throbber
Trials@uspto.gov
`Tel: 571-272-7822
`
`Paper No. 7
`Entered: July 19, 2018
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`INITIATIVE FOR MEDICINES, ACCESS & KNOWLEDGE (I-MAK), INC.,
`Petitioner
`
`v.
`
`GILEAD PHARMASSET LLC,
`Patent Owner.
`_______________
`
`Case IPR2018-00390
`Patent 8,889,159 B2
`_______________
`
`
`Before ERICA A. FRANKLIN, GRACE KARAFFA OBERMANN
`and RICHARD J. SMITH, Administrative Patent Judges.
`
`OBERMANN, Administrative Patent Judge.
`
`
`
`DECISION
`Denying Institution of Inter Partes Review
`35 U.S.C. § 314(a)
`
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`

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`Case IPR2018-00390
`Patent 8,889,159 B2
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`
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`I. INTRODUCTION
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`Petitioner filed a Petition for inter partes review of claims 1–37 of U.S.
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`Patent 8,889,159 B2 (“the ’159 patent”). Paper 2 (“Pet.”). Patent Owner filed a
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`Preliminary Response. Paper 6 (“Prelim. Resp.”). We have authority to institute
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`an inter partes review only upon a showing that Petitioner is reasonably likely to
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`prevail with respect to at least one challenged patent claim. 35 U.S.C. § 314(a).
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`Applying that standard, we conclude that Petitioner has not established the
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`threshold showing for review and, accordingly, we deny the Petition and do not
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`institute review of any challenged claim.
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`
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`A. Related Proceedings
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`Petitioner identifies as a related matter a pending patent application (U.S.
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`Patent Appl. No. 15/410,438) that claims priority through the ’159 patent. Pet. 2.
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`Petitioner avers that it “is not aware of any other matter that would affect, or be
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`affected by, a decision in this proceeding.” Id.
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`Patent Owner identifies the same pending application under a heading titled
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`“Related Matters.” Paper 3, 2. Patent Owner also identifies a second pending
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`application (U.S. Patent Appl. No. 14/538,736) as a related matter and, further,
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`“notes” that Petitioner filed eight prior petitions for inter partes review, none of
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`which was directed to any claims of the ’159 patent. Id. at 2–3 (citations omitted).
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`“Patent Owner does not concede that any” of those identified matters— “aside
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`from” the ’159 patent—“would affect, or be affected by this proceeding.” Id.
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`Case IPR2018-00390
`Patent 8,889,159 B2
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`B. The ’159 Patent
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`The ’159 patent relates to a pharmaceutical composition and unit dosage
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`form of a specific agent for treating hepatitis C virus (“HCV”). Ex. 1001,
`
`Abstract. The specification discloses that (S)-isopropyl 2-(((S)-(((2R,3R,4R,5R)-
`
`5-(2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl )-4-fluoro-3 -hydroxy-4-
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`methyltetrahydrofuran-2-yl)methoxy)(phenoxy)phosphoryl)amino)propanoate is
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`“available from Gilead Sciences, Inc.” and, further, is disclosed and claimed in
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`U.S. Pat. No. 7,964,580. Ex. 1001, 7:65–8:2.
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`The specification states that this HCV agent is, or has been, known variously
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`as “GS-7977,” “sofosbuvir,” and “PSI-7977.” Id. at 7:67; 5:20–21. We refer to
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`that agent in this decision as sofosbuvir. According to the ’159 patent
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`specification, sofosbuvir has the following general structure:
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`
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`Id. at 7:65–8:15. Patent Owner directs us to information that sofosbuvir may exist
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`in different crystalline forms known as “polymorphs,” which “can, and often do,
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`exhibit different properties.” Prelim. Resp. 5–6 (and evidence cited therein).
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`The ’159 patent discloses a polymorphic form of sofosbuvir identified as
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`“Form 6.” Ex. 1001, 8:42; 32:24, 31. According to the specification, Form 6 is
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`Case IPR2018-00390
`Patent 8,889,159 B2
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`characterized by an X-ray powder diffraction (“XRPD”) pattern of “2θ-reflections
`
`(o) at about: 6.1, 8.2. 10.4, 12.7, 17.2, 17.7, 18.0, 18.8, 19.4, 19.8, 20.1, 20.8, 21.8,
`
`and 23.3.” Id. at 8:18–26, 40–56; see id. at 9:51–55 (disclosing “preferred
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`subembodiment” of “crystalline” sofosbuvir having that characteristic XRPD
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`pattern of 2θ-reflections); 11:40–12:55 (disclosing embodiments having that
`
`characteristic XRPD pattern of 2θ-reflections).
`
`The specification discloses an example that includes instructions for forming
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`“polymorphic Form 6” into a 400 mg tablet dosage form. Id. at 32:6–63.
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`Specifically, the ’159 patent describes milling Form 6 “with extragranular
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`excipients (microcrystalline cellulose, croscarmellose sodium, colloidal silicon
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`[dioxide], magnesium stearate) to yield a powder blend comprising 33.33% w/w”
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`sofosbuvir, which “was compressed to a target tablet weight of 1200 mg, with each
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`tablet comprising about 400 mg of” sofosbuvir. Id. Patent Owner avers that
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`Form 6 is used in its commercial pharmaceutical product known as Sovaldi.
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`Prelim. Resp. 6.
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`
`
`C. Illustrative Claims
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`Petitioner challenges claims 1–37 of the ’159 patent, of which claims 1
`
`and 16 are the only independent claims.
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`Claim 1 is reproduced below:
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`Case IPR2018-00390
`Patent 8,889,159 B2
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`Ex. 1001, 46:36–56. Claims 2–15 and 33 depend directly or indirectly from
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`
`
`claim 1. Id. at 46:57–47:50; 49:15–17.
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`Case IPR2018-00390
`Patent 8,889,159 B2
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`Claim 16, the only other independent claim, is reproduced below:
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`
`
`
`
`
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`Ex. 1001, 47:51–48:5. Claims 17–32 and 34–37 depend directly or
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`indirectly from claim 16. Id. at 48:6–49:14; 49:18–29.
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`Case IPR2018-00390
`Patent 8,889,159 B2
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`D. The Asserted Grounds of Unpatentability
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`The Petition, supported by the declaration of Joseph M. Fortunak, Ph.D.
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`(Ex. 1014), asserts the following grounds of unpatentability against claims 1–37:
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`Reference
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`Ross ’6451
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`Ross ’645
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`Ross ’2572,3
`
`Ross ’257
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`Statutory Basis
`
`§ 102
`
`§ 103
`
`§ 102
`
`§103
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`Pet. 3.
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`II. ANALYSIS
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`A. Person of Ordinary Skill in the Art
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`Petitioner asserts that a person of ordinary skill in the art at the time of the
`
`invention would have had either “(1) [] a Ph.D. in chemistry or a closely related
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`field with some experience in an academic or industrial laboratory focusing on
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`drug discovery and/or development, including formulations, and would also have
`
`some familiarity with antiviral drugs and their design and mechanism of action, or”
`
`
`1 WO 2011/123645 A2, to Bruce Ross, et al., published Oct. 6, 2011 (Ex. 1008,
`“Ross ’645”).
`
`2 U.S. Pat. Pub. 2010/0298257 A1, to Bruce S. Ross, et al., published Nov. 25,
`2010 (Ex. 1005, “Ross ’257”).
`
`3 The table of grounds presented in the Petition twice refers to “Ross ’237.” Pet. 3.
`We determine that the reference to Ross ’237 is a typographical error, given that
`the arguments and evidence asserted in the analysis sections of the Petition relate
`to Ross ’257. See, e.g., Pet. 23–26, 45–64; Ex. 1005 (asserted prior art reference).
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`Case IPR2018-00390
`Patent 8,889,159 B2
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`alternatively “(2) a Bachelor’s or Master’s degree in chemistry or a closely related
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`field with significant experience in an academic or industrial laboratory focusing
`
`on drug discovery and/or development, including formulations, for the treatment of
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`viral diseases.” Pet. 8 (citing Ex. 1014 ¶ 39).
`
`Patent Owner, by contrast, contends that a person of ordinary skill in the art
`
`would have had either “(1) a Ph.D. in chemistry, pharmacy or a closely related
`
`field, with some experience in an academic or industrial laboratory focusing on
`
`drug formulation, and would also have some familiarity with the clinical
`
`development of antiviral drugs, or work in collaboration with someone who has
`
`expertise in the clinical development of antiviral drugs; or” alternatively “(2) a
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`Bachelor’s or Master’s degree in chemistry, pharmacy, or a closely related field,
`
`with significant experience in an academic or industrial laboratory focusing on
`
`drug formulation, and some familiarity with clinical development of antiviral
`
`drugs, or work in collaboration with someone who has expertise in the clinical
`
`development of antiviral drugs.” Prelim. Resp. 10.
`
`Based on the information presented, we determine that the prior art asserted
`
`in the Petition demonstrates the level of skill in the art at the time of the invention.
`
`See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that
`
`specific findings regarding ordinary skill level are not required “where the prior art
`
`itself reflects an appropriate level and a need for testimony is not shown”) (quoting
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`Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir.
`
`1985)). To the extent more specific findings are necessary, we adopt Petitioner’s
`
`proposed definition, which, unlike Patent Owner’s counter definition, is supported
`
`by declaration testimony. Compare Pet. 8 (citing Ex. 1014 ¶ 39), with Prelim.
`
`Resp. 10 (citing no evidence in support of Patent Owner’s proposed definition).
`
`However, like Patent Owner, we discern no appreciable difference in the parties’
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`Case IPR2018-00390
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`respective definitions, much less any difference that would alter the outcome of
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`this decision based on our acceptance of one definition over the other. See Prelim.
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`Resp. 11 (Patent Owner, arguing that any difference between the parties’ proposed
`
`definitions “does not affect the arguments” advanced in the Preliminary Response).
`
`
`
`B. Claim Construction
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`In an inter partes review, we construe claims an unexpired patent using the
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`“broadest reasonable construction in light of the specification of the patent.” 37
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`C.F.R. § 42.100(b); Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2144–46
`
`(2016) (upholding use of broadest reasonable construction standard in inter partes
`
`reviews). Under that standard, we apply “the broadest reasonable meaning of the
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`words in their ordinary usage as they would be understood by one of ordinary skill
`
`in the art, taking into account whatever enlightenment by way of definitions or
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`otherwise that may be afforded by the written description contained in the
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`applicant’s specification.” In re Morris, 127 F.3d 1048, 1054 (Fed. Cir. 1997).
`
`“Under a broadest reasonable interpretation, words of the claim must be
`
`given their plain meaning, unless such meaning is inconsistent with the
`
`specification and prosecution history.” Trivascular, Inc. v. Samuels, 812 F.3d
`
`1056, 1062 (Fed. Cir. 2016). Neither Petitioner nor Patent Owner raises any
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`disputed claim construction term or proposed construction. On the contrary, both
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`acknowledge that the claim terms should be given their ordinary and customary
`
`meaning. Pet. 8; Prelim. Resp. 11.
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`Based on the information presented, including the disclosures of the ’159
`
`patent specification and the asserted prior art references, we agree with the parties
`
`that no claim term requires express construction for purposes of this decision. See
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`Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Ltd., 868 F.3d 1013,
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`Patent 8,889,159 B2
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`1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy,
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`and only to the extent necessary to resolve the controversy’” (quoting Vivid Techs.,
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`Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).
`
`
`
`C. Anticipation by Ross ’645
`
`Petitioner asserts that claims 1–37 are anticipated by Ross ’645. Pet. 26.
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`We agree with Petitioner that Ross ’645 discloses Form 6 of sofosbuvir. Id. at 29
`
`(citing Ex. 1008, 20:16–18; 116:17–18). We further agree that Ross ’645 discloses
`
`that “[a] typical preparation will contain from about 5% to about 95% active
`
`compound or compounds (w/w).” Id. at 30 (citing Ex. 1008, 21:22–23). We
`
`disagree, however, that the mere fact that the range specified in independent
`
`claim 1 (“about 25% to about 35% w/w”) falls within the range disclosed in
`
`Ross ’645 (“about 5% to about 95%”) shows sufficiently that the reference
`
`anticipates the narrower claimed range. Id. at 30–31 (Petitioner’s conclusory
`
`argument that the encompassing prior art range disclosed in Ross ’645 necessarily
`
`anticipates the narrower range specified in claim 1, and citing, by way of support,
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`only bare opinion testimony that repeats the conclusory argument verbatim without
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`any analysis (Ex. 1014 ¶ 98)).
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`A reference that discloses a broad range encompassing a narrower claimed
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`range anticipates the narrower claimed range only if the reference describes the
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`narrower claimed range “with sufficient specificity.” Prelim. Resp. 15 (quoting
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`Atofina v. Great Lakes Chem. Corp., 441 F.3d 991, 999 (Fed. Cir. 2006)). Patent
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`Owner persuasively argues that the “sufficient specificity” requirement demands a
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`showing (which is entirely absent in the Petition) that an ordinarily skilled artisan
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`“would ‘at once envisage’ the claimed arrangement or combination,” which, in this
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`Patent 8,889,159 B2
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`case, requires a composition of Form 6 of sofosbuvir in a percentage range of
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`about 25% to about 35% (w/w). Prelim. Resp. 15 (quoting Kennametal, Inc. v.
`
`Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381 (Fed. Cir. 2015)). The Petition
`
`does not address, much less show sufficiently, how or why a person of ordinary
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`skill in the art “would ‘at once envisage’” a formulation of about 25% to about
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`35% (w/w) of Form 6, as required by claim 1, from the much broader range of
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`“about 5% to about 95%” (w/w) that is disclosed in Ross ’645 in the general
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`context of any “active compound or compounds.” Ex. 1008, 21:22–23; see
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`Pet. 30–31 (citing Ex. 1014 ¶ 98) (Petitioner and Dr. Fortunak, failing to address
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`that key point).
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`Patent Owner, for its part, directs us to persuasive information that the broad
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`range disclosed in Ross ’645 for any “active compound” does not suggest the
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`narrower range required by claim 1 for Form 6. Prelim. Resp. 12–16. On that
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`point, we agree with Patent Owner that the range disclosed in Ross ’645 is so
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`broad that it suggests “almost all percentages of active ingredient(s)” and reveals a
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`“lack of any direction about a sub-range.” Id. at 16; see Ex. 1008, 21:22–23
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`(Ross ’645, disclosing a range of “about 5% to about 95%” without any suggestion
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`of a preferred sub-range of percentages for Form 6 or any other particular
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`polymorph of sofosbuvir).
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`Patent Owner identifies compelling authority that a broad range must be
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`shown to describe a narrower claimed range “with sufficient specificity” to
`
`represent an anticipatory disclosure. Prelim. Resp. 15. For example, in Atofina,
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`our reviewing court held that a prior art disclosure of a temperature range of 100
`
`to 500o C did not anticipate a claimed range of 330 to 450o C “with sufficient
`
`specificity.” Atofina, 441 F.3d at 999. Similarly, the Petition contains no analysis
`
`tending to show that the broad percentage range disclosed in Ross ’645 teaches,
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`“with sufficient specificity” (id.), the narrower range required by claim 1. Instead,
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`the Petition rests on a faulty assumption that a broad encompassing range disclosed
`
`in the prior art necessarily anticipates a narrower claimed range. Pet. 30–31.
`
`The Federal Circuit’s opinion in OSRAM Sylvania, Inc. v. Am. Induction
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`Techs., Inc., 701 F.3d 698 (Fed. Cir. 2012) also is instructive. There the dispute
`
`centered on whether a prior art disclosure of “approximately 1 torr or less”
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`anticipated a claim limitation that required “less than 0.5 torr.” Id. at 706. Our
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`reviewing court there reversed a district court’s grant of summary judgment of
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`anticipation on those facts. Id. Similar to Petitioner in this case, the patent
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`challenger in OSRAM Sylvania relied on “the conclusory claim that less than 0.5
`
`torr necessarily falls within ‘approximately 1 torr or less’ as a matter of fact.” Id.
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`The Federal Circuit explained that “the inquiry does not end there.” Id. “[H]ow
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`one of ordinary skill in the art would understand the relative size of a genus or
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`species in [the] particular technology is of critical importance.” Id.
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`The Petition nowhere addresses that critical inquiry. Accordingly, we find
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`that Petitioner fails to show sufficiently that the broad range disclosed in Ross ’645
`
`anticipates the narrower range required by claim 1. Pet. 30–31 (bridging
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`paragraph, for totality of Petitioner’s argument on that point).
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`That finding is consistent with prior Board decisions identified by Patent
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`Owner. Prelim. Resp. 15–16. Specifically, the Board previously held that a
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`disclosure of a dosage range of 1–1000 mg, with a preferred dosage range of 1–100
`
`mg, did not anticipate a claimed amount of 2.5 mg or 5 mg. Mylan Pharm. Inc. v.
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`Boehringer Ingelheim Int’l GmbH, Case IPR2016-01566, Paper 15, 6–7 (P.T.A.B.
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`Feb. 3, 2017). Applying the same principles, the Board also previously held that a
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`concentration range of 0.01% to 4% w/w, with a preferred range of 0.1–0.2% w/w,
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`Patent 8,889,159 B2
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`did not anticipate a claimed concentration of 0.3% w/w. Complex Innovations,
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`LLC v. Astrazeneca AB, Case IPR2017-00631, Paper 13, (P.T.A.B. July 24, 2017).
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`Given that the Petition is devoid of analysis tending to establish that the
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`broad range of about 5% to about 95% (w/w) disclosed in Ross ’645 anticipates
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`with sufficient specificity the narrower range of about 25% to about 35% (w/w)
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`specified in claim 1, we conclude that Petitioner fails to show a reasonable
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`likelihood of prevailing as to claim 1 (and claims 2–15 and 33, which depend
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`directly or indirectly therefrom).
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`Our reasoning applies with equal force to independent claim 16 (and
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`claims 17–32 and 34–37, which depend directly or indirectly therefrom). Claim 16
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`requires a unit dosage of 400 mg. Patent Owner persuasively points out that the
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`Petition does not show sufficiently “that Ross ’645’s broad generic disclosure of a
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`dosage range” of “10 to 10,000 mg” anticipates the narrower range of “400 mg”
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`required by claim 16. Prelim. Resp. 19. The decisions in Atofina, Mylan, and
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`Complex Innovations, discussed above in connection with claim 1, apply with
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`equal force to claim 16, and refute Petitioner’s contention that the broad dosage
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`range disclosed in Ross ’645 anticipates “all incremental values” falling between
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`the endpoints of the prior art range. Pet. 38. The Petition lacks information or
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`analysis from which we reasonably can conclude that the 400 mg unit dosage
`
`required by claim 16 (and all claims that depend directly or indirectly therefrom) is
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`disclosed “with sufficient specificity” in Ross ’645. Atofina, 441 F.3d at 999.
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`Accordingly, on this record, we find that Petitioner does not demonstrate a
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`reasonable likelihood of prevailing at trial in showing that any challenged claim of
`
`the ’159 patent is anticipated by Ross ’645.
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`D. Obviousness over Ross ’645
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`Petitioner also asserts that the subject matter of claims 1–37 would have
`
`been obvious from the disclosure of Ross ’645. Pet. 26. The Petition does not
`
`provide a separate analysis of the obviousness challenge, but rather, asserts
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`obviousness in a conclusory fashion as part of the anticipation challenge. Pet. 26–
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`31. The information presented in the Petition does not include reasoning with a
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`rational underpinning sufficient to show how or why a person of ordinary skill in
`
`the art would have been led to modify the disclosure of Ross ’645 to arrive at the
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`claimed invention. Id.
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`Specifically, when discussing independent claim 1, the Petition states only
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`that Ross ’645 renders the invention obvious because a person of ordinary skill in
`
`the art “would have been motivated to prepare a suitable pharmaceutical
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`composition with the known HCV agent,” namely, Form 6 of sofosbuvir. Pet. 31
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`(citing Ex. 1014 ¶ 98). When discussing independent claim 16, the Petition states
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`only that a person of ordinary skill in the art would have understood from
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`Ross ’645 and “common knowledge” that the prior art would “at least” have
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`“rendered” claim 16 “obvious.” Pet. 38 (citing Ex. 1014 ¶ 129). Those conclusory
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`statements are insufficient to support trial institution. A petitioner in our forum
`
`cannot satisfy its burden of proving obviousness by employing “mere conclusory
`
`statements” regarding the motivations of an ordinarily skilled artisan. In re
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`Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1380 (Fed. Cir. 2016).
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`Notably, by way of evidentiary support, the Petition directs us only to
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`opinion testimony of Dr. Fortunak, which merely repeats verbatim the conclusory
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`statements set forth in the Petition, without providing any factual analysis or citing
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`any supporting objective proof. See Ex. 1014 ¶¶ 98, 129 (the portions of
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`Dr. Fortunak’s declaration testimony relied upon to establish the ground based on
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`obviousness). Even if we accept that Dr. Fortunak is qualified to testify from the
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`perspective of a person of ordinary skill in the art, his inadequately supported
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`opinion on the question of obviousness “is entitled to little or no weight.” 37
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`C.F.R. § 42.65(a); see Ashland Oil, Inc. v. Delta Resins & Refractories, Inc., 776
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`F.2d 281, 294 (Fed. Cir. 1985) (“Lack of factual support for expert opinion going
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`to factual determinations” that underpin an obviousness determination “may render
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`the testimony of little probative value in a validity determination.”).
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`Accordingly, on this record, we find that Petitioner is not reasonably likely
`
`to prevail at trial in showing that the subject matter of independent claim 1 or 16
`
`would have been obvious to an ordinarily skilled artisan from the disclosure of
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`Ross ’645. Given that Petitioner’s arguments pertaining to the dependent claims
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`rest on the same insufficient showing made in connection with independent
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`claims 1 and 16, we find also that Petitioner fails to meet the threshold showing
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`required to support institution of trial with respect to any challenged claim on the
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`ground based on obviousness over Ross ’645. See Pet. 31–45 (for analysis of the
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`challenges directed to dependent claims 2–16 and 17–37).
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`E. Grounds Based on Ross ’257
`
`The Petition asserts that claims 1–37 are anticipated by, or obviousness over,
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`the disclosure of Ross ’257. Pet. 23–26, 45–64. Petitioner acknowledges,
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`however, that during patent prosecution, “the Examiner made only one prior art
`
`rejection of the pending claims”—a rejection based on obviousness over Ross ’257
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`in view of two other references. Id. at 6–7. Petitioner also acknowledges that, in
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`response to that “obviousness rejection, Patent Owner amended the claims to recite
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`polymorphic Form 6” of sofosbuvir; an amendment that resulted in withdrawal of
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`the rejection and allowance of the claims to issue in their present form. Id. The
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`Examiner fully considered Ross ’257 but, nonetheless, determined that “the
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`claimed polymorph appears to be free of art.” Id. at 7 (quoting prosecution history
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`(Ex. 1002, 114)). Under these circumstances, we agree with Patent Owner that a
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`question arises whether it is “unnecessary and wasteful to re-adjudicate” those
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`issues previously considered and decided by the Office. Prelim. Resp. 62.
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`Patent Owner invites us to exercise our discretion to deny the grounds that
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`assert Ross ’257 because those grounds present “the same or substantially the same
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`prior art or arguments previously” “presented to the Office.” Id. at 60 (quoting 35
`
`U.S.C. § 325(d)). We agree with Patent Owner that the Examiner fully considered,
`
`and expressly rejected, the argument that Ross ’257 discloses or suggests Form 6
`
`of sofosbuvir. See id. at 61–62 (directing us to the relevant portions of the
`
`prosecution history (Ex. 1002, 85, 88–89, 114, 141–142)). Patent Owner’s
`
`argument in support of an application of our discretion under Section 325(d),
`
`therefore, is not without merit. Id. at 60–62. However, we determine on the
`
`merits, based on our own analysis, that Petitioner has not met the threshold
`
`showing necessary to support trial institution on the grounds based on Ross ’257.
`
`See Pet. 23–26, 45–64 (argument pertaining to Ross ’257).
`
`Based on the information presented in the Petition and Preliminary
`
`Response, we agree with the Examiner that Ross ’257 “does not disclose or
`
`suggest the claimed polymorph” required by each challenged claim; namely,
`
`Form 6 of sofosbuvir, which is characterized by “XRPD 2θ-reflections (o) at about:
`
`6.1 and 12.7.” Ex. 1002, 141. The Examiner found, and we agree, that the
`
`reference on its face teaches crystalline sofosbuvir having “XRPD 2θ-reflections
`
`(o) at about: 5.0, 7.3, 9.4 and 18:1.” Id.; Ex. 1005 ¶ 99. Petitioner’s argument that
`
`the further disclosure of a “substantially pure crystalline” form of sofosbuvir
`
`represents a teaching of “a genus” that would have included “any additional
`
`
`
`
`16
`
`

`

`Case IPR2018-00390
`Patent 8,889,159 B2
`
`
`crystalline forms” is not persuasive. Pet. 47. Petitioner directs us to information
`
`insufficient to show that the specific polymorph required by each challenged claim
`
`(that is, Form 6, having characteristic XRPD 2θ-reflections (o) at about: 6.1 and
`
`12.7) is anticipated by, or would have been obvious from, any of the “six
`
`crystalline forms” disclosed in Ross ’257. Pet. 47 (citing Ex. 1005 ¶¶ 98–106).
`
`Accordingly, on this record, we determine that Petitioner is not reasonably
`
`likely to prevail at trial in showing that any challenged claim of the ’159 patent is
`
`unpatentable under either ground that asserts Ross ’257.
`
`
`
`III. CONCLUSION
`
`Based on the information presented in the Petition and Preliminary
`
`Response, we conclude that Petitioner has not established a reasonable likelihood
`
`of prevailing at trial in showing that any of claims 1–37 of the ’159 patent are
`
`unpatentable.
`
`
`
`It is
`
` IV. ORDER
`
`ORDERED that the Petition is denied and an inter partes review is not
`
`instituted.
`
`
`
`
`
`
`
`17
`
`
`
`

`

`Case IPR2018-00390
`Patent 8,889,159 B2
`
`
`PETITIONER:
`
`Daniel Ravicher
`dan@ravicher.com
`
`
`PATENT OWNER:
`
`David Cavanaugh
`David.cavanaugh@wilmerhale.com
`
`Emily Whelan
`Emily.whelan@wilmerhale.com
`
`Dorothy Whelan
`whelan@fr.com
`
`Mike Kane
`kane@fr.com
`
`Chad Shear
`shear@fr.com
`
`
`
`
`
`18
`
`
`
`

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