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`Paper No. 22
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`Entered: January 9, 2015
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`ACTAVIS, INC., ACTAVIS LABORATORIES FL, INC.,
`ACTAVIS PHARMA, INC., AMNEAL PHARMACEUTICALS, LLC,
`AMNEAL PHARMACEUTICALS OF NEW YORK, LLC, AUROBINDO
`PHARMA LTD., AUROBINDO PHARMA USA, INC., BRECKENRIDGE
`PHARMACEUTICAL, INC., VENNOOT PHARMACEUTICALS, LLC,
`SANDOZ INC., SUN PHARMA GLOBAL FZE, and
`SUN PHARMACEUTICAL INDUSTRIES, LTD.,
`Petitioner,
`
`v.
`
`RESEARCH CORPORATION TECHNOLOGIES, INC.,
`Patent Owner.
`____________
`
`Case IPR2014-01126
`Patent RE38,551 E
`____________
`
`
`Before FRANCISCO C. PRATS, JACQUELINE WRIGHT BONILLA, and
`ZHENYU YANG, Administrative Patent Judges.
`
`YANG, Administrative Patent Judge.
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`DECISION
`Denying Institution of Inter Partes Review
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`IPR2014-01126
`Patent RE38,551 E
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`37 C.F.R. §§ 42.108
`INTRODUCTION
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`Actavis, Inc., Actavis Laboratories FL, Inc., Actavis Pharma, Inc.,
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`Amneal Pharmaceuticals, LLC, Amneal Pharmaceuticals of New York,
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`LLC, Aurobindo Pharma Ltd., Aurobindo Pharma USA, Inc., Breckenridge
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`Pharmaceutical, Inc., Vennoot Pharmaceuticals, LLC, Sandoz Inc., Sun
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`Pharma Global FZE, and Sun Pharmaceutical Industries, Ltd. (collectively,
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`“Petitioner”) filed a petition for an inter partes review of claims 1–13 of
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`U.S. Patent No. RE38,551 E (Ex. 1001, “the ’551 patent”). Paper 6 (“Pet.”).
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`Research Corporation Technologies, Inc. (“Patent Owner”) timely filed a
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`Preliminary Response. Paper 19 (“Prelim. Resp.”). We have jurisdiction
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`under 35 U.S.C. § 314.
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`For the reasons provided below, we determine Petitioner has not
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`established a reasonable likelihood that it would prevail in showing the
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`unpatentability of at least one of the challenged claims. Because the Petition
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`fails to meet the threshold requirement set forth in 35 U.S.C. § 314(a), we
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`deny the Petition.
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`Related Proceedings
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`Parties state that Patent Owner previously filed multiple lawsuits,
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`asserting the ’551 patent against several entities, including some of
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`Petitioner. Pet. 5; Paper 10, 2–3. Most of these cases are consolidated with
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`UCB, Inc. v. Accord Healthcare Inc., 1:13-cv-01206 (D. Del.). See Pet. 5;
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`Paper 10, 2–3.
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`2
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`IPR2014-01126
`Patent RE38,551 E
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`The ’551 Patent
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`The ’551 patent relates to enantiomeric compounds and
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`pharmaceutical compositions useful in the treatment of epilepsy and other
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`central nervous system (CNS) disorders. Ex. 1001, 1:21–23. According to
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`the ’551 patent, at the time of the invention, many anticonvulsant drugs were
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`well known but they exhibited liver toxicity over chronic administration. Id.
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`at 1:45–47, 2:62–3:6. The ’551 patent discloses “a group of compounds that
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`is generally potent, exhibit minimal neurological toxicity, has a high
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`protective index and is relatively non-toxic to the body organs, including the
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`liver upon multiple dosing.” Id. at 3:56–60. One of those compounds is
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`lacosamide, (R)-N-Benzyl-2-Acetamide-3-methoxypropionamide. Id. at
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`claim 8.
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`Illustrative Claim
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`Among the challenged claims, claim 1 is the sole independent claim.
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`It reads:
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`1. A compound in the R configuration having the formula:
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`
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`wherein
`Ar is phenyl which is unsubstituted or substituted with at least
`one halo group;
`Q is lower alkoxy, and
`Q1 is methyl.
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`3
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`IPR2014-01126
`Patent RE38,551 E
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`Claims 2–9 are compound claims that depend directly or indirectly
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`from claim 1. Claim 8 is directed specifically to lacosamide. Claim 10 is
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`directed to a therapeutic composition:
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`10. A therapeutic composition comprising an anticonvulsant
`effective amount of a compound according to any one of claims
`1–9 and a pharmaceutical carrier therefor.
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`Claims 11–13 are method claims. Claim 11 reads:
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`11. A method of treating central nervous system disorders in an
`animal comprising administering to said animal in need thereof
`an anticonvulsant effective amount of a compound according to
`any one of claims 1–9.
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`Asserted Grounds of Unpatentability
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`Petitioner asserts the following grounds, each of which challenges the
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`patentability of claims 1–13:
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`Basis
`§ 102(e)
`§ 102(b)
`§ 103
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`Reference(s)
`The ’301 patent1
`The LeGall thesis2
`The LeGall thesis and the ’729 patent3
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`
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`1 Kohn et al., U.S. Patent No. 5,654,301, issued on Aug. 5, 1997 (Ex. 1003)
`(“the ’301 patent”).
`2 Philippe LeGall, 2-Substituted-2-acetamido-N-benzylacetamides.
`Synthesis, Spectroscopic and Anticonvulsant Properties (Ex. 1005) (“the
`LeGall thesis”).
`3 Kohn et al., U.S. Patent No. 5,378,729, issued on Jan. 3, 1995 (Ex. 1008)
`(“the ’729 patent”).
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`IPR2014-01126
`Patent RE38,551 E
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`ANALYSIS
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`Claim Construction
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`In an inter partes review, the Board interprets a claim term in an
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`unexpired patent according to its broadest reasonable construction in light of
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`the specification of the patent in which it appears. 37 C.F.R. § 42.100(b).
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`Under that standard, and absent any special definitions, we assign claim
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`terms their ordinary and customary meaning, as would be understood by one
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`of ordinary skill in the art at the time of the invention, in the context of the
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`entire patent disclosure. In re Translogic Tech., Inc., 504 F.3d 1249, 1257
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`(Fed. Cir. 2007).
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`Petitioner argues that the claim terms have no special meanings. Pet.
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`8. According to Petitioner, based on its ordinary meaning, the term
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`“compound” as used in each challenged claim includes the compound
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`known as lacosamide. Id. Patent Owner contends that Dr. Clayton H.
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`Heathcock, Petitioner’s witness, correctly recognized the term that should be
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`construed (i.e., “compound in the R configuration,” not “compound”), but
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`incorrectly construed the term. Prelim. Resp. 12–13. Patent Owner also
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`asks us to construe the term “therapeutic composition” as used in claim 10.
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`Id. at 13–14.
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`We determine that, for purposes of this Decision, it is unnecessary,
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`and thus, we decline, to expressly construe these terms at this time.
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`5
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`Anticipation by the ’301 Patent
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`Patentability Analysis
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`Petitioner asserts, and Patent Owner does not dispute, that the ’301
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`patent qualifies as prior art under 35 U.S.C. § 102(e). Pet. 27. According to
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`Petitioner, the ’301 patent discloses each and every limitation of the
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`challenged claims. Id. Dr. Heathcock testifies that claims 44 and 45 of the
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`’301 patent “disclose a genus and a subgenus that include lacosamide.”
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`Ex. 1002 ¶ 73. In addition, applying the preferences identified in the ’301
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`patent for the variables, including n, R, R1, and the stereoisomer, would lead
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`to a single compound, lacosamide. Id. Petitioner argues that because
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`lacosamide, a species in the genus of the challenged claim 1, is disclosed in
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`the ’301 patent, the ’301 patent anticipates claim 1. Pet. 28. We are not
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`persuaded.
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`Claim 44 of the ’301 patent depends indirectly from claim 39, which
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`reads as follows:
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` 39. A compound of the formula
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`or the pharmaceutically acceptable salts thereof wherein
`R is aryl, aryl lower alkyl, heterocyclic, heterocyclic lower
`alkyl, cycloalkyl or
`lower cycloalkyl
`lower alkyl,
`wherein R is unsubstituted or is substituted with at least
`one electron withdrawing group or an electron donating
`group;
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`R1 is hydrogen or lower alkyl and R1 is unsubstituted or
`substituted with at least one electron withdrawing group
`or at least one electron donating group;
`A and Q are both O;
`one of R2 and R3 is hydrogen and the other is lower alkyl
`which is substituted with an electron donating group or
`a[n] electron withdrawing group and n is 1–4.
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`Ex. 1003, 93:3–23 (emphases added). Claim 44, through a series of
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`dependency, limits one of R2 and R3 to hydrogen and the other to methyl
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`substituted with methoxy. Id. at 94:1–13.
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`Petitioner proposes to apply the following disclosures of the ’301
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`patent to claim 44: (1) claim 45, a multiple dependent claim depending from
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`claims 39–44, which specifies n=1 (see Pet. 20 (citing Ex. 1003, claim 45));
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`(2) the specification description that the D-stereoisomer, which corresponds
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`to the R configuration in the ’551 patent, is preferred (see id. (citing
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`Ex. 1003, 11:20)); and (3) the specification description of preferred
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`substituents for R and R1 (see id. (citing Ex. 1003, 5:12–14)). Assuming,
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`without deciding, that it is factually and legally sound to apply these
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`preferences to claim 44, Petitioner nevertheless incorrectly concludes that it
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`would lead to “a defined and limited class of only one compound that would
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`have been at once envisaged by a POSA—namely, the lacosamide
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`compound.” Pet. 29.
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`Claim 44, through its indirect dependency from claim 39,
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`recites that both R and R1 are unsubstituted or substituted with “at
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`least one electron withdrawing group or an electron donating group.”
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`Ex. 1003, 93:13–18. It is true that the ’301 patent discloses that “[t]he
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`preferred values [sic] of R is . . . especially benzyl, and . . . [t]he most
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`preferred R1 group is methyl.” Ex. 1003, 5:12–14. But immediately
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`following that disclosure, the ’301 patent further discloses:
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`The most preferred electron donating substituent and
`electron withdrawing substituent are halo, nitro, alkanoyl,
`formyl, arylalkanoyl, aryloyl, carboxyl, carbalkoxy,
`carboxamide, cyano, sulfonyl, sulfoxide, heterocyclic,
`guanidine, quaternary ammonium, lower alkenyl, lower
`alkynyl, sulfonium salts, hydroxy, lower alkoxy, lower
`alkyl, amino, lower alkylamino, di(loweralkyl)amino,
`amine lower alkyl mercapto, mercaptoalkyl, alkylthio;
`and alkyldithio.
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`Id. at 5:15–22. Patent Owner contends that Petitioner and
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`Dr. Heathcock improperly ignore these express preferences for
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`substitution at R and R1. Prelim. Resp. 19–20. We agree.
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`Given the explicit language in claim 39, the genus analysis does
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`not stop at applying benzyl as R and methyl as R1. Instead, a skilled
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`artisan still has to pick from unsubstituted and substituted R (and R1),
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`and if substituted, which substitution. With this consideration, the
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`size of the genus encompassed in claim 44, even after applying all the
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`specific preferences Petitioner identifies, would amount to thousands
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`of compounds, too numerous for one to at once envisage each member
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`of the class. With such large number of compounds in the genus and
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`no specific identification of lacosomide, we conclude that Petitioner
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`has not established a reasonable likelihood that the ’301 patent
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`discloses lacosomide and anticipates claim 1. See, e.g., Impax Labs.,
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`Inc. v. Aventis Pharm. Inc., 468 F.3d 1366, 1383 (Fed. Cir. 2006)
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`(holding that when a reference discloses a genus, if a person of
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`ordinary skill in the art cannot “at once envisage” each species within
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`the genus, the reference does not disclose the species).
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`Because claims 2–13 depend from claim 1, we similarly
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`conclude that that Petitioner has not established a reasonable
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`likelihood that the ’301 patent anticipates those claims. See Hartness
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`Int’l, Inc. v. Simplimatic Eng’g Co., 819 F.2d 1100, 1108 (Fed. Cir.
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`1987). Therefore, we deny the Petition on the ground of anticipation
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`by the ’301 patent.
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`Anticipation by the LeGall Thesis
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`Petitioner contends that the LeGall thesis is prior art under 35 U.S.C.
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`§ 102(b). Pet. 34. To qualify as a printed publication within the meaning of
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`§ 102(b), a reference “must have been sufficiently accessible to the public
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`interested in the art” before the critical date. In re Cronyn, 890 F.2d 1158,
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`1160 (Fed. Cir. 1989). Whether a reference is publicly accessible is
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`determined on a case-by-case basis based on the “facts and circumstances
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`surrounding the reference's disclosure to members of the public.” In re
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`Lister, 583 F.3d 1307, 1311 (Fed. Cir. 2009). A reference is considered
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`publicly accessible if it was disseminated or otherwise made available to the
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`extent that persons interested and ordinarily skilled in the subject matter or
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`art, exercising reasonable diligence, can locate it. Id. Having reviewed the
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`parties’ arguments and supporting evidence, we determine that Petitioner has
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`not satisfied its burden to prove that the LeGall thesis is a printed publication
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`under § 102(b).
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`To support its position that the LeGall thesis is prior art under
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`§ 102(b), Petitioner relies on two pieces of evidence. First, Petitioner points
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`out that “[t]he first page of the LeGall thesis states that it was completed and
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`approved by faculty members and a Dean of the University of Houston in
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`December 1987,” more than one year before the earliest possible priority
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`date of the ’551 patent. Id. at 34–35 (citing Ex. 1005, cover page, iv).
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`Petitioner argues that “a single cataloged thesis in one university library was
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`sufficiently accessible to those interested in the art.” Pet. 35 (citing In re
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`Hall, 781 F.2d 897, 899–900 (Fed. Cir. 1986)) (quotation marks and internal
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`alterations omitted). We are not persuaded.
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`In Hall, the Federal Circuit held that a dissertation shelved in the
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`stacks and indexed in the catalog at a university library was a printed
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`publication. 781 F.2d at 898–900. In that case, the director and manager of
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`the loan department of the university library submitted an affidavit, in which
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`he, based on the library’s general practice for indexing, cataloging, and
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`shelving theses, estimated that the dissertation “most probably was available
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`for general use toward the beginning of the month of December, 1977.” Id.
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`at 899. The court concluded that the affidavit was competent and persuasive
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`evidence and established that the dissertation was publicly accessible prior
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`to the critical date. Id.
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`In contrast, a thesis, merely deposited in a university library where it
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`remained “uncatalogued and unshelved” before the critical date, is not
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`sufficiently accessible to qualify as a printed publication. In re Bayer, 568
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`F.2d 1357, 1362 (CCPA 1978). Similarly, in In re Cronyn, the Federal
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`Circuit held that three theses filed in college libraries were not sufficiently
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`accessible to the public, even though “the titles of the theses were listed
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`on . . . cards filed alphabetically by author in a shoebox in the chemistry
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`department library.” 890 F.2d at 1161.
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`Here, Petitioner points to the December 1987 date on the cover page
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`of the LeGall thesis itself. Pet. 34. Petitioner, however, does not argue that
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`date is the date of publication. In fact, Petitioner does not argue or present
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`competent evidence to show that the LeGall thesis was indexed, cataloged,
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`shelved, or even deposited in the University of Houston library, at any date.
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`Instead, Petitioner asserts that the title of the LeGall thesis would have
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`alerted a reasonably diligent skilled artisan of its subject matter and “to
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`locate the thesis at the University of Houston’s library.” Pet. 35. As
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`support, Petitioner cites to the declaration of Dr. Heathcock. But
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`Dr. Heathcock merely testifies that “[t]he title [of the LeGall thesis] would
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`have informed a POSA of the generic structure of the compounds studied
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`and described therein.” Ex. 1002 ¶ 81. Even if that is true, neither Dr.
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`Heathcock nor Petitioner explains how a skilled artisan would become aware
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`of the title of the LeGall thesis, or how knowing the generic structure of the
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`compounds studied would lead to locating the thesis, assuming it was
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`deposited.
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`Petitioner relies on a second piece of evidence, a 1988 journal article
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`LeGall co-authored that allegedly refers to the LeGall thesis.4 Id. at 35.
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`According to Petitioner, “[t]his article describes the same type and class of
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`4 Phillipe LeGall et al., Synthesis of Functionalized Non-Natural Amino Acid
`Derivatives via Amidoalkylation Transformations, 32 Int’l J. Peptide Protein
`Res. 279 (1988) (Ex. 1014) (“the 1988 article”).
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`compounds described in the LeGall thesis and specifically refers the reader
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`to that thesis.” Id. Citing Cornell University v. Hewlett-Packard Company,
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`No. 5:01-1974, 2008 U.S. Dist. LEXIS 39343 (N.D.N.Y. May 14, 2008),
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`Petitioner asserts that the 1988 article “serves ‘as a roadmap’ that would
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`guide a POSA to the LeGall thesis, and it further confirms that a POSA
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`would have access to” the thesis. Pet. 35–36. We are not persuaded.
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`In Cornell, the court held that a Master’s thesis qualified as a § 102(b)
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`prior art based on several pieces of evidence. 2008 U.S. Dist. LEXIS 39343.
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`First, the record showed that the university library indexed all graduate
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`theses by author and year, and gave access to anyone requesting a specific
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`thesis. Id. Second, the second page of the thesis proclaimed that it was
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`“open for inspection,” and the record showed that it was indeed accessed
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`four times by the public, three of which were prior to the critical date. Id.
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`Third, the thesis was cited in a journal article “in such a way as to make it
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`accessible to any reader interested in its subject matter. The thesis title,
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`author name, institution, department, and even geographic location [were]
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`provided, giving any reader the tools he would need to access the thesis.”
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`Id.
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`In contrast, here, Petitioner asserts that the LeGall thesis is available
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`through University of Houston’s library but provides no competent evidence
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`to show that the library allows public access to the thesis. Nor does
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`Petitioner point to any competent evidence to show the thesis was accessed
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`by the public prior to the critical date. In addition, the 1988 article does not
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`include the title5 or any other information of the LeGall thesis. Instead, it
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`merely states, in its entirety: “Abstracted from the Masters dissertation of
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`this author. Additional structure proof and experimental and spectra data
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`may be found in this reference.” Ex. 1014, 279 n.*. Unlike the article in
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`Cornell, the 1988 article does not cite the LeGall thesis in such a way as to
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`give “any reader the tools he would need to access the thesis.”
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`Therefore, based on the record before us, we determine that Petitioner
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`has not provided competent evidence to qualify the LeGall thesis as a
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`“printed publication” under § 102(b). Petitioner may have recognized this
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`deficiency. Indeed, in a footnote, Petitioner states that it “reserves the right
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`to supplement this Petition with additional evidence that the LeGall thesis
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`was accessible to a POSA well before” the critical date. Pet. 36 n. 3. But a
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`party may only submit supplemental information after a trial has been
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`instituted (37 C.F.R. § 42.123) while we must decide whether to institute a
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`trial based on “the information presented in the petition” (35 U.S.C.
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`§ 314(a)). Because the Petition and the accompanying evidence are
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`insufficient to qualify the LeGall thesis as a § 102(b) prior art, we deny the
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`Petition regarding this ground.
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`Obviousness over the LeGall Thesis, the ’729 Patent, and Other Prior Art
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`Petitioner contends that claims 1–13 would have been obvious over
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`“the LeGall thesis in view of other prior art, including (but not limited to)
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`5 Patent Owner argues, and we agree, that the title of the LeGall thesis
`“bears no resemblance to the title of the [1988] article.” Prelim. Resp. 29 &
`n.11.
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`the ’729 patent.” Pet. 41–49. Patent Owner argues that Petitioner not only
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`violates 37 C.F.R. §§ 42.6(a)(3), 42.22(a)(2), 42.104(b)(4), but also fails to
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`establish a reasonable likelihood to prevail substantively. Prelim. Resp. 38–
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`56. We do not need to address these issues because, as explained above,
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`Petitioner has not provided competent evidence to qualify the LeGall thesis
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`as a § 102(b) prior art. Therefore, we decline to review whether the
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`challenged claims would have been obvious over the combination of the
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`LeGall thesis and other references.
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`Accordingly, it is
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`ORDER
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`ORDERED that Petitioner’s request for an inter partes review of
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`claims 1–13 of the ’551 patent is denied.
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`For PETITIONER:
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`Samuel Park
`spark@winston.com
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`Andrew Sommer
`asommer@winston.com
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`For PATENT OWNER:
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`Andrea Reister
`areister@cov.com
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`Enrique Longton
`rlongton@cov.com
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`Gregory Discher
`gdischer@cov.com
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