Regents of the University of Minnesota

Patent Trials and Appeals Board

Dec 21, 2020

IPR2017-01753 (P.T.A.B. Dec. 21, 2020)

Trials@uspto.gov Paper 46
571-272-7822 Date: December 21, 2020

UNITED STATES PATENT AND TRADEMARK OFFICE

BEFORE THE PATENT TRIAL AND APPEAL BOARD

GILEAD SCIENCES, INC.,
Petitioner,
v.
REGENTS OF THE UNIVERSITY OF MINNESOTA,
Patent Owner.

IPR2017-01753
Patent 8,815,830 B2

Before ERICA A. FRANKLIN, ZHENYU YANG, and
CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
Opinion for the Board filed by Administrative Patent Judge YANG.

Opinion Dissenting filed by Administrative Patent Judge PAULRAJ.

YANG, Administrative Patent Judge.
DECISION
Denying Petitioner’s Request for Rehearing of Decision Denying Institution
37 C.F.R. § 42.71(d)

IPR2017-01753
Patent 8,815,830 B2

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INTRODUCTION
Gilead Sciences, Inc. (“Petitioner”) filed a Petition (Paper 1 (“Pet.”)),
seeking an inter partes review of claims 1–9, 11–21, 23, 24, and 26–28 of
U.S. Patent No. 8,815,830 B2 (Ex. 1101, “the ’830 patent”). We denied the
Petition. Paper 42 (“Dec.”). Petitioner filed a request for rehearing of the
Decision, along with Exhibits 1135–1137. Paper 43 (“Req. Reh’g”).
For the reasons discussed below, we deny Petitioner’s request for rehearing.1
STANDARD OF REVIEW
The party challenging a decision in a request for rehearing bears the
burden of showing the decision should be modified. 37 C.F.R. § 42.71(d). A
request for rehearing “must specifically identify all matters the party
believes the Board misapprehended or overlooked, and the place where each
matter was previously addressed.” Id. When rehearing a decision on
institution, the Board reviews the decision for an abuse of discretion. 37
C.F.R. § 42.71(c). It is not an abuse of discretion to have made an analysis
or conclusion with which a party disagrees. Instead, an abuse of discretion
occurs if a decision is based on an erroneous interpretation of law, if a
factual finding is not supported by substantial evidence, or if the decision
represents an unreasonable judgment in weighing relevant factors. Arnold
P’ship v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004).
ANALYSIS
In the Decision Denying Institution, we determined that Petitioner did
not demonstrate a reasonable likelihood of success in showing that the
challenged claims would have been obvious over the asserted combination

1 Petitioner also filed a request for Precedential Opinion Panel
Review. See Paper 44. That request was denied. Paper 45.
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of the ’985 patent, Maruyama, and Sato. See Dec. 14–23. In its Request for
Rehearing, Petitioner contends that our determination not to institute an inter
partes review is improper for two reasons. First, Petitioner argues that we
misapprehended the weight afforded to the evidence submitted by Petitioner
and Patent Owner. Reh’g Req. 2–6. Second, Petitioner argues that we
misapprehended the scope and content of the prior art as viewed by a person
of ordinary skill in the art. Id. at 6–15. We address each of these arguments
in turn.
Weight Afforded to the Evidence Submitted by the Parties
Petitioner argues that Rule 42.108(c) applies broadly and is not
limited to testimonial evidence. Reh’g Req. 2–3. According to Petitioner, the
Majority “perceived that a dispute of material fact existed regarding what a
POSA would understand the prior art’s teachings to be.” Id. at 2 (citing
Dec. 21, 23). “But rather than resolve this genuine dispute in the light most
favorable to the Petitioner,” Petitioner continues, “the Majority deferred to
Patent Owner’s attorney argument and denied institution.” Id. We are not
persuaded.
Under Rule 42.108(c),
The Board’s decision will take into account a patent owner
preliminary response where such a response is filed, including
any testimonial evidence, but a genuine issue of material fact
created by such testimonial evidence will be viewed in the light
most favorable to the petitioner solely for purposes of deciding
whether to institute an inter partes review.
Thus, under the Rule, it is only genuine issues of material fact created
by testimonial evidence provided by a patent owner with its preliminary
response that we view “in the light most favorable to the petitioner.”
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37 C.F.R. § 42.108(c) (2017).2 Because Patent Owner did not provide
testimonial evidence in this proceeding, there is no “genuine issue of
material fact created by such testimonial evidence.”
Accepting Petitioner’s argument that we must always resolve any
genuine dispute of material fact in the light most favorable to the petitioner
would compel institution in every case where a petitioner presents
unrebutted expert testimony. But a patent owner has no obligation to rebut
the petitioner’s contentions or to submit an expert declaration rebutting the
petitioner’s expert testimony. See 37 C.F.R. §§ 42.107(a) (“The patent
owner may file a preliminary response to the petition.” (emphasis added));
42.108(c) (“The Board’s decision will take into account a patent owner
preliminary response where such a response is filed, including any
testimonial evidence.” (emphasis added)). And the Board is not required to
accept every statement made by a petitioner’s expert as established fact
simply because the patent owner does not submit contradictory expert
testimony. Fanduel, Inc. v. Interactive Games LLC, 966 F.3d 1334, 1344
(Fed. Cir. 2020). Instead, “it is the Board’s duty to independently assess the
strength of a petitioner’s argument and evidence.” Id., see also id. (“[I]n
every case, it remains the Board’s essential function to make factual findings
based on its view of the record.”).

2 This Rule has recently been amended. The new Rule no longer provides for
a presumption in favor of a petitioner for a genuine issue of material fact
created by testimonial evidence submitted with a patent owner’s preliminary
response. See 85 Fed. Reg. 79120, 79129 (December 9, 2020). The new
Rule, however, does not apply here as it will not become effective until
January 8, 2021. Id. at 79120. In any event, the outcome of this case remains
the same under either Rule.
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Petitioner argues that the Majority erred by relying on “attorney
arguments alone about how a person of skill would have viewed” the art.
Reh’g Req. 5. According to Petitioner, the Majority relied “on Patent
Owner’s attorney arguments characterizing two references presented for the
first time in Patent Owner’s preliminary response.” Id. at 5–6. We are not
persuaded.
In the Decision denying institution, we concluded that the evidence
before us did not support Petitioner’s alleged reasons to modify the
references (Dec. 16–22), nor establish a reasonable expectation of success of
doing so (id. at 22–23). In reaching this conclusion, we did not rely solely on
references presented by Patent Owner. Instead, we mainly relied on the
express teachings of the art cited by Petitioner, including Marquez I and
Marquez II. Id. at 17–20. Our plain reading of the prior art persuades us that
Petitioner has not demonstrated a reasonable likelihood of prevailing in its
patentability challenge. See Rovalma, S.A. v. Bohler-Edelstahl GmbH & Co.
KG, 856 F.3d 1019, 1027 (Fed. Cir. 2017) (noting that the Board is not
precluded “from relying on arguments made by a party and doing its job, as
adjudicator, of drawing its own inferences and conclusions from those
arguments, even when the result is use of the party’s submissions against
it”).
In sum, we are not persuaded that we misapprehended the weight
afforded to the evidence submitted by Petitioner and Patent Owner.
Scope and Content of the Prior Art
Petitioner contends the Board “misapprehended how a POSA would
have understood Meier and Marquez III in 2004, including overlooking
critical statements and data that contradict its own conclusion that a 2ʹ fluoro
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Patent 8,815,830 B2

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down ‘destroys the activity and increases the toxicity.’” Reh’g Req. 6 (citing
Dec. 21). Petitioner contends that its expert’s testimony “addressed a
POSA’s understanding of the prior art as a whole in 2004” in contrast to
Patent Owner’s preliminary response which “presented no evidence
supporting a POSA’s perspective as of 2004.” Id. at 6–7. We are not
persuaded by this argument either.
As in initial matter, as explained above, when denying institution, we
relied mainly on the express teachings of Marquez I and Marquez II, both of
which were cited by Petitioner, not Patent Owner. See Dec. 17–20.
Moreover, while the Board may appreciate receiving expert opinion
from both sides to help it decide a case, no expert submissions are required.
See Belden Inc. v. Berk-Tek LLC, 805 F.3d 1064, 1079 (Fed. Cir. 2015) (“No
rule requires . . . an expert guiding the Board as to how it should read prior
art.”). Indeed, although expert testimony may be presented to help establish
the scope and content of the prior art, expert testimony “cannot take the
place of a disclosure in a prior art reference.” Patent Trial and Appeal Board
Consolidated Trial Practice Guide (Nov. 21, 2019) (“Consolidated TPG”)
36.3 In the Decision, we considered the testimony of Petitioner’s expert in
light of the other evidence of the record, including prior art cited by
Petitioner. As discussed in the Decision, Petitioner’s argument, including the
expert’s testimony, “fails to consider that the prior art as a whole, including
references Petitioner relies on, teaches that substituting fluorine at the 2ʹ
down position renders numerous anti-HIV compounds inactive, and
increases their toxicity.” Dec. 23.

3 Available at
https://www.uspto.gov/sites/default/files/documents/tpgnov.pdf?MURL=
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Petitioner argues that the Majority ignored “other relevant compounds
in Meier that, like compounds 5 and 6 of the ’985 patent, include a
pronucleotide moiety at the 5ʹ-position.” Reh’g Req. 8. Petitioner contends
the Majority disregarded Meier’s additional teachings that “when the
pronucldeotide [sic] moiety was present at the 5ʹ position, compounds with a
fluorine at the 2ʹ down position were some of the most active against HIV
that Meier studied.” Id. at 10. According to Petitioner, an ordinarily skilled
artisan would not “disregard such compounds in favor of nucleoside
analogues without prodrug moieties at the 5ʹ position, let alone do so to draw
the conclusion that the Majority does that ALL compounds with a 2ʹ-fluoro
down are inactive.” Id. at 11. We are not persuaded by Petitioner’s
argument.
First, the Decision did not conclude that the prior art teaches that all
compounds with a 2ʹ-fluoro down substitution are inactive. Rather, we
determined that: (1) “substituting fluorine at the 2' down position of several
compounds with anti-HIV activity not only renders the compounds inactive,
but also increases their toxicity;” (2) “fluorine atoms at the same positions,
but with inverted stereochemistry, consistently produced inactive
compounds;” and (3) “substituting fluorine at the 2' down position renders
numerous anti-HIV compounds inactive, and increases their toxicity.” Dec.
17, 21, 23 (emphases added). Simply put, the prior art as a whole teaches
that substituting fluorine at the 2ʹ position in the down orientation yields
unpredictable results.
Second, the Petition argues that it would have been obvious to modify
the ’985 patent in view of Maruyama and Sato, not in view of Meier. Pet. 40.
Neither Maruyama nor Sato teaches compounds with pronucleotide moieties
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Patent 8,815,830 B2

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at the 5ʹ-position. Accordingly, Petitioner has not shown that the Board
overlooked Meier’s teachings as applied to modifying the ’985 patent with
Maruyama and Sato. See In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364,
1381 (Fed. Cir. 2016) (stating that the Board is not “free to adopt arguments
on behalf of petitioners that could have been, but were not, raised by the
petitioner during an IPR. Instead, the Board must base its decision on
arguments that were advanced by a party, and to which the opposing party
was given a chance to respond”).
Petitioner further argues that “Marquez’s later work highlighted the
importance of ring orientation on biological activity” and “includes
nucleosides with hydroxy groups at the 3ʹ down position—just like those
that Maruyama and Sato reported.” Reh’g Req. 12–14. As support,
Petitioner submits Exhibits 1135–1137. See id. at 12–14.
Exhibits 1135–1137 were not of record when we issued the Decision
denying institution. Petitioner argues that good cause exists for the Board to
consider these new exhibits because the exhibits “support Petitioner’s
testimonial evidence already of record about the proper view of the art and
contradict Patent Owner’s attorney argument.” Id. at 13 n. 2.
Absent a showing of “good cause” prior to filing the request for
rehearing or in the request for rehearing itself, new evidence will not be
admitted. Consolidated TPG 90 (citing Huawei Device Co., Ltd. v. Optis
Cellular Tech., LLC, IPR2018-00816, Paper 19 at 4 (Jan. 8, 2019)
(precedential)). Here, we are not persuaded that there is good cause to
consider Petitioner’s new exhibits because they support the new argument
that Marquez’s later work includes nucleosides with hydroxy groups at the 3ʹ
down position. See Reh’g Req. 14. Petitioner does not explain how the
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Patent 8,815,830 B2

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Board misapprehended or overlooked this new argument, or why Petitioner
could not have submitted the new evidence and argument with the Petition.
Accordingly, these exhibits should not be admitted and are not entitled to
consideration. Consequently, we exercise our authority under 37 C.F.R.
§ 42.7(a) to expunge Exhibits 1135–1137.
In sum, we are not persuaded that we misapprehended how an
ordinarily skilled artisan would have understood the scope and content of
prior art.
CONCLUSION
For the foregoing reasons, Petitioner has not demonstrated that we
abused our discretion, or that we misapprehended or overlooked any issue in
denying institution of an inter partes review in this case.
ORDER
Accordingly, it is
ORDERED that Petitioner’s Request for Rehearing is denied; and
FURTHER ORDERED that, pursuant to 37 C.F.R. § 42.7(a),
Exhibits 1135–1137 are expunged from the record of this proceeding.

Trials@uspto.gov Paper 46
571-272-7822 Date: December 21, 2020

UNITED STATES PATENT AND TRADEMARK OFFICE

BEFORE THE PATENT TRIAL AND APPEAL BOARD

GILEAD SCIENCES, INC.,
Petitioner,
v.
REGENTS OF THE UNIVERSITY OF MINNESOTA,
Patent Owner.

IPR2017-01753
Patent 8,185,830 B2

Before ERICA A. FRANKLIN, ZHENYU YANG, and
CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
PAULRAJ, Administrative Patent Judge, dissenting.
I respectfully dissent for the reasons previously stated in my dissent
from the original Decision Denying Institution. In this rehearing decision,
the majority declines to consider the new evidence that Petitioner cites in its
request for rehearing. While I agree that a rehearing request is typically not
the appropriate stage to introduce new evidence, the presence of such
exhibits does highlight the fact that the majority resolved critical factual
issues at the institution stage based on an incomplete record.

IPR2017-01753
Patent 8,815,830 B2

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FOR PETITIONER:
Alicia Russo
Frederick Millett
Robert S. Schwartz
VENABLE LLP
arusso@venable.com
gilead830ipr@venable.com
rschwartz@Venable.com

Adam K. Mortara
J. Scott McBride
Nevin M. Gewertz
BARTLIT BECK LLP
adam.mortara@bartlit-beck.com
scott.mcbride@bartlit-beck.com
nevin.gewertz@bartlit-beck.com

FOR PATENT OWNER:
Edward Gates
Richard Giunta
Gerald Hrycyszyn
WOLF, GREENFIELD & SACKS, P.C.
egates-ptab@wolfgreenfield.com
rgiunta-ptab@wolfgreenfield.com
ghrycyszyn-ptab@wolfgreenfield.com