Regents of the University of Minnesota

Patent Trials and Appeals Board

May 28, 2020

IPR2017-02005 (P.T.A.B. May. 28, 2020)

Trials@uspto.gov Paper 40
571-272-7822 Entered: May 28, 2020
2

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.
____________

IPR2017-02005
Patent 8,815,830 B2
____________

Before ERICA A. FRANKLIN, ZHENYU YANG, and
CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.

YANG, Administrative Patent Judge.

DECISION
Denying Institution of Inter Partes Review
35 U.S.C. § 314
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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, 12, and 28 of U.S. Patent
No. 8,815,830 B2 (Ex. 1301, “the ’830 patent”). Regents of the University
of Minnesota (“Patent Owner”) filed a Preliminary Response. Paper 35
(“Prelim. Resp.”).
We have authority under 35 U.S.C. § 314, which provides that an
inter partes review may not be instituted “unless . . . there is a reasonable
likelihood that the petitioner would prevail with respect to at least 1 of the
claims challenged in the petition.” 35 U.S.C. § 314(a) (2012).
For the reasons provided below, we determine that Petitioner has not
demonstrated a reasonable likelihood that it would prevail with respect to at
least one of the claims challenged in the Petition. Accordingly, we deny
institution of an inter partes review.
Related Matters
According to the parties, Patent Owner asserted the ’830 patent
against Petitioner in Regents of the University of Minnesota v. Gilead
Sciences, Inc., No. 16-cv-02915 (D. Minn.). Pet. viii; Paper 3, 1. The case
was later transferred to the U.S. District Court for Northern District of
California and was docketed as Regents of the University of Minnesota v.
Gilead Sciences, Inc., No. 3:17-cv-06056 (N.D. Ca.). Paper 21, 1.
Petitioner also filed three other petitions (IPR2017-01712,
IPR2017-01753, IPR2017-02004), all challenging the claims of the ’830
patent. Pet. viii.
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Patent 8,815,830 B2

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Case History
Petitioner filed the Petition on August 29, 2017. Paper 5. With our
authorization, the parties briefed the issue of whether the doctrine of
sovereign immunity applies in this proceeding such that we should grant
Patent Owner’s Motion to Dismiss the Petition. Papers 12, 15, 16.
While the Motion to Dismiss in this case was pending, the Board
denied Patent Owner’s motions to dismiss based on sovereign immunity in
several other inter partes review proceedings. LSI Corp. v. Regents of the
Univ. of Minn., IPR2017-01068, Paper 19 (PTAB Dec. 19, 2017); Ericsson
Inc. v. Regents of the Univ. of Minn., IPR2017-01186, -01197, -01213,
-01214, -01200, -01219 (PTAB Dec. 19, 2017). On February 12, 2018,
Patent Owner filed a Notice of Appeal, seeking immediate appellate review
of those decisions. See, e.g., IPR2017-01186, Paper 22.
Under such circumstances, and at the request of Patent Owner, we
suspended this proceeding in view of the appellate adjudication of the state-
sovereign-immunity issue. Papers 17, 20, 23. Petitioner then sought, and was
granted, leave to intervene in those appeals. Paper 21, 2.
On June 14, 2019, the Federal Circuit affirmed the Board’s decision
denying Patent Owner’s motion to dismiss in those proceedings. Regents of
the Univ. of Minn. v. LSI Corp., 926 F.3d 1327, 1330 (Fed. Cir. 2019).
On January 13, 2020, the Supreme Court denied Patent Owner’s petition for
writ of certiorari. Regents of the Univ. of Minn. v. LSI Corp., 140 S. Ct. 908
(Jan. 13, 2020) (No. 19-337). The next day, we denied Patent Owner’s
Motion to Dismiss and lifted the stay order in this proceeding. Paper 27.
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Patent 8,815,830 B2

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Because Petitioner filed four petitions, challenging largely
overlapping claims of the ’830 patent, we requested that Petitioner rank
them in the order in which it wishes the panel to consider the merits. Paper
32, 2 (citing Office Patent Trial Practice Guide, July 2019 Update,1 26). We
also invited Patent Owner to respond to Petitioner’s notice. Id. at 3. The
parties have since filed their respective papers. Papers 33, 34.
The ’830 Patent
The ’830 patent relates to nucleosides with antiviral and anticancer
activity. Ex. 1301, 1:1–2.
The ’830 patent acknowledges that “U.S. Pat. No. 6,475,985 reports
certain specific nucleoside phosphoramidate analogs having anticancer
and/or antiviral properties.” Id. at 1:61–63. It states that there were other,
continued interests “in phosphoramidate nucleoside analogs due to their
demonstrated utility as prodrugs of antiviral and anticancer nucleoside
monophosphates, or pronucleotides.” Id. at 1:63–66. But despite the prior-art
studies on this topic, there was still “a need for chemotherapeutic agents
with antiviral and[/]or anticancer properties.” Id. at 2:6–8. According to the
’830 patent, its invention provides such “compounds that act as antiviral
and[/]or anticancer agents.” Id. at 2:48–49.

1 84 Fed. Reg. 33,926 (July 16, 2019), available at
https://www.uspto.gov/TrialPracticeGuide3.
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Illustrative Claim
Claim 1 is independent and is reproduced below:
1. A compound of formula I:

wherein:
R1 is guanine, cytosine, thymine, 3-deazaadenine, or uracil,
optionally substituted by 1, 2, or 3 U; wherein each U is
independently halo, hydroxy, (C1-C6)alkyl, (C3-C6)cycloalkyl,
(C1-C6)alkoxy, (C3-C6)cycloalkyloxy, (C1-C6)alkanoyl,
(C1-C6)alkanoyloxy, trifluoromethyl, hydroxy(C1-C6)alkyl,
––(CH2)1-4P(=O)(ORw)2, aryl, aryl(C1-C6)alkyl, or NRxRy;
R2 is halo;
R6 and R7 are independently H or (C1-C6)alkyl;
R3 is hydroxy;
R4 is hydrogen, (C1-C6)alkyl, (C3-C6)cycloalkyl, aryl,
aryl(C1-C6)alkyl, or 2-cyanoethyl;
R5 is an amino acid;
X is oxy, thio, or methylene;
each Rw is independently hydrogen or (C1-C6)alkyl;
Rx and Ry are each independently hydrogen, (C1-C6)alkyl,
(C3-C6)cycloalkyl, phenyl, benzyl, phenethyl, or
(C1-C6)alkanoyl; or Rx and Ry together with the nitrogen to which
they are attached are pyrrolidino, piperidino or morpholino;
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Patent 8,815,830 B2

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wherein any (C1-C6)alkyl of R1, R4-R7, Rw, Rx, and Ry is
optionally substituted with one or more halo, hydroxy,
(C1-C6)alkoxy, (C3-C6)cycloalkyloxy, (C1-C6)alkanoyl,
(C1-C6)alkanoyloxy, trifluoromethyl, azido, cyano, oxo (=O),
(C1-C6)alkyl, (C3-C6)cycloalkyl, (C3-C6)cycloalkyl(C1-C6)alkyl,
(C1-C6)alkyl-S––(C1-C6)alkyl-, aryl, heteroaryl,
alkyl(C1-C6)alkyl, or heteroaryl(C1-C6)alkyl, or NRajRak;
wherein each Raj and Rak is independently hydrogen,
(C1-C6)alkyl, (C3-C6)cycloalkyl, phenyl, benzyl, or phenethyl;
and wherein any aryl or heteroaryl may optionally be substituted
with one or more substituents selected from the group consisting
of halo, hydroxy, (C1-C6)alkyl, (C3-C6)cycloalkyl,
(C1-C6)alkoxy, (C3-C6)cycloalkyloxy, (C1-C6)alkanoyl,
(C1-C6)alkanoyloxy, trifluoromethyl, trifluoromethoxy, nitro,
cyano, and amino;
or a pharmaceutically acceptable salt thereof.
Asserted Ground of Unpatentability
Petitioner challenges claims 1–9, 11, 12, and 28 under a single
ground, alleging they are unpatentable for obviousness over the combined
teachings of the ’787 patent2 and Brox.3
In support of its patentability challenge, Petitioner relies on the
Declaration of David MacMillan, Ph.D. Ex. 1307.

2 Christopher McGuigan, U.S. Pat. No. 7,951,787 B2, issued May 31, 2011
(Ex. 1302).
3 L. W. Brox et al., Studies on the Growth Inhibition and Metabolism of 2'-
Deoxy-2'-fluorocytidine in Cultured Human Lymphoblasts, 34 CANCER RES.
1838 (1974) (Ex. 1306).
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ANALYSIS
Discretionary Denial
Patent Owner contends that we should exercise our discretion and
deny institution because Petitioner filed four petitions to challenge the
claims of the ’830 patent. Prelim. Resp. 11–12, 68. According to Patent
Owner, “[f]our parallel petitions are inappropriate and have placed a
substantial and unnecessary burden on the Board and Patent Owner.” Id. at
68.
Petitioner points out that all four petitions were filed in 2017, before
the Office started to disfavor multiple petitions against the same patent.
Paper 33, 1. According to Petitioner, but for Patent Owner’s “efforts to stop
these proceedings before they began” by asserting sovereign immunity,
these proceedings would have concluded before the policy shift. Id. at 1–2.
Under such circumstances, and because, as explained below, we deny
institution based on substantive analysis of the Petition, we decline to
consider whether institution should be denied on a discretionary basis.
Claim Construction
In an inter partes review based on a petition filed before
November 13, 2018, the Board interprets a claim term in an unexpired patent
according to its broadest reasonable construction in light of the specification
of the patent in which it appears. 37 C.F.R. § 42.100(b) (2017);4 Cuozzo

4 The final rule changing the claim construction standard does not apply
here, as the Petition was filed before the effective date of the final rule,
November 13, 2018. See Changes to the Claim Construction Standard for
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Patent 8,815,830 B2

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Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2144–46 (2016). Under that
standard, and absent any special definitions, we assign claim terms their
ordinary and customary meaning, as would be understood by one of ordinary
skill in the art at the time of the invention, in the context of the entire patent
disclosure. In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir.
2007). Any special definitions for claim terms must be set forth with
reasonable clarity, deliberateness, and precision. In re Paulsen, 30 F.3d
1475, 1480 (Fed. Cir. 1994).
Petitioner states that the terms in the ’830 patent should be construed
under the broadest-reasonable-interpretation standard. Pet. 14. It generally
notes that the ’830 patent offers some specific definitions. Id.
Patent Owner discusses the terms “alkyl” and “aryl.” Prelim.
Resp. 37–55. According to Patent Owner, “alkyl” means “a hydrocarbon
group containing only single bonds.” Id. at 50. It points to Mcgraw-Hill
Dictionary of Scientific and Technical Terms, which defines “alkyl” as “[a]n
organic group that results from removal of a hydrogen atom from an acyclic,
saturated hydrocarbon;” and “saturated hydrocarbon” as “[a] saturated
carbon-hydrogen compound with all carbon bonds filled; that is, there are no
double or triple bonds as in olefins and acetylenics.” Id. (quoting Ex. 2315,
64. 1754). Patent Owner argues that its construction is consistent with the
disclosures of the ’830 patent. Id. at 50 (noting that in the ’830 patent, alkyl
denotes “both straight and branched groups”) (quoting Ex. 1301, 5:15–16),

Interpreting Claims in Trial Proceedings Before the Patent Trial and Appeal
Board, 83 Fed. Reg. 51,340 (Oct. 11, 2018) (amending 37 C.F.R.
§ 42.100(b) effective November 13, 2018).
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Patent 8,815,830 B2

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52 (observing that each named group of (C1-C6)alkyl in the ’830 patent is a
hydrocarbon group containing only single bonds) (citing Ex. 1301, 6:37–39).
Petitioner, although not offering any construction of the term, acknowledges
that “alkyl” is “commonly understood” to include only saturated
hydrocarbons. Pet. 21. On this record, we find Patent Owner’s argument
persuasive and agree that “alkyl” is “a hydrocarbon group containing only
single bonds.”
Patent Owner points to the ’830 patent for defining “aryl” as “a
phenyl radical or an ortho-fused bicyclic carbocyclic radical having about
nine to ten ring atoms in which at least one ring is aromatic.” Prelim.
Resp. 41 (quoting Ex. 1301, 5:14–22). The parties agree that this definition
excludes heteroaryl groups, that is, “ring systems with heteroatoms (i.e.,
atoms that are not carbon or hydrogen) incorporated into the ring(s).” Id. at
42; Pet. 21.
Claim terms need only be construed to the extent necessary to resolve
the controversy. Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361
(Fed. Cir. 2011). On this record and for purposes of this Decision, we see no
need to construe any other term expressly.
Prior-Art Disclosures
The ’787 Patent
The ’787 patent describes phosphoramidate derivatives of nucleotides
and their use in the treatment of cancer. Ex. 1302, Abstract. It teaches a
compound of formula I:
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Patent 8,815,830 B2

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wherein
R is selected from the group comprising alkyl, aryl and alkylaryl;
R´ and R´´ are, independently, selected from the group
comprising H, alkyl and alkylaryl, or R´ and R´´ together form
an alkylene chain so as to provide, together with the C atom to
which they are attached, a cyclic system;
Q is selected from the group comprising –O– and –CH2–;
X and Y are independently selected from the group comprising
H, F, Cl, Br, I, OH and methyl (–CH3);
Ar is a monocyclic aromatic ring moiety or a fused bicyclic
aromatic ring moiety, either of which ring moieties is carbocyclic
or heterocyclic and is optionally substituted;
Z is selected from the group comprising H, alkyl and halogen;
and
n is 0 or 1,
wherein
when n is 0, Z´ is –NH2 and a double bond exists between
position 3 and position 4, and
when n is 1, Z´ is =O;
or a pharmaceutically acceptable derivative or metabolite of a
compound of formula I;
with the proviso that when n is 1, X and Y are both H, R is methyl
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(–CH3), one of R´ and R´´ is H and one of R´ and R´´ is methyl
(–CH3), then Ar is not phenyl (–C6H5).
Id. at 3:30–4:3.
Brox
Brox teaches that nucleoside 2'-deoxy-2'-tluorocytidine (FCdR)
inhibits the growth of various human lymphoblastic cell lines in culture.
Ex. 1306, Abstract, 1839.
Analysis
Petitioner asserts that claims 1–9, 11, 12, and 28 would have been
obvious over the combination of the ’787 patent and Brox. Pet. 33–59.
Based on this record, we determine Petitioner has not established a
reasonable likelihood that it would prevail in this assertion.
Petitioner argues that the ’787 patent “discloses a genus of nucleoside
phosphoramidate compounds that are an obvious subgenus that is almost
entirely within the scope of the genera claimed in the ’830 patent, and/or
substantially overlaps those genera.” Id. at 33 (citing Ex. 1307 ¶ 24, 75), see
also id. at 38 (“The Markush group selections in the ’787 patent fall largely
within the Markush group selections of the claims of the ’830 patent.”).
Petitioner states that “[t]he ’787 patent subgenus is slightly broader in its
available substituent choices at the 2’-position than the claims of the ’830
patent.” Id. at 44. Petitioner relies on Brox for the “narrowing selections” at
this position. Id. at 46–49. Petitioner argues that an ordinarily skilled artisan
would have been motivated to combine the teachings of the ’787 patent and
Brox. Id. at 48–49. Thus, Petitioner concludes that the challenged claims
would have been obvious over the ’787 patent and Brox. Id. at 52–59.
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Patent Owner contends that we should deny the Petition because,
among other reasons, the premise of the obviousness challenge, that is, the
genus of the ’787 patent “substantially overlaps” with that of the challenged
claims, is flawed. Prelim. Resp. 6–9, 37–58. Patent Owner argues that “[t]he
’787 Patent defines ‘alkyl’ and ‘aryl’ far more broadly than the meaning of
those terms in the ’830 Patent.” Id. at 38. As a result, Patent Owner
concludes that “the claimed ’830 Patent genus neither substantially overlaps
nor virtually encompasses the ’787 genus (even if modified according to
Brox).” Id. at 40. We find Patent Owner’s argument more persuasive.
The Petition includes a chart comparing the Markush group selections
in the ’787 patent with those of challenged claim 1:

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Pet. 43 (highlighting in original).
For the R4 position, Petitioner argues that “aryl, aryl(C1-C6)alkyl” of
the ’830 patent encompasses the “Ar” of the ’787 patent. Id., see also id.
at 40 (“[B]oth the ’787 patent and the ’830 patent include an aryl
substituent.”). We find that for the following two reasons, despite using the
same term “aryl,” the R4 substituent options claimed in the ’830 patent does
not encompass the “Ar” substituent selections of the ’787 patent.
First, as discussed in the claim-construction section, the parties agree
that “aryl,” as defined in the ’830 patent, excludes heteroaryl groups. Supra
at 9; Pet. 21; Prelim. Resp. 42. “Aryl” in the ’787 patent, in contrast, “may
be a heteroaromatic group containing one, two, three or four” heteroatoms.
Ex. 1302, 4:65–5:3, see also id. at 3:56–58 (“Ar is a monocyclic aromatic
ring moiety or a fused bicyclic aromatic ring moiety, either of which ring
moieties is carbocyclic or heterocyclic and is optionally substituted.”).
Second, when “aryl” is an ortho-fused bicyclic carbocyclic radical, the
’830 patent limits the system to “about nine to ten ring atoms.” Ex. 1301,
5:14–22. In contrast, in the ’787 patent, “an aryl group means an aromatic
group containing 5 to 14 ring atoms.” Ex. 1302, 4:65–66. Because of at least
these two differences, the “Ar” substituent selections of the ’787 patent are
broader than the “aryl” substituent selections of the claims of the ’830
patent.
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Similarly, we find that the ’787 patent discloses broader selections
corresponding to the R1 position of the ’830 patent. At R1, Petitioner argues
that the U substituents of “halo” and “(C1-C6)alkyl” of the ’830 patent
encompass the “H, alkyl and halogen” Z substituents of the ’787 patent.
Pet. 43, see also id. at 38–39 (arguing that the ’787 patent discloses “an alkyl
or halogen substituted derivative thereof as options at R1 . . . all of which are
contained within the ’830 patent claims”). Pet. 38–39. For the following two
reasons, we disagree.
First, as discussed in the claim-construction section, the parties agree
that “alkyl” as defined in the ’830 patent, includes only saturated
hydrocarbons. Supra 8; Pet. 21; Prelim. Resp. 50. In contrast, in the ’787
patent, an “alkyl” group includes either “saturated or unsaturated
(e.g. alkenyl or alkynyl) hydrocarbyl radical.” Ex. 1302, 4:58–60.
Second, as, the ’830 patent limits the claimed U substituents to
“(C1-C6)alkyl.” Ex. 1301, 19:13. In contrast, the ’787 patent does not limit
the number of carbon atoms. Because of at least these two differences, the
“alkyl” substituent selections of the ’787 patent are broader than the
“(C1-C6)aryl” substituent selections of the claims of the ’830 patent.
Petitioner acknowledges that “the ’787 patent expressly broadens the
commonly understood definitions of ‘alkyl’ (to include unsaturated
hydrocarbons) and ‘aryl’ (to include heteroaryls), but the corresponding
definitions in the ’830 patent do not contain those broadened definitions.” Id.
at 21; see also id. at 39 n.3 (“[T]he ’787 patent’s specific definition [of
“alkyl”] somewhat broadens this shared substituent terminology by allowing
‘alkyl’ to encompass unsaturated hydrocarbons more commonly known as
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‘alkenyl’ or ‘alkynyl.’”); id. at 40 n.5 (“The ’787 patent has specifically
broadened the term ‘aryl’ beyond its commonly understood definition to
include heteroatoms.”).
Despite these admissions, Petitioner contends that an ordinarily
skilled artisan “would regardless understand” “alkyl” and “aryl” as they are
“commonly understood.” Id. at 39 n.3, id. at 40 n.5. As support, Petitioner
relies on the testimony of Dr. MacMillan, who chalks up the broadened
definitions of “alkyl” and “aryl” in the ’787 patent as a “minor difference”
from the challenged patent. Ex. 1307 ¶ 99 n.3. According to Dr. MacMillan,
an ordinarily skilled artisan would be “naturally directed towards the
common and shared definition of both of those terms in each of the ’787
patent and the ’830 patent, meaning that the resulting genus of compounds
disclosed in the ’787 patent will be entirely within those claimed in the ’830
with respect to those choices.” Id. We are not persuaded.
Dr. MacMillan relies on the challenged patent itself to support his
opinion. See, e.g., id. ¶ 88 n.1 (“[A]s between the definitions of alkyl in the
’787 patent and the ’830 patent, a person of skill would understand the term
‘alkyl’ to be focused on the commonly understood definition of alkyl,
namely saturated hydrocarbon chains, as defined in the ’830 patent.”) (citing
Ex. 1301, 5:15–19). “The inventor’s own path itself,” however, “never leads
to a conclusion of obviousness; that is hindsight.” Otsuka Pharm. Co. v.
Sandoz, Inc., 678 F.3d 1280, 1296 (Fed. Cir. 2012). Instead, “[w]hat matters
is the path that the person of ordinary skill in the art would have followed, as
evidenced by the pertinent prior art.” Id. Here, that prior-art evidence is
missing. Because Dr. MacMillan’s opinion on this issue is not properly
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supported, we accord it little weight. See 37 C.F.R. § 42.65(a) (“Expert
testimony that does not disclose the underlying facts or data on which the
opinion is based is entitled to little or no weight.”).
In sum, both “aryl” and “alkyl” are broader in the ’787 patent than in
the ’830 patent. Thus, even if an ordinarily skilled artisan, based on the
teachings of Brox, would have modified the formula I genus of the ’787
patent, such modified genus would not be “almost entirely within the scope
of” the genus of the challenged claims. As a result, Petitioner has not
sufficiently demonstrated the obviousness of the challenged claims over the
’787 patent and Brox.
CONCLUSION
For the reasons explained above, we determine that Petitioner has not
established a reasonable likelihood that it would prevail in showing that at
least one of the challenged claims is unpatentable as obvious over the
combination of the ’787 patent and Brox.
ORDER
In consideration of the foregoing, it is hereby:
ORDERED that the Petition is denied, and we do not institute inter
partes review of any claim of the ’830 patent based on the ground asserted
in the Petition.

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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.
Rgiunta-ptab@wolfgreenfield.com
Ghrycyszyn-ptab@wolfgreenfield.com