DECLARATION OF DR. R. RANDALL WICKETT
`REGARDING U.S. PATENT NO. 6,423,327
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`PETITION FOR INTER PARTES REVIEW
`
`OF U.S. PATENT NO. 6,423,327
`
`DECLARATION OF R. RANDALL WICKETT, PH.D.
`
`L'OREAL USA, INC. EX. 1010
`
`
`REGARDING U.S. PATENT NO. 6,423,327
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`PETITION FOR INTER PARTES REVIEW
`
`OF U.S. PATENT NO. 6,423,327
`
`DECLARATION OF R. RANDALL WICKETT, PH.D.
`
`L'OREAL USA, INC. EX. 1010
`
`
`
`DECLARATION OF DR. R. RANDALL WICKETT
`
`REGARDING U.S. PATENT NO. 6,423,327
`
`TABLE OF CONTENTS
`
`BACKGROUND AND QUALIFICATIONS ...................................3
`
`II.
`
`PRIOR TESTIMONY...............................................................6
`
`III.
`
`COMPENSATIONAND RELATIONSHIP TO THE PARTIES..........7
`
`IV.
`
`MATERIALS CONSIDERED .....................................................7
`
`A.
`
`Relevant Law ...................................................................9
`
`i.
`
`ii.
`
`Anticipation .............................................................9
`
`Obviousness ........................................................... 10
`
`B.
`
`C.
`
`Person of Ordinary Skill in the Art..................................... 12
`
`Claim Construction ...................................................... 12
`
`i.
`
`“wherein the adenosine concentration applied to the dermal
`cells is 10'4 M to 10'1r M” ........................................... 13
`
`CLAIMS 1, 3, 5-7, AND 9 OF THE ‘327 PATENT ARE NOT NOVEL
`IN VIEW OF DE ‘107 ............................................................. 17
`
`CLAIMS 1, 3-7 AND 9 OF THE ‘327 PATENT WOULD HAVE BEEN
`OBVIOUS OVER DE ‘107.......................................................28
`
`VII.
`
`CLAIMS 1, 3—7 AND 9 OF THE ‘327 PATENT WOULD HAVE BEEN
`OBVIOUS OVER JP ‘153 AND DE ‘107 ...................................... 29
`
`
`
`I, R. Randall Wickett, Ph.D., declare as follows:
`
`DECLARATION OF DR. R. RANDALL WICKETT
`
`REGARDING U.S. PATENT NO. 6,423,327
`
`I.
`
`The Opinions set forth below are based on my over 40 years of
`
`experience as an expert in formulating and testing skin care products, including
`
`topical cosmetic compositions, and on the review of materials discussed herein.
`
`1. BACKGROUND AND QUALIFICATIONS
`
`2.
`
`My curriculum vitae (“CV") (a copy of which is attached) highlights
`
`my education, experience, and qualifications as an expert in formulating and
`
`testing skin care products, including topical products. Some of the information
`
`relevant to this case is summarized below.
`
`3.
`
`I received my Bachelor of Arts in Chemistry in 1968 from Western
`
`Washington State College. I received a Ph.D. in Biophysics from the Department
`
`of Biochemistry and Biophysics at Oregon State University in 1973.
`
`I was a
`
`postdoctoral fellow at the University of Minnesota, Minneapolis in the Department
`
`of Chemistry from 1972-1974, where I studied protein conformational dynamics.
`
`4.
`
`I worked in the Cosmetics and Personal Care industry from 1974 to
`
`1991, first at Procter and Gamble in Cincinnati, Ohio from 1974 to 1985 and then
`
`at S.C. Johnson Wax in Racine, Wisconsin until 1991.
`
`I performed research on
`
`skin and hair care products at both of these companies.
`
`
`
`DECLARATION OF DR. R. RANDALL WICKETT
`
`REGARDING U.S. PATENT NO. 6,423,327
`
`5.
`
`Since 1991, I have had an extensive consulting practice in which I
`
`have performed consulting and training for cosmetic and pharmaceutical
`
`companies, including Procter and Gamble, DuPont, Estee Lauder, 3M, Unilever,
`
`Clairol, Pfizer, Wyeth Consumer Products, Hill T0p Research, Bioscreen and
`
`many others.
`
`6.
`
`I am currently Emeritus Professor of Pharmaceutics and Cosmetic
`
`Science, University of Cincinnati, College of Pharmacy. I joined the University of
`
`Cincinnati, College of Pharmacy as Associate Professor of Pharmaceutics and
`
`Cosmetic Science in 1991 and was promoted to Professor of Pharmaceutics and
`
`Cosmetic Science in 1998. In that capacity I teach graduate classes on cosmetic
`
`science including, among other topics, skin care science. The Cosmetic Science
`
`Program at the University of Cincinnati is one of the few graduate programs in the
`
`United States offering a MS. or PhD. degree in pharmaceutical sciences with
`
`emphasis in cosmetic science.
`
`7.
`
`I have given more than 100 invited lectures and taught classes and
`
`workshops in the United States and abroad, including in Thailand, Taiwan, Israel,
`
`South Africa, Brazil, Argentina, Guatemala, Chile, Scotland, Estonia, South Korea,
`
`The Netherlands, Germany, Russia, Romania, Canada and France. The lectures
`
`and classes covered topics on various aspects of cosmetic science and cosmetic
`
`product technology.
`
`
`
`DECLARATION OF DR. R. RANDALL WICKE'IT
`
`REGARDING U.S. PATENT NO. 6,423,327
`
`8.
`
`I was elected as a fellow of the Society of Cosmetic Chemists in 1996.
`
`I served as the Editor of the Journal of the Society of Cosmetic Chemists from
`
`1991 to 1997 and as the Chairman of the International Society for Bioengineering
`
`and the Skin from 2000-2005.
`
`I was President of the Society of Cosmetic
`
`Chemists in 201 1 and am currently chairman of the International Society for
`
`Stratum Comeum Research.
`
`9.
`
`I have received numerous technical awards from the Society of
`
`Cosmetic Chemists including the Maison G. deNavarre Medal Award, the
`
`Society's highest honor, awarded to me in 1997 for technical contributions to
`
`cosmetic science. I was appointed an International Corresponding Member of the
`
`Chilean Academy of Pharmaceutical Sciences, August 7, 2009.
`
`10.
`
`I have more than 100 scientific publications. My research has
`
`included making and testing all manner of cosmetics and personal care products.
`
`Publications that I have authored or co-authored within the preceding ten years are
`
`listed on my curriculum vitae.
`
`11.
`
`I am a named inventor on four United States patents and two
`
`European patents.
`
`
`
`DECLARATION OF DR. R. RANDALL WICKETI'
`
`REGARDING U.S. PATENT NO. 6,423,327
`
`12. Of particular relevance to this matter, I have evaluated transdermal
`
`delivery systems.
`
`I have also researched ingredients to enhance topical penetration
`
`of pharmaceutical compositions.
`
`II.
`
`PRIOR TESTIMONY
`
`13.
`
`I have testified as an expert in several cases, including: International _
`
`Flora Technologies, Inc. v. Desert Whale Jojoba Company, Inc. (TTAB
`
`Cancellation Proceeding No. 92048012) (deposition); Shen Wei (USA), Inc. et al.
`
`v. Sempermed, Inc. (ND. Ill.) (deposition); International Flora Technologies, Inc.
`
`v. Desert Whale Jojoba Company, Inc. (TTAB Cancellation Proceeding No.
`
`92045327) (deposition); and Laboratory Skin Care, Inc., and Zahra Mansourt' v
`
`Limited Brands, Inc. and Bath & Body Works Inc. (D.Del.) (deposition and trial
`
`testimony);and Bayer Healthcare Pharmaceuticals, inc v. River ’s Edge
`
`Pharmaceuticals, LLC, et al. Case No. 1:11-cv-01634-LMM (by deposition).
`
`14.
`
`I have also testified before the National Advertising Division (NAD)
`
`of the Council of Better Business Bureaus and Federal Trade Commission on claim
`
`support matters.
`
`15.
`
`I also provided testimony in L’Oréal USA, Inc., v. Liqwd, Inc.,
`
`PGR2018-00023, PGR2018-00024, PGR2018-00025.
`
`
`
`DECLARATION OF DR. R. RANDALL WICKETT
`REGARDING U.S. PATENT NO. 6,423,327
`III. COMPENSATIONAND RELATIONSHIP TO THE PARTIES
`
`16.
`
`I am being compensated at an hourly rate of $400 for the time I spend
`
`studying materials and issues associated with this matter and for the time I spend
`
`providing testimony. This rate is my standard consulting rate. My compensation is
`
`not contingent upon the outcome of this matter.
`
`17.
`
`It is my understanding that University of Massachusetts is the
`
`assignee of the ‘327 patent. Prior to this matter, I have not worked for University
`
`of Massachusetts, and am aware of no financial interest that I have in the
`
`University of Massachusetts.
`
`IV. MATERIALS CONSIDERED
`18.
`I have reviewed U.S. Patent No. 6,423,327, as well as the file history
`
`thereof. I have also reviewed the documents listed in the following table:
`
`Exhibit No.
`
`Description
`
`1001
`
`1002
`
`1004
`
`1006
`
`1007
`
`1009
`
`U.S. Patent No. 6,423,327 to Dobson et al.
`
`U.S. Patent No. 6,645,513 to Dobson et al.
`
`Certified Translation of DE 198459107 with Affidavit attesting
`to accuracy under 37 CFR 42.63(b)
`
`Certified Translation of JP-H-09-157153 with Affidavit
`attesting to accuracy under 37 CFR 42.63(b)
`
`U.S. Patent No. 5,091,182 to Ong et al.
`
`File History of U.S. Patent No. 6,423,327
`
`
`
`-7-
`
`
`
`DECLARATION OF DR. R. RANDALL WICKETT
`REGARDING U.S. PATENT NO. 6,423,327
`PCT Publication WO1996014822A1 Porter et al.
`
`U.S. Patent No. 6,316,012 to N’Guyen et al.
`Robert J. Scheuplein, Permeability of the Skin: A Review of
`Major 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).
`
`R 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).
`
`
`
`-8-
`
`1012
`
`1013
`
`1016
`
`1017
`
`1018
`
`1019
`
`1020
`
`1021
`
`
`
`
`
`
`
`
`
`DECLARATION OF DR. R. RANDALL WICKETT
`
`REGARDING U.S. PATENT NO. 6,423,327
`
`A. Relevant Law:
`
`19. Although I am not a lawyer, I have been advised on certain relevant
`
`legal principles that I accept for the purpose of my analysis. Specifically, I am
`
`informed that 35 U.S.C. § 102 governs the determination of anticipation and that
`
`35 U.S.C. § 103 governs the determination of obviousness. These are outlined
`
`below.
`
`i.
`
`Anticipation
`
`20.
`
`It is my understanding that for a patent claim to be invalid as
`
`anticipated in the context of an Inter Partes Review, it must be shown by a
`
`preponderance ofthe evidence (“more likely than not”) that all limitations of the
`
`claim are disclosed in a single prior art reference, either expressly or inherently.
`
`21.
`
`A claim limitation is inherent in the prior art if it is necessarily
`
`present in the prior art reference. This can occur, for example, (1) when the natural
`
`result flowing from an express disclosure in the prior art would result in the
`
`performance of the inherent feature, even if that result would not have been
`
`appreciated by a skilled artisan at the time of the invention; or (2) in situations
`
`where the common knowledge of technologists is not recorded in the reference,
`
`such as where technological facts are known to those in the field of the invention
`
`but not to lay persons.
`
`
`
`DECLARATION OF DR. R. RANDALL WICKETT
`
`REGARDING U.S. PATENT N0. 6,423,327
`
`22. A prior art reference does not need to anticipate every possible
`
`embodiment within the scope of the claim; it anticipates if it discloses an
`
`embodiment that is within the scope of the claim.
`
`23. Anticipation does not require actual performance of the teachings of a
`
`reference, nor are the anticipatory disclosures of a prior art reference limited to the
`
`reference’s preferred embodiments. Anticipation requires only that the reference
`
`describe the claimed invention in a manner to have placed the public in possession
`
`of it. Such possession is achieved if a skilled artisan at the time of the invention
`
`could have combined the reference’s description of the invention with his own
`
`knowledge to make the claimed invention without undue experimentation.
`
`ii.
`
`Obviousness
`
`24.
`
`It is my understanding that in order to invalidate a patent claim as
`
`obvious in the context of an Inter Partes Review, it must be shown by a
`
`preponderance of the evidence that the claim would have been obvious to a skilled
`
`artisan at the time the invention was made. The prior art does not need to render
`
`obvious every possible embodiment within the scope of the claim. Rather, the
`
`prior art renders the claim obvious if the combined teachings disclose an
`
`embodiment that is within the scope of the claim. In determining whether a patent
`
`claim is invalid because of obviousness, one must consider the scope and content
`
`-10-
`
`
`
`DECLARATION OF DR. R. RANDALL WICKETT
`
`REGARDING U.S. PATENT NO. 6,423,327
`
`of the prior art, the differences between the prior art and the claimed invention, and
`
`the level of ordinary skill in the art.
`
`25.
`
`I am also informed that obviousness can be established by combining
`
`or modifying the teachings of the prior art to produce the claimed invention where
`
`there is some teaching, suggestion, or motivation to do so; and that a reasonable
`
`expectation of success in achieving the subject matter of the claim at issue must
`
`also be shown. Further, I am informed that the teaching, suggestion or motivation
`
`test is flexible and that an explicit suggestion to combine the prior art is not
`
`necessary—the motivation to combine may be implicit and may be found in the
`
`knowledge of one of ordinary skill in the art, from the nature of the problem to be
`
`solved, market demand, or common sense.
`
`26.
`
`A prior art reference is pertinent to the obviousness analysis if it
`
`discloses information designed to solve the same problems faced by the patent’s
`
`inventors or if the reference discloses information that has obvious uses beyond its
`
`main purpose that a skilled artisan would reasonably examine to solve the same
`
`problems faced by the inventors.
`
`27.
`
`In undertaking an obviousness analysis, I also understand that I may
`
`take into account the inferences and creative steps that a skilled artisan would have
`
`employed in reviewing the prior art at the time of the invention. If the claimed
`
`invention combines elements known in the prior art and the combination yields
`
`-11-
`
`
`
`DECLARATION OF DR. R. RANDALL WICKETT
`
`REGARDING U.S. PATENT NO. 6,423,327
`
`results that would have been predictable to a skilled artisan at the time of the
`
`invention, then this evidence would make it more likely that the claim was
`
`obvious.
`
`B.
`
`Person of Ordinary Skill in the Art
`
`28.
`
`A person having ordinary skill in the art (POSITA or skilled artisan)
`
`at the time of the alleged invention for the ‘327 patent (in 1998 up to and including
`
`the October 26, 1998 filing date of the ‘006 application) would have a Bachelor’s
`
`degree in Biochemistry or Chemistry with some academic exposure to, or industry
`
`courses or research in, topical delivery of drugs or cosmetic ingredients.
`
`C.
`
`Claim Construction
`
`29.
`
`I understand that in the context of an Inter Partes Review, the Patent
`
`Trial and Appeal Board of the USPTO is charged with applying the “broadest
`
`reasonable interpretation” of the claims “consistent with the specification,” and
`
`that the claim language should read in light of the specification as it would be
`
`understood by a skilled artisan at the time of the invention. However, I am
`
`informed that the ‘327 patent will expire in October 2018, which may be prior to
`
`the conclusion of a proceeding based on the Petition. Thus, I have been asked to
`
`consider the claims using a more narrow standard: that claims are generally given
`
`their ordinary and customary meaning in light of the specification, which is the
`
`meaning that the term would have to a person of ordinary skill in the art in
`
`-12-
`
`
`
`DECLARATION OF DR. R. RANDALL WICKETT
`
`REGARDING U.S. PATENT NO. 6,423,327
`
`question at the time of the invention, i.e., as of the effective filing date of the patent
`
`application.
`
`I am informed that the file history is to be considered and that
`
`arguments and statements made during the prosecution of the patent application
`
`can inform a skilled artisan of the meaning of the claims. In reaching my
`
`conclusions expressed below, I have interpreted the challenged claims consistent
`
`with these standards and requirements. I further note that my opinions below
`
`would not change under either the BRI or narrower standard.
`
`i.“wherein the adenosine concentration applied to the dermal cells is 10"
`M to 10'7 M”
`
`30.
`
`Claim 1 of the ‘327 patent recites that “the adenosine concentration
`
`applied to the dermal cells is 10“1 M to 10J M.” For the reasons that follow, it is
`
`my opinion that term “wherein the adenosine concentration applied to the dermal
`
`cells is 10" M to 10'7 M” would have been interpreted by a skilled artisan in
`
`October 1998 to mean “the concentration of adenosine in the composition that is
`
`t0pically applied to the unbroken epidermal layer of a region of the skin containing
`
`the dermal cells is 104M to 10'7 M (Le, 0.00265 wt% to 0.00000265 wt %)'.”
`
`1 During prosecution, the inventors of the ‘327 patent submitted a declaration
`
`asserting that a concentration of adenosine of 10'4 M corresponded to 0.00265
`
`wt%. (Ex. 1009, at 91). Thus, the claimed range of 10'“ M to 10'7M corresponds to
`
`a range of 0.00000265 to 0.00265 wt %.
`
`-13-
`
`
`
`DECLARATION OF DR. R. RANDALL WICKETT
`
`REGARDING U.S. PATENT NO. 6,423,327
`
`31.
`
`Skin is comprised of many layers, including an outer, epidermal layer,
`
`which covers multiple inner layers (including the dermal layers). (Ex. 1001, col. 1,
`
`11. 19-20).
`
`I note that ‘327 patent describes the skin as having “a surface layer,
`
`known as the epidermis, and a deeper connective tissue layer, known as the
`
`dermis.” (Id) Further, the ‘327 patent discloses that the “dermis is composed of a
`
`variety of cell types, including fibroblasts.” (Id) Thus, a skilled artisan would
`
`have understood that dermal fibroblasts are covered by the outer, epidermal layer
`
`of the skin. (Id)
`
`32.
`
`I note that claim 1 requires topical application to “unbroken skin.”
`
`Thus, a skilled artisan would have understood that because the epidermal layer is
`
`“unbroken,” the dermal layer is not exposed, and adenosine cannot be directly
`
`applied to dermal cells located in the dermal layer through a topical application.
`
`Rather, the adenosine concentration would necessarily be applied to the epidermal
`
`layer (i.e., the outermost layer of the skin). The top layer of the epidermis, the
`
`Stratum Corneum (SC) is a significant barrier to the ingress of exogenous
`
`chemicals to the skin. (Ex. 1016). Accordingly, a skilled artisan would not have
`
`understood the limitation “the adenosine concentration applied to the dermal cells
`
`is 10" M to 10‘7 M” to mean a direct application of the concentration of adenosine
`
`to dermal cells.
`
`I note that there is no disclosure in the ‘327 patent regarding direct
`
`topical application of adenosine to dermal cells. In fact, direct application to the
`
`-14-
`
`
`
`DECLARATION OF DR. R. RANDALL WICKETT
`
`REGARDING U.S. PATENT NO. 6,423,327
`
`dermal cells would require intradermal methods of application, which the ‘327
`
`patent distinguishes from topical application. (Ex. 1001, col. 5, 11. 12-29). Further,
`
`the ‘327 patent discloses ex vivo administration of adenosine to dermal cell
`
`cultures. (Ex. 1001, col. 1, 11. 37-39; col. 2, 11. 9-13). However, a skilled artisan
`
`would have understood that administration of adenosine to ex vivo cultures is not
`
`topical application of adenosine to unbroken skin. Thus, a skilled artisan would
`
`have understood that topical application to unbroken skin requires a topical
`
`application to the epidermal layer of the skin.
`
`33.
`
`Regarding the concentration of adenosine in the claims, I have
`
`reviewed the prosecution file history for the ‘327 patent and note that the Patent
`
`Owner added the limitation “the adenosine concentration applied to the dermal
`
`cells is 10“ M to 10'7 M” and made arguments to overcome prior art references. In
`
`particular, the Patent Owner argued that adenosine concentration of the prior art
`
`composition of Hartzshtark (i.e., 0.1%) was outside the scope of the claimed range
`
`of 10" M to 10.7 M. (Ex. 1009, 83-87). Thus, based on Patent Owner’s arguments,
`
`a skilled artisan would have understood that the claimed concentration of
`
`adenosine is the amount in the composition that is topically applied, and not an
`
`amount that reaches the dermal cells.
`
`34.
`
`Further, in my opinion, an interpretation that the claimed
`
`concentration is the concentration that reaches the dermal cells is incorrect. In
`
`-15-
`
`
`
`DECLARATION OF DR. R. RANDALL WICKETT
`
`REGARDING U.S. PATENT NO. 6,423,327
`
`1998, a skilled artisan would have understood that it was not possible to calculate
`
`with any reasonable certainty an amount of adenosine that reaches the dermal cells
`
`when tepically applied in view of the numerous variables that would need to be
`
`identified and factored into any such calculation. For example, a skilled artisan
`
`would have understood that the following is a non-exclusive list of variables that
`
`would influence any such calculation: the thickness of the stratum comeum, the
`
`condition of the skin, the age of the skin, the vehicle in which the adenosine is
`
`applied, the manner in which the adenosine is applied, the area in which it is
`
`applied, the time it left on the skin, etc. (Ex. 1017). Some of these factors are
`
`recognized in the ‘327 patent without any indication as to how they would affect
`
`the claimed concentration of adenosine. (Ex. 1001, col. 5, lines 30-35). In
`
`addition, several of these factors vary depending on the part of the body on which
`
`the composition is applied (e.g., elbow, foot, forehead, etc.) This is because the
`
`stratum comeum layer is thicker and less permeable on some portions of the body
`
`than others. (Ex. 1018). In addition, a skilled artisan would have been aware that
`
`many of these factors vary from individual to individual. (Ex. 1017). Further, a
`
`skilled artisan would have known that adenosine may metabolize in the epidermis
`
`prior to reaching the dermis. (Ex. 1019). A skilled artisan would have also known
`
`that the upper part of the dermis contains a network of small capillaries that
`
`-16-
`
`
`
`DECLARATION OF DR. R. RANDALL WICKETT
`
`REGARDING U.S. PATENT NO. 6,423,327
`
`transport substances that have penetrated the epidermis into the blood stream.
`
`Attempting to account for capillary clearance is extremely complex.(Ex. 1020)
`
`35.
`
`I note that the ‘327 patent does not provide any guidance or
`
`suggestion as to how such a calculation or measurement of the actual concentration
`
`reaching the “dermal cells” could be done. Thus, in View of Patent Owner’s
`
`arguments distinguishing the claimed concentration over concentrations in the
`
`compositions of the prior art, and the general knowledge of a skilled artisan in
`
`1998, it is my opinion that the only way the claimed concentration would make any
`
`sense (i.e., be capable of being determined) is the claimed concentration of
`
`adenosine is the amount in the composition that is topically applied, and not an
`
`amount that reaches the dermal cells.
`
`36.
`
`In view of the foregoing, it is my opinion that the term “the adenosine
`
`concentration applied to the dermal cells is 10“ M to 10'7 M” should be interpreted
`
`to mean the concentration ofadenosine in the composition that is topically
`
`applied to the unbroken epidermal layer ofa region ofthe skin containing the
`
`dermal cells is 104M to 107M (i.e., 0.00265 to 0.00000265 wt %).
`
`V.
`
`CLAIMS 1, 3, 5-7, AND 9 OF THE ‘327 PATENT ARE NOT
`NOVEL IN VIEW OF DE ‘107
`
`37.
`
`DE‘107 discloses cosmetic compositions containing adenosine for
`
`care and prevention of signs of aging of the skin. (Ex. 1003, p. 1, 11. 1-39).
`
`-17-
`
`
`
`DECLARATION OF DR. R. RANDALL WICKETT
`
`REGARDING U.S. PATENT N0. 6,423,327
`
`Specifically, DE’ 107 teaches that the adenosine compositions can be applied to the
`
`skin to treat damage resulting from aging, such as wrinkling and drying out of the
`
`skin. (Id., 11. 20, 29.) DE’107’s compositions contain adenosine in an amount
`
`ranging from 0.001% to 10% by weight. (Id., p. 14, 11. 17-20.)
`
`Claim 1
`
`38.
`
`Claim 1 is not novel in View of DE ‘ 107. Specifically, I note that DE
`
`‘ 107 discloses cosmetic compositions, where the compositions contain adenosine
`
`in an amount ranging from 0.001% to 10%, by weight. DE ‘107 also discloses
`
`application of the compositions to the skin for treatment of skin conditions such as
`
`dryness. The following Table 1 summarizes where each element of claim 1 of the
`
`‘327 patent is found in DE ‘107:
`
`-13.
`
`
`
`DECLARATION OF DR. R. RANDALL WICKETT
`
`REGARDING U.S. PATENT NO. 6,423,327
`
`DE ‘107 discloses a cosmetic
`
`product for the prevention and
`therapy of cosmetic or
`dermatological skin changes such as,
`for example, skin aging. (Ex. 1004,
`p. 1, lines 3-9)
`
`DE ‘107 discloses cosmetic
`
`processes for protection of the skin
`against oxidative and photoxidative
`processes. (Ex. 1004, p. 14, lines 10-
`1 5)
`
`DE ‘ 107 does not disclose the
`
`treatment of wounds or broken skin,
`so a skilled artisan would understand
`
`DE ‘ 107 to include treatment of
`
`unbroken skin.
`
`DE ‘ 107 discloses application to
`human skin. (Ex. 1004, p. 2, lines 1-
`
`4 “
`
`(d) Limited regenerative turnover in
`the epidermis in conjunction with
`abnormal formation of the horny
`layer (homification) that leads to
`drying out of the skin.” (Ex. 1004, p.
`1, lines 27-29).
`
`1. 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,
`
`Discussed below—inherently
`disclosed
`
`the method comprising topically
`
`DE ‘107 discloses cosmetic
`
`applying to the skin
`
`compositions for tepical application.
`(Ex. 1004, p. 2, line 30 to p. 3, line 5,
`
`
`
`DECLARATION OF DR. R. RANDALL WICKETT
`
`REGARDING U.S. PATENT NO. 6,423,327
`
`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 to the dermal cells is 10‘4M
`to 1 0‘7 M.
`
`DE ‘107 discloses cosmetic
`
`compositions for topical application
`containing an amount of adenosine
`ranging from 0.001% to 10%:
`
`“According to the use as described in
`the invention, cosmetic or
`dermatological formulations can be
`composed as usual and used for the
`treatment, care and cleansing of the
`skin and/or hair, and as a make-up
`product in decorative cosmetics.
`They contain preferably 0.001
`percent by weight to 10 percent by
`weight, in particular 0.01 percent
`by weight to 6 percent by weightI
`of the active substance combinations
`
`relative to the total weight of the
`product.” (Ex. 1004, at 132, line 28
`to p. 3, line 5, emphasis added).
`
`
`
`“The present invention also includes
`a cosmetic method of protecting the
`skin and the hair against oxidative
`and photo-oxidative processes,
`which is characterized in that a
`
`cosmetic composition; which
`contains an effective concentration
`
`of adenosine, in a sufficient men—m
`is applied to the skin or hair.
`Preferably, the amount of
`adenosine in these preparations
`0.001 wt.% to 10 wt.%, more
`preferably 0.01 wt.% to 6 wt.%,
`based on the gross weight of the
`preparations.” (Ex. 1004, at p. 14,
`lines 10-20, em-hasis added .
`
`-20.
`
`
`
`DECLARATION OF DR. R. RANDALL WICKETT
`
`REGARDING U.S. PATENT N0. 6,423,327
`
`39.
`
`In my review of the file history of the ‘327 patent, I note that the
`
`Examiner rejected certain claims of the application as anticipated by DE ‘ 107. The
`
`Examiner stated that DE ‘ 107 rendered the claims not novel because it “discloses a
`
`cosmetic and dermatological preparation containing adenosine for the treatment of
`
`natural, chemical induced or UV induced skin aging and its sequelae.” (Ex. 1009,
`
`p. 74).
`
`40.
`
`In response, the inventors amended the claims to specify the
`
`adenosine concentration range of 104M to 10'7M, and submitted a Declaration
`
`describing testing of adenosine at IOuM (10'5M) and 100uM (104M) on human
`
`fibroblasts in culture. (Ex. 1009, p. 81-92 and 107-11 1). The results of the testing
`
`concluded that there was no proliferation of the fibroblasts. (Id)
`
`41.
`
`Therefore, the inventors argued to the Examiner that DE ‘ 107 “must
`
`be mistaken" in its disclosure that the range of 0.001 % to 10% by weight increases
`
`“cell” proliferation. (Ex. 1009, at p. 89-92 and 107-111). Specifically, the
`
`inventors argued that their test results showed that “low concentrations of
`
`adenosine do not increase dermal cell proliferation,” supposedly contrary to DB
`
`‘107’5 disclosure.
`
`(1d,) It is important to note, however, that the data the inventors
`
`submitted was limited to fibroblasts, which are only one of the cell types in the
`
`skin in addition to other cells in the epidermal, dermal, and sub-dermal layers.
`
`-21-
`
`
`
`DECLARATION OF DR. R. RANDALL WICKETT
`
`REGARDING U.S. PATENT NO. 6,423,327
`
`42. However, I note that DE ‘ 107 states that its compositions are usefiil
`
`for treating a variety of dermatological skin changes associated with skin aging
`
`including problems associated with “limited regenerative turnover in the epidermis
`
`in conjunction with abnormal formation of the horny layer (homification) that
`
`leads to drying out of the skin” and “Abnormal regulation of cell division
`
`(proliferation) and cell maturation (differentiation) in the epidermis resulting in
`
`atypical cells and polarity loss.” (Ex. 1004, at p. 1, lines 27-34, emphasis added).
`
`Thus, DE ‘107’s disclosure of cell proliferation at any particular concentration of
`
`adenosine is not limited to fibroblasts or other cells of the dermal layer. Further, a
`
`skilled artisan in 1998 would have understood that enhancing epidermal cell
`
`“turnover” was desirable in order to overcome the slowdown in epidermal
`
`“tumover” rate that was known to occur with age. (Ex. 1021).
`
`43.
`
`In other words, a skilled artisan, reading DE ‘107, would not have
`
`understood the disclosure of “cell proliferation” to be limited to proliferation of
`
`fibroblasts or any other dermal cells. Rather, the skilled artisan would have
`
`understood that DE ‘ 107 was discussing skin cell proliferation without limitation to
`
`any particular type of skin cell including proliferation of epidermal cells.
`
`44.
`
`Importantly, if the inventors’ data shows that concentrations of
`
`adenosine of lOuM (1 O'SM) and IOOuM (104M) does not increase proliferation of
`
`fibroblasts, then a skilled artisan would understand that the overlapping range of
`
`-22-
`
`
`
`DECLARATION OF DR. R. RANDALL WICKETT
`
`REGARDING U.S. PATENT N0. 6,423,327
`
`adenosine disclosed by DE ‘ 107 necessarily does not promote proliferation of
`
`fibroblasts at those concentrations. In other words, based on the inventor’s data, the
`
`natural result flowing from the overlapping range of adenosine disclosed by DE
`
`‘ 107 would result in the claimed limitation “without increasing dermal cell
`
`proliferation,” even if that result would not have been appreciated by a skilled
`
`artisan at the time of the invention. Likewise, the inventors’ extrapolation
`
`regarding the lack of proliferation of dermal cells associated with the tested
`
`concentrations of adenosine applied to fibroblasts must necessarily apply to the
`
`overlapping range disclosed in DE ‘107.
`
`45. Accordingly, as I note in Table 1 above, the claim language “without
`
`increasing dermal cell proliferation” is necessarily disclosed through the
`
`overlapping ranges of adenosine disclosed in DE ‘ 107.
`
`46.
`
`In view of the foregoing, it is my opinion that a skilled artisan would
`
`have understood that DE ‘ 107 discloses each element of claim 1 explicitly or
`
`inherently. As such, it is my opinion that DE ‘ 107 anticipates claim 1.
`
`Claim 3
`
`47.
`
`Claim 3 states that the adenosine concentration is 10‘4M to 10'6 M.
`
`As discussed above regarding claim 1, DE ‘107 discloses cosmetic compositions
`
`for topical application containing an amount of adenosine ranging from 0.001% to
`
`10%. (Ex. 1004, at p. 2, line 28 to p. 3, line 5; p. 14, lines 10-20). As admitted by
`
`-23-
`
`
`
`the inventors in their declaration, the lower limit of the adenosine amount of DE
`
`DECLARATION OF DR. R. RANDALL WICKETT
`
`REGARDING U.S. PATENT NO. 6,423,327
`
`‘ 107 (0.001%) corresponds to 3.8 x 10'5M adenosine, which falls within the range
`
`of claim 3. (Ex. 1009, at p. 89-92 and 107-111). Thus, because DE ‘107 discloses
`
`each element of claim 3, it is my opinion that DE ‘107 anticipates claim 3.
`
`Claim 5
`
`48.
`
`Claim 5 states that the composition further comprises a conditioning
`
`agent. DE ‘ 107 discloses that the composition includes a conditioning agent. The
`
`‘327 patent defines “conditioning agent” as inclusive of “an emollient, a
`
`humectant, or an occlusive agent.” (Ex. 1001, Col. 2, 11. 18-26). The ‘327 patent
`
`further states “emollients help to maintain the soft, smooth, and pliable appearance
`
`of skin and Motion by remaining on the ski
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