Trials@uspto.gov
`571.272.7822
`
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`
`
`
`
`
`Paper No. 12
`Entered: July 10, 2017
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`FAMY CARE LIMITED,
`Petitioner,
`
`v.
`
`ALLERGAN, INC.,
`Patent Owner.
`____________
`
`Case IPR2017-00567
`Patent 8,629,111 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
`Entered: July 10, 2017
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`FAMY CARE LIMITED,
`Petitioner,
`
`v.
`
`ALLERGAN, INC.,
`Patent Owner.
`____________
`
`Case IPR2017-00567
`Patent 8,629,111 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 IPR2017-00567
`Patent 8,629,111 B2
`
`I.
`
`INTRODUCTION
`Famy Care Limited (“Famy Care” or “Petitioner”) filed a Petition,
`seeking an inter partes review of claims 1–27 of U.S. Patent
`No. 8,629,111 B2 (“the ’111 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.,
`IPR2016-01128. 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 1–27. 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 ’111 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, 2–3.
`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),
`IPR2017-00568 (U.S. Patent No. 8,633,162 B2), IPR2017-00569 (U.S.
`Patent No. 9,248,191 B2), IPR2017-00570 (U.S. Patent No. 8,642,556 B2),
`and IPR2017-00571 (U.S. Patent No. 8,685,930 B2).
`The ’111 Patent (Ex. 1001)
`B.
`
`The ’111 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 14:20–30. 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
`14:35–40. The patent indicates that “[t]his is surprising for a number of
`reasons.” Id. at 14:41. 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 14:49–52.
`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 14:52–
`57. 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 15:5–8.
`Illustrative Claims
`C.
`
`Petitioner challenges claims 1–27 of the ’111 patent. Independent
`claim 1 is illustrative, and is reproduced below:
`1. A topical ophthalmic emulsion for treating an eye of a human
`comprising 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;
`wherein cyclosporin A is the only peptide present in the topical
`ophthalmic emulsion.
`Independent claims 13 and 18 also recite a topical ophthalmic
`emulsion comprising CsA in an amount of about 0.05% by weight and castor
`
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`oil in an amount of 1.25% by weight, and further specify particular amounts
`for the other components.
`The Asserted Grounds of Unpatentability
`D.
`
`Petitioner challenges the patentability of the claims of the ’111 patent
`on the following grounds:
`References
`Ding ’9791
`
`Claims challenged
`1–27
`
`Basis
`§ 102(b)
`
`Ding ’979 and Sall2
`
`§ 103(a)
`
`1–27
`
`§ 103(a)
`
`11 and 16
`
`Ding ’979, Sall, and
`Acheampong3
`
`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 IPR2016-01128, which was
`instituted as to claims 1–27 of the ’111 patent based on a petition filed by
`Mylan Pharmaceuticals Inc. (“Mylan”).
`
`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 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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`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. 52–73.
`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;
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`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.
`
`Paper 9, 2.
`
`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
`2–3. 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 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.
`
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`Under the circumstances, we determine that joinder of Famy Care to
`IPR2016-01128 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
`IPR2016-01128. 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.
`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 ¶ 56,
`Ex. 1003 ¶¶ 71–72). Petitioner further contends that this person typically
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`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
`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).
`
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`1.
`
`“effective”/“therapeutically effective”
`
`Dependent claims 20-27 state the emulsion is “therapeutically
`effective” in increasing tear production, treating dry eye disease or treating
`KCS, while dependent claim 17 recites that the emulsion is “effective” in
`treating KCS. Petitioner contends that the broadest reasonable
`interpretations of these “effective” clauses do not limit the claim scope
`because they merely recite intended results of the emulsion. Pet. 17.
`Petitioner asserts that because the plain meaning of the word “therapeutic”
`includes palliative as well as curative treatments, the broadest reasonable
`interpretation of the term includes “an emulsion effective to increase tear
`production or reduce symptoms.” Id. at 18 (citing Ex. 1002 ¶74; Ex. 1003
`¶¶ 77–81; Ex. 1022, 7).
`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
`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)).
`
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`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, 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
`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:
`
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`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
`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
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`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
`blood trough concentration used for monitoring the safety of patients
`receiving systemic cyclosporin therapy. Id. at 1004.
`
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`E.
`
`Anticipation of Claims 1–27 by Ding ’979
`
`Petitioner contends that claims 1−27 of the ’111 patent are anticipated
`by Ding ’979. Pet. 26−38. 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. Petitioner also provides a claim chart including
`citations to Ding ’979. Id. at 19–25.
`We recognize 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. 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. 27 (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
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`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
`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 1−27 as anticipated by Ding ’979.
`
`
`
`16
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`Case IPR2017-00567
`Patent 8,629,111 B2
`
`
`F. Obviousness of Claims 1–27 Over the Combination of Ding
`’979 and Sall
`
`Petitioner contends that claims 1–27 are rendered obvious by the
`combined teachings of Ding ’979 and Sall. Pet. 38–50. 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
`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. 39. (citing Ex. 1007, 1; Ex. 1002 ¶ 212; Ex. 1003 ¶¶ 112–
`118).
`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. 40; 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
`
`
`
`17
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`Case IPR2017-00567
`Patent 8,629,111 B2
`
`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 it
`will prevail in showing that claims 1–27 are obvious over the teachings of
`Ding ’979 and Sall.
`G. Obviousness of Claims 11 and 16 Based on Ding ’979, Sall,
`and Acheampong
`
`Petitioner asserts that claims 11 and 16 are unpatentable as obvious
`over Ding ’979, Sall, and Acheampong. Pet. 50–52. .
`Claims 11 and 16 depend directly from claims 1 and 13 and further
`recite as follows: “wherein, when the topical ophthalmic emulsion is
`administered to an eye of a human in an effective amount in treating dry eye,
`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 at
`“peak” or “trough” levels. Id. at 51 (citing Ex. 1008, Table 1). Petitioner
`further asserts that “Acheampong and Sall together give the ordinary-skilled
`artisan a reasonable expectation of success that administering a 0.05% CsA/
`1.25% castor oil emulsion will yield ‘substantially no detectable
`concentration of cyclosporin A’ in the blood.” Id. (citing Ex. 1002 ¶ 244;
`Ex. 1003 ¶ 143–46).
`Based on the arguments presented and evidence of record, we
`determine that Petitioner has demonstrated a reasonable likelihood that
`
`
`
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`Case IPR2017-00567
`Patent 8,629,111 B2
`
`claims 11 and 16 are obvious over the teachings of Ding ’979, Sall, and
`Acheampong.
`III. CONCLUSION
`We conclude that Petitioner has established a reasonable likelihood of
`prevailing on its assertions that claims 1–27 of the ’111 patent are
`unpatentable as anticipated and/or 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. Thus, our view with regard to any
`conclusion reached in the foregoing could change upon consideration of
`Patent Owner’s merits response and upon completion of the current record.
`IV. ORDER
`Accordingly, it is
`ORDERED that trial is instituted in IPR2017-00567 on the following
`grounds:
`A. Claims 1–27 as anticipated by Ding ’979;
`B. Claims 1–27 as obvious over Ding ’979 and Sall;
`C. Claims 11 and 16 as obvious over Ding ’979, Sall, and
`Acheampong;
`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; and
`FURTHER ORDERED that Famy Care’s Motion for Joinder with
`IPR2016-01128 is denied.
`
`
`
`
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`Case IPR2017-00567
`Patent 8,629,111 B2
`
`PETITIONER:
`Deanne M. Mazzochi
`John D. Polivick
`Patrick N. Abbott
`RAKOCZY MOLINO MAZZOCHI SIWIK LLP
`dmazzochi@rmmslegal.com
`jpolivivk@rmmslegal.com
`pabbott@rmmslegal.com
`
`PATENT OWNER:
`Dorothy Whelan
`Mike Kane
`FISH & RICHARDSON P.C.
`whelan@fr.com
`kane@fr.com
`
`
`
`20
`
`
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