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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
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`
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`CIPLA LIMITED,
`Petitioner
`
`v.
`
`ALCON RESEARCH, LTD.,
`Patent Owner.
`
`U.S. Patent No. 9,533,053 to Gamache et al.
`Issue Date: January 3, 2017
`Title: High Concentration Olopatadine Ophthalmic Composition
`
`
`
`Inter Partes Review No. 2018-01021
`
`
`
`
`
`
`Petition for Inter Partes Review of U.S. Patent No. 9,533,053 Under
`35 U.S.C. §§ 311-319 and 37 C.F.R. §§ 42.1-.80, 42.100-.123
`
`
`
`
`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
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`

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`TABLE OF CONTENTS
`
`Page
`
`
`INTRODUCTION ...............................................................................1
`I.
`II. OVERVIEW .......................................................................................1
`III. STANDING
`(37 C.F.R.
`§
`42.104(a);
`PROCEDURAL
`STATEMENTS)..................................................................................2
`IV. MANDATORY NOTICES (37 C.F.R. § 42.8(a)(1)) .................................2
`A.
`Each Real Party-in-Interest (37 C.F.R. § 42.8(b)(1)) ........................2
`B. Notice of Related Matters (37 C.F.R. § 42.8(b)(2)) ..........................3
`1.
`Judicial Matters .................................................................3
`2.
`Administrative Matters .......................................................3
`C. Designation of Lead and Back-up Counsel and Service (37
`C.F.R. §§ 42.8(b)(3), 42.8(b)(4), 42.10(a), and 42.10(b)) .................4
`STATEMENT OF THE PRECISE RELIEF REQUESTED AND THE
`REASONS THEREFOR (37 C.F.R. § 42.22(a)).......................................4
`VI. THE ’053 PATENT .............................................................................4
`A.
`Claim Construction .....................................................................5
`VII. NONE OF THE CLAIMS ARE ENTITLED TO THE PRIORITY
`DATE OF PROVISIONAL APPLICATION 61/487,789 ..........................7
`VIII. A PERSON OF ORDINARY SKILL IN THE ART .................................9
`IX.
`IDENTIFICATION OF CHALLENGE (37 C.F.R. § 42.104(b)) .............. 10
`X.
`INVALIDITY ANALYSIS ................................................................. 11
`A. Ground 1: Claims 1-13 are Rendered Obvious by Bhowmick in
`View of Yanni, Castillo, and Abelson .......................................... 12
`1.
`The Level of Ordinary Skill in the Pertinent Art and the
`Scope and Content of the Prior Art ..................................... 13
`
`V.
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`2.
`
`2.
`
`Differences between the Claims and the Prior Art ................ 16
`a.
`Claim 1 ................................................................. 16
`b.
`Claim 8 ................................................................. 30
`c.
`Claim 2 ................................................................. 31
`d.
`Claims 3 and 9........................................................ 31
`e.
`Claims 4 and 10 ...................................................... 32
`f.
`Claims 5 and 11 ...................................................... 32
`g.
`Claims 6 and 12 ...................................................... 33
`h.
`Claims 7 and 13 ...................................................... 34
`B. Ground 2: Claims 1-13 Are Rendered Obvious by Schneider in
`View of Hayakawa, Bhowmick, Castillo, and Abelson .................. 37
`1.
`The Level of Ordinary Skill in the Pertinent Art and the
`Scope and Content of the Prior Art ..................................... 38
`Differences between the Claims and the Prior Art ................ 38
`a.
`The Prior Art .......................................................... 38
`a.
`Claim 1 ................................................................. 40
`b.
`Claim 8 ................................................................. 46
`c.
`Claim 2 ................................................................. 47
`d.
`Claims 3 and 9........................................................ 48
`e.
`Claims 4 and 10 ...................................................... 48
`f.
`Claims 5 and 11 ...................................................... 49
`g.
`Claims 6 and 12 ...................................................... 49
`h.
`Claims 7 and 13 ...................................................... 50
`C. Ground 3: Claims 1-13 Are Rendered Obvious by Bhowmick,
`Schneider, Castillo, and Abelson................................................. 51
`1.
`The Level of Ordinary Skill in the Pertinent Art and the
`Scope and Content of the Prior Art ..................................... 51
`Differences Between the Claims and the Prior Art ................ 51
`a.
`Claim 1 ................................................................. 51
`b.
`Claim 8 ................................................................. 56
`c.
`Claim 2 ................................................................. 56
`d.
`Claims 3 and 9........................................................ 57
`e.
`Claims 4 and 10 ...................................................... 57
`
`2.
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`D.
`
`2.
`
`3.
`
`Claims 5 and 11 ...................................................... 57
`f.
`Claims 6 and 12 ...................................................... 58
`g.
`Claims 7 and 13 ...................................................... 58
`h.
`The District Court’s Decision Not to Invalidate the ’154 Patent
`Should Not Dissuade the PTAB from Instituting Review ............... 59
`1.
`The District Court Did Not Rule on the Validity of the
`’053 Patent...................................................................... 59
`The Board Instituted Review of the Claims of the ’154
`Patent ............................................................................. 60
`The District Court Focused Too Heavily on Preferred
`Embodiments .................................................................. 60
`The District Court Focused Too Heavily on
`the
`Commercial Formulations ................................................. 61
`E. Objective Indicia of Non-Obviousness......................................... 62
`1.
`No Unexpected Results..................................................... 62
`2.
`No Commercial Success ................................................... 63
`3.
`No Failure of Others......................................................... 63
`XI. CONCLUSION ................................................................................. 64
`
`
`
`4.
`
`
`
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`
`TABLE OF AUTHORITIES
`
` Page(s)
`
`Cases
`Alcon Research, Ltd. v. Cipla Limited,
`1-17-cv-01244 (D. Del.) ...................................................................... 3, 20
`Alcon Research, Ltd. v. Lupin Limited,
`1-17-cv-00321 (D. Del.) ............................................................................ 3
`Alcon Research, Ltd. v. Watson Labs. Inc.,
`1-17-cv-00252 (D. Del.) ............................................................................ 3
`Amneal Pharms. LLC v. Hospira, Inc.,
`IPR2016-01577...................................................................................... 62
`Amneal Pharms. LLC v. Purdue Pharma L.P.,
`IPR2016-01412................................................................................. 38, 61
`Amneal Pharms. LLC v. Purdue Pharma L.P.,
`IPR2016-01413...................................................................................... 38
`Amneal Pharms., LLC v. Supernus Pharms., Inc.,
`IPR2013-00368...................................................................................... 61
`Apotex, Inc. v. Alcon Research Ltd.,
`IPR2016-01640........................................................................................ 1
`Argentum Pharm. LLC v. Alcon Research, Ltd.,
`IPR2016-00544........................................................................................ 1
`Ariad Pharms., Inc. v. Eli Lilly & Co.,
`598 F.3d 1336 (Fed. Cir. 2010) (en banc) .................................................... 8
`Bayer Pharma AG v. Watson Laboratories, Inc.,
`874 F. 3d 1316 (Fed. Cir. 2017) ............................................................... 61
`Chi Mei Innolux Corp. v. Semiconductor Energy Lab. Co., Ltd.,
`IPR2013-00028...................................................................................... 11
`
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`CRS Advanced Techs., Inc. v. Frontline Techs., Inc.,
`CBM2012-00005 ..................................................................................... 6
`Cuozzo Speed Techs., LLC v. Lee,
`136 S. Ct. 2131 (2016) ........................................................................ 7, 11
`In re Fulton,
`391 F.3d 1195 (Fed. Cir. 2004) ......................................................... passim
`Gnosis S.P.A., et al. v. South Alabama Medical Science Foundation,
`IPR2013-00116...................................................................................... 61
`Graham v. John Deere Co. of Kansas City,
`383 U.S. 1 (1966) ................................................................................... 11
`Iron Grip Barbell Co. v. USA Sports, Inc.,
`392 F.3d 1317 (Fed. Cir. 2004) ........................................................... 21, 63
`Koios Pharm LLC v. Medac Gesellschaft Fur Klinische
`Spezialpraparate,
`IPR2016-01370...................................................................................... 18
`Kyocera Corp. v. Softview LLC,
`IPR2013-00007........................................................................................ 6
`In re Mouttet,
`686 F.3d 1322 (Fed. Cir. 2012) ......................................................... passim
`Newell Cos., Inc. v. Kenney Mfg. Co.,
`864 F.2d 757 (Fed. Cir. 1988) .................................................................. 61
`Ormco Corp. v. Align Tech., Inc.,
`463 F.3d 1299 (Fed. Cir. 2006) ................................................................ 63
`Owens Corning v. Fast Felt Corp.,
`IPR2015-00650...................................................................................... 11
`In re Peterson,
`315 F.3d 1325 (Fed. Cir. 2005) ..................................................... 21, 53, 62
`In re Peterson,
`315 F.3d at 1329–30 ........................................................................ passim
`
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`Pfizer, Inc. v. Apotex, Inc.,
`480 F.3d 1348 (Fed. Cir. 2008) ................................................................ 61
`Polaris Wireless, Inc. v. TruePosition, Inc.,
`IPR2013-00323........................................................................................ 8
`PowerOasis, Inc. v. T-Mobile USA,
`522 F.3d 1299 (Fed. Cir. 2008) .................................................................. 8
`SAP America, Inc. v. Pi-Net Int’l., Inc.,
`IPR2014-00414........................................................................................ 8
`Sharp Corp. v. Surpass Tech Innovation LLC,
`IPR2015-00021...................................................................................... 11
`In re Translogic Tech., Inc.,
`504 F.3d 1249 (Fed. Cir. 2007) .................................................................. 7
`Vandenberg v. Dairy Equip. Co.,
`740 F.2d 1560 (Fed. Cir. 1984) ................................................................ 62
`Watson Labs., Inc. v. United Therapeutics Corp.,
`IPR2017-01621...................................................................................... 37
`Statutes
`35 U.S.C. §§ 102(a) .................................................................................... 37
`35 U.S.C. § 102(b) ............................................................................... passim
`35 U.S.C. § 103(a) ...................................................................... 10, 12, 37, 51
`35 U.S.C. § 112 ¶ 1 ....................................................................................... 8
`35 U.S.C. § 325(d) ...................................................................................... 38
`Regulations
`37 C.F.R. § 42.6(d) ..................................................................................... 10
`37 C.F.R. § 42.10(b)...................................................................................... 2
`37 C.F.R. § 42.63(e) ...................................................................................... 2
`
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`37 C.F.R. § 42.100(b) .................................................................................... 7
`37 CPR. § 42.100(b) .................................................................................... 7
`37 C.F.R. § 42.106(a) .................................................................................... 2
`37 CPR. § 42.106(a) .................................................................................... 2
`
`
`
`
`
`
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`Vii
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`

`TABLE OF EXHIBITS
`
`Exhibit
`Ex #
`1001 U.S. Patent No. 8,791,154 B2 (“’154 Patent”)
`1002 U.S. Patent No. 9,533,053 B2 (“’053 Patent”)
`1003 WO 2008/015695 A2 (“Bhowmick”)
`1004 YANNI et al., “The In Vitro and In Vivo Ocular Pharmacology of
`Olopatadine (AL-4943A), an Effective Anti-Allergic/Antihistaminic
`Agent,” Journal of Ocular Pharmacology and Therapeutics, Volume
`12, Number 4, 1996, pp. 389-400 (“Yanni”)
`1005 U.S. Pat. No. 6,995,186 B2 (“Castillo”)
`1006 U.S. Pat. Pub. No. 2011/0082145 A1 (“Schneider”)
`1007 U.S. Pat. No. 5,641,805 (“Hayakawa”)
`File Wrapper for U.S. Patent No. 8,791,154 B2
`1008
`1009
`File Wrapper for U.S. Provisional Appl. No. 61/487,789
`1010
`File Wrapper for U.S. Provisional Appl. No. 61/548,957
`1011
`Physician’s Desk Reference - PATANOL®; PATADAY® (“PDR”)
`1012 Handbook of Pharmaceutical Excipients
`David B. Troy, Remington: The Science and Practice of Pharmacy,
`Philadelphia College of Pharmacy and Science 21st Ed., 229, 856-866
`(2005)
`1014 Declaration of Dr. Laskar
`1015
`Argentum Pharm. LLC v. Alcon Research, Ltd., IPR2016-00544,
`Paper 8 (PTAB July 18, 2016)
`
`1013
`
`1016
`
`1017
`
`Apotex, Inc. v. Alcon Research Ltd., IPR2016-01640, Paper 2 (PTAB
`Aug. 18, 2016)
`
`Alcon Research, Ltd. v. Watson Labs., 1-15-cv-01159 (D. Del.) Paper
`69 (November 18, 2016)
`
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`1018 Abelson & Gomes, “Olopatadine 0.2% ophthalmic solution: the first
`ophthalmic antiallergy agent with once-daily dosing,” Expert
`Opinion on Drug Metabolism & Toxicology, 4:4, 453-461 (2008)
`
`Pharmaceutical Calculations, 13th Ed., Ansell, 2010
`
`1019
`
`1020 U.S. Patent No. 6,770,675
`
`1021
`
`1022
`
`1023
`
`1024
`
`Argentum Pharm. LLC v. Alcon Research, Ltd., IPR2016-00544,
`Paper 1 (PTAB Feb. 2, 2016)
`
`Apotex, Inc. v. Alcon Research Ltd., IPR2016-01640, Paper 3 (PTAB
`Aug. 18, 2016)
`
`Apotex, Inc. v. Alcon Research Ltd., IPR2016-01640, Paper 8 (PTAB
`Oct. 5, 2016)
`
`Apotex, Inc. v. Alcon Research Ltd., IPR2016-01640, Paper 9 (PTAB
`Nov. 30, 2016)
`
`1026
`
`1025 Abelson & Loeffler, Conjunctival Allergen Challenge: Models in the
`Investigation of Ocular Allergy, Current Allergy and Asthma Reports
`3:363-368 (2003)
`Eiichi Uchio, Treatment of allergic conjunctivitis with olopatadine
`hydrochloride eye drops, Clinical Ophthalmology 2(3):525-531, 527-
`528 (2008)
`1027 Abelson et al., “Efficacy of Once-Daily Olopatadine 0.2%
`Ophthalmic Solution Compared to Twice-Daily Olopatadine 0.1%
`Ophthalmic Solution for the Treatment of Ocular Itching Induced by
`Conjunctival Allergen Challenge,” Current Eye Research 32:1017-
`1022 (2007)
`
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`

`1028
`
`Leonardi, et al., “The anti-allergic effects of a cromolyn sodium-
`chlorpheniramine combination compared
`to ketotifen
`in
`the
`challenge model,” European
`J. of
`conjunctival allergen
`Ophthalmology 13(2):128-133 (2003)
`
`1029 U.S. Patent Publication No. 2008/0085922
`
`1030
`
`1031
`
`Alcon Research, Ltd. v. Watson Labs., 1-15-cv-01159 (D. Del.) Paper
`155 (March 1, 2018)
`https://www.pazeodrops.com/
`
`1032 Orange Book entry for PAZEO®
`
`1033
`
`EP 0214779
`
`1034 U.S. Pat. No. 4,871,865
`
`1035
`
`EP 0235796
`
`1036 U.S. Pat. No. 5,116,863
`
`1037 CV of Dr. Paul Laskar
`
`1038 Handbook of Chemistry and Physics 2006, 87th Ed.
`
`1039 U.S. Publication No. 2004/0198828 (“Abelson”)
`
`1040 Nandi et al., “NANDI et al., “Synergistic Effect of PEG-400 and
`Cyclodextrin
`to Enhance Solubility of Progesterone,” AAPS
`PharmSciTech 2003; 4 (1), pp 1-5.”
`
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`1041
`
`LOFTSSON et al., “Cyclodextrins in eye drop formulations:
`enhanced topical delivery of corticosteroids to the eye,” Acta
`Ophthamologica Scandinavica, 2002, pp. 144-150.
`
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`
`
`I.
`
`INTRODUCTION
`
`Cipla Limited (“Petitioner”) petitions for Inter Partes Review (“IPR”), and
`
`seeks cancellation of Claims 1–13 (“challenged claims”) of U.S. Patent
`
`No. 9,533,053 (“the ’053 patent”) (EX1002).
`
`II. OVERVIEW
`The patent family to which the ’053 patent belongs has a troubled past
`
`before the PTAB. The parent patent, U.S. Patent No. 8,791,154 (EX1001), has
`
`already been subject to an IPR challenge by Argentum. Argentum Pharm. LLC v.
`
`Alcon Research, Ltd., IPR2016-00544, Paper 1 (PTAB Feb. 2, 2016) (EX1021). In
`
`response to that Petition, the PTAB instituted review of U.S. Patent No. 8,791,154
`
`(parent patent) (“the ’154 patent”) on every challenged claim on every ground. Id.,
`
`Paper 8 (EX1015). Shortly thereafter, Apotex filed another petition seeking
`
`joinder with Petitioner Argentum. See Apotex, Inc. v. Alcon Research Ltd.,
`
`IPR2016-01640, Paper 2, (PTAB Aug. 18, 2016) (EX1016); Id., Paper 3
`
`(EX1022). The PTAB granted joinder. Id., Paper 8 (EX1023). Rather than
`
`allowing Argentum or Apotex’s IPR challenges to proceed as to the parent patent,
`
`Alcon settled with both of them. Id., Paper 9 (EX1024).
`
`Not surprisingly, the claims of the ’053 patent are similar to the claims of the
`
`’154 (parent) patent. Generally, the claims of the ’053 patent cover a composition
`
`of a well-known drug—olopatadine—for
`
`the
`
`treatment of ocular allergy
`
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`
`symptoms, which olopatadine was known to treat. Physicians’ Desk Reference,
`
`Petition for Inter Partes Review
` of U.S. Patent No. 9,533,053
`
`62nd Ed., 532-533 (2008) (“PDR”) (EX1011) (disclosing PATADAY™ and
`
`PATANOL®);1 EX1002, 1:30-35. The other claim limitations of the ’053 patent
`
`recite common classes of excipients used in ophthalmic formulations including
`
`those containing olopatadine. Nothing new is claimed. EX1014, ¶70.
`
`III. STANDING (37 C.F.R. § 42.104(a); PROCEDURAL STATEMENTS)
`Petitioner certifies that: (1) the ’053 patent is available for IPR; and
`
`(2) Petitioner is not barred or estopped from requesting IPR of any claim of the
`
`’053 patent on the grounds identified herein. This Petition is filed in accordance
`
`with 37 C.F.R. § 42.106(a). Filed herewith are a Power of Attorney and an Exhibit
`
`List pursuant to § 42.10(b) and § 42.63(e). The required fee is paid through an
`
`online credit card, and the Office is authorized to charge any fee deficiencies and
`
`credit overpayments to Deposit Acct. No. 501710 (Customer ID No. 27160).
`
`IV. MANDATORY NOTICES (37 C.F.R. § 42.8(a)(1))
`A. Each Real Party-in-Interest (37 C.F.R. § 42.8(b)(1))
`Petitioner Cipla Limited is the real party-in-interest. Out of an abundance of
`
`
`
`caution, and for purposes of this Petition only, Petitioner additionally discloses the
`
`
`1 PDR was published 2008 and is prior art under 35 U.S.C. § 102(b). PDR was not
`
`disclosed to or discussed by the Examiner during prosecution of the ’053 patent.
`
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`

`
`following entities as additional real parties-in-interest: Cipla USA, Inc., InvaGen
`
`Petition for Inter Partes Review
` of U.S. Patent No. 9,533,053
`
`Pharmaceuticals, Inc., and Cipla (EU) Limited.
`
`B. Notice of Related Matters (37 C.F.R. § 42.8(b)(2))
`Judicial Matters
`1.
`To Petitioner’s knowledge, the ’053 patent is (or was) the subject of the
`
`following litigation: Alcon Research, Ltd. v. Cipla Limited, 1-17-cv-01244 (D.
`
`Del.); Alcon Research, Ltd. v. Lupin Limited, 1-17-cv-00321 (D. Del.); Alcon
`
`Research, Ltd. v. Watson Labs. Inc., 1-17-cv-00252 (D. Del.).
`
`Administrative Matters
`2.
`At least the following related ’053 patent family members exist: U.S. Patent
`
`No. 8,791,154 (“the ’154 patent”) and U.S. Application No. 15/358,367, now
`
`abandoned. Concurrently filed herewith is a petition for inter partes review of the
`
`’154 patent (IPR2018-01020).2
`
`
`2 The ’154 patent (EX1001) is also involved in the same litigation as the
`
`’053 patent.
`
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`
`
`Petition for Inter Partes Review
` of U.S. Patent No. 9,533,053
`
`C. Designation of Lead and Back-up Counsel and Service (37 C.F.R.
`§§ 42.8(b)(3), 42.8(b)(4), 42.10(a), and 42.10(b))
`
`Lead Counsel
`Jitendra Malik, Ph.D.
`Reg. No. 55,823
`Katten Muchin Rosenman LLP
`555 S. Tryon Street, Suite 2900
`Charlotte, NC 28202-4213
`jitty.malik@kattenlaw.com
`
`Back-Up Counsel
`Brian Sodikoff
`Reg. No. 54,697
`Katten Muchin Rosenman LLP
`525 West Monroe Street
`Chicago, IL 60661-3693
`brian.sodikoff@kattenlaw.com
`
`Alissa M. Pacchioli
`Reg. No. 74,252
`Katten Muchin Rosenman LLP
`555 S. Tryon Street, Suite 2900
`Charlotte, NC 28202-4213
`alissa.pacchioli@kattenlaw.com
`Petitioner consents to email service.
`
`V.
`
`STATEMENT OF THE PRECISE RELIEF REQUESTED AND THE
`REASONS THEREFOR (37 C.F.R. § 42.22(a))
`
`Petitioner requests IPR and cancellation of Claims 1–13 of the ’053 patent.
`
`Petitioner’s full statement of the reasons for the relief requested is set forth in
`
`detail below.
`
`VI. THE ’053 PATENT
`The ’053 patent has two independent claims (Claim 1 and 8). EX1002.
`
`Claim 1 recites an aqueous ophthalmic solution for treatment of ocular allergic
`
`conjunctivitis comprising: at least 0.67 w/v% olopatadine dissolved in the
`
`solution; PEG having a molecular weight of 200 to 800; polyvinylpyrrolidone; a
`
`cyclodextrin selected
`
`from
`
`the group consisting of SAE-β-cyclodextrin,
`4
`
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`
`hydroxypropyl-β-cyclodextrin and hydroxypropyl-γ-cyclodextrin; and water.
`
`Petition for Inter Partes Review
` of U.S. Patent No. 9,533,053
`
`EX1002, 27:46-55. Claim 8 is similar to Claim 1 but includes benzalkonium
`
`chloride and hydroxypropyl methylcellulose (“HPMC”). The associated dependent
`
`claims, generally speaking, recite additional amounts of excipients, or incorporate
`
`the results according to the “FDA accepted CAC model.” EX1014, ¶39.
`
`A. Claim Construction
`As noted above, the ’154 patent was previously subject to an IPR. Argentum
`
`Pharm. LLC, IPR2016-00544. The ’053 patent is a continuation of the application
`
`that led to the ’154 patent. In IPR2016-00544, the PTAB gave preliminary
`
`constructions for the ’154 patent:
`
`Term
`Preamble
`“w/v %”
`
`
`EX1015, 7.
`
`Construction
`
`Non-limiting
`The mass of the component in grams per 100 milliliters of
`solution multiplied by 100 (EX1014, ¶42)
`
`The PTAB declined to construe the preambles of Claims 1, 4, 8, and 21, as
`
`well
`
`as
`
`the phrase
`
`“solution
`
`comprising…at
`
`least 0.67 w/v %
`
`olopatadine…dissolved
`
`in
`
`the solution,” at
`
`the
`
`time of
`
`institution of
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`IPR2016-00544, finding no construction was necessary in light of the claim term
`
`“comprising”. Id., 6.
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`5
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`Although the PTAB is not bound, 3 for completeness, the District of
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`Petition for Inter Partes Review
` of U.S. Patent No. 9,533,053
`
`
`
`Delaware provided the following constructions with respect to the ’154 patent:
`
`Construction
`The preamble is limiting
`
`An aqueous ophthalmic solution for treatment of ocular
`allergic conjunctivitis that contains at least 0.67 w/v %
`[but no greater than 1.0 w/v % olopatadine] dissolved in
`the solution.
`
`Term
`
`aqueous
` “An
`solution
`ophthalmic
`for the treatment of
`ocular
`allergic
`conjunctivitis,
`the
`solution comprising...”
`“at least 0.67 w/v %
`olopatadine dissolved
`in the solution” and “at
`least 0.67 w/v % but
`no greater than 1.0 w/v
`%
`olopatadine
`dissolved
`in
`the
`solution”
`
`EX1017, 2.
`
`The preambles of Claims 1 and 8 of the ’053 patent (EX1002) are the same
`
`as the preambles of the ’154 patent (EX1001). Petitioner contends that the PTAB
`
`does not have to resolve any discrepancy between its preliminary construction for
`
`the ’154 patent and the District Court’s construction because, as the PTAB noted,
`
`in IPR2016-00544, it is not necessary to determine the precise limiting nature of
`
`3 Kyocera Corp. v. Softview LLC, IPR2013-00007, Order, Paper 31 at 4 (PTAB
`
`Oct. 8, 2013); CRS Advanced Techs., Inc. v. Frontline Techs., Inc.,
`
`CBM2012-00005, Final Decision, Paper 66 at 6 (PTAB Jan. 26, 2015).
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`6
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`the preamble because the identified evidence in IPR2016-00544 was sufficient to
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`Petition for Inter Partes Review
` of U.S. Patent No. 9,533,053
`
`show that the preambles were taught or otherwise suggested by the relied-upon art.
`
`EX1015, 6. Petitioner contends the evidence presented herein addresses these
`
`limitations.
`
`As to the District Court’s construction of the ’154 patent’s recitation of “at
`
`least 0.67 w/v % olopatadine dissolved in the solution,” again the limitation
`
`appears in the ’053 patent and Petitioner submits that the broadest reasonable
`
`interpretation (“BRI”) would at least encompass the district court’s construction.
`
`37 C.F.R. § 42.100(b). In any event, Petitioner contends the evidence presented
`
`herein addresses these limitations.
`
`All remaining claim terms should be given their BRI, i.e., their ordinary and
`
`customary meaning as would have been understood by a person of skill in the art
`
`(“POSA”) at the time in the context of the entire patent disclosure. Id.; 37 C.F.R. §
`
`42.100(b); Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2144–46 (2016); In
`
`re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007); EX1014, ¶45.
`
`VII. NONE OF THE CLAIMS ARE ENTITLED TO THE PRIORITY
`DATE OF PROVISIONAL APPLICATION 61/487,789
`
`The ’053 patent claims priority to two U.S. Provisional Applications,
`
`61/487,789 (EX1009, “the ’789 Provisional”) and 61/548,957 (EX1010), filed
`
`May 19, 2011 and October 19, 2011, respectively. The Office never considered
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`7
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`priority during prosecution of the ’053 patent, and no presumption of priority
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`Petition for Inter Partes Review
` of U.S. Patent No. 9,533,053
`
`applies. PowerOasis, Inc. v. T-Mobile USA, 522 F.3d 1299, 1305 (Fed. Cir. 2008).
`
`Raising a priority issue involves “identifying, specifically, the features,
`
`claims, and ancestral applications allegedly lacking § 112, first paragraph, written
`
`description and enabling disclosure support for the claims based on the identified
`
`features.” Polaris Wireless, Inc. v. TruePosition, Inc., IPR2013-00323, Paper 9 at
`
`29 (PTAB Nov. 15, 2013); SAP America, Inc. v. Pi-Net Int’l., Inc.,
`
`IPR2014-00414, Paper 11 at 13-14 (PTAB Aug. 8, 2014). The test for sufficiency
`
`under the written description requirement of 35 U.S.C. § 112 ¶1 is whether the
`
`application disclosure relied on reasonably conveys to a POSA that the inventors
`
`had possession of the claimed subject matter. Ariad Pharms., Inc. v. Eli Lilly &
`
`Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc).
`
`None of the claims of the ’053 patent are supported by the ’789 Provisional.
`
`The
`
`independent
`
`claims
`
`of
`
`the
`
`’053
`
`patent
`
`recite
`
`a
`
`“hydroxypropyl-γ-cyclodextrin.” EX1002. The ’789 Provisional fails to even
`
`mention any γ-cyclodextrins or derivatives of γ-cyclodextrins; instead, the ’789
`
`Provisional exclusively focuses on “includ[ing] a β-cyclodextrin derivative to aid
`
`in the solubility of the olopatadine” (EX1009, Bates page 9, lines 2-7), with all
`
`examples relying on a β-cyclodextrin derivative (id., Tables A-H). Therefore, as
`
`Dr. Laskar explains, the ’789 Provisional fails to reasonably convey to the skilled
`
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`8
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`artisan the inclusion of hydroxypropyl-γ-cyclodextrin in the compositions, and
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`Petition for Inter Partes Review
` of U.S. Patent No. 9,533,053
`
`therefore fails to support that Patent Owner had possession of such compositions at
`
`the time of filing of the ’789 Provisional. EX1014, ¶¶27-29.
`
`Because Claims 1-13 of
`
`the ’053 patent find no support
`
`in the
`
`’789 Provisional and cannot benefit from the filing date of the ’789 Provisional,
`
`the ’053 patent should be afforded the October 19, 2011 priority date of
`
`Provisional Application No. 61/548,957 (EX1010).
`
`VIII. A PERSON OF ORDINARY SKILL IN THE ART
`As of the relevant priority date,4 a POSA in the relevant field would have
`
`had: (i) an M.D., Pharm. D., or Ph.D. in chemistry, biochemistry, pharmaceutics,
`
`or in a related field, and at least about two years of relevant experience in the
`
`treatment of ocular diseases and developing formulations used to treat ocular
`
`diseases, including topical eye pharmaceuticals; (ii) a master’s degree in chemistry,
`
`biochemistry, pharmaceutics, or in a related field, and at least about five years of
`
`the same relevant experience; or (iii) a bachelor’s degree in pharmacy, chemistry,
`
`4 Even if the PTAB decides the correct priority date is May 19, 2011, rather than
`
`October 19, 2011, given the closeness of these two dates, the understanding of a
`
`POSA would not change, and related testimony of the POSA would not change, as
`
`Dr. Laskar explains. EX1014, ¶48.
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`9
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`

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`biochemistry, or in a related field, and have at least about 10 years of the same
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`Petition for Inter Partes Review
` of U.S. Patent No. 9,533,053
`
`relevant experience.
`
`Further, a POSA would typically work as part of a multidisciplinary team
`
`and draw upon not only his or her own skills, but also take advantage of certain
`
`specialized skills of others in the team to solve a given problem should the need
`
`arise. EX1014, ¶30-35.
`
`IX.
`
`IDENTIFICATION OF CHALLENGE (37 C.F.R. § 42.104(b))
`Petitioner respectfully requests IPR of Claims 1-13 of the ’053 patent on
`
`each specific ground of unpatentability outlined below. Per 37 C.F.R. § 42.6(d),
`
`copies of the references are filed herewith. In support of the proposed grounds,
`
`this Petition includes the declaration of Dr. Paul Laskar (EX1014) explaining what
`
`the art would have conveyed to a POSA as of the priority date of the ’053 patent.
`
`Ground
`
`References
`
`1
`
`2
`
`3
`
`Bhowmick in view of Yanni,
`Castillo, and Abelson
`Schneider
`in
`view
`Hayakawa,
`Bhowmick, Castillo,
`Abelson
`Bhowmick in view of Castillo,
`Schneider, and Abelson
`
`and
`
`of
`
`Basis
`
`35 U.S.C. §
`103(a)
`
`35 U.S.C. §
`103(a)
`
`35 U.S.C. §
`103(a)
`
`Claims
`Challenged
`1-13
`
`1-13
`
`1-13
`
`Prior art references in addition to the primary references listed above provide
`
`
`
`further background in the art, motivation to combine the teachings of these
`
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`10
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`

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`references, and/or support for why a POSA would have had a reasonable
`
`Petition for Inter Partes Review
` of U.S. Patent No. 9,533,053
`
`expectation of success to arrive at the purported invention recited in the challenged
`
`claims.
`
`Moreover, the fact that a reference was disclosed to the Examiner is not a
`
`bar to institution of an IPR. For example, the Board instituted IPR in Sharp Corp.
`
`v. Surpass Tech Innovation LLC, IPR2015-00021, Paper 10 (PTAB Mar. 18,
`
`2015), even though the petitioner relied on previously considered references,
`
`because the petitioner presented different arguments that “shed[] a different light
`
`on the [repeated] reference.” Id., 14; Chi Mei Innolux Corp. v. Semiconductor
`
`Energy Lab. Co., Ltd., IPR2013-00028, Paper 14 at 10 (PTAB Mar. 21, 2014)
`
`(instituting IPR where the petitioner submitted an expert declaration even though
`