Trials@uspto.gov
`571.272.7822
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`Paper No. 12
`Filed: July 12, 2017
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`FAMY CARE LIMITED,
`Petitioner,
`
`v.
`
`ALLERGAN, INC.,
`Patent Owner.
`____________
`
`Case IPR2017-00570
`Patent 8,642,556 B2
`____________
`
`
`Before SHERIDAN K. SNEDDEN, TINA E. HULSE, and
`CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`
`PAULRAJ, Administrative Patent Judge.
`
`
`
`
`
`
`DECISION
`Institution of Inter Partes Review and Denial of Motion for Joinder
`35 U.S.C. § 315(c); 37 C.F.R. § 42.108
`
`
`
`
`
`571.272.7822
`
`
`
`
`
`
`Paper No. 12
`Filed: July 12, 2017
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`FAMY CARE LIMITED,
`Petitioner,
`
`v.
`
`ALLERGAN, INC.,
`Patent Owner.
`____________
`
`Case IPR2017-00570
`Patent 8,642,556 B2
`____________
`
`
`Before SHERIDAN K. SNEDDEN, TINA E. HULSE, and
`CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`
`PAULRAJ, Administrative Patent Judge.
`
`
`
`
`
`
`DECISION
`Institution of Inter Partes Review and Denial of Motion for Joinder
`35 U.S.C. § 315(c); 37 C.F.R. § 42.108
`
`
`
`
`
`
`Case IPR2017-00570
`Patent 8,642,556 B2
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`I.
`
`INTRODUCTION
`Famy Care Limited (“Famy Care” or “Petitioner”) filed a Petition,
`seeking an inter partes review of claims 1–20 of U.S. Patent
`No. 8,642,556 B2 (“the ’556 patent,” Ex. 1001). Paper 4 (“Pet”). Allergan,
`Inc. (“Allergan” or “Patent Owner”) did not file a Preliminary Response to
`the Petition.
`Along with the Petition, Petitioner filed a Motion for Joinder to join
`this proceeding with Mylan Pharmaceuticals Inc. v. Allergan, Inc.,
`IPR2016-01129. Paper 5 (“Mot”). Patent Owner filed an Opposition to the
`Motion for Joinder. Paper 9.
`For the reasons stated below, we deny Petitioner’s motion for joinder.
`As for the Petition, 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, we determine that Petitioner has established a
`reasonable likelihood that it would prevail in showing the unpatentability of
`claims 1–20. Accordingly, we institute an inter partes review of those
`claims.
`A. Related Proceedings
`The parties identify petitions for inter partes review previously filed
`by other petitioners that challenge the claims of the ’556 patent and related
`patents. Pet. 4–5; Paper 8, 2–3. Certain petitions were terminated before
`decisions on institution were entered. Id. Other petitions have been granted
`and inter partes review has been instituted for the following U.S. Patents:
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`U.S. Patent No. 8,633,162 (IPR2016-01130, IPR2017-00599, IPR2017-
`00583); U.S. Patent No. 8,685,930 (IPR2016-01127, IPR2017-00594,
`IPR2017-00576); U.S. Patent No. 8,629,111 (IPR2016-01128, IPR2017-
`00596, IPR2017-00578); U.S. Patent No. 8,642,556 (IPR2016-01129,
`IPR2017-00598, IPR2017-00579); U.S. Patent No. 8,648,048 (IPR2016-
`01131, IPR2017-00600, IPR2017-00585); and U.S. Patent No. 9,248,191
`(IPR2016-01132, IPR2017-00601, IPR2017-00586). Paper 8, 3.
`The parties also identify several district court cases that 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. Tex.); Allergan, Inc.,
`v. Innopharma, Inc., No. 2:15-cv-1504 (E.D. Tex.); Allergan, Inc. v. Famy
`Care, Ltd., No. 2:16-cv-0401 (E.D. Tex.); and Allergan, Inc. v. DEVA
`Holding AS, No. 2:16-cv-1447 (E.D. Tex.). Pet. 5; Paper 8, 2.
`Petitioner has also sought inter partes review for related patents in the
`following proceedings: IPR2017-00566 (U.S. Patent No. 8,648,048 B2),
`IPR2017-00567 (U.S. Patent No. 8,629,111 B2), IPR2017-00568 (U.S.
`Patent No. 8,633,162 B2), IPR2017-00569 (U.S. Patent No. 9,248,191 B2),
`and IPR2017-00571 (U.S. Patent No. 8,685,930 B2).
`B. The ’556 Patent (Ex. 1001)
`The ’556 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, 1:18–20, 1:58–65, 2:63–64. According to the specification, the
`prior art recognized the use of emulsions containing CsA and CsA
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`derivatives to treat ophthalmic conditions. Id. at 1:26–65. 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
`cylcosporin A.” Id. at 1:66–2:1. 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 1:66–2:6.
`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 2:35–38.
`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 efficacy of the composition. Id.
`at 2:42–48. Furthermore, using reduced amounts of cyclosporin component
`mitigates against undesirable side effects or potential drug interactions. Id.
`at 2:48–51.
`The patent identifies two particular compositions that were selected
`for further testing, as shown below:
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`Id. at 15:1–13. 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
`15:18–22. The patent indicates that “[t]his is surprising for a number of
`reasons.” Id. at 15:23. 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 15:24–26.
`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 15:26–
`32. 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 15:54–
`58.
`C. Illustrative Claims
`Petitioner challenges claims 1–20 of the ’556 patent. Independent
`claim 1 is illustrative, and is reproduced below:
`1. A first topical ophthalmic emulsion for treating an eye of a
`human, wherein the first 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 first topical ophthalmic emulsion is
`therapeutically effective in treating dry eye disease; and
`wherein the first topical ophthalmic emulsion provides
`overall efficacy substantially equal to a second topical
`ophthalmic emulsion comprising cyclosporin A in an amount of
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`about 0.1% by weight and castor oil in an amount of about
`1.25% by weight.
`
`Independent claims 13, 14, and 15 also recite a topical ophthalmic
`emulsion comprising CsA in an amount of about 0.05% by weight and castor
`oil in an amount of 1.25% by weight, and further specify particular amounts
`for other components.
`D. Asserted Grounds of Unpatentability
`Petitioner challenges the patentability of the claims of the ’556 patent
`on the following grounds:
`References
`Ding ’9791
`
`Claim(s) challenged
`1–20
`
`Basis
`§ 102
`
`Ding ’979 and Sall2
`
`§ 103(a)
`
`1–20
`
`Ding ’979, Sall, and Glonek3
`
`§ 103(a)
`
`14 and 19
`
`Ding ’979, Sall, and
`Acheampong4
`Ding ’979, Sall, Glonek, and
`Acheampong
`
`
`§ 103(a)
`
`§ 103(a)
`
`11, 18, and 20
`
`19
`
`
`1 Ding et al., US 5,474,979, issued Dec. 12, 1995 (Ex. 1006).
`2 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 631–39 (2000) (Ex. 1007).
`3 Glonek et al., US 5,578,586, issued Nov. 26, 1996 (Ex. 1009).
`4 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, LACRIMAL GLAND, TEAR
`FILM, AND DRY EYE SYNDROMES 2: BASIC SCIENCE AND CLINICAL
`RELEVANCE 1001–04 (David A. Sullivan et al. eds., 1998) (Ex. 1008).
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`Petitioner further relies upon the declarations of Dr. Peter Kador (Ex.
`1002) and Dr. Michael A. Lemp (Ex. 1003).
`II. ANALYSIS
`A. Motion for Joinder
`Famy Care requests joinder with IPR2016-01129, which was
`instituted as to claims 1–20 of the ’556 patent based on a petition filed by
`Mylan Pharmaceuticals Inc. (“Mylan”).
`Based on authority delegated to us by the Director, we have discretion
`to join an inter partes review to a previously instituted inter partes review.
`35 U.S.C. § 315(c). Section 315(c) provides, in relevant part, that “[i]f the
`Director institutes an inter partes review, the Director, in his or her
`discretion, may join as a party to that inter partes review any person who
`properly files a petition under section 311.” Id. When determining whether
`to grant a motion for joinder we consider factors such as timing and impact
`of joinder on the trial schedule, cost, discovery, and potential simplification
`of briefing. Kyocera Corp. v. SoftView, LLC, Case IPR2013-00004, slip op.
`at 4 (PTAB Apr. 24, 2013) (Paper 15).
`Although Famy Care’s Petition is similar to Mylan’s Petition in terms
`of the patentability challenges presented, it differs in its presentation of
`arguments. For example, Famy Care relies upon the declarations of Dr.
`Kador (Ex. 1002) and Dr. Lemp (Ex. 1003) to support its Petition, whereas
`Mylan relies upon the declaration of Mansoor Amiji, Ph.D. Famy Care also
`presents additional arguments and evidence regarding secondary
`considerations that were not presented with Mylan’s Petition. Pet. 58–78.
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`Allergan asserts that there are “significant differences between Famy
`Care’s petition and Mylan’s petition.” Paper 9, 1. Nevertheless, Allergan
`indicated that it will not oppose joinder if Famy Care agrees to participate in
`the joined proceedings under the following conditions:
`1. Famy Care agrees to rely solely on Mylan’s expert;
`
`2. Famy Care agrees to consolidated briefing subject to the
`word count limits for a single party except for motions that
`involve only Famy Care;
`
`3. Famy Care agrees that cross-examination of Patent Owner’s
`witnesses will occur within the timeframe that the rules allot for
`one party; and
`
`4. Famy Care agrees that Mylan will conduct the oral
`argument.
`
`Id.
`
`In its Reply in support of the Motion for Joinder, Famy Care indicates
`that it only agrees to one of Allergan’s conditions—to conduct the cross-
`examination of Patent Owner’s witnesses within the timeframe allotted for
`one party. Paper 10, 1. Famy Care, however, states that it cannot agree to
`forgo reliance on its expert declarants because its experts “include a
`distinguished clinician who can provide the Board a valuable perspective on
`the secondary considerations arguments Allergan leans heavily on.” Id. at 2.
`Famy Care also asserts that it cannot agree to limit its briefing in the joined
`proceeding on the basis that it “believes additional briefing, including on its
`secondary considerations arguments, will give [Famy Care] a fair chance to
`present its own arguments and aid the Board in considering the instituted
`grounds.” Id. at 4. Famy Care only agrees to “consolidate its briefing with
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`Mylan if permitted separate briefing of up to seven pages (including but not
`limited to arguments on which Mylan lacks standing, or [Famy Care] and
`Mylan disagree).” Id. Finally, with respect to oral arguments, Famy Care
`agrees to have Mylan argue first, but asserts a right to “present its own
`arguments (if necessary) only on issues where the Petitioners disagree, or
`where Mylan has no standing to address, all within the allotted time for one
`party.” Id. at 3.
`Under the circumstances, we determine that joinder of Famy Care to
`IPR2016-01129 is not appropriate. Famy Care argues that if an inter partes
`review is instituted based on its Petition, “but joinder is denied, Allergan
`would be compelled to go through duplicative discovery to defend against
`two IPR petitions, and the Board would be required to consider similar
`arguments on the same ground twice.” Id. at 4. As noted above, however,
`Famy Care does not concede to simply taking a “silent understudy” role with
`respect to Mylan, and instead seeks the opportunity to present additional
`arguments, briefing, and evidence, including two additional expert
`declarations, beyond what is being considered based on Mylan’s Petition in
`IPR2016-01129. Moreover, to the extent that a denial of joinder would
`result in duplicative proceedings for Allergan, we note that Allergan has
`opposed joinder in this instance. Accordingly, we determine that joinder
`under these conditions would not “secure the just, speedy, and inexpensive
`resolution” of the proceeding. See 37 C.F.R. § 42.1(b). Thus, Famy Care’s
`Motion for Joinder is denied.
`Having determined that joinder is not appropriate, we now consider
`Famy Care’s Petition on the merits.
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`Person of Ordinary Skill in the Art
`B.
`Petitioner asserts that as of September 15, 2003, a person of ordinary
`skill in the art would likely have had “some combination of: (a) knowledge
`regarding designing and preparing products intended for ocular
`administration; and/or (b) the ability to understand results and findings
`presented or published by others in the field.” Pet. 10 (citing Ex. 1002 ¶ 54).
`Petitioner further contends that this person typically would have an
`advanced degree, such as a medical degree, or a Ph.D. in organic chemistry,
`pharmaceutical chemistry, medicinal chemistry, pharmaceutics, physical
`pharmacy, or a related field, or less education but considerable professional
`experience in these fields. Id.
`On this record, we adopt Petitioner’s definition of the level of
`ordinary skill in the art. We further note that the prior art itself demonstrates
`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
`C.
`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);
`Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2142 (2016) (affirming
`applicability of broadest reasonable construction standard to inter partes
`
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`review proceedings). Under that standard, and absent any special
`definitions, we generally 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).
`“effective”/“therapeutically effective”
`1.
`Independent claims 1 and 13 state that the emulsion is “therapeutically
`effective in treating dry eye disease.” Claim 11 recites administering “an
`effective amount in treating dry eye disease.” Petitioner asserts that the
`plain meaning of the word “therapeutic” includes palliative as well as
`curative treatments, and, in the context of the ‘556 patent, an emulsion
`effective to increase tear production or reduce symptoms is an example of
`one therapeutically effective in treating dry eye. Pet. 17–18 (citing Ex. 1002
`¶¶ 63–66; Ex. 1003 ¶¶ 76–78).
`At this stage of the proceeding, we are persuaded that Petitioner’s
`arguments and evidence support the broadest reasonable interpretation in
`light of the specification, and find that “effective,” “therapeutically
`effective,” and similar terms encompass both palliative and curative
`treatments of dry eye disease/KCS.
`Remaining Claim Terms
`2.
`Petitioner proposes constructions for a number of additional claim
`terms. At this stage of the proceeding, we determine it is unnecessary to
`expressly construe any other claim terms for purposes of this Decision. See
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`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)).
`D. Content of the Prior Art
`
`Petitioner relies upon the following prior art in its challenges.
`Ding ’979 (Ex. 1006)
`1.
`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, Abstract, 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
`delivery of medications to sensitive areas such as ocular tissues.” Id. at
`2:65–3:3.
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`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:
`
`
`
`Id. at 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), glycerine,
`sodium hydroxide, and purified water at a pH range of 7.2–7.6. Id.
`According to Ding ’979, the formulations of Example 1 was “made for
`treatment of keratoconjunctivitis sicca (dry eye) syndrome).” Id. at 5:10–12.
`Sall (Ex. 1007)
`2.
`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
`dry eye disease. Id. Sall found that topical treatment with either CsA 0.05%
`or 0.1% resulted in significantly greater improvements than vehicle
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`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 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.
`Acheampong (Ex. 1008)
`3.
`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
`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
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`blood trough concentration used for monitoring the safety of patients
`receiving systemic cyclosporin therapy. Id. at 1004.
`Glonek (Ex. 1009)
`4.
`Glonek relates to a dry eye treatment process and a composition
`“capable of augmenting and maintaining a stable tear film over the ocular
`surface and/or delivering a medicant to said surface without causing
`substantial blurring of vision.” Ex. 1009, 1:25–29. Glonek teaches that “an
`emulsion over the surface of the eye is expected to cause blurring” and
`“[t]he duration of blur is dependent upon the time required for the emulsion
`to differentiate and form separate layers replicating a tear film. . . . [I]t is
`preferred that the emulsion be stable for long term storage, but rapidly
`differentiate in the eye.” Id. at 6:37–50. Glonek studied the effect of
`surfactant concentration in different emulsion formulations, and concluded
`that “[t]he lower concentrations resulted in poor to fair tear film formation
`up to about 0.05% surfactant content,” whereas the “[b]est results were
`obtained within a range of from 0.05 to 0.15% surfactant. Additional
`surfactant provided little improvement and blurring occurred at the higher
`concentrations.” Id. at 20:25–31.
`Anticipation of Claims 1–20 by Ding ’979
`E.
`Petitioner contends that claims 1−20 of the ’556 patent are anticipated
`by Ding ’979. Pet. 28−40. 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. Petitioner also provides a claim chart including
`citations to Ding ’979. Id. at 21–27.
`We recognize that that Ding ’979 does not disclose the specific
`composition of the challenged claims having 0.05% by weight CsA, 1.25%
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`by weight castor oil, polysorbate 80, and an acrylate/C10-30 alkyl acrylate
`polymer. However, 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). Ex. 1006, 4:30−45. With respect to the CsA
`and castor oil elements, Petitioner points out that Example 1E of Ding ’979
`specifically uses 0.05% CsA, and that Example 1D specifically uses 1.25%
`castor oil. Pet. 30 (citing Ex. 1006, 4:33–43). Additionally, Ding ’979
`discloses that the weight ratio of CsA to castor oil is below 0.16 and
`preferably between 0.12 and 0.02. Ex. 1006, 3:15−20. A composition
`containing 0.05% cyclosporin/1.25% castor oil yields a weight ratio of
`cyclosporin to castor oil of 0.04, which falls within the range disclosed in
`Ding ’979.
`The primary issue presented is whether one skilled in the art would “at
`once envisage” the claimed composition based on the ratio range and
`examples disclosed in Ding ’979. See Kennametal, Inc. v. Ingersoll Cutting
`Tool Co., 780 F.3d 1376, 1381 (Fed. Cir. 2015) (“[A] reference can
`anticipate a claim even if it ‘d[oes] not expressly spell out’ all the limitations
`arranged or combined as in the claim, if a person of skill in the art, reading
`the reference, would ‘at once envisage’ the claimed arrangement or
`combination.”). Here, based on the current record, Petitioner has
`demonstrated a reasonable likelihood of showing that the skilled artisan
`would have at once envisaged a combination that includes about 0.05% CsA
`and about 1.25% castor oil based on Ding ’979. Furthermore, on the present
`record, there is insufficient evidence demonstrating the criticality of the
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`claimed amounts or any difference in the claimed emulsion where CsA and
`castor oil are present across the range disclosed in the prior art. See
`ClearValue, Inc. v. Pearl River Polymers, Inc., 668 F.3d 1340, 1345 (Fed.
`Cir. 2012) (explaining the importance of establishing the criticality of a
`claimed range to the claimed invention in order to avoid anticipation by a
`prior art reference disclosing a broader range); see also Ineos USA LLC v.
`Berry Plastics Corp., 783 F.3d 865, 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 1−20 as anticipated by Ding ’979.
`F. Obviousness of Claims 1–20 Based on Ding ’979 and Sall
`Petitioner contends that claims 1–20 are rendered obvious by the
`combined teachings of Ding ’979 and Sall. Pet. 40–54. The primary 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.
`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, that the
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`skilled artisan would have looked to Sall’s teachings regarding 0.05% and
`0.10% CsA emulsions in formulating a topical emulsion for dry eye
`treatment. Pet. 41. (citing Ex. 1007, 1; Ex. 1002 ¶218, Ex. 1003 ¶ 126–129).
`Upon consideration of the arguments set forth in the Petition, we
`conclude that Petitioner has shown a reasonable likelihood that a skilled
`artisan would have found it obvious to make the castor oil concentration in
`the emulsion to reach the claimed amount of 1.25% by balancing the need to
`minimize any undesirable effects associated with castor oil used at an
`excessive concentration with the desire to take advantage of the “substantial
`palliative benefits” of castor oil for the treatment of dry eye. Pet. 42; Ex.
`1007, 1. See In re Peterson, 315 F.3d 1325, 1330 (Fed. Cir. 2003) (“The
`normal desire of scientists or artisans to improve upon what is already
`generally known provides the motivation to determine where in a disclosed
`set of percentage ranges is the optimum combination of percentages.”); In re
`Boesch, 617 F.2d 272, 276 (CCPA 1980) (“[D]iscovery of an optimum value
`of a result effective variable in a known process is ordinarily within the skill
`of the art.” (citations omitted)).
`Thus, based on the arguments presented and evidence of record, we
`determine that Petitioner has demonstrated a reasonable likelihood that
`claims 1–20 are obvious over the teachings of Ding ’979 and Sall.
`G. Obviousness of Claims 14 and 19 Based on Ding ’979, Sall,
`and Glonek
`Petitioner asserts that claims 14 and 19 are unpatentable as obvious
`over Ding ’979, Sall, and Glonek. Pet. 54–55.
`Claim 14 recites a topical ophthalmic emulsion with the same
`ingredients as claim 1, and further recites that the emulsion “breaks down
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`more quickly in the eye of a human . . . thereby reducing vision distortion”
`as compared to a second emulsion with only half as much castor oil. Claim
`19 depends from claim 14, and recites that “when the first topical
`ophthalmic emulsion is administered to an eye of a human, the blood of the
`human has substantially no detectable concentration of cyclosporin A.”
`Petitioner asserts “Glonek discloses oil-in-water emulsions for the
`treatment of dry eye which are formulated so ‘blurred vision is reduced or
`eliminated and the residence time of tear film on the eye is prolonged.’” Pet.
`54 (citing Ex. 1009, 3:3–7). Petitioner also relies upon Glonek’s teaching
`that “[t]he duration of the blurring is dependent upon the time required for
`the emulsion to differentiate and form separate layers,” and that “it is
`preferred that the emulsion be stable for long term storage, but rapidly
`differentiate in the eye.” Id. at 55 (citing Ex. 1009, 6:37–40, 6:48–50).
`Based on these teachings of Glonek, Petitioner contends that a skilled artisan
`“would reasonably expect a 1.25% castor oil emulsion to break down into its
`differentiated eye layers faster than a 0.625% castor oil emulsion because of
`the increased instability from the higher oil concentration, and that the faster
`differentiation would result in a reduction of blurring.” Id. (citing Ex. 1002
`¶ 271; Ex. 1003 ¶¶ 167–169).
`Based on the arguments presented and evidence of record, we
`determine that Petitioner has demonstrated a reasonable likelihood that
`claims 14 and 19 are obvious over the teachings of Ding ’979, Sall, and
`Glonek.
`H. Obviousness of Claims 11 and 18–20 Based on Ding ’979, Sall,
`and Acheampong
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`Petitioner asserts that claims 11 and 18–20 are unpatentable as
`obvious over Ding ’979, Sall, and Acheampong. Pet. 55–57.
`Claims 11, 18, and 20 depend from independent claims 1, 13, and 15
`respectively and further recite that “when the first topical ophthalmic
`emulsion is administered to an eye of a human, the blood of the human has
`substantially no detectable concentration of cyclosporin A.” Petitioner
`asserts that Acheampong teaches that an emulsion with 0.05% CsA resulted
`in no detectable CsA in the blood, even at the maximum time point. Pet. 56
`(citing Ex. 1008, 6 (Table 1); Ex. 1002 ¶¶ 274–77; Ex. 1003 ¶¶ 172–78).
`Petitioner asserts that Acheampong, together with Sall’s teaching, would
`provide a skilled artisan with a reasonable expectation of success that when
`the 0.05% CsA-in-castor oil emulsion is administered to the eye there is
`“substantially no detectable concentration of cyclosporin A” in the blood.
`Id. at 57.
`Based on the arguments presented and evidence of record, we
`determine that Petitioner has demonstrated a reasonable likelihood that
`claims 11, 18, and 20 are obvious over the teachings of Ding ’979, Sall, and
`Acheampong.
`Obviousness of Claim 19 Based on Ding ’979, Sall, Glonek,
`I.
`and Acheampong
`Petitioner asserts that claim 19 is unpatentable as obvious over Ding
`’979, Sall, Glonek, and Acheampong. Pet. 57. Petitioner contends that
`“[t]he obviousness of the blood level limitation of claim 19 is further
`demonstrated by Acheampong for the reasons explained in Ground 4.” Id.
`(citing Ex. 1002 ¶ 278; Ex. 1003 ¶¶ 1
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