`Tel: 571-272-7822
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`Paper 12
`Date: August 6, 2020
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`AYLA PHARMA LLC,
`Petitioner,
`
`Vv.
`
`NOVARTISAG,
`Patent Owner.
`
`IPR2020-00295
`Patent 9,533,053 B2
`
`Before GRACE KARAFFA OBERMANN, CHRISTOPHERM.KAISER,
`and JAMIE T. WISZ, Administrative Patent Judges.
`
`KAISER,Administrative Patent Judge.
`
`DECISION
`Denying Institution of Inter Partes Review
`35 U.S.C. § 314
`
`
`
`IPR2020-00295
`Patent 9,533,053 B2
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`INTRODUCTION
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`A. Background
`Ayla Pharma LLC (“Petitioner’’) filed a Petition (Paper 1, “Pet.’’)
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`requesting an inter partes review of claims 1-13 of U.S. Patent
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`No. 9,533,053 B2 (Ex. 1002, “the ’053 patent”). Novartis AG (“Patent
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`Owner”) filed a Preliminary Response.! Paper 7 (Prelim. Resp.”). With
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`our authorization, Petitioner filed a Reply (Paper 10), and Patent Owner filed
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`a Sur-Reply (Paper 11).
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`We have authority to determine whetherto institute an inter partes
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`review. 35 U.S.C. § 314(b) (2018); 37 C.F.R. § 42.4(a) (2019). The
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`standard for instituting an inter partes review is set forth in 35 U.S.C.
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`§ 314(a), which provides that an inter partes review may notbeinstituted
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`unless “there is a reasonable likelihood that the petitioner would prevail with
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`respect to at least 1 of the claims challenged in the petition.”
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`After considering the Petition, the Preliminary Response, the Reply,
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`the Sur-Reply, and the evidence currently of record, we conclude that
`Petitioner has not shownareasonable likelihoodthat it would prevail with
`respect to at least one challenged claim. Accordingly, we do notinstitute an
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`inter partes review ofthe challenged claims on the groundsasserted in the
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`Petition.
`
`' Pursuant to the Notice of Waiver of Patent-Related Timing Deadlines
`under the Coronavirus Aid, Relief, and Economic Security Act issued
`March 31, 2020, Patent Owner requested, and we granted, a 30-day
`extension of the deadline for Patent Ownerto file its Preliminary Response.
`Ex. 3001.
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`IPR2020-00295
`Patent 9,533,053 B2
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`B. Related Matters
`The parties identify five lawsuits as related to this proceeding: Alcon
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`Research, Ltd. v. Cipla Ltd., No. 1-17-cv-01244 (D. Del.); Alcon Research,
`Ltd. v. Lupin Ltd., No. 1-17-cv-00321 (D. Del.); Alcon Research, Ltd. v.
`Watson Labs. Inc., No. 1-17-cv-00252 (D. Del.); Alcon Research, Ltd. v.
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`Watson Labs., Inc., No. 1:15-cv-1159 (D. Del.); and Alcon Research, Ltd. v.
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`Lupin Ltd., No. 1:16-cv-00195 (D. Del.). Pet. 4; Paper 5, 2-3. In addition,
`the ’053 patent previously was challenged in IPR201 8-01021, and a related
`patent, U.S. Patent No. 8,791,154 B2 (Ex. 1001, “the ’154 patent’’),
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`previously was challenged in IPR2016-00544, IPR2016-01640, and
`IPR2018-01020. Jd.
`|
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`C. The Asserted Grounds of Unpatentability
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`Petitioner contends that claims 1-13 of the ’053 patent are
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`unpatentable based on the following grounds (Pet. 13-66):?
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`Reference(s)/Basis ‘1-13ss Bhowmick,> Yanni,‘ and Castillo®
`aChallenged|35 U.S.C. §
`
`? Petitioner also relies on a Declaration from S. Craig Dyar, Ph.D., adopting
`the earlier testimony of Paul A. Laskar, Ph.D. Ex. 1042 (adopting
`Ex. 1014).
`3 WO 2008/015695 A2, published Feb. 7, 2008 (Ex. 1003).
`- 4J.M.Yanniet al., The In Vitro and In Vivo Ocular Pharmacology of
`Olopatadine (AL-4943A), an Effective Anti-Allergic/Antihistaminic Agent,
`12 J. OCULAR PHARMACOLOGY & THERAPEUTICS 389, 389-400 (1996)
`(Ex. 1004).
`5 US 6,995,186 B2, issued Feb. 7, 2006 (Ex. 1005).
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`IPR2020-00295
`Patent 9,533,053 B2
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`Claim(s) Challenged|35 U.S.C.§ Reference(s)/Basis
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`Schneider,° Hayakawa,’
`Bhowmick, and Castillo
`103(a)
`Bhowmick, Schneider, and
`
`
`
`
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`D. The ’053 Patent
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`The 053 patent,titled “High Concentration Olopatadine Ophthalmic
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`Composition,” issued on January 3, 2017. Ex. 1002, codes (45), (54).
`
`The ’053 patent “relates to an ophthalmic composition containing a
`relatively high concentration ofolopatadine.” Jd. at 1:17-19.
`According to the ’053 patent, symptomsof“allergic conjunctivitis,”
`including “ocularirritation [and] redness” are known to be “significantly
`reduced using topical ophthalmic solutions containing olopatadine.” Jd. at
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`1:28-35. Using higher concentrations of olopatadine in these topical
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`ophthalmic solutions leads to “significantly improved reduction of late phase
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`ocular allergic conjunctivitis symptoms”and “significantly improved
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`reduction of redness in the early phase.” Jd. at 1:36-46. Additionally, with
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`these higher concentrations, symptom relief “can be achieved through once a
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`day dosing”rather than only with “greater dosing frequencies.” Jd. at 1:46—-
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`50. These benefits comeat a cost, though: “[s]olubilizing high
`concentrations of olopatadine in a stable manner has proven difficult.” Id.
`at 2:3-4. The ’053 patent describes polyethylene glycol and
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`polyvinylpyrrolidone as “hav[ing] proven incapable, alone or in
`
`combination, of solubilizing sufficient concentrations of olopatadine in
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`6 US 2011/0082145 Al, published Apr. 7, 2011 (Ex. 1006).
`7US 5,641,805, issued June 24, 1997 (Ex. 1007).
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`-4
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`IPR2020-00295
`Patent 9,533,053 B2
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`compositions having approximately neutral pH.” Jd. at 2:10-18. In
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`addition, although cyclodextrins “have the ability to solubilize significantly
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`higher concentrations of olopatadine,” the “use of undesirably high
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`concentrations of cyclodextrins has been found to reduce olopatadine
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`efficacy and/or preservation efficacy of solutions.” Jd. at 2:19-29.
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`Accordingly, the invention of the ’053 patent“is directed at an ophthalmic
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`composition that can provide high concentrations of olopatadine topically to
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`the eye,” particularly “such a composition wherein the olopatadineis
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`solubilized in solution in a stable manner, the composition exhibits
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`consistent efficacy against late phase symptomsofallergic conjunctivitis,
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`the composition exhibits sufficient antimicrobial activity to provide desired
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`levels of preservation efficacy or any combination thereof.” Jd. at 2:34-42.
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`E. Illustrative Claims
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`Claims 1-13 of the *514 patent are challenged. Claims 1 and 8 are
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`independent, and claim 1 isillustrative; it recites:
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`1. An aqueous ophthalmic solution for treatment of
`ocular allergic conjunctivitis, the solution comprising:
`at least 0.67 w/v % olopatadine dissolved in the
`solution;
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`PEG having a molecular weight of 200 to 800;
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`‘ polyvinylpyrrolidone;
`a cyclodextrin selected from the group consisting of
`SAE-B-cyclodextrin, hydroxypropyl-B-cyclodextrin
`and hydroxypropyl-y-cyclodextrin; and
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`water. .
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`Ex. 1002, 27:46—55.
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`A. Claim Construction
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`ANALYSIS
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`In an inter partes review, we construe claim terms in an unexpired
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`patent “in accordance with the ordinary and customary meaning of such
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`claim as understood by oneofordinary skill in the art and the prosecution
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`history pertaining to the patent,” as the claims would be construed “‘in a civil
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`action under 35 U.S.C. 282(b).” 37 C.F.R. § 42.100(b) (2019). “[T]he
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`ordinary and customary meaningof a claim term is the meaning that the
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`term would haveto a person ofordinary skill in the art in question at the
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`time of the invention.” Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed.
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`Cir. 2005) (en banc). “Importantly, the person of ordinary skill in the art is
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`deemedto read the claim term not only in the context of the particular claim
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`in which the disputed term appears, but in the context ofthe entire patent,
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`including the specification.” Jd.
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`Petitioner proposes construing “at least 0.67 w/v % olopatadine
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`dissolved in the solution”as “at least encompass[ing] the district court’s
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`construction.” Pet. 6-8. Patent Owner does not propose construing any
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`terms. Prelim. Resp. 1-62. For the reasons discussed more fully below, we
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`determine that we can decide whetherto institute review without construing
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`any terms. Accordingly, we do not decide any claim construction issues
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`expressly. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co.,
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`868 F.3d 1013, 1017 (Fed. Cir. 2017) (citing Vivid Techs., Inc. v. Am. Sci. &
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`Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those terms need be
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`construedthat are in controversy, andonlyto the extent necessary to resolve
`the controversy.”)).
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`B. Obviousness over Bhowmick, Yanni, and Castillo
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`Petitioner argues that claims 1-13 of the ’053 patent would have been
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`obvious given the combined teachings of Bhowmick, Yanni, and Castillo.
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`Pet. 13-38.
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`1.
`
` Bhowmick
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`Bhowmickrelates to ‘“‘an aqueous topical solution comprising a
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`therapeutically effective amount of olopatadine.” Ex. 1003, code (57). It
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`teaches that such solutionsare “indicated for the treatment of signs and
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`symptomsofallergic conjunctivitis.” Jd. at 1:18-19. Bhowmickalso
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`teaches various compositions that “enhance the physicalstability of”its
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`olopatadine solutions, including cyclodextrin derivatives, such as “the
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`hydroxypropyl derivatives of alpha-, beta-, and gamma-cyclodextrin” and
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`“sulfoalkyl ether cyclodextrin.” Jd. at 4:16-5:12. When discussing the use
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`of hydroxypropyl-B-cyclodextrin to stabilize olopatadine solutions “for
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`ophthalmic administration,” Bhowmick teaches using “about 1.0% to about
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`5%”of the cyclodextrin derivative. Jd. at 6:5—6. More broadly, Bhowmick
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`teaches including between about 1.65 and about 50 times as much
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`hydroxypropyl-B-cyclodextrin as olopatadine by weight. Jd. at 6:18—20.
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`Bhowmickteachesthe use of other stabilizers, including hydroxypropyl
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`methylcellulose in “concentrations ranging from about 0.001% to about
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`5%.” Id. at 7:10-13. In addition, Bhowmick teaches adding other
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`compounds, such as benzalkonium chloride as a preservative “in an amount
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`ranging from about 0.005% to about 1%w/v,” and sodium borate as a
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`buffering agent. Jd. at 7:20-22, 8:14-21. Bhowmick teachesthatits
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`solution “is intended to be administered as .
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`.
`
`. eye drops,”that its solution
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`has an osmolality “between 150 [and] 450 mOsm,”andthatits solution “has
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`a pH [of] 4 to 8, preferably pH of 6.5 to 7.5.” Jd. at 8:10—-12, 8:22-24.
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`2.
`
`Yanni
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`Yanni teaches that olopatadine “‘is an anti-allergic agent” and reports
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`results of in vitro andin vivo studies of olopatadine using “human
`conjunctival mastcell preparations”as well as “guinea pigs.” Ex. 1004,
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`389. Yanni teaches using solutions containing 0.001 to 1.0 w/v %
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`olopatadine. Jd. at 395.
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`3.
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`Castillo
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`Castillo relates to “[t]opical formulations of olopatadine for treatment
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`of allergic or inflammatory disorders of the eye.” Ex. 1005, code (57), 2:13-
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`15. Castillo teaches aqueous solutions with 0.17 to 0.62 w/v % of
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`olopatadine and “an amountof polyvinylpyrrolidone. .
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`. sufficient to
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`enhance the physical stability of the formulations.” Jd. at code (57), 2:17—
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`27, 2:66-3:2. The polyvinylpyrrolidone concentration in Castillo is taught
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`as 0.1 to 3%. Id. at 3:22—25. Castillo also teaches the presence of other
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`substancesin the solutions, including polyols as tonicity-adjusting agents,
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`benzalkonium chloride as a preservative, borates as buffering agents, and
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`400-molecular-weight polyethylene glycol at a concentration of 2 w/v %.
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`Id. at 3:64-67, 4:2-3, Table 5.
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`4.
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`Analysis
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`Petitioner argues that claims 1-13 of the 053 patent would have been
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`obvious given the combined teachings of Bhowmick, Yanni, and Castillo.
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`Pet. 13-38. “An invention is not obviousjust ‘becauseall of the elements
`999
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`that comprise the invention were knowninthepriorart.’”
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`Broadcom Corp.
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`v. Emulex Corp., 732 F.3d 1325, 1335 (Fed. Cir. 2013) (quoting Power-One,
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`Inc. v. Artesyn Techs., Inc., 599 F.3d 1343, 1351 (Fed. Cir. 2010)). Instead,
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`“a finding of obviousnessat the time of invention requires a ‘plausible
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`rational[e] as to why the prior art references would have worked together.’”
`Id. (quoting Power-One, 599 F.3d at 1352). Weare notpersuadedthat
`Petitioner has shown sufficiently that a person of ordinary skill in the art
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`would have had a reason to combine the teachings of Bhowmick, Yanni, and
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`Castillo.
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`Petitioner argues first that, “[i]n instituting on the challenged claims
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`of the related ‘154 patent, the Board” found sufficient evidence of a reason
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`to combine Bhowmick, Yanni, and Castillo, and “[s]imilar evidence exists
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`here.” Pet. 17 (citing Ex. 1003, 7:20—22; Ex. 1005, 2:19—22; Ex. 1006 { 7;
`Ex. 1014 ff 59, 60, 62-64, 70, 78, 79, 83, 90, 98, 119, 127, 136, 146, 149-
`151, 161, 180; Ex. 1015, 10, 25). This argumentfails for two reasons.
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`First, “mere statements .. . do not amount to a developed argument.”
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`SmithKline Beecham Corp. v. Apotex Corp., 439 F.3d 1312, 1320 (Fed. Cir.
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`2006). Thus, the mere statement that evidence exists here that is “similar” to
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`that which existed in an earlier proceedingfails to carry Petitioner’s burden
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`to “set forth .. . [h]ow the construed claim is unpatentable” and to “state
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`[the] relevance” of the evidence cited. 37 C.F.R. § 42.104(b)(4), (5). A
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`proper argument would explain why the evidence showsthat a person of
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`ordinary skill in the art would have had a reason to combinethe teachings of
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`the references. Petitioner choosesinstead to “ask [us] to play archaeologist
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`with the record,” which we decline to do. DeSilva v. DiLeonardi, 181 F.3d
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`865, 866-68 (7th Cir. 1999).
`Second, Petitioner’s reliance on the Board’s reasoning in IPR2016-
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`00544is the incorporation of an argument “by reference from one document
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`into another document,” which is prohibited by our rules. 37 C.F.R.
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`§ 42.6(a)(3). Accordingly, we conclude that this argumentis insufficient to
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`demonstrate a reason to combine the teachings of Bhowmick, Yanni, and
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`Castillo.
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`Petitioner offers a second argument for combining the teachings of
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`Bhowmickand Castillo: “A [person of ordinary skill in the art] would have
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`been motivated to look to Castillo because, like Bhowmick,Castillo taught
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`ophthalmic olopatadine solutions for treatmentofallergic disorders
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`comprising similar excipients.” Pet.23. This argumentalsofalls short.
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`First, although this argument may be enoughto showthat the two references
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`are analogousart, see Wyers v. Master Lock Co., 616 F.3d 1231, 1238 (Fed.
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`Cir. 2010), simply demonstrating that a set of referencesareall directed to
`
`the sameproblem is not, byitself, a sufficient rationale to combine the
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`references. See id. (upon finding that two references were directed to the
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`same problem, proceeding to analyze whether a person of ordinary skill in
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`the art would have been motivated to combinethe references); see also In re
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`Kahn, 441 F.3d 977, 987-88 (Fed. Cir. 2006) (inquiry as to whether a person
`of ordinary skill in the art would have sought to combine the references
`“picks up where the analogousart test leaves off”). Second, evenif this
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`argument were sufficient to show a reason to combine,it applies only to the
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`combination of Castillo and Bhowmick, not to the combination of
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`Bhowmick, Castillo, and Yanni on which Petitioner’s obviousness argument
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`rests. Accordingly, we concludethat this argument also is insufficient to
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`demonstrate a reason to combinethe teachings of Bhowmick, Yanni, and
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`Castillo.
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`Becauseneither of Petitioner’s arguments sufficiently shows a reason
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`to combine the teachings of Bhowmick, Yanni, and Castillo, we conclude
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`that Petitioner has not demonstrated a reasonable likelihood of prevailing in
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`showing the obviousness of any challenged claim over this combination of
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`references.
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`C. Obviousness over Schneider, Hayakawa, Bhowmick, and Castillo
`Petitioner argues that claims 1-13 of the 053 patent would have been
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`obvious given the combined teachings of Schneider, Hayakawa, Bhowmick,
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`and Castillo. Pet. 38-54.
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`1.
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`Schneider
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`Schneiderrelates to “solution compositions comprising olopatadine.”
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`Ex. 1006, code (57). In particular, Schneider “relates to formulations of
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`olopatadine andtheir use for treating and/or preventing allergic or
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`inflammatory disorders of the eye, nose, skin, and ear.” Jd.
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`It teaches that,
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`“ijn general, it is more desirable for active ingredients to be in solution
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`rather than suspension in a pharmaceutical composition.” Jd. 7.
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`Schneider’s products are “pharmaceutical aqueous solution compositions,”
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`id. | 9, that “are used to treat... allergic conjunctivitis,” id. 448. The
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`amount of olopatadine in Schneideris taught as “about .
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`.
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`. 0.60% w/v,or
`
`higher.” Jd. | 45. In addition to olopatadine, Schneider teaches adding
`several other compoundsto its ophthalmic solutions, including sodium
`borate as a buffer, id. § 44, water, id. | 49, benzalkonium chloride as a
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`preservative, id. J 51, polyethylene glycol and polyvinylpyrrolidone “as
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`lubricants or as viscosity agents,” id. ] 52, and dextrose, mannitol, sorbitol,
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`propylene glycol, or glycerol as tonicity agents, id. 53. Schneider teaches
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`a composition pH between 6.0 and 7.5. Jd. 4 44. It also teaches osmolality
`“about 150-450 mOsm,preferably 250-350 mOsm.” Id. { 53.
`
`Hayakawa
`2.
`Hayakawarelates to “[t]opical ophthalmic formulations” containing
`olopatadine.® Ex. 1007, code (57). Olopatadine is disclosed as having
`“human conjunctival mastcell stabilizing activity” and “significant
`
`antihistaminic activity.” Jd. at 3:18-22. Accordingly, Hayakawanotesthat
`olopatadine has both “a prophylactic effect” and “a therapeutic effect.” Id.
`at 3:22-23. Hayakawadiscloses using olopatadine in concentrations ranging
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`from “0.0001 to 5 w/v %,”id. at 6:43-44, with histamine inhibition
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`increasing as the dose of olopatadine increases,id. at Table 1.
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`Analysis
`3.
`Petitioner argues that claims 1-13 of the ’053 patent would have been
`obvious given the combined teachings of Schneider, Hayakawa, Bhowmick,
`
`and Castillo. Pet. 38-54.
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`In arguing the obviousness of claims 1—13, Petitioner relies on the
`same arguments for reason to combine that we discussed above. Pet. 41-42
`
`8 Hayakawauses “Compound A”or “11-(3-dimethylaminopropylidene)-
`6,1 1-dihydrodibenz[b,e]oxepin-2-acetic acid” to refer to either individual
`isomer or to a mixture of both isomers of 11-(3-dimethylaminopropylidene)-
`6,11-dihydrodibenz[b,e]oxepin-2-acetic acid. Ex. 1007, 3:10-15. This
`compound,in the hydrochloride salt of its Z isomer,is identified as
`olopatadine in Yanni. Ex. 1004, 389. Schneider identifies this compound,
`notin its hydrochloridesalt, butstill in its Z isomer, as olopatadine.
`Ex. 1006 9 3. There is no evidence in the record contradicting the
`identification of the compound disclosed in Hayakawaas olopatadine.
`Accordingly, we use the term “olopatadine” whenreferring to the compound
`that Hayakawadiscloses.
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`(arguing that we should find a reason to combine Schneider, Bhowmick,
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`Castillo, and Hayakawabecause “[s]Jimilar evidence [to that in IPR2016-
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`00544] exists here’), 46 (arguing that a person of ordinary skill in the art
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`would have combined Schneider and Castillo “because both references teach
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`ophthalmic solutions for treatmentof allergic disorders comprising
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`olopatadine, reciting similar excipients”). As discussed above, however,
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`neither of these arguments sufficiently shows a reason to combine the
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`references. Accordingly, we conclude that Petitioner has not demonstrated a
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`reasonable likelihood of prevailing in showing the obviousness of any
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`challenged claim over the combination of Schneider, Hayakawa, Bhowmick,
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`and Castillo.
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`D. Obviousness over Bhowmick, Schneider, and Castillo
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`Petitioner argues that claims 1—13 of the ’053 patent would have been
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`obvious given the combined teachings of Bhowmick, Schneider, and
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`Castillo. Pet. 54-66. With respect to a reason to combinethe references,
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`Petitioner argues that “the skilled artisan would have been motivated to
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`combine the teachings of Schneider, Bhowmick and Castillo because theyall
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`teach olopatadine solutions for treatmentof allergic disorders using similar
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`excipients.” Jd. at 54. As discussed above, this argumentis insufficient to
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`show a reason to combine because it speaks only to whether the teachings of
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`the references could be combined, not why a person ofordinary skill in the
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`art would have combined them. Accordingly, we conclude that Petitioner
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`has not demonstrated a reasonable likelihood of prevailing in showing the
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`obviousness of any challenged claim over the combination of Bhowmick,
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`Schneider, and Castillo.
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`CONCLUSION
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`Uponconsideration of the Petition, the Preliminary Response, the
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`Reply, the Sur-Reply, and the evidence presently before us, we determine
`that Petitioner has not shownareasonablelikelihoodthatit will prevail in
`showingthat at least one of the challenged claims is unpatentable.
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`Accordingly, we do notinstitute an inter partes review of any challenged
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`claim based on any groundasserted in the Petition.
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`It is hereby
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`ORDER
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`ORDEREDthat, pursuant to 35 U.S.C. § 314, the Petition is denied,
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`and no inter partes reviewis instituted.
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`For PETITIONER:
`
`Jitendra Malik
`Alissa Pacchioli
`KATTEN MUCHIN ROSENMAN LLP
`jitty.malik@katten.com
`alissa.pacchioli@katten.com
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`For PATENT OWNER:
`
`Andrew Trask
`WILLIAMS & CONNOLLY LLP
`atrask@we.com
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