Trials@uspto.gov
`571.272.7822
`
`
`
`
`
` Paper No. 24
`
` Entered: February 23, 2016
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`COALITION FOR AFFORDABLE DRUGS X LLC,
`Petitioner,
`
`v.
`
`ANACOR PHARMACEUTICALS, INC.,
`Patent Owner.
`____________
`
`Case IPR2015-01776
`Patent 7,582,621 B2
`____________
`
`
`
`
`
`
`Before MICHAEL P. TIERNEY, GRACE KARAFFA OBERMANN, and
`TINA E. HULSE, Administrative Patent Judges.
`
`
`
`HULSE, Administrative Patent Judge.
`
`
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`571.272.7822
`
`
`
`
`
` Paper No. 24
`
` Entered: February 23, 2016
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`COALITION FOR AFFORDABLE DRUGS X LLC,
`Petitioner,
`
`v.
`
`ANACOR PHARMACEUTICALS, INC.,
`Patent Owner.
`____________
`
`Case IPR2015-01776
`Patent 7,582,621 B2
`____________
`
`
`
`
`
`
`Before MICHAEL P. TIERNEY, GRACE KARAFFA OBERMANN, and
`TINA E. HULSE, Administrative Patent Judges.
`
`
`
`HULSE, Administrative Patent Judge.
`
`
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`IPR2015-01776
`Patent 7,582,621 B2
`
`
`
`INTRODUCTION
`Coalition for Affordable Drugs X LLC (“Petitioner”) filed a Petition
`requesting an inter partes review of claims 1–12 of U.S. Patent No.
`7,582,621 B2 (Ex. 1001, “the ’621 patent”). Paper 1 (“Pet.”). Anacor
`Pharmaceuticals, Inc. (“Patent Owner”) filed a Preliminary Response to the
`Petition. Paper 17 (“Prelim. Resp.”).
`We have jurisdiction 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 Petition and Preliminary Response, we determine that Petitioner has
`established a reasonable likelihood that it would prevail in showing the
`unpatentability of claims 1–12. Accordingly, we institute an inter partes
`review of those claims.
`
`Related Proceedings
`A.
`Petitioner has filed concurrently two other petitions for inter partes
`review of related U.S. Patent No. 7,767,657 B2 in IPR2015-01780 and
`IPR2015-01785. Pet. 5.
`
`The ’621 Patent
`B.
`The ’621 patent relates to boron-containing compounds useful for
`treating fungal infections, including infections of the nail and hoof known as
`ungual and/or periungual infections. Ex. 1001, Abstract, 1:12–13. One type
`of ungual and/or periungual fungal infection is onychomycosis. Id. at 1:15–
`17. 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
`
`2
`
`
`
`IPR2015-01776
`Patent 7,582,621 B2
`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
`1:17–24.
`Each of the approaches has major drawbacks. 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. Id. at 1:28–45. Surgical treatment is painful and
`undesirable cosmetically (or not realistic for animals such as horses). Id. at
`1:46–52. 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 ineffective. Id. at 1:53–2:11. 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 treat
`ungual and/or periungual infections.” Id. at 2:36–39.
`The ’621 patent claims a method of treating an infection using 1,3-
`dihydro-5-fluoro-l-hydroxy-2, 1-benzoxaborole, which is referred to as
`either compound 1 (see id. at 32:10–17) or compound C10 (see id. at 51:55–
`61) in the Specification, and has the following chemical structure:
`
`
`
`
`
`
`3
`
`
`
`IPR2015-01776
`Patent 7,582,621 B2
`
`Illustrative Claim
`C.
`Petitioner challenges claims 1–12 of the ’621 patent. Claim 1 is
`illustrative and is reproduced below:
`1. A method of treating an infection in an animal, said method
`comprising administering to the animal a therapeutically
`effective amount of 1,3-dihydro-5-fluoro-l-hydroxy-2, 1-
`benzoxaborole, or a pharmaceutically acceptable salt thereof,
`sufficient to treat said infection.
`D.
`The Asserted Grounds of Unpatentability
`Petitioner challenges the patentability of claims 1–12 of the
`’621 patent on the following grounds:
`References
`Basis
`Austin1 and Brehove2
`§ 103
`
`Claim(s) challenged
`1–12
`
`Austin and Freeman3
`
`Austin, Freeman, and Sun4
`
`§ 103
`
`§ 103
`
`1–12
`
`9
`
`Petitioner also relies on the Declarations of Stephen Kahl Ph.D.
`(“Kahl Decl.,” Ex. 1006) and S. Narasimha Murthy Ph.D. (“Murthy Decl.,”
`Ex. 1008).
`
`
`1 Austin et al., WO 95/33754, published Dec. 14, 1995 (Ex. 1002).
`
`2 Brehove, US 2002/0165121 A1, published Nov. 7, 2002 (Ex. 1003).
`3 Freeman et al., WO 03/009689 A1, published Feb. 6, 2003 (Ex. 1004).
`4 Sun et al., US 6,042,845, issued Mar. 28, 2000 (Ex. 1005).
`
`4
`
`
`
`IPR2015-01776
`Patent 7,582,621 B2
`
`
`ANALYSIS
`Person of Ordinary Skill in the Art
`A.
`Petitioner asserts that a person of ordinary skill in the art at the time
`the ’621 patent was filed would have had an advanced degree (Master’s or
`Ph.D.) or equivalent experience in chemistry, pharmacology, or
`biochemistry, and at least two years of experience with the research,
`development, or production of pharmaceuticals. Pet. 23 (citing Ex. 1006
`¶ 21; Ex. 1008 ¶ 34). Patent Owner largely agrees with Petitioner’s
`definition, further adding that a skilled artisan must also have knowledge
`and experience with developing potential drugs candidates for treating
`onychomycosis and ungual and other infections. Prelim. Resp. 15–16.
`We need not decide at this time whether one skilled in the art would
`have possessed the additional knowledge identified by Patent Owner for
`purposes of this Decision. Moreover, Patent Owner acknowledges that
`Petitioner’s declarants purport to have experience in the additional fields
`(Prelim. Resp. 16), and 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) (holding the absence of
`specific findings on “level of skill in the art does not give rise to reversible
`error ‘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),
`
`5
`
`
`
`IPR2015-01776
`Patent 7,582,621 B2
`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
`(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.
`“1,3-dihydro-5-fluoro-1-hydroxy-2,1-benzoxaborole”
`Independent claims 1, 11, and 12 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 parties agree that the claimed compound may also be referred to
`as “5-fluoro-1,3-dihydro-1-hydroxy-2,1-benzoxaborole.” Pet. 11; Prelim.
`Resp. 17–18. Patent Owner further notes that the claimed compound is also
`known as “tavaborole.” Prelim. Resp. 18.
`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.
`
`6
`
`
`
`IPR2015-01776
`Patent 7,582,621 B2
`
`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
`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 1–12 are unpatentable as obvious over
`Austin and Brehove. Pet. 23–42. Patent Owner opposes Petitioner’s
`assertion. Prelim. Resp. 19–45. Based on the current record, we determine
`that Petitioner has established a reasonable likelihood that it would prevail in
`showing claims 1–12 are unpatentable as obvious over Austin and Brehove.
`1.
`Austin (Ex. 1002)
`Austin relates to the use of oxaboroles as industrial biocides, and
`especially as fungicides for the protection of plastic materials. Ex. 1002,
`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 1:35–38.
`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, Aureobasidium pullulans, Candida albicans, Gliocladium
`roseum, and Penicillium pinophylum. Id. at 37 (Table 9).
`
`7
`
`
`
`IPR2015-01776
`Patent 7,582,621 B2
`
`Brehove (Ex. 1003)
`2.
`Brehove relates to the topical treatment of nail infections such as
`onychomycosis caused by bacteria, fungi, and other pathogens. Ex. 1003
`¶ 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”). Ex. 1003 ¶¶ 15, 30. Brehove describes the results of both
`in vitro and in vivo testing of the antifungal activity of S1 and S2 against
`Candida albicans. Id. ¶¶ 30–38.
`
`8
`
`
`
`IPR2015-01776
`Patent 7,582,621 B2
`
`Analysis
`3.
`Petitioner argues that claims 1–12 are unpatentable as obvious over
`the combination of Austin and Brehove. Through claim charts and Dr.
`Murthy’s testimony, Petitioner asserts that the combination teaches each
`limitation of the claims. Pet. 38–42; Ex. 1008 ¶¶ 87–92, 107–15. Having
`reviewed the arguments and evidence, we are persuaded that Petitioner has
`shown sufficiently that each limitation of the challenged claims is taught by
`the combination of Austin and Brehove.
`Petitioner then provides a detailed explanation supported by the
`testimony of its two declarants as to why a person of ordinary skill in the art
`would have administered Austin’s tavaborole in Brehove’s method of
`treating onychomycosis with a reasonable expectation of success. Pet. 31–
`38. Specifically, Petitioner asserts that a person of ordinary skill in the art
`would have combined Austin and Brehove because:
`(1) both references teach the use of boron-based compounds as
`fungicides; (2) both references also disclose the use of boron-
`based compounds to specifically inhibit Candida albicans,
`which is one of the fungi responsible for onychomycosis; and (3)
`Austin discloses boron-based compounds that have lower
`molecular weight than the successful compounds of Brehove and
`are therefore likely to effectively penetrate the nail barrier.
`
`Pet. 31 (citing Ex. 1006 ¶¶ 33-34, 36; Ex. 1008 ¶¶ 86, 93-96, 116).
`In its Preliminary Response, Patent Owner does not appear to
`challenge that the combination of references teaches each limitation of the
`claims. Instead, Patent Owner argues that Petitioner has failed to meet its
`burden to show that a person of ordinary skill in the art would have
`combined Austin and Brehove in the manner recited in the claims with a
`reasonable expectation of success.
`
`9
`
`
`
`IPR2015-01776
`Patent 7,582,621 B2
`First, Patent Owner argues that a skilled artisan would not have started
`with a compound selected from Austin because Austin discloses a biocide,
`which is a toxic poison designed to kill living organisms. Prelim. Resp. 21.
`The parties, however, dispute the toxicity of boron-containing compounds.
`For example, Petitioner’s declarant, Dr. Kahl, testifies that “[b]oron-
`containing compounds are generally considered safe.”5 Ex. 1006 ¶ 30. And
`Brehove identifies at least one article that states that the toxicity of the
`dioxiborinane tested was “very low.” Ex. 1003 ¶ 15. Thus, at this stage of
`the proceeding, we are persuaded that Petitioner has made a sufficient
`showing that a person of ordinary skill in the art would not have been
`dissuaded from starting with Austin because it teaches boron-containing
`compounds.
`Patent Owner also argues that a person of ordinary skill in the art
`would not have selected tavaborole from the millions of compounds
`disclosed in Austin. Prelim. Resp. 23–29. It is well settled that a reference
`may be relied upon for all that it would have reasonably suggested to one
`having ordinary skill in the art. Merck & Co., Inc. v. Biocraft Labs., Inc.,
`874 F.2d 804, 807 (Fed. Cir. 1989). Here, Austin discloses 5-fluoro
`benzoxaboroles as preferred fungicides in the Abstract, and tavaborole is one
`of three preferred compounds tested that effectively inhibits Candida
`albicans, which is a cause of onychomycosis. Pet. 31–32 (citing Ex. 1006
`
`
`5 We acknowledge Patent Owner’s argument challenging Dr. Kahl’s
`credibility regarding the toxicity of boron-containing compounds. Prelim.
`Resp. 4 (citing a paper by Dr. Kahl (Ex. 2002) allegedly emphasizing the
`toxicity of boron-containing compounds). At this stage of the proceeding,
`however, we decline to comment on this issue until the record has been
`developed further during trial.
`
`10
`
`
`
`IPR2015-01776
`Patent 7,582,621 B2
`¶¶ 34, 38; Ex. 1008 ¶¶ 61, 64, 67–71, 90). Accordingly, evaluating Austin
`for all that it teaches, we conclude on the present record that one of ordinary
`skill in the art would have recognized that tavaborole is a preferred fungicide
`for inhibiting Candida albicans, which is a cause of onychomycosis.
`Patent Owner then asserts that Petitioner has not provided a credible
`reason to combine the tavaborole of Austin with the method of treating
`onychomycosis in Brehove with a reasonable expectation of success.
`Prelim. Resp. 29–38. Patent Owner argues that Brehove would not supply a
`reasonable expectation of success because a skilled artisan would not be
`convinced that dioxaborinanes are not toxic, particularly given the lack of
`data in Brehove. Id. at 30–32, 37–38. Patent Owner also argues that a
`skilled artisan would not combine the references given the structural
`differences between tavaborole and dioxaborinanes. Id. at 32–35.
`Petitioner, however, offers the testimony of its declarant, Dr. Murthy, who
`states that both Austin and Brehove disclose boron heterocycles, and that a
`person of ordinary skill in the art would have expected that compounds that
`share similar structural features would likely share similar functional
`features, such as the inhibition of additional fungi responsible for
`oncyhomycosis. Ex. 1008 ¶¶ 100-01. As to the lack of in vivo data in
`Brehove, we note the specificity of the examples and reported results of
`those examples. Ex. 1003 ¶¶ 34–38. Moreover, citing the examples, Dr.
`Murthy testifies that “the topical application of the [Brehove] compositions .
`. . effectively treated the onychomycosis with ‘[n]o skin irritation . . . and no
`[evidence of] side effects.’” Ex. 108 ¶ 71 (citing Ex. 1003 ¶¶ 22, 30, 34–
`38). Thus, although we acknowledge Patent Owner’s arguments to the
`contrary, on this record and at this stage of the proceeding, we determine
`that Petitioner has set forth sufficient evidence to show that a person of
`
`11
`
`
`
`IPR2015-01776
`Patent 7,582,621 B2
`ordinary skill in the art would have had a reason to apply Austin’s
`tavaborole to Brehove’s method of treating onychomycosis with a
`reasonable expectation of success. See Pet. 31–51.
`Accordingly, we determine that Petitioner has established a
`reasonable likelihood that it would prevail in showing claims 1–12 are
`unpatentable as obvious over Austin and Brehove.
`D. Obviousness over Austin and Freeman
`Petitioner argues that claims 1–12 are unpatentable as obvious over
`Austin and Freeman. Pet. 43–56. Patent Owner opposes. Prelim. Resp. 45–
`58. Based on the current record, we determine that Petitioner has
`established a reasonable likelihood that it would prevail in showing claims
`1–12 are unpatentable over Austin and Freeman. We incorporate here our
`earlier findings and discussion regarding the disclosure of Austin.
`1.
`Freeman (Ex. 1004)
`Freeman discloses phenyl boronic acid and related boronic acid
`compounds that are used for treating fungal infections such as
`onychomycosis. Ex. 1004, Abstract, ¶ 1. Freeman identifies Trichophyton
`rubrum (“T. rubrum”) as one of the most common dermatophyte causes of
`onychomycosis. Id. ¶ 8. Freeman also identifies non-dermatophytes,
`“especially Candida Sp.,” as another cause of onychomycosis. Id.
`According to Freeman, phenyl boronic acids “have been found to be
`particularly useful in treating nail fungal infections.” Id. ¶ 22.
`Freeman also discloses results of in vitro testing of the fungicidal
`activity of phenyl boronic acid. Id. ¶¶ 31–34. In particular, Freeman notes
`that phenyl boronic acid exhibited fungicidal effect on T. rubrum. Id. ¶ 34.
`Freeman also notes that the compounds tested had a fungicidal effect on
`Candida parapsylosis at 10 mg/ml. Id.
`
`12
`
`
`
`IPR2015-01776
`Patent 7,582,621 B2
`
`Analysis
`2.
`Petitioner asserts that the combination of Austin and Freeman render
`the subject matter of claims 1–12 obvious. Pet. 43– 56. Through claim
`charts and Dr. Murthy’s testimony, Petitioner asserts that the combination
`teaches each limitation of the claims. Pet. 51–56; Ex. 1008 ¶¶ 119–24, 138–
`46. Having reviewed the arguments and evidence, we are persuaded that
`Petitioner has shown sufficiently that each limitation of the challenged
`claims is taught by the combination of Austin and Freeman.
`Petitioner also asserts that a person of ordinary skill in the art would
`have had a reason to combine Austin’s tavaborole with Freeman’s method of
`treating onychomycosis with a reasonable expectation of success. Pet. 45–
`51. Specifically, Petitioner asserts:
`(1) both references teach the use of boron-based compounds as
`fungicides; (2) both references disclose the use of boron-based
`compounds to specifically inhibit Candida albicans or T.
`rubrum, which are fungi responsible for onychomycosis; and (3)
`Austin discloses boron-based compounds that have structural
`similarity to Freeman’s preferred compounds for treating and
`inhibiting onychomycosis in humans.
`
`Id. at 45–46 (citing Ex. 1008 ¶¶ 65, 74, 77, 125–27). Patent Owner
`challenges Petitioner’s assertions, making similar arguments as described
`above with the combination of Austin and Brehove.
`For example, Patent Owner again argues that a person of ordinary
`skill in the art would not have selected tavaborole from Austin. Prelim.
`Resp. 46–47. Patent Owner also argues a person of ordinary skill in the art
`would not combine Austin and Freeman because a skilled artisan would
`expect Austin’s benzoxaboroles to be toxic. Id. at 47–48. Finally, Patent
`Owner asserts that a person of ordinary skill in the art would not combine
`
`13
`
`
`
`IPR2015-01776
`Patent 7,582,621 B2
`the references given the differences in structure and function of tavaborole
`and Freeman’s phenyl boronic acid. Id. at 48–54.
`For similar reasons stated above with respect to the challenge over
`Austin and Freeman, we determine that Petitioner has made a sufficient
`showing as to why a person of ordinary skill in the art would combine
`Austin and Freeman with a reasonable expectation of success. For example,
`in light of the dispute over the toxicity of boron-containing compounds, we
`are not persuaded, on this record, that the alleged toxicity of benzoxaboroles
`would deter a skilled artisan from looking to Austin and recognizing that
`tavaborole is a preferred fungicide for inhibiting Candida albicans.
`Moreover, although Austin describes the fungicidal activity against Candida
`albicans and Freeman describes the fungicidal activity against T. rubrum,
`Freeman also teaches that its compounds are effective against a different
`species of Candida (Candida parapsylosis). See Ex. 1004 ¶ 34. Petitioner’s
`declarant, Dr. Murthy, explains that “Freeman links Candida Sp., also a
`common target of Austin and Brehove, to onychomycosis and further
`recognizes, consistent with the knowledge of a [person of ordinary skill in
`the art] before February 16, 2005, that the ‘dermatophyte species that most
`often causes onychomycosis in North America’ includes ‘T. rubrum.’”
`Ex. 1008 ¶ 74. Thus, Petitioner offers evidence to show that Austin and
`Freeman’s disclosure of Candida as a cause of onychomycosis would give a
`skilled artisan a reason to combine the references.
`Regarding the structural and functional similarities of the compounds,
`Dr. Murthy testifies that because tavaborole and the compounds of Freeman
`are boron-based cyclic compounds, a skilled artisan would expect the
`compounds to share functional features, such as the inhibition of additional
`fungi responsible for onychomycosis. Id. ¶¶ 132–33. Thus, while we
`
`14
`
`
`
`IPR2015-01776
`Patent 7,582,621 B2
`acknowledge Patent Owner’s arguments to the contrary, we are persuaded
`that Petitioner has set forth sufficient evidence at this stage of the proceeding
`to show that a person of ordinary skill in the art would have had a reason to
`combine Austin and Freeman with a reasonable expectation of success.
`Accordingly, we determine that Petitioner has established a
`reasonable likelihood that it would prevail in showing claims 1–12 are
`unpatentable as obvious over Austin and Freeman.
`E.
`Remaining Challenge
`Petitioner also asserts that claim 9 is unpatentable as obvious over
`Austin, Freeman, and Sun. Pet. 56–59. In light of our findings above with
`respect to Austin and Brehove and Austin and Freeman, we exercise our
`discretion not to institute an inter partes review on this ground. See
`37 C.F.R. § 42.108(a).
`
`
`CONCLUSION
`We conclude that Petitioner has established a reasonable likelihood of
`prevailing on its assertions that claims 1–12 of the ’621 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.
`
`ORDER
`In consideration of the foregoing, it is hereby:
`ORDERED that pursuant to 35 U.S.C. § 314(a), an inter partes
`review is hereby instituted on the following grounds:
`A. Claims 1–12 as obvious over Austin and Brehove; and
`B. Claims 1–12 as obvious over Austin and Freeman;
`
`15
`
`
`
`IPR2015-01776
`Patent 7,582,621 B2
`FURTHER ORDERED that no other proposed grounds of
`unpatentability are authorized.
`FURTHER ORDERED that, pursuant to 35 U.S.C. § 314(c) and
`37 C.F.R. § 42.4, notice is hereby given of the institution of a trial
`commencing on the entry date of this decision.
`
`
`
`
`
`PETITIONER:
`
`Jeffrey Blake
`jblake@merchantgould.com
`
`Kathleen Ott
`kott@merchantgould.com
`
`PATENT OWNER:
`
`Andrea Reister
`areister@cov.com
`
`Enrique Longton
`elongton@cov.com
`
`16
`
`
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
