Trials@uspto.gov
`571.272.7822
`
`
`
`
` Paper No. 9
`
` Entered: June 8, 2018
`
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`FLATWING PHARMACEUTICALS, LLC,
`Petitioner,
`
`v.
`
`ANACOR PHARMACEUTICALS, INC.,
`Patent Owner.
`____________
`
`Case IPR2018-00169
`Patent 9,566,289 B2
`____________
`
`
`Before GRACE KARAFFA OBERMANN, TINA E. HULSE, and
`JACQUELINE T. HARLOW, Administrative Patent Judges.
`
`HULSE, Administrative Patent Judge.
`
`
`
`DECISION TO INSTITUTE
`35 U.S.C. § 314(a)
`
`
`
`
`
`
`
`
`571.272.7822
`
`
`
`
` Paper No. 9
`
` Entered: June 8, 2018
`
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`FLATWING PHARMACEUTICALS, LLC,
`Petitioner,
`
`v.
`
`ANACOR PHARMACEUTICALS, INC.,
`Patent Owner.
`____________
`
`Case IPR2018-00169
`Patent 9,566,289 B2
`____________
`
`
`Before GRACE KARAFFA OBERMANN, TINA E. HULSE, and
`JACQUELINE T. HARLOW, Administrative Patent Judges.
`
`HULSE, Administrative Patent Judge.
`
`
`
`DECISION TO INSTITUTE
`35 U.S.C. § 314(a)
`
`
`
`
`
`
`
`
`
`IPR2018-00169
`Patent 9,566,289 B2
`
`
`I. INTRODUCTION
`
`Flatwing Pharmaceuticals, LLC (“Petitioner”) filed a Petition
`
`requesting an inter partes review of claims 1–15 of U.S. Patent No.
`
`9,566,289 B2 (Ex. 1001, “the ’289 patent”). Paper 1 (“Pet.”). Anacor
`
`Pharmaceuticals, Inc. (“Patent Owner”) did not file a Preliminary Response
`
`to the Petition.
`
`We have authority under 35 U.S.C. § 314, which provides that an
`
`inter partes review may not be instituted “unless . . . there is a reasonable
`
`likelihood that the petitioner would prevail with respect to at least 1 of the
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`claims challenged in the petition.” 35 U.S.C. § 314(a). Upon considering
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`the argument and evidence presented in the Petition, we determine that
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`Petitioner has established a reasonable likelihood that it would prevail in
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`showing the unpatentability of at least one claim challenged in the Petition.
`
`Accordingly, we institute an inter partes review of all claims and all grounds
`
`asserted in the Petition.
`
`A.
`
`Related Proceedings
`
`Petitioner has filed three other petitions for inter partes review of
`
`related patents: U.S. Patent No. 9,549,938 (IPR2018-00168), U.S. Patent
`
`No. 9,566,290 (IPR2018-00170), and U.S. Patent No. 9,572,823 (IPR2018-
`
`00171). Paper 4, 2.
`
`Case IPR2015-01776 is an inter partes review of U.S. Patent No.
`
`7,582,621 (“the ’621 patent”), which, according to Patent Owner, “asserts
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`substantially the same claim of priority as U.S. Patent No. 9,566,289.” Id.
`
`The Board determined each of the claims of the ’621 patent was
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`unpatentable over the prior art. Coalition for Affordable Drugs X LLC v.
`
`Anacor Pharms., Inc., Case IPR2015-01776, slip op. at 42 (PTAB Feb. 23,
`
`2
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`
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`IPR2018-00169
`Patent 9,566,289 B2
`
`2017) (Paper 70). The Federal Circuit recently affirmed the Board’s final
`
`written decision as to claim 6 of the ’621 patent (the only claim on appeal) in
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`Anacor Pharmaceuticals, Inc. v. Iancu, No. 2017-1947, 2018 WL 2187768,
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`at *9 (Fed. Cir. May 14, 2018).
`
`The parties also identify U.S. Patent Application Nos. 15/355,393 and
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`15/355,813 as administrative matters that may be affected by this
`
`proceeding. Pet. x; Paper 4, 2.
`
`B.
`
`The ’289 Patent
`
`The ’289 patent relates to boron-containing compounds useful for the
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`topical treatment of onychomycosis and/or cutaneous fungal infections.
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`Ex. 1001, Abstract. The invention is directed to compounds that are active
`
`against fungi and have physicochemical properties that facilitate penetration
`
`of the nail plate. Id. According to the Specification, current treatment for
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`ungual and/or periungual infections generally falls into three categories:
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`systemic administration of medicine; surgical removal of the nail or hoof
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`followed by topical treatment of the exposed tissue; or topical application of
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`medicine with bandages to keep the medication in place on the nail or hoof.
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`Id. at 1:47–53.
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`Each of the approaches has major drawbacks. Id. at 1:53–54.
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`Systemic administration of medicine typically requires long-term, high-dose
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`therapy, which can have significant adverse effects on, for example, the liver
`
`and testosterone levels, which further negatively affects patient compliance.
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`Id. at 1:58–2:8. Surgical treatment is painful and undesirable cosmetically
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`(or not realistic for animals such as horses). Id. at 2:10–16. And topical
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`dosage forms cannot keep the drug in contact with the infected area for
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`therapeutically effective periods of time and, because of the composition of
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`the nail, topical therapy for fungal infections have generally been
`
`3
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`
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`IPR2018-00169
`Patent 9,566,289 B2
`
`ineffective. Id. at 2:17–41. Accordingly, the Specification states that “there
`
`is a need in the art for compounds which can effectively penetrate the nail.
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`There is also need in the art for compounds which can effectively penetrate
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`the nail . . . [and] effectively treat ungual and/or periungual infections.” Id.
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`at 2:66–3:2.
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`Dermatophytes are the most common cause of onychomycosis. Id. at
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`131:29–31. Onychomycosis caused by a dermatophyte is called Tinea
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`unguium. Id. at 131:31–32. The most frequently isolated dermatophyte in
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`Tinea unguium is Trichophyton rubrum followed by T. mentagophytes. Id.
`
`at 131:32–33.
`
`The ’289 patent claims a pharmaceutical formulation comprising 1,3-
`
`dihydro-5-fluoro-l-hydroxy-2, 1-benzoxaborole, which is also referred to as
`
`compound 1 (see id. at 137:52–61) and has the following chemical structure:
`
`
`
`
`
`C.
`
`Illustrative Claim
`
`Petitioner challenges claims 1–15 of the ’289 patent. Claims 1,
`
`4, and 12 are independent claims. Claim 1 is illustrative and is
`
`reproduced below:
`
`4
`
`
`
`IPR2018-00169
`Patent 9,566,289 B2
`
`1. A pharmaceutical composition comprising:
`
`1,3-dihydro-5-fluoro-l-hydroxy-2,1-benzoxaborole, or a
`pharmaceutically acceptable salt thereof; and
`
`a pharmaceutically acceptable topical carrier.
`
`D.
`
`The Asserted Grounds of Unpatentability
`
`Petitioner challenges the patentability of claims 1–15 of the
`
`’289 patent on the following grounds:
`
`References
`
`Austin1 and Brehove2
`
`Basis
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`§ 103
`
`Claims challenged
`
`1 and 2
`
`Austin, Brehove, and Samour3 § 103
`
`4–7, 10, and 11
`
`Austin, Brehove, Samour, and
`the Excipients Handbook4
`Austin and Freeman5
`
`§ 103
`
`§ 103
`
`3, 8, 9, and 12–15
`
`1 and 2
`
`Austin, Freeman, and Samour
`
`§ 103
`
`4–7, 10, and 11
`
`Austin, Freeman, Samour, and
`the Excipients Handbook
`
`§ 103
`
`3, 8, 9, and 12–15
`
`Petitioner also relies on the Declarations of Stephen Kahl Ph.D.
`
`(“Kahl Decl.,” Ex. 1003) and S. Narasimha Murthy Ph.D. (“Murthy Decl.,”
`
`Ex. 1005).
`
`
`
`1 Austin et al., WO 95/33754, published Dec. 14, 1995 (“Austin,” Ex. 1007).
`2 Brehove, US 2002/0165121 A1, published Nov. 7, 2002 (“Brehove,”
`Ex. 1008).
`3 Samour et al., US 6,224,887 B1, issued May 1, 2001 (“Samour,”
`Ex. 1010).
`4 Handbook of Pharmaceutical Excipients (Arthur H. Kibbe, ed., 3d ed.
`2000) (“Excipients Handbook,” Ex. 1011)
`5 Freeman et al., WO 03/009689 A1, published Feb. 6, 2003 (“Freeman,”
`Ex. 1009).
`
`5
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`IPR2018-00169
`Patent 9,566,289 B2
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`II. ANALYSIS
`
`A.
`
`Person of Ordinary Skill in the Art
`
`Petitioner asserts that a person of ordinary skill in the art at the time of
`
`the invention would have had either a Master’s degree or Ph.D. in chemistry,
`
`pharmacology, or biochemistry, and at least two years of experience with the
`
`research, development, or production of pharmaceuticals. Pet. 18 (citing Ex.
`
`1005 ¶¶ 19–21; Ex. 1003 ¶ 22).
`
`At this stage of the proceeding, and absent opposition from Patent
`
`Owner, we adopt Petitioner’s definition of the level of ordinary skill in the
`
`art. Moreover, the prior art itself is sufficient to demonstrate the level of
`
`skill in the art at the time of the invention. See Okajima v. Bourdeau, 261
`
`F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding
`
`ordinary skill level are not required “where the prior art itself reflects an
`
`appropriate level and a need for testimony is not shown”) (quoting Litton
`
`Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir.
`
`1985)).
`
`B.
`
`Claim Construction
`
`In an inter partes review, 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. § 100(b);
`
`In re Cuozzo Speed Techs., LLC, 793 F.3d 1268, 1278–79 (Fed. Cir. 2015),
`
`cert. granted sub nom. Cuozzo Speed Techs., LLC v. Lee, 84 U.S.L.W. 3218
`
`(U.S. Jan. 15, 2016) (No. 15-446). Under that standard, and absent any
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`special definitions, we give claim terms their ordinary and customary
`
`meaning, as would be understood by one of ordinary skill in the art at the
`
`time of the invention. See In re Translogic Tech., Inc., 504 F.3d 1249, 1257
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`6
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`
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`IPR2018-00169
`Patent 9,566,289 B2
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`(Fed. Cir. 2007). Any special definitions for claim terms must be set forth
`
`with reasonable clarity, deliberateness, and precision. See In re Paulsen,
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`30 F.3d 1475, 1480 (Fed. Cir. 1994).
`
`1.
`
`“1,3-dihydro-5-fluoro-1-hydroxy-2,1-benzoxaborole”
`
`Each of the claims recite the compound 1,3-dihydro-5-fluoro-1-
`
`hydroxy-2,1-benzoxaborole. 1,3-dihydro-5-fluoro-1-hydroxy-2,1-
`
`benzoxaborole has the following structure:
`
`The claimed compound may also be referred to as “5-fluoro-1,3
`
`dihydro-1-hydroxy-2,1-benzoxaborole,” as in Austin, or “tavaborole.” Ex.
`
`
`
`1005, ¶ 34.
`
`We determine that the broadest reasonable interpretation of 1,3-
`
`dihydro-5-fluoro-1-hydroxy-2,1-benzoxaborole includes “5-fluoro-1,3-
`
`dihydro-1-hydroxy-2,1-benzoxaborole” and “tavaborole.” Accordingly, for
`
`ease of reference, we refer to the claimed compound as “tavaborole” in this
`
`Decision.
`
`2.
`
`Remaining Claim Terms
`
`At this stage of the proceeding, we determine that it is unnecessary to
`
`expressly construe the remaining claim terms for purposes of this Decision.
`
`See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir.
`
`2011) (“[C]laim terms need only be construed ‘to the extent necessary to
`
`resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g,
`
`Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).
`
`7
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`IPR2018-00169
`Patent 9,566,289 B2
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`C. Obviousness over Austin and Brehove
`
`Petitioner asserts that claims 1 and 2 of the ’289 patent are
`
`unpatentable as obvious over Austin and Brehove. Pet. 23–42. Based on the
`
`current record, we determine that Petitioner has established a reasonable
`
`likelihood that it would prevail in showing claims 1 and 2 are unpatentable
`
`as obvious over Austin and Brehove.
`
`1.
`
`Austin (Ex. 1007)
`
`Austin relates to the use of oxaboroles as industrial biocides, and
`
`especially as fungicides for the protection of plastic materials. Ex. 1007, 1
`
`(Abstract). The Abstract further states that “[p]referred compounds are 5-
`
`and 6-fluoro or bromo-1,3-dihydro-1-hydroxy-2,1-benzoxaborole including
`
`O-esters thereof.” Id. Austin notes that it has been found that compounds
`
`containing an oxaborole ring are “particularly effective against micro-
`
`organisms such as bacteria, algae, yeasts and particularly fungi, especially
`
`fungi which cause degradation of plastics materials.” Id. at 3:35–38.
`
`Along with a number of different preferred oxaboroles, Austin
`
`discloses tavaborole as Example 64, as well as the results of a study showing
`
`tavaborole has effective antifungal activity against five different fungi:
`
`Aspergillus niger (AN), Candida albicans (CA), Aureobasidium pullulans
`
`(AP), Gliocladium roseum (GR), and Penicillium pinophylum (PP). Id. at 39
`
`(Table 9). Of the preferred compounds tested (i.e., Examples 64, 68, and
`
`70), tavaborole had the lowest Minimum Inhibitory Concentration (“MIC”)
`
`value of five parts per million for Candida albicans. Id.; Ex. 1003 ¶ 36.
`
`2.
`
`Brehove (Ex. 1008)
`
`Brehove relates to the topical treatment of nail infections such as
`
`onychomycosis caused by bacteria, fungi, and other pathogens. Ex. 1008
`
`¶ 3. Brehove explains that onychomycosis is a nail disease typically caused
`
`8
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`IPR2018-00169
`Patent 9,566,289 B2
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`by Candida albicans, Trichophyton mentagrophytes, Trichophyton rubrum,
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`or Epidermpophyton floccusum. Id. ¶ 5. Brehove states that Candida
`
`albicans is the most common pathogen causing onychomycosis. Id. ¶ 18.
`
`Brehove teaches that to be effective for onychomycosis, the topical
`
`treatment should exhibit a powerful potency for pathogens, be permeable
`
`through the nail barrier, and be safe for patient use. Id. ¶ 6. According to
`
`Brehove, “[t]here exists a need in the art for a topical application that
`
`combines these traits in high degree.” Id.
`
`Brehove states that the “safety and non-toxicity of organo-boron
`
`compounds has been questioned.” Id. ¶ 13. On the one hand, Brehove
`
`describes one reference that states that boron compounds are “very toxic,”
`
`while on the other hand, Brehove describes references that found the toxicity
`
`of a certain boron-containing compound to be “very low” and another
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`industrial fungicide compound called Biobor® JF to cause “mild irritation.”
`
`Id. ¶¶ 14–15.
`
`Biobor® JF contains a combination of 2,2’-(1-methyltrimethylene
`
`dioxy) bis-(4-methyl-1, 3, 2-dioxaborinane) (referred to by Brehove as “S1”)
`
`and 2,2’-oxybis (4, 4, 6-trimethyl-1, 3, 2-dioxaborinane) (referred to by
`
`Brehove as “S2”). Id. ¶¶ 15, 30. Brehove describes the results of in vitro
`
`testing of the antifungal activity of S1 and S2 against Candida albicans. Id.
`
`¶¶ 30–33. Brehove also describes in vivo testing of S1 and S2 on various
`
`patients with onychomycosis of the toenails. Id. ¶¶ 34–38.
`
`3.
`
`Analysis
`
`Petitioner argues that claims 1 and 2 are unpatentable as obvious over
`
`the combination of Austin and Brehove. Claim 1 recites a pharmaceutical
`
`formulation comprising tavaborole or a pharmaceutically acceptable salt,
`
`and a pharmaceutically acceptable topical carrier. Petitioner asserts that
`
`9
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`IPR2018-00169
`Patent 9,566,289 B2
`
`Austin teaches that tavaborole is an effective fungicide against C. albicans.
`
`Pet. 32 (citing Ex. 1007, Abstract, 3:35–40; Ex. 1005 ¶¶ 101–103).
`
`Petitioner further asserts that Brehove teaches topical application of
`
`pharmaceutical compositions containing boron-containing compounds to
`
`treat onychomycosis of human toenails. Id. (citing Ex. 1008 ¶¶ 34–38; Ex.
`
`1005 ¶ 107).
`
`Regarding the limitations reciting a “pharmaceutically acceptable
`
`topical carrier” that comprises one or more members selected from a group
`
`that includes “waxes or oils, emollients, . . . and a solvent or mixed solvent
`
`system,” Petitioner notes that Brehove teaches pharmaceutical compositions
`
`that include mineral oil, petroleum jelly, wax, or organic film formers to
`
`create a reservoir for the active compound, “thereby allowing ‘extended
`
`diffusion and penetration’ into the toenail and to the nail bed.” Id. at 32–33
`
`(citing Ex. 1008 ¶¶ 25–26).
`
`Having considered the arguments and evidence set forth in the
`
`Petition, we are persuaded that Petitioner has shown sufficiently that each
`
`limitation of claims 1 and 2 is taught by the combination of Austin and
`
`Brehove.
`
`Petitioner then asserts that a person of ordinary skill in the art would
`
`have had numerous reasons to use Austin’s tavaborole to topically treat
`
`onychomycosis, as taught by Brehove with a reasonable expectation of
`
`success. Pet. 33–40. First, Petitioner asserts that a person of ordinary skill
`
`in the art would have combined Austin and Brehove because both references
`
`teach the use of boron-containing compounds as effective fungicides. Pet.
`
`34; Ex. 1005 ¶ 111.
`
`Petitioner also notes that both references teach the efficacy of boron-
`
`containing compounds against onychomycosis-causing Candida albicans.
`
`10
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`IPR2018-00169
`Patent 9,566,289 B2
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`Pet. 34; Ex. 1005 ¶ 111. Moreover, because it was known in the art that
`
`antifungal activity against yeasts such as C. albicans is predictive against
`
`dermatophytes such as T. rubrum and T. mentagrophytes, Petitioner asserts a
`
`person of ordinary skill in the art would have been motivated to combine the
`
`effective antifungal tavaborole taught by Austin with the topical composition
`
`taught by Brehove to treat all primary causes of onychomycosis: C. albicans,
`
`T. rubrum, and T. mentagrophytes. Pet. 34 (citing Ex. 1005 ¶ 162).
`
`Finally, Petitioner asserts that a person of ordinary skill in the art
`
`would have been motivated to replace the topical compositions of Brehove
`
`with Austin’s tavaborole because of tavaborole’s lower molecular weight.
`
`Id. at 35 (citing Ex. 1005 ¶ 112). According to Petitioner’s declarant, it was
`
`known in the art that smaller, lower molecular weight molecules are more
`
`effective at penetrating the human nail barrier and therefore have a greater
`
`likelihood of reaching the underlying nail plate at lower concentrations. Id.
`
`(citing Ex. 1005 ¶¶ 112–113).
`
`We note that we previously held unpatentable the claims of related
`
`U.S. Patent No. 7,767,657 B2 in IPR2015-01780. We determined that
`
`claims 1 and 2 of the ’657 patent, which are very similar to claims 1 and 2 of
`
`the ’289 patent, were unpatentable as obvious over Austin and Brehove.
`
`Ex. 1017, 17–39; compare Ex. 1-15, 323:2–11 (claims 1 and 2 of the ’657
`
`patent) with Ex. 1001, 323:2–11 (claims 1 and 2 of the ’289 patent). Patent
`
`Owner did not appeal that final written decision.
`
`Moreover, the Federal Circuit affirmed our conclusion that claim 6 of
`
`the ’621 patent is unpatentable as obvious over Austin and Brehove. Anacor
`
`Pharms., 2018 WL 2187768, at *9. Claim 6 recites a method of treating
`
`Tinea unguium with a therapeutically effective amount of tavaborole.
`
`Ex. 1012, 68:25–26 (claim 6). The Federal Circuit concluded that
`
`11
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`IPR2018-00169
`Patent 9,566,289 B2
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`“substantial evidence supports the Board’s findings that a person of ordinary
`
`skill in the art would have been motivated to combine the pertinent teachings
`
`of Austin and Brehove and would have had a reasonable expectation of
`
`success in doing so.” Anacor Pharms., 2018 WL 2187768, at *7.
`
`Accordingly, having considered the arguments and evidence in the
`
`Petition—and absent opposition from Patent Owner at this time—we
`
`determine Petitioner has shown a reasonable likelihood of prevailing on its
`
`assertion that claims 1 and 2 are unpatentable as obvious over Austin and
`
`Brehove.
`
`D. Obviousness over Austin, Brehove, and Samour
`
`Petitioner argues that claims 4–7, 10, and 11 are unpatentable as
`
`obvious over Austin, Brehove, and Samour. Pet. 41–46. Based on the
`
`current record, we determine that Petitioner has established a reasonable
`
`likelihood that it would prevail in showing claims 4–7, 10, and 11 are
`
`unpatentable over Austin, Brehove, and Samour. We incorporate here our
`
`earlier findings and discussion regarding the disclosures of Austin and
`
`Brehove.
`
`1.
`
`Samour (Ex. 1010)
`
`Samour relates to a nail lacquer formulation effective for treating or
`
`preventing fungal infections, such as onychomycosis. Ex. 1010, Abstract.
`
`Samour states that onychomycosis is frequently caused by dermatophytes,
`
`but can also be caused by molds and Candida. Id. at 1:22–24. Samour
`
`further provides examples of lacquer formulations containing 5% w/w active
`
`antifungal ingredient with propylene glycol and ethanol (id. at 23:53–24:8).
`
`2.
`
`Analysis
`
`Petitioner contends that the combination of Austin, Brehove, and
`
`Samour teaches each limitation of the claims. Pet. 41–44. Having reviewed
`
`12
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`IPR2018-00169
`Patent 9,566,289 B2
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`the arguments and evidence, we are persuaded that Petitioner has shown
`
`sufficiently at this stage of the proceeding that each limitation of claims 4–7,
`
`10, and 11 is taught by the combination of cited references for the reasons
`
`stated in the Petition. Id.
`
`Petitioner also asserts that a person of ordinary skill in the art would
`
`have had a reason to combine the cited references. Specifically, Petitioner
`
`argues:
`
`[A person of ordinary skill in the art] would have been motivated
`to combine the compound of Austin, a small, boron-based
`compound known for its efficacy against Candida albicans, in
`view of Brehove’s proven safe and effective topical application
`of an industrial boron-based compound for treatment of
`onychomycosis, with Samour’s
`improved nail
`lacquer
`formulation, which was shown to have improved physical
`properties (e.g., durability, water-resistance, flexibility) as well
`as improved diffusion characteristics for active agents, for
`effective topical treatment of onychomycosis.
`
`Pet. 45 (citing Ex. 1005 ¶ 143). Moreover, Petitioner argues that
`
`formulating pharmaceutical compositions and amounts of active ingredients
`
`was well known in the art of topical pharmaceuticals, involving nothing
`
`more than routine experimentation based on well-known protocols. Id.
`
`(citing Ex. 1005 ¶ 142). Finally, Petitioner argues that a person of ordinary
`
`skill in the art would have had a reason to replace the preferred antifungal of
`
`Samour with tavaborole because tavaborole has a lower molecular weight
`
`than econazole. Pet. 48 (citing Ex. 1005 ¶144). According to Petitioner, a
`
`person of ordinary skill in the art would have understood that lower
`
`molecular weight fungicidal compounds are more effective at penetrating the
`
`nail plate. Thus, a person of ordinary skill in the art would have had a
`
`reasonable expectation of success that such topical compositions would
`
`effectively treat onychomycosis. Id. at 45–46 (citing Ex. 1005 ¶ 146).
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`13
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`IPR2018-00169
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`We further note that we found a person of ordinary skill in the art
`
`would have had a reason to combine the disclosures of Austin, Brehove, and
`
`Samour in our Final Written Decision in IPR2015-01780 for substantially
`
`the same reasons stated in the Petition. Ex. 1017, 43–44. Patent Owner did
`
`not appeal that decision.
`
`Having considered the arguments and evidence presented in the
`
`Petition—and absent opposition from Patent Owner at this time—we
`
`determine that Petitioner has established a reasonable likelihood that it
`
`would prevail in showing claims 4–7, 10, and 11 are unpatentable as obvious
`
`over Austin, Brehove, and Samour.
`
`E. Obviousness over Austin, Brehove, Samour, and
`the Excipients Handbook
`
`Petitioner argues that claims 3, 8, 9, and 12–15 are unpatentable as
`
`obvious over Austin, Brehove, Samour, and the Excipients Handbook. Pet.
`
`46–51. Based on the current record, we determine that Petitioner has
`
`established a reasonable likelihood that it would prevail in showing claims 3,
`
`8, 9, and 12–15 are unpatentable over the cited references. We incorporate
`
`here our earlier findings and discussion regarding the disclosures of Austin,
`
`Brehove, and Samour.
`
`1.
`
`The Excipients Handbook (Ex. 1011)
`
`The Excipients Handbook is an excerpt from the Handbook of
`
`Pharmaceutical Excipients relating to edetic acid, which is also known as
`
`EDTA. Ex. 1011, 1, 3. The Excipients Handbook states that EDTA is used
`
`in pharmaceutical formulations as chelating agents. Id. at 3. That is, EDTA
`
`forms “water-soluble complexes (chelates) with alkaline earth and heavy
`
`metal ions.” Id.
`
`14
`
`
`
`IPR2018-00169
`Patent 9,566,289 B2
`
`2.
`
`Analysis
`
`Petitioner asserts that the combination of Austin, Brehove, Samour,
`
`and the Excipients Handbook teaches each limitation of claims 3, 8, 9, and
`
`12–15. Pet. 47–50. Having reviewed the arguments and evidence, we are
`
`persuaded that Petitioner has shown sufficiently at this stage of the
`
`proceeding that each limitation of claims 3, 8, 9, and 12–15 is taught by the
`
`combination of cited references for the reasons stated in the Petition. Id.
`
`Petitioner further asserts that a person of ordinary skill in the art
`
`would have had a reason to combine the cited references with a reasonable
`
`expectation of success for all the same reasons discussed above. Moreover,
`
`according to Petitioner, a person of ordinary skill in the art would have had a
`
`reasonable expectation of success for such a combination because Samour
`
`teaches the use of a chelating agent as a “conventional additive customarily
`
`present in medicinal topical formulations . . . and because EDTA is a well-
`
`known and widely available, effective chelating agent.” Pet. 50–51 (citing
`
`Ex. 1005 ¶ 184).
`
`Having considered the arguments and evidence presented in the
`
`Petition—and absent opposition from Patent Owner at this time—we
`
`determine that Petitioner has established a reasonable likelihood that it
`
`would prevail in showing claims 3, 8, 9, and 12–15 are unpatentable as
`
`obvious over Austin, Brehove, Samour, and the Excipients Handbook.
`
`On April 24, 2018, the Supreme Court held that a decision to institute
`
`under 35 U.S.C. § 314 may not institute on fewer than all claims challenged
`
`in the petition. SAS Inst. Inc. v. Iancu, No. 16-969, 2018 WL 1914661, at
`
`*10 (U.S. Apr. 24, 2018). After considering the evidence and arguments
`
`presented in the Petition, we determine that Petitioner has demonstrated a
`
`15
`
`
`
`IPR2018-00169
`Patent 9,566,289 B2
`
`reasonable likelihood of success in proving that claims 1–15 of the ’289
`
`patent are unpatentable.
`
`III. CONCLUSION
`
`We conclude that Petitioner has established a reasonable likelihood of
`
`prevailing on its assertions that claims 1–15 of the ’289 patent are
`
`unpatentable as obvious.
`
`At this stage of the proceeding, the Board has not made a final
`
`determination as to the patentability of any challenged claim or the
`
`construction of any claim term.
`
`IV. ORDER
`
`In consideration of the foregoing, it is hereby:
`
`ORDERED that pursuant to 35 U.S.C. § 314(a), an inter partes
`
`review of claims 1–15 of the ’289 patent is instituted with respect to all
`
`grounds set forth in the Petition; and
`
`FURTHER ORDERED that, pursuant to 35 U.S.C. § 314(c) and
`
`37 C.F.R. § 42.4(b), inter partes review of the ’938 patent shall commence
`
`on the entry date of this Order, and notice is hereby given of the institution
`
`of a trial.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`16
`
`
`
`IPR2018-00169
`Patent 9,566,289 B2
`
`
`PETITIONER:
`
`Philip Segrest
`philip.segrest@huschblackwell.com
`
`Eric Rakestraw
`ptab-erakestraw@huschblackwell.com
`
`
`PATENT OWNER:
`
`Aaron Maurer
`amaurer@wc.com
`
`David Berl
`dberl@wc.com
`
`
`
`
`
`17
`
`
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