`
`
`
`I.
`
`
`
`Paper 9
`
`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
`
`____________
`
`IPR2018-00608
`Patent 9,161,926 B2
`____________
`
`
`PATENT OWNER PRELIMINARY RESPONSE
`
`
`
`INTRODUCTION
`The Petition should be denied because (a) Petitioner presents no
`
`evidence that the claimed copolymer was known to be capable of replacing
`
`Garrett’s Carbopol to form microparticulate dapsone; (b) Petitioner ignores
`
`Nadau-Fourcade’s express teaching to avoid crystallization; and (c) Petitioner
`
`fails to show that evidence it relies on is prior art.
`
`
`
`Patent Owner Preliminary Response
`
`IPR2018-00608
`Patent 9,161,926 B2
`
`
`
`I.
`II.
`
`TABLE OF CONTENTS
`INTRODUCTION ................................................................................ 1
`DISCUSSION OF CHALLENGES ..................................................... 2
`A. Ground 1 — Garrett and Nadau-Fourcade ..................................2
`1.
`Petitioner does not show that the claimed copolymer
`was known to have the properties required for it to
`replace Garrett’s Carbopol. ...............................................2
`Petitioner offers no evidence to show a reasonable
`expectation of success to form microparticulate
`dapsone with the claimed copolymer. ..............................8
`Nadau-Fourcade teaches away from Garrett’s
`microparticulate dapsone by insisting on no
`crystallization. ................................................................ 13
`Ground 2 — Garrett and Bonacucina ...................................... 14
`1.
`Bonacucina does not remedy Petitioner’s failure to
`present evidence that the claimed copolymer was
`known to be capable of “playing a role” in
`microparticulate dapsone formation. ............................. 14
`Petitioner relies on Exhibit 1026 in its obviousness
`case but fails to show that it is a prior-art printed
`publication...................................................................... 16
`III. THE PTAB MAY STILL DENY OR CRITIQUE
`INDIVIDUAL GROUNDS UNDER SAS .......................................... 18
`IV. CONCLUSION .................................................................................. 19
`
`2.
`
`3.
`
`B.
`
`2.
`
`
`
`i
`
`
`
`Patent Owner Preliminary Response
`
`IPR2018-00608
`Patent 9,161,926 B2
`
`
`II. DISCUSSION OF CHALLENGES
`A. Ground 1 — Garrett and Nadau-Fourcade
`1. Petitioner does not show that the claimed copolymer was
`known to have the properties required for it to replace
`Garrett’s Carbopol.
`Petitioner argues that Garrett’s Carbopol® 980 carbomer (“Carbopol”)
`
`could have been replaced by Sepineo P 600 (“Sepineo”) because Sepineo was
`
`known to include the claimed acrylamide/sodium acryloyldimethyl taurate
`
`copolymer (“copolymer”) and was included in a list of gelling agents with
`
`Carbopol by Nadau-Fourcade. Pet. 31–32. But Petitioner presents no
`
`evidence that a person of ordinary skill in the art would have known that the
`
`claimed copolymer possessed properties that made it a suitable substitute for
`
`Garrett’s Carbopol. Petitioner thus fails to demonstrate a rationale in the prior
`
`art for its proposed modification.
`
`Garrett expressly teaches that it is the addition of the Carbopol
`
`“thickener component” to the dapsone component of its gel formulation that
`
`“immediately result[s] in the formation of crystalline microparticles.”
`
`2
`
`
`
`IPR2018-00608
`Patent 9,161,926 B2
`
`
`Ex. 1004, 24:33–34.1 Petitioner’s witness Dr. Michniak-Kohn agrees,
`
`Patent Owner Preliminary Response
`
`testifying that Garrett’s Carbopol is the “thickening agent” and that “the
`
`thickening agent plays a role in the formation of the microparticulate
`
`dapsone.” Ex. 1002 ¶¶ 81–82 (cited at Pet. 46, 47).
`
`Petitioner offers no evidence, however, that its proposed Carbopol
`
`substitute—Sepineo (a product which includes the claimed copolymer)—was
`
`also recognized at the time of the invention as being capable of “play[ing] a
`
`role” in the formation of microparticulate dapsone. Petitioner’s evidence
`
`shows, at best, that Sepineo was included with Carbopol in Nadau-Fourcade’s
`
`listing of gelling agents, e.g. Pet. 32 (citing Ex. 1005, 47:12–32 and 48:1–7),
`
`but not that these agents were known to be interchangeable for the function of
`
`dapsone microparticulate formation.
`
`Petitioner cites prior cases for the unremarkable proposition that
`
`“[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
`
`
`
`
` 1
`
` Patent Owner follows Petitioner’s convention of citing exhibits by page
`
`numbers added to the exhibits by Petitioner, instead of to page numbers
`
`already present in the document.
`
`3
`
`
`
`IPR2018-00608
`Patent 9,161,926 B2
`
`
`substitution obvious.” Pet. 32 (citations omitted). But Petitioner has not in
`
`Patent Owner Preliminary Response
`
`fact offered any evidence that Carbopol and Sepineo were known alternatives
`
`interchangeable for the function that Garrett and Petitioner demand of
`
`Carbopol, specifically, dapsone microparticulate formation.
`
`Even if Carbopol and Sepineo were “interchangeable for use in a topical
`
`composition with a water-insoluble drug,” as Dr. Michniak-Kohn asserts
`
`without evidentiary support (Ex. 1002 ¶ 57), Petitioner cites no evidence that
`
`they were “interchangeable” for the specific function that the Carbopol is
`
`called upon to perform: dapsone microparticulate formation. Without putting
`
`forward evidence that Sepineo was known to be capable of this function,
`
`Petitioner provides no basis to argue that one of ordinary skill in the art even
`
`would have thought of Sepineo as a potential substitute for Carbopol in
`
`forming microparticulate dapsone.
`
`Although Petitioner bases its arguments on Garrett’s microparticulate
`
`dapsone reservoir embodiments, Petitioner does not establish a reason to
`
`modify the very component that it says “plays a role” in triggering those
`
`reservoirs. Ex. 1002 ¶ 81 (cited at Pet. 46–47). Petitioner acknowledges that
`
`Garrett
`
`teaches a “ ‘pharmaceutical carrier
`
`system comprising a
`
`dermatological composition that is a semi-solid aqueous gel, wherein dapsone
`
`4
`
`
`
`IPR2018-00608
`Patent 9,161,926 B2
`
`
`is dissolved in the gel such that the dapsone has the capacity to cross the
`
`Patent Owner Preliminary Response
`
`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.’ ” Pet. 21–22, 23 (citing Ex. 1004, Abs.)
`
`(emphasis added); see id. at 13 (citing Ex. 1004, 3:20–26); Ex. 1002 ¶¶ 44, 81
`
`(citing Ex. 1004, 17:24–26, 24:33–34).
`
`Indeed, Garrett’s very goal is to “minimiz[e] the hematologic effects
`
`associated with oral dapsone treatment” in patients with an enzyme deficiency
`
`by ensuring that “microparticulate dapsone will be retained in or above the
`
`stratum corneum and will therefore serve as a reservoir or provide drug action
`
`in the supracorneum zone.” Ex. 1004, 11:22–27 (cited, e.g., at Pet. 12).
`
`Garrett explains, for its topical dapsone gels in particular, that “the
`
`composition exhibits an optimal balance between dissolved dapsone that is
`
`available to cross through the stratum corneum to become systemically
`
`available, and microparticulate dapsone that is retained in or above the stratum
`
`corneum to serve as a reservoir or to provide dapsone to the supracorneum
`
`zone.” Id. at 12:8–12 (cited, e.g., at Pet. 11). As stated by Petitioner’s witness
`
`Dr. Michniak-Kohn, when Carbopol was added to the dapsone component in
`
`Garrett’s gel formulation example, it “immediately result[ed] in the formation
`
`5
`
`
`
`IPR2018-00608
`Patent 9,161,926 B2
`
`
`of crystalline microparticles.” Ex. 1002 ¶ 81 (citing Ex. 1004, 24:33–34); see
`
`Patent Owner Preliminary Response
`
`id. ¶ 44 (citing Ex. 1004, 17:24–26).
`
`Petitioner asserts that “it would have been obvious to a POSA to
`
`substitute the claimed acrylamide copolymer for the thickening agent
`
`disclosed in Garrett because such thickening agents were known to be
`
`predictable and interchangeable.” See Pet. 31. But Garrett teaches that its
`
`“polymer thickener component” also triggers a dapsone microparticulate
`
`reservoir that is central to Garrett’s topical formulation. See supra; see e.g.,
`
`Ex. 1004, 11:25–27; 24:33–34 (cited at, e.g., Pet. 12 and Ex. 1002 ¶ 81).
`
`Petitioner fails to provide specific evidence addressing why one of ordinary
`
`skill in the art would replace a key ingredient that is involved in forming
`
`Garrett’s microparticulate reservoir. See Pet. 31–33.
`
`Moreover, Garrett reports that its microparticulate dapsone formulation
`
`offered an unexpected safety benefit over an earlier formulation. Ex. 1004,
`
`10:22–25 (“compositions of the invention . . . demonstrate the unexpected
`
`result that treatment of G6PD-deficient patients with the Aczone™ gel, 5%,
`
`formulation does not result in adverse hematological effects”). Petitioner does
`
`not address Garrett’s unexpected benefits, nor does Petitioner explain why
`
`one of ordinary skill in the art would have been motivated to swap out
`
`6
`
`
`
`IPR2018-00608
`Patent 9,161,926 B2
`
`
`ingredients of a topical composition reported to have unexpected benefits. See
`
`Patent Owner Preliminary Response
`
`Leo Pharm. Prods. v. Rea, 726 F.3d 1346, 1355–56 (Fed. Cir. 2013)
`
`(specifically addressing the lack of motivation to replace ingredients in
`
`surprisingly effective topical formulations). Notably, Petitioner does not even
`
`address whether its asserted replacement—Sepineo—would have been known
`
`or expected to confer the triggering function that Garrett required.
`
`Petitioner’s further contentions that “both [Garrett and Nadau-
`
`Fourcade] relate to topical pharmaceutical compositions of drugs that are
`
`insoluble in water,” and “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” also fall short of identifying a
`
`rationale to modify Garrett. Pet. 31, 34 (Ground 1); see also 49–50 (Ground
`
`2). In particular, Petitioner makes no showing that one of ordinary skill in the
`
`art would have undertaken the replacement of Garrett’s microparticulate
`
`reservoir trigger on the basis that the modified formulation would be “routine”
`
`relative to Garrett’s extant formulation. “[O]bviousness concerns whether a
`
`skilled artisan not only could have made but would have been motivated to
`
`make the combinations or modifications of prior art to arrive at the claimed
`
`invention.” Belden v. Berk-Tek LLC, 805 F.3d 1064, 1073 (Fed. Cir. 2015)
`
`7
`
`
`
`IPR2018-00608
`Patent 9,161,926 B2
`
`
`(emphasis in original). In any event, Petitioner’s assertions that these
`
`Patent Owner Preliminary Response
`
`modifications would have been “routine” are unsupported by evidence and
`
`also contradict Petitioner’s argument that even “small variations” in a
`
`microparticulate composition can affect its properties. Pet. 58 (discussed
`
`infra at p. 10).
`
`2. Petitioner offers no evidence to show a reasonable
`expectation of success to form microparticulate dapsone
`with the claimed copolymer.
`Petitioner similarly fails to present evidence that one of ordinary skill
`
`would have had a reasonable expectation of success in making the proposed
`
`modification. Garrett emphasizes that its main purpose is to provide a
`
`reservoir of undissolved dapsone. Ex. 1004, 11:24–27 (explaining that
`
`microparticulate dapsone “serve[s] as a reservoir”). Petitioner proposes
`
`replacing the very ingredient that Garrett, Petitioner, and Dr. Michniak-Kohn
`
`agree “plays a role” in forming that reservoir: the Carbopol. Ex. 1002 ¶ 81
`
`(cited at Pet. 46, 47); see Ex. 1004, 11:24–27. Yet Petitioner has not shown
`
`that Carbopol and Sepineo, although both identified by Nadau-Fourcade as
`
`gelling agents, were known to be interchangeable for the function of
`
`triggering microparticulate dapsone formation.
`
`In the absence of such evidence, Petitioner fails to show that a person
`
`8
`
`
`
`IPR2018-00608
`Patent 9,161,926 B2
`
`
`of ordinary skill would have had a reasonable expectation of successfully
`
`Patent Owner Preliminary Response
`
`obtaining Garrett’s microparticulate dapsone by using the claimed copolymer
`
`in Sepineo. See Procter & Gamble v. Teva Pharm., 566 F.3d 989, 994 (Fed.
`
`Cir. 2009) (challenger must demonstrate that “a skilled artisan would have
`
`been motivated to combine the teachings of the prior art references to achieve
`
`the claimed invention, and . . . would have had a reasonable expectation of
`
`success in doing so”). For at least this reason, Petitioner fails to demonstrate
`
`a reasonable likelihood of prevailing on any claim under either asserted
`
`ground.
`
`Petitioner instead merely asserts that one of ordinary skill would have
`
`had a reasonable expectation of success because “Garrett’s thickening agents
`
`and the acrylamide copolymer are known thickening agents being used in their
`
`known amounts for their intended purpose—to thicken the composition and
`
`stabilize the undissolved dapsone.” Pet. 37. But Petitioner’s argument here
`
`ignores the evidence it relies on elsewhere that the Carbopol is intended to
`
`“play[] a role” in the formation of the microparticulate dapsone. Ex. 1002 ¶
`
`81 (cited at Pet. 46, 47). Petitioner nowhere demonstrates, or even alleges,
`
`that the claimed copolymer was known to be capable of fulfilling an “intended
`
`purpose” of microparticulate dapsone formation. Whether a person of
`
`9
`
`
`
`IPR2018-00608
`Patent 9,161,926 B2
`
`
`ordinary skill in the art could have used the claimed copolymer in a known
`
`Patent Owner Preliminary Response
`
`amount for its disclosed purpose as a gelling agent is irrelevant to the question
`
`of whether that person would have had a reasonable expectation of success in
`
`using it for forming microparticulate dapsone, a purpose that Petitioner has
`
`not demonstrated was known.
`
`Petitioner and Dr. Michniak-Kohn even admit that “small variations in
`
`the preparation of the composition can affect the properties (e.g., particle size,
`
`polymorph) of a resulting recrystallized precipitate” (Pet. 58, citing Ex. 1002
`
`¶¶ 102–03), yet they fail to address how the complete replacement of a key
`
`ingredient reasonably would have been expected not to alter the resulting
`
`formulation’s properties.
`
`Petitioner points out no disclosure in Garrett or in Nadau-Fourcade
`
`relating to how one of ordinary skill reasonably would have expected that the
`
`claimed copolymer could play a role in forming a microparticulate reservoir.
`
`Notably, Nadau-Fourcade specifically seeks
`
`to avoid crystallization.
`
`Ex. 1005, 41:13–14 (explaining that its claimed compositions have “no
`
`crystallization of the active ingredient” visible even on microscopic
`
`examination); infra Section II(A)(3) at p. 13. Consistent with this directive,
`
`Nadau-Fourcade provides no teaching that its “gelling agent” ingredients
`
`10
`
`
`
`IPR2018-00608
`Patent 9,161,926 B2
`
`
`function as an active ingredient microparticulate trigger. See, e.g., Ex. 1005,
`
`Patent Owner Preliminary Response
`
`47:12–48:7.
`
`Dr. Michniak-Kohn reinforces Petitioner’s hindsight-driven analysis
`
`by entirely omitting consideration of one of Nadau-Fourcade’s preferred
`
`gelling agent families—polysaccharides—and instead plucking out only the
`
`claimed element as the asserted replacement for Garrett’s formulation. See
`
`Ex. 1002 ¶¶ 56–57; see Ex. 1005, 48:5–7 (“Preferred gelling agents include
`
`carbomers, for instance Carbopol 980® or 981®, polyacrylamides, for instance
`
`Sepineo P 600® or Simulgel 600 PHA®, and polysaccharides, for instance
`
`xanthan gum.”). And although Dr. Michniak-Kohn alleges that Carbopol and
`
`Sepineo were known to be “interchangeable for use in a topical composition
`
`with a water-insoluble drug” from Nadau-Fourcade, she provides no citation
`
`support for this position. Ex. 1002 ¶ 57.
`
`Petitioner’s reliance on references not even asserted in its statutory
`
`Grounds is equally unavailing. E.g., Pet. 11, 37, 50–52, 57 (discussing Guo,
`
`Ex. 1013); id. at 37, 47, 49, 50, 52, 53 (discussing Sepineo brochure,
`
`Ex. 1026). Petitioner argues that one of ordinary skill in the art “knew from
`
`Guo that dapsone compositions were compatible with concentrations of about
`
`1% w/w to about 10% w/w of the acrylamide copolymer.” Pet. 52 (citing
`
`11
`
`
`
`IPR2018-00608
`Patent 9,161,926 B2
`
`
`Ex. 1013); see also id. at 37. Yet Guo does not even mention the claimed
`
`Patent Owner Preliminary Response
`
`copolymer. See, e.g., Ex. 1013 ¶ 200. Petitioner further states that Sepineo
`
`was “known in 2012 to be generally compatible with a wide variety of
`
`conditions.” Pet. 37 (citing Ex. 1026 (“Sepineo brochure”)); id. at 52 (citing
`
`same). Consistent with the discussion of the record evidence above, however,
`
`neither Guo nor the Sepineo brochure teaches that the copolymer triggers
`
`microparticulate dapsone formation. See Ex. 1013; Ex. 1026 (which, as
`
`discussed below in Section II(B)(2) on page 16 has not even been shown to
`
`be a prior-art printed publication).
`
`Nor do these references discuss how Garrett’s formulation might have
`
`been modified to address the characteristics of Sepineo, yet preserve the
`
`microparticulate reservoir. Rather, Nadau-Fourcade discloses Sepineo as a
`
`gelling agent, without mentioning any properties it might have had with
`
`respect to drug crystal formation. Indeed, as mentioned previously and
`
`detailed below, Nadau-Fourcade expressly seeks to avoid crystalline
`
`formation in its formulations. Ex. 1005, 41:13–14; infra subsection 3.
`
`For these reasons, Petitioner has failed to demonstrate that one of
`
`ordinary skill in the art reasonably would have expected that replacing
`
`Garrett’s microparticulate dapsone-triggering Carbopol in favor of Sepineo
`
`12
`
`
`
`IPR2018-00608
`Patent 9,161,926 B2
`
`
`could have achieved the claimed invention.
`
`Patent Owner Preliminary Response
`
`3. Nadau-Fourcade teaches away from Garrett’s
`microparticulate dapsone by insisting on no
`crystallization.
`Petitioner’s Ground 1 challenge fails for the additional reason that the
`
`Petition does not account for Nadau-Fourcade’s directive to avoid
`
`crystallization of the active ingredient in its topical formulations. As a result,
`
`Petitioner cannot establish that one of ordinary skill in the art would have had
`
`any rationale for modifying Garrett’s crystallized active microparticulate
`
`formulations based on Nadau-Fourcade.
`
`Petitioner acknowledges that Garrett’s topical gel formulations require
`
`crystallization, see supra Section II(A)(1) at p. 5, but does not address the
`
`express instruction in Nadau-Fourcade to avoid crystallization entirely. In
`
`particular, Nadau-Fourcade reports:
`
`The problem that this invention proposes to solve herein is
`thus to develop an aqueous pharmaceutical composition of an
`oil-in-water emulsion
`type, which
`is physically and
`chemically stable and contains at least one water-sensitive
`active ingredient, in dissolved form. . . . The term ‘dissolved
`form of the active ingredient’ means a dispersion of the active
`ingredient
`in molecular form
`in a
`liquid, with no
`crystallization of the active ingredient being visible to the
`
`13
`
`
`
`IPR2018-00608
`Patent 9,161,926 B2
`
`
`
`Patent Owner Preliminary Response
`
`naked eye or even under a cross-polarized optical microscope.
`
`Ex. 1005, 40:28–30, 41:12–14 (emphases added); see id. at 39:16–18
`
`(“degradation and/or crystallization of the active ingredient . . . runs counter
`
`to the desired objective”).
`
`Petitioner fails to explain how one of ordinary skill in the art would
`
`have reconciled Nadau-Fourcade’s express teaching against crystallization
`
`with Garrett’s express teaching for crystallization. Petitioner asserts that both
`
`Garrett and Nadau-Fourcade “relate to topical pharmaceutical compositions
`
`of drugs and are within the pertinent art.” Pet. 31. However, because a
`
`combination of Garrett and Nadau-Fourcade would render both references
`
`unsuitable for their respective intended purposes, the Petition falls short of
`
`showing the ordinarily skilled artisan had sufficient reason to combine them.
`
`See In re Gordon, 733 F.2d 900, 902 (Fed. Cir. 1984) (proposed modification
`
`cannot render the prior art unsatisfactory for its intended purpose).
`
`For these reasons, Ground 1 should be denied.
`
`B. Ground 2 — Garrett and Bonacucina
`1. Bonacucina does not remedy Petitioner’s failure to
`present evidence that the claimed copolymer was known
`to be capable of “playing a role” in microparticulate
`dapsone formation.
`As discussed above in Sections II(A)(1)–(2) on pages 2–10, Petitioner
`
`14
`
`
`
`IPR2018-00608
`Patent 9,161,926 B2
`
`
`fails to cite any evidence that one of ordinary skill would have known that the
`
`Patent Owner Preliminary Response
`
`claimed copolymer was capable of “playing a role” in the formation of
`
`microparticulate dapsone. Consequently, no evidence supports Petitioner’s
`
`assertions that one of ordinary skill would have had any reason (a) to replace
`
`Garrett’s Carbopol with a material not known to be able to replicate
`
`Carbopol’s role in microparticulate dapsone formation, or (b) reasonably to
`
`expect that such a substitution would work. Bonacucina supplies none of the
`
`missing evidence.
`
`Dr. Michniak-Kohn asserts that: “Both Garrett’s thickening agent,
`
`Carbopol® 980, and acrylamide/sodium acryloyldimethyl taurate copolymer
`
`are known thickening agents being used in their known amounts for their
`
`intended purpose: to thicken the composition and stabilize the undissolved
`
`dapsone. (AMN1029, 1.)” Ex. 1002 ¶ 90. Yet the only support Dr. Michniak-
`
`Kohn provides for this statement is the Kim article (Ex. 1029), which neither
`
`mentions the copolymer nor addresses the alleged purpose of stabilizing
`
`undissolved actives. See Ex. 1029, 1 (study of Carbopol rheology and
`
`structure). Here, as with Ground 1, Petitioner fails to demonstrate any
`
`guidance concerning Sepineo’s function, or other information pertaining to
`
`Sepineo’s interaction with dapsone, or why one of ordinary skill reasonably
`
`15
`
`
`
`IPR2018-00608
`Patent 9,161,926 B2
`
`
`would have expected such a formulation to be successful.
`
`Patent Owner Preliminary Response
`
`Bonacucina is devoid of any description of Sepineo’s interaction with
`
`an active component. Tellingly, in Ground 2 Petitioner does not rely on either
`
`Garrett or Bonacucina for its assertion of a reasonable expectation of
`
`successfully using the claimed copolymer. Petitioner instead relies on
`
`evidence not cited in the challenge, some of which it does not even show to
`
`be prior art. See Pet. 51–53; infra subsection 2. Bonacucina contains no
`
`teaching of an active ingredient, much less Sepineo’s function with regard to
`
`any active. Instead, Bonacucina confines itself to “characteriz[ing] the
`
`Sepineo gel systems as well as to study how the addition of oil affects gel
`
`characteristics” without actives present. Ex. 1015, 7. Bonacucina does not
`
`address how Sepineo would behave in the presence of dapsone or other
`
`actives.
`
`2. Petitioner relies on Exhibit 1026 in its obviousness case
`but fails to show that it is a prior-art printed publication.
`Petitioner relies repeatedly in Ground 2 on a document it has not shown
`
`to be prior art: the “Sepineo brochure” filed as Exhibit 1026. Petitioner has
`
`presented no evidence that the Sepineo brochure is a prior-art printed
`
`publication published before the effective filing date of the ’926 patent.
`
`Petitioner bears “the initial burden of production” to establish the existence of
`
`16
`
`
`
`IPR2018-00608
`Patent 9,161,926 B2
`
`
`prior art on which it relies. Dynamic Drinkware, LLC v. Nat’l Graphics, Inc.,
`
`Patent Owner Preliminary Response
`
`800 F.3d 1375, 1378–79 (Fed. Cir. 2015); see, e.g., Mylan Pharm. v.
`
`Boehringer Ingelheim Int’l GmbH, IPR2016-01566, Paper 15 at 10–12 (Feb.
`
`3, 2017) (denying institution because petitioner had not shown that purported
`
`“printed package insert” was a printed publication); Frontier Therap., LLC v.
`
`Medac Ges. Fur Klinische Spezial. MBH, IPR2016-00649, Paper 10 at 22
`
`(Sep. 1, 2016) (same).
`
`Petitioner relies on the Sepineo brochure to assert that a person of
`
`ordinary skill would have known that (a) Sepineo has properties making it
`
`desirable for topical use (see Pet. 47); (b) up to 5% w/w Sepineo is useful
`
`(id. at 49, 50); and (c) Sepineo is compatible with a wide variety of solvents
`
`and tolerates wide pH and temperature ranges (id. at 52–53). Petitioner cites
`
`no other documentary evidence in support of any of these assertions, aside
`
`from passing references to Bonacucina . Dr. Michniak-Kohn similarly relies
`
`on the Sepineo brochure and little else to support the same assertions.
`
`Ex. 1002 ¶¶ 28, 61, 84, 90.
`
`Yet despite its near-exclusive reliance on this document for several
`
`elements of its Ground 2 challenge, Petitioner provides no evidence showing
`
`that the Sepineo brochure is a prior-art printed publication. Petitioner does
`
`17
`
`
`
`IPR2018-00608
`Patent 9,161,926 B2
`
`
`not even allege a publication date in its Exhibit List. Paper 3, 3. The Sepineo
`
`Patent Owner Preliminary Response
`
`brochure itself sets forth only the inscription “3664/GB/02/April 2008,” with
`
`no explanation of the inscription’s meaning or any indication of the brochure’s
`
`source and availability prior to 2012. Ex. 1026, 2. Petitioner offers no
`
`evidence to explain the meaning of this inscription, which without more does
`
`not prove publication. BMC Medical Co. Ltd. v. ResMed Ltd, IPR2014-
`
`01196, Paper 7 at 7 (Dec. 21, 2014) (denying institution where only asserted
`
`evidence of publication was an inscription “LK 3/15/01” printed on last page
`
`of document).
`
`The assertions by Petitioner and Dr. Michniak-Kohn that are supported
`
`only by this document therefore are unsupported by any prior-art documentary
`
`evidence and should be given little or no weight. 37 C.F.R. § 42.65(a).
`
`Because Petitioner relies principally on the Sepineo brochure to support its
`
`rationale for combination but has not shown the brochure to be prior art, this
`
`ground should be denied.
`
`For these reasons, Ground 2 should be denied.
`
`III. THE PTAB MAY STILL DENY OR CRITIQUE INDIVIDUAL
`GROUNDS UNDER SAS
`If the Board decides to institute review despite the Petition’s
`
`deficiencies, including those identified above, it may still deny an individual
`
`18
`
`
`
`IPR2018-00608
`Patent 9,161,926 B2
`
`
`ground or explain why it fails to demonstrate a reasonable likelihood of
`
`Patent Owner Preliminary Response
`
`unpatentability. Nothing in SAS Institute Inc. v. Iancu, --- U.S. ---
`
`(No. 16-969, Apr. 24, 2018) prevents the Board from doing so. Such guidance
`
`from the Board would help the parties prioritize arguments and marshal
`
`resources efficiently, should review be instituted.
`
`IV. CONCLUSION
`For the foregoing reasons, the Board should deny institution of inter
`
`partes review for the ’926 patent.
`
`
`
`Dated: June 8, 2018
`
`Respectfully submitted,
`
` /Scott E. Kamholz/
`Scott E. Kamholz, Reg. No. 48,543
`Jessica L. Parezo, Reg. No. 50,286
`Covington & Burling LLP
`One CityCenter
`850 Tenth Street, NW
`Washington, DC 20001
`Phone: (202) 662-5339
`Fax: (202) 778-5339
`
`Counsel for Patent Owner
`
`19
`
`
`
`IPR2018-00608
`Patent 9,161,926 B2
`
`
`
`CERTIFICATE OF WORD COUNT
`
`Patent Owner Preliminary Response
`
`Pursuant to 37 C.F.R. § 42.24(d), I certify that the present paper
`
`contains 3,536 words based on the word count indicated by the word-
`
`processing program used to generate the paper and excluding those portions
`
`exempted by §§ 42.24(a) and (b).
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` /Scott E. Kamholz/
` Scott E. Kamholz
` Reg. No. 48,543
`
`
`
`ii
`
`
`
`IPR2018-00608
`Patent 9,161,926 B2
`
`
`
`Patent Owner Preliminary Response
`
`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. § 42.6, I certify that on the date listed below, a
`
`copy of this paper and every exhibit filed with this paper was served on the
`
`petitioner by electronic mail to the following counsel of record for Petitioner:
`
`
`
`
`
`Dated: June 8, 2018
`
`
`
`Dennies Varughese (dvarughe-PTAB@skgf.com)
`Adam C. LaRock (alarock-PTAB@skgf.com)
`PTAB@skgf.com
`Sterne, Kessler, Goldstein & Fox
`1100 New York Avenue, NW
`Washington, DC 20005
`
` /Scott E. Kamholz/
`Scott E. Kamholz, Reg. No. 48,543
`
`
`
`
`
`
`
`iii
`
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
