserted the following claims against Bio-Rad:

Patent Asserted Claims

°024 Patent Claims 1, 5, 17, 19, 22

°204 Patent Claims 27, 29, 31, 33

°468 Patent Claims 1, 6, 7, 9, 21

°530 Patent Claims 1, 4, 11, 14, 19, 26, 28

See ID at 16-17, 58, 70, 89; see also 10X Posthearing Br. at 4.

On July 12, 2019, the ALJ issued her final initial determination (“ID”) on violation. The
ID found that Bio-Rad imported into the United States, sold for importation, or sold within the
United States after importation “the accused microfluidic systems and components thereof and
products containing same.” ID at 154. The ID found that Bio-Rad indirectly infringed all of the
remaining asserted claims of the ’024, ’468, and ’530 patents, but that 10X had not established
that Bio-Rad infringed any asserted claims of the ’204 patent. Jd. The ID found that Bio-Rad
failed to establish invalidity of any of the asserted claims of any patent. Jd. The ID found that the
domestic industry requirement was satisfied for each of the asserted patents. Jd. at 154-55.
Finally, the ID found that Bio-Rad had not carried its burden with respect to various additional
affirmative defenses, including improper inventorship and ownership. Jd. at 155. Thus, the ID
concluded that Bio-Rad violated Section 337 with respect to the 024, ’468, and ’530 patents, but

not with respect to the ’204 patent. Jd. at 154.

PUBLIC VERSION
3
On July 25, 2019, the ALJ issued her recommended determination on remedy and bonding
(“RD”). The RD recommended issuance of a limited exclusion order upon a finding of violation,
without a certification provision. RD at 1–2. The RD further recommended issuance of a cease
and desist order. Id. at 2–3. The RD also recommended imposition of a bond of twenty-five (25)
percent of the entered value of any covered products during the Presidential review period. Id. at
3–5. On July 29, 2019, 10X, Bio-Rad, and OUII submitted petitions seeking review of the ID.1
On August 6, 2019, 10X, Bio-Rad, and OUII submitted responses to the others’ petitions.2
On October 17, 2019, the Commission issued a notice of its determination to review the
ID in part. Particularly, the Commission determined to review the ID with respect to:
(1) all findings related to a violation based on the ’024 patent; (2) all findings related
to a violation based on the ’468 patent; (3) noninfringement of the ’204 patent; (4)
all findings related to a violation based on the ’530 patent; (5) Bio-Rad’s
inventorship and ownership defenses; and (6) a typographical error on page 91.
84 Fed. Reg. 56835. The Commission also requested briefing on multiple issues. Id.
1 Complainant 10X Genomics, Inc.’s Petition for Review of the Initial Determination (July 29,
2019) (“10X Pet.”); Respondent Bio-Rad Laboratories, Inc.’s Petition for Review of the Initial
Determination on Violation of Section 337 (July 30, 2019) (“Bio-Rad Pet.”); Petition of the Office
of Unfair Import Investigations for Review of the Initial Determination on Violation of Section
337 (July 29, 2019) (“OUII Pet.”).
2 Complainant 10X Genomics, Inc.’s Response to Respondent Bio-Rad Laboratories, Inc.’s
Petition for Review of the Initial Determination on Violation of Section 337 (Aug. 6, 2019) (“10X
Resp. to Bio-Rad Pet.”); Complainant 10X Genomics, Inc.’s Response to Petition of the Office of
Unfair Import Investigations Petition for Review of the Initial Determination on Violation of
Section 337 (Aug. 6, 2019) (“10X Resp. to OUII Pet.”); Respondent Bio-Rad Laboratories, Inc.’s
Combined Response to 10X’s and the Office of Unfair Import Investigations’ Petitions for Review
of the Initial Determination (Aug. 6, 2019) (“Bio-Rad Resp. to Pets.”); The Office of Unfair Import
Investigations’ Combined Response to Petitions for Review of the Initial Determination on
Violation of Section 337 (Aug. 6, 2019) (“OUII Resp. to Pets.”).

PUBLIC VERSION
4
On October 31, 2019, the parties filed their respective responses to the Commission’s
questions on review.3 On November 7, 2019, the parties filed their respective replies.4
B. 	Overview of the Technology
The 	technology 	at 	issue 	in 	this 	investigation 	relates 	to 	methods 	of 	preparing
deoxyribonucleic acid (“DNA”) and ribonucleic acid (“RNA”) samples for genetic sequencing and
analysis. 	Particularly, the technology seeks to preserve certain information about nucleic acid
segments that would otherwise be lost during sequencing, e.g., whether two nucleic acid segments
originated from the same source. This is accomplished by tagging nucleic acid segments, prior to
sequencing, with oligonucleotide “barcodes.”5 These barcodes allow researchers to later identify
nucleic acid segments that originated from a common sample. 	The barcoding process involves
partitioning nucleic acids from a sample into droplets along with single gel beads to which
oligonucleotide barcodes are attached. The barcodes are released from the gel beads and combined
with the nucleic acids. 	At that point, the nucleic acids in each droplet bear a unique barcode.
Those nucleic acids can then be pooled and sequenced, and it will still be possible to associate
nucleic acid segments from a common droplet. 	The partitioning of nucleic acids and gel beads
3 Complainant 10X Genomics, Inc.’s Opening Written Submission Regarding the Commission’s
October 17, 2019 Notice (Oct. 31, 2019) (“10X Resp. to Qs.”); Respondent Bio-Rad Laboratories,
Inc.’s Opening Submission Responding to the Commission’s Notice Dated October 17, 2019 (Oct.
31, 2019) (“Bio-Rad Resp. to Qs.”); The Office of Unfair Import Investigations’ Responses to the
Commission’s October 17, 2019 Questions (Oct. 31, 2019) (“OUII Resp. to Qs.”).
4 Complainant 10X Genomics, Inc.’s Reply Written Submission Regarding the Commission’s
October 17, 2019 Notice (Nov. 7, 2019) (“10X Reply”); Respondent Bio-Rad Laboratories, Inc.’s
Combined 	Reply to 10X’s and the Office of Unfair Import Investigations’ Response to the
Commission Notice Dated October 17, 2019 (Nov. 7, 2019) (“Bio-Rad Reply”); The Office of
Unfair Import 	Investigations’ Reply to the Private Parties’ Responses to the Commission’s
October 17, 2019 Questions (Nov. 7, 2019) (“OUII Reply”).
5 A “barcode” is a short DNA sequence of 3–12 DNA bases. See Bio-Rad Prehearing Br. at 8.

PUBLIC VERSION
5
into droplets is accomplished with microfluidic systems that rely on small channels to combine
streams of nucleic acids and gel beads into droplets. 	The asserted claims that remain in this
investigation are directed to various aspects of this barcoding process.
C. 	Products at Issue
The accused products are components and assays of Bio-Rad’s ddSEQ system, which
includes ddSEQ version 1 and version 2. ID at 3. The ID explained that the ddSEQ v1 products
include Bio-Rad’s ddSEQ v1 Cartridge, ddSEQ v1 Single-Cell Isolator, ddSEQ Cartridge Holder,
and consumables and assays used with and/or as part of Bio-Rad’s ddSEQ v1 system, including
the SureCell WTA 3’ v1 assay. 	Id. (citing CX-0004C (Butte DWS) at Q/A 54; RX-0665C
(Metzker RWS) at Q/A 29). 	The ddSEQ v2 products include
, scATACseq, 	. Id. 10X provided the following image
of the ddSEQ v1 Single-Cell Isolator and WTA 3’ library prep kit products:

PUBLIC VERSION
6
See CX-1485C (product launch announcement); CDX-2 at 22 (reproducing CX-1485C).
The domestic industry products are 10X’s GemCode™ and Chromium™ product lines.
Id. at 3. The ID explained that these products were developed by 10X based on its GEM (“Gel
bead in Emulsion”) architecture, and the first GemCode™ product was sold in 2015. Id. (citing
CX-0003C at Q/A 47-52). The domestic industry products include both single-cell and linked-read
applications, including the Chromium™ Single Cell 3’ Solution, Chromium™ Single Cell V(D)J
Solution, and GemCode™ Single Cell platform, and the Chromium™ Genome Solution,
Chromium™ Exome Solution, Chromium™ de nova Assembly Solution, and GemCode™ Long
Read platform. Id. 10X provided the following image of its domestic industry products:

PUBLIC VERSION
7
See CDX-2 at 80 (reproducing images from 10X’s website).
III. 	T HE ’024 PATENT
The Commission determined to review all of the ID’s findings related to the ’024 patent.
84 Fed. Reg. 56835. 	On review, the Commission has determined to affirm with modified
reasoning the ID’s finding that Bio-Rad has violated section 337 based on infringement of the ’024
patent. 	Specifically, the Commission finds that Bio-Rad failed to raise the location of
amplification as a basis for noninfringement in its petition for review and has therefore abandoned
that argument. 	The Commission further finds that the ’024 patent is infringed regardless of
whether the claim term “amplification” encompasses reverse transcription, and therefore the
Commission need not resolve that dispute as it will not have a material effect on the outcome of
this investigation. Concerning invalidity, the Commission affirms the ID’s finding that Bio-Rad
has not established that any of the asserted claims are invalid under modified reasoning. 	The
Commission adopts the remainder of the ID’s findings with respect to the ’024 patent to the extent
they are not inconsistent with this opinion.

PUBLIC VERSION
8
For reference, claim 1 of the ’024 patent follows:
1. 	A method for sample preparation, comprising:
a) 	providing a droplet comprising a porous gel bead and a target nucleic acid
analyte, wherein said porous gel bead comprises at least 1,000,000
oligonucleotide molecules comprising barcode sequences, wherein said
oligonucleotide molecules are releasably attached to said porous gel bead,
wherein 	said 	barcode 	sequences 	are 	the 	same 	sequence 	for 	said
oligonucleotide molecules;
b) 	applying a stimulus to said porous gel bead to release said oligonucleotide
molecules from said porous gel bead into said droplet, wherein upon release
from said porous gel bead, a given oligonucleotide molecule from said
oligonucleotide molecules attaches to said target nucleic acid analyte; and
c) 	subjecting said given oligonucleotide molecule attached to said target
nucleic acid analyte to nucleic acid amplification to yield a barcoded target
nucleic acid analyte.
’024 patent at cl. 1 (emphasis added on contested terms).
A. 	Construction of “Amplification” and the Effect on Infringement
OUII petitioned 	for 	review 	of 	the ALJ’s 	construction 	of 	the term 	“nucleic acid
amplification,” which appears in asserted claim 1 of the ’024 patent and asserted claim 21 of the
’468 patent. See OUII Pet. at 18–26. Specifically, OUII asserted that the Markman order erred by
construing “nucleic acid amplification” such that “creation of a single complementary copy
through reverse transcription constitutes ‘amplification.’” 	Id. at 20. 	However, OUII also
acknowledged 	that 	whether 	“amplification” 	should 	be 	construed 	to 	encompass 	reverse
transcription may be immaterial to the ID’s ultimate conclusion that Bio-Rad violated section 337
based on infringement of the ’024 patent. See id. at 19 (“[T]his issue may not be material since,
under the proper construction, the ID’s ultimate violation holdings on [the ’024 and ’468] patents
are correct.”). 	OUII elaborated that “10X provided evidence of infringement and the technical
prong under both the broader construction adopted by the Court, as well as the narrower

PUBLIC VERSION
9
construction supported by OUII,” and noted that “the ID appeared to rely on 10X’s evidence under
both constructions, although the ID focused at times on reverse transcription.” Id. at 25.
10X disagreed with OUII’s assertion that the Markman order misconstrued “nucleic acid
amplification,” 10X Resp. to OUII Pet. at 7–13, but agreed that “under either the ALJ’s or Staff’s
proposed construction of ‘amplification,’ the findings of violation for the [’]024 and [’]468 Patents
are correct and should stand.” 	Id. at 13. 	Particularly, 10X asserted that because no party
challenged the ID’s infringement findings based on the construction of “amplification,” “[OUII]’s
challenge to one aspect of the claim construction will have no material effect and any error would
be harmless.” Id.
Bio-Rad did not petition for review of the Markman order’s construction of “nucleic acid
amplification.” See generally Bio-Rad Pet. Bio-Rad did petition for review of the ID’s finding
that the asserted claims of the ’024 and ’468 patents were infringed, but the arguments Bio-Rad
advanced in support of that aspect of its petition were based on entirely different limitations in the
claims. See Bio-Rad Pet. at 6–9, 27–33, 66–73. In its response to OUII’s petition, however, Bio-
Rad agreed with OUII that the Markman order misconstrued “amplification” to encompass reverse
transcription. See Bio-Rad Resp. to Pets. at 35–38.
Notwithstanding the fact that Bio-Rad did not petition for review of the construction of
“nucleic acid amplification,” it argued for the first time in its response to OUII’s petition that its
products do not infringe the ’024 patent “under the correct construction of the ‘amplification’
terms.” Bio-Rad Resp. to Pets. at 38. The noninfringement argument Bio-Rad laid out in support
of that assertion did not relate to whether “nucleic acid amplification” encompassed reverse
transcription, however. See id. at 38–40 (no discussion of reverse transcription). Rather, Bio-Rad
argued that “claim 1 of the ’024 Patent requires that amplification occur in the droplet,” and that

PUBLIC VERSION
10
the evidence does not show that amplification occurs in a droplet in Bio-Rad’s products. Id. at 39.
In making that argument, Bio-Rad revived a dispute decided in the Markman order — whether
amplification must occur in a droplet — for which no party sought review. See Order No. 22 at
44–45 (rejecting the same Bio-Rad argument and finding that “[t]he requirement that the ‘said
given oligonucleotide molecule attached to said target nucleic acid analyte’ be created in a droplet
in the second step does not mean that it has to remain in the droplet for all subsequent steps”).
Given the disagreement over the materiality of the construction of “amplification” as set
forth 	in 	OUII’s 	petition 	for 	review, 	and 	the 	apparent 	disconnect 	between 	Bio-Rad’s
noninfringement argument and the question of whether “amplification” encompasses reverse
transcription, the Commission sought briefing from the parties addressing those issues. 84 Fed.
Reg. 56836. 10X and OUII both responded that modifying the construction of “amplification” to
exclude reverse transcription would have no effect on the ID’s infringement findings because the
evidence of record shows other multiple types of amplification in the accused products, including
polymerase chain reaction (“PCR”), which would meet the definition of “amplification” even if
that term did not encompass reverse transcription. 10X Resp. to Qs. at 21–23; OUII Resp. to Qs.
at 13. Further, both 10X and OUII responded that whether “amplification” must occur in a droplet
and whether “amplification” encompasses reverse transcription are distinct issues and therefore
modifying the ID’s construction of “amplification” to exclude reverse transcription would not give
rise to a noninfringement finding based on the location where amplification occurs. See 10X Resp.
to Qs. at 23–24; OUII Resp. to Qs. at 14. Accordingly, both 10X and OUII responded that Bio-
Rad waived its noninfringement argument based on whether amplification must occur in a droplet.
10X Resp. to Qs. at 26–27; OUII Resp. to Qs. at 14–15.

PUBLIC VERSION
11
Bio-Rad responded that “[i]f amplification does not include reverse transcription, than [sic]
all but Bio-Rad’s scATACseq products do not infringe Claim 1 of the ’024 Patent or Claim 21 of
the ’468 Patent,” because reverse transcription is the only amplification reaction that occurs in a
droplet in Bio-Rad’s products. 	See Bio-Rad Resp. to Qs. at 28. 	We note that, by taking this
position, Bio-Rad expanded its previous noninfringement argument, which was limited to the ’024
patent. See Bio-Rad Resp. to Pets. at 38. Bio-Rad’s briefing in support of its position also included
a new argument not previously made in its petition or in response to the other parties’ petitions.
Particularly, Bio-Rad argued that the “said target nucleic acid analyte” in claim 1 of the ’024 patent
and claim 21 of the ’468 patent must be messenger RNA (“mRNA”), but that in proving
infringement 10X relied on complementary DNA (“cDNA”) to establish amplification of nucleic
acids outside a droplet. See Bio-Rad Resp. to Qs. at 29–31.
Concerning waiver, Bio-Rad responded that OUII’s petition preserved its noninfringement
argument. 	The crux of Bio-Rad’s position in this regard appears to be that by challenging one
aspect of the Markman order’s construction of “amplification” — whether “amplification”
encompasses reverse transcription — OUII’s petition opened the door for Bio-Rad (or 10X) to
challenge other aspects of that construction in its response to OUII’s petition. See id. at 31–33.
Bio-Rad also argued that the ID only relied on reverse transcription as the basis for its infringement
finding, and therefore, Bio-Rad was not required to specifically petition for review of whether its
products are infringing based on amplification outside the droplet. See id. at 33–34. Bio-Rad then
submitted that “[i]f the Commission determines that ‘amplification’ can occur outside of the
droplet, the Commission should remand to the ALJ to make specific findings on infringement
under that construction.” 	Id. at 34. 	Notably, notwithstanding the Commission’s request for
“citations to where this [amplification location] issue was raised in Bio-Rad’s prehearing brief,

PUBLIC VERSION
12
posthearing brief, and petition for review,” 84 Fed. Reg. 56836, Bio-Rad provides none in its
response to the Commission’s waiver question. See Bio-Rad Resp. to Qs. at 31–34.
The dispute regarding whether the term “nucleic acid amplification” encompasses reverse
transcription is immaterial to any issue in the investigation, and thus the Commission need not
resolve that dispute. As the Federal Circuit has explained, “only those terms need be construed
that are in controversy, and only to the extent necessary to resolve the controversy.” Vivid Techs.,
Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999). 	The Commission need not
resolve issues of claim construction that are not material to any issue in this investigation. 	See
Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Matal, 868 F.3d 1013, 1017 (Fed. Cir.
2017) (“[W]e need not construe the claim preambles here where the construction is not material to
the 	[obviousness] 	dispute.” 	(alteration 	in 	original) 	(internal 	quotation 	marks 	omitted));
EmeraChem Holdings, LLC v. Volkswagen Grp. of Am., Inc., 714 F. App’x 995, 997 (Fed. Cir.
2017) (unpublished) (declining to decide claim construction dispute “because the prior art would
anticipate the ’558 patent claims regardless of which construction we apply.”).
The dispute over whether “amplification” should encompass reverse transcription is
immaterial because, as noted in the ID, 10X pointed to four different reactions in the accused
products to satisfy the “amplification” limitation of claim 1 of the ’024 patent. See ID at 25–26
(“[Dr. Butte] further explains that barcoded cDNA strands are generated from the oligonucleotide
molecules through several different processes, which 10X identifies in its brief as four types of
amplification.”). 	One of the processes identified is PCR, which is explicitly listed as an
amplification reaction in the ’024 patent. See ’024 patent at 25:25–28 (“[O]ligonucleotide primers
containing bar code sequences may be used in amplification reactions (e.g., PCR, qPCR, reverse-
transcriptase PCR, digital PCR, etc.) of the DNA template analytes, thereby producing tagged

PUBLIC VERSION
13
analytes.”). Even Bio-Rad has acknowledged that PCR is a type of amplification reaction. See
Bio-Rad Initial Claim Construction Br. at 16 (listing evidence where PCR is described as an
amplification reaction). 	While 10X argued in its pre- and post-hearing briefs that PCR in the
accused products satisfied the “amplification” limitation in claim 1 of the ’024 patent, Bio-Rad did
not address whether the PCR relied on by 10X satisfied the “nucleic acid amplification” limitation.
Compare 10X Prehearing Br. at 33–35; 10X Initial Posthearing Br. at 24–26 with Bio-Rad
Posthearing Br. at 62–63 (disputing infringement of “amplification” limitation without addressing
PCR) and Bio-Rad Posthearing Reply at 12 (same). Instead, Bio-Rad limited itself to arguing that
“the oligonucleotide molecule containing the barcode that attaches to the target nucleic acid
analyte (mRNA) acts as a primer during the reverse transcription reaction,” and because “this
portion of the oligonucleotide molecule is not amplified in reverse transcription,” 10X could not
show that the accused products satisfy the “amplification” limitation. Bio-Rad Posthearing Br. at
62–63; see also Bio-Rad Posthearing Reply Br. at 12; Bio-Rad Prehearing Br. at 65–68. Bio-Rad
never challenged 10X’s assertion that the “amplification” limitation is satisfied by PCR. 	See
generally 10X Initial Posthearing Br. at 24–26.
Given Bio-Rad’s failure to present evidence or argument disputing 10X’s evidence and
argument that the “amplification” limitation is satisfied by PCR in the accused products, the
Commission affirms the ID’s finding that the accused products practice the “amplification”
limitation. 	A preponderance of the evidence supports that finding under the broad construction
applied in the ID, as well as under a narrow construction that excludes reverse transcription from
the definition of “amplification.” 	Accordingly, whether “amplification” should be construed to
encompass reverse transcription is not material to any issue in this investigation; the Commission

PUBLIC VERSION
14
need not resolve that question and takes no position on it. The Commission affirms the remainder
of the ID’s infringement findings with respect to the ’024 patent.6
With respect to the argument regarding whether amplification must occur in a droplet,
which Bio-Rad raised as a basis for noninfringement in its response to OUII’s petition, Bio-Rad
abandoned that argument and waived it by failing to raise it in its petition for review. Commission
Rule 210.43(b)(2) states that “[a]ny issue not raised in a petition for review will be deemed to have
been abandoned by the petitioning party and may be disregarded by the Commission in reviewing
the initial determination . . . and any argument not relied on in a petition for review will be deemed
to have been abandoned and may be disregarded by the Commission.” 19 C.F.R. § 210.43(b)(2).
Further, the ALJ’s Ground Rule 8.2 states that “[a]ny contentions not set forth in detail as required
herein shall be deemed abandoned or withdrawn, except for contentions of which a party is not
aware and could not be aware in the exercise of reasonable diligence at the time of filing the pre-
trial brief,” while Ground Rule 11.1 states that issues not raised in post-trial briefs “shall be deemed
waived.” See Order No. 2 (Ground Rules). During the Markman process, the ALJ resolved three
distinct disputes with respect to the meaning of “amplification” in the asserted patents. See Order
No. 22 at 31–45. 	Whether “amplification” encompassed reverse transcription was one dispute;
whether amplification must occur in a droplet was another. Compare id. at 31–41 with id. at 42–
6 The Commission notes that Bio-Rad did not assert in response to OUII’s petition that the ID’s
domestic industry findings would be affected by construing “amplification” to exclude reverse
transcription. See Bio-Rad Resp. to Pets. at 34–40. To avoid confusion, however, the Commission
finds that the ID’s determination that 10X satisfies the domestic industry requirement is supported
by a preponderance of the evidence regardless of whether “amplification” encompasses reverse
transcription. This is because, as with the accused products, 10X presented unrebutted evidence
that PCR in the domestic industry products satisfies the “amplification” limitation of claim 1 of
the ’024 patent. See 10X Posthearing Br. at 39 (citing CX-0004C at Q/A 278-279; CX-0481 at
11; CX-0542 at 1; CX-0579 at 1–2; CX-0578 at 15, 53). 	Accordingly, the Commission also
affirms the ID’s finding that 10X satisfied the domestic industry requirement with respect to the
’024 patent.

PUBLIC VERSION
15
45. 	The Markman order resolved both disputes — “amplification” is broad enough to include
reverse transcription and “amplification” need not occur only in a droplet. See Order 22 at 32–41,
44–45.
OUII petitioned for review of the Markman order’s conclusion on the reverse transcription
issue, see OUII Pet. at 18–26, but no party petitioned for review of the Markman order’s conclusion
on the location of amplification issue. Bio-Rad contends that it was entitled to raise the issue in
its response to OUII’s petition because OUII’s petition put the construction of “amplification” at
issue. See Bio-Rad Resp. to Qs. at 31–33. That line of reasoning, if accepted, necessarily implies
that by petitioning for review of one of the three issues regarding the construction of
“amplification,” OUII opened the door to review the other two issues as well, even though no party
petitioned for review of those issues. 	Commission Rule 210.43(b)(2) provides that “[a]ny issue
not raised” and “any argument not relied on” in a petition for review will be deemed abandoned.
Such is the case with Bio-Rad’s belated challenge to the Markman order’s resolution of whether
“amplification” must occur in a droplet. By withholding that argument until its response to OUII’s
petition, Bio-Rad precluded 10X and OUII from responding to that argument in their own petition
responses. There would be obvious prejudice to both if the Commission declined to enforce Rule
210.43(b)(2).
Finally, the Commission notes that the noninfringement argument Bio-Rad advances in its
response to the Commission’s questions bears little resemblance to the argument it raised in its
response to OUII’s petition. 	Indeed, the new argument raised in Bio-Rad’s response to the
Commission’s 	questions 	strongly 	suggests 	that 	even 	Bio-Rad 	understands 	that 	the
noninfringement argument it raised in its response to OUII’s petition is unrelated to the reverse
transcription issue. For example, Bio-Rad’s argument in its response to OUII’s petition relied on

PUBLIC VERSION
16
evidence from the Markman phase of this investigation to ultimately argue that “[t]he structure of
claim 1 of the ’024 Patent requires that amplification occur in the droplet. But 10X has presented
no evidence that amplification in the Bio-Rad Accused Products (i.e., PCR) occurs in the droplet
and, in fact, there is evidence that this step takes place after the droplets are broken.” 	Bio-Rad
Resp. to Pets. at 39–40. The success of that argument is contingent on a claim construction that
requires amplification to occur in a droplet such that the PCR in Bio-Rad’s products will not read
on the “amplification” limitation. 	As noted, Bio-Rad abandoned this argument by failing to
include it in its petition for review.
By contrast, in its responses to the Commission’s questions, Bio-Rad shifted its focus away
from claim construction. 	Instead, Bio-Rad argued that the subject of the “nucleic acid
amplification” limitation — “said given oligonucleotide molecule attached to said target nucleic
acid analyte” — “only exists in the droplet,” in Bio-Rad’s products. Bio-Rad Resp. to Qs. at 29
(internal quotations omitted). That argument relies on the assumption that the target nucleic acid
analyte is mRNA. See id. at 29–30. The argument fails to address, however, the fact that 10X did
not rely solely on amplification of mRNA to satisfy the “amplification” limitation. In two of the
four types of amplification 10X relied on, cDNA is the target nucleic acid analyte in both steps (b)
and (c) of claim 1 of the ’024 patent. See 10X Posthearing Br. at 24–25. As previously noted,
Bio-Rad’s posthearing briefing and evidence only addressed 10X’s infringement allegations that
relied on reverse transcription as the amplification reaction. Bio-Rad did not present evidence or
argument to counter 10X’s evidence and arguments that the amplification reaction is satisfied by
PCR. Accordingly, the Commission finds that Bio-Rad’s most recent noninfringement argument
does not change the fact that a preponderance of the evidence shows that the amplification step of
claim 1 of the ’024 patent is satisfied regardless of whether “amplification” encompasses reverse

PUBLIC VERSION
17
transcription. 	Moreover, because Bio-Rad raised this argument for the first time before the
Commission, it is also waived. See 19 C.F.R. § 210.43(b)(2).
The Commission notes that Bio-Rad’s response to OUII’s petition for review did not argue
that modifying the construction of “amplification” to exclude reverse transcription would alter the
ID’s conclusion that 10X satisfied the domestic industry requirement for any asserted patent, or
the ID’s conclusion that the ’468 patent is infringed. 	See BioRad Resp. to Pets. at 39–40.
Moreover, as OUII noted in its petition, 10X presented, and the ID identified, similar evidence
showing amplification through PCR in the context of the domestic industry products and
infringement of the ’468 patent. 	See OUII Pet. at 25–26; ID at 32, 63, 66. 	Accordingly, the
Commission also finds that whether “amplification” encompasses reverse transcription is
immaterial to those issues as well.
B. 	Validity: Disclosure of “Porous Gel Beads” in the Prior Art
Bio-Rad petitioned for review of the ID’s finding that the asserted claims of the ’024 patent
were not invalid as anticipated or obvious. Bio-Rad Pet. at 10–26. Like the ID, Bio-Rad’s petition
focused on two limitations in the asserted claims: 	(1) porous gel beads and (2) releasable
attachment of barcodes to those gel beads. 	See id. 	In Bio-Rad’s view, those limitations are
anticipated or rendered obvious by U.S. Patent No. 9,347,059 (JX-0031, “the ’059 patent”) and/or
U.S. Patent No. 9,902,950 (RX-0462, “the Church patent”). See id. On review, the Commission
has determined to affirm the ID’s finding that the asserted claims of the ’024 patent are not invalid
as anticipated or obvious with supplemented reasoning concerning the disclosure of “porous gel
beads” in the prior art.
First, Bio-Rad asserted that the ID erred by relying on (1) the ’059 patent’s description of
certain beads as “coated” and (2) the testimony of the inventor of the ’059 patent that he believed
he disclosed solid beads in the ’059 patent to conclude that the beads were solid as opposed to

PUBLIC VERSION
18
porous. See Bio-Rad Pet. at 10–11. However, even if those assertions of error are true, they would
not provide a basis to find an affirmative disclosure of porous gel beads in the ’059 patent. Bio-
Rad’s arguments are limited to criticizing evidence the ID relied on to support the conclusion that
the antibody-linked beads are solid, i.e., not porous. At best, Bio-Rad’s arguments may lead to the
conclusion that the composition of the antibody-linked beads is not disclosed in the ’059 patent.
However, Bio-Rad’s arguments do not show, by clear and convincing evidence, that the antibody-
linked beads of the ’059 patent are disclosed as being porous.
Second, with respect to Bio-Rad’s reliance on the Roche 454 sequencing technique listed
in the specification of the ’059 patent as disclosing the “porous gel bead” limitation, the
Commission notes that neither the ’059 patent itself, nor the publication by Margulies, et al., cited
in the ’059 patent in connection with the Roche 454 sequencing technique, disclose the use of
Sepharose beads with the technique. Both the ’059 patent and the Margulies paper are in evidence,
but neither mentions Sepharose beads. See JX-0031 (’059 patent); CX-1940 (Margulies, et al.).
Rather than acknowledge this lack of disclosure, Bio-Rad represented in its petition that “[t]he
undisputed testimony from 10X’s expert Dr. Dear is that Margulies describes the 454 beads as
being Sepharose.” Bio-Rad Pet. at 11 (citing Tr. at 869:21–870:4; JX-31 at 26:52–54). However,
the evidence Bio-Rad cites does not support its representation. 	The cited portion of Dr. Dear’s
evidentiary hearing testimony follows:
Q. 	Now the 454, beads, those are Sepharose beads; correct?
A. 	You mean the 454 sequencing beads?
Q. 	That’s correct.
A. 	Yes, I believe — at the time 454 was published, I believe they used
Sepharose beads. That’s the Margulies paper. Whether they did since in
their commercial instruments, I don’t know. But in the Margulies paper, I
believe they are Sepharose — Sepharose beads.

PUBLIC VERSION
19
Tr. at 869:21–870:4 (emphasis added). Dr. Dear did not testify that the Margulies paper describes
the 454 beads as being Sepharose beads. See id. He testified that he believed Sepharose beads
were used with the technique at the time Margulies was published. See id. The fact that one of
the expert witnesses in this investigation had a belief as to the particular type of bead used with
the Roche 454 sequencing technique by the authors of the Margulies paper does not lead to the
conclusion that the paper discloses the composition of those beads. Indeed, one need only review
the Margulies paper, which is in evidence, to see that Margulies does not discuss Sepharose beads.
See generally CX-1940. Moreover, Dr. Dear’s testimony falls short of establishing that persons
of ordinary skill in the art would understand Margulies to disclose the use of Sepharose beads. Cf.
Akamai Techs., Inc. v. Cable & Wireless Internet Servs., Inc., 344 F.3d 1186, 1192 (Fed. Cir. 2003)
(“[T]he dispositive question regarding anticipation is whether one skilled in the art would
reasonably understand or infer from the prior art reference’s teaching that every claim [limitation]
was disclosed in that single reference.”); Rosco v. Mirror Lite, 304 F.3d 1373, 1380 (Fed. Cir.
2002) (“[I]f an element is not expressly disclosed in a prior art reference, the reference will still be
deemed to anticipate a subsequent claim if the missing element is necessarily present in the thing
described in the reference, and that it would be so recognized by persons of ordinary skill.”
(internal quotation marks omitted)). In addition, his testimony does not indicate that Sepharose
beads must necessarily or inevitably be used with the Roche 454 technique, which would be
required to show inherent disclosure. 	See Akamai Techs., Inc., 344 F.3d at 1192 (“A claim
limitation is inherent in the prior art if it is necessarily present in the prior art, not merely probably
or possibly present.”).
The portion of the ’059 patent on which Bio-Rad relies is also inapposite to its position.
The cited portion of that patent merely provides that “[i]n some embodiments, the next generation

PUBLIC VERSION
20
sequencing technique is 454 sequencing (Roche) (see e.g., Margulies, M et al. (2005) Nature 437:
376-380).” JX-31 at 26:52–54. That statement does not support the conclusion that the Margulies
publication discloses the use of Sepharose beads with the Roche 454 sequencing technique. See
id.
Finally, the Commission notes, as did OUII, that the Roche 454 technique is a sequencing
technique as opposed to the sample preparation technique that is the subject of the asserted claims.
See OUII Resp. to Pets. at 7 (citing CX-1827C at Q/A 108–109). 	The ID makes that point
explicitly in its discussion of the releasable attachment limitation, see ID at 37 (citing CX-1827C
at Q/A 87, 108), but the Commission reiterates it here because it is equally applicable to the
“porous gel bead” limitation. Thus, nothing in the ’059 patent or the Margulies paper discloses
the porous gel beads of the asserted claims. Accordingly, neither reference anticipates the asserted
claims of the ’024 patent, all of which include limitations drawn to porous gel beads. Similarly,
neither reference can supply that limitation as part of a combination of prior art references to show
that the asserted claims are obvious.
Consistent with the supplemented reasoning above, the Commission affirms the ID’s
finding that the porous gel bead limitation is not disclosed in the prior art. The Commission further
affirms the remainder of the ID’s findings with respect to the validity of the ’024 patent to the
extent they are not inconsistent with the reasoning herein. Those findings include that the prior
art, including the Church patent, does not disclose porous gel beads with “releasably attached”
oligonucleotide molecules, and that the asserted claims are not rendered obvious by a combination
of prior art. Accordingly, the Commission affirms the ID’s finding that no asserted claim of the
’024 patent is invalid.

PUBLIC VERSION
21
IV. 	T HE ’468 PATENT
The Commission determined to review all of the ID’s findings related to a violation of
section 337 based on the ’468 patent. 	84 Fed. Reg. 56835. 	On review, the Commission has
determined to affirm with modified reasoning the ID’s finding that Bio-Rad has violated section
337 based on infringement of the ’468 patent. 	The Commission also affirms with modified
reasoning the ID’s findings that 10X satisfies the domestic industry requirement with respect to
the ’468 patent and that no asserted claim of the ’468 patent is invalid. The Commission adopts
the remainder of the ID’s findings with respect to the ’468 patent to the extent they are not
inconsistent with this opinion.
For reference, claims 1 and 21 of the ’468 patent follow:
1. 	A method for droplet generation, comprising:
(a) providing at least 1,000,000 oligonucleotide molecules comprising barcode
sequences, wherein said barcode sequences are the same sequence for said
at 	least 	1,000,000 	oligonucleotide 	molecules, 	wherein 	said 	at 	least
1,000,000 oligonucleotide molecules are releasably attached to a bead,
wherein said bead is porous;
(b) combining said at least 1,000,000 oligonucleotide molecules and a sample
comprising a nucleic acid analyte each in an aqueous phase at a first
junction of two or more channels of a microfluidic device to form an
aqueous mixture comprising said at least 1,000,000 oligonucleotide
molecules attached to said bead and said sample; and
(c) generating a droplet comprising said at least 1,000,000 oligonucleotide
molecules attached to said bead and said sample comprising said nucleic
acid analyte by contacting said aqueous mixture with an immiscible
continuous phase at a second junction of two or more channels of said
microfluidic device.
* 	* 	*
21. The method of claim 1, wherein subsequent to generating said droplet in (c), a
given 	oligonucleotide 	molecule 	of 	said 	at 	least 	1,000,000 	oligonucleotide
molecules 	attaches 	to 	said 	nucleic 	acid 	analyte, 	and 	wherein 	said 	given
oligonucleotide molecule attached to said given nucleic acid analyte is subjected to
nucleic acid amplification to yield a barcoded nucleic acid analyte.

PUBLIC VERSION
22
’468 patent at cls. 1, 21 (emphasis added on contested limitations).
A. 	Construction of “Amplification” and the Effect on Infringement and Domestic
Industry
As noted in the context of the ’024 patent, the Commission has determined to take no
position on whether “amplification” encompasses reverse transcription. As with the ’024 patent,
that issue is immaterial to the issue of whether Bio-Rad infringes the ’468 patent and 10X satisfies
the domestic industry requirement for the ’468 Patent because a preponderance of the evidence
shows that that “amplification” limitation is satisfied by PCR in the accused and domestic industry
products even under a narrower construction of “amplification” than the one employed by the ID.
See discussion supra Section III.A. Accordingly, the Commission affirms the ID’s findings that
the ’468 patent is infringed and that 10X satisfies the domestic industry requirement for the ’468
patent. 	See ID at 58–66. 	A preponderance of the evidence supports this finding under the
construction the ID applied, as well as under a narrower construction that would exclude reverse
transcription from the definition of “amplification.”
B. 	Validity
Bio-Rad petitioned for review of the ID’s finding that none of the asserted claims of the
’468 patent are invalid as anticipated or obvious based on the ’059 patent. See Bio-Rad Pet. at 33–
38 	The ID’s finding is based on three principal findings: 	(1) that the “releasably attached”
limitation of the asserted claims is not disclosed in the prior art; (2) that the “combining” step of
the asserted claims is not disclosed in the prior art; and (3) that the “generating a droplet” limitation
of the asserted claims is not disclosed in the prior art. See ID at 66–70. The ID also found that
secondary considerations weighed against finding any of the asserted claims obvious. See id. at
70.

PUBLIC VERSION
23
On review, the Commission has determined to affirm the ID’s finding that the asserted
claims of the ’468 patent are not invalid, but under modified reasoning. 	Particularly, the
Commission affirms the ID’s finding that the “releasably attached” limitation in (1) above is not
disclosed in the prior art and the ID’s finding that secondary considerations weigh against finding
the asserted claims obvious and adopts those findings in whole. See ID at 66, 70. Those findings,
including particularly the absence of the “releasably attached” limitation from the prior art, are
sufficient to support the ID’s finding that the asserted claims are not invalid as anticipated or
obvious by the prior art. 	The Commission has determined to take no position on whether the
“combining” and “generating a droplet” limitations in (2) and (3) above are disclosed by the ’059
patent.
V. 	T HE ’204 PATENT
The ID found that 10X failed to establish that Bio-Rad’s accused products infringe any
asserted claim of the ’204 patent. See ID at 77. The ID’s noninfringement finding follows from
two subsidiary findings: (1) the ID found that Bio-Rad’s accused products do not meet a Markush
group limitation that defines the type of stimulus used to cause a capsule to release its contents;
and (2) the ID found that 10X could not rely on the doctrine of equivalents to satisfy the Markush
group limitation. 10X petitioned for review of the ID’s noninfringement finding by challenging
both findings. See 10X Pet. at 9–18. The Commission has determined to affirm with supplemented
reasoning the ID’s finding that none of the asserted claims of the ’204 patent are infringed. The
Commission adopts the ID’s findings to the extent they are not inconsistent with this opinion.

PUBLIC VERSION
24
For reference, claims 1 and 27 of the ’204 patent follow:
1. 	A composition comprising a plurality of capsules, said capsules situated within
droplets in an emulsion, wherein said capsules are configured to release their
contents into said droplets upon the application of a stimulus to provide said
contents in said droplets in said emulsion, wherein said stimulus is selected from
the group consisting of a change in pH, a change in ion concentration, reduction
of disulfide bonds, and combinations thereof.
* 	* 	*
27. The composition of claim 1, wherein said contents comprise at least 10,000
barcoded oligonucleotides releasably attached to each of said capsules.
’204 patent at cls. 1, 27 (emphasis added on contested Markush group).
A. 	Literal Infringement
The salient issue addressed in 10X’s petition is the ID’s determination that Bio-Rad’s
products “do not literally infringe the asserted claims because they do not have a stimulus ‘selected
from the group consisting of a change in pH, a change in ion concentration, reduction of disulfide
bonds, and combinations thereof.’” ID at 73. The crux of the ID’s decision with respect to this
limitation is that the stimulus that causes barcode molecules to be released in Bio-Rad’s products
are 	. 	See id. at 74. 	are not
listed among the stimulus choices in the Markush group (a change in pH, a change in ion
concentration, reduction of disulfide bonds, and combinations thereof) and, therefore, Bio-Rad’s
products do not practice this limitation, which is incorporated into every asserted claim of the ’204
patent. See id.
In concluding that Bio-Rad’s products do not satisfy the Markush group limitation, the ID
rejected several arguments from 10X. 	First, the ID rejected 10X’s reliance on an
as the stimulus responsible for causing barcode molecules to be released from the
gel beads in Bio-Rad’s products. See id. at 74–78. The ID explained that the evidence of record
did not show that an 	alone would cause the release of barcode

PUBLIC VERSION
25
molecules from gel beads. 	See id. at 75 (“[T]here is no evidence that the 	by
themselves would have any effect on the attached barcode molecules or the gel bead.”). Rather,
at best, 10X’s evidence showed that barcode release is caused by
See id. (“Thus, as understood by [10X’s expert,]
Dr. Butte, the stimulus that causes the release of the barcode molecules from the gel bead in the
accused products is the
”). Relying on the closed transition phrase “consisting of” in the Markush group,
however, the ID interpreted the group to exclude additional unrecited elements, in this case, the
. 	See id. at 75–77. 	Thus, the ID determined that the stimulus limitation of the
asserted claims could not be satisfied by the combination of an 	and
provision of 	in Bio-Rad’s products. See id. at 78.
The ID also rejected reliance on the 	alone as the claimed stimulus. See
ID at 77. 	Further to that finding, the ID noted that “there is no evidence that changing the
without the 	will cause the release of barcode
molecules from the gel beads.” Id. The ID also pointed to a portion of 10X’s posthearing brief
that acknowledges the role of 	in releasing the barcode molecules. See id. (citing
10X Posthearing Br. at 181–182). Regarding 10X’s assertion that only the
is the claimed stimulus, the ID characterized that assertion as “unsupported attorney argument
that is contradicted by the testimony of [10X’s] own expert.” Id. at 78 (citing Tr. (Butte) at 474:18-
21). For these reasons, the ID found that “the accused products do not literally infringe the asserted
claims.” Id.
10X’s primary argument is that an 	is the claimed stimulus, and
that the actions of 	is the mechanism through which release is effectuated. See 10X

PUBLIC VERSION

Pet. at 9-10 Pe is the start of a chain reaction: the
ee. and the contents of the capsule are released as a result. This
Po is applied as the trigger of a series of events leading to the

release of the contents of the capsule and meets the claimed stimulus within the Markush group
consisting of a change in pH, a change in ion concentration, reduction of disulfide bonds, and
combinations thereof.”). Relying on this premise, 10X attacks the ID from several directions,
including arguing that the ID erroneously construed the claim such that the stimulus must
“effectuate by itself the release of the contents without any facilitating or intermediate steps,” 10X
Pet. at 10, and that the ID erred by failing to give due weight to the fact that 10X stated in its
various infringement contentions that only im is the claimed stimulus,
id. at 12-14.

None of 10X’s arguments show that the ID erred in finding no literal infringement by Bio-
Rad’s products. First, as the ID noted, there is a pronounced lack of evidence supporting 10X’s

argument. For example, 10X’s own expert never testified that an Po

alone was the stimulus recited in the asserted claims. Rather, Dr. Butte consistently testified that

the sinus ws (he I Fo: exomple, Dr.

Butte testified as follows:

Q: Sure. You’re not claiming that the Po is one of the
claimed stimuli that’s mentioned in claim | of the ’204 patent; correct?

A: It’s

* * *

Q: Right. But it’s not the ii itself; right?

26

PUBLIC VERSION

A: It’s not the itself. It’s the combination with the P|
specifically.

* * *

Q: Now, it’s your view that the stimulus in the accused products is the
correct?
A: That is correct.

Tr. 371:14-18, 371:19-23, 432:13-16. Moreover, while 10X argues that the
ee
a. see 10X Pet. at 9, its primary support for that contention is a section of equivocal corporate
deposition testimony from a Bio-Rad witness who testified repeatedly that he was unsure of the
purpose of Po in Bio-Rad’s process. See, e.g., CX-0009C at 425:7—22
(“There are — there is P| in that reaction. But it’s required for a lot of DNA modifying
enzymes. So I don’t —I don’t know. It’s — it’s not uncommon for an enzyme to bind a cofactor

and — and not require additional — addition of a cofactor to — to be active. So I don’t know if that

—I don’t know if the ae we add is — is necessary for the a. ). Further
still, Bio-Rad and OUII point to evidence suggesting that the Po in Bio-
Rad’s products is unrelated to the action of the a. which would directly refute 10X’s
srqunent a he rrr ..
OUII Resp. to Pets. at 22; Bio-Rad Resp. to Pets. at 9-15; see also Tr. at 376:19-377:7, 377:11—
379:4, 381:5-382:9, 383:18—-384:16, 533:12—-19, 564:15—565:9: JX-0050C at 56: JX-0132 at 65;
RX-503C at Q/A 60-64; RX-537 at 5, RX-665C at Q/A 52, 59-65 (evidence relied on by OUII
and Bio-Rad).

Second, 10X’s argument that the ALJ misinterpreted its contentions about the accused

stimulus is largely immaterial. See 10X Pet. at 12-14. Regardless of whether 10X asserted in its

27

PUBLIC VERSION
28
briefs that only 	is the claimed stimulus, the fact remains that there
is little, if any, evidence to support that contention. That is, 10X’s infringement argument did not
fail because the ID misunderstood its contentions; it failed because those contentions do not show
infringement by a preponderance of the evidence.
Finally, 10X’s reliance on the word “comprising” in the preamble of the claims to argue
that the presence of 	in the accused products does not defeat infringement is at
odds with the most analogous cases addressing the issue. Here, each of the independent claims
begins with a preamble such as, “A composition comprising . . . ,” ’024 patent at cl. 1, “A device
comprising . . . ,” id. at cl. 23, or “A method comprising . . . ,” id. at cl. 25. 10X relies on the word
“comprising” in each to argue that the claims are open to additional unrecited elements. 10X Pet.
at 11 (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 811 (Fed. Cir. 1999);
Northern Telecom, Inc. v. Datapoint Corp., 908 F.2d 931, 945 (Fed. Cir. 1990)). Based on that
uncontroversial legal principle, 10X argues that “ 	is no different than any other unaccused
component of the buffer that plays a role in creating the right operating environment such that the
results in release of contents.” 10X Pet. at 11 (emphasis in
original).
10X’s argument misapprehends the ID’s reasoning and fails to acknowledge the rest of the
claim language. First, the ID did not find that the mere presence of 	in the accused
products defeated infringement. The ID found that 10X’s own expert admitted that
alone did not stimulate the release of barcodes as required by the claims, but rather the
were an essential component of the stimulus. See ID at 75. Second, each claim uses the
phrase “said stimulus is selected from the group consisting of . . .” in the limitation at issue. ’204
patent at cls. 1, 23, 25 (emphasis added). The transitional phrase “consisting of” indicates a closed

PUBLIC VERSION
29
group of elements, including only “a change in pH, a change in ion concentration, reduction of
disulfide bonds, and combinations thereof.” Id. Because the evidence shows that
are all or part of the stimulus that caused the release of barcodes, this limitation is not met. The
presence of the word “comprising” in the preamble of each claim does not negate the closed nature
of the Markush group defining the set of stimuli that will read on the claim. Indeed, the cases the
ID relied on to support its interpretation of the Markush group as a closed set of options dealt with
exactly such claims — introduced by an open preamble with “comprising,” but including a closed
Markush group signaled with “consisting of.” See Multilayer Stretch Cling Film Holdings, Inc. v
Berry Plastics Corp., 831 F.3d 1350, 1358 (Fed. Cir. 2016) (analyzing claims with “comprising”
in the preamble followed by an element reciting, “selected from the group consisting of”); Abbott
Labs. v. Baxter Pharm. Prod., Inc., 334 F.3d 1274, 1276 (Fed. Cir. 2003) (same); see also ID at
74 (citing Multilayer and Abbott).
Under 10X’s interpretation of the claim, the Markush group limitation would effectively
become an open limitation, allowing any number of additional unrecited stimuli as long as one of
the recited stimuli also had some connection to causing the capsules to release their contents. 10X
cites no precedent interpreting a Markush group that introduces its elements with the signal
“consisting of” in that way. To the contrary, precedent uniformly treats Markush groups using the
signal “consisting of” as closed, excluding other unrecited elements absent explicit language in the
claim permitting as much. 	See Multilayer, 831 F.3d at 1358; Abbott Labs., 334 F.3d at 1276.
Given the Federal Circuit’s binding precedent, the Commission affirms the ID’s reasoning that the
Bio-Rad products do not infringe because the 	are part of the stimulus that releases
barcodes in the accused products, but the Markush group recited in the asserted claims does not
encompass the 	. We adopt those findings.

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30
The Commission notes that the ID reached its conclusion without resolving the disputed
issue of whether an
in the accused products. 	In response to the Commission’s request for
briefing, 10X argued that the
See 10X Resp. to Qs. at 28–35. In support of that argument,
10X argued that (1)
. See id. at 33–35. This facet of
10X’s argument relied on a publication by Melamede, et al., listed on the face of the
product insert.7 	See JX-0050C at 56; CX-1965. 	Particularly, 10X asserted that “Figure 6C of
Melamede plots the activity of Endo VIII
. Id. at 34; see also id. at 35.
7 The 	product insert lists five articles and one U.S. Patent on its face. JX-0050C at
56. 10X relies on one of those references — Melamede, R.J., Hatahet, Z., Kow, Y.W., Ide, H. and
Wallace, S.S. (1994) Biochemistry 33, 1255–1264 (hereinafter “Melamede”) (CX-1965) — to
support its argument that an 	activity. Bio-Rad
relies on the U.S. Patent — U.S. Patent No. 7,435,572, “Methods and Compositions for DNA
Manipulation,” issued to Jurate Bitinaite on October 14, 2008 (hereinafter “the ’572 patent”)
(JX-0132) — and one of the articles — Lindhal, T., Ljungquist, S., Siegert, W., Nyberg, B. and
Sperens, B. (1977) J. Biol. Chem. 252, 3286–3294 (hereinafter “Lindhal”) (RX-0537) — to
support its counter-argument that an
.

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10X also relies on the testimony of a Bio-Rad employee, Dr. Agresti, who provided
corporate deposition testimony on behalf of Bio-Rad, and also testified at the evidentiary hearing.
See id. at 36. Specifically, 10X notes that “Dr. Agresti provided corporate deposition testimony
that 	, but that he did not recall which of the
required it.” Id. In 10X’s view, Dr. Agresti’s deposition testimony supports its argument that “the
activity [of] [sic]
.” Id. 10X further noted that Dr. Agresti testified at the evidentiary hearing that he did not
believe 	, 	but 	10X 	characterizes 	that 	testimony 	as
contradictory to his deposition testimony. 10X also argued that the bases of Dr. Agresti’s hearing
testimony — a publication by Lindhal, RX-0537, and U.S. Patent No. 7,435,572, JX-0132, both
of which appear on the 	product insert — were cherry-picked for him by Bio-Rad’s
counsel, and that neither are reliable because they concern 	activity under conditions
that are materially different from those found in the accused products. See id. at 36–40. Based on
these arguments, 10X submits that a “preponderance of evidence therefore shows that an
, meeting the relevant
language of Claim 1 of the 204 Patent.” Id. at 41.
Bio-Rad argued in its response that any 	in the workflow of its products
does not 	. See Bio-Rad Resp. to Qs. at 34–35. Bio-Rad
does not appear to dispute that 	to the ddSEQ system, but submits that the
purpose of that addition is to
). See id. at 37 (“On the contrary, the evidence shows that
Bio-Rad 	,

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.”). Bio-Rad argued that the 	is already 100%
active without any 	. See id. at 35–37.
The strongest part of Bio-Rad’s counter-argument is that 10X’s cited evidence purporting
to show a relationship between 	is inapposite
because of material differences in the conditions surrounding the experiments in the cited article
and the conditions present in Bio-Rad’s products. See id. at 41–43. For example, Bio-Rad points
out that while 10X relies heavily on Melamede, that article “tested the activity of Endonuclease
VIII on DNA containing thymine glycols.” Bio-Rad Resp. to Qs. at 42 (emphasis in original).
Moreover, Bio-Rad submits that “Melamede expressly states that Endonuclease VIII
” Id. (citing CX-1965.00008). Thus, Bio-Rad argues that 10X is relying
on information about 	activity that is insufficiently related to the behavior of the
in the accused products. 	See id. at 41–43 (“10X does not even attempt to
demonstrate that the context of Melamede has any relevance to the context of the Bio-Rad Accused
Products”).
Bio-Rad also argued that 10X’s calculations of the amount of 	to Bio-
Rad’s products are unsupported attorney argument, and are also contradicted by witness testimony
in the record. Bio-Rad Resp. to Qs. at 43–44 (citing Greiner Tr. 539:16-541:15). The point of that
argument, presumably, is to further undermine any reliance on Melamede by arguing that the
concentrations of 	investigated in Melamede are not similar to the concentrations
present in Bio-Rad’s products.
Finally, Bio-Rad pointed to the Lindhal article and the ’572 patent referenced on the
product insert as evidence that the 	are either unaffected or inhibited by
the 	. 	See id. at 44–46; see also Bio-Rad Resp. to Pets. at 12–15.

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Particularly, Bio-Rad argued that “according to Lindahl, UDG,
,” Bio-Rad Resp. to Qs. at 44, and that “the ’572 Patent describes the
and confirms that
,” id. at 44–45.
OUII’s response was in substantial alignment with Bio-Rad’s. OUII Resp. to Qs. at 15–
19. 	OUII reiterated the evidence it pointed to in its petition for review to show that the
used in the Bio-Rad products are active without any 	, that the
, and that the purpose of the
present in the Bio-Rad products is to
. See id. at 15–18. With respect to the Melamede article, OUII takes the position that the
experiments reported therein are insufficiently related to the accused products to conclude that an
. See id. at
18. OUII was also critical of the absence of expert testimony supporting 10X’s interpretation of
Melamede. Id.
There is no dispute that Bio-Rad’s processes involve an 	. There
is, however, a lack of reliable evidence as to the effect, if any, that
. This is because the parties failed to show that the articles and references upon which they
rely analyzed 	activity in conditions that are the same or similar to those in the
accused products. 	10X has the burden of proving infringement by a preponderance of the
evidence; the evidence does not establish that Melamede’s reported relationship between
and Endo VIII’s activity in nicking thymine glycols is probative of the
relationship between

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in the accused products to release barcodes. See Bio-Rad
Reply at 35–37 (discussing evidence supporting the distinction between
in the accused products and Endonuclease VIII nicking thymine glycol). Dr. Agresti’s deposition
testimony is hardly persuasive on the effect of 	in the accused products. When
viewed in whole, the relevant portion of Dr. Agresti’s deposition transcript demonstrates that Dr.
Agresti did not know at the time whether the 	was necessary for the
to work. See CX-0009C at 422:20–429:15.
Even if 10X’s argument is accepted as true, it would not show that an
is the “trigger of a series of events leading to the release of” barcodes from the
beads in the accused products. 	Cf. 10X Pet. at 10 (arguing that an
). 	According to 10X, prior to any
in the accused
products, see 10X Pet. at 35 (“According to Melamede, that
Thus, even
under 10X’s theory, an 	does not “trigger” the release of barcodes from
beads in the accused products. 	The 	is already active, and the presence of
only improves its activity. 10X fails to explain how that 	reads
onto the ’204 patent’s claim language requiring capsules “configured to release their contents . . .
upon the application of a stimulus.” See, e.g., ’204 patent at cl. 1. Under 10X’s theory, the
will stimulate the capsules in Bio-Rad’s products to release barcodes regardless
of whether 	is added, albeit possibly at a slower rate. 	Accordingly, even
under its own theory of how 	in the accused products, 10X

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has not shown that an 	is the stimulus that causes the capsules in Bio-
Rad’s products to release their barcodes.
In conclusion, the Commission affirms the ID’s finding that 10X failed to show that the
asserted claims of the ’204 patent are literally infringed by the accused products.
B. 	Doctrine of Equivalents
Before the ALJ, 10X argued in the alternative that the Markush group limitation was
satisfied by the 	in the presence of a change in 	ion concentration as an
equivalent to the recited “reduction in disulfide bonds” element. See ID at 78. The ID rejected
this argument, finding that 10X was estopped from relying on the doctrine of equivalents (“DOE”)
to satisfy this limitation. The ID’s finding in that regard has two facets: (1) there is a presumption
that 10X is estopped from relying on DOE based on its amendments during prosecution, see id. at
82; and (2) 10X had not established that its narrowing amendment was tangential to the alleged
equivalent (which would overcome the presumption against DOE), see id. at 85.
10X petitioned for review of the ID’s finding that it is estopped from relying on DOE to
satisfy this element of the asserted claims. 	10X does not dispute the ID’s finding that a
presumption of estoppel is proper, but rather faults the ID for misunderstanding what evidence was
in the record.8 10X Pet. at 16. Particularly, 10X faults the ID’s statement that “the record is devoid
of any evidence concerning Trnovsky’s teachings.” Id. (quoting ID at 84 (emphasis 10X’s)).
8 10X spends several pages of its petition reciting the “procedural history of Staff’s [prosecution
history estoppel] argument” to show “the improper burden the ID imposes on 10X.” 	10X,
however, does not explain how the procedural history of the issue supports modifying or reversing
the ID, and we find such argument meritless in any event. 10X’s chief complaint appears to be
that Bio-Rad raised but abandoned a similar argument, while OUII raised the argument for the first
time in its prehearing brief. 	Presumably, 10X’s implication is that it did not receive a fair
opportunity to prepare evidence in response to OUII’s argument. If that is the case, 10X’s recourse
was to seek relief from the ALJ.

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10X argues this statement is clear error because Trnovsky itself is in the record, as is testimony
from 10X’s expert, Dr. Butte. Id. at 16–17.
As explained in the ID, “[d]uring the prosecution of the ’204 patent, application claims 1,
78, and 110 matured into issued claims 1, 23, and 25, respectively.” ID at 79 (citing JX-0009 at
13630). 	As originally filed, application claims 1 and 78 required a capsule(s) “configured to
release their contents . . . upon the application of a stimulus,” but did not require that the stimulus
be selected from a particular group of stimuli. Id. (quoting JX-0009 at 80 (application claim 1);
JX-0009 at 85 (application claim 78) (requiring a capsule “configured to release its contents into
said droplets upon the application of a stimulus”). Similarly, application claim 110 required a step
of “providing a stimulus to cause said capsules to release their contents into said droplets,” without
requiring the stimulus be selected from a group of stimuli. Id. (citing JX-0009 at 87).
The ID further explains that while “application claim 1 did not limit the stimulus to a group
of stimuli, two of its dependent claims [(application claims 19 and 21)] did.” ID at 80. Application
claim 19 required the stimulus to be “selected from the group consisting of a chemical stimulus, a
bulk stimulus, a biological stimulus, a light stimulus, a thermal stimulus, a magnetic stimulus, and
combinations thereof,” while application claim 21 required the stimulus to be “selected from the
group consisting of a change in pH, a change in ion concentration, reduction of disulfide bonds,
and combinations thereof.” JX-0009 at 81.
A brief description of the prosecution history is helpful before addressing 10X’s argument.
In an office action issued on January 29, 2016, the examiner rejected all of the pending claims as
anticipated in view of several prior art references. 	Id. at 9770–9781. 	Application claim 1 was
found to be anticipated by seven references: (1) U.S. Patent Publication No. 2005/007951 to Berka
et al. (“Berka”), (2) U.S. Patent Publication No. 2015/0079510 to Church et al. (“Church”), (3)

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U.S. Patent Publication No. 2014.0227706 to Kato et al. (“Kato”), (4) U.S. Patent Publication No.
2003/0207260 to Trnovsky et al. (“Trnovsky”), (5) U.S. Patent Publication No. 2013/0189700 to
So 	et 	al. 	(“So”); 	(6) 	U.S. 	Patent 	Publication 	No. 	2004/0258701 	to 	Dominowski 	et 	al.
(“Dominowski”); and (7) U.S. Patent Publication No. 2009/0025277 to Takanashi (“Takanashi”).
Id. at 9777–9780. Application claim 19 was rejected as anticipated by five references: (1) Berka,
(2) Trnovsky, (3) So, (4) Dominowski, and (5) Takanashi. Id. Application claims 78 and 110 were
rejected as being anticipated by Berka. Id. Application claim 21 was rejected as being anticipated
by Kato. Id.
On April 28, 2016, the applicants responded to the rejections by, inter alia, cancelling
application claims 19 and 21 and amending application claims 1, 78, and 110. 	As amended,
application claims 1, 78, and 110 incorporated application claim 21’s limitation requiring that the
stimulus be “selected from the group consisting of a change in pH, a change in ion concentration,
reduction of disulfide bonds, and combinations thereof.” Id. at 10009; see also id. at 10000, 10002,
10003. 	With this amendment, the applicants argued that the amended application claims were
allowable over the cited prior art with the exception of Kato. Id. at 10009 (“Initially, as Claim 21
was rejected only over Kato, Applicant understands that the Office acknowledges that none of
Berka, Church, Trnovsky, So, Dominowski and Takanashi teach or disclose ‘wherein said stimulus
is selected from the group consisting of a change in pH, a change in ion concentration, reduction
of disulfide bonds, and combinations thereof,’ as recited in claims 1, 31, 78, 89, 110 and 118.”).
With regard to Kato, the applicants argued that “Kato does not teach or disclose, ‘wherein said
capsules are configured to release their contents into said droplets upon the application of a
stimulus,’ as recited in Claim l.” Id. at 10010. The applicants also argued that Kato did not qualify
as prior art. Id.

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On August 5, 2016, the examiner rejected the amended claims in view of a new set of prior
art references and noted that the previous rejections had been rendered moot in view of the new
grounds of rejection. Id. at 10074. The examiner also “noted that the 102(b) rejection of Claims
1 and 21 over Kato has been withdrawn in light of the applicant’s persuasive arguments.” Id. In
response to the new rejections, the applicants further amended application claims 1, 78, and 110
to require that the capsule or capsules “provide said contents in said droplets in said emulsion”
upon the application of a stimulus. Id. at 10118, 10120–21. The application claims as amended
were allowed. Id. at 13617.
The Commission finds that 10X is correct that Trnovsky is in the record, and thus the ID
was wrong to state that there is no record evidence of Trnovsky’s teachings. Trnovsky is exhibit
JX-0030, and was admitted on March 25, 2019. 	Tr. at 480. 	The ID apparently interpreted the
statement in 10X’s posthearing reply brief that “Staff [] did not introduce the underlying
references, and the evidence of record is that they do not disclose 	with a
change in ion concentration,” to mean that the Trnovsky was not introduced at all, when apparently
10X only meant that OUII did not introduce Trnovsky as an exhibit. CRB at 85; see also ID at 84
(citing same). 	Because the ID’s statement concerning Trnovsky’s admission is incorrect, the
Commission reverses that limited portion of the ID’s reasoning. However, notwithstanding that
correction, 10X still has not shown why it is entitled to rely on DOE based on correction of this
error.
The crux of 10X’s tangential relationship argument is that Trnovsky did not disclose the
combination of an enzyme with a change in ion concentration as the stimulus to cause a capsule to
release its contents. 	10X Pet. at 17 (quoting CX-0004C (Butte WS) at Q/A 331). 	Rather, the
reference only disclosed the use of a specific enzyme (agarase) on its own. 	See id. 	Thus, 10X

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argued that the amendment to overcome Trnovsky only surrendered the use of enzymes that did
not work in combination with a change in pH, a change in ion concentration, or a reduction of
disulfide bonds. See id. Thus, according to 10X, the combination of an enzyme with a change in
pH, a change in ion concentration, or a reduction of disulfide bonds continued to be covered by
the claims. See id.
The Commission finds that the legal support for 10X’s tangential relation argument is
lacking. Particularly, 10X’s argument implicitly relies on the premise that the tangential relation
exception to prosecution history estoppel applies if the prior art does not contain the asserted
equivalents. This is incorrect. As explained by the Federal Circuit, while “[a]n amendment made
to avoid prior art that contains the equivalent is not tangential,” “[i]t does not follow [] that
equivalents not within the prior art must be tangential to the amendment.” 	Integrated Tech.
Corp. v. Rudolph Techs., Inc., 734 F.3d 1352, 1358 (Fed. Cir. 2013) (emphasis added) (internal
citations and quotation marks omitted). Indeed, an applicant may surrender by amendment more
than what was required to overcome the prior art, and yet, the applicant cannot reclaim that excess
via the DOE. See Southwall Techs., Inc. v. Cardinal IG Co., 54 F.3d 1570, 1581 (Fed. Cir. 1995)
(“[T]he limits imposed by prosecution history estoppel on the permissible range of equivalents can
be broader than those imposed by the prior art.”).
What 10X must show to rely on the tangential relation exception to prosecution history
estoppel is that the reason for the applicant’s “narrowing amendment was peripheral, or not directly
relevant, to the alleged equivalent.” 	Integrated Tech. Corp. v. Rudolph Techs., Inc., 734 F.3d
1352, 1358 (Fed. Cir. 2013) (quoting Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 344
F.3d 1359, 1369 (Fed. Cir. 2003) (en banc)). In other words, 10X must show that the reason the
applicant amended the Markush group limitation to recite a change in pH, a change in ion

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concentration, or a reduction of disulfide bonds was peripheral, or not directly relevant, to its
alleged equivalent, i.e., the action of
. That showing should “focus[] on the patentee’s objectively apparent reason for the narrowing
amendment, which should be discernible from the prosecution history record.” Integrated Tech.
Corp., 734 F.3d at 1358 (internal quotation marks omitted) (quoting Festo, 344 F.3d at 1369).
Here, 10X has not made the required showing. 	Rather, 10X relies on the following
testimony from its expert, Dr. Butte:
Trnovsky did not describe 	generally, but digestion with a
specific enzyme: agarase (which Bio-Rad incorrectly quoted as agarose). JX-
0030.00010 ([0009]). 	Trnovsky was overcome by the amendment because
Trnovsky has no description, either in paragraph 9 or 102, which were cited by the
examiner, see JX-0009.09778, of the use of agarase with a change in a change in
pH, a change in ion concentration, or a reduction of disulfide bonds. 	One of
ordinary skill in the art would understand that the amended claims no longer
covered enzymes such as agarase that did not work with a change in a change in
pH, a change in ion concentration, or a reduction of disulfide bonds. However, one
of ordinary skill would also understand that the claims continue to cover the use of
enzymes with change in a change in pH, a change in ion concentration, or a
reduction of disulfide bonds.
10X Pet. at 17 (quoting CX-0004C at Q/A 331) (emphasis added). 	Even assuming that this
testimony is uncontested, as 10X claims it is, it does not show that the tangential relation exception
applies. Here, Dr. Butte merely testifies that the reference “Trnovsky has no description, either in
paragraph 9 or 102, which were cited by the examiner, see JX-0009.09778, of the use of agarase
with a change in a change in pH, a change in ion concentration, or a reduction of disulfide bonds.”
Id. But, as explained above, “[i]t does not follow [] that equivalents not within the prior art must
be tangential to the amendment.” Integrated Tech. Corp. v. Rudolph Techs., Inc., 734 F.3d 1352,
1358 (Fed. Cir. 2013) (internal citations and quotation marks omitted).
The applicant’s amendment drastically reduced the universe of stimuli covered by the
Markush group to overcome an anticipation rejection based on references, such as Trnovsky, that

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disclosed stimuli covered by the applicant’s original, broader claims. 	That reason is neither
peripheral nor irrelevant to 10X’s alleged equivalent, which would replace a reduction in disulfide
bonds with the action of 	in the presence of an 	ions. The
action of 	would have been included within the scope of the applicant’s original
claims, but also would have been anticipated by the disclosure of Trnovsky concerning agarase,
both 	and agarase enzymes being within the original Markush group consisting of a chemical
stimulus, a bulk stimulus, and a biological stimulus. The applicant’s amendment surrendered both
enzymes by narrowing the universe of claimed stimuli drastically. Though 10X now tries to create
space between the amendment’s rationale and its claimed equivalent by relying on
in combination with an 	, it points to nothing “objectively apparent” in
the prosecution history to show that the rationale for its amendment was irrelevant to enzymes in
combination with an increase in ion concentrations. 	Particularly, Dr. Butte’s testimony to that
effect is wholly conclusory, and not part of the prosecution history. See Integrated Tech. Corp.,
734 F.3d at 1358 (“The tangential relation inquiry ‘focuses on the patentee’s objectively apparent
reason for the narrowing amendment,’ which ‘should be discernible from the prosecution history
record.’” (quoting Festo, 344 F.3d at 1369)).
At bottom, 10X’s tangential relation argument against prosecution history estoppel lacks
legal and evidentiary support. The ID was correct to discount it. However, the ID erroneously
stated that Trnovsky is not in evidence, and that the record is devoid of evidence concerning its
teachings. 	Accordingly, the Commission affirms the ID’s finding that 10X is estopped from
relying on the doctrine of equivalents to show infringement, see ID at 78 (finding that 10X “is
precluded from relying on the DOE to satisfy the Markush group limitation.”), but with the

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correction that Trnovsky is in evidence and with the additional reasoning laid out above. 	See
discussion supra pp. 35–41.
VI. 	T HE ’530 PATENT
The Commission previously determined to review all of the ID’s findings related to a
violation of section 337 based on the ’530 patent. 84 Fed. Reg. 56835. On review, the Commission
has determined to affirm with modified reasoning the ID’s finding that Bio-Rad has violated
section 337 based on infringement of the ’530 patent. The Commission also affirms with modified
reasoning the ID’s finding that 10X satisfies the domestic industry requirement with respect to the
’530 patent. 	The Commission has determined to take no position on whether Bio-Rad
contributorily infringes the ’530 patent. The Commission also finds that Bio-Rad abandoned the
indefiniteness argument raised for the first time in its petition for review of the ID, but that even if
not abandoned, the argument would fail. 	The Commission adopts the remainder of the ID’s
findings with respect to the ’530 patent to the extent they are not inconsistent with this opinion.
A. 	Background
Of the asserted claims — claims 1, 4, 11, 14, 19, 26, 28 — claim 1 is the sole independent
claim, and the bulk of the disputes with respect to the ’530 patent involve the limitations recited
in claim 1. All of the other asserted claims depend, both directly and indirectly, from independent
claim 1. Claim 1 reads as follows:
1. 	A method for nucleic acid preparation or analysis, comprising:
(a) providing:
(i) 	at least 1,000 gel beads;
(ii) 	releasably attached to each of said at least 1,000 gel beads, at least
1,000 barcode molecules comprising identical barcode sequences that
are distinct from barcode sequences of at least 1,000 barcode molecules
releasably attached to any other gel bead of said at least 1,000 gel
beads; and

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(iii) a plurality of cells each comprising a plurality of polynucleotide
molecules;
(b) generating a plurality of droplets, wherein at least 1,000 droplets of said
plurality of droplets each comprise:
(i) 	a single gel bead from said at least 1,000 gel beads; and
(ii) 	a single cell from said plurality of cells; and
(c) in each of said at least 1,000 droplets, using said plurality of polynucleotide
molecules from said single cell and barcode molecules of said at least 1,000
barcode molecules from said single gel bead to generate a plurality of
barcoded polynucleotide molecules,
wherein said barcode molecules become detached from said gel bead.
’530 patent at cl. 1 (emphasis added on contested limitations; indentation from “wherein said
barcode molecules become detached from said gel bead” paragraph maintained from admitted joint
exhibit, JX-7).
In construing claim 1, the Markman order rejected proposed constructions from OUII and
Bio-Rad that would limit the claim by requiring that the 1,000 droplets be provided in a single
experiment (Bio-Rad’s proposal) or by requiring that the plurality of cells come from a common
sample (OUII’s proposal). 	See Order No. 22 at 46 (Markman Order) at 46–48. 	The Markman
order also rejected 10X’s argument that multiple runs of the method could be combined to reach
the 1,000-droplet threshold in step (b). See id. at 50–51. Ultimately, the Markman order concluded
that “claim 1 requires that the step of generating ‘at least 1,000 droplets’ be completed before the
third step of forming a ‘plurality of barcoded polynucleotide molecules’ is performed in any of the
droplets.” Id. at 51.
Thereafter, on March 5, 2019, the ALJ issued Order No. 35, which denied Bio-Rad’s
motion for summary determination of non-infringement with respect to the ’530 patent, among
others things. In its motion, Bio-Rad had argued that its products did not infringe because, in them,
barcoding began before all of the at least 1,000 droplets were formed. See Order No. 35 at 4–5.

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Order No. 35 rejected Bio-Rad’s argument on the basis that the Markman order did not interpret
claim 1 such that “all 1,000 droplets form before any barcoding begins.” Id. at 6 (internal quotation
marks omitted). Rather, “[t]he claim language merely requires that any accused step of generating
a plurality of barcoded molecules occurs after the at least 1,000 droplets are generated.” Id. Order
No. 35 then further explained that even if Bio-Rad’s assertion were true that some barcoded
molecules were formed at room temperature before the at least 1,000 droplets were generated, that
would “not preclude a finding of infringement based on a subsequent step of generating barcoded
molecules in a thermal cycler.” Id. The crux of Order No. 35’s reasoning is that some barcoding
may occur during the droplet generation claimed in step (b) without precluding the possibility that
after 1,000 droplets are generated in step (b) additional barcoding may occur that will satisfy step
(c) of claim 1. See id. (citing Kaneka Corp. v. Xiamen Kingdomway Group Co., 790 F.3d 1298,
1306, (Fed. Cir. 2015)).
The final ID reiterated and applied the claim constructions for the ’530 patent from Order
Nos. 22 and 35, discussed above. ID at 91.
B. 	“wherein said barcode molecules become detached from said gel bead.”
Bio-Rad petitioned for review of the ID’s findings of infringement and domestic industry
with respect to the ’530 patent. Among the arguments raised in Bio-Rad’s petition is that neither
the accused products nor the domestic industry products practice the final clause of step (c) of
claim 1, which reads: “. . . wherein said barcode molecules become detached from said gel bead.”
’530 patent at cl. 1. Bio-Rad’s arguments rely on the premise that this “wherein” clause is part of
step (c), and thus subject to the ID’s requirement that step (c) occur after at least 1,000 droplets
are generated in step (b). 	In other words, barcode detachment must occur after at least 1,000
droplets are generated. There is no question that barcode detachment occurs in the accused and

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domestic industry products; thus, the salient dispute raised by Bio-Rad’s petition is the timing of
barcode detachment.
Step (c) of claim 1, as it appears in the ’530 patent, sets off the “wherein” clause with
separate indentation from the other limitations of step (c). See ’530 patent at cl. 1.9 At the same
time, the wherein clause is separated from the other clauses of step (c) with only a comma, where
elsewhere in the claim separate steps are set off with semi-colons. Because the unusual indentation
of the “wherein” clause raises some ambiguity as to whether that clause is part of step (c) — and
thus subject to the timing requirement at the heart of Bio-Rad’s argument — the Commission
sought briefing from the parties on whether the “wherein” clause is included within step (c). The
parties all agreed in response that the “wherein” clause is part of step (c) of the method claimed in
claim 1. The Commission agrees, and therefore affirms the ID’s finding that the third step of the
9 Images from the ’530 patent follow:
* 	* 	*
’530 patent at cl. 1 (highlighting added on disputed clause).

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claimed process “requires that the ‘barcode molecules become detached from said gel bead.’” ID
at 98. 	Accordingly, because the “wherein” clause is part of step (c), the barcode detachment
required by that clause must occur after at least 1,000 droplets have been generated in step (b).
The parties dispute whether the accused and domestic industry products practice the “wherein”
clause so construed.
10X argued that a “preponderance of evidence shows that Bio-Rad’s accused products and
10X’s domestic industry products practice step (c) of Claim 1 of the [’]530 Patent if the
Commission finds that the barcode molecules must become detached from the gel bead during that
step.” 10X Resp. to Qs. at 46. Concerning the accused Bio-Rad products, 10X pointed to evidence
showing that
, i.e., the barcodes are released during step (c). See id. at 46–48.
Concerning its own domestic industry products, 10X argued that “[o]n the thermal cycler
in 10X’s single-cell products, barcode detachment occurs and those barcodes are used to form
barcoded cDNAs.” Id. at 49. 10X further argued that “[t]he entire droplet formation process takes
only several minutes, whereas 10X’s technical fact witness explained upon cross-examination that
the gel bead with attached barcodes persists after droplet formation.” 	Id. at 50 (citing Schnall-
Levin, Tr. at 224:18-23). 	In making that point, 10X implicitly argues that barcode release does
not happen instantaneously in its products such that at least 1,000 droplets can be formed and
transferred to a thermal cycler before the barcodes are released in those droplets.
By contrast, Bio-Rad argued that neither the accused nor domestic industry products satisfy
the “wherein said barcode molecules become detached from said gel bead” limitation of claim 1
because in both sets of the products the barcodes become detached before a collection of at least
1,000 droplets can be generated. See Bio-Rad Resp. to Qs. at 54. With respect to the domestic

PUBLIC VERSION
47
industry products, Bio-Rad pointed to evidence showing that 	dissolves the
gel beads and thus releases the barcodes immediately after droplet formation and prior to
incubation on the thermal cycler. See id. at 58–64. Because the barcodes are released immediately
after barcode formation, Bio-Rad argued that the domestic industry products do not release
barcodes after at least 1,000 droplets have been formed, as required by step (b) of claim 1. Thus,
Bio-Rad argued that the domestic industry products do not practice the “wherein” clause during
step (c), because there is never a collection of at least 1,000 droplets in which gel beads release
their barcodes. Bio-Rad also pointed out that the evidence cited in the ID to support the conclusion
that barcodes are detached during incubation (and thus as part of step (c)), does not actually support
that conclusion. See id. at 59–60. Bio-Rad further pointed to portions of the user manual cited by
the ID that actually tend to show that barcodes are released prior to incubation on the thermal
cycler. Id. at 60 (citing CX-0481 at 11).
With respect to its accused products, the crux of Bio-Rad’s argument is that the
. 	See id. at 65–66. 	Bio-Rad disputed the ID’s
finding that the purpose of heating the droplets in the accused products on a thermal cycler10 — a
process that occurs after droplet formation — is to activate the
. See id. at 66. Bio-Rad argued that the ID incorrectly described the product label for
as describing a reaction temperature and time when the label only actually
specifies a temperature. See id. Bio-Rad also disputed that many of its own documents cited by
10 A thermal cycler, also known as a thermocycler, is a laboratory instrument that can be used to
raise and lower the temperature of a sample in discrete, pre-programmed steps. See CX-0481 at
26 (10X Chromium™ Single Cell 3’ Reagent Kits v2 User Guide describing three-step incubation
procedure on a thermal cycler); see also id. at 9 (listing recommended thermal cyclers).

PUBLIC VERSION
48
the ID show that 	. See id. at 66–67. Bio-Rad also
argued that the ID erred in concluding that even if the
. 	See id. at 67–68. 	Finally, Bio-Rad argued that the weight of expert and fact witness
testimony presented supported the conclusion that the
. See id. at 68–70.
OUII argued, like 10X, that the ID’s finding that the accused products infringe should stand
under its position on the relationship between the “wherein” clause and step (c) of claim 1. OUII
Resp. to Qs. at 22. OUII pointed to evidence showing that the purpose of incubating the accused
products on a thermal cycler at 37℃ is to
. Id. at 22–24. OUII thus concluded that a preponderance of the evidence shows
that the accused products practice step (c) of the claimed method, including the
.
OUII agreed with Bio-Rad, however, that a preponderance of the evidence does not support
the conclusion that the domestic industry products practice step (c) of claim 1. 	Like Bio-Rad,
OUII pointed to documentation produced by 10X that indicates that the gel beads in the droplets
dissolve “immediately” upon droplet generation, thus releasing barcode molecules, before droplets
are placed on the thermal cycler. See id. at 24–25 (citing CX-423C at 15; CX-0004C at Q/A 242,
260; CX-540 at 5:48–6:08).
On review, the Commission has determined to affirm, with modified reasoning, the ID’s
conclusion that the accused products infringe the asserted claims of the ’530 patent, and affirm,
with modified reasoning, the ID’s conclusion that the domestic industry products practice claim 1.

PUBLIC VERSION
49
1. 	Accused Products
With respect to the accused products, there is ample evidence to show that barcode
cleavage happens on the thermal cycler when the samples are heated at 37℃ for 30 minutes. This
evidence comes in the form of (1) a declaration submitted by a Bio-Rad scientist during
prosecution of a Bio-Rad patent, see JX-0171 at 328–29 (Declaration from Bio-Rad scientist
Andrew Kohlway) (“The data was generated using the protocol from the Illumina-Biorad SureCell
WTA 3’ Library Prep kit . . . Droplets were incubated at 37º for 30 minutes to allow the cleaving
agent to cleave the dT oligonucleotides off the bead. Next droplets were incubated at 50ºC for 1
hour to allow cellular RNA to be reverse transcribed using dT oligonucleotide primers.”)
(emphasis added), and (2) Bio-Rad’s own expert’s testimony, see RX-665C at Q/A 41 (“Then
another step is carried out to make sure that the 	and reverse
transcription reactions, which took place
. In this step, the tube with the emulsion is placed into a thermocycler
that is programmed to operate at two temperatures, 	. First, the thermocycler
operates at 37°C (basically our body temperature) for 30 minutes
.
Bio-Rad’s counter arguments are unpersuasive. Bio-Rad simply lacks evidentiary support
for its position that “the barcode molecules
” Bio-Rad Resp. to Qs. at 65. Bio-Rad relies heavily on the testimony of its
own expert, Dr. Michael Metzker, and one of its own employees, Dr. Douglas Greiner, who testify
not only that
. See RX-665C at Q/A 97, 102, 107; RX-507C at Q/A 65; RX-727C
at Q/A 8–11, 17–20. However, as noted in the ID, Dr. Metzker’s testimony stands only for the

PUBLIC VERSION
50
proposition that 	. See
RX-665C at Q/A 97, 102, 107; ID at 101. That testimony does not contradict the ID’s ultimate
finding that the
.
Dr. Greiner’s initial testimony is similar, establishing only that
. See RX-507C at Q/A 65. Dr. Greiner’s rebuttal testimony goes
further and, if accepted, would establish that both
. See RX-727C at Q/A 8–11,
17–20. Even this rebuttal testimony, however, stops short of establishing error in the ID’s finding
that the 	. The claimed process does
not 	include 	a 	negative 	limitation 	precluding 	any 	or 	barcoding 	from 	occurring
immediately upon droplet formation. The process requires only that 	and barcoding occur
in at least 1,000 droplets after those droplets are generated. See ’503 patent at cl. 1.
Moreover, Dr. Greiner’s rebuttal testimony relies on the assumption that the
is active at room temperature, which is contradicted by the
. 	Compare RX-727C at Q/A 11
(“Based on my own experience, I know that enzymes generally are active at room temperature,
25℃. 	Also, the scientific literature shows that the
”) with JX-0050C at 56 (“
(emphasis added)). 	Similarly, Dr. Greiner’s testimony that
is contradicted by Bio-Rad’s own reference guide, which explains that reverse
transcription occurs on the thermal cycler. Compare RX-727C at Q/A 18 (“

PUBLIC VERSION

ES

JX-0034 at 25 (“This step reverse transcribes samples on a thermal cycler.”).

Order No. 35 specifically rejected Bio-Rad’s interpretation of claim 1 wherein all droplet
formation must be complete before any barcode release and barcoding began. See Order 35 at 6.
Under such a construction, Bio-Rad might have a stronger argument that some limited amount of
barcode release and barcoding occurs before 1,000 droplets have been generated. Thus, Bio-Rad’s
arguments are most persuasive when viewed through the lens of a claim construction that was
never adopted. While Bio-Rad now tries to adjust its argument to fit the ID’s claim construction
— which does not require a// droplet generation to be complete before any barcodes are released
— the two are an imperfect match, which leads to Bio-Rad’s failure on this issue.

At bottom, the dispute here is a factual one about the operation of Bio-Rad’s products. The
ID considered this dispute, including the testimonial evidence from Bio-Rad’s expert, and
concluded that “10X has shown by the preponderance of the evidence that at least the bulk of the
following processes occur while the droplets are being heated on the thermal cycler: (1) the
a release the barcode molecules from the gel bead and (2) the reverse transcription of
barcoded cDNA from mRNA and barcode molecules.” ID at 102. The Commission has

determined to affirm that ultimate finding under the modified reasoning given above. !!

11 The ID misstates a piece of evidence on which it relies to reach that conclusion. Particularly,
the ID describes exhibit JX-0050C at 56, which is a picture of the

” TD at 100. However, the label reproduced on the exhibit does not state that incubation
should occur for 30 minutes. Instead, it states as follows: ‘
” JX-0050C at 56.

Bio-Rad pointed out this discrepancy in its petition for review, see Bio-Rad Pet. at 61, and
neither OUII nor 10X disputed the point. To the contrary, 10X’s response to Bio-Rad’s petition
is carefully worded to avoid misrepresenting i product label. See 10X Resp. to
Bio-Rad Pet. at 65 (“The ALJ relied upon Bio-Rad’s documentation that shows the RT program
at the thermal cycler contains a step of incubating the droplets at 37°C for 30 minutes, which

51

PUBLIC VERSION

2. Domestic Industry Products

Turning to the domestic industry products, although the ID found that “[w]hile the droplets
are being heated on the thermal cycler, the barcode molecules are released from the gel bead
through the application of. which dissolves the disulfide bonds holding the barcode molecules
to the gel beads,” the exhibits that were cited to support that statement do not, on their face, support
it. ID at 115 (citing CX-0481.0 at 11; CX-0004C (Butte DWS) at Q/A 481). Page 11 of CX-0481
(10X’s Single Cell 3’ Reagent Kits v2 User Guide) says nothing about barcode molecules being
released from a gel bead during incubation on a thermal cycler. CX-0481 at 11. Rather, that
exhibit describes incubation as occurring afer dissolution of the gel bead delivering the barcodes.
See id. That evidence does not address whether barcodes are released in the domestic industry
products after at least 1,000 droplets have been generated as required by step (b) of the asserted
claims.

Further, Q/A 481 of CX-0004C, Dr. Butte’s witness statement, relates to infringement by
Bio-Rad’s accused products, not 10X’s domestic industry products. CX-0004C at Q/A 481.
Though no party petitioned for correction, this citation in the ID appears to be an inadvertent error.
However, even assuming that the citation is an oversight, the portions of Dr. Butte’s witness
statement that are directed to domestic industry still do not support the conclusion that barcodes

are released on the thermal cycler. See id. at Q/A 580-81.”

matches the reaction femperature for as shown in P| product label.”
(emphasis added)). Accordingly, the Commission has determined to modify the sentence startin
on the seventh line of page 100 of the ID to read

Notwithstanding this modification, the Commission nonetheless agrees with and affirms
the ID’s conclusion that the accused products practice step (c) of claim 1.

2 The parties addressed waiver at length in their responses to the Commission’s request for
briefing on whether the domestic industry products practice the “wherein” clause limitation of step

52

PUBLIC VERSION
53
Nevertheless, the Commission has determined that, more likely than not, barcodes are still
being released in the domestic industry products after at least 1,000 droplets have been generated,
thus satisfying step (c) in combination with the ID’s finding that barcoding of the polynucleotide
molecules occurs on the thermal cycler in the domestic industry products. See ID at 115–16; see
also CX-0481 at 11; CX-0004C at Q/A 576–78. Particularly, while evidence identified by Bio-
Rad and OUII does establish that some of 10X’s promotional materials explain that the gel bead
dissolves “immediately” after droplet generation, see CX-423C at 15; CX-540 at 5:48–6:08; RX-
665C at Q/A 116, counter-evidence identified by 10X shows that while the process may begin
immediately, gel bead dissolution is not instantaneous, and that when at least the last 1,000 droplets
are formed in the domestic industry products, dissolution of the gel beads in those droplets will
not yet have occurred, but will occur shortly thereafter. See CX-0076C at 36; CX-0116C at 27;
see also 10X Reply at 50–53 (citing same).
10X’s counter-evidence establishes two main points in support of its position. 	First, it
establishes that, if used according to 10X’s recommendations, 17,000 cells are loaded into each of
eight reaction lanes on a 10X chip, which results in recovery of about 8,000 droplets each with one
gel bead and one cell. See CX-0004C at Q/A 570; CX-0481 at 15; see also 10X Reply at 50 (citing
same). 	Because a typical run of droplet formation lasts approximately 6.5 minutes, more than
1,000 droplets are generated just in the last minute of the droplet formation process. See CX-0481
at 13, 23 (describing ~6.5 minute run time); 10X Reply at 51–52 (“Taking the example described
above of loading a small number of cells per channel to generate 8,000 good droplets over a six
(c). See 10X Reply at 39; OUII Resp. to Qs. at 24, 24 n.12; OUII Reply at 19 n.14; Bio-Rad Resp.
to Qs. at 54 n.9; Bio-Rad Reply at 48–50. The parties fail to acknowledge that the Commission
enjoys sua sponte authority to review any aspect of an ID. See 19 C.F.R. § 210.44. Here, where
the evidence cited by the ID does not support the ID’s finding, such sua sponte review is
appropriate.

PUBLIC VERSION
54
minute run (see CX-0477.00002) means that at least 1,000 good droplets are generated in the last
minute alone of droplet formation.” (footnote omitted)). The crucial question then is whether those
droplets generated in the last minute still contain gel beads with attached barcodes. 	If they do,
then the release of those barcodes will satisfy the “wherein” clause of step (c) of the claimed
method. 	If, however, the gel beads dissolve instantaneously as each droplet is formed, the
“wherein” clause of step (c) would not be satisfied because, per the construction of this claim, step
(c) must occur after at least 1,000 droplets have been generated in step (b).13
The second point established by 10X’s counter-evidence addresses that crucial question.
The evidence shows that the gel beads in 10X’s domestic industry products are only partially
dissolved two (2) minutes after droplet formation. See CX-0076C at 36; CX-0116C at 27; see also
10X Reply at 52 (citing same). The following slide, which appears in two of 10X’s investment
presentations admitted into evidence, is illustrative:
13 The claim requires that a generated droplet must contain within it both a single gel bead with
barcodes attached and a single cell made up of polynucleotide molecules. See ’530 patent at cl. 1
(steps (a) and (b)). Inside the droplet, barcodes are released from the gel bead and then combine
with the polynucleotide molecules to form barcoded polynucleotide molecules. See id. (step (c)).
There is no dispute that all of this occurs in each droplet generated in the domestic industry
products. 	See, e.g., Bio-Rad Pet. at 63 (acknowledging formation of barcoded polynucleotide
molecules in droplets in the domestic industry products). The dispute between the parties is over
the timing of this process. See, e.g., id. at 63–65.

PUBLIC VERSION
55
CX-0076C at 36; see also CX-0116C at 27 (same image in black and white). The image on the
left of the middle row shows that immediately after droplet formation (t=0 min), the gel beads
inside the droplet have a defined, circular boundary:

PUBLIC VERSION
56
Id.; see also id. at 23 (illustrating components of droplet containing a gel bead). At two (2) minutes
after droplet formation (t=2 min), the image in the center of the middle row shows gel beads with
a blurred boundary, which are described as “partially dissolved”:

PUBLIC VERSION
57
See CX-0076C at 36. And, at five (5) minutes after droplet formation (t=5 min), the image on the
right of the middle row shows droplets with no visible boundary around a gel bead, which are
described as “dissolved”:
See id. 	Accordingly, the Commission agrees that “whatever ‘immediately’ means in 10X’s
promotional literature, it does not mean that 	dissolves the gel beads so fast that fewer than
1,000 of them still have barcodes attached after the completion of droplet formation.” 10X Reply
at 52.
The Commission also agrees that this evidence adequately addresses OUII’s and Bio-Rad’s
argument that the use of the word “immediately” in 10X’s promotional material means that all
barcodes were released instantaneously after droplet formation. 10X’s evidence is also consistent
with the testimony of Dr. Schnall-Levin, who testified on cross-examination that the gel bead does
not disappear instantaneously after droplet formation:

PUBLIC VERSION
58
Q. 	When you take the first droplet, the cell and bead disappear immediately;
right?
A. 	No, I don’t think so.
Tr. at 224:18–23. 	Accordingly, the Commission has determined to affirm under modified
reasoning the ID’s finding that 10X satisfied the domestic industry requirement with respect to the
’530 patent.
C. 	Infringement of Dependent Claim 26
Dependent claim 26 requires that the gel beads have at least 1,000,000 barcode molecules.
’530 patent at cl. 26 (“26. The method of claim 1, wherein said at least 1,000 barcode molecules
are at least 1,000,000 barcode molecules.”). The ID found that “the WTA 3’ v1, 	and
scATAC-seq assays infringe claim 26.” 	ID at 105.
10X and OUII both petitioned for review of the ID’s finding that dependent claim 26 of
the ’530 patent is infringed by the accused products. 	See 10X Pet. at 19; OUII Pet. at 17.
Particularly, both argued that the ID inadvertently omitted the 	from the list of
infringing assays for claim 26. See 10X Pet. at 19; OUII Pet. at 17. Bio-Rad did not dispute 10X
and OUII’s position in its response to their petitions for review. See generally Bio-Rad Resp. to
Pets.
Upon review of the ID, we agree with 10X and OUII that the omission of the
in the portion of the ID listing the assays that infringe dependent claim 26 of the ’530 patent
is the result of a clerical error and should be corrected. Cf. ID at 105. Where the ID excluded an
assay from its infringement findings, it did so explicitly and with an explanation, as in the case of
claim 4. See id. at 103. However, in the ID’s analysis of claim 26, there is no discussion of the
specifically. 	See id. at 105. 	Moreover, the record shows that 10X timely
submitted evidence to establish infringement of claim 26 with respect to all four assays. 	CX-

PUBLIC VERSION
59
0004C at Q/A 554–556. Accordingly, the Commission has determined to modify the ID’s findings
to include the 	among the assays that infringe claim 26.
D. 	Contributory Infringement
OUII petitioned for review of the ID’s finding that “10X has failed to show that using the
scATAC-seq assay with isolated nuclei is not a substantial non-infringing use of the ddSEQ vl
products,” ID at 112, which defeated 10X’s allegations of contributory infringement with respect
to the ’530 patent. See OUII Pet. at 17–18. In OUII’s view, the finding should be reversed because
“as of the time of the hearing, the record evidence showed a lack of substantial, non-infringing uses
for the ddSEQ v1 products under the ’530 patent.” Id. at 18. OUII noted, however, that even if the
ID’s finding was reversed, the ID’s ultimate finding of violation would not be affected because the ID
found that Bio-Rad induced infringement of the ’530 patent. 10X summarily joined OUII on this issue
in its response to OUII’s petition for review. See 10X Resp. to OUII Pet. at 7. Bio-Rad did not respond
to OUII’s petition on this issue. See generally Bio-Rad Resp. to Pets.
The Commission has determined to take no position on whether 10X has established
contributory infringement with respect to the ’530 patent. The Commission affirms the remainder of
the ID’s findings with respect to indirect infringement of the ’530 patent, including specifically its
finding that Bio-Rad induced infringement of the ’530 patent.
E. 	Indefiniteness
The Commission asked the parties to brief whether “any party argue[d] in its pre- or post-
hearing briefing that the ALJ’s construction of claim 1 of the ’530 patent, as laid out in orders 22
and 35, was indefinite.” 	Notice at 4. 	No party contended in response that indefiniteness was
briefed in either pre- or post-hearing briefing. Bio-Rad and OUII, nonetheless, argued that Bio-
Rad’s indefiniteness argument is not waived. 	Notably, Bio-Rad and OUII adopted different
rationales for why waiver does not apply.

PUBLIC VERSION
60
OUII pointed back to Bio-Rad’s briefing during the Markman stage of the hearing, where
Bio-Rad argued that claim 1 of the ’530 patent was indefinite. See OUII Resp. to Qs. at 26. The
Markman order rejected that indefiniteness argument on the basis that Bio-Rad had conflated
breadth with indefiniteness. 	See Order No. No. 22 at 46. 	OUII submitted that because the
“Markman Order rejected Bio-Rad’s indefiniteness arguments in view of the ‘clear and readily
understood’ meaning of the disputed terms,” it also “implicitly h[eld] that the Order’s own
construction did not render the claim indefinite.” Id. OUII further submitted that an instruction
in the Markman order directing the parties’ subsequent briefing to apply the Markman order’s
constructions “presumably limit[ed] the parties to challenging the ordered constructions in
petitions for review.” 	Id. (citing Order No. 22 at 52 (“Hereafter, discovery and briefing in this
Investigation shall be governed by the construction of the claim terms in this Order.”).
Bio-Rad did not point to its Markman stage indefiniteness argument to avoid waiver.
Instead, Bio-Rad argued it was precluded from raising its indefiniteness argument by the timing
of Order Nos. 22 and 35. 	Bio-Rad Resp. to Qs. at 70–71. 	Expanding on that idea, Bio-Rad
explained that it “believed that, as a result of the limitations imposed on the claimed method in the
Markman Order, in particular, the requirement that step (b) of the method be completed in all 1,000
droplets before step (c) was performed on any of the droplets, a requirement the judge identified
in finding the claim definite, it no longer had a basis to argue indefiniteness in its Prehearing Brief,
as it had previously argued during claim construction.” Id. at 71. Bio-Rad appears to have argued
though that Order No. 35, which clarified the construction of claim 1 given in the Markman Order,
either gave rise to a new basis for arguing indefiniteness or revived its prior basis. See id. at 72.
Bio-Rad’s briefing also suggested that the language of the Markman Order directing the parties to

PUBLIC VERSION
61
apply the constructions therein precluded it from raising its indefiniteness arguments. 	Bio-Rad
Reply at 53.
On review, the Commission has determined that the indefiniteness challenge raised by Bio-
Rad in its petition for review is new, could have been presented before the ALJ, was not presented
before the ALJ, and therefore is waived. See Ground Rule 11.1.
If OUII were correct that Bio-Rad’s indefiniteness arguments before the ALJ during the
Markman phase of the investigation preserved the indefiniteness arguments in its petition, Bio-
Rad would, presumably, be limited to challenging the Markman Order’s resolution of Bio-Rad’s
indefiniteness argument. 	Bio-Rad’s petition is, however, silent on the reasoning given in the
Markman Order rejecting Bio-Rad’s indefiniteness argument at the time. See Bio-Rad Pet. at 48–
55. The Markman order explained that:
Bio-Rad asserts that the terms “providing,” “plurality of cells,” and “at least 1,000
droplets” render the claim indefinite because the claim “calls for the generation of
1,000 droplets containing specific material but does not describe how or under what
circumstances those droplets are formed.” RRB at 23. In making this argument,
Bio-Rad confuses breadth with indefiniteness. Breadth does not render a claim
indefinite. BASF Corp. v. Johnson Matthey Inc., 875 F.3d 1360, 1367 (Fed. Cir.
2017 (“[B]readth is not indefiniteness.”) (quoting SmithKline Beecham Corp. v.
Apotex Corp., 403 F.3d 1331, 1341 (Fed. Cir. 2005)) (internal quotation marks
omitted); Manual of Patent Examining Procedure § 2173.02 (“A broad claim is not
indefinite merely because it encompasses a wide scope of subject matter provided
the scope is clearly defined”). Standing alone and in the context of the claim, the
claim terms identified by Bio-Rad are clear and readily understood “even to lay
judges.” Phillips, 415 F.3d at 1314. Based on the foregoing, I find that Bio-Rad has
not shown that claim 1 is indefinite.
Order No. 22 at 46. Bio-Rad’s petition did not address the Markman Order’s conclusion that Bio-
Rad mistook breadth for indefiniteness. 	Instead, Bio-Rad’s petition argued that “[t]he ID
construction renders the claim indefinite both because it permits aggregation of multiple runs and
because it eliminates the requirement that the method steps be performed in a specific order.” Bio-
Rad Pet. at 48. Moreover, Bio-Rad’s petition made clear that the indefiniteness argument raised

PUBLIC VERSION
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therein is based on the construction applied in the ID, which, in Bio-Rad’s view, is consistent with
the clarified construction of Order No. 35, but not with the construction in the Markman Order.
See Bio-Rad Pet. at 48 (“The ID construction renders the claim indefinite both because it permits
aggregation of multiple runs and because it eliminates the requirement that the method steps be
performed in a specific order.” (emphasis added)). Bio-Rad’s focus on the clarified construction
of Order No. 35 suggests that Bio-Rad itself does not view its Markman indefiniteness argument
and its petition indefiniteness argument as one and the same. Moreover, Bio-Rad’s focus on the
timing of Order No. 35, i.e., that it was issued after Bio-Rad submitted its prehearing brief, as a
reason it could not raise its indefiniteness argument at the hearing or in post-hearing briefing
further supports the conclusion that the indefiniteness argument in the petition is distinct from the
one raised before the ALJ. 	If not, the timing of Order No. 35 would be irrelevant, as Bio-Rad
would have already had the opportunity to raise its indefiniteness argument during the Markman
proceeding. Put differently, by arguing unfairness in the timing of Order No. 35 to support raising
indefiniteness 	on 	review, 	Bio-Rad 	effectively 	undercut 	any 	argument 	that 	its 	petition’s
indefiniteness argument was preserved by its Markman indefiniteness argument.
Moreover, the indefiniteness argument in Bio-Rad’s petition included new arguments that
it did not raise in its Markman briefing. During the Markman process, Bio-Rad relied exclusively
on the fact that the claims did not specify whether the droplets had to be generated in a single
experiment or in multiple experiments. 	Bio-Rad Opening Markman Br. at 31 (“Nothing in the
intrinsic evidence clarifies how or when the claimed 1,000 droplets each containing a gel bead and
a cell should be generated. For example, the droplets could be generated in one experiment or in
multiple experiments.”). By contrast, the indefiniteness argument in Bio-Rad’s petition is based
on the theories that “numerical limitations in method claims must be met in each run of the method,

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63
and cannot be met through aggregation of multiple runs,” Bio-Rad Pet. at 48, and “[i]f the ‘530
Patent encompasses a continuous process, the ‘530 Patent is indefinite because the plain language
of the claims does not inform a person of skill in the art with reasonable certainty about the scope
of the claimed method.” Id. at 54–55. Even assuming that the multiple experiment argument of
the Markman brief and the aggregation argument of the petition are the same — an assumption
which is not clearly justified — the continuous-process argument is still a new theory of
indefiniteness that was never presented to the ALJ.
In a similar vein, the indefiniteness argument in Bio-Rad’s petition relies on new evidence
that was never presented to the ALJ in connection with indefiniteness. Particularly, Bio-Rad relies
on deposition testimony from one of the inventors of the ’530 patent and a 10X executive (Dr.
Michael Schnall-Levin) to support its petition’s indefiniteness argument. See Bio-Rad Pet. at 52.
Bio-Rad did not rely on testimony from Dr. Schnall-Levin in its Markman briefing.
At bottom, the indefiniteness argument raised in Bio-Rad’s petition is a new argument that
was never raised before the ALJ. The Commission does not agree with OUII that the instruction
in Order No. 22 requiring the parties to apply the constructions therein precluded the parties from
asserting the indefiniteness of those claims as construed. 	A more reasonable reading of that
statement is that the parties should not present multiple analyses based on different claim
constructions going forward in the case.
Bio-Rad’s argument that it has not waived its petition’s indefiniteness arguments because
the timing of Order No. 35 prevented it from raising the argument at the hearing or in its briefing
is not persuasive. First, the argument is premised on Bio-Rad’s belief that Order No. 35 reversed
the construction of claim 1 given in Order No. 22. The Commission does not agree, however, that
the two orders are inconsistent with each other. 	Rather, Bio-Rad interpreted Order No. 22 in a

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way that was not correct — it interpreted the order such that any barcoding that occurred prior to
the completion of droplet formation would defeat infringement — and Order No. 35 pointed out
as much in denying Bio-Rad’s motion for summary determination of no infringement. Bio-Rad’s
misinterpretation of Order No. 22 cannot be a reason to excuse its failure to argue indefiniteness
before the ALJ.
However, even if Order No. 35 had materially altered the construction of claim 1 of the
’530 patent, Bio-Rad’s late indefiniteness argument would still be waived. This is because Bio-
Rad could have sought relief from the ALJ, but did not. For example, Bio-Rad could have asked
the ALJ for leave to amend its prehearing filings on the basis that Order No. 35 provided a new
construction that it could not possibly have addressed in those filings. But Bio-Rad did not seek
such leave. Instead, it waited until after the ID issued to argue that the clarification given in Order
No. 35 rendered claim 1 indefinite. 	That course of action prevented 10X and OUII from
developing testimony or introducing evidence to rebut that argument, and prevented the ALJ from
considering the argument. While Bio-Rad argues repeatedly that it was “denied the opportunity”
to argue that the ALJ’s construction of claim 1 was indefinite, there is no support for that statement.
Bio-Rad Reply at 53. Particularly, it is not clear why Order No. 22’s statement that “[h]ereafter,
discovery and briefing in this Investigation shall be governed by the construction of the claim
terms in this Order,” would preclude Bio-Rad from arguing that claim 1 was indefinite. If Bio-
Rad had sought leave to raise its indefiniteness argument at the hearing after receiving Order No.
35, and if the ALJ denied that request, Bio-Rad would be on much stronger ground to argue that it
was not permitted to make its indefiniteness argument. That is not what happened though. Bio-
Rad simply did not argue that claim 1 as construed was indefinite until after the ID issued. That
is waiver.

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In the alternative, even if there were no waiver, Bio-Rad has not shown by clear and
convincing evidence that claim 1 of the ’530 patent is indefinite. 	See BASF Corp. v. Johnson
Matthey Inc., 875 F.3d 1360, 1365 (Fed. Cir. 2017) (explaining that the defendant has “the burden
of proving indefiniteness by clear and convincing evidence.”). Concerning the argument it made
at the Markman phase of the investigation, the Commission agrees with the ALJ’s reasoning in
Order No. 22 that Bio-Rad’s arguments conflated broad claims with indefinite ones. The fact that
the claim does not limit droplet generation to one particular mode, i.e., in a single experiment, or
from a single sample, or in one run, etc., simply means the claim is broad and all of those modes
are covered. Bio-Rad cannot manufacture uncertainty in the claim by arguing that only one mode
can be claimed and then arguing that the claims fail to specify the particular mode.
Bio-Rad’s petition-stage indefiniteness argument fails for multiple reasons. 	First, the
argument is based on Bio-Rad’s continued misinterpretation of the ID’s construction of the claim.
Bio-Rad argued that the ID’s construction of claim 1 allows aggregation of multiple runs to meet
the numerical limitations therein. Explaining that assertion, Bio-Rad argued that because its chips
each have four lanes, processing droplets on one chip is actually four different experimental runs.
Because the ID found that a chip generates approximately 1,200 droplets, Bio-Rad argued that the
ID relied on the aggregation of four different runs that each generate about 300 droplets to find
infringement. See Bio-Rad Pet. at 49. Bio-Rad relies on Applera Corp. v. Illumina, Inc., 375 Fed.
App’x. 12, 20-21 (Fed. Cir. 2010), and In re Varma, 816 F.3d 1352, 1362–64 (Fed. Cir. 2016), for
the proposition that aggregation is not permitted.
The Commission disagrees with Bio-Rad’s aggregation argument because nothing in the
claim indicates that the method must be confined to a single lane on a chip. See ’530 patent at cl.
1. To the contrary, the specification clearly contemplates that different machinery used together

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can practice the invention. See ’530 patent at 10:1–18 (describing use of a device with microwell
chambers to practice the method). Further, the concerns animating In re Varma and Applera are
not present here. 	The portion of In re Varma relied on by Bio-Rad simply stands for the
proposition that where a claim recites an object that performs two functions, the claim is not
practiced by two objects that each perform one of the functions. In re Varma, 816 F.3d at 1363
(“For a dog owner to have ‘a dog that rolls over and fetches sticks,’ it does not suffice that he have
two dogs, each able to perform just one of the tasks.”). That issue is not present here where the
claims do not include a requirement that a single lane on the chip generate at least 1,000 droplets.
Applera is no more on point. There, the claim at issue, in simple terms, covered a three-
step process where the third step was to repeat the first two. Applera, 375 Fed. App’x at 20. The
patentee advanced a construction that would allow one to skip the second step of the process for
some repetitions of the process. 	The Federal Circuit agreed with the district court that such a
construction was incorrect because it abrogated the second step of the process. Id. at 20–21. Thus,
neither Applera nor In re Varma stand for a broad prohibition on aggregation as Bio-Rad contends.
The Commission further notes that neither of those cases addresses indefiniteness based on
aggregation.
Separate from Applera and In re Varma, Bio-Rad argued that if aggregation is permitted,
claim 1 is indefinite because “there is no starting point and no endpoint that defines any particular
method cycle” and “[a]ny number of droplets containing a single bead and a single cell, with
reagents for barcoding, can be generated at any time over the course of any number of runs, on
any number of independent droplet generators.” 	Bio-Rad Pet. at 50. 	Bio-Rad then argued that
“[a]s long as, at some point, it is determined that at least 1,000 productive droplets were generated
where barcoding occurred, the limitations of the claim are met,” and submits that such a claim is

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in conflict with Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. 898 (2014). Bio-Rad relied on
Dow Chemical Co. v. Nova Chemicals Corp., 803 F.3d 620 (Fed. Cir. 2015), and Icon Health &
Fitness, Inc. v. Polar Electric Oy, 656 Fed. Appx. 1008 (Fed. Cir. 2016), as analogous situations
where indefiniteness was found. Bio-Rad at 50. Bio-Rad also argued that deposition testimony
from 10X’s expert and an inventor of the ’530 patent indicates that claim 1 has no objective
boundaries. Bio-Rad Pet. at 51.
First, Bio-Rad’s assertions that claim 1 has no starting point or end point under the ID’s
constructions are baseless. Claim 1 has three steps: (a) a “providing” step in which raw materials
are provided; (b) a “generating” step in which those raw materials are used to generate droplets;
and (c) a barcoding step where barcoded polynucleotides are generated in at least 1,000 droplets.
’530 patent at claim 1. The claimed method starts at the providing step and ends after barcoding
has occurred in at least 1,000 droplets. 	Id. 	Bio-Rad’s argument attempts to manufacture
uncertainty in an otherwise straightforward three-step claim by focusing on limitations that are not
present in the claim — for example, that droplets must be generated in a single “run,” or that they
must be generated only in a single droplet generator, or only in droplet generators that are not
independent. Cf. Bio-Rad Pet. 50. Bio-Rad’s indefiniteness argument is not directed at claim 1
of the ’530 patent; it is directed at a claim of its own making, i.e., a strawman.
The cases Bio-Rad relies on bear little resemblance to the facts in this investigation and are
of little relevance. Dow dealt with the claim phrase “slope of strain hardening coefficient greater
than or equal to 1.3,” which the facts in that case showed could be calculated four different ways
— each with different results. Dow Chemical Co., 803 F.3d at 631–634. This investigation does
not present that scenario, nor even an analogous scenario. Icon Fitness found a claim indefinite
where the evidence of record showed that the terms “in-band” and “out-of-band” were relative

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terms that only have meaning in the context of a defined reference. Icon Health & Fitness, Inc.,
656 Fed. App’x at 1016. Here again, that scenario is not presented in this investigation. And, with
respect to Nautilus, a case that dealt with the meaning of the phrase “spaced relationship” in
exercise equipment, see Nautilus, 572 U.S. at 903–906, but which is legally significant for striking
down the Federal Circuit’s prior formulations of the test for indefiniteness, see id. at 901, Bio-Rad
relies on the case for broad assertions unrelated to the facts of Nautilus. This includes the assertion
that “the fact that the ALJ issued and applied two conflicting constructions over the course of the
investigation supports the indefiniteness of the ’530 Patent claims,” Bio-Rad Pet. at 38–39 (citing
Nautilus), and that open ended claims “violate[] the strictures of Nautilus,” id. at 50. 	Yet,
Bio-Rad’s reliance on Nautilus is little more than a collection of unsupported assertions that the
ID’s construction of claim 1 somehow conflicts with the reasonable certainty standard for
indefiniteness laid out in Nautilus. 	Merely identifying the case that lays out the standard for
indefiniteness and then asserting that the standard is met, or not met, is not clear and convincing
evidence of invalidity, which is what is required.
The expert testimony Bio-Rad relies on does not meet its burden either. See Bio-Rad Pet.
at 51. The citations from the transcript of Dr. Butte’s deposition show the attorney and Dr. Butte
having a lengthy discussion about what is and is not a “common process,” with Dr. Butte giving,
admittedly, widely varying answers. 	See JX-157 at 123:13–137:3. 	Bio-Rad relied on this
testimony to argue that whether aggregation is permitted depends on the vagaries of a person’s
opinion, thus rendering claim 1 indefinite. See Bio-Rad Pet. at 51–52. This entire line of reasoning
is tainted however by the fact that, again, there is no limitation in the claim requiring droplet
generation to occur on a single machine, in a single experiment, as part of a single “run,” from a
single “sample,” or as part of a “common process.” See generally ’530 patent at cl. 1. An expert’s

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extrinsic testimony on a limitation that is not present in the claims is not probative evidence of
indefiniteness. For that reason, we also find Bio-Rad’s reliance on Interval Licensing LLC v. AOL,
Inc., 766 F.3d 1364, 1371 (Fed. Cir. 2014), which found the term “unobtrusive manner” depended
on a person’s subjective opinion and therefore rendered the claim in which it appeared indefinite,
to be inapposite. 	See Bio-Rad Pet. at 51–52. Teva Pharm. USA, Inc. v. Sandoz, Inc., 789 F.3d
1335, 1345 (Fed. Cir. 2015), which Bio-Rad also relies on in connection with Dr. Butte’s
testimony, is also unhelpful as the indefiniteness issue in Teva is essentially identical to the one in
Dow. See Bio-Rad Pet. at 52.
Bio-Rad’s reliance on Dr. Schnall-Levin’s deposition testimony is no more probative. See
id. (citing RX-413C at 285:19–24). 	Bio-Rad asked Dr. Schnall-Levin if the patent provided
directions of how many cells to run per chip in claim 1, and Dr. Schnall-Levin answered that there
were no instructions on cells per chip. 	See id. 	This testimony does not show that a person of
ordinary skill in the art would not understand the boundaries of the three-step process laid out in
claim 1 of the ’530 patent. It simply shows that Bio-Rad can concoct a limitation that is not present
in the claim, ask if the patent describes that limitation, and then get an answer in the negative. This
is manufactured uncertainty — not indefiniteness.
As to Bio-Rad’s continuous-process indefiniteness argument, Bio-Rad Pet. at 53–55, the
argument fails because it is based on a faulty premise: that the ID’s construction does not require
the steps to be performed in order. Id. at 54. That is not the case. The ID, as well as Order Nos.
35 and 22, all require step (b) to be completed before step (c). Thus, the ID does not permit an
assembly-line style process where step (c) is completed on a droplet as soon as it is generated in
step (b). Bio-Rad, however, appears to mean something different when it refers to performing the
steps of the claim in order. In Bio-Rad’s view, no barcoding can occur in any droplet before at

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least 1,000 droplets are generated in step (b). This is something more than simply requiring the
steps be performed in order. What Bio-Rad seeks is to include a new negative limitation in claim
1 that excludes any barcoding from occurring before at least 1,000 droplets have been generated.
This was the issue that was clarified in Order No. 35, and the basis of Bio-Rad’s unsuccessful
motion for summary determination of noninfringement.
Claim 1, however, is an open-ended claim, and thus other non-recited activity may occur
that will not defeat infringement. Here, as 1,000 droplets are generated in step (b), there may be
some barcoding happening as soon as each droplet is generated. This will not preclude the process
from reading on step (c) though if, after 1,000 droplets are generated, barcodes are released in
those droplets and a plurality of polynucleotides are barcoded. The fact that barcoding of other
polynucleotides also happened before 1,000 droplets were generated is irrelevant. 	Bio-Rad
incorrectly characterizes the ALJ’s observation to that effect as permitting a continuous process.
The ALJ correctly determined that extraneous unrecited activity will not defeat infringement of a
claim drafted in open language.
Finally, we note that Bio-Rad offers no real reasoning why construing claim 1 to
encompass a continuous process would render it indefinite. Bio-Rad simply parrots the reasonable
certainty language of Nautilus. Bio-Rad Pet. at 54–55.
For all these reasons, the Commission finds that Bio-Rad waived the indefiniteness
arguments raised in its petition for review, but even if not waived, those arguments and the
evidence presented therein would fail to establish that claim 1 is indefinite by clear and convincing
evidence.
VII. 	I NVENTORSHIP
The Commission determined to review the ID’s findings with respect to Bio-Rad’s
inventorship defense. 	See Notice at 2. 	On review, the Commission has determined to take no

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position on whether Dr. Heredia should have been named as a joint inventor of the ’204 patent.
The Commission affirms the ID’s findings with respect to Bio-Rad’s inventorship defense for the
other three patents. Because the Commission has affirmed the ID’s finding of noninfringement
with respect to the ’204 patent, the Commission’s determination to take no position on Bio-Rad’s
inventorship defense with respect to the ’204 patent does not affect the ID’s ultimate finding of no
violation with respect to the ’204 patent.
VIII. 	O WNERSHIP
The ID rejected Bio-Rad’s claim that it had an ownership interest in each of the asserted
patents based on work done by Drs. Hindson and Saxonov during their time at QuantaLife/Bio-
Rad. See ID at 136–152. The ID began by explaining that inventorship and ownership are distinct
issues, and that while federal patent law governs inventorship, ownership is a question of state
contract law. 	Id. at 136–141. 	The ID noted with disapproval that the parties conflated the two
issues in their briefing. See id. at 141. The ID went on to explain that the crux of the dispute with
respect to Bio-Rad’s ownership defense involves defining the “inventive concept” in the asserted
patents. See id. The ID rejected Bio-Rad’s approach to that issue, explaining that Bio-Rad “briefed
the matter as if it owned a share of the patents because it could trace some elements of the asserted
patents to work done at Quanta/Life and Bio-Rad.” 	Id. 	The ID explained that while Bio-Rad
“owns many ideas conceived by Drs. Hindson and Saxonov, [] it does not own the idea for the
specific arrangement of elements claimed in the asserted patents . . . because there is insufficient
evidence that that idea was conceived-during the period of employment.” Id. at 142.
Concerning the pertinent contract language, the ID noted that “[n]o provision of any of the
applicable contracts governs future inventions that are based on or developed from work done
during employment.” Id. at 144. Based on this observation, the ID found Bio-Rad’s interpretation
of the contract to be unreasonable because it “read out the plain meaning of the durational

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limitation in the pertinent contracts, and in its place suggest[ed] an interpretation of the contracts
in which inventions developed by the employee after his employment belong to the company if
they are related to ideas conceived during employment.” Id. at 145. The ID went on to reject Bio-
Rad’s theory that it is entitled to a pro-rata undivided co-ownership interest in the asserted patents
based on Drs. Hindson and Saxonov’s discovery of ideas that are related to the invention in the
asserted patents, as opposed to their actual discovery of the invention. See id.
The ID next considered whether Bio-Rad had presented evidence showing that the
inventive idea embodied in the asserted patents was conceived at QuantaLife/Bio-Rad. 	The ID
concluded that Bio-Rad presented no direct evidence of such conception. 	See id. 	As for
circumstantial evidence, the ID determined that the relatively short time between when Drs.
Hindson and Saxonov left Bio-Rad and when they filed their first provisional patent application
did not, on its own, establish conception by Drs. Hindson and Saxonov at Bio-Rad. Id. at 146.14
The ID also rejected several challenges to Dr. Hindson’s credibility. Id. at 147–48.
Next, the ID rejected Bio-Rad’s argument that certain concepts disclosed by Drs. Hindson
and Saxonov at Bio-Rad can be traced to the asserted patents such that conception at Bio-Rad
should be implied. 	Id. at 149. 	In rejecting this argument, the ID credited testimony from Dr.
Saxonov that the ideas formed at Bio-Rad were only directions for further research, as opposed to
ideas that would work. See id. at 149–150. The ID also rejected a similar argument based on the
’059 patent’s disclosure of certain numerical ranges, see id. at 150, and based on lab notebooks
offered by 10X. See id. at 150–51. The ID concluded as follows: “In sum, the evidence before
me is insufficient to permit the conclusion that, more likely than not, the work Drs. Hindson and
14 The ID noted that Drs. Hindson and Saxonov left Bio-Rad in April 2012 and founded 10X
several months later. 	ID at 146. 	In August 2012, Drs. Hindson and Saxonov filed their first
provisional patent application at 10X. Id.

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Saxonov did at QuantaLife and Bio-Rad led them to conceive the idea described in the 10X patents
while they were still under contract.” Jd. at 151. Accordingly, the ID found that Bio-Rad “failed
to establish ownership of the asserted patents.” Jd.

The ownership dispute in this investigation revolves around Drs. Hindson and Saxonov’s

employment contracts with QuantaLife and Bio-Rad. The relevant portions of the QuantaLife

contracts contain identical language, as follows:

RX-0623C (Hindson-QuantaLife contract) at §2; RX-0624C (Saxonov-QuantaLife
contract) at § 2; see also ID at 143-44 (quoting same). The relevant portions of the Bio-

Rad contracts also contain identical language, as follows:

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RX-0619C (Hindson-Bio-Rad employment agreement) at JJ 3, 6; RX-0620C (Saxonov-
Bio-Rad employment agreement) at {J 3, 6; see a/so ID at 144 (quoting same).

The Commission finds that Bio-Rad has failed to show that the “ideas” developed by Drs.
Hindson and Saxonov at QuantaLife/Bio-Rad would entitle them to an ownership interest in the
asserted patents. This follows for several reasons. First, in its response to the Commission’s
questions, Bio-Rad only attempted to map the ideas developed at QuantaLife/Bio-Rad onto a
single claim: claim | of the ’468 patent. See Bio-Rad Resp. to Qs. at 4-12. Bio-Rad summarily
asserted that the “’468 Patent is representative of the claims of the four 10X Patents,” id. at 5, but
did not attempt to show a direct correspondence between the “ideas” developed at QuantaLife/Bio-
Rad and the particular limitations of any claim of the ’024, ’204, and ’530 patents.!° Instead, Bio-
Rad argued that all four asserted patents have the same “fundamental architecture,” and thus its
mapping of ideas onto the limitations of claim 1 of the ’468 patent should entitle it to an ownership
interest in the other asserted patents as well. See id. at 12-14. Thus, at best, Bio-Rad’s showing
of ownership under its theory would be limited to the ’468 patent.

Second, Bio-Rad was only able to map the “ideas” it relies on to claim 1 of the ’468 patent
because it substituted generic descriptions in place of the specific limitations of that claim. For

example, Bio-Rad argued that Dr. Hindson “came up with ideas at QuantaLife about a

1° Among other “ideas,” Bio-Rad argued that Drs. Hindson and Saxonov conceived of the idea to
use porous gel beads as a reagent delivery system while at QuantaLife. See Bio-Rad Resp. to Qs.
at 10. However, Order No. 43 precluded Bio-Rad from arguing that the idea for porous gel beads
was conceived at QuantaLife/Bio-Rad. Bio-Rad did not petition for review of that order, nor has
the Commission determined to review that order sua sponte. Accordingly, Bio-Rad may not now
argue that it is entitled to an ownership interest in the asserted patents because the idea of using
porous gel beads was developed at QuantaLife.

74

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and that “[t]he use of droplets to partition sample (and achieve a single cell per partition)
is fundamental to claim 1 of the ’468 Patent.” Bio-Rad Resp. to Qs. at 5. But claim 1 of the ’468
patent recites a method for droplet generation with three steps, each of which has a number of
specific internal limitations; it does not broadly claim the use of droplets to partition a sample. See
’468 patent at cl. 1. 	That disconnect undercuts Bio-Rad’s theory of ownership based on Drs.
Hindson and Saxonov’s prior “ideas.”
In the same vein, the Commission also notes that the “ideas” Bio-Rad identified relate to
different architectures and applications than those central to the asserted patents. See CX-0001C
(Hindson WS) at Q/A 79–107 (discussing 10X’s development of its GEMs and their attributes);
see also ID at 142 (“the inventive idea is a specific arrangement of elements which, when
combined, works to achieve a desired goal.”). This follows from the fact that the “ideas” relied on
by Bio-Rad were developed in connection with the droplet-in-droplet architecture described in the
’059 patent. 	See, e.g., Bio-Rad Pet. at 84, 87 (citing lab notebook (RX-127C at 95, 97) and
, to
support ownership claim based on “ideas” developed at QuantaLife). 	The asserted patents,
however, do not use a droplet-in-droplet approach, as the ’059 patent did (Dr. Saxonov is the
named inventor of the ’059 patent, and he assigned the patent to Bio-Rad). See Tr. (Metzker) at
656–657; CX-1829C (Saxonov WS) at Q/A 28–32 (discussing the droplet-in-droplet concept for
barcoding before sequencing and its disclosure in the ’059 patent); CX-1827C (Dear WS) at Q/A
40. Rather, the asserted patents, in contrast, require features such as the release of the barcodes
from the bead into the droplet in the ’024 patent, a particular microfluidic arrangement for
generating droplets with the beads in the ’468 patent, and a large diversity of beads for use in

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generating droplets with single cells in the ’530 patent. See CX-1827C (Dear WS) at Q/A 40; see
also ID at 33–40 (finding that the ’024 patent was novel and not obvious vis-à-vis the ’059 patent
and Church (RX-0462)). 	As such, the asserted patents are based on a different architecture
involving beads or capsules that release key reactants. See CX-1828C (Hindson WS) at Q/A 24–
34 (describing how 10X invented its GEM architecture “from scratch . . . because there was no
such architecture at QuantaLife.”). 	Thus, the inventions claimed in the asserted patents are
fundamentally different from the prior work conducted at QuantaLife/Bio-Rad.
Third, even under Bio-Rad’s theory that it owns a share of the patents based on joint
inventorship principles, see, e.g., Bio-Rad Pet. at 77–80, Bio-Rad has not shown that the “ideas”
it relies on to build its joint inventorship argument are distinct from the prior art. Indeed, many of
these “ideas” are embodied in the ’059 patent — a patent naming Dr. Saxonov as an inventor that
was assigned to Bio-Rad because the underlying invention was developed during his employment
at Bio-Rad — which make those ideas part of the prior art. See ’059 patent (JX-0031) at 1:26–55.
But merely explaining the prior art is not sufficient to render someone a joint inventor. See Fina
Oil & Chem. Co. v. Ewen, 123 F.3d 1466, 1473 (Fed. Cir. 1997) (“[A] person will not be a co-
inventor if he or she does no more than explain to the real inventors concepts that are well known
and the current state of the art.”). No part of Drs. Hindson and Saxonov’s employment agreements
preclude them from building on ideas in the prior art. Moreover, the existence of the ’059 patent
demonstrates that Bio-Rad received the benefit of its bargain with respect to the employment
agreements. For the ideas that were conceived at QuantaLife or Bio-Rad, Dr. Saxonov did assign
his rights. See ’059 patent (JX-0031) at Cover (“Assignee: Bio-Rad Laboratories, Inc.”). Bio-
Rad overreaches insomuch as it now attempts to extend its rights to inventions conceived outside
the term of Drs. Hindson and Saxonov’s employment agreements. Cf. Israel Bio-Eng’g Project v.

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Amgen, Inc., 475 F.3d 1256, 1267 (Fed. Cir. 2007) (in a case involving an Israeli contract, the
Federal Circuit concluded that the plaintiff “was not entitled to further assignments of any other
newly developed inventions, even when these inventions built on proprietary information
developed during the [contractual] R & D process,” which concluded in December 1987); see also
ID at 148–49 n.29 (reasoning that if Hindson and Saxonov’s prior, generic work
were sufficient to trigger ownership rights, “the
contracts’ 	would be nullities.”); Dawson v. Dawson, 710 F.3d 1347, 1353–
56 (Fed. Cir. 2013) (concluding that, along with other evidence, a preliminary statement about a
potential use was insufficient to establish that an inventor conceived the claimed invention while
employed by his former employer). Accordingly, for the reasons provided above, the Commission
finds that Bio-Rad has failed to show that the “ideas” Bio-Rad relies on entitle it to an ownership
interest in the asserted patent.
Concerning the ID’s use of the phrase “inventive concept,” the Commission notes that the
phrase has some history in patent law and its use in the ID may invite confusion, as evidenced by
Bio-Rad’s brief. 	See, e.g., Bio-Rad Ans. at 16 (“The ALJ’s analysis was incorrect because it
treated the ownership question as requiring proof of a singular eureka moment at a specific point
in time when everything was finalized and established to work.”). 	Particularly, “inventive
concept” may imply similarity to the pre-1952 patent law’s requirement for a “flash of genius,”
compare Cuno Eng’g Corp. v. Automatic Devices Corp., 314 U.S. 84, 91 (1941) (requiring an
invention to “reveal the flash of creative genius not merely the skill of the calling.”) with Pub. L.
82-593, § 103, July 19, 1952, 66 Stat. 798 (Patent Act of 1952) (“Patentability shall not be
negatived by the manner in which the invention was made.”), or it may suggest the search for an
“inventive concept” in step 2 of an Alice patent-eligibility analysis. See Alice Corp. Pty. v. CLS

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Bank Int’l, 573 U.S. 208, 217 (2014) (“We have described step two of this analysis as a search for
an ‘inventive concept.’”).
Upon review of the ID, the Commission has determined to clarify that the ID’s use of the
phrase “inventive concept” is synonymous with “the specific arrangement of elements claimed in
the asserted patents.” ID at 142; see also id. (“[T]he invention claimed in the asserted patents is
complex and consists of many elements. CX-0001C (Hindson WS) at Q/A 88. The inventive idea,
which emerged from many other ideas (some of which clearly were in the prior art), is to combine
these elements in a process resulting in what 10X calls the GEM (‘gel bead in emulsion’)
architecture. 	As confirmed by both parties, the inventive idea is a specific arrangement of
elements which, when combined, works to achieve a desired goal.”). Bio-Rad’s position that
the use of the phrase “inventive concept” in the ID is indicative of a search for a singular eureka
moment conflicts with the ID’s explanation that the inventive concept is the combination and
specific arrangement of elements laid out in the claims of the asserted patents. The Commission
finds no error in the ID’s focus on the inventions as laid out in the claims in its analysis of Bio-
Rad’s ownership defense.
Consistent 	with 	the reasoning 	above, 	the Commission 	affirms 	with supplemented
reasoning the ID’s finding that Bio-Rad has not shown that it is entitled to an ownership interest
in any of the asserted patents.
IX. 	CLERICAL E RROR
10X’s petition for review included a request to correct two clerical errors in the ID. See
10X Pet. at 18–19. One of the errors appears on page 91 of the ID, and the other on page 105. See
id. at 19. 	The error on page 105 relates to the same absence of an accused assay in the ID’s
infringement findings for dependent claim 26 of the ’530, which has already been addressed supra
in this opinion. Concerning the error on page 91, 10X explained that “[t]he ID states on page 91

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that ‘[i]n Order No. 35, this claim construction was further clarified so that it does preclude the
generation of some barcoded molecules before the start of the claimed third step,’ which should
have stated ‘so that it does not preclude the generation of some barcoded molecules before the start
of the claimed third step.’” Id. OUII agreed that the omission of the word “not” was an oversight.
See OUII Resp. to Pets. at 44–45. 	Bio-Rad did not directly respond to 10X’s assertion that the
omission of the word “not” was a clerical error. 	See generally Bio-Rad Resp. to Pets. Instead,
through its own petition, Bio-Rad pointed to the absence of the word “not” as evidence of
“contradictory statements” by the ALJ for the purpose of bolstering its argument that the ALJ
adopted two contradictory claim constructions for the ’530 patent in Order No. 22 and Order No.
35. See Bio-Rad Pet. at 46, n.7.
Upon review of Order No. 35, the Commission agrees with 10X and OUII that the omission
of the word “not” on page 91 of the ID is a simple clerical error. Cf. Order No. 35 (“Bio-Rad reads
the claims to require ‘that all 1,000 droplets form before any barcoding begins,’ Reply at 8, but no
such limitation was contemplated in the Markman order. The claim language merely requires that
any accused step of generating a plurality of barcoded molecules occurs after the at least 1,000
droplets are generated.”). 	Bio-Rad’s attempt to frame that error as evidence of contradictory
statements by the ALJ is not persuasive. Accordingly, the last sentence of the first full paragraph
on page 91 of the ID is modified to read: “In Order No. 35, this claim construction was further
clarified so that it does not preclude the generation of some barcoded molecules before the start of
the claimed third step.”
X. 	REMEDY
The RD recommended that the Commission issue an LEO and CDO directed to Bio-Rad.
There was no dispute among the parties that an LEO would be the appropriate remedy. See RD at
1. 	The RD also explained that while Bio-Rad “suggest[ed]” that the LEO should include a

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certification provision, “there is no evidence in the record that a certification provision will be
necessary to distinguish between infringing and non-infringing products,” and on that basis
declined to recommend the inclusion of a certification provision. Id. at 2.
With respect to the CDO, the RD found that Bio-Rad maintains a commercially significant
domestic inventory of ddSEQ products and on that basis recommended that the Commission issue
a CDO directed to Bio-Rad.16 	See id. at 2–3. 	Specifically, the RD found that Bio-Rad had
inventory of ddSEQ Single-Cell Isolators and ddSEQ-M cartridges in California. See id. at 2. The
RD found these inventories to be significant because the number of units in inventory exceeded
the number of such units Bio-Rad actually sold between 2017 and 2018. See id. While there was
a dispute regarding whether some number of the cartridges should be discounted because they
were for testing purposes, the RD agreed with 10X’s expert, Dr. Vander Veen, that the inventory
of cartridges would be significant even if the test cartridges were not considered. See id. at 2–3.
A. 	Limited Exclusion Order
Section 337(d)(1) provides that “[i]f the Commission determines, as a result of an
investigation under this section, that there is a violation of this section, it shall direct that the
articles concerned, imported by any person violating the provision of this section, be excluded
from entry into the United States, unless, after considering the [public interest], it finds that such
articles should not be excluded from entry.” 19 U.S.C. § 1337(d)(1). The Commission has “broad
discretion in selecting the form, scope, and extent of the remedy.” 	Viscofan, S.A. v. US. Int’1
16 As explained in Certain Road Construction Machines and Components Thereof, “[t]he
Commission generally issues cease and desist orders with respect to the imported infringing
products when ‘respondents maintain commercially significant inventories in the United States or
have significant domestic operations that could undercut the remedy provided by an exclusion
order.’” Inv. No. 337-TA-1088, Comm’n Op. at 51 (June 27, 2019) (quoting Certain Table Saws
Incorporating Active Injury Mitigation Technology and Components Thereof, Inv. No. 337-TA-
965, Comm’n Op. at 4 (Jan. 27, 2017)).

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Trade Comm’n, 787 F.2d 544, 548 (Fed. Cir. 1986). Thus, the Commission may issue an LEO
excluding the goods of the person(s) found in violation.
Here, all parties agree that an LEO is appropriate in this investigation should the
Commission affirm the ID’s finding of a violation, and we agree that an LEO is appropriate here.
There are, however, questions about the scope of that LEO and the exemptions it should contain.
The questions concern: 	(1) whether the LEO should include an exemption for all ddSEQ v2
products (“v2 product exemption”); (2) whether the LEO should include exemptions for any
product used for warranty, repair, or service purposes, and/or for consumables for existing
deployments of Bio-Rad’s ddSEQ v1 products (“existing use exemptions”); (3) whether the LEO
should include an exemption for internal research and development testing by Bio-Rad (“internal
research and development exemption”); and (4) whether a certification of noninfringement
provision should be included in the LEO (“certification provision”).17 	The parties disagree on
questions (1), (3) and (4) but agree that the LEO should include existing use exemptions.
1. 	v2 Product Exemption
The most significant disagreement between the parties is whether the LEO should
explicitly exempt the ddSEQ v2 products because the ID found that 10X did not establish indirect
infringement of those products. 	Bio-Rad seeks an exemption for its ddSEQ v2 products on the
17 10X also includes a section explaining that Bio-Rad has admitted “that the scATAC-seq assay
is now commercially available and has been used by its customers in the United States,” and
therefore “Bio-Rad now also contributorily infringes 10X’s Asserted Patents through sales of the
scATAC-seq assay and induces infringement of others’ uses of its scATAC-seq assay.” 10X Resp.
to Qs. at 55–56. The purpose of 10X’s briefing on this point is far from clear, but it appears that
10X is asking the Commission to expand the indirect infringement findings in the ID to include
the scATAC-seq assay, though it fails to explicitly make that request. To the extent 10X intends
to request a Commission ruling as to whether the scATAC-seq assay indirectly infringes, the
Commission’s Rules provide procedures for obtaining such as ruling through a request for an
advisory opinion or a petition for modification of the remedial orders. See 19 C.F.R §§ 210.76,
210.79.

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basis that the ID found no indirect infringement due to the fact that the products were not available
for commercial sale and had not yet been used in the United States, which necessarily precluded a
finding of indirect infringement due to an underlying lack of direct infringement. 	See Bio-Rad
Resp. to Qs. at 72–73. 10X counters that the ID nonetheless found the v2 products to be infringing,
just like the v1 products, and that the Commission’s longstanding practice has been to direct its
exclusion orders broadly to articles that infringe, whether those articles currently exist or if they
are manufactured and imported in the future. See 10X Reply at 58–59. OUII’s position is that the
v2 products should not be exempted because the ID did not foreclose the possibility that the
importation of the v2 products would constitute a violation of section 337 if the requirements for
indirect infringement are later met. 	See OUII Reply at 22. 	OUII does, however, recommend
including a certification provision in the LEO allowing Bio-Rad to certify that either the v1 or v2
products are imported for use in a noninfringing manner. See id. at 22–23.
The ID uses a two-step approach to its infringement analysis. 	First, for each asserted
patent, the ID determines whether the accused products practice the limitations of the asserted
claims of that patent. Those determinations revolve around an analysis of how the microfluidic
chips and instruments operate when used with the assays specific to those chips, i.e., the v1 chips
with the WTA 3’ v1 assay, and the v2 chips with the 	, scATAC-seq,18
See ID at 3 (listing assays for the v1 and v2 ddSEQ systems). For the ’024 and
’468 patents, the ID found that the v1 and v2 systems/processes infringe all of the claims asserted
from those patents. 	See id. at 27, 62–63. 	For the ’530 patent, only the WTA 3’ v1
scATAC-seq, and 	assays were accused. See id. at 91. The ID found that all of those
18 The ID also includes a finding that shows that the scATAC-seq assay can be used with a v1
cartridge. 	See ID at 96 (“If the scATAC-seq assay is performed using the ddSEQ vl cartridge,
each lane is capable of generating 500 droplets with a cell and gel bead.”).

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accused products infringe independent claim 1 of the ’530 patent. 	See id. at 102–103. 	For the
dependent claims of the ’530 patent, the ID found infringement with respect to all of the asserted
dependent claims and all of the accused products except in two instances. The ID explicitly found
that the scATAC-seq assay does not infringe claim 4, and the ID omitted 	from the list
of assays that infringe claim 26. 	See id. at 103, 104. 	As explained above, the omission of the
assay from the claim 26 findings is an inadvertent error that the Commission has
corrected on review. Accordingly, for the ’530 patent, there is a single accused assay — scATAC-
seq — that does not infringe one particular asserted dependent claim: dependent claim 4.
The second step in the ID’s analysis was the determination of whether Bio-Rad induced or
contributed to the infringement of any of the asserted claims. Of particular importance here, for
each of the ’024, ’468, and ’530 patents, the ID first considered whether there was an underlying
act of direct infringement that could support a finding of indirect infringement. For each of the
’024, ’468, and ’530 patents, the ID found that an act of direct infringement had occurred with
respect to the v1 products but not the v2 products. The failure as to the v2 products was based on
the fact that 10X could not show actual use of the v2 products in the United States by entities other
than Bio-Rad at the time of the hearing. See ID at 28–29, 64, 105–108. Because the ID found no
act of direct infringement with respect to the v2 products, it did not make findings about whether
Bio-Rad induced infringement with the v2 products, or if the v2 products have a substantial
noninfringing use.
Upon review of the parties’ submissions, the Commission has determined not to adopt an
exemption for the v2 products. 	The Commission’s established practice is to direct its remedial
orders to articles that infringe, as opposed to specific product model numbers. 	See Certain
Hardware Logic Emulation Systems and Components Thereof, Inv. No. 337-TA-383, USTIC Pub.

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3089 (Mar. 1998), Comm’n Op. on Remedy, the Public Interest, and Bonding at 16 (“The limited
exclusion order is not limited to the specific models of emulation system found by the Commission
to infringe, as urged by respondents. As the ALJ noted, the Commission’s long-standing practice
is to direct its remedial orders to all products covered by the patent claims as to which a violation
has been found, rather than limiting its orders to only those specific models selected for the
infringement analysis. As the IAs noted, while individual models may be evaluated to determine
importation and infringement, the Commission’s jurisdiction extends to all models of infringing
products that are imported at the time of the Commission’s determination and to all such products
that will be imported during the life of the remedial orders.”).
2. 	Existing Use Exemptions
There is broad agreement among the parties that certain exemptions to the LEO are
appropriate. These consist of an exemption for customers who currently have access to ddSEQ
equipment to continue to purchase repair parts and warranty replacements as well as consumables.
See 10X Resp. to Qs. at 59–60; Bio-Rad Resp. to Qs. at 73–74; OUII Reply at 23. 	These
exemptions will allow the work of researchers already using Bio-Rad’s products to continue.
Consistent with the existing use exemption adopted in the LEO and CDO issued in Certain
Microfluidic Devices, Inv. No. 337-TA-1068 (“the 1068 investigation”),19 researchers seeking to
19 In the 1068 investigation, Bio-Rad was the complainant and 10X was the respondent. See 82
Fed. Reg. 42115 (Sep. 6, 2017). The Commission found that 10X had violated section 337 through
the importation of microfluidic devices that infringed Bio-Rad’s patents. 	Certain Microfluidic
Devices, Inv. No. 337-TA-1068, Comm’n Op. at 1 (Jan. 10, 2020) (public version). 	Due to
substantial public interest concerns and supporting record evidence, particularly with respect to
the public health and welfare, the Commission tailored its remedial orders in the 1068 investigation
to exempt otherwise covered microfluidic devices, provided that scientists and medical researchers
using those devices established that they had a documented need to continue receiving the devices
to continue ongoing research and that no alternative product could be substituted for the covered
microfluidic device. See id. at 46.

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receive ddSEQ consumables under that provision must provide Bio-Rad with a documented need
to continue receiving those consumables for an identified current ongoing research project for
which that need cannot be met by any alternative product. 	With respect to warranty and repair
parts, the orders also exempt service or repair articles imported for use in servicing or repairing
microfluidic systems that were imported as of the date of this Order and are under a warranty that
existed as of the date of this Order, if such servicing or repairing is provided for in terms of the
warranty.
The Commission’s remedial orders include as attachments questionnaires that Bio-Rad is
to provide to its customers for purposes of obtaining infringing ddSEQ consumables after the
effective date of the Commission’s orders. 	Bio-Rad may provide a modified version of that
questionnaire to its customers, but whatever documentation it uses must request from its customers
at least the information requested in the attached questionnaires using the verbiage as it appears in
the questionnaires. 	A completed questionnaire (or its modified equivalent) establishes a
“documented need” to qualify for the exemption, as that phrase is used in this opinion. 	The
questionnaires request, inter alia, a researcher to identify the date the research for which he or she
is using the ddSEQ system began and to state whether other products could meet his or her research
needs. The questionnaires also require both Bio-Rad and its customers to certify their statements
and to acknowledge that U.S. law (including, but not limited to, 18 U.S.C. § 1001) imposes
criminal sanctions on individuals who knowingly and willfully make material false statements to
the U.S. Government. To qualify for the exemption, the researcher must attest in the questionnaire
that the research using the ddSEQ system began prior to the date of issuance of these remedial
orders, and also attest that other products cannot meet his or her research needs. 	In addition,
researchers who avail themselves of this exemption are required to maintain records to support

PUBLIC VERSION
86
their declarations in case an audit is carried out or such records are required for any future
enforcement proceeding. These accompanying records are not to be provided to Bio-Rad.
United States Customs and Border Protection (“CBP”) may choose to require Bio-Rad to
furnish the relevant completed questionnaires for each entry that is claimed to be exempted. See
LEO, at ¶¶ 2–3. CBP may require that the questionnaires be submitted in advance of the date of
entry of the ddSEQ consumables and pursuant to procedures that CBP establishes. 	The
recordkeeping provision of the CDO requires Bio-Rad to retain such questionnaires, and the
reporting provision requires Bio-Rad to report such records. See CDO, at §§ V, VI.
Consistent with the 1068 investigation, the CDO in this investigation requires Bio-Rad to
provide a detailed accounting showing that the consumables imported and/or sold in the United
States after importation (including sales of any infringing domestic inventory existing at the time
of the Commission’s decision) are being sent to only those identified customers and that
consumables are not being stockpiled, sent to unauthorized customers, or used for research projects
other than those identified. See CDO at § V. That accounting must be supported by documentation
(including the questionnaires) referencing all relevant information, including the number of
consumables imported and/or sold and the identity of the customers, their exempted research
project(s), and the projected completion date of such projects. The reporting provision requires
monthly, rather than the Commission’s standard annual, reports.
3. 	Internal Research and Development Exemption
Bio-Rad also seeks an exemption for its internal research and development testing by Bio-
Rad; 10X has not acquiesced to that exemption. See Bio-Rad Resp. to Qs. at 74; 10X Reply at 57.
Bio-Rad makes two arguments in favor of such an exemption. The first is that the Commission
has incorporated such exemptions before. Id. (citing Certain Devices for Connecting Computers

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via Tel. Lines, Inv. No. 337-TA-360, Comm’n Op. at 7–10 (Nov. 18, 1994) (“A complainant that
seeks exclusion of other types of entry [other than for consumption] should present evidence that
activities by respondents involving other types of entry either are adversely affecting it or are likely
to do so.”); Certain Magnetic Data Storage Tapes and Cartridges Containing the Same, Inv. No.
337-TA-1012, Comm’n Op. at 128–133 (Apr. 2, 2018) (“Magnetic Storage Tapes”) (exempting
infringing products used for U.S.-based compliance testing that was necessary for foreign sales)).
The second argument is that because the asserted claims for which a violation was found are
method claims, Bio-Rad’s own use of its products cannot be a violation of Section 337. See Bio-
Rad Reply at 55 (citing Electronic Devices with Image Processing Systems, Components Thereof,
and Associated Software, Inv. No. 337-TA-724, Comm’n Op at 18-20 (Dec. 1, 2011)). 	10X
opposes this exemption on the basis that Bio-Rad waived it by failing to ask for it in briefing before
the ALJ, and that the cases relied on by Bio-Rad are factually distinguishable from this
investigation. See 10X Reply at 57–58. OUII also opposes an exemption for internal development
and testing purposes. See OUII Reply at 23.
The Commission has determined not to include an exemption for internal development and
testing. Neither of the cases Bio-Rad cited in its initial response to the Commission’s questions
stand for the proposition that an “entry for consumption” excludes research and development uses.
Further, Bio-Rad has not established an evidentiary basis to support a need for this exemption in
contrast to the respondent in Magnetic Storage Tapes. See Comm’n Op. at 132 (finding that denial
of an exemption for compliance verification testing would amount to a “world-wide” prohibition
against Sony’s products, since verification testing in the United States appears to be necessary even
for foreign sales of Sony’s LTO-7 products). 	Bio-Rad’s request that it be allowed to continue
importing infringing products for research and development purposes finds no precedent as a
matter of patent law or section 337. As the Federal Circuit has recognized, there “is no fair use or

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research and development exception for infringement of normal commercial processes.” Soitec,
S.A. v. Silicon Genesis Corp., 81 F. App’x 734, 737 (Fed. Cir. 2003) (citing Madey v. Duke
Univ., 307 F.3d 1351, 1362 (Fed. Cir. 2002) (stating that “the experimental use defense is . . .
limited to actions performed ‘for amusement, to satisfy idle curiosity, or for strictly philosophical
inquiry.’”) (citation omitted)). Likewise, Bio-Rad points to no Commission investigation where a
respondent was allowed to continue importing its own products, which had been found in violation,
for such internal testing purposes that would continue to infringe the patents.
4. 	Certification Provision
Finally, the parties dispute whether a certification of noninfringement provision should be
included with the exclusion order. 	10X argues that no certification provision is appropriate
because here, unlike in the 1068 investigation, there is no evidence that the determination of
whether a Bio-Rad product is infringing will be technically difficult. See 10X Resp. to Qs at 57–
58. OUII supports including a certification provision “because it is possible that certain accused
‘v2 products’ will not infringe if imported, and because it is possible that the accused products
could be used in non-infringing ways.” OUII Resp. to Qs at 28. Bio-Rad joins OUII’s reasoning
and also argues that a certification provision will facilitate enforcing the exemptions on which the
parties agree. Bio-Rad Reply at 56.
Upon consideration of the parties’ submissions, the Commission has determined to include
a standard certification provision in the LEO to facilitate CBP’s enforcement of the order. 	See
Certain Composite Aerogel Insulation Materials and Methods for Manufacturing the Same, Inv.
No. 337-TA-1003, Comm’n Op. at 62 (Feb. 22, 2018) (“[T]he Commission’s standard practice for
the past several years [has been] to include certification provisions in exclusion orders to aid
CBP.”). This provision does not, however, provide Bio-Rad with the ability to self-certify that its

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products are noninfringing. That determination must be made by the Commission or CBP. 	See
id. (“CBP only accepts a certification that the goods have been previously determined by CBP or
the Commission not to violate the exclusion order.”). 	The standard certification can be used to
facilitate entry of products adjudicated to be non-infringing as well as for products imported for
warranty and repair service pursuant to the express terms of Bio-Rad’s warranty provisions. 	In
addition to the standard provision, the LEO provides a separate procedure by which Bio-Rad may
certify that the microfluidic devices are being imported for use by researchers who have been using
such devices in the United States as of the date of the issuance of the LEO, and who have provided
Bio-Rad a documented need to continue receiving the devices for an identified current ongoing
research project for which that need cannot be met by any alternative product.
B. 	Cease and Desist Order
Section 337(f)(1) provides that in addition to, or in lieu of, the issuance of an exclusion
order, the Commission may issue a CDO as a remedy for violation of section 337. See 19 U.S.C.
§ 1337(f)(1). CDOs are generally issued when, with respect to the imported infringing products,
respondents maintain commercially significant inventories in the United States or have significant
domestic operations that could undercut the remedy provided by an exclusion order.20 See, e.g.,
Certain Table Saws Incorporating Active Injury Mitigation Technology & Components Thereof
(“Table Saws”), Inv. No. 337-TA-965, Comm’n Op. at 4-6 (Feb. 1, 2017); Certain Protective
Cases & Components Thereof, Inv. No. 337-TA-780, USITC Pub. No. 4405, Comm’n Op. at 28
20 When the presence of infringing domestic inventory or domestic operations is asserted as the
basis for a CDO under section 337(f)(1), Commissioner Schmidtlein does not adopt the view that
the inventory or domestic operations needs to be “commercially significant” in order to issue the
CDO. See, e.g., Certain Magnetic Tape Cartridges and Components Thereof, Inv. No. 337-TA-
1058, Comm’n Op. at 65, n.24 (Mar. 25, 2019); Table Saws, Comm’n Op. at at 6-7, n.2 (Feb. 1,
2017). In Commissioner Schmidtlein’s view, the presence of some infringing domestic inventory
or domestic operations, regardless of its commercial significance, provides a basis to issue a CDO.
Id.

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(Nov. 19, 2012) (citing Certain Laser Bar Code Scanners & Scan Engines, Components Thereof
& Prods. Containing Same, Inv. No. 337-TA-551, Comm’n Op. at 22 (June 24, 2007)).
Complainants bear the burden on this issue. “A complainant seeking a cease and desist order must
demonstrate, based on the record, that this remedy is necessary to address the violation found in
the investigation so as to not undercut the relief provided by the exclusion order.” Table Saws,
Comm’n Op. at 5 (citing Certain Integrated Repeaters, Switches, Transceivers, & Prods.
Containing Same, Inv. No. 337-TA-435, USITC Pub. No. 3547 (Oct. 2002), Comm’n Op. at 27
(Aug. 16, 2002); see also H.R. REP. No. 100-40, at 160 (1987)).
The RD recommended issuing a cease and desist order based on its finding that Bio-Rad
maintains a commercially significant inventory of ddSEQ products in the United States. RD at 2–
3. 	Both 10X and OUII supported the RD’s recommendation. 	See 10X Resp. to Qs. at 58–59;
OUII Resp. to Qs. at 29. 	Bio-Rad opposed the recommendation and argued that 10X’s expert
incorrectly included noninfringing test chips in his analysis of Bio-Rad’s inventory. See Bio-Rad
Reply at 56–57.
The Commission has determined to adopt the RD’s recommendation and issue a cease and
desist order to Bio-Rad. 	The RD considered the argument Bio-Rad raised, and determined that
even if the test chips were discounted, the inventory of ddSEQ chips in the United States would
still be commercially significant. 	RD at 2–3 (“I agree with 10X and Dr. Vander Veen that
regardless of whether the ‘test’ cartridges are counted, Bio-Rad’s inventory of ddSEQ products is
commercially significant.”). Bio-Rad has shown no error in that finding, which is supported by
record evidence. See CX-0005C at Q/A 39.
Like the LEO discussed above, the CDO exempts from its scope the importation of certain
microfluidic consumables for use by researchers who have been using such consumables in the

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United States as of the date of the issuance of the CDO, and who have provided Bio-Rad a
documented need to continue receiving the consumables for an identified current ongoing research
project for which that need cannot be met by any alternative product. The CDO also exempts from
its scope service or repair articles imported for use in servicing or repairing microfluidic systems
that were imported as of the date of the issuance of the CDO and are under a warranty that existed
as of the date of this Order, if such servicing or repairing is provided for in terms of the warranty
XI. 	B OND
If the Commission enters an exclusion order or a cease and desist order, a respondent may
continue to import and sell its products during the 60-day period of Presidential review under a
bond in an amount determined by the Commission to be “sufficient to protect the complainant
from any injury.” 19 U.S.C. § 1337(j)(3); see also 19 C.F.R. § 210.50(a)(3). When reliable price
information is available in the record, the Commission has often set the bond in an amount that
would eliminate the price differential between the domestic product and the imported, infringing
product. See Certain Microsphere Adhesives, Processes for Making Same, & Prods. Containing
Same, Including Self-stick Repositionable Notes, Inv. No. 337-TA-366, USITC Pub. No. 2949,
Comm’n Op. at 24 (Jan. 16, 1996). The Commission also has used a reasonable royalty rate to set
the bond amount where a reasonable royalty rate could be ascertained from the evidence in the
record. 	See, e.g., Certain Audio Digital-to-Analog Converters & Prods. Containing Same, Inv.
No. 337-TA-499, Comm’n Op. at 25 (Mar. 3, 2005). 	Where the record establishes that the
calculation of a price differential is impractical or there is insufficient evidence in the record to
determine a reasonable royalty, the Commission has imposed a 100 percent bond. 	See, e.g.,
Certain Liquid Crystal Display Modules, Prods. Containing Same, & Methods Using the Same,
Inv. No. 337-TA-634, Comm’n Op. at 6-7 (Nov. 24, 2009). The complainant, however, bears the
burden of establishing the need for a bond. Certain Rubber Antidegradants, Components Thereof

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& Prods. Containing Same, Inv. No. 337-TA-533, USITC Pub. No. 3975, Comm’n Op. at 40 (July
21, 2006).
The RD recommended that the Commission impose a bond of 25 percent of the entered
value of infringing products imported by Bio-Rad during the presidential review period. 	In
reaching that recommendation, the RD rejected an argument from Bio-Rad that 10X had failed to
show that it was injured by the importation of Bio-Rad’s products. See RD at 4. While the RD
acknowledged some contrary evidence, it ultimately credited the testimony and analysis of 10X’s
expert, Dr. Vander Veen, that 10X was forced to lower its prices in response to Bio-Rad’s presence
in the market. See id.
On the amount of bond, the RD reached the 25 percent figure based on a comparison of the
average selling prices of Bio-Rad’s ddSEQ Single-Cell Isolator and 10X’s Chromium Single Cell
Controller, i.e., the parties’ single cell instruments. See id. at 5. That comparison was one of two
offered by Bio-Rad’s expert, Mr. Herrington. See id. at 4–5. The RD declined to compare the cost
of the parties’ consumables because experts on both sides agreed that such a comparison was
impractical. See id. The RD also rejected 10X’s request for a 100 percent bond rate, which was
based on 10X’s assertion that no reliable price comparison could be performed at all. See id. at 5.
The RD explained that while “Mr. Herrington’s comparison between the average selling prices of
the parties’ single cell instruments is not perfect, [] absent any other price comparison offered by
10X, the 25 percent price differential is the most reliable evidence in the record for an appropriate
bond amount.” Id.
The Commission has determined to adopt the recommendation of the RD and impose a
bond in the amount of 25 percent of the entered value of the subject articles. OUII supports that
approach. 	See OUII Resp. to Qs. at 30–33. 	10X and Bio-Rad do not support the RD’s

PUBLIC VERSION

recommendation, but their positions merely rehash the arguments addressed in the RD, or advance
unendorsed methodologies. Particularly, 10X first argues that a price differential is not possible,

and therefore a 100 percent bond is appropriate. See 10X Resp. to Qs. at 68—71. In support of that
first argument, 10X makes three points: (1) 10X argues that the parties’ PO

Po undercuts any price differential’s ability to protect 10X

from harm; (2) 10X argues that importation of Bio-Rad’s ddSEQ system may affect 10X’s
Chromium product line in addition to its single-cell instrument sales, and the absence of analysis
on those products precludes a reliable price comparison; and (3) 10X criticizes an alternative “price
per cell” calculation Bio-Rad offered but that the RD did not adopt. Jd. at 68-70.

As to the first point, 10X fails to explain why Pe
precludes a price differential calculation. If 10X’s position is that it is entitled to a price differential
based on higher sales prices for its own products, it had months of discovery and then an
evidentiary hearing to produce evidence of those higher P| prices. Moreover, such
evidence about 10X’s own sales prices, and reasoning therefore, was in 10X’s control. On the
second point, 10X’s argument is supported only by a handful of conclusory statements from its
economic expert. This testimony does not provide sufficient justification to abandon any attempt
at calculating a price differential, which is what 10X has done. See 10X Resp. to Qs. at 69 (citing
CX-0005C at Q/A 46-51). As to 10X’s third point, the RD did not rely on a price per cell
calculation, and the Commission has determined not to adopt such an approach. Accordingly, the
Commission declines to impose a 100 percent bond on the basis that a price comparison is
impractical.

10X makes a backup argument that if a price differential can be calculated based on

instrument sales, then the correct calculation yields a bond ys 060U™Ut~<“ititi‘“‘SC‘C*@ See 10X

93

PUBLIC VERSION
94
Resp. to Qs. at 71–73. 10X reaches these percentages by taking the difference of either the average
sales or lists prices of the parties’ single cell instruments and then dividing that difference by the
entered value of the Bio-Rad instruments,
. 	See id. at 72. 	10X asserts that this calculation is supported by Certain
Reclosable Plastic Bags and Tubing, Inv. No. 337-TA-266, USITC Pub. 2058, Comm’n Op. at 6
(Dec. 1, 1987) (“Reclosable Plastic Bags”). 	This approach appears to be endorsed by 10X’s
expert, Dr. Thomas Vander Veen, as well. See CX-0005C at Q/A 48.
10X’s calculation is without support in Commission precedent. Reclosable Plastic Bags
stated only that CBP preferred bonds to be calculated as a percentage of entered values, so the
Commission issues a bond as a percentage of entered value and not as a dollar amount per product.
Id. at Comm’n Op. at 6. The typical method for calculating a price differential is to subtract the
price of the respondent’s product from the price of the complainant’s product, divide the difference
by the price of the respondent’s product, and then multiply by 100 to reach a percentage value.
See Certain Two-Handle Centerset Faucets and Eschutcheons, and Components Thereof, Inv. No.
337-TA-422, USITC Pub. No. 3332, Comm’n Op. on Remedy, the Public Interest, and Bonding,
2000 WL 1159298, at *10 n.13 (July 2000) (stating that “[t]he amount of the bond was derived by
dividing the remainder of the average price of the Moen faucet minus the average price of the
infringing Foremost/Chung Cheng faucets by the average price of the Foremost/Chung Cheng
faucets, and then multiplying the result by 100”). Indeed, this appears to be the method used in
Certain Protective Cases and Components Thereof, Inv. No. 337-TA-780, USITC Pub. 4405,
Initial Determination at 121–22, (July 10, 2012), upon which 10X relies in its brief. See 10X Resp.
to Qs. at 73 n.12. 	Accordingly, the Commission declines to adopt 10X’s proposed calculation,
which departs from the Commission’s established method of calculating price differentials.

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With respect to Bio-Rad, it merely argued that 10X failed to establish injury warranting a
bond. Particularly, pointing to its price per cell metric, it argued that
, and thus no bond at all is appropriate. Bio-Rad Resp. to Qs. at 75. As noted above though,
the RD declined to adopt Bio-Rad’s price per cell metric, and Bio-Rad has not shown why the
Commission should adopt it. See RD at 5.
For the reasons provided above, the Commission has determined to impose a bond of
twenty-five percent (25%) of entered value of infringing articles imported during the period of
Presidential review.
XII. 	PUBLIC I NTEREST
Section 337 requires the Commission, upon finding a violation of section 337, to issue an
LEO “unless, after considering the effect of such exclusion upon the public health and welfare,
competitive conditions in the United States economy, the production of like or directly competitive
articles in the United States, and United States consumers, it finds that such articles should not be
excluded from entry.” 19 U.S.C. § 1337(d)(l). 	Similarly, the Commission must consider these
public interest factors before issuing a CDO. 19 U.S.C. § 1337(f)(1).
Under appropriate facts and circumstances, the Commission may determine that no remedy
should issue because of the adverse impacts on the public interest. 	See, e.g., Certain Fluidized
Supporting Apparatus & Components Thereof, Inv. Nos. 337-TA-182/188, USITC Pub. 1667,
Comm’n Op. at 1–2, 23–25 (Oct. 1984) (finding that the public interest warranted denying
complainant’s requested relief). Moreover, when the circumstances of a particular investigation
require, the Commission has tailored its relief in light of the statutory public interest factors. For
example, the Commission has allowed continued importation for ongoing medical research,
exempted service parts, grandfathered certain infringing products, and delayed the imposition of
remedies to allow affected third party consumers to transition to non-infringing products. 	E.g.,

PUBLIC VERSION
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Certain Microfluidic Devices, Inv. No. 337-TA-1068 Comm’n Op. at 1, 22–48, 53–54 (analyzing
the public interest, discussing applicable precedent, and ultimately issuing a tailored LEO and a
tailored CDO); Certain Road Milling Machines & Components Thereof, Inv. No. 337-TA-1067,
Comm’n Op. at 32–33 (July 18, 2019) (exempting service parts); Certain Baseband Processor
Chips & Chipsets, Transmitter, & Receiver (Radio) Chips, Power Control Chips, & Prods.
Containing Same, Including Cellular Tel. Handsets, 337-TA-543, USITC Pub. No. 4258, Comm’n
Op. at 150–51 (Oct. 2011) (grandfathering certain products); Certain Personal Data & Mobile
Comm’n Devices & Related Software, 337-TA-710, USITC Pub. No. 4331, Comm’n Op., at 72–
73, 80–81 (June 2012) (delaying imposition of remedy).
The statute requires the Commission to consider and make findings on the public interest
in every case in which a violation is found regardless of the quality or quantity of public interest
information supplied by the parties. 19 U.S.C. § 1337(d)(l), (f)(l). Thus, the Commission publishes
a notice inviting the parties as well as interested members of the public and interested government
agencies to gather and present evidence on the public interest at multiple junctures in the
proceeding. 19 U.S.C. § 1337(d)(l) & (f)(l).
On July 25, 2019, the Commission issued a notice soliciting comments on public interest
issues raised by the relief recommended in the RD. Notice at 1 (July 25, 2019). No comments
from the public were received in response to that notice. 	On August 26, 2019, pursuant to
Commission Rule 210.50(a)(4), 10X and Bio-Rad each submitted briefs addressing the effect the
RD’s proposed remedies would have on the public interest.21 The parties also submitted additional
public interest arguments with their responses to the Commission’s notice of review, and their
21 Complainant 10X Genomics, Inc.’s Submission on the Public Interest (Aug. 26, 2019) (“10X
BPI”); Bio-Rad’s Statement on Public Interest (Aug. 26, 2019) (“Bio-Rad BPI”).

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97
replies to those responses. The parties’ arguments with respect to each of the public interest factors
are summarized below.22
A. 	Public Health and Welfare
Concerning the public health and welfare, 10X submitted that “[t]here are no public health,
safety, or welfare concerns relating to the requested remedial orders.” 10X BPI at 1. 10X also
argued that Bio-Rad should not be permitted to argue that remedial orders would adversely affect
the public health and welfare in this investigation because it argued that remedial orders in the
1068 investigation would not cause such adverse effects. 	See 10X BPI at 1–2. 	Further, 10X
asserted that
. See id. at 2. 10X substantially reiterated these arguments
in its brief responding to the Commission’s notice of review. See 10X Resp. to Qs. at 60–61.
For its part, Bio-Rad confined itself to arguing that if 10X’s public health and welfare
arguments in the 1068 investigation justify a modification of the remedy in that investigation then
the same arguments should justify a modification in this investigation. See Bio-Rad BPI at 3.
On the record of this investigation, the Commission has determined that the public health
and welfare will not be adversely affected by issuance of a tailored LEO and a similarly tailored
CDO. Of note, the LEO and CDO issued today include exemptions to allow researchers who have
been using Bio-Rad’s ddSEQ systems in the United States as of the date of the issuance of those
orders, and who have provided Bio-Rad a documented need to continue procuring consumables
for those systems for an identified current ongoing research project for which that need cannot be
22 The Commission did not delegate responsibility to the ALJ for taking evidence and making
findings concerning the effect of a remedy on the public interest in this investigation.

PUBLIC VERSION
98
met by any alternative product, to continue to procure and use such consumables. 	Bio-Rad’s
ddSEQ system is used by medical researchers “to study the ways in which individual cells from a
tumor differ from each other.” Bio-Rad BPI at 1; see also id. at 2, n.2 (listing published research
that used Bio-Rad’s technology). In the 1068 investigation, the Commission considered a large
volume of evidence about the adverse effects attendant to disrupting important medical research
by forcing researchers to switch instruments mid-study, which Bio-Rad contested. See Inv. No.
337-1068, Comm’n Op. at 45–46. 	On the record of the 1068 investigation, the Commission
determined that disruption of such research would adversely affect the public health and welfare
to such a degree that the remedial orders in that investigation should include exemptions to allow
ongoing research to continue without disruption. See id.
The record on the public interest in this investigation is not nearly as robust as the one in
the 1068 investigation. As noted, in addressing the public health and welfare, Bio-Rad has merely
argued that whatever argument prevails in the 1068 investigation should prevail here as well. See
Bio-Rad BPI at 3. Bio-Rad’s argument suggests that its ddSEQ systems are so comparable to the
accused products in the 1068 investigation that any adverse effects attendant to the exclusion of
those products must attend the exclusion of its products as well. 	Bio-Rad has not, however,
presented evidence sufficient for the Commission to draw that conclusion, and the Commission
does not agree with Bio-Rad’s underlying premise that the remedies in the 1068 investigation and
this one must be reciprocal because the underlying products have similar uses. Nonetheless, here,
unlike Bio-Rad’s position in the 1068 investigation, 10X affirmatively proposed an exemption to
the remedial orders to allow the use of Bio-Rad’s ddSEQ systems in ongoing research to continue.
See 10X BPI at 1 (“[T]o address any potential public interest concern, 10X does not oppose a
limited carveout for sales of consumables imported for sale to customers who have access to

PUBLIC VERSION
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existing instruments in the United States as of the Target Date so that Bio-Rad’s current customers
with access to existing instruments may continue to perform their research, as well as for warranty
support, service, repair, and replacement of existing instruments if such warranty is currently
offered and covers such activities.”).23
Accordingly, as stated above, the Commission has determined to issue an LEO and CDO
in this investigation that incorporate 10X’s proposed exemptions because the parties have agreed
to this remedy.
B. 	Competitive Conditions in the United States Economy
With respect to competitive conditions, 10X argued that exclusion of Bio-Rad’s accused
products would have no material impact on competitive conditions in the United States because
, 10X’s own products provide similar functionality
to Bio-Rad’s, and 10X’s own products are superior to Bio-Rad’s. 	See 10X BPI at 2–3. 	10X
disputed any suggestion that competitive conditions would be harmed due to the removal of a large
supplier from the market because, in 10X’s view, 	. 	See id. at 3.
10X further submitted that the introduction of its next generation products will also blunt any
detrimental effects to competition that may result from exclusion of its older products in other
litigation. See id. at 3–4. Finally, 10X asserted that Bio-Rad’s assertion in the 1068 investigation
that numerous alternatives exist to both 10X and Bio-Rad’s products should preclude it from
arguing in this investigation no suitable alternatives exist. 	See id. at 4. 	Here again, 10X
substantially reiterated these arguments in its brief responding to the Commission’s notice of
review. See 10X Resp. to Qs. at 61–63, 64–65.
23 Bio-Rad’s arguments regarding availability of 10X’s products, and alleged flaws in those
products, are addressed below in section XII.C.

PUBLIC VERSION
100
Bio-Rad did not specifically identify any adverse effects on competitive conditions in the
United States economy that would flow from issuance of remedial orders in this investigation. See
generally Bio-Rad BPI; Bio-Rad Resp. to Qs. at § XI.C; Bio-Rad Reply at § XI.D.
On the record of this investigation, the Commission has determined that competitive
conditions in the United States economy will not be adversely affected by the issuance of the
remedial orders in this investigation. Bio-Rad has not rebutted 10X’s assertions that
. Moreover, evidence submitted
by 10X shows that Bio-Rad’s ddSEQ products appear in only a small number of research
publications, which tends to reinforce the conclusion that adoption of Bio-Rad’s ddSEQ products
has been modest. See 10X Resp. to Qs., Ex. I (search results for “ddSEQ” in medical publication
database). 	, the Commission
finds that exclusion of those products will not adversely affect competitive conditions in the United
States.
C. 	Production of Like or Directly Competitive Articles in the United States
10X submitted that “[t]he production of ‘like or directly competitive’ articles in the United
States will not be harmed and may be helped by the recommended orders,” because Bio-Rad
while 10X manufactures consumables and assembles
instruments in the United States. 10X BPI at 4. In 10X’s view, “[s]ubstituting 10X’s products for
Bio-Rad’s will not harm domestic production and will, if anything, increase it.” Id.
Bio-Rad disputed 10X’s position based on the fact that “10X has been enjoined from
selling any of the products it used to establish the domestic industry in this case to new customers.”
Bio-Rad BPI at 4 (citing Bio-Rad et al. v. 10X, No. 1:15-cv-00152-RGA, Dkt. 576 (D. Del. Aug.
12, 2019)). 	Bio-Rad also pointed to the possibility of an exclusion order in the 1068

PUBLIC VERSION
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investigation.24 See id. Concerning 10X’s next generation Next GEM product, Bio-Rad pointed
to an SEC filing from 10X calling into question whether the Next GEM chip will be a viable
replacement for the GEM chip. See id. (citing https://www.sec.gov/Archives/edgar/data/1770787/
000119312519224368/d737378ds1.htm 	at 	7). 	Additionally, 	Bio-Rad 	suggested 	that 	the
Commission should not rely on 10X’s own products as possible replacements for Bio-Rad’s
because 10X’s financial stability is uncertain. See Bio-Rad BPI at 4–5. Bio-Rad drew support for
that suggestion from an SEC filing by 10X discussing the various risks its business currently faces.
See 	Bio-Rad 	BPI 	at 	4–5 	(citing 	https://www.sec.gov/Archives/edgar/data/1770787/
000119312519224368/d737378ds1.htm 	at 	15). 	Finally, 	Bio-Rad 	argued 	that 	10X’s 	own
arguments in the 1068 investigation regarding the infeasibility of switching its customers to other
instruments should apply equally in this investigation to Bio-Rad’s customers and instruments.
See id. at 5.
In response to Bio-Rad’s arguments, 10X first argued that neither the district court
injunction nor any exclusion order in the 1068 investigation will prevent it from filling the demand
created by excluding Bio-Rad’s products because 10X’s next generation products, which were
launched in May 2019, are not subject to either order. 	See 10X Resp. to Qs. at 62. 	10X also
disputed Bio-Rad’s characterization of its next generation products as “unproven.” See id. at 63.
Further, 10X asserted that its transition to its next generation products will not prevent it from
being able to meet any demand resulting from exclusion of Bio-Rad’s products. See id.
Next, 10X disputed Bio-Rad’s suggestion that its financial stability would hamper its
ability to meet demand for microfluidic systems and components. See id. at 64. Particularly, 10X
24 Since the parties submitted their briefs, an exclusion order and a cease and desist order have
issued in connection with the 1068 investigation. See 84 Fed. Reg. 70999 (Dec. 26, 2019).

PUBLIC VERSION
102
pointed to its initial public offering and its revenue numbers for the first half of 2019 as evidence
of its financial stability. See id. And finally, cornering the litigation mentioned in its prospectus,
10X acknowledged that there is ongoing litigation related to its next generation products, but
submitted that speculation about the outcome of that litigation at some point in the future should
not preclude issuance of an exclusion order where a violation has already been proven. See id.
In its own response to the Commission’s notice of review, Bio-Rad argued that a recently
published study demonstrates flaws in 10X’s Chromium scATAC-seq assay. See Bio-Rad Reply
at 58–59. 	Bio-Rad asserted that the flaws identified in this study are present throughout all of
10X’s products, including its next generation product line. See id. The thrust of Bio-Rad’s point
is that 10X’s products are not superior to Bio-Rad’s, and that the public interest will be harmed if
researches are forced to utilize inferior equipment. See id. at 59.
The Commission finds Bio-Rad’s assertion that 10X will be unable to fill demand created
by the exclusion of its ddSEQ products to be speculative. While 10X’s domestic industry products
may be subject to an exclusion order and an injunction, its next generation products are not. As
noted above, an exemption for existing use of ddSEQ products in this investigation, in combination
with the similar exemption for 10X’s products in the 1068 investigation, will protect the public
interest with respect to extant use of those products where switching to a new product would be
unworkable. For new uses, the public is free to use 10X’s next generation products. Bio-Rad cites
no evidence to support its assertions that 10X’s next generation products are “unproven” or have
“no track record,” and therefore the Commission does not credit those assertions. 	By contrast,
10X produced two white papers supporting its assertion that its next generation products provide
comparable performance to its earlier products. See 10X Resp. to Qs., Ex. J at 1, 8; Ex. K at 1, 4.
While 10X’s SEC filings do acknowledge the risks and inherent uncertainty involved in launching

PUBLIC VERSION
103
a new product, the statements therein primarily concern 10X’s ability to replace its own prior
products with its next generation products. See id., Ex. H at 6–7. The filing does not suggest that
10X will be unable to manufacture its next generation products in volumes sufficient to replace
Bio-Rad’s ddSEQ products in use. See id.
Bio-Rad points out that 10X’s SEC filings acknowledge that one of the risks potential
investors should consider is the fact that, as of June 30, 2019, it had accumulated a deficit of $245.6
million. 	See https://www.sec.gov/Archives/edgar/data/1770787/000119312519224368/d737378
ds1.htm at 15. 	However, 10X has since completed its initial public offering with a market
capitalization near $5 billion. See 10X Resp. to Qs., Ex. L at 1. Thus, while the record evidence
indicates that investors in 10X may be subject to some risk based on 10X’s revenue and deficits,
the Commission finds that it would be speculative at this point to determine that 10X’s financial
health will hinder it from offering its next generation products to the public. The Commission also
finds that the discussion of litigation risk in the SEC filings is similarly speculative. Bio-Rad has
identified no litigation currently precluding 10X from offering its next generation products
domestically, and the Commission declines to speculate on the outcome of ongoing litigation.
Finally, with respect to Bio-Rad’s argument that all of 10X’s products are tainted by
common flaws, Bio-Rad relied on a publication titled “Inference and effects of barcode multiplets
in droplet-based single-cell assays” by Lareau et al. and a declaration by Dr. Lior Pachter, a Bio-
Rad expert witness from the 1068 investigation. See Bio-Rad Reply, Ex. A & Pachter Decl. While
the Lareau publication does report flaws associated with 10X’s scATAC-seq assay, Bio-Rad
Reply, Ex. A at 2, which Dr. Pachter asserts are equally applicable across 10X’s entire line of
products, see Pachter Decl. at ¶ 7, Dr. Pachter also acknowledges in his declaration that 10X is
aware of the issue reported in the Lareau publication and that it has published a statement on its

PUBLIC VERSION
104
website indicating that the issue in its scATAC product can be corrected with software processing,
see id. at ¶ 10. 	Dr. Pachter’s declaration reproduces a portion of that statement in which 10X
acknowledges the issue identified in the Lareau publication, but omits the portion of the statement
in which 10X explains the actions it has or will take to address the issue. 	Compare id. with
https://www.10xgenomics.com/blog/letter-from-10x-genomics. Based on the publication and Dr.
Pachter’s declaration, Bio-Rad concluded that if its products “are excluded and [Bio-Rad’s] future
potential customers are forced to use 10X systems, their medical research efforts — research which
10X characterizes as very important to public health — will be hampered by 10X’s faulty data
output.” Bio-Rad Reply at 15.
Bio-Rad’s conclusion overreaches with respect to what the evidence shows. 	The
underlying publication shows a flaw attendant to 10X’s scATAC-seq assay. See Bio-Rad Reply,
Ex. A at 2. 	Dr. Pachter’s declaration, if accepted as true, supports the conclusion that the
underlying flaw is present across all of 10X’s single cell product line. See Pachter Decl. at ¶¶ 7,
12. 	However, Dr. Pachter’s declaration also supports the conclusion that 10X is aware of the
Lareau publication and the issue reported therein, and has devised a method of correcting the issue
through computational means. See id. at ¶ 10. Though Dr. Pachter stated that “10X Genomics has
not released any data or validation demonstrating that their computational solution to eliminating
barcode multiplets removes all multiplets, and does not erroneously filter out single barcode cells,”
see id. at 15, that fact is not surprising given the short time between when the publication was
published on October 30, 2019, and November 7, 2019, when Dr. Pachter signed his declaration.
The Commission declines to presume that 10X’s entire product line is flawed beyond
correction based on a publication that does not go so far, and testimony from a declarant who only
implies, without support, that the computational correction proposed by 10X will not be effective.

PUBLIC VERSION
105
Accordingly, on the record of this investigation, the Commission finds that the issuance of
remedial orders in this investigation will not adversely affect the production of like or directly
competitive articles in the United States.
D. 	United States Consumers
10X argued that the proposed remedial orders would have a minimal impact on U.S.
consumers due to 	and the fact that, as discussed
above, 10X does not oppose exempting existing users of Bio-Rad’s ddSEQ instruments from such
orders. 	See 10X BPI at 5. 	As with the other public interest factors, 10X also argued that Bio-
Rad’s statements in the 1068 investigation to the effect that United States consumers would not be
harmed by an exclusion order in that investigation should preclude Bio-Rad from arguing that the
proposed remedial orders in this investigation would harm consumers. See id. 10X’s assertions
in its responses to the Commission’s notice of review regarding the effect of remedial orders
United States consumers are substantially aligned with its arguments in its public interest briefing.
See 10X Resp. to Qs. at 65–66.
Bio-Rad argued only that “[b]ecause 10X’s prior products are subject to an injunction and
its new products are unproven, an exclusion order against Bio-Rad’s products could force
consumers to use noncommercial and unproven technologies to pursue their research objectives.”
Bio-Rad BPI at 5.
The arguments presented addressing the effect of a remedy on United States consumers are
substantially coextensive with the arguments advanced in the context of the other public interest
factors. 	10X relies on the 	for ddSEQ products to argue that any impact on
consumers from their exclusion will be minimal, while Bio-Rad again asserts that 10X’s products
are already subject to exclusion, or if not are unproven. For reasons similar to those given above,
the Commission finds that the evidence in this investigation does not establish that United States

PUBLIC VERSION
106
consumers will be harmed by the issuance of a tailored LEO and similarly tailored CDO in this
investigation.
E. 	Commission Determination on Public Interest
Upon consideration of the parties’ submissions, and after considering the effect that
remedial orders would have on the public interest, the Commission has determined to issue a
tailored LEO and a similarly tailored CDO. The exemptions to the LEO and CDO proposed by
10X will allow the work of researchers already using Bio-Rad’s products to continue.
XIII. 	CONCLUSION
For the reasons discussed above, the Commission has determined that Bio-Rad violated
Section 337 by importing into the United States, selling for importation, or selling in the United
States after importation certain microfluidic systems and components thereof and products
containing same by reason of infringement of certain claims of the ’024,’468, and ’530 patents.
The Commission finds no violation with respect to the asserted claims of the ’204 patent. 	The
Commission has determined to issue a limited exclusion order and a cease and desist order against
Bio-Rad. The Commission finds that the public interest factors do not weigh against issuing these
remedial orders. The Commission has further determined that during the Period of Presidential
review, a bond in the amount of twenty-five (25) percent of entered value shall be applied to
covered Bio-Rad products.
Lisa R. Barton
Secretary to the Commission
Issued: March 24, 2020
By order of the Commission.

CERTAIN MICROFLUIDIC SYSTEMS AND
COMPONENTS THEREOF AND PRODUCTS
CONTAINING SAME
Inv. No. 337-TA-1100
PUBLIC CERTIFICATE OF SERVICE
I, Lisa R. Barton, hereby certify that the attached COMMISSION OPINION has been
served by hand upon the Commission Investigative Attorney, Monica Bhattacharyya, Esq.,
and the following parties as indicated, on March 25, 2020.
Lisa R. Barton, Secretary
U.S. International Trade Commission
500 E Street, SW, Room 112
Washington, DC 20436
On Behalf of Complainants 10X Genomics, Inc.:
Paul T. Ehrlich
TENSEGRITY LAW GROUP LLP
555 Twin Dolphin Dr., Suite 650
Redwood Shores, CA 94061
Email: paul.ehrlich@tensegritylawgroup.com
☐ Via Hand Delivery
☐ Via Express Delivery
☐ Via First Class Mail
☒ Other: Email Notification
of Availability for Download
On Behalf of Respondents Bio-Rad Laboratories, Inc.:
S. Alex Lasher
QUINN EMANUEL URQUHART & SULLIVAN, LLP
1300 I Street NW, Suite 900
Washington, DC 20005
Email: alexlasher@quinnemanuel.com
☐ Via Hand Delivery
☐ Via Express Delivery
☐ Via First Class Mail
☒ Other: Email Notification
of Availability for Download

PUBLIC VERSION
UNITED STATES INTERNATIONAL TRADE COMMISSION
Washington, D.C.
In the Matter of
CERTAIN MICROFLUIDIC SYSTEMS 	I“v‘s‘ig“‘i°" N°- 337'TA'11“"
AND COMPONENTS THEREOF AND I
PRODUCTS CONTAINING SAME
NOTICE OF A COMMISSION DETERMINATION TO REVIEW IN PART A FINAL
INITIAL DETERMINATION FINDING A VIOLATION OF SECTION 337 AND TO
EXTEND THE TARGET DATE; SCHEDULE FOR FILING WRITTEN SUBMISSIONS
AGENCY: U.S. Intemational Trade Commission.
ACTION: Notice. 	‘ 	_
SUMMARY: Notice is hereby given that the U.S. Intemational Trade Commission has
detennined to review in part the Administrative Law Judge’s (“ALJ”) final initial detennination
(“ID”), issued on July 12, 2019, finding a violation of section 337 in the above-referenced
investigation and to extend the target date for completion of the above-referenced investigation
to December 19, 2019. The Commission requests briefing from the parties on certain issues
under review, as indicated in this notice. I 	.
FOR FURTHER INFORMATION CONTACT: Benjamin S. Richards, Esq., Office of the
General Counsel, U.S. International Trade Commission, 500 E Street SW, Washington, DC
20436, telephone (202) 708-5453. Copies of non-confidential documents filed in connection
with this investigation are or will be available for inspection during official business hours (8:45
a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E
Street SW, Washington, DC 20436, telephone (202) 205-2000. General information conceming
the Commission may also be obtained by accessing its Intemet server at httgs://www.usitc.gov.
The public record for this investigation may be viewed on the Commission’s electronic docket
(EDIS) at httgs://edis. usitc.gov. Hearing-impaired persons are advised that infonnation on this
matter can be obtained by contacting the Commission’s TDD terminal on (202) 205-1810.
SUPPLEMENTARY INFORMATION: On February 21, 2018, the Commission instituted
this investigation based on a complaint filed by 10X Genomics, Inc. of Pleasanton, CA. 83 FR
7491 (Feb. 21, 2018). The complaint alleges violations of section 337 of the Tariff Act of 1930,
as amended, 19 U.S.C. 1337, in the importation into the United States, the sale for importation,
or the sale within the United States after importation of certain microfluidic systems and
components thereof and products containing same by reason of infringement of one or more
claims of U.S. Patent Nos. 9,644,204 (“the ’204 patent”); 9,689,024 (“the ’024 patent”);

PUBLIC VERSION
9,695,468 (“the ’468 patent”); and 9,856,530 (“the ’530 patent”). Id. The Commission’s
notice of investigation named as the sole respondent Bio—RadLaboratories, Inc. of Hercules, CA.
Id. The Office of Unfair Import Investigations (“OUII”) is participating in this investigation.
Id.
On July 12, 2019, the ALJ issued the final ID. The ID found a violation of section 337
by virtue of Bio-Rad’s indirect infringement of the ’024, the ’468, and the ’53Opatents. The ID
found that 10X had not established a violation with respect to the ’204 patent. The ID also
found that Bio-Rad failed to establish invalidity of any of the asserted claims of any patent. The
ID further found that the domestic industry requirement was satisfied for each of the asserted
patents. Finally, the ID found that Bio-Rad had not carried its burden with respect to various
additional affirmative defenses, including improper inventorship and ownership. .
On July 25, 2019, the ‘ALJissued her recommended determination on remedy and
bonding. The ALJ recommended, upon a finding of violation, that the Commission issue a
limited exclusion order, issue a cease and desist order, and impose a bond in the amount of
twenty-five percent of the entered value of any covered products imported during the period of
Presidential review.
On July 29, 2019, 10X, Bio-Rad, and OUII submitted petitions seeking review of the ID.
On August 6, 2019, 10X, Bio-Rad, and OUII submitted responses to the others’ petitions. On
August 26, 2019, 10X and Bio-Rad submitted comments on the public interest pursuant to
Commission Rule 2l0.50(a)(4). 	.
Having examined the record of this investigation, including the ID, the petitions for
review, and the responses thereto, the Commission has detennined to review the ID with respect
to (l) all findings related to a violation based on the ’024 patent; (2) all findings related to a
violation based on the ’468 patent; (3) noninfringement of the ’204 patent; (4) all findings related
to a violation based on the ’530 patent; (5) Bio-Rad’s inventorship and ownership defenses; and
(6) a typographical error on page 91. The Commission has determined not to review the
remainder of the ID. 	'
The Commission has further determined to extend the target date in this investigation to
December l9, 2019. 	'
The parties are requested to brief their positions on only the following issues under
review with reference to the applicable law and the evidentiary record:
l. With respect to Bio-Rad’s ownership defense, would Drs. Hindson and Saxanov
be considered inventors of the asserted patents based only on the “ideas” they
developed at QuantaLife/Bio-Rad? Your response should address how, if at all,
those “ideas” correspond to the particular inventions claimed in the asserted
patents. ’
2

PUBLIC VERSION
Was the ALJ correct to focus on the “inventive concept” of the asserted patents in
determining whether Bio-Rad has ownership rights in the asserted patents? If
not, what is the correct focus?
The ID construed the term “amplification” in the ’024 and ’468 patent claims to
mean “increasing the number of copies of the target sequence to be detected,
including by reverse transcription.” Explain whether the ID’s construction is
supported by the Application No. PCT/US 99/01705 (“the ’705 application”),
U.S. Patent Application Publication No. 2011/0053798 (“the ’798 application”),
or the specifications of the ’024 and ’468 patents. Please cite and explain each
section that supports or detracts from this construction as well as any expert
testimony that interprets those sections.
If the Commission determined to construe “amplification” to exclude reverse
transcription, consistent with OUII’s petition, what effect, if any, would that have
on the ID’s finding of infringement of the asserted claims of the ’024 and ’468
patents?
In its response to OUII’s petition on the construction of “amplification,” Bio-Rad
argues that, if the ID’s construction of “amplification” is modified to exclude
reverse transcription, then the lD’s infringement findings with respect to the ’024
patent should be reversed. Bio-Rad’s argument focuses particularly on whether
amplification occurs in a droplet. Explain how, if at all, modifying the ID’s
construction of “amplification” to exclude reverse transcription could give rise to
a noninfringement finding based on the location where amplification occurs.
Has Bio-Rad waived its noninfringement argument for the ’024 patent based on
the location where amplification occurs, as described in question 5, by failing to
raise the argument in its petition for review? If you contend that the argument is
not waived, provide citations to where this issue was raised in Bio-Rad’s
prehearing brief, posthearing brief, and petition for review.
Does the evidence of record support the conclusion that [[
]] in the
context of the products accused of infringing the ’204 patent?
Claim l of the ’53Opatent includes the clause “wherein said barcode molecules
become detached from said gel bead.” Is this clause part of step (c) of the
claimed method such that barcode molecules must become detached from the gel
bead during that step, or does the clause modify the entire method such that the
barcode molecules may become detached during any step of the method?
Address the significance of the separate indentation of the “wherein” clause and
the punctuation setting it off from the rest of the claim.
3

PUBLIC VERSION
9. If claim 1 of the ’530 patent is construed such that the barcode molecules must
become detached from the gel bead during step (c) of the claimed method, does
a preponderance of the evidence show that Bio-Rad’s accused products and/or
l0X’s domestic industry products practice step (c) of claim 1? Please identify all
evidence supporting your position.
10. Did any party argue in its pre- or post-hearing briefing that the ALJ’s construction
of claim 1 of the ’530 patent, as laid out in orders 22 and 35, was indefinite? If
they did, identify where in the briefing those arguments were made.
The parties are not to brief other issues on review, which are adequately presented in the
parties’ existing filings.
In connection with the final disposition of this investigation, the Corrrrnissionmay issue:
(1) an exclusion order that could result in the exclusion of the subject articles from entry into the
United States, and/or (2) a cease-and-desist order that could result in the respondent being
required to cease and desist from engaging in unfair acts in the importation and sale of such
articles. Accordingly, the Commission is interested in receiving written submissions that
address the form of remedy, if any, that should be ordered. If a par'ty seeks exclusion of an
article from entry into the United States for pmposes other than entry for consumption, the party
should so indicate and provide information establishing that activities involving other types of
entry either are adversely affecting it or likely to do so. For backgrotmd, see Certain Devices
for Connecting Computers via Telephone Lines, Inv. No. 337-TA-360, USITC Pub. No. 2843,
Comm’n Op. at 7-10 (Dec. l994).
If the Commission contemplates some form of remedy, it must consider the effects of that
remedy upon the public interest. The factors the Commission will consider include the effect
that an exclusion order and/or cease and desist orders would have on (1) the public health and
welfare, (2) competitive conditions in the U.S. economy, (3) U.S. production of articles that are
like or directly competitive with those that are subject to investigation, and (4) U.S. constuners.
The Cormnission is therefore interested in receiving written submissions that address the
aforementioned public interest factors in the context of this investigation.
If the Conunission orders some form of remedy, the U.S. Trade Representative, as
delegated by the President, has 60 days to approve or disapprove the Commission’s action. See
Presidential Memorandum of July 21, 2005, 70 FR 43251 (July 26, 2005). During this period,
the subject articles would be entitled to enter the United States under bond, in an amount
determined by the Commission and prescribed by the Secretary of the Treasury. The
Commission is therefore interested in receiving submissions concerning the amount of the bond
that should be imposed if a remedy is ordered.
WRITTEN SUBMISSIONS: The parties to this investigation are requested to file written
submissions on the issues identified in this Notice and on the issues of remedy, the public
interest, and bonding. Complainant and OUII are requested to submit proposed remedial orders
4

PUBLIC VERSION
for the Commission’s consideration. Complainant is also requested to state the date that the
patents expire and the HTSUS numbers under which the accused products are imported.
Complainant is further requested to supply the names of known importers of the Respondent’s
products at issue in this investigation. 	.
The parties’ written submissions and proposed remedial orders must be filed no later than
the close of business on October 31, 2019. Reply submissions must be filed no later than the
close of business on November 7, 2019. Opening submissions are limited to 75 pages. Reply
submissions are limited to 60 pages. Such submissions should address the ALJ’s recommended
determination on remedy and bonding. Interested government agencies and any other interested
parties are also encouraged to file written submissions on the issues of remedy, the public
interest, and bonding. Third-party submissions should be filed no later than the close of
business on October 31, 2019, 2019. No further submissions on any of these issues will be
permitted unless otherwise ordered by the Commission.
Persons filing written submissions must file the original document electronically on or
before the deadlines stated above and submit eight true paper copies to the Office of the
Secretary pursuant to Section 210.4(f) of the Commission’s Rules of Practice and Procedure (19
CFR 210.4(1)). Submissions should refer to the investigation number (“Inv. No. 337-TA-1100”)
in a prominent place on the cover page and/or the first page. (See Handbook on Filing
Procedures, https://www.usitc.gov/documents/hana'b00k_0n_filing_pr0cedures.pdj). Persons
with questions regarding filing should contact the Secretary at (202) 205-2000. 	4
Any person desiring to submit a document to the Commission in confidence must request
confidential treatment unless the infonnation has already been granted such treatment during the
proceedings’. All such requests should be directed to the Secretary of the Commission and must
include a full statement of the reasons why the Commission should grant such treatment. See 19
CFR 210.6. Documents for which confidential treatment by the Commission is sought will be
treated accordingly. A redacted non-confidential version of the document must also be filed
simultaneously with any confidential filing. All information, including confidential business
infomlation and documents for which confidential treatment is properly sought, submitted to the
Commission for purposes of this Investigation may be disclosed to and used: (i) by the
Commission, its employees and Offices, and contract personnel (a) for developing or
maintaining the records of this or a related proceeding, or (b) in internal investigations, audits,
reviews, and evaluations relating to the programs, personnel, and operations of the Conunission
including under 5 U.S.C. Appendix 3; or (ii) by U.S. govemment employees and contract
personnel‘, solely for cybersecurity ptuposes. All non-confidential written submissions will be
available for public inspection at the Office of the Secretary and on EDIS
The authority for the Commission’s determination is contained in section 337 of the
Tariff Act of 1930, as amended (19 U.S.C. 1337), and in part 210 of the Commission’s Rules of
' All contract personnel will sign appropriate nondisclosure agreements.
5

Practice and Procedure (19 CFR 210).
By order of the Commission.
Issued: October 17-,2019
PUBLIC VERSION
7%Lisa R. Barton
Secretary to the Commission
6

CERTAIN MICROFLUIDIC SYSTEMS AND 	Inv. No. 337-TA-1100
COMPONENTS THEREOF AND PRODUCTS
CONTAINING SAME 	'
PUBLIC CERTIFICATE OF SERVICE
I, Lisa R. Barton, hereby certify that the attached NOTICE has been served by hand
upon the Commission Investigative Attorney, Monica Bhattacharyya, Esq., and the following
parties as indicated, on October 18, 2019.
Lisa R. Barton, Secretary
U.S. International Trade Commission
500 E Street, SW, Room 112
Washington, DC 20436
On Behalf of Complainants 10XGenomics, Inc.:
Paul T. Ehrlich 	D Via Hand Delivery
TENSEGRITY LAW GROUP LLP 	5 vie ExpressDelivery
555 Twin Dolphin Dr., Suite 650 	Via First Class Mail
Redwood Shores, CA 94061 	D Other:
On Behalf of Respondents Bio-Rad Laboratories, Inc.:
S. Alex Lasher 	_ 	El Via Hand Delivery
QUINN EMANUELIURQUHART & SULLIVAN, LLP 	[| Via Express Delivery
1300 Street NW, Suite 900 	Via F-EstClass Mail
Washington, DC 20005 	U other

PUBLIC VERSION
UNITED STATES INTERNATIONAL TRADE COMMISSION
Washington, D.C.
In the Matter of \
CERTAIN NIICROFLUIDIC SYSTEMS 	In“ No_ 337_TA_1100
AND COIVIPONENTS THEREOF AND
PRODUCTS CONTAINING SAME
INITIAL DETERMINATION ON VIOLATION OF SECTION 337
Administrative Law Judge Dee Lord
- (July 12, 2019)
Appearances:
For Complainant 10X Genomics, Inc. .' A
Matthew D. Powers, Esq., Paul T. Ehrlich, Esq., Azra M. Hadzimehmedovic, Esq., Aaron M.
Nathan, Esq., and Stefani C. Smith, Esq. of Tensegrity Law Group, LLP of Redwood Shores,
CA.
For Respondent Bi0—Raa'Laboratories, Inc;
Kevin P.B. Johnson, Esq., Brian Cannon, Esq., and Victoria Maroulis, Esq. of Quinn, Emanuel,
Urquhart & Sullivan, LLP of Redwood Shores, CA; S. Alex Lasher, Esq. and Sean Gloth, Esq.
of Quinn, Emanuel, Urquhart & Sullivan, LLP of Washington, DC; and David Bilsker, Esq. of
Quinn, Emanuel, Urquhart & Sullivan, LLP of San Francisco, CA.
For the Commission Investigative Staf/Q
Monica Bhattacharyya, Esq. and Anne Goalwin, Esq. of the Office of Unfair Import
Investigations.

PUBLIC VERSION
Pursuant to the Notice of Investigation (Dec. l3, 2017) and Commission Rule 210.42, this
is the administrative law judge’s final initial determination in the matter of Certain Microfluidic
Systems and Coinponents Thereof and Products Containing Same, Commission Investigation
No. 337-TA-1100. 19 C.F.R. § 2l0.42(a)(1)(i). "
For the reasons discussed herein, it is my final initial determination that there is a
violation of section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. § 1337, in the
importation into the United States, the sale for importation, and/or the sale within the United
States after importation of certain microfluidic systems and components thereof and products
containing same by reason of infringement of certain claims of U.S. Patent No. 9,689,024 (“the
’024 Patent”), U.S. ‘PatientNo. 9,695,468 (“the ’468 Patent”), and U.S. Patent No. 9,856,530
(“the ’530 Patent”). There is no violation with respect to U.S. Patent No. 9,644,204 (“the ’204
Patent”).
1Pursuant to Commission Rule 2l0.42(a)(l)(ii), a recommended determination on remedy and
bonding shall issue within 14 days of this initial detennination. 19 C.F_R.§ 2l0.42(a)(l)(ii).
ii

I.
II.
A.
B.
C.
A.
B.
C.
IV.
V.
VI.
IX.
I.
PUBLIC VERSION
TABLE or CONTENTS
BACKGROUND............ . . . 	. .
Procedural History.........
The Private Parties ............................................................................................................ ..
Products at Issue ............................................................................................................... ..
BackgroundofAssertedPatents
Level OfOrdinary Skill in the Art ..................................................................................... ..
Witness Testimony......... ................................................................................................... ..
JURISDICTION
Subject Matter Jurisdiction .................
Personal Jurisdiction ......................... ..
InRem	Jurisdiction
LEGAL STANDARDS ............................... 	. . . .
Infringement ................................................... ..
Invalidity ........
Domestic Industry ........................................................................................................... ..
THE ’024 PATENT .........................................................................................
Asserted Claims ....
Claim Construction ..................
Infringement ........................... .. 	18
Domestic Industry.......... 	31
Invalidity ............... 	33
THE ’468PATENT . 	. 	. 	. 	. 	58
Asserted Claims .... 	58
Claim Const1'uction........ 	59.
Infringement............... 	59
Domestic 1ndustry.......... 	64
Invalidity ............... 	66
THE ’204 PATENT....... . 	. 	. . . 70
Asserted Claims .... 	70
Claim Construction........ 	72
Infringement................... 	72
Domestic Industry.......... 	85
Invalidity ............... 	88
THE ’530 PATENT....... 	. . . . . . 89
Asserted Claims .... 	89
Claim C0nstructi0n.,...... 	91
Infringement................... 	......91
Domestic 1ndustry................ 	113
Invalidity ......................... 	118
ADDITIONAL DEFENSES 	. . 	. . 119
Inventorship .................... 	119
Ownership .................... 	136
Other Affirmative Defenses........ 	152
CONCLUSIONS OF LAW ............................................................................................ 154
18
iii

The following abbreviations may be used in this Initial Determination
PUBLIC VERSION
Tr. Transcript
WS Witness Statement
DWS Direct Witness Statement
RWS Rebuttal Witness Statement
JX Joint Exhibit
CX C0mplainant’s exhibit ,
CPX Complainant’s physical exhibit
CDX C0mplainant’s demonstrative exhibit
RX Respondent’s exhibit
RPX Respondent’s physical exhibit
RDX Respondent’s demonstrative exhibit
CPHB Complainant’s pre-hearing brief
CIB Complainanfs initial post-hearing brief
CRB C0mplai11ant’sreply post-hearing brief
RPHB Respondent’s pre-hearing brief
RIB Respondent’s initial post-hearing brief
RRB Respondent’s reply post-hearing brief
SPHB Staff s pre-hearing brief
SIB 	Staffs initial post-hearing brief
SRB Staffs reply post-hearing brief
iv

PUBLIC VERSION
I. BACKGROUND
A. Procedural History
The Commission instituted this investigation in response to a complaint filed by 10X
Genomics, Inc. (“10X”) alleging violations of section 337 of the Tariff Act of 1930, as amended,
by reason of infringement of certain claims of U.S. Patent No. 9,644,204 (“the ’_204Patent”),
U.S. Patent No. 9,689,024 (“the ’024 Patent”), U.S. Patent No. 9,695,468 (“the ’468 Patent”),
and U.S. Patent No. 9,856,530 (“the ’530 Patent”) by Respondent Bio-Rad Laboratories, Inc.
(“Bio-Rad”). The Commission ordered that an investigation be instituted to determine:
Whetherthere is a violation of subsection (a)(1)(B) of section 337 in the
importation into the United States, the sale for importation, or the sale
Withinthe United States after importation of certain microfluidic systems
and components thereof and products containing same by reason of
infringement of one or more of claims 1-4, 6-9, 17, 20, 21, 23, 25, 27, 29,
31, and 33 ofthe ’204 Patent; claims 1, 2, 5, 8,10,11,13,15-17,19, 21,
and 22 ofthe ’024 Patent; claims 1-4, 6-9, ll, 12, 21, and 22 of the ’468
Patent; and claims 1-6, 8-11, 14-20, and 24-30 of the ’530 Patent; and
whether an industry in the United States exists as required by subsection
(a)(2) of section 337;
Notice of Investigation at 2. The investigation was instituted upon publication of the notice of
investigation in the Federal Register on Wednesday, February 21, 2018. 83 Fed. Reg. 7491-92
(2018); see 19 C.F.R. § 210.lO(b). Bio-Rad filed a response to the complaint and notice of
investigation on March 6, 2018.
A Markman hearing was held in this investigation on July 25, 2018, and a Markman
order, issued on October 31, 2018. Order No. 22.
On October 5, 2018, 10X’s motion for summary determination was granted pursuant to a
stipulation between 10X and Bio-Rad that 10X has satisfied the economic prong of the domestic
industry requirement. Order No. 19 (Oct. 5, 2018), not reviewed by Comm’n Notice (Nov. 6,
2018).
1

PUBLIC VERSION
10X withdrew its allegations of infringement with respect to claims 2, 8, 10, 11, 13, 15,
16, and 21 ofthe ’024 patent, claims 1, 2, 3, 4, 6, 7, 8, 9, 17, 20, 21, 23, and 25 ofthe ’204
patent, claims 2, 3, 4, 8, 11, 12, and 22 ofthe ’468 patent, and claims 2, 3, 5, 6, 8, 9, 10, 15, 16,
17, 18, 20, 24, 25, 27, 29, and 30 ofthe ’530 patent. Order No. 26 (Nov. 30, 2018); Order No.
27 (Dec. 10, 2018); Comm’n Notice (Dec. 21, 2018). Part of Bi0—Rad’sinventorship defense
was tenninated pursuant to Order No. 34 (Feb. 21, 2019), not reviewed by Comm’n Notice (Mar
13, 2019). The evidentiary hearing proceeded on March 25-29, 2019, and the target date was
extended to November 12, 2019, pursuant to Order N0. 45 (May 29, 2019), not reviewed by
Comm’n Notice (Jun. 13, 2019).
B. The Private Parties
1. Complainant
The complainant is 10X Genomics, Inc. (“10X”). Notice of Investigation at 2. 10X was
founded in 2012 in Pleasanton, Califomia, where it maintains its headquarters and a
manufacturing facility. Complaint 116 (Jan. 9, 2018); Order No. 19 at 3-4 (Oct. 5, 2018).
2. Respondents
The respondent is Bio-Rad Laboratories, Inc. (“Bio-Rad”). Notice of Investigation at 2.
Bio-Rad is a Delaware corporation with its principal place of business in Hercules, California.
Response to Complaint 1122 (Mar. 6, 2018).
C. Products at Issue
I The products at issue are microfluidic cartridges, droplet generation instruments, and
assays used in single-cell sequencing. 	,
2

PUBLIC VERSION
1. Domestic Industry
The domestic industry products (“DI products”) are lOX’s GernCodeTMand ChromiumTM
product lines. Order No. 19 at 3. These products were developed by 10X based on its GEM
(“Gel bead in Emulsion”) architecture, and the first GemCodeTMproduct Was sold in 2015. CX
0003C (Schnall-Levin DWS) at Q/A 47-52. The DI products include both single-cell and linked
read applications, including the Chromium” Single Cell 3’ Solution, Chromium” Single Cell
V(D)J Solution, and GemCodeTMSingle Cell platform (collectively, “l0X’s single-cell
applications), and the cl1fOI1’1lL1lTlTM	Genome Solution, Chromiumm Exome Solution,
ChromiumTMde nova Assembly Solution, and GemCodeTMLong Read platform (collectively,
“l 0X’s linked-read applications”). Order No. l9 at 3. Pursuant to Order No. 19, l0X has
satisfied the economic prong of the domestic industry requirement with respect to these products.
See Comm’n Notice (Nov. 6, 2018).
2. Accused Products
The accused products are components and assays of Bio-Rad’s ddSEQ system, which
includes	ddSEQ_. 	cueat4-5;RIBat11-12.TheddSEQ	vl products
include Bio-Rad’s ddSEQ vl Cartridge, ddSEQ vl Single-Cell Isolator, ddSEQ Cartridge
Holder, and consmnables and assays used with and/or as part of Bio-Rad’s ddSEQ vl system
including the SureCell WTA 3’ vl assay. Id.; CX-0004C (Butte DWS) at Q/A 54; RX-0665C
(Metzger RWS) at Q/A 29. The ddSEQ
Id. Bio-Rad has admitted that each of
the ddSEQ vl instruments and the v1
-. 	CX-0041C	atInterrogatory	Nos.4 and5;seeRPHBat53.
3

PUBLIC VERSION
.’D. Background of Asserted Patents
1. The ’024 and ’468 Patents
Through application 13/966,150 (“the ’150 application”), which was filed on August 13,
2013, the ’468 and ’024 patents claim priority to six provisional applications filed between
August 14, 2012 and July 10, 2013. ’024 patent (JX-0003), cover; ’468 patent (JX-0005), cover.
The ’024 patent was filed as a divisional of the ’150 application and the ’468 patent was filed as
a continuation of the ’150 application. ’024 patent, cover; ’468 patent, cover. Because of their
ancestry, the ’024 and ’468 patents share a common specification. The patents identify
Benjamin Hindson, Serge Saxonov, and Michael Schnall-Levin as inventors. ’024 patent, cover;
’468 patent, cover. H
Analysis of biological materials, such as sequencing nucleic acids, requires proper
sample preparation. ’024 patent, col. 1:28-30. “Sample preparation may . . . involve
fragmenting molecules, isolating molecules, and/or attaching unique identifiers to particular
fragments of molecules . . . .” Id. at col. 1:34-37. A microwell partition capsule array can be
used in sample preparation operations. Id., col. 4:28-29. Such a device consists of “an assembly
of partitions (e.g., microwells, droplets) that are loaded with microcapsules.” [d., col. 4:24-27.
The array divides the sample “such that a portion of the sample is present in each partition.” Id.,
col. 4:29-32. Each partition “may include one or more capsules that contain one or more
reagents (e.g., enzymes, unique identifiers (e.g., bar codes), antibodies, etc.).” Id., col. 4:41-44.
A “trigger” can be used to cause the microcapsules to release the reagents into the partitions, so
that the reagents come into contact with the subdivided sample. Id., col. 4:44-48.
Microcapsules are used (1) to “provide for the controlled and/or timed release of reagents
for sample preparation of an analyte,” (2) to control the release and transport of reagents, (3) to
4

PUBLIC VERSION
deliver reagents in discrete and definable amounts, (4) to “prevent premature mixing of reagents
with the sample,” and (5) to ease handling of and limit contact with reagents. Id., col. 6:62-col.
7:13. Microcapsules can be formed using gel beads. Id., col. 9:28-35. Analytes and/or reagents
can “be coupledl immobilized to the interior surface of a gel bead (e.g., the interior accessible via
diffusion of an oligonucleotide barcode and/or materials used to generate an oligonucleotide
barcode) and/or the outer surface of a gel bead.” Id., col. 9:36-42. Release of the analytes or
reagents from the microcapsule may be the result of applying a trigger. Id., col. 22:4-6. Various
types of stimuli can be used as a trigger, including chemical stimuli, enzymes, light, heat, and
magnetic fields. 1d., col. 19:43-48, col. 22:4-21.
One sample preparation reagent that can be delivered by a microcapsule is a “molecular
barcode.” Id., col. 12:9-14. For most applications, such as in the case of the nucleic acid
sequencing, analyzing multiple samples simultaneously “substantially decreases the cost of
analysis as well as increases through-put of the process.” Id., col. 12:33-36. To analyze multiple
samples, different samples are pooled together. Id, col. 12:36-39. Before the samples are
pooled together, the analytes from each sample are tagged with a unique identifier, known in the
art as a “molecular barcode,” so that analytes from different samples can be identified and
tracked in the pooled sample. Ial, col. 12:11-13, col. 12:36-39. Molecular barcodes “may
comprise a variety of different forms such as oligonucleotide bar codes, antibodies or antibody
fragments, fluorophores, nanoparticles, and other elements or combinations thereof.” Id., col.
12:14-17. In nucleic acid sequencing, oligonucleotide barcodes are particularly useful. 1d., col.
12:43-44.
5

PUBLIC VERSION
2. The ’204 Patent
The ’204 patent issued on May 9, 2017 from an application filed on February 7, 2014.
’204 patent (IX-0001), cover. The ’204 patent claims priority to four provisional applications
filed between February 8, 2013 and July 10, 2013. The provisional applications to which the
’204 patent claims priority are also relied on for priority by the ’024 and ’468 patents. The
patent names Benjamin Hindson, Serge Saxonov, Kevin Ness, Paul Hardenbol, Christopher
Hindson, Donald Masquelier, Mirna Jarosz, and Michael Schnall-Levin as inventors. Three of
the named inventors-—Dr.Hindson, Dr. Saxonov, and Dr. Schnall-Levin—are also the named
inventors of the ’024 and ’468 patents.
The disclosed subject matter of the ’204 patent is similar to that of the ’024 and ’468
patents. As with those patents, the ’204 patent is directed to sample preparation methods and
discloses “compositions comprising a plurality of capsules, the capsules situated within droplets
in an emulsion, wherein the capsules are configured to release their contents into the droplets
upon the application of a stimulus.” Id., col. 1:42-46. The capsules may contain reagents and/or
analytes. Ia/., col. 1:47-48.
3. The ’530 Patent
The ’530 patent issued on January 2, 2018 from an application filed on May 5, 2017.
’530 patent (JX-0007), cover. Through intervening applications, the ’53Opatent is a
continuation in part of an application filed on February 7, 2014. Id. The ’530 patent also claims
priority to five provisional applications filed between December 14, 2012 and July 10, 2013. Id.
Four of the provisional applications to which the ’204 patent claims priority are also relied on for
priority by the ’024, ’468, and ’204 patents. The patent names Benjamin Hindson, Serge
Saxonov, Kevin Ness, Paul Hardenbol, Mirna Jarosz, and Michael Schnall-Levin as inventors.
6

PUBLIC VERSION
These same individuals are named inventors of the ’204 patent and three of them—Dr. Hindson,
Dr. Saxonov, and Dr. Schnall-Levin—are also named inventors of the ’024 and ’468 patents.
The claimed subject matter of the ’53Opatent is similar to the subject matter disclosed in
the ’O24, ’468, and ’204 patents. As with those patents, the ’530 patent discloses sample
preparation methods that use microcapsules and beads to provide reagents and analytes in
response to stimuli. ’530 patent, col. 23:60-col. 24:13.
E. Level of Ordinary Skill in the Art
In the Markman order, I adopted Bio-Rad’s proposed definition for the level of ordinary
skill in the art: either a Ph.D. in molecular biology, molecular genetics, chemistry, engineering,
or equivalent disciplines with two years of experience or [B.S.] in such fields with five years of
experience, with such experience including libraly preparation methods, microfluidic
technology, and/or bead attachment chemistries. Order No. 22 at 2-3.
F. Witness Testimony
I received testimonial evidence in this investigation in the fonn of witness statements,
live testimony, and deposition designations.
1. Fact Witnesses
10X began the hearing with the testimony of Benjamin Hindson, co-founder of 10X and
co-inventor of the asserted patents. CX-0001C; CX-1828C; Tr. 132-187. The next witness was
Michael Schnall-Levin, a vice president at 10X and another co-inventor of the asserted patents.
CX-0003C; CX-1830C; Tr. 189-231. 10X also called Serge Saxonov, its CEO and also a co
founder of 10X and co-inventor of the asserted patents. CX-1829C; Tr. 768-820.
Bio-Rad presented the testimony of Annette Tumolo, the president of its Life Sciences
Group. RX-0502C; Tr. 509-511. Bio-Rad also presented the testimony of Douglas Greiner, a
7

PUBLIC VERSION
senior manager in its product development group. RX-0507C; RX-0727C; Tr. 511-565. Bio
Radhalso called another of its employees, Nicholas Heredia, Whois an alleged co-inventor of the
asserted patents. RX-0504C; Tr. 565-604. In addition, Bio-Rad presented the testimony of one
of its fonner employees, Kelly Kaihara (RX-0506C), and she was examined as an adverse
Witnessby 10X. Tr. 234-282. Bio-Rad also presented the testimony of its employee Jeremy
Agresti (RX-0503C), who was filrther examined as an adverse witness by 10X. Tr. 283-348.
2. Expert Witnesses
l0X’s expert on infringement is Atul Butte, whose testimony was qualified as that of an
expert in the field of genomic sequencing solutions. CX-0004C; Tr. 351-474 (expert
qualification at 364:9-17). l0X’s expert on invalidity is Paul Dear, whose testimony was
qualified as that of an expert in the field of genomic sequencing solutions. CX-1827C; Tr. 822
934 (expert qualification at 828120-829:1).
Bio-Rad’s technical expert is Michael Metzker, whose testimony was qualified as that of
an expert in next generation sequencing, including sample preparation technologies,
microfluidics, enzyme chemistry, high throughput assays, bead properties and attachment
chemistries RX-0664C; RX-0665C; Tr. 608-767 (expert qualification at 613:22-614: 14), 935
961.
The parties also stipulated to the admission of witness statements from Thomas Vander
Veen (CX-0005C) and Ryan Herrington (RX-0666C), and their designated deposition transcripts
(JX-0162C and JX-0170C), discussing the issues of remedy and bOnd. Tr. 24-25.
3. Deposition Designations
10X submitted designated deposition transcripts for several witnesses: Jeremy Agresti
(CX-0009C), Mark DiPanfi1o (CX-0010C), Lucas Frenz (CX-0011C), Jodi Goodrich (CX
8

PUBLIC VERSION
0012C), Nicholas Heredia (CX-0014C and CX-0015C), Kelly Kaihara (CX-0016C), Ronald
Lebofsky (CX-0018C), Dan Norton (CX-0019C), Carolyn Reifsnyder (CX-0020C), Annette
Tumolo (CX-0022C), and Svilen Tzonev (CX-0023C). Tr. 23.
Bio-Rad also submitted designated deposition transcripts for several witnesses: Paul
Hardenbol (RX-0396C), Benjamin Hindson (RX-0399C), Christopher Hindson (RX-0400C),
Mima Jarosz (RX-0401C), Donald Masquelier (RX-0405C), Kevin Ness (RX-0408C), Serge
Saxonov (RX-0412C), and Michael Schnall-Levin (RX-0413C). Tr. 23-24.
II. JURISDICTION
In order to have the power to decide a case, a court or agency must have both subject
matter jurisdiction and jurisdiction over either the parties or the property involved. 19 U.S.C.
§ 1337; Certain Steel Rod Treating Apparatus and Components Thereofi Inv. No. 337-TA-97,
Commission Memorandum Opinion, 215 U.S.P.Q. 229, 231 (1981).
A. Subject Matter Jurisdiction
Section 337 confers subject matter jurisdiction on the Commission to investigate, and if
appropriate, to provide a remedy for, unfair acts and unfair methods of competition in the
importation, the sale for importation, or the sale after importation of articles into the United
States. See 19 U.S.C. §§ 1337(a)(1)(B) and (a)(2). The Commission has subject matter
jurisdiction over this investigation based on l0X’s allegation that Bio—Radhas imported the
accused products. Amgen Inc. v. Int’! Trade Comm ‘n, 902 F.2d 1532, 1536 (Fed. Cir. 1990).
Bio-Rad does not contest the Commission’s subject matter jurisdiction in this investigation.
RPHB at 53.
9

PUBLIC VERSION
B. Personal Jurisdiction
Bio-Rad does not contest the Commission’s in personam jurisdiction in this investigation
RPHB at 49. Bio-Rad has submitted to the personal jurisdiction of the Commission by
answering the Complaint and Notice of Investigation, participating in discovery, appearing at
hearings, and filing motions and briefs. See Certain Miniature Hac/(saws, Inv. No. 337-TA-237,
USITC Pub. No. 1948, Initial Determination at 4, 1986 WL 379287, *1 (Oct. 15, 1986), not
reviewed in relevantpart by CoInn1’nAction and Order, 1987 WL 450871 (Jan. 15, 1987).
C. In Rem Jurisdiction
The Commission has in rem jurisdiction over the accused products by virtue of their
importation into the United States. See Sealed Air Corp. v. U.S.Int’! Trade Comm ’n, 645 F.2d
976, 985-86 (Ci.C.P.A. 1981) (holding that the ITC’s jurisdiction over imported articles is
sufficient to exclude such articles). Bio-Rad does not contest that it has imported, sold for
importation, and/or sold after importation certain ddSEQ products. RPHB at 53.
III. LEGAL STANDARDS
A. Infringement
Section 337(a)(l)(B)(i) prohibits “the importation into the United States, the sale for
importation, or the sale Within the United States after importation by the owner, importer, or
consignee, of articles that —(i) infringea valid and enforceable United States patent or a valid
and enforceable United States copyright registered under title 17.” 19 U.S.C. §l337(a)(l)(B)(i).
The Commission has held that the word “infringe” in Section 337(a)(l)(B)(i) “derives its legal
meaning from 35 U.S.C. § 271, the section of the Patent Act that defines patent infringement.”
Certain Electronic Devices with Image Processing Systems, Components Thereof and
Associated Software, Inv. No. 337-TA-724, Comm’n Op. at 13-14 (December 21, 2011). Under
35 U.S.C. § 27l(a), direct infringement of a patent consists of making, using, offering to sell, or
10

PUBLIC VERSION
selling the patented invention without consent of the patent owner.
In addition to direct infringement, a respondent may be liable for indirect infringement,
including induced infringement, which is defined in section 271(b) of the Patent Act: “Whoever
actively induces infringement of a patent shall be liable as an infringer.” 35 U.S.C. § 271(b).
See DSU Med. Corp. v. JMS C0., Ltd., 471 F.3d 1293, 1305 (Fed. Cir. 2006) (en bane) (“To
establish liability under section 271(b), a patent holder must prove that once the defendants knew
of the patent, they actively and knowingly aided and abetted another’s direct infringement”)
(citations omitted). “The mere knowledge of possible infringement by others does not amount to
inducement; specific intent and action to induce infringement must be proven.” Id. (citations
omitted). The Federal Circuit has held that induced infringement “requires knowledge that the
induced acts constitute . . . infringement.” GZ0bal~TechAppliances, Inc. v. SEB S.A., 563 U.S.i
754, 766 (2011). In Suprema, Inc. v. Inz"l Trade Comm ‘n,the Federal Circuit upheld the
Commission’s interpretation of the section 337 language “articles that infringe” in the context of
induced infringement, holding that the statute “covers goods that were used by an importer to
directly infringe -post-importation as a result of the seller’s inducement.” 796 F.3d 1338, 1352
53 (Fed. Cir. 2015). p i
Another form of indirect infringement is contributory infringement, defined in section
271(0) of the Patent Act: “Whoever offers to sell . . . or imports into the United States a
component of a patented machine, . . . or a material or apparatus for use in practicing a patented
process, constituting a material part of the invention, knowing the same to be especially made or
especially adapted for use in an infringement of such patent, and not a staple article or
commodity of commerce suitable for substantial noninfringing use, shall be liable as a
contributory infringer.” 35 U.S.C. § 271(c). The intent requirement for contributory
11

PUBLIC VERSION
infringement requires that respondent knows “that the combination for which [the] component
was especially designed was both patented and infringing.” Global-Tech Appliances, Inc. v. SEB
S.A., 563 U.S. at 763. A violation of section 337 based on contributory infringement requires
that “the accused infringer imported, sold for importation, or sold after importation within the
United States, the accused components that contributed to another’s direct infiingement.”
Spansion, Inc. v. Int ’l Trade Comm ’n, 629 F.3d 1331, 1353 (Fed. Cir. 2010).
“An infringement analysis entails two steps. The first step is determining the meaning
and scope of the patent claims asserted to be infringed. The second step is comparing the
properly construed claims to the device accused of infringing.” Markrnan v. Weslview
Instruments, Inc., 52 F.3d 967, 976 (Fed. Cir. 1995) (en banc), aff'd, 517 U.S. 370 (1996)
(citation omitted). Infringement must be proven by a preponderance of the evidence. SmithKline
Diagnostics, Inc. v. Helena Labs. C0rp., 859 F.2d 878, 889 (Fed. Cir. 1988). A preponderance
of the evidence standard “requires proving that infringement was more likely than not to have
occurred.” Warner-Lambert C0. v. Teva Pharm. USA,Inc., 418 F.3d 1326, 1341 11.15(Fed. Cir.
2005).
A complainant must prove either literal infringement or infringement under the doctrine
of equivalents. Literal infringement requires the patentee to prove that the accused device
contains each and every limitation of the asserted claim(s). F rank ’s Casing Crew & Rental
Tools, Inc. v. Weatherford Int 'l, Inc., 389 F.3d 1370, 1378 (Fed. Cir. 2004). “If even one
limitation is missing or not met as claimed, there is no literal infringement.” Elkay Mg. Co. v.
EBCO Mfg. C0., 192 F.3d 973, 980 (Fed. Cir. 1999). Literal infringement is a question of fact.
Finisar Corp. v. DirecTV Grp., Inc., 523 F.3d 1323, 1332 (Fed. Cir. 2008).
12

PUBLIC VERSION
B. Invalidity
It is the respondents’ burden to prove invalidity, and the burden of proof never shifts to
the patentee to provc validity. Scanner Techs. Corp. v. ICOS Vision Sys. Corp. N. V., 528 F.3d
1365, 1380 (Fed. Cir. 2008). “Under the patent statutes, a patent enjoys a presumption of
validity, see 35 U.S.C. § 282, which can be overcome only through facts supported by clear and
convincing evidence . . . .” SRAM Corp. v. AD-II Eng ’g,Inc., 465 F.3d 1351, 1357 (Fed. Cir.
2006); see also Jtdicrosofi‘Corp. v. i4i Ltd. P’ship, 564 U.S. 91, 100-1.14(2011) (upholding the
“clear and convincing” standard for invalidity). 	_
The clear and convincing evidence standard placed on the party asserting an invalidity
defense requires a level of proof beyond the preponderance of the evidence. Although not
susceptible to precise definition, “clear and convincing” evidence has been described as evidence
that produces in the mind of the trier of fact “an abiding conviction that the truth of a factual
contention is ‘highly probable.” Price v. Symsek, 988 F.2d 1187, 1191 (Fed. Cir. 1993) (quoting
Buildex, Inc. v. Kason lndus., Inc., 849 F.2d 1461, 1463 (Fed. Cir. 1988)).
1. Anticipation
Pursuant to 35 U.S.C. § 102, a patent claim is invalid as anticipated if:
(a) the invention was knownor used by others in this country, or patented or
described in a printed publication in this or a foreign country, before the invention
thereof by the applicant; V
(b) the invention was patented or described in a printed publication in this or a
foreign country or in public use or on sale in this country, more than one year
prior to the date of the application for patent in the United States;
(e) the invention was described in (1) an application for patent, published under
section 122(b), by another filed in the United States before the invention by the
applicant for patent or (2) a patent granted on an application for patent by another
filed in the United States before the invention by the applicant for patent;
(g)(2) before such person’s invention thereof, the invention was made in this
country by another inventor who had not abandoned, suppressed, or concealed it.
13

PUBLIC VERSION
35 U.S.C. § 102 (2000)? “A patent is invalid for anticipation if a single prior art reference
discloses each and every limitation of the claimed invention. Moreover, a prior art reference
may anticipate without disclosing a feature of the claimed invention if that missing characteristic
is necessarily present, or inherent, in the Single anticipating reference.” Schering Corp. v.
Geneva Pharm., Inc., 339 F.3d 1373, 1377 (Fed. Cir. 2003) (citations omitted).
2. Obviousness V
Section 103 of the Patent Act states:
A patent may not be obtained though the invention is not identically disclosed or
described as set forth in section 102 of this title, if the differences between the
subject matter sought to be patented and the prior art are such that the subject
matter as a whole would have been obvious at the time the invention was made to
a person having ordinary skill in the art to Which said subject matter pertains.
Patentability shall not be negatived by the marmer in which the invention was
made.
35 U.S.C. § l03(a) (2000).3
I “Obviousness is a question of law based on underlying questions of fact.” Scanner
Techs., 528 F.3d at 1379. The underlying factual determinations include: “(1) the scope and
content of the prior art, (2) the level of ordinary skill in the art, (3) the differences between the
claimed invention and the prior art, and (4) objective indicia of non-obviousness.” Id. (citing
Graham v. John Deere Co., 383 U.S. 1, 17-18 (1966)). These factual determinations are often
referred to as the “Graham factors.”
The critical inquiry in determining the differences between the claimed invention and the
prior art is whether there is a reason to combine the prior art references. KSR Int ’l C0. v. Teleflex
2 As explained in the revision notes and legislative reports in 35 U.S.C.A. § 100 (May 13, 2015),
the language of 35 U.S.C. § 102 that was effective prior to the America Invents Act controls in
this investigation.
3See supra, n.2.
l4

PUBLIC VERSION
Ina, 550 U.S. 398, 418-21 (2007). In KSR, the Supreme Court rejected the Federal Circuit’s
rigid application of the teaching-suggestion-motivation test. While the Couit stated that “it can
be important to identify a reason that would have prompted a person of ordinary skill in the
relevant field to combine the elements in the way the claimed new invention does,” it described a
more flexible analysis:
Often, it will be necessary for a court to look to interrelated teachings of multiple
patents; the effects of demands known to the design community or present in the
marketplace; and the background knowledge possessed by a person having
ordinary skill in the art, all in order to determine Whetherthere was an apparent
reason to combine the known elements in the fashion claimed by the patent at
issue . . . . As our precedents make clear, however, the analysis need not seek out
precise teachings directed to the specific subject matter of the challenged claim,
for a court can take account of the inferences and creative steps that a person of
ordinary skill in the art would employ.
Id. at 418. Applying KSR, the Federal Circuit has held that, where a patent challenger contends
that a patent is invalid for obviousness based on a combination of prior art references, “the
burden falls on the patent challenger to show by clear and convincing evidence that a person of
ordinary skill in the art would have had reason to attempt to make the composition or device . . .
and would have had a reasonable expectation of success in doing so.” P/'zarmaStem Therapeutics,
Inc. v. ViaCelZ,Inc., 491 F.3d 1342, 1360 (Fed. Cir. 2007).
In addition to demonstrating that a reason exists to combine prior art references, the
challenger must demonstrate that the combination of prior art references discloses all of the
limitations of the claims. Hearing Components, Inc. v. Shure Inc., 600 F.3d 1357, 1373-1374
(Fed. Cir. 2010), abrogated on other grounds by Nautilus, Inc. v. Biosig Instruments, Inc., 572
U.S. 898 (2014) (upholding finding of non-obviousness based on substantial evidence that the
asserted combination of references failed to disclose a claim limitation); Velander v. Garner, 348
15

PUBLIC VERSION
F.3d 1359, 1363 (Fed. Cir. 2003) (explaining that a requirement for a finding of obviousness is
that “all the elements of an invention are found in a combination of prior art references”).
C. Domestic Industry
In patent-based proceedings under section 337, a complainant must establish that an
industry “relating to the articles protected by the patent . . . exists or is in the process of being
established” in the United States. 19 U.S.C. § l337(a)(2). Under Commission precedent, the
domestic industry requirement of section 337 consists of anV“ec0n0micprong” and a “technical
prong.” See, e.g., Alloc, Inc. v. Intl Trade Comm 'n, 342 F.3d 1361, 1375 (Fed. Cir. 2003). To
meet the technical prong, the complainant must establish that it practices at least one claim of the
asserted patent. Certain Point of Sale Terminals and Components Thereof, Inv. No. 337-TA
524, Order No. 40 at 17-18 (Apr. 11, 2005). “The test for satisfying the ‘technical prong’ of the
industry requirement is essentially [the] same as that for infringement, 1'.e., a comparison of
domestic products to the asserted claims.” Alloc, 342 F.3d at 1375.
With respect to the “economic prong,” subsection (3) of Section 337(a) provides:
For purposes of paragraph (2), an industry in the United States shall be
considered to exist if therevisin the United States, with respect to the
aiticles protected by the patent, copyright, trademark, mask work, or design
concemed —
(A) significant investment in plant and equipment;
(B) significant employment of labor or capital; or
(C) substantial investment in its exploitation, including engineering,
research and development, or licensing.
19 U.S.C. § l337(a)(3).
1v. THE ’024 PATENT
A. Asserted Claims
16

PUBLIC VERSION
10X is asserting claims l, 5, 17, 19, and 22 of the ’024 patent. Claim l is independent
and the remaining claims depend directly or indirectly from claim 1. Claim l recites:
A method for sample preparation, comprising:
a) providing a droplet comprising a porous gel bead and a target nucleic acid
analyte, wherein said porous gel bead comprises at least 1,000,000
oligonueleotide molecules comprising barcode sequences, wherein said
oligonucleotide molecules are releasably attached to said porous gel bead,
wherein said bareode sequences are the same sequence for said
oligonucleotide molecules;
b) applying a stimulus to said porous gel bead to release said oligonucleotide
molecules from said porous gel bead into said droplet, wherein upon
release from said porous gel bead, a given oligonucleotide molecule from
said oligonucleotide molecules attaches to said target nucleic acid analyte;
and
c) subjecting said given oligonucleotide molecule attached to said target
nucleic acid analyte to nucleic acid amplification to yield a barcoded
target nucleic acid analyte.
’024 patent (JX-0003), col. 33:56-col. 34:7.
Claims 5 and 19 depend directly from claim 1. Claim 5 requires that the stimulus applied
to the gel bead be “selected from the group consisting of a biological stimulus, a chemical
stimulus, a thermal stimulus, an electrical stimulus, a magnetic stimulus, and a photo stimulus.”
Id., col. 34:15-19. Claim 19 requires that the oligonucleotide molecules attach to the target
nucleic acid analytes by hybridization. Id., col. 341.65-67. Claim 17 depends on claim 16, which
requires that the droplet “comprise[] a plurality of target nucleic acid analytes, which plurality of
target nucleic acid analytes comprises said target nucleic acid analyte.” Id., col. 34:54-56;
Claim 17 requires that each of the plurality of target nucleic acid analytes attach to one of the
oligonucleotide molecules. Id., col. 34:58-61. Claim 22 depends on claim 21, which requires
that the gel bead be formed from polymer gel. Id., col. 35:4-5. Claim 22 requires that the
polymer gel be a polyaerylamide. Id., col. 35:6-7.
17

PUBLIC VERSION
B. Claim Construction
The parties agreed to construe “barcode” to mean a “label that may be attached to an
analyte to convey identifying information about the analyte.” Order No. 22 at 2. They agreed to
construe “applying a stimulus to said porous gel bead to release said oligonucleotide molecules
from said porous gel bead into said droplet” to have its plain and ordinary meaning. Id. In the
Markman order, “1,()00,000 oligonucleotides comprising barcode sequences” was construed to
mean “1,000,000 oligonucleotidevmolecules that include, but are not necessarily limited to,
barcode sequences.” Id. at 17-22. The temi “releasably attached” was construed to mean
“attached in a manner that allows the attached object to be released.” Id. at 22-30. The terms
“amplify” and “amplification” were construed to mean “increasing the number of copies of the
target sequence to be detected,” including by reverse transcription and Withoutrequiring
amplification to be performed in a droplet. Id. at 31-45.
C. Infringement
10X accusesBio-Rad’sddSEQ system(vl _) of infringingclaims 1, 5, 17, 19, and
22 of the ’O24patent.
1. Claim 1
‘Thereis no dispute that the ddSEQ system includes a method of sample preparation, as
recited in the preamble of claim 1, and 10X relies on Dr. Butte’s testimony to identify steps
corresponding to each limitation. CX-0004C at Q/A 109-226.
a. “providing a droplet . . .”
There is no dispute with respect to a majority of the elements in the first limitation of
claim 1, which requires “providing a droplet comprising a porous gel bead and a target nucleic
acid analyte,” Wherein the porous gel bead has certain characteristics. CIB at 8-19; SIB 24-29.
1 8 	,

PUBLIC VERSION
Dr.Butteidentifies— 	gelbeadsusedbytheddSEQsystem,whichare
“porous.	becauseeachbeadhasathree-dimensional	network	ofpores—
CX-00°46 at Q/A 116
He identifies the steps of making droplets in the ddSEQ vl workflow, Id. at Q/A 61-66, and the
—. 	Id.atQ/A73-80.Hefiutheridentifies	atargeted	nucleicacidanalyte:
mRNA from a cell or a genomic DNA fragment. Id. at Q/A 116-17, 120-23. Bio-Rad does not
dispute 10X’s allegations with respect to the “porous gel bead” or “nucleic acid analyte.”
The claim limitation further requires that the porous gel bed “comprises at least
1,000,000 oligonucleotide molecules comprising barcode sequences,” and Dr. Butte cites Bio
Rad documents for the ddSEQ vl process describing a concentration of oligonucleotides in a
droplet	with	avolume	consistent	with 	CX-0004C	atQ/A128
(citing IX-0050C). This is consistent With Dr. Agresti’s deposition testimony, where he was
asked, “HoWmany oligo molecules are attached to each gel bead in ddSEQ?” CX-0009C at 434
He answered:
_ 	CX-0004Cat Q/A 133(citingJX-0090C;cx-1529c). Dr.Agresticonfirmedthatthe
number of oligonucleotides in the scATAC-seq is 	CX-0009C at
436-37. Bio-Rad disputed this limitation in its pre-hearing brief, RPHB at 57, but does not raise
this argument it its post-hearing briefs. See RIB at 50-68; RRB at 5-14.
The next clement of this limitation requires that “said oligonucleotide molecules are
releasably attached to said porous gel bed.” As discussed above, “releasably attached” Was
construed to mean “attached in a manner that allows the attached object to be released.” Id. at
19

PUBLIC VERSION
22-30. There is no dispute that the oligonucleotide molecules i11Bio~Rad’s ddSEQ system are
attached to the gel bead. See RRB at 5-6. 10X relies on Dr. Butte’s opinion that the
oligonucleotide molecules are “releasably attached” to the gel bead through a “linker” that is
— 	cx-0004c	atQ/A	143-45	(citing	JX-0050000026).	Bio
Rad’s	expert,	Dr.	Metzker,	explains	that	t 	inthe
oligonucleotides	oftheaccused	products, :
RX—D665(‘at Q/A 78-79 (citing IX-008700005).
10Xcontends	that— 	intheaccusedddSEQsystemshowsthatthe
oligonucleotide molecules are “releasably attached.” CD3at 12-15. There is no dispute that an
oligonucleotide	molecule	containing	barcode	sequences	isreleased	after—
- 	Staffagreesthatthis processshowsthat the accusedproductsmeetthe “releasably
attached” limitation. SIB at 26-29.
Bio-Rad argues that its products do not ineet the “releasably attached” limitation because
— 	arepartofa longoligonucleotide	moleculethatcontainsthebarcodesequences
andisattached	tothegelbead.RIBat54-59.\iVhen_ 	areremoved	by
- 	part of the long oligonucleotidemoleculeis thus destroyed,and Bio-Radarguesthat
destroying part of an oligonucleotide molecule is inconsistent with the claim language requiring
20

PUBLIC VERSION
that the “oligonucleotide molecules are releasably attached.” RIB at 54-59.
In reply, 10X explains that the accused “oligonucleotide molecule” is the molecule that is
released 	andnoportionofthismoleculeisdestroyedwhenit isreleased.CRBat
24 Relying on the opinions of Dr. Butte, 10X divides the Bio-Rad’s long oligonucleotide into an
accused “oligonucleotide molecule” and a separate “linker.”
CRB at 2; CX-0004C (Butte DWS) at Q/A 143-45. Bio-Rad argues that there is no basis for
dividing the oligonucleotide in this way, RRB at 5-8, but there are examples of linkers described
in the specification. ’024 patent, col. 9:57-58 (identifying “chemical linkers”); see SIB at 28.
Moreover, there is nothing that precludes the claimed “oligonucleotide molecule” from being
part of a larger oligonucleotide 1nolecule—-asrecog.m'zedin the Markmmr order, the clann’s
“recital of ‘oligonucleotide molecules’ Withouta qualifier encompasses both larger and smaller
oligonucleotide molecules.” Order No. 22 at 19. Bio-Rad fails to identify any intrinsic or
extrinsic evidence that precludes 10X from identifying the accused portion of Bio—Rad’s
oligonucleotide as the claimed “oligonucleotide molecule.” The claim only requires that the
accused “oligouucleotide molecule" include the claimed barcode sequences and that it be
released--the molecule identified by 10X meets these limitations.
Bio-Rad further argues that the construction of“1'eleasably attached” requires a K
reversible process, citing a discussion of the prosecution history in the Mar‘/mrmzorder. RIB at
54-57; RRB at 8. The portion of the Murkmmzorder cited by Bio-Rad does not support the
21

PUBLIC VERSION
imposing a “reversible” limitation on the claims, however. At the Markman hearing, Bio-Rad
had proposed a construction for “releasably attached” that required the gel bead to be configured
or designed to release the attached molecules. Order No. 22 at 22-23. The Markman order
rejected Bio-Rad’s proposed construction for several reasons, including a discussion of the
prosecution history where the applicants identified “reversible immobilization” as an example of
releasable attachment. Id. at 26-27, 29. The discussion of reversible immobilization was cited
an example to show that the claims “encompass [] situations wherein a barcode molecule is
released from a bead by severing a portion of the barcode molecule,” Id. at 29, and nothing in the
Markman order requires that every releasable attachment be reversible. ‘Moreover, limiting
“releasably attached” to reversible immobilization would be inconsistent with the claims of the
’024 patent, because dependent claim 15 adds “reversibly immobilized” as a limitation. See
Phillips, 415 F.3d at 1315 (“[T]he presence of a dependent claim that adds a particular limitation
gives rise to a presumption that the limitation in question is not present in the independent
claim.”). Bio-Rad’s proposed “reversible” limitation is not consistent with the claims,
specification, or prosecution history of the ’024 patent.
There is no dispute with respect to the final element of the gel bead limitation, requiring
that “said barcode sequences are the same sequence for said oligonucleotide molecules.”
Dr. Butte identifies documentation for ddSEQ vl describing the same barcodes for each
oligonucleotide	inabead.CX-0004C	atQ/A177-79.	Inparticular,—
— 	cx-0149000019.	Dr.	Butte	explains	that	forBio-Rad’s
products to perform their intended purpose, “the barcode sequence should be the same for all the
oligonucleotide	molecules	onagelbead.”CX-0004C	atQ/Al80.—
22

PUBLIC VERSION
JX-009lC.0009, .0001l. ln addition, Bio-Rad employee Dr. Lebofsky confirmed at his
deposition that in the scATAC-seq assay, a single bead will have the same barcode on all of the
single-stranded DNA fragments on it. CX-0018C at 208211-15.
Accordingly,the accusedddSEQvl i processesinfringethe “providinga droplet . .
.” limitation of claim 1 of the ’024 patent.
b. “applying a stimulus . . .”
The second limitation of claim 1 of the ’024 patent requires “applying a stimulus to said
porous gel bead to release said oligonucleotide molecules from said porous gel bead into said
droplet.”Dr.Butteidentifiesthe_ 	astheclaimedstimulus,whichcausesthe
release of the oligonucleotide molecules from the porous gel bead. CX-0004C at Q/A 181-83.
Bio-Rad argues that the accused products do not infringe this limitation because the
- 	actsontheoligonucleotides,	notthegelbead. RIBat 59-62.Thereisnodispute
thatthe— 	actsontheoligonucleotide,	but 10XandStaffarguethatthisis a
distinction without a difference, because the oligonueleotide is part of the gel bead. CIB at 19
22; SIB at 29-31. For the reasons discussed below, I agree with 10X and Staff that a
preponderance	oftheevidenceshowsthatthe_ 	is appliedto thegelbeadinthe
accused products, and a stimulus that acts on the oligonucleotides attached to the gel bead is
consistent Withinfringement of the “applying a stimulus” limitation.
Dr.Butteexplainsthatthe_ 	ispartofanaqueoussolutionthatis appliedto
the gel bead in the accused products. CX-0004C at Q/A 184. One of Bio-Rad’s witness,
Dr. Agresti,admittedat his depositionthat “in ddSEQ,[] the- entersthe entirevolumeof
thebead.”	cx-0009c	at343112-13.	Asdiscussed	above,	the-
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releasing the oligonncleotide molecule. Id. ‘There is no dispute
that the 	thus acts as the stimulus that releases the oligonucleotide molecule from
the gel bead into the droplet.
Bio-Radarguesthatthe: 	is appliedtotheoligonucleotide,	notthegelbead;
but in the accused products, tl1eoligonucleotides are part of the gel bead. Any stimulus applied
to the oligonucleotide is therefore also applied to the gel bead. As Dr. Agresti admitted at the "
hearing, the oligonucleotides are "“[i]nsidethe volume” of the beads. Tr. 289. See also CX
0001 lC (Frenz Dep. Tr.) at 59-60 (describing oligos “in the volume of the . . . bead”). Bio-Rad
cites the language of the ’024 patent to argue that the oligonucleotide molecules and gel beads
are separately claimed structu1'es_,but the claim language explicitly describes the oligonucleotide
molecules as a part of the gel beads: “said porous gel bead comprises at least about 1,000,000
oligonucleotide molecules.” See SIB at 30; SRB at 8. As stated in the A/farlmmnOrder, “[t]he
plain and ordinary meaning of ‘comprise’ is ‘to include esp. with a particular"scope,’ ‘to be made
up of,’ ‘compose,’ or ‘constitute.'”’ Order No. 22 at l7-18. Recognizing that the
oligonucleotides are part of the gel beads is consistent with stnlctine of the accused products and
with the language of the asserted claims.
There is no dispute with respect to the remaining elements of this limitation. Dr. Butte
identifiesa targetnucleicacidanalytein theddSEQvl — 	“whereinuponrelease
from said porous gel bead, a given oligonucleotide molecule from said oligonucleotide
molecules attaches to said target nucleic acid analyte.” CX-0004C at Q/A 198 (ddSEQ vl:
describing hybridization between the poly-T sequence of the oligonucleotide molecule and the
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Poly-A	tail	of	the	mRNA>,	Q/A	199	<
—>» 	Q/A	20°	<S@ATAC-Seq	and-= Name
adaptor binding sequence).
c. “. . . nucleic acid amplification”
The third and final limitation of claim 1 of the ’024 patent requires “subjecting said given
oligonucleotide molecule attached to said target nucleic acid analyte to nucleic acid amplification
to yield a barcoded target nucleic acid analyte.” As discussed above, the term “amplification”
was construed to mean “increasing the number of copies of the target sequence to be detected,”
including by reverse transcription. Order No. 22 at 31-45.
10X relies on Dr. Butte’s analysis of reverse transcription in the accused products to
show infringement of this limitation. CIB at 24-28. In the ddSEQ vl products, Dr. Butte
explains that an oligonucleotide molecule attached to mRNA is “subjected to reverse
transcription, second strand symthesis,and further PCR, to yield a barcoded cDNA strand.” CX
0004C at Q/A 203. He further explains that barcoded cDNA strands are generated from the
oligonucleotide molecules through several different processes, which 10X identifies in its brief
as four types of amplification. CIB at 24-26 (citing CX-0004C at Q/A 205). In “Type A” the
oligonucleotide-mRNA hybrids are subjected to reverse transcription to generate barcoded first
cDNA strands. Id. In “Type B” the hybrids are subjected to second strand synthesis and further
PCR to generate additional barcoded cDNA strands outside the droplet. Id. In “Type C” the
oligonucleotide molecule attaches to the mRNA through reverse transcription to form the first
barcoded cDNA strand, and this cDNA strand is subjected to second strand synthesis outside the
droplet to create a second strand of cDNA. Id. In “Type D” the first cDNA strand is subjected
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to PCR to generate additional double-stranded cDNA outside the droplet. Id. In Dr. Butte’s
opinion, any of these processes would meet the “amplification” limitation of the ’024 patent.
Bio-Rad argues that the oligonucleotide molecule only acts as a primer during the reverse
transcription reaction, and that this limitation is not infringed because the oligonucleotide
molecule itself is not subjected to amplification. RIB at 62-63 (citing RX-0665C (Metzker
RWS) at Q/A 87). This interpretation of the claim language was rejected in the Markman order,
however, which recognized that persons of ordinary skill in the art would understand
“amplification” to include reverse transcription. Order No. 22 at 32-4l. Notably, the
construction of “amplification” does not require exact copies of the oligonucleotide barcodes—
the product of amplification can be complementary copies, which are the result of reverse
transcription. Id. at 35-41. Moreover, dependent claims of the ’024 patent explicitly discuss the
usage of the oligonucleotide molecule as a primer during amplification. See ’024 patent, claim 8
(“The method of claim 1, wherein said given oligonucleotide molecule of said oligonucleotide
molecules comprises a region which functions as a primer during said nucleic acid amplification
in c).”), claim 10 (“The method of claim 8, wherein said primer is configured to amplify said
target nucleic acid analyte”). Bio-Rad’s non-infringement argument is not consistent with the
claim language of the ’024 patent, as construed in this investigation.
Accordingly,the accusedddSEQvl ! systemsinfringeall of the limitationsof
claim 1 of the ’024 patent.
2. Dependent Claims 	_
There is no dispute with respect to the infringement of any the limitations added by
dependent claims 5, 17, l9, and 22 of the ’024 patent.
Claim 5 requires that the stimulus that is applied to release the oligonucleotides “is
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selected from the group consisting of a biological stimulus, a chemical stimulus, a thermal
stimulus, an electrical stimulus, a magnetic stimulus, and a photo stimulus.” As discussed above,
the_ 	istheclaimedstimulusintheaccusedproducts,andDr.Butteexplainsthat
“[t]he— 	is botha biologicalstimulusanda chemicalstimulus.”CX-0004Cat Q/A
215.
Claim 17 requires that the claimed droplet “comprises a plurality of target nucleic acid
analytes” and that “each of said plurality of target nucleic acid analytes attaches to an individual
oligonueleotide	molecule.”	Asdiscussed	above,	theddSEQ	v1,—
- comprisea pluralityof mRNAs,whichattachto individualoligonucleotidemolecules
through hybridization and reverse transcription. See CX-0004C (Butte DWS) at Q/A 219-20.
Thedroplets	inthescATAC-seq— 	comprise	aplurality	ofgenomic	DNA
fragments, which attach to individual oligonucleotide molecules through hyhdridization
involving the Nextera Adaptor binding sequence. Id.
These processes also infringe the limitations of claim 19, which requires that “said given
oligonucleotide molecule from said oligonucleotide molecules attaches to said target nucleic acid
analyte by hybridization.” See CX-0004C (Butte DWS) at Q/A 223.
There is no dispute that the ddSEQ system infringes the limitations of claim 22, which
requires that the “porous gel bead comprises a polymer gel” and “said polymer gel is a
polyacrylamide.” See CX-0004C (Butte DWS) at Q/A 224-26.
Accordingly,	theaccusedddSEQvl : 	infringedependentclaims5, l7, 19,
and 22 of the ’024 patent. 	'
3. Indirect Infringement
The asserted claims of the ’024 patent are method claims, and 10X contends that there is
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a violation of section 337 by Bio-Rad based on theories of contributory and induced
infringeluent. CIB at 30-37.
a. Underlying Direct Infringement
Indirect infringeinent requires evidence of an underlying direct iufringenient. As
discussed above, ordinary use of the ddSEQ products would be direct infringement of the
asserted claims of the ’024 patent by Bio-Rad’s customers. See CIB at 31-32. There is no
dispute that Bio-Rad’s customers have used and continue to use the ddSEQ vl products in the
United States. 1d.: SIB at 36. In particular, 10X cites evidence that by early 2017, Bio-Rad had
engaged	wi 	of	ddSEQ	vl	products.	C	X
0004C (Butte DWS) at Q/A 599; CX-1494C; CX-1584C. Dr. Kaihara testified at her deposition
that she has helped niany Bi0—Radcustomers use the ddSEQ vl system, including several in the
United States. CX-0016C at 48-49; see Tr. 270. Bio-Rad’s corporate representatives confirmed
thatBio-Rad	hadsold— 	toitscustoiners.	CX-0019C	(Reifsnyder	Dep.Tr.)
at 70-71; (‘X-0020C (Norton Dep. Tr.) at 32-33. This evidence is sufficient to show direct
iilfiingement of the ’O24patent by Bio-Rad’s customers.
10X contends that
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Dr. Kaihara’s testimony is sufficient to show direct infiingernent by
b. Induced Infringement
Bio-Radadmitsthatit hadknowledgeofthe applicationforthe ’024patent
—, 	CX-0050C	at8,andthecomplaint	inthisinvestigation	explicitly	accused
Bio-Rad of induced infringement. Complaint 1172; see Certain Television Sets, Television
Receivers, Television Tuners, and Components Thereofi lnv. N0. 337-TA-910, C0mm’n Op. at
39-43 (Oct. 14, 2015) (holding that service of the complaint on a respondent is sufficient to
establish knowledge for indirect infringement). l0X identifies Bio-Rad’s promotional materials
and instmction manuals as evidence that Bio-Rad has induced infiingement of the asserted
claims. CIB at 36-37. This includes advertising materials, instructional manuals, and materials
describing Bio-Rad’s customer support and services for installation, repair, and troubleshooting
of ddSEQ products. See CX-0004C (Butte DWS) at Q/A 629-37. Bio-Rad does not dispute this
evidence of inducement, and Staff agrees With 10X that the dissemination of these materials is
sufficient to show that Bio-Rad has induced infringement of the asserted claims of the ’O24
patent by the ddSEQ vl products. SIB at 39-40.
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Accordingly, 10X has shown that Bio-Rad has induced infringement of claims l, 5, l7,
l9, and 22 of the ’024 patent by the ddSEQ vl products.
c. Contributory Infringement
As discussed above, Bio-Rad had knowledge of its contributory infringement upon
service of the complaint in this investigation. See Complaint 1[73 (alleging contributory
infringement). Dr. Butte explained how the accused components of Bio-Rad’s ddSEQ system
are especially adapted for use in practicing the infringing methods. CX-0004C at Q/A 602-609.
With respect to the ddSEQ vl products, Dr. Butte identifies specific components, including the
ddSEQ cartridges, ddSEQ single-cell isolator, ddSEQ cartridge holder, and consumables and
assays used with the ddSEQ vl process, including the SureCell WTA 3’ vl assay, which are
designed and adapted for performing the infringing ddSEQ vl workflow. Id. at Q/A 604. These
components and their use in the ddSEQ vl system are described in Bio-Rad product literature,
including	a— 	presentation	(IX-0088C),	andnumerous	instruction
manuals and training materials. See, e.g., CX-l405C; CX-1406C; CX-l435C; CX-1436C; CX
l460C; CX-1437C; CX-1451C; CX-1452C; CX-1454C; CX-1461C; CX-1473C; CX-1488C.
Dr.	Butte	also	identifies 	Id.	atQ/A	605-609.
Bio-Rad disputes 1OX’sallegations of contributory infringement by arguing that the
ddSEQ vl system has a substantial non-infringing use. RIB at 66-68. Specifically, Dr. Metzker
describes the Drop-seq protocol, Wherethe barcode molecules are not releasably attached to the
gel bead and are not released, as required by the claims of the ’024 patent. RX-0665C at Q/A
138-143. During the course of this investigation, Bio-Rad developed a Drop-seq protocol for its
ddSEQ system, releasing the protocol to the public in late 2018. Id. at Q/A 144-147; IX-0131C;
JX-0130; see Tr. (Kaihara) at 239.
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10X does not dispute that Drop-seq would be a non-infringing use of the ddSEQ system,
but 10X and Staff argue that it is not a “substantial non-infringing use,” because there is no
evidence that any ddSEQ user has actually used the Drop-seq protocol. CIB at 34-35; SIB at 37
38. The Bio-Rad employee who was responsible for updating the Drop-seq protocol admitted at
the hearing that she was not aware of any customer using Drop-seq on any Bio-Rad ddSEQ
device. Tr. (Kaihara) at 240-41. Bio-Rad did not publish the Drop-seq protocol for ddSEQ until
afier the close of discovery in this investigation. Id. at 239. Dr. Butte considered the evidence
regarding Bio-Rad’s Drop-seq protocol and offered his opinion that it would not be a substantial
use of the ddSEQ products because it would require additional reagents not included in the
ddSEQ products, and it would not use several of the accused ddSEQ components, including Bio
Rad’s SureCell kits and certain assays. CX-0004C at Q/A 611-616. Based on this evidence, I
agree with 10X and Staff that the Drop-seq protocol is not a substantial non-infringing use of the
ddSEQ system, and accordingly, 10X has carried its burden to show contributory infringement
with respect to the accused ddSEQ vl products. See Certain Beverage Brewing Capsules,
Components Thereof; and Products Containing the Same, Inv. No. 337-TA-929, Comm’n Op. at
22-24 (Apr. 5, 2016) (finding contributory infringement based on a lack of substantial non
infringing uses).
Accordingly, 10X has shown that Bio-Rad contributorily infringed of claims 1, 5, 17, 19,
and 22 of the ’024 patent by importing and selling components of the ddSEQ vl system.
D. Domestic Industry
There is no dispute that l0X’s DI products practice claims 1, 5, 17, 19, and 22 of the ’024
patent. CIB at 37-40; SIB at 40-41. 10X relies on the testimony of Dr. Butte to show that the DI
products practice the asserted claims. CX-0004C at Q/A 227-287.
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1. Claim 1
lOX’s DI products are part of a method of sample preparation of gDNA or mRNA for
sequencing applications. CX-0004C (Butte DWS) at Q/A 256-58. The steps in the method meet
each of the limitations of claim 1 of the ’O24patent. Id. at Q/A 259-79. In particular, l0X’s DI
products provide a droplet that contains a porous gel bead formed of polyaciylamide. Id. at Q/A
260-61. l0X’s single cell applications contain an 1nRNA as a target nucleic acid analyte, while
the linked read solutions contain a gDNA fragment. Id. In each of the DI products, there are at
least 1.000.000 oligonucleotide molecules that include barcode sequences. Id. at Q/A 263-64.
These barcode sequences are the same for the oligonucleotide molecules on each gel bead. Id. at
Q/A 269-70. The oligonucleotide molecules are releasably attached to the gel bead through a
— 	thatcanbebroken	uponapplication	of 	Id.atQ/A265-68.	- 	isapplied
to thegelbeadaspartof “AdditiveA,”whichcleavestl1e_ 	toreleasethebarcodes
and also dissolves the gel bead. Id. at Q/A 272-73. Upon release, the barcodes attach through
liybridization to the n1RNA or gDNA fragment. Id. at Q/A 274-76. In the single-cell
applications. a reverse transcription process then generates barcoded cDNA strands, which
undergo further PCR outside the droplet to create barcoded double-stranded cDNAs. Id. at Q/A
278. In the linked-read applications. an isothennal amplification in the droplet creates a DNA
amplicon, which undergoes further amplification outside the droplet. Id. at Q/A 279. l
Accordingly. the DI products meet the technical prong of the domestic industry
requirement with respect to claim 1 of the ’024 patent.
2. Dependent Claims 	i
The additional limitations of the asserted dependent claims are also practiced by the DI
products. With respect to claim 5, 	CX—0004C(Butte DWS) at Q/A
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281. With respect to claim 17, the mRNA of the single-cell applications and the gDNA of the
linked-read applications are the target nucleic acid analytes, and they attach to individual
oligonucleotide molecules in each of the Dl products. Id. at Q/A 283. With respect to claim 19,
the oligonucleotides attach to the mRNA or gDNA fragment through hybridization. See Id. at
Q/A 274-76. With respect to claim 22, the porous gel beads of the DI products are comprised of
polyacrylamide. Id. at Q/A 287.
Accordingly, the DI products meet the technical prong of the domestic industry
requirement with respect to dependent claims 5, 17, 19, and 22 of the ’024 patent.
E. Invalidity
r Bio-Rad contends that the asserted claims of the ’024 patent are invalid as anticipated or
rendered obvious by U.S. Patent N0. 9,347,059 (JX-0031, “the ’059 patent”) and/or U.S. Patent
No. 9,902,950 (RX-0462, “Church”), alone or in combination with additional prior art. RIB at
68-1 l 1. I
1. The ’059 patent
The ’059 patent issued from a patent application filed by Bio-Rad in April 2012, based on
a provisional application that was filed in April 2011 by Dr. Saxonov, around the time that
QuantaLife Wasacquired by Bio-Rad. CX-1829C (Saxonov RWS) at Q/A 25-27; JX-0031.
Dr. Saxonov is the sole named inventor on the ’059 patent, and Bio-Rad is the assignee. JX
0031. There is no dispute that the ’059 patent is prior art to the ’024 patent and all of the other
asserted patentsiit is listed as a cited reference on each of the asserted patents. See SIB at 41.
The ’059 patent discloses methods for barcoding mRNA and DNA in droplets. The
specification of the ’059 patent explains the benefits of barcoding, allowing separately prepared
samples to be pooled and sequenced, while “each sample can have its own unique barcode.”
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‘O59 patent, col. 3:53-62. The specification further describes “adaptors” with barcodes that “can
be bundled within a partition, e.g., an aqueous phase of an emulsion, e.g. a droplet.” Id., col.
4:4-5. Also, “[t]he adaptor-filled droplets can be burst (e.g., through a temperature adjustment)
to release reaction components . . . .” Id., col. 4:34-37. The specification also describes “end
modifications” that “can be attached to a nucleic acid strand through a linker.” Id., col. 12:30
36. Moreover, the specification describes “an amplification reaction” that “comprises a
polymerase chain reaction.” Id., col. 2:41-46. The specification further provides that “[a]
barcode can be attached to a polynucleotide by amplification with a primer comprising a
barcode.” Id. at col. 9:63-65.
There is no dispute that many of the limitations of the asserted claims of the ’O24patent
are disclosed in the ’059 patent. In particular, the ’059 patent discloses a method for sample
preparation using a droplet containing barcoded oligonucleotide molecules and that the
oligonucleotide molecules are subject to amplification. The parties dispute Whether the ’059
patent discloses several specific claim limitations, however, including the limitations regarding
porous gel beads, and the limitations requiring releasable attachment to those beads.
a. Porous gel beads
l0X and Staff argue that the ’059 patent fails to disclose the porous gel beads claimed in
the ’O24patent. CIB at 62-75; SIB at 42-44. Bio-Rad concedes that there is no explicit
disclosure of porous gel beads in the ’059 patent specification. RRB at 20-21. Bio-Rad points to
an embodiment described in the ’059 patent where barcodes attach to a bead: “In some
embodiments, antibodies can be linked to beads coated with short DNA fragments with a unique
barcode.” ’059 patent, col. 36:59-60. Although the ’059 patent does not describe the type of
bead used with these antibodies, the use of the term “coated” suggests that the barcodes are
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attached to the surface of a solid bead, rather than the interior of a porous bead. See CX-1872C
(Dear RWS) at Q/A 108 (“Not only are the antibody-linked beads not being described as gel or
porous, they are described as being ‘coated’ with short DNA fragments. Thus, the beads are not
permeated with oligonucleotide molecules, and instead their surface is “coated.” This further
confirms that the beads are not porous gel beads, and are instead rigid, non-porous beads”); CX
1829C (Saxonov RWS) at Q/A 16 (“I was assuming that the beads were solid throughout or that
only the exterior solid surface was going to be used.”). Bio-Rad identifies an alleged reference
to gel beads in another embodiment in the ’059 patent specification describing a “next generation
sequencing technique” called Roche 454 sequencing. ’059 patent, col. 26:43-66. Dr. Metzker
explains that the Roche 454 system used Sepharose beads, which he describes as porous gel
beads. RX-0664C at Q/A 162-63, 1166-68.
lOX disputes Bio-Rad’s assertion that the Roche 454 beads are porous gel beads as
required by the claims of the ‘O24patent. CIB at 64-75. Although Dr. Metzker identifies the
Roche 454 beads as Sepharose, there is no direct evidence in the record of the composition of
these beads.5 The only evidence that Bio-Rad cites is cross-examination testimony of 10X’s
expert, Dr. Dear, who identified a publication by Marcel Margulies et al. (CX-1940) describing
the use of Sepharose beads in the context of Roche 454 sequencing: “Yes, Ibelieve—at the time
454 published, I believe they used sepharose beads. That’s the Margulies paper. Whether they
did since in their commercial instruments, I don’t know.” Tr. 869-70.
10X also challenges Bio-Rad’s assertion that Sepharose is a porous gel, relying on the
opinion of Dr. Dear that Sepharose beads are rigid and lack the deforrnability that characterizes
5 Certain evidence regarding Sepharose beads was excluded from Dr. Metzker’s witness
statement pursuant to a motion in limine. Order No. 38 at 8-9 (Mar. 12, 2019).
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the gel beads described in the asserted patents. CIB at 64-75 (citing CX-1827C (Dear RWS) at
Q/A 110-15). Bio-Rad supports its contention that Sepharose is Vaporous gel with testimony
from Dr. Agresti, who describes Sepharose as “a crosslinked agarose, which is a material that I
would consider to be a hydrogel,” citing a document listing Sepharose as a “gel filtration media.”
RX-0503C (Agresti DWS) at Q/A 69; RX-0692. During cross-examination, however,
Dr. Agresti admitted that gel filtration is different from microfluidics. Tr. 336. In addition,
Dr. Agresti had previously testified at his deposition that he was not sure whether prior art using
Sepharose would disclose a hydrogel bead. Id. at Q/A 66-68; Tr. 334.6 Bio-Rad also offers
testimony from Dr. Grenier describing Sepharose as a porous gel bead based on his work in
graduate school in the mid-1990s. RX-0507C at Q/A 47-50.
Although I agree with Bio-Rad that Dr. Dear’s strict requirements for rigidity and
deformability may not be necessary to satisfy the “porous gel bead” limitation, Bio-Rad bears the
burden on invalidity, and the conflicting evidence regarding Sepharose is neither clear nor
convincing. Even if Bio-Rad had shown that Sepharose beads existed in the prior art that were
porous gel beads, the record is far from clear that such beads were used in the Roche 454
sequencing process described in the ’059 patent. Bio-Rad does not identify any disclosure in the
’059 patent or the Margulies paper describing the composition or the characteristics of the Roche
454 beads, and Bio-Rad’s witness testimony does not convincingly show that these beads
described in the ’O59patent are porous gel beads. Accordingly, Bio-Rad has failed to carry its
6 Dr. Agresti equivocated on this issue when he was presented with a document filed at the
USPTO by Bio-Rad’s counsel when prosecuting a different patent application, which is
discussed in more detail, infra, in the context of the Church patent. JX-O171.0027.
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burden to show that the porous gel bead limitation of the ’024 patent is anticipated by disclosures
in the ’Q59 patent. I
b. Releasable attachment
Even if Bio-Rad had presented sufficient evidence at the hearing to show that the ’O59
patent disclosed porous gel beads, the beads identified by Dr. Metzker cannot anticipate the
limitation of claim l of the ’024 patent requiring that “said oligonucleotide molecules are
releasably attached to said porous gel bead.” 10X’s expert, Dr. Dear, notes that the ’059 patent
describes the Roche 454 beads as “capture beads,” and these beads are only discussed in the
context of sequencing, which is a separate process in a separate embodiment from any discussion
of releasing barcodes. CX-l 827C at Q/A 87, 108. The ’O59patent only references the Roche
454 beads as a substrate for sequencing, and Dr. Dear explains that “nucleic acids to be
sequenced must remain attached to the substrate for their sequences to be determined.” Id. at
Q/A 108. Bio-Rad fails to connect the ’O59patent’s disclosure of Roche 454 beads to any
discussion of releasable attachment, and the ’059 patent’s separate disclosure of these beads
cannot form the basis for a finding of anticipation of this limitation. See Net M0neyIN, Inc. v.
VeriSign, Inc., 545 F.3d 1359, 1371 (Fed. Cir. 2008) (holding that the district court was “wrong
to combine parts of the separate protocols shown in the iKP reference in concluding that claim
23 was anticipated”).
‘ Bio-Rad argues in the altemative that it would have been obvious ‘touse porous gel beads
for releasable attachment of the oligonucleotides described in the ’059 patent. See RRB at 20
21. Dr. Metzker identifies the ’059 patent’s disclosure of antibody-linked beads and droplets as
a disclosure of releasable attachment. RX-0664C at Q/A 181-85. In particular, the ’059 patent
specification describes an embodiment where “antibodies can be linked to beads coated With
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short DNA fragments with a unique barcode,” and further suggests that “[t]he antibodies could
also be linked to droplets containing DNA fragmentsfwhich can be burst as appropriate.” JX
0031, col. 36:59-64. Based on this disclosure, Dr. Metzker suggests that the ’059 patent “teaches
three interchangeable ways to deliver ba.rcodes—droplets, capsules, and beads.” RX-0664C at
Q/A 181.
10X argues that Bio-Rad improperly mixes and matches different embodiments of the
’059 patent. CIB at 53-64. The portion of the ’O59specification that describes the release of
“barcode adaptors” is limited to droplets, disclosing that “[t]he adaptor-filled droplets can be
burst (e.g., through a temperature adjustment) to release reaction components (e.g., PCR or
ligation components) that can be used for library preparation.” JX-0031, col. 4:34-37. The
antibody-linked beads are described in a separate embodiment, and the DNA fragments attached
to these beads are not the barcodes described in the ’059 patent’s droplet embodiment. See CX
1827C (Dear RWS) at Q/A 40, 87. Moreover, although the ’()59patent describes the droplets
being “burst” to release barcode adaptors, there is no description of any mechanism for releasing
the attached DNA fragments from beads. Id. at Q/A 155-56. Dr. Metzker concedes that the
antibody-linked embodiment does not disclose the claimed barcodes but submits that “one of
ordinary skill in the art would have immediately envisioned from the bead antibody disclosure in
Saxonov that it could also apply to barcoding the cellular material.” RX-0664C at Q/A 183.
Dr. Metzker’s suggestion that the antibody-linked DNA fragments could be replaced with
barcodes is plausible, but this would only result in barcodes attached to beads, with no teaching
regarding release.
To meet the releasable attachment limitation, Dr. Metzker further suggests that “[t]he
only way for the barcodes in the inner droplet to ftmction is by having them released from the
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PUBLIC VERSION
inner droplet,” and “[o]ne of ordinary skill in the art would have therefore recognized that the
barcodes on beads would be functioning in the same Way,they would be released from the
bead.” Id. at Q/A 184. Thereiis no disclosure in the ’059 patent indicating how the beads could
function to release barcodes in the same way as the burstable droplets, however, and Bio-Rad
fails to offer a convincing argument for how one of ordinary skill in the art would use prior art
teachings to replace the burstable droplets with beads. As Dr. Dear explains, the ’059 patent
specification shows that “although Saxonov specifically had the idea of releasing adaptors from a
droplet,” he “did not have the idea of releasing short DNA fragments from a bead.” CX-1827C
at Q/A 161.
Dr. Metzker attempts to supply a mechanism for releasably attaching barcodes to beads
by suggesting that one of ordinary skill in the art would recognize that certain parts of the
barcodes disclosed in the ’059 patent “would be susceptible to cleavage and could remove the
barcode adaptor molecule at the point of contact with the bead.” RX-0664C at Q/A 186. This
conclusory expert opinion cannot meet Bio-Rad’s burden on invalidity, however. See K/S
Himpp v. Hear- Wear Techs., LLC, 751 F.3d 1362, 1365-66 (Fed. Cir. 2014) (affirming a finding
of non-obviousness Wherethe USPTO properly rejected “a conclusory assertion from a third
party about general knowledge in the art without evidence on the record,” noting that the
limitation “an important structural limitation that is not evidently and indisputably within the
common knowledge of those skilled in the art!”). Dr. Metzker’s suggestion for barcode cleavage
is not based i11any prior art disclosure but on hindsight, using the limitations of the ’024 patent
to selectively modify the prior art. See Ortho-McNeil Pharm., Inc. v. Mylan Labs., Inc., 520 F.3d
1358, 1364 (Fed. Cir. 2008) (“In other words, Mylan’s expert, Dr. Anderson, simply retraced the
path of the inventor with hindsight, discounted the number and complexity of the alternatives,
39

PUBLIC VERSION
and concluded that the invention [] was obvious. Of course, this reasoning is always
inappropriate for an obviousness test . . . .”).
Accordingly, I agree with 10X and Staff that Bio-Rad has failed to show that releasably
attaching oligonucleotide molecules to a bead would be obvious in view of the ’059 patent.
c. Combinations with other references
Bio-Rad further contends that the claimed porous gel beads are disclosed in other prior
art references that would have been obvious to combine with the ’059 patent. RIB at 77-80.
These references include the Church patent (RX-0462), an article by Dr. Adam Abate, Beating
Poisson Encapsulation Statistics Using Cl0se—Pac/tedOrdering (RX~0lO2, “Abate”), and U.S.
Patent Application Pub. No. 2010/0304982, naming inventors Wolfgang Hinz et al. (RX-0461,
“HinZ”). These references each disclose beads that appear to meet the “porous gel bead”
limitations of the asserted claims of the ’024 patent, but Bio-Rad fails to offer any credible
motivation for combining the gel beads disclosed in these references with the droplet-based
barcoding system disclosed in the ’059 patent. As discussed above, Dr. Metzker’s proposal for
replacing the ’059 patent’s burstable droplets with beads having releasably attached barcodes is
conclusory and relies on hindsight. Bio-Rad has identified no credible motivation for one of
ordinary skill in the art to look to the gel beads disclosed in Church, Abate, or Hinz for releasable
attachment of the barcodes contained in droplets in the ’059 patent. Accordingly, Bio-Rad has
failed to show that any asserted claim of the ’024 patent is rendered obvious by the ’059 patent in
combination with these additional references.
2. The Church patent V
The Church patent issued from a patent application filed in October 2011 and is assigned
to Harvard College. RX-0462. There is no dispute that the Church patent is prior art to the ’024
40

PUBLIC VERSION
patent and all of the other asserted patents—the published patent application for the Church
patent is listed as a cited reference on each of the asserted patents. See SIB at 50-51.
Church describes a process for producing beads coated with barcoded oligonucleotides
RX-0462, col. 2:28-34. The specification explicitly discloses “a variety of materials” for its
beads, including “paramagnetic materials, ceramic, plastic, glass, polystyrene, methylstyrene,
acrylic polymers, titanium, latex, sepharose, cellulose, nylon and the like.” 1d., col. 12:38-42.
Figure Z of Church depicts a process where a single cell and barcoded bead are captured in an
emulsion (Fig. 2A), nucleic acid sequences are released into the emulsion upon cell lysis (Fig.
2B), and the nucleic acid target is annealed to the barcoded bead (Fig. 2C).
\:)%€/
FIG. 2a 	_;’%<__/)L>=L-»=*
FIG.2C ( "~/'“-ak
\ 	‘Y
\ 	c
Id. at Fig. 2, col. 3:49-53, col 5:50-6:10. The barcoded beads are then further processed, with
cDNA synthesis for RNA, followed by PCR amplification. Id., col. 6:18-24.
There is no dispute that the Church patent discloses a method for sample preparation
using a barcoded bead with oligonucleotides attached that are subject to amplification. The
parties dispute whether Church discloses several limitations of the asserted claims of the ’024
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PUBLIC VERSION
patent, however, including Whetherthe bead is a porous gel bead and Whetherthe barcoded
oligonucleotides are releasably attached.
a. Porous gel beads
Bio-Rad primarily relies on the Church patent’s disclosure of Sepharose beads to
anticipate the porous gel bead limitation of the ‘O24patent. RIB at 95-96. As discussed above in
the context of the “O59 patent, Bio-Rad relies on the testimony of Dr. Metzker and certain other
evidence that Sepharose beads are porous gel beads. RX-0664C (Metzker DWS) at Q/A 213; see
also RX-0503C (Agresti DWS) at Q/A 66-69; RX-0507C (Grenier DWS) at Q/A 47-50. l0X’s
expert, Dr. Dear, disagrees with Dr. Metzker’s opinion, contending that Sepharose beads are
rigid and lack the deformability to meet the gel bead limitation. CX-1827C (Dear RWS) at Q/A
110-115. Moreover, Bio-Rad’s counsel represented to the USPTO in August 2017 that “Church
does not teach or suggest particles that are hydrogels nor cleaving the oligonucleotides from the
particles as recited in the claims.” JX-0171.0027, Applicant’s Response to Final Office Action
at 8 (Aug. 21, 2017).7 On this record, Bio-Rad has failed to carry its clear and convincing
burden to show that Church’s disclosure of Sepharose as a bead material anticipates the claim
limitation requiring a porous gel bead.
Bio-Rad further contends that Church’s disclosure of cellulose and polystyrene as bead
materials anticipates the porous gel bead limitation. RIB at 95-96. Bio-Rad offers little evidence
to support these assertions, however. With respect to cellulose, Bio-Rad cites cross-examination
testimony from Dr. Dear, where he was presented with a catalog describing cellulose as having
7Bio-Rad later filed a correction with USPTO Withdrawing this statement, conforming their
prosecution filings to their arguments here that “Sepharose is a cross-linked agarose with a
porous structure and is a hydrogel.” RX-0660 at 9.
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PUBLIC VERSION
porosity, but Dr. Dear testifies that ‘Tm familiar with cellulose in the ordinary sense of the word,
and as I know it, it’s —as Ihave encountered it, it’s nonporous and rigid.” Tr. 890-91. For
polystyrene, Bio-Rad cites testimony from Dr. Metzker that “[p]o1ystyrene can be cross-linked”
and that “there are only two choices . . . of going with either a nonporous or a porous polystyrene
bead.” Tr. 676-77. This expert testimony, without additional evidentiary support, is insufficient
to meet Bio-Rad’s clear and convincing burden, particularly when considered in the context of
Bio-Rad’s prior representation to the USPTO that “Church does not teach or suggest particles
that are hydrogels.” JX-0l7l.0027.
Accordingly, the porous gel bead limitations of the ’024 patent are not anticipated by the
Church patent.
b. Releasable attachment
With respect to the releasable attaclnnent limitations of the ’O24patent, Bio-Rad points to
a paragraph in the Church patent’s specification describing “functional groups attached to [a
bead] surface, which can be used to bind one or more reagents described herein to the bead.”
RX-0462, col. 12:43-53. Church further states: “One or more reagents can be attached to a
support (e.g., a bead) by hybridization, covalent attachment, magnetic attachment, affmity
attachment and the like.” Id. Church then references “a variety of attachments” that “are
commercially available” and states that beads “may also be functionalized using, for example,
solid-phase chemistries known in the art,” citing another patent, U.S. Patent No. 5,919,523 to
Sundberg, er al. (RX-0466, “Su11dberg’;). Id.
According to Dr. Metzker, Sundberg “teaches the attachment of oligonucleotides to
porous gel bead surfaces for the synthesis of oligonucleotides using spacer molecules.” RX
0664C at Q/A 222. Sundberg provides that “[i]n some embodiments, the spacer may provide for
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PUBLIC VERSION
a cleavable function by way of, for example, exposure to acid or base.” RX-0466, col. 8:57-59.
In addition, “[a]ccording to other embodiments, small beads may be provided on the surface, and
compounds synthesized thereon may be released upon completion of the synthesis. Id., col.
6:14-16. Based on these disclosures, Bio-Rad argues that the releasable attachment limitation of
the ’024 patent is rendered obvious by Church, incorporating Sundberg by reference. RIB at 100
- 	>
102; RRB at 30-34.8 _
10X and Staff disagree with Bio-Rad’s contention, arguing that Sundberg is only cited by
Church in the context of attaching functional groups to bind reagents to beads, Without any
discussion of releasing barcodes. CIB at 95-96; SRB at 19-20; see CX-1927C (Dear RWS) at
Q/A 286. Moreover, the disclosures in Sundberg relied upon by Dr. Metzker are found under the
heading “Pin-Based Methods,” which is separate from “Bead Based Methods.” See RX-0466,
col. 8:23-59, 8:60-13:49. As Dr. Dear explains, the pin-based methods in Sundberg are methods
of synthesis where “[e]ach tray is filled with a particular reagent for coupling in a particular
chemical reaction on an individual pin.” CX-1827C at Q/A 289 (quoting RX-0466, col. 8:33
34). According to-Dr. Dear, the “cleavable function” cited by Dr. Metzker relates to the removal
of a substance synthesized on a pin, not the release of barcodes attached to a bead. Id. Dr. Dear
also notes that where Sundberg references release in the context of beads, it describes release
“upon completion of the synthesis,” which is not a release of barcodes into a droplet, as claimed
8It is unclear from Bio-Rad’s post-hearing briefs Whether it contends that this limitation is
anticipated by the Church patent. Bio-Rad’s initial post-hearing brief contains a section heading
stating that “Church anticipates or renders obvious the claims of the ’024 Patent.” RIB at 94; see
also id. at 106. Nevertheless, Bio-Rad_does not appear to make an explicit contention that
Church anticipates the “releasably attached” limitation of the ’024 patent, see RTBat 100-102,
and in Bio-Rad’s post-hearing reply brief, Bio-Rad only contends that Church renders the
asserted claims obvious. RRB at 30-34.
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PUBLIC VERSION
in the ’024 patent. Id. Moreover, there is nothing in Church to suggest that one of ordinary skill
would look to Sundberg for methods of releasing barcodes, because Church only describes a
process where the barcodes remain attached to the bead. Id. These are significant gaps in
Dr. Metzker’s analysis that undercut Bio-Rad’s obviousness contentions.
Bio-Rad’s contentions are further contradicted by the representation of its attorneys to the
USPTO that “Church does not teach or suggest particles that are hydrogels nor cleaving the
oligonucleotides from the particles as recited in the claims.” JX-Ol7l.0O27, Applicant’s
Response to Final Office Action at 8 (Aug. 21,'20l7).° On this record, I agree with 10X and
Staff that Bio-Rad has failed to show that the “releaseably attached” limitation is obvious in view
of Church and Sundberg.
c. Combination with other references
Bio-Rad further contends that the asserted claims of the ’024 patent are obvious in view
of Church in combination with several additional references. RIB at 94-111; RRB at 30-34.
I agree with Bio-Rad that the use of a porous gel bead would have been obvious in view
of Church in combination with Sundberg or Hinz (RX-0461). The list of bead materials in
Church is non-exhaustive. RX-0462, col. 12:38-42 (“Beads may comprise a variety of materials
including, but not limited to paramagnetic materials, ceramic, plastic, glass, polystyrene,
methylstyrene, acrylic polymers, titanium, latex, scpharose, cellulose, nylon and the like”).
Sundberg explicitly describes “polymer-coated supports” including “polyacrylamides.” RX
0466, col. 5:32-38. Hinz teaches using polyacrylamide gel beads for nucleic acid analysis,
9 Although Bio-Rad later retracted its argument regarding hydrogels, see n.7, supra, there has
been no retraction of its statement reading cleaving the oligonucleotides. Bio-Rad submits that it
amended the pending claims, however, to remove a limitation regarding cleaving the
oligonucleotides. RRB at 33 (citing RX-0660.0005).
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PUBLIC VERSION
noting that these porous gel beads “allow polynucleotides to be attached throughout their
volumes for higher loading capacities than those achievable solely with surface attachment.”
RX-0461, Abstract. Polyacrylamide is explicitly identified in the ’024 patent specification and
claims as a polymer gel that can be used for a porous gel bead. ’024 patent, col. 1:51-53, 2:28
31. In addition, Dr. Dear agreed that Hinz discusses porous gel beads. Tr. 895-96. Accordingly,
I agree with Bio-Rad that one of ordinary skill in the art, reading the statement in Church
identifying a variety of bead materials, would have pursued other known materials available in
the prior art, including the polyacrylamide beads described in Sundberg and Hinz. As
recognized by Dr. Metzker, one of ordinary skill in the art would have been motivated to use
these porous gel beads because of their increased loading capacities, consistent with the Church
patent’s stated goals of generating millions of barcoded beads for high-throughput sequencing.
See RX-0664C at Q/A 216; RX-0462, col. 2:30-34, 2:51-3:6.
Bio-Rad has failed to make its case for obviousness with respect to the “releasably
attached” limitation, however. Bio-Rad contends that it would have been obvious to use
releasable attachments to the beads in Church when viewed in combination with the ’059 patent,
Sundberg, and the knowledge of one of ordinary skill in the art. RIB at 100-102; RRB at 30-34.
Bio-Rad identifies no motivation for adding releasability of barcodes to the process disclosed in
Church, however. As discussed above, Bio-Rad’s attorneys argued to the USPTO that “Church
does not teach or suggest . . . cleaving the oligonucleotides fiom the particles as recited in the
claims.” JX-0l71.0027. Bio-Rad fails to identify any evidence in Church to contradict this prior
representation.
Bio-Rad argues that the releasably attached limitation is obvious because there are only
two options for the barcodes attached to the beads in Church: either the barcode remains attached
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PUBLIC VERSION
to the bead or it is detached. RRB at 32-33. Bio-Rad’s argument relies on a misreading of KSR,
however, which describes a case for obviousness where there is “a design need or market
pressure to solve a problem,” and one of ordinary skill would have “good reason to pursue the
known options within his or her technical grasp.” 550 U.S. at 421. Whether or not to release
barcodes attached to bead does not present a choice of two solutions to a known problem,
however—these are two methods for addressing different problems in the prior art. In Church,
the problem is attaching barcodes to a bead, and these barcodes remain attached to the bead for
synthesis and amplification. RX-0462, col. 6:18-24. In the ’O59patent, droplets are burst to
release reaction components with the barcodes. JX-0031, col. 4:34-36. Bio-Rad’s framing of the
issue as two known options has been constructed in hindsight, and it does not prove that this
limitation is obvious. See CRB at 37-38.10
Accordingly, Bio-Rad has failed to show that any asserted claim of the ’024 patent is
rendered obvious by Church in combination with any of these additional references.
3. Secondary considerations of non-obviousness
In Graham v. John Deere C0. of Kansas City, the Supreme Court held that in determining
obviousness “[s]uch secondary considerations as commercial success, long felt but unsolved
needs, failure of others, ezc., might be utilized” as “indicia of obviousncss or nonobviousness,”
383 U.S. 1, 17-18 (1966). Indeed, “evidence of secondary considerations may often be the most
probative and cogent evidence in the record.” In re Cyclobenzaprine Hydrochloride Extended
“) At the hearing, Dr. Dear testified: “No, there’s not only two options as to what you do. If you
say do—I mean, there are many things you can do in droplets. If you simply say do we cleave it
off the bead or do we not cleave it off the bead, the point I’m making is that that doesn’t
constitute a conception. It’s just saying those are two options for that particular feature.”
Tr. 912:3-13.
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PUBLIC VERSION
Release Capsule Patent Litigation, 676 F.3d 1063, 1075-76 (Fed. Cir. 2012) (quoting Stratoflex,
Inc. v.Aeroquip C0rp., 713 F.2d 1530, 1538-39 (Fed. Cir. 1983)) (internal quotation marks
omitted). Accordingly, such evidence “must always when present be considered en route to a
determination _ofobviousness.” Id. (quoting Stratoflex, 713 F.2d at 1538-39) (internal quotation
marks omitted). Secondary considerations of non-obviousness “include: cormnercial success
enjoyed by devices practicing the patented invention, industry praise for the patented invention,
copying by others, and the existence of a long-felt but unsatisfied need for the invention.” Apple
Inc. v. Samsung Electronics C0., 839 F.3d 1034, 1052 (Fed. Cir. 2016).
10X identifies five secondary considerations that it alleges weigh against a finding of
obviousness. Four of these considerations-——(1)	solving a long-felt need, (2) industry praise, (3)
commercial success, and (4) failure of others—relate to the success of 10X’s domestic industry
products and the failure of a competitor to develop a competing product. With regard to these
secondary considerations, Bio-Rad argues that 10X has not shown a nexus between the asserted
claims and the domestic industry products. RRB at 94-95. With respect to the fifth secondary
consideration identified by 10X——copyingby another, viz., Bio-Rad—Bio-Rad contests 10X’s
allegations of copying. 	'
a. The success of the domestic industry products weighs against
obviousness.
i. 10X has established the required nexus.
There must be a “nexus between the merits of the claimed invention and evidence of
secondary considerations . . . in order for the evidence to be given substantial weight in an
obviousness decision.” Ruiz v. A.B. Chance C0., 234 F.3d 654, 668 (Fed. Cir. 2000)); see also
Ormco Corp v. Align Tech., Inc, 63 F.3d 1299, 1311-12 (Fed. Cir. 2006) (“Evidence of
commercial success, or other sec ndary considerations, is only significant if there is a nexus
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between the claimed invention and the commercial success.”). As discussed herein, the domestic
industry single-cell products practice all of the asserted patents, while the domestic industry
linked-read products practice the asserted claims of the ’024, ’468, and ’204 patents. Citing
WBIP,LLC v. Kohler C0., both l()X and Staff argue that the domestic industry products’ practice
of the asserted claims triggers a presumption that there is a nexus between the claims and the
“asserted objective evidence” tied to the domestic industry products. 829 F.3d 1317, 1329 (Fed.
Cir. 2016) (internal citations and quotation marks omitted). Such a presumption is only
applicable, however, if a product is coextensive with the claimed invention. Polaris Indus, Inc.
v. Artic Cat, Inc., 882 F.3d 1056, 1072 (Fed. Cir. 2018) (“[W]hen the thing that is commercially
successful is not coextensive with the patented invention—-forexample, if the patented invention
is only a component of a commercially successful machine or process—the patentee must show
prima facie a legally sufficient relationship between that which is patented and that which is
sold.”) (internal citation and quotation marks omitted). Neither 10X nor Staff provide analysis
regarding whether the domestic industry products are coextensive with the claimed invention.
At least in some instances, the claimed invention is only a component of the domestic
industry products. For example, the asserted claims of the ’2()4patent are directed to droplets
containing capsules, wherein the capsules contain barcode molecules. See, e.g., ’204 patent, col.
44:42-49 (unasserted claim 1), col. 46:24-27 (claim 27). Althoughvthe domestic industry
products have such capsules in the form of a gel beads, they also include unclaimed components,
such as “microfluidic chips, chip holders, droplet generating instmments, . . . and various other
reagents.” CIB at 5. Accordingly, I find that the domestic industry products’ practice of the
asserted claims does not trigger the presumption of a nexus.
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Although the presumption of a nexus does not apply, 10X has shown that the evidence
relating to the success of its products is sufficiently related to the claimed invention to provide
the necessaly nexus. All of the asserted claims require a droplet containing a capsule that is
capable of releasing barcode molecules. See, e.g., CX-1827C (Dear RWS) at Q/A 966. This
claimed invention is employed in the domestic industry products in the form of “GemCode” or
“GEM technology,” wherein gel beads capable of releasing barcode molecules are encapsulated
in droplets. Id. at Q/A 966. Using GEM technology, the domestic industry products are able to
achieve “high-throughput profiling of large numbers of single cells or molecules in a single
procedure.” Id. As discussed below, the ability to achieve a high-throughput Wasthe key to the
domestic products’ success. Conversely, the failure of a competitor with a commanding position
in the market to develop a high-throughput solution led to the competitor abandoning the market.
Bio-Rad counters that high throughput “is not a patented feature of the commercial
product.” RIB at 219. The domestic industry products, however, are only able to achieve a high
throughput by using the claimed invention, viz., by encapsulating gel beads Withattached
barcode molecules into droplets. CX-1827C (Dear RWS) at Q/A 967. This relationship between
the domestic industry product’s high throughput and the claimed invention provides the
necessary nexus. See Rambus Inc. v Rea, 731 F.3d 1248, 1256-57 (Fed. Cir. 2013) (fmding a
nexus between evidence relating to the unclaimed high speed achieved by a memory system and
the challenged claims, because the high speed was enabled by the claimed functionality).
ii. The success of the domestic industry products and the
failure of a competitor to develop a competing product
weigh against obviousness.
Bio-Rad does not dispute that the domestic industry products (1) solved a long-felt need,
(2) received industry praise, (3) were a commercial success, and (4) that others failed in
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PUBLIC VERSION
developing a high-throughput system. With regard to long-felt need, at the time of the invention,
it was widely recognized that it would be beneficial for both single-cell analysis and linked-read
analysis to increase the single-run throughput of the single cells or molecules being analyzed.
For instance, in the context of single-cell analysis,
Id.
At the time of the presentation, the industry leader in the field of sample preparation
systems for SCG was Fluidigm. Id. at .0001 1; CX-0016C (Kaihara Dep. Tr.) at 25:19-26:3. In
2012, Fluidigm released its “C1 Single-Cell Aut0Prep System for cell isolation, sample prep, and
analysis.” CX-1946C.000ll (bold-face type removed), see also, id. at .00003 (“20l2:
Introduction of Fluidign1’s SC automated cell prep instrument”). The Fluidigmlsystem had
throughput of “up to 96 cells per run.” Id. at .0OO13. This, however, was inadequate, as it was
necessary to analyze “many more single cells . . . within a single experiment” in order “to
address biological and stoichiometric noise or at least to achieve a better understanding of cell
to—cellvariation Within tissue[.]” CX-l269.00005 (quoting Jokim Lundeberg, KTH Royal
Instituteof Technology(SWeden))(internalquotationmarksomitted).Thisleft an
- 	In2014 timeframe, such a need was even acknowledged by Fluidigm’s CEO: “As the science of
single-cell analysis unfolds, it’s clear to us the field is evolving in several important ways.
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[There is] an increasing need for higher throughput to enable large volume studies.” CX
1946C.00012 (quoting Fluidigm CEO, Gajus Worthington) (intemal quotation marks omitted
and alterations in original). In the context of linked-read technology, high throughput Wasalso a
“long-felt but unresolved need in accessing long range DNA sequence -information.” CX-1827C
(Dear RWS) at Q/A 997. 	_
Upon its introduction, l0X’s GEM technology received industry praise and recognition.
hi particular, Dr. Hindson presented l0X’s GEM technology at the Advances in Genome
Biology Technology conference (“AGBT”). CX-0001C (Hindson WS) at Q/A 143-48. After
Dr. Hindson described the data that was obtained through the technology, the audience
applauded. Id. at 149-50. Dr. Agresti, who attended the conference on behalf of Bio-Rad,
congratulated Dr. Hindson on “l0X’s achievements and said something to the effect that he’s
real amazed and it’s awesome what we’ve done with the technology.” Id. at Q/A 152-53. As
acknowledgedby Dr. Tzonev, another Bio-Rad witness, l0X’s presentationat the AGBT2
cx-00230 (Tzonev Dep. Tr.) at
127: 19-25.
The domestic industry products have been a commercial success. Between the second
quarter of 2015 and the second quarter of 2018, the domestic industry products generated $159
million in revenues. CX-1827C (Dear RWS) at Q/A 1073; JX-0043C. 10X has sold the
domestic industry products to over 550 customers, including the National Institutes of Health,
University of California, Harvard University, Cornell University, California Institute of
Technology, Dartmouth College, Duke University, Georgetown University, John Hopkins
University, and the University of Georgia. CX-1827C (Dear RWS) at Q/A 1071-72; CX-1265C.
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The success of l0X’s domestic industry products stands in marked contrast to Fluidigm’s
failure to develop a competing high throughput product. Although it was “the sole player in the
single cell market in 2009” and recognized by at least Z014 that there was “an increasing need
for higher throughput to enable large volume studies,” Fluidigm was ultimately unable to
develop a high throughput solution. CX-1827C (Dear RWS) at Q/A 1078-1083; CX
l69lC.0OO24; CX-l946C.O00l2 (quoting Fluidigm CEO, Gajus Worthington). In a May 4, '
2017 earnings call, Fluidigm acknowledged that its “single-cell genomics business,” which was
“overwhelmingly [Fluidigm’s] Cl product line, was down in the quaiter by over 70% year-on
year.” CX-l273.00003. One of the reasons for the decline, according to Fluidigm, was “the
announcement of new competition.” Id. As a result of the decline, Fluidigm announced that it
would continue “to shifi [its] primary business focus” away from the single cell market. Id.
In view of the foregoing, I find that the domestic industry products solved a long-felt, but
unmet need, received industry praise, were commercially successful, and that another tried but
failed to develop a solution to satisfy the unmet need. I further find that this evidence weighs
against obviousness.
b. 10X has not established that Bio-Rad copied the claimed
invention.
A10X argues that Bio-Rad’s copying of the claimed invention shows that the invention is
not obvious. 10X’s argument that Bio-Rad copied its invention, however, is unpersuasive. 10X
publicly disclosed its GEM teclrmologyfor the first time at the February 2015 AGBT conference,
which was attended by Dr. Agresti and two other Bio-Rad employees. CX-0001C (Hindson WS)
atQ/A143;151-51
. 	Prior	tojoining	Bio-Rad,	Dr.	Agresti	worked	at
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Amyris, where he
By at least 2009, as shown in a paper that he co
authored, Dr. Agresti was aware that a gel beads could be used to deliver DNA molecules to
droplets. RX-0l02.0000l (“[T]he gel particles can be functionalized with a variety of
compounds, including fluorophores, DNA fragments, antibodies, and enzymes”); RX-0503C
(Agresti DWS) at Q/A 40. The paper notes that gel particles “are useful substrates for chemical
and biological applications” and “[t]he compliance of the particles prevents clogging of the
channels” of microfluidic devices. RX-0l02.0000l.
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The presentation attached to the email
1s JX-0065C; JX-0067C 1s a higher quality copy of the presentation. Jd. at Q/A 49.

LA)
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PUBLIC VERSION
JX-0067C.000l4; RX-0503C (Ag1'estiDWS)atQ/A 54.
Accordingly, there is clear d0cu1nenta1y evidence, as well as D1:Agres’ti’s testimony,
showing that,
In support of its a1"gu111ent	that Bio-Rad copied the claimed invention, 10X points to Dr.
Ag1'esti’s trial testimony and an
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PUBLIC VERSION
-is an advantage discussed in the 2009 paper he co
authored, entitled “Beating Poisson encapsulation statistics using close-packed orden'ng.” RX
0102.000}, (“We use compliant gel particles in these expeiinlents. The compliance of the
paiticles prevents clogging of the cl1am1els.”)(footnotes omitted).
. 10X’s aroument is un ersuasive.	R?
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PUBLIC VERSION
Based on the foregoing, I find that 10X has not shown that Bio-Rad copied the claimed
invention.
V. THE ’468 PATENT
A. Asserted Claims
10X is asserting claims 1, 6, 7, 9, and 21 of the ’468 patent. Claim 1 is independent and
the remaining claims depend directly or indirectly from claim 1. Claim 1 recites:
A method for droplet generation, comprising:
(a) providing at least 1,000,000 oligonucleotide molecules comprising barcode
sequences, wherein said barcode sequences are the same sequence for said
at least 1,000,000 oligonucleotide molecules, wherein said at least
1,000,000 oligonucleotide molecules are releasably attached to a bead,
wherein said bead is porous;
(b) combining said at least 1,000,000 oligonucleotide molecules and a sample
comprising a nucleic acid analyte each in an aqueous phase at a first
junction of two or more channels of a microfluidic device to form an
aqueous mixture comprising said at least 1,000,000 oligonucleotide
molecules attached to said bead and said sample; and
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PUBLIC VERSION
(c) generating a droplet comprising said at least 1,000,000 oligonucleotide
molecules attached to said bead and said sample comprising said nucleic
acid analyte by contacting said aqueous mixture with an immiscible
continuous phase at a second junction of two or more channels of said
microfluidic device.
’468 patent (JX-0005), col. 33:56-col. 34:9.
Claims 6, 7, 9, and 21 depend directly from claim 1. Claim 6 requires that the bead be
formed from a polyacrylamide. Id., col. 34:25-26. Claim 7 requires that the bead be a gel bead.
la’., col. 34:27. Claim 9 requires that the “at least 1,000,000 oligonucleotide molecules” have a
region that functions as a primer. Id, col. 34:30-32. Claim 21 requires that after the generation
of a droplet “a given oligonucleotide molecule of said at least 1,000,000 oligonucleotide
molecules attaches to said nucleic acid analyte,” before being ‘-‘subjectedto nucleic acid
amplification to yield a barcoded nucleic acid analyte.” Id., col. 35:3-9.
B. Claim Construction
The parties agreed to construe “barcode” to mean a “label that may be attached to an
analyte to convey identifying information about the analyte.” Order No. 22 at 2. In the
Markman order, “1,000,000 oligonucleotides comprising barcode sequences” was construed to
mean “1,000,000 oligonucleotide molecules that include, but are not necessarily limited to,
barcode sequences.” Id. at 17-22. The term “releasably attached” Wasconstrued to mean
“attached in a manner that allows the attached object to be released.” Id. at 22-30. The term
“amplification” was construed to mean “increasing the number of copies of the target sequence
to be detected,” including by reverse transcription. Id. at 31-45.
C. Infringement
10X accuses Bio-Rad of infringing claims 1, 6, 7, 9, and 21 of the ’468 patent.
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PUBLIC VERSION
1. Claim 1 	‘
There is no dispute that Bio-Rad’s ddSEQ system includes a method for droplet
generation, and 10X relies on Dr. Butte’s analysis to show infringement of the limitations of
claim 1 of the ’468 patent. CX-0004C at Q/A 418-437.
a. “providing at least 1,000,000 oligonucleotide molecules . . .”
There is no dispute with respect to a majon'ty of the elements in the first limitation of
claim l of the ’468 patent, which includes limitations that are substantively identical to those
discussed above for claim l of the ’024 patent. Dr. Butte refers back to his analysis for the ’024
patent for these limitations, which require “providing at least 1,000,000 oligonucleotide
molecules,” that the “barcode sequences are the same,” that the molecules are “releasably
attached to a bead,” and “said bead is porous.” CX-0004C at Q/A 422-424. As discussed above,
Bio-Rad disputes infringement of the “releasably attached” limitation, but its non-infringement
arguments are not consistent with the claim construction adopted in this investigation.
Accordingly, the accused ddSEQ products infringe the “providing . . .” limitation of claim 1 of
the ’468 patent.
b. “combining said at least 1,000,000 oligonucleotide molecules
and a sample comprising a nucleic acid analyte each in an
aqueous phase . . .” _
Dr. Butte identifies Bio-Rad documentation describing the mixing of two input aqueous
solutions in the ddSEQ v1 process: one solution contains the oligonucleotide molecules and the
other solution contains a sample of single cells comprising the mRNA nucleic acid analyte. CX
00O4C at Q/A 427-28. Dr. Butte testifies that these two solutions are combined at a first junction
of two channels of the ddSEQ vl cartridge, citing a Bio-Rad document showing the mixing of
the aqueous solutions. Id. at Q/A 429.
60

PUBLIC VERSION
on
~ a r as 	"K
-it . 	\. 	g 	l
Cell isolation Reagents 	\ Q 	i 	, ,_ ,_	"\ 	‘ 	_ .
(includingbarcodes) 	;f, 510i;
, 	..
s 	. 	, 	.
Sing|e~Ce|| 	,4
Suspension ’
_ 	/' 	,', 	on	~ 	l
JX-O035.00009. He further cites the testimony of Bio-Rad employee Lucas Frenz, describing the
junction where the two solutions are combined. CX-0011C (Frenz Dep. Tr.) at 229-30.
Bio-Rad contends that Dr. Butte’s testimony fails to carry l0X’s burden to show
infringement of this limitation. RIB at 165-66.12 In particular, Bio-Rad cites Dr. Butte’s
testimony	oncross-examination	Where	heagrees	th
Tr
408:6-13. Dr. Butte further testifies that “it would be a big mess” if the two solutions mixed
“Without forming a droplet.” Id. at 409: 12-21. As Dr. Butte further explains his testimony,
12Pursuant to Order No. 39 (Mar. 12, 2019), Bio-Rad was precluded from offering affirmative
evidence of non-infringement regarding this limitation.
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PUBLIC VERSION
however, these statements do not contradict his infringement opinions. See SRB at 43-44.
Dr. Butte explains that tl1etwo solutions
_ 	In’. And althoughhe concedesthat “lysismightstait, it takes time to complete.” Id. at
408120-498:2. VVl1enDr. But1e’s cross-examination testimony is considered in the context of his
infringement opinions and the evidence fiom Bio~Rad’s documents and testimony, there is a
preponderance of evidence that the ddSEQ system infiinges the “combining” limitation.
c. “generating a droplet . . .”
There is no dispute with respect to the elements of the final limitation of claim l.
D11Butte identifies evidence that a droplet is fonned when the mRNA or genomic DNA
fragment contacts the aqueous mixture at a second junction. CX-0004C at Q/A 436-37. This
droplet generation is depicted in Bio-Rad documents.
JX-0088C00013. Dr. Butte explainshow the limitationis met for both the ddSEQvl I
products. CX—O004Cat Q/A 436-37. Dr. Frenz continued the location of the junction in the
ddSEQt/1- cartridges.CX-0011Cat23l-32; cx-00560; CX-1458C.
Accorclingly,	boththeddSEQvl — 	processesinfiingethemethodofclaim1
of the ’468 patent.
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PUBLIC VERSION
2. Dependent Claims
There is no dispute with respect to the ddSEQ system’s infiingement of the limitations in
dependent claims 6, 7, 9, and 21 of the ’468 patent. CIB at 197-98; SIB at 92.
As discussed in the context of the ’024 patent, there is no dispute that the ddSEQ system
usesa gelbeadcomprisedof—, 	asrequiredbyclaims6 and7 ofthe ’468patent.
See CX-0004C (Butte DWS) at Q/A 224-26, 438-43.
Claim 9 of the ’468 patent requires that the oligonucleotide molecule “comprises a region
Which	functions	asaprimer.”Dr.Butteexplains	thatintheWTA3’vl_
- 	CX-00°
446. InthescATAC-seq- 	assays,theNexteraAdaptorbindingsequenceattachesto
the Nextera Adaptor and functions as a primer during PCR in the droplet. Id.
Claim 21 of the ’468 patent requires that the “nucleic acid analyte is subjected to nucleic
acid amplification to yield a barcoded nucleic acid analyte.” The limitations of this claim are
similar to those recited in limitation (c) of claim 1 of the ’024 patent, and the ddSEQ system
infringes claim 21 for the same reasons discussed above. See CX-0004C (Butte DWS) at Q/A
449.
Accordingly,	2 theddSEQv1— 	processesinfnngeclaims6,7, 9,and21
of the ’468 patent.
3. Indirect Infringement
10X accuses Bio-Rad of indirect infringement of the method claims of the ’468 patent
based on the same evidence cited for the ’O24patent. CIB at 198. Staff and Bio-Rad raise the
same indirect infringement arguments for the ’468 patent that were addressed in the context of
the ’O24patent. RIB at 166; SIB at 92-93.
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PUBLIC VERSION
As discussed above, 10X has shown that the ddSEQ v1 system has been used in the
same reasons discussed above in the context of the ’024 patent, 10X has thus shown that Bio
Rad has induced infringement and contributorily infiinged claims 1, 6, 7, 9, and 21 of the ’468
patent by importing and selling components of the ddSEQ vl system.
D. Domestic Industry
10X contends that "itsDI products practice claims 1, 6, 7, 9, and 21 of the ’468 patent,
relying on the testimony of Dr. Butte. CIB at 198-201; CX-0004C at Q/A 450-77.
1. Claim 1
There is no dispute that the DI products include a method for droplet generation, and 10X
\
	a 	a
relies on Dr. Butte s analysis to show infringement of the limitations of claim 1 of the 468
patent. CX-0004C at Q/A 453-66.
There is no dispute with respect to the first limitation of claim 1 of the ’468 patent, which
includes limitations that are substantively identical to those discussed above for claim 1 of
the ’024 patent. Dr. Butte refers back to his analysis for the ’024 patent for these limitations,
which require “providing at least 1,000,000 oligonucleotide molecules,” that the “barcode
sequences are the same,” that the moleculesare “releasably attached to a bead,” and “said bead is
porous.” cx-0004c at Q/A 455-56. 	V
With respect to the second limitation of claim 1 of the ’468 patent requiring forming an
aqueous mixture, Dr. Butte identifies two aqueous input solutions for 10X’s single-cell products:
one solution comprising an mRNA nucleic acid analyte and a second solution including gel
beads with oligonucleotide molecules attached. CX-0004C at Q/A 458-59. He further identifies
a junction of channels on the Chromium Single Cell 3’ microfluidic chip where the two solutions
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PUBLIC VERSION
are combined. Id. at Q/A 460. With respect to 10X’s linked-read products, Dr. Butte identifies a
Sample Master Mix with denatured genomic DNAs and a second solution containing gel beads.
Id. at Q/A 462. He further identifies the junction on the Chromium Genome microfluidic chip
where the two solutions are combined. Id. at Q/A 463. Bio-Rad argues that 10X has failed to
carry its burden with respect to the “aqueous solution” limitation, raising arguments similar to
those discussed above in the context of infringement. RIB at 166-67. As discussed above,
however, Dr. Butte’s testimony on cross-examination does not contradict his affirmative
opinions with respect to this limitation.
There is no dispute with respect to the third limitation of claim l of the ’468 patent,
Whichrequires generating a droplet. Dr. Butte identifies images of the claimed second junction
in the 10X single-cell and linked-read applications and documents showing the portioning oil
loaded on the Genome microfluidic chip. CX-0004C at Q/A 465-66; CX-0581C; CX-0622C;
CX-0481; CX-0578.
Accordingly, the DI products practice claim l of the ’468 patent.
2. Dependent Claims
There are no disputes with respect to the limitations recited in dependent claims 6, 7, 9,
10, 17, and 21 ofthe ’468 patent. CIB at 200-01; SIB at 94.
With respect to claims 6 and 7, Dr. Butte refers back to his opinions with respect to
the ’024 patent, and there is no dispute that the DI products use a polyaciylamide gel bead. CX
0004C at Q/A 467-70.
With respect to claims 9 and 10, Dr. Butte explains that the DI products use the 10X
Barcoded Primer——inthe single-cell applications, the poly-T sequence attaches to the 1nRNA and
functions as a primer during reverse transcription, and in the linked-read applications, a 6
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PUBLIC VERSION
nucleotide random primer is used in isothermal amplification. CX-0004C at Q/A 472; CX-0579;
CX-0578.
With respect to claim 17, Dr. Butte explains that the gel bead is dissolved upon p
applicationof-. cx-0004c at Q/A476.
With respect to claim 21, Dr. Butte refers to his testimony regarding the ’024 patent,
explaining how the DI products undergo amplification. CX-0004C at Q/A 478.
Accordingly, the DI products practice claims 1, 6, 7, 9, 10, 17, and 21 of the ’468 patent.
E. Invalidity
Bio-Rad contends that the asserted claims of the ’468 patent are invalid as anticipated or
rendered obvious by the ’059 patent (JX-O031), alone or in combination with additional prior art,
including Hinz (RX-0461), PCT Pub. No. WC 2010/036352 Al naming inventors Billy W.
Colston, Jr. and Benjamin J. Hindson, er al. (RX-0473, “Colston”), and U.S. Patent App. Pub.
No. US 2012/0220494 Al naming inventor Michael Samuels et al. (RX-0474, “Samuels”). RIB
at 168-85. ’
1. “at least 1,000,000 oligonucleotide molecules . . . releasably attached to
a bead”
As discussed above in the context of the ’024 patent, Bio-Rad has failed to show that
the ’059 patent anticipates or renders obvious, alone or in combination with other references, the
claim limitation requiring that oligonucleotide molecules be releasably attached to a bead. For
this rcason alone, Bio-Rad has not shown that the asserted claims of the ’468 patent are invalid.
2. “combining said at least 1,000,000 oligonucleotide molecules and a
sample comprising a nucleic acid analyte each in an aqueous phase at
a first junction” 	'
Bio-Rad contends that the “combining” step of claim l of the ’468 patent is anticipated or
rendered obvious by the ’059 patent through the incorporation by reference of Colston. RIB at
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PUBLIC VERSION
170-79. In the ’O59patent’s discussion of dropletgeneration, the specification states that
droplets may be generated by devices described in Colston. JX-0031, col. 13:8-l4. Colston is a
patent application published in April 2010 that is assigned to QuantaLife, naming Dr. Hindson as
one of the co-inventors. RX-0473. Colston teaches that “samples and/or reagents may be . . .
mixed selectably before they are supplied to a downstream region of the system,” identifying a
“droplet generator” as one such region. Id. at 243. Figure 114 of Colston is a schematic
showing the mixing of a sample and reagents prior to a droplet generator.
Fig_ 1 	T 	SIGNAL 	g
25756 	574OX 	5754 [ 5750
SAMPLE 	5742 	FEEDBACK/‘ 	AND CONTROL A
C5758
TEST 	if 	tr	REAGEN-rs 	5144 	5"/4e 	5748
TTT-'" 	DROPLET‘ i \THERMALHDETECTOR‘_____.__¢§l§Q 	GENERATOR 	CYCLER
CONTROL
REAGENTS 	5764 	5766
C5162
CALIBRATION 	5752 _ DATA
REAGENTS 	5'/5°\> ANALYZER
RX-0473000340, Fig. 114. Based on these disclosures, Dr. Mctzker submits that the ’059 patent
discloses the combination of a nucleic acid analyte sample and oligonucleotide molecules at a
first junction to form an aqueous mixture. RX-0664C at Q/A 264.
10X contends that Bio-Rad’s anticipation argument fails because the ’059 patent only
references Colston in the context of droplet generation, with no discussion of mixing
polynucleotides and barcode adaptors. CIB at 201-02. Dr. Dear notes that the ’O59patent
describes the step of combining adaptors with polynucleotides as “merging,” rather than droplet
67

PUBLIC VERSION
fonnation. CX-1827C at Q/A 401 (citing JX-0031, col. 1:40-51). On this record, I agree with
10X that the “combining” limitation is not anticipated the ’059 patent’s incorporation of Colston
by reference.
Bio-Rad further contends that it would have been obvious to combine the ’059 patent’s
polynucleotides and barcode adaptors with the microfluidics disclosed in Colston. RIB at 170
72. Dr. Metzker suggests that one of ordinary skill “would have been motivated . . . to keep
assay reagents separate from the nucleic acid or cellular analyte solutions” and “would have been
motivated to see what methods others have used in droplet formation devices to improve the
efficiency of her system.” RX-0664C at Q/A 265. 10X disagrees with these obviousness
contentions, arguing that Colston’s disclosures are too vague to render obvious the “first
junction” limitation of the ’468 patent. CH3at 201-02. As explained by Dr. Dear, Colston does
“not disclose how reagents and samples are combined, beads with barcodes, a junction of two
channels to form an aqueous mixture of beads with barcodes and sample, and generation of
droplets with beads and sample at a second junction.” CX-1827C at Q/A 403. Dr. Dear further
criticizes Dr. Metzker’s reliance on Figure 114, because it is a “schematic” rather than a
“microfluidic layout.” Id. at Q/A 404. In reply, Bio-Rad argues that the ’468 patent itself has no
figures illustrating the claimed junctions and cites cross-examination testimony from Dr. Dear
admitting that Colston shows mixing of the sample and reagents in an aqueous phase. RRB at
85; Tr. (Dear) at 902.
Although I agree WithBio-Rad that the disclosures in Colston are sufficient to show the
mixing of a sample and reagents in an aqueous phase, Bio-Rad has failed to offer clear and
convincing evidence that it would have been obvious to apply this mixing to the polynucleotides
and barcode adaptors in the ’059 patent. Dr. Metzker only offers conclusory opinions regarding
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PUBLIC VERSION
the motivations of one of ordinary skill in the art to implement a microfluidics system meeting
the limitations of the ’468 patent. RX-0664C at Q/A 265. Bio-Rad fails to cite any evidence
from the ’059 patent or other contemporaneous references indicating a need or desire to
implement a particular microfluidic mixing process for the ’059 patent’s polynucleotides and
barcode adaptors. Accordingly, Bio-Rad has failed to carry its burden to show that this
limitation is obvious in view of the ’059 patent, alone or in combination with Colston.
Bio-Rad’s proposed combinations of the ’059 patent with other references fail for the
same reason, because Dr. Metzker only offers conclusory opinions regarding the obviousness of
combining these references. See RX-0664C at Q/A 268. Although Samuels (RX-0474), Song
(RX~0475), and Abate (RX-0102) teach microfluidic systems that meet at least some of the claim
limitations of the ’468 patent, Bio-Rad fails to identify a credible reason for implementing these
processes to mix the polynucleotides and barcode adaptors of the ’059 patent. There is no
evidence that these references solve a known problem for the process described in the ’059
patent, and there is no evidence that the particular microfluidic systems identified by Bio-Rad are
among a finite number of identified, predictable solutions. Accordingly, Accordingly, Bio-Rad
has failed to carry its burden on obviousness with respect to this limitation.
3. “generating a droplet . . . by contacting said aqueous mixture with an
immiscible continuous phase at a second junction”
Bio-Rad contends that the “generating a droplet” step of claim l of the ’468 patent is
anticipated or rendered obvious by the ’059 patent aloneor in combination with Colston and
Samuels. RIB at 179-83. In particular, Bio-Rad cites a disclosure in the ’059 patent that
“[m]icrofluidic methods of producing emulsion droplets using microchannel cross-flow focusing
on physical agitation can produce either monodisperse or polydisperse emlusions.” JX-0031,
col. 14:6-8. Dr. Metzker submits that “[o]ne of ordinary skill in the art would have understood
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PUBLIC VERSION
that the ‘cross-flow focusing’ as taught by Saxonov involves the concept of flow-focusing using
a cross junction with two or more input channels, one being oil and one being an aqueous
channel.” RX-0664C at Q/A 276.
The ’059 patent’s reference to “cross-flow focusing” is not sufficient to anticipate the
“generating a droplet” limitation of the ’468 patent. As Dr. Dear explains, the ’059 patent’s
discussion of droplet generation is separate from any discussion of mixing polynucleotides and
barcode adaptors. CX-1827C at Q/A 427. Accordingly, Bio-Rad’s anticipation argument fails
for the same reasons discussed above for the “combining” limitation.
Bio-Rad’s obviousness arguments for the “generating a droplet” limitation rely on the
same combinations discussed above for the “combining” limitation. RIB at 180-83. Again, Bio
Rad fails to offer credible evidence for using the mierofluidic systems disclosed in Colston,
Samuels, Song, or Abate with the polynucleotides and barcode adaptors of the ’O59patent.
Accordingly, Bio-Rad’s obviousness arguments fail to the same reasons discussed above for the
“combining” limitation.
4. Secondary considerations of n0n—obvi0usness
For the same reasons discussed above in the context of the ’024 patent, the success of
lOX’s domestic industry products further weigh against a finding of obviousness.
VI. THE ’204 PATENT
A. Asserted Claims
10X is asserting claims 27, 29, 31, and 33 of the ’204 patent. The asserted claims depend
from unasserted independent claims 1, 23, and 25. Unasserted claim l recites:
A composition comprising a plurality of capsules, said capsules situated
within droplets in an emulsion, wherein said capsules are configured to
release their contents into said droplets upon the application of a
stimulus to provide said contents in said droplets in said emulsion,
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PUBLIC VERSION
wherein said stimulus is selected from the group consisting of a change
in pH, a change in ion concentration, reduction of disulfide bonds, and
combinations thereof.
Id., col. 44:42-48. Asserted claims 27 and 33 depend directly from claim l. Claim 27 requires
that the contents of each capsule “comprise at least 10,000 barcoded oligonucleotides releasably
attached” to the capsule. Id., col. 46:24-26. Claim 33 limits the claimed capsules to gel
capsules. 1d., col. 46:42-43. V
Unasserted claim 23 recites:
A device comprising a plurality of partitions, wherein at least one
partition ol’said plurality of partitions comprises a capsule, wherein said
capsule is situated Within a droplet in an emulsion, wherein said capsule
is configured to release its contents into said droplet upon the application
of a stimulus to provide said contents in said droplet in said emulsion,
wherein said stimulus is selected from the group consisting of a change
in pH, a change in ion concentration, reduction of disulfide bonds, and
combinations thereof.
la'., col. 45:51-58. Claim 29 depends directly from claim 23 and requires that the contents of the
claimed capsule “comprise at least 10,000 barcoded oligonucleotides rcleasably attached” to the
capsule. Id., col. 46:30-32.
Unasserted claim 25 recites:
A method comprising:
a. providing a plurality of inner capsules, said inner capsules situated
within outer capsules in an emulsion, wherein said inner capsules are
configured to release their contents into said outer capsules upon the
application of a stimulus, wherein said stimulus is selected from the
group consisting of a change in pH, a change in ion concentration,
reduction of disulfide bonds, and combinations thereof; and
b. providing a stimulus to cause said irurer capsules to release their
contents into said outer capsules in said emulsion.
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PUBLIC VERSION
Id., col. 46:3-12. Claim 27 requires that the contents of each capsule “comprise at least 10,000
barcodcd oligonuclcotidcs releasably attached” to the capsule. Id., col. 46:36-38.
For the technical prong of the domestic industry requirement, in addition to the asserted
claims, 10X relies on claim 10 of the ’204 patent. Claim 10 depends from claim 1 through
claims 2, 7, and 8. Claim 1 is recited above. Claim 2 requires that the capsules of claim 1
include “at least one of said capsules and said droplets comprise a species selected from the
group consisting of a reagent and an analyte.” Id., col. 44:50-52. Claim 7 requires that the
analyte of claim 2 be selected “from the group consisting of a cell, a polynucleotide, a
chromosome, a protein, a peptide, a polysaccharide, a sugar, a lipid, a small molecule, and
combinations thereof.” Id., col. 44:66-col. 45:2. Claim 8 requires the analyte of claim 7 to be a
polynucleotide. Id., col. 45:3-4. Claim 10 requires that the amount of polynucleotide in the
composition of claim 8 bc “sufficient to provide about 100-2OOXsequence coverage.” Id., col.
45:8-10,
B. Claim Construction
The parties agreed to construe “barcode” to mean a “label that may be attached to an
analyte to convey identifying information about the analyte.” Order No. 22 at 2. They agreed to
construe “wherein said capsules are [capsule is] configured to release their [its] contents into said
droplets [droplet] upon the application of a stimulus” to have its plain and ordinary meaning. Id.
C. Infringement
10XassertsthatBio-Rad’sddSEQv1— 	productsinfringeclaims27,29,31,
and 33 of the ’204 patent. With the exception of claim 33, the asserted claims of the ’204 patent
require a “capsule” or “capsules,” wherein the contents of each capsule include barcode
molecules that are “releasably attached” to the capsule. ’204 patent, col. 44:42-49 (claim 1), col.
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PUBLIC VERSION
46:24-26 (claim 27), col. 46:30-32 (claim 29), col. 46:36-38 (claim 31). Bio-Rad’s infringement
argument relating to the “releasably attached” limitation are addressed above in the context of
the ’024 and ’468 patents and are rejected for the same reasons in the context of the ’204 patent.
All of the asserted claims require a “capsule” or “capsules” that are “configured to release their
contents into said droplets upon the application of a stimulus.” Id., col. 44:44-46 (claim 1), col.
46:5-7 (claim 25); see also id., col. 45:53-56 (claim 23) (“wherein said capsule is configured to
release its contents into said droplet upon the application of a stimulus to provide said contents in
said droplet in said emulsion”). The parties agreed that the term “wherein said capsules are
[capsule is] configured to release their [its] contents into said droplets [droplet] upon the
application of a stimulus” did not need to be construed and should be given its “plain and
ordinary meaning.” Order No. 22 (Oct. 31, 2018) at 2. The claims fl1I'lZl1CI‘	require that the
stimulus be “selected fiom the group consisting of a change in pH, a change in ion concentration,
reduction of disulfide bonds, and combinations thereof.” Id., col. 44:46-49 (claim 1), col. 45:56
58 (claim 23), col. 46:7-10 (claim 25). 	V
For the reasons set forth below, the accused products do not literally infringe the asserted
claims because they do not have a stimulus “selected from the group consisting of a change in
pH, a change in ion concentration, reduction of disulfide bonds, and combinations thereof.” In
addition, 10X is estopped from relying on the doctrine of equivalents to show infringement.
1. Literal Infringement
The claims require that the capsules release their contents in response to a stimulus that is
“selected from the group consisting of a change in pH, a change in ion concentration, reduction
of disulfide bonds, and combinations thereof.” ’204 patent, col. 44:44-46 (claim 1), col. 45:44
58 (claim 23), col. 46:5-10 (claim 25). The recited stimuli form a “Markush group.” In Markush
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PUBLIC VERSION
claims, altemative species or elements that can be selected as part of the claimed invention are
listed as a group, called a Markush group. MulIila_verSn'ercl1Cling Film Holdings, Inc. v Berijv
Plastics Corp, 831 F.3d 1350. 1357 (Fed. Cir. 2016) (citing Abbot! Labs. v. Baxter PI/arm.
Pr0ds., Inc, 334 F.3d 1274. 1280 (Fed. Cir. 2003)). The term “group of” is traditionally used by
patent drafters to signal a Markush group. Irl. (citing Gillette C0. v. Energizer Holdings, Ina,
405 F.3d 1367, 1372 (Fed. Cir. 2005)). Typically, Markush groups take the following form: “a
meinber selected from the group consisting of A, B, and C.” Id. (quoting Gillette, 405 F.3d at
1372) (internal quotation marks omitted). Each member of a Markush group is “alternatively
usable for the purposes of the invention." Id. at 1357-58 (quothig In re Driscoll, 562 F.2d 1245,
1249 (CCPA 1977)) (internal quotation marks omitted).
I11the accused products, 10X argues that the barcode molecules are linked to the gel bead
by“chemicalbondssusceptible	to— 	sothatthebarcodemoleculesarereleased
whenthe— 	CIBat173.Itisundisputed	thatthe
— 	arenotoneoftherecitedstimuli.See,e.g.,Tr.(Butte)at371324-372:l7
(testifying	that— 	bythemselves	arenotachangeinpHorionconcentration
anddonotreducedisulficlebonds). 10X,however,pointsto evidenceshowingthat
See es» ¢X~
0004C (Butte DWS) at Q/A 317-319. Relying on this evidence, 10X identifies the combination
of	leii 	as	MdCIBat 173. WhileBio—Rad	and Staffdisputel0X‘s contentionthatthepresenceof
the accused
products still would not literally infringe the asserted claims.
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PUBLIC VERSION
Whilethereisnodisputethattheadditionof— 	constitutesa “changeinthe
ion concentration,” which is a recited element of tl1eMarkush group, there is no evidence that the
would have any effect on the attached barcode molecules or the
gel bead. See, e.g., Tr. (Butte) at 474118-21 (“Q1 And yioudid not provide an opinion in your
witness	statement	th 	A:	That’s	con'ect.”).
Rather,	according	tol0X’s	expert,	Dr.	Butte,
sever the barcode molecules from the gel beadi See, e.g., CX
0004C (Butte DW S) at Q/A 318. Thus, as understood by Dr. Butte, the stimulus that causes the
releaseofthebarcodemoleculesfromthegelbeadintheaccusedproductsisthe_
-Dr.Butte’sidentification	ofthe_ 	incombination	witha changein
ll13g;I1BSilll1'l	ion concentration for the claimed stimulus is legally flawed. By its express
language—“whe1‘einsaid stimulus is selected from the group consisting of a change in pH, a
change in ion concentration, reduction of disulfide bonds, and combinations thereof’-the
Markush group at issue is limited to (1) one of the recited stimuli or (2) a combination of the
recited stimuli; it does not encompass a combination of a recited stimulus and an unrecited
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stimulus. In particular, the asserted claims define the Markush group as “consisting of’ the
recited stimuli and combinations thereof, as opposed to being “comprised” of the recited stimuli.
“‘Consisting of is a tenn of patent convention meaning that the claimed invention contains only
what is expressly set forth in the claim.” Multilayer, 831 F.3d at 1358 (quoting Norian Corp. v.
Siryker Corp, 363 F.3d 1321, 1331 (Fed. Cir. 2004)) (internal quotation marks omitted). While
the term “comprising” would have indicated that the group was open to additional, unrecited
stimuli, the tenn “consisting of’ indicates that unrecited stimuli are excluded fiom the group. Ia’.
at 1358.
As explained by the Federal Circuit, “[t]he presumption that a claim term set off by the
transitional phrase ‘consisting of is closed to imrecited elements is at least a century old and has
been reaffirrned many times by our court and other courts.” Id. While “the exceptionally strong
presumption that a claim term set off with ‘consisting of is closed to tmrecited elements” may be
overcome if a patentec acts as his own lexicographer and “give[s] ‘consisting of an alternative,
less restrictive meaning,” the specification and prosecution history must “unmistakably manifest
[such] an alternative meaning.” Id. 10X does not contend that the patentees acted as their own
lexicographers and re-defined “consisting of.”
As shown in Multilayer, the closed nature of the claim language at issue excludes a
combination of a recited stimulus (change in ion concentration) and an unrecited stimulus
(enzymes). In Multilayer, the asserted claims were directed to a thermoplastic stretch Wrapfilm
having two outer layers and five 1111161‘	layers. Id. at 1353. The claims further required that “five
identifiable inner layers” be formed from materials selected from a Markush group “consisting
of’ various resins. Id. At issue was Whetheran inner layer composed of a combination of a
recited resin and an unrecited resin fell outside the scope of the claimed Markush group. Id. at
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PUBLIC VERSION
1358. Answering the question in the affinnative, the Federal Circuit held that “constru[ing] the
claims to cover a11yplastic film with five compositionally different inner layers, each of which
contains any amount of one of the four recited resins,” would “render the ’O55patent’s Markush
1angnage—each layer being selected from the group consisting ol:‘——-equivalent	to the phrase
‘each layer comprising one or more of.’” Id. at 1358.
10X has not pointed to any basis for distinguislling the closed Markush group at issue in
Multilayer that would allow interpreting the Markush group at issue in this investigation to
encompass a combination of a recited stimulus and an unrecited stimulus. 10X’s only response
to the argument that such a combination falls outside the scope of the claims, is to argue that the
accused stimulus does not include the
Relying on the 	as the claimed stimulus
has no legal basis and makes no logical sense. The claims require that the capsules release their
contents in response to the claimed stimulus. See CIB at 1_81(“The claimed function of applying
a stimulus is to allow the release of the contents of a capsule into the droplet”). l0X does not
argue and there is no evidence that
- 	willcausethereleaseofbarcodemoleculesfiomthe gelbeads.
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PUBLIC VERSION
l0X‘s attempt to limit the accused stimulus to the
Based on the foregoing, I find that the accused products do not literally inflinge the
asserted claims.
2. Doctrine of Equivalents
10X argues that the accused products satisfy the stimulus under the doctrine of
equivalents (“DOE”). CIB at 181-84. In the accused products, the barcode molecules are
released	fromthegelbeadwhen	the_
—. 	10X,however,	isprecluded	fromrelyingontheDOEtosatisfythe
Markush group limitation.
Under the DOE, “a product or process that does not literally infringe upon the express
teims of a patent claim may nonetheless be found to infringe if there is ‘equivalence’ between
the elements of the accused product or process and the claimed elements of the patented
invention.” Wr/1'11er'-Jzmkirzsoll	C0. v. Hilton Davis Chem. C0.. 520 U.S. 17, 21 (1997).
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PUBLIC VERSION
Although the DOE allows a “patentee to claim those insubstantial alterations that were not
captured in drafting the original patent claim but which could be created through trivial
changes,” under prosecution history estoppel a patentee cannot use the DOE to recapture subject
matter surrendered during prosecution. F esto Corp. v. Shoketsu Kinzoku Kogyo Kabuskiki C0.,
535 U.S. 722, 733-34 (2002) (“Festo VIII”). Such surrender occurs “[w]here the original
application once embraced the purported equivalent but the patentee narrowed his claims to
obtain the patent or to protect its validity.” Id.
Making a narrowing amendment to secure a claim’s issuance creates a presumption that
prosecution history estoppel applies. Id at 740-41. The presumption, however, is rebuttable as
there may be some instances “where the amendment cannot reasonably be viewed as
surrendering a particular equivalent.” Id. Such situations include where the equivalent was
unforeseeable at the time of the application or where the rationale underlying the amendment
bears no more than a tangential relation to the equivalent in question. Id. at 741.
During the prosecution of the ’204 patent, application claims 1, 78, and 110 matured into
issued claims l, 23, and 25, respectively. JX-000913630. In their original form, application
claims 1 and 78 required a capsule (application claim 1) or capsules (application claim 78)
“configured to release their contents . . . upon the application of a stimulus,” but did not require
that the stimulus be selected from a particular group of stimuli. Id. at .00080 (application claim
1); see also id._at .00085 (application claim 78) (requiring a capsule “configured to release its
contents into said droplets upon the application of a stimulus”). Similarly, application claim 110
required a step of “providing a stimulus to cause said capsules to release their contents into said
droplets,” without requiring the stimulus be selected from a group of stimuli. Id. at .0O087.
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PUBLIC VERSION
Although application claim 1 did not limit the stimulus to a group of stimuli, two of its
dependent claims did. Application claims 19 and 21 depended directly from application claim 1.
Application claim 19 required the stimulus to be “selected from the group consisting of a
chemical stimulus, a bulk stimulus, a biological stimulus, a light stimulus, a thermal stimulus, a
magnetic stimulus, and combinations thereof.” Id. at .0008l. Application claim 21 required the
stimulus to be “selected from the group consisting of a change in pH, a change in ion
concentration, reduction of disulfide bonds, and combinations thereof.” Id. at .0()08l.
In an office action issued on January 29, 2016, the examiner rejected all of the pending
claims as being anticipated in view of several prior art references. Id. at .09770-09781.
Application claim 1 was found to be anticipated by seven references: (1) U.S. Patent Publication
No. 2005/007951 to Berka et al. (“Berka”), (2) U.S. Patent Publication No. 2015/0079510 to
Church el al. (“fIhmch”), (3) U.S. Patent Publication No. 20140227706 to Kato et al. (“Kato”),
(4) U.S. Patent Publication No. 2003/0207260 to Tmovsky et al. (“Trnovsky”), (5) U.S. Patent
Publication No. 2013/0189700 to So et al. (“So”); (6) U.S. Patent Publication No. 2004/0258701
to Dominowski et al. (“Dominowski”); and (7) U.S. Patent Publication No. 2009/0025277 to
Takanashi (“Takanashi”) Id. at .09777-099780. Id. at .09774-.099780. Application claim 19
was rejected as anticipated by five references: (1) Berka, (2) Trnovsky, (3) So, (4) Dorninowski,
and (5) Takanashi. Id. Application claims 78 and 110 were rejected as being anticipated by
Berka. Id. Application claim 21 was rejected as being anticipated by Kato. Id.
On April 28, 2016, the applicants responded to the rejections by, inter ilia, cancelling
application claims 19 and 21 and amending application claims 1, 78, and 110. As amended,
application claims 1, 78, and 110 incorporated application claim 21’s limitation requiring that the
stimulus be “selected from the group consisting of a change in pH, a change in ion concentration,
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PUBLIC VERSION
reduction of disulfide bonds, and combinations thereof.” Id. at .l00O9 (“[C]laims 1, 31, 78, 89,
110 and 118 have been amended to recite ‘wherein said stimulus is selected from the group
consisting of a change in pH, a change in ion concentration, reduction of disulfide bonds, and
combinations thereof,’ thus incorporating the elements of Claim 21.”); see also id. at .l()000,
.l0002, .10003. With this amendment, the applicants argued that the amended application claims
were allowable over the cited prior art with the exception of Kato. Id. at .l00O9 (“Initially, as
Claim 21 was rejected only over Kato, Applicant understands that the Office acknowledges that
none of Berka, Church, Tmovsky, So, Dominowski and Takanashi teach or disclose ‘wherein
said stimulus is selected from the group consisting of a change in pH, a change in ion
concentration, reduction of disulfide bonds, and combinations thereof,’ as recited in claims 1, 31,
78, 89, 110 and 118.”). With regard to Kato, the applicants argued that “Kato does not teach or
disclose, ‘wherein said capsules are configured to release their contents into said droplets upon
the application of a stimulus,’ as recited in Claim 1.” Id. at .10010. The applicants also argued
that Kato did not qualify as prior art. Id.
On August 5, 2016, the examiner rejected the amended claims in view of a new set of
prior art references and noted that the previous rejections had been rendered moot in view of the
new grounds of rejection. Id. at .l0074. The examiner also “noted that the l02(b) rejection of
Claims 1 and 21 over Kato has been withdrawn in light of the app1icant’s persuasive arguments.”
Id. hi response to the new rejections, the applicants further amended application claims 1, 78,
and 110 to require that the capsule or capsules “provide said contents in said droplets in said
emulsion” upon the application of a stimulus. Id. at .10118, .l0l20-. 10121. The application
claims as amended were allowed. Id. at .13617.
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10X argues that “[i]nfringe1nentunder the doctrine of equivalents is not haired here by
the prosecution history estoppel because there was no disclaimer dining prosecution of all
chemical, bulk, or biological stimuli.” CIB at 182. l0X’s argument, however, is uupersuasive.
A narrowing amendment made in order to gain issuance triggers the presumption that atpatentee
is estopped fiom relying on the DOE to show infringement. Festo VIII, 535 U.S, at 740-41. It is
indisputable that the April 28, 2016 amendments to application claims l_,78; and 110 narrowed
the scope of the claims. As originally drafted, the application claims did not require the claimed
stimulus to be selected from any group of stimuli, much less from the “group consisting of a
change in pH, a change in ion concentration, reduction of disulfide bonds, and combinations
thereof.” It is also indisputable that the narrowing amendment was made to overcome prior art
as the applicants expressly cited the amendment to overcome several prior art references relied
upon by the examiner: “[A]s Claim 21 was rejected only over Kato, Applicant iuiderstands that
the Office acknowledges that none of Berka, Church, Tinovsky, So, Dominowski and Takanashi
teach or disclose ‘wherein said stimulus is selected from the group consisting of a change in pH,
a change in ion concentration, reduction of disulfide bonds, and combinations thereof,’ as recited
in claims l, 31, 78, 89, ll0 and ll8." JX-0009 at .10009
Thus. the applicants’ narrowing amendment triggers the presumption that 10X is
estopped from relying on the DOE to show that accused products satisfy the stimulus limitation.
See Festo VLU,535 U.S. at 740-41. l0X attempts to rebut the presumption by arguing that the
narrowing amendment was tangential to the alleged equivalent, which IOXidentifies as
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different Markush element, 	The only basis that 10X has
put forth in support of its contention that the amendment was tangential to the alleged equivalent
is that the alleged equivalent was not disclosed in the prior art references relied upon by the
examiner to reject the pending claims. This argument, however, fails on examination.
“[A]n amendment made to avoid prior art that contains the equivalent in question is not
tangential; it is central to allowance of the claim.” Feslo Corp. v. Sl10ketsuKin:0lruK0gy0
Kabuskiki C‘0.,Ltd, 344 F.3d 1359, 1369-70 (Fed. Cir. 2003) (“Fesro LX”).“ It is 10X’s burden
to show that the reason for the amendment is tangential to the alleged equivalent. Id. at 1369.
Moreover, the reason for the ainendnient must be “objectively apparent” from the prosecution
history “without the introduction of additional evidence, except, when necessary, testimony from
those skilled in the art as to the interpretation of that record.” Id; see also Integrated Tech.
Corp. v. Rudolph Techs., Ina, 734 F.3d 1352, 1358. This is a burden that 10X has not met.
i ,At the hearing, 10X’s own expert Dr. Butte confnined that one of the references in
question, Tmovsky. discloses the use of the enzyme agarase as a stimulus. Tr. 43l:l4—16.
Describing Tmovsky as a “complicated paper,” Dr. Butte further testified that he was unable to
“tell one way or the other whether” Tmovsky disclosed the use of ion cofactors with agarase. Id.
at 431117-25. Dr. Butte, however, acknowledged that Tmovsky discloses “buffers used with
13Initsinitial ost-hearinbrief.10Xalsoar uedinthealternative	that“
owever, appears to ave a an one t s argument. ee C at 84-85.
*4The converse is not necessarily true. Integrated Tech. Corp. v. Rudolph Techs. Inc, 734 F.3d
1352. 1358 (Fed. Cir. 2013) (“It does not follow . . . that equivalents not within the prior art must
be tangential to the aniendment”) (quoting Chimie v. PPG Indus. Inc., 402 F.3d 1371, 1383
(Fed. Cir. 2005)) (internal quotation marks omitted).
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PUBLIC VERSION
agarase which may provide a cofactor and that there may be an ion cofactor.” Id. at 432: 1-5.
This testimony by its own expert is fatal to l0X’s argument that the reason for the narrowing
amendment is tangential to the alleged equivalent.
l0X’s only response to its expert’s testimony is to characterize it as “hypothetical
testimony” and argue that surrender of the alleged equivalent must be shown through “the actual
prior art disclosure and amendment in prosecution.” CRB at 85 n. 36.15 It is l0X’s burden,
however, to show that the narrowing amendment is tangential to the alleged equivalent, not
Staff’s and Bio-Rad’s burden to show the converse. F esto IX, 344 F.3d at 1369-70. l0X would
be unable to meet its burden, even if its expert’s testimony on the issue was discounted in its
entirety as “hypothetical testimony.” This is because the record is devoid of any evidence
concerning Trnovsky’s teachings. As 10X acknowledges, Tmovsky and the other references
relied upon by the examiner are not in evidence. CRB at 85. Nor does the prosecution history
describe Tmovsky’s disclosurein sufficient detail to determine whether the narrowing
amendments are tangential to the alleged equivalent. In rejecting application claims 1 and 19 in
view of Trnovsky, the examiner did not describe the reference’s teachings, but cited particular
portions of Trnovsky. For example, with respect to application claim 19, the examiner’s
rejection reads as follows:
Claim 19 is drawn, in part, to an embodiment of the composition of
Claim 1 wherein said stimulus is selected from a defined group
consisting of a chemical stimulus, a bulk stimulus and a biological
stimulus.
'5 The Federal Circuit has held that it is appropriate to rely on “testimony from those skilled in
the art as to the interpretation of’ the prosecution history “when necessary.” Festo IX, 344 F.3d
at 1369-70. Such testimony is appropriate for a “complicated paper,” such as Tmovsky. Tr.
(Butte) at 431 :17-25.
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Tmovsky et al. teach these limitations, see {ls9 and 102.
JX-0009 at D9778; see also id. at .O9777(“Trnovsky et al. teach a composition comprising all of
the limitations of Claims 1-2, 4-5, 7-10, 13 and 28-30 see at least the abstract, as well as, 11s32,
84, 88, 99 and 102). Nor does the applicants’ response provide any information about
Trnovsky’s disclosure other than Trnovsky does not disclose the recited stimuli. JX-0009 at
.l0009 (“[A]s Claim 21 was rejected only over Kato, Applicant understands that the Office
acknowledges that none of Berka, Church, Trnovsky, So, Dominowski and Takanashi teach or
disclose ‘wherein said stimulus is selected from the group consisting of a change in pH, a change
in ion concentration, reduction of disulfide bonds, and combinations thereof,’ as recited in claims
1, 31, 78, 89,110 and 118.”).
Based on the foregoing, I find that 10X has not shown that the reason for the narrowing
amendment is tangential to the alleged equivalent. Accordingly, 10X is estopped fiom relying
on the DOE to show that the stimulus limitation is satisfied by the accused products.
D. Domestic Industry
10X asserts that each of its domestic industry products practice claims 10, 27, 29, 31, and
33 of the ’204 patent. CIB at 187-188. lOX’s contentions regarding the practice of the ’204
patent by its domestic industry products are undisputed by both Bio-Rad and Staff. SIB at 86
(arguing that the DI products practice the claims at issue); RIB at 136-64 (not addressing the
technical prong with respect to the ’204 patent). As set forth below, I find that 10X’s linked-read
DI products practice claims 10, 27, 29, 31, and 33 of the ’204 patent and 10X’s single cell DI
products practice claims 27, 29, 31, and 33 of the ’204 patent.
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1. Claim 10
Claim 10 depends from claim 1 through claims 2, 7, and 8. Claim 1 consists of a
preamble and three limitations. To the extent that the preamble is limiting, l0X’s DI products
provide a “composition.” CX-0004C (Butte DWS) at Q/A 369-370. As required by first
limitation of claim 1, the DI products provide a plurality of capsules in the fonn of gel beads. Id.
at Q/A 372. In accordance with the second limitation of claim 1, the gel beads are situated
within droplets in an emulsion. Id. at Q/A 374; CX-053800002 (“A GEM is a ‘Gel bead in
EMulsion’ droplet that encapsulates each tiny micro-reaction within the Chromium System.
Here we show a Single Cell GEM with a single T-cell, reagents and barcoded gel bead all
partitioned within a single oil droplet”). As required by third limitation, the gel beads are
configured to release their contents (barcoded primers) into the droplets upon application of
-, 	wh 	connecting	thebarcoded	primers	tothegelbeads.	CX
0004c (Butte DWS) at Q/A 376, 378. 	1
As required by claims 2, 7, and 8, in l0X’s single-cell DI products, droplets
encapsulating a cell containing a plurality of mRNA (a claimed analyte and a polynucleotide) are
formed. Id. at Q/A 381, 384, and 387. In l0X’s linked-read DI products, droplets containing
gDNA molecules (a claimed analyte and a polynucleotide) are formed. Id.
As required by claim 10, the amount of gDNA provided by l0X’s linked-read DI
products is sufficient to provide about 100-200X sequence coverage. Id. at Q/A 390. 10X,’
however, does not address how the single-cell DI products satisfy the limitation of claim 10.
Based on the foregoing, I find that l0X’s linked-read DI products practice claim 10, but
that lOX has failed to show that its single-cell DI products practice claim 10.
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2. Claims 27 and 33.
Claims 27 and 33 depend from claim 1, which is discussed above with respect to claim
10. As required by claim 27, each gel bead in 10X’s domestic industry products contains
millions of barcoded primers that are releasably attached to the bead. Id. at Q/A 392. As
required by claim 33, the capsules (gel beads) in the domestic industry products are made of a
gel. Id. at Q/A 370, 372, 374, 376, and 378.
Based on the foregoing, I filld that l0X’s linked-read DI products and single cell DI
products practice claims 27 and 33.
3. Claim 29
Claim 29 depends from claim 23. Claim 23 is consists of a preamble and three
limitations. To the extent the preamble is limiting, l0X’s DI products provide a “composition.”
CX-0004C (Butte DWS) at Q/A 395. As required by first limitation of claim 1, the DI products
provide a plurality of partitions in the fonn of gel beads. Id at Q/A 372, 397. As further
required by the first limitation, each gel bead is a capsule. Id. iIn accordance with the second
limitation, each gel bead is situated within a droplet in an emulsion. Id. at Q/A 374, 399; CX
0538.00002 (“A GEM is a ‘Gel bead in EMulsion’ droplet that encapsulates each tiny micro
reaction within the Chromium System. Here we show a Single Cell GEM with a single T-cell,
reagents and barcoded gel bead all partitioned Within a single oil droplet”). As required by the
third limitation, the gel beads are configured to release their contents in the form of barcoded
primers	into	thedroplets	upon	application	of-, 	wh 	connecting
the barcoded primers to the gel beads. CX-0004C (Butte DWS) at Q/A 376, 378, 400. As
required by claim 29, each gel bead in l()X’s domestic industry products contains millions of
barcoded primers that are releasably attached to the bead. Id. at Q/A 392, 402.
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Based on the foregoing, I find that 10X’s lin1ced~readDI products and single cell DI
products practice claim 29.
4. Claim 31
Claim 31 depends from claim 25. Claim 25 is a method claim consisting of a preamble
and two steps. To the extent the preamble is limiting, lOX’s DI products perfonn a method.
CX—0OO4C(Butte DWS) at Q/A 405. As required by first step of claim 25, the DI products
provide a plurality of capsules in the fonn of gel beads. Id. at Q/A 372, 407. Each gel bead is
situated within a droplet in an emulsion. Id. at Q/A 374, 407; CX-053800002 (“A GEM is a
‘Gel bead in EMulsion’ droplet that encapsulates each tiny micro-reaction within the Chroniium
System. Here we show a Single Cell GEM with a single T—cell,reagents and barcoded gel bead
all partitioned Withina single oil droplet”). The gel beads are configured to release their
contents(barcoded	primers)intothedropletsuponapplication	of-, which
— 	connectingthebarcodedprimersto thegelbeads.CX-0004C(ButteDWS)at
Q/A 376. 378, 407. As required by the second step, 1OX’sdomestic industry products apply a
stimulus to the gel beads provided in the first step, resulting in the gel beads releasing their
contents, the barcode primers. Id. at Q/A 376, 378, 409. As required by claim 31, each gel bead
contains millions of barcoded primers that are releasably attached to the bead. Id. at Q/A 392,
41 l.
Based on the foregoing. I fnd that 1OX”slinked-read DI products and single cell DI
products practice claim 31.
E. Invalidity
Bio-Rad contends that the asserted claims of the ’204 patent are invalid as anticipated or
rendered obvious by the ’059 patent and/or the Church patent, alone or in combination with
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PUBLIC VERSION
additional prior art. RIB at 145-56. The asserted claims of the ’204 patent require either barcode
molecules that are releasably attached to a capsule (claims 27, 29, and 31) or a gel bead that is
“configured to release” its contents (claim 33). Accordingly, the parties’ arguments regarding
invalidity for the ’204 patent are substantially identical to those addressed above in the context of
the “releasable attachment” limitation of the ’024 patent. See Sl{B at 38-39. For the same
reasons discussed above, Bio-Rad has failed to show that any asserted claim of the ’204 patent is
anticipated and/or rendered obvious by the ’O59patent and/or the Church patent because these
references do not disclose the “releasably attached” or “configured to release” limitations.
Moreover, the success of 10X’s domestic industry products further weigh against a finding of
obviousness.
VII. THE ’530 PATENT
The ’530 patent issued on January 2, 2018, naming inventors Benjamin Hindson, Serge
Saxonov, Kevin Ness, Paul Hardenbol, Mima Jarosz, and Michael Schnall-Levin. JX-0007.
A. Asserted Claims *
10X is asserting claims l, 4, ll, l4, l9, 26, and 28 ofthe ’530 patent. Claim l is
independent and the remaining claims depend directly or indirectly from claim l. Claim l
recites:
A method for nucleic acid preparation or analysis, comprising:
(a) providing:
(i) at least 1,000 gel beads;
(ii) releasably attached to each of said at least 1,000 gel beads, at least
1,000 barcode molecules comprising identical barcode sequences that
are distinct from barcode sequences of at least 1,000 barcode
molecules releasably attached to any other gel bead of said at least
1,000 gel beads; and
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(iii) a plurality of cells each comprising a plurality of polynucleotide
molecules; 	,
(b) generating a plurality of droplets, wherein at least 1,000 droplets of
said plurality of droplets each comprise:
(i) a single gel bead from said at least 1,000 gel beads; and
(ii) a single cell from said plurality of cells; and
(c) in each of said at least 1,000 droplets, using said plurality of
polynucleotide molecules from said single cell and barcode molecules of
said at least 1,000 barcode molecules from said single gel bead to
generate a plurality of barcoded polynucleotide molecules,
wherein said barcode molecules become detached from said gel bead.
Id., col. 47:58-67, col. 48:57-col. 49:4.
Claim 4 depends from claim 1 through unasserted claim 3. Claim 3 requires that the
polynucleotide molecules be mRNA. Id., col. 49:8-l0. Claim 4 further requires that the
barcoded polynucleotide molecules be generated by reverse transcribing the mRNA in the
presence of the barcode molecules. 1d., col. 49:11-14. Claim 19 depends fi'om claim 1 through
unasserted claim 17. Claim 17 requires that the barcode molecules “comprise combinatorial
assemblies of sequences from sequence modules.” 1d., col. 50:5-7. Claim 19 further requires
that each of the combinatorial assemblies comprise a first sequence, a second sequence, and a
third sequence. Id., col. 50:13-15.
Claims 11, 14, 26, and 28 depend directly from claim l. Claim ll requires that the barcode
molecules in each of the droplets be released from a single gel bead. Id., col. 49:34-36. Claim
14 requires that each gel bead have “disposed within” it at least 1,000 barcode molecules. Id.,
col. 49:44-45. Claim 26 requires that each gel bead contain at least 1,000,000 barcode
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molecules. ]d., col. 50:30-31. Claim 28 requires that the barcode molecules become detached
before the generation of the barcoded polynucleotide molecules. Id., col. 50:35-37.
B. Claim Construction
The parties agreed to construe “barcode” to mean a “labe1that may be attached to an
analyte to convey identifying information about the analyte.” Order N0. 22-at 2. They agreed
that the term “wherein said barcode molecules become detached from said gel bead” has its lpain
and ordinary meaning. Id. In the Markman order, the term “amplifying” Wasconstrued to mean
“increasing the number of copies of the target sequence to be detected,” including by reverse
transcription. Id. at 31-45. The terms “providing,” “said at least 1,000 droplets,” and “a plurality
of cells” were given their plain and ordinary meaning, with a requirement that all of the “at least
1,000 droplets” in the second step be generated before the third step of the claim is performed on
any of “said at least 1,000 droplets.” Id. at 45-51. In Order No. 35, this claim construction Was
further clarified so that it does preclude the generation of some barcoded molecules before the
start of the claimed third step. Order No. 35 at 4-6 (Mar. 5, 2019).
C. Infringement
10X is asserting claims 1, 4, 11, 14, 19, 26, and 28 of the ’530 patent against Bio-Rad’s
“ddSEQ	Cartridges	(vi-), 	ddSEQ	Single-Ce11Isolator(v1_),
ddSEQ Cartridge Holder, and consumables and assays used with and/or as part of Bio-Rad’s
ddSEQv1-2 productsincludingSureCe1lWTA3' (alsoreferredto as WTA3' v1),I
1. Claim 1
As discussed in the Markman order, claim 1 is directed to a three-step method. Order
No. 22 (Oct. 31, 2018) at 44. The first step requires “providing” at least 1,000 gel beads with
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“releasably attached” barcode molecules and “a plurality of cells” containing
polynucleotides. ’530 patent, col. 47:60-67 & col. 48:58-64. The second step requires
generating “a plurality of droplets, wherein at least 1,000 droplets of said plurality of droplets
each” have “a single gel bead from said plurality of cells” and “a single cell from said plurality
of cells.” Id., col. 48:60-64. The third step requires using the polynucleotide molecules and
barcode molecules to form “a plurality of barcoded polynucleotide molecules” “in each of said
1,000 droplets.” Id., col. 48:65-col. 49:4. As found in the Markman Order, the second step of
generating “at least 1,000 droplets” must be completed before the third step of generating a
“plurality of barcoded polynucleotide molecules” is performed in any of the droplets. Order No.
22 (Oct. 22, 2018) at 51.
a. Preamble
To the extent that the preamble is limiting, there is no dispute that the accused products
are methods of nucleic acid preparation and analysis or are used in such methods. ’530 patent,
col. 47:58-59. Specifically, Bio-Rad’s ddSEQ vl products are used with the WTA 3’vl assay to
prepare the mRNA of a single cell for single cell whole transcriptome analysis. See CX-0004C
(Butte DWS) at Q/A 68 (describing the release and barcoding of mRNA from cell in the WTA 3’
vl assay’s workflow).
See CX-0004C (Butte DWS) at Q/A 68 (describing the release and
barcoding of mRNA from cell in the WTA 3' vl assay’s Workflow), 84
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performs the same work flow as the WTA 3’ v1 assay to partition and barcode the 1nRNA
transcripts of individual cells.")_,93 (In tl1escATAC—seqassay, “[t]he oligonucleotide barcodes
are released from the gel bead 	and attach to the genomic DNA
fragments for amplification through PCR in the droplet”), 100
5JX-0091C .OOO06-D0007 l
(describing the workflow of the scATAC—seqassay); CX—l491C.00O13—.000l6(describing the
WTA 3' v1 assay); JX-0105C.O0024
b. Step 1: “providing” a plurality of cells and at least 1,000 gel
heads
The first step of claim l requires “providing” at least 1,000 gel beads and a plurality of
cells. ‘S30 patent, col. 47:60-67 & col. 48:57-58. Each gel bead must have “releasably
attached” to it “at least 1,000 barcode molecules conlpiising identical barcode sequences.” Id. at
col. 47:62-67. The barcode sequences of barcode molecules attached to each bead must be
distinct from the barcode serluences of the barcode molecules attached to any other bead. Id.
Each cell must “c0n1p1is[e]a plurality of polynucleotide molecules.” Id. at col. 48:57-58.
There is no dispute that the accused products ca11be used to provide at least 1,000 gel
beads and a plurality of cells. The accused products use gel beads. CX-0004C at Q/A 489
(“[T]he ddSEQ v1 products provide gel beads composed of polyacrylamide and users provide
these	gelbeads	inperfonning	theclaimed	n1eth0d.”),	491t
—). 	Theaccusedproductshavetheabilitytoprovideatleast1,000gelbeads
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and a corresponding number of cells. CX-0004C (Butte DWS) at Q/A 490 (testifying that Bio
Rad’s ddSEQ v1 products provide at least 1,000 beads and an equal number of cells); 492
-, 	493 (testifyingthat Bio-Rad’sscATAC-seqassayusingthe v1 cartridgeprovideat least
1,000 beads and an equal number of cells); JX-003600002-00003 (data sheet showing that 1,384
single cells were barcoded in one WTA 3’ vl assay); CX-1573C (18,000 cells processed in WTA
3'	V1	assays);	OX-15290-°°°37
The cells provided by the accused products contain a plurality of polynucleotide
molecules. CX-0004C (Butte DWS) at 502 (testifying that the cells provided by the ddSEQ vl
products comprise a plurality of mRNA molecules), 504
Although Bio-Rad disputes whether the barcode molecules are releasably attached to the
gel beads, here is no dispute that each of the gel beads has at least 1,000 barcode molecules
attached to it. CX-0004C (Butte DWS) at 496; JX-003600004 (showing at least 3,000 genes are
detected per cell and thus confirming at least 3,000 barcode molecules per bead). The barcode
molecules have barcode sequences in the fonn of oligonucleotide molecules. CX-0004C (Butte
DWS) at Q/A 127 (testifying that “oligonucleotide molecules released from the gel beads in
Bio-Rad’s ddSEQ vl products each include a Cell Barcode sequence”) (’024 patent, claim 1),
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13°
—), 	131(testifying	that“[t]heclaimed	oligonucleotide	molecules	inthe
ATAC-seq assay” include a barcode sequence). The barcode molecules attached to each gel
bead have barcode sequences that are distinct from the sequences of barcode molecules attached
to other gel beads. CX-0004C (Butte DW S) at Q/A 497. In particular, for the ddSEQ v1
products,thereare ahn0stI 	poolsofbarcodemoleculesandeachpool of barcode
molecules has a unique barcode sequence. Id; IX—005OC.00026;CX-0018C (Lebofsky Depo.
Tr.) at 115:l3-l 16:4.
CX-0004C (Butte DWS) at Q/A
497; CX-0009C (Agresti Dep. Tr.) at 437:1-7.
Thebarcodemoleculesarereleasablyattachedto thegelbeadthrougha-
CX-0004C (Butte DWS) at Q/A 143 (ddSEQ v1
products), 160 	); IX-003600001 (“Comprehensive Single-Cell RNA
Sequencing Workflow”). Bio-Rad disputes that its products satisfy the “releasably attached”
requirement for the same reasons that it contested that the requirement was satisfied with respect
to the asserted claims of the ’024 and ’468 patents. Bio-Racl’s argument is rejected for the same
reasons that it was rejected with respect to the ’024 and ’468 patents.
For the foregoing reasons, I find that the accused products satisfy the fust step of claim 1.
c. Step 2: “generating a plurality of droplets”
The second step ofclaim 1 requires generating a plurality of droplets, wherein at least
1,000 of the droplets comprise a “single gel bead” and a “single cell.” ’530 patent, col. 48 59-64.
The accused products are capable of producing a plurality of droplets. CX~0004C (Butte DWS)
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at Q/A 508-509; CX-1357C.O0018; JX-0050C.00014 (ddSEQ vl products provide between
50,000-75,000 droplets for each sample, and about 260,000 droplets per chip); CX
1519C-°°°37;	IX-011°C-00°06	<
K); 	cx-001scat 197124-198:5.
The accused systems can be used to generate at least 1,000 droplets with a cell and gel
bead. When all four lanes are primed with a Cell Suspension Mixture, the ddSEQ vl cartridge
can generate approximately 1,200 droplets having a cell and a gel bead. CX-0004C (Butte
DWS) at Q/A 512; JX-003500011 (requirement of 40,000 input cells for 1,200 processed cells);
CX-0016C(KaiharaDepo.Tr.)at l66:2l-167:l7 (testifyingthatmostusershave_ 	to
input into a ddSEQ v1 cartridge); JX-0036.00002—03(1,384 droplets containing a single cell and
agelbeadgenerated	usingoneddSEQ	vlcartridge);	cx-1494000016	<_
. 	Ifthe	scATAC-seq	assay	isperformed	using
the ddSEQ v1 cartridge, each lane is capable of generating 500 droplets with a cell and gel bead.
CX-0016C (Kaihara Depo. Tr.) at 155;15-15825; cvx-0004c (Butte DWS) at Q/A 515-516. I
—. 	CX-0004C	(Butte	DWS)	atQ/A	513;	cx-1529000037.
Bio-Rad does not dispute that the accused products are capable of generating at least
1,000 droplets containing a cell and gel bead. Instead, Bio-Rad argues that the accused products
do not satisfy the second step of claim l because they do not generate a “collection” of at least
1,000 of such droplets. RIB at 194-95. Bio-Rad argues that droplets are formed one-by-one in
each chamber of the ddSEQ v1- cartridgeand, after each dropletis formed,the cell in the
droplet is “destroyed almost immediately.” RX-0665C (Metzker RWS) at Q/A 100 (“Think of it
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PUBLIC VERSION
this way, as droplet number one forms with a cell and a gel bead in it, the cell is destroyed almost
immediately because the cell lysis reagent acts on the cell membrane. So, you never form a
collection of 1,000 droplets containing a single cell and a single gel bead before any barcoding
begins”). As a result, Bio-Rad argues, that there is never an instant of time where there is at
least 1,000 droplets with a cell and gel bead. Bio-Rad’s non-infringement argument reads a
limitation into the claim that is not present, viz., that a collection of at least 1,000 droplets with a
cell and gel bead must exist in some instant of time.
Neither the claim language nor the Markman order require amassing such a “collection.”
The claim language and Markman order only require that all of the droplets be generated prior to
proceeding to the third step. ’530 patent, col. 48:59-64 (“generating a plurality of droplets,
wherein at least 1,000 droplets of said plurality of droplets each comprise” a single gel bead and
a single cell); Order No. 22 (Oct. 31, 2019) at 48 (“The second step of claim l’s three-step
method requires the generation of ‘at least 1,000 droplets’ . . . .”). Although the step of
generating droplets with a cell and gel bead must be completed before the start of the third step,
the third step does not require at least 1,000 droplets having a cell and a gel bead. The third step
requires at least 1,000 droplets containing (1) a plurality of polynucleotide molecules from a
single cell and (2) the barcode molecules from a single bead ’530 patent, col. 48:65-col. 49:2.
Therefore, even if the cells are lysed almost immediately after droplet formation so that there is
never more than a handful of droplets with a cell and gel bead at any single point in time, the
claim language is still satisfied so long as at least 1,000 of such droplets had been generated
before the start of the third step.
Based on the foregoing, I find that the accused products satisfy the second step of
claim 1.
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d. Step 3: generating a plurality of “barcoded polynucleotide
molecules”
The third step requires that, in each of said at least 1,000 droplets, a plurality of barcoded
polynucleotide molecules be generated using the polynucleotide molecules fiom the cell and the
barcode molecules from the gel bead. ’530 patent, col. 48:65-col. 49:2. The step further requires
that the “barcode molecules become detached from said gel bead.” Id. at col. 49:3-4.
There does not appear to be a dispute that in each droplet containing a single cell and
single gel bead the following processes occur: (l) the cell lyses and releases polynucleotide
molecules	intheformofmRNA	orgDNA	intothedroplet;	(2)— 	the
barcode molecules from the gel bead; (3) the released barcode molecules bind with either mRNA
(WTA	3') 	ortagmented	gDNA	fiagnlents	(scATAC-seq
assay); and (4) the barcode molecules and polynucleotide molecules are used as templates to
generate	either	barcoded	cDNA	(WTA	3’vl,) 	orbarcoded
gDNA (scATAC—seqassay).
.lX~0075C.000l8 (describing the WTA 3' vl assay); see also IX-0074C.00009 (describing the
WTA 3' vl assay); JX-O088C.O00l5 (describing the WTA 3' vl assay); IX-0O91C.O002O
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(describing the scATAC-seq assay); CX-1491C.00018 (describing the scATAC-seq assay); JX
0034.00027, 00031, 00037 CX—0O04C(Butte DWS) at Q/A 198-200, 204-209, 519, 523; CX
00l8C (Lebofsky Depo. Tr.) at 154:7-157:22, 160:8-161:l8; CX-0019C (Norton Depo. Tr.) at
194:24-195:13.
According to 10X, the third step occurs when the droplets are heated on a thermal cycler.
Bio-Rad argues that 10X has not shown that a plurality of polynucleotide molecules are barcoded
in each of at least 1,000 droplets while the droplets are being incubated on the thermal cycler.
RIB at 196. According to Bio-Rad, the enzymes in the droplets “are active and start reacting to
form barcoded molecules immediately upon droplet formation” and suggests—but does not
state—that all of the barcoding is completed in a subset of the droplets prior to incubation, so
that barcoded polynucleotides are generated in less than 1,000 droplets during the incubation
step. Id.
With regard to the WTA 3' v1, 	Bio-Rad’s
documentation indicates that barcoded cDNA is generated when the droplets are incubated in
accordance to the thennal cycler’s “Reverse Transcription (RT) program.”
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PUBLIC VERSION
' 	I 	\ 	.1 	n 	1
(“Cell lysis and cell barcoding of mRNA transcripts takes place in each droplet during reverse
transcriptionf’), 00025 (“Reverse Transcribe Samples This step reverse transciibes samples on
a thermal cycler,”), .O0026 (“Save the following Reverse Transcription (RT) program on a
thennal cycler V. . .”).
The thermal cyoler’s reverse trarlscription program heats the droplets at 37°C for 30
rninutesand	thenheatsthedropletsat50°Cfor60minutes.IX003400026.	—
. 	This	evidence	supports	l0X’s	position	that	the
following processes occur in the thermal cycler: (1) the release of the barcode molecules from
the gel bead and (2) the generation of barcoded polynucleotides through reverse trauscriptioii.
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PUBLIC VERSION
With regard to the scATAC-seq assay, Dr. Ronald Lebofsky—who ‘holdsthe position R&
D 	11	at	Bio-Rad	and	—conf1med 	that
barcoded polynucleotides are generated dining the trrst heating cycle of the thermal cycler. (IX
0018C (Lebofsky Depo, Tr.) at 157:8-16, l59:24-160:9.
Bio-Rad dismisses the statements in its own documents as “general statements,” but does
not point to any persuasive evidence cormtering those statements. RIB at 109. Bi0—Rad
primarilyreliesonthetestimony	ofitsexpertDr.Metzger,	whotestifiesthat
i 	RX-066“?	(Meeke
RWS)	atQ/A	97-98.	D1‘.	Metzer	also	testifies	tl 	thebarcode
molecules from the gel bead soon after the droplet is formed. Id. Dr. Metzker, however, does
not state that these processes are completed before the droplets are incubated on the thermal
cycler; only that the processes start before incubation. Id. at Q/A 97-108. In support of its
argument, Bio-Rad also points to the hearing testimony of l0X’s expert, who testified that the
reverse trarrscriptase used in the accused products may exhibit a “small element” of activity at
room ternperatrue. Tr. (Butte) at 397:7-12. As discussed above, however, Bio-Rad’s ovm
documents	clearly	show	tl1at
P1'imaIi1Y <>¢<=m"
during incubation. 	i
Assuming	nrguendo	thatDr.Metzkeriscorrectand— 	a11d	reverse
trarlscriptase are active as soon as droplets are formed in the single-cell isolator, the enzymes
would be active only fora relatively short period of time at a suboptimal temperature. The
single-cell isolator operates at room temperature (~20°C) and completes a run within five
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PUBLIC VERSION
minutes. CX-0004C (Butte DWS) at Q/A 526; IX-0O75C.O00l6; JX-0034 (“Single-cell isolation
begins automatically after the ddSEQ Single-Cell Isolator door is closed and takes approximately
5minutes”).Inthatperiodoftime,forBio-Rad’sargument	toholdtrue,the_
and reverse transcriptase must not only be active, but they must reach a point where all the
barcoded molecules have been cleaved from the gel bead and/or the reverse transcriptase has
finished forming barcoded cDNA in a sufficient number of droplets so that these processes occur
in less than 1,000 droplets during incubation. As shown by their product labels, however, room
temperature	is a suboptimal	temperature	forboththe_ 	andthereverse
transcriptase	usedintheaccusedproducts.Thereactiontemperature	ofthe_
(37°C) is significantly higher than room temperature (2O°C)and the optimal reaction‘
temperature of the reverse transcriptase is higher still (50-'55°C). JX-0050C.0OO56. Moreover,
the period of time that droplets are being generated in the single-cell isolator is short relative to
the periods of time that the droplets are being incubated. Specifically, the droplets are incubated
at37°C(the- 	reactiontemperature)	for30minutesandthenheatedat 50°C(the
reverse transcriptase’s optimal reaction temperature) for another 60 minutes. JX-0034C.000l26.
There is no evidence suggesting that the single-cell isolator’sgive-minute run-time provides the
enzymes sufficient time to finish catalyzing their reactions within the droplets, especially at a
suboptimal temperature. 	0
On the basis of this evidence, I find that 10X has shown by the preponderance of the
evidence that at least the bulk of the following processes occur while the droplets are being
heatedonthethermalcycler:(1)the_ 	releasethebarcodemoleculesfromthegel
bead and (2) the reverse transcription of barcoded cDNA from mRNA and barcode molecules.
Accordingly, I find that the accused products satisfy the third step of claim 1 and infringe
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PUBLIC VERSION
claim l.
2. Claims 4, 11, 14, 19, 26, and 28
Claim 4, ll, 14, 19, 26, and 28 depend either directly or indirectly from claim 1.
a. Claim 4
Claim 4 depends from claim 1 through unasserted claim 3. Claim 3 requires that the
polynucleotide molecules be mRNA. ’530 patent, col. 49:8-10. Claim 4 further requires that the
third step of claim l comprise reverse transcribing “said plurality of mRNA molecules in
presence of said barcode molecules to generate said plurality of barcoded polymucleotide
molecules.” ’530 patent, col. 49:11-14. As discussed above, the WTA 3’ v1, WTA 3’ V2, and
CITE-seq assays generate barcoded cDNA by reverse transcribing mRNA in the presence of
barcode molecules. See, e.g., JX-0075C.00018 (describing the WTA 3’ vl assay); JX
0O74C.00009 (describing the WTA 3' vl assay); JX-0088C.00O15; JX-003400027, 00031,
00037; CX-0004C (Butte DWS) at Q/A 198-200, 204-209, 519, 523; CX-0018C (Lebofsky
Depo. Tr.) at 154:7-157:22, 160:8-l6l:l8; CX-0019C (Norton Depo. Tr.) at l94:24-195213.
With regard to the scATAC-seq assay, however, gDNA fragments, not n1RNA, are barcoded and
the assay does not form barcoded polynucleotides through reverse transcription. See, e.g., JX
0O9lC.00020; CX-l491C.00018.
For the foregoing reasons, I find that WTA 3’vl,
infringe claim 4. I further find that the scATAC-seq assay does not infringe claim 4.
b. Claim 11
Claim 11 depends directly from claim 1 and requires that the barcode molecules be
released from the gel bead. ’530 patent, col. 49:34-36. As discussed above, in the WTA 3’ vl,
— 	and	scATAC-seq	assays,	- 	I 	the	barcode	molecules
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PUBLIC VERSION
from the gel bead. See supra. Accordingly, I find that the accused assays infringe claim 11.
c. Claim 14
Claim 14 requires that there be at least 1,000 barcode molecules “disposed within” each
gel bead. ’53Opatent, col. 49:44-45. The gel beads used in the accused products are formed
from polyacrylamide, which is a polymer hydrogel formed by polymerization of acrylamide
monomers, acrydite oligos and crosslinker methylene-bis-acrylamide in Water. CX-0004C
(Butte DWS) at Q/A 116-17, 122-23; JX-010lC.00006. Each gel bead is porous having a three
dimensional network of pores. Id. The gel beads are created by combining the acrylarnide pre
mix and barcode molecules, which results in barcode molecules bonded throughout each gel
bead. CX-1548C.00006. Each resulting bead has at least 1,000,000 barcode molecules disposed
Within the bead. CX-0004C (Butte DWS) at Q/A 128-31, 133, 546-47; JX-0101C.00006
(“Entire	volumeisaccessible”).	Accordingly,	I fmdthattheWTA3'vl,—,
and scATAC-seq assays infringe claim 14.
d. Claim 19
Claim 19 depends from claim 1 through unasserted claim 17. Claim 17 requires that the
barcode molecules “comprise combinatorial assemblies of sequences from sequence modules.”
Id., col. 50:5-7. Claim 19 further requires that the combinatorial assemblies have a first
sequence, a second sequence, and a third sequence. Id, col. 50:13-15. The barcode molecules in
the- 	1>0105C.00021; JX-0075C.00018; CX-0004C (Butte DWS) at Q/A 550-51; ]X
0101c.0007-.o000s.	Accordingly,	1findthattheWTA3'v1,—, 	and
scATAC-seq assays infringe claim 19.
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e. Claim 26
Claim 26 depends directly from claim l and requires that the gel beads have at least
1,000,000 barcocle molecules. ’530 patent, col. 50:30-3 l_ The gel beads in the accused assays
have over 1,000,000 barcode molecules. CX-0004C (Butte DWS) at Q/A 128-29; JX
0050c.00026;JX-0105000020-00022.Accordingly,1fmdthattheWTA3' vl,-, 	and
scATAC-seq assays infringe claim 26. 	0
f. Claim 28
Claim 28 depends directly from claim l and requires that the barcode molecules be
released from the gel bead before the formation of the barcoded polynucleotide molecules. ’530
patent,col.50:35-37.Intheaccusedassays,the‘ 	seversthebarcodemolecules
from the gel bead before the generation of barcoded cDNA strands and barcoded gDNA
fragments. CX-0004C (Butte DWS) at Q/A 557-559; see, e.g., JX-0075C.00018. Accordingly, I
findthattheWTA3’vl,—, 	andscATAC-seq	assaysinfringe	claim28.
3. Indirect Infringement
l0X alleges that Bio—Radindirectly infringed the asserted claims by inducing
infringement or tlnough contributory infringement.
' 	I a. Underlying Acts of Direct Infringement
Both induced infringement and contributory infringement require an act of direct
infringement. Carb0rmm’mn Co. v. Molten Metal Equip. Innovrlrions, Inc, 72 F.3d 872, 876 11.4
(Fed. Cir. 1995) (“Absent direct infiingement of the claims of a patent, there can be neither
contributory infringement nor inducement of infringement”) (quoting Mer—CoilSvs. Corp. v.
Korners Unlimited, 1nc._,803 F.2d 684, 687 (Fed. Cir. 1986)) (internal quotation marks omitted).
Moreover, the act of direct infringement must be by an entity other than Bio-Rad. AIDS
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Healthcare Found, Inc. v. Gilead Sci., Inc., 890 F.3d 986, 992-93 (Fed. Cir. 2018) (“Liability
for induced infringement requires that some other entity is directly infringing the patent.”);
Spansion, Inc. v. Int 'l Trade Com ’n, 629 F.3d 133il, 1352 (Fed. Cir. 2010) (“[T]o prevail on
contributory infringement in a Section 337 case, the complainant must show: . . . the accused
infringer imported, sold for importation, or sold after importation within the United States, the
accused components that contributed to another’s direct infringement”).
With Bio-Rad’s assistance, Berkeley researchers performed SureCell 3' WTA assays,
using 12 ddSEQ v1 cartridges. CX-l573.00001. The researchers were able to obtain barcoded
cDNA from a total of 18,000 cells resulting in an average of 1500 cells being barcoded per
cartridge.	Id.	at.000o2-.0o003.	In	addition,
-. CX-l494C.00016. A Bio-Raddocumentdescribesanotherexperimentin which a
SureCell 3' WTA assay was conducted using a single ddSEQ v1 cartridge. JX
0036.00002-.00003. The experiment resulted in 1,384 cells being barcoded. Id. at .00003. 10X,
however, has not pointed to any evidence showing that the SureCell 3‘WTA assay was used with
—. 	Accordingly,	I fndthattheSureCell	3‘WTAassayhasbeenusedwith
the ddSEQ vl products to infringe the asserted claims. I further find that 10X has not shown that
theSureCell	3'WTAassayhasbeenusedWith— 	toinfringe	theasserted
claims.
Although	there	istestimony	indicating	that	t
, 	ehe	eeeemeev	deee	nee	Peevide
sufficient details that would allow for a determination of whether this was an infiinging use. It is
possible to use the ddSEQ v1 cartridge in a non-infringing manner by using only a subset of
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PUBLIC VERSION
cartridge’s four chambers to conduct an assay. Using only a subset of the chambers will fall
outside the scope of the claims because the cartridge will not produce at least 1,000 droplets
containing a cell and gel bead. See, e.g., JX-003400005 (teaching that, if primed with input
cells, each chamber will produce approximately 300 droplets with one cell and one gel
bead), .000l7 (providing instructions on how to use cartridge without priming all of the
chambers with cells). At least one or two of Bio-Rad’s customers have so used the ddSEQ v1
cartridge. CX-0016C‘ (Kaihara Depot Tr.) at 167:18-168:3. There is no evidence regarding the
methodology employed with nmning the
With regard to the scATAC-seq assay, in September 19, 2018, Bio-Rad made the
scATAC-seq assay available to its “Early Access Customers" for use with the ddSEQ v1 system.
CX-1739C; see also, CX-0004 (Butte DWS) at Q/A 95. There is, however, no evidence of any
of the “Early Access Customers” purchasing, n1uch less using, the scATAC-seq assay for use
withtheddSEQv1system.Asdiscussedabove,althoughthescATAC-seq
! 	Tr. (Kaihara)at 275:2-6;cx-0016c (KaiharaDepo.Tr.)at 148113-19.Accordingly,
I find that 10Xhas not shown that the scATAC-seqassay has been used with —the ddSEQ
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PUBLIC VERSION
vl system_ 	systemtoinfringetheassertedclaimsofthe’530patent.“
Based on the foregoiilg, the only acts of direct infringement by entities other than Bio
Rad involve the 3' WTA vl assay used with the ddSEQ vl system.
b. Induced Infringement
For induced infringement, 10X must show that Bio-Rad acted to induce infringement of
the asserted claims and that it was aware “that the induced acts constitute[d] patent
in£r'mgement.” Gl0b0l~Tech, 563 U.S. at 760-66. As confirmed by the testimony of Bio-Rad
witnesses, Bio-Rad actively induced end-users to infiiuge the asserted claims by using the 3'
WTA v1 assay with the ddSEQ v1 system. See, e.g., CX-0019C (Norton Depo. Tr.) at 32:6-11
(testifying that Bio-Rad will “generally train the customer after they purchase the system”),
32: 15-33:4 (testifying that Bio-Rad demonstrated the ddSEQ v1 system to each of its customers
and that the demonstrations taught the customers “each step of the Workflow to use the ddSEQ
system"). Bio—Radprovides customers with specific instiuctions on how to perform the 3' WTA
vl by priming all four chambers of the ddSEQ vl cartridge with cells. JX-003400017 (“T0 load
the same cell sample across all 4 chambers, make a Cell Suspension Mix using the volumes
listed for 1 cartridge.”). As discussed above, if all four chambers are primed with cells, the
16
_. 	Bi0~Rad’s	ownactsofdirectinfiingement,	however,	cannotberelied
upon to support a finding of indirect infringement. AIDS Hea/fllcare, 890 F.3d at 992~93;
Spansion, 629 F.3d at 1352.
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PUBLIC VERSION
cartridge will generate approximately 1,200 droplets containing a cell and gel bead.
With regard to Bio-Rad’s knowledge that the induced acts constituted patent
infringement, Bio-Rad was aware of the l0X’s infringement allegations and “the ’530 Patent as
of at least January 15, 2018, when 10X served its summons and complaint in 10X Genomics, Inc.
v. Bio-RadLabs., Inc., Case No. 3:18-cv-00209 (N.D. Cal. Jan. 9, 2018).” Bio-Rad’s Response
to the Complaint (Mar. 6, 2018), 1186. With regard to whether Bio-Rad knew that the acts that
induced were intended to cause a third party to infringe the ’530 patent, there is no evidence that
Bio-Rad sought and obtained a n0n~infringernent opinion. Bio~Rad’s failure to do so is
circumstantial evidence that it was aware that the acts brought about by its conduct would
infringe the ’530 patent. See, e.g., Broadcom Corp. v. Qualcomm ]nc., 543 F.3d 683, 699 (Fed.
Cir. 2008) (failure to procure a non-infringement opinion is “circumstantial evidence of intent to
infringe”).
Based on the foregoing, I find that Bio-Rad induced infringement of the asserted claims
of the ’530 patent by inducing others to use the 3' WTA v1 assay with the ddSEQ v1 system.
c. Contributory Infringement
“[T]o prevail on contributory infringement in a Section 337 case, the complainant must
show inter alia: (1) there is an act of direct infringement in violation of Section 337; (2) the
accused device has no substantial non-infiinging uses; and (3) the accused infringer imported,
sold for importation, or sold after importation within the United States, the accused components
that contributed to another’s direct infi-ingement.” Spansion, 629 F.3d at 1353. With regard to
the first and third elements, as discussed above, Bio-Rad “imported, sold for importation, or sold
after importation within the United States” the 3‘WTA v1 assay and the ddSEQ v1 products,
which were used by others to infringe the asserted claims of the ’530 patent.
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With regard to the second element identified by the Spansion coint, it is l0X’s burden to
show “that there are no substantial non-infringing uses" of the accused system. Toshiba Corp. v
Immion Corp, 681 F.3d 1358, 1362 (Fed. Cir. 2012) (citing 35 U._S.C_§ 27l(c)). Pointing to
three uses for the accused product that it contends are substantial and noii-infringing, Bio-Rad
argues that 10X has not met its b1u‘den.17“‘[N]on-infiinging uses are substantial when they are
not unusual, far-fetched, illusory, impractical, occasional, aberrant, or experimental.” Id.
(quoting Vim—11/[ix	C011).v. Basic Holding, Inc, 581 F.3d 1317, 1327 (Fed. Cir. 2009) (internal
quotation marks omitted). “In assessing whether a use is substantial, the fact-fnder may
consider ‘the use’s frequency, . . . the use’s practicality, the invention’s intended purpose, and
the intended n1arket.’” Id. (quoting 1'41’	Ltd. P’ship v. Microsoft Corp, 598 F.3d 831, 851 (Fed.
Cir. 2010)) (omission in original).
The first use that Bio-Rad contends is substantial and non-infiinging is the DROP—seq
assay. This assay and Bio-Rad’s contentions are addressed above. I find that the DROP—seq
assay is not a substantial, non-infiinging use of the accused ddSEQ v1 products with respect to
the asserted claims of the ’530 patent for the same reasons that it does not constitute such a use
with the respect to the ’024 patent.
The second alleged substantial non-infringing use is processing samples using less than
all four chaJ.ubersof the ddSEQ vl cartridge. The asserted claims require the generation of at
least 1,000 droplets containing a single cell and a single gel bead. ‘S30 patent, col. 48:65-col.
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49:2 (claim 1). The ddSEQ vl cartridge has four chambers and each chamber is capable of
producing an average of 300 droplets containing a cell and gel bead. JX-00340005.
Accordingly, if less than four of the chambers are used, the ddSEQ v1 cartridge will generate
less than 1,000 droplets containing a cell and a gel bead. RX-0665 (Metzker DWS) at Q/A 148.
Bio-Rad provides instructions on how to use the cartridge without using all four chambers to
process samples:
All 4 sample chambers must be loaded with Cell Suspension Mix.
If you choose not to bad any cells into a chamber, prepare and load _
the Cell Suspension Mix, substituting an equivalent volume 1X
PBS +0.l% BSA in place of Filtered Cells.
JX-0034.000l7.
Although it is possible to use the ddSEQ v1 cartridge without using all four chambers, the
evidence indicates that such usage would be an uncommon practice at best. In order to generate
1,200 droplets containing a cell and gel bead, Bio-Rad teaches that each of the four chambers
should be loaded with between 10,125-12,375 cells. JX-0034.000l2. It is Bio-Rad’s expectation
that its customers will use all four chambers and it counsels potential customers with less than
40,000 cells that the ddSEQ vl “system is not right for them.” JX-O0l6C (Kaihara Depo. Tr.) at
— 	Id	at	161=18-21	—
_ 	Accordingly,	I findthatusinglessthanallfourchambers	oftheddSEQvl
cartridge for an assay is not a substantial use of the ddSEQ vl cartridge.
The third alleged substantial non-infringing use is performing the scATAC-seq assay
using purified nuclei, instead of cells. While the scATAC-seq assay can be used to generate
droplets containing a cell and gel bead, it can also be used to generate droplets containing
purified nuclei and a gel bead. CX-0004C (Butte DWS) at Q/A 92 (“The scATAC-seq assay can
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partition either whole cells or purified nuclei for analysis”). Using the assay to encapsulate
nuclei instead of cells is a 11011-infiinginguse because the claims require the generation of
droplets containing a cell and gel bead. ‘S30 patent, col. 48:59-63.
10X does not dispute that using the assay to encapsulate purified nuclei is a non
infringing use, but takes the position that “[t]here is no substantial use of scATAC-seq with
isolated nuclei.” CIB at 233. In support of its position. 10X argues that “using isolated nuclei
rather than single cells is merely an option for scATAC-seq” and that “all use of scATAC-seq is
atmost_.” 	Id. 10X’sargumentisunpersuasive.AlthoughBio-Radhasnotfully
released the scATAC-seq assay, on September 19, 2018 Bio-Rad started to offer the assay to
“Early Access Customers” for use with the ddSEQ vl system. CX-1739C; CX-0004 (Butte
DWS) at Q/A 95. Although using the assay with nuclei instead of cells may only be an “option,”
it is an option customers will likely select in particular situations. Bio-Rad developed alternate
protocols for the scATAC-seq assay-—-oneusing cells and one using nuclei-—because for certain
types of cells “one would work better than the other.” CX-0018C (Lebofsky Depo. Tr.) at
157124-158:16. End users would be expected to use nuclei with the scATAC-seq assay in those
instances Whereusing nuclei “would work better” than using intact cells and vice versa.
Based on the foregoing, I fmd that 10X has failed to show that using the scATAC-seq
18
assay with isolated nuclei is not a substantial non-iniringing use of the ddSEQ vl products.
18Pointing to the hearing testimony of Dr. Kaihara,‘Staff argues that using the scATAC assay
with nuclei is not a substantial non-infringing use of the ddSE v1 roducts because “ t he
evidence shows that ATAC-se on the v1 roducts,
SIB at 105. Although Staff correctly
characterizes Dr. Kaihara’s testimony, it ignores that Bio-Rad offered the scATAC assay to its
customers for use with the ddSEQ vl products. CX-1739C; CX-0004 (Butte DWS) at Q/A 95.
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D. Domestic Industry
l0X asserts that its single-cell domestic industry products practice claims 1, 4, ll, 14, 19,
26, and 28 of the ’530 patent.
1. Claim 1
a. Preamble
To the extent that the preamble is limiting, there is no dispute that the domestic industry
products either are methods of nucleic acid preparation and analysis or are used in such methods.
’530 patent, col. 47:58-59. Specifically, l0X’s single cell applications are used to prepare cell
samples for transcriptome analysis. CX-0004C (Butte DWS) at Q/A 564.
b. Step 1: “providing” a plurality of cells and at least 1,000 gel
heads
There is no dispute that the domestic industry products provide at least 1,000 gel beads
and a plurality of cells. See, e.g., CX-0477.0000l (“Within each microfluidic channel, ~l00,000
GEMs are formed per ~6-min run, encapsulating thousands of cells in GEMs.”), .00O02(“The
core of the technology is a Gel bead in EMulsion (GEM). GEM generation takes place in an 8
channel microfluidic chip that encapsulates single gel beads at ~80% fill rate . . . .”); CX-0004C
(Butte DWS) at Q/A 566. Each cell contains a plurality of polynucleotides in the fonn of
mRNA. CX-0004C (Butte DWS) at Q/A 260, 570; CX-048100015; CX-0477.00004. Each gel
bead has millions of barcode molecules attached to it. CX-044700002 (“Each gel bead is
functionalized with barcoded oligonucleotides that consists of: (i) sequencing adapters and
primers, (ii) a 14 bp barcode drawn fiom ~750,000 designed sequences to index GEMS, (iii) a 10
bp randomer to index molecules (unique molecular identifier, UMI) and (iv) an anchored 30 bp
oligo-dT to prime polyadenylated RNA transcripts . . . .”); CX-0004C (Butte DWS)'at Q/A 263.
The barcode molecules comprise identical barcode sequences that are distinct from the barcode
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sequences of the barcode molecules attached to any other gel bead. Id. The barcode molecules
arereleasablyattachedto thegelbeadsthrougha_ 	thatcanbebrokenthroughthe
applicationof CX-0477.00002(“Gelbeads dissolveand releasetheir oligonucleotidesfor
reverse transcription of polyadenylated RNAs.”); CX-0004C (Butte DWS) at Q/A 266.
Based on the foregoing, I find that the single-cell domestic industry products satisfy the
first step of claim l.
c. Step 2: “generating a plurality of droplets”
As required by the second step of claim l, the domestic industry products generate a
plurality of droplets, wherein at least 1,000 of the droplets comprise a “single gel bead” and a
“single cell.” See, e.g., CX-0477.0000l (“Within each microfluidic channel, ~l00,000 GEMS
are formed per ~6-min run, encapsulating thousands of cells in GEMs.”), .00002 (“The core of
the technology is a Gel bead in EMulsion (GEM). GEM generation takes place in an 8-channel
microfluidic chip that encapsulates single gel beads at ~80% fill rate . . . .”); CX-0004C (Butte
DWS) at Q/A 566.
Bio-Rad argues that the domestic industiy products do not satisfy the second step of
claim ll because the products do not “generate a collection of ‘at least 1,000 droplets’ each having a
‘single gel bead‘ and ‘single cell?” RIB at 198. This is the same argument that Bio-Rad made with
respect to the accused products: Because the cells start to lyse ahnost immediately after droplet
formation, at any instant of time there are less than 1,000 droplets with a cell and gel bead. Id. As
discussed above in the context of infringement, claim l only requires the generation of at least 1,000
droplets containing a cell and gel bead before the third step, not that a “collection” of such droplets
exist before the start of the third step.
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Based on the foregoing, I find that the accused products satisfy the second step of claim
1.
cl. Step 3: generating a plurality of “barcoded polynucleotide
molecules”
The domestic industry products perform the third step of claim l when the droplets are
heated on the thermal cycler. After the droplets are generated, they are transferred to a thermal
cycler and heated at 53°C for 45 minutes and then heated at 85°C for 5 minutes. BX
048l.00Ol3. While the droplets are being heated on the thermal cycler, the barcode molecules
arereleasedfromthegelbeadthroughtheapplicationofI, whichdissolves—
— holding the barcode moleculesto the gel beads. CX-048100011; CX-0004C(Butte
DWS) at Q/A 481. In each of at least 1,000 droplets, two or more barcoded polynucleotide
molecules are generated using the mRNA fiom the cell and the barcode molecules from the bead
CX-048l.000l l (“Incubation of the GEMs then produces barcoded, full-length cDNA from
poly-adenylated mRNA.”); CX-0004C (Butte DWS) at Q/A 576-78.
Bio-Rad argues that 10X has “not provided any evidence showing that a plurality of
barcoded polynucleotides are formed in each droplet on l0X’s thennocycler.” RIB at 199. Bio
Rad’s argument is thc same as the one it made with respect to accused products: Because cell
lysis begins as soon as the droplets are fonned, the generation of barcoded polynucleotides
begins before the droplets are incubated. This argument fails for the same reasons that it failed
in the context of infringement.
According to 10X documents, barcoded polynucleotides are generated when the droplets
are being heated on the thermal cycler. CX-048100011 (“Incubation of the GEMs then
produces barcoded, full-length cDNA from poly-adenylated rnRNA.”); see also CX-0004C
(Butte DWS) at Q/A 576-78. To counter this evidence, Bio-Rad points to the testimony of its
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expert'Dr. Metzker, Whotestifies that the generation of barcoded mRNA starts in each droplet
almost as soon as the droplet is formed. RX-0665C (Mctzker RWS) at Q/A 117. Dr. Metzker,
however, does not testify that barcoding is completed in any or all of the droplets before they are
incubated. Even if barcoded polynucleotides start to form immediately alter the droplet is
fonned, there is no evidence that the generation of barcoded polynucleotides would be completed
in any of the droplets before they are transferred to the thermal cycler.
The droplets in the domestic industry product are heated at temperatures and durations
similar to those used in the accused products to stimulate the release of the barcode molecules
from the gel beads and the generation of the barcoded molecules. In the domestic industry .
products, droplets are generated at room temperature (~20°C) in 6.5 minutes. CX-048100013
(“GEM Generation ~ 6.5 minutes”), .00018 (“Equilibrate to room temperature before use . . . .”).
In the ddSEQ vl products, the droplets are generated at room temperature in five minutes. JX
003400005. In the domestic industry products, the droplets are heated on the thermal cycler at
53°C for 45 minutes and then at 85°C for 5 minutes. CX-048100026. In the ddSEQ vl
products, the droplets are heated ion the thermal cycler at 37°C for 30 minutes and then at 50°C
for 60 minutes. JX0034.00026. Similar to l0X’s documentation for the domestic industry
products, Bio-Rad’s documentation describes barcoded cDNA being generated through reverse
transcription while the droplets are being heated on the thermal cycler. See, e.g., JX
0O88C.000l5; JX-003400043; JX-0034C.0O025, .00026.
Based on the foregoing, I find that the domestic industry products practice claim l.
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2. Claims 4, 11, 14, 19, 26, and 28
Claim 4, 11, 14, 19, 26, and 28 depend either directly or indirectly from claim l. There is
no dispute that the single-cell domestic industry products satisfy the additional limitations of
these dependent claims.
a. Claim 4
The cells provided by the domestic industry products have mRNA. CX-0004C (Butte
DWS) at Q/A 260, 570; CX-0481.000l5; CX-0477.00004. As further required by claim 4,
barcoded polynucleotides are generated by reverse transcribing the mRNA in the presence of the
barcode molecules. CX-0481.0001l; CX-0004C (Butte DWS) at Q/A 576-78. Accordingly, I
find that the domestic industry products practice claim 4.
b. Claim 11
As required by claim ll, in each droplet, the barcode molecules are released from the gel
bead. CX-048 1.0001 l; CX-0004C (Butte DWS) at Q/A 481. Accordingly, I find that the
domestic industry products practice claim ll.
c. Claim 14
In accordance Withclaim l4, there at least 1,000 barcode molecules “disposed within”
each gel bead. Specifically, the beads are porous polyacrylamide gel beads. CX-0004C (Butte
DWS) at Q/A 587. Each gel bead has over 1,000 barcode molecules disposed throughout its
entire volume. Id; CX-0479C.000l0; CX-054200001 (“Each Gel Bead contains millions of
oligo primers . . . .”). Accordingly, l find that the domestic industry products practice claim l4.
d. Claim 19
The barcode molecules of the domestic industry products include combinatorial
assemblies of sequences formed from sequence modules. CX-0004C (Butte DWS) at Q/A 589;
CX-0425C.00016; IX-0037C.O0036-.00O42. As required by claim 19, each of the combinatorial
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assemblies	hasafirst	sequence— 	asecond	sequence	_ 	and	a
thirdsequence— 	Id.Accordingly,	Ifindthatthedomestic	industry
products practice claim 19.
e. Claim 26 	.
As required by claim 26, the gel beads have at least 1,000,000 barcode molecules. (IX
048l.O0O6l (“Gel Beads are the foundation of 10x Genomics®’technology, and are beads
functionalized with millions of copies of a 10x Barcoded primer.”); CX-0004C (Butte DWS) at
Q/A 263, 592. Accordingly, I find that the domestic industry products practice claim 26.
f. Claim 28
As required by claim 28, the barcode molecules of the domestic industly products
become detached from the gel beads before the barcoded polynucleotide molecules are
generated. CX-0004C (Butte DWS) at Q/A 275, 594; CX-O542.0000l (“Once partitioned, the
Gel Bead dissolves and its oligo primers are released into the aqueous enviromnent of the GEM.
The cell captured in the GEM is also lysed. The contents of the GEM (oligos, lysed cell
components and Master Mix) are incubated in an RT reaction to generate full-length, barcoded
cDNA from the poly A-tailed mRNA transcripts”). Accordingly, I find that the domestic
industry products practice claim 28.
E. Invalidity
Bio-Rad contends that the asserted claims of the ’530 patent are invalid as anticipated or
rendered obvious by the ’059 patent and/or the Church patent, alone or in combination with
additional prior art. RlB at 199-215. All of the recited claims require barcode molecules that are
“releasably attached” to a gel bead, and the parties’ arguments regarding invalidity for the ’530
patent are substantially identical to those addressed above in the context of the “releasable
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attachment” limitation of the ’024 patent. See SRB at 107. For the same reasons discussed
above, Bio-Rad has failed to show that any asserted claim of the ’53Opatent is anticipated and/or
rendered obvious by the ’059 patent and/or the Church patent because these references do not
disclose the “releasably attached” limitation. 19 In addition, the success of l0X’s domestic
industiy products further weigh against a finding of obviousness.
VIII. ADDITIONAL DEFENSES
A. Inventorship 	p
1. Pertinent Factual Background
In 2008, Dr. Benjamin Hindson and others founded QuantaLife to develop a droplet
digital PCR system. Tr. (Hindson) 137:20-22; CX-0001C (Hindson WS) at Q/A 22-25. Dr.
Hindson was Chief Scientific Officer. Tr. (Hindson) at 137123-25;CX-000lC (Hindson WS) at
Q/A 25. Dr. Nicholas Heredia joined QuantaLife in May 2009 as a Senior Molecular Biologist.
RX-504C (Heredia WS) at Q/A 8. Dr. Serge Saxonov joined QuantaLife in 2010. Tr. (Saxonov)
at 771:13-15. Dr. Saxonov was Vice President of Application Development for QuantaLife’s
droplet digital PCR system. Id. at 771:l6-21.
In 2011, Bio-Rad purchased QuantaLife. CX-0001C (Hindson WS) at Q/A 31. Drs.
Hindson, Saxonov, and Heredia became Bio-Rad employees. Tr. (Saxonov) at 771:9-12); CX
'9 10X further contends that the ’059 patent and the Church patent fail to disclose the step of
“generating” droplets, CIB at 241-42, arguing for a distinction between the tenn “merging” and
the term “generating,” which is supported by Dr. Dear’s citation to deposition testimony from
Dr. Agresti. See CX-1827C (Dear RWS) at Q/A 604-09, 719-22. 10X cites no evidence from
the intrinsic record that the claim language of the ’530 patent makes a distinction between
“merging” and “generating” droplets, however. The ’059 patent includes several paragraphs
under the heading “Droplet Generation,” which includes discussions of emulsions and the
coalescence of smaller droplets with larger droplets. JX-0031, col. 13:5-37. In addition,
Dr. Metzker has identified specific disclosures in the ’059 patent and in Church that meet this
limitation. RX-0664C at Q/A 349, 382.
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0001C (Hindson WS) at Q/A 33; RX-0504C (Heredia WS) at Q/A 6. Dr. Hinds0n’s role at Bio
Rad— CX-0001C (HindsonWS) at Q/A34. In April 2012, Drs. Hindson and Saxonovresigned
their positions at Bio-Rad on the same day. Tr. (Hindson) at 163:6-14. Dr. Heredia remained at
Bio-Rad, where he still works. RX-0504C (Heredia WS) at Q/A 3, 6. Three months later, after
taking a break from work, Drs. Hindson and Saxonov founded 10X. Tr. (Hindson) at 163222-24;
CX-0001C (Hindson WS) at Q/A 38-40. The first provisional patent applications for the
asserted patents were filed in August 2012. See, e.g., JX-0003 (’024 patent, cover), JX-0005
(’468 patent, cover). 	I
Bio-Rad and Dr. Heredia claim that Dr. Heredia was improperly omitted as a co-inventor
on the asserted patents, and that the patents are therefore invalid. Pannu v. Iolab C0rp., 155 F.3d
1344, 1349 (Fed. Cir. 1998) (“[I]f nonjoinder of an actual inventor is proved by clear and
convincing evidence . . . a patent is rendered invalid.”). Bio-Rad contends that Drs. Hindson and
Saxonov, Whilethey were at QuantaLife, “built off of’ the “fundamental solution that Hindson
andHerediahadcomeupwith-.” 	Tr.(OpeningStatement)at95:8-10.10X
counters that the technology described in the asserted patents is distinct from anything that was
described by Dr. Heredia or worked on by him or any others at QuantaLife.
2. Alleged inventorship
Dr. Heredia claims to be an inventor on all four of the patents in suit. RX-0504C
(Heredia WS) at Q/A 20
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In terms of his claim of co-inventorship, however, he points only to his Workwith Dr.
Hindson. Id. at Q/A ll. Dr. Heredia alludes to
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JX-0057C.00018 .
:
20
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JX-0120C.00007;

JX-120C.00008; and

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JX-0120C.00009
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3. Discussion
a. Legal Standards
The statutory requirements regarding joi11tinventorship state, in pertinent part:
When an invention is made by two or more persons jointly, they shall apply for
patent jointly and each make the required oath, except as otherwise provided i11
this title. Inventors may apply for a patent jointly even though (1) they did not
physically work together or at the same time, (2) each did not make the same type
or amount of contribution, or (3) each did not make a contribution to the subject
matter of every claim of the patent.
35 U.S.C, § 116 (a).
A joint invention is “the product of collaboration,“ and requires that “each of the
inventors work on the same subject matter and make some contribution to the inventive thought
and to the final result.’” Vanderbilt Univ. v. [COS Corp, 601 F.3d 1297, l302 (Fed. Cir. 2010)
(quoting A/IonsrmroC0. v. Knmp, 269 F. Supp. 818, 824 (D.D.C. 1967)) (internal quotation marks
omitted). “[T]he critical question for joint conception is who conceived, as that term is used in
the patent law, the subject matter of the claims at issue.” Erhicon, Inc. v. US. Sz11'g1‘caI	Colp,
135 F.3d 1456, 1460 (Fed. Cir. 1998). “Conception is the touchstone of inventorship” and “(i]t
is ‘the formation in the mind of the inventor, of a definite and permanent idea of the complete
and operative invention, as it is hereafter to be applied in practice?” Burro:/ghs Wellcome Co. v.
2‘ In several instances, Dr. Heredia’s testimony at hearing had evolved significantly from the
was 	See infin.
His credibility suffers as a result.
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Barr Labs. lnc., 40 F.3d 1223, 1227-28 (Fed. Cir. 1994) (quoting Hybritech Inc. v. Monoclonal
Antibodies, Inc., 802 F.2d 1367, 1376 (Fed. Cir. 1986)).
“It is not necessary that the entire invention concept should occur to each of the joint
inventors . . . .” Vanderbilt, 601 F.3d at 1302 (quoting Monsanto, 269 F. Supp. at 824). “‘[E]ach
contributor need not have their own contemporaneous picture of the final claimed invention in
order to qualify as joint inventors.”’ Id. at 1303 (citing Fina Oil & Chem. C0. v. Ewen, 123 F.3d
1466, 1473 (Fed. Cir. 1997)). However, “‘[o]ne who simply provides the inventor with well
known principles or explains the state of the art without ever having a firm and definite idea of
the claimed combination as a Wholedoes not qualify as a joint inventor.” Nartron Corp. v.
Schukra U.S.A.Inc., 558 F.3d 1352, 1356 (Fed. Cir. 2009) (quoting Ethican, 135 F.3d at 1460).
“‘[T]he qualitative contribution of each collaborator is the key—each inventor must contribute to
the joint arrival at a definite and pennanent idea of the invention as it will be used in practice.’”
Vanderbilt, 601 F.3d at 1303 (quoting Burroughs, 40 F.3d at 1229).
In general, ‘“[t]he inventors as named‘in an issued patent are presumed to be correct.”
Nartron, 558 F.3d at 1356 (quoting Hess v. Advanced Cardiovascular Sys., Ina, 106 F.3d 976,
980 (Fed. Cir. 1997). Proof of joint inventorship requires clear and convincing evidence.
Vanderbilt, 601 F.3d at 1305.
b. Insufficient evidence of collaboration
“A primary focus of section 116 has [] always been on collaboration and joint behavior.”
Vanderbilt, 601 F.3d at 1303. “The interplay between conception and collaboration requires that
each co-inventor engage with the other co-inventors to contribute to a joint conception.” Id.
Dr. Hindson testifies that he did not collaborate with Dr. Heredia on the
He explains that Dr. Heredia was a new employee at QuantaLife in May 2009 and that his role
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was limited to “assisting in validation and testing.” CX-l 828C (Hindson RWS) at Q/A 6; see Tr.
a*181=19-13
_ 	Herecalls	discussing	Dr.Heredia’s	_ 	forfiveor10minutes,	but
h<=fl1a¢ 	ex1828C (Hindson RWS) at Q/A 11; Tr. at 181:24-182:16. Dr. Hindson says he commented to Dr.
Heredia that he had done well to put his idea down on paper only because he did not want to
discourage him. CX-1828C at Q/A 11. Dr. Hindson testifies that he did not know of any follow
upworkonDr.Heredia’s—, 	thatnoresearchplanwasdevelopedbasedonthe
idea, that no experiments were conducted, and that the idea did not inform any work Dr. Hindson
performed at QuantaLife or Bio-Rad. Id. at Q/A 21-22.
Dr. Heredia does not specifically dispute Dr. Hindson's recollection that there was no
significant collaboration between him and Dr. Hindson based on the 	. See, e.g.,
CX—O0l5C(Heredia Dep.) at 335121-336:2
_). 	Hemaintains,	however,	that 	show	“an
inventive contribution,” Tr. (Heredia) at 602:7-13, and collaboration, and that
JX-0120C, shows follow-up RX-0504C at Q/A 16
He recalls no
subsequent development or any additional conversations with Dr. Hindson or others at
QuantaLifeconcerning-, 	however.E.g.,Tr.(Heredia)at 584:15-19(“.. . Ican’t
recall. . . . ButI havea vaguesensethatDr.Hindsontalkedabout,youknow,
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594112-18
Dr. Heredia also testifies that he recalls no
conversations with Dr. Saxonov about the 	Id. at 594:7-l l.
In sum,apartfromDr. Heredia’ssomewhatvagueanduncertaintestimony,his
, 	which	do	not	clearly	demonstrate	acollaborative
effort to develop Dr. Heredia’s idea, Bio-Rad points to no evidence to show that Dr. Heredia
collaboratedwith other scientistsat QuantaLifeor Bio-Radon any project concerningthe:
-. Dr. Hindson denies that such a collaborationoccurred, and Dr. Heredia cannotrecall any
specificcollaborative	activitiesconcerningdevelopment	ofhis—, 	beyondthe
alleged brainstorming discussion with Dr. Hindson, the details of which are disputed by Dr.
Hindson. On this record, I find insufficient evidence to establish that Dr. Heredia collaborated
with others to develop the teclmology in the asserted patents. 	l
c. Insufficient evidence of conception
The “core idea” of the “gel bead-in-emulsion” or “GEM” architecture claimed in the
asserted patents
is about partitioning nucleic acids, DNA or RNA, in droplets together with gel
beads that are used to deliver the barcodes into the droplet. The gel beads contain
oligonucleotide barcodes. In each gel bead there are a large number of
oligonucleotide molecules that include barcode sequences . . . Those
oligonucleatide barcodes are released from the gel beads using a stimulus. They
attach to the nucleic acids in the droplet. An amplification reaction is used to
create barcoded nucleic acids, and those can be used for downstream processing.
CX-0003C (Schnall-Levin WS) at Q/A 27 (discussing the ’O24patent).
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Dr. Heredia’s
Id. at .00OO4.
Id. at .00005.
Bio~Rad’s argument is that Dr. Heredia’s
address the same problem of “samplepreparation for analysis of
biological materials such as nucleic acids,” that ultimately is addressed in the asserted patents.
Tr. at 86: 22-23. Bid-Rad maintains that Dr. Heredia’s solution to the problem can be reduced to
four parts that track the invention described in the asserted patents: First, Bio Rad identifies
“partitioning the sample into droplets.” Id. at 86:25-87:1. Second is “creating a reagent delivery
system.” Id. at 87:1-2. Third is “combining the sample and reagent delivery system with
droplets using microfluidics.” Id. at 87:2-3. Fotuth is tracking “the sample reagent reaction
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complex with a barcode mechanism.” Id. at 87:4-5. Bio-Rad’s counsel use this construct to
maintain that all of the elements ultimately found in the patents-in-issue were conceptualized by
Dr. Heredia in 2009.
The evidence fails to persuade clearly and convincingly that Dr. Heredia in 2009 had in
mind anything like the architecture of the GEM, however, as described by Dr. Schnall-Levin,
above. This is true for several reasons. ' i V
Fundamentally, nothing in Dr. Heredia’s materials indicates how his idea would work.
Dr.Heredia’s	— 	does	notexplain	even	onabasic	level	howhis—
functions.CX-1827C(DearRWS)‘atQ/A1145(“Thedescriptionin— 	is a bare
sketch of at best a partially formed idea that does not show any way to deal with even the basic
issues that would confront someone trying to make such a thing work.”); see CX-1828C
(Hindson RWS) at Q/A 16-19. One who “merely suggests an idea of a result to be
accomplished, rather than means of accomplishing it, is not a joint inventor.” Nartron, 558 F.3d
at 1359 (quoting Garrett Corp. v. United States, 422 F.2d 8'74, 881 (1970)).
More specifically, Bio-Rad’s efforts, through Dr. Metzker, to isolate various aspects of
the patented technology to claim that they were conceived by Dr. Heredia in 2009 fail due to lack
of evidentiary support. For example, Dr. Metzker indicates that Dr. Heredia’s inventive
contribution was “a reagent delivery system.” Tr. (Metzker) at 717:5-22; 716: 19-21 (“thinking
about it as a reagent delivery system within an aqueous droplet”). Dr. Heredia, however, appears
to have had no idea of the reagent delivery system described in the asserted patents. Tr.
(Media)	at	58%-11	<
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Bio-Radseeksto drawan equivalencebetweenthe- 	describedby Dr.Heredia
and the porous gel bead described in the asserted patents and used in l0X’s GEM technology.
The effort fails. First,Dr. Metzker concedesthat Dr. Heredia’sidea entailedthe use of ai
- thatwas“alreadyintheart.” Tr.at718:7-8.HetestifiesthatDr.Heredia’s— 	are
T1 at
712: 19-2l. Luminex beads were “extremely well understood at the time of Dr. Heredia’s ‘lab
notebook entry,” Dr. Metzker says. Tr. 716:3-5. Dr. Metzker concedes that “the idea of a
capsule in a droplet that can release its contents into the droplet also “might very well be”
something known in the state of the art at the time. Tr. at 722122-723112. Putting an analyte
within an aqueous droplet was “certainly known state of the art by 2009,” Dr. Metzker testifies.
Id at 724: 12-22. The case law is clear that merely describing prior art is not an inventive idea.
Nartron, 558 F.3d at 1356.
In addition, Dr. Heredia’s idea of a does not encompass the functionality of a
gel bead. Dr. Metzker opines that Dr. Heredia’s
_ 	RX-0664C	(MetzkerDWSatQ/A480).Theseassertions	areunconvincing.
As explained by l0X’s expert, Dr. Dear, Dr. Hereclia’s
which is not the same as a bead, a distinction that would have been
understood	intheartatthetime.cx-1827c(DearRWS)atQ/A1148._
Id. at Q/A 1149. See Tr. (Hindson) at
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172:6-7 (describing Lumiriex as “a capture bead, a solid bead that’s used to capture analytes
from solution for subsequent detection”); see also CX-1828C (Hindson RWS) at Q/A l0.
Dr. Heredia not only did not describe the functionality of the patented gel beads in his
2009 materials, he did not conceive of that functionality. As noted by Dr. Dear, Dr. Heredia at
deposition and at trial “struggled to articulate an understanding of what the relationship between
_ 	andanyoftheclaimedinventionswas.” Id. at Q/A1172.In fact,Dr.Heredia
apparently struggled at his deposition to understand what a porous gel bead (as disclosed in the
asserted patents), actually is. See, e.g., CX-0014C (Heredia Dep.) at 42:2-ll (“Q [] Are porous
gelbeadsand_ 	thesamething? A. Well,gelsarejust an extremelyviscousliquid,in
nziyunderstanding. So_they’re very related”). Dr. Metzker, Bio-Rad’s expert, implicitly
contradicts Dr. Heredia's testimony, agreeing that “a gel is not a viscous liquid,” id. at 713:5, and
rejectsthenotionthatDr.Heredia’s- 	is a gel. Tr.(Metzker)at 7l2:23-25,713:5-8.
Although	Dr.	Metzker	testifies	that	Dr.	Heredia’s
- 	Tr.at712114-22,	he admitsthatnothingiiiDI.Hc1'edia’s	depictionofhisK
indicates that it was either porous or a gel. Tr. 714110-2. Dr. 1-Ierediahimself cannot say
Whether in 2009 he knew what a porous gel bead was. Tr. 581318-22.
Dr.Metzkeropinesthat“Dr.Herediaspecificallyconceivedandcontributed
RX-0664C (Metzker DWS) at Q/A 480. Dr.
Metzker opines that Dr. Heredia’s idea as set forth in
Id. Dr.Metzker	saysDr.Heredia’s	idea
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Ii at 481- D1 Heredia’s
materials, however, depict no mechanism for achieving this result. As noted above, Dr. Heredia
himself testifies that he cannot recall having “the idea of applying a stimulus to a bead to release
oligonucleotide molecules from it.” Tr. (Heredia) at 590:9-22-. Dr. Dear confirms that Dr.
Heredia’s— 	doesnotdepictoligonucleotide	barcodesorbarcodesreleasably
attached to anything; it does not show any attachment that is releasable upon the application of a
stimulus. CX-1827C (Dear RWS) at Q/A 1142. Dr. Heredia himself concedes that the
oligonucleotides he envisioned were “not going to be released into the interior.” CX-0014C
(Heredia Dep.) at 172121-173:4; see also Tr. at 589:6-11. Again, Dr. Metzker’s efforts to
extrapolateelements of the GEM architecturefrom Dr. Heredia’sdepictionsof his liquic
- are unpersuasive. 	V 	'
Evenif onewereto acceptthepropositionthatDr.Heredia’s- 	couldbe
considered a porous gel bead, Dr. Heredia’s notebook does not disclose barcoding nucleic acids
or any microfluidic system; it does not disclose a barcode that can function as a unique label; and
it does not disclose what the numbers of droplets would be. CX-1827C (Dear RWS) at Q/A
1142.“Inshort,”Dr.Deartestifies,“this—ntry 	doesnotcomecloseto showing
conception of any claim in any 10X Asserted Patent.” Id. at Q/A 1146-1147. See CX—1828C
(Hindson RWS) at Q/A 16-l 9.
Specifically with respect to the draft provisional application, Dr. Dear notes that Dr.
Heredia diS<=umS
i 	as	dmd	we	10X
cx-13270	(Dear	RWS)	atQ/A1156.	Dr.Dear	notes	further	that_
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. 	Id.atQ/A	1158.	Dr.	Heredia’s_ does	not	depict	how
in
other words, Dr. Heredia’s idea “would not work without something not actually depicted.” Id.
at Q/A 1165. In sum, Dr. Dear demonstrates persuasively that Dr. Heredia’s 2009 idea lacks the
elements which, combined, interact to effectuate the patented invention.
Bio-Rad argues that an inventor need only contiibute one individual feature to an
invention. But the evidence, as discussed, does not suppoit the contention that Dr. Heredia
contributed even one element. D1‘.Heredia himself does not point to anything his idea for a
liquid bead contiibuted to the invention patented by 10X. See, e.g., Ex. CX-0014C (Heredia
Dep. ) at 114110-12
Bio-Rad lays great stress on case law that says each contiibutor need not have “their
own contenlporaneous picture” of the final claimed invention to qualify as a joint inventor. RIB
at 13 (quoting Vmzderbili, 601 F.3d at 1302). Bio—Radrelies on case law holding that a
contribution to individual features of a patented invention, “even at diffei'e11tt.i1nes,”may qualify
for joint inventorship. Id. at 14. The evidence here does not establish clearly a11dconvincingly
that Dr. Heredia’s work contributed to the patented technology at any time. Dr. Heredia did not
conceive of anything at all that worked at the time he thought of it or that contributed to
technology that was developed later. These facts distinguish this case from the cases Bio-Rad
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cites in support of its arguments. “[O]ne who is ‘too far removed from the real-World realization
of an invention’ is not a co-inventor.” Nartron, 558 F.3d at 1359 (quoting Eli Lilly & Co. v.
Aradigm Corp, 376 F.3d 1352, 1359 (Fed. Cir. 2004)).
Bio-Rad argues that Dr. Heredia’s disclosures share the “context” of the patented
inventions. This is truc only at a level of generality so high that it would render the concept of
inventorship	meaningless.As 10Xasserts,“Dr.Heredia’s‘— 	wasa goalwithno
operative means to achieve it.” CIB at 160. While Dr. Heredia’s idea may have related
generally to sample preparation and the “same sample preparation context,” RRB at 61-62, he
made no contribution toward meeting the goals of the invention in the way described in the
patents. I cannot find clear and convincing evidence that Dr. Heredia’s conception contributed at
all, much less in a qualitative way, to the invention claimed in the asserted patents.
d. Insufficient evidence of significance
“‘A joint inventor must contribute in some significant manner to the conception or
reduction to practice of the invention [and] make a contribution to the claimed invention that is
not insignificant in quality, when that contribution is measured against the dimension of the full
invention.”’ Nartron, 558 F.3d at 1356-57 (quoting Pannu, 155 F.3d at 1351).
Even Dr. Metzker admits that Dr. Heredia’s idea “in isolation” is not a “significant
contribution.” Id. at Tr. 726:3-9. Dr. Heredia’s idea, according to Dr. Metzker, is significant
only if it
Id. at 728:14-22. In this respect, 10X and
Bio-Rad seem to agree. See Tr. (Schnall-Levin) at 23O:15-24 (“[T]his invention is not like a bag
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of words, like barcodes, gel beads. It’s actually how they’re all put together, which is really
important for driving the performance of the system.”). Because there is no evidence that Dr.
Heredia had an idea of how the elements that he allegedly conceived of would be put together to
achieve the desired result, he made no significant contribution.
Absent evidence that Dr. Heredia’s liquid bead contributed anything of significance to
the patented technology (or any teclmology), Bio-Rad cannot demonstrate clearly and
convincingly that Dr. Heredia is a joint inventor.
B. Ownership V
As an affinnative defense to l0X’s allegations of infiingement, Bio-Rad claims
ownership of each of the asserted patents in this investigation. 10X disputes Bio-Rad’s claims of
ownership, and Staff agrees with 10X. Although, in briefing the matter, the parties have lost
their way in arguments concerning the law of inventorship, this is a contract dispute that boils
down to a simple question: is there evidence that the idea embodied in the asserted patents Was
conceived by Drs. Hindson and Saxonov during the period in which they were employed by
Quanta/Life and Bio-Rad? If the answer is yes, then as a matter of contract law, the asserted
patents belong to Bio-Rad. If the answer is no, the asseited patents belong to 10X.
1. Legal Standards
“It is elementary that inventorship and ownership are separate issues.” Beech Aircraft
Corp. v. EDO Corp, Sl90F.3d 1237, 1248 (Fed. Cir. 1993). Accord, Israel Bi0—Eng’gProject v.
Amgen, Inc., 475 F.3d 1256, 1263 (Fed. Cir. 2007) (“[1]ssues of patent ownership are distinct
from questions of inventorship.”). Ownership “is a question of who owns legal title to the
subject matter in a patent,” While“inventorship is a question of who actually invented the subject
matter claimed in a patent.” Beech, 990 F.2d at 1248. Bio-Rad confuses the issue by attempting
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PUBLIC VERSION
to use the legal analysis that applies to joint inventorship to resolve its ownership dispute with
10X. The distinction is illustrated in this case: the question whether Dr. Heredia should be
treated as a co-inventor is one of inventorship; but there is no question that Drs. Hindson and
Saxonov are inventors on the asserted patents. The question with respect to them is one of
ownership, i.e., do their contractual agreements with Bio-Rad and QuantaLife require that the
asserted patents be assigned to Bio-Rad? See FilmTec Corp. v. Hydranautics, 982 F.2d 1546,
1550 (Fed. Cir. 1992) (stating that in a case that “turns on” “ownership”, the court only needs “to
decide whether the invention . . . was made or conceived” during the period of employment)”
Bio-Rad’s ownership claims arise solely as the result of the contract terms governing the
employment of Drs. Hindson and Saxonov, who are among the named inventors of the asserted
patents. In general, contract terms must be construed under state law. Board of Trustees of
Leland Stanford Junior Univ. v. Roche Molecular Sys., Inc., 583 F.3d 832, 841 (citing Jim
Arnold Corp. v. Hydrotech Sys., 109 F.3d 1567, 1572 (Fed. Cir. 1997)). The exception to this
22Bio-Rad asserts that I adopted joint inventorship as a “guide” to ownership. RIB at 20 (citing
Order No. 34). To the contrary, on reconsideration, Order. No. 41 clarified that “Order No. 34
did not conclusively establish the legal framework for deciding Bio-Rad’s ownership claim.”
Order No. 41 at 2. In affinning denial of l0X’s motion for summary determination on the
ownership issue, Order No. 41 recognized that the “legal standard for addressing the ownership
issue” continued to be disputed, and that “the parties’ dispute would be better resolved after the
conclusion of the evidentiary hearing, with the benefit of a complete evidentiary record regarding
the contractual relationships between the parties and the contributions of the inventors.” Id. As
stated in Order No. 41, doubt concerning the facts and the law precluded a ruling on summary
determination, including on the applicable legal standards. See also Gen ’lElec. C0. v. Wilkins,
No. CV F 10-0674 LJO ILT, 2012 WL 3778865(E.D. Cal. 2012) at *19 note 3 (“[T]his Court is
not bound by its interlocutory orders, which are not final, and may reconsider or modify them at
any time”) (quoting Marconi Wireless Telegraph Co. v. United States, 320 U.S. 1, 63 (1943);
City of Los Angeles, Harbor Div. v. Santa Monica Baykeeper, 254 F.3d 882(9th Cir. 2001)).
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rule covers matters that are “intimately bound up with the question of standing in patent cases,”
such as “whether contractual language effects a present assignment of patent rights, or an
agreement to assign rights in the future.” Id. No such question is presented_here.23 This is
important because the standard for determining joint ownership is a matter of patent law
determined by federal courts, while the federal courts defer to state law on questions of contract.
“[Q]uestions of contract law are matters of state law, questions related to patent law are
interpreted according to federal law.” General Elec. C0. v. Wilkins,No. CV F l0-0674 LJO JLT,
2012 WL 3778865 (E.D.Cal. 2012).
Confusing the two issues leads to error, as described by the federal court in
ST.Micr0electr0nics, Inc. v. Harari, Case No. C 05-4691 JF, 2006 WL 2032580 (N.D. Cal.
2006).“ In that case, the court addressed a dispute similar to the facts here: a company sued its
fonner employee alleging that certain inventions were subject to a contract in which the
employee agreed to assign inventions made during the term of his employment. Id. at *1-2. The
district court initially found federal jurisdiction based on a substantial question of federal patent
law. Id. at *2. The court reversed its decision on reconsideration, holding that “[o]wnership and
inventorship issues are completely separate issues,” and that the resolution of the ownership
dispute depended entirely on the terms of the employment contract and the question of when “the
23 Obviously, if Bio-Rad owns the patents, l0X lacks standing to assert them. But this is not a
case in which there is a dispute concerning a present vs. a future assignment of rights, or how the
actual assignment of patent rights among multiple parties affects standing. Interpretation of the
contractual provisions, not application of the law of standing, determines the outcome in this
instance.
24Harari is an unpublished decision. It is cited here not as precedent but as an instance in which
a court mistakenly applied patent law inventorship principles to the issue of ownership, and
thereafter recognized and corrected its mistake.
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PUBLIC VERSION
inventions described in the subject patents were ‘made or conceived.” Id. at *l0-11. This
“presen[ted] a factual question that does not implicate a substantial question of patent law,” the
court ruled, sending the case back to state court. Id. at *12-14.
The Harari court explicitly rejected the idea that detennining the “inventive
contribution” made by the employee mattered at all in deciding whether the company owned the
inventions made by him. “It is unclear,” the court lamented, “how Defendants, and subsequently
the Court, came to inject the phrase ‘inventive contribution’ into the discussion of Harari’s
contractual disclosure and assignment obligations. The phrase does not appear in the Inventions
Agreement . . . .” Id. at *8. Because the employment agreements required disclosure and
assignment of all inventions and rights to inventions made dtuing the term of employment,
“there was no need to inquire into Harari’s precise inventive contribution.” Id. at *11.
Harari relies onAT&T v. Integrated Network Corp., 972 F.2d 1321 (Fed. Cir. 1992), a
precedential Federal Circuit decision involving similar facts, in which the Federal Circuit
reversed a district court decision asserting jurisdiction and remanded with instructions to send
the case to a state court. Id. at 1325. InAT&T, four employees left AT&T to join another firm,
INC, “as a team.” Ia’.at 1323. The employees were subject to agreements giving AT&T
assignment rights in inventions made or conceived, either solely or jointly with others, during the
course of their employment. Id.
The patent in question was filed about a year and a half later, naming the four former
AT&T employees as inventors, and disclosing that the application for the patent Wasassigned to
INC. Id. AT&T sued alleging that the invention in question had been disclosed in a proprietary
[AT&T] memorandum prepared by one of the four employees during the period of employment.
Id. AT&T alleged contract and tort claims. INC removed the case to federal district court, but
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PUBLIC VERSION
AT&T moved the district court to remand the case back to state court, arguing that it would seek
to prove that the invention was conceived during the period of employment by AT&T, and that
this did not present “a substantial question of federal patent law.” Id. Accord, e.g., ReC0r Med.
Inc. v. Warnking, C.A. No. 7387-VCN, 2013 Del. Ch. LEXIS 142 at *34 (Del. Ch. Ct. May 31,
2013) (“[T]he Court can see no reason Whypatent laW-should displace contract law here.” (citing
AT&T).)
The district court kept the case but on appeal, the Federal Circuit held that it should be
remanded to the state court for decision. Id. at 1324. The Circuit explained that “conception of
inventions, as used in the employment agreement, is [not] solely a technical question of patent
law.” Id. Specifically, the Circuit opined that the moment “when an invention was conceived
may be more a question of common sense than of patent law.” Id. The Circuit said the state
court was “free to look for guidance to the law on the conception of inventions as we may have
explained it, but in light of the different facets of the Wordconceive, indeed of inventions, this
may well not be determinative of the outcome . . . .” Id. at 1325 (quoting Ingersoll-Rand C0. v.
Ciavatta, 542 A.2d 879 (1988). Accord, e.g., Motorola, Inc. v. Lemko Corp., No. 08 C 5427,
2012 WL 743,19, at *4-5 (N.D. I11.Jan. 10, 2012) (“the parties did not necessarily use terms in
their agreements in the same way in which they are defined in patent law”).
While the jurisdictional question addressed in AT&T does not arise in a case brought
pursuant to section 337, the principle is the same: where an action sounding in contract is
brought, the resolution of the contract dispute should be decided based on state law, even in a
patent case.” A state court may look to federal law for “guidance” on questions of inventorship
25Ingersoll-Rand states that it is the employer’s burden to establish that conception occurred
during the period of the employment contract. 542 A.2d at 894. Accord, e.g., ReC0r, 2013 Del.
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where that is appropriate, but an action for breach of contract remains a question of state law and
does not arise under federal patent law. AT&T§supra. In the case before me, as in AT&T, the
contract requires detennination of when the idea that gave rise to the patents~in-issue was
conceived. The time of conception, as the Circuit noted in AT&T, is not a patent law issue.
The parties in this case fall into the same trap bemoaned by the court in Harari to the
extent that they argue about whether the concept of “complete inventorship” applies to Drs.
Hindson and Saxonov. The notion of “complete inventorship” has no application with respect to
ownership under the pertinent contracts. These contracts, like the contracts in Harari, are silent
as to any inventive contribution, complete or incomplete, made by an employee. Under the
unambiguous contract provisions, see infi'a, the only fact that matters is the actual time when the
inventors conceived of the inventive idea embodied in the asserted patents. See also Motorola,
2012 WL 74319 at *5 (“[T]he terms ‘developed or conceived . . . during the term of my
employment’ are not ambiguous. Their meaning is sufficiently clear that a jury could simply
examine evidence of when the inventions or ideas embodied in the Lemko patents first came into
existence in order to determine whether Pan and Labun’s actions were within the scope of the
contractual term.”).
2. Discussion
The real dispute involves defining the inventive concept in the asserted patents. Bio-Rad
has the burden to identify the idea of which it claims ownership. It has not done so. Instead, it
has briefed the matter as if it owned a share of the patents because it could trace some elements
of the asserted patents to Workdone at Quanta/Life and Bio-Rad. This is inconsistent with the
Ch. LEXIS 142 at *32 (employer “must show by a preponderance of the evidence that it is
entitled to the relief it requested”).
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contractsi
- 	Bio-Rad,as 10Xfreelyconcedes,ownsmanyideasconceivedbyDrs.Hindson
and Saxonov, but it does not own the idea for the specific arrangement of elements claimed in
the asseited patents, as discussed herein, because there is insufficient evidence that that idea was
conceived during the period of employment.
As described by Dr. Hindson, the invention claimed in the asserted patents is complex
and consists of many elements. CX-0001C (Hindson WS) at Q/A 88. The inventive idea, which
emerged from many other ideas (some of which clearly were in the prior art), is to combine these
elements in a process resulting in what 10X calls the GEM (“gel bead in emulsion”) architecture.
As confirmed by both parties, the inventive idea is a specific arrangement of elements Which,
when combined, works to achieve a desired goal. See Tr. (Metzker) at 728: 14-22 (“[I]t has to
work Withinthe architecture of a droplet, so partitioning the analyte from other analytes, having
a reagent delivery system that adds the reagents that we can then combine, barcode, analyze and
then track back to the different droplets, to what is the makeup of that analyte. All of that, all of
that together is important”). See also Tr. (VSchnall-Levin)at 23O:l5-24 (“[T]his invention is not
like a bag of words, like barcodes, gel beads. It’s actually how they’re all put together, which is
really important for driving the performance of the system”). The asserted patents each claim
particular steps in the GEM architecture, and for purposes of ownership, the employment
contracts at issue require deterrninationof who conceived of this architecture and when. See
ReC0r, 2013 Del. Ch. Ct. LEXIS at *29, 42 (examining the record to determine when the “aha”
or “eureka” moment occurred). Bio-Rad does not address squarely the critical contractual
question of when the inventive concept in the asserted patents was conceived. Instead, Bio-Rad
clouds the real issue with misplaced arguments about inventive contributions.
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Consistent with the Federal Cii'cuit’s holding in AT&T, Califoinia law goveins the
peitinent employment agreements between Bio-Rad and Dis. Hindson and Saxonov. RX-0624C
at 1]ll; RX-0623C‘ at 1[l 1; RX~06l9C at 1]ll; RX-0620C at {Ill. “Under Califoinia law, the
inteipretation of a written contract is a matter of law for the court even though questions of fact
are involved.” S01/rlrlrmdCorp. v. Emerald Oil Ca, 789 F.2d 1441, 1443 (9th Cir.l9S6).
Conlract language that is plain and unambiguous requires no construction. “‘In inteipreting an
unambiguous contractual provision we are bound to give effect to the plain and ordinaiy
meaning of the language used by the pa1ties.”’ Loclqvel"v. R.J. Reynolds Tobacco Co., 107 Cal.
App. 4th 516,517 (2003) (quoting Coast Plaza Doctors Hospital v. Blue Cross of California, 83
Cal. App, 4th 677, 684 (2000)). Where “‘cont1‘actlanguage is clear and explicit and does not
lead to absurd results, we ascertain intent from the wiitten tenns and go no further.’” Slmw v.
Regents 0fUniv. ofCnlif0rm'(1, 58 Cal. App. 4tl144, 53, 67 (1997). See Cal. Civ. Code § 1639
(“When a contract is reduced to writing, the intention of the parties is to be asceitained fi'0m the
writing alone, if possible.”)l
The contracts in this case state, in pertinent pait, with respect to QuantaLife:
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PUBLIC VERSION
And with respect to Bio-Rad:
RX-()6l9C at W 3, 6; RX-0620C at1[1]3, 6.
As set foith above, the QuantaLife contracts
RX-0623C at 112(1) The B10-Rad contiacts
_ 	RX-0619C	at$113,	6.
— 	1”-*"t3~
N0 provision of any of the applicable contracts govems future inventions that are based
on or developed fi'o1nwork done during employment. To the contraiy, the plain, unambiguous
contract language pertains only to ideas actually conceived during the employment peuiod. Bio
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PUBLIC VERSION
Rad’s arguments improperly read out the plain meaning of the durational limitation in the
pertinent contracts, and in its place suggest an interpretation of the contracts in which inventions
developed by the employee afler his employment belong to the company if they are related to
cc:
ideas conceived during employment. When a dispute arises over the meaning of contract
language, the first question to be decided is Whetherthe language is ‘reasonably susceptible’ to
the interpretation urged by the party. If it is not, the case is over.’" Lockyer, 107 Cal. App. 4th
at 524. Bio-Rad’s (implicit) construction is not reasonable.“
Bio-Rad’s contention that “[b]ecause Hindson and Saxonov made contributions to the
inventions	that	are	now	claimed	inthe	Asserted	Patents
_ 	. . .’Bio-Radhasaprorataundivided	co-ownership	interestintheAsserted
Patents based on those contributions,” RRB at 40, therefore is unavailing. Bio-Rad owns no
interest in any of the patents unless it can demonstrate, in conformity with the contractual
requirements, that Drs. Hindson and Saxonov actually conceived the inventive idea embodied in
the asserted patents during the employment period. Bio-Rad does not cite to any provision of the
employment contracts to support its contentions that an idea that is related to the invention
embodied in the asserted patents, but is not the actual inventive idea in the asserted patents,
confers ownership on Bio-Rad.
On review of this record, Bio-Rad has failed to present any direct evidence that the actual
inventive idea embodied in the asserted patents was first conceived at Quanta/Life or Bio-Rad, as
required by the contracts. Since it has presented no direct evidence of conception, Bio-Rad
necessarily falls back on circumstantial evidence, asking me to infer that conception likely
26Bio-Rad has not actually offered any alternative construction of the contract terms.
145

PUBLIC VERSION
occuired during the period of employment. Bio-Rad’s argument is grounded mainly on the
temporal proximity of DIS. Hinclson and Saxonov’s departure from Bio-Rad and the inventions
developed thereafter by 10X.
These facts are basically undisputed: In October 2011, Bio-Rad acquired QuantaLife
— 	RIBat44(citing	RX-0502C	(Tumolo	DWS)	atQ/A32).DIS.
Hindson and Saxonov worked at Bio-Rad for six months thereafter, leaving in what was a
“coordinated event” in April 2012. Id. at 44-45 (citing Tr. (Hindson) at 162:3-9, 163:6-14; Tr.
(Saxonov) at 797:4-21, 798:3-9). After taking off several months, Drs. Hindson and Saxonov
foimed 10X. Tr. (Hindson) at 163:3-164:3; CX-0001C (Hindson WS) at Q/A 38-40. Within
four months of leaving Bio-Rad and less than a month after founding 10X, they filed their first
provisional patent application at 10X on August l4, 2012, Provisional App. No. 61/683,192 (the
‘"192 application”). RX-0299.
This chronology alone does not establish circumstantially that the inventions at issue
were conceived during Drs. Hindson and Saxonov’s employment with QuantaLife and Bio-Rad.
The circumstances of their departure make it likely that Drs. Hindson and Saxonov left Bio-Rad
with the intention of pursuing oppoitunities to invent and market new technologies~they were
free to do so. But these circunistances in themselves do not support a finding that Drs. Hindson
and Saxonov conceived of the idea embodied in the asselted patents before they left Bio-Rad’s
employ. 27
27 The
l-24.
l46

PUBLIC VERSION
Bio-Rad challenges Dr. Hindson’s credibility, asking me to infer that he is lying about the
time frame in which the inventive idea in the asserted patents was conceived. Bio-Rad maintains
that the ’192 provisional application, submitted in August 2012, refers to gel beads, and that that
disclosure is inconsistent with Dr. Hindson’s testimony that conception of the claimed porous gel
bcads did not occur until the 	Id. at 45 (citing CX
0001C(HindsonWS) at Q/A 85). In context,however,Dr. Hindson’stestimonythat
is not
inconsistent with the ’l92 provisional. Dr. Hindson recalls
-CX-0001C 	(HindsonWS)atQ/A86. “Aroundthattimeorshortlythereafter,‘
Id. Bio-Rad has not pointed to any portion of the
’192 provisional patent application showing that the idea to use porous gel beads to deliver
barcodeswasc0nceived- 	beforetheeventsdescribedin detailbyDr.Hindson.28
Bio-Rad also points to a paper published in 2009 by inventors at Harvard, referred to as
the “Beating Poisson” article. RIB at 47. The significance of the “Beating Poisson” article is
that it discusses using microfluidics to deliver deformable gel beads to droplets that can be
The ’192 application states in pertinent part: “The microcapsules may also comprise a polymer
within the interior of the capsule. In some instances this polymer may be a porous polymer bead
that may entrap reagents or combinations of reagents. In other instances, this polymer may be a
bead that has been previously swollen to create a gel." RX-0299 at 110050.This provision refers
to a porous polymer bead that may entrap reagents but not to such a bead with barcodes or other
reagents releasably attached, as in the asserted patents. As Staff notes, Bio-Rad’s expert, Dr.
Metzker, does not opine that the asserted claims were conceived in August 2012. SRB at 28
(citing Tr. (Metzker) at 705:2-22.)
28
147

PUBLIC VERSION
functionalized with DNA. In’. See RX-0102. Dr. Hindson testifies in his directwitness
statement he came across the “Beating Poisson” paper only in late 2012, while at 10X. CX
0001C (Hindson WS) at Q/A 132. On cross-examination, he concedes that he had encountered
the paper in April 201 1, while still at QuantaLife, but he claims not to have read it at that time.
T1‘.at 16925-22, 172:8-18.
Bio-Rad maintains that Dr. Hindson’s denial is implausible given the importance of the
“Beating Poisson” article, pointing in particular to
RIB at 48; T1‘.(Hindson) at 169: 18-171123). Bio-Rad maintains that D1".Hinds0n’s recollection
also is undermined by
Id. (citing JX-0145C; Tr. (Saxonov)
at 793:8-794:5.
I ain not persuaded that this evidence imdemnnes Dr. Hindson’s credibility. I find it at
least plausible that Dr. Hindson did not remember seeing the “Beating Poisson” article or
. 	The	record	does	not	indicate	that	Dr.	Hindson	attached
particular	significance	tothearticle	atthattime,	orth 	indicated
the conception of the idea for the inventions claimed in the asserted patents.” If Dr. Hjndson did
at ilrs. HlH!'OD an! Saxonov
patents. On the contrary, it indicates that they had
s at that tune, because there is no mention of usinv
idea
not conceived the idea embodied in the patent ' V " i‘ ' i D
porous gel beads or releasabl attached oli yonucleotides. The record shows that Drs. Hindson _
148

PUBLIC VERSION
not realize in 2011 the significance of porous gel beads in the eventual development of the GEM
architecture	at10X,	itwould	be	easy	to	forget
— 	I concludethat Dr. Hindson’sallegedlack of credibilityis a slimreed for Bio-Radto
stand on.3°
In addition to challenging Dr. Hindson’s credibility, Bio-Rad points to evidence that
certain concepts disclosed in Drs. Hindson and Sax0nov’s earlier work prefigured the patented
invention. Presumably, Bio-Rad would contend (if Bio-Rad were attempting to establish
conception under the correct legal theory) that because certain discoveries made by Drs. Hindson
and Saxonov during the period of their employment included elements that also are found in the
asserted patents, the particular arrangement of those elements, set forth in the asserted patents,
musthaveoccurredto them. Forexample,Bio-Raddiscussestheconcepts
RIB at 40-44. Dr. Saxonov testifies,
however, that
CX-1829C
—. 	Ifthatinitselfweresufficient	totri erownership	ofinventions
patented after they left Bio-Rad, the contracts’ 	would be nullities.
3°I agree with Bio-Rad that Dr. Hindson on several occasions was not forthcoming in his
representations to Bio-Rad’s representative about the work that was being conducted at 10X, but
Dr. Hindson testifies credibly that he felt threatened by Bio-Rad; people are known to react
defensively when they perceive they are under attack, even when they have done nothing wrong.
See CX-1828C (Hindson RWS) at Q/A 55 (“It was very clear to me based on our conversations
What she was asking me was ‘are you using Quantalife droplets,’ essentially fishing for whether
we were competing with our old Quantalife products, and the answer to that was clearly ‘no,’
because we were using GEMs.”)
149

PUBLIC VERSION
(Saxonov RWS) at Q/A 22 (“We had not thought through these issues or come up with solutions
that would have made it work.”).
Bio-Rad also points out that certain number ranges of “cells, droplets, beads, and
barcodes” were disclosed in the ’059 patent, JX-0031, and that the numbers discussed in the
claims of the asserted patents, as Dr. Saxonov concedes, could be derived easily based on those
ranges. RRB at 55 (quoting RX-0412C (Saxonov Dep. Tr.) at l48:15-149: 12). These facts do
not demonstrate, even circumstantially, that the idea for the inventions claimed in the asserted
patents had already been conceived at the time the ’059 application Wasfiled.“
Bio-Rad also contends that the entries in notebooks offered into evidence by 10X to
support conception by the 10X inventors is “much more consistent with the theory that Dr.
Hindson and others founded 10X to commercialize the ideas they had at QuantaLife and Bio
Rad.” RRB at 57. Bio-Rad cites testimony from Dr. Sclnrall-Levin and Dr. Dear that allegedly
corroborates Bio-Rad’s argument that l0X’s lab notebooks do not evidence the conception of the
inventions claimed in the asserted patents. RIB at 130-131. Even assuming Bio-Rad’s argument
about the nature of l0X’s notebooks is correct (and this is disputed), it would not necessarily
3110X responds persuasively to each of the many circumstances alleged by Bio-Rad concerning
the work done by Drs. Hindson and Saxonov during their period of employment, maintaining
that their Workwas conducted in a variety of technological contexts distinct from the particular
GEM architecture described in the asserted patents. See CIB at 139-151. It is not necessary or
useful to try to resolve every one of the parties’ disputes. These disputes are largely beside the
point because, as discussed above, they are not probative on the issue of when the particular
arrangement that constitutes the inventive concept of the asserted patents actually was conceived
by Drs. Hindson and Saxonov.
150

PUBLIC VERSION
lead to the conclusion that the claimed inventions were conceived at QuantaLife or Bio-Rad.
Several months elapsed between the time Drs. Hindson and Saxonov left Bio-Rad and the
founding of 10X. The actual idea could have been conceived at any time after Dr. Hindson and
Saxonov left Bio-Rad’s employ; the record does not indicate more likely than not that conception
of the inventive idea in the asserted patents occurred before their departure.”
In sum, the evidence before me is insufficient to permit the conclusion that, more likely
than not, the work Drs. Hindson and Saxonov did at QuantaLife and Bio-Rad led them to
conceive the idea described in the 10X patents while they were still under contract. Compare
Agilent Techs., Inc. v. Kirkland, C.A. N0. 3512-VCS, 2010 VVL610725 at *15 (Del. Ch. Ct. Feb.
18, 2010) (finding employees conceived of technology at issue “based upon insights they formed
and recorded at Agilent from observing the empirical results of experiments they conducted at
Agilent”). Bio-Rad presents no pertinent records showing insights or experiments that support
the argument that the inventive idea in the asserted patents was conceived before these
employees left Bio-Rad. Given that Bio-Rad bears the burden of proof on this issue, Bio-Rad
has failed to establish 0WI1€fS1'11p	of the asserted patents. See CX-1827C (Dear RWS) at Q/A
1129 (“Nothing [Dr. Metzker] cites shows whether there was a partial experiment involving
some but not all of these elements. Nothing shows how the experiments would work. Nothing
he cites shows any experimental observation. Dr. Metzkcr does not rely upon anything in his
3210X’s interrogatory responses detail with some specificity the timeline regarding development
of the patented technology. See RX-0643C. In these res onses, 10X seeks to show that the
claims	ofthepatents	were	conceived	. 	Id.at63-65.	SeealsoCX
1827C (Dear RWS) at Q/A 1269-1279. Dr. Metzker, Bio-Rad’s witness, reviewed 10X’s
timeline regarding conception and declined to offer an opinion disagreeing with 10X’s alleged
- conceptiondates. Tr. (Metzker)at 704:7-705:22.
151

PUBLIC VERSION
testimony offering a reasonable basis to conclude that any such experiments occurred nor,
importantly, what happened in them.”).
C. Other Affirmative Defenses
Bio-Rad raises several additional affinnative defenses. None has any merit.
Bio-Rad’s equitable estoppel defense has two prongs. Bio-Rad contends that the
employment	agreements	signed	byDrs.Hindson	andSaxonov—
RIB at 131
First, the agreements cited by Bio-Rad give no such “explicit contractual assurances.” Second,
the evidence does not show that the inventions in the asserted 10X patents were made at
QuantaLife and/or Bio-Rad.
Bio-Rad also contends that 10X is equitably estopped from bringing this action because
Bio-Rad had no notice of infringement until this litigation was instituted, and Bio-Rad allegedly
relied on l0X’s “silence and inaction” in developing its product line “with the reasonable belief
that it would not be subject to an infringement action.” Id. at 133. Bio-Rad points to no
evidence to support the contention that it relied on any lack of notice of infringement from l0X.
See id. Bio-Rad’s equitable estoppel defense fails for lack of proof.
Bio-Rad also claims to have an express license to practice each of the asserted patents,
based	on	D»	Hm	and —
Id. at 133. Since Bio-Rad has not shown that the invention
embodied in the 10X patents was made during the course of the employment agreement, this
defense also fails.
152

PUBLIC VERSION
Bio-Rad claims an implied license, Wavier, and acquiescence based on ‘“circumstances
[that] plainly indicate that the grant of a license should be inferred. ”’ Id. (quoting Bandag, Inc.
v. Al B0lser’s Tire Stores, Inc., 750 F.2d 903, 925 (Fed. Cir. 1984)). This defense is based on the
same contractual provisions asserted by Bio-Rad “Withrespect to Bio-Rad’s affirmative defenses
of acquiescence and equitable estoppel,” and is rejected for the same reasons stated above. See
Id. at 133. Bio-Rad has not demonstrated that Drs. Hindson and Saxonov were under any
obligation to Bio-Rad with respect to the asserted l0X patents.
The “shop rights” defense similarly is predicated on the assertion that Drs. Hindson and
ac:
Saxonov conceived’ of the claimed inventions of the Asserted Patents while employed by and
under contract at QuantaLife and/or Bio-Rad—or at the very least significantly and extensively
contributed to the conception, development or making of the claimed inventions of the Asserted
Patents —and did so using their employer’s resources and personnel.” Id. at 134-135.33 As
discussed above, the evidence does not show that Drs. Hindson and Saxonov conceived of the
claimed inventions while under contract to QuantaLife and/or Bio-Rad, and the contracts that
detemiine Bio-Rad’s rights do not cover “contributions” made by employees during the course
of their employment to inventions conceived afier the employment ends. Accordingly, the shop
rights doctrine affords Bio-Rad no defense.
33“The doctrine of shop rights has its origins in equity. A shop right is an empl0yer’s
nonexclusive right to use an employee’s patented process or invention that Wasdeveloped during
the employee’s hours of employment. The right is based on the employer’s presumed
contribution to the invention through materials, time, and equipment.” California Eastern Labs.,
Inc. v. Gould, 896 F.2d 400, 402 (9th Cir. l99O) (citing U.S. v. Dubilier Condenser C0rp., 239
U.S. 178 (1933)).
153

PUBLIC VERSION
IX. CONCLUSIONS OF LAW
Based on the foregoing, and the record as a whole, it is my final initial detennination that
there is a violation of section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. § 1337, in the
importation into the United States, the sale for importation, and/or the sale within the United
States after importation of certain microfluidic systems and components thereof and products
containing same by reason of infringement of certain claims of U.S. Patent No. 9,689,024 (“the
’024 Patent”), U.S. Patent No. 9,695,468 (“the ’468 Patent”), and U.S. Patent No. 9,856,530
(“the ’530 Patent”). There is no violation with respect to U.S. Patent No. 9,644,204 (“the ’204
Patent”).
This detennination is based on the following conclusions of law:
1. The Commission has subject matter jurisdiction over this investigation, in
personam jurisdiction over Bio-Rad, and in rem jurisdiction over the accused
microfluidic systems and components thereof and products containing same.
2. There has been an importation into the United States, sale for importation, or sale
within the United States after importation of the accused microfluidic systems and
components thereof and products containing same by Bio-Rad.
3. Bio-Rad has indirectly infringed claims 1, 5, 17, 19, and 22 of the ’024 patent
with respect to its ddSEQ v1 products.
4. Bio-Rad has indirectly infringed claims 1, 6, 7, 9, and 21 of the ’468 patent with
respect to its ddSEQ v1 products.
5. 10X has not shown that any claims of the ’204 patent are infringed by Bio-Rad.
6. Bio-Rad has indirectly infringed claims 1, 4, 11, 14, 19, 26, and 28 of the ’530
patent with respect to its ddSEQ v1 products.
7. No claims of the ’024 patent have been shown to be invalid.
8. No claims of the ’468 patent have been shown to be invalid.
9. No claims of the ’204 patent have been shown to be invalid.
10. No claims of the ’53Opatent have been shown to be invalid. 	‘
ll. The domestic industry requirement is satisfied with respect to claims of the ’024
154

PUBLIC VERSION
patent.
12. The domestic industry requirement is satisfied with respect to claims of the ’468
patent.
13. The domestic industry requirement is satisfied with respect to claims of the ’204
patent.
14. The domestic industry requirement is satisfied with respect to claims of the ’530
patent.
15. Bio-Rad has failed to carry its burden with respect to its allegations of improper
inventorship, ownership, and other affirmative defenses. 	i
I hereby certify the record in this investigation to the Commission with my final initial
determination. Pursuant to Commission Rule 210.38, the record further comprises the
Complaint and exhibits thereto filed with the Secretary, the Markman order, and"the exhibits
attached to the parties’ summary determination motions and the responses thereto. 19 C.F.R.
§ 210.38(a).
Pursuant to Commission Rule 2l0.42(c), this initial detennination shall become the
determination of the Commission 45 days after the service thereof, unless a party files a petition
for review pursuant to Commission Rule 210.43(a), the Commission orders its own review
pursuant to Commission Rule 210.44, or the Commission changes the effective date of the initial
determination. 19 C.F.R. § 2l0.42(h)(6).
This initial determination is being issued with a confidential designation pursuant to
Commission Rule 210.5 and the protective order in this investigation. Within ten (10) days of
the date of this initial determination, each party shall submit to the Administrative Law Judge a
statement as to whether or not it seeks to have any portion of this document deleted from the
public version. See 19 C.F.R. § 210.5(f). A party seeking to have a portion of this document
deleted from the public version thereof must attach to its submission a copy of the document
with red brackets indicating the portion(s) asserted to contain confidential business
155

PUBLIC VERSION
infonnation.“ The parties’ submissions under this subsection shall not be filed with the
Commission Secretary but shall be submitted by paper copy to the Administrative Law Judge
and by c-mail to the Administrative Law Judge’s attorney advisor.
SO ORDERED.
$66 	l47\/A/'
Dee Lord
Administrative Law Judge
34To avoid depriving the public of the basis for understanding the result and reasoning
underlying the decision, redactions should be limited. Parties who submit excessive redactions
may be required to provide an additional written statement, supported by declarations from
individuals with personal knowledge, justifying each proposed redaction and specifically
explaining why the information sought to be redacted meets the definition for confidential
business information set forth in Commission Rule 20l.6(a). 19 C.F.R. § 201.6(a).
156

CERTAIN MICROFLUIDIC SYSTEMS AND 	Inv. N0. 337-TA-1100
COMPONENTS THEREOF AND PRODUCTS
CONTAINING SAME
PUBLIC CERTIFICATE OF SERVICE
I, Lisa R. Barton, hereby certify that the attached INITIAL DETERMINATION has
been served by hand upon the Commission Investigative Attorney, Monica Bhattacharyya,
Esq., and the following parties as indicated, on August 12, 2019.
Lisa R. Barton, Secretary
U.S. International Trade Connnission
500 E Street, SW, Room 112
Washington, DC 20436
On Behalf of Complainants 10X Genomics, Inc.:
Paul T. Ehrlich, Esq. 	III ia Hand Delivery
TENSEGRITY LAW GROUP LLP 	%/ia ExpressDefivfiry
555 TWIJI DOIphi1'l DIX, SLl1'[€650 U Via First Class
Redwood Shores, CA 94061 	U other
On Behalf of Respondents Bio-Rad Laboratories. Inc.:
S. Alex Lasher, Esq. 	_ 	3)/ia Hand Delivery	QUINN EMANUEL URQUHART & SULLIVAN, LLP 	Via ExprfissDelivery
I300 I StI'6€INW, Sllillfi900 	|:| Via First Class
Washington, DC 20005 	U other

PUBLIC VERSION
UNITED STATES INTERNATIONAL TRADE COMMISSION
Washington, D.C.
In the Matter of
CERTAIN MICROFLUIDIC SYSTEMS
AND COMPONENTS THEREOF AND
PRODUCTS CONTAINING SAME
Inv. No. 337-TA-1100
RECOMMENDED DETERMINATION ON REMEDY AND BONDING
(July 25, 2019)
Pursuant to Commission Rule 210.42(a)(1)(ii), this is the Administrative Law Judge's
recommended determination on remedy and bonding. 19 C.F.R. § 210.42(a)(1)(ii).1
A. Limited Exclusion Order
Complainant 10X Genomics, Inc.("10X")seeks a limited exclusion order("LEO")for
the infringing products. CIB at 243-44. The Commission Investigative Staff("Staff') agrees
with 10X that a limited exclusion should issue, and Respondent Bio-Rad Laboratories, Inc.
("Bio-Rad") does not dispute that a limited exclusion order should issue upon a finding of
violation. SIB at 109; RPHB at 367. Pursuant to 19 U.S.C. §1337(d)(1),"If the Commission
determines, as a result of an investigation under this section, that there is a violation of this
section, it shall direct that the articles concerned... be excluded from entry into the United
States," unless the Commission determines that such exclusion would be contrary to the public
interest.2 Accordingly, I recommend that a limited exclusion order issue in this investigation.
'The final initial determination in this investigation issued on July 12, 2019.
2 Consideration ofthe public interest factors articulated in section 337(d)(1) has not been
delegated to the All in this investigation. See Notice of Investigation (Feb. 12, 2018).

PUBLIC VERSION
Bio-Rad suggests that any remedial order should include a certification provision, but
there is no evidence in the record that a certification provision will be necessary to distinguish
between infringing and non-infringing products. See CRB at 96-97.
B. Cease and Desist Order
10X seeks a cease and desist order("CDO")pursuant to 19 U.S.C. §1337(0(1). CIB at
244-45. The Commission has issued a CDO where a respondent "maintains a commercially
significant inventory and/or has significant domestic operations that could undercut the remedy
provided by an exclusion order." Certain Road Construction Machines and Components
Thereof, Inv. No. 337-TA-1088, Comm'n Op. at 51-53(Jun. 27,2019).
10X relies on a review of Bio-Rad's inventory conducted by Dr. Thomas Vander Veen.
CX-0005C (Vander Veen DWS)at Q/A 29-39. In particular, Dr. Vander Veen identifies II
ddSEQ Single-Cell Isolators in Bio-Rad's California inventory in the first quarter of 2018. Id. at
Q/A 29-31; CDX-0007.0004 (citing CX-0067C). Dr. Vander Veen offers his opinion that this
amount is significant by comparing this inventory to Bio-Rad's domestic sales of ddSEQ Single-
Cell Isolators over a full year from 2017 to 2018. Id. at Q/A 32-35; CDX-0007.0005. Bio-Rad
only sold these products in that time, and Dr. Vander Veen thus considers the products
in inventory to be a commercially significant amount. Id. at Q/A 30. Dr. Vander Veen further
identifies ddSEQ-M cartridges in Bio-Rad's California inventory, including ddSEQ-M
cartridges and ddSEQ-M "test" cartridges. Id. at Q/A 36-37. Dr. Vander Veen identifies
yearly sales of ddSEQ-M cartridges, offering his opinion that the number of cartridges in
inventory is commercially significant because it exceeds Bio-Rad's yearly sales. Id. at Q/A 38.
Bio-Rad argues that Dr. Vander Veen improperly counted the "test" cartridges that are
manufactured domestically, RIB at 228-29, but Dr. Vander Veen explains that excluding the
2

PUBLIC VERSION
"test" cartridges would not change his conclusion regarding the significance ofthe inventory.
CX-0005C at Q/A 39.
I agree with 10X and Dr. Vander Veen that regardless of whether the "test" cartridges are
counted, Bio-Rad's inventory of ddSEQ products is commercially significant. See CRB at 97;
see also SIB at 110 (agreeing that inventory is significant). Accordingly, I recommend that a
cease and desist order issue with respect to products that have been found to infringe.
C. Bond
Commission Rule 210.50(a)(3)specifies that the amount ofa bond must be "sufficient to
protect the complainant from any injury." 19 C.F.R. § 210.50(a)(3); see 19 U.S.C. § 1337(j).
("[A]rticles directed to be excluded from entry under subsection(d)of this section or subject to a
cease and desist order under subsection(0 of this section shall, until such determination becomes
final, be entitled to entry under bond prescribed by the Secretary in an amount determined by the
Commission to be sufficient to protect the complainant from any injury."). The Commission has
set bond amounts based on the price difference between the infringing imports and the domestic
industry products or on a reasonable royalty the respondent would otherwise pay to the
complainant. See Certain Inject Ink Supplies And Components Thereof, Inv. No. 337-TA-691,
Comm'n Op. at 15-18(Nov. 1, 2011). Where the calculation ofa price differential is impractical
and there is insufficient evidence in the record to determine a reasonable royalty, the
Commission has set a bond in the amount of 100% ofthe entered value ofthe infringing
products. Certain Marine Sonar Imaging Devices, Including Downscan and Sidescan Devices,
Products Containing the Same, and Components Thereof, Inv. No. 337-TA-921, Comm'n Op. at
83-89(Jan. 6, 2016). The complainant bears the burden of establishing the need for a bond.
3

PUBLIC VERSION
Certain Rubber Antidegradants, Components Thereof and Products Containing Same,Inv. No.
337-TA-533, Comm'n Op. at 40(July 21, 2006).
As an initial matter, Bio-Rad disputes whether 10X has carried its burden to show injury
based on the importation of accused products. RIB at 231-34. 10X relies on Dr. Vander Veen's
analysis ofthe competition between Bio-Rad and 10X, where he finds evidence
" CX-0005C at Q/A 41. In particular,
Dr. Vander Veen cites internal presentations and communications at 10X and Bio-Rad
Id. at Q/A 42-45 (citing ix-
0026C, CX-1708C, RX-0557C). Bio-Rad cites certain contrary evidence, including Dr. Vander
Veen's testimony that the Bio-Rad and 10X products are "imperfectly substitutable" and the
absence of"any study or data" that shows"how Bio-Rad's pricing below all ofthe affects 10X's
profitability on each." Id. at Q/A 47. In addition, when asked at her deposition whether Bio-Rad
took market share from 10X in single cell genomics, 1OX's vice-president offinance, Jamie
Osborn, testified: " J)(-044C at 134:8-10. Staff submits
that a bond is appropriate in an amount that will protect 10X from injury due to lost instrument
sales. SIB at 110-14. Based on Dr. Vander Veen's supporting analysis, I agree with 10X that
there is sufficient evidence of injury to support the imposition of a bond.
The parties also dispute whether and how a bond amount can be computed for the
infringing products. 10X contends that a 100% bond is appropriate because the prices for
components ofthe Bio-Rad's ddSEQ system cannot be meaningfully compared with the prices
for components of 1OX's domestic industry products. See CX-0005C(Vander Veen DWS)at
Q/A 47. Bio-Rad's expert, Ryan Herrington, agrees that a price comparison ofthe parties'
4

PUBLIC VERSION
consumable products is not practicable, RX-0666C at Q/A 33-36, but Bio-Rad identifies two
other comparisons based on the prices of the parties' single cell instruments and the "price per
cell" metric. RIB at 234-238. With respect to the single cell instruments, Mr. Herrington
compares the average selling prices of Bio-Rad's ddSEQ Single-Cell Isolator and 1OX's
Chromium Single Cell Controller, finding aIM price differential. RX-0666C at Q/A 33-36.
Mr. Herrington also compares the cost of preparing cells for sequencing using a "price per cell"
metric, Id.
at Q/A 44-45. 10X identifies certain discrepancies in Mr. Herrington's analysis, CIB at 245-49,
but I agree with Bio-Rad that his testimony is sufficient to rebut 10X's contention that there can
be no meaningful comparison between the parties' products.
Mr. Herrington's comparison between the average selling prices ofthe parties' single cell
instruments is not perfect, but absent any other price comparison offered by 10X,the M price
differential is the most reliable evidence in the record for an appropriate bond amount. The
Commission has previously imposed bond amounts based on comparisons of average selling
prices. See, e.g., Certain Robotic Vacuum Cleaning Devices and Components ThereofSuch As
Spare Parts, Inv. No. 337-TA-1057, Comm'n Op. at 68-72(Feb. 1, 2019). Accordingly, I
recommend that a bond of of entered value be imposed on infringing products imported
during the Presidential review period.
This determination is being issued with a confidential designation, and pursuant to
Ground Rule 1.10, each party shall submit to the Administrative Law Judge a statement as to
whether or not it seeks to have any portion of this order deleted from the public version within
seven (7) days. See 19 C.F.R. § 210.5(f). A party seeking to have a portion ofthe order deleted
from the public version thereof must attach to its submission a copy of the order with red
5

PUBLIC VERSION
brackets indicating the portion(s) asserted to contain confidential business information.3 The
parties' submissions under this subsection need not be filed with the Commission Secretary but
shall be submitted by paper copy to the Administrative Law Judge and by e-mail to the
Administrative Law Judge's attorney advisor.
SO ORDERED.
Tce- trorl-aLDee Lord
Administrative Law Judge
3 Redactions should be limited to avoid depriving the public ofthe basis for understanding the
result and reasoning underlying the decision. Parties who submit excessive redactions may be
required to provide an additional written statement, supported by declarations from individuals
with personal knowledge,justifying each proposed redaction and specifically explaining why the
information sought to be redacted meets the definition for confidential business information set
forth in Commission Rule 201.6(a). 19 C.F.R. § 201.6(a).
6

CERTAIN MICROFLUIDIC SYSTEMS AND
COMPONENTS THEREOF AND PRODUCTS
CONTAINING SAME
PUBLIC CERTIFICATE OF SERVICE
Inv. No.337-TA-1100
I, Lisa R. Barton, hereby certify that the attached RECOMMENDED
DETERMINATION has been served by hand upon the Commission Investigative Attorney,
Monica Bhattacharyya, Esq., and the following parties as indicated, on August 12,2019.
Lisa R. Barton, Secretary
U.S. International Trade Commission
500 E Street, SW,Room 112
Washington, DC 20436
On Behalf of Complainants 10X Genomics,Inc.:
Paul T. Ehrlich, Esq.
TENSEGRITY LAW GROUP LLP
555 Twin Dolphin Dr., Suite 650
Redwood Shores, CA 94061
On Behalf of Respondents Bio-Rad Laboratories,Inc.:
S. Alex Lasher, Esq.
QUINN EMANUEL URQUHART & SULLIVAN,LLP
1300 I Street NW,Suite 900
Washington, DC 20005
O Via Hand Delivery
ECl/Iia Express Delivery
O Via First Class Mail
O Other:
I(ia Hand Delivery
Via Express Delivery
O Via First Class Mail
O Other:

I ~.
2*
UNITED STATES INTERNATIONAL TRADE COMMISSION
Washington, D.C.
In the Matter of
CERTAIN MICROFLUIDIC SYSTEMS 	Inv. N0. 337-TA-1100
AND COMPONENTS THEREOF AND
PRODUCTS CONTAINING SAME
ORDER NO. 22: 111/IRKIMANORDER
(October 31, 2018)
A Markman hearing was held in this investigation on July 25, 2018. Counsel for
Complainant 10X Genomics, Inc. (“IOX”), counsel for Respondent Bio-Rad.Laboratories, Inc.
(“Bio-Rad”), and counsel for the Officc of Unfair Import Investigations (“Staff”) appeared at the
hearing. In advance of the hearing, 10X, Bio-Rad, and Staff filed initial and rebuttal Markman
briefs.‘
1 lOX’s initial and rebuttal briefs are referenced herein as “CIB” and “CRB,” respectively; Bio
Rad’s initial and rebuttal briefs are referenced herein as “RIB” and “RRB,” respectively; Staff‘s
initial and rebuttal briefs are referenced herein as “SIB” and “SRB,” respectively.

Table 0f Contents
I. Procedural History ............................................................................................................... .. 1
II. Level of Ordinary Skill in the Art ........................................................................................ .. 2
III. Legal Standards.................................................................................................................... .. 3
IV. The Asserted Patents .......... 	6
A. The ’024 and ’468 Patents ............................................................................................. .. 6
B. The ’204 Patent ............................................................................................................ .. 11
C. The ’530 Patent ............................................................................................................ .. 14
V. Claim Construction ............................................................................................................ .. 17
A. “1,000,000 oligonucleotides comprising barcode sequences” ..................................... .. 17
B. “releasably attached” .............................................. ..................................................... .. 22
C. “reversibly immobilized” ............................................................................................. .. 30
D. Amplification terms .............................................................. 	31
E. “providing”/“said at least 1,000 droplets”/“a plurality of cells”.................................. .. 45
VI. Conclusion ........ ............................................................................................................... .. 51
ii

II 	,
I. PROCEDURAL HISTORY
This investigation was instituted to determine whether there is a violation of section 337
of the Tariff Act of 1930, as amended, in the importation into the United States, the sale for
importation, or the sale within the United States after importation of certain microfluidic systems
and components thereof and products containing same by reason of infringement of U.S. Patent
No. 9,644,204 (“the ’204 patent”); U.S. Patent No. (“the ’024 patent”); U.S. Patent No.
9,695,468 (“the ’468 patent”); and U.S. Patent No. 9,856,530 (“the ’530 patent”). Notice of
Investigation at 2 (Feb. 14, 2018); 83 Fed. Reg. 7491-92 (Feb. 21, 2018). 10X asseits that Bio
Rad infringes the following claims: claims 1-4, 6-9, 17, 20, 21, 23, 25, 27, 29, 31, and 33 ofthe
’204 patent; claims 1, 2, 5, 8, 10, 11, 13, 15-17, 19, 21, and 22 ofthe ’024 patent; claims 1-4, 6
9, 11, 12,21, and 22 ofthe ’468 patent; and claims 1-6, 8-11, 14-20, and 24-30 ofthe ’53O
patent. Notice of Investigation at 2; 83 Fed. Reg. at 7492.
The parties have agreed on constructions for the following terms:
1

In 	I
Term 	Patent 	Agreed-Upon Constructions
“barcode” 	’204 patent, claims 3
6, 27, 29, 31
’024 patent, claim l
’468 patent, claim 1
’53Opatent, claims 1,
4,11,14,17, 24, 25,
26, 28, 29, 30
, “label that may be attached to an
analyte to convey identifying
infonnation about the analyte”
204 patent, claims l,
23, 25
“wherein said capsules are
[capsule is] configured to
release their [its] contents
into said droplets [droplet]
upon the application of a .
stimulus”
plain and ordinary meaning; no
construction required
“applying a stimulus to said ’024 patent, claim l
porous gel”
bead to release said
oligonucleotide molecules
from said porous gel bead
into said droplet”
plain and ordinary meaning; no
construction required
’530 patent, claims 1,
28, 29, 30
“wherein said barcode
molecules become detached
from said gel bead”
plain and ordinary meaning and
above agreed-to construction for
“barcode;” no construction required
CIB, App. B.
II. LEVEL OF ORDINARY SKILL IN THE ART
Bio-Rad contends that the level of ordinary skill in the art for the asserted patents is either a
Ph.D. “in molecular biology, molecular genetics, chemistry, engineering, or equivalent
disciplines with two years of experience or [B.S.] in such fields with five years of experience,
with such experience including library preparation methods, microfluidic technology, and/or
bead attachment chemistries.” RIB at 5. Staff does not address the relevant level of ordinary
skill in the art. Although 10X does not address the relevant level of ordinary skill in the art in its
briefs, its expert does so in a declaration submitted in support of lOX’s initial brief (“Butte Initial
Declaration”). In that declaration, Dr. Atul J. Butte opines that a person of ordinary skill in the
2

I
art “would have a master’s degree in bio-engineering, genetics, biochemistry or a related
discipline, with two to three years of academic, research, or industry experience in the field of
genomic sequencing solutions.” Butte Initial Declaration at fl 22. In his declaration submitted in
support of 1OX’srebuttal brief (“Butte Rebuttal Declaration”), Dr. Butte states that the
differcnces between the parties’ proposed definitions of the level of ordinary skill in the art are
immaterial to the claim construction disputes. Butte Rebuttal Declaration at 1[7.
Accordingly, for the purposes of this order, 1 adopt Bio-Rad’s proposed definition of the
level of ordinary skill.
III. LEGAL STANDARDS
“The construction of claims is simply a way of elaborating the normally tersc claim
language[] in order to understand and explain, but not to change, the scope of thc claims.”
Embrex, Inc. v. Serv. Eng ’g Corp, 216 F.3d 1343, 1347 (Fed. Cir. 2000) (alterations in original)
(quoting Scripps Clinic v. Genentech, Ina, 927 F.2d 1565, 1580 (Fed. Cir. 1991)). “[O]nly thosc
[claim] terms need be construed that are in controversy, and only to the extent necessary to
resolve the controversy.” Vivid Techs., Inc. v. Am. Sci. & Eng ’g, Ina, 200 F.3d 795, 803 (Fed.
Cir. 1999).
Claim construction focuses mainly on the intrinsic evidence, which consists of the claims
themselves, the specification, and the prosecution history. See generally Phillips v. AWH C0rp.,
415 F.3d 1303, 1313-17 (Fed. Cir. 2005) (en banc). The words ofa claim “‘are generally given
their ordinary and customary meaning,”’ which is “the meaning that the tcrm would have to a
person of ordinary skill in art” as of the date that the patent application was filed. Id. at 1312-13
(quoting Vilronics Corp. v. Conceplronic, Ina, 90 F.3d 1576, 1582 (Fed. Cir. 1996)) (citations
omitted). A person of ordinary skill in the art “is deemed to read the claim term not only in the
context of the particular claim in which the disputed term appears, but in the context of the entire
3

' 	r
patent, including the specification.” Id. In some cases, “the ordinary meaning of claim language
as understood by a person of skill in the art may be readily apparent even to layjudges.” Id. at
1314. Often, however, “determining the ordinary and customary meaning of the claim requires
examination of terms that have a particular meaning in a field of art.” Id. “[T]he court looks to
‘those sources available to the public that show what a person of skill in the art would have
understood disputed claim language to mean.” Id. (quoting Innova/Pure Water, Inc. v. Safari
Water Filtration Sys., 381 F.3d 1111, 1116 (Fed. Cir. 2004)). Those sources include “the words
of the claims themselves, the remainder of the specification, the prosecution history, and
extrinsic evidence concerning relevant scientific principles, the meaning of technical terms, and
the state of the art.” Id.
“It is a ‘bedrock principle’ ofpatent law that ‘the claims of a patent define the invention
to which the patentee is entitled the right to exclude?” Id. at 1312 (quoting Innova, 381 F.3d. at
1115)). “Quite apart from the written description and the prosecution history, the claims
themselves provide substantial guidance as to the meaning of particular claim tenns.” Id. at
1314. For example, “the context in which a term is used in the asserted claim can be highly
instructive,” and “[o]ther claims of the patent in question, both asserted and unasserted, can also
be valuable sources of enlightenment as to the meaning of a claim term.” Id.
“[T]he specification ‘is always highly relevant to the claim construction analysis.
Usually, it is dispositive; it is the single best guide to the meaning of a disputed term?” Id. at
1315 (quoting Virronics, 90 F.3d at 1582). “The longstanding difficulty is the contrasting nature
of the axioms that (a) a claim must be read in view of the specification and (b) a court may not
read a limitation into a claim from the specification.” Innova, 381 F.3d at 1117.
' 1n addition to the claims and the specification, the prosecution history should be
4

' 	1
examined if in evidence. “The prosecution history . . . consists of the complete record of the
proceedings before the PTO and includes the prior art cited during the examination of the patent.
Like the specification, the prosecution history provides evidence of how the PTO and the
inventor understood the patent.” Phillips, 415 F.3d at 1317. “[T]he prosecution history can
often infonn the meaning of the claim language by demonstrating how the inventor understood
the invention and whether the inventor limited the invention in the course of prosecution, making
the claim scope narrower than it would otherwise be.” Id
If the intrinsic evidence does not establish the meaning of a claim, then extrinsic evidence
may be considered. Extrinsic evidence “consists of all evidence externalto the patent and the
prosecution history, including inventor and expert testimony, dictionaries, and learned treatises.”
Id. at 1317. Extrinsic evidence is generally viewed “as less reliable than the patent and its
prosecution history in determining how to read claim terms.” Id. at 1318. “The cotut may
receive extrinsic evidence to educate itself about the invention and the relevant technology, but
the court may not use extrinsic evidence to arrive at a claim construction that is clearly at odds
with the construction mandated by the intrinsic evidence.” Elkay Mfg. C0. v. Ebco Mfg. C0., 192
F.3d 973, 977 (Fed. Cir. 1999). 	. '
Although “[c]laim terms are generally given their plain and ordinary meanings to one of
skill in the art when read in the context of the specification and prosecution history,” there are
two instances in which a court will depart from the plain and ordinary meaning. Hill-Rom
Service, Inc. v. Stryker C0rp., 755 F.3d 1367, 1371 (Fed. Cir. 2014). The first is when a patentee
acts as its own lexicographer. Id. “To act as its own lexicographer, a patentee must ‘clearly set
forth a definition of the disputed claim term.”’ Thorner v. Sony Comput. Entm ’z‘Am.,669 F.3d
1362, 1365 (Fed. Cir. 2012) (quoting CCS Fitness, Inc. v. Brunswick Corp, 288 F.3d 1359, 1366
5

(Fed. Cir. 2002)). The second is when the patentee disavows the full scope of the claim term.
Id. Disavowal can be effectuated by language in the specification or the prosecution history. See
Phillips, 415 F.3d at .1316-17. “In either case, the standard for disavowal is exacting, requiring
clear and unequivocal evidence that the claimed invention includes or does not include a
particular feature.” Poly-America, LP. v. APIIndus., Ina, 839 F.3d 1131, 1136 (Fed. Cir.
2017).
IV. THE ASSERTED PATENTS
A. The ’024 and ’468 Patents
Through application 13/966,150 (“the ’15Oapplication”), which was filed on August 13,
2013, the ’468 and “O24patents claim priority to six provisional applications filed between
August l4, 2012 and July 10, 2013. ’O24patent, cover; ’468 patent, cover.2 The ’024 patent was
filed as a divisional of the ’150 application and the ’468 patent was filed as a continuation of the
’l50 application. ’024 patent, cover; ’468 patent, cover. Because of their ancestry, the ’O24and
’468 patents share a common specification. The patents identify Benjamin Hindson, Serge
Saxonov, and Michael Schnall-Levin as inventors. ’024 patent, cover; ’468 patent, cover.
1. The Specification
Analysis of biological materials, such as sequencing nucleic acids, requires proper
sample preparation. ’O24patent, col. 1:28-30.) “Sample preparation may . . ‘.involve
fragmenting molecules, isolating molecules, and/or attaching unique identifiers to particular
fragments of molecules . . . .” Id. at col. 1:34-37. A microwell partition capsule array can be
used in sample preparation operations. Id., col. 4:28-29. Such a device consists of “an assembly
of partitions (e.g. , microwells, droplets) that are loaded With microcapsules.” 1d., col. 4:24-27.
2 The ’024 and ’468 patents are attached to l0X’s initial brief as Exhibits 1 and 3, respectively.
6

' 	1
The array divides the sample “such that a portion of the sample is present in each partition.” Id,
col. 4:29-32. Each partition “may include one or more capsules that contain one or more
reagents (e.g., enzymes, unique identifiers (e.g., bar codes), antibodies, etc.).” Id., col. 4:41-44.
A “trigger” can be used to cause the microcapsules to release the reagents into the partitions, so
that the reagents come into contact with the subdivided sample. Id., col. 4:44-48.
Microcapsules are used (1) to “provide for the controlled and/or timed release of reagents
for sample preparation of an analyte,” (2) to control the release and transport of reagents, (3) to
deliver reagents in discrete and defmable amounts, (4) to “prevent premature mixing of reagents
with the sample,” and (5) to ease handling of and limit contact with reagents. Id., col. 6:62-col.
7:13. Microcapsules can be formed using gel beads. ld., col. 9:28-35. Analytes and/or reagents
can “be coupled/ immobilized to the interior surface of a gel bead (e.g., the interior accessible via
diffusion of an oligonucleotide barcode and/or materials used to generate an oligonucleotide
barcode) and/or the outer surface of a gel bead.” Id., col. 9:36-42. Release of the analytes or
reagents from the microcapsule may be the result of applying a trigger. Id., col. 22:4-6. Various
types of stimuli can be used as a trigger, including chemical stimuli, enzymes, light, heat, and
magnetic fields. Id, col. 19:43-48, col. 22:4-21.
One sample preparation reagent that can be delivered by a microcapsule is a “molecular
barc-ode.” 1d., col. 12:9-14. For most applications, such as in the case of the nucleic acid
sequencing, analyzing multiple samples simultaneously “substantially decreases the cost of
analysis as well as increases through-put of the process.” Id, col. 12:33-36. To analyze multiple
samples, different samples are pooled together. ]d., col. 12:36-39. Before the samples are
pooled together, the analytes from each sample are tagged Witha unique identifier, known in the
art as a “molecular barcode,” so that analytes from different samples can be identified and
' 7

' 	I
tracked in the pooled sample. Id., col. 12:11-13, col. 12:36-39. Molecular barcodes “may
comprise a variety of different forms such as oligonueleotide bar codes, antibodies or antibody
fragments, fluorophores, nanoparticles, and other elements or combinations thereof.” Id., col.
12:14-17. In nucleic acid sequencing, oligonueleotide barcodes are particularly useful. Id., col.
12:43-44.
2. Asserted Claims
10X is asserting claims 1, 2, 5, 8, 10,l1,13, 15-17,19, 21, and 22 ofthe ’O24patent and
claims 1-4, 6-9, ll, 12, 21, and 22 ofthe ’468 patent.
a. The Asserted Claims of the ’O24Patent
Of the asserted claims of the ’O24patent, claim 1 is independent and the remaining
claims depend directly or indirectly from claim 1. Claim l recites:
A method for sample preparation, comprising:
a) providing a droplet comprising a porous gel bead and a target nucleic
acid analyte, wherein said porous gel bead comprises at least 1,000,000
oligonueleotide molecules comprising barcode sequences, wherein said
oligonueleotide molecules are releasably attached to said porous gel
bead, wherein said barcode sequences are the same sequence for said
oligonueleotide molecules;
b) applying a stimulus to said porous gel bead to release said
oligonueleotide molecules from said porous gel bead into said droplet,
wherein upon release irom said porous gel bead, a given oligonueleotide
molecule from said oligonueleotide molecules attaches to said target
nucleic acid analyte; and 	'
c) subjecting said given oligonueleotide molecule attached to said target
nucleic acid analyte to nucleic acid amplification to yield a barcoded
target nucleic acid analyte. 	_
Id., col. 33:56-col. 34:7.
8

Claims 2, 5, 8, 11, 13, 15, l6, 19, and 21 depend directly from claim 1. Claim 2 requires
that the droplet be “an aqueous droplet in a continuous oil phase.” Id, col. 34:8-9. Claim 5
requires that the stimulus applied to the gel bead be “selected from the group consisting of a
biological stimulus, a chemical stimulus, a thermal stimulus, an electrical stimulus, a magnetic
stimulus, and a photo stimulus.” Id, col. 34:15-19. Claim 8 requires that the oligonucleotidc
molecule attached to the analyte have “a region which functions as a primer during said nucleic
acid amplification.” Id., col. 34:25-28. Claim 11 requires that the “droplet further comprise[] a
polymerase.” Id., col. 34:34-35. Claim 13 requires the nucleic acid analyte to be selected from a
particular group. Id., col. 34:39-47. Claim 15 requires that the oligonucleotidc molecules be
reversibly immobilized to the porous gel bead. Id, col. 34:51-53. Claim 16 requires that the
droplet “comprise[] a plurality of target nucleic acid analytes, which plurality of target nucleic
acid analytes comprises said target nucleic acid analyte.” Id., col. 34:54-56. Claim 19 requires
that the oligonucleotidc molecules attach to the target nucleic acid analytes by hybridization. Id.,
col. 34:.65-67. Claim 21 requires that the gel bead be formed from polymer gel. Id., col. 35:4-5.
Claim 10 requires that the primer of claim 8 be “configured to amplify said target nucleic
acid analyte” so that a barcoded target nucleic acid analyte is produced. Id., col. 34:31-33.
Claim 17 requires that each of the plurality of target nucleic acid analytes of claim 16 attach to
one of the oligonucleotidc molecules. Id., col. 34:58-61. Claim 22 requires that the polymer gel
of claim 21 be a polyacrylamide. Id., col. 35:6-7.
b. The Asserted Claims of the ’468 Patent
Of the asserted claims of the ’468 patent, claim 1 is independent and the remaining
claims depend directly or indirectly from claim 1. Claim 1 recites:
A method for droplet generation, comprising:
9

(a) providing at least 1,000,000 oligonucleotide molecules comprising
i barcode sequences, wherein said barcode sequences are the same
sequence for said at least 1,000,000 oligonucleotide molecules, wherein
said at least 1,000,000 oligonucleotide molecules are releasably attached
to a bead, wherein said bead is porous; 	,
(b) combining said at least 1,000,000 oligonucleotide molecules and a
sample comprising a nucleic acid analyte each in an aqueous phase at a
first junction of two or more channels of a microfluidic device to form an
aqueous mixture comprising said at least 1,000,000 oligonucleotide
molecules attached to said bead and said sample; and
(c) generating a droplet comprising said at least 1,000,000 	V
oligonucleotide molecules attached to said bead and said sample
comprising said nucleic acid analyte by contacting said aqueous mixture
With an immiscible continuous phase at a second jrmction of two or more ,
channels of said microfluidic device.
1d., col. 33:56-col. 34:9.
Claims 2, 6-9, 12, 21, and 22 depend directly from claim 1. Claim 2 requires that the
aqueous fluid formed at the firstjunction include a reagent necessary for amplification of the
nucleic acid analyte. Id, col. 34: 10-18. Claim 6 requires that the bead be formed from a
polyacrylamide. Id., col. 34:25-26. Claim 7 requires that the bead be a gel bead. Id., col. 34:27.
Claim 8 requires that the “at least 1,000,000 oligonucleotide molecules” include uracil. Id, col.
34:28-29. Claim 9 requires that the “at least 1,000,000 oligonucleotide molecules” have a region
that functions as a primer. Id. , col. 34:30-32. Claim 12 requires that the nucleic acid analyte be
selected from a particular group. Id, col. 34:37-46. Claim 21 requires that after the generation
of a droplet “a given oligonucleotide molecule of said at least 1,000,000 oligonucleotide
molecules attaches to said nucleic acid analyte,” before being “subjected to nucleic acid
amplification to yield a barcoded nucleic acid analyte.” Id., col. 35:3-9. Claim 22 requires the
bead to have a chemical cross-linker. Id. , col. 35:12-13. 	r
10

1
Claim 3 requires that the reagents ofclaim 2 be situated in the droplet. Id., col. 34:19-20.
Claim 4 requires that the reagents of claim 3 include polymerase. 1d., col. 34:23-24. Claim ll
requires that the primer of claim 9 be used to amplify the nucleic acid analyte. Id., col. 34:35-36.
B. The ’204 Patent 	_
The ’204 patent issued on May 9, 2017 from an application filed on February 7, 2014.
’204 patent, cover.3 The ’204 patent claims priority to four provisional applications filed
between February 8, 2013 and July 10, 2013. The provisional applications to which the ’204
patent claims priority are also relied on for priority by the ’024 and ’468 patents. The patent
names Benjamin Hindson, Serge Saxonov, Kevin Ness, Paul Hardenbol, Christopher Hindson,
Donald Masquelier, Mima Jarosz, and Michael Schnall-Levin as inventors. Three of the named
inventorsWBenj amin Hindson, Mr. Saxonov, and Mr. Schnall-Levin——arealso the named
inventors of the ’O24and ’468 patents.
1. The Specification
The disclosed subject matter of the ’204 patent is similar to that of the ’024 and ’468
patents. As with those patents, the ’204 patent is directed to sample preparation methods and
discloses “compositions comprising a plurality of capsules, the capsules situated within droplets
in an emulsion, wherein the capsules are configured to release their contents into the droplets
upon the application of a stimulus.” 1d., col. 1:42-46. The capsules may contain reagents and/or
analytes. Id., col. 1:47-48.
3 The ’204 patent is attached to l0X’s initial brief as Exhibit 5.
11

2. Asserted Claims
10X is asserting claims 1-4, 6-9, l7, 20, 21, 23, 25, 27, 29, 31, and 33 ofthe ’204 patent.
Claims 1, 23, and 25 are independent and the remaining claims depend directly or indirectly
from these claims. Claim 1 recites:
A composition comprising a plurality of capsules, said capsules situated
Within droplets in an emulsion, Wherei11said capsules are configured to
release their contents into said droplets upon the application of a
stimulus to provide said contents in said‘droplets in said emulsion,
wherein said stimulus is selected from the group consisting of a change
in pH, a change in ion concentration, reduction of disullide bonds, and
combinations thereof.
Id., col. 44:42-48.
Claims 2, 17, 20, 21, 27, and 33 depend directly from claim l. Claim 2 requires that “at
least one of [the] capsules and [the] droplets comprise a species selected from the group
consisting of a reagent and an analyte.” Id, col. 44:50-52. Claim 17 requires that the “droplets
comprise a fluid that is of a lesser density than the density of [the] capsules.” Id., col. 45:27-29.
Claim 20 requires that the stimulus be applied to the capsules. Id., col. 45:37-38. Claim 21
requires that the stimulus be applied to the droplets. Id., col. 45:39-40. Claim 27 requires that
the capsules’ “contents comprise at least 10,000 barcoded oligonucleotides releasably attached to
each of [thc] capsules.” Id., col. 46:24-26. Claim 33 requires that the capsules be gels. Id, col.
46:42-43.
Claims 3, 4, and 6-9 depend indirectly from claim 1. Claim 3 depends from claim 2 and
requires that the reagent be selected from a group ofreagents. ld., col. 44:53-57. Claim 4
depends from claim 3 and requires that the reagent be selected from a group of enzymes. 1d.,
col. 44:58-61. Claim 6 depends from claim 3 and requires that the barcode be an oligonucleotide
barcode. Id., col. 44:64-65. Claim 7 depends from claim 2 and requires that the analyte be
12

l 	>
selected from a group of analytes. Id., col. 44:66-col. 45:2. Claim 8 depends from claim 7 and
requires that the analyte be a polynucleotide. Id., col. 45:3-4. Claim 9 depends from claim 8 and
requires that the polynucleotide be selected from a group of polynucleotides. Id., col. 45:5-7.
Claim 23 recites: ‘
A device comprising a plurality of partitions, wherein at least one
partition of said plurality of partitions comprises a capsule, wherein said
capsule is situated within a droplet in an emulsion, wherein said capsule
is configured to rclcase its contents into said droplet upon the application
of a stimulus to provide said contents in said droplet in said emulsion,
wherein said stimulus is selected from the group consisting of a change
in pH, a change in ion concentration, reduction of disulfide bonds, and
combinations thereof.
Id., col. 45:51-58. Claim 29 depends from claim 23 and requires that the capsules’ “contents
comprise at least 10,000 barcoded oligonucleotides releasably attached to each of [the]
capsules.” 1d., col. 46:30-32.
Claim 25 recites:
A method comprising:
a. providing a plurality of inner capsules, said inner capsules situated
within outer capsules in an emulsion, wherein said inner capsules are
configured to release their contents into said outer capsules upon the
application of a stimulus, wherein said stimulus is selected from the
group consisting of a change in pH, a change in ion concentration,
reduction of disulfide bonds, and combinations thereof; and
b. providing a stimulus to cause said inner capsules to release their
contents into said outer capsules in said emulsion.
1d., col. 46:3-l2. Claim 3l depends from claim 25 and requires that the capsules’ “contents
comprise at least 10,000 barcoded oligonucleotides releasably attached to each of [the]
capsules.” Id., col. 46:36-38.
13

' 	0
C. The ’530 Patent
» The ’530 patent issued on January 2, 2018 from an application filed on May 5, 2017.
’530 patent, cover.4 Through intervening applications, the ‘S30 patent is a continuation in part of
an application filed on February 7, 2014. Id. The ’530 patent also claims priority to five
provisional applications filed between December 14, 2012 and July 10, 2013. Id. Four of the
provisional applications to which the ’204 patent claims priority are also relied on for priority by
the ’024, ’468, and ’204 patents. The patent names Bcnjamin Hindson, Serge Saxonov, Kevin
Ness, Paul Hardenbol, Mirna Jarosz, and Michael Schnall-Levin as inventors. These same
individuals are named inventors of the ’203 patent and three ofthem—Mr. Hindson, Mr.
Saxonov, and Mr. Schnall-Levin»are named inventors of the ‘O24and ’468 patents.
1. The Specification
The claimed subject matter of the ’530 patent is similar to the subject matter disclosed in
the ’024, ’468, and ’204 patents. As with those patents, the "530 patent discloses sample
preparation methods that use microcapsules and beads to provide reagents and analytes in
response to stimuli. ’530 patent, col. 23:60-col. 24:13. "
2. Asserted Claims
10X is asserting claims 1-6, 8-11, 14-20, and 24-30 ofthe ’530 patent. Claim l is
independent and the remaining claims depend directly or indirectly from claim 1. Claim 1
recites:
A method for nucleic acid preparation or analysis, comprising:
(a) providing:
(i) at least 1,000 gel beads;
4 The ’530 patent is attached to 10X’s initial brief as Exhibit 7.
14

I 	b
(ii) releasably attached to each of said at least 1,000 gel beads, at least
1,000 barcode molecules comprising identical barcode sequences that
are distinct from barcode sequences of at least 1,000 barcode
molecules releasably attached to any other gel bead of said at least
1,000 gel beads; and
(iii) a plurality of cells each comprising a plurality of polynucleotide
molecules;
(b) generating a plurality of droplets, wherein at least 1,000 droplets of
said plurality of droplets each comprise:
(i) a single gel bead from said at least 1,000 gel beads; and
(ii) a single cell from said plurality of cells; and
(c) in each of said at least 1,000 droplets, using said plurality of
polynucleotide molecules from said single cell and barcode molecules of
said at least 1,000 barcode molecules from said single gel bead to
generate a plurality of barcoded polynucleotide molecules,
wherein said barcode molecules become detached from said gel bead.
Id, col. 47:58-67, col. 48:57-col. 49:4. 	I
Claims 2, 3, 5, 8-11, 14, 15, 17, 20, and 24-30 depend directly from claim 1. Claim 2
requires that the plurality of polynucleotide molecules be released in each of the at least 1,000
droplets before step (c) of claim 1. Id, col. 49:7-10. Claim 3 requires that the polynucleotide
molecules be messenger ribonucleic acid (“mRNA”) molecules. Id, col. 49:8-10. Claim 5
requires that the barcoded polynucleotide molecules be released from the droplets. Id, col.
49:15-17. Claim 8 requires that the bareoded polynucleotide molecules or a “derivative thereof’
be sequenced. Id., col. 49:27-29. Claim 9 requires that a subset of the droplets not contain a
cell. Id, col. 49:30-31. Claim 10 requires that a subset of the droplets not contain a gel bead.
Id, col. 49:32-33. Claim l l requires that the barcode molecules in each of the droplets be
released by a single gel bead. Id, col. 49:34-36. Claim 14 requires that each gel bead have at
15

least 1,000 barcode molecules. Id., col. 49:44-45. Claim 15 requires that the gel beads recited in
step (a) constitute a subset of the gel beads. Id., col. 50:1-2. Claim 17 requires that the barcode
molecules “comprise combinatorial assemblies of sequences from sequence modules.” Id., col.
50:5-7. Claim 20 requires that the plurality of droplets be at least 10,000. Id., col. 50:15-16.
Claim 24 requires that the gel beads contain at least 10,000 barcode molecules. Id., col. 50:26
27. Claim 25 requires that the gel beads contain at least 100,000 barcode molecules. Id., col.
50:28-29. Claim 26 requires that the gel beads contain at least 1,000,000 barcode molecules.
Id., col. 50:30-31. Claim 27 requires that the nmnber of polynucleotide molecules range from
10,000-100,000 molecules. Id., col. 50:31-32. Claim 28 requires that the barcode molecules
become detached before the formation of the barcoded polynucleotide molecules. Id., col.
50:35-37. Claim 29 requires that the barcode molecules become detached after the barcoded
polynucleotide molecules are generated. Id., col. 50:39-41. Claim 30 requires that the barcode
molecules detach while the barcoded polynucleotide molecules are being generated. Id., col.
50:42-44.
Claim 4 depends from claim‘3 and requires that barcoded polynucleotide molecules be
generated by reverse transcribing the mRNA molecules in the presence of the barcode molecules.
Id., col. 49:11-14. Claim 6 depends from claim 5 and requires that the barcoded polynucleotide
molecules be amplified by nucleic acid amplification after the barcoded polynucleotide
molecules are released from the droplets. Id , col. 49:18-22. Claim 18 depends from claim 17
and requires that each of the combinatorial assemblies comprise a first sequence and a second
sequence. Id., col. 50:8-10. Claim 18 depends from claim 17 and requires that each of the
combinatorial assemblies comprise a first sequence, a second sequence, and a third sequence.
Id., col. 50:11-14.
16

V. CLAIM CONSTRUCTION
Because the asserted patents are directed to similar subject matter, share common
inventors, and stem from common priority documents, the claim construction disputes cut across
patents. The disputed terms can be placed into five categories, which are addressed below.
A. “1,000,000 oligonucleotides comprising barcode sequences”
. ..._..___________.. 	_. . .__...__- .”
“1,000,000 oligonucleotide molecules comprising barcode sequences
g (’024 patent, claim 1; ’468 patent claim 1)
Party l 	_ 	Construction
lOX Plain meaning and proposed construction for barcode sequence
Bio-Rad “1,000,000 oligonucleotide molecules, part of which are barcode sequences”
Staff “1,000,000 oligonucleotide molecules that include, but are not necessarily limited
to, barcode sequences”
Claim l of the ’024 patent and claim l of the ’468 patent require “at least 1,000,000
oligonucleotide molecules comprising barcode sequences” that are “releasably attached”‘to a
porous bead. ’024 patent, col. 33:57-60; ’468 patent, col. 33:57-63. _The parties agree that the
recited oligonucleotide molecules encompass molecules that have a barcode sequence and
components in addition to the barcode sequence, but disagree on whether the claims encompass
molecules consisting solely of a barcode sequence. Bio-Rad contends that the oligonucleotide
molecules consisting solely of a barcode sequence fall outside of the scope of the claims,
whereas 10X and Staff argue that the claims capture such molecules.
The plain language of the claims is consistent with 10X’s and Staffs position. The plain
and ordinary meaning of “comprise” is “to include esp. with a particular scope,” “to be made up
of,” “compose,” or “constitute.” Webster’s Ninth Collegiate Dictionary (1984) at 270-71.5 All
5 When used as a transitional phrase to join the preamble of a claim with the claim’s body, the
term “comprising” is open-ended and allows for,-but does not require, additional elements.
Vehicular Techs. Corp. v. Titan Wheel Inf], Inc, 212 F.3d 1377, 1382-83 (Fed. Cir. 2000) (“The
17

1 	r
of the definitions of “comprise” are consistent with lOX’s and Staff”s position that the claimed
molecules encompass oligonucleotide molecules consisting solely of a barcode sequence. None
of the ‘definitions are consistent with Bio-Rad’s position that the oligonucleotide molecule must
have elements in addition to the barcode sequence.
~ The specification further supports 1OX’sand Staff s position. Describing the use of
“oligonucleotide barcodes” to tag analytes, the specification describes the oligonucleotide
barcodes as “compris[ing] a unique sequence (e.g., a barcode sequence) that gives the
oligonucleotide barcode its identifying functionality.” ’468 patent, col. 12:44-47. The
specification notes that “an oligonucleotide barcode may consist solelyof a unique barcode
sequence or may be included as part of an oligonucleotide of longer sequence length.” Id., col.
12:58-60. Thus, the specification expressly contemplates that an oligonucleotide molecule used
to tag analytes can either consist solely of a barcode sequence or include additional elements.
Bio-Rad counters that the specification supports its proposed construction. In particular,
Bio-Rad points to a portion of the specification in which the term “oligonucleotide barcode” is
used to refer to oligonucleotide barcodes consisting solely of a barcode sequence and the tenn
“larger oligonucleotide” in used to refer oligonucleotide barcodes having elements in addition to
the barcode sequence. [d., col. 13:6-10. Bio-Rad argues that the specification’s use of the term
“a larger oligonucleotide comprising an oligonucleotide barcode” to describe oligonucleotide
phrase ‘consisting of’ is a term of art in patent law signifying restriction and exclusion, while, in
contrast, the term ‘comprising’ indicates an open-ended construction. . . . A drafter uses the term
‘comprising’ to mean ‘l claim at least what follows and potentially more.’”) (internal citation
omitted). In the instant case, however, the term “comprising” is not being used as a transitional
phrase. Accordingly, the term “should be interpreted according to the normal rules of claim
interpretation.” Moleculon Research Corp. v. CBS Inc., 793 F.2d 1261, 1272 n. 8 (Fed. Cir.
1986), abrogated on other grounds, Egyptian Goddess, Inc. v. Swisa, 1nc., 543 F.3d 665 (Fed.
Cir. 2008).
18

molecules having elements in addition to a barcode sequence supports its interpretation of the ‘
claim language. Tr. at 7:11-8:4. The specification can only limit claim scope through
lexicography or disavowal. Hill-Rom, 755 F.3d at 1371.
The specification’s use of the tenn “a larger oligonucleotide comprising an
oligonucleotide barcode” to describe molecules containing elements in addition to a barcode
sequence is not a clear statement defining “oligonucleotide molecules” and is not a clear
statement disavowing claim scope. See, e.g., Thorner, 669 F.3d at 1365 (“To act as its own
lexicographer; a patentee must ‘clearly set forth a definition of the disputed claim term.”’)
(quoting CCS Fitness, 288 F.3d at 1366); Poly-America, 839 F.3d at 1136 (“[T]he standard for
disavowal is exacting, requiring clear and unequivocal evidence that the claimed invention
includes or does not include a particular feature”). The specification’s use of the qualifier '
“larger” to describe oligonucleotide molecules that have elements in addition to barcode:
sequences suggests that “smaller” oligonucleotide molecules do not have elements in addition to
barcode sequences. Claim l’s recital of “oligonucleotide molecules” without a qualifier
encompasses both larger and smaller oligonucleotide molecules.
Bio-Rad also argues that interpreting the claims to encompass oligonucleotide molecules
comprised solely ofa barcode sequence captures subject matter surrendered during prosecution
of the ’O24patent. RIB at 9-10. The premise underlying Bio-Rad’s argument is that, during the
prosecution of the ’O24patent, the applicants “changed “oligonucleotide barcode’ to
‘oligonucleotide molecules comprising barcode sequences’ to overcome” the examiner’s
anticipation and obviousness rejections. Id. at 9 (underlining in original). Bio-Rad’s
interpretation of the prosecution history is incorrect.
19

As originally drafted, application claim 78, which would mature into claim 1, was
directed to a method of sample preparation wherein an “oligonucleotide barcode” and an analyte
are released from a microcapsule in response to a stimulus. ’O24Patent File History,
Amendment (Feb. 17, 2017) at 0.6 The examiner rejected application claim 78 as anticipated and
obvious in view of several prior art references. See, generally, ’024 Patent File History, Offiee
Action (June 24, 2016). The applicants filed two responses to the office action. In the first
response, the applicants extensively amended application claim 78. ’024 Patent File History,
Response (Dec. 21, 2016) at 2. As amended, the application claim required a “droplet
comprising a porous gel bead and a target nucleic acid analyte, wherein said porous gel bead
comprises at least 1,000,000 oligonucleotide barcodes” and required the bareoded analyte to
undergo an amplification step. Id.
The applicants argued that the amended application claim was allowable over the cited
prior art, because the prior art did not disclose one or more of the following elements:
(1) “providing a ‘droplet comprising a porous gel bead . . . wherein said porous ‘gelbead
comprises at least 1,000,000 oligonucleotide barcodes that are releasably attached to said porous
gel bead,” (2) “applying a stimulus to said porous gel bead to release said oligonucleotide
bareodes from said porous gel bead, wherein upon release from said gel bead, a given
oligonucleotide barcode from said oligonucleotide from said oligonucleotide bareodes attaches to
said target nucleic acid analyte,” and (3) “subjecting said given oligonucleotide barcode attached
to said target nucleic acid analyte to nucleic acid amplification to yield a bareoded target nucleic
acid analyte.” id. at 8-14. Notably, none of the bases cited by the applicants to distinguish the
pending claims from the prior art relate to the composition of the “barcode molecules.”
6A certified copy of the file history of the ’O24patent was filed as Appendix B to the complaint.
20

4
	n
Three months after submitting their initial response, the applicants submitted a
supplementary response, amending the application claim 78 to replace the term “oligonucleotide
barcodes” with the tenn “oligonucleotides comprising barcode sequences.” ’O24Patent File
History, Response (Mar. _28,2016) at 3. Bio-Rad argues that the applicants made this
amendment in order to fiirther distinguish the pending claims from the cited prior art. The
prosecution history clearly indicates, however, that the amendment in the supplementary
response was not made in order to distinguish prior art.
The supplementary response was filed after the examiner conducted an interview with the
applicants. “O24Prosecution History, Examiner Initiated Interview Summary (Apr. 25, 2017).
In that interview, the examiner informed the applicants that application claim 78 would be
allowable if it was further amended “to specify that the barcode sequence of oligonucleotides are
the same,” not to overcome an obviousness or anticipation rejection, but to overcome a “potential
rejection under 35 USC 112 second paragraph.” ’024 Prosecution History, Examiner Initiated
Interview Summary (Apr. 25, 2017). The supplementary response was submitted eight days
after the interview. Thus, amending the claims to recite “oligonucleotides comprising barcode
sequences” rather than “oligonucleotide barcodes” was made “to specify that the barcode
sequence of oligonucleotides are the same,” not to disclaim oligonucleotide molecules that
consist solely of a barcode sequence. See Core Licensing S.A.R.L. v. LG Electronics, [nc., 880
F.3d 1356, 1367 (Fed. Cir. 2018) (“The patentee’s statements during prosecution do not amount
to a clear and unmistakable disclaimer restricting the meaning of ‘un~launched state’ only to
those applications that are not running any processes”).
In view of the foregoing, I reject Bio-Rad’s argument that the oligonucleotide molecules
do not encompass molecules that consist solely of a barcode sequence. I find that the term
21

“l,O00,000 oligonucleotides comprising barcode sequences” means “l,000,000 oligonucleotide
molecules that include, but are not necessarily limited to, barcode sequences.”
B. “releasably attached”
“releas'ablj'_latt'ached” (’024 patent, claim I; 5468patent, claim 1) H
- Party 	Construction
10X “attached, directly or through chemical moieties or chemical linkers, and
releasable upon application of a stimulus”
Bio-Rad “wherein said oligonucleotide molecules are releasably attached to said
porous gel bead “wherein said porous gel bead is configured to release said
oligonucleotide molecules” (’024 patent, claim 1) means “wherein said porous
gel bead is configured to release said oligonucleotide molecules”
“wherein said at least 1,000,000oligonucleotide molecules are releasably
attached to a bead” (’468 patent, claim 1) means “wherein said bead is
configured to release said at least 1,000,000 oligonucleotide molecules”
“10,000 barcoded oligonucleotides releasably attached to [each of said
capsules] [said capsule] [each of said capsule]” (’204 patent, claim 27, 29, 31)
means “l0,000 barcoded oligonucleotides attached to [each of said capsules]
[said capsule] [each of said capsule], which is [are] configured to release them”
“1,000 barcode molecules releasably attached to any other gel bead” (’530
patent, claim l) means “any other gel bead is configured to release said at least
1,000 barcode molecules”
“releasably attached to each of said at least 1,000 gel beads, at least 1,000
barcode molecules” (’530 patent, claim l) means “said at least 1,000 gel
beads are configured to release said at least 1,000 barcode molecules”
Staff Same as lOX’s
The asserted claims of the ’024, ’468, and ’530 patents require a gel bead comprising
barcode molecules, wherein the barcode molecules are “releasably attached” to the gel bead.
’024 patent, col. 33:60-62 (claim l); ’468 patent, col. 33:60-63 (claim 1); ‘S30 patent, col. 47:62
67 (claim l). The asserted claims of the ’204 patent require a “capsule,” the contents of Which
include barcode molecules that are “releasably attached” to the capsule. ’204 patent, col. 44:42
49 (claim l), col. 46:25-27 (claim 27), col. 46:30-32 (claim 29), col. 46:36-38 (claim 31). The
asserted claims of the ’024 patent require that the barcode molecules be released from the gel
22

bead in response to a stimulus applied to the gel bead. ’024 patent, col. 33:65-col.34:1 (claim 1).
The asserted claims of the ’53Opatent require the barcodes to “become detached” or be
“released” from a gel bead without specifying how they become detached or released. ’530
patent, col. 49:3-4 (claim 1) (“become detached”), col. 49:34-36 (claim 11) (“released”), col.
50:35-38 (claim 28) (“become detached”), col. 50:38-41 (claim 29) (“become detached”), col.
50:42-44 (claim 30) (“become detached”). The asserted claims of the ’468 patent do not require
the barcode molecules to become detached or released from the bead. ’468 patent, col. 33:57
col. 34:9 (claim 1). The parties agree that the term “releasably attached” should be construed
consistently across the patents. RRB at 2; CIB at 25; SIB at 30.
According to Bio-Rad, the term “releasably attached” requires that the bead or capsule be
configured or designed to release the barcode molecules. RIB at 12. 10X and Staff counter that
the term only requires that the barcode molecules be attached and releasable upon application of
a stimulus. SIB at 16; CIB at 12-13. The term “releasably attached” is not a tenn of art and its
meaning is apparent to even a lay judge: the barcode molecules are attached to the bead or
capsule in a way that allows them be released. Phillips, 415 F.3d at 1314 (“In some cases, the
ordinary meaning of claim language as understood by a person of skill in the art may be readily
apparent even to lay judges, and claim construction in such cases involves little more than the
application of the widely accepted meaning of commonly tmderstood words”). There is no
support in the claim language, the specifications, and prosecution histories of the asserted patents
for Bio-Rad’s proposed construction. l0X’s and.Staff‘s proposed construction is also flawed
because it imports limitations from the specification into the claims.
23

0
1. Bio-Rad’s proposed construction is inconsistent with the claim
language of the asserted claims.
Although Bio-Rad argues that the langiage of the asserted claims supports its proposed
construction of “releasably attached,” the claim language is actually inconsistent with Bio-Rad’s
proposed claim construction. Bio-Rad places particular emphasis on the claim language of
the ’204 and ’O24patents. RRB at 2-4. Independent claim l of the ’204 patent is directed to
“capsules” that “are configured to release their contents . . . upon the application of a stimulus.”
’204 patent, col. 44:42-49 (claim 1). Dependent claims 27, 29, and 31 require that each
capsule’s contents include barcode molecules “releasably attached” to the capsule. Id, col.
46:25-27 (claim 27), col. 46:30-32 (claim 29), coll 46:36-38 (claim 31). The asserted claims of
the ’O24patents require the barcode molecules to be released in response to a stimulus applied to
the gel bead. ’O24patent, col. 33:65-col.3-4:1 (claim l). To the extent that the claims of the ’204
and ’O24patents may be interpreted to require a capsule or bead configured to release the
barcode molecules, such an interpretation—as acknowledged by Bio-Rad—would be based on
claim language other than “releasably attached?” 	g 	K
Claim 1. A composition comprising a plurality of capsules, said
capsules situated within droplets in an emulsion, wherein said capsules
are configured to release their contents into said droplets upon the
application of a stimulus . . . .
RRB at 3 (quoting ’204 Patent, col. 44:42-49 (claim 1)) (emphasis added by Bio-Rad);
(b) applying a stimulus to said porous gel bead to release said
oligonucleotide moleculesfrom said porous gel bead into said droplet . .
7This order is limited to addressing whether the term “releasably attached” requires a capsule or
bead configured to release the barcode molecules and makes no finding on whether other claim
language so requires.
24

Id. at 4 (quoting ’024 patent, col. 33:65-col.34:l (claim 1)) (emphasis added by Bio-Rad).
The claim language relied on by Bio-Rad with respect to the ’204 and ’024 patents is not
present in the asserted claims of the ’468 and ’53Opatents. Bio-Rad does not even make the
argument that the claim language of the ’468 patentsupports its proposed construction. While
requiring barcode molecules that are “releasably attached” to a gel bead, the asserted claims of
the ’468 patent do not require the barcode molecules to be released from the gel bead, much less
be released in response to a stimulus applied to the gel bead. ’468 patent, col. 33:57-col. 34:9
(claim 1). Although Bio-Rad argues that the claims of the ’53Opatent support its proposed
construction of “releasably attached,” its argument is unpersuasive. RRB at 5-6.
Independent claim l of the ’530 patent requires barcode molecules that are “releasably
attached” to the gel bead to “become detached,” while certain dependent claims (e.g. , claim l 1)
require the barcode molecules to be “released.” Compare ’530 patent, col. 49:3-4 (claim l)
(“become detached”) wizh z'd.,col. 49:34-36 (claim ll) (“released”). According to Bio-Rad,
“[l]ogically, ‘released’ must be narrower than ‘detached’ or Claim ll would not be limiting
Claim l in any way.” RRB at 5 (citing Hutchirzs v. Zoll Medical Corp, 492 F.3d 1377, 1382
(Fed. Cir. 2007). Whether “released” has a narrower scope than “detached” is irrelevant to the
construction of “releasably attached.” Claim 1 describes the “releasably attached” barcode
molecules as “becom[ing] detached,” not being “released.” ’530 patent, col. 47:62-66, col. 49:3
4. Accordingly, “releasably attached” barcode molecules encompasses barcode molecules that
can be “detached.” ~ 	4
2. The specifications of the asserted patents are inconsistent with Bio
Rad’s proposed construction.
Bio-Rad’s proposed construction is also inconsistent with the specifications of the
asserted patents. The specification of the ’024 and ’468 patents teaches that “oligonucleotide
25

barcodes . . . may be coupled/immobilized to the interior surface of a gel bead (e.g., the interior
accessible via diffusion of an oligonucleotide barcode and/or materials used to generate an
oligonucleotide barcode) and/or the outer surface of a gel bead or any other microcapsule.” ’024
patent, col. 9:36-42. The “[c]oupling/immobilization may be via any form of chemical bonding
(e.g., covalent bond, ionic bond) or physical phenomena (e.g., Van der Waals forces, dipole
dipole interactions, etc.)” and in certain circumstances may be reversible. Id., col. 9:42-49. Bio
Rad argues that this description is inapplicable because it addresses barcode molecules that are
“reversibly immobilized” on a bead or capsule, not barcode molecules that are “releasably
attached” to a bead or capsule. RRB at l2-13. Bio—Rad’sargument ignores that reversible
immobilization is a species of releasable attachment. 	V
The relationship between the claim term “releasably attached” and the specifications’
discussion of reversible immobilization is confirmed by the ’468 patent’s prosecution history.8
During the prosecution of that patent, the examiner questioned whether application “claim 99
requiringlthe limitation of ‘said at least 1,000,000 oligonucleotide molecules are attached to said
bead via a covalent bond’ . . . further limit[ed] the limitation of amended claim 78, requiring
‘oligonucleotide molecules [that] are rcleasably attached to a bead.”’ ’468 Patent Prosecution I
History, Email from B. Narayan to A. Alemozafar (Apr. 20, 2017). ln response, the applicants
argued that “the ‘oligonucleotide molecule’ of Claim 78 may be ‘releasably attached to a bead’
via covalent bonds or ionic bonds, to provide a few examples.” ’468 Patent Prosecution History,
Email from A. Alemozafar to B. Narayan (Apr. 20, 2017). In support of their position, the
applicants pointed to the specification’s discussion of reversible immobilization and quoted the
following sentences:
8A certified copy of the file history of the ’468 patent was filed as Appendix C to the complaint.
26

Coupling/irnmobilization may be via any form of chemical bonding (e.g.,
covalent bond, ionic bond) or physical phenomena (e.g.,_Vander Waals
forces, dipole-dipole interactions, etc.). In some cases,
coupling/immobilization of a reagent to a gel bead or any other
microcapsule described herein may be reversible, such as, for example,
via a labile moiety (e.g., via a chemical cross-linker, including chemical
cross-linkers described herein). Upon application of a stimulus, the labile
moiety may be cleaved and the immobilized reagent set free.
Id. (quoting ’O24patent, col. 9:42-52) (internal citations omitted). The examiner agreed that the
cited paragraph described how barcode molecules can be “releasably attached” using covalent
bonds and ionic bonds, and allowed application claim 99. Notice of Allowability (Apr. 28,
2017) at 2-3 (“[A]n agreement was reached that the limitation of claim 99 still further limits the
limitations of claim 78 because ‘oligonucleotide molecules’ of claim 78 may be ‘releasably
attached to a bead’ via covalent bonds or ionic bonds, as discussed in the instant published
specification paragraph 0056.”).9
Bio-Rad further argues the specifications of the asserted patents support its proposed
construction because they “describe the bead or capsule as configured to release the 1
oligonucleotide molecules.” RIB at 12-13. The patents, however, also disclose embodiments in
which the barcode molecules are released by severing a portion of the barcode molecule. The
’O24patent specifically discusses the use of“a labile moiety” to “coupl[e]/immobiliz[e]” a
barcode molecule to a gel bead. ’O24patent, col 9:45-49. In order to free the immobilized
barcode, the labile moiety is cleaved “upon application of a stimulus.” [d., col. 9:49-51.
9Both the applicants in their email to the examiner and the examiner in the intcrvicw summary
refer to paragraph 56 of the application of the ’O24patent. Although the “reversible
immobilization” discussion occurs in paragraph 54, not paragraph 56, it is clear from the
sentences quoted in the applicants’ email that the applicants and examiner are referring to
paragraph 54.
27

Importantly, the specification teaches that the labile moiety may be part of the barcode molecule
itself. [d., col§ 9:56-59. 	p
The specification of the ’O24and ’468 patents further undercuts Bio-Rad’s proposed
construction. The specification explains that the release of the barcode molecule can be
effectuated by “[v]arious different stimuli.” Id, col. 19:36-38. Such a stimulus can trigger the
release of barcode molecules by causing “disruption or degradation of any chemical bonds that
immobilize a reagent to the microcapsule,” as opposed to causing “disruption or degradation of
the shell or membrane enveloping the microcapsule” or “disruption or degradation of the interior
of a microcapsule.” 1d., col. 19:39-43. This description does not limit the “chemical bonds that
immobilize a reagent to the microcapsule” to chemical bonds on the bead or capsule, but
encompasses chemical bonds that are part of the barcode molecules.
Despite the clarity of the specification’s description, Bio-Rad argues that this portion of
the specification supports its construction because
The phrase “any chemical bonds” only concerns bonds that can be
broken when a stimulus is applied to the microcapsule. It is not stating
that “any chemical bonds” disrupted in any manner is Withinthe scope of
release.
RRB at 13. In the description at issue, however, the specification does not state that the
“stimulus is applied to the microcapsule.” Id. Bio-Rad’s only apparent support for so
interpreting the specification is the specification’s statement that stimuli can be used to “‘trigger
release of reagentsfrom the micr0capsules.’” RRB at 13 (quoting ’024 patent, col. l9:36-43)
(emphasis added by Bio-Rad). That a stimuluscauses the barcode molecules to be released
“from the microcapsules” does not necessarily mean that the stimulus acts upon the
microcapsules.
28

3. The prosecution history of the ’024 patent is inconsistent with Bio
Rad’s proposed construction.
The prosecution history of the ’024 patent further undercuts Bio-Rad’s proposed
construction. During prosecution, the examiner rejected application claims 102 and 103 as being
anticipated by U.S. Patent Application 2012/0316074 (‘"074 application”). ’024 Patent
Prosecution History, Office Action (June 24, 2016) at 4-5. Application claims 102 and 103
depended from application claim 78, which required a “microcapsule [that] is degradable upon
the application of a stimulus to said microcapsule,” so that an oligonucleotide barcode is released
upon the application of the “stimulus to said microcapsule.” ’024 Patent Prosecution History,
Preliminary Amendment (February 17, 2015) at 3. Application claim 103 further required the 1
oligonucleotide barcode to be “reversibly immobilized” to the microcapsule. Id. at 5. The
examiner found that the “reversible immobilization” limitation was satisfied by the ’074
application’s disclosure of an “oligonucleotide barcode . . . , which can be cut and ligated.” ’024
Patent Prosecution History, Office Action (June 24, 2016) ati5. In their response to the office
action, the applicants did not dispute the examiner’s determination that the ’074 application
disclosed the “reversibly immobilized” limitation. ’O24Patent File History, Response (Dec. 12,
2016) at 9-l0. Thus, both the examiner and the applicants understood that “reversible
immobilization” a fonn of releasable attachment—enc0mpasses situations wherein a barcode
molecule is released from a bead by severing a portion of the barcode molecule.
4. 10X’sand Staff’s proposed construction imports limitations from the
specification.
10X and Staff argue that “releasably attached” should be construed to mean “attached,
directly or through chemical moieties or chemical linkers, and releasable upon application of a
stimulus." This proposed construction imports limitations from the specification by requiring the
barcode molecule to be releasable “upon application of a stimulus” and requiring any indirect
29

attaclnnent be “through chemical moieties or chemical linkers.” In support of these limitations,
10X and Staff point to the specifications of the asserted patents, not the claim language. It is
axiomatic that limitations from the specification should not be imported into the claims. Phillips,
415 F.3d at 1319-20.
Based on the foregoing, I find that “releasably attached” means “attached in a manner
that allows the attached object to be released.”
C. “reversibly immobilized”
“reversibly immobilized” (’024 patent, claim 15)
Party | 	Construction
10X “bound by a chemical bond or physical phenomenon that can be undone”
Bio-Rad “reversibly immobilized to said porous gel bead” means “releasable by
reversing the process of attachment to said porous gel bead”
Staff “immobilized through any form of chemical bonding or physical phenomena that
can be specifically disrupted or degraded”
Claim 15 of the ’O24patent requires the barcode molecules of claim 1 to be “reversibly
immobilized” to the gel bead. ’024 patent, col. 34:51-53. As noted by Staff, “it is unclear
what—if any—substantive dispute exists among the parties.” RRB at 7. Although 10X argued
at the hearing that there is some potential ambiguity that could arise from Bio-Rad’s proposed
construction, the cause of 10X’s concern is not Bio-Rad’s proposed construction ‘of“reversibly
immobilized,” but Bio-Rad’s proposed construction of “releasably attached.” Tr. at 45 (“. . .
Bio-Rad’s construction leaves ambiguity as to what they think it means to have the ‘bead
releasing the barcode.”’). 	I 	'
Because there is no dispute regarding the interpretation of the term “reversibly
immobilized,” its construction is not addressed in this order. U.S. Surgical Corp. v. Elhicorz, 1110.,
103 F.3d 1554, 1568 (Fed. Cir. 1997) (“Claim construction is a matter of resolution of disputed
meanings and technical scope, to clarify and when necessary to explain what the patentee
covered by the claims.”).
3 0

D. Amplification terms
“amplification”(’024 patent, claims 1‘;8'; ’46s}?a1;;.t, claims 2, 21)/“amplify” (*024
patent, claim 10)/“amplifying” (’468 patent, claim 11; ’530 patent, claim 6)
Party 	Construction
10X 	“amplification”: “polymerization of’
“amplify”: “polymerize”
“amplifying”: “polymerizing one or more additional nucleic acid sequences
based on a template nucleic acid sequence”
Bio-Rad “amplification”: “creation of multiple copies of’
“amplify”: “create multiple copies of’
“amplifying”: “creating multiple copies oi”
Staff “amplification ”: “replication” i
“amplify”: “replicate”
“amplifying”: “replicating”
The asserted claims of the ’O24patent require that the barcode molecule attached to a
nucleic acid analyte be subjected “to nucleic acid amplification to yield a barcoded target nucleic
acid analyte.” ’O24patent, col. 34:4-7 (claim l). Claim 6 of the ’53Opatent requires a step of
“amplifying” barcoded polynucleotide molecules “by nucleic acid amplification.” ’53Opatent,
col. 34:25-28. Claim 2 of the ’468 patent requires forming an aqueous solution by combining the
nucleic acid analyte and gel bead of claim 1 with “one or more reagents necessary for
amplification.” ’468 patent, col. 34:10-18. Claim ll of the ’468 patent requires “amplifying” a
nucleic acid analyte. Id., col. 34:35-36. The parties raise two disputes concerning the
construction of “amplification” and its variants. The first issue is whether amplification
encompasses synthesizing complementary copies of mRNA strands through reverse
transcription. The second issue is whether amplification requires the creation of multiple copies
of the nucleic acid being amplified. With regard to the asserted claims of the ’O24patent, the
parties raise a third dispute regarding whether the amplification step must be performed yvithina
droplet. 	'
‘ 	31

1. Amplification encompasses reverse transcription.
1OX’sproposed constructions of the “amplification” terms encompass reverse
transcription of RNA (ribonucleic acid) into DNA (deoxyribonucleic acid). Both Bio-Rad and
Staff argue that reverse transcription is not a form of amplification. For the reasons set forth
below, I find that reverse transcription can be used as a method of amplification.
a. Nucleic Acid Replication and Reverse Transcription
By way of background, DNA and RNA are comprised of sequences of nucleotides. Butte
Initial Declaration at 1i37. DNA strands are comprised of four nucleotides: adenine (A),
guanine (G), cytosine (C), and thymine (T). Id. RNA strands are also composed of four
nucleotides. With the exception of thymine, the nucleotides in an RNA strand are the same as
those in a DNA strand. Id instead of thymine, RNA strands have the nucleotide uracil (U). Id.
DNA molecules typically occur as double-stranded molecules, known as DNA double
helices. Id. at 1[39. A DNA double helix is comprised of two DNA strands oriented antiparallel
to each other. Id The nucleotides in one strand of a double helix are complementary to those in
the other strand and bonds will form between the complementary nucleotides. Id. Adenine pairs
with thymine and cytosine pairs with guanine. Id.
32

u
c gr] 3 c 	LT}
;£lG,r;q§ 	I‘ G 	A 	iv
sugar-phosphate hydrogen-bonded
backbone base pairs
(Hi DNAdouble helix ]
t 	I 	C
C A lJ.~q§rfi
A " G
Tl ' G G I
tr‘ ' 	, ,__, G
G 	C D "
t 	A I c A
c _
Alberts, Molecular Biology of the Cell (SmEd.) (“Alberts”), Fig. 1-2 (excerpt); Butte Initial
Declaration at {I39.10 In DNA replication, an enzyme called DNA polymerase binds to each
strand and forms a new strand that is complementary to the template strand. Butte Initial
Declaration at 1]40. 	i
In a process called “transcription,” a DNA strand serves as a template to create a strand
of messenger RNA (“mRNA”). Id. at 1i41. In this process, an enzyme called RNA polymerase
uses one DNA strand as a template to form an mRNA strand that is composed of nucleotides
complementary to those on the DNA strand. Id. To form the mRNA strand, adenine, thymine,
cytosine and guanine in the DNA strand are transcribed into uracil, adenine, guanine, and
1°Excerpts from Alberts are attached as Exhibit 13 to 10X’s initial brief and as Exhibit SMX
0010 to Staff s rebuttal brief.
33

cytosine, respectively. Id. The mRNA strand is then used to create proteins in a process known
as “translation.” Id.
Because of the complementary relationship between the nucleotide sequences comprising
the DNA strand and the mRNA strand, in a process called “reverse transcription,” the mRNA
strand can be used as a template to form a strand of complementary DNA (“cDNA”). Id at 1]42.
To form a cDNA strand, adenine, uracil, cytosine and guanine in the mRNA strand are reverse
transcribed into thymine, adenine, guanine, and cytosine, respectively. Id.
b. Amplification is increasing the copy number of the target sequence to
be detected.
The ’530 patent teaches that “[a]mplification may be used to increase the quantity of a
target polynucleotide.” ’530 patent, col. 19:5-6. To provide a general description of
“polynucleotide amplification,” the ’530 patent cites Application No. PCT/U S 99/01705 (“"705
application”).“ ’53Opatent, col. 18:28-34 (teaching that “target polynucleotides” can be _
obtained through a Varietyof ways including “polynucleotide amplification (as generally
described in PCT/US/99/01705)”). In addition, the ’530 patent expressly incorporates the ’705
application by reference. Id. col. 5:5-22 (“All publications, patents, and patent applications
mentioned in this specification are herein incorporated by reference to the same extent as if each
individual publication, patent, or patent application was specifically and individually indicated to
be incorporated by reference”). 	'
The ’705 application teaches that “[t]arget amplification involves the amplification
(replication) of the target sequence to be detected, such that the number of copies of the target
sequence is increased.” ’705 application, p. 20; see also id at 2 (“Target amplification involves
1‘The ’705 application is attached as Exhibit SMX-0004 to Staff‘s initial brief.
34

the amplification (i.e. replication) of the target sequence to be detected, resulting in a significant
increase in the number of target molecules”). Accordingly, “amplification” as used in the ’53O
patent is a process that “increases the number of copies of the target sequence to be detected.”
’705 application, p. 20; see also ’530 patent, col. 19:5-6 (“Amplification may be used to increase
the quantity of a target polynucleotide”).
With regard to the ‘O24and ’468 patents, there is no indication that “amplification” is
being used differently in these patents. The ’O24, ’468, and ’53Opatents share common
inventors and stem from common priority documents; accordingly the term “amplification” and
its variants should be construed consistently across the patents. NTP, Inc. v. Research in Motion,
Ltd, 418 F.3d 1282, 1293 (Fed. Cir. 2005), abrogated on other grounds as recognized in IRIS’
Corp. v. Japan Airlines Corp, 769 F.3d 1359, 1361 n. 1 (Fed. Cir. 2014) (“Because NTP's
patents all derive from the same parent application and share many common terms, we must
interpret the claims consistently across all asserted patents”).
Based on the foregoing, I findtthat the amplification terms recited in the claims of the
’53O,’O24and ’468 patents refers to increasing “the number of copies of the target sequence to
be detected.”
c. The “target sequence to be detected” includes complementary copies.
Pointing to the ’705 application’s equation of “amplification” to “replication,” Staff
argues that “amplification” requires the creation of exact copiesénot complementary copies—of
the target sequence. In support of this argtunent, Staff points to teclmical dictionaries defining
“replication” as “the process of duplicating or reproducing, as replication of an exact copy of a
polynucleotide strand of DNA or RNA.” Miller-Keane Encyclopedia and Dictionary of
Medicine, Nursing, Allied Health at 1530 (7“‘Ed. 2003) (“Miller-Keane”); see also Oxford
Dictionary of Biochemistry and Molecular Biology at 565 (Oxford Univ. Press 1997) (“Oxford
3 5

Dicti0riary”).12 10X, however, cites references that show that “replication” can be used more
broadly to refer to the creation of complementary copies through reverse transcription. V.
Potapov, er al., Base Modifications Afleeting RNAPolymerase and Reverse Transcriptase
Fidelity, Nucleic Acids Research, Vol. 46, Iss. 11, June 20, 2018 (“Potapov”), at 5753, 5756
(“RNA is replicated by a reverse transcriptase to produce cDNA, then the first strand is
replicated by the same reverse transcriptase to produce double-stranded DNA, which is then
prepared for sequencing by ligating SMRTbell adaptors”); U.S. Patent No. 7,153,672 (‘"672
patent”) at 2:18-20 (“Eukaryotic genomes in particular are filled with mobile elements,
retrotransposons, that use reverse transcriptase for rep1ication.”).13
Consistent with the references cited by 10X, the ’705 application uses “amplification”
(and, by extension, “replication”) broadly to encompass the creation of complementary copies, as
well as exact copies, of a target sequence to be detected. In particular, the ’705 application
discusses “strand displacement amplification” (“SDA”), as one method of target amplification.
’705 application at 20-21. In SDA, a “single stranded target nucleic acid, usually a DNA target
sequence, is contacted with an SDA primer.” Id. at 20. The SDA primcr hybridizes with the
target sequence and is extended by an SDA polymerase to form a “newly synthesized strand.”
Id. at 20-21. The newly synthesized strand is complementary to the original strand. Id. at 21-22.
The ’705 application considers the formation of the complementary strand to be an amplification
reaction noting that a “second amplification reaction can be done using the complementary target
12Excerpts from Miller-Keane and Oxford Dictionary are attached as Exhibits SMX-0006 and
SMX-0005, respectively, to Staff‘s initial brief.
13Popatov and the ’627 patent are attached as Exhibits 16 and 17, respectively, to l0X’s initial
brief.
36

sequence, resulting in a substantial increase in amplification during a set period of time.” Id. at
22. 	I
d. Reverse transcription can be used increase the copy number of the
target sequence to be detected. 	. ,
In support of its construction of “amplification,” Bio-Rad places significant emphasis on
the fact that reverse transcription produces a cDNA copy, not an RNA copy, of an mRNA strand.
RIB at l7 (“mRNA and cDNA are not the same molecule”); Tr. at 82:13-84:12. Ifthe cDNA
copy is the “target sequence to be detected,” however, reverse transcription increases the copy
number of target molecules to be detected and is therefore an amplification reaction. This is
shown in the ’705 application’s discussion of nucleic acid sequence based amplification
(“NASBA”), which the ’705 application teaches can be used for target amplification. ’705
application at 2. In NASBA, “[a] single stranded target nucleic acid, usually an RNA target
sequence,” is used as a first template. Id at 23. A cDNA copy of the first template is
synthesized through reverse transcription. Id. This cDNA copy is the second template. Id. A
strand of DNA complementary to the second template is synthesized resulting in a double
stranded cDNA copy. Id at 23-24. The double-stranded copy is referred to as the third
template. Id. Each strand of the third template is used to generate multiple RNA strands that are
“essentially the same as the first template.” Id. at 24. The method can be repeated using the
newly synthesized RNA strands as the first template for the new cycle. Id; see also U.S. Patent
No. 5,409,818 (“’8l8 patent”), col. 5:54-56 (“Each newly synthesized first template can be
converted to further copies of the second template and the third template byirepeating the
cycle”). 14 	.
14The ’705 application incorporates by reference the ’8l8 patent in its entirety and cites it as
providing a general description of NASBA. ’705 application at p. 22. ’
37

Although the RNA sequence that serves as the first template is described as an “RNA
target sequence,” it is not the “target sequence to be detected.” In a NASBA reaction, the target
sequence to be detected is typically the cDNA copy of the RNA. As the ’705 application notes,
it “will be appreciated by those in the art, [that] it is preferable to detect DNA strands during
NASBA since the presence of the ribonuclease makes the RNA strands potentially labile.” ’705
application at p. 24. In the NASBA process, a substantial portion of the cDNA copies are
produced through reverse transcription reactions. Id. (“[NASBA] result[s] in a single starting
RNA template generating a single DNA duplex; however, since this DNA duplex results in the
creation of multiple RNA strands, which can then be used to initiate the reaction again,
amplification proceeds rapidly.”).’ Accordingly, if the cDNA sequence is the target sequence to
be detected, reverse transcription is an amplification reaction because it increases the copy
nmnber of cDNA strands. On the other hand, if the RNA sequence is the target sequence to be
detected, reverse transcription would not be an amplification reaction because it docs not
increase the copy number of RNA strands.
Staff and Bio-Rad argue that the asserted patents distinguish amplification from reverse
transcription. In particular, they point out that in identifying examples of various reactions that
can be used to amplify polynucleotide analytes, the asserted patents omit reverse transcription.
’204 patent, col. 31:29-40 (“An [sic] suitable amplification method may be utilized, including
polymerase chain reaction (‘PCR’), ligase chain reaction (‘LCR’), helicase-dependent
amplification, linear after the exponential PCR (‘LATE-PCR’) asymmetric amplification, digital
PCR, degenerate oligonucleotide primer PCR (‘DOP-PCR’), primer extension pre-amplification
PCR (‘PEP-PCR’) and ligation mediated PCR, rolling circle amplification, multiple
displacement amplification (‘MDA’), and single primer isothermal linear amplification”); ’53O
38

it
patent, col. 18:40-43 (“Amplification may include PCR amplification, multiple displacement
amplification (MDA), rolling circle amplification and other amplification methods”); ’O24
patent, col. 25:24-28 (“amplification reactions (e.g., PCR, qPCR, reverse-transcriptase PCR,
digital PCR, ete.)”). The lists of amplification reactions provided in the patents are non
exhaustive, as indicated by the use of the words “including,” “may include,” “other amplification
methods,” “e.g.,” and “etc.” Accordingly, the omission of “reverse transcription” from the list of
exemplary amplification reactions is not a basis for finding that reverse for transcription cannot
be used for amplification. Intervet Inc. v. Merial Ltd, 617 F.3d 1282, 1287 (Fed. Cir. 2010)
(“[T]he five deposited strains and listed sequences are ‘representative of’ a ‘type of porcine
circovirus,’ and thus do not constitute the entire scope of the invention”).
Bio-Rad makes two additional arguments in support of its position that the patents
distinguish between amplification and reverse transcription. First, Bio-Rad argues that the ’530
patent discusses reverse transcription and amplification as separate and distinct processes.
Specifically, the second full paragraph of column 18 of the ’530 patent discusses various
amplification methods that can be used to isolate genomic DNA, before discussing the use of
reverse transcription to create cDNA copies of mRNA. Compare ’530 patent, col. 18:39-43
(discussing various methods of amplification) with id., col. 18:51-54 (discussing reverse
transcription). There is no inconsistency between the ’530 patent’s separate discussions of
reverse transcription and amplification in column 18 and finding that reverse transcription can be
used for amplification. In column 18, the ’530 patent is not discussing amplification in general
but amplification of genomic DNA. Ia'., col. 18:37-43 (“For example, genomic DNA may be
isolated with or without amplification. Amplification may include PCR amplification, multiple
displacement amplification (MDA), rolling circle amplification and other amplification
39

methods”). Reverse transcription cannot be used to increase the number of genomic DNA
copies, but——asacknowledged in the same paragraph—is used to increase the number of cDNA
copies. Id., 18:51-54 (“If the isolated polynucleotide is an mRNA, it may be reverse transcribed
into cDNA . . . .”). Thus, the ’53Opatent’s separate treatment of reverse transcription and
amplification of genomic DNA does not indicate that reverse transcription cannot be used for
amplification of cDNA strands. 	'
Second, Bio-Rad argues that the ’530 patent claims reverse transcription and
amplification separately. Specifically, claim 4 depends fiom claim l through claim 3 and
requires the generation of barcoded polynucleotide molecules using reverse transcription. ’53O
patent, col. 49:11-14. Claim 7 depends directly from claim 1 and requires the barcoded
polynucleotide molecules generated in step (c) of claim l to be amplified. ld., col. 49:23-26.
Claims 4 and 7 are sister claims that depend from a common claim, but do not refer back to or
limit each other. Construing amplification to embrace reverse transcription creates no
inconsistency between the two claims. Dependent claim 4 is narrowly drawn to embrace a
particular form of amplification (reverse transcription), while dependent claim 7 is broader and
embraces allfonns of amplification. I
In addition to their arguments conceming the disclosures of the asserted patents, Staff and
Bio-Rad also cite prior art references discussing reverse-transcription PCR (“RT-PCR”). Of
these references, U.S. Patent Application No. 2011/0053798 (“’798 application”) is typical.“ As
described in the application, RT-PCR is a two-step process. ’798 application, fl 0054. The first
step is “forming complementary DNA copies of RNA” through reverse transcription. Id. The
second step is “PCR amplification using the complementary DNA as a template.” 1d. According
15The ’798 application is attached to Bio-Rad’s initial brief as Exhibit RXM-0013.
40

to Staff and Bio-Rad, because these references describe amplification as occurring in the second
step and not the first step, reverse transcription is not amplification. This argument is
unpersuasive. The descriptions do not state that “amplification” occurs in the second step, but
that “PCR amplification” occurs in the second step. Amplification using polymerase chain
reaction (“PCR”) techniques is routinely referred to as “PCR amplification.” For example, the
’530 patent teaches that “[a]mplification may include PCR amplification,” as well as “multiple
displacement amplification (MDA), rolling circle amplification and other amplification
methods.” ’53Opatent, col. 18:40-43; see also id, col 18:29-34 (stating that polynuclcotides
may be obtained through “polymerase chain reaction (PCR) amplification,” as well as
“recombinant cloning, polynucleotide amplification (as generally described in PCT/US99/01705)
. . . purification methods (such as purification of genomic DNA or RNA), and synthesis
reactions”); ’024 patent, col. 22:45-47 (“[I]fPCR amplification is desired . . . .”). Thus, the ’798
application’s reference to “PCR amplification” in describing the second step of the RT-PCR
method indicates only that a specific amplification method is performed in the second step. The
reverse transcription reaction performed in the first step may not be “PCR amplification,” but
this does not mean that reverse transcription is not an amplification reaction.
Moreover, in contrast to the descriptions cited by Staff and Bio-Rad, at least one
description of RT-PCR expressly acknowledges that amplification occurs in the reverse
transcription step of RT-PCR, as well as the PCR step. U.S. Patent Application No.
2015/0315629 (“’629 application”) describes RT-PCR as a two-step reaction in which “the first
amplification reaction is reverse transcription,” and “[t]he single stranded cDNA produced by
reverse transcription is then used for subsequent PCR.” ’629 application, 1]0073.16
'6 The ’629 application is attached to l0X’s initial brief as Exhibit l3.
41

| 	4|
2. Amplification only requires the creation of one or more copies.
Bio-Rad argues that amplification requires the creation of multiple copies and that the
creation of a single copy is not amplification. Such a construction is inconsistent with the claims
of the ’024 patent. Claim 1 of the ’024 patent is directed to a droplet with “a target nucleic acid
analyte” and a gel bead with “at least 1,000,000 oligonueleotide molecules comprising barcode
sequences.” ’024 patent, col. 33:57-60. After the oligonucleotide molecules are released from
the gel bead, “a given oligonucleotide molecule from said oligonucleotide molecules attaches to
said target nucleic acid analyte.” Id., col. 33:65-col. 34:3. The “said given oligonucleotide
molecule attached to said target nucleic acid analyte” is subjected to nucleic acid amplification to
yield “a barcoded target nucleic acid analyte.” Id., col. 33:4-7. Thus, claim 1 of the ’024 patent
uses amplification to refer to the creation of a single copy of a single target nucleic acid.
Although Bio-Rad cites a number of statements in the specifications of the asserted
patents in support of its position, these statements indicate only that amplification can be used to
create multiple copies of a sequence, not that amplification requires the creation of multiple
copies. For instance, Whilethe ’204 patent states that amplification can be used for various
ptuposes “including but not limited to generating multiple copies ofpolynucleotide sequences,”
it specifically notes that amplification can be used to add “adaptor sequences or barcodes to
polynucleotides.” ’204 patent at col. 31:23-25. As shown with respect to claim l of the ’024
patent, using amplification to add a barcode sequence to a polynucleotide does not require the
creation of multiple copies. Bio-Rad also notes that the specification of the ’204 patent teaches
that “amplification may be used to increase the quantity of a polynucleotide.” ’204 patent, col.
24:23-25. The creation of a single copy, however, will increase the quantity of the target
polynucleotide.
42

' 	ii
In a similar vein, Bio-Rad points to the ’798 application and argues that the application
“describes the amplification as a process to ‘form multiple copies of a template/” RIB at 16
(quoting ’798 application, 1]0052). Bio-Rad’s argument is not supported by the full quotation:
“Amp1ification~a process in which a copy number increases. Amplification may be a process
in which replication occurs repeatedly over time to form multiple copies of a template.” ’798
application, 110052. Thus, according to the ’798 application, the creation of multiple copies of
the template is an option, not a requirement, of amplification. Id.
Bio-Rad further notes that the methods identified in the patents as examples of
amplification methods are used to create multiple copies of a target sequence. RIB at 16. The
methods identified in the patents, however, are only examples of amplification reactions and the
patents explicitly indicate that “amplification” is not limited to such methods. ’530 patent, col.
18:40.-43(“Amplification may include PCR amplification, multiple displacement amplification
(MDA), rolling circle amplification and other amplification rncthods.”); ’024 patent, col. 25:24
28 (“amplification reactions (e.g., PCR, qPCR, reverse-transcriptase PCR, digital PCR, etc.)”);
’204 patent, col 31:29-40 (“An suitable amplification method may be utilized, including . . . .”).
Even if the patents were interpreted as teaching that the identified methods are the preferred
amplification methods, the claims would not be limited to such embodiments. See Martek
Biosciences Corp. v. Nutrinova, Ina, 579 F.3d 1363, 1380-82 (Fed. Cir. 2009) (“Although the
patent contemplates that certain animals are ‘[p]referred animals from which to produce a food
product,’ that statement does not disavow human animals because it relates to preferred
embodiments only; it does not state that all animals covered by the claims must produce a food
product”).
43

k
3. Claim 1 of the ’024 patent does not require amplification t0 be
performed in a droplet.
Although it is not explicitly required by its proposed construction, Bio-Rad contends that
the amplification step of claim 1 of the ’024 patent must be performed in a droplet. Claim l of
the ’024 patent is directed to a three-step method. The first step requires “providing a droplet"
with “a target nucleic acid analyte” and a gel bead with “at least 1,000,000 oligonucleotide
molecules comprising barcode sequences.” ’024 patent, col. 33:57-64. The second step requires
the “said oligonucleotide molecules” to be released into “said droplet” and “a given
oligonucleotide molecule from said oligonucleotide molecules attach[] to said target nucleic acid
analyte.” Id., col. 33:65-col. 34:3. In the third step, the “said given oligonucleotidc molecule
attached to said target nucleic acid analyte” is subjected to nucleic acid amplification to yield “a
barcoded target nucleic acid analyte.” Id, col. 33:4-7. Bio-Rad argues that all three steps must
be performed in a droplet. There is no dispute that the first two steps must be performed in a
droplet, but l0X and Staff argue that the third step, an amplification step, can be—-butdoesvnot
have to be—performed in a droplet.
The third step, unlike the first and second steps, makes no reference to the droplet. Bio
Rad argues that because “said given oligonucleotide molecule attached to said target nucleic acid
analyte” refers to antecedents in the second step, the third step must also occur in the droplet of
the second step. Bio-Rad’s argument lacks merit. The requirement that the “said given
oligonucleotide molecule attached to said target nucleic acid analyte” be created in a droplet in
the second step does not mean that it has to remain in the droplet for all subsequent steps. The
use of “comprising” in the preamble of claim l-indicates that there could be additional steps
between the second step and the third step. Vehicular Techs. Corp. v. Titan WheelInfl, Ina, 212
F.3d 1377, 1382-83 (Fed. Cir. 2000) (“The phrase ‘consisting of is a tenn of art in patent law
44

signifying restriction and exclusion, While,in contrast, the tenn ‘comprising’ indicates an open
ended construction. . . . A drafter uses the term ‘comprising’ to mean ‘I claim at least what
follows and potentially more.’”) (internal citation omitted). Thus the claim would cover a four
step method that included a step wherein the droplet was broken after the second step, but before
the third step, so long as all three recited steps are perforrned. See id.
E. “providing”/“said at least 1,000 droplets”/“a plurality of cells”
. 	“providing” (’530 patent, claim 1) .
Party 	Construction
10X Plain meaning
Bio-Rad Indefinite; or, in the alternative, “in one experiment”
Staff “providing as inputs for a droplet generation p_ro_c__e_s_s_”__
””“§iii£iZileast 1,000 droplets” 0530 patent, claim 1)
Party 	Construction
10X “1,000 or more droplets”
Bio-Rad “said at least 1,000 droplets from one experiment”
Staff Plain and ordinary meaning __“_M p 7
' " 	' ‘ _' “a plurality of cells”0530 patent, claim 1)
Party 	Construction
10X “two or more cells”
Bio-Rad Indefinite; or, in the alternative, “a plurality of cell from the same sample”
Staff “two or more cells from a common sample (which may be a pooled sample)”
Claim l of the ’53Opatent is directed to a three-step method. The first step requires
“providing” at least 1,000 gel beads and “a plurality of cells.” ’530 patent, col. 47:60-67 & col.
48:58-64. Barcode molecules are attached to each of the gel beads and each of the cells contains
polynucleotides. Id The second step requires generating “a plurality of droplets, wherein at
least 1,000 droplets of said plurality of droplets each” have “a single gel bead from said plurality
of cells”-and “a single cell from said plurality of cells.” Id., col. 48:60-64. The third step
requires using the polynucleotide molecules and barcode molecules to forrn “a plurality of
barcoded polynucleotide molecules” “in each of said 1,000 droplets.” Id, col. 48:65-col. 49:4.
45

' Bio-Rad asserts that the terms “providing,” “plurality of cells,” and “at least 1,000
droplets” render the claim indefinite because the claim “calls for the generation of 1,000 droplets
containing specific material but does not describe how or under what circumstances those
droplets are formed.” RRB at 23. In making this argument, Bio-Rad confuses breadth with
indefiniteness. Breadth does not render a claim indefinite. BASF Corp. v. Johnson Matthey 1nc.,
875 F.3d 1360, 1367 (Fed. Cir. 2017 (“[B]readth is not indefiniteness/’) (quoting SmithKline
Beecham Corp. v. Apotex C0rp., 403 F.3d 1331, 1341 (Fed. Cir. 2005)) (intemal quotation marks
omitted); Manual of Patent Examining Procedure § 2173.02 (“A broad claim is not indefinite
merely because it encompasses a wide scope of subject matter provided the scope is clearly
defined”). Standing alone and in the context of the claim, the claim terms identified by Bio-Rad
are clear and readily understood “even to lay judges.” Phillips, 415 F.3d at 1314. Based on the
foregoing, I find that Bio-Rad has not shown that claim 1 is indefinite.
Through their proposed constructions, both Staff and Bio-Rad seek to narrow the scope
of the claims of the ’530 patent. As discussed above, a claim term is to be given its plain and
ordinary meaning unless the palentee alters the scope of the term through lexicography or
disavowal. Hill-Rom, 755 F.3d at 1371. Bio-Rad’s proposed constructions of the terms
“providing” and “said at least 1,000 droplets” require the claimed method to be performed in
“one experiment.”17 According to Bio-Rad, this “construction is most consistent with the plain
language of the claim,” because “a person of ordinary skill would normally think of the steps in a
17Staff has proposed that “providing” be construed to mean “providing as inputs for a droplet
generation process.” While 10X does not dispute the substance of Staff’s proposed construction,
it argues that the Staff’s proposed construction is unnecessary in view of other claim limitations.
CIB at 35-36. “Providing” is not a term of art, but rather an ordinary word that is readily
understood by a lay judge. Phillips, 415 F.3d at 1314. Accordingly, I agree with 10X that
Staffs proposed construction is unnecessary.
46

method” as being performed in a single experiment. RIB at 32. Thus, Bio-Rad’s proposed
constructions of the tenns “providing” and “at least 1,000 drops” attempt to construe “method”
as a single “experiment.” As used in the claim, the term “method” is not a term of art, but a legal
term. Nassau Precision Casting Co. v. Acushnet Co., 566 Fed. Appx. 933 (Fed. Cir. 2014) (non
precedential). A “method” is a “process” and both ‘“method’ and ‘process’ have a clear and
settled meaning: ‘a set of actions, necessarily taken over time.’” Id.; see also Bilski v. Kappos,
561 U.S. 593, 607 (2010) (relying on definition of “method” as “way or manner of doing
anything”); Gottschalk v. Benson, 409 U.S. 63, 70 (1972) (defining “a process” as “an act, or a
series of acts”); NTP, Inc. v. Research in Motion, Ltd., 418 F.3d 1282, 1316 (Fed. Cir. 2005)
(defining “a process” as “a series of acts”) (quoting Minton v. Nat ’lAss ’n0fSec. Dealers, Inc.,
336 F.3d 1373, 1378 (Fed. Cir. 2003)) (intemal quotation marks omitted); In re Kollar, 286 F.3d
1326, 1332 (Fed. Cir. 2002) (defining “a process” as “a series of acts or steps”); MPEP § 2106
(“Processfan act, or a series of acts or steps.”). In contrast, as 10X and Staff note, the contours
of What would constitute a “single experiment” is not Well-defmed. CIB at 37-38; SRB at 22 n.
12. Thus, defining “method” as a “single experiment” would only create ambiguity by replacing
a temi that has clear and well-established meaning with one that does not. See E-Pass Tech, Inc.
v. 3Com Corp, 473 F.3d 1213, 1220 (Fed. Cir. 2007) (“[T]he terms courts use to enunciate the
proper construction of a claim are not themselves limitations that require interpretation”).
Bio-Rad’s and Staffs proposed constructions also seek to limit the claimed “pltnality of
cells,” by requiring that the cells be obtained from “the same sample” (Bio-Rad) or “a common
sample (which may be a pooled sample)” (Staft).’ Bio-Rad’s proposed construction of “plurality
of cells” stems from its proposed constructions of “providing” and “at least 1,000 droplets.” RIB
at 33-34 (“Just as a person of ordinary skill in the art attempting to determine the boundaries of
47

' 	‘ 	ta
the claim would focus on the number 1,000 to indicate components of a single experiment, the
person of ordinary skill would limit the undefined term ‘plurality of cells’ to mean cells from one
sample used in that single experiment. That is the way a researcher would think about carrying
out a single experiment according to the steps identified/’). As discussed above, there is no basis
for constming “method” to be a “single experiment.” Accordingly, Bio-Rad’s proposed
construction of “plurality of cells” is rejected.
Staff argues that its proposed construction of “plurality of cells” is necessary in order to
give life to the claim’s numerical limitations requiring at least 1,000 cells, “at least 1,000 gel
beads” and “at least 1,000 droplets.” CIB at 37-3 8.18 According to Staff, absent a requirement
that the plurality of cells be drawn from a common sample, the claim’s “numerical requirements
would not make sense, as the claim could be infringed simply by 5 unrelated repetitions of a
droplet generation process using at least 200 gel beads and least 200 cells, or 10 unrelated
repetitions of the process using at least 100 gel beads and 100 cells, or 20 unrelated repetitions of
the process using at least 50 gel beads and at least 50 cells, etc.” Id. Staff‘s concern about
preserving the vitality of claim 1’s numerical limitations is ungrounded. As drafted, claim 1 is
not satisfied by repeating a process that uses less than required number of cells and gel beads or
generates less than the required ntunber of droplets.
The second step of claim 1’s three-step method requires the generation of “at least 1,000
droplets,” while the third step requires generation of barcoded polynueleotide molecules in each
13Both 10X and Staff have proposed constructions of “plurality of cells” which would
encompass as few as two cells. While such an interpretation is consistent with plain and
ordinary meaning of “plurality,” it is not consistent with a later claim limitation requiring the
generation of at least 1,000droplets, wherein each droplet has “a single cell from said plurality of
cells.” ’530 patent, col. 48:59-64. Thus, within the context of claim l, the claimed “plurality of
cells” must comprise at least 1,000 cells.
48

on
ofthe “said at least 1,000 droplets.” ’530 patent, col. 47:60-67 & col. 48:58-64. This language
requires that all of the “at least 1,000 droplets” be generated before the third step of claim is
performed on any of “said at least 1,000 droplets.” If less than 1,000 droplets are generated in
the second step, then there is no “said at least 1,000 droplets” for the third step. E-Pass, 473
F.3d at 1222 (“[B]ecause the language of most of the steps of its method claim refer to the
completed results of the prior step, E—Passmust show that all of those steps were performed in
order.”). Claim 2, which depends directly from claim 1, supports this interpretation. Claim 2
requires that “prior to (c) [the third step of claim 1], said plurality of polynucleotide molecules
are released from said single cell in each of said at least 1,000 droplets.” ’530 patent, col. 2:5-7.
The added step of claim 2 can only be satisfied if all of the “at least 1000 droplets” are generated
before any of the droplets are subjected to the third step. See Gillette C0. v. Energizer Holdings,
Inc., 405 F.3d 1367, 1373 (Fed. Cir. 2005) (relying on dependent claim’s use ofthe term “a
span” to construe independent claim as covering razors with more than one span between razor
blades). Interpreting claim 1 otherwise would-as Staff correctly notes—negate the elaim’s
numerical limitations. Such a result is strongly disfavored. Wasica Finance GmbH v. Cont’!
Automotive Sys., Inc., 853 F.3d 1272, 1288 n. 10 (Fed. Cir. 2017) (“Construing ‘bit sequence’ to
allow for an empty, zero-bit sequence would effectively remove the ‘first bit sequence,’ ‘second,
or third bit sequence,’ and ‘fourth and final bit sequence’ limitations from the claim, as it would
make them optional or potentially nonexistent. It is highly disfavored to construe terms in a way
that renders them void, meaningless, or superfluous”) (internal citations omitted); Bicon Inc. v.
Straumann, C0., 441 F.3d 945, 950-51 (Fed. Cir. 2006) (“[Cjlaims are interpreted with an eye
toward giving effect to all terms in the claim.”). Accordingly, a method that generates less than a
1,000 droplets will not infringe claim 1 irrespective _ofhow many times that method is
49

9|
performed. See In re Varma, 816 F.3d 1352, 1362-64 (Fed. Cir. 2016) (finding that the claim
requiring “a statistical analysis request corresponding to two or more selected investments” did
not encompass two single-investment analyses conducted seriatim, but required two investments
to be analyzed at the same time).
1OX’sarguments to the contrary are unpersuasive. While conceding that “unrelated
repetitions of non-infringing processes” would not “constitute a single infringing process,” 10X
contends that the 1,000-droplet threshold can be met though “multiple runs” so long as the runs
“are all done as part of the same process.” CRB at 21, 40. As discussed above, such an
interpretation is contrary to the language of claims 1 and 2. In support of its positon, 10X points
to portions of the specification of the ’530 patent, which 10X argues teach that the claimed
method can be repeated. See, e.g., ’530 patent, col. col. 36:49-50 (“With continued reference to
FIG. 2, the methods described above are then repeated . . . .”). 10X’s reliance on these portions
of the specification is misplaced. First, the cited portions of the specification relate to methods
for the “[g]encration of [n]on-[o]verlapping DNA [flragments for [s]equencing,” not the claimed
method, which is a “method for nucleic acid preparation or analysis.” Compare id, col. 36:6-7
with id., col. 47:58-59. Second, While the specification states that the “methods” can be
repeated, there is no suggestion that the number of partitions (droplets) used in each repetition
can be aggregated. Third, even if the specification disclosed aggregating the number of
partitions used in multiple runs of the same method, such a disclosure cannot expand the scope
of claim 1. See Scheonhaus v. Genesco, Inc., 440 F.3d 1354, 1359 (Fed. Cir. 2006) (“[W]here a
patent specification includes a description lacking a feature, but the claim recites that feature, the
language of the claim controls”). As discussed above, the claim language ofclaim 1 requires
50

9'!
that all of the “at least 1,000 droplets” be formed before the third step is performed on any of the
droplets.
Based on the foregoing, I find that claim 1 requires that the step of generating “at least
1,000 droplets” be completed before the third step of fonning a “plurality of barcoded
polynucleotide molecules” is performed in any of the droplets. With that clarification, I find that
the terms “providing,” “said at least 1,000 droplets,” and “a plurality of cells” recited in claim 1
of the ’530 patent should be given their plain and ordinary meaning.
VI. CONCLUSION
For the reasons discussed above, I construe the disputed terms from the asserted patents
as follows:
The term “1,000,000 oligonucleotides comprising barcode sequences” recited in claim 1
of the ‘O24patent and claim 1 of the ’468 patent means “1,000,000 oligonucleotide molecules
that include, but are not necessarily limited to, barcode sequences.”
The term “releasably attached” recited in claim 1 of the ‘O24patent and claim 1 of the
’468 patent means “attached in a manner that allows the attached object to be released.”
No construction is necessary for the term “reversibly immobilized” recited in claim 15 of
the ’024 patent.
The term “amplification” recited in claims 1 and 8 of the ’024 patent and claims 2 and 21
of the ’468 patent; the term “amplifying” recited in claim 11 of the ’468 patent and claim 6 of
the ’530 patent; and the tenn “amplify” recited in claim 10 of the ’024 patent means “increasing
the number of copies of the target sequence to be detected.” The copies can be exact copies or
complementary copies. Reverse transcription is a form of amplification if a cDNA sequence is
the target sequence to be detected. Amplification only requires the creation of one or more
copies of a template.
51

ll
lllfif in
The amplification step of claim 1 of the ’O24patent can be—but does not have to be_—
perfonned in a droplet.
The terms “providing,” “said at least 1,000 droplets,” and “a plurality of cells” recited in
claim 1 of the ’53Opatent should be given their plain and ordinary meaning. As a point of
clarification, the step of generating “at least 1,000 droplets” must be completed before “a
plurality of barcoded polynucleotide molecules” is formed in any of the “said at least 1,000
droplets.”
Hereafter, discovery and briefing in this Investigation shall be governed by the
construction of the claim tenns in this Order.
so ORDERED. 	'
Q» law/L” 	r
Dee Lord
Administrative Law Judge
52

CERTAIN MICROFLUIDIC SYSTEMS AND 	Inv. No. 337-TA-1100
COMPONENTS THEREOF AND PRODUCTS
CONTAINING SAME
PUBLIC CERTIFICATE OF SERVICE
I, Lisa R. Barton, hereby certify that the attached ORDER has been served by hand upon
the Commission Investigative Attomey, Monica Bhattacharyya, Esq., and the following parties
as indicated, on October 31, 2018.
.3
Lisa R. Barton, S cretary
U.S. International Trade Commission
500 E Street, SW, Room 112
A 	Washington, DC 20436
On Behalf of Complainants 10X Genomics. Inc.:
Paul T. Ehrlich, Esq. 	U ia Hand Delivery
TENSEGRITYLAW GROUPLLP 	A1 ExpressDelivfiry
DT.,‘ U Class
Redwood Shores, CA 94061 	D other
On Behalf of Respondents Bio-Rad Laboratories, Inc.:
5- Alex Lasher, ESq- 	B ia Hand Delivery
I Sheet NW, SUIIC 	. 	U First Class
Washington, DC 20005 	U other

UNITED STATES INTERNATIONAL TRADE COMMISSION
Washington, D.C.
In the Matter of 	_
CERTAIN MICROFLUIDIC SYSTEMS 	Investigation N0_337_TA_l100
AND COMPONENTS THEREOF AND
PRODUCTS CONTAINING SAME
NOTICE OF COMMISSION DETERMINATION NOT TO REVIEW AN INITIAL
DETERMINATION GRANTING A SUMMARY DETERMINATION THAT THE
COMPLAINANT HAS SATISFIED THE ECONOMIC PRONG OF THE DOMESTIC
INDUSTRY REQUIREMENT
AGENCY: U.S. International Trade Commission.
ACTION: Notice.
SUMMARY: Notice is hereby given that the U.S. Intemational Trade Commission
(“Commission”) has determined not to review an initial determination (Order No. 19) (“ID”)
granting a summary determination that the complainant has satisfied the economic prong of the
domestic industry requirement in this investigation.
FOR FURTHER INFORMATION, CONTACT: Ron Traud, Office of the General Counsel,
U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone 202
205-3427. Copies of non-confidential documents filed in connection with this investigation are
or will be available for inspection during official business hours (8:45 a.m. to 5:15 p.m.) in the
Office of the Secretary, U.S. International Trade Commission, 500 E Street SW., Washington,
DC 20436, telephone 202-205-2000. General information concerning the Commission may also
be obtained by accessing its Intemet server at httQs.'//www.usitc.gov. The public record for this
investigation may be viewed on the Commission’s electronic docket (“EDIS”) at
httgs://edis. usitc.gov. Hearing-impaired persons are advised that information on this matter can
be obtained by contacting the Comtnission’s TDD terminal, telephone 202-205-1810.
SUPPLEMENTARY INFORMATION: On February 21, 2018, the Commission instituted this
investigation based on a complaint filed by 10X Genomics, Inc. of Pleasanton, CA (“10X”). 83
FR 7491 (Feb. 21, 2018). The complaint alleges violations of section 337 of the Tariff Act of
1930, as amended, 19 U.S.C. 1337, based upon the importation into the United States, the sale
for importation, and the sale within the United States after importation of certain microfluidic
systems and components thereof and products containing same by reason of infringement of one
or more of claims 1-4, 6-9, 17, 20, 21, 23, 25, 27, 29, 31, and 33 ofU.S. Patent No. 9,644,204;
claims 1, 2, 5, 8, 10, 11,-13, 15-17, 19, 21, and 22 ofU.S. Patent No. 9,689,024; claims 1-4, 6-9,
11, 12, 21, and 22 ofU.S. Patent No. 9,695,468; and claims 1-6, 8-11, 14-20, and 24-30 of U.S.

Patent No. 9,856,530. Id. The Con1rnission’sNotice of Investigation named as the sole
respondent Bio-Rad Laboratories, Inc. of Hercules, CA. _1d.The Office of Unfair Import
Investigations is participating in this investigation. Ia’.
On October 5, 2018, the ALJ issued the subject ID (Order No. 19), which grants 10X’s
unopposed motion for a summary determination that it has satisfied the economic prong of the
domestic industry requirement. N0 petitions for review of the subject ID were filed. The
Commission has determined not to review the ID.
The authority for the Commission’s determination is contained in section 337 of the
Tariff Act of 1930, as amended (19 U.S.C. 1337), and in part 210 ofthe Commission’s Rules of
Practice and Procedure (19 CPR part 210).
By order of the Commission.
Lisa R. Barton
Secretary to the Commission
Issued: November 6, 2018
2

CERTAIN MICROFLUIDIC SYSTEMSAND 	Inv. No. 337-TA-1100
COMPONENTS THEREOF AND PRODUCTS
CONTAINING SAME
PUBLIC CERTIFICATE OF SERVICE
I, Lisa R. Barton, hereby certify that the attached NOTICE has been sewed by hand
upon the Commission Investigative Attorney, Monica Bhattacharyya, Esq., and the following
parties as indicated, on November 6, 2018.
Lisa R. Barton, Secretary
U.S. International Trade Commission
500 E Street, SW, Room 112
Washington, DC 20436
On Behalf of Complainants 10X Genomics. Inc.:
Paul T. Ehrlich 	II Via Hand Delivery
TENSEGRITY LAW GROUP LLP 	[J Via Express Delivery
555 Twin Dolphin Dr., Suite 650 	Via First class Mail .
Redwood Shores, CA 94061 	U Other:
On Behalf of Respondents Bio-Rad Laboratories. Inc.:
S. Alex Lasher 	U Via Hand Delivery
QUINN EMANUEL URQUHART & SULLIVAN, LLP 	[| Via Express Delivery
Stffifit NW, SUIIB 	First Class l
Washmgton, DC 20005 	U other

PUBLIC VERSION
UNITED STATES INTERNATIONAL TRADE COMMISSION
Washington, D.C.
In the Matter of
CERTAIN MICROFLUIDIC SYSTEMS
AND COMPONENTS THEREOF AND
PRODUCTS CONTAINING SAME
Inv. No. 337-TA-1100
ORDER NO. 19: INITIAL DETERMINATION GRANTING SUMMARY
DETERMINATION THAT COMPLAINANT HAS SATISFIED THE
ECONOMIC PRONG OF THE DOMESTIC INDUSTRY
REQUIREMENT
(October 5, 2018)
On August 15, 2018, Complainant 1OX Genomics, Inc. ("1OX") moved for summary
determination that l 0X's investments in the United States in the products that IOX alleges
practice the claims of the asserted patents (the "domestic industry" or "DI" products) satisfy the
economic prong of the domestic industry requirement under each subsection of 19 U.S.C.
§ 1337(a)(3)(A)-(C). Motion Docket No. 1100-010 (the "motion"). The motion is unopposed.
Further, l0X and Respondent Bio-Rad Laboratories, Inc. ("Bio-Rad") have stipulated that lOX
satisfies the economic prong of the domestic industry requirement by making significant and
substantial investments in the DI products in the United States under each subsection of section
337(a)(3). Motion, Exhibit A (the "Stipulation").
Federal Rule of Civil Procedure 56(a) provides a party may seek summary judgment
upon "all or part" of a claim. Fed.R.Civ.P. 56(a).1 Under section 337, summary determination
1 Commission Rule 210.18 is analogous to a motion for summary judgment under Rule 56.
Certain Carbon and Alloy Steel Products, Inv. No. 337-TA-1002, Initial Determination, 2017
WL 5167413 at *11, not reviewed by Commission Notice, 2017 WL 6434923 (Nov. 1, 2017).

PUBLIC VERSION
can be granted as to the economic prong even where disputes remain concerning the technical
prong. E.g. , Certain Composite Aerogel Insulation Materials and Methodsfor Manufacturing
the Same, Inv. No. 337-TA-1003, Order No. 19 at 2-3 (Nov. 15, 2016), unreviewed in pertinent
part by Cornm'n Notice (Dec. 2, 2016) at 1-2; Certain Graphics Processing Chips, Systems on a
Chip, and Products Containing the Same, Inv. No. 337-TA-941, Order No. 12 (July 16, 2015).
I have reviewed lOX's statement of undisputed material facts and the parties' stipulation.
I conclude that the undisputed facts stated therein satisfy the Commission's requirements under
the economic prong of section 337(a)(3)(A), (B), and (C), as a matter oflaw. The facts stated in
the parties' Stipulation are adopted and incorporated into this initial determination by reference.2
As stated by the Commission in Investigation No. 337-TA-1097:
In patent proceedings under section 337, a complainant must establish
that an industry "relating to the articles protected by the patent ... exists
or is in the process of being established" in the United States. 19 U.S.C.
§ 1337(a)(2). Under Commission precedent, the domestic industry
requirement of section 337 consists of an "economic prong" and a
"technical prong." See, e.g., Alloc, Inc. v. Intl Trade Comm'n, 342 F.3d
1361, 1375 (Fed. Cir. 2003).
The "economic prong" of the domestic industry requirement is satisfied
when it is determined that the economic activities and investments set
forth in subsections (A), (B), and/or (C) of section 337(a)(3) have taken
place or are taking place. Certain Variable Speed Wind Turbines &
Components Thereoflnv. No. 337-TA-376, USITC Pub. No. 3003,
Comm'n Op.at 21 (Nov. 1996) ("Wind Turbines''). With respect to the
"economic prong," 19 U.S.C. § 1337(a)(3) provides that:
[A]n industry in the United States shall be considered to exist if there is
in the United States, with respect to the articles protected by the patent,
copyright, trademark, mask work, or design concemed-
(A) significant investment in plant and equipment;
2 Bio-Rad stipulates only that the economic prong of the domestic industry requirement, not the
technical prong, has been satisfied. Bio-Rad disputes that l0X's products practice any of the
asserted patents. This decision makes no findings concerning the technical prong, or any issue in
this investigation, other than satisfaction of the economic prong.
2

PUBLIC VERSION
(B) significant employment of labor or capital; or
(C) substantial investment in its exploitation, including engineering,
research and development, or licensing.
Given that these criteria are listed in the disjunctive, satisfaction of any
one of them will be sufficient to meet the domestic industry requirement.
Wind Turbines, Inv.No. 337-TA-376, Comm'n Op. at 15.
The statutory text of section 337 does not limit sections 337(a)(3)(A) and
(B) to investments related to manufacturing or any other type of industry.
It only requires that the domestic investments in plant and equipment,
and employment of labor or capital be "with respect to the articles
protected by the patent." 19 U.S.C.§ 1337(a)(3). Moreover, even though
subsection (C) expressly identifies "engineering" and "research and
development" as exemplary investments in the "exploitation" of the
patent, that language does not unambiguously narrow subsections (A)
and (B) to exclude those same types of investments. 19 U.S.C. §
1337(a)(3)(C).
Comm'n Op. at 7-8.
There is no dispute that 1OX has provided sufficient evidence to satisfy the economic
prong under subsection (A), (B) and (C) of section 337 with respect to the DI products, which
are lOX's GemCode™ and Chromium™ product lines for single-cell and linked-read
applications, including with respect to each of Chromium™ Genome Solution, ChromiumTM
Exome Solution, Chromium™ de nova Assembly Solution, and GemCode™ Long Read
platform (collectively, "lOX's linked-read applications"), and Chromium™ Single Cell 3'
Solution, Chrorniwn™ Single Cell V(D)J Solution, and GemCode™ Single Cell platform
(collectively, "lOX's single-cell applications). Stipulation at ,r 1-2. A summary of the
expenditw·es related to the DI products folJows, as stipulated to by the parties.
The parties agree that 1OX has made significant investments in plant and equipment
related to each of the DI Products. 19 U.S.C. § 1337(a)(3)(A). Specifically, 1OX maintains its
headquarters, including its manufacturing facility, in Pleasanton, California.
3

PUBLIC VERSION
The parties also agree that 1OX has made significant investments in the United States in
labor and capital related to each of the DI products. 19 U.S.C. §1337(a)(3)(B).
l0X's entire labor force is
substantially dedicated to manufacturing, developing, selling, promoting and supporting l0X's
DI products.
4

PUBLIC VERSION
Further, IOX has made substantial investments in the U.S. in the exploitation ofthe
asserted patents through the engineering, research and development of each ofthe DI products.
19 U.S.C. §1337(a)(3)(C).
The par
ties agree, moreover, that 1OX's investments are significant and substantial both
qualitatively and quantitatively. Id. at ,i 7. The parties stipulate that activities involving 10X's
DI Products account for substantially all of 1 0X's operations. Id. at ,i 77.
Accordingly, Motion Docket No. 1100-010 is GRANTED.
5

PUBLIC VERSION
Pursuant to Commission Rule 210.42(h), this initial determination shall become the
determination of the Commission unless a party files a petition for review of the initial
determination pursuant to Commission Rule 210.43(a), or the Commission, pursuant to
Commission Rule 210.44, orders, on its own motion, a review of the initial determination or
certain issues contained herein. 19 C.F.R. § 210.42( d).
This order is being issued with a confidential designation, and pursuant to Ground Rule
1.10, each party shall submit to the Administrative Law Judge a statement as to whether or not it
seeks to have any portion of this order deleted from the public version within seven (7) days.
See 19 C.F.R. § 210.5(f). A party seeking to have a portion of the order deleted from the public
version thereof must attach to its submission a copy of the order with red brackets indicating the
portion(s) asserted to contain confidential business information.3 The parties' submissions under
this subsection need not be filed with the Commission Secretary but shall be submitted by paper
copy to the Administrative Law Judge and by e-mail to the Administrative Law Judge's attorney
advisor.
SO ORDERED.
�f,�
Dee Lord
Administrative Law Judge
3 Redactions should be limited to avoid depriving the public of the basis for understanding the
result and reasoning underlying the decision. Parties who submit excessive redactions may be
required to provide an additional written statement, supported by declarations from individuals
with personal knowledge, justifying each proposed redaction and specifically explaining why the
information sought to be redacted meets the definition for confidential business information set
forth in Commission Rule 201.6(a). 19 C.F.R. § 201.6(a).
6

CERTAIN MICROFLUIDIC SYSTEMS AND
COMPONENTS THEREOF AND PRODUCTS
CONTAINING SAME
Inv. No. 337-TA-1100
PUBLIC CERTIFICATE OF SERVICE
I, Lisa R. Barton, hereby certify that the attached ORDER has been served by hand upon
the Commission Investigative Attorney, Monica Bhattacharyya, Esq., and the following parties
as indicated, on October 31, 2018.
On Behalf of Complainants lOX Genomics, Inc.:
Paul T. Ehrlich, Esq.
TENSEGRITY LAW GROUP LLP
555 Twin Dolphin Dr., Suite 650
Redwood Shores, CA 94061
��3 :::::Lisa R. Barton, Secretary
U.S.International Trade Commission
500 E Street, SW, Room 112
Washington, DC 20436
D)Tia Hand Delivery
6Via Express Delivery
□ Via First Class Mail
D Other:------
On Behalf of Respondents Bio-Rad Laboratories, Inc.:
S. Alex Lasher, Esq.
QUINN EMANUEL URQUHART & SULLIVAN, LLP
1300 I Street NW, Suite 900
Washington, DC 20005
□j.ia Hand Delivery
J;K'\/ia Express Delivery
□ Via First Class Mail
D Other:------