University of Washington v. Eli Lilly & Co.

The opinion in support of the decision being
entered today is not binding precedent of the Board.
Paper 45
Filed by: Trial Section Motions Panel
Box Interference Filed: June 11, 2002
Washington, D.C . 20231
Tel: 703-308-9797
Fax: 703-305-0942
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES
BOARD OF REGENTS OF THE
UNIVERSITY OF WASHINGTON
(5,302,529),
Junior Party,
v.
ELI LILLY & CO.
(09/185,663),
Senior Party.
Interference No. 104,733
Before SCHAFER, TORCZON, and TIERNEY, Administrative Patent Judges.
TIERNEY, Administrative Patent Judge.
JUDGMENT
(PURSUANT TO 37 CFR § 1.640)
This interference is before a motions panel for a decision on preliminary motions.
Oral argument took place on April 3, 2002. No transcript of the oral argument is
available as the parties did not provide a court reporter.

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I. Summary of the Decision
The issues presented in this interference are straightforward. University of
Washington (“UW”) has requested a judgment of no interference-in-fact. As permitted
by the rules, Lilly has requested that, prior to determining the question of no
interference-in-fact, we designate an additional UW claim as corresponding to the
count.
The Federal Circuit has stated that no interference-in-fact means that there is no
interfering subject matter. Thus, no interference-in-fact means that the parties are
claiming different patentable inventions, an example of which occurs when the claimed
subject matter of a party’s patent would not impede the granting of an applicant’s
claims. As such, the issues raised by the parties are simply a question of whether or
not UW’s patent claims would prevent the issuance of Lilly’s claims.
There is a rebuttable presumption that each claim designated as corresponding
to a count defines the same patentable invention as all other claims designated as
corresponding to the count. Indeed, 37 CFR § 1.601(j) states that:
An "interference-in-fact" exists when at least one claim of a party that is
designated to correspond to a count and at least one claim of an
opponent that is designated to correspond to the count define the same
patentable invention.
Accordingly, in analyzing the question of no interference-in-fact, we compare a party’s
corresponding claims to an opponent’s corresponding claims. Specifically, we presume
that the subject matter of a party’s corresponding claims are “prior art” to an opponent’s
corresponding claims in order to determine whether or not the parties invented the
same patentable invention. Where a party’s corresponding claims are separately

Interference No. 104,733
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patentable from an opponent’s corresponding claims, a judgment of no interference-in-
fact is appropriate.
Presently, UW is involved in this interference on the basis of UW claim 3, a
“species” claim. Lilly has requested that UW claim 1, a “genus” claim, be added to the
interference as corresponding to Count 1, the sole count in the interference.
UW’s corresponding “species” claim does not anticipate or render obvious any of
Lilly’s corresponding claims. Nor would UW’s “genus” claim, should it correspond,
anticipate or render obvious any of Lilly’s corresponding claims. Accordingly, UW’s
species and genus claims are not an impediment to granting Lilly’s corresponding
claims. As such, we grant UW’s motion for no interference-in-fact.
The parties have entered into a vigorous dispute as to the relative merits of the
Board’s precedential decision in Winter v. Fujita, 53 USPQ2d 1234 (Bd. Pat. App. & Int.
1999). As the questions presented in this interference do not require our reliance on
any issue resolved in Winter, we need not address the parties’ comments regarding that
decision.
II. The Technology in Question
Generally, the technology involved in this interference relates to cDNA that
codes for a polypeptide (“protein”) having human protein C activity. Protein C is a
zymogen, or inactive precursor, of a plasma serine protease, activated protein C
(“APC”). Specifically, protein C is formed as a single-chain polypeptide that undergoes
processing to form a two-chain molecule having a heavy chain and a light chain that are

Interference No. 104,733
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1A detailed discussion of the mechanism by which protein C down regulates
blood coagulation is provided in Bang et al., U.S. Patent No. 4,775,624. (Ex 1018).
connected via disulfide bonds. This two-chain intermediate is converted to APC by
cleaving a 12-residue peptide from the heavy chain. APC plays a critical role in the
regulation of blood coagulation as it represents a physiological mechanism for blood
anticoagulation.1
To understand the nature of cDNA it is necessary to understand the function of
DNA. DNA (“deoxyribonucleic acid”) is the blueprint of an organisms genetic makeup
as it is the primary genetic material. In an organism, a portion of DNA, a gene, may
undergo transcription to form mRNA (messenger ribonucleic acid). The mRNA in turn,
may then be translated to form a polypeptide, e.g., an enzyme or a structural protein.
DNA is the term used to represent the complex macromolecules made up of
nucleotide units. A nucleotide unit is characterized by a specific combination of a base,
a sugar and a phosphoric acid residue. There are four different nucleotide units in
DNA: adenine (“A”), guanine (“G”), cytosine (“C”) and thymine (“T”).
As explained in In re Deuel:
A sequential grouping of three such nucleotides (a "codon") codes for
one amino acid. A DNA's sequence of codons thus determines the
sequence of amino acids assembled during protein synthesis. Since
there are 64 possible codons, but only 20 natural amino acids, most
amino acids are coded for by more than one codon. This is referred to as
the "redundancy" or "degeneracy" of the genetic code.
DNA functions as a blueprint of an organism's genetic information. It is
the major component of genes, which are located on chromosomes in the
cell nucleus. Only a small part of chromosomal DNA encodes functional
proteins.

Interference No. 104,733
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Messenger ribonucleic acid ("mRNA") is a similar molecule that is made or
transcribed from DNA as part of the process of protein synthesis.
Complementary DNA ("cDNA") is a complementary copy ("clone") of
mRNA, made in the laboratory by reverse transcription of mRNA. Like
mRNA, cDNA contains only the protein-encoding regions of DNA. Thus,
once a cDNA's nucleotide sequence is known, the amino acid sequence
of the protein for which it codes may be predicted using the genetic code
relationship between codons and amino acids. The reverse is not true,
however, due to the degeneracy of the code. Many other DNAs may code
for a particular protein. The functional relationships between DNA, mRNA,
cDNA, and a protein may conveniently be expressed as follows:
In re Deuel, 51 F.3d 1552, 1554, 34 USPQ2d 1210, 1211 (Fed. Cir. 1995).
III. Findings of Fact
1. Real Parties in Interest
a. Junior Party
F1. University of Washington (“UW”) is the owner of the entire right, title and interest
in the involved U.S. Patent No. 5,302,529 (“‘529"). Zymogenetics, Inc. is the exclusive
licensee of the ‘529 patent. (Paper No. 11, Notice as to Real Parties In Interest, p. 2).

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b. Senior Party
F2. Eli Lilly & Co. (“Lilly”) is the real party in interest in the involved U.S. Reissue
Patent Application 09/185,663. (Paper No. 5, Eli Lilly & Co. Identification of Real Party
in Interest, p. 2).
2. Accorded Priority Benefit
a. Junior Party
F3. UW’s involved U.S. Patent No. 5,302,529 issued on April 12, 1994, based upon
U.S. Application No. 07/512,961, filed April 23, 1990. Solely for the purposes of priority,
UW ‘529 has been accorded benefit of the filing date of:
U.S. Patent No. 4,968,626, issued November 6, 1990, based upon U.S.
Application 06/766,109, filed August 15, 1985.
(Notice Declaring Interference, Paper No. 1, p. 3).
b. Senior Party
F4. Lilly’s involved ‘663 reissue application is based upon U.S. Patent No. 4,775,624,
which issued on October 4, 1988 from U.S. Application 06/699,967, filed February 8,
1985. (Notice Declaring Interference, Paper No. 1, p. 3).
3. The Count and Claim Correspondence
F5. Count 1, the sole count in the interference, is claim 3 of UW’s U.S. Patent No.
5,302,529.
UW ‘529 claim 3 reads as follows:

Interference No. 104,733
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3. The plasmid or transfer vector of claim 1, comprising the cDNA sequence
of FIG. 3, from bp 127 to bp 1383.
F6. The claims of the parties are as follows:
UW: 1-4
Lilly: 1-82 and 84-90
The claims of the parties that have been designated as corresponding to Count 1
are:
UW: 3
Lilly: 1-82 and 84-90
The claims of the parties that were not designated as corresponding to Count 1
are:
UW: 1, 2 and 4
Lilly: None
(Notice Declaring Interference, Paper No. 1, p. 4).
4. Relevant Facts Admitted By Lilly
a. Differences between the cDNA Sequence of UW Claim 3 and Lilly’s
Claimed Sequences
Lilly has admitted, among other things, the following material facts presented by
UW.
F7. The human protein C cDNA sequence of UW claim 3, from bp 127 to bp 1383 of
Foster’s Fig. 3, encodes a protein of 419 amino acids, which is a precursor of protein C.

Interference No. 104,733
Page No. 8
(UW Preliminary Motion 1, Paper No. 17, p. 2, ¶4; Lilly Opposition 1, Paper No. 27, p.
2, ¶4, admitting first sentence of UW fact 4.)
F8. Comparing the sequence of UW Fig. 3, bp 127 to bp 1383, with the pertinent
portions of the cDNA sequence of Lilly claim 1, two nucleotide differences are revealed
in the coding region:
1) UW Fig. 3, nucleotide 423 (third position of codon 99) is thymine (“T”),
whereas Lilly’s is guanine (“G”).
2). UW Fig. 3, nucleotide 768, (third position of codon 214) is cytosine (“C”),
whereas Lilly’s is thymine (“T”).
(Paper No. 17, p. 3, ¶6; Paper No. 27, p. 3, admitting UW facts 6-16.) Both Lilly and
UW’s cDNA sequences are said to encode for human protein C. (Paper No. 27,
additional facts ¶¶4, 6 and 7).
F9. The nucleotide variations between UW’s Fig. 3 cDNA sequence and the
sequence of Lilly claim 1 may be a DNA polymorphism. A polymorphism is defined as
one of two different but normal nucleotide sequences existing at a particular site in
DNA. The polymorphism may exist in the same individual, e.g., a heterozygous
individual or among different individuals, and may encode the same or a different amino
acid sequence. (Paper No. 17, pages 2-3, ¶7; Paper No. 27, p. 3, admitting UW facts
6-16.)
F10. According to several of Lilly’s named inventors the variations between Lilly’s
sequence and UW’s “may represent a true genetic variant.” (Paper No. 17, page 4, ¶8;

Interference No. 104,733
Page No. 9
Paper No. 27, p. 3, admitting UW facts 6-16.)
F11. In seeking to provoke an interference with UW’s ‘529 patent, Lilly represented to
the reissue application examiner that:
. . . it is very likely that the actual Foster [UW] sequence is identical to the
corresponding Bang [Lilly] sequence. Indeed, the sequence deposited by
Foster in GenBank is identical to the corresponding sequence in claim 1
of the Bang application.
Lilly also informed the examiner that:
The Differences Between the Bang and Foster Sequences are Probably Foster
Mistakes
As the Patent Office has recently recognized, it is well known that
sequencing errors are a common problem in molecular biology. [omitted
footnote] Evidence supporting the conclusion that the differences between
the Bang and Foster sequences are due to sequencing errors by Foster
may be found within the Foster patents themselves: the protein C DNA
sequences shown in Figure 2 of Foster contains only one of the base
differences: that at position 99. Further evidence may be found in the
publications of Foster. Specifically, Foster published articles in the
Proceedings of the National Academy of Sciences that showed DNA
sequences matching both Patent Figure 3 (two base differences) and
Figure 2 (one base difference). [omitted footnote] Later, Foster made a
deposit of their protein C DNA sequence in GenBank; this deposited
sequence is identical to the sequence of the Bang application.
* * *
Applicants submit that this evidence, when viewed as a whole, clearly
supports the conclusion that the two nucleotide differences in the Foster
sequence are due to sequencing errors, and not due to true differences in cDNA
sequence.
(Paper No. 17, pages 6-8, ¶13, bold emphasis added; Paper No. 27, p. 3, admitting UW
facts 6-16.)

Interference No. 104,733
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F12. GenBank is a publicly accessible database of nucleic acid sequences.
According to a review article published in 1985, it was GenBank’s practice during the
1980's to gather nucleic acid sequences for their database from published scientific
literature. (Paper No. 17, p. 8, ¶14; Paper No. 27, p. 3, admitting UW facts 6-16.)
F13. Lilly advised the reissue application examiner that Lilly’s sequence was
deposited with GenBank under Accession Number X02750. Specifically, Lilly informed
the examiner that there is “absolute similarity” between the sequence in Lilly’s ‘663
reissue application and the GenBank X02750 sequence. (Paper No. 17, p. 8, ¶16;
Paper No. 27, p. 3, admitting UW facts 6-16.)(Paper No. 17, p. 8, ¶16; Paper No. 27, p.
3, admitting UW facts 6-16.)
F14. Lilly informed the reissue application examiner that GenBank Sequence
NM_000312 was UW’s protein C DNA sequence. (Paper No. 17, p. 9, ¶17; Paper No.
27, p. 3, fact 17, stating that Lilly had a good faith belief that its statements regarding
the origins of UW’s sequences were true and if Lilly was in error, the error was
inadvertent.)
F15. Lilly’s reissue prosecution statements that Foster deposited the NM_0003212
are mistaken. The record demonstates that the NM_0003212 sequence was derived
from Lilly’s X02750 sequence. (Paper No. 17, p. 10, ¶20; Paper No. 27, p. 3, admitting
UW facts 18-21).

Interference No. 104,733
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b. Coding Sequence Unpredictability
F16. Even if one predicted the existence of at least one DNA polymorphism in a gene,
one could not predict where in the coding sequence the difference(s) would occur, how
many differences would occur, or what the differences would be. As such, provided
with the coding sequence of a single gene, one of ordinary skill in the art could not
predict with accuracy the number or location of DNA differences between the genes of
different people encoding the same protein. (Paper No. 17, p. 5, ¶10; Paper No. 27, p.
3, admitting UW facts 6-16.)
F17. The two codon differences between UW’s claim 3 sequence and Lilly’s claim 1
sequence could not have been predicted in advance based on knowledge of either
Lilly’s nucleotide sequence or Lilly’s amino acid sequences. (Paper No. 17, p. 5, ¶11;
Paper No. 27, p. 3, admitting UW facts 6-16.)
F18. One of ordinary skill in the art could not have predicted the particular DNA
sequence of UW claim 3 based on the amino acid sequence of human protein C light
chain, such as that recited in Lilly claim 81, or a particular DNA encoding that amino
acid sequence, such as that provided in Lilly claim 82. (Paper No. 17, p. 11, ¶21; Paper
No. 27, p. 3, admitting UW facts 18-21).

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IV. Opinion
An Administrative Patent Judge (“APJ”) declared this interference based, in part,
on statements made during the examination of Lilly’s reissue application. UW claim 3 is
directed to a plasmid or transfer vector comprising a string of base pairs identified in the
cDNA sequence of UW Figure 3. During the prosecution of Lilly’s reissue application,
Lilly represented to the examiner that Foster (“UW”) had deposited a nucleotide
sequence encoding protein C that was identical to the corresponding sequence of
Lilly’s claim 1. (UW Preliminary Motion 1, Paper No. 17, pages 6-8, ¶13, Lilly
Opposition 1, Paper No. 27, p. 3, admitted facts 6-16). According to Lilly:
Applicants submit that this evidence, when viewed as a whole, clearly
supports a conclusion that the two nucleotide differences in the Foster
sequence [UW Figure 3] are due to sequencing errors, and not due to true
differences in cDNA sequence.
Id.
When the interference was declared, the Office was unaware that the purported
“Foster sequence,” Accession No. NM_00312 was Lilly’s own sequence. (Paper No.
17, p. 9, ¶¶17, 20; Paper No. 27, p. 3, Lilly stated that it had a good faith belief that its
statements were true and that any error was “inadvertent.”). In light of the evidence
provided by UW, we find that Lilly’s statements regarding the origin of the deposited
sequence were incorrect and that the claimed UW species and Lilly species are
apparently genetic variants. (See, Paper No. 17, p. 4, ¶8, Paper No. 27, p. 3, admitting
facts 6-16).
UW has filed a preliminary motion seeking a judgment of no interference-in-fact

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2 Rule 633(i) allows a party to respond to a motion for no interference in fact by
filing, among other things, a motion under Rule 633(c) to redefine the interfering subject
matter.
based on the differences between the sequence of UW claim 3 and the sequences
recited in Lilly’s claims. (UW Preliminary Motion 1, Paper No. 17, p. 1). In response to
UW’s motion, Lilly filed a preliminary motion requesting that the interfering subject
matter be redefined to have UW claim 1 designated as corresponding to Count 1. (Lilly
Preliminary Motion 1, Paper No. 27, p. 1).2
1. What is Required for a Determination of “No Interference-In-Fact”
Both UW and Lilly agree that there is an interference-in-fact when two parties are
claiming the same patentable subject matter. The parties, however, disagree as to the
test for determining whether the parties claims define the same patentable subject
matter.
While 35 U.S.C. § 135(a) sets forth the requirements for declaring an
interference, the statute fails to explicitly state the requirements for determining whether
there is no interference-in-fact once an interference has been declared. To aid us in
our understanding, we look to the United States Patent & Trademark Office’s
(“USPTO”) rules regarding no interference-in-fact. Yet, as the comments to the rules
specifically state that USPTO would continue to follow the decisions rendered in Case

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3730 F.2d 745, 221 USPQ 196 (Fed. Cir. 1984).
4547 F.2d 566, 192 USPQ 486 (CCPA 1977).
5537 F.2d 539, 190 USPQ 413 (CCPA 1976).
6The decision in Nitz occurred prior to the merger of the Board of Interferences
with the Board of Patent Appeals.
v. CPC International, Inc.,3 Aelony v. Arni,4 and Nitz v. Ehrenreich,5 we review these
decisions prior to our review of the USPTO rules. Notice of Final Rules, 49 Fed. Reg.
48416, 48,421 (Dec. 12, 1984).
A. The Opinions of the Federal Circuit and the Court of Customs and
Patent Appeals (“CCPA”)
1. Nitz v. Ehrenreich
Nitz involved an appeal from the Board of Patent Interferences6 awarding priority
of invention to Ehrenreich. Specifically, the Board awarded priority of invention as to
two counts, counts 1 and 2, to Ehrenreich. Nitz appealed the decision arguing, among
other things, that there was no interference-in-fact as to either count.
The interference was provoked when senior party Ehrenreich copied, in modified
form, claims 3 and 13 of Nitz’s U.S. Patent No. 3,552,533. The subject matter of the
two copied claims involved carbonized articles having a modifying agent to increase the
coefficient of friction of carbon. Of note, count 1 required up to about 48 percent by
weight of a friction modifier and count 2 required carbonized layers of filamentary
materials.
During the Board proceeding, Nitz argued that the counts did not define common

Interference No. 104,733
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subject matter that was claimed by both parties. In reviewing Nitz’s arguments with
respect to count 1, the Board recommended to the Commissioner that the interference
be dissolved. Specifically, the Board viewed Nitz’s limitation of up to 12 weight percent
of a friction modifier as defining a patentably distinct invention from that of count 1,
which required up to about 48 weight percent of the friction modifier. The
Commissioner, however, disapproved of the recommendation as the Commissioner
was of the opinion that the amount of the modifier was not a critical limitation and that
there was no basis for Nitz and Ehrenreich’s claims to exist in separate patents. As to
count 2, the Board determined that the count’s failure to recite the term “woundup,” as
found in Nitz’s claimed carbonized layers, was not a patentable distinction.
Additionally, Nitz raised the issue of Ehrenreich’s “right to make count 1.” As to
this issue, the Board determined that Ehrenreich’s disclosure was sufficient to support
the limitations of the count. Having decided the issues of no interference-in-fact and
right to make the counts, the Board awarded priority on both counts to Ehrenreich. Nitz
appealed.
In reviewing the question of interference-in-fact and the court’s jurisdiction to
consider that issue, the CCPA stated:
The existence of common subject matter defined by the interference
count is a prerequisite for an award of priority, i.e., the existence or
nonexistence of interfering subject matter goes to the very foundation on
which an interference rests. Determination of the presence or absence of
interfering subject matter is "logically related" to the jurisdiction-conferring
issue of priority because that determination necessarily precedes a priority
award.
537 F.2d at 543, 190 USPQ at 416.

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As to the question of no interference-in-fact, the CCPA compared the disclosure
and claims of Nitz with the count and the disclosure of Ehrenreich. According to the
CCPA:
In the case before us the materiality of the questioned limitation and its
variation must be determined in a two-step process wherein the first
inquiry is [1] whether the variation changes a material aspect of the
patentee's invention (here, whether the maximum amount of friction
modifier of "up to 12 percent by weight" is a material limitation) and, if that
inquiry be decided in the affirmative, the second inquiry is [2] whether the
variation is itself a material variation (here, whether "up to 48% by weight"
results in the counts being drawn to a different invention).
Id. at 544, 190 USPQ at 417.
Conducting the two-step inquiry, the CCPA focused on Nitz’s description that at
least 80 weight percent carbon was a critical feature of the invention and the limitation
that the modifier was present in an amount “up to 12% by weight.” Furthermore, the
CCPA focused on Ehrenreich’s disclosure of using up to 48% by weight modifier, which
would allow for a maximum of 52% by weight carbon. Id. at 544, 190 USPQ at 417-18.
The CCPA determined that Nitz’s claim recitation of “up to 12% by weight” of a
modifier was a material limitation due to the critical nature of having at least 80%
carbon. The CCPA then determined that the count language “up to about 48% by
weight” of the modifier was a material variation from Nitz’s claimed invention. As such,
the CCPA concluded that no interference-in-fact existed with respect to count 1. Id. at
545, 190 USPQ at 418.
As to count 2, the only issue on appeal was the materiality of Nitz’s recitation that
the carbonized layers of filamentary materials were “woundup” layers. The CCPA,
however, determined that the structure of woundup layers was known in the prior art

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and that the limitation was not necessary for the patentability of Nitz’s claim. As such,
the CCPA determined that Nitz’s “woundup” limitation was not a material limitation of
Nitz’s claim and that an interference-in-fact existed with respect to count 2.
Nitz is consistent with the principle that there is no interference-in-fact when two
parties are claiming “materially” different inventions. Further, Nitz is consistent with the
principle that, for purposes of no interference-in-fact, claims of different scope can be
separate patentable inventions even where one party’s claim is literally encompassed
by a second party’s claim. Specifically, the CCPA found that Nitz’s claimed “up to 12%
by weight” modifier was a materially different invention from Ehrenreich’s claimed “up to
48% by weight” modifier even though Nitz’s claimed amount of modifier was literally
encompassed by Ehrenreich’s claimed amount of modifier.
2. Aelony v. Arni
Aelony concerned an appeal from a decision of the Board awarding priority of
invention to Arni, the senior party. The subject matter of the interference was a method
for purifying malononitrile. In particular, both parties treated an impure malononitrile
with a conjugated diene in a Diels-Alder reaction to aid in the removal of impurities. Of
note, Aelony taught the use of cyclopentadiene, a conjugated diene. In contrast, Arni
did not specifically describe or claim cyclopentadiene as a suitable Diels-Alder reaction
component for the removal of impurities. Rather, Arni specifically described eight other
materials having conjugated double bonds as suitable for undergoing a Diels-Alder
reaction for the removal of impurities. Aelony v. Arni, 547 F.2d 566, 567, 192 USPQ

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486, 487 (CCPA 1977).
Before the Board, neither Aelony nor Arni took testimony. Rather, Aelony argued
that there was no interference-in-fact between the parties. Specifically, Aelony argued
that, for the purification method in dispute, cyclopentadiene was patentably distinct from
the eight materials described by Arni. Id. at 568, 192 USPQ at 488. The Board did not
agree. According to the Board, both parties carried out substantially the same process.
Moreover, the Board found that Aelony’s patentable distinctiveness argument was
unsupported by the evidence. As such, the Board rejected Aelony’s no interference-in-
fact argument and awarded priority to senior party Arni. Id. at 568, 192 USPQ at 488.
In reviewing the merits of Aelony’s appeal, the CCPA specifically rejected
Aelony’s argument that there was no interference-in-fact. The CCPA agreed with the
Board “that the test of interference-in-fact is not whether two sets of claims overlap, but
whether they are patentably distinct from each other.” Id. at 570, 192 USPQ at 490
(bold emphasis added). According to the CCPA, the law contemplates that “where
different inventive entities are concerned – that only one patent should issue for
inventions which are either identical to or not patentably distinct from each other.” Id.
(bold emphasis added). The CCPA went on to state that “[m]oreover, we believe that
there is ample precedent from this court for framing the test of interference in fact in
terms of whether two sets of claims are patentably distinct from each other.” Id. (bold
emphasis added).
On the facts presented, the CCPA determined that “both parties are claiming
the same inventive concept” and rejected Aelony’s argument that there was no

Interference No. 104,733
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interference-in-fact. Id. (bold emphasis added). In particular, the CCPA noted that
both parties carried out the same process in which a conjugated diene material reacted
with impurities according to the Diels-Alder reaction. Further, there was no dispute that
the cyclopentadiene of Aelony and the eight conjugated dienes of Arni were all common
Diels-Alder dienes. Id.
The decision in Aelony denied a motion for no interference-in-fact where two
parties were claiming patentably indistinct inventions. Specifically, in deciding the
question of no interference-in-fact, the CCPA focused its attention on whether or not the
parties claims were patentably distinct from each other. Where the claims of the
parties are not patentably distinct from each other, the parties are claiming the same
inventive concept and it is understood that only one patent should issue.
3. Case v. CPC International, Inc.
Case involved an appeal from a decision of a district court in a civil action under
35 USC §146 upholding the award of priority to CPC International, Inc., (“CPC”) in an
interference proceeding in the USPTO. The subject matter in the interference was
directed to polyether polyols that consisted essentially of oxyalkylated polyalcohols and
oxyalkylated polysaccharides. Case v. CPC Int'l, Inc., 730 F.2d 745, 747, 221 USPQ
196, 198 (Fed. Cir. 1984).
The interference was provoked by CPC. To provoke the interference, CPC
copied Case’s patented claims. Of note, Case’s patented claims specified that an
oxyalkylated polyalcohol was present in an amount of 10 to 95% by weight and that an

Interference No. 104,733
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7Specifically, the Federal Circuit stated:
Case challenges the declaration of the interference on the ground that no
interference in fact exists. Relying on Nitz v. Ehrenreich, 537 F.2d 539,
190 USPQ 413 (CCPA 1976), Case argues that the question of
interference in fact turns on whether or not the weight limitations present
in the claims of Case's patent but omitted from the counts are material.
We agree with this analysis but we see no departure by the board or the
court in stating the law or applying it to the facts of this case.
oxyalkylated polysaccharide was employed in an amount of 5 to 95% by weight. During
examination, CPC’s claims were rejected as lacking sufficient written descriptive
support under 35 U.S.C. § 112, 1st paragraph, for the copied weight limitations. The
examiner, however, advised CPC to submit claims directed to “a polyether polyol which
is the reaction product of starch and the various disclosed derivatives thereof with
glycerin and propylene oxide.” Id. In response to the examiner’s rejection of the copied
claims, CPC canceled the copied claims and submitted new claims that complied with
the examiner’s suggestion. Id. The newly added CPC claims, however, did not recite a
particular weight limitation for the two oxyalkylated components. Moreover, when the
interference was declared, the counts did not recite the weight limitations found in
Case’s patented claims.
Case presented numerous arguments challenging both the district court and the
Board’s award of priority to CPC. Of interest, Case argued that no interference-in-fact
existed between Case’s claims and CPC’s. According to Case, the question of no
interference-in-fact turned on whether or not the weight limitations present in Case’s
claims, but not CPC’s claims, were material. The Federal Circuit agreed with this
analysis.7 Id. at 750, 221 USPQ at 200.

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Id.
According to the Federal Circuit, the question of materiality of the omitted
limitations was one of fact. Id. The Court noted that both the district court and the
Board had determined that the omitted weight limitations were not material as the range
of proportions was quite broad and that Case’s prosecution history demonstrated that
the omitted limitations were not pertinent to patentability.
Additionally, Case argued that there was no interference-in-fact as the counts
were unpatentable. Having reviewed Case’s arguments, the Federal Circuit stated that:
No interference in fact means that there is no interfering subject
matter, that Case's patent is no impediment to granting CPC the
claims of its application. It was Case's burden to prove that CPC claims
a different invention from his own. Case cannot carry that burden with
argument that the counts are unpatentable.
Id. (emphasis added). The Federal Circuit also stated that “[i]n sum, since the Case
patent and the CPC application contain interfering subject matter, an interference
proceeding was appropriate.” Id. at 752, 221 USPQ at 202. The Court then went on to
uphold the decision awarding priority of invention to CPC based upon its earlier
application. Id.
As apparent from the decision in Case, the question of no interference-in-fact
turns on whether or not the parties claims are “materially” different. The question of
“material” differences being one of fact. Further, Case specifies that no interference-in-
fact exists where one party’s patent does not impede the grant of another party’s
claims.

Interference No. 104,733
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4. Summary of the CCPA and Federal Circuit Opinions on the
Question of No Interference-in-Fact
An interference in fact involves interfering subject matter. As shown by the
above decisions, there is no interfering subject matter, and thus, no interference-in-fact
when the parties are claiming different patentable inventions. For example, there is no
interference-in-fact when it is demonstrated that a party’s claims are no impediment to
the granting of an opponents claims. Case, 730 F.2d at 750, 221 USPQ at 200.
The cases analyzed above, Nitz, Aelony and Case and our interpretations
thereof are all consistent with the no interference-in-fact decisions in Almasi v. Strauss,
589 F.2d 523, 200 USPQ 511 (CCPA 1979), and Brailsford v. Lavet, 318 F.2d 942, 138
USPQ 28 (CCPA 1963) as well as the interference-in-fact decision in McCabe v.
Cramblet, 65 F.2d 459, 18 USPQ 71 (CCPA 1933).
B. The USPTO Rules and the Comments to the Rules Provide that No
Interference-in-Fact Exists for Patentably Distinct Inventions
The interference rules were revised in 1984 to implement the interference
provisions of the Patent Law Amendments Act of 1984 (Public Law 98-622). Notice of
Final Rule, Patent Interference Proceedings, 49 Fed. Reg. 48416 (Dec. 12, 1984). As
part of the rule revision, the Commissioner (now Director) promulgated several rules
regarding the existence of an interference-in-fact. For example, the Commissioner
promulgated 37 CFR Section 1.601(j)(definition of an interference-in-fact), Section
1.601(n)(definition of same and separate patentable inventions) and Section 1.633(b),
which authorized parties to file preliminary motions for judgment on the ground that

Interference No. 104,733
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there is no interference-in-fact.
In their present form, Rules 601(j), 601(n) and 633(b) read as follows:
Rule 601(j) An interference-in-fact exists when at least one claim of a
party that is designated to correspond to a count and at least
one claim of an opponent that is designated to correspond to
the count define the same patentable invention.
Rule 601(n) Invention "A" is the same patentable invention as an invention "B"
when invention "A" is the same as (35 U.S.C. 102) or is obvious (35
U.S.C. 103) in view of invention "B" assuming invention "B" is prior
art with respect to invention "A". Invention "A" is a separate
patentable invention with respect to invention "B" when invention
"A" is new (35 U.S.C. 102) and non-obvious (35 U.S.C. 103) in
view of invention "B" assuming invention "B" is prior art with respect
to invention "A".
Rule 633(b) A motion for judgment on the ground that there is no interference-
in-fact. A motion under this paragraph is proper only if the
interference involves a design application or patent or a plant
application or patent or no claim of a party which corresponds to a
count is identical to any claim of an opponent which corresponds to
that count. See §§1.637(a). When claims of different parties are
presented in "means plus function" format, it may be possible for
the claims of the different parties not to define the same patentable
invention even though the claims contain the same literal wording.
Rules 601(j) and (n): 49 FR 48416, Dec. 12, 1984, effective Feb. 11, 1985; 50 FR
23123, May 31, 1985; revised, 60 FR 14488, Mar. 17, 1995; Rule 633(b): 49 FR 48416,
Dec. 12, 1984, added effective Feb. 11, 1985; 50 FR 23124, May 31, 1985; revised, 60
FR 14488, Mar. 17, 1995, effective Apr. 21, 1995.
While the rules explicitly define when an interference-in-fact exists, the rules do
not explicitly define “no” interference-in-fact. The comments to the rules, however,
provide that the USPTO will continue to follow the decisions rendered in Nitz, Aelony
and Case. Notice of Final Rules, 49 Fed. Reg. 48416, 48421 (Dec. 12, 1984). As

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provided above, these three decisions demonstrate that the test for no interference-in-
fact is grounded in patentable distinctness. Nitz, 537 F.2d at 545, 190 USPQ at 418;
Aelony, 547 F.2d at 570, 192 USPQ at 490; Case, 730 F.2d at 750, 221 USPQ at 200.
As such, a party may demonstrate that no interference-in-fact exists between two
parties by proving that a first party’s claim(s) are patentably distinct from the second
party’s claim(s).
The test for patentable distinctness is set forth in Rule 601(n), which states that
an invention “A” is a separately patentable invention, i.e. patentably distinct, with
respect to invention “B” when invention “A” is novel and non-obvious in view of invention
"B" assuming invention "B" is prior art with respect to invention "A". For example, party
A’s claims are patentably distinct, i.e., separately patentable, when the party A’s claims
are no impediment to the granting of the opponents claims. See, e.g., Nitz, 537 F.2d at
544-45, 190 USPQ at 417-18 (No interference-in-fact where “up to 48%” modifier did
not interfere with “up to 12%” modifier); Case, 730 F.2d at 750, 221 USPQ at 200 (“No
interference in fact means that there is no interfering subject matter, that Case’s patent
is no impediment to granting CPC the claims of its application.”).
C. Lilly’s Species Anticipates Dominating Genus Theory of Interference-in-
Fact Lacks Merit
Lilly argues that for an interference in fact, the interference rules and comments
require nothing more than a “species anticipates dominating genus” determination.
Thus, according to Lilly, its claimed species is the “same patentable invention” as UW ’s

Interference No. 104,733
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claimed genus based on the fact that its species would anticipate UW’s genus.
Lilly states that the comments specifically inform the public that the test under
Rule 601(n) for determining the “same” patentable invention could not be applied two
ways, i.e. a party need only demonstrate “one-way” anticipation or obviousness for an
interference-in-fact. Specifically, Lilly has argued that:
The regulations of the PTO, 37 CFR §1.601(n), having the force and
effect of law, require nothing more than the “species anticipates
dominating genus” determination to establish the existence of an
interference-in-fact. Indeed, the official commentary issued by the PTO at
the time the rules were adopted made clear that the test for the “same
patentable invention” under 37 CFR §1.601(n) could not be applied two
ways. 49 FR 48416 at 48434 (Dec. 12, 1984). As stated by the PTO in
the administrative history for the regulations, the “same patentable
invention’ [test] . . . under §1.601(n) . . . [is] not intended to be
‘applied in a mutuality sense.’” [Footnote omitted].
(Lilly Preliminary Motion 1, Paper No. 22, p. 5, emphasis added). Additionally,
responding to comments from UW, Lilly stated:
In response to a specific question posed by one commentator in 1984
asking whether the PTO’s proposed Rule 1.601(n) would involve a one-
way or two-way patentability determination, the Office responded in
unequivocal terms that a one-way test would be applied. Notice of Final
Rules, 49 Fed. Reg. 48,416, 48,433 (1984). Six years later this rule was
restated by the Board in Chiong v. Roland, 17 U.S.P.Q.2d 1541, 1544
(Bd. Pat. App. & Int. 1990)(“As pointed out in the Notice, supra at 48433,
the standard of patentability will not be applied on a ‘mutual basis.’”)
(Lilly Reply 1, Paper No. 30, pages 8-9, emphasis added). This panel has reviewed the
comments to the rules and finds no merit in Lilly’s “species anticipates dominating
genus” test.
Lilly has relied upon two specific comments to the rules. The comments may be
found at pages 48,433-48,434 of the Notice of Final Rules, 49 Fed. Reg. 48,416 (Dec.

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8While not specifically mentioned by Lilly, Lilly’s relied upon comments were
written in response to questions concerning whether or not the standard of patentability
would be applied on a mutual basis in determining whether to add an additional count.
Each count, of course, must be directed to a separate patentable invention. 37 CFR
§1.601(f). In other words, the comments responded to a question of whether the
USPTO would require that Invention A be separately patentable from Invention B
considered as prior art and Invention B be separately patentable from Invention A
considered as prior art), in order for an interference to have both a species count and a
genus count. The answer to this was no. Notice of Final Rules, 49 Fed. Reg. 48,416,
12, 1984). Provided below are the full paragraphs ((1) & (2)) from which Lilly’s quoted
material is derived:
(1) With respect to paragraph (1) of the comment, the standard of
patentability will not be applied "on a mutual basis." Thus, if a
species is patentable over a genus, the species is a "separate
patentable invention" from the genus. Compare In re Taub, 348
F.2d 556, 146 USPQ 384 (CCPA 1965) (fluorine species might be
patentable over genus of Markush group of hydrogen and
halogen). A first count to a genus and a second count to a species
which is patentable over the genus may properly appear in an
interference. See e.g., Example 4. The comment suggests that if
"such mutuality is not applied * * * then a number of irreconcilable
anomalies * * * will be manifest." The urged "irreconcilable
anomalies" are not readily apparent to the PTO.
(Fed. Reg., p. 48433, underline emphasis added denotes Lilly’s cited commentary, bold
emphasis added to highlight application of Rule 601(n) for genus/species situations).
(2) Analysis of Commentator's Example A. Example A does not describe any
practice under these rules, because "same patentable invention" and
"separate patentable invention" under § 1.601(n) are not intended to be
"applied in a mutuality sense." Where a first count is to a genus and a
second count is to a species within the scope of the genus, there
may be two counts if the species is separately patentable from the
genus. The species is "invention A" referred to in § 1.601(n); the genus is
"invention B" referred to in § 1.601(n).
(Fed. Reg., p. 48434, underline emphasis added denotes Lilly’s cited commentary, bold
emphasis added to highlight application of Rule 601(n) for genus/species situations).8

Interference No. 104,733
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48432-434 (Dec. 12, 1984). Note, the test for no interference-in-fact and the addition of
new count is essentially the same, i.e., patentable distinctness. See, e.g., Hester v.
Allgeier, 646 F.2d 513, 521, 209 USPQ 370, 378 (CCPA 1982).
The comments to the rules regarding the test for “same or separate patentable
inventions” are highly relevant and material to the issues raised in this interference as
they inform the public that a genus and a patentably distinct species are separate
patentable inventions. If the rule were only applied in the manner suggested by Lilly,
i.e., nothing more than species anticipates dominating genus, then the comments to the
rule that a species that is patentable over a genus is a “separate patentable invention”
from the genus would make no sense. Specifically, Lilly’s argument would have us
determine that the species and dominating genus defined both the same patentable
invention and, at the same time, a separate patentable invention. Consistent with the
precedential Federal Circuit and CCPA opinions mentioned above, the comments to
rules explicitly provide that a patentably distinct species and a dominating genus are
separately patentable inventions.
2. Lilly and UW’s Corresponding Claims Are Separate Patentable Inventions
As UW’s Corresponding Claims Do Not Impede the Grant of Lilly’s
Corresponding Claims
The test for no interference-in-fact is whether or not the parties are claiming
separately patentable inventions. In applying this test, we begin with a comparison of
the parties’ corresponding claims as there exists a rebuttable presumption that each
claim designated to correspond to a count defines the same patentable invention as all

Interference No. 104,733
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other claims designated to correspond to the count. See, e.g., Orikasa v. Oonishi, 10
USPQ2d 1996, 2004 (Comm’r Pat. & Trademark 1989).
Count 1 is the sole count in interference. As declared, UW claim 3 and Lilly
claims 1-82 and 84-90 correspond to Count 1. Additionally, Lilly has requested that UW
claim 1 be designated as corresponding to Count 1. For purposes of determining if
there is no interference-in-fact between the parties, we will assume that Lilly is correct
in stating that UW claim 1 corresponds to Count 1. Accordingly, we compare UW
claims 1 and 3 with Lilly’s corresponding claims to determine whether the parties are
claiming separately patentable inventions.
A. Anticipation and Obviousness
A prima facie case of obviousness is established when the teachings of the prior
art would have suggested the claimed subject matter to a person of ordinary skill in the
art with a reasonable likelihood of success of achieving the suggested invention. In re
Dow Chem., 837 F.2d 469, 473, 5 USPQ2d 1529, 1531 (Fed. Cir. 1988). Any
motivation or suggestion to modify the prior art references must flow from some
teaching in the art that suggests the desirability or incentive to make the modification
needed to arrive at the claimed invention. In re Napier, 55 F.3d 610, 613, 34 USPQ2d
1782, 1784 (Fed Cir. 1995); In re Gorman, 933 F.2d 982, 986-87, 18 USPQ2d 1885,
1888, (Fed. Cir. 1991).
A claim to a specific cDNA is not made obvious by mere knowledge of a desired
protein sequence and methods for generating the various cDNA that have the potential

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to encode that protein. Cf., Regents of the Univ. of Cal. v. Eli Lilly & Co., 119 F.3d
1559, 1567, 43 USPQ2d 1398, 1405 (Fed. Cir. 1997)(“We had previously held that a
claim to a specific DNA is not made obvious by mere knowledge of a desired protein
sequence and methods for generating the DNA that encodes that protein.”); In re
Deuel, 51 F.3d 1552, 1558, 34 USPQ2d 1210, 1215 (1995)("A prior art disclosure of
the amino acid sequence of a protein does not necessarily render particular DNA
molecules encoding the protein obvious because the redundancy of the genetic code
permits one to hypothesize an enormous number of DNA sequences coding for the
protein."); In re Bell, 991 F.2d 781, 787, 26 USPQ2d 1529, 1531 (Fed. Cir. 1993)(“It
may be true that, knowing the structure of the protein, one can use the genetic code to
hypothesize possible structures for the corresponding gene and that one thus has the
potential for obtaining that gene. . . Therefore, given the nearly infinite number of
possibilities suggested by the prior art, and the failure of the cited prior art to suggest
which of those possibilities is the human sequence, the claimed sequences would not
have been obvious.”).
Anticipation is the epitome of obviousness. Connell v. Sears, Roebuck & Co.,
722 F.2d 1542, 1548, 220 USPQ 193, 198 (Fed. Cir. 1983) (citing In re Fracalossi, 681
F.2d 792, 215 USPQ 569 (CCPA 1982)). Anticipation is established only if each and
every element of a properly construed claim is found, either expressly or inherently
described, in a prior art reference. PPG Indus., Inc. v. Guardian Indus. Corp., 75 F.3d
1558, 1566, 37 USPQ2d 1618, 1624-1625 (Fed. Cir. 1996).

Interference No. 104,733
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9While Lilly’s corresponding claims encompass several distinct species of cDNA,
for reasons of convenience we refer to Lilly claims as “species” claims as opposed to
“genus” or “subgenus” claims.
B. UW Claim 3 is Patentably Distinct from Lilly’s Corresponding
Claims
UW claim 3 is directed to a plasmid or transfer vector that comprises the cDNA
sequence depicted in UW Figure 3, from base pair 127 to base pair 1383. Lilly claim 1
corresponds to Count 1 and requires a constructed DNA compound that encodes a
polypeptide with human protein C activity wherein the coding strand comprises several
distinct cDNA species. Lilly claims 2-75, 77-80 and 84-88 all depend from Lilly claim 1
or require a DNA compound of Lilly claim 1. Of the remaining Lilly corresponding
claims, Lilly claim 76 is directed towards several “intermediate” plasmids that lack the
protein C cDNA, while Lilly claims 81 and 82 relate to recombinant DNA sequences that
comprise the coding sequence for the active light chain of human protein C. Thus, as it
is readily apparent that Lilly’s intermediate plasmids are patentably distinct from UW
claim 3, the proper comparison for patentable distinctness is between the cDNA
species of UW claim 3 and the cDNA species recited in Lilly claim 1 and Lilly claims 81
and 82.9
The sequence claimed in UW claim 3 is a cDNA sequence having at least 1257
base pairs, i.e., 419 codons (three base pairs to a codon), that encode a protein of 419
amino acids. For such a sequence, the odds of randomly changing a single codon are
1 in 419, changing any two codons at random is 1 in 175,142 (419 x 418), changing any
three codons at random is 7,303,214 (419 x 418 x 417), etcetera. (See generally,

Interference No. 104,733
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Paper No. 17, pages 5-6, ¶ 11).
Comparing the sequence of UW claim 3 (UW Fig. 3, bp 127 to bp 1383) with the
pertinent portions of the cDNA sequence of Lilly claim 1, two nucleotide differences are
revealed in the coding region:
1) UW Fig. 3, nucleotide 423 (third position of codon 99) is thymine (“T”),
whereas Lilly’s is guanine (“G”).
2). UW Fig. 3, nucleotide 768, (third position of codon 214) is cytosine (“C”),
whereas Lilly’s is thymine (“T”).
(Paper No. 17, p. 3, ¶6; Paper No. 27, p. 3, admitting UW facts 6-16.). The parties
agree that:
The particular differences in the nucleotide sequences that occur between
the sequences of Foster [UW ] claim 3 and Bang [Lilly] claim 1 within two
different codons could not have been predicted in advance based on
knowledge of either Bang’s nucleotide or amino acid sequences alone.
(Paper No. 17, p. 5, ¶11; Paper No. 27, p. 3, admitting UW facts 6-16.).
When there is a specific, structurally related prior art compound, the question of
obviousness is whether the prior art suggested the specific modifications necessary to
achieve the claimed compound. In re Deuel, 51 F.3d at 1557-58, 34 USPQ2d at 1214.
On the record presented, there is insufficient evidence that Lilly’s claimed sequence,
taken in combination with the prior art, would have suggested the specific modifications
to nucleotide 423 and nucleotide 768 such that one skilled in the art would arrive at the
cDNA sequence described by UW claim 3. Additionally, there is insufficient evidence
that one skilled in the art presented with the amino acid sequence of human protein C
would have been guided to form the specific cDNA sequence recited in UW claim 3. In
re Deuel, 51 F.3d at 1559, 34 USPQ2d at 1215-16 (Due to enormous number of DNA

Interference No. 104,733
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molecules encoding for the protein, disclosure of amino acid sequence did not render
particular DNA molecules encoding the protein obvious). We conclude that Lilly claim 1
and UW claim 3 are patentably distinct as Lilly claim 1 does not render UW claim 3
obvious. Furthermore, Lilly claim 1 does not anticipate UW claim 3 as Lilly claim 1,
taken in light of the prior art, fails to teach all the limitations of UW claim 3.
Lilly claims 81 and 82 are directed to the coding sequence for the active light
chain of human protein C. Lilly claim 81 does not specifically recite the structure of the
coding sequence whereas Lilly claim 82 specifically sets forth the coding strand. The
coding strand in Lilly claim 82 contains 465 base pairs, i.e., 155 codons. In contrast,
UW claim 3 is directed to the cDNA encoding protein C and contains 1257 base pairs,
i.e., 419 codons. The amino acid sequence of human protein C light chain, such as
that recited in Lilly claim 81, and a particular DNA encoding that amino acid sequence,
such as that provided in Lilly claim 82, do not provide sufficient information for one
skilled in the art to predict the particular DNA sequence of UW claim 3. (Paper No. 17,
p. 11, ¶21; Paper No. 27, p. 3, admitting UW facts 18-21). As Lilly claims 81 and 82 fail
to teach or suggest the cDNA of UW claim 3, we conclude that UW claim 3 is
patentably distinct from Lilly claims 81 and 82.
C. Lilly’s Corresponding Claims Are Patentably Distinct from UW
Claim 1
UW claim 1 is directed to a plasmid or transfer vector that comprises cDNA
coding for a human protein C. According to Lilly, there are two possible claim
constructions for UW claim 1. (See, Paper No. 30, pages 4-5). First, Lilly contends that

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UW claim 1 must be construed as “limited to the specific allelic cDNA sequence
disclosed in the UW ‘529 Patent, as is claim 3 of the UW ‘529 Patent” and that “claim 1
of the UW ‘529 Patent is essentially equivalent to claim 3 of the UW ‘529 Patent.”
(Paper No. 27, p. 7 and p. 9 and Paper No. 30, p. 4). Alternatively, Lilly argues that it is
expected that UW will contend that claim 1 is generic and encompasses not only the
cDNA sequence that UW discovered, but also the cDNA sequence discovered by Lilly.
(See, Paper No. 27, p. 9). It is not necessary for us to determine whether UW claim 1
is as broad or as narrow as Lilly contends. There is no interference-in-fact under either
claim construction. If we construe UW claims 1 and 3 as “essentially equivalent,” there
is no interference-in-fact as Lilly’s corresponding claims do not teach or suggest the
cDNA of UW claim 3 and would likewise not teach or suggest an “essentially
equivalent” cDNA of UW claim 1. Specifically, Lilly’s corresponding claims do not teach
or suggest the particular number and location of the polymorphisms in the cDNA of UW
claim 3 nor would they teach or suggest a such polymorphisms in a similarly construed
claim.
If we construe UW claim 1 to be a generic claim covering any cDNA sequence
that encodes human protein C, there is still no interference-in-fact. So construed, UW
claim 1 would encompass thousands of possible sequences. Given such a vast
number of possible sequences encompassed by a broadly construed UW claim 1, there
would need to exist some suggestion or teaching in the prior art that guided one skilled
in the art to the specific species claimed by Lilly. See In re Baird, 16 F.3d 380, 29
USPQ2d 1550 (Fed. Cir. 1994)(Prior art teaching of “vast number” of possible diphenol

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compounds did not teach or suggest the selection of Baird’s claimed bisphenol A); In re
Belle, 991 F.2d 781, 26 USPQ2d 1529 (Fed. Cir. 1993)(DNA sequence would not have
been obvious in view of prior art reference that taught a vast number of possibilities but
did not teach or suggest why, among all those possibilities, one would seek the claimed
sequence). The evidence presented fails to teach or suggest the selection of Lilly’s
claimed cDNA species from among the vast number of potential sequences that would
be encompassed by a broadly construed UW claim 1. As UW claim 1, taken in light of
the prior art, does not fairly teach or suggest Lilly’s specifically claimed species, Lilly’s
claimed species are patentably distinct from a broadly construed UW claim 1. As a
patentably distinct species is a “separate patentable invention” from its dominating
genus, there is no interference in fact between a broadly construed UW claim 1 and
Lilly’s corresponding claims.
Based on the facts presented, neither UW claim 1 nor UW claim 3 impedes the
grant of Lilly’s corresponding claims. Case, 730 F.2d at 750, 221 USPQ at 200. As
UW’s allegedly corresponding claims do not impede the issuance of Lilly’s
corresponding claims, there is no interference-in-fact. UW Preliminary Motion 1 for no
interference-in-fact is granted.
3. Lilly Did Not Have Authorization to Set Its Own Time Period for Filing
Motions to Add or Substitute a Count
Lilly had a full and fair opportunity to file motions responding to UW’s motion for
no interference-in-fact. Specifically, UW’s motion was filed under Rule 633(b). Rule
633(i) permits a party to respond to such a motion by filing a motion to: (i) redefine the

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interfering subject matter (633(c)); (ii) substitute a different application (633(d)); or (iii)
add a reissue application to the interference (633(h)). As such, Lilly had the opportunity
to file a motion to redefine the interfering subject matter by adding or substituting a
count or seek to have the claim correspondence changed. See, 37 CFR §§ 1.633(b),
(c) and (i). Rather than file a motion to add or substitute a count, Lilly stated that:
If this interference proceeds, further redefinition of the interfering subject
matter would be necessary and desirable. For example, some
modification of the Count itself will be necessary under 37 C.F.R. §
1.633(c)(1) so that it encompasses the subject matter of the involved
Bang reissue claims currently designated as corresponding to the count.
Otherwise, Lilly could be improperly denied the opportunity to present its
best priority proofs. [Citation omitted]. Such modification of the Count is
not necessary to resolve the interference-in-fact issue that is the subject
of this special motion period, which merely turns on the “same patentable
invention” relationship between the respective claims of the parties
designated as corresponding to the Count. If a Preliminary Motion Period
is set, Lilly will present an appropriate motion to modify the Count itself to
exercise its right to have a count representing its “best proofs.” In the
same vein, Lilly will move during the Preliminary Motions Period to
appropriately further modify the scope of the interference by designating
the appropriate claims of the parties as corresponding to the Count.
(Lilly Preliminary Motion 1, Paper No. 22, p. 6, fn. 2).
Under the rules, a preliminary motion under §§ 1.633 (a) through (h) shall be
filed within a time period set by an APJ . Moreover, the time for filing motions under
§ 1.633 (i) is twenty (20) days after service of the initial motion under rule 633(a), (b),
(c)(1) or (g), unless otherwise ordered by an APJ. 37 CFR §§ 1.636 (a) and (b).
In this case, an APJ set a specific time period for filing motions for no
interference-in-fact or for judgment of unpatentability under 35 U.S.C. § 135(b). (Order,
Paper No. 16). The APJ also set a specific time period for filing responsive rule 633(i)
and (j) preliminary motions. (Order, Paper No. 16). As noted above, Lilly has chosen to

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sua sponte set its own schedule for submitting motions to redefine the interfering
subject matter.
Lilly’s failure to comply with the times set by the APJ undermines the APJ’s
ability to secure a “just, speedy, and inexpensive” determination of this interference.
By failing to timely file its motions to redefine the interfering subject matter, Lilly has
avoided the difficult and complex question of what a proper count and claim
correspondence would be if this interference were to proceed. Further, if Lilly had
timely filed its “necessary and desirable” motions to redefine the interfering subject
matter, Lilly’s motions may have provided additional evidence regarding the existence
of an interference-in-fact or lack thereof. Lilly instead chose a more limited approach
and is subject to the consequences of its choices.
4. The Panel Will Not Exercise Its Discretion Under Rule 641 to Review the
Patentability of UW Claim 1
Lilly has argued that the issue of UW’s written descriptive support for UW claim 1
is presently before the Board. This is not the case. Neither Lilly nor UW has briefed
this particular issue. Moreover, as the panel has determined that there is no
interference-in-fact between UW and Lilly, no Rule 1.633(a) patentability motions will be
accepted from the parties. This is not to say that the panel has determined that UW
claim 1 is patentable, but rather it is a recognition that Lilly will not be afforded the
opportunity to submit unpatentability motions where there is no interference-in-fact.
Berman v. Housey, 2002 U.S. App. LEXIS 10256 at *24 (Fed. Cir. 2002)(Refusal by
Board to address issues of priority and patentability once it determined that there is no

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interference-in-fact is supported by sound policy considerations).
During the course of an interference, if an APJ become aware of a reason why a
claim designated as corresponding to the count may not be patentable, the APJ has the
discretion to enter an order notifying the parties of the reasons and set a time for each
party to present its views. 37 CFR § 1.641. This interference was declared based, in
part, on Lilly’s allegations that a nucleotide sequence encoding protein C deposited by
UW was identical to that of Lilly’s. These allegations proved to be erroneous, albeit
inadvertently. Given the circumstances of this interference, the panel chooses not to
exercise its discretion under Rule 1.641 and explore the patentability or unpatentability
of UW claim 1.
5. Lilly Contingent Miscellaneous Motion 2 is Moot
Lilly filed a motion seeking leave to belatedly file a preliminary statement. (Lilly
Contingent Miscellaneous Motion 2, Paper No. 41, p. 1). Lilly’s motion is contingent on
the determination that there is an interference-in-fact. As we have granted UW
Preliminary Motion 1 for no interference-in-fact, Lilly’s miscellaneous motion is moot.
6. Additional Comments
Lilly has argued that they have no other remedy in the USPTO. (Paper No. 27,
p. 11). According to Lilly, a reexamination of UW’s 529 patent is not available as Lilly’s
‘624 patent was cited during the prosecution of UW’s patent and UW overcame this
rejection by filing a declaration under 37 CFR § 1.131. As such, Lilly concludes that the

Interference No. 104,733
Page No. 38
issue of Lilly’s alleged work under § 102(g) should be resolved in an interference
proceeding. Lilly also argues that the failure to recognize an interference-in-fact under
the present circumstances leads to the “absurd, inequitable, and unlawful” result that
Lilly’s practice of its own prior invention may be alleged to infringe UW’s claims.
The existence or nonexistence of another remedy within the USPTO is not a
basis for continuing an interference where none exists. Should Lilly believe that an
actual controversy exists between the UW ‘529 patent and Lilly’s activities, Lilly may file
a declaratory judgment action in district court.
ORDER
Upon consideration of the motions, it is:
ORDERED that UW Preliminary Motion 1 for no interference-in-fact is granted.
FURTHER ORDERED that there is no interference-in-fact between claims 1 and
3 of UW, U.S. Patent No. 5,302,529 and claims 1-82 and 84-90 of Lilly, U.S. Application
No. 09/185,663.
FURTHER ORDERED that Lilly Preliminary Motion 1 to designate an additional
patent claim is moot.
FURTHER ORDERED that Lilly Contingent Miscellaneous Motion 2 for leave to
belatedly file a preliminary motion is moot.
FURTHER ORDERED that if there is a settlement agreement, attention is
directed to 35 U.S.C. § 135(c) and 37 CFR § 1.661.
FURTHER ORDERED that a copy of this final decision shall be placed and given

Interference No. 104,733
Page No. 39
a paper number in the file of Foster, U.S. Patent No. 5,302,529 and Bang, U.S.
Application No. 09/185,663.
RICHARD E. SCHAFER
Administrative Patent Judge
RICHARD TORCZON
Administrative Patent Judge
MICHAEL P. TIERNEY
Administrative Patent Judge
BOARD OF
PATENT
APPEALS AND
INTERFERENCES
INTERFERENCE
TRIAL SECTION
cc (first-class mail):
Counsel for University of Washington
(Zymogenetics, Inc., exclusive
licensee):
Edward J. Keeling
Steven W. Parmalee
TOWNSEND AND TOWNSEND AND
CREW , LLP
Counsel for Eli Lilly & Co.:
Charles E. Lipsey
Kenneth J. Meyers
FINNEGAN, HENDERSON, FARABOW,
GARRETT & DUNNER, L.L.P.