Filed on behalf of L’Oréal USA, Inc.
`
`By: Michelle E. O’Brien
`Timothy J. Murphy
`Joanna Cohn
`
`The Marbury Law Group, PLLC
`11800 Sunrise Valley Drive
`15th Floor
`
`Tel: (703) 391-2900
`Fax: (703) 391-2901
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`PETITION FOR INTER PARTES REVIEW
`
`OF U.S. PATENT NO. 6,645,513
`
`Mail Stop PATENT BOARD
`Patent Trial and Appeal Board
`U.S. Patent & Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`
`
`
`
`
`
`
`

`

`
`I. Mandatory Notices (37 C.F.R. §42.8(a)(1)) ………………………………….3
`
`TABLE OF CONTENTS
`
`REAL PARTY IN INTEREST ....................................................................... 3
`
`RELATED MATTERS .................................................................................... 3
`
`LEAD AND BACKUP COUNSEL ................................................................. 4
`
`SERVICE INFORMATION: .......................................................................... 4
`
`II. Grounds For Standing (37 C.F.R. §42.104(a)) ............................................. 5
`
`III. Identification of Challenge (37 C.F.R. §42.104(b)) ...................................... 5
`
`A. Citation of Prior Art ................................................................................... 5
`
`B. Statutory Grounds for Challenge and Non-Redundancy ....................... 6
`
`IV. The ‘513 Patent ............................................................................................... 7
`
`A. Technical Background ................................................................................ 8
`
`B. Specification of the ‘513 Patent ................................................................. 9
`
`C. Prosecution of the ‘513 Patent .................................................................11
`
`V. Level of Ordinary Skill in the Art ...............................................................13
`
`VI. Claim Construction .......................................................................................13
`
`A. Legal Standard ..........................................................................................13
`
`B. Claim Language of the ‘513 Patent .........................................................15
`
`1. “Topical” application to “unbroken skin” ...........................................15
`
`2. Adenosine “applied to the dermal cells” ..............................................20
`
`3. PO’s Potential Alternative Interpretation Would Be Improper .......26
`
`VII. Grounds of Rejection ....................................................................................29
`
`A. GROUND 1: Claims 1-7 and 9 are unpatentable under 35 U.S.C.
`
`§102(b) as anticipated by JP ‘153 ............................................................30
`
`1. Claim 1 .....................................................................................................30
`
`2. Claim 2 .....................................................................................................37
`
`ii
`
`

`

`3. Claim 3 .....................................................................................................39
`
`4. Claim 4 .....................................................................................................40
`
`5. Claim 5 .....................................................................................................41
`
`6. Claim 6 .....................................................................................................43
`
`7. Claim 7 .....................................................................................................43
`
`8. Claim 9 .....................................................................................................45
`
`B. GROUND 2: Claim 4 is unpatentable under 35 U.S.C. §103 as obvious
`
`over JP ‘153 ...............................................................................................49
`
`1. JP ‘153 Teaches and Renders Obvious Using a Concentration of
`
`“About 10-3M” Adenosine in His Compositions and Methods ...........49
`
`2. Secondary Considerations .....................................................................52
`
`C. GROUND 3: Claims 1-7 and 9 are unpatentable under 35 U.S.C. §103
`
`as obvious over JP ‘153 and DE‘107 .......................................................52
`
`1. The JP ‘153/DE ‘107 Combination Would Have Rendered Claims 1-
`
`7 and 9 Obvious to a POSITA ...............................................................54
`
`2. Secondary Considerations .....................................................................68
`
`VIII. CONCLUSION .............................................................................................69
`
`
`
`
`
`iii
`
`

`

`Cases
`
`TABLE OF AUTHORITIES
`
`Advance Transformer Co. v. Levinson, 837 F.2d 1081, 1083 (Fed.Cir.1988) ........15
`
`Atlas Powder Co. v. IRECO, Inc.,
`
`190 F.3d 1342, 1347 (Fed.Cir.1999) .....................................................................36
`
`Biogen Idec, Inc. v. GlaxoSmithKline LLC,
`
`7713 F.3d 1090, 1095 (Fed.Cir.2013) ..................................................................... 2
`
`ClearValue Inc. v. Pearl River Polymers Inc., 668 F.3d 1340 (Fed.Cir.2012)...…51
`
`Cont’l Can Co. v. Monsanto Co., 948 F.2d 1264, 1268 (Fed.Cir.1991) .......... 45, 62
`
`Graham v. John Deere Co., 383 U.S. 1 (1966) .......................................................29
`
`Hockerson-Halberstadt, Inc. v. Avia Grp. Int’l, Inc.,
`
`222 F.3d 951, 957 (Fed.Cir.2000) .........................................................................15
`
`In re Aller, 220 F.2d 454, 456 (C.C.P.A. 1955) ............................................... 51, 53
`
`In re Antonie, 559 F.2d 618, 620 (C.C.P.A. 1977) ..................................... 51, 53, 55
`
`In re Arkley, 455 F.2d 586, 587 (C.C.P.A. 1972) ............................................ passim
`
`In re Wertheim, 541 F.2d 257 (CCPA 1976)……………………………………..50
`
`In re Woodruff, 919 F.2d 1575 (Fed. Cir. 1990)………………………………….50
`
`KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398 (2007) ........................................ 29, 51
`
`LSI Corp. and Avago Tech. U.S., Inc. v. Reg. of the Univ. of Minn.,
`
`IPR2017-01068, Paper 19 at 10 (P.T.A.B. December 19, 2017) ............................ 5
`
`Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157, 1167 (Fed.Cir.2006)....................55
`
`Modine Mfg. Co. v. United States ITC, 75 F.3d 1545, 1557 (Fed.Cir.1996) ..........27
`
`Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364 (Fed.Cir.2007) ............................55
`
`Phillips v. AWH Corp., 415 F.3d 1303, 1312-13 (Fed.Cir.2005). ...........................14
`
`Spansion, Inc. v. ITC, 629 F.3d 1331, 1356 (Fed.Cir.2010)....................................29
`
`Tempo Lighting, Inc. v. Tivoli, LLC, 742 F.3d 973 (Fed.Cir.2014) ........................14
`
`iv
`
`

`

`
`
`Statutes
`Statutes
`
`35 U.S.C. §102 .........................................................................................................29
`35 U.S.C. §102 ......................................................................................................... 29
`
`35 U.S.C. §102(a) ....................................................................................................11
`35 U.S.C. §102(a) .................................................................................................... 11
`
`35 U.S.C. §102(b) ......................................................................................... 6, 29, 48
`35 U.S.C. §102(b) ......................................................................................... 6, 29, 48
`
`35 U.S.C. §102(e) ....................................................................................................11
`35 U.S.C. §102(e) .................................................................................................... 11
`
`35 U.S.C. §103 ........................................................................................ 7, 29, 50, 66
`35 U.S.C. §103 ........................................................................................ 7, 29,50, 66
`
`35 U.S.C. §103(a) ....................................................................................................11
`35 U.S.C. §103(a) .................................................................................................... 11
`
`35 U.S.C. §112 .................................................................................................. 26, 28
`35 U.S.C. §112 .................................................................................................. 26, 28
`
`
`
`Rules
`Rules
`
`37 C.F.R. §42.10(a) .................................................................................................... 4
`37 CPR. §42.10(a) ....................................................................................................4
`
`37 C.F.R. §42.10(b) ................................................................................................... 4
`37 CPR. §42.10(b) ...................................................................................................4
`
`37 C.F.R. §42.104(a) .................................................................................................. 5
`37 CPR. §42.104(a) .................................................................................................. 5
`
`37 C.F.R. §42.104(b) ................................................................................................. 5
`37 CPR. §42.104(b) ................................................................................................. 5
`
`37 C.F.R. §42.8(a)(1) ................................................................................................. 3
`37 CPR. §42.8(a)(1) ................................................................................................. 3
`
`37 C.F.R. §42.8(b)(3) ................................................................................................. 4
`37 CPR. §42.8(b)(3) .................................................................................................4
`
`
`
`
`
`v
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`

`

`
`
`EXHIBIT LIST
`
`Exhibit No.
`
`Description
`
`1001
`
`U.S. Patent No. 6,423,327 to Dobson et al.
`
`1002
`
`U.S. Patent No. 6,645,513 to Dobson et al.
`
`1003
`
`German Published Unexamined Application No. DE 19545107
`
`1004
`
`Certified Translation of DE 19545107 with Affidavit attesting to
`accuracy under 37 CFR 42.63(b)
`
`1005
`
`Japanese Unexamined Publication JP-H-09-157153
`
`1006
`
`Certified Translation of JP-H-09-157153 with Affidavit attesting
`to accuracy under 37 CFR 42.63(b)
`
`1007
`
`U.S. Patent No. 5,091,182 to Ong et al.
`
`1008
`
`File History of U.S. Patent No. 6,645,513
`
`1009
`
`File History of U.S. Patent No. 6,423,327
`
`1010
`
`Declaration of R. Randall Wickett, Ph.D.
`
`1011
`
`Declaration of S. Jamal Mustafa, Ph.D.
`
`1012
`
`PCT Publication WO1996014822A1 Porter et al.
`
`1013
`
`U.S. Patent No. 6,316,012 to N’Guyen et al.
`
`1014
`
`Kathryn M. Neurath et al., AMP-Dependent Protein Kinase Alpha
`2 Isoform Promotes Hypoxia-Induced VEGF Expression in Human
`Glioblastoma, 53 Glia 733, 733–743 (2006).
`
`1015
`
`Geoffrey Burnstock et al., Purinergic Signaling in Healthy and
`Diseased Skin, 132 J. Invest. Dermatol 526, 526–546 (2012).
`
`1016
`
`Robert J. Scheuplein, Permeability of the Skin: A Review of Major
`
`1
`
`

`

`1017
`
`1018
`
`1019
`
`1020
`
`1021
`
`Concepts and Some New Developments, 67 J. INVESTIGATIVE
`DERMATOL. 672, 672-76 (1976).
`
`Karen A. Holbrook & George F. Odland, Regional Differences in
`the Thickness (Cell Layers) of the Human Stratum Corneum: An
`Ultrastructural Analysis , 62 J. Investigative Dermatol. 415, 415-
`22 (1974).
`
`C. Lotte et al., In vivo relationship between transepidermal water
`loss and percutaneous penetration of some organic compounds in
`man: effect of anatomic site, 279 Arch Dermatol Res 351, 351-6
`(1987).
`
`H. Koizumi et al., Adenosine Deaminase in Human Epidermis
`from Healthy and Psoriatic Subjects, 275 Arch Dermatol Res 310,
`310-14 (1983).
`
`P. Singh & M.S. Roberts, Skin Permeability and Local Tissue
`Concentrations of Nonsteroidal Anti-Inflammatory Drugs after
`Topical Application, 268 J. Pharmacol. Exp. Ther 144, 144-51
`(1994).
`
`Gary L. Grove et al., Use of nonintrusive tests to monitor age-
`associated changes in human skin, 32 J. Soc. Cosmet. Chem. 15,
`15-26 (1981).
`
`
`
`
`
`
`2
`
`

`

`
`
`
`L’Oréal USA, Inc. (“Petitioner”) petitions for inter partes review of claims
`
`1-7 and 9 of U.S. Patent No. 6,645,513 to Dobson, Jr. et al., entitled
`
`“TREATMENT OF SKIN WITH ADENOSINE OR ADENOSINE ANALOG”
`
`(“the ‘513 patent,” Ex. 1002).
`
`
`
`
`
`
`
`
`
`I. Mandatory Notices (37 C.F.R. §42.8(a)(1))
`
`REAL PARTY IN INTEREST:
`
`The real parties-in-interest are L’Oréal USA, Inc. and L’Oréal SA.
`
`RELATED MATTERS:
`
`The ‘513 patent, entitled “Treatment of Skin with Adenosine or Adenosine
`
`Analog,” issued on November 11, 2003, from U.S. Patent Application No.
`
`10/184,810, filed June 28, 2002, as a continuation of U.S. Patent Application No.
`
`09/672,348 (“the ‘348 application”), filed September 28, 2000, as a continuation of
`
`U.S. Patent Application No. 09/179,006, filed October 26, 1998.1 (See Ex. 1002.)
`
`
`
`A petition for inter partes review was filed on March 15, 2018 (IPR2018-
`
`00778), challenging claims 1-7 and 9 of U.S. Patent No. 6,423,327 (“the ‘327
`
`
`
`1 Petitioner does not concede that any claim of the ‘513 patent is entitled to any
`
`claim of priority and reserves the right to challenge priority; however, for purposes
`
`of this Petition, Petitioner will refer to the earliest possible priority date of the ‘513
`
`patent as October 26, 1998.
`
`3
`
`

`

`patent,” Ex. 1001), which issued from the ‘348 application to which the ‘513
`
`patent claims priority.
`
`
`
`University of Massachusetts Medical School and Carmel Laboratories, LLC
`
`v. L’Oréal S.A. and L’Oréal USA, Inc., Case 1:17-cv-00868, filed on June 30,
`
`2017, in United States District Court for the District of Delaware, includes a
`
`complaint for patent infringement of the ‘513 patent (“Delaware suit”).
`
`
`
`
`
`LEAD AND BACKUP COUNSEL:
`
`Pursuant to 37 C.F.R. §42.8(b)(3) and 37 C.F.R. §42.10(a), Petitioner
`
`appoints Michelle E. O’Brien (Reg. No. 46,203) as its lead counsel, and Timothy
`
`J. Murphy (Reg. No. 62,585) and Joanna Cohn (Reg. No. 68,010) as its back-up
`
`counsel. Pursuant to 37 C.F.R. §42.10(b), a power of attorney is being filed with
`
`this designation of counsel.
`
`
`
`SERVICE INFORMATION:
`
`Petitioner provides the following service information for designated counsel:
`
`The Marbury Law Group, PLLC
`11800 Sunrise Valley Drive
`15th Floor
`Reston, VA 20191
`
`Tel: (703) 391-2900
`Fax: (703) 391-2901
`
`
`
`Petitioner consents to electronic service by email to the email addresses:
`
`4
`
`

`

`mobrien@marburylaw.com;
`
`tjmurphy@marburylaw.com;
`
`jcohn@marburylaw.com; and
`
`513IPR@marburylaw.com.
`
`II. Grounds for Standing (37 C.F.R. §42.104(a))
`
`
`
`
`Petitioner certifies that the ‘513 patent is available for inter partes review
`
`and that Petitioner is not barred or estopped from requesting an inter partes review
`
`challenging the claims on the grounds identified in this Petition.
`
`
`
`Furthermore, although Petitioner does not concede that PO is entitled to
`
`sovereign immunity, PO waived any possible claim of sovereign immunity in this
`
`proceeding by asserting the ‘513 patent against Petitioner in the Delaware suit.
`
`See, e.g., LSI Corp. and Avago Tech. U.S., Inc. v. Reg. of the Univ. of Minn.,
`
`IPR2017-01068, Paper 19 at 10 (P.T.A.B. December 19, 2017).
`
`III.
`
`Identification of Challenge (37 C.F.R. §42.104(b))
`
`A. Citation of Prior Art
`
`
`
`Petitioner cites the following prior art references:
`
`• Japanese Unexamined Publication JP-H-09-157153 (“JP’153,” Ex.
`
`1005, with reference herein to Ex. 1006 (certified translation)) is prior
`
`art under at least 35 U.S.C. §102(b) because it published on June 17,
`
`5
`
`

`

`1997, more than 1 year before the earliest possible priority date of the
`
`‘513 patent. JP’153 was not considered by the Examiner who
`
`examined the ‘513 patent.
`
`• U.S. Patent No. 5,091,182 to Ong (“Ong,” Ex. 1007) is prior art
`
`under at least 35 U.S.C. §102(b) because it issued on February 25,
`
`1992, more than 1 year before the earliest possible priority date of the
`
`‘513 patent. Ong, which is relied on for what was known in the art,
`
`was not considered by the Examiner who examined the ‘513 patent.
`
`• German Published Unexamined Application No. DE 198459107
`
`(“DE‘107,” Ex. 1003, with reference herein to Ex. 1004 (certified
`
`translation)) is prior art under at least 35 U.S.C. §102(b) because it
`
`published on June 5, 1997, more than 1 year before the earliest
`
`possible priority date of the ‘513 patent.
`
`B. Statutory Grounds for Challenge and Non-Redundancy
`
`Petitioner requests review of claims 1-7 and 9 of the ‘513 patent on the
`
`following grounds:
`
`• GROUND 1: Claims 1-7 and 9 are unpatentable under 35 U.S.C.
`
`§102(b) as anticipated by JP’153 (Ex. 1005, 1006).
`
`• GROUND 2: Claim 4 is unpatentable under 35 U.S.C. §103 as
`
`obvious over JP’153 (Ex. 1005, 1006).
`
`6
`
`

`

`• GROUND 3: Claims 1-7 and 9 are unpatentable under 35 U.S.C.
`
`§103 as obvious over JP’153 (Ex. 1005, 1006) and DE‘107 (Ex. 1003,
`
`1004).
`
`The grounds are not redundant because they are based on different statutory
`
`bases and combinations. Further, JP‘153 was not considered by the Examiner
`
`during prosecution of the ‘513 patent.
`
`IV. The ’513 Patent
`
`The ‘513 patent relates to “[m]ethods for enhancing the condition of non-
`
`diseased skin by application of compositions containing adenosine2 [to the
`
`skin]….” (Ex. 1002, Abstract.)
`
`Claim 1 recites “[a] method for enhancing the condition of unbroken skin of
`
`a mammal by reducing one or more of wrinkling, roughness, dryness, or laxity of
`
`the skin, without increasing dermal cell proliferation, the method comprising
`
`topically applying to the skin a composition comprising a concentration of
`
`adenosine in an amount effective to enhance the condition of the skin without
`
`increasing dermal cell proliferation, wherein the adenosine concentration applied
`
`
`
`2 The ‘513 patent specification discusses both adenosine and adenosine analogs
`
`throughout; however, since adenosine analogues were canceled from the claims,
`
`Petitioner’s discussion will focus only on adenosine.
`
`7
`
`

`

`to the dermal cells is 10−3 M to 10−7 M.” (Ex. 1002, 10:17-26.)
`
`A. Technical Background
`
`As was well-known prior to and in 1998, human skin is comprised of many
`
`layers, including outer, epidermal layers, which cover inner layers, including the
`
`dermis. (Ex. 1002, 1:25-30; Ex. 1010, ¶31-32.) As the ‘513 patent explains, skin
`
`has “a surface layer, known as the epidermis, and a deeper connective tissue layer,
`
`known as the dermis.” (Ex. 1002, 1:25-30.) Further, the “dermis is composed of a
`
`variety of cell types, including fibroblasts.” (Id.) Thus, the dermis, made up of
`
`different types of dermal cells including dermal fibroblast cells, is covered by the
`
`outer layer, the epidermis, made up of different types of epidermal cells. (Ex.
`
`1010, ¶31.)
`
`It was also well known prior to 1998 that human skin changes with age and
`
`exposure to environmental agents such as ultraviolet radiation and atmospheric
`
`pollutants. (Ex. 1002, 1:31-33; Ex. 1004, 1:11-34; Ex. 1006, 2:7-28; Ex. 1012,
`
`1:13-16; Ex. 1013, 1:16-24; Ex. 1010, ¶34.) Indeed, age, ultraviolet radiation, and
`
`pollution have long been understood to damage the skin and contribute to an
`
`increase in the appearance of wrinkles and a decrease in the skin’s brightness and
`
`smoothness. (Ex. 1004, 1:11-34; Ex. 1006, p. 2, ll. 7-28; Ex. 1012, 1:13-16; Ex.
`
`1013, 1:16-23; Ex. 1010, ¶34.) It was, therefore, known well before the ‘513
`
`patent’s earliest priority date to treat skin that had such damage by topically
`
`8
`
`

`

`applying cosmetic compositions comprising various compounds and chemicals,
`
`such as antioxidants, to the outer, epidermal layer of the skin. (Ex. 1006, 2:29-35
`
`and Abstract; Ex. 1012, 1:14-3:14; Ex. 1013, 1:55-59 and Abstract; Ex. 1010, ¶38,
`
`55, 58.)
`
`Adenosine is a nucleoside that occurs naturally in all human cells, and is
`
`relevant to many biochemical processes in the human body. (Ex. 1011, ¶15.) Prior
`
`to 1998, adenosine was known to have antioxidant properties. (Ex. 1013, 1:32-35.)
`
`Likewise, adenosine was known prior to 1998 to be useful in cosmetic
`
`compositions for treating skin dryness and wrinkling, such as that caused by aging,
`
`ultraviolet radiation, and pollution. (Ex. 1004, 1:1-34; Ex. 1006, 2:7-28; Ex. 1013,
`
`1:16-23.)
`
`B. Specification of the ‘513 Patent
`
`The ‘513 patent states that “adenosine stimulates DNA synthesis, increases
`
`protein synthesis, and increases cell size in cultures of human skin fibroblasts,”
`
`which effects the ‘513 patent asserts permit the use of adenosine in the disclosed
`
`“methods and compositions for enhancing the condition of skin.” (Ex. 1002, 1:43-
`
`47.) According to the ‘513 patent, “the invention provides a method for enhancing
`
`the condition of non-diseased skin of a mammal, e.g., a human” utilizing the
`
`aforementioned effects of adenosine, by “topically applying a therapeutically
`
`effective amount of a composition including adenosine…to non-diseased skin of
`
`9
`
`

`

`the mammal.” (Id., 1:48-53.) Finally, the ‘513 patent states that the methods
`
`include “topically administering a composition including a therapeutically
`
`effective amount of adenosine...to a region of skin of the mammal containing the
`
`dermal cell,” and that “the adenosine…does not cause proliferation of the dermal
`
`cell.” (Id., 1:61-65, 2:1–5, 2:9–13.)
`
`According to the ‘513 patent, “a ‘therapeutically effective amount’ of
`
`adenosine…means an amount that enhances the skin when applied to the skin.”
`
`(Id., 2:44-47.) Specifically, the ‘513 patent states that “[t]he therapeutically
`
`effective amount of adenosine used in the above-described methods is preferably
`
`10-3M to 10-7M, more preferably 10-4M to 10-6M, and most preferably about 10-4
`
`M.” (Id., 2:20-23.) These molar ranges correspond to weight percents of
`
`preferably 0.0265% to 0.00000265%, more preferably 0.00265% to 0.0000265%,
`
`and most preferably about 0.00265%.3 (Ex. 1010, ¶30.)
`
`Finally, the ‘513 patent defines the phrase “enhancement of skin condition”
`
`as bringing about “a noticeable decrease in the amount of wrinkling, roughness,
`
`dryness, laxity, shallowness, or pigmentary mottling in skin.” (Ex. 1002, 2:41-43.)
`
`
`
`
`
`
`
`3 The claimed ranges of 10-3M to 10-7M (claim 1) and 10-3M to 10-6M (claim 3)
`
`correspond to 0.0265% to 0.00000265% and 0.0265% to 0.0000265%,
`
`respectively. (Ex. 1010, ¶30.)
`
`10
`
`

`

`C. Prosecution History of the ‘513 Patent
`
`The application that issued as the ‘513 patent was filed on June 28, 2002,
`
`along with a preliminary amendment cancelling some of the claims and adding
`
`priority information to the specification. (Ex. 1008, pp. 6-45.)
`
`On October 28, 2002, the Examiner issued a non-final office action rejecting
`
`claims 1 and 3-10 under 35 U.S.C. 102(e) as anticipated by U.S. Patent No.
`
`5,998,423 to Manneth et al. (“Manneth”). (Id. at 56-57.) The Examiner further
`
`rejected claims 1, 6, and 10 under 35 U.S.C. §102(a) as anticipated by U.S. Patent
`
`No. 5,770,582 to von Borstel et al. (“von Borstel”) (id. at 57), and rejected claims
`
`2-5, 9, 52 and 53 under 35 U.S.C. §103(a) as unpatentable over von Borstel (id. at
`
`57-58). Claims 1-10, 52 and 53 were also rejected based on obvious-type double
`
`patenting over claims 1-10 of the parent U.S. Patent No. 6,423,327. (Id. at 55-56.)
`
`In a response dated January 14, 2003, the applicant cancelled the pending
`
`claims and added new claims 54-63, arguing that the cited references did not
`
`disclose the elements recited in the new claims. (Id. at 62-64.) In particular, in
`
`distinguishing the claimed adenosine concentration (i.e., 10-3 M to 10-7M), the
`
`applicant argued that:
`
`What Manneth describes at column 4, lines 7-17, are the Ki values of
`
`adenosine receptor Al antagonists and A2 agonists. These values of Ki
`
`are inhibition constants for these compounds, not concentrations to be
`
`administered.... The Ki and Ka values are used to express the potency
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`of compounds. The more potent the antagonist or agonist is at a given
`
`receptor, the lower the Ki or Ka will be. This is useful to Manneth in
`
`comparing the relative potency of a group of agonists or antagonists,
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`but is certainly not the same as stating a concentration to be
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`administered.
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`(Id. at 66-67.)
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`
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`Further, the applicant argued against the amount of adenosine recited in the
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`composition of Von Borstel:
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`Von Borstel does not describe the use of adenosine at all, and thus it
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`cannot have been obvious to "optimize" the amount of adenosine for
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`use in von Borstel's methods. One of skill in the art would not have
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`thought to use adenosine based on the von Borstel patent, much less
`
`known what amount to apply to skin.
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`(Id. at 67, emphasis added)
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`
`
`A notice of allowance issued on April 22, 2003, which included the
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`following statement of reasons for allowance:
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`The closest prior art of record teaches administering adenosine in skin
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`care compositions. However, the art of record utilizes concentrations
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`much higher than claimed and also require the presence of epidermal
`
`growth factor to stimulate cell proliferation. Whereas, instant claims
`
`are directed to treating skin without increasing the dermal cell
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`proliferation. Further, prior art of record does not teach or suggest
`
`any reason for the addition of adenosine in skin care compositions, in
`
`particular, in amounts as low as those claimed.
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`(Id. at 74.) The applicant submitted comments to the reasons for allowance that
`
`did not dispute the Examiner’s reasons. (Id. at 82.) The ‘513 patent issued on
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`November 11, 2013.
`
`V. Level of Ordinary Skill in the Art
`
`
`
`As explained above, adenosine is a nucleoside which is found in all human
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`cells and is relevant to many biochemical processes in the human body. (Section
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`IV.A., supra.) Therefore, a person having ordinary skill in the art (POSITA) at the
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`time of the alleged invention for the ‘513 patent (in 1998 up to and including the
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`October 26, 1998, filing date of the ‘006 application) would have a Bachelor
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`degree in Biochemistry or Chemistry with some academic exposure to, or industry
`
`courses or research in, topical delivery of drugs or cosmetic ingredients. (Ex.
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`1010, ¶28.)
`
`VI. Claim Construction
`
`A. Legal Standard
`
`The ‘513 patent will expire on October 26, 2018, which is less than 18
`
`months from the filing of this Petition. Thus, the ‘513 patent will expire before a
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`final Decision, and Petitioner therefore submits that the Phillips standard should be
`
`applied for claim construction.4 Under the Phillips standard, claim terms are
`
`
`
`4 Although the Broadest Reasonable Interpretation (BRI) is typically used to
`
`interpret the terms of a patent in an IPR, Petitioner has interpreted the claims using
`
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`“generally given their ordinary and customary meaning,” which is “the meaning
`
`that the term would have to a person of ordinary skill in the art in question at the
`
`time of the invention, i.e., as of the effective filing date of the patent application.”
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`Phillips v. AWH Corp., 415 F.3d 1303, 1312-13 (Fed.Cir.2005).
`
`In Tempo Lighting, Inc. v. Tivoli, LLC, 742 F.3d 973 (Fed.Cir.2014), the
`
`Federal Circuit stressed the primacy of intrinsic evidence over extrinsic dictionary
`
`definitions, explaining that “[i]n claim construction, this court gives primacy to the
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`language of the claims, followed by the specification.” (Id. at 977.) The court
`
`further stated that “[t]he prosecution history, while not literally within the patent
`
`document, serves as intrinsic evidence for purposes of claim construction. This
`
`remains true in construing patent claims before the PTO.” Id., citing In re Morris,
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`127 F.3d 1048, 1056 (Fed.Cir.1997). To this end, “[p]ositions taken in order to
`
`obtain allowance of an applicant’s claims are pertinent to an understanding and
`
`interpretation of the claims that are granted by the PTO ... and may work an
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`estoppel as against a subsequent different or broader interpretation.” Advance
`
`
`the narrower Phillips standard but submits that the Petition should be granted and
`
`Trial instituted under either standard, because “[t]he broadest reasonable
`
`interpretation of a claim term may be the same as or broader than the construction
`
`of a term under the Phillips standard. But it cannot be narrower.” Facebook Inc. v.
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`Pragmatus AV LLC, 582 Fed. Appx. 864, 869 (Fed.Cir.2014).
`
`14
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`Transformer Co. v. Levinson, 837 F.2d 1081, 1083 (Fed.Cir.1988). Prosecution
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`history disclaimer “promotes the public notice function of the intrinsic evidence
`
`and protects the public’s reliance on definitive statements made during
`
`prosecution.” Biogen Idec, Inc. v. GlaxoSmithKline LLC, 713 F.3d 1090, 1095
`
`(Fed.Cir.2013). Members of the public, including competitors, are entitled to rely
`
`on the prosecution history. Hockerson-Halberstadt, Inc. v. Avia Grp. Int’l, Inc.,
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`222 F.3d 951, 957 (Fed.Cir.2000).
`
`B. Claim Language of the ‘513 Patent
`
`For the reasons set forth below, the language “wherein the adenosine
`
`concentration applied to the dermal cells is 10-3 M to 10-7 M” of claim 1 is properly
`
`construed as requiring a concentration of adenosine in the composition that is
`
`topically applied to an unbroken, epidermal layer of a region of the skin containing
`
`
`
`the dermal cells to be from 10-3 M to 10-7 M (i.e., 0.0265 % to 0.00000265%). This
`
`construction is consistent with the plain language of the claim, the specification,
`
`and the prosecution history.
`
`Any other claim term should be, and herein are, given its plain and ordinary
`
`meaning as would have been understood by a POSITA in 1998.
`
`1. “Topical” application to “unbroken skin”
`
`Claim 1 of the ‘513 patent expressly requires “topical” application of a
`
`composition containing adenosine to “unbroken skin” (Ex.1002, 10:18-23),
`
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`although there is no explanation in the ‘513 specification regarding what is meant
`
`by either “topical” application or “unbroken skin.” (See generally Ex. 1002; Ex.
`
`1010, ¶32.) However, the plain meaning of this language, the ‘513 patent
`
`specification, and the prosecution history of the ‘513 patent would all lead a
`
`POSITA to understand that “topical” application of a composition containing
`
`adenosine to “unbroken skin” requires that a composition be applied directly to the
`
`outer, epidermal layer of the skin that is intact and does not have any damage, such
`
`as wounds or cuts, burns, etc., such that the inner, dermal layer of the skin is not
`
`exposed. (Ex. 1010, ¶32; Ex. 1009, pp. 64-67.)
`
`a. Plain meaning
`
`The plain meaning of the terms “topical” application and “unbroken skin”
`
`support Petitioner’s proposed construction that topical application of a composition
`
`containing adenosine to unbroken skin requires that the composition be applied
`
`directly to the outer, epidermal layer of skin that is intact and does not have any
`
`damage.
`
`Specifically, it was well known at the time of the alleged invention for the
`
`’513 patent that “topical” application of an agent conventionally required that the
`
`agent is applied to the exterior surface of the target, such as the outer, epidermal
`
`layer of the skin. (Ex. 1010, ¶31-32.) Similarly, the plain meaning of the term
`
`“unbroken” with regard to skin was understood by a POSITA at that time as skin
`
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`that is free from any cuts, wounds, burns, or other damage that would expose inner
`
`layers of the skin, such as the dermis. (Id.)
`
`b. Specification
`
`The above understanding is consistent with the ‘513 patent specification.
`
`Specifically, the ‘513 patent does not give an alternate, unconventional meaning
`
`for the term “topical,” but rather uses it in a conventional way and distinguishes
`
`topical administration from other conventionally non-topical routes of
`
`administration, such as “oral, subdermal, intraderma