Trials@uspto.gov
`571-272-7822
`
` Paper: 19
`
`Entered: February 19, 2015
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`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`METRICS, INC., MAYNE PHARMA, and JOHNSON MATTHEY, INC.,
`Petitioner,
`
`v.
`
`SENJU PHARMACEUTICAL CO., LTD., BAUSCH & LOMB, INC., and
`BAUSCH & LOMB PHARMA HOLDINGS CORP.,
`Patent Owner.
`_______________
`
`Case IPR2014-01041
`Patent 8,129,431 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
`Petitioner requests an inter partes review of claims 1–22 of U.S.
`Patent No. 8,129,431 B2 (Ex. 1001, “the ’431 patent”). Paper 9 (“Pet.”).
`Patent Owner filed a Preliminary Response. Paper 13 (“Prelim. Resp.”).
`We have jurisdiction under 35 U.S.C. § 314(a), which provides that an inter
`
`
`571-272-7822
`
` Paper: 19
`
`Entered: February 19, 2015
`
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`METRICS, INC., MAYNE PHARMA, and JOHNSON MATTHEY, INC.,
`Petitioner,
`
`v.
`
`SENJU PHARMACEUTICAL CO., LTD., BAUSCH & LOMB, INC., and
`BAUSCH & LOMB PHARMA HOLDINGS CORP.,
`Patent Owner.
`_______________
`
`Case IPR2014-01041
`Patent 8,129,431 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
`Petitioner requests an inter partes review of claims 1–22 of U.S.
`Patent No. 8,129,431 B2 (Ex. 1001, “the ’431 patent”). Paper 9 (“Pet.”).
`Patent Owner filed a Preliminary Response. Paper 13 (“Prelim. Resp.”).
`We have jurisdiction under 35 U.S.C. § 314(a), which provides that an inter
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`partes review may be instituted upon a showing of “a reasonable likelihood
`that the petitioner would prevail with respect to at least 1 of the claims
`challenged in the petition.” Petitioner makes that showing with respect to
`claims 1–22; therefore, we institute review as to those claims.
`We authorized, and the parties filed, additional briefing on the issue
`whether the Petition identifies all real parties-in-interest as required by 35
`U.S.C. § 312(a)(2). Paper 15 (“Pet. Opp.”); Paper 17 (“PO Reply”).
`Our findings of fact and conclusions of law, including those relating
`to the Petition’s identification of all real parties-in-interest, are based on the
`record developed thus far, prior to Patent Owner’s Response. This is not a
`final decision as to the patentability of any challenged claim. Our final
`decision will be based on the full record developed during trial.
`A. Related Proceedings
`The ’431 patent is the subject of two district court actions. Senju
`Pharmaceutical Co. v. Lupin, Ltd., C.A. No. 1:14-CV-00667-MAS-LHG
`(D.N.J.); Senju Pharmaceutical Co. v. Metrics, Inc, C.A. No. 1:14-cv-
`03962-JBS-KMW (D.N.J.); see Pet. 12.
`Concurrently herewith, we issue a decision to institute in IPR2014-
`01043, involving the same parties and directed to U.S. Patent No. 8,669,290
`B2, which claims priority to the ’431 patent.
`
`B. The ’431 Patent
`The ’431 patent relates to an aqueous liquid preparation consisting
`essentially of two components: (1) bromfenac (or its salts and hydrates);
`and (2) tyloxapol. Ex. 1001, 11:66–12:10 (independent claim 1).
`Bromfenac is a non-steroidal anti-inflammatory drug (“NSAID”) and
`tyloxapol serves as a non-ionic surfactant, or stabilizer, in the preparation
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`recited in the challenged claims. Id. at 1:24–47, 2:34–49, 4:37–41. The
`’431 patent discloses a preparation useful for ophthalmic administration,
`such as an eye drop to treat blepharitis, conjunctivitis, scleritis, and
`postoperative inflammation. Ex. 1001, Abstract. The ’431 patent discloses
`that the preparation also is useful as a nasal drop for treatment of allergic
`rhinitis and inflammatory rhinitis. Id.
`According to the ’431 patent, an object of the invention is to provide
`an aqueous liquid preparation of bromfenac that “is stable within a pH range
`giving no irritation to eyes” when preserved with a quaternary ammonium
`compound, such as benzalkonium chloride (“BAC”). Id. at 2:14–22.
`Petitioner contends, and Patent Owner does not contest at this stage of the
`proceeding, that NSAIDs were known to interact with BAC to form
`insoluble complexes, which reduce the stability of the ophthalmic
`preparation, by rendering the preservative (BAC) less available to serve its
`function. Pet. 23 (citing Ex. 1003 ¶ 31). The inventors claim to have
`discovered that addition of an alkyl aryl polyether alcohol type polymer,
`such as tyloxapol, provides the sought-after stability, giving no irritation to
`the eyes. Ex. 1001, 2:35–49.
`
`C. Illustrative Claim
`Petitioner seeks inter partes review of claims 1–22 of the ’431 patent.
`Independent claim 1 is illustrative of the subject matter and is reproduced
`below.
`
`1. An aqueous liquid preparation consisting essentially
`of the following two components, wherein the first
`component is 2-amino-3-(4-bromobenzoyl)-
`phenylaceticacid 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
`
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`Ex. 1001, 11:66–12:10.
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`hydrate and the second component is tyloxapol, wherein
`said liquid preparation is formulated for ophthalmic
`administration, and wherein when a quaternary
`ammonium compound is included in said liquid
`preparation, the quaternary ammonium compound is
`benzalkonium chloride.
`
`D. Prior Art Relied Upon
`Petitioner relies upon the following prior art references:
`Owaga, U.S. Patent No. 4,910,225, issued Mar. 20, 1990
`(Ex. 1004) (“Owaga”).
`
`Sallmann et al., U.S. Patent No. 6,107,343, issued Aug. 22,
`2000 (Ex. 1009) (“Sallmann”).
`
`Fu, AU-B-22042/88, issued Mar. 16, 1989 (Ex. 1011 (“Fu”).
`
`E. The Asserted Grounds of Unpatentability
`Petitioner challenges the patentability of claims 1–22 of
`the ’431patent on the grounds set forth in the chart below. See Pet.
`18–19, 43–46.1 Petitioner also relies on a declaration of Dr. Uday B.
`Kompella. Ex. 1003.2
`
`
`1 Petitioner’s identification of challenged claims in its chart of grounds
`(Pet. 18–19) differs from the arguments presented in support of the
`challenges (see Pet. 43–46). We identify the challenged claims based on the
`arguments presented in the Petition.
`
` Dr. Kompella has a Ph.D. in Pharmaceutical Sciences and has significant
`experience, as a tenured professor, researcher, and author, in the field of
`ophthalmology and ophthalmic preparations. Ex. 1003 ¶¶ 12–17. 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
`
` 2
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`References
`
`Owaga and Sallmann
`
`Owaga, Sallmann, and Fu
`
`
`
`Basis
`
`§ 103
`
`§ 103
`
`Claims
`Challenged
`1–5, 7–14,
`and 18–19
`6, 15–17,
`and 20–22
`
`II. ANALYSIS
`A. Threshold Issues Under 35 U.S.C. §§ 312 (a)(2), 315(a)(1)
`We first address two threshold issues raised by Patent Owner: (1)
`
`whether the Petition identifies all real parties-in-interest, as required under
`35 U.S.C. § 312(a)(2); and (2) whether Petitioner is barred from pursuing an
`inter partes review under 35 U.S.C. § 315(a)(1).
`i. Real Parties-in-Interest under 35 U.S.C. § 312(a)(2)
`Patent Owner contends that the filing date of the Petition should be
`
`vacated because the Petition does not identify all real parties-in-interest, as
`required by 35 U.S.C. § 312(a)(2). Prelim. Resp. 14–20. The gravity of that
`contention, and its potential ramifications, prompted us to authorize further
`briefing on the issue. We may consider a petition for inter partes review
`only if it identifies all real parties-in-interest. 35 U.S.C. § 312(a)(2).
`
`Patent Owner argues that Coastal Pharmaceuticals, Inc. (“Coastal”) is
`an unidentified real party-in-interest in this proceeding. Prelim. Resp. 1. On
`that point, Patent Owner contends that Coastal filed, “on [Petitioner’s]
`behalf,” a certification with the U.S. Food and Drug Administration
`(“FDA”) pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (“Paragraph IV
`certification”). Id. Patent Owner states that Petitioner’s “arguments in the
`
`
`in the art at the time of the invention. See id. At this stage of the
`proceeding, we find his testimony credible and persuasive.
`
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`[P]etition are copies of those in Coastal’s Paragraph IV Notice Letter,”
`which “issued [on] the same day by the same counsel” as the Petition. Id.
`at 2; see id. at 15–16 (citing Ex. 2001) (comparing pages A-2–A-30 in that
`letter with pages 1–55 in the Petition). Patent Owner also argues that
`Petitioner “conceded in district court that [Petitioner] and Coastal are in
`privity and that any judgment reaching one would reach the other.” Id. at 2;
`see id. at 16–17 (citing Ex. 2003, 4–5; Ex. 2004, 30–31).
`
`Petitioner responds that Coastal is no more than “a business name” for
`Petitioner. Pet. Opp. 1. Petitioner argues that its “assumed name” is not a
`juridical entity apart from Petitioner; therefore, Coastal cannot be considered
`a separate real party-in-interest. Id. at 5 (citing Ex. 1054, “Corporate
`Certificate of Assumed Name”). In fact, Petitioner comes forward with
`persuasive evidence that, prior to the filing of the Preliminary Response in
`this proceeding, counsel for Patent Owner admitted in district court that
`Coastal and Petitioner are “one and the same” juridical party. Id. at 5–6
`(citing Ex. 1056, 30:2-23) (transcript of proceeding in New Jersey action).
`Petitioner argues, persuasively, “that it would be ‘nonsensical’ to
`maintain an action against both a legal entity and its assumed name.”
`Pet. Opp. 8 (citing Pinkerton’s, Inc. v. Superior Court, 57 Cal. Rptr.2d 356,
`360 n.1 (Cal. Ct. App. 1996)). As Petitioner points out, where Samuel
`Clemens is dismissed from a case, a plaintiff cannot continue to pursue the
`action against Mark Twain. Id. (quoting Pinkerton’s, Inc., 57 Cal. Rptr.2d
`at 357). In fact, because a business name is not a separate juridical entity,
`the district court in the related New Jersey action “dismissed and terminated
`the case against Coastal as a d/b/a.” Id. at 4. “[I]n an effort to promptly
`resolve this issue,” however, Petitioner is amenable to identifying itself as
`
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`“Metrics, Inc. d/b/a Coastal Pharmaceuticals” in this proceeding, provided
`that the Petition retains its original filing date. Id.
`
`The evidence of record persuades us that the Petition and the
`Paragraph IV certification were filed by the same party (namely, Petitioner)
`on the same day, by the same counsel, and with what appear to be essentially
`the same arguments—yet Petitioner did not identify the Paragraph IV
`certification in the Petition. PO Reply 1–2. Although that action, on
`Petitioner’s part, falls short of a model of candor, we are not persuaded that
`Petitioner was required to identify Coastal as a real party-in-interest in the
`Petition, based on the evidence presented at this stage of the proceeding.
`Petitioner’s counsel represents that Coastal is an “assumed name” of
`Petitioner. Pet. Opp. 5. Petitioner also comes forward with a copy of “a
`sworn affidavit,” which was filed in the related district court litigation,
`wherein “Stefan Cross, President of Metrics,” attests “that Coastal is not a
`recognized separate entity and is used in the marketplace to distinguish
`Metrics’ contract services business segment from its pharmaceutical
`products business.” Ex. 1055 ¶¶ 12–13; see Pet. Opp. 5–6 (quoting
`Ex. 1056, 30:2–23) (counsel for Petitioner, affirming in district court that
`Coastal “is not a juridical party, it’s not anything other than a trade name”).
`We agree with Petitioner that “a corporate entity using a business
`name, or a d/b/a (‘doing business as’) name, does not create a legal entity in
`the name” that is “separate from the underlying corporate entity.” Pet. Opp.
`2; see id. at 8 (citing Snowden v. CheckPoint Check Cashing, 290 F.3d 631,
`634–35 n.2 (4th Cir. 2002); Pinkerton’s, Inc., 57 Cal. Rptr.2d at 360 (citing
`consistent treatment of business names from different jurisdictions)). “The
`business name is a fiction, and so too is any implication that the business is a
`
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`legal entity separate from its owner.” Pinkerton’s, Inc., 57 Cal. Rptr.2d
`at 360 (quotations omitted). Accordingly, based on the record developed
`thus far, we determine that Coastal is not a separate juridical entity or,
`therefore, a separate real party-in-interest in this proceeding.
`Any collateral estoppel effect that arises from our Final Written
`Decision will bind Petitioner, whether operating as Metrics or under its
`business name, Coastal. Petitioner, therefore, is not required to file an
`updated mandatory notice, correcting the real party-in-interest. Based on the
`information presented thus far, we decline to vacate the filing date accorded
`the Petition.
`
`ii. Paragraph IV Certification as an “Effective”
`Declaratory Judgment Action under 35 U.S.C. § 315(a)(1)
`Petitioner filed the Paragraph IV certification and, thereby, challenged
`
`the validity of the ’431 patent prior to the filing of the instant Petition.
`Prelim. Resp. 12. Patent Owner argues that the filing of that Paragraph IV
`certification was “the full functional equivalent of initiating a declaratory
`judgment action and should be viewed as foreclosing” Petitioner’s access to
`an inter partes review. Prelim. Resp. 12 (citing 35 U.S.C. § 315(a)(1)). We
`disagree. Our governing statute states, in relevant part:
`(1) INTER PARTES REVIEW BARRED BY CIVIL
`ACTION.—An inter partes review may not be instituted if,
`before the date on which the petition for such a review is filed,
`the petitioner or real party in interest filed a civil action
`challenging the validity of a claim of the patent.
`35 U.S.C. § 315(a)(1).
`
`When the statute refers to filing a civil action, it refers to filing a
`complaint with a court to commence a civil action. See, e.g., Baldwin Cnty.
`Welcome Ctr. v. Brown, 466 U.S. 147, 149 (1984) (a civil action is brought
`
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`upon filing a complaint with a court); Ariosa Diagnostics v. Isis Innovation
`Ltd., Case IPR2012-00022, slip op. at 4–5 (PTAB Feb. 12, 2013)(Paper 20)
`(citing Baldwin, 466 U.S. at 149). Petitioner’s act of initiating a challenge to
`patent validity, by filing of a Paragraph IV certification with the FDA, did
`not involve filing of a complaint with a court. A Paragraph IV certification
`may represent an out-of-court challenge to patent validity, but it does not
`constitute “a civil action challenging the validity of” any patent claim. 35
`U.S.C. § 315(a). Thus, Petitioner’s action of filing a Paragraph IV
`certification does not bar institution of the present Petition under 35 U.S.C.
`§ 315(a). We have considered, but find unpersuasive, Patent Owner’s
`arguments that a perceived conflict between the America Invents Act and the
`Hatch-Waxman Act compels a different result. Prelim. Resp. 4–14.
`
`On this record, we determine that the Petition is not time-barred under
`35 U.S.C. § 315(a)(1).
`
`B. Claim Construction
`In an inter partes review, claim terms in an unexpired patent are
`
`interpreted according to their broadest reasonable construction in light of the
`specification of the patent in which they appear. 37 C.F.R. § 42.100(b);
`Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,766
`(Aug. 14, 2012). Claim terms are given their ordinary and customary
`meaning, as understood by one of ordinary skill in the art in the context of
`the entire disclosure. In re Translogic Tech., Inc., 504 F.3d 1249, 1257
`(Fed. Cir. 2007). If an inventor acts as his or her own lexicographer, the
`definition must be set forth in the specification with reasonable clarity,
`deliberateness, and precision. Renishaw PLC v. Marposs Societa’ per
`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
`description, is likely the correct interpretation. Id. at 1250.
`At this stage of the proceeding, we determine that the claim terms are
`clear on their face, and none is specially defined in the written description of
`the ’431 patent. No claim term requires express construction for the
`purposes of this decision. We observe, however, that, notwithstanding
`Patent Owner’s arguments to the contrary, both parties acknowledge that the
`phrase “consisting essentially of,” which appears, for example, in claim 1,
`has a well-defined meaning in patent law; and that the transitional phrase
`excludes unrecited ingredients that materially affect the composition. See,
`e.g., Pet. 3, 14 (correctly stating that definition); Prelim. Resp. 3 (arguing
`that “the petition misstates or ignores” that transitional phrase); PPG Indus.
`Inc. v. Guardian Indus. Corp, 156 F.3d 1351, 1354 (Fed. Cir. 1998) (“By
`using the term ‘consisting essentially of,’ the drafter signals that the
`invention necessarily includes the listed ingredients and is open to unlisted
`ingredients that do not materially affect the basic and novel properties of the
`invention.”).
`
`C. The Applied Prior Art
`We next turn to the prior art references raised in the Petition and, in
`particular, to our analysis of what those references convey about the state of
`the art at the time of the invention of the ’431 patent.3 We discuss facts as
`
`
`3 Patent Owner argues that the Petition fails to include “[a] full statement of
`the reasons for the relief requested,” because the Petition advances
`additional prior art references, outside of those identified in the stated
`grounds of unpatentability. Prelim. Resp. 37 (quoting 37 C.F.R. § 42.22
`(a)(2)); see id. at 26 n.4 (citing 37 C.F.R. §§ 42.104(b)(2), (b)(4)). We limit
`our analysis to “patents or printed publications” identified in the Petition
`
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`presented thus far in the record. Any inferences or conclusions drawn from
`those facts are neither final nor dispositive of any issue.
`i. Owaga and Sallmann
`Petitioner shows sufficiently that Owaga’s Example 6 discloses an
`aqueous liquid preparation consisting essentially of bromfenac (an NSAID),
`polysorbate 80 (a non-ionic surfactant), and BAC (a preservative)—and that
`the liquid preparation is formulated for ophthalmic administration. Pet. 21–
`22 (claim chart for claim 1); Ex 1004, 10:5–18 (for aqueous liquid
`preparation), 10:5–9 (for bromfenac and polysorbate 80).
`Petitioner also shows sufficiently that Sallmann’s Example 2 discloses
`an aqueous liquid preparation consisting essentially of diclofenac (an
`NSAID), tyloxapol (a non-ionic surfactant), and BAC (a preservative)—and
`that the liquid preparation is formulated for ophthalmic administration.
`Pet. 21–22 (claim chart for claim 1); Ex 1009, 8:1–15 (for aqueous liquid
`preparation), 8:1–10 (for diclofenac and tyloxapol); Ex. 1003 ¶ 54.
`We are persuaded, based on the information presented, that Owaga
`discloses every element of claim 1, but for the use of tyloxapol as the non-
`ionic surfactant—Owaga discloses polysorbate 80 for that function.
`Sallmann, by contrast, discloses every element of claim 1, but for the use of
`bromfenac as the NSAID—Sallmann discloses diclofenac for that function.
`
`
`with particularity for each ground; here, that is a first ground based on
`Owaga and Sallmann, and a second ground based on Owaga, Sallmann, and
`Fu. 37 C.F.R. § 42.104(b)(2); see 35 U.S. C. § 312 (a petition must identify
`“with particularity . . . the grounds on which the challenge to each claim is
`based”).
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`That sets up the central dispute, at this early stage of the proceeding,
`which is whether Petitioner shows sufficiently that a person of ordinary skill
`in the art would have been prompted to (1) modify the ophthalmic
`preparation of Owaga’s Example 6, by replacing polysorbate 80 with
`tyloxapol; or, alternatively, (2) modify the ophthalmic preparation of
`Sallmann’s Example 2, by replacing diclofenac with bromfenac. Either
`substitution results in a preparation that satisfies every limitation of claim 1.
`
`ii. Fu
`The second ground asserted in the Petition relies on Owaga and
`Sallmann in combination with Fu. Pet. 19, 43–46. Petitioner shows
`sufficiently that Fu discloses that ophthalmic preparations of NSAIDs and
`BAC, which contain octylphenols (the class to which tyloxapol belongs) as
`the non-ionic surfactants, are more stable than those containing
`polysorbate 80 as the non-ionic surfactant. Ex. 1011, Example 5; Ex. 1003
`¶¶ 33, 64. Fu discloses that the non-ionic surfactant will stabilize an
`ophthalmic preparation of an NSAID and BAC, when included in a weight-
`volume percent of 0.02. Ex. 1011, 18:5–28, Example 2, Example 5;
`Ex. 1003 ¶¶ 75, 93. That disclosure bears upon the dependent claims, which
`require that “the concentration of the tyloxapol is about 0.02 w/v %.” See,
`e.g., Ex. 1001, 12:33–34 (claim 6), 13:23 (claim 15).
`
`Analysis of Grounds of Unpatentability
`D.
`We next turn to the two asserted grounds of unpatentability, which are
`based on obviousness over Owaga and Sallmann alone (for claims 1–5, 7–14
`and 18–19) and in combination with Fu (for claims 6, 15–17, and 20–22).
`Pet. 19. Our inferences and conclusions are based on the information
`presented thus far, and are neither final nor dispositive of any issue. Based
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`on the information presented in the Petition and the Preliminary Response,
`we determine that Petitioner is reasonably likely to prevail in showing that
`(1) claims 1–5, 7–14 and 18–19 are unpatentable over Owaga and Sallmann
`under 35 U.S.C. § 103; and (2) claims 6, 15–17, and 20–22 are unpatentable
`over Owaga, Sallmann, and Fu under 35 U.S.C. § 103.
`
`i. Claims 1–5, 7–14 and 18–19 over Owaga and Sallman
`Petitioner shows sufficiently that Owaga’s Example 6 discloses each
`element of claim 1, except that Owaga discloses polysorbate 80 as the non-
`ionic surfactant, whereas claim 1 recites tyloxapol for that function. Pet. 21–
`22 (claim chart for claim 1, and citations to record therein). Petitioner also
`shows sufficiently that an ordinary artisan, equipped with the disclosures of
`Owaga and Sallmann, would have recognized that tyloxapol and
`polysorbate 80 serve a common function in the art; both are useful as non-
`ionic surfactants for stabilizing an ophthalmic preparation of an NSAID and
`BAC. See Ex. 1003 ¶¶ 55–58.
` In that regard, Sallmann discloses tyloxapol as a preferred non-ionic
`surfactant in an aqueous ophthalmic preparation of an NSAID and BAC.
`Ex. 1009, 4:62. Based on the record developed thus far, we are persuaded
`that, taken together, the disclosures of Owaga and Sallmann would have
`suggested to an ordinary artisan that either tyloxapol or polysorbate 80
`would work to stabilize an ophthalmic preparation of an NSAID and BAC,
`by preventing the formation of the insoluble complexes that destabilize the
`preparation. See Ex. 1003 ¶¶ 31, 55–58.
`A claim likely is obvious if it is no “more than the predictable use of
`prior art elements according to their established functions,” even without an
`express suggestion to combine. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398,
`
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`417 (2007). Where two known alternatives are interchangeable for a desired
`function, an express suggestion to substitute one for the other is not needed
`to render a substitution obvious. In re Fout, 675 F.2d 297, 301 (CCPA
`1982); In re Siebentritt, 372 F.2d 566, 568 (CCPA 1967). On this record,
`Petitioner shows sufficiently that a person of ordinary skill in the art would
`have expected that substituting tyloxapol, in place of polysorbate 80 in
`Owaga’s Example 6, predictably would result in a stable ophthalmic
`preparation of bromfenac and BAC.
`Patent Owner argues that test results presented in the ’290 patent
`show that polysorbate 80 and tyloxapol, although useful for the common
`function of stabilizing BAC in a NSAID-containing ophthalmic preparation,
`nonetheless “were not interchangeable and [] the skilled person would not
`have substituted one for the other.” Prelim. Resp. 28. In that regard, Patent
`Owner points out that, during patent prosecution, the Office was persuaded
`that information reflected in Table 1 of the ’290 patent establishes “that
`tyloxapol has an unexpected property in stabilizing an aqueous solution of
`bromfenac in comparison with polysorbate 80.” Id. (quoting Ex. 2005, 3–4)
`(emphasis omitted).
`We are not persuaded, however, at this preliminary stage of the
`proceeding, that Table 1 is probative of secondary considerations of
`nonobviousness, that is, unexpected results. Ex. 1001, 7:40–55. On this
`record, the information in Table 1 is insufficient to establish unexpected
`results, because no comparison is made between the subject matter of the
`claimed invention and the closest prior art, that is, Owaga or Sallmann. See
`Pet. 51; Ex. 1003 ¶¶ 95–99. A comparison of the information in Table 1
`with that in Table 2, moreover, suggests that another factor—a change in pH
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`from 7.0 in Table 1 to over 8.0 in Table 2—may influence stability.
`Ex. 1001, 7:40–55 (Table 1, reporting a stability for tyloxapol-containing
`preparation of 73.8% at pH of 7), 8:16–32 (Table 2, reporting a stability for
`tyloxapol-containing preparation of over 90% at pH of slightly over 8).
`Other evidence of record—specifically, Table 11 of Owaga—suggests that
`the information in Table 1 of the ’431 patent, which persuaded the
`Examiner, is not reliable to establish unexpected results when tyloxapol is
`selected over polysorbate 80 in a preparation that contains the other elements
`of claim 1. See Ex. 1004, 10:49–52, Table 11 (reporting a stability of 100%
`for Owaga’s Example 6 preparation, formulated with polysorbate 80).
`In the alternative, we are persuaded that Petitioner is reasonably likely
`to prevail in showing that an ordinary artisan would have been led to
`substitute bromfenac for the diclofenac in the ophthalmic preparation of
`Sallmann’s Example 2. Pet. 26–27 (citing Ex. 1003 ¶ 53); Ex. 1009, 8:1–15
`(Sallmann’s Example 2, disclosing an ophthalmic preparation that meets
`every limitation of claim 1, except that Sallmann uses diclofenac and not
`bromfenac as the NSAID). Sallmann in Example 2 discloses that diclofenac
`is suitable for use as the NSAID in an ophthalmic preparation of an NSAID
`and BAC. Ex. 1009, 8:1–15. Owaga in Example 6 discloses that bromfenac
`is suitable for use as the NSAID in an ophthalmic preparation of an NSAID
`and BAC. Ex. 1004, 10:5–9. At the time of the invention, bromfenac and
`diclofenac were known to share several structural features. Pet. 27;
`Ex. 1003 ¶¶ 24, 27.
`Petitioner shows sufficiently that an ordinary artisan, equipped with
`the disclosures of Sallmann and Owaga, would have expected that
`diclofenac and bromfenac would work interchangeably in an ophthalmic
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`preparation of an NSAID and BAC. At this stage of the proceeding, we are
`persuaded that those disclosures would have led one to modify the
`preparation of Sallmann’s Example 2, by using bromfenac as an
`interchangeable alternative to diclofenac, because both were known to serve
`the same function in an ophthalmic preparation. See KSR Int’l Co., 550 U.S.
`at 417 (a claim likely is obvious if it is no “more than the predictable use of
`prior art elements according to their established functions”).
`On this record, Petitioner establishes also a reasonable likelihood of
`showing that the subject matter of claims 2–5, 7–14 and 18–19 would have
`been obvious over Owaga and Sallmann. Pet. 31–43, 47–50. Claim 18 is
`the only independent claim, other than claim 1. Ex. 1001, 13:16–14:9
`(claim 18). Petitioner comes forward with evidence adequate to establish
`that the subject matter of claim 18 would have been obvious over Owaga
`and Sallmann, for the same reasons discussed above in connection with
`claim 1. Pet. 31–35. Petitioner also shows sufficiently that the dependent
`claims “merely recite concentrations or ranges of specific ingredients” that
`“the ’431 patent characterizes as ‘conventional.’” Pet. 35 (citing Ex. 1001,
`6:11–31). Petitioner advances evidence adequate to establish that the
`additional features recited in the dependent claims add nothing of patentable
`consequence. Pet. 36–43, 47–50.
`Accordingly, based on the information presented at this preliminary
`stage of the proceeding, Petitioner is reasonably likely to prevail in showing
`that claims 1–5, 7–14 and 18–19 are unpatentable over Owaga and
`Sallmann. Our findings and conclusions are not final and may change upon
`consideration of the whole record developed during trial.
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`ii. Claims 6, 15–17, and 20–22 over Owaga, Sallmann, and Fu
`Petitioner is reasonably likely to prevail in showing that claims 6, 15–
`17, and 20–22 are unpatentable over Owaga, Sallmann, and Fu under 35
`U.S.C. § 103. Those claims require a concentration of tyloxapol that “is
`about 0.02 w/v %.” See, e.g., Ex. 1001, 12:55 (claim 6); 13:2–3 (claim 15).
`Based on the record developed at this preliminary stage of the proceeding,
`we are persuaded the Petitioner comes forward with evidence sufficient to
`establish that a person of ordinary skill in the art would have been prompted
`by Fu to include tyloxapol, in a concentration of “about 0.02 w/v %,” id., in
`the modified composition of Owaga or Sallmann. Pet. 44–46.
`Specifically, Petitioner shows sufficiently that Fu would have
`suggested to an ordinary artisan “that ophthalmic formulations of NSAIDs
`and BAC containing ethyoxylated octylphenols (the class that includes
`tyloxapol) as the non-ionic surfactant are more stable than those containing
`polysorbate 80 as the non-ionic surfactant.” Pet. 46 (citing Ex. 1011,
`Example 5; Ex. 1003 ¶¶ 34–35, 75–76); Ex. 1011, 4. Furthermore, Fu
`suggests using that class of non-ionic surfactants in a concentration of 0.02
`w/v % in the modified ophthalmic formulation” suggested by Owaga and
`Sallmann. Id. (citing Ex. 1011, 18:5–28, Example 2, Example 5; Ex. 1003
`¶¶ 75–76).
`Moreover, it appears to us, at this stage of the proceeding, that it
`would have been within the grasp of an ordinary artisan to manipulate the
`concentration of tyloxapol in the modified preparation of Owaga or
`Sallmann “to discover the optimum or workable ranges by routine
`experimentation.” In re Aller, 220 F.2d 454, 456–57 (CCPA 1955) (“where
`the general conditions of a claim are disclosed in the prior art, it is not
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`inventive to discover the optimum or workable ranges by routine
`experimentation”).
`Here again, our findings and conclusions are not final and may change
`upon consideration of the whole record developed during trial. Based on the
`information presented at this early stage of the proceeding, however, we are
`persuaded that Petitioner is reasonably likely to prevail in showing that
`claims 6, 15–17, and 20–22 are unpatentable over Owaga, Sallmann, and Fu.
`E. Patent Owner’s Other Arguments
`We have considered each counterargument presented in Patent
`Owner’s Preliminary Response. At this early stage of the proceeding,
`however, none persuades us to deny the Petition. We discuss some of those
`arguments below, observing that our factual findings and conclusions of law
`are not final at this preliminary stage of the proceeding.
`i. Multiple Proceedings under 35 U.S.C. § 325(d)
`We have considered Patent Owner’s suggestion that we should
`
`exercise our discretion to deny the Petition because it raises substantially the
`same arguments or prior art that were raised during patent prosecution.
`Prelim. Resp. 25–37. Patent Owner’s arguments and evidence do not
`persuade us that the Office previously considered or resolved the arguments
`as to Owaga and Sallmann that are raised in the Petition. Id.; Ex. 2005
`(evidence of patent prosecution file history). Accordingly, we decline to
`exercise our discretion to deny the Petition under 35. U.S.C. § 325(d).
`
`ii. Presentation of Alternative Arguments
`Patent Owner also contends that the Petition is defective because, for
`
`example, as to the ground based on Owaga and Sallmann, the Petition
`“switches Owaga’s order of application, making it a s
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