Trials@uspto.gov
`Tel: 571-272-7822
`
`Paper 80
`Entered: June 6, 2018
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`ACRUX DDS PTY LTD., ACRUX LIMITED, and
`ARGENTUM PHARMACEUTICALS LLC,
`Petitioner,
`v.
`KAKEN PHARMACEUTICAL CO., LTD. and VALEANT
`PHARMACEUTICALS INTERNATIONAL, INC.,
`Patent Owner.
`
`
`Case IPR2017-001901
`Patent 7,214,506 B2
`
`
`
`Before ERICA A. FRANKLIN, SUSAN L. C. MITCHELL, and
`ROBERT A. POLLOCK Administrative Patent Judges.
`
`MITCHELL, Administrative Patent Judge.
`
`
`
`FINAL WRITTEN DECISION
`Inter Partes Review
`35 U.S.C. § 318(a) and 37 C.F.R. § 42.73
`
`
`
`
`
`
`
`
`1 Case IPR2017-01429 has been joined with the instant proceeding.
`
`

`

`IPR2017-00190
`Patent 7,214,506 B2
`
`
`I. INTRODUCTION
`This is a final written decision in an inter partes review of claims 1 and 2 of
`U.S. Patent No. 7,214,506 B2 (Ex. 1001, “the ’506 patent”) entered pursuant to 35
`U.S.C. § 318(a) and 37 C.F.R. § 42.73. For the reasons set forth below, we
`determine that Petitioner has shown, by a preponderance of the evidence, that
`claims 1 and 2 of the ’506 patent are unpatentable under 35 U.S.C. § 103(a). See
`35 U.S.C. § 316(e).
`
`A. Procedural History
`Petitioner Acrux DDS Pty Ltd. and Acrux Limited (collectively,
`“Petitioner”)2 filed a Petition (Paper 1, “Pet.”) requesting an inter partes review of
`claims 1 and 2 (the “challenged claims”) of the ’506 patent. See 35 U.S.C.
`§§ 311–319. Petitioner relied upon Declarations of Kenneth A. Walters, Ph.D. and
`Jeff Karr. Exs. 1005, 1044, respectively; see Pet. 6–61. Patent Owner Kaken
`Pharmaceutical Co., Ltd. and Valeant Pharmaceuticals International, Inc.
`(collectively, “Patent Owner”) filed a Preliminary Response. Paper 8 (“Prelim.
`Resp.”). Patent Owner relied upon a Declaration of Yoshiyuki Tatsumi, PhD.
`Exs. 2003 (English translation).
`Pursuant to 35 U.S.C. § 314(a), on May 1, 2017, we instituted an inter
`partes review of challenged claims 1 and 2 to determine if the claims are
`unpatentable under 35 U.S.C. § 103(a) as obvious over the combinations of Ogura
`with JP ’639, ’367 Patent, or Hay, or the Kaken Abstracts with JP ’639, ’367
`Patent, or Hay. Paper 12, 5 (“Dec.”).
`
`
`2 Argentum Pharmaceuticals LLC is also a petitioner in this case by virtue of
`joinder with IPR2017-01429.
`
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`IPR2017-00190
`Patent 7,214,506 B2
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`
`On May 12, 2017, Argentum Pharmaceuticals LLC (“Argentum”) filed a
`petition asserting the same grounds as the Petition in this case. See Argentum
`Pharm. LLC v. Kaken Pharma. Co., Ltd., IPR2017-1429, Paper 2, 4. On the same
`day, Argentum filed a motion to join the instant case. Id. at Paper 3, 2. On
`November 13, 2017, we instituted trial in IPR2017-1429 on the same grounds as in
`this inter partes review and granted Argentum’s motion to join. See id. at Paper
`10, 7; Paper 11, 5.
`Patent Owner filed its Patent Owner Response (Paper 27, “PO Resp.”),
`along with Declarations of Dr. Tatsumi, Ph.D. (Exs. 2025), Boni E. Elewski, M.D.
`(Ex. 2027), and Vincent A. Thomas, CPA, CVA, CFF, ABV (Exhibit 2028) to
`support its positions. Petitioner filed a Reply (Paper 37, “Reply”) to the Patent
`Owner Response along with Declarations of Dr. Walters (Ex. 1509), Jeffrey M.
`Weinberg, M.D. (Ex. 1510), and John C. Staines, Jr. (Exhibit 1511).
`Petitioner and Patent Owner each filed several motions to seal various
`papers and exhibits. See Papers 25, 36, 50, 59, 62, 72, 77. These motions are
`decided in a separate order. Patent Owner filed a Motion to Strike (Paper 46),
`which we authorized (see Paper 43), and also filed a Motion to Exclude certain
`exhibits and portions of Dr. Walter’s declarations (Paper 58). Petitioner also filed
`a Motion to Exclude portions of Mr. Thomas’s declaration and associated exhibits.
`(Paper 51 (public version)). These motions are decided in a separate order.
`An oral hearing was held on January 26, 2018. A transcript of the hearing is
`included in the record. Paper 78 (“Tr.”).
`
`B. Related Proceedings
`Patent Owner indicated that there is a reissue application pending for the
`’506 patent. Paper 7. We ordered the examination of Reissue Application No.
`
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`IPR2017-00190
`Patent 7,214,506 B2
`
`15/405,171 involving the ’506 patent stayed pending the termination or completion
`of this inter partes review. See Paper 31.
`
`C. The ’506 Patent (Ex. 1001)
`The ’506 patent involves a method for accurately evaluating an effect of an
`antimicrobial agent and a therapeutic agent for onychomycosis that can be obtained
`using this method. See Ex. 1001, Abst., 2:55–62. The ’506 patent states that an
`object of the invention “is to provide a therapeutic agent for onychomycosis which
`exhibits the effect on tinea unguium by topical application and which is capable of
`curing tinea unguium [by a] shorter period than that of the marketed oral
`preparation due to good permeability, good retention capacity and conservation of
`high activity in nail plate as well as the potent antifungal activity thereof” and “to
`provide the effective therapeutic agent for onychomycosis exhibiting no side effect
`even if therapeutically effective amounts of it are administered sufficiently.” Id. at
`3:40–51. The ’506 patent lists KP-103 as one of the most preferred antimicrobial
`agents that can be used to cure “disease such as mycosis completely, and prevent[]
`a relapse.” Id. at 9:10–13, 30–31. KP-103 is also known as efinaconazole.
`PO Resp. 6; Reply 1.
`In describing the disease to be cured, the ’506 patent describes
`onychomycosis as a superficial mycosis caused by invading and proliferating in the
`nail of a human by Trichophyton rubrum or Trichophyton mentagrophytes, and in
`rare cases, Microsporum, Epidermophyton, Candida, Aspergillus, or Fusarium. Id.
`at 9:32–39. The ’506 patent includes tinea unguium caused by the Trichophyton
`species in the definition of onychomycosis, the symptoms of which include
`
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`IPR2017-00190
`Patent 7,214,506 B2
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`“opacity, tylosis, destruction and deformation of [the] nail plate.” Id. at 2:21–25,
`9:40–43.3
`The ’506 patent describes the term “nail” as including “nail plate, nail bed,
`nail matrix, further side nail wall, posterial nail wall, eponychium and
`hyponychium which make up a tissue around thereof.” Id. at 4:65–67.
`
`D. Challenged Claims
`Claim 1 is independent and claim 2 depends from claim 1. Those claims
`recite as follows.
`
`1. A method for treating a subject having onychomycosis wherein the
`method comprises topically administering to a nail of said subject
`having onychomycosis a therapeutically effective amount of an
`antifungal compound represented by the following formula:
`
`
`wherein, Ar is a non-substituted phenyl group or a phenyl group
`substituted with 1 to 3 substituents selected from a halogen
`atom and trifluoromethyl group,
`
`
`R1 and R2 are the same or different and are hydrogen atom, C1-6 alkyl
`group, a non-substituted aryl group, an aryl group substituted
`with 1 to 3 substituents selected from a halogen atom,
`trifluoromethyl group, nitro group and C1-16 alkyl group, C2-8
`alkenyl group, C2-6 alkynyl group, or C7-12 araklyl group,
`
`3 According to Petitioner’s expert, Dr. Walters, “[O]nychomycosis, also referred to
`as tinea unguium, is a fungal infection of the nail usually caused by a group of
`keratinophilic fungi known as dermatophytes.” Ex. 1005 ¶ 41.
`
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`IPR2017-00190
`Patent 7,214,506 B2
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`
`m is 2 or 3,
`n is 1 or 2,
`X is nitrogen atom or CH, and
`*1 and *2 mean an asymmetric carbon atom.
`2.
`The method of claim 1, in which the compound represented by
`the formula (II) is (2R, 3R)-2-(2,4-difluorophenyl)-3-(4-
`methylen piperidine-1-yl)-1-(1H-1,2,4-triazole-1-yl)butane-2-
`ol.
`
`Ex. 1001, 17:33–18:32.
`The compound of claim 2, also known as KP-103 or efinaconazole, is the
`active ingredient in Patent Owner’s Jublia® product, “an azole antifungal indicated
`for the topical treatment of onychomycosis of the toenails due to Trichophyton
`rubrum and Trichophyton mentagrophytes.” Ex. 1043; Pet. 62; PO Resp. 6.
`
`E. Grounds of Unpatentability
`We instituted the instant trial based on the following grounds of
`unpatentability. Dec. 5.
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`IPR2017-00190
`Patent 7,214,506 B2
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`
`References
`JP ’6394 and Ogura5
`’367 Patent6 and Ogura
`Hay7 and Ogura
`JP ’639 and Kaken Abstracts8
`’367 Patent and Kaken Abstracts
`Hay and Kaken Abstracts
`
`Basis
`§ 103(a)
`§ 103(a)
`§ 103(a)
`§ 103(a)
`§ 103(a)
`§ 103(a)
`
`Claims Challenged
`1 and 2
`1 and 2
`1 and 2
`1 and 2
`1 and 2
`1 and 2
`
`II. ANALYSIS
`
`A. Claim Interpretation
`In an inter partes review, claim terms in an unexpired patent are given their
`broadest reasonable construction in light of the specification of the patent in which
`
`4 Yoichi Ohta and Yukari Tsutsumi, Japanese Pat. App. Pub. No. 10-226639, pub.
`Aug. 25, 1998 (Ex. 1011, “JP ’639”). Petitioner asserts that JP ’639 is prior art
`under 35 U.S.C. § 102(b) because the ’506 patent is not entitled to the priority date
`of the priority document JP 11/214369. Pet. 14–22. Although Patent Owner
`disagrees, its states that “Petitioner’s challenge to the claimed priority application
`is moot” because Patent Owner has shown reduction to practice before the date of
`the only intervening prior art, Ogura. PO Resp. 31–32.
`5 Hironobu Ogura et al., Synthesis and Antifungal Activities of (2R,3R)-2-Aryl-1-
`azolyl-3-(substituted amino)-2-butanol Derivatives as Topical Antifungal Agents,
`47 CHEM. PHARM. BULL. 1417–25 (1999) (Ex. 1012, “Ogura”). Patent Owner is
`disputing whether Ogura is prior art based on a prior reduction to practice of the
`invention. See infra Section II.D.1.
`6 Teresa J. DeVincentis et al., U.S. Patent No. 5,391,367, issued Feb. 21, 1995
`(Ex. 1013, “’367 patent”).
`7R.J. Hay, R.M. Mackie, and Y.M. Clayton, “Tioconazole nail solution—an open
`study of its efficacy in onychomycosis,” 10 CLIN. AND EXPERIMENTAL
`DERMATOLOGY 111–15 (1985) (Ex. 1014, “Hay”).
`8 H. Ogura et al., “KP-103, a Novel Topical Antifungal Triazole: Structure-Activity
`Relationships of Azolylamine Derivatives,” ABSTRACTS OF THE 36TH ICAAC F78
`(1996); Y. Tatsumi et al., “In Vitro Activity of KP-103, a Novel Topical Antifungal
`Triazole,” ABSTRACTS OF THE 36TH ICAAC F79 (1996); Y. Tatsumi et al.,
`“Therapeutic Efficacy of KP-103, a Novel Topical Antifungal Triazole, on
`Experimental Superficial Mycosis,” ABSTRACTS OF THE 36TH ICAAC F80
`(Ex. 1015, collectively, “Kaken Abstracts”).
`
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`
`they appear. 37 C.F.R. § 42.100(b); Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct.
`2131, 2144–46 (2016). Under this standard, we interpret claim terms using “the
`broadest reasonable meaning of the words in their ordinary usage as they would be
`understood by one of ordinary skill in the art, taking into account whatever
`enlightenment by way of definitions or otherwise that may be afforded by the
`written description contained in the applicant’s specification.” In re Morris, 127
`F.3d 1048, 1054 (Fed. Cir. 1997). “Under a broadest reasonable interpretation,
`words of the claim must be given their plain meaning, unless such meaning is
`inconsistent with the specification and prosecution history.” Trivascular, Inc. v.
`Samuels, 812 F.3d 1056, 1062 (Fed. Cir. 2016). Only terms in controversy must
`be construed and 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).
`In our Decision on Institution, we discussed the terms “onychomycosis,”
`“nail,” and “therapeutically effective amount” as used in the challenged claims of
`the ’506 patent. See Dec. 6–9. Specifically, we stated that:
`On the record before us, we find that when read in light of the
`Specification of the ’506 patent, the broadest reasonable construction
`of the claim term “nail” includes “nail plate, nail, bed, nail matrix,
`further side nail wall, posterial nail wall, eponychium and
`hyponychium which make up the tissue around thereof,” that includes
`skin structures. The fact that the ’506 patent does not use the term “skin
`structures” is not dispositive as the Specification of the ’506 patent
`clearly identifies skin structures surrounding the nail plate, matrix, and
`bed, as part of the “nail.”
`that
`that “even assuming
`Patent Owner further asserts
`eponychium and hyponychium qualify as ‘skin structures,’ Petitioner’s
`argument still fails because it provides no support for any construction
`of the term ‘onychomycosis’ as including infections of just the
`eponychium and/or hyponychium.” Prelim. Resp. 22. This argument
`lacks merit on the record before us because the challenged claims
`require treating onychomycosis by “topically administering to a nail of
`
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`Patent 7,214,506 B2
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`
`said subject having onychomycosis a therapeutically effective amount
`of an antifungal compound . . . .” Ex. 1001, 17:33–18:2. As just
`discussed, “nail” includes many structures and is not limited to the nail
`plate, matrix, or bed, or the surrounding structures, but includes all of
`them. Also, “onychomycosis” is defined in the ’506 as a kind of
`superficial mycosis, “which is caused by invading and proliferating in
`the nail of human or an animal.” Id. at 9:32–35 (emphasis added).
`Dec. 8.
`We also noted in our Decision that “[a]lthough the Specification of
`the ’506 patent does not expressly define ‘therapeutically effective amount’
`as it does for ‘nail’ and ‘onychomycosis,’ Petitioner does provide citations to
`references where it alleges a ‘therapeutically effective amount’ is taught.”
`Dec. 9 (citing Pet. 22–23, 28–29, 30–31, 34, 35–36, 38–39, 41, 45, 47, 49,
`51, 53–54).
`Patent Owner asserts that because the claims require treating onychomycosis
`by topically administering to a nail a therapeutically effective amount of the
`claimed compound, the claim term “nail” must be read in tandem with the
`requirements to “treat onychomycosis” by administering a “therapeutically
`effective amount” of a compound. PO Resp. 27–28. When the claim requirements
`are read “in tandem,” Patent Owner asserts that “[t]he claims therefore require
`applying the compound to nail in an amount effective to treat onychomycosis at
`least in the nail plate and nail bed where the infection resides.” PO Resp. 27–28.
`Patent Owner also states that “[n]otably, treatment of the eponychium and
`hyponychium alone would not constitute a treatment for onychomycosis, but rather
`for paronychia (i.e., an infection of the skin around the nail).” Id. at 29–30 (citing
`Ex. 2007, 3; Ex. 2048, 2628; Ex. 2027 ¶¶ 81–85; see also Ex. 1001, 1:47–50,
`1:63–67, 3:40–48, 8:10–28, 9:23–26, 11:33–41, 16:58–64; Ex. 2010, 422 (focus on
`nail plate)).
`
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`Patent 7,214,506 B2
`
`
`Patent Owner concludes that “[t]reatment of onychomycosis thus requires
`treating the infection at least where it primarily resides in the keratinized nail plate
`and underlying nail bed. Treatment may also include eliminating infection in the
`skin structures surrounding the keratinous nail plate, but those skin structures
`cannot be singled out for treatment in isolation.” PO Resp. 30–31 (citing Ex. 1001,
`3:40–48 (stating effective “therapeutic agent for onychomycosis” must have “good
`permeability, good retention capacity and conservation of high activity in nail plate
`as well as the potent antifungal activity” after penetrating the plate); Ex. 1005
`¶¶ 76–77 (stating Dr. Walters admits that identifying a “therapeutically effective
`amount” according to the challenged claims “requires actual testing in an animal
`model of nail infection”); Ex. 2021, 352).
`Petitioner responds that Patent Owner ignores the express definitions of
`“onychomycosis” and “nail” that are set forth in the ’506 patent. Reply 2, 16–17.
`Specifically, Petitioner asserts that Patent Owner’s definition of onychomycosis
`that excludes onychomycosis of skin structures of the nail, such as white
`superficial onychomycosis (“WSO” or “SWO”), is contrary to articles authored by
`Patent Owner’s declarant, Dr. Elewski, explaining that onychomycosis usually
`begins in the hyponychium or nail fold, i.e. skin structures. Id. at 2, 16 (citing
`Ex. 1508, 81:14–82:8 (discussing Ex. 2010); 88:15–90:18 (discussing Ex. 1500),
`91:5–92:16 (discussing Ex. 1501)). Petitioner also points to Dr. Elewski’s
`testimony in which she “admitted that ‘onychomycosis’ as used in the claims is
`broader and includes SWO, for which ‘treatment is fairly simple, . . . you can put
`any topical antifungal on it.’” Reply 16 (quoting Ex. 1508, 158:8–159:8).
`We agree with Petitioner that Patent Owner’s definition of “onychomycosis”
`is not the broadest reasonable construction of the term. Patent Owner applies its
`narrow definition of onychomycosis in order to restrict the definition of “nail” as
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`IPR2017-00190
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`
`used in the challenged claims to require treatment of “at least the nail plate and nail
`bed where the infection resides.” See PO Resp. 27–28. Petitioner is correct that
`the definitions that are expressly set forth in the ’506 patent do not support Patent
`Owner’s view.
`The ’506 patent states that “[o]nychomycosis means a kind of the above-
`mentioned superficial mycosis, in the other word a disease which is caused by
`invading and proliferating in the nail of human or an animal.” Ex. 1001, 9:32–35.
`In discussing what is meant by “mycosis,” the Specification of the ’506 patent sets
`forth the following.
`Mycosis means a disease which is caused by invading and
`proliferating in the tissue of human or animal. Usually mycosis is
`broadly divided into superficial mycosis and deep mycosis. A seat of
`the disease lie in the skin or visible mucosa in case of the former, in
`viscus, central nervous system, subcutaneous tissue, muscle, born or
`articulation in case of the latter.
`Id. at 5:20–26 (emphases added).
`Based on these definitions in the Specification of the ’506 patent, the express
`definition of onychomycosis includes superficial mycosis, which in turn is
`expressly defined as a disease that lies in the skin or visible mucosa. Therefore, the
`express definition of onychomycosis set forth in the ’506 patent includes infections
`of skin contrary to Patent Owner’s interpretation of this term to require infection of
`the nail plate and nail bed. See Ex. 1510 ¶ 46 (stating “in the late 1990s a POSA
`would have understood the ’506 patent claim term, ‘treating a subject having
`onychomycosis’ (Ex. 1001, 17:33–18:32), to include any and all types and
`subtypes of onychomycosis, as broadly defined at col. 9, lines 32–29 of the ’506
`patent.”); Ex. 1005 ¶¶ 48 (onychomycosis includes superficial mycosis), 61; Ex.
`1509 ¶ 9 (noting “Dr. Elewski bases her analysis on an interpretation of
`[onychomycosis] that requires that the nail plate and the nail bed both be infected
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`‘in the deeper structures of the nail’ and excluding onychomycosis of the skin
`structures that are part of the nail (as ‘nail is defined in the ’506 patent), as well as
`superficial white onychomycosis, which is an infection on the top surface of the
`nail plate”).
`This express definition of onychomycosis also is consistent with the express
`definition of “nail” as provided in the Specification of the ’506 patent. As we
`noted in our Decision on Institution, the term “nail” is expressly defined in the
`Specification of the ’506 patent as including “nail plate, nail bed, nail matrix,
`further side nail wall, posterial nail wall, eponychium and hyponychium which
`make up a tissue around thereof.” Ex. 1001, 4:65–67; see Dec. 3, 7. Therefore,
`nail includes the tissue or skin around the nail plate, nail bed, and nail matrix.
`Patent Owner’s reliance on a statement in the Specification of the ’506
`patent concerning features of an effective therapeutic agent for onychomycosis as
`including “good permeability, good retention capacity and conservation of high
`activity in nail plate as well as the potent antifungal activity” does not convince us
`that onychomycosis as used in the claims of the ’506 patent should be limited to
`treating infections that involve the nail plate or nail bed. See PO Resp. 30–31
`(quoting Ex. 1001, 3:40–48). The particular passage of the Specification upon
`which Patent Owner relies specifically discusses “a therapeutic agent for
`onychomycosis which exhibits the effect on tinea unguium by topical application
`and which is capable of curing tinea unguium [within a] shorter period than that of
`the marketed oral preparation . . . .” Ex. 1001, 3:41–45 (emphasis added). This
`passage in the Specification of the ’506 patent is discussing specifically the
`treatment of tinea unguium, which is included in the definition of onychomycosis,
`but is not co-extensive with it. See id. at 9:40–44 (discussing tinea unguium is
`included as “a disease which is susceptible to treat with a therapeutic agents for
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`onychomycosis of the present invention”); see also id. at 5:30–31 (stating that
`[t]inea may be conventionally employed a[s] a synonym with dermatophytosis”).
`As discussed above, the ’506 patent expressly contemplates a broader definition of
`onychomycosis to include superficial mycosis or diseases of the skin or visible
`mucosa.
`Also, contrary to Patent Owner’s assertions that onychomycosis must
`involve infection in the nail plate and nail bed, Dr. Elewski also testified that white
`superficial onychomycosis is a form of onychomycosis that “superficially infect[s]
`the top of the nail plate, so treatment is fairly simple, you can scrape it off and that
`would cure it or you can put any topical antifungal on it.” Ex. 1508, 158:7–159:2;
`see also id. at 82:9–18 (confirming white superficial onychomycosis that infect the
`surface of the nail plate is a form of onychomycosis); Ex. 1510 ¶ 28 (Dr. Weinberg
`agreeing that “successful treatment of superficial white onychomycosis is
`relatively simple with topical antifungals and the same was true in the late 1990s”).
`Dr. Elewski also confirmed that she agreed with a statement that she made in an
`article authored in 1998 that distal subungual onychomycosis is the most common
`form of onychomycosis characterized by invasion of the nail bed and underside of
`the nail plate beginning in the hyponychium. Ex. 1508, 79:1–80:5 (discussing Ex.
`2010). Dr. Elewski admitted that the hyponychium is skin. Id. at 80:13–81:13; see
`also id. 81:14–82:8 (reviewing article’s discussion of proximal subungual
`onychomycosis that begins in the proximal nail fold, i.e. skin, through the cuticle
`area).
`
`Therefore, we conclude that on this record, “nail” includes “nail plate, nail
`bed, nail matrix, further side nail wall, posterial nail wall, eponychium and
`hyponychium which make up a tissue around thereof.” We also conclude on this
`record that “onychomycosis” is not limited to infections of the nail plate and nail
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`bed, but includes superficial mycosis that involves disease of the skin or visible
`mucosa.
`
`B. Principles of Law
`A patent claim is unpatentable under 35 U.S.C. § 103(a)9 if the differences
`between the claimed subject matter and the prior art are such that the subject
`matter, as a whole, would have been obvious at the time the invention was made to
`a person having ordinary skill in the art to which said subject matter pertains. KSR
`Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). The question of obviousness is
`resolved on the basis of underlying factual determinations including: (1) the scope
`and content of the prior art; (2) any differences between the claimed subject matter
`and the prior art; (3) the level of ordinary skill in the art; and (4) objective evidence
`of nonobviousness. Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966).
`In that regard, an obviousness analysis “need not seek out precise teachings
`directed to the specific subject matter of the challenged claim, for a court can take
`account of the inferences and creative steps that a person of ordinary skill in the art
`would employ.” KSR, 550 U.S. 398, 418 (2007); see In re Translogic Tech., Inc.,
`504 F.3d 1249, 1259 (Fed. Cir. 2007). In KSR, the Supreme Court also stated that
`an invention may be found obvious if trying a course of conduct would have been
`obvious to a person having ordinary skill:
`When there is a design need or market pressure to solve a problem and
`there are a finite number of identified, predictable solutions, a person
`of ordinary skill has good reason to pursue the known options within
`his or her technical grasp. If this leads to the anticipated success, it is
`
`9 The Leahy-Smith America Invents Act, Pub. L. No. 112-29, 125 Stat. 284 (2011)
`(“AIA”), amended 35 U.S.C. §§ 102 and 103. Because the challenged claims of
`the ’506 patent have an effective filing date before the effective date of the
`applicable AIA amendments, throughout this Final Written Decision we refer to
`the pre-AIA versions of 35 U.S.C. §§ 102 and 103.
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`likely the product not of innovation but of ordinary skill and common
`sense. In that instance the fact that a combination was obvious to try
`might show that it was obvious under § 103.
`550 U.S. at 421. “KSR affirmed the logical inverse of this statement by stating that
`§ 103 bars patentability unless ‘the improvement is more than the predictable use
`of prior art elements according to their established functions.’” In re Kubin, 561
`F.3d 1351, 1359−60 (Fed. Cir. 2009) (citing KSR, 550 U.S. at 417).
`We analyze the asserted grounds of unpatentability in accordance with the
`above-stated principles.
`
`C. Level of Ordinary Skill
`In its Preliminary Response, Patent Owner disagreed with Petitioner about
`the breadth of the level of ordinary skill in the art stating that the proper field of art
`for the challenged claims should be treatment of fungal infections of the nail alone,
`because there “is little if any overlap between treatments indicated for fungal
`infections of the nail and treatments for infections of the skin.” Prelim. Resp. 23.
`Petitioner states that the level of skill in the art at the time of the invention is a
`person who “would have had familiarity with the biology and pathology of
`common fungal agents that infect the nail and skin, and a familiarity with
`antifungal agents and their clinical use.” Pet. 21. Petitioner also states such a
`person would have had “(i) a bachelor’s or master’s degree in medicinal chemistry,
`biochemistry, pharmacology, and/or biology, and at least 3-5 years of experience
`working with topical antifungal agents, or (ii) a M.D., Pharm.D., or Ph.D. in
`medicinal chemistry, biochemistry, pharmacology, and/or biology and at
`least 1 year of experience working with topical antifungal agents.” Id.
`In our Decision on Institution, we applied Petitioner’s stated level of skill set
`forth above “that encompasses the field of treatment of fungal infections of nails
`and skin.” Dec. 11. In making this determination, we stated:
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`We are mindful that the level of ordinary skill in the art is
`reflected by the prior art of record. See Okajima v. Bourdeau, 261 F.3d
`1350, 1355 (Fed. Cir. 2001); In re GPAC Inc., 57 F.3d 1573, 1579
`(Fed. Cir. 1995). The art asserted against the claims in the Petition
`shows the overlap between treatment of fungal infections of skin and
`nails. See Ex. 1011 (testing antifungal agent on skin and hoof wall);
`Ex. 101 (describing use of KP-103 on skin). Also, the ’506 patent
`defines nail in such a way as to include the skin structures surrounding
`the nail plate, matrix, and bed. See supra Section II.A.
`
`Id.
`In its Patent Owner Response, Patent Owner does not dispute our stated
`
`level of skill in the art, but relies on our statement of the relevant field involving
`treatment of fungal infections of nails and skin to assert that it requires skill in the
`treatment of both nail and skin, not just skin alone. See PO Resp. 24–26. Patent
`Owner’s relies on its definition of “nail” and “onychomycosis” to include only
`treatment of the nail plate and nail bed to assert that the relevant field excludes
`experience or knowledge of disorders of the skin such as tinea pedis or tinea
`corporis alone. Id. at 25.
`
`Patent Owner concludes the following:
`There is no basis to extrapolate between treatments indicated for
`fungal infections of the nail and treatments for infections of the skin.
`And the art was replete with effective treatments in skin or hair that
`simply provided no guidance for predictably treating onychomycosis
`in nail.
`
`A person of ordinary skill in the art would therefore recognize
`the specialized nature of treating onychomycosis and need to have a
`specific background in nail and its pathologies beyond just having
`knowledge of dermatophytosis in skin more generally.
`Id. at 25–26 (citations omitted).
`As set forth in our claim interpretation analysis above, however, we do not
`agree that the claim terms “onychomycosis” and “nail” are so limited. See supra
`Section II.A. As we discussed, Dr. Elewski, Patent Owner’s declarant, admitted
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`that onychomycosis includes infections of the skin, such as the hyponychium or the
`proximal nail fold, in addition to the nail plate and nail bed. Id. Because we have
`determined that the term “nail” includes side nail wall, posterial nail wall,
`eponychium and hyponychium, which make up a tissue around the nail, and is not
`limited to only the nail plate, nail bed, and nail matrix, and that the term
`“onychomycosis” is not limited to the treatment of infections of only the nail plate
`and nail bed, but includes superficial mycosis that involves disease of the skin or
`visible mucosa, see id., we do not agree with Patent Owner that the relevant field
`of art is limited to fungal infections of the nail plate or nail bed. We apply
`Petitioner’s stated description of the level of ordinary skill in the art here as we did
`in our Decision on Institution, wherein that description encompasses the field of
`treatment of fungal infections of nails and skin, which may be met by knowledge
`of fungal infections of the skin.
`
`D. Obviousness over the Ogura with each of JP ’639, the ’367 patent, or
`Hay
`Petitioner presents three challenges to claims 1 and 2 of the ’506 patent
`based on Ogura with each of JP ’639, the ’367 patent, or Hay. As support,
`Petitioner provides detailed explanations as to how each claim limitation is met by
`the references and rationales for combining the references as well as detailed claim
`charts and the declarations of Dr. Walters (Exs. 1005, 1509), Jeffrey M. Weinberg,
`M.D. (Ex. 1510), and John C. Staines, Jr. (Exhibit 1511). Pet. 21–40; see
`generally Reply.
`Patent Owner asserts that Petitioner fails to explain why one of ordinary skill
`in the art would have combined the teachings of the asserted references to arrive at
`the claimed invention and has failed to show a reasonable expectation of success in
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`making such a combination. PO Resp. 32–33. Patent Owner also presents
`evidence of secondary considerations. Id. at 34.
`As an initial matter, however, Patent Owner challenges Ogura as prior art.
`We address this issue first as it resolves the challenges based on Ogura because we
`conclude that Patent Owner has shown prior reduction to practice of the invention.
`
`1. Ogura as Prior Art
`Patent Owner asserts that any challenge to the claims based on Ogura should
`be denied because the invention was reduced to practice before Ogura was
`allegedly published. PO Resp. 41–43. Patent Owner relies on a May 1999 Report
`(Ex. 2004) to establish its claim of prior reduction to practice. Id. at 41. This May
`1999 Report discusses KP-103 or efinaconazole, the compound specifically
`claimed in claim 2, and encompassed by claim 1 of the ’506 patent. Ex. 1043; Pet.
`62; PO Resp. 6.
`
`Regarding the May 1999 Report, Patent Owner asserts the following.
`Kaken’s contemporaneous May 1999 Report uses a “guinea pig
`onychomycosis model and