`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`________________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________________________
`
`FAMY CARE LIMITED
`Petitioner
`v.
`ALLERGAN, INC.
`Patent Owner
`________________________________
`
`Patent No. 8,629,111 B2
`________________________________
`
`Declaration of Michael A. Lemp, M.D.
`
`FAMY CARE - EXHIBIT 1003-0001
`
`

`

`TABLE OF CONTENTS
`
`I.
`
`INTRODUCTION. ........................................................................................... 1
`
`II. QUALIFICATIONS. ........................................................................................ 1
`
`III. SCOPE OF ENGAGEMENT. .......................................................................... 3
`
`IV. SUMMARY OF OPINIONS. ........................................................................... 4
`
`V. THE ’111 PATENT OVERVIEW. .................................................................. 6
`
`A.
`
`B.
`
`The ’111 Patent Specification. .............................................................. 6
`
`The ’111 Patent Claims. ........................................................................ 7
`
`1.
`
`2.
`
`3.
`
`4.
`
`“Emulsion” Independent Claims................................................. 7
`
`“Emulsion” Dependent Claims. .................................................. 9
`
`“Substantially No Detectable Concentration Of CsA”
`Dependent Claims. ....................................................................10
`
`“Therapuetically Effective” Dependent Claims. ......................10
`
`C.
`
`’111 Patent File History. .....................................................................10
`
`VI. LEGAL STANDARDS. .................................................................................14
`
`A. Anticipation – 35 U.S.C. § 102. ..........................................................14
`
`B.
`
`Obviousness – 35 U.S.C. § 103. ..........................................................14
`
`VII. STATE OF THE ART AS OF SEPTEMBER 15, 2003. ...............................19
`
`A.
`
`CsA Was a Known Treatment for Dry Eye Disease. ..........................19
`
`VIII. DETAILED BASES FOR OPINIONS. .........................................................29
`
`A.
`
`B.
`
`Person Of Ordinary Skill In The Art. ..................................................29
`
`Claim Construction..............................................................................30
`
`1.
`
`“Therapeutically Effective.” .....................................................30
`
`ii
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`FAMY CARE - EXHIBIT 1003-0002
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`

`2.
`
`“Substantially No Detectable Concentration Of [The]
`Cyclosporin A.” ........................................................................33
`
`C.
`
`Comparison of the Claims of the ’111 Patent to the Prior Art. ...........34
`
`1.
`
`Ground 1: Anticipation By Ding ’979. .....................................34
`
`a.
`
`b.
`
`Blood level claim elements (claims 11, 16). ..................39
`
`Efficacy claim elements (claims 17, 20-27). ..................43
`
`2.
`
`Ground 2: Obviousness In View Of Sall And Ding ’979. .......45
`
`a.
`
`b.
`
`c.
`
`d.
`
`e.
`
`0.05% CsA. .....................................................................49
`
`1.25% Castor Oil. ...........................................................52
`
`Blood Level claim elements (claims 11, 16). .................56
`
`Efficacy claim elements (Claims 17, 20-27). .................57
`
`All performance-related elements: inherency. ...............59
`
`3.
`
`Ground 3: Obviousness Of The ’111 Patent Claims 11
`And 16 In View Of Sall, Ding ’979, And Acheampong. .........59
`
`D.
`
`Secondary Considerations of Nonobviousness. ..................................62
`
`1.
`
`No Unexpected Results. ............................................................68
`
`a.
`
`b.
`
`c.
`
`d.
`
`Schiffman Exhibit B. ......................................................70
`
`Schiffman Exhibit C/Attar Exhibit B. ............................75
`
`Schiffman Exhibit D. ......................................................78
`
`Schiffman Exhibits E and F/Attar Exhibits D and
`E. .....................................................................................83
`
`IX. CONCLUDING STATEMENTS ...................................................................87
`
`iii
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`FAMY CARE - EXHIBIT 1003-0003
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`TABLE OF EXHIBITS
`
`Exhibit
`Description
`1001 U.S. Patent No. 8,629,111 B2 to Acheampong et al., filed August 14,
`2013 (“the ’111 patent”)
`
`1002 Declaration of Peter Kador, Ph.D.
`
`1003
`
`Intentionally Blank
`
`1004
`
`File history of U.S. Patent No. 8,629,111 to Acheampong et al., filed
`August 14, 2013 (“’111 patent FH”)
`
`1005
`
`File history of U.S. Patent Application No. 10/927,857 to Acheampong
`et al., filed August 27, 2004 (“’857 application FH”)
`1006 U.S. Patent No. 5,474,979 to Ding et al., filed May 17, 1994 (“Ding
`’979”)
`
`1007
`
`K. 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 (2000) (“Sall”)
`
`1008 A. Acheampong et al., Cyclosporine Distribution into the Conjunctiva,
`Cornea, Lacrimal Gland, and Systemic Blood Following Topical Dosing
`of Cyclosporine to Rabbit, Dog, and Human Eyes, in 2 LACRIMAL
`GLAND, TEAR FILM, & DRY EYE SYNDROMES 1001 (David A. Sullivan et
`al. eds., 1998) (“Acheampong”)
`1009 U.S. Patent No. 5,578,586 to Glonek et al., filed February 4, 1994
`(“Glonek”)
`1010 U.S. Patent No. 5,981,607 to Ding et al., filed January 20, 1998 (“Ding
`’607”)
`1011 R. Kaswan, Intraocular Penetration of Topically Applied Cyclosporine,
`20 TRANSPL. PROC. 650 (1988) (“Kaswan”)
`
`1012 K. Kunert et al., Analysis of Topical Cyclosporine Treatment of Patients
`with Dry Eye Syndrome, 118 ARCH OPHTHALMOL 1489 (2000)
`(“Kunert”)
`
`iv
`
`
`FAMY CARE - EXHIBIT 1003-0004
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`

`1013
`
`PHYSICIANS’ DESK REFERENCE FOR OPHTHALMOLOGY 13-18 (Medical
`Economics Co., 27th ed. 1999) (“Ophthalmic PDR”)
`
`1014 K. Turner et al., Interleukin-6 Levels in the Conjunctival Epithelium of
`Patients with Dry Eye Disease Treated with Cyclosporine Ophthalmic
`Emulsion, 19 CORNEA 492 (2000) (“Turner”)
`
`1015
`
`D. Stevenson et al., Efficacy and Safety of Cyclosporin A Ophthalmic
`Emulsion in the Treatment of Moderate-to-Severe Dry Eye Disease, 107
`OPHTHALMOLOGY 967 (2000) (“Stevenson”)
`1016 G. Hecht, Ophthalmic Preparations, in Remington: The Science and
`Practice of Pharmacy 821 (20th ed. 2000) (“Remington”)
`
`1017
`
`1018
`
`E. Goto et al., Low-Concentration Homogenized Castor Oil Eye Drops
`for Noninflamed Obstructive Meibomian Gland Dysfunction, 109
`OPHTHALMOLOGY 2030 (2002) (“Goto”)
`
`A. Kanpolat et al., Penetration of Cyclosporin A into the Rabbit Cornea
`and Aqueous Humor After Topical Drop and Collagen Shield
`Administration, 20 CLAO J. 119 (1994) (“Kanpolat”)
`
`1019
`
`C. Vieira et al., Effect of Ricinoleic Acid in Acute and Subchronic
`Experimental Models of Inflammation, 9 MEDIATORS INFLAMMATION
`223 (2000) (“Vieira”)
`1020 R. Murphy, The Once and Future Treatment of Dry Eye, REVIEW OF
`OPTOMETRY ONLINE (Feb. 15, 2000) (“Murphy”)
`
`1021
`
`D. Small et al., Blood Concentrations of Cyclosporin A During Long-
`Term Treatment with Cyclosporin A Ophthalmic Emulsions in Patients
`with Moderate
`to Severe Dry Eye Disease, 18 J. OCULAR
`PHARMACOLOGY & THERAPEUTICS 411 (2002) (“Small”)
`
`1022
`
`STEDMAN’S MEDICAL DICTIONARY 585, 944, 958, 1300, 1548, 1634,
`1788, 1821 (27th ed. 2000) (“Stedman’s”)
`1023 Allergan, Inc.’s Complaint for Patent Infringement, Allergan, Inc. v.
`Famy Care Ltd., No. 2:16-cv-401 (E.D. Tex. Apr. 12, 2016)
`
`v
`
`
`FAMY CARE - EXHIBIT 1003-0005
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`

`

`1024 APPROVED DRUG PRODUCTS WITH THERAPEUTIC EQUIVALENCE
`EVALUATIONS (34th ed. 2014) (Excerpts)
`
`1025
`
`1026
`
`Intentionally Blank
`
`7/30/2003 Allergan Correspondence to FDA regarding RESTASIS™
`
`1027 RESTASIS Orange Book Listing (dated Jan. 12, 2015)
`1028 U.S. Patent No. 6,635,654 B1 to Chang et al., filed January 9, 2003
`(“the ’654 patent”)
`1029 U.S. Patent No. 6,984,628 B2 to Bakhit et al., filed July 15, 2003 (“the
`’628 patent”)
`
`1030
`
`S. Pflugfelder et al., The Diagnosis and Management of Dry Eye, 19
`CORNEA 644 (2000) (“Pflugfelder”)
`1031 Mylan Pharm., Inc. v. Allergan, Inc., IPR2016-01128, Paper No. 8
`(P.T.A.B. Dec. 8, 2016)
`
`1032 Curriculum Vitae of Dr. Peter Kador
`
`1033 Curriculum Vitae of Dr. Michael A. Lemp
`
`
`vi
`
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`FAMY CARE - EXHIBIT 1003-0006
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`

`

`I, Michael A. Lemp, M.D., hereby declare as follows.
`
`I.
`1.
`
`
`INTRODUCTION.
`
`I, Michael A. Lemp, M.D., submit this Declaration on behalf of Famy
`
`Care Limited (“Petitioner”). I understand that Petitioner is filing a petition with
`
`the Patent Trial and Appeal Board (“PTAB”) of the United States Patent and
`
`Trademark Office (“USPTO”) for inter partes review of U.S. Patent No. 8,629,111
`
`B2 (“the ’111 patent”) (EX1001).
`
`2.
`
`
`This Declaration contains my qualifications; my opinions based on
`
`my expertise and my review of the ’111 patent; the factual basis for those opinions;
`
`and data or other information I considered in forming my opinions. The opinions
`
`and facts set forth in this Declaration are based upon information and my analysis
`
`of the ’111 patent, as well as my knowledge and experience in the area of
`
`ophthalmology and treating patients experiencing ophthalmic or ocular conditions
`
`such as dry eye.
`
`II. QUALIFICATIONS.
`3.
`Prior to my retirement from clinical practice, I held positions as
`
`
`Professor and Chairman of the Department of Ophthalmology. I am currently
`
`clinical professor of ophthalmology at Georgetown University School of Medicine
`
`and George Washington University Schools of Medicine. I have served on the
`
`board of directors for the International Society of Refractive Surgery and the
`
`
`
`1
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`FAMY CARE - EXHIBIT 1003-0007
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`

`International Eye Foundation, the FDA Ophthalmic Devices advisory panel and
`
`currently as Chief Medical Officer of TearLab Corporation, a manufacturer of
`
`diagnostic devices for dry eye disease. I am the author of more than 234 scientific
`
`papers and six books, including The Dry Eye (1992) and Clinical Anatomy of the
`
`Eye (second edition 1997). I was the Founding Editor–in-Chief of “The Ocular
`
`Surface,” and currently serve as a scientific reviewer for seven ophthalmic
`
`journals. I also organized and chaired the workshops which led to the publication
`
`of The National Eye Institute’s global guidelines for classification and diagnosis of
`
`dry eye in 1995. I have received a number of national and international awards,
`
`including the 1998 Castroviejo Medal, the highest honor in the field of corneal
`
`research for lifetime achievement.
`
`4.
`
`
`I am a 1962 graduate of the Georgetown University School of
`
`Medicine. I completed residency training in ophthalmology at Georgetown
`
`University and a fellowship in corneal and external disease at the Massachusetts
`
`Eye and Ear Infirmary and the Schepens Eye Research Institute—Harvard
`
`University clinical and research facilities ophthalmic. I returned to Washington in
`
`1970 to found the Cornea Service at Georgetown, which I directed for 13 years. In
`
`1983, I was selected to become the professor, chairman, and director of the Center
`
`for Sight at Georgetown University, a post I held until 1992, when I founded
`
`University Ophthalmic Consultants of Washington with my partners.
`
`
`
`2
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`FAMY CARE - EXHIBIT 1003-0008
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`

`
`
` My major areas of research interest have included dry eye, the ocular 5.
`
`surface, corneal and cataract surgery, contact lenses, and laser and other forms of
`
`refractive correction of vision. I have been a visiting professor and lecturer at over
`
`60 universities and organizations in the U.S. and abroad, and have delivered eight
`
`named lectureships.
`
`6.
`
`
`In my clinical practice I have been a consultant managing referred
`
`cases with dry eye disease and other conditions of the ocular surface with both
`
`medication and surgical treatment.
`
`7.
`
`
`Accordingly, I am an expert in the field of ophthalmology and treating
`
`patients experiencing ophthalmic or ocular conditions such as dry eye. Additional
`
`information concerning my education and experience can be found in my
`
`curriculum vitae, a copy of which is attached. (See EX1033).
`
`III. SCOPE OF ENGAGEMENT.
`8.
`I have been retained by Petitioner as a technical expert to consider the
`
`
`claims of the ’111 patent in relation to the state of the art as of September 15, 2003.
`
`I have also considered the prosecution history of the ’111 patent, including the
`
`purported objective evidence of non-obviousness alleged in the Declarations of
`
`Drs. Rhett M. Schiffman and Mayssa Attar. (’111 patent FH (EX1004-0246-70
`
`(Schiffman Declaration I), 0272-89 (Attar Declaration), 0301-414 (Schiffman
`
`Declaration II)).
`
`
`
`3
`
`FAMY CARE - EXHIBIT 1003-0009
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`
`
` My opinions and views set forth in this Declaration are based on my 9.
`
`education and training; my experience as a clinician, educator, researcher, and
`
`consultant to government and industry in the field of ophthalmology and treating
`
`patients experiencing ophthalmic or ocular conditions for over 50 years; and on the
`
`materials I have reviewed for this case.
`
`
`
` My time spent on this project is compensated at $500 per hour. My 10.
`
`compensation does not depend in any way on the outcome of Petitioner’s petition
`
`for inter partes review of the ’111 patent. Furthermore, I have no financial interest
`
`in this matter.
`
`IV. SUMMARY OF OPINIONS.
` First, it is my opinion that claims 1-27 of the ’111 patent are 11.
`
`
`anticipated and obvious. More specifically, Ding ’979 discloses and teaches each
`
`and every element of the claims of the ’111 patent, and the claims of the ’111
`
`patent are anticipated because they would have been immediately apparent to one
`
`of ordinary skill in the art in view of Ding ’979 at the time of the invention. It is
`
`also my opinion that claims 1-27 of the ’111 patent would have been obvious to a
`
`person of ordinary skill in the art at the time of the invention in view of Ding ’979
`
`in combination with Sall, and in view of the combination of Ding ’979, Sall and
`
`Acheampong.
`
`
`
` Second, in my opinion the data presented in Schiffman Declaration I 12.
`
`
`
`4
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`and the Attar Declaration do not support the conclusion that the ophthalmic
`
`emulsions claimed by the ’111 patent provided unexpectedly superior results over
`
`the closest prior art. Among other reasons, the data relied upon by Drs. Schiffman
`
`and Attar lack the necessary parameters (e.g., raw data values and error rates) to
`
`support a scientific conclusion that the claimed emulsions achieved any superior
`
`results in comparison to the closest prior art that would have been unexpected at
`
`the time of the invention.
`
`
`
` Third, in my opinion the validity of the ’111 patent is not supported 13.
`
`by commercial success and industry praise for RESTASIS™. Ding ’979 taught
`
`and claimed the 0.05% CsA/1.25% castor oil emulsion that is the subject of the
`
`’111 patent years before the ’111 patent’s priority application was ever filed. The
`
`prior art Ding ’979 patent was listed in the FDA’s Orange Book by Allergan as
`
`covering RESTASIS™. (EX1026; EX1027). Any evidence of commercial
`
`success or industry praise for RESTASIS™ should be attributed to the prior art
`
`Ding ’979 patent, because this evidence lacks a nexus to any novel feature of the
`
`’111 patent claims.
`
`
`
` Fourth, in my opinion, the validity of the ’111 patent is not supported 14.
`
`by long-felt need or failure of others. Ding ’979 satisfied any purported long-felt
`
`need for an emulsion comprising 0.05% CsA, 1.25% castor oil, 1.00% polysorbate,
`
`0.05% Pemulen®, 2.20% glycerine, sodium hydroxide, and water with a pH
`
`
`
`5
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`FAMY CARE - EXHIBIT 1003-0011
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`between 7.2-7.6 long before the ’111 patent was filed. Moreover, the ’111 patent
`
`concedes that the “compositions may be produced using conventional and well
`
`known methods useful in producing ophthalmic products including oil-in-water
`
`emulsions.” (EX1001, 13:20-23). In my opinion, this admission shows that
`
`Allergan’s purported evidence of other failures is irrelevant and not credible.
`
`V. THE ’111 PATENT OVERVIEW.
`A. THE ’111 PATENT SPECIFICATION.
`
`
` The ’111 patent cover page states that the ’111 patent issued January 15.
`
`14, 2014 to Applicant and Assignee Allergan, Inc., and is entitled “Methods of
`
`Providing Therapeutic Effects Using Cyclosporin Components.” (EX1001-0001).
`
`The named inventors are Andrew Acheampong, Diane D. Tang-Liu, James N.
`
`Chang, and David F. Power. (Id.)
`
`
`
` The ’111 patent cover page further states that the application for the 16.
`
`’111 patent—U.S. Patent Application No. 13/967,163 (“the ’163 application”)—
`
`was filed on August 14, 2013, and asserts priority through a series of continuation
`
`applications to U.S. Patent Application No. 10/927,857 (“the ’857 application”)
`
`(see EX1005), and to U.S. Provisional Patent Application No. 60/503,137, filed on
`
`September 15, 2003. (EX1001-0001).
`
`17.
`
`
`I understand that the earliest claimed priority date—September 15,
`
`2003—is a key date relevant to my analysis.
`
`
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`
`
` The ’111 patent is generally directed to pharmaceutical compositions 18.
`
`of CsA for the treatment of ophthalmic conditions in humans and animals.
`
`(EX1001, Abstract). The ’111 patent is also directed to methods of providing
`
`desired therapeutic effects to humans or animals using compositions containing
`
`CsA. (Id. at 1:18-20).
`
`
`
` The ’111 patent specification acknowledges that the use of CsA and 19.
`
`CsA derivatives to treat ophthalmic conditions was previously known in the art.
`
`(EX1001, 1:26-57). The ’111 patent specification further acknowledges that CsA
`
`oil-in-water emulsions had previously been clinically tested, including emulsions
`
`with castor oil. (Id. at 1:53-57).
`
`THE ’111 PATENT CLAIMS.
`“Emulsion” Independent Claims.
`
`B.
`1.
`
`
` The ’111 patent recites 27 claims, including independent claims 1, 13 20.
`
`and 18:
`
`
`
`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 emulsion.
`
`. . .
`
`7
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`13. A topical ophthalmic emulsion for treating an eye of a
`human, wherein the topical ophthalmic emulsion comprises:
`cyclosporin A in an amount of about 0.05% by weight;
`castor oil in an amount of 1.25% by weight;
`polysorbate 80 in an amount of about 1.0% by weight;
`acrylate/C10-30 alkyl acrylate cross-polymer
`in an
`amount of about 0.05% by weight;
`a tonicity component or a demulcent component in an
`amount of about 2.2% by weight;
`a buffer; and
`water;
`wherein the topical ophthalmic emulsion has a pH in the
`range of about 7.2 to about 7.6 and wherein cyclosporin A is
`the only peptide present in the total ophthalmic emulsion.
`. . .
`18. A topical ophthalmic emulsion for treating an eye of a
`human, the topical ophthalmic emulsion comprising:
`cyclosporin A in an amount of about 0.05% by weight;
`castor oil in an amount of about 1.25% by weight;
`polysorbate 80 in an amount of about 1.0% by weight;
`acrylate/C10-30 alkyl acrylate cross-polymer
`in an
`amount of about 0.05% by weight;
`glycerine in an amount of about 2.2% by weight;
`sodium hydroxide; and
`water; and
`wherein cyclosporin A is the only peptide present in the
`topical ophthalmic emulsion.
`
`
`
`8
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` “Emulsion” Dependent Claims.
`
`2.
`
`
` Claims 2-3, depending from claim 1, recite that the emulsion further 21.
`
`comprises a tonicity agent or demulcent component (claim 2), and that the tonicity
`
`agent or demulcent component is glycerine (claim 3).
`
`
`
` Claims 4-5, depending from claim 1, recite that the emulsion further 22.
`
`comprises a buffer (claim 4), and that the buffer is sodium hydroxide (claim 5).
`
`
`
` Claims 6-9, depending from claim 1, recite that: (A) the emulsion 23.
`
`comprises glycerine and a buffer (claim 6); (B) the emulsion comprises
`
`polysorbate 80 in an amount of about 1.0% by weight (claim 7); (C) the emulsion
`
`comprises acrylate/C10-30 alkyl acrylate cross-polymer in an amount of about
`
`0.05% by weight (claim 8); and (D) the emulsion comprises glycerine in an
`
`amount of about 2.2% by weight, water, and a buffer (claim 9). Percent values
`
`refer to % by weight throughout this Declaration unless otherwise indicated.
`
`
`
` Claim 10 depends directly from claim 9 (and indirectly from claim 1) 24.
`
`and recites that the buffer is sodium hydroxide.
`
`
`
` Claim 12 depends directly from claim 6 (and indirectly from claim 1) 25.
`
`and recites that the emulsion has a pH in the range of about 7.2 to about 7.6.
`
`
`
` Claims 14-15 and 17 each depend from claim 13 and recite that the 26.
`
`buffer is sodium hydroxide (claim 14); that the tonicity or demulcent component is
`
`glycerine (claim 15); and that the emulsion of claim 13 is effective in treating
`
`
`
`9
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`FAMY CARE - EXHIBIT 1003-0015
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`

`

`keratoconjunctivitis sicca (claim 17).
`
`
`
` Claim 19, depending from claim 18, recites that the emulsion of claim 27.
`
`18 has a pH in the range of about 7.2 to about 7.6.
`
`3.
`
`“Substantially No Detectable Concentration Of CsA”
`Dependent Claims.
`
`
`
` Claim 11 (depending from claim 1) and claim 16 (depending from 28.
`
`claim 13) both recite “when the topical ophthalmic emulsion is administered to an
`
`eye of a human, the blood of the human has substantially no detectable
`
`concentration of the cyclosporin A.”
`
`“Therapuetically Effective” Dependent Claims.
`
`4.
`
`
` Claims 20-27, depending from one of independent claims 1, 13, or 18, 29.
`
`recite that the claimed emulsion is therapeutically effective in treating dry eye,
`
`therapeutically effective in treating keratoconjunctivitis sicca, or is therapeutically
`
`effective in increasing tear production.
`
`’111 PATENT FILE HISTORY.
`C.
`
`
` As noted above, the ’111 patent asserts to be a continuation of the 30.
`
`’857 application. (EX1001-0001). During prosecution of the ’857 application, the
`
`Applicants expressly admitted that the emulsion—referred to as Composition II
`
`and which remains the emulsion recited in the claims of the ’111 patent—was
`
`squarely within the teachings of U.S. Patent No. 5,474,979 to Ding et al., filed May
`
`17, 1994 (“Ding ’979”) (EX1006). The Applicants stated:
`
`
`
`10
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`

`

`The applicants concede that it would have been obvious to modify
`examples 1A-1E of the Ding [’979] reference to arrive at
`Composition II of the present application. The differences are
`insignificant. One need only use the cyclosporin concentration of
`Example 1E (0.05%), the castor oil concentration of Example 1D
`(1.250%), and the remaining ingredients of those examples. As the
`examiner correctly observes, one of ordinary skill in the art “would
`readily envisage” such a composition, especially in view of
`Example 1B: having selected 0.05% as the concentration of
`cyclosporin, Example 1B (wherein the ratio of cyclosporin to castor
`oil is 0.04) teaches that the concentration of castor oil should be
`1.250% (0.05% / 1.250% = 0.04). The applicants concede that in
`making this selection (0.05% cyclosporin and 1.250% castor oil)
`there would have been a reasonable expectation of success; the
`differences between Examples 1A-1E and Composition II are too
`small to believe otherwise. The formulation of Composition II is
`squarely within the teaching of the Ding [’979] reference, and the
`Office should disregard any statements by the applicants suggesting
`otherwise[.]
`
`(’857 application FH (EX1005-0435 (emphasis added)).
`
`31.
`
`
` I have reviewed the ’857 application concurrently with the ’111
`
`patent, and find that the ’857 application Composition II is indistinguishable from
`
`the emulsion claimed in the ’111 patent. In fact, the Applicants submitted a table
`
`(below) during prosecution of the ’857 application comparing the ’857 application
`
`Composition II with Ding ’979. The chart below from the Declaration of Dr.
`
`
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`Kador includes the emulsion claimed in the ’111 patent for comparison.
`
`
`
`’111 Patent
`Composition
`0.05%
`1.25%
`1.00%
`0.05%
`2.20%
`qs
`qs
`7.2-7.6
`
`
`
`0.04
`
`
`
`(EX1002, ¶49). The ’857 application was ultimately abandoned. (See EX1001-
`
`0001).
`
`
`
` The Applicants acknowledged 32.
`
`their prior admissions during
`
`prosecution of the ’111 patent, and alleged that evidence supporting the
`
`patentability of the claims had been collected “[s]ince these comments have been
`
`filed.” (EX1004-0007). The pending claims were rejected by the Examiner under,
`
`inter alia, 35 U.S.C. § 103 in view of Ding ’979 and for double patenting in view
`
`of Ding ’979. (Id. at 0173-81; see generally id. at 0170-89).
`
`
`
` The Applicants’ written summary of an October 3, 2013 examiner 33.
`
`interview states that they presented “[d]ata demonstrating unexpected results and
`
`commercial success of the claimed formulation” and “[d]ata and information
`
`regarding the claimed formulation’s satisfaction of a long felt need.” (EX1004-
`
`
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`0234). The Applicants argued that “evidence of non-obviousness presented at the
`
`interview overcomes the prima facie obviousness rejection.” (Id.)
`
`
`
` Shortly thereafter, on October 23, 2013, the Applicants filed a 34.
`
`response to the Examiner’s Office Action. (EX1004, 0229-44). The Applicants
`
`amended the pending claims, for example substituting the generic term
`
`“acrylate/C10-30 alkyl acrylate cross-polymer” for the trade name “Pemulen” and
`
`substituting the full term “keratoconjunctivitis sicca” for the acronym “KCS.” (Id.
`
`at 0230-33). The Applicants argued that “the prima facie case of obviousness has
`
`not been properly established against the pending claims,” and that “the
`
`unexpected results, commercial success, and satisfaction of long felt need obtained
`
`with the claimed formulations and failure of others overcome the prima facie
`
`obviousness rejection asserted in the Office Action.” (Id. at 0235).
`
`
`
` Four declarations were submitted to the USPTO in support of these 35.
`
`arguments: declarations from Dr. Rhett Schiffman (“Schiffman Declaration I”) and
`
`Dr. Mayssa Attar (the “Attar Declaration”) concerning surprising and unexpected
`
`results; and declarations from Aziz Mottiwala (the “Mottiwala Declaration”) and
`
`Dr. Rhett Schiffman (“Schiffman Declaration II”) concerning commercial success
`
`and satisfaction of a long-felt need. (EX1004-0246-70, 0272-89, 0291-99, 0301-
`
`414). The Examiner issued a Notice of Allowance on November 21, 2013. (Id. at
`
`0428). The Examiner found that the Applicants had failed to demonstrate
`
`
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`commercial success or long-felt need. (Id. at 0439-41). However, relying on
`
`Schiffman Declaration I and Attar Declaration, the Examiner concluded that “the
`
`specific combination of 0.05% by weight cyclosporin A with 1.25% by weight
`
`castor oil is surprisingly critical for therapeutic effectiveness in the treatment of
`
`dry eye or keratoconjunctivitis sicca,” and therefore, “demonstrate[s] surprising
`
`and unexpected results.” (Id. at 0443).
`
`
`
` As discussed in Section VIII.D below, I disagree with the opinions of 36.
`
`Dr. Schiffman and Dr. Attar that the results in the submitted declarations were
`
`unexpected or surprising.
`
`VI. LEGAL STANDARDS.
`A. ANTICIPATION – 35 U.S.C. § 102.
`I understand that a patent claim is anticipated if each and every
`
`37.
`
`
`element of the claimed invention is found, expressly or inherently, in a single prior
`
`art reference. I further understand that a combination of elements disclosed in a
`
`single prior art reference anticipate a patent claim if the combination of elements in
`
`the patent claim would be “immediately apparent to one of ordinary skill in the
`
`art,” or “at once envisaged” from the prior art reference.
`
`B. OBVIOUSNESS – 35 U.S.C. § 103.
`I have been informed and understand that a person cannot obtain a
`
`38.
`
`
`patent if his or her invention would have been obvious to a person of ordinary skill
`
`in the field of the invention at the time of the invention.
`
`
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`39.
`
`
`I have been informed that a patent is invalid as obvious “if the
`
`differences between the subject matter sought to be patented and the prior art are
`
`such that the subject matter as a whole would have been obvious at the time the
`
`invention was made to a person having ordinary skill in the art.”
`
`40.
`
`
`In evaluating obviousness, I have been asked to consider: (1) the
`
`scope and content of the prior art; (2) what the level of ordinary skill in the art was
`
`at the time the invention was made; (3) if there are any perceived differences
`
`between the prior art and the asserted claims and whether the differences involve a
`
`modification that would have been beyond the existing knowledge, or ordinary
`
`creativity, to the person of ordinary skill in the art (in other words, were not
`
`obvious to the person of ordinary skill), and to provide my opinions on the reasons
`
`why the person of ordinary skill would have had a reason or motivation or other
`
`suggestion to make these modifications; and (4) any secondary considerations of
`
`non-obviousness (also known as objective indicia of non-obviousness).
`
`41.
`
`
`I have been informed and understand that in analyzing the question of
`
`obviousness, it is improper to use hindsight reconstruction, and that one cannot use
`
`the patent as a road map for selecting and combining items of prior art. I have
`
`been informed and understand that the relevant question is what a person of
`
`ordinary skill in the art would have understood at the time the invention was made.
`
`42.
`
`
`I have been informed and understand that the combination of familiar
`
`
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`elements according to known methods is likely to be obvious when it does no more
`
`than yield predictable results. I have been informed that it is not necessary for a
`
`person having ordinary skill in the art to know with certainty that such results will
`
`occur; a reasonable expectation of success is enough.
`
`43.
`
`
`I have been informed and understand that in an obviousness analysis,
`
`it is not necessary that the prior art contain an explicit teaching, suggestion, or
`
`motivation to combine the references in order to make the claimed invention.
`
`Instead, when a patent merely arranges known elements from the prior art, with
`
`each performing the same known function and yielding expected results, the
`
`combination is obvious. I have been informed that I may take into account the
`
`inferences and creative steps that a person of ordinary skill in the art would
`
`employ.
`
`44.
`
`
`I have examined obviousness from the perspective of a person of
`
`ordinary skill in the art as of September 15, 2003.
`
`45.
`
`
`I understand that such secondary considerations, where in evidence,
`
`may include: (i) commercial success of a product due to the merits of the claimed
`
`invention; (ii) a long-felt, but unsatisfied need for the invention; (iii) failure of
`
`others to find the solution provided by the claimed invention; (iv) deliberate
`
`copying of the invention by others; (v) unexpected results achieved by the
`
`invention; (vi) praise of the invention by others skilled in the art; (vii) lack of
`
`
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`independent simultaneous invention within a comparatively short space of time;
`
`and (viii) teaching away from the invention in the prior art.
`
`46.
`
`
`I understand that secondary considerations of non-obviousness must
`
`be commensurate in scope with the claims for which the evidence is offered to
`
`support. In other words, the alleged secondary considerations must result from
`
`what is claimed. For example, evidence of unexpected results for a given claim
`
`element or performance attribute for one embodiment of the claimed invention is
`
`not enough if similar results could be observed for or achieved by other
`
`embodiments within the scope of the prior art. Similarly, evidence that one
`
`claimed embodiment demonstrated unexpected results is not enough if these
`
`unexpected results would not occur across the full scope of what is claimed.
`
`47.
`
`
`I also understand that for such objective evidence to be accorde