`Tel: 571-272-7822
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`Paper 8
`Entered: December 8, 2016
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`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`
`v.
`
`ALLERGAN, INC.,
`Patent Owner.
`_______________
`
`Case IPR2016-01127
`Patent 8,685,930 B2
`_______________
`
`
`
`Before SHERIDAN K. SNEDDEN, TINA E. HULSE, and
`CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`
`SNEDDEN, Administrative Patent Judge.
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
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`FAMY CARE - EXHIBIT 1031-0001
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`I. INTRODUCTION
`
`Mylan Pharmaceuticals Inc. (“Petitioner”) filed a Petition to institute
`an inter partes review of claims 1−36 (Paper 3; “Pet.”) of US 8,685,930 B2
`(Ex. 1001, “the ’930 patent”). Allergan, Inc. (“Patent Owner”) filed a Patent
`Owner Preliminary response. Paper 7 (“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 consideration
`of the above-mentioned Petition and Preliminary Responses, we conclude
`that Petitioner has established that there is a reasonable likelihood that it will
`prevail with respect to at least one of the challenged claims. We institute an
`inter partes review as to claims 1−36 of the ’930 patent.
`Related Proceedings
`A.
`The parties indicate that the following judicial matters may affect or
`be affected by a decision in this proceeding: Allergan, Inc. v. Teva
`Pharmaceuticals USA, Inc., No. 2:15-cv-01455 (E.D. Texas); Allergan, Inc.,
`v. Innopharma, Inc. and Pfizer, Inc., No. 2:15-cv-1504 (E.D. Texas); and
`Allergan, Inc. v. Famy Care, Ltd., No. 2:16-cv-0401 (E.D. Texas). Pet. 11;
`Paper 6, 2.
`Moreover, Petitioner has sought inter partes review for related patents
`in the following proceedings: Case IPR2016-01128 (U.S. Patent No.
`8,629,111 B2), Case IPR2016-01129 (U.S. Patent No. 8,642,556 B2), Case
`IPR2016-01130 (U.S. Patent No. 8,633,162 B2), Case IPR2016-01131 (U.S.
`Patent No. 8,648,048 B2), and Case IPR2016-01132 (U.S. Patent No.
`
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`9,248,191 B2).
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`B. The ’930 patent (Ex. 1001)
`The ’930 patent generally relates to methods of providing therapeutic
`effects using cyclosporin components, and more specifically to a
`formulation containing, inter alia, cyclosporin-A (“CsA”) and castor oil
`emulsions for treating dry eye syndrome (i.e., keratoconjunctivitis sicca).
`Ex. 1001, 2:54–3:60. According to the specification, the prior art recognized
`the use of emulsions containing CsA and CsA derivatives to treat ophthalmic
`conditions. Id. at 1:17–64. The specification notes, however, that “[o]ver
`time, it has been apparent that cyclosporin A emulsions for ophthalmic use
`preferably have less than 0.2% by weight of cyclosporin A.” Id. at 1:65–67.
`Moreover, if reduced amounts of CsA are used, reduced amounts of castor
`oil are needed because one of the functions of castor oil is to solubilize
`cyclosporin A. Id. at 1:67–2:5.
`Accordingly, the specification states that “[i]t has been found that the
`relatively increased amounts of hydrophobic component together with
`relatively reduced, yet therapeutically effective, amounts of cyclosporin
`component provide substantial and advantageous benefits.” Id. at 2:34–37.
`The relatively high concentration of hydrophobic component provides for a
`more rapid breaking down of the emulsion in the eye, which reduces vision
`distortion and/or facilitates the therapeutic effectiveness of the composition.
`Id. at 2:41–47. Furthermore, using reduced amounts of cyclosporin
`component mitigates against undesirable side effects or potential drug
`interactions. Id. at 2:47–50.
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`The patent identifies two particular compositions that were selected
`for further testing, as shown below:
`
`
`
`Id. at 13:45–60. Based on the results of a Phase III clinical study, the
`specification concludes that “Composition II . . . provides overall efficacy in
`treating dry eye disease substantially equal to that of Composition I.” Id. at
`13:63–67. The patent indicates that “[t]his is surprising for a number of
`reasons.” Id. at 14:1. According to the specification, a reduced
`concentration of CsA in Composition II would have been expected to result
`in reduced overall efficacy in treating dry eye disease. Id. at 14:1–4.
`Moreover, although the large amount of castor oil relative to the amount of
`CsA in Composition II might have been expected to cause increased eye
`irritation, it was found to be substantially non-irritating in use. Id. at 14:4–9.
`Accordingly, the specification states that physicians can prescribe
`Composition II “to more patients and/or with fewer restrictions and/or with
`reduced risk of the occurrence of adverse events, e.g., side effects, drug
`interactions and the like, relative to providing Composition I.” Id. at 14:31–
`35.
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`C. Illustrative Claims
`
`Petitioner challenges claims 1–36 of the ’930 patent. Independent
`claims 1, 13, and 25 are illustrative of the challenged claims, and are
`reproduced below:
`1. A topical ophthalmic emulsion for treating an eye of a human
`having keratoconjunctivitis sicca,
`wherein the topical ophthalmic emulsion comprises
`cyclosporin A in an amount of about 0.05% by weight,
`polysorbate 80, acrylate/C10-30 alkyl acrylate cross-polymer,
`water, and castor oil in an amount of about 1.25% by weight; and
`wherein the topical ophthalmic emulsion is therapeutically
`effective in treating keratoconjunctivitis sicca.
`
`13. A topical ophthalmic emulsion for treating an eye of a human
`having dry eye,
`wherein the topical ophthalmic emulsion comprises
`cyclosporin A in an amount of about 0.05% by weight,
`polysorbate 80, acrylate/C10-30 alkyl acrylate cross-polymer,
`water, and castor oil in an amount of about 1.25% by weight; and
`wherein the topical ophthalmic emulsion is therapeutically
`effective in treating dry eye.
`
`25. A topical ophthalmic emulsion for increasing tear production
`in an eye of a human having keratoconjunctivitis sicca,
`wherein the topical ophthalmic emulsion comprises
`cyclosporin A in an amount of about 0.05% by weight,
`polysorbate 80, acrylate/C10-30 alkyl acrylate cross-polymer,
`water, and castor oil in an amount of about 1.25% by weight; and
`wherein the topical ophthalmic emulsion is therapeutically
`effective in increasing tear production in the eye of the human
`having keratoconjunctivitis sicca.
`
`Ex. 1001, 14:41–48, 15:14–21, 16:4–13.
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`Claims 2–12 depend from claim 1, either directly or indirectly.
`Claims 14–24 depend from claim 13, either directly or indirectly. Claims
`26–36 depend from claim 25, either directly or indirectly.
`
`D. The Asserted Grounds
`
`Petitioner challenges claims 1−36 of the ’930 patent on the following
`grounds. Pet. 12.
`Ground
`
`Reference[s]
`
`Basis
`§ 102
`
`Claims challenged
`1−36
`
`§ 103
`
`1−36
`
`1
`
`2
`
`Ding ’9791
`
`Ding ’979 and Sall2
`Ding ’979, Sall, and
`Acheampong3
`
`3
`
`Petitioner further relies on the declaration of Dr. Mansoor Amiji (Ex.
`1002).
`
`§ 103
`
`11, 23, and 35
`
`
`
` 1
`
` Ding et al., U.S. Patent No. 5,474,979, issued December 12, 1995 (Ex.
`1006, “Ding ’979”).
`2 Kenneth Sall et al., Two Multicenter, Randomized Studies of the Efficacy
`and Safety of Cyclosporine Ophthalmic Emulsion in Moderate to Severe Dry
`Eye Disease, 107 OPHTHALMOLOGY 631−639 (2000) (Ex. 1007, “Sall”).
`3 Andrew Acheampong et al., Cyclosporine Distribution Into The
`Conjunctiva, Cornea, Lacrimal Gland, And Systemic Blood Following
`Topical Dosing Of Cyclosporine To Rabbit, Dog, And Human Eyes, in
`LACRIMAL GLAND, TEAR FILM, AND DRY EYE SYNDROMES 2, BASIC SCIENCE
`AND CLINICAL RELEVANCE, 1001−1004 (1998) (Ex. 1008, “Acheampong”).
`6
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`II. ANALYSIS
`A. Claim Interpretation
`We interpret claims using the “broadest reasonable construction in
`light of the specification of the patent in which [they] appear[].” 37 C.F.R.
`§ 42.100(b); Cuozzo Speed Techs. LLC v. Lee, 136 S. Ct. 2131, 2144–46
`(2016). Under the broadest reasonable construction standard, claim terms
`are generally given their “ordinary and customary meaning,” as would be
`understood by one of ordinary skill in the art at the time of the invention. In
`re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007) (quoting
`Phillips v. AWH Corp, 415 F.3d 1303, 1312 (Fed. Cir. 2006)). “Absent
`claim language carrying a narrow meaning, the PTO should only limit the
`claim based on the specification . . . when [it] expressly disclaim[s] the
`broader definition.” In re Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004)
`(citation omitted). “Although an inventor is indeed free to define the
`specific terms used to describe his or her invention, this must be done with
`reasonable clarity, deliberateness, and precision.” In re Paulsen, 30 F.3d
`1475, 1480 (Fed. Cir. 1994).
`1. “therapeutically effective”
`Claims 1–36 recite a composition for “therapeutically effective in
`treating keratoconjunctivitis sicca” or “therapeutically effective in increasing
`tear production in the eye of the human having keratoconjunctivitis sicca.”
`Petitioner asserts that because the plain meaning of the word “therapeutic”
`includes palliative as well as curative treatments, the broadest reasonable
`interpretation of the terms includes “an emulsion that is effective in
`increasing tear production is an example of an emulsion therapeutically
`
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`effective in treating dry eye disease/KCS palliative and curative treatments.
`Pet. 14–15 (citing Ex. 1002 ¶¶ 41–44; Ex. 1022, 3, 7).
`Patent Owner argues that Petitioner’s proposed construction is too
`broad, and that the claims should be construed to require that “the emulsion
`treat the underlying disease,” and not just its symptoms. Prelim. Resp. 21–
`23. Patent Owner argues that its construction is supported by a dictionary
`definition of “therapeutic,” defined as “[r]elating to therapeutics or to the
`treatment, remediating, or curing of a disease or disorder.” Id. (citing Exs.
`2005, 2006). Patent Owner contrasts this definition of “therapeutic” with the
`definition of “palliative,” defined as “reducing the severity of: denoting the
`alleviation of symptoms without curing the underlying disease,” thereby
`suggesting that the phrase “therapeutically effective” would not include
`palliative effects. Id. at 22 n.2 (citing Ex. 2007). We disagree. The
`definition of “therapeutic” provided by the Patent Owner is not limited to a
`cure of a disease or disorder, but also includes either treatment or
`remediating of a disease or disorder. We thus conclude, on the current
`record, that the ordinary meaning of the phrase “therapeutically effective” is
`not so limited as to exclude palliative effects.
`Patent Owner further argues that the Specification supports its
`construction because “the ‘930 patent specification does not use the word
`‘therapeutic’ to refer to the activity of the other components of the emulsion,
`including castor oil.” Prelim. Resp. 22. We disagree. Contrary to Patent
`Owner’s assertion, the specification does refer to the “therapeutic effects” of
`castor oil: “it is believed that castor oil includes a relatively high
`concentration of ricinoleic acid which itself may be useful in benefitting
`ocular tissue and/or in providing one or more therapeutic effects when
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`administered to an eye.” Ex. 1001, 9:9–14 (emphasis added). Thus,
`notwithstanding Patent Owner’s extrinsic evidence it offers in support of its
`more-limited construction (Prelim. Resp. 21–23), we decline to construe the
`claims in a manner inconsistent with the specification.
`Accordingly, at this stage of the proceeding, we find that
`“therapeutically effective” and similar terms encompass both palliative and
`curative treatments of dry eye disease.
`2. Remaining Claim Terms
`Petitioner proposes constructions for a number of additional claim
`terms. At this stage of the proceeding, we determine that no explicit
`construction of any other claim term is necessary to determine whether to
`institute a trial in this case. we determine it is unnecessary to expressly
`construe any other 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))).
`
`B. Principles of Law
`An inter partes review may be instituted only if “the information
`presented in the [Petition and Preliminary Response, if filed,] shows that
`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).
`To prevail in its challenges to the patentability of the claims, a petitioner
`must establish facts supporting its challenges by a preponderance of the
`evidence. 35 U.S.C. § 316(e); 37 C.F.R. § 42.1(d).
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`We analyze the proposed grounds of unpatentability in accordance
`with the following stated principles.
`1. Law of Anticipation
`The Court of Appeals for the Federal Circuit summarized the
`analytical framework for determining whether prior art anticipates a claim as
`follows:
`
`If the claimed invention was “described in a printed publication”
`either before the date of invention, 35 U.S.C. § 102(a), or more
`than one year before the U.S. patent application was filed, 35
`U.S.C. § 102(b), then that prior art anticipates the patent.
`Although § 102 refers to “the invention” generally, the
`anticipation inquiry proceeds on a claim-by-claim basis. See
`Hakim v. Cannon Avent Group, PLC, 479 F.3d 1313, 1319 (Fed.
`Cir. 2007). To anticipate a claim, a single prior art reference
`must expressly or inherently disclose each claim limitation.
`Celeritas Techs., Ltd. v. Rockwell Int’l Corp., 150 F.3d 1354,
`1361 (Fed. Cir. 1998). But disclosure of each element is not
`quite enough—this court has long held that “[a]nticipation
`requires the presence in a single prior art disclosure of all
`elements of a claimed invention arranged as in the claim.”
`Connell v. Sears, Roebuck & Co., 722 F.2d 1542, 1548 (Fed. Cir.
`1983) (citing Soundscriber Corp. v. United States, 175 Ct. Cl.
`644, 360 F.2d 954, 960 (1966) (emphasis added)).
`Finisar Corp. v. DirecTV Grp., Inc., 523 F.3d 1323, 1334–35 (Fed. Cir.
`2008). We must analyze prior art references as a skilled artisan would. See
`Scripps Clinic & Research Found. v. Genentech, Inc., 927 F.2d 1565, 1576
`(Fed. Cir. 1991) (to anticipate, “[t]here must be no difference between the
`claimed invention and the reference disclosure, as viewed by a person of
`ordinary skill in the field of the invention”).
`When a patent claims a range, that range is anticipated by a prior art
`reference if the reference discloses a point within the broader range.
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`Titanium Metals Corp. v. Banner, 778 F.2d 775, 782 (Fed. Cir. 1985). If the
`prior art discloses its own range, rather than a specific point, then the prior
`art is anticipatory insofar as it describes the claimed range with sufficient
`specificity. See ClearValue, Inc. v. Pearl River Polymers, Inc., 668 F.3d
`1340, 1345 (Fed. Cir. 2012); Atofina v. Great Lakes Chem. Corp., 441 F.3d
`991, 999 (Fed. Cir. 2006).
`2. Law of Obviousness
`A patent may not be obtained if the differences between the subject
`matter sought to be patented 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 the subject matter pertains.
`35 U.S.C. § 103(a). The legal 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 skill in the art; and (4) objective
`evidence of nonobviousness, i.e., secondary considerations. See Graham v.
`John Deere Co., 383 U.S. 1, 17–18 (1966).
`In KSR International Co. v. Teleflex Inc., the Supreme Court 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 likely the product not of
`innovation but of ordinary skill and common sense. In that
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`instance the fact that a combination was obvious to try might
`show that it was obvious under § 103.
`550 U.S. 398, 421 (2007). “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, 1359−1360 (Fed. Cir.
`2009) (citing KSR, 550 U.S. at 417).
`The factual inquiries for an obviousness determination also include
`secondary considerations based on evaluation and crediting of objective
`evidence of nonobviousness. Graham v. John Deere Co., 383 U.S. at
`17−18. Notwithstanding what the teachings of the prior art would have
`suggested to one with ordinary skill in the art at the time of the invention,
`the totality of the evidence submitted, including objective evidence of
`nonobviousness, may lead to a conclusion that the claimed invention would
`not have been obvious to one with ordinary skill in the art. In re Piasecki,
`745 F.2d 1468, 1471–72 (Fed. Cir. 1984).
`Such a conclusion, however, requires the finding of a nexus to
`establish that the evidence relied upon traces its basis to something novel in
`the claim and not to something in the prior art. Institut Pasteur & Universite
`Pierre et Marie Curie v. Focarino, 738 F.3d 1337, 1347 (Fed. Cir. 2013).
`Generally, objective evidence of nonobviousness must be shown to have a
`nexus. In re GPAC Inc., 57 F.3d 1573, 1580 (Fed. Cir. 1995) (nexus
`generally); In re Kao, 639 F.3d 1057, 1069 (Fed. Cir. 2011) (unexpected
`results); In re Huang, 100 F.3d 135, 140 (Fed. Cir. 1996) (commercial
`success); Rambus Inc. v. Rea, 731 F.3d 1248, 1256 (Fed. Cir. 2013) (long-
`felt need).
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`Objective evidence of nonobviousness also must be reasonably
`commensurate in scope with the claim. Kao, 639 F.3d at 1068. This does
`not mean that the proffered evidence must reach every embodiment within
`the scope of the claim, so long as there is an “adequate basis to support the
`conclusion that other embodiments falling within the claim will behave in
`the same manner.” Id.
`
`C. Content of the Prior Art
`Petitioner relies upon the following prior art in its challenges.
`1. Ding ’979 (Ex. 1006)
`Ding ’979, assigned to Patent Owner, relates to ophthalmic emulsions
`including cyclosporin, castor oil, and polysorbate 80 that have a high
`comfort level and low irritation potential. Ex. 1006, cover, 1:4–9. Ding
`’979 explains that cyclosporins have “known immunosuppressant activity”
`and have been found “effective in treating immune medicated
`keratoconjunctivitis sicca (KCS or dry eye disease) in a patient suffering
`therefrom.” Id. at 1:10–16. Although the solubility of cyclosporins in water
`is extremely low, cyclosporins have some solubility in oily preparations
`containing higher fatty acid glycerides such as castor oil. Id. at 1:40–41,
`2:39–42. Ding ’979 notes, however, that formulations with a high
`concentration of oils have several drawbacks, including exacerbation of the
`symptoms of dry eyes and low thermodynamic activity of cyclosporin,
`which leads to poorer drug bioavailability. Id. at 2:42–57. Accordingly,
`Ding ’979 “is directed to an emulsion system which utilizes higher fatty acid
`glycerides but in combination with polysorbate 80 which results in an
`emulsion with a high comfort level and low irritation potential suitable for
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`delivery of medications to sensitive areas such as ocular tissues.” Id. at
`2:65–3:3.
`Ding ’979 discloses that the preferable weight ratio of CsA to castor
`oil is below 0.16, and more preferably between 0.12 and 0.02. Id. at 3:15–
`20. Specifically, Ding ’979 discloses several compositions as Example 1,
`shown below:
`
`
`Ex. 1006, 4:32–43. Example 1 identifies compositions A through E, which
`contain varying amounts of CsA, castor oil, polysorbate 80, Pemulen® (an
`acrylate/C10-30 alkyl acrylate cross-polymer) (id. at 4:1–5), glycerine,
`sodium hydroxide, and purified water at a pH range of 7.2–7.6. Id. at 4:32–
`43. According to Ding ’979, the formulations of Example 1 was “made for
`treatment of keratoconjunctivitis sicca (dry eye) syndrome.” Id. at 5:10–12.
`2. Sall (Ex. 1007)
`Sall describes the results of two identical clinical trials—supported by
`a grant from Patent Owner—in which patients were treated twice daily with
`either CsA 0.05% or 0.1% ophthalmic emulsions or vehicle for six months.
`Ex. 1007, Abstract, 631. The study sought to compare the efficacy and
`safety of CsA 0.05% and 0.1% to vehicle in patients with moderate to severe
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`dry eye disease. Id. Sall found that “topical treatment with either CsA
`0.05% or 0.1% resulted in significantly greater improvements than vehicle
`treatment in two objective signs of dry eye disease.” Id. at 637. Sall also
`found that treatment with CsA 0.05% resulted in significantly greater
`improvements in several subjective parameters. Id. Sall also found that
`trough blood concentrations of CsA were undetectable in all samples of CsA
`0.05%, whereas CsA was quantifiable in only six samples for six different
`patients in the CsA 0.1% group. Id.
`Sall discloses that “[b]oth the CsA emulsions and vehicle were sterile,
`nonpreserved castor oil in water emulsions whose precise formulation is
`proprietary.” Id. at 632.
`Sall notes that the only treatments available for dry eye disease are
`palliative in nature. Id. at 638. In light of the results of the study, Sall states
`that it “represents the first therapeutic treatment specifically for dry eye
`disease and a significant breakthrough in the management of this common
`and frustrating condition.” Id.
`3. Acheampong (Ex. 1008)
`Acheampong describes a study by Patent Owner as part of its
`evaluation of the clinical efficacy of 0.05%–0.4% cyclosporin emulsion for
`the treatment of immuno-inflammatory eye diseases such as dry eye
`syndrome. Ex. 1008, 1001. Acheampong describes the results of its
`research to determine the ocular tissue distribution of cyclosporin in rabbits
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`and dogs, and to compare tissue concentrations in rabbits, dogs, and humans
`after topical administration. Id.
`In the study of humans, the subjects with dry eye disease received an
`eyedrop of vehicle or 0.05%, 0.1%, 0.2%, or 0.4% cyclosporin emulsions
`twice daily for 12 weeks. Id. at 1002. Blood samples were collected from
`all subjects at morning troughs after 1, 4, and 12 weeks of dosing, and from
`certain subjects at 1, 2, and 4 hours after the last dose at week 12. Id.
`Acheampong found that the human blood cyclosporin A concentrations were
`less than 0.2 ng/ml for each emulsion, which is lower than the 20−100 ng/ml
`blood trough concentration used for monitoring the safety of patients
`receiving systemic cyclosporin therapy. Id. at 6.
`
`D. Asserted Grounds of Unpatentability
`
`1. Anticipation of Claim 1−36 Over Ding ’979
`
`Petitioner contends that claims 1−36 of the ’930 patent are anticipated
`by Ding ’979. Pet. 20−38. In support of its assertion that Ding ’979 teaches
`each element of the challenged claims, Petitioner sets forth the teachings of
`Ding ’979 discussed above and provides a detailed claim chart explaining
`how each claim limitation is disclosed in Ding ’979. Id.
`Patent Owner argues that Ding ’979 does not disclose the specific
`composition of the challenged claims having 0.05% by weight CsA, 1.25%
`by weight castor oil, polysorbate 80, and an acrylate/C10-30 alkyl acrylate
`polymer. Prelim. Resp. 24. Patent Owner acknowledges that Ding ’979
`discloses that the weight ratio of cyclosporin to castor oil is below 0.16 and
`preferably between 0.12 and 0.02, but contends “[t]his [range] is very
`broad.” Id. (citing Ex. 1006, 3:15−20).
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`Patent Owner further acknowledges that Ding ’979 discloses five
`specific compositions having the following CsA/castor oil ratios:
`0.40%/5.00% (Sample A), 0.20%/5.00% (Sample B), 0.20%/2.50% (Sample
`C), 0.10%/1.25% (Sample D), and 0.05%/0.625% (Sample E). Prelim.
`Resp. 24–25 (citing Ex. 1006, 4:30−45). Patent Owner contends, however,
`that Ding ’979 fails to disclose a specific composition containing 0.05%
`cyclosporin/1.25% castor oil. Id.
`On the current record, there appears to be no dispute between the
`parties that a composition containing 0.05% cyclosporin/1.25% castor oil
`yields a weight ratio of cyclosporin to castor oil of 0.04 falling within the
`range disclosed in Ding ’979. Id. at 23−29; Pet. 20. Rather, the dispute
`between the parties appears to be whether Ding ’979 describes the claimed
`amounts with sufficient specificity to anticipate this limitation of the
`challenged claims.
`As stated by the Federal Circuit:
`It is well established that the disclosure of a genus in the prior art
`is not necessarily a disclosure of every species that is a member
`of that genus. There may be many species encompassed within
`a genus that are not disclosed by a mere disclosure of the genus.
`On the other hand, a very small genus can be a disclosure of each
`species within the genus.
`Atofina, 441 F.3d at 999 (citation omitted). In reaching our conclusion with
`regard to anticipation, we must determine whether Ding ’979 discloses a
`broad genus such that different portions of the broad range would work
`differently. ClearValue, 668 F.3d at 1345; see also Ineos USA LLC v. Berry
`Plastics Corp., 783 F.3d 865, 871 (Fed. Cir. 2015) (“Ineos is also correct
`that when the prior art discloses a range, rather than a point, the court must
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`evaluate whether the patentee has established that the claimed range is
`critical to the operability of the claimed invention.”).
`In Atofina, the Federal Circuit reversed the district court’s finding of
`anticipation where the claims recited temperature between 330–450 degrees
`Celsius and the prior art disclosed a “broader temperature range” of 100–500
`degrees Celsius. Atofina, 441 F.3d at 998–99. The key to the court’s
`conclusion in Atofina “was the fact that the evidence showed that a person of
`ordinary skill in the art would have expected the [method] to operate
`differently, or not [at] all, outside of the temperature range claimed in the
`patent-in-suit.” Ineos, 783 F.3d at 869 (citing Atofina, 441 F.3d at 999;
`ClearValue, 668 F.3d at 1345). Here, based on the current record, there is
`insufficient evidence demonstrating the criticality of the claimed amounts or
`any difference across the range disclosed in the prior art.4 See ClearValue,
`668 F.3d at 1345 (explaining the importance of establishing the criticality of
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` To the extent that Patent Owner relies upon the Examiner’s conclusion that
`“the specific combination of 0.05% by weight cyclosporin A with 1.25%
`castor oil is surprisingly critical for the therapeutic effectiveness in the
`treatment of dry eye or keratoconjunctivitis sicca,” which was based on the
`same evidence relied upon to assert unexpected results in response to
`Petitioner’s obviousness challenges, we determine at this preliminary stage
`that it is more appropriate to allow further evidence to be developed during
`trial regarding any such alleged criticality. Prelim. Resp. 17−19 (citing Ex.
`1004, 276–77).
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`a claimed range to the claimed invention in order to avoid anticipation by a
`prior art reference disclosing a broader range); see also Ineos, 783 F.3d at
`870 (Fed. Cir. 2015) (finding that patentee failed to establish that certain
`properties would differ if range from prior art patent was substituted for
`range of limitation); OSRAM Sylvania, Inc. v. Am. Induction Techs., Inc.,
`701 F.3d 698, 705−06 (Fed. Cir. 2012) (emphasizing that “how one of
`ordinary skill in the art would understand the relative size of a genus or
`species in a particular technology is of critical importance”).
`Accordingly, on the current record, we determine that there is a
`reasonable likelihood that Petitioner would prevail in demonstrating the
`unpatentability of claims 1−36 as anticipated by Ding ’979.
`2. Obviousness of Claims 1–36 over the Combination of
`Ding ’979 and Sall
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`Petitioner contends that claims 1–36 are rendered obvious by the
`combined teachings of Ding ’979 and Sall. Pet. 38–45. Petitioner has
`included a claim chart for claims 1 and 7–12 specific to this ground. Id. at
`42–45. The issue before us is whether it would have been obvious to use the
`particular concentrations of 0.05% CsA and 1.25% castor oil recited in the
`challenged claims. Id. at 38–42.
`As noted above, Ding ’979 specifically identifies examples that
`include 0.05% CsA and 1.25% castor oil, albeit not as part of the same
`composition. Ex. 1006, 4:32–43. Petitioner contends, however, Sall
`“provides a strong rationale to deliver 0.05% CsA using the 1.25% castor oil
`vehicle taught by Ding ’979 (Example 2C).” Pet. 39. Petitioner contends
`that Sall teaches that either the 0.05% or 0.10% CsA emulsion is
`therapeutically effective in increasing tear production and treating dry eye
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`disease/KCS. Id. (citing Ex. 1007, 631, 635; EX1002 ¶¶ 77, 107).
`Petitioner contends that Sall discloses that the vehicle used in the study
`reported in Sall (castor oil) “contributed to the overall improvements
`observed in all treatment groups in this study.” Id. at 8, 40 (citing Ex. 1007,
`632, 639; Ex. 1002 ¶¶ 112–113). Petitioner further contends that
`
`[t]he 1.25% castor oil vehicle is the only vehicle from Ding ʼ979
`Example 2 for which both 0.05% and 0.10% CsA have a ratio of
`CsA-to-castor oil inside Ding ’979’s more preferred range of
`between 0.12 and 0.02 (id. at 3:17-20) and also within the ratio
`range found with each of the Example 1 emulsions (0.04-0.08).
`Id. at 40 (citing Ex. 1006, 3:17–20). Finally, Petitioner provides the
`following rationale for combining Ding ’979 and Sall:
`
`In light of Ding ’979 and Sall, a person of ordinary skill
`would have had a reasonable expectation that this emulsion
`would be effective in treating dry eye disease/KCS based on at
`least the success described by Sall: “Treatment with CsA, 0.05%
`or 0.1% gave significantly (P ≤ 0.05) greater improvements than
`vehicle in two objective signs of dry eye disease.” Id. at 631;
`EX1002, ¶107. As explained by Dr. Amiji, it would have been a
`routine matter for a skill