Trials@uspto.gov
`571.272.7822
`
`
`
`
`
`
`
` Paper No. 13
`
` Filed: May 10, 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
`Petitioners,
`
`v.
`
`ALMIRALL, LLC,
`Patent Owner.
`____________
`
`Case IPR2019-00207
`Patent 9,517,219 B2
`____________
`
`
`Before SUSAN L. C. MITCHELL, CHRISTOPHER G. PAULRAJ, and
`RYAN H. FLAX, Administrative Patent Judges.
`
`FLAX, Administrative Patent Judge.
`
`
`
`DECISION
`Institution of Inter Partes Review
`35 U.S.C. § 314
`
`
`
`
`
`

`

`IPR2019-00207
`Patent 9,517,219 B2
`
`
`
`Almirall, LLC (“Patent Owner”) is the owner of U.S. Patent No.
`9,517,219 B2 (Ex. 1001, “the ’219 patent”). Amneal Pharmaceuticals LLC,
`and Amneal Pharmaceuticals of New York, LLC (collectively, “Petitioners”)
`filed a Petition requesting inter partes review of claims 1–8 of the
`’219 patent. Paper 3 (“Pet.”). Patent Owner, in turn, filed a Preliminary
`Response. Paper 8 (“Prelim. Resp.”). Further, pursuant to our authorization,
`Petitioners and Patent Owner filed a Reply and a Sur-reply, respectively.
`Papers 10, 11.
`Under 37 C.F.R. § 42.4(a), we have authority to determine whether to
`institute an inter partes review. We may institute an inter partes review if
`the information presented in the petition filed under Section 311, and any
`response filed under Section 313, shows that there is a reasonable likelihood
`that the Petitioners would prevail with respect to at least one of the claims
`challenged in the petition. 35 U.S.C. § 314. After reviewing the parties’
`submissions, we conclude that Petitioners have demonstrated a reasonable
`likelihood that they would prevail in showing at least one claim of the
`’219 patent is unpatentable. Therefore, we institute inter partes review of all
`aforementioned claims on all grounds raised in the petition, pursuant to
`35 U.S.C. § 314; see also Guidance on the Impact of SAS on AIA Trial
`Proceedings (April 26, 2018) (available at https://www.uspto.gov/patents-
`application-process/patent-trial-and-appealboard/trials/guidance-impact-sas-
`aia-trial).
`
`2
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`IPR2019-00207
`Patent 9,517,219 B2
`
`
`I.
`
`BACKGROUND
`RELATED MATTERS
`A.
`Petitioners have disclosed:
`The following matters would affect, or be affected by, a
`decision in this proceeding: (1) IPR2018-00608, challenging
`claims of the related [U.S. Patent 9,161,926], which are directed
`to the same topical dapsone compositions as the ’219 patent; and
`(2) Almirall, LLC v. Taro Pharmaceutical Industries Ltd., C.A[.]
`1-17-cv-00663 (consolidated) (D.Del.), to which[, the district
`court case,] Petitioners are not a party.
`Pet. 64–65. Patent Owner identifies the same related matters. See Patent
`Owner’s Mandatory Notices (filed Jan. 10, 2019) (Paper 5).
`B.
`THE CLAIMED INVENTION
`The invention claimed in the ’219 patent relates to a method for
`treating at least one of acne vulgaris or rosacea by administering a
`compound including dapsone, diethylene glycol (also called ethoxydiglycol,
`diethylene glycol monoethyl ether, and DGME), acrylamide/sodium
`acryloyldimethyl taurate copolymer (also identified by the commercial
`product name Sepineo P 600), and water, but not including adapalene.
`Ex. 1001, 15:40–16:13. The ’219 patent’s abstract states:
`Dapsone and dapsone/adapalene compositions can be useful for
`treating a variety of dermatological conditions. The compo-
`sitions of this disclosure include dapsone and/or adapalene in a
`polymeric viscosity builder. Subject compositions can be
`adjusted to optimize the dermal delivery profile of dapsone to
`effectively treat dermatological conditions and improve the
`efficiency of pharmaceutical products applied to the skin. Use
`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 Abstract. The specification of the ’219 patent further states:
`
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`IPR2019-00207
`Patent 9,517,219 B2
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`
`
`Dapsone, (4,4′-diaminodiphenyl sulfone) is a medicament
`possessing several beneficial medicinal activities. Dapsone is
`typically administered as one of the medicinal agents used in the
`treatment of leprosy. Dapsone and its derivatives are also
`effective for
`treatment of bacterial
`infections, protozoal
`infections such as malaria, pneumocystis carinii, and plasmonic
`infections such as toxoplasmosis.
`Dapsone is also useful as an anti-inflammatory agent. It
`has been used to treat skin diseases characterized by the
`abnormal infiltration of neutrophils, such as Dermatitis herpetic-
`formis, linear IgA dermatosis, pustular psoriasis, pyoderma
`gangrenosum, acne vulgaris, and Sweet’s Syndrome.
`Id. at 2:12–24.
`Regarding the additional claimed components used in the claimed
`acne/rosacea-treating method, the ’219 patent states, “[d]iethylene glycol
`monoethyl ether is a solubilizer for dapsone, thereby allowing compositions
`to be prepared with increased solubilized concentrations of dapsone.” Id. at
`2:48–50. The ’219 patent further states:
`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 2:54–61. Regarding this polymeric viscosity builder, the ’219 patent
`further states, “[i]n some embodiments, the polymeric viscosity builder is an
`acrylamide/sodium acryloyldimethyltaurate copolymer, and further includes
`isohexadecane, sorbitan oleate, water, and Polysorbate 80.” Id. at 5:47–50.
`The ’219 patent describes 62 different “embodiments” where various
`amounts of these, and other, components are provided for an acne/rosacea-
`
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`IPR2019-00207
`Patent 9,517,219 B2
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`
`treating composition. Id. at 6:58–12:40. The ’219 patent also describes
`eight different “examples” of formulations including these, and other,
`components. Id. at 12:42–15:33.
`The ’219 patent has eight claims, of which claims 1 and 6 are
`independent claims. Independent claims 1 and 6 are illustrative and
`reproduced below:
`1. A method for treating a dermatological condition
`selected from the group consisting of acne vulgaris and rosacea
`comprising administering to a subject having the dermatological
`condition selected from the group consisting of acne vulgaris and
`rosacea a topical pharmaceutical composition comprising:
`about 7.5% w/w dapsone;
`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 comprising acrylamide/sodium acryloyldimethyl taurate
`copolymer; and
`water;
`wherein the topical pharmaceutical composition does not
`comprise adapalene.
`6. A method for treating a dermatological condition
`selected from the group consisting of acne vulgaris and rosacea
`comprising administering to a subject having the dermatological
`condition selected from the group consisting of acne vulgaris and
`rosacea 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 comprising
`acrylamide/sodium acryloyldimethyl taurate copolymer; and
`water;
`
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`IPR2019-00207
`Patent 9,517,219 B2
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`
`wherein the topical pharmaceutical composition does not
`comprise adapalene.
`Id. at 15:40–16:13, 16:23–36.
`C.
`PETITIONERS’ ASSERTED GROUNDS FOR UNPATENTABILITY
`Petitioners assert two grounds for unpatentability, each under
`35 U.S.C. § 103(a) for obviousness. Pet. 20–55. Petitioners’ grounds are as
`follows:
`
`Ground 1: Claims 1–8 are obvious over Garrett ’2981 and
`Nadau-Fourcade;2
`
`Ground 2: Claims 1–8 are obvious over Garrett ’298 and
`Bonacucina.3
`In support of these grounds for unpatentability, Petitioners submit,
`inter alia, a Declaration of Bozena B. Michniak-Kohn, Ph.D., FAAPS,
`M.R.Pharm.S.4 and a Declaration of Elaine S. Gilmore, M.D., Ph.D.5
`II. DISCUSSION
`A. ORDINARY LEVEL OF SKILL IN THE ART
`The only express evidence regarding what would have constituted the
`ordinary level of skill in the art at the time of the invention is submitted by
`Petitioners. The Michniak-Kohn Declaration states:
`
`
`1 WO 2009/061298 Al (published May 14, 2009) (Ex. 1004, “Garrett ’298”).
`2 WO 2010/072958 A2 (published July 1, 2010), English translation
`(Ex. 1005, “Nadau-Fourcade”).
`3 Giulia Bonacucina et al., Characterization and Stability of Emulsion Gels
`Based on Acrylamide/Sodium Acryloyldimethyl Taurate Copolymer, 10(2)
`AAPS PHARMSCITECH 368–75 (2009) (Ex. 1015, “Bonacucina”).
`4 Declaration of Bozena B. Michniak-Kohn, Ph.D., FAAPS, M.R.Pharm.S.
`(Ex. 1002, “Michniak-Kohn Declaration”).
`5 Declaration of Elaine S. Gilmore, M.D., Ph.D. (Ex. 1018, “Gilmore
`Declaration”).
`
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`IPR2019-00207
`Patent 9,517,219 B2
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`
`. . . In my opinion, a POSA [(person of ordinary skill in the art)]
`would work as part of a multi-disciplinary team and have access
`to and draw upon individuals with comparable levels of
`education and experience in relevant disciplines that lie outside
`his or her primary training. In particular, the relevant POSA for
`the ’219 patent would have the knowledge of both a clinician and
`a formulator of topical pharmaceutical compositions.
` I
`understand from counsel that another expert on behalf of Amneal
`will speak on those clinical aspects.
`. . . For the formulator portion of a POSA, it is reasonable to
`think of a hypothetical POSA in 2012 as possessing a doctoral
`degree in pharmaceutics, chemistry or a related discipl[ine] such
`as pharmacology, or chemical engineering who also has practical
`experience (at least two years) of formulating topical drug
`delivery products, or someone possessing a Bachelors or Masters
`degree in one of the preceding disciplines but with a
`correspondingly greater level (at least four years) of formulating
`topical drug delivery products. That is, the person of ordinary
`skill would have knowledge and skill relating to the use,
`function, and formulation of pharmaceutical actives and
`excipients; knowledge and training regarding the equipment,
`processes and techniques used to analyze and test formulation
`materials; and an understanding of pharmacokinetic principles
`and how they relate to drug development and use.
`Ex. 1002 ¶¶ 17–18. The Gilmore Declaration states:
`. . . For the clinical portion of a POSA, it is reasonable to think
`of a POSA as possessing an M.D. with a board certification in
`dermatology with at
`least
`two years of experience
`in
`dermatology, or otherwise treating skin conditions. It is also
`possible that an M.D. without a certification in dermatology (i.e.,
`a primary care physician, or a pediatrician) may qualify as a
`clinical POSA, assuming that they have more than two years of
`knowledge and experience treating skin conditions.
`Ex. 1018 ¶ 20.
`
`7
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`IPR2019-00207
`Patent 9,517,219 B2
`
`
`
`Patent Owner neither contests this definition of the relevant “skilled
`artisan” nor offers any evidence to the contrary. See generally Prelim. Resp.
`We have reviewed Petitioner’s evidence as to the level of ordinary skill in
`the art and find that Petitioner’s definition of the level of ordinary skill in the
`art is commensurate with the level of skill evidenced by the prior art. See,
`e.g., Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior
`art itself [may] reflect[] an appropriate level” as evidence of the ordinary
`level of skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys.
`Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). Therefore, at this stage in the
`proceeding, we accept and use Petitioner’s definition of the skilled artisan,
`as supported by the evidence of record. We further take into account the
`level of skill in the art reflected in the prior art of record. See Okajima, 261
`F.3d at 1355.
`B.
`CLAIM CONSTRUCTION
`Based on the filing date of the Petition (November 6, 2018), the Board
`interprets claim terms in an unexpired patent according to the broadest
`reasonable construction in light of the specification of the patent in which
`they appear. 37 C.F.R. § 42.100(b) (2018); Cuozzo Speed Techs., LLC v.
`Lee, 136 S. Ct. 2131, 2142–46 (2016).6 Under that standard, and absent any
`
`
`6 On October 11, 2018, the USPTO revised its rules to harmonize the
`Board’s claim construction standard for interpreting claims in trial
`proceedings before the Patent Trial and Appeal Board with the standard used
`in federal district court. Changes to the Claim Construction Standard for
`Interpreting Claims in Trial Proceedings Before the Patent Trial and Appeal
`Board, 83 Fed. Reg. 51,340 (Oct. 11, 2018) (to be codified at 37 C.F.R.
`pt. 42). This rule change, however, applies to petitions filed on or after
`November 13, 2018, and, therefore, does not apply to this proceeding. Id.
`
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`IPR2019-00207
`Patent 9,517,219 B2
`
`
`special definitions, we generally give claim terms their ordinary and
`customary meaning, as would be understood by one of ordinary skill in the
`art in the context of the entire patent disclosure. In re Translogic Tech., Inc.,
`504 F.3d 1249, 1257 (Fed. Cir. 2007).
`Any special definitions for claim terms must be set forth in the
`specification with reasonable clarity, deliberateness, and precision. See In re
`Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994). In the absence of such a
`definition, limitations are not to be read from the specification into the
`claims. See In re Van Geuns, 988 F.2d 1181, 1184 (Fed. Cir. 1993). “[W]e
`need only construe terms ‘that are in controversy, and only to the extent
`necessary to resolve the controversy.’” See Nidec Motor Corp. v.
`Zhongshan Broad Ocean Motor Co. Ltd., 868 F.3d 1013, 1017 (Fed. Cir.
`2017) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795,
`803 (Fed. Cir. 1999)).
`Petitioners state, “[t]he broadest reasonable interpretation of the term
`‘acne vulgaris,’ found in claims 1, 5, 6, and 8, means ‘acne consisting of
`inflammatory or non-inflammatory lesions.’” Pet. 19–20 (citing Ex. 1018
`¶¶ 22–26); see also (as further cited by Petitioners) Ex. 1001, 4:2–28, 4:45–
`48; Ex. 1004, 25:8–9. Patent Owner does not contest Petitioners’ proposed
`interpretation of “acne vulgaris” or propose an alternative interpretation. See
`generally Prelim. Resp.
`At this stage of the proceedings, and for the purposes of this decision,
`we find it unnecessary to construe “acne vulgaris,” or any other claim terms
`(no other claim terms were presented for interpretation).
`
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`IPR2019-00207
`Patent 9,517,219 B2
`
`
`
`BOARD’S DISCRETION UNDER 35 U.S.C. §§ 314(a) AND 325(d)
`C.
`Patent Owner’s Preliminary Response focuses solely on arguments
`that institution here should be denied under 35 U.S.C. §§ 314(a) and 325(d)
`in view of the related case IPR2018-00608, also brought by Petitioners, and
`the prior art considered during the prosecution of the application that issued
`as the ’219 patent, respectively.
`1.
`Section 314(a)
`“The Director may not authorize an inter partes review to be instituted
`unless the Director determines . . . that there is a reasonable likelihood that
`the petitioner would prevail with respect to at least 1 of the claims
`challenged in the petition.” 35 U.S.C. § 314(a). This section grants the
`Director discretion to deny institution of a later-filed petition. General
`Plastic Indus. Co. v. Canon Kabushiki Kaisha, Case IPR2016-01357, slip
`op. at 15 (PTAB Sept. 6, 2017) (Paper 19) (precedential). As the Board has
`explained, “[t]here is no per se rule precluding the filing of follow-on
`petitions after the Board’s denial of one or more first-filed petitions on the
`same patent.” Id. at 15. General Plastic sets forth seven non-exhaustive
`factors that inform our analysis:
`1. whether the same petitioner previously filed a petition
`directed to the same claims of the same patent;
`2. whether at the time of filing of the first petition the petitioner
`knew of the prior art asserted in the second petition or should
`have known of it;[ ]
`3. whether at the time of filing of the second petition the
`petitioner already received the patent owner’s preliminary
`response to the first petition or received the Board’s decision on
`whether to institute review in the first petition;[ ]
`
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`IPR2019-00207
`Patent 9,517,219 B2
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`
`
`4. the length of time that elapsed between the time the petitioner
`learned of the prior art asserted in the second petition and the
`filing of the second petition;
`5. whether the petitioner provides adequate explanation for the
`time elapsed between the filings of multiple petitions directed to
`the same claims of the same patent;
`6. the finite resources of the Board; and
`7. the requirement under 35 U.S.C. § 316(a)(11) to issue a final
`determination not later than 1 year after the date on which the
`Director notices institution of review.
`Id. at 16. We recognize that these General Plastic factors have been used to
`analyze situations in which the same party files multiple petitions
`challenging the same patent. No one factor is dispositive and, as the Board
`has explained in denying institution, “not all the factors need to weigh
`against institution for us to exercise our discretion under § 314(a).”
`Abiomed, Inc. v. Maquet Cardiovascular, LLC, Case IPR2017-02150, slip
`op. at 7 (PTAB Mar. 12, 2018) (Paper 11). However, we are unaware of,
`and Patent Owner has not identified, any decision by the Board denying
`institution under section 314(a), pursuant to the guidance of General Plastic,
`where a subsequent IPR petition was filed challenging a different patent than
`a first IPR petition.
`As explained in General Plastic: “In exercising discretion under
`35 U.S.C. § 314(a) and 37 C.F.R. § 42.108(a), we are mindful of the goals of
`the [America Invents Act (“AIA”)]—namely, to improve patent quality and
`make the patent system more efficient by the use of post-grant review
`procedures.” General Plastic, slip op. at 16 (citing H.R. Rep. No. 112-98,
`pt. 1, at 40 (2011)). Additionally, although “an objective of the AIA is to
`provide an effective and efficient alternative to district court litigation, . . .
`
`11
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`IPR2019-00207
`Patent 9,517,219 B2
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`
`[there is a] potential for abuse of the review process by repeated attacks on
`patents.” Id. at 16–17. “A central issue addressed by the General Plastic
`factors is balancing the equities between a petitioner and a patent owner
`when information is available from prior Board proceedings for a
`subsequent proceeding.” Apple Inc. v. Immersion Corp., Case IPR2017-
`01371, slip op. at 10–11 (PTAB Nov. 21, 2017) (Paper 7) (citing General
`Plastic, slip op. at 15–19). The General Plastic decision was principally
`directed to preventing the use of multiple patent office procedures to harass
`patent owners, of which there is no evidence here. See Wirtgen Am., Inc. v.
`Caterpillar Paving Prods. Inc., Case IPR2018-01201, slip op. at 11 (PTAB
`Jan. 8, 2019) (Paper 13) (IPR instituted, distinguishing follow-on petitions
`from other, non-duplicative petitions).
`Considering the General Plastic factors here, we initially note that,
`while “balancing the equities between a petitioner and a patent owner” is a
`focus, analysis under General Plastic does not default to simply tallying
`each factor to determine whether or not an IPR should be instituted. Rather,
`we consider all factors to determine a balance of the equities.
`Here, different patents are challenged in this case and in the related
`IPR2018-00608. Thus, factor 1 does not support denial of institution.
`Although some of the other General Plastic factors, e.g., factor 2 (asserted
`prior art was known), factor 3 (related IPR preliminary response filed and
`IPR instituted), and factor 4 (nearly 9 months’ time elapsed), may weigh in
`favor of Patent Owner’s position for discretional denial here (see, e.g.,
`Prelim. Resp. 10–15), we decline to exercise our discretion under Section
`314(a) to deny institution based on those factors because, here, two different
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`IPR2019-00207
`Patent 9,517,219 B2
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`
`patents are at issue, which we find dispositive of the issue. As noted above,
`we are not aware of any case before the Board where discretion has been
`exercised under Section 314(a) to deny institution under such circumstances,
`and we decline to do so here.
`2.
`Section 325(d)
`In Becton, Dickinson & Co. v. B. Braun Melsungen AG, the Board
`enumerated non-exhaustive factors to be considered in exercising discretion
`under 35 U.S.C. § 325(d) on whether to institute inter partes review. Case
`IPR2017-01586, slip op. at 17–18 (PTAB Dec. 15, 2017) (Paper 8)
`(informative). The non-exhaustive Becton factors are:
`1. the similarities and material differences between the asserted
`art and the prior art involved during examination;
`2. the cumulative nature of the asserted art and the prior art
`evaluated during examination;
`3. the extent to which the asserted art was evaluated during
`examination, including whether the prior art was the basis for
`rejection;
`4. the extent of the overlap between the arguments made during
`examination and the manner in which Petitioner relies on the
`prior art or Patent Owner distinguishes the prior art;
`5. whether Petitioner has pointed out sufficiently how the
`Examiner erred in its evaluation of the asserted prior art; and
`6. the extent to which additional evidence and facts presented in
`the Petition warrant reconsideration of the prior art or arguments.
`Id. Like the General Plastic factors, the Becton factors are not dispositive,
`but are part of a balanced assessment of the relevant circumstances in a
`particular case and we do not simply default to a tally of each factor to
`determine whether or not an IPR should be instituted.
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`Patent 9,517,219 B2
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`Regarding Becton factors 1–4, as identified by Patent Owner, we
`recognize there are similarities between the prior art considered by the
`Examiner during prosecution and the prior art asserted in the Petition.
`Prelim. Resp. 20–22. For example, although Garrett ’298 (of focus here)
`was not the prior art reference of primary focus in the Examiner’s rejections
`of the pending claims as obvious, it was nonetheless considered and its
`disclosure has some subject-matter-overlap with the disclosure of Garrett
`’147, which was the prior art reference of focus in those rejections. See Ex.
`1004, 4:2–5;7 compare with Garrett ’174, 2:30–4:4 (Ex. 2001, “Garrett
`’174”); see also Prosecution History File for ’219 Patent 59–63 (Ex. 1070,
`“the ’219 patent prosecution history”) (Non-Final Office Action dated Nov.
`18, 2015 (“Non-Final Action”).8
`There are, however, material differences between the asserted prior art
`here and the prior art involved during examination. Although Garrett ’298
`was explicitly considered during prosecution in combination with
`Garrett ’147 during prosecution, it was cited by the Examiner only for its
`teachings “that oral dapsone was known to be effective for the treatment of
`acne (p.9, 1.31-34)” and “that topical dapsone gel formulations have been
`shown to be effective in the treatment of acne vulgaris and result in ≤1% of
`the systemic exposure that is seen with typical oral dapsone treatment.”
`
`
`7 We note that, as submitted by Petitioners, Garrett ’298 (Ex. 1004) includes
`page numbering at both the top and bottoms of the pages. We use the
`pagination at the bottom of the exhibit’s pages, as has Petitioner.
`8 We note the ’219 patent prosecution history (Ex. 1017) is a file wrapper
`including multiple documents, but which has been sequentially numbered at
`the bottom of each page. We use these added page numbers when
`referencing this exhibit.
`
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`Ex. 1017, 63 (Non-Final Action 12). Petitioners here rely on additional
`teachings of Garrett ’298 not explicitly relied upon by the Examiner.
`Garrett ’298 is now relied upon by Petitioners to establish the teaching of the
`majority of claim limitations at issue based on its disclosure of a preferred
`embodiment, which is not explicitly disclosed by Garrett ’147, which
`allegedly teaches all the elements of Patent Owner’s claim 1 except for the
`specific claimed polymeric viscosity builder. Compare Ex. 1004, 4:2–5 (5–
`10% dapsone, 30% ethoxydiglycol, water), 13:3–16 (0.2–4% Carbopol);
`with Ex. 2001, 2:30–4:4 (0.5–10% dapsone, 25% DGME, 0.85% carbomer
`980, water).
`Also, the specific combination of prior art relied upon by Petitioners
`was not considered by the Examiner during prosecution. Prelim. Resp. 22.
`Petitioners’ unpatentability grounds rely on the combination of Garrett ’298
`with either Nadau-Fourcade or Bonacucina. Neither of Nadau-Fourcade and
`Bonacucina, individually, nor their combination with Garrett ’298 was
`expressly considered by the Examiner. Id.; see also Ex. 2017, 59–63 (Non-
`Final Action). We also find that neither Nadau-Fourcade nor Bonacucina is
`cumulative of the Hani reference, which was cited by the Examiner.9 See
`Ex. 2017, 59–63 (Non-Final Action), 71–118 (Hani).
`Nadau-Fourcade and Bonacucina are relied upon by Petitioners for
`their disclosures of the gelling agent Sepineo P 600, which is a commercially
`marketed acrylamide/sodium acryloyldimethyl taurate copolymer product,
`and its use as a thickener/gelling agent in topical applications. For a related
`disclosure, during prosecution the Examiner relied on the Hani reference.
`
`
`9 WO 2010/105052 A1 (published Sept. 16, 2010) (Ex. 2002, “Hani”).
`
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`See Ex. 2017, 59–63 (Non-Final Action), 71–118 (Hani); see also Ex. 1015,
`368 (identifying Sepineo P 600 as this copolymer). Although Patent Owner
`contends that the Nadau-Fourcade and Bonacucina references “are
`conveniently swapped for Hani,” but “are employed for the identical premise
`as was Hani during prosecution” (Prelim. Resp. 22), the evidence of record
`suggests that the substitution of prior art here was not so simple or direct.
`During prosecution, the Examiner cited Hani’s paragraph 118 as
`disclosing the claimed acrylamide/sodium acryloyldimethyl taurate
`copolymer (see Ex. 1017, 60). Hani, however, lists this thickener among
`(what appears to be) hundreds of choices, spanning several pages of the
`reference, with no specific guidance as to how to select that particular
`thickener among the listed agents. See Ex. 1017, 95 (Hani ¶ 118). This is in
`sharp contrast to the disclosure of Nadau-Fourcade, which lists Sepineo P
`600 as one of just four preferred gelling agents useful for topical
`pharmaceutical compositions, and the disclosure of Bonacucina, which
`discusses no gelling/thickening agent other than Sepineo P 600 and
`identifies it as a prime candidate for such use. See Ex. 1005, 48:5–9;
`Ex. 1015, 368–74. Thus, the currently cited prior art is much more direct
`and explicit in disclosing the use and virtues of the claimed polymeric
`viscosity builder than the prior art relied upon by the Examiner during
`prosecution.
`Based on these facts, we find: (1) there are material differences
`between the asserted art and the prior art involved during examination;
`(2) the prior art asserted here is not cumulative in view of the prior art
`evaluated during examination; (3) the presently asserted art was not
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`similarly evaluated during examination; and (4) there are substantial
`differences between the arguments made during examination by the
`Examiner and the manner in which Petitioners rely on the prior art here.
`Thus, the Becton factors 1–4 weigh against denying institution here.
`Regarding Becton factors 5 and 6, Petitioners assert that the Examiner
`erred in the evaluation of the asserted prior art and that there is related
`additional evidence and facts that warrant reconsideration of the prior art and
`the arguments for patentability made during prosecution that were relied
`upon by the Examiner in allowing the claims. See Pet. 18, 21–61. As
`recognized by Patent Owner:
`Petitioner[s’] main basis for requesting reconsideration is
`new testimonial evidence from Petitioner[s’] experts challenging
`the Examiner’s unexpected results findings, which new
`testimonial evidence was not considered by the Examiner.
`However, these arguments by Petitioner[s] merely ask the Board
`to reweigh the Examiner’s consideration of the unexpected
`results evidence already considered during examination.
`Prelim. Resp. 34 (emphasis omitted). Patent Owner is correct. See Pet. 1–3
`(“It is no wonder that the examiner repeatedly found the challenged claims
`obvious during prosecution. Notably, the examiner never found any claim
`limitation to be missing from the prior art or not prima facie obvious, and
`allowed the claims only after Allergan submitted alleged unexpected results
`evidence. As discussed below, there were no ‘unexpected’ results.”).
`The unexpected results findings to which Patent Owner refers are set
`forth in the Warner Declaration, submitted during the prosecution of the
`’219 patent, which was unrebutted. Ex. 1017, 289–92 (Declaration of Kevin
`S. Warner, Ph.D. Under 37 C.F.R. § 1.132 dated Feb. 2, 2015 (“Warner
`Declaration”)). The Warner Declaration was submitted by the ’219 patent
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`applicant in response to the Non-Final Action (id. at 51 et seq.) referenced
`above, and was identified by the Examiner as “Applicant’s most pertinent
`argument set forth in the record with regard to the nonobviousness of the
`claimed invention,” and was determined by the Examiner “to be probative of
`unexpected properties of the claimed formulation,” such that “the
`obviousness rejections . . . [were] withdrawn in light of the evidence.” Id. at
`466–68 (Final Office Action dated Mar. 7, 2016 (“Final Action”)); see also
`id. at 284–85 (Office Action Response dated Feb. 18, 2016 (discussing
`Warner Declaration)). Hence, the Warner Declaration and the Examiner’s
`analysis thereof was the fulcrum about which the Examiner’s determination
`of patentability and non-obviousness pivoted during prosecution toward
`allowance of the claims.
`Petitioners argue “[t]he unexpected results argument and evidence
`Allergan advanced is factually and legally flawed” and that the ’219 patent
`applicants “presented only one unexpected observation,” that is, “Carbopol®
`980’s incompatibility with 40% w/w ethoxydiglycol.” Pet. 56–57.
`Petitioners cite the Michniak-Kohn Declaration as support for this
`contention, which states:
`The only unexpected observation Dr. Warner claims in his
`declaration is the apparent unexpected incompatibility of
`Carbopol® 980 with 40% w/w ethoxydiglycol. Dr. Warner does
`not, however, argue that it was unexpected that Sepineo P 600
`was compatible with 40% w/w ethoxydiglycol. Because
`Carbopol is not recited in the claims of the ’219 patent,
`Dr. Warner’s unexpected incompatibility is not an unexpected
`result that is evidence of the non-obviousness of the claims of the
`’219 patent.
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`Ex. 1002 ¶ 100 (emphasis added); see also Ex. 1017, 289–92 (Warner
`Declaration ¶¶ 5–10).
`“[B]y definition, any superior property must be unexpected to be
`considered evidence of non-obviousness. . . . Thus, in order to properly
`evaluate whether a superior property was unexpected, the . . . [fact-finder]
`should have considered what properties were expected.” Pfizer, Inc. v.
`Apotex, Inc., 480 F.3d 1348, 1371 (Fed. Cir. 2007); see also Bristol-Myers
`Squibb Co. v. Teva Pharms. USA, Inc., 752 F.3d 967, 977 (Fed. Cir. 2014)
`(“To be particularly probative, evidence of unexpected results must establish
`that there is a difference between the results obtained and those of the closest
`prior art, and that the difference would not have been expected by one of
`ordinary skill in the art at the time of the invention.”); In re Skoner, 517 F.2d
`947, 950 (CCPA 1975) (expected beneficial results are