Trials@uspto.gov
`571-272-7822
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` Paper No. 50
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` Entered: August 27, 2019
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`AMNEAL PHARMACEUTICALS LLC AND
`AMNEAL PHARMACEUTICALS OF NEW YORK, LLC,
`Petitioner,
`
`v.
`
`ALLERGAN, INC.,
`Patent Owner.
`____________
`
`Case IPR2018-00608
`Patent 9,161,926 B2
`____________
`
`Before GRACE KARAFFA OBERMANN, SHERIDAN K. SNEDDEN,
`and CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`
`SNEDDEN, Administrative Patent Judge.
`
`
`
`FINAL WRITTEN DECISION
`Claims 1–6 Not Shown to Be Unpatentable
`35 U.S.C. § 318(a); 37 C.F.R. § 42.73
`
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`
`
`571-272-7822
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`
`
`
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`
`
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`
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` Paper No. 50
`
`
` Entered: August 27, 2019
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`AMNEAL PHARMACEUTICALS LLC AND
`AMNEAL PHARMACEUTICALS OF NEW YORK, LLC,
`Petitioner,
`
`v.
`
`ALLERGAN, INC.,
`Patent Owner.
`____________
`
`Case IPR2018-00608
`Patent 9,161,926 B2
`____________
`
`Before GRACE KARAFFA OBERMANN, SHERIDAN K. SNEDDEN,
`and CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`
`SNEDDEN, Administrative Patent Judge.
`
`
`
`FINAL WRITTEN DECISION
`Claims 1–6 Not Shown to Be Unpatentable
`35 U.S.C. § 318(a); 37 C.F.R. § 42.73
`
`
`
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`
`
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`
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`
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`IPR2018-00608
`Patent 9,161,926 B2
`
`
`ORDERS
`Dismissing Petitioner’s Motion to Exclude (Paper 34)
`37 C.F.R. § 42.64(c)
`
`Dismissing Patent Owner’s Motion to Exclude (Paper 36)
`37 C.F.R. § 42.64(c)
`
`INTRODUCTION
`
`I.
`
`This Final Written Decision is issued pursuant to 35 U.S.C. § 318(a)
`and 37 C.F.R. § 42.73. For the reasons that follow, we determine that
`Petitioner has failed to establish by a preponderance of the evidence that
`claims 1–6 of U.S. Patent No. 9,161,926 B2 (Ex. 1001, “the ’926 patent”)
`are unpatentable.
`
`A. Procedural History
`Amneal Pharmaceuticals LLC and Amneal Pharmaceuticals of New
`York, LLC (collectively, “Petitioner”), filed a Petition requesting an inter
`partes review of claims 1–6 of the ’926 patent. Paper 2 (“Pet.”). Biogen,
`Inc. (“Patent Owner”) filed a Preliminary Response. Paper 8 (“Prelim.
`Resp.”). Based on the information set forth in the Petition, we instituted trial
`on the following grounds of unpatentability asserted by Petitioner:
`
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`
`Ground Claims
`1
`1–6
`2
`1–6
`
`References
`Basis
`§ 103(a) Garrett1 and Nadau-Fourcade2
`§ 103(a) Garrett and Bonacucina3
`
`Decision to Institute (Paper 10, “DI”).
`After institution of trial, Patent Owner filed a Patent Owner Response
`(Paper 23, “PO Resp.”), Petitioner filed a Reply (Paper 29; “Reply”), and
`Patent Owner filed a Sur-Reply (Paper 33; “Sur-Reply”).
`Petitioner relies on the Declarations of Bozena B. Michniak-Kohn,
`Ph.D. (Exs. 1002, 1050) and Dr. Elaine Gilmore, M.D., Ph.D. (Exs. 1018,
`1034) in support of the proposed grounds of unpatentability.
`Patent Owner relies on the Declarations of Alexander M. Klibanov,
`Ph.D. (Ex. 2003) and Julie Harper, M.D. (Ex. 2022).
`Oral argument was conducted on June 5, 2019. A transcript is entered
`as Paper 48 (“Tr.”).
`
`B. The ’926 patent
`The ’926 patent describes compositions containing the drug dapsone,
`which are useful for treating a variety of dermatological conditions.
`
`
`1 Ex. 1004, International Patent Application Publication No. WO
`2009/061298 (“Garrett”).
`2 Ex. 1015, Bonacucina, G., et al., Characterization and Stability of
`Emulsion Gels Based on Acrylamide/Sodium Acryloyldimethyl Taurate
`Copolymer, 10 AAPS PHARMASCITECH 368–75 (2009) (“Bonacucina”).
`3 Ex. 1005, International Application Publication No. WO 2010/072958 A2,
`English Translation at pages 38–72 (“Nadau-Fourcade”).
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`Ex. 1001, Abst. The ’926 patent discloses that “[u]se of the polymeric
`viscosity builder provides compositions with increased concentrations of
`diethylene glycol monoethyl ether relative to compositions without the
`polymeric viscosity builder.” Id. at Abst.
`The ’926 patent describes the invention as follows:
`it has been found that use of a polymeric viscosity builder
`minimizes the intensity of yellowing of the composition caused
`by the increased solubility of dapsone in diethylene glycol
`monoethyl ether. In addition, the polymeric viscosity builder
`influences dapsone crystallization. This, in turn, results in
`compositions with improved aesthetics (i.e., reduction in particle
`size which minimizes “gritty” feeling upon application).
`Id. at 2:46–53.
`According to one embodiment, the compositions include about 5%
`w/w to about 10% w/w dapsone, a first solubilizing agent (i.e., diethylene
`glycol monoethyl ether), optionally at least one second solubilizing agent, a
`polymeric viscosity builder, and water. Id. at 2:54–59.
`Example 1 of the ’926 patent “show[s] the impact of
`acrylamide/sodium acryloyldimethyltaurate copolymer based thickener on
`dapsone particle size.” Id. at 12:23–26. The results disclosed in that
`example show that larger crystals were observed in the sample with
`carbomer homopolymer type C, as compared to an acrylamide/sodium
`acryloyldimethyltaurate copolymer based thickener. Id. at 12:23–35.
`
`C. Illustrative Claims
`Independent claims 1 and 5, reproduced below, are illustrative:
`1. A topical pharmaceutical composition comprising:
`about 7.5% w/w dapsone;
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`about 30% w/w to about 40% w/w diethylene glycol
`monoethyl ether;
`about 2% w/w to about 6% w/w of a polymeric viscosity
`builder consisting of acrylamide/sodium acryloyldimethyl
`taurate copolymer; and
`water;
`wherein the composition does not comprise adapalene.
`
`
`
`5. A topical pharmaceutical composition comprising:
`about 7.5% w/w dapsone;
`about 30% w/w diethylene glycol monoethyl ether;
`about 4% w/w of a polymeric viscosity builder consisting
`of acrylamide/sodium acryloyldimethyl taurate copolymer; and
`water;
`wherein the composition does not comprise adapalene.
`
`
`Ex. 1001, 15:21–16:14–21.
`
`II. DISCUSSION
`
`A. Person of Ordinary Skill in the Art
`Petitioner asserts that a person having ordinary skill in the art
`(“POSA”) “would have the knowledge of both a formulator of topical
`pharmaceutical compositions and [a] clinician with experience treating
`dermatological diseases.” Pet. 7. Petitioner asserts that a “formulator
`POSA”
`would possess a Ph.D. or equivalent degree in pharmaceutics,
`chemistry or a related discipline such as pharmacology, who also
`has practical experience (at least two years) of formulating
`topical drug delivery products, or the POSA could possess a
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`Bachelors or Masters degree in one of the preceding disciplines
`with a greater level (at least four years) of the same formulating
`experience. (AMN1002, ¶¶16-18).
`Pet. 7. Petitioner defines a “clinical POSA” as a person who would possess
`an M.D. with a board certification in dermatology with at least two years of
`experience in dermatology, or otherwise treating skin conditions.” Id.
`Patent Owner contends that “the claims of the ’926 patent are not
`directed to methods of treatment, but rather to compositions useful for
`treating dermatological conditions,” and thus “Petitioner’s requirement that a
`person of ordinary skill in the art have both the formulator and rigorous
`clinical qualifications is incorrect.” PO Resp. 29. Rather, Patent Owner
`contends that a POSA
`would have either (i) a bachelor- or master-level degree in
`chemistry, polymer science, pharmaceutics, or a related
`discipline, plus at least three years of experience in drug delivery,
`pharmaceutical formulations, or a related field; or (ii) a doctoral
`degree in chemistry, polymer science, pharmaceutics, or a related
`discipline, plus
`some
`experience
`in drug delivery,
`pharmaceutical formulations, or a related field. Ex. 2003 ¶ 41.
`In addition, a person of ordinary skill in the art to which the ’926
`patent pertains would have consulted with a person having
`clinical experience treating acne and other dermatological
`conditions. Id. ¶ 42; Ex. 2022 ¶¶ 33–34.
`
`Id.
`
`Having considered the parties positions and evidence of record,
`summarized above, we agree with Patent Owner that the claims are limited
`to compositions useful for treating dermatological conditions and also agree
`that the definition of a POSA should likewise be limited to those persons
`having the relevant education and/or expertise in formulating such
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`compositions. Accordingly, we adopt Patent Owner’s definition of a POSA
`for the purposes of this decision. That said, we discern no appreciable
`difference in the respective definitions of a POSA as that definition relates to
`the dispositive issues of this case, discussed below.
`We further note that prior art may also demonstrate the level of skill
`in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d
`1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding
`ordinary skill level are not required “where the prior art itself reflects an
`appropriate level and a need for testimony is not shown”) (quoting Litton
`Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir.
`1985)).
`
`B. Claim Construction
`For petitions filed before November 13, 2018, such as the case here,4
`we interpret the claims of an unexpired patent that will not expire before
`issuance of a final written decision using the broadest reasonable
`interpretation in light of the specification. See 37 C.F.R. § 42.100(b) (2018);
`Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2144–46 (2016). Under
`the broadest reasonable construction standard, claim terms are presumed to
`have their ordinary and customary meaning, as would be understood by one
`
`
`4 The Petition was filed on February 12, 2018. The Final Rule changing the
`claim construction standard does not apply here, as the Petition was filed
`before the effective date of the Final Rule, November 13, 2018. See
`Changes to the Claim Construction Standard for Interpreting Claims in Trial
`Proceedings Before the Patent Trial and Appeal Board, 83 Fed. Reg. 51,340,
`51,340, 51,344 (Oct. 11, 2018).
`
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`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). Any special
`definitions for claim terms must be set forth with reasonable clarity,
`deliberateness, and precision. In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir.
`1994).
`Only terms that are in controversy need to be construed, and then only
`to the extent necessary to resolve the controversy. Vivid Techs., Inc. v. Am.
`Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999); Nidec Motor Corp. v.
`Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017)
`(applying Vivid Techs. in the context of an inter partes review).
`
`1. “consisting of acrylamide/sodium acryloyldimethyl taurate
`copolymer”
`Independent claim 1 is directed to a topical pharmaceutical
`composition comprising, inter alia, “about 2% w/w to about 6% w/w of a
`polymeric viscosity builder consisting of acrylamide/sodium
`acryloyldimethyl taurate copolymer.” Ex. 1001, 16:1–3 (emphasis added).
`Although not presented as a claim construction issue, Patent Owner contends
`that this element is properly interpreted to mean that the claims of the ’926
`patent require a polymeric viscosity builder (“PVB”) that contains only
`acrylamide/sodium acryloyldimethyl taurate copolymer (“A/SA
`copolymer”). PO Resp. 53–54 (citing Multilayer Stretch Cling Film
`Holdings, Inc. v. Berry Plastics Corp., 831 F.3d 1350, 1359 (Fed. Cir. 2016)
`(explaining that “a claim term set off with ‘consisting of’ is closed to
`unrecited elements”)). Petitioner does not dispute that the “consisting of”
`language limits “polymeric viscosity builders” to only A/SA copolymers.
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`Reply 10. Petitioner, however, contends that because the recitation of the
`“comprising” transitional phrase in the claims’ preamble allows for
`additional unrecited ingredients, “the ‘consisting of’ language only limits the
`universe of ‘polymeric viscosity builders’ to A/SA copolymers, but does not,
`as a matter of law, foreclose any unrecited features that are not PVBs.” Id.
`(emphasis added). As such, the real dispute between the parties is whether
`certain additional ingredients included in prior art compositions may
`properly fall within the broader open-ended “comprising” language of the
`claims, or whether those additional ingredients should be considered part of
`the PVBs in the prior art composition and thus excluded from the claim
`scope based on the closed “consisting of” language. See id. (arguing that
`isohexadecane (a solvent) and polysorbate 80 (a surfactant), found in the
`commercial product Sepineo that contains A/SA copolymers, are not PVBs).
`We address that dispute hereinbelow as part of our analysis of Petitioner’s
`grounds.
`Nonetheless, to the extent the phrase needs to be construed, we do not
`perceive any reason or evidence that compels deviation from Patent Owner’s
`interpretation of the phrase “consisting of acrylamide/sodium
`acryloyldimethyl taurate copolymer,” which is consistent with the
`“exceptionally strong presumption that a claim term set off with ‘consisting
`of’ is closed to unrecited elements.” Multilayer Stretch Cling Film
`Holdings, Inc., 831 F.3d at 1359. We conclude that the plain language of the
`claim indicates that the composition must contain A/SA as the only PVB
`present in the formulation, and A/SA must be present in an amount the falls
`within the claimed range of between about 2% and 6% w/w. Accordingly,
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`we adopt Patent Owner’s interpretation of that phrase to require a PVB that
`contains only A/SA copolymers within the recited weight percentages.
`
`2. Other Claim Terms
`We determine that no explicit construction of any other claim term is
`necessary to resolve the dispute between the parties. See Nidec, 868 F.3d at
`1017 (“[W]e need only construe terms ‘that are in controversy, and only to
`the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc.
`v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).
`
`C. Petitioner’s Ground 1: Obviousness over the Combination of
`Garrett and Nadau-Fourcade
`1. Garrett
`Garrett discloses a topical pharmaceutical composition containing
`dapsone useful for treating glucose-6-phosphate dehydrogenase-deficient
`patients. Ex. 1004, 3:9–10, 11:14–16. In particular, Garrett discloses “a
`pharmaceutical carrier system comprising a dermatological composition that
`is a semi-solid aqueous gel, wherein dapsone is dissolved in the gel such that
`the dapsone has the capacity to cross the stratum corneum layer of the
`epidermis, and wherein the composition also contains dapsone in a
`microparticulate state that does not readily cross the stratum corneum of the
`epidermis.” Id. at Abst. That is, “the composition may include dissolved
`dapsone and microparticulate dapsone.” Id. at 3.
`With regard to the concentrations of dapsone, diethylene glycol
`monoethyl ether, and water in the disclosed compositions, Garrett discloses
`the following:
`
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`In one preferred embodiment, the composition includes about
`0.5% to 4.0% carbomer; about 53.8% to 84.2% water; about
`10% to 30% ethoxydiglycol; about 0.2% methylparaben; about
`5% to 10% dapsone in a microparticulate and dissolved state;
`and about 0.1% to 2% sodium hydroxide solution.
`Id. at 4:2–5 (emphasis added); see also Ex. 1018 ¶ 23 (indicating that the
`chemical names “ethoxydiglycol” and “diethylene glycol monoethyl ether”
`refer to the same compound).
`Garrett further discloses the use of polymer thickeners in its
`compositions. In particular, Garrett discloses:
` Polymer
`Thickening agents include polymer thickeners.
`thickeners that may be used include those known to one skilled
`in the art, such as hydrophilic and hydroalcoholic gelling agents
`frequently used in the cosmetic and pharmaceutical industries
`. . . . Preferably, the gelling agent comprises between about
`0.2% to about 4% by weight of the composition.
`Id. at 13:3–11 (emphasis added).
`Garrett discloses the role of the solvent system for the dapsone
`microparticulate compositions in the following manner:
`The solvent or mixed solvent system is important to the
`formation of the microparticulate to dissolved dapsone ratio. The
`formation of the microparticulate, however, should not interfere
`with the ability of the polymer thickener or preservative systems
`to perform their functions.
`Id. at 14:15–19. Garrett also discloses that “[t]he relative percentages for
`each of the reagents used in the present invention may vary depending upon
`. . . the desired ratio of microparticulate to dissolved dapsone.” Id. at 18:17–
`20.
`
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`Garrett does not disclose specifically the use of acrylamide/sodium
`acryloyldimethyl as a polymeric thickener or gelling agent.
`
`2. Nadau-Fourcade
`Nadau-Fourcade discloses “a topical pharmaceutical composition
`containing, as an active pharmaceutical ingredient, a water-sensitive
`compound in a dissolved form in a physiologically acceptable medium, . . .
`the method of preparing it, and . . . its use in dermatology.” Ex. 1005, 38:4–
`6. Nadau-Fourcade discloses the use of hydrophilic-phase gelling agents in
`its compositions and expressly identifies polyacrylamides as preferred
`gelling agents. Id. at 47:11–12, 48:5–6 (“Preferred gelling agents include
`. . . polyacrylamides, for instance Sepineo P 600® or Simulgel 600
`PHA®.”). Nadau-Fourcade further discloses that “[t]he gelling agent . . .
`may be used at preferential concentrations ranging from 0.001% to 15% and
`more preferentially ranging from 0.01% to 5%.” Id. at 48:8–9.
`
`3. Petitioner’s Contentions
`Petitioner asserts that claims 1–6 are unpatentable under § 103 as
`obvious in view of the combination of Garrett and Nadau-Fourcade.
`Pet. 21–40. In support of its assertion that the combination of Garrett and
`Nadau-Fourcade renders claims 1–6 obvious, Petitioner sets forth the
`foregoing teachings of Garrett and Nadau-Fourcade and provides a detailed
`claim chart explaining how each claim limitation is disclosed in the
`combination of references. Id. Specifically, Petitioner contends that Garrett
`discloses a “topical pharmaceutical composition” of “about 7.5% w/w
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`dapsone,” “water,” and “about 30% w/w to about 40% w/w ethoxydiglycol.”
`Id. at 24–30 (citing Ex. 1004, 3:33–4:15; Ex. 1002 ¶¶ 50–54).
`With regard to the specific thickening agent required by the claims,
`Petitioner contends that “[i]t would have been obvious to a [person of
`ordinary skill in the art] to substitute the claimed acrylamide copolymer for
`the thickening agent disclosed in Garrett because such thickening agents
`were known in the art to be predictable and interchangeable.” Pet. 31 (citing
`Ex. 1002 ¶¶ 56–57). In this regard, Petitioner contends that both Garrett and
`Nadau-Fourcade “relate to topical pharmaceutical compositions of drugs that
`are insoluble in water and are within the pertinent art to the claims of the
`’926 patent.” Id. Petitioner also notes that Garrett discloses dapsone
`compositions containing polymeric thickeners, and specifically teaches that
`“polymeric thickeners that may be used include those known to one skilled
`in the art, such as hydrophilic and hydroalcohol gelling agents frequently
`used in the cosmetic and pharmaceutical industries.” Id. at 31 (quoting
`Ex. 1004, 13:2–25). By comparison, Petitioner notes that Nadau-Fourcade
`discloses polyacrylamides (i.e., Sepineo® P 600 or Simulgel® 600 PHA)5 as
`“preferred” gelling agents for use in the hydrophilic-phase of topical
`pharmaceutical compositions of water-insoluble drugs. Pet. 31–32 (citing
`Ex. 1002 ¶ 56; Ex. 1005, 47:12–32, 48:1–7).
`
`
`5 Petitioner contends that “Nadau-Fourcade shows that Sepineo® P 600 or
`Simulgel® 600 PHA are commercial grade acrylamide/sodium
`acryloyldimethyl taurate copolymers.” Pet. 32, n.5 (citing Ex. 1005, 48:5–
`7).
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`Based on the disclosures of the cited prior art, summarized above,
`Petitioner contends that it would have been obvious to substitute the
`thickening agents disclosed in Garrett for the polyacrylamide thickening
`agents of Nadau-Fourcade because, “[w]here 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.” Id. at 32
`(quoting Conopco, Inc. v. Procter & Gamble Co., Case IPR2013-00505, slip
`op. at 21–23 (PTAB Feb. 10, 2015) (Paper 69)); see also KSR International
`Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007) (holding that a claim 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).
`With regard to the amount of thickening agent in the composition,
`Petitioner further contends as follows:
`modification of the amount of copolymer was known in the art.
`Dr. Michniak-Kohn explains that modifying the amount of a
`thickening agent is well-known and routine in the development
`of topical compositions, and would have had a known impact on
`the viscosity of the composition. (AMN1002, ¶58). Consistent
`with this understanding, Garrett teaches that “the relative
`percentages for [the thickening agent] may vary depending on …
`gel viscosity,” which a [person of ordinary skill in the art] would
`have understood to mean that modifications to the amount of
`thickening agent are routine, well-understood, and predictable.
`(AMN1004, 18:17-22). Thus, a [person of ordinary skill in the
`art] in 2012 would have had a reason to use between about 2%
`w/w to about 6% w/w of the claimed acrylamide copolymer in
`Garrett’s composition, with a reasonable expectation of success,
`thus rendering the claimed invention obvious.
`Pet. 33–34.
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`With regard to the negative limitation expressly excluding adapalene
`from the recited composition, Petitioner contends that “none of Garrett’s
`compositions include adapalene.” Id. at 30 (citing Ex. 1002 ¶ 54, Ex. 1004,
`Abst., 3:33–4:15, 14:20–15:18; Sud-Chemie, Inc. v. Multisorb Techs., Inc.,
`554 F.3d 1001, 1004–05 (Fed. Cir. 2009) (finding prior art reference that did
`not require adhesive coatings on films to teach “uncoated” films, even
`though the reference “fail[ed] to specifically refer to the films as
`uncoated”)).
`
`D. Petitioner’s Ground 2: Obviousness over the Combination of
`Garrett and Bonacucina
`1. Bonacucina
`Bonacucina discloses that “Sepineo P 600 is a prime candidate for use
`in the formulation of gels and emulsion gels with rheological properties
`suitable for topical administration.” Ex. 1015, 7. In particular, Bonacucina
`discloses that
`Sepineo P 600, a concentrated dispersion of acrylamide/sodium
`acryloyldimethyl taurate copolymer in isohexadecane, has self-
`gelling and thickening properties and the ability to emulsify oily
`phases, which make it easy to use in the formulation of gels and
`o/w emulsion gels. In this paper, gels were prepared using a
`Sepineo P 600 concentration between the 0.5% and 5% (w/w)
`. . . . [T]he elastic properties of the gel-like structure even at
`elevated polymer concentrations were not strongly long-lasting,
`as demonstrated by the increase of the viscous contribution in the
`low frequency range during acoustic spectroscopy analysis. This
`fact could indicate that the gel structure is characterized by weak
`polymer–polymer interactions, an advantageous characteristic
`for topical administration, as the sample is thus easier to rub into
`the skin. . . . Thus, Sepineo P 600 gel and emulsion gel are very
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`effective systems for use in topical and other types of
`applications.
`Id. at Abst.
`Bonacucina further discloses that
`Sepineo® P 600 thickens and gels well, a property that depends
`strongly on polymer concentration. Concentration increases
`from 0.5% (w/w) to 5% (w/w) modified the viscoelastic
`properties of the Sepineo® samples, changing the typical
`behavior of a concentrated non-entangled solution to that of a
`‘gel-like’ sample.”
`Id. at 7.
`
`2. Petitioner’s Contentions
`For substantially similar reasons, Petitioner contends that claims 1–6
`are unpatentable under § 103 as obvious in view of the combination of
`Garrett and Bonacucina. Pet. 52–54. For this ground, Petitioner substitutes
`Nadau-Fourcade for Bonacucina for, inter alia, its disclosure of the recited
`acrylamide copolymer in topical compositions. Pet. 47 (citing Ex. 1015, 1;
`Ex. 1002 ¶ 84). In particular, Petitioner contends that Bonacucina discloses
`the product Sepineo P 600 as “a concentrated dispersion of
`acrylamide/sodium acryloyldimethyl taurate copolymer in isohexadecane”
`that “has self-gelling and thickening properties . . . which make[s] it easy to
`use in the formulation of gels and [oil-in-water] emulsion gels.” Id. at 48
`(citing Ex. 1015, Abst.). Petitioner contends that Bonacucina also discloses
`that the acrylamide copolymer has weak polymer-polymer interactions
`resulting in compositions that are “easier to rub into the skin”—an
`“advantageous characteristic for topical administration.” Id. (citing
`Ex. 1015, Abst.).
`
`16
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`IPR2018-00608
`Patent 9,161,926 B2
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`
`Petitioner further contends that Bonacucina discloses
`acrylamide/sodium acryloyldimethyl taurate copolymer concentrations up to
`5% w/w were useful for topical applications, which encompasses the
`claimed range of “about 4% w/w.” Id. at 50 (citing Ex. 1015, 7
`(“Concentration increases from 0.5% (w/w) to 5% (w/w) modified the
`viscoelastic properties of the Sepineo® samples, changing the typical
`behavior of a concentrated non-entangled solution to that of a ‘gel-like’
`sample.”); see also Ex. 1002 ¶¶ 83, 88, and 89.
`In combining the references, Petitioner contends as follows:
`Because [the recited] components are used in the claims for the
`same purpose as they had been successfully used in the prior art
`. . ., a [person of ordinary skill in the art] would have reasonably
`expected those components to be acceptable and suitable for the
`claimed composition.”).
`Id. at 52.
`
`E. Petitioner Has Not Shown That the Prior Art Teaches a
`Composition Comprising about 2% w/w to about 6% w/w of a PVB
`Consisting of A/SA copolymer
`Initially, we note that Petitioner does not point to—and we do not
`find—any express disclosure in an asserted prior art reference disclosing a
`composition comprising about 2% w/w to about 6% w/w of a PVB
`consisting of A/SA copolymer as required by the claims. In each of
`Petitioner’s Grounds, Petitioner contends that commercial PVB
`compositions disclosed in Nadau-Fourcade and Bonacucina meet this
`element of the claims. For example, in Ground 1, Petitioner relies on
`Nadau-Fourcade for its disclosure of the commercial PVB compositions
`Sepineo P 600 or Simulgel 600 PHA and contends that “[i]t would have
`17
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`IPR2018-00608
`Patent 9,161,926 B2
`
`been obvious to a POSA to substitute the claimed acrylamide copolymer for
`the thickening agent disclosed in Garrett because such thickening agents
`were known in the art to be predictable and interchangeable.” Pet. 31 (citing
`Ex. 1002 ¶¶ 56–57). In Ground 2, Petitioner relies on Bonacucina for its
`disclosure of the commercial PVB composition Sepineo P 600 and similarly
`contends that “it would have been obvious to a POSA to combine the
`claimed acrylamide copolymer as taught in Bonacucina with Garrett’s
`topical dapsone composition.” Pet 46 (citing Ex. 1002 ¶¶ 80–85). However,
`even assuming that a person of ordinary skill in the art would have been
`motivated to substitute the thickening agents disclosed by Garret with the
`Sepineo products disclosed by Nadau-Fourcade and Bonacucina, the
`evidence of record fails to support the conclusion that any of the disclosed
`Sepineo compositions contains about 2% w/w to about 6% w/w of a PVB
`consisting of A/SA copolymer. Nor does Petitioner explain how or why an
`ordinarily skilled artisan, having made the proposed substitution, would have
`further manipulated the composition to attain, through routine optimization,
`a composition containing PVB consisting of A/SA copolymer in the required
`w/w concentration. See Pet. 33–34.
`Rather, as noted by Patent Owner, although the Sepineo compositions
`appear to contain A/SA copolymer and at least isohexadecane and
`polysorbate 80, Petitioner provides insufficient evidence of the relative
`concentrations of the various components of the Sepineo products. PO
`Resp. 53–54, 58–59 (citing Ex. 1005, 48:5–7; Ex. 1015, 2; Ex. 1026, 2; Ex.
`2053, 196:19–197:2). That is, Petitioner has not identified the percentages
`(w/w) of A/SA copolymer in any of the disclosed Sepineo compositions.
`18
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`IPR2018-00608
`Patent 9,161,926 B2
`
`Thus, we are unable to find, based on the evidence of record, that the
`Sepineo products disclosed by the asserted prior art are, in fact,
`compositions having about 2% w/w to about 6% w/w of a PVB consisting of
`A/SA copolymer as required by the challenged claims. Accordingly, we
`determine that the combination of references fails to disclose all elements of
`the challenged claims, namely, a composition comprising about 2% w/w to
`about 6% w/w of a PVB consisting of A/SA copolymer as required by the
`claims.
`Petitioner also argues that a person of ordinary skill in the art would
`have understood that Sepineo P 600 falls within the scope of the challenged
`claims because the FDA’s Orange Book lists the ʼ926 patent with reference
`to the ACZONE® gel, 7.5% commercial product, and that product allegedly
`contains a Sepineo product. Reply 7, 12. During oral argument, Patent
`Owner argued that the composition of the commercially available Sepineo
`products are not disclosed anywhere in the record developed during trial
`and, therefore, it is not known on this record whether Sepineo contains the
`required about 2% w/w to about 6% w/w of a PVB consisting of A/SA
`copolymer. Tr. 54. Patent Owner conceded that its ACZONE® gel product
`contains Sepineo and, because of that very reason, Patent Owner has
`requested that the FDA remove the ’926 patent from the FDA Orange Book
`as a patent that covers their ACZONE® gel product.6 Tr. 45, 17–23;
`Ex. 3001.
`
`
`6 Petitioner, in its Reply, also recognizes that Patent Owner has requested
`that the FDA delist the ’926 patent from the Orange Book. Reply, 12 n.5.
`19
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`IPR2018-00608
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`
`Petitioner also argues that “the patent specification expressly
`contemplates Sepineo®’s use with the claimed compositions by prominently
`stating that the viscosity builder ‘further includes isohexadecane, . . . and
`polysorbate 80’” and that, during prosecution, “co-inventor Dr. Warner
`submitted a declaration . . . showing alleged ‘unexpected results’ for what he
`called ‘dapsone/Sepineo compositions,’ which standing alone negates any
`presumption that ‘consisting of’ excludes Sepineo®.” Reply 11 (citing
`Ex. 1001, 5:35-38; Ex. 1050 ¶ 62; Ex. 1017, 349–355, 504–506; Ex. 1031,
`29–30). We are not persuaded that either of those arguments is sufficient to
`overcome the “strong presumption” that the use the phrase “consisting of” is
`closed and therefore “exclude[s] any elements, steps, or ingredients not
`specified in the claim.” Shire Dev., LLC v. Watson Pharm., Inc., 848 F.3d
`981, 984 (Fed. Cir. 2017). “Overcoming that presumption requires the
`specification and prosecution history to unmistakably manifest an alternative
`meaning, such as when the patentee acts as its own lexicographer.” Id. at
`1359 (internal citation omitted). As discussed in Section II.A.1. above, we
`interpret the phrase “consisting of acrylamide/sodium acryloyldimethyl
`taurate copolymer” to require a PVB that contains only A/SA copolymers
`within the recited weight percentages.
`We do not find that either the patent specification or the prosecution
`history clearly equates any Sepineo composition with the claimed PVB.
`While the patent does state that isohexadecane and polysorbate 80 may be
`included, among other ingredients, as part of the PVB in some embodiments,
`it does not mention Sepineo at all, let alone suggest that Sepineo
`compositions necessarily satisfy the claim requirements. See Ex. 1001,
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`IPR2018-00608
`Patent 9,161,926 B2
`
`5:35–38. Moreover, we recognize that, during prosecution, the inventor
`submitted a declaration referencing Sepineo and applicant made arguments
`relying up
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