Trials@uspto.gov
`571.272.7822
`
`
`
`
`
` Paper No. 9
`
` Entered: June 14, 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 IPR2018-00170
`Patent 9,566,290 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 14, 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 IPR2018-00170
`Patent 9,566,290 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)
`
`
`
`
`
`
`
`
`
`IPR2018-00170
`Patent 9,566,290 B2
`
`
` INTRODUCTION
`Flatwing Pharmaceuticals, LLC (“Petitioner”) filed a Petition
`requesting an inter partes review of claims 1–12 of U.S. Patent No.
`9,566,290 B2 (Ex. 1001, “the ’290 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
`claims challenged in the petition.” 35 U.S.C. § 314(a). Upon considering
`the argument and evidence presented in the Petition, we determine that
`Petitioner has established a reasonable likelihood that it would prevail in
`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.
`
`Related Proceedings
`A.
`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. 9,566,289 (IPR2018-00169), 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
`substantially the same claim of priority as U.S. Patent No. 9,566,290.” Id.
`The Board determined each of the claims of the ’621 patent was
`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
`
`
`
`IPR2018-00170
`Patent 9,566,290 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
`Anacor Pharmaceuticals, Inc. v. Iancu, No. 2017-1947, 2018 WL 2187768,
`at *9 (Fed. Cir. May 14, 2018).
`The parties also identify U.S. Patent Application Nos. 15/355,393 and
`15/355,813 as administrative matters that may be affected by this
`proceeding. Pet. xi; Paper 4, 2.
`The ’290 Patent
`B.
`The ’290 patent relates to boron-containing compounds useful for the
`topical treatment of onychomycosis and/or cutaneous fungal infections.
`Ex. 1001, Abstract. The claimed invention relates 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 ungual and/or periungual infections generally falls into three
`categories: systemic administration of medicine; surgical removal of the
`nail or hoof followed by topical treatment of the exposed tissue; or topical
`application of medicine with bandages to keep the medication in place on
`the nail or hoof. Id. at 1:52–58.
`Each of the approaches has major drawbacks. Id. at 1:58–59.
`Systemic administration of medicine typically requires long-term, high-dose
`therapy, which can have significant adverse effects on, for example, the liver
`and testosterone levels, which further negatively affects patient compliance.
`Id. at 1:63–2:7. Surgical treatment is painful and undesirable cosmetically
`(or not realistic for animals such as horses). Id. at 2:14–20. And topical
`dosage forms cannot keep the drug in contact with the infected area for
`therapeutically effective periods of time and, because of the composition of
`the nail, topical therapy for fungal infections have generally been
`
`3
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`IPR2018-00170
`Patent 9,566,290 B2
`ineffective. Id. at 2:21–45. Accordingly, the Specification states that “there
`is a need in the art for compounds which can effectively penetrate the nail.
`There is also need in the art for compounds which can effectively penetrate
`the nail . . . [and] effectively treat ungual and/or periungual infections.” Id.
`at 3:3–7.
`Dermatophytes are the most common cause of onychomycosis. Id. at
`130:54–56. Onychomycosis caused by a dermatophyte is called Tinea
`unguium. Id. at 129:56–58. The most frequently isolated dermatophyte in
`Tinea unguium is Trichophyton rubrum followed by T. mentagrophytes. Id.
`at 130:58–59.
`The ’290 patent claims a method of treating onychomycosis of a
`toenail caused by T. rubrum or T. mentagrophytes by topically administering
`1,3-dihydro-5-fluoro-l-hydroxy-2, 1-benzoxaborole, which is referred to as
`either compound 1 (see id. at 137:5–15) or compound C10 (see id. at
`179:60) in the Specification, and has the following chemical structure:
`
`
`
`
`
`Illustrative Claim
`C.
`Petitioner challenges claims 1–12 of the ’290 patent. Claim 1,
`the only independent claim, is illustrative and is reproduced below:
`
`4
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`IPR2018-00170
`Patent 9,566,290 B2
`1. A method of treating a human having onychomycosis of
`a toenail caused by Trichophyton rubrum or Trichophyton
`mentagrophytes, the method comprising:
`topically administering to the toenail a pharmaceutical
`composition comprising an amount of 1,3-dihydro-5-
`fluoro-l-hydroxy-2,1-benzoxaborole or a
`pharmaceutically acceptable salt thereof, effective to
`inhibit an aminoacyl tRNA synthetase in the
`Trichophyton rubrum or Trichophyton mentagrophytes.
`The Asserted Grounds of Unpatentability
`D.
`Petitioner challenges the patentability of claims 1–12 of the
`’290 patent on the following grounds:
`References
`Basis
`Austin1 and Brehove2
`§ 103
`
`Claims challenged
`1, 4, 7, 9, and 10
`
`Austin, Brehove, and Samour3
`
`§ 103
`
`2, 3, 5, 6, 8, 11, and 12
`
`Austin and Freeman4
`
`§ 103
`
`1, 4, 7, 9, and 10
`
`Austin, Freeman, and Samour
`
`§ 103
`
`2, 3, 5, 6, 8, 11, and 12
`
`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 Freeman et al., WO 03/009689 A1, published Feb. 6, 2003 (“Freeman,”
`Ex. 1009).
`
`5
`
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`IPR2018-00170
`Patent 9,566,290 B2
`
` ANALYSIS
`Person of Ordinary Skill in the Art
`A.
`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. 21 (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)).
`
`Claim Construction
`B.
`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
`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
`
`6
`
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`
`IPR2018-00170
`Patent 9,566,290 B2
`(Fed. Cir. 2007). Any special definitions for claim terms must be set forth
`with reasonable clarity, deliberateness, and precision. See In re Paulsen,
`30 F.3d 1475, 1480 (Fed. Cir. 1994).
`“1,3-dihydro-5-fluoro-1-hydroxy-2,1-benzoxaborole”
`1.
`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:
`
`
`Petitioner notes that the claimed compound may also be referred to as
`“5-fluoro-1,3 dihydro-1-hydroxy-2,1-benzoxaborole,” as in Austin. Pet. 29;
`Ex. 1005 ¶¶ 35–46. Petitioner’s declarant further notes that the short name
`for the claimed compound is “tavaborole.” Ex. 1005 ¶ 35.
`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.
`
`Remaining Claim Terms
`2.
`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
`
`7
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`IPR2018-00170
`Patent 9,566,290 B2
`resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g,
`Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).
`C. Obviousness over Austin and Brehove
`Petitioner asserts that claims 1, 4, 7, 9, and 10 are unpatentable as
`obvious over Austin and Brehove. Pet. 32–42. Based on the current record,
`we determine that Petitioner has established a reasonable likelihood that it
`would prevail in showing the challenged claims are unpatentable as obvious
`over Austin and Brehove.
`
`Austin (Ex. 1007)
`1.
`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.
`
`8
`
`
`
`IPR2018-00170
`Patent 9,566,290 B2
`
`Brehove (Ex. 1008)
`2.
`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
`by Candida albicans, Trichophyton mentagrophytes, Trichophyton rubrum,
`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
`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.
`
`9
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`IPR2018-00170
`Patent 9,566,290 B2
`
`Analysis
`3.
`Petitioner argues that claims 1, 4, 7, 9, and 10 are unpatentable as
`obvious over the combination of Austin and Brehove. Claim 1 recites a
`method of treating a human having onychomycosis of a toenail caused by T.
`rubrum or T. mentagrophytes, comprising “topically administering to the
`toenail a pharmaceutical composition comprising an amount of [tavaborole]
`. . . effective to inhibit an aminoacyl tRNA synthetase in the T. rubrum or T.
`mentagrophytes.” Petitioner asserts that Austin specifically teaches that
`tavaborole is an effective fungicide. Pet. 33 (citing Ex. 1007, Abstract,
`Table 9). Petitioner further asserts that Brehove teaches topical application
`of boron-containing compounds to treat onychomycosis of human toenails.
`Id. (citing Ex. 1008 ¶¶ 34–38; Ex. 1005 ¶ 102).
`Moreover, Petitioner asserts that Austin teaches that tavaborole is
`inhibitory against Candida albicans in vitro, and that Brehove teaches that T.
`rubrum and T. mentagrophytes are typical causes of onychomycosis. Pet. 34
`(citing Ex. 1007, 35–39; Ex. 1008 ¶ 5; Ex. 1005 ¶¶ 98, 100. Petitioner also
`notes that Brehove teaches topical formulations containing organo-boron
`compounds that inhibit C. albicans in vitro and treat onychomycosis in vivo,
`describing its formulations as effective in curing onychomycosis caused by
`“bacteria, fungi or other pathogens.” Id. (citing Ex. 1008 ¶¶ 3, 32, 33).
`Accordingly, Petitioner’s declarant contends that a person of ordinary skill
`in the art would have understood “inhibitory activity against yeasts such as
`Candida albicans to be predictive of antifungal activity against
`dermatophytes, including T. rubrum and T. mentagrophytes.” Ex. 1005
`¶ 99.
`As for the limitation that the compound be administered in an amount
`“effective to inhibit an aminoacyl tRNA synthetase in [T. rubrum or T.
`
`10
`
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`
`IPR2018-00170
`Patent 9,566,290 B2
`mentagrophytes],” Petitioner argues that such inhibition is an inherent
`outcome of the topical application of tavaborole for treating onychomycosis.
`Pet. 35. That is, Dr. Murthy testifies that “[a]minoacyl tRNA synthetase
`inhibition is the mechanism of action by which tavaborole inhibits the
`growth of or kills microorganisms it contacts, thereby making the compound
`therapeutically effective against onychomycosis causing microorganisms
`(e.g., Candida species, T. rubrum, T. mentagrophytes).” Ex. 1005 ¶ 103; see
`also id. ¶ 105 (citing supporting literature).
`Having considered the arguments and evidence set forth in the
`Petition, we are persuaded that Petitioner has shown sufficiently that each
`limitation of claim 1 is taught or suggested by the combination of Austin and
`Brehove. We have also considered Petitioner’s arguments with respect to
`dependent claims 4, 7, 9, and 10 and find that Petitioner has made a
`sufficient showing as to those claims, as well. See Pet. 36–38.
`Petitioner then asserts that a person of ordinary skill in the art would
`have used Austin’s tavaborole in Brehove’s method of topically treating
`onychomycosis with a reasonable expectation of success. Pet. 38–45.
`Specifically, 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. 38–39; Ex. 1005
`¶ 110.
`Petitioner also notes that both references teach the efficacy of boron-
`containing compounds against onychomycosis-causing Candida albicans.
`Pet. 39; Ex. 1005 ¶ 110. 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
`
`11
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`IPR2018-00170
`Patent 9,566,290 B2
`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. 39 (citing Ex. 1005 ¶ 110).
`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.
`Pet. 40 (citing Ex. 1005 ¶¶ 111–112). 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 ¶¶ 111–112).
`Petitioner contends that a person of ordinary skill in the art would
`have had a reasonable expectation of success in combining Austin’s
`tavaborole with Brehove’s method of treating onychomycosis for the
`following reasons:
`1) boron-containing compounds were well known in the art as
`effective biocides and the boron containing compounds of
`Brehove and Austin share common structural features,
`indicating similar fungicidal activity; 2) the preferred
`tavaborole compound of Austin is taught to have similar
`fungicidal activity with the active ingredient compounds used
`in the method of Brehove; 3) the tavaborole compound of
`Austin has a lower molecular weight than the active ingredient
`compounds used in the method of Brehove; 4) Brehove
`demonstrates that an industrial boron-based biocide such as the
`tavaborole compound of Austin can be incorporated as an active
`ingredient in a safe and effective topical application for
`treatment of onychomycosis.
`Pet. 41–42 (citing Ex. 1005 ¶¶ 114–124); see also id. at 42–45.
`We note that the Federal Circuit affirmed our conclusion that claim 6
`of the ’621 patent is unpatentable as obvious over Austin and Brehove.
`12
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`IPR2018-00170
`Patent 9,566,290 B2
`Anacor Pharms., 2018 WL 2187768, at *9. Claim 6 is similar to claim 1 of
`the ’290 patent, as both claims recite a method of treating Tinea unguium
`(i.e., onychomycosis caused by dermatophytes such as T. rubrum and T.
`mentagrophytes) with a therapeutically effective amount of tavaborole.
`Compare Ex. 1012, 68:25–26 (claim 6) with Ex. 1001, 321:26–34 (claim 1).
`The Federal Circuit concluded that “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 at this
`stage of the proceeding, we determine Petitioner has shown a reasonable
`likelihood of prevailing on its assertion that claims 1, 4, 7, 9, and 10 are
`unpatentable as obvious over Austin and Brehove.
`D. Obviousness over Austin, Brehove, and Samour
`Petitioner argues that claims 2, 3, 5, 6, 8, 11, and 12 are unpatentable
`as obvious over Austin, Brehove, and Samour. Pet. 44–49. Based on the
`current record, we determine that Petitioner has established a reasonable
`likelihood that it would prevail in showing the challenged claims are
`unpatentable over Austin, Brehove, and Samour. We incorporate here our
`earlier findings and discussion regarding the disclosures of Austin and
`Brehove.
`
`Samour (Ex. 1010)
`1.
`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
`
`13
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`IPR2018-00170
`Patent 9,566,290 B2
`further provides examples of lacquer formulations containing 5% w/w active
`antifungal ingredient with propylene glycol and ethanol (id. at 23:53–24:8).
`Analysis
`2.
`Dependent claims 2 and 5 further recite wherein the pharmaceutical
`composition is in the form of a solution comprising 5% w/w of tavaborole.
`Dependent claims 3 and 6 further recite wherein the composition further
`comprises ethanol and propylene glycol. Dependent claim 8 further recites
`administering the composition once a day, and dependent claims 11 and 12
`recite inhibiting leucyl tRNA synthetase in T. rubrum and T.
`mentagrophytes, respectively.
`Petitioner contends that the combination of Austin, Brehove, and
`Samour teaches each limitation of the claims. Pet. 46–50 (citing Ex. 1005
`¶¶ 139–141, 148–164). Having reviewed the arguments and evidence, we
`are persuaded that Petitioner has shown sufficiently that each limitation of
`claims 2, 3, 5, 6, 8, 11, and 12 is taught by the combination of cited
`references for the reasons stated in the Petition. Pet. 46–50.
`Petitioner also asserts that a person of ordinary skill in the art would
`have had a reason to combine Austin’s tavaborole with the improved
`pharmaceutical composition of Samour in Brehove’s method of topically
`treating onychomcosis for the same reasons asserted with respect to Austin
`and Brehove alone. Pet. 50 (citing Ex. 1005 ¶¶ 142, 143, 146, 165, 166).
`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. at 51 (citing Ex. 1005 ¶ 143). Petitioner
`further notes that Samour teaches formulations including 5% w/w active
`
`14
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`IPR2018-00170
`Patent 9,566,290 B2
`fungicidal ingredient, which falls within the concentration ranges taught in
`Austin and Brehove. Id. (citing Ex. 1005 ¶ 143).
`Finally, Petitioner argues that a person of ordinary skill in the art
`would have had a reason to replace the preferred antifungal econazole of
`Samour with tavaborole because tavaborole has a lower molecular weight
`than econazole. Pet. 51 (citing Ex. 1005 ¶145). 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. Id. (citing Ex. 1005 ¶ 145). 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, including that caused
`by T. rubrum and T. mentagrophytes. Id. at 51–52 (citing Ex. 1005 ¶ 147).
`Having considered the arguments and evidence presented in the
`Petition, we determine that Petitioner has established a reasonable likelihood
`that it would prevail in showing claims 2, 3, 5, 6, 8, 11, and 12 are
`unpatentable as obvious over Austin, Brehove, and Samour.
`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
`reasonable likelihood of success in proving that claims 1–12 of the ’290
`patent are unpatentable.
`
` CONCLUSION
`We conclude that Petitioner has established a reasonable likelihood of
`prevailing on its assertions that claims 1–12 of the ’290 patent are
`unpatentable as obvious.
`
`15
`
`
`
`IPR2018-00170
`Patent 9,566,290 B2
`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.
`
` 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 1–12 of the ’290 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 ’290 patent shall commence
`on the entry date of this Order, and notice is hereby given of the institution
`of a trial.
`
`
`
`
`
`
`
`
`16
`
`
`
`IPR2018-00170
`Patent 9,566,290 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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