Ex parte Chowdhury

UNITED STATES PATENT AND TRADEMARK OFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. 	FILING DATE 	FIRST NAMED INVENTOR 	ATTORNEY DOCKET NO. 	CONFIRMATION NO.
17/005,548 	08/28/2020 	Dipanjan Chowdhury 	1971.D01US/680.1971US02 	4105
194190 	7590 	02/05/2026 	EXAMINER
MRG/Dana-Farber Cancer Institute, Inc. HANEY, AMANDA MARIE	
c/o Mueting Raasch Group
111 WASHINGTON AVE. S., SUITE 700 ART UNIT 	PAPER NUMBER	MINNEAPOLIS, MN 55401
1682
NOTIFICATION DATE 	DELIVERY MODE
02/05/2026 	ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address( es):
ip_ docketing@dfci.harvard.edu
ptodocketing@mrgs.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte DIPANJAN CHOWDHURY and CHANDAN GUHA
Appeal 2025-002261
Application 17 /005,548
Technology Center 1600
Before DEBORAH KATZ, RYAN H. FLAX, and
CYNTHIA M. HARDMAN, Administrative Patent Judges.
FLAX, Administrative Patent Judge.
DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals the Examiner's
rejections of claims 60, 66, 67, 88, 90-95, and 101-104, which stand
rejected as reciting improper Markush groupings.2 We have jurisdiction
under 35 U.S.C. § 6(b).
We reverse.
1 "Appellant" herein refers to the "applicant" as defined by 37 C.F.R. § 1.42.
Appellant identifies "Dana-Farber Cancer Institute, Inc. and Albert Einstein
College of Medicine, Inc.," as the real parties-in-interest. Appeal Br. 3 (we
refer to the first Appeal Brief filed October 16, 2024, and the supplemental
Appeal Brief filed October 30, 2024, interchangeably).
2 A rejection under 35 U.S.C. § 101 was withdrawn. 	See Advisory Action
(June 26, 2024); see also Answer 3 (listing grounds of rejection).

Appeal 2025-002261
Application 17 /005,548
BACKGROUND AND CLAIMED SUBJECT MATTER
The Specification3 states, "[m]icroRNAs (miRNAs) are small non
coding RNAs, typically about 19-22 nucleotides in size, that play important
roles in the regulation of gene expression and various biological processes,
such as cell cycle control. 	MiRNAs have been implicated in a number of
diseases and are detected in biological fluids, such as serum." Spec. 2. 	The
Specification further states that
specific changes in the serum levels of specific miRNAs occur
in subjects that have been exposed to total body irradiation, and
that the changes in the levels of these specific miRNAs are
radiation dose-dependent and correlate with a subject's risk of
subsequent development of radiation disease, a subject's risk of
poor prognosis from radiation exposure, and the efficacy of a
treatment for reducing radiation-induced damage in a subject
exposed to a significant dose of radiation (e.g., when the
treatment for reducing radiation-induced damage in a subject is
administered before or after total body irradiation).
Id. 	The Specification goes on to list dozens of miRNAs that fall into this
category. 	Id. at 2-4.
The Specification describes that embodiments of the invention include
the following basic steps, conducted using well-known techniques:
(1) isolate and amplify miRNAs in a sample of biological fluid; (2) contact
the amplified products to a substrate; and (3) detect the amplified miRNA
products bound to the substrate. 	Id. at, inter alia, 43, 94-95, 102, 108, 114.
The Specification explains that this miRNA assay and quantification allows
the determining of a patient's exposure to and risk from radiation before the
onset of symptoms. 	Id. at 66-68.
3 "Specification" or "Spec." refers to the application disclosure as filed.
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Appeal 2025-002261
Application 17 /005,548
Claim 60, reproduced below, is representative of the rejected claims:
60. A method of treating radiation-induced damage in a
human subject in need thereof, the method comprising:
(a) determining at a first time point a first level of one or
more miRNAs in a first serum sample obtained from the human
subject, wherein the one or more miRNAs is selected from the
group consisting of miR-130a-3p, miR-150-Sp, miR-142-Sp,
miR-706, miR-342-3p, miR-136-Sp, miR-17-3p, miR-126-3p,
miR-322-3p, miR-34b-3p, miR-187-3p, miR-194-Sp, miR-27a-
3p, miR-30a-3p, and miR-30c-5p;
(b) after the first time point and before a second time
point, administering a first treatment for reducing radiation
induced damage to the human subject, wherein the first
treatment for reducing radiation-induced damage is selected
from the group consisting of: a cytokine, potassium iodide,
Prussian blue, diethylenetriamine pentaacetic acid, bone
marrow transplantation, blood transfusion, and surgery to
remove damaged tissues;
(c) determining a second level of the one or more
miRNAs of step (a) in a second serum sample obtained from
the human subject at the second time point; and
(d) (i) determining that the first treatment administered in
step (b) was effective and administering one or more additional
doses of the first treatment for reducing radiation-induced
damage to the human subject; or
(d) (ii) determining that the first treatment administered
in step (b) was not effective and administering a second
treatment for reducing radiation-induced damage to the human
subject, wherein the first treatment for reducing radiation
induced damage is not the same as the second treatment for
reducing radiation-induced damage;
wherein one or more of:
(i) an elevation in the second level of one or more
miRNAs selected from the group consisting ofmiR-136-Sp,
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Appeal 2025-002261
Application 17 /005,548
miR-322-3p, miR-142-Sp, miR-706, miR-150-Sp, miR-342-3p,
miR-17-3p, miR-187-3p, miR-194-Sp, and miR-27a-3p, and
(ii) a decrease in the second level of one or more
miRNAs selected from the group consisting ofmiR-130a-3p,
miR-126-3p, miR-34b-3p, miR-30a-3p, and miR-30c-Sp,
as compared to the first level(s) of one or more miRNAs
selected from the group consisting ofmiR-136-Sp, miR-322-3p,
miR-142-Sp, miR-706, miR-150-Sp, miR-342-3p, miR-17-3p,
miR-187-3p, miR-194-Sp, miR-27a-3p, miR-130a-3p, miR-
126-3p, miR-34b-3p, miR-30a-3p, and miR-30c-5p, indicates
that the treatment for reducing radiation-induced damage
administered to the human subject was effective.
Appeal Br. 28 (Claims App'x).
REJECTION
Claims 60, 66, 67, 88, 90-95, and 101-104 stand rejected as
containing improper Markush groupings.4 Final Action 6-10.
4 Appellant states:
the Examiner does not list claim 97 or claim 98 among the
rejected claims in the body of the Final Office Action or in the
body of the Advisory Action. 	See January 2024 Final Office
Action, page 6, and June 2024 Advisory Action, page 2.
Therefore, Appellant assumes that claims 97, 98, and
105-107 are allowed and that claims 60, 66-67, 88, 90-95, and
101-104 are the subject of this appeal (see Claims Appendix).
Appeal Br. 5; see also Answer 3 (confirming rejected claims) and Advisory
Action summary sheet, item 15 (listing allowed and rejected claims).
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Appeal 2025-002261
Application 17 /005,548
OPINION
I. 	LEGAL STANDARDS
A. 	BURDEN & STANDARD OF REVIEW
"[T]he examiner bears the initial burden, on review of the prior art or
on any other ground, of presenting aprimafacie case ofunpatentability. 	If
that burden is met, the burden of coming forward with evidence or argument
shifts to the applicant." In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992).
Arguments made by Appellant in the Appeal Brief and properly presented in
the Reply Brief (dated April 18, 2025) have been considered. 	See 37 C.F.R.
§ 41.37(c)(l)(iv) (2021). 	We review the record, per Appellant's arguments,
for (reversible) examiner error.
B. 	MARKUSH GROUPS
According to the Office's Manual of Patent Examination Procedure
("MPEP") § 2117.I, "[a] 'Markush' claim recites a list of alternatively
useable members. 	In re Harnisch, 631 F.2d 716, 719 ... (CCPA 1980)."
Furthermore, according to MPEP § 2117 .II:
A Markush claim may be rejected under judicially
approved "improper Markush grouping" principles when the
claim contains an improper grouping of alternatively useable
members. A Markush claim contains an "improper Markush
grouping" if either: ( 1) the members of the Markush group do
not share a "single structural similarity" or (2) the members do
not share a common use. 	Supplementary Guidelines at 7166
(citing In re Harnisch, 631 F.2d 716, 721-22[)] ....
Where a Markush grouping describes part of a
combination or process, the members following "selected from
the group consisting of' (or a similar introductory phrase) must
be substitutable, one for the other, with the expectation that the
same intended result would be achieved. 	Multilayer Stretch
Cling Film Holdings, Inc. v. Berry Plastics Corp., 831 F.3d
1350, 1357 ... (Fed. Cir. 2016)("It is generally understood that
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Appeal 2025-002261
Application 17 /005,548
... the members of the Markush group ... are alternatively
usable for the purposes of the invention . ... ")(citations
omitted).
(emphasis added). 	Per the quoted MPEP text above, the Office cites
Multilayer Stretch as explaining the law, in particular, quoting that a
Markush group's members must be "alternatively usable/or the purposes of
the invention." Multilayer Stretch, 831 F.3d at 1357 (emphasis added).
Multilayer Stretch also phrases this another way: the "listed group of species
... are useful for the purposes of the claim." Id. (in the cited case, the claim
listed resin materials that were usable in an inner, strong and stretchable,
layer of a multilayer film). 	Thus, when considering the propriety of the
members of a recited Markush group, the context of the claimed invention is
of paramount importance.
II. 	ANALYSIS OF THE REJECTION
The Examiner determines that the claims' listings of miRNAs (the
lists are extensive and we will not reproduce them here, but see quoted
independent claim 60 above as an example) constitute improper Markush
groups. Final Action 7. 	The Examiner determines that the recited lists of
miRNAs "do not share a single structural similarity, as each miRNA has a
different chemical structure in that it consists of a different nucleotide
sequence. The only structural similarity present is that all of the miRNAs
comprise nucleotides." Id. at 9. 	The Examiner continues, "the recited
miRNAs do not belong to a chemical or art-recognized class because there is
no expectation from the knowledge in the prior art that the miRNAs behave
in the same manner and can be substituted for one another with the same
intended result achieved." Id.
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Application 17 /005,548
The Examiner states that, "while the different miRNAs are asserted to
have the property of being correlated with radiation exposure, they do not
share a substantial structural similarity essential to this activity." Id. 	Thus,
the Examiner concludes that "the recited miRNAs are not members of the
same recognized physical or chemical class or the same art-recognized
class," and, therefore, the recited lists of miRNAs are improper Markush
groups per the MPEP § 706.07 (now MPEP § 2117)5. Id. at 12.
Appellant argues that "when the Markush group occurs in a claim
reciting a process or a combination (not a single compound), it is sufficient
if the members of the group are disclosed in the specification to possess at
least one property in common which is mainly responsible for their function
in the claimed relationship, and it is clear from their very nature or from the
prior art that all of them possess this property." Appeal Br. 17 (citing In re
Harnisch, 631 F .2d at 724 ). 	Appellant argues that, "[t ]he instant claims are
not drawn to the members of the Markush group as compounds per se, i.e.,
the claims are not compound or composition of matter claims reciting a
Markush group of miRNA molecules. Rather, the claims are directed to
methods of treating that use a cellular state or miRNA signature that is
present after exposure to radiation." Id. at 20.
Moreover, as argued by Appellant, "[t]he miRNAs recited in the
claim[ s] are markers, i.e., whose presence or relative amount( s) trigger (or
not) the steps of the claimed method of treatment." Id. at 21. As markers,
argues Appellant, the miRNAs of the claims are substitutable for one
another and they are structurally similar enough to be classified as a unified
5 See Appeal Br. 18 n.3 (identifying this modification to the MPEP).
7

Appeal 2025-002261
Application 17 /005,548
class in the context of the claimed methods, thus, the recited Markush
groups are proper. 	See id. at 21-24.
We find Appellant's arguments persuasive.
The seminal case regarding claims reciting a Markush group is, as
cited by the MPEP (above), In re Harnisch, 631 F.2d 716. 	In Harnisch, the
invention related to compounds useful as dyes and claimed a group of such
that were actual dyes or intermediates of dyes, which the court found to be
of "a single structural similarity" in this claimed objective so as to be
considered to "belong to a subgenus, as defined by appellant, which is not
repugnant to scientific classification." Id. at 722. The court called this a
"unity of invention," similar to the facts of prior case In re Jones, 162 F.2d
4 79 (CCPA 1947), where "the court found all of the [claimed Markush
group] compounds included in the claims were plant growth stimulants, thus
having a common function," therefore, the court reversed a rejection for an
improper Markush group. 	Harnisch, 631 F.2d at 722.
What both of these cases make clear, particularly in view of the
Federal Circuit's holding in Multilayer Stretch, quoted above, is that, if a
recited Markush group lists a set of things that the inventor describes as a
subgenus, and those things are described in the specification as useful for the
function of the invention because of their similarities, then their inclusion in
a Markush group is not improper.
This concept is also illustrated by the language of MPEP § 2117.II.A:
A recognized physical class, a recognized chemical class, or an
art-recognized class is a class wherein there is an expectation
from the knowledge in the art that members of the class will
behave in the same way in the context of the claimed
invention. 	In other words, each member could be substituted
one for the other, with the expectation that the same intended
8

Appeal 2025-002261
Application 17 /005,548
result would be achieved. 	For example, in the context of a
claim covering a disposable diaper, a limitation "the fastener
selected from the group consisting of a pressure sensitive
adhesive and complementary release material, a complementary
hook and loop structure, a snap, and a buckle" would likely be
considered an art recognized class because a review of the prior
art would establish that it was well known that each member
could be substituted for each other with the expectation that the
intended result (repositionable and refastenable) would occur.
(emphasis added). 	As shown by the diaper claim example, a Markush
group's species may be structurally divergent, i.e., a buckle is very different
than a hook and loop structure, but if they would be expected to perform the
same function in the context of the invention, they are properly grouped.
The Examiner states, "[t]he examiner agrees that the claimed miRNAs
are all disclosed in the specification to be correlated with the radiation
exposure." Final Action 10. 	"[T]he Examiner acknowledges that ... the
miRNAs are transcribed and processed the same way." Answer 8. 	Thus, the
Examiner acknowledges some structural and functional similarity amongst
the recited group of miRNAs, in the context of the invention. The
Examiner, however, then asserts that "it is essential to study the function of
each miRNA singularly and in a specific cellular context in order to
understand its precise function." Id. at 9 (emphasis omitted) (quoting
"Oliveto (WJBC Feb 26, 2017 Vol 8 Issue 1 pages 45-56)"). The
Examiner's position is that the claimed lists of miRNAs must perform their
biological miRNA functions in some way, in relation to the claimed
invention, but the Examiner misinterprets or overlooks the claimed
invention. 	Individual miRNA functionality is not contemplated in the
context of the claimed invention.
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Appeal 2025-002261
Application 17 /005,548
Here, as acknowledged by the Examiner, the Specification identifies
the claimed miRNA species as representative of a patient's exposure to
radiation, as they are quantifiable and can be observed to either increase or
decrease in quantity as a patient's reaction to such exposure. 	See, e.g., Spec.
2-4. 	The listed miRNA species need not function as miRNAs, in the same
way, to the same end, or at all, for the invention to work. 	The listed miRNA
species need only be quantifiable to achieve the invention's purpose and this
function is not disputed here. 	The Examiner does not suggest that this
functionality is not common amongst the claimed group. 6 Like the diversity
of diaper fasteners listed by the MPEP text above, the diversity of miRNA
species may be structurally different (in that they are composed of different
nucleotide sequences and potentially perform differently as biomolecules),
but they are the same in that they all reportedly function as quantitatively
representative of patient radiation exposure and, so, they are substitutable for
this purpose and are common members of an art recognized class.
Here, what matters in the context of the invention is whether the
claimed miRNAs are produced in response to radiation exposure, and at
what level they are produced. 	Therefore, as argued by Appellant, per the
explanation in the Specification (see supra Background and Claimed Subject
Matter), we find that the recited miRNAs are interchangeable in the context
of the invention and we do not agree with the Examiner that the recited
Markush groups are improper. 	For the reasons above, we are persuaded by
Appellant's arguments and we reverse the Examiner's rejection.
6 In fact, the Examiner might even concede it "The examiner agrees that the
claimed miRNAs are all disclosed in the specification to be correlated with
the radiation exposure." Final Action 10.
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Application 17 /005,548
CONCLUSION
Based on the foregoing, we reverse the Examiner's rejection.
DECISION SUMMARY
.....................................
cHHmijs> j
aiWietecU	..................................
60, 66, 67,
88, 90-95,
101-104
Improper Markush
Group
60, 66, 67,
88, 90-95,
101-104
REVERSED
11