Trials@uspto.gov
`571-272-7822
`
`Paper: 19
`
` Entered: October 30, 2017
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`ARGENTUM PHARMACEUTICALS LLC,
`Petitioner,
`
`v.
`
`CIPLA LTD.,
`Patent Owner.
`____________
`
`Case IPR2017-00807
`Patent 8,168,620 B2
`____________
`
`
`
`Before JAMES T. MOORE, ZHENYU YANG, and
`KRISTI L. R. SAWERT, Administrative Patent Judges.
`
`SAWERT, Administrative Patent Judge.
`
`
`
`
`
`DECISION
`Denying Petitioner’s Request for Rehearing
`37 C.F.R. § 42.71(d)
`
`
`
`
`
`
`
`
`571-272-7822
`
`Paper: 19
`
` Entered: October 30, 2017
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`ARGENTUM PHARMACEUTICALS LLC,
`Petitioner,
`
`v.
`
`CIPLA LTD.,
`Patent Owner.
`____________
`
`Case IPR2017-00807
`Patent 8,168,620 B2
`____________
`
`
`
`Before JAMES T. MOORE, ZHENYU YANG, and
`KRISTI L. R. SAWERT, Administrative Patent Judges.
`
`SAWERT, Administrative Patent Judge.
`
`
`
`
`
`DECISION
`Denying Petitioner’s Request for Rehearing
`37 C.F.R. § 42.71(d)
`
`
`
`
`
`
`
`
`
`IPR2017-00807
`Patent 8,168,620 B2
`
`
`
`
`
`
`INTRODUCTION
`I.
`Argentum Pharmaceuticals LLC (“Petitioner”) filed a Petition for an
`inter partes review of claims 1, 4–6, 24–26, 29, and 42–44 of U.S. Patent
`No. 8,168,620 B2 (“the ’620 patent,” Ex. 1001). Paper 2 (“Pet.”). The
`Board instituted an inter partes review of claims 1, 4–6, 24–26, 29, and 42–
`44 on the ground of obviousness over Hettche,1 Phillips,2 and Segal,3 and on
`the ground of obviousness over Hettche, Phillips, Segal, and the Flonase
`Label.4 Paper 11 (“Instit. Dec.”), 27. The Board declined to institute an
`inter partes review of claims 1 and 25 on Petitioner’s proposed ground of
`anticipation by Segal. Id. at 14. Petitioner now files a Request for
`Rehearing on that ground. Paper 13 (“Rehearing Request” or “Reh’g
`Req.”). For the following reasons, we deny Petitioner’s Rehearing Request.
`II. STANDARD OF REVIEW
`A party requesting rehearing bears the burden of showing that a
`decision should be modified. 37 C.F.R. § 42.71(d). The party must identify
`all matters it believes the Board misapprehended or overlooked, and the
`place where each matter was addressed previously in a motion, an
`opposition, or a reply. Id. When rehearing a decision on petition, we review
`the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of
`
`
`1 Helmut Hettche, U.S. Patent No. 5,164,194 (Nov. 17, 1992)
`(“Hettche”). Ex. 1007.
`2 Gordon H. Phillipps, et al., U.S. Patent No. 4,335,121 (Jun. 15,
`1982) (“Phillipps”). Ex. 1009.
`3 Catherine A. Segal, Int’l Publication No. WO 98/48839 (Nov. 5,
`1998) (“Segal”). Ex. 1012.
`4 FLONASE® (fluticasone propionate) Nasal Spray, 50 mcg Product
`Information (Dec. 1998) (“Flonase Label”). Ex. 1010.
`2
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`IPR2017-00807
`Patent 8,168,620 B2
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`discretion occurs when a “decision was based on an erroneous conclusion of
`law or clearly erroneous factual findings, or . . . a clear error of judgment.”
`PPG Indus. Inc. v. Celanese Polymer Specialties Co., 840 F.2d 1565, 1567
`(Fed. Cir. 1988) (citations omitted).
`III. DISCUSSION
`Petitioner requests rehearing the decision declining to institute review
`on the ground of anticipation by Segal. Petitioner contends that the Board
`misapplied the applicable law and misapprehended the prior art in finding
`that Segal “literally discloses more than 800 million combinations within its
`broad genus,” rather than the 54 combinations cited in the Petition. Reh’g
`Req. 1 (quoting Instit. Dec. 13). In particular, Petitioner asserts that the
`Board’s finding “disregard[s] the express preferences set forth in Segal’s
`specification” and ignores the “preferred embodiments” identified in Segal’s
`claims. Id. at 1–2. Petitioner also asserts that this finding led the Board to
`incorrectly determine that Segal does not anticipate the challenged claims.
`Id. at 2.
`
`A. The Scope of Segal’s Disclosure
`In declining institution of an inter partes review of claims 1 and 25
`over Segal, the Board found that Petitioner had not shown sufficiently, for
`the purpose of institution, that an ordinarily skilled artisan would
`immediately envision from Segal’s disclosure the combination of fluticasone
`propionate and azelastine, as recited in the challenged claims. Instit.
`Dec. 11. Specifically, the Board was not persuaded by Petitioner’s assertion
`that Segal discloses the combination of fluticasone propionate and azelastine
`as one of “at most 54 discrete compositions.” Id. at 11–13 (citing Pet. 19).
`
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`IPR2017-00807
`Patent 8,168,620 B2
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`The Board explained that Petitioner arrived at the “54 discrete components”
`number by improperly multiplying the number of anti-inflammatory agents
`recited in claim 2 by the number of antihistamines recited in claim 4 (i.e.,
`6 x 9 = 54). Id. at 13. The Board was not persuaded by this analysis, in part,
`because claim 4 of Segal depends from claim 1, instead of claim 2. Id.
`In its Request for Rehearing, Petitioner asserts that Segal does, in fact,
`disclose a “small[] genus of 54 compositions.” Reh’g Req. 7. Petitioner
`points out that Segal discloses 6 preferred topical anti-inflammatory agents,
`of which fluticasone propionate is one. Id. at 8 (citing Ex. 1012, 2:23–26, 5
`(claim 2)). Petitioner also points out that Segal identifies azelastine as one
`of 9 preferred antihistamines. Id. (citing Ex. 1012, 3:19–20, 5 (claim 4)).
`Petitioner contends that the Board “erred by not finding that Segal discloses
`merely 54 readily envisioned compositions.” Id. at 7.
`We remain unpersuaded that Segal discloses a limited genus of “at
`most 54” compositions, Pet. 19, such that the claimed composition would be
`immediately envisioned by an ordinarily skilled artisan. Although Segal
`discloses 6 topical anti-inflammatory agents and 9 antihistamines, Segal also
`discloses 4 vasoconstrictors, 3 antiallergic agents, 1 anticholinergic agent, 3
`anesthetics, 3 mucolytic agents, 3 leukotriene inhibitors, and 1
`neuraminidase inhibitor. See Instit. Dec. 11–12 (citing Ex. 1012, 2:23–26,
`3:3–9, 5 (claims 1 and 2)). Petitioner fails to explain persuasively how Segal
`expresses a preference for the particular combination of a topical anti-
`inflammatory agent and an antihistamine over the other possible
`combinations encompassed in Segal’s broad disclosure. See In re Petering,
`301 F.2d 676, 681 (CCPA 1962) (affirming finding of anticipation where
`
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`IPR2017-00807
`Patent 8,168,620 B2
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`prior art set forth a “pattern of . . . specific preferences in connection with [a]
`generic formula” so as to “constitute[] a description of a definite and limited
`class of compounds”). Thus, we are not persuaded that Segal discloses
`“merely 54 readily envisioned compositions,” as Petitioner contends. Reh’g
`Req. 7.
`Also in its Request for Rehearing, Petitioner alleges that the Board
`erred by failing to consider Segal’s disclosure of 6 preferred anti-
`inflammatory agents and 9 antihistamines as a “starting point for an
`anticipation analysis under § 102.” Reh’g Req. 10 (emphasis added). We
`are not persuaded that the Board erred, because that “starting point” is in our
`view likely the product of hindsight. See In re Ruschig, 343 F.2d 965, 974
`(CCPA 1965) (criticizing “the mechanistic dissection and recombination of
`the components of the specific illustrative compounds in every chemical
`reference containing them, to create hindsight anticipations with the
`guidance of an applicant’s disclosures”).
`Specifically, the Petition highlighted claims 2 and 4 of Segal to create
`a genus of “at most 54” compositions encompassing the combination of
`fluticasone propionate and azelastine, Pet. 18–19, but did not address all
`other compositions recited in Segal’s other claims, i.e., claim 3 (four
`vasoconstrictors), claim 5 (three antiallergic agents), claim 6 (one
`anticholinergic agent), claim 7 (three anesthetics), claim 8 (three mucolytic
`agents), claim 9 (three leukotriene inhibitors), and claim 10 (one
`neuraminidase inhibitor). Ex. 1012, 5–6. Petitioner did not adequately
`explain in the Petition why those compositions should be disregarded.
`
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`Finally, we are unpersuaded that the Board “incorrectly credited
`Patent Owner’s argument that Segal discloses more than 800 million
`compositions,” Reh’g Req. 7, because this argument fails to take into
`consideration Segal’s description of the therapeutic agents. As explained in
`the Institution Decision, Segal consistently describes the disclosed nasal
`compositions as comprising an anti-inflammatory agent and “at least one”
`additional therapeutic agent. Instit. Dec. 13 (citing Ex. 1012, 2:12, 2:19, 3:3,
`3:5, 3:30, 4:16, 5 (claim 1)). Given that description, the Board agreed with
`Patent Owner that the potential combinations in Segal could result in more
`than 800 million possible compositions. Id. (citing Prelim. Resp. 21 & n.4).
`Regardless, Petitioner does not show persuasively that that the genus of
`compositions is “at most 54,” as set forth in the Petition. Pet. 19. We
`therefore are unpersuaded the Board overlooked or misapprehended any fact
`or argument in the Institution Decision.
`B. The Case Law Does Not Compel a Different Outcome
`We now turn to Petitioner’s argument that the Board misapplied the
`applicable law of Wm. Wrigley Jr. Co. v. Cadbury Adams USA LLC, 683
`F.3d 1356 (Fed. Cir. 2012), In re Schaumann, 572 F.2d 312 (CCPA 1978),
`and In re Petering, 301 F.2d 676 (CCPA 1962), in the Institution Decision.
`Reh’g Req. 1–6. Petitioner asserts that these cases require the Board to use
`Segal’s disclosure of 6 preferred anti-inflammatory agents and 9
`antihistamines as a “starting point for conducting” an anticipation analysis,
`and that the Board erred in not doing so. Id. at 2. In particular, Petitioner
`first cites to Petering and Schaumann for the “proposition that if a person of
`ordinary skill in the art can envision each and every species of a ‘limited’
`
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`IPR2017-00807
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`genus taught by the prior art, the reference will anticipate each of those
`species if later claimed.” Reh’g Req. 2–3. Petitioner then cites to Wrigley
`for the proposition that “a reference’s disclosure of other optional
`ingredients is immaterial to the § 102 analysis . . . where such optional
`ingredients are not implicated or precluded by the claim being analyzed.”
`Id. at 6. We disagree that these cases compel a different outcome for the fact
`pattern presented here.
`In Petering and Schaumann, the Court of Customs and Patent Appeals
`found that the prior art disclosed a pattern of preferences that narrowed the
`scope of a broadly disclosed generic formula to a limited class of
`compounds, thus anticipating claims covering specific chemical compounds.
`In Schaumann, the prior-art reference disclosed a class of B-(meta-
`hydroxyphenyl)-isopropylamines having a general formula with a single
`variable substituent “R” in its specification. 572 F.2d at 314. The prior-art
`reference narrowed that broad class of compounds by expressly setting forth
`in claim 1 a limited genus of isopropylamine compounds having “lower
`alkyl radicals” as the “R” substituent. Id. The specification listed, in the
`definition of “alkyl radical,” an ethyl group. Id. The CCPA thus found that
`claim 1 “expresses a preference for lower alkyl secondary amines.” Id.
`Because claim 1 “embraces a very limited number of compounds
`closely related to one another in structure,” the court explained, “we are led
`inevitably to the conclusion that the reference provides a description of those
`compounds just as surely as if they were identified in the reference by
`name.” Id. at 316–17. The court in Petering found a similar disclosure of
`“specific preferences” that limited the prior-art reference’s “broad generic
`
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`IPR2017-00807
`Patent 8,168,620 B2
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`disclosure” to a “definite and limited class” of approximately 20 compounds.
`301 F.2d at 681–82.
`Here, however, Petitioner has failed to show persuasively a similar
`“pattern of preferences” that inevitably leads the ordinarily skilled artisan to
`a limited class of compositions encompassing the specific combination of
`fluticasone propionate and azelastine. Claim 1 here—unlike claim 1 in
`Schaumann—encompasses a large number of drug combinations, and
`Petitioner has not alleged that these drug combinations share closely related
`chemical structures. Instit. Dec. 13. Petitioner’s assertions otherwise
`notwithstanding5, claim 4 does not in our view narrow that broad genus into
`“at most 54” compositions. Although claim 4 lists certain antihistamines, it
`does not limit the “at least one” therapeutic agent recited in claim 1 to an
`antihistamine, nor does it express a “preference” for antihistamines over
`other therapeutic agents suitable for topical nasal administration. See
`Ex. 1012, 5 (claims 1 and 4).
`Moreover, the “pattern of preferences” in Petering and Schaumann
`instructed the skilled artisan to narrow a large, generically described genus
`of compounds to a limited, specific set of preferred compounds. See
`Petering, 301 F.2d at 681 (stating that the prior art “discloses certain specific
`preferences . . . through [its] preferred R groups and [its] eight specific
`isoalloxazines”); Schaumann, 572 F.2d at 316–17. Petitioner does not direct
`us to similar disclosure in Segal that—through the expression of
`preferences—specifically narrows the broad genus of a topical anti-
`
`
`5 Reh’g Req. 4.
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`IPR2017-00807
`Patent 8,168,620 B2
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`inflammatory agent in combination with at least one therapeutic agent to a
`preferred class of compositions encompassing fluticasone and azelastine.
`Finally, Petitioner alleges that, in Wrigley, the Court of Appeals for
`the Federal Circuit found that the prior art anticipated a chewing gum
`composition comprising the combination of menthol and WS-23, even
`though the prior art disclosed an untold “number of combinations that the
`other disclosed optional ingredients could hypothetically be used to create.”
`Id. at 5–6 (citing Wrigley, 683 F.3d at 1360, 1362). Thus, Petitioner alleges,
`“the [Institution] Decision’s reliance on Patent Owner’s argument that Segal
`discloses more than 800 million combinations does not comport with
`Wrigley—because the claims here do not exclude any of the other optional
`ingredients identified in Segal.” Reh’g Req. 6 (citation omitted).
`Even if we read claim 1 as limited to an anti-inflammatory agent and
`only one therapeutic agent suitable for topical nasal administration,
`Petitioner’s calculation of “at most 54 discrete compositions” still
`underrepresents the total number of compositions encompassed by Segal’s
`disclosure. Accordingly, we are unpersuaded that the Board
`misapprehended or overlooked any fact or argument made in the Petition.
`C. Summary
`In summary, we are unpersuaded that Petitioner’s arguments, as set
`forth in the Petition, satisfied Petitioner’s burden to show that an ordinarily
`skilled artisan would readily envision the combination of fluticasone
`propionate and azelastine from Segal’s disclosure. None of the arguments
`Petitioner presents in the Request for Rehearing persuade us that the Board
`misapplied the applicable law or misapprehended the prior art.
`
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`IPR2017-00807
`Patent 8,168,620 B2
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`IV. ORDER
`
`
`
`Accordingly, it is
`ORDERED that Petitioner’s Rehearing Request is denied.
`
`PETITIONER:
`Michael R. Houston, Ph.D.
`Joseph P. Meara, Ph.D.
`James P. McParland, Ph.D.
`FOLEY & LARDNER LLP
`mhouston@foley.com
`jmeara@foley.com
`jmcparland@foley.com
`
`Tyler C. Liu
`ARGENTUM PHARMACEUTICALS LLC
`tliu@agpharm.com
`
`
`PATENT OWNER:
`Dennies Varughese
`Deborah A. Sterling
`Adam C. LaRock
`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`dvarughe-PTAB@skgf.com
`dsterlin-PTAB@skgf.com
`alarock-PTAB@skgf.com
`
`
`
`
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`10
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