`571-272-7822
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` Paper: 17
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`Entered: August 7, 2015
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
`
`INNOPHARMA LICENSING, INC., INNOPHARMA LICENSING LLC,
`INNOPHARMA INC., INNOPHARMA LLC,
`MYLAN PHARMACEUTICALS INC., and MYLAN INC.,
`Petitioner,
`
`v.
`
`SENJU PHARMACEUTICAL CO., LTD., BAUSCH & LOMB, INC., and
`BAUSCH & LOMB PHARMA HOLDINGS CORP.,
`Patent Owner.
`________________
`
`Case IPR2015-00902
`Patent 8,669,290 B2
`________________
`
`
`Before FRANCISCO C. PRATS, ERICA A. FRANKLIN, and
`GRACE KARAFFA OBERMANN, Administrative Patent Judges.
`
`OBERMANN, Administrative Patent Judge.
`
`
`
`DECISION
`Instituting Inter Partes Review
`37 C.F.R. § 42.108
`
`I. BACKGROUND
`
`On March 19, 2015, Petitioner filed a request for an inter partes
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`review of claims 1–30 of U.S. Patent No. 8,669,290 B2 (Ex. 1001, “the ’290
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`patent”). Paper 2 (“Pet.”). Patent Owner filed a Preliminary Response.
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`Paper 13 (“Prelim. Resp.”). Also on March 19, 2015, Petitioner filed a
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`Motion for Joinder (Paper 3) of this case with Metrics, Inc. v. Senju
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`Pharmaceutical Co., Ltd., IPR2014-01043. We address the Motion for
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`Joinder in an Order filed concurrently herewith.
`
`We have jurisdiction under 35 U.S.C. § 314(a), which provides that an
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`inter partes review may be instituted upon a showing of “a reasonable
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`likelihood that the petitioner would prevail with respect to at least 1 of the
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`claims challenged in the petition.” Petitioner makes that showing with
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`respect to claims 1–30; therefore, we institute review as to those claims.
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`Our findings of fact and conclusions of law are based on the record
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`developed thus far, prior to Patent Owner’s Response. This is not a final
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`decision as to the patentability of any challenged claim. If a final decision is
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`issued in this case, it will be based on the full record developed during trial.
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`A. Related Proceedings
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`Petitioner identifies eight district court actions involving the ’290
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`patent, including one that involves Petitioner as a defendant. Pet. 11–13; see
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`Senju Pharmaceutical Co. v. InnoPharma Licensing, Inc., C.A. No. 1:14-
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`CV-06893-JBS-KMW (D.N.J. filed Nov. 3, 2014).
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`Concurrently herewith, we issue a decision to institute in IPR2015-
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`00903, involving the same parties and directed to U.S. Patent No. 8,129,431
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`B2 (the ’431 patent). The ’290 patent claims priority to the ’431 patent.
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`B. The ’290 Patent (Ex. 1001)
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`The ’290 patent relates to an aqueous liquid preparation comprising
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`two components: (1) bromfenac (or its salts and hydrates); and (2)
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`tyloxapol. Ex. 1001, 12:2–13 (independent claim 1). Bromfenac is a non-
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`steroidal anti-inflammatory drug (“NSAID”). Id. at 1:26–49. Tyloxapol is
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`present in the preparation “in an amount sufficient to stabilize” the
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`bromfenac. Id. at 12:10–11. The preparation is useful for ophthalmic
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`administration, such as an eye drop to treat blepharitis, conjunctivitis,
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`scleritis, and postoperative inflammation. Id., Abstract; 12:12.
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`An object of the invention is to provide an aqueous liquid preparation
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`of bromfenac that “is stable within a pH range giving no irritation to eyes”
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`when preserved with a quaternary ammonium compound, such as
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`benzalkonium chloride (“BAC”). Id. at 2:16–24. The inventors claim to
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`have discovered that addition of an alkyl aryl polyether alcohol type
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`polymer, such as tyloxapol, provides the sought-after stability, giving no
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`irritation to the eyes. Id. at 2:35–49. The inventors acknowledge that
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`tyloxapol “is a non-ionic surfactant.” Id. at 4:37–39.
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`C. Illustrative Claim
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`Petitioner seeks inter partes review of claims 1–30 of the ’290 patent.
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`Independent claim 1, reproduced below, is illustrative of the subject matter.
`
`1. A stable aqueous liquid preparation comprising: (a) a
`first component; and (b) a second component; wherein the first
`component is 2-amino-3-(4-bromobenzoyl)phenylacetic acid or
`a pharmacologically acceptable salt thereof or a hydrate thereof,
`wherein the hydrate is at least one selected from a 1/ 2 hydrate,
`1 hydrate, and 3/2 hydrate; the first component is the sole
`pharmaceutical active ingredient contained in the preparation;
`the second component is tyloxapol and is present in said liquid
`preparation in an amount sufficient to stabilize said first
`component; and wherein said stable liquid preparation is
`formulated for ophthalmic administration.
`
`Ex. 1001, 12:2–13.
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`D. The Applied Prior Art
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`Petitioner relies upon the following prior art references:
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`Ogawa et al., U.S. Patent No. 4,910,225, issued Mar. 20, 1990
`(Ex. 1004) (“Ogawa”).
`
`Sallmann et al., U.S. Patent No. 6,107,343, issued Aug. 22,
`2000 (Ex. 1009) (“Sallmann”).
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`E. The Asserted Grounds of Unpatentability
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`Petitioner challenges the patentability of claims 1–30 of
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`the ’290 patent on a single ground, specifically, unpatentability over
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`Ogawa and Sallmann under 35 U.S.C. § 103. Pet. 18. Petitioner
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`relies on a declaration of Dr. Paul A. Laskar. Ex. 1003.1
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`II. ANALYSIS
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`A. Claim Construction
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`
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`In an inter partes review, claim terms in an unexpired patent are
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`interpreted according to their broadest reasonable construction in light of the
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`specification of the patent in which they appear. 37 C.F.R. § 42.100(b); In
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`re Cuozzo Speed Techs., LLC, No. 2014–1301, 2015 WL 4097949, at *5–*8
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`(Fed. Cir. July 8, 2015). Claim terms are given their ordinary and customary
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`meaning, as understood by one of ordinary skill in the art in the context of
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`the entire disclosure. In re Translogic Tech., Inc., 504 F.3d 1249, 1257
`
`
`1 Dr. Laskar has a Ph.D. in Pharmaceutical Sciences and is the founder of a
`pharmaceutical development consulting firm focused on development and
`evaluation of pharmaceuticals, including ophthalmic products. Ex. 1003
`¶¶ 14–15, 19. Dr. Laskar has significant experience in the development and
`assessment of ophthalmic preparations. Ex. 1003 ¶¶ 16, 18. He appears on
`this record to have the requisite familiarity with ophthalmic preparations to
`opine on the views of a hypothetical person of ordinary skill in the art at the
`time of the invention. See id. at ¶¶ 12–19. At this stage of the proceeding,
`we find his testimony credible and persuasive.
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`(Fed. Cir. 2007). If an inventor acts as his or her own lexicographer, the
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`definition must be set forth in the specification with reasonable clarity,
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`deliberateness, and precision. Renishaw PLC v. Marposs Societa’ per
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`Azioni, 158 F.3d 1243, 1249 (Fed. Cir. 1998). The construction that stays
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`true to the claim language, and most naturally aligns with the inventor’s
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`description, is likely the correct interpretation. Id. at 1250.
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`Neither Petitioner nor Patent Owner proposes a specific claim
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`construction for any claim term. Pet. 16; Prelim. Resp. 14. At this stage of
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`the proceeding, we determine that the claim terms are clear on their face, and
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`none is specially defined in the written description of the ’290 patent. No
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`claim term requires express construction for the purposes of this decision.
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`B. The Applied Prior Art
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`We next turn to the prior art references applied in the Petition and, in
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`particular, to what those references would have conveyed to an ordinary
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`artisan about the state of the art at the time of the invention of the ’290
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`patent. At this stage of the proceeding, we consider the applied prior art as
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`representative of the level of ordinary skill in the art. We discuss facts as
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`presented thus far in the record. Any inferences or conclusions drawn from
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`those facts are neither final nor dispositive of any issue.
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`i. Ogawa (Ex. 1004)
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`Ogawa’s Example 6 discloses a stable aqueous liquid preparation,
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`formulated for ophthalmic administration, which comprises bromfenac, as
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`the sole pharmaceutical active ingredient, and polysorbate 80. Ex 1004,
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`10:5–18, 49–57 (for stable aqueous liquid preparation); 10:5–9 (for
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`bromfenac, as sole pharmaceutical active ingredient, and polysorbate 80);
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`14:45–50 (Table 11, reporting 100% stability for the Example 6
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`preparation). The ophthalmic preparation of Ogawa’s Example 6 includes
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`BAC, which, as a pharmaceutically inactive ingredient, is not excluded by
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`the terms of claim 1. Ex. 1004, 10:5–9. On this record, Petitioner shows
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`sufficiently that the preparation of Ogawa’s Example 6 meets every
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`limitation of claim 1, but for the recited use of tyloxapol, in place of
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`polysorbate 80, “in an amount sufficient to stabilize” the bromfenac.
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`Ex. 1001, 12:10–11; see Pet. 21–22 (claim chart for claim 1).
`
`ii. Sallmann (Ex. 1009)
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`Sallmann discloses tyloxapol as a non-ionic surfactant in an
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`ophthalmic preparation of an NSAID—although Sallmann discloses
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`diclofenac potassium, and not bromfenac, as the NSAID. Specifically,
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`Sallmann’s Example 2 discloses an aqueous ophthalmic preparation that
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`includes diclofenac and tyloxapol. Ex 1009, 8:1–15. Petitioner shows
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`sufficiently that the remaining ingredients of Sallmann’s Example 2 would
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`not have been expected to adversely affect the stability or preservative
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`efficacy of the preparation. Ex. 1003 ¶ 58. Bromfenac and diclofenac share
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`several structural similarities, for example, a phenylacetic acid moiety.
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`Pet. 26 (citing Ex. 1003 ¶ 29). Like Ogawa’s Example 6, Sallmann’s
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`Example 2 discloses a preparation including BAC. Ex. 1009, 8:1–10.
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`The ’290 patent discloses that the tyloxapol range, effective to
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`stabilize a bromfenac-BAC preparation, is from about 0.01 and 0.5 w/v %.
`
`Ex. 1001, 5:37–38. Petitioner shows sufficiently that Sallmann’s Example 2
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`employs tyloxapol in a concentration of 0.1 w/v %, which falls within that
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`disclosed range. Pet. 39 (citing Ex. 1003 ¶ 80). On this record, Petitioner
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`shows sufficiently that Sallmann’s Example 2 meets every limitation of
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`claim 1, but for the use of bromfenac in place of diclofenac. See Pet. 25–29
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`(directing us to information that an ordinary artisan would have understood
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`that bromfenac was superior to diclofenac and, moreover, would have
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`recognized those two NSAIDs as interchangeable based on their similar
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`pharmacological properties).
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`C.
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`Analysis of the Ground of Unpatentability
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`We next turn to whether an ordinary artisan, equipped with the
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`combined disclosures of Ogawa and Sallman, would have had a reason to
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`replace polysorbate 80 in Ogawa’s Example 6 with tyloxapol in an amount
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`“sufficient to stabilize” the bromfenac. Ex. 1001, 12:10–11. Alternatively,
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`we consider whether that artisan would have been led to replace diclofenac
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`with bromfenac in the ophthalmic preparation of Sallmann’s Example 2. On
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`this record, either substitution results in a preparation that satisfies every
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`limitation of claim 1.
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`We then address whether the information presented is adequate to
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`show that the subject matter of the other challenged claims, that is, claims 2–
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`30, would have been obvious over Ogawa and Sallmann. We conclude with
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`an analysis of Patent Owner’s contentions as to secondary considerations of
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`non-obviousness.
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`i. Replacing Polysorbate 80 with Tyloxapol in Ogawa
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`We agree with Patent Owner that “Ogawa is completely silent on the
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`function of polysorbate 80, ascribing no express role to it” in the ophthalmic
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`preparation of Ogawa’s Example 6. Prelim. Resp. 21; see generally
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`Ex. 1004. Notwithstanding that fact, however, the information presented is
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`sufficient to show that, at the time of the invention, polysorbate 80 and
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`tyloxapol were added to aqueous ophthalmic preparations as surface-active
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`agents. Pet. 23–24; see Ex. 1003 ¶¶ 34, 40, 54 (Dr. Laskar’s declaration
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`testimony). At this stage, Patent Owner does not refute adequately that, at
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`the time of the invention, an ordinary artisan would have recognized
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`polysorbate 80 as a non-ionic surfactant in this art. Prelim. Resp. 10
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`(referring to “polysorbate 80” and “tyloxapol” as “surfactants”); Prelim.
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`Resp. 28–29 (bridging paragraph, suggesting that polysorbate 80 and
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`tyloxapol are both non-ionic surfactants, but arguing that how they function
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`in different mediums “is highly unpredictable”).
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`On this record, moreover, Petitioner shows sufficiently that Sallmann
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`adds tyloxapol to an NSAID-BAC preparation in an amount that falls within
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`the preferred amount disclosed in the ’290 patent. See Pet. 39 (citing
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`Ex. 1003 ¶ 80) (Sallmann’s Example 2 discloses a tyloxapol concentration
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`of 0.1 w/v %); Ex. 1001, Ex. 1001, 5:37–38 (the ’290 patent, disclosing that
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`the tyloxapol range, effective to stabilize a bromfenac-BAC preparation, is
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`from about 0.01 and 0.5 w/v %). Based on the record developed at this early
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`stage of the proceeding, we accept that a person of ordinary skill in the art,
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`when replacing polysorbate 80 with tyloxapol in Ogawa’s Example 6, would
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`have used the concentration of tyloxapol that is disclosed in Sallmann’s
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`Example 2. Pet. 19–25; Ex. 1003 ¶¶ 49–51.
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`Patent Owner contends that Ogawa does not add polysorbate 80 to
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`stabilize the preparation of Example 6 and, on that basis, contends that
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`Petitioner fails to establish that an ordinary artisan would have included
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`tyloxapol for a stabilizing purpose. Prelim. Resp. 21–22; compare
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`Ex. 1003 ¶ 54 (Dr. Laskar’s opinion that polysorbate 80 enhances the
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`stability of Ogawa’s preparation) to Ex. 1004, 3:7–15 (Ogawa, discussing
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`the factors that enhance stability, without indicating that polysorbate 80
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`affects the stability of the preparation). Specifically, Patent Owner directs us
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`to disclosures suggesting that Ogawa uses a water soluble polymer
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`(polyvinyl pyrrolidone) and a sulfite (sodium sulfite) to stabilize the
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`bromfenac preparation. Prelim. Resp. 21–22 (discussing Experimental
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`Examples 4–6).
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`As Patent Owner readily admits, however, those disclosures do not
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`speak to the function of polysorbate 80 and, accordingly, do not establish
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`that polysorbate 80 serves no stabilizing function in the preparation. Id.
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`at 21 (“Ogawa is completely silent on the function of polysorbate 80,
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`ascribing no express role to it.”) Petitioner, by contrast, directs us to
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`information that an ordinary artisan would have recognized that
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`polysorbate 80 is a non-ionic surfactant in Ogawa’s Example 6, and would
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`have understood that tyloxapol was interchangeable with polysorbate 80 as a
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`non-ionic surfactant in ophthalmic preparations. Pet. 23–24; see Ex. 1003
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`¶¶ 34, 40, 54 (Dr. Laskar’s declaration testimony).
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`We acknowledge that Patent Owner has not yet filed a Response and
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`that the Preliminary Response necessarily rests on argument unsupported by
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`new testimonial evidence. See 37 C.F.R. § 42.107(c) (no new testimonial
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`evidence may be submitted with a preliminary response). However, the
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`disclosures in the references advanced in the Preliminary Response, standing
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`alone, are insufficient to establish Patent Owner’s factual assertions.
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`Specifically, Patent Owner has not refuted adequately, at this stage of the
`
`proceeding, that polysorbate 80 and tyloxapol were used interchangeably as
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`surfactants in ophthalmic preparations. See Prelim. Resp. 10 (referring to
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`both “polysorbate 80” and “tyloxapol” as “surfactants”).
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`Based on the information presented at this stage of the proceeding, the
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`interchangeability of those components is suggested by the combined
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`teachings of the applied art, where Ogawa includes a non-ionic surfactant,
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`polysorbate 80, in a stable NSAID-containing ophthalmic preparation, and
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`Sallmann similarly includes a non-ionic surfactant, tyloxapol, in a stable
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`NSAID-containing ophthalmic preparation. At this early stage, Patent
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`Owner’s factual contentions, regarding what the applied references would
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`have conveyed to an ordinary artisan, rest on attorney argument, whereas
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`Petitioner’s assertions are supported by the declaration testimony of
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`Dr. Laskar.
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`For example, Patent Owner argues that the undesirable “red insoluble
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`particles” in Ogawa’s preparation are caused by dimerization of bromfenac,
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`rather than complexation of bromfenac and BAC. Prelim. Resp. 20. Patent
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`Owner further argues that polysorbate 80 “plays no role in preventing the
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`oxidative degradation of bromfenac” in Ogawa’s Example 6. Id. at 21.
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`Neither of those facts, however, is adequately supported at this stage of the
`
`proceeding. On this record, moreover, we are not persuaded that Petitioner
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`must establish that an ordinary artisan would have grasped exactly how
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`polysorbate 80 or tyloxapol interacts with the components of the aqueous
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`preparation. See Prelim. Resp. 22 (arguing that Dr. Laskar’s testimony, that
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`polysorbate 80 stabilizes bromfenac in Ogawa’s Example 6 preparation, “is
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`fundamental to” Petitioner’s challenge).
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`The issue is whether a person of ordinary skill in the art would have
`
`had a reason (such as a simple substitution) to use tyloxapol, instead of
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`polysorbate 80, in an amount that would have stabilized Ogawa’s Example 6
`
`preparation—whether or not that artisan would have recognized any
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`stabilizing benefit of doing so. See Ex parte Obiaya, 227 USPQ 58, 60
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`(BPAI 1985) (The fact that a patent applicant may have “recognized another
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`advantage which would flow naturally from following the suggestion of the
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`prior art cannot be the basis for patentability when the differences would
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`otherwise be obvious.”).
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`Based on the information presented, we determine that Petitioner
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`shows sufficiently that an ordinary artisan would have recognized that
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`“tyloxapol and polysorbate 80 had previously been used interchangeably as
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`surfactants in ophthalmic formulations.” Pet. 23 (citing Ex. 1003 ¶ 40) (Dr.
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`Laskar’s testimony that, at the time of the invention, “tyloxapol was a
`
`widely-used non-ionic surfactant in aqueous liquid preparations comprising
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`anti-inflammatory agents, and was used interchangeably with polysorbate
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`80”). That known interchangeability, absent persuasive objective evidence
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`to the contrary, is enough to support the proposed substitution. An express
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`suggestion to substitute one known equivalent non-ionic surfactant for
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`another in Ogawa’s ophthalmic preparation is not needed to render the
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`substitution obvious. See In re Fout, 675 F.2d 297, 301 (CCPA 1982); In re
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`Siebentritt, 372 F.2d 566, 568 (CCPA 1967); see also In re Mayne, 104 F.3d
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`1339, 1340 (Fed. Cir. 1997) (“Because the applicants merely substituted one
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`element known in the art for a known equivalent, this court affirms [the
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`conclusion of obviousness].”).
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`At this stage of the proceeding, absent evidence to the contrary, it
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`would have been well within the level of ordinary skill in the art to replace
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`one non-ionic surfactant (polysorbate 80) with another non-ionic surfactant
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`(tyloxapol) in Ogawa’s Example 6, because both were known to be useful as
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`surfactants in ophthalmic preparations. See KSR Int’l Co. v. Teleflex Inc.,
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`550 U.S. 398, 417 (2007) (“If a person of ordinary skill in the art can
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`implement a predictable variation, and would see the benefit of doing so,
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`§ 103 likely bars its patentability.”).
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`ii. Replacing Diclofenac with Bromfenac in Sallmann
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`Alternatively, Petitioner is reasonably likely to prevail in showing that
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`an ordinary artisan would have replaced diclofenac with bromfenac in the
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`ophthalmic preparation of Sallmann’s Example 2. Pet. 25–28; Ex. 1003
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`¶¶ 29, 43–44, 57; see Ex. 1009, 8:1–15 (Sallmann’s Example 2, disclosing
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`an ophthalmic preparation that meets every limitation of claim 1, except that
`
`Sallmann uses diclofenac and not bromfenac as the NSAID); see also
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`Ex. 1003 ¶¶ 66–69 (Dr. Laskar’s testimony that, at the time of the invention,
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`bromfenac and diclofenac would have been recognized as interchangeable
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`NSAIDs suitable for use in aqueous liquid ophthalmic preparations).
`
`Sallmann in Example 2 discloses that diclofenac is useful as the
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`NSAID in an ophthalmic preparation of an NSAID and BAC. Ex. 1009,
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`8:1–15. Ogawa in Example 6 discloses that bromfenac is useful as the
`
`NSAID in an ophthalmic preparation of an NSAID and BAC. Ex. 1004,
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`10:5–9. At the time of the invention, bromfenac and diclofenac were known
`
`to share several structural features. Pet. 26; Ex. 1003 ¶ 29. Furthermore,
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`based on the information presented, a person of ordinary skill in the art at the
`
`time of the invention would have recognized the two NSAIDs as “suitable
`
`and desirable for ophthalmic administration.” Pet. 26; Ex. 1003 ¶¶ 25–28.
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`Accordingly, on the current record, Petitioner shows sufficiently that
`
`an ordinary artisan would have expected diclofenac and bromfenac to work
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`interchangeably in an ophthalmic preparation of an NSAID and BAC.
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`Pet. 28–29; Ex. 1003 ¶¶ 66–69. Patent Owner’s counterviews—including
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`that structural and functional differences between the two NSAIDs would
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`have dissuaded an ordinary artisan from making the proposed substitution—
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`are not adequately supported on this record and, therefore, are insufficient to
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`persuade us to deny review. See Prelim. Resp. 32–41, 51–52.
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`Specifically, Patent Owner contends that a person of ordinary skill in
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`the art “would not have replaced diclofenac potassium with bromfenac
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`sodium” because one would have known that “[d]oing so would have
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`destroyed the entire purpose and essence of Sallmann’s invention.” Id.
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`at 32. By way of support, Patent Owner avers to “Sallmann’s indisputable
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`preference for potassium salts.” Id. at 33. Patent Owner also avers that a
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`person of ordinary skill in the art would have “more likely honed in on
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`Sallmann’s Examples 8 and 11” instead of Example 2. Id. at 34. Patent
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`Owner suggests that an ordinary artisan would have recognized that
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`cyclodextrins in Sallmann’s Example 2 “can unpredictably impact the
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`stability of a formulation.” Id. Patent Owner argues that the ordinary artisan
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`“would have recognized from Ogawa that bromfenac degraded via
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`oxidation.” Id. at 35–36. Patent Owner also attempts to establish that, as
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`between bromfenac and diclofenac, a difference in the amine moiety “affects
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`at least polarity and electron density distribution.” Id. at 40. On the current
`
`record, however, Patent Owner’s conclusion—that these facts show that an
`
`ordinary artisan would not have considered bromfenac and diclofenac to be
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`interchangeable, ophthalmically-suitable NSAIDs—is based on attorney
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`argument that is not shown to reflect the perspective of an ordinary artisan.
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`At this stage of the proceeding, given the evidence before us,
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`including that discussed above, we are persuaded that Petitioner shows
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`sufficiently that it would have been obvious to a person of ordinary skill in
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`the art to replace diclofenac with bromfenac, including bromfenac’s sodium
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`salt as required in some of the challenged claims, in the preparation of
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`Sallmann’s Example 2, because diclofenac and bromfenac were recognized
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`as interchangeable, alternative NSAIDs serving the same function in an
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`ophthalmic preparation. Pet. 25–29; Ex. 1003 ¶¶ 25–29, 57, 66–68; see KSR
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`Int’l Co., 550 U.S. at 417 (a claim likely is obvious if it is no “more than the
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`predictable use of prior art elements according to their established
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`functions”).
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`iii. The Remaining Challenged Claims
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`Petitioner also alleges that subject matter of claims 2–30 would have
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`been obvious over the combined teachings of Ogawa and Sallmann. Pet. 18.
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`Based on the information presented, we determine that there is a reasonable
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`likelihood that Petitioner also will prevail on those other challenged claims.
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`Pet. 29–48. We have taken account of the counterarguments presented in
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`the Preliminary Response, but on this record, we determine that Petitioner
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`has made a showing sufficient to support institution of an inter partes review
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`on claims 2–30. Prelim. Resp. 51–59.
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`In particular, on this record, we are satisfied that, where the
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`challenged claims reflect ranges that do not overlap the prior art ranges, they
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`are close enough that an ordinary artisan would have expected them to have
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`the same properties. See Pet. 40 (citing Titanium Metals Corp. v. Banner,
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`778 F.2d 775, 783 (Fed. Cir. 1985). To the extent that a claimed range is
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`critical, the information presented supports a reasonable inference that an
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`ordinary artisan would have arrived at the specified range using only routine
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`experimentation. Pet. 41; see In re Aller, 220 F.2d 454, 456–58 (CCPA
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`1955) (“[W]here the general conditions of a claim are disclosed in the prior
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`art, it is not inventive to discover the optimum or workable ranges by routine
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`experimentation.” (citations omitted)); In re Peterson, 315 F.3d 1325, 1330
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`(Fed. Cir. 2003) (“The normal desire of scientists or artisans to improve
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`upon what is already generally known provides the motivation to determine
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`where in a disclosed set of percentage ranges is the optimum combination of
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`percentages.”).
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`iv. Secondary Considerations
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`We have taken account of the information presented in the
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`Preliminary Response, but on this record, we determine that Petitioner has
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`made a showing sufficient to support institution of an inter partes review.
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`For example, we have taken account of the information advanced by Patent
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`Owner in support of secondary considerations of non-obviousness. Prelim.
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`Resp. 42–50. We have noted in particular Petitioner’s concession that “[t]he
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`subject matter of many of the challenged claims of the ’290 patent is
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`commercially embodied by Prolensa®, a product marketed by” Patent
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`Owner. Pet. 9. Nonetheless, at this early stage of the proceeding, before the
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`filing of Patent Owner’s Response, many of Patent Owner’s factual
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`assertions, regarding the commercial success of Prolensa®, are not
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`adequately supported.
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`Patent Owner contends that “[t]yloxapol’s stabilization effect
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`permitted formulating Prolensa® at pH 7.8;” that such a pH is “closer to the
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`pH of natural tears” than other bromfenac preparations; that the lowered pH
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`is “less irritating to the patient,” which “improve[s] bromfenac’s intraocular
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`penetration and permit[s] a lowering of its concentration” compared to a
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`different product; and that Prolensa®, therefore, “advantageously puts less
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`drug in contact with surgically compromised ocular tissue without a
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`reduction in efficacy.” Prelim. Resp. 48–49 (bridging paragraph). At this
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`stage, however, Patent Owner refers to entire exhibits, without any pin-cites,
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`and supplies no cogent explanation of how the exhibits support these fact-
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`laden contentions, or whether the asserted properties were unexpected or
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`otherwise unobvious. Id. at 48, n.6 (citing Ex. 2013, Ex. 2026, Ex. 2027,
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`Ex. 2030). Similarly, Patent Owner refers to sales data for Prolensa®, as
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`projected by a competitor, but at this stage of the proceeding, comes forward
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`with no objective evidence of revenues based on actual sales. Id. at 49.
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`Patent Owner also refers to test results to establish that tyloxapol is a
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`better stabilizer of bromfenac, compared to polysorbate 80—but advances
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`no information that the asserted results would have been considered truly
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`“surprising” or “unexpected” by a person of ordinary skill in the art. Id. at
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`45–48. At this early stage, Patent Owner’s position on that point rests
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`entirely on attorney argument. Id.; see In re Geisler, 116 F.3d 1465, 1471
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`(Fed. Cir. 1997) (argument of counsel cannot take the place of evidence).
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`The record is devoid of objective evidence in that regard. Not even the
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`inventors described tyloxapol as “surprising” or “unexpected” in its
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`stabilizing effect: When comparing tyloxapol to other alkyl aryl polyether
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`alcohol type polymers, the inventors described tyloxapol as “especially
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`preferable.” Ex. 1001, 4:65–67.
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`In sum, Patent Owner’s information, at this stage of the proceeding,
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`depends on attorney argument as to what the combined teachings of the
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`applied art would have conveyed to a person of ordinary skill in the art.
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`Prelim. Resp. 36–41, 51–59. And Patent Owner’s information, at this stage,
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`regarding secondary considerations, similarly lacks adequate objective
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`support. Id. at 42–50. As such, Patent Owner does not persuade us to
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`decline to institute an inter partes review, given the teachings in Ogawa and
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`Sallmann, and the supporting testimony of Dr. Laskar.
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`III. CONCLUSION
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`Taking account of the information presented in the Petition and the
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`Preliminary Response, we institute an inter partes review of claims 1–30
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`based on obviousness over Ogawa and Sallmann under 35 U.S.C. § 103. We
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`institute an inter partes review on that ground. Our findings and conclusions
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`are not final and may change upon consideration of the whole record
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`developed during trial.
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`It is:
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`IV. ORDER
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`ORDERED that an inter partes review is instituted, as to claims 1–30
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`of the ’290 patent, as unpatentable over Ogawa and Sallmann under
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`35 U.S.C. § 103;
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`FURTHER ORDERED that no other ground of unpatentability is
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`authorized; and
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`FURTHER ORDERED that notice is hereby given of the institution of
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`a trial commencing on the entry date of this decision. 35 U.S.C. § 314(c);
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`37 C.F.R. §42.4.
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`PETITIONER:
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`Jitendra Malik
`Bryan L. Skelton
`Lance Soderstrom
`ALSTON & BIRD LLP
`Jitty.Malik@alston.com
`bryan.skelton@alston.com
`lance.soderstrom@alston.com
`
`
`
`PATENT OWNER:
`
`Bryan Diner
`M. Andrew Holtman
`Justin Hasford
`Jonathan R. Stroud
`Joshua Goldberg
`FINNEGAN, HENDERSON, FARABOW, GARRETT & DUNNER, LLP
`bryan.diner@finnegan.com
`andy.holtman@finnegan.com
`justin.hasford@finnegan.com
`jonathan.stroud@finnegan.com
`joshua.goldberg@finnegan.com
`
`
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