Filed on behalf of OmniActive Health Technologies, Inc.
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` DC: 6277580-1
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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
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`OMNIACTIVE HEALTH TECHNOLOGIES, INC.,
`Petitioner,
`
`
`
`v.
`
`
`
`KEMIN INDUSTRIES, INC.,
`Patent Owner
`
`
`
`
`
`Case No. to Be Assigned
`Patent No. 9,226,940
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`PETITION FOR INTER PARTES REVIEW OF U.S. PATENT NO. 9,226,940
`UNDER 35 U.S.C. §§311–319 AND 37 C.F.R. §42.100 et seq.
`
`

`
`Petition for Inter Partes Review of U.S. Patent No. 9,226,940
`
`TABLE OF CONTENTS
`Introduction ..................................................................................................... 1
`
`I.
`
`II. Mandatory Notices (37 C.F.R. §42.8(a)(1)) ................................................... 5
`
`A.
`
`B.
`
`C.
`
`D.
`
`Real Party-in-interest (37 C.F.R. §42.8(b)(1)) ..................................... 5
`
`Notice of Related Matters (37 C.F.R. §42.8(b)(2)) .............................. 5
`
`Lead and Back-up Counsel (37 C.F.R. §42.8(b)(3)) ............................ 6
`
`Service Information (37 C.F.R. §42.8(b)(3)) ....................................... 6
`
`III.
`
`Fees (37 C.F.R. §42.103) ................................................................................ 6
`
`IV. Requirements for IPR Under 37 C.F.R. §42.104 ........................................... 7
`
`A. Grounds for Standing (37 C.F.R. §42.104(a)) ..................................... 7
`
`B.
`
`C.
`
`Prior Art Publications Relied Upon ..................................................... 7
`
`Claims and Statutory Grounds (37 C.F.R. §§42.104(b)(1)
`&(b)(2)) ................................................................................................ 8
`
`V.
`
`Summary of the ’940 Patent ........................................................................... 9
`
`VI. Level of Ordinary Skill in the Art ................................................................ 14
`
`VII. Claim Construction ....................................................................................... 14
`
`VIII. Summary of References Applied in This Petition ........................................ 16
`
`A.
`
`Snider (Ex. 1003) ............................................................................... 16
`
`B. McLaughlan (Ex. 1004) ..................................................................... 20
`
`C.
`
`D.
`
`E.
`
`Chaine (Ex. 1005)............................................................................... 21
`
`Richer (Ex. 1006) ............................................................................... 23
`
`Ciolkowski (Ex. 1007) ....................................................................... 24
`
`IX. The Challenged Claims Are Unpatentable ................................................... 25
`
`A.
`
`Summary of Obviousness Arguments ................................................ 25
`
`i
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`

`
`Petition for Inter Partes Review of U.S. Patent No. 9,226,940
`
`B.
`
`Ground I - Claims 1–6 and 9 of the ’940 Patent are
`unpatentable as obvious over Snider. ................................................. 30
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`6.
`
`7.
`
`Claim 1 (preamble) - “A method of reducing the
`increased blue and ultraviolet light damage to the retina
`of a subject having a condition that causes such blue or
`ultraviolet light to fall disproportionally on or in front of
`the retina relative to the blue and ultraviolet light damage
`present in a subject having no such condition, wherein
`the condition is presbyopia or hyperopia or astigmatism,
`comprising” .............................................................................. 30
`
`Claim 1 (body) - “administering to the subject having
`such condition a composition comprising a
`therapeutically effective amount of one or more ocular
`antioxidants.” ........................................................................... 37
`
`Claim 2 - “The method of claim 1, wherein said ocular
`antioxidant is selected from the group consisting of
`antioxidant vitamins, carotenoids, antioxidant minerals,
`natural antioxidant extracts and synthetic antioxidants.” ........ 39
`
`Claim 4 - “The method of claim 2, wherein the
`carotenoid is selected from the list consisting of lutein,
`zeaxanthin, beta-carotene, retinoids, retinal,
`retinaldehyde, and meso-zeaxanthin.” ..................................... 40
`
`Claim 9 - “The method of claim 2, wherein said
`therapeutically effective amount of said carotenoid is
`between 0.0001 and 2 mg per kilogram of body weight of
`said subject per day.” ............................................................... 41
`
`Claim 3 - “The method of claim 2, wherein said
`antioxidant vitamin is selected from the list consisting of
`vitamins A, C, and E.” ............................................................. 43
`
`Claim 5 - “The method of claim 2, wherein said
`antioxidant mineral is selected from the list consisting of
`zinc, copper, and selenium.” .................................................... 45
`
`ii
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`

`
`Petition for Inter Partes Review of U.S. Patent No. 9,226,940
`
`8.
`
`Claim 6 - “The method of claim 2, wherein said natural
`extract is selected from the list consisting of polyphenols,
`quercitin, anthocyanins, and anthocyanidins.” ........................ 46
`
`C.
`
`Ground II - Claims 8, 10, and 12 of the ’940 Patent are
`unpatentable as obvious over the combination of Snider and
`Richer. ................................................................................................ 47
`
`1.
`
`2.
`
`3.
`
`Claim 8 - “The method of claim 2, wherein said
`therapeutically effective amount of said antioxidant
`vitamin is between 0.02 (1 IU) and 15 mg (150 IU) per
`kilogram of body weight of said subject per day.” .................. 47
`
`Claim 10 - “The method of claim 2, wherein said
`therapeutically effective amount of said antioxidant
`mineral is between 0.0001 and 5 mg per kilogram of
`body weight of said subject per day.” ...................................... 50
`
`Claim 12 - “The method of claim 2, wherein said
`therapeutically effective amount of said natural extract is
`between 0.0001 and 20 mg per kilogram of body weight
`of said subject per day.” ........................................................... 53
`
`D. Ground III - Claims 7, 11, and 13 of the ’940 Patent are
`unpatentable as obvious over the combination of Snider and
`Ciolkowski. ......................................................................................... 56
`
`1.
`
`2.
`
`3.
`
`Claim 7 - “The method of claim 2, wherein said synthetic
`antioxidant is selected from the list consisting of BHT,
`BHA, and BTHQ.” ................................................................... 56
`
`Claim 11 - “The method of claim 2, wherein said
`therapeutically effective amount of said synthetic
`antioxidant is between 0.001 and 15 mg per kilogram of
`body weight of said subject per day.” ...................................... 59
`
`Claim 13 - “The method of claim 2, wherein said
`therapeutically effective amount of said synthetic
`antioxidant is between 0.0001 and 20 mg per kilogram of
`body weight of said subject per day.” ...................................... 62
`
`X.
`
`Conclusion .................................................................................................... 65
`
`iii
`
`

`
`Exhibit
`Ex. 1001
`Ex. 1002
`Ex. 1003
`
`Ex. 1004
`
`Ex. 1005
`
`Ex. 1006
`
`Ex. 1007
`
`Ex. 1008
`Ex. 1009
`Ex. 1010
`Ex. 1011
`Ex. 1012
`Ex. 1013
`Ex. 1014
`
`Ex. 1015
`
`Ex. 1016
`
`Petition for Inter Partes Review of U.S. Patent No. 9,226,940
`
`LIST OF EXHIBITS
`
`Description
`U.S. Patent No. 9,226,940 (“the ’940 Patent”)
`Prosecution History of the ’940 Patent
`Lloyd Snider, Evidence Supports New Approaches for Reducing
`the Risk of Macular Degeneration, Optometric Management
`(November 2008) (“Snider”)
`Barbara McLaughlan, Awareness of Age-related Macular
`Degeneration and Associated Risk Factors, AMD Alliance
`International (September 2005) (“McLaughlan”)
`Gilles Chaine, Case-control study of the risk factors for age
`related macular degeneration (“Chaine”), British Journal of
`Ophthalmology (September 1998)
`Stuart Richer, Double-masked, placebo-controlled, randomized
`trial of lutein and antioxidant supplementation in the intervention
`of atrophic age-related macular degeneration: the Veterans LAST
`study (Lutein Antioxidant Supplementation Trial), Optometry
`(April 2004) (“Richer”)
`U.S. Patent Application Publication No. US 2009/0239836 to
`Ciolkowski (“Ciolkowski”)
`Declaration of Dr. John Landrum
`Curriculum Vitae of Dr. John Landrum
`Declaration of Rachel Watters A
`Declaration of Rachel Watters B
`Declaration of Raymond Weschler
`WIPO International Publication No. WO2007118095 A2
`Shirley Sarkes, Relationship of Basal Laminar Deposit and
`Membranous Debris to the Clinical Presentation of Early Age-
`Related Macular Degeneration, Investigative Ophthalmology &
`Visual Science (March 2007)
`John T. Landrum & Richard A. Bone, Chapter 22: Mechanistic
`Evidence for Eye Diseases and Carotenoids, Carotenoids in
`Health and Disease (Oxidative Stress and Disease) (September
`30, 2004)
`Johanna M. Seddon, MD, et al., Dietary Carotenoids, Vitamins
`A, C, and E, and Advanced Age-Related Macular Degeneration,
`The JAMA Network (November 9, 1994)
`
`iv
`
`

`
`Exhibit
`Ex. 1017
`
`Ex. 1018
`
`Ex. 1019
`
`Ex. 1020
`
`Ex. 1021
`
`Ex. 1022
`
`Ex. 1023
`Ex. 1024
`
`Ex. 1025
`
`Ex. 1026
`
`Ex. 1027
`
`Ex. 1028
`
`Ex. 1029
`
`Ex. 1030
`
`Petition for Inter Partes Review of U.S. Patent No. 9,226,940
`
`Description
`K. Kirschfeld, Carotenoid pigments: their possible role in
`protecting against photooxidation in eyes and photoreceptor
`cells, Proc. R. Soc. Lond. (1982)
`Werner K. Noell, et al., Retinal damage by light in rats, Invest.
`Opthalmol. Visual Sci (October 1966)
`William T. Ham, Jr., et al., Histologic analysis of photochemical
`lesions produced in rhesus retina by short-wave-length light.,
`Invest. Ophthalmol. Visual Sci (October 1978)
`W. T. Ham, Jr., Basic mechanisms underlying the production of
`photochemical lesions in the mammalian retina, Current Eye
`Research (1984)
`John J. Weiter, M.D., et al., Central Sparing in Annual Macular
`Degeneration, American Journal of Ophthalmology (September
`1988)
`Anna Pawlak, et al., Action spectra for the photoconsumption of
`oxygen by human ocular lipofuscin and lipofuscin extracts,
`Archives of Biochemistry and Biophysics (2002)
`[reserved]
`Michael A. Sandberg, PhD, Hyperopia and Neovascularization in
`Age-related Macular Degeneration, Ophthalmology (July 1993)
`M. Kamran Ikram, et al., Relationship between Refraction and
`Prevalent as well as Incident Age-Related Maculopathy: The
`Rotterdam Study, Invest. Ophthalmol. Visual Sci. (September
`2003)
`Richard A. Bone, et al., Macular Pigment in Donor Eyes with
`and without AMD: A Case-Control Study; Invest. Ophthalmol.
`Visual Sci. (January 2001)
`John T. Landrum, et al., A One Year Study of the Macular
`Pigment: The Effect of 140 Days of Lutein Supplement, Exp. Eye
`Res. (1997)
`Yin Chen, A Study of Carotenoids Uptake in Human Subjects
`and Their Metabolites, Thesis - Florida International University
`(1999)
`Richard A. Bone & John T. Landrum, Dose-dependent response
`of serum lutein and macular pigment optical density to
`supplementation with lutein esters, Elsevier (June 2010)
`John T. Landrum & Richard A. Bone, Carotenoid nutrition and
`the human retina, Int’l J. of Integrative Med. (May/June 2000)
`
`v
`
`

`
`Petition for Inter Partes Review of U.S. Patent No. 9,226,940
`
`Description
`Richard A. Bone, et al., Lutein and Zeaxanthin Dietary
`Supplements Raise Macular Pigment Density and Serum
`Concentrations of these Carotenoids in Humans, J. Nutr. (2003)
`
`Exhibit
`Ex. 1031
`
`
`
`vi
`
`

`
`Petition for Inter Partes Review of U.S. Patent No. 9,226,940
`
`I.
`
`Introduction
`OmniActive Health Technologies, Inc. (“Petitioner”) petitions for Inter
`
`Partes Review (“IPR”) seeking cancellation of claims 1–13 (“challenged claims”)
`
`of U.S. Patent No. 9,226,940 (Ex. 1001, “the ’940 Patent”), assigned to Kemin
`
`Industries, Inc.
`
`The ’940 Patent “relates generally to a method of early diagnosis and
`
`treatment of ocular disorders and, more specifically, to the early diagnosis of
`
`subjects at risk for age-related macular degeneration [(“AMD”)] and the
`
`administration of ocular antioxidants to subjects having hyperopia, presbyopia or
`
`astigmatism.” Ex. 1001, 1:14–19. AMD “is a disease that affects the central
`
`vision necessary for reading, facial recognition, and other fine visually associated
`
`tasks.” Ex. 1008, ¶15. AMD worsens gradually as a result of “oxidative damage
`
`in the central retina.” Id. at ¶35. More specifically, “blue and UV [ultraviolet]
`
`light damage to the retina [is] a contributing factor in the development of AMD.”
`
`Id. at ¶34. The macular pigment “reduc[es] blue and UV light damage to the
`
`retina” and is “composed principally of three carotenoids: Lutein; R,R-
`
`Zeaxanthin; and R,S-Zeaxanthin [meso-zeaxanthin].” Id. at ¶¶34, 19.
`
`The ’940 Patent acknowledges the long-understood use of ocular
`
`antioxidants to treat AMD based on the “definite relationship between the
`
`ingestion of ocular antioxidants and a reduction in the risk for the incidence and/or
`
`1
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`

`
`Petition for Inter Partes Review of U.S. Patent No. 9,226,940
`
`progression of AMD.” Ex. 1001, 5:11–13. The ’940 Patent further discloses that
`
`“[t]he principles behind the relationships between MPOD [macular pigment optical
`
`density] values, blue light damage to ocular tissues, and the risk of AMD are based
`
`upon known data.” Ex. 1001, 10:33–35 (emphasis added). The ’940 Patent does
`
`not purport to disclose any new forms of treatment; rather it purports to “address
`
`the link between hyperopia, presbyopia, and/or astigmatism and AMD.” Ex. 1001,
`
`11:28–30. Hyperopia, presbyopia, and astigmatism are eye conditions. Hyperopia
`
`is also known as “farsightedness.” Id. at 2:60. Presbyopia is an “age-related visual
`
`disorder that affects virtually everyone to some extent” that results in “improper
`
`focus of the image upon the retina.” Id. at 3:1–9. Astigmatism is a defect of the
`
`cornea or the lens in which there is “irregular curvature to one or both of these
`
`structures.” Id. at 3:34–37.
`
`The claims of the ’940 Patent are directed to a method of treating retinal
`
`damage in a subject “comprising administering to the subject . . . a composition
`
`comprising a therapeutically effective amount of one or more ocular antioxidants.”
`
`In the face of the long-established practice of using antioxidants to combat retinal
`
`damage, the Examiner allowed the claims of the ’940 Patent only after amendment
`
`to address reduction of the so-called “increased blue and ultraviolet light damage
`
`to the retina of a subject having a condition that causes such blue or ultraviolet
`
`light to fall disproportionally on or in front of the retina relative to the blue and
`
`2
`
`

`
`Petition for Inter Partes Review of U.S. Patent No. 9,226,940
`
`ultraviolet damage present in a subject having no such condition, wherein the
`
`condition is presbyopia or hyperopia or astigmatism.” Ex. 1002, 13–14 (emphasis
`
`added).
`
`Notably, rather than disclose any original science regarding the matter, the
`
`inventor of the ’940 Patent acknowledged that this purported link between AMD
`
`and presbyopia, hyperopia, and astigmatism “is based upon the known effects of
`
`the cornea and lens of the eye in relation to the focusing light of upon the retina
`
`[and] the available information on ocular disorders including AMD.” Ex. 1001,
`
`4:22–25 (emphasis added).
`
`As admitted by the inventor, both “the factors associated with [the]
`
`incidence [of AMD]” and “the reported effect of ocular antioxidants in helping to
`
`reduce the progression of AMD” were well known at the time. Ex. 1001, 4:24–30.
`
`The inventor specifically acknowledged that a person of ordinary skill in the art
`
`(“POSA”) would have understood that “blue light-induced damage from oxidative
`
`processes that occur in retinal tissues of the human [] has been related to increased
`
`likelihood of AMD,” noting that “[a]lthough this theory of macular damage
`
`associated with the blue wavelengths of visible light has long been speculated,
`
`proof that these wavelengths actually damage retinal tissue has only recently been
`
`demonstrated in-vivo.” Id. at 10:36–38, 5:30–34. The inventor further recognized
`
`that “[the prior-art Richer and AREDS studies] along with a plethora of other
`
`3
`
`

`
`Petition for Inter Partes Review of U.S. Patent No. 9,226,940
`
`results from in-vitro, ex-vivo, and animal and human studies[,] support a definite
`
`relationship between the ingestion of ocular antioxidants and a reduction in the risk
`
`for the incidence and/or progression of AMD.” Id. at 5:9–13. These prior-art
`
`studies also demonstrate that vitamins, minerals, and carotenoids were among the
`
`ocular antioxidants that would be effective for such treatment. See id. at 4:37–
`
`5:13. Moreover, the ’940 Patent concedes that information regarding the purported
`
`“relationship between hyperopia, presbyopia and astigmatism, Age-Related
`
`Macular Degeneration (AMD) and ocular antioxidants” was available through
`
`other references and known in the field at the time. Ex. 1001, 4:20–30.
`
`So what is the purported inventive contribution of the ’940 Patent? As noted
`
`above, and as conceded by the inventor, it is not any new method of treatment, not
`
`any new composition, and not any new scientific principle purportedly discovered
`
`by the inventor through original science. Rather, the problem purportedly
`
`addressed by the ’940 Patent is that “no publications or references have been
`
`identified relating all of these factors in a unified manner.” Ex. 1001, 4:32–34.
`
`The prior art cited in this petition demonstrates that statement to be wrong. Prior
`
`publications such as the Snider article (Ex. 1003) did combine these teachings “in a
`
`unified manner.”
`
`Based on the knowledge and teachings available at the time, and as reflected
`
`in Snider, a POSA would have understood that: (1) hyperopia was a risk factor
`
`4
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`

`
`Petition for Inter Partes Review of U.S. Patent No. 9,226,940
`
`associated with the development of AMD, (2) “oxidative stress from cumulative
`
`blue light damage” contributed to the development of AMD, and (3) treatment
`
`with ocular antioxidants, and specifically the macular pigments, could reduce
`
`damage to the macula and therefore reduce the progression of AMD by “serving as
`
`both antioxidants and blue light filters.” See Ex. 1003, 2, 3, 7. A POSA therefore
`
`would have had motivation to administer ocular antioxidants to treat any increased
`
`blue light damage in subjects with hyperopia, presbyopia, or astigmatism, as
`
`claimed by the ’940 Patent. See Ex. 1008, ¶56. Moreover, based on the successful
`
`treatment of AMD patients using ocular antioxidants in previous studies, a POSA
`
`would reasonably expect such treatment to be successful. Id. Therefore, as shown
`
`in detail below, the prior art shows the claims of the ’940 Patent were obvious at
`
`the time of the alleged invention.
`
`II. Mandatory Notices (37 C.F.R. §42.8(a)(1))
`A. Real Party-in-interest (37 C.F.R. §42.8(b)(1))
`The real parties in interest for this IPR petition are Petitioner OmniActive
`
`Health Technologies, Inc. and OmniActive Health Technologies Ltd.
`
`B. Notice of Related Matters (37 C.F.R. §42.8(b)(2))
`The ’940 Patent is the subject of a complaint under 19 U.S.C. §1337 against
`
`Petitioner in the International Trade Commission (ITC), captioned Certain Food
`
`Supplements and Vitamins, Including Ocular Antioxidants and Components
`
`Thereof and Products Containing the Same, Inv. No. 337-TA-3177. In addition,
`
`5
`
`

`
`Petition for Inter Partes Review of U.S. Patent No. 9,226,940
`
`the ’940 Patent is the subject of a civil action in the District of New Jersey for
`
`declaratory judgment of non-infringement filed by Petitioner against Patent Owner
`
`in OmniActive Health Technologies, Inc. v. Kemin Industries, Inc., Civil Action
`
`No. 16-4988.
`
`C. Lead and Back-up Counsel (37 C.F.R. §42.8(b)(3))
`Lead Counsel is David A. Garr (Reg. No. 74,932); T: (202) 662-5250; F:
`
`(202) 778-5250; E: dgarr@cov.com. Backup Counsel is Jay I. Alexander (Reg.
`
`No. 32,678); T: (202) 662-5622; F: (202) 778-5622; jalexander@cov.com. The
`
`postal and hand delivery address for the foregoing counsel is: Covington &
`
`Burling LLP, One CityCenter, 850 Tenth Street, NW, Washington, DC 20001.
`
`Service Information (37 C.F.R. §42.8(b)(3))
`
`D.
`Service information is provided in the designation of counsel above.
`
`Counsel for Petitioner consents to service of all documents via electronic mail at
`
`OmniActive-Kemin@cov.com.
`
`III. Fees (37 C.F.R. §42.103)
`The undersigned authorizes the United States Patent and Trademark Office
`
`(“Office”) to charge $23,000 ($9,000 request fee, and $14,000 post-institution fee)
`
`to Deposit Account No. 50-0740 for the fees set forth in 37 C.F.R. §42.15(a) for
`
`this Petition. The undersigned also authorizes payment for any additional fees that
`
`might be due in connection with this Petition to be charged to the Deposit Account.
`
`6
`
`

`
`Petition for Inter Partes Review of U.S. Patent No. 9,226,940
`
`IV. Requirements for IPR Under 37 C.F.R. §42.104
`A. Grounds for Standing (37 C.F.R. §42.104(a))
`Pursuant to 37 C.F.R. §42.104(a), Petitioner certifies that the ’940 Patent is
`
`available for IPR and that Petitioner is not barred or estopped from requesting an
`
`IPR challenging the ’940 Patent on the grounds identified in the present petition.
`
`Prior Art Publications Relied Upon
`
`B.
`Exhibit Reference
`
`Publication Date
`
`1003
`
`Lloyd Snider, Evidence
`
`November 2008
`
`Supports New Approaches for
`
`Reducing the Risk of Macular
`
`Degeneration, Optometric
`
`Management (“Snider”)
`
`Availability as
`Prior Art
`35 U.S.C.
`
`§102(b)
`
`1004
`
`Barbara McLaughlan,
`
`September 2005
`
`35 U.S.C.
`
`§102(b)
`
`Awareness of Age-related
`
`Macular Degeneration and
`
`Associated Risk Factors, AMD
`
`Alliance International Global
`
`Report 2005 (“McLaughlan”)
`
`1005
`
`Gilles Chaine, Case-control
`
`September 1998
`
`35 U.S.C.
`
`study of the risk factors for age
`
`§102(b)
`
`7
`
`

`
`Petition for Inter Partes Review of U.S. Patent No. 9,226,940
`
`35 U.S.C.
`
`§102(b)
`
`related macular degeneration,
`
`British Journal of
`
`Ophthalmology (“Chaine”)
`
`1006
`
`Stuart Richer, Double-masked,
`
`April 2004
`
`placebo-controlled, randomized
`
`trial of lutein and antioxidant
`
`supplementation in the
`
`intervention of atrophic age-
`
`related macular degeneration:
`
`the Veterans LAST study
`
`(Lutein Antioxidant
`
`Supplementation Trial),
`
`Optometry (“Richer”)
`
`1007
`
`U.S. Patent Application
`
`September 24, 2009 35 U.S.C.
`
`Publication No. 2009/0239836
`
`§102(a) & (e)
`
`(“Ciolkowski”)
`
`C. Claims and Statutory Grounds (37 C.F.R. §§42.104(b)(1) &(b)(2))
`Ground Claims
`Basis
`I
`’940 Patent claims 1–6, and 9
`Under 35 U.S.C. §103 as
`
`unpatentable over Snider
`
`8
`
`

`
`Petition for Inter Partes Review of U.S. Patent No. 9,226,940
`
`II
`
`’940 Patent claims 8, 10, and 12
`
`Under 35 U.S.C. §103 as
`
`unpatentable over Snider
`
`and Richer
`
`III
`
`’940 Patent claims 7, 11, and 13
`
`Under 35 U.S.C. §103 as
`
`unpatentable over Snider
`
`and Ciolkowski
`
`
`
`V.
`
`Summary of the ’940 Patent
`
`The ’940 Patent (Ex. 1001), entitled “Methods of Treating Ocular
`
`Disorders,” issued on January 5, 2016 from U.S. Patent Application No.
`
`14/307,684 (“the ’684 Application”), which was filed on June 18, 2014. The ’684
`
`Application claims priority through a parent application to U.S. Provisional
`
`Application No. 61/384,958, filed on September 21, 2010.1 Therefore, any
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`documents published before September 21, 2009 are prior art under 35 U.S.C.
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`§102(b).2 Documents published before September 21, 2010 are prior art under 35
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`1 Petitioner reserves the right to challenge the priority date in subsequent legal
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`proceedings.
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`2 Because the ’684 Application was filed prior to March 16, 2013, the provisions of
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`35 U.S.C. §102 prior to the amendments of the America Invents Act (“AIA”)
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`(continued…)
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`9
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`Petition for Inter Partes Review of U.S. Patent No. 9,226,940
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`U.S.C. §102(a). Issued United States patents and United States patent application
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`publications filed before September 21, 2010 are prior art under 35 U.S.C. §102(e).
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`The ’940 Patent contains 13 claims, all of which are challenged in this
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`petition. The ’940 Patent relies on prior studies in the field of ocular nutrition
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`demonstrating “a definite relationship between the ingestion of ocular antioxidants
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`and a reduction in the risk for the incidence and/or progression of AMD.” Ex.
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`1001, 5:11–13. More specifically, the ’940 Patent cites multiple studies
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`demonstrating the successful treatment of AMD “as a result of lutein and
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`zeaxanthin supplementation or a combination of these xanthophylls with other
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`antioxidants.” Id. at 4:41–43.
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`Acknowledging the known practice of treating AMD with ocular
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`antioxidants, the ’940 Patent clarifies that “[t]he methods of the present invention
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`are not meant to cover damage that might be induced in the eye as a result of other
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`conditions/diseases [other than hyperopia, presbyopia, or astigmatism] that might
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`also result in AMD, including but not limited to inherited conditions (a genetic
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`component) or damage from other forms of retinopathies aside from AMD.” Ex.
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`1001, 11:23–28.
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`apply. Therefore, all references to 35 U.S.C. §102 herein are to the pre-AIA
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`version.
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`Petition for Inter Partes Review of U.S. Patent No. 9,226,940
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`The ’940 Patent further relies on “known data” demonstrating that “blue-
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`light induced damage has been related to increased likelihood of AMD.” Ex. 1001,
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`10:33–38. In discussing the reduction of blue light damage, the patent notes that
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`the “known blue light-absorbing capability and/or antioxidant capacity of the
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`xanthophylls (lutein and zeaxanthin) comprising the macular pigment and the
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`presence of other ocular antioxidants . . . help limit the blue light-induced
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`damage.” Id. at 11:18–22 (emphasis added).
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`The ’940 Patent characterizes the “present invention” as “the administration
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`to subjects having or at risk for having hyperopia, presbyopia or astigmatism with
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`a composition having a therapeutically effective amount of ocular antioxidants,
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`including specifically macular pigments, to prevent, treat, or delay the onset of
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`AMD.” Ex. 1001, 1:36–41. The alleged inventive concept involves presentation,
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`in a “unified manner,” of (i) the relationship between AMD and hyperopia,
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`presbyopia, and astigmatism,3 (ii) “the effects of light upon the retina” associated
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`3 The ’940 Patent states that “[t]he epidemiological literature contains conflicting
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`reports of a relationship between hyperopia and AMD with one report indicating
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`that people who exhibit hyperopia are more likely to get AMD in later life and
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`other reports indicated [sic] that such a relationship was weak at best.” Ex. 1001,
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`7:7-13 (citations omitted). Despite some conflicting studies in the field regarding a
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`(continued…)
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`Petition for Inter Partes Review of U.S. Patent No. 9,226,940
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`with development of AMD, and (iii) the effects of “ocular antioxidants in helping
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`reduce the progression of AMD.” Ex. 1001, 4:20–34.
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`Claims 1–13 at issue in this petition are directed to methods of reducing “the
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`increased blue and ultraviolet light damage to the retina of a subject having a
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`condition that causes such blue or ultraviolet light to fall disproportionately on or
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`in front of the retina . . . , wherein the condition is presbyopia or hyperopia or
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`astigmatism” by administering ocular oxidants. Claim 1, the lone independent
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`claim of the ’940 Patent, claims a method to accomplish such reduction in blue and
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`ultraviolet light damage by the administration of “a composition comprising a
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`therapeutically effective amount of one or more ocular antioxidants.” Claim 2
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`specifies that the ocular antioxidants of claim 1 be members of the Markush group:
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`“antioxidant vitamins, carotenoids, antioxidant minerals, natural antioxidants
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`extracts and synthetic antioxidants.”
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`Claims 3–13 all expand upon claim 2, with each claim adding a narrowing
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`limitation to one of the constituent ocular antioxidant groups in claim 2.
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`causal link between hyperopia and AMD, prior art to the ’940 Patent identified a
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`“general consensus” in the field that hyperopia was a risk factor for developing
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`AMD. Ex 1003, 3; see also Ex. 1004, 10.
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`Petition for Inter Partes Review of U.S. Patent No. 9,226,940
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`Claim 3 specifies that the antioxidant vitamin in claim 2 be “selected from
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`the list consisting of vitamins A, C, and E.” Claim 8 specifies that the
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`“therapeutically effective amount” of the antioxidant vitamins of claim 2 be in the
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`range between “0.02 (1 IU) and 15 mg (150 IU) per kilogram of body weight of
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`said subject per day.”
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`Claim 4 specifies that the carotenoid in claim 2 be “selected from the list
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`consisting of lutein, zeaxanthin, beta-carotene, retinoids, retinal, retinaldehyde, and
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`meso-zeaxanthin.” Claim 9 specifies that the “therapeutically effective amount” of
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`the carotenoid in claim 2 be in the range between “0.0001 and 2 mg per kilogram
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`of body weight of said subject per day.”
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`Claim 5 specifies that the antioxidant mineral in claim 2 be “selected from
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`the list consisting of zinc, copper, and selenium.” Claim 10 specifies that the
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`“therapeutically effective amount” of the antioxidant mineral in claim 2 be in the
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`range between “0.0001 and 5 mg per kilogram of body weight of said subject per
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`day.”
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`Claim 6 specifies that the natural extract in claim 2 be “selected from the list
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`consisting of polyphenols, quercitin, anthocyanins, and anthocyanidins.” Claim 12
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`specifies that the “therapeutically effective amount” of the natural extract in claim
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`2 be in the range between “0.0001 and 20 mg per kilogram of body weight of said
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`subject per day.”
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`13
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`Petition for Inter Partes Review of U.S. Patent No. 9,226,940
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`Claim 7 specifies that the synthetic antioxidant in claim 2 be “selected from
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`the list consisting of BHT, BHA, and BTHQ.” Claim 11 specifies that the
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`“therapeutically effective amount” of the synthetic antioxidant in claim 2 be in the
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`range between “0.001 and 15 mg per kilogram of body weight of said subject per
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`day,” while claim 13 specifies that this amount be in the range between “0.0001
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`and 20 mg per kilogram of body weight of said subject per day.”
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`VI. Level of Ordinary Skill in the Art
`Based on the disclosure of the ’940 Patent, a person of ordinary skill in the
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`art of the ’940 Patent at the time of the alleged invention (“POSA”) “would have
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`been an individual with a Bachelor’s degree in the physical or life sciences
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`(Chemistry, Physics, or Biology) along with at least two years of experience
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`researching ocular disorders.” See Ex. 1008, ¶13.
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`VII. Claim Construction
`An unexpired claim in IPR is given its “broadest reasonable construction in
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`light of the specification of the patent in which it appears.” 37 C.F.R. §42.100(b).
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`Claim terms are given their “broadest reasonable construction in light of the
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`specification as they would be interpreted by one of ordinary skill in the art.”
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`TriVASCULAR, INC. v. Samuels, 812 F.3d 1056, 1061–62 (Fed. Cir. 2016).
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`Petitioner does not believe any terms of the ’940 Patent require specialized
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`constructions, at least for purposes of the issues in this proceeding, and should be
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`Petition for Inter Partes Review of U.S. Patent No. 9,226,940
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`interpreted consistent with their ordinary and customary definition, in accordance
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`with the applicable standard. Petitioner notes that the ’940 Patent provides an
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`express definition of “treating,” which is consistent with the ordinary and
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`customary meaning of the term:
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`As used herein, the terms ‘treated’ and ‘treating’ refers to preventing
`or delaying the appearance of clinical symptoms of a disease or
`condition in a subject that may be afflicted with or predisposed to the
`disease or condition, but does not yet experience or display clinical or
`subclinical symptoms of the disease or condition. ‘Treating’ also
`refers to inhibiting the disease or condition, i.e., arresting or reducing
`its development or