DECLARATIONOF DR. R. RANDALL WICKETT
`REGARDINGU.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.
`
`-|-
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`L'OREALUSA,INC. EX. 1010
`
`
`REGARDINGU.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'OREALUSA,INC. EX. 1010
`
`
`
`DECLARATIONOF DR. R. RANDALL WICKETT
`REGARDINGU.S. PATENT NO. 6,423,327
`
`TABLE OF CONTENTS
`
`BACKGROUND AND QUALIFICATIONG..........scccscecsececersecscssees3
`
`II.
`
`PRIOR. TESTIMONY.ccccsesvscscncsssocscvscosesccscnsceccansuscovnccecancvssnnees6
`
`Ill.
`
`COMPENSATIONAND RELATIONSHIP TO THE PARTIES..........7
`
`IV.
`
`MATERIALS CONSIDERED. ..........sscccccescccsscccccesencsscscscverscesess7
`
`A.
`
`Relevant Law..........sceccsceccccenseceesccessesncensescesensenvesenscsnes sees9
`
`i.
`
`Ti.
`
`Anticipation..........ccececccvcceccccscesescseesessccsccscssseseescnees9
`
`ODVIOUSTESS.........cccceccccccecceccsccercceccnscssccccsscsseccoccoes 10
`
`B.
`
`C.
`
`Person of Ordinary Skill in the Art..........sssssccssssesecserseeeeees12
`
`Claim Construction,..........cccccccerececscecencevsvsvevecssssccecens 12
`
`i.
`
`“wherein the adenosine concentration applied to the dermal
`cells is 104M to 10°7M”...ccscsscccccsccacsnscccsvesesesvsssceses 13
`
`CLAIMS1, 3, 5-7, AND 9 OF THE ‘327 PATENT ARE NOT NOVEL
`IN VIEW OF DE‘107........cccccsscccssceeveccereevscccsscssescesvccessensevors 17
`
`CLAIMS1, 3-7 AND 9 OF THE ‘327 PATENT WOULD HAVE BEEN
`OBVIOUS OVERDE ‘107........sccscccescecsecscesceerescssccevscccsecesacence28
`
`VII.
`
`CLAIMS1, 3-7 AND 9 OF THE ‘327 PATENT WOULD HAVE BEEN
`OBVIOUS OVERJP ‘153 AND DE ‘107.........csscsssseeccecscevesecceveees 29
`
`a
`
`
`
`DECLARATIONOF DR. R. RANDALL WICKETT
`REGARDINGU.S. PATENT NO.6,423,327
`I, R. Randall Wickett, Ph.D., declare as follows:
`
`1.
`
`The opinionsset forth below are based on my over 40 years of
`
`experienceas an expert in formulating and testing skin care products, including
`
`topical cosmetic compositions, and on the review of materials discussed herein.
`
`I. BACKGROUND AND QUALIFICATIONS
`
`2.
`
`My curriculum vitae (“CV”) (a copy of whichis attached) highlights
`
`my education, experience, and qualifications as an expert in formulating and
`
`testing skin care products, including topical products. Someof the information
`
`relevant to this case is summarized below.
`
`3.
`
`I received my Bachelor ofArts 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 1974to
`
`1991, first at Procter and Gamble in Cincinnati, Ohio from 1974 to 1985 and then
`
`at S.C. Johnson Waxin Racine, Wisconsin until 1991.
`
`I performed research on
`
`skin and hair care products at both ofthese companies.
`
`Be
`
`
`
`DECLARATION OF DR. R. RANDALL WICKETT
`REGARDINGU.S. PATENT NO.6,423,327
`Since 1991, I have had an extensive consulting practice in which I
`
`5.
`
`have performed consulting andtraining for cosmetic and pharmaceutical
`
`companies, including Procter and Gamble, DuPont, Estee Lauder, 3M, Unilever,
`
`Clairol, Pfizer, Wyeth ConsumerProducts, Hill Top Research, Bioscreen and
`
`many others.
`
`6.
`
`I amcurrently 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 promotedto Professor of Pharmaceutics and
`
`Cosmetic Science in 1998. In that capacity I teach graduate classes on cosmetic
`
`science including, amongother topics, skin care science. The Cosmetic Science
`
`Program at the University of Cincinnati is one of the few graduate programsin the
`
`United States offering a M.S. or Ph.D. degree in pharmaceutical sciences with
`
`emphasis in cosmetic science.
`
`7.
`
`Ihave given more than 100invited lectures and taught classes and
`
`workshopsin 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. Thelectures
`
`and classes covered topics on various aspects of cosmetic science and cosmetic
`
`product technology.
`
`ae
`
`
`
`DECLARATION OFDR. R. RANDALL WICKETT
`REGARDINGU.S. PATENT NO.6,423,327
`I was elected as a fellow of the Society of Cosmetic Chemists in 1996.
`
`8.
`
`I served as the Editor of the Journal of the Society of Cosmetic Chemists from
`
`1991 to 1997 and as the Chairman ofthe International Society for Bioengineering
`
`and the Skin from 2000-2005.
`
`I was President of the Society of Cosmetic
`
`Chemists in 2011 and am currently chairman ofthe International Society for
`
`Stratum Corneum Research.
`
`9,
`
`I have received numeroustechnical 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 Memberofthe
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`Chilean Academy of Pharmaceutical Sciences, August 7, 2009.
`
`10.
`
`Ihave 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.
`
`Iamanamed inventor on four United States patents and two
`
`European patents.
`
`5-
`
`
`
`DECLARATIONOF DR. R. RANDALL WICKETT
`REGARDINGU.S. PATENT NO.6,423,327
`12. Of particular relevanceto this matter, I have evaluated transdermal
`
`delivery systems.
`
`I have also researched ingredients to enhance topical penetration
`
`of pharmaceutical compositions.
`
`Il,
`
`PRIOR TESTIMONY
`
`13.
`
`I havetestified 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.etal.
`
`v. Sempermed, Inc. (N.D.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 Mansouri v
`
`Limited Brands, Inc. and Bath & Body Works Inc. (D.Del.) (deposition andtrial
`
`testimony);and Bayer Healthcare Pharmaceuticals, inc v. River’s Edge
`
`Pharmaceuticals, LLC, et al. Case No. 1:11-cv-01634-LMM (by deposition).
`
`14.
`
`Ihavealsotestified before the National Advertising Division (NAD)
`
`of the Council of Better Business Bureaus and Federal Trade Commission on claim
`
`support matters.
`
`15.
`
`Ialso 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-
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`
`
`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
`REGARDINGU.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 andthat
`
`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
`
`preponderanceofthe evidence (“more likely than not”) thatall limitations of the
`
`claim are disclosed in a single prior art reference, either expressly or inherently.
`
`21.
`
`Acclaim limitation is inherent in the priorart if it is necessarily
`
`presentin 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
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`performanceofthe inherentfeature, even if that result would not have been
`
`appreciatedbyaskilled artisan at the time ofthe invention; or (2) in situations
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`where the common knowledgeof technologists is not recordedin the reference,
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`such as where technological facts are known to thosein the field of the invention
`
`but not to lay persons.
`
`-9-
`
`
`
`DECLARATION OF DR. R. RANDALL WICKETT
`REGARDINGU.S. PATENT NO.6,423,327
`A prior art reference does not needto anticipate every possible
`
`22.
`
`embodimentwithin the scope of the claim;it anticipates if it discloses an
`
`embodimentthat is within the scope ofthe claim.
`
`23. Anticipation does not require actual performanceofthe teachings of a
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`reference, nor are the anticipatory disclosures ofa priorart reference limited to the
`
`reference’s preferred embodiments. Anticipation requires only that the reference
`
`describe the claimed invention in a mannerto have placed the public in possession
`
`ofit. Such possession is achievedif a skilled artisan at the time of the invention
`
`could have combinedthe reference’s description of the invention with his own
`
`knowledge to makethe claimed invention without undue experimentation.
`
`ii.
`
`Obviousness
`
`24.
`
`It is my understandingthat in orderto invalidate a patent claim as
`
`obviousin the context of an Inter Partes Review,it must be shown by a
`
`preponderanceofthe evidence that the claim would have been obviousto a skilled
`
`artisan at the time the invention was made. Theprior art does not need to render
`
`obvious every possible embodimentwithin the scope of the claim. Rather, the
`
`prior art renders the claim obviousif the combined teachings disclose an
`
`embodimentthat 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
`
`0:
`
`
`
`DECLARATION OF DR. R. RANDALL WICKETT
`REGARDINGU.S. PATENT NO.6,423,327
`ofthe priorart, the differences betweenthe prior art and the claimed invention, and
`
`the level of ordinary skill in theart.
`
`25.
`
`Iam also informed that obviousness can be established by combining
`
`or modifying the teachingsofthe prior art to produce the claimed invention where
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`there is some teaching, suggestion, or motivation to do so; and that a reasonable
`
`expectation of success in achieving the subject matter ofthe claim at issue must
`
`also be shown.Further, I am informedthat the teaching, suggestion or motivation
`
`test is flexible and that an explicit suggestion to combinethepriorart is not
`
`necessary—the motivation to combine may be implicit and may be foundin the
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`knowledgeofoneofordinary skill in the art, from the nature ofthe problem to be
`
`solved, market demand, or commonsense.
`
`26.
`
`Appriorart reference is pertinent to the obviousness analysisifit
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`discloses information designed to solve the same problemsfaced bythe patent’s
`
`inventors or if the reference discloses information that has obvious uses beyondits
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`main purposethata skilled artisan would reasonably examine to solve the same
`
`problems faced by the inventors.
`
`27.
`
`In undertaking an obviousnessanalysis, I also understand that I may
`
`take into account the inferences andcreative steps thata skilled artisan would have
`
`employed in reviewingthe priorart at the time of the invention. If the claimed
`
`invention combines elements knownin theprior art and the combination yields
`
`-l1-
`
`
`
`DECLARATION OF DR. R. RANDALL WICKETT
`REGARDINGU.S. PATENT NO.6,423,327
`results that would have been predictable to a skilled artisan at the time ofthe
`
`invention, then this evidence would makeit more likely that the claim was
`
`obvious.
`
`B.
`
`‘Person of Ordinary Skill in the Art
`
`28.
`
`A person having ordinary skill in the art (POSITAorskilled artisan)
`
`at the time of the alleged invention for the ‘327 patent (in 1998 upto and including
`
`the October 26, 1998filing date of the ‘006 application) would have a Bachelor’s
`
`degree in Biochemistry or Chemistry with some academic exposureto,or industry
`
`coursesor researchin, topical delivery of drugs or cosmetic ingredients.
`
`C.
`
`Claim Construction
`
`29.
`
`I understandthat in the contextof an Inter Partes Review,the Patent
`
`Trial and Appeal Board of the USPTOis charged with applying the “broadest
`
`reasonable interpretation”of the claims“consistent with the specification,” and
`
`that the claim language shouldread in light of the specification as it would be
`
`understood byaskilled artisan at the time of the invention. However, I am
`
`informedthat the ‘327 patent will expire in October 2018, which maybepriorto
`
`the conclusion of a proceeding based on the Petition. Thus, I have been asked to
`
`considerthe claims using a more narrow standard: that claims are generally given
`
`their ordinary and customary meaninginlight of the specification, whichis the
`
`meaningthat the term would haveto a person of ordinary skill in the art in
`
`
`
`DECLARATION OFDR. R. RANDALL WICKETT
`REGARDINGU.S. PATENT NO.6,423,327
`questionat the time ofthe invention,i.e., as of the effective filing date of the patent
`
`application.
`
`I am informedthatthe 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 undereither the BRI or narrowerstandard.
`
`i.“wherein the adenosine concentration applied to the dermalcells 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 10M to 107M.” Forthe reasonsthatfollow,it is
`
`my opinion that term “wherein the adenosine concentration applied to the dermal
`
`cells is 10“ M to 10°77 M” would havebeeninterpreted byaskilled artisan in
`
`October 1998 to mean “the concentration of adenosine in the composition thatis
`
`topically applied to the unbroken epidermallayerof a region of the skin containing
`
`the dermalcells is 10“Mto 10°7M (i.e., 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 10M correspondedto 0.00265
`wt%. (Ex. 1009, at 91). Thus, the claimed range of 10M to 10°7M correspondsto
`
`a range of 0.00000265 to 0.00265 wt %.
`
`13
`
`
`
`DECLARATION OF DR. R. RANDALL WICKETT
`REGARDING U.S. PATENT NO.6,423,327
`Skin is comprised ofmanylayers, including an outer, epidermallayer,
`
`31.
`
`which covers multiple inner layers (including the dermal layers). (Ex. 1001, col.1,
`
`ll. 19-20).
`
`I note that ‘327 patent describes the skin as having “a surfacelayer,
`
`knownas the epidermis, and a deeper connective tissue layer, known as the
`
`dermis.” (/d.) Further, the ‘327 patent discloses that the “dermis is composed of a
`
`variety ofcell types, including fibroblasts.” (Jd.) Thus, a skilled artisan would
`
`have understood that dermal fibroblasts are covered by the outer, epidermal layer
`
`of the skin. (/d.)
`
`32.
`
`I note that claim 1 requires topical application to “unbrokenskin.”
`
`Thus, a skilled artisan would have understood that because the epidermallayeris
`
`“unbroken,” the dermal layer is not exposed, and adenosine cannotbedirectly
`
`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 outermostlayerof the skin). Thetop 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
`
`understoodthe limitation “the adenosine concentration applied to the dermal cells
`
`is 10M to 10°’ M”to meana directapplication of the concentration of adenosine
`
`to dermalcells. 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
`
`Ai
`
`
`
`DECLARATION OF DR. R. RANDALL WICKETT
`REGARDINGU.S. PATENT NO.6,423,327
`dermalcells would require intradermal methods of application, which the ‘327
`
`patent distinguishes from topical application. (Ex. 1001, col. 5, ll. 12-29). Further,
`
`the ‘327 patent discloses ex vivo administration of adenosine to dermalcell
`
`cultures. (Ex. 1001, col. 1, ll. 37-39; col. 2, Il. 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 understoodthat topical application to unbroken skin requires a topical
`
`application to the epidermallayer of the skin.
`
`33.
`
`Regarding the concentration of adenosinein the claims, I have
`
`reviewedthe prosecutionfile history for the ‘327 patent and note that the Patent
`
`Owneraddedthe limitation “the adenosine concentration applied to the dermal
`
`cells is 10*M to 10°’ M” and made arguments to overcomepriorart references. In
`
`particular, the Patent Owner argued that adenosine concentration ofthe priorart
`
`composition of Hartzshtark(i.e., 0.1%) was outside the scope ofthe claimed range
`
`of 10*M to 10°’ M.(Ex. 1009, 83-87). Thus, based on Patent Owner’s arguments,
`
`a skilled artisan would have understoodthat the claimed concentration of
`
`adenosineis the amountin the composition that is topically applied, and not an
`
`amountthat reaches the dermalcells.
`
`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
`REGARDINGU.S. PATENT NO.6,423,327
`1998, a skilled artisan would have understoodthat it was not possible to calculate
`
`with any reasonable certainty an amount of adenosine that reaches the dermalcells
`
`whentopically applied in view of the numerousvariables that would need to be
`
`identified and factored into any such calculation. For example, a skilled artisan
`
`would have understoodthat the following is a non-exclusivelist of variables that
`
`would influence any such calculation: the thickness of the stratum corneum,the
`
`condition of the skin, the age of the skin, the vehicle in which the adenosineis
`
`applied, the mannerin which the adenosineis applied, the area in whichitis
`
`applied, the timeit left on the skin, etc. (Ex. 1017). Some of these factors are
`
`recognizedin 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 onthe part of the body on which
`
`the composition is applied (e.g., elbow, foot, forehead, etc.), This is because the
`
`stratum corneum layer is thicker and less permeable on someportions of the body
`
`than others. (Ex. 1018). In addition, a skilled artisan would have been aware that
`
`many ofthese factors vary from individualto 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 upperpart of the dermis contains a network of small capillaries that
`
`16:
`
`
`
`DECLARATION OFDR. R. RANDALL WICKETT
`REGARDINGU.S. PATENT NO.6,423,327
`transport substancesthat have penetrated the epidermisinto the blood stream.
`
`Attempting to accountfor capillary clearance is extremely complex.(Ex. 1020)
`
`35.
`
`I note that the ‘327 patent does not provide any guidance or
`
`suggestion as to how suchacalculation or measurement ofthe actual concentration
`
`reaching the “dermal cells” could be done. Thus, in view of Patent Owner’s
`
`arguments distinguishing the claimed concentration over concentrationsin the
`
`compositionsofthepriorart, and the general knowledge ofa 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
`
`adenosineis the amountin the composition that is topically applied, and not an
`
`amountthat reaches the dermalcells.
`
`36.
`
`In view ofthe foregoing, it is my opinion that the term “the adenosine
`
`concentration applied to the dermalcells is 10“ M to 10°’ M”shouldbeinterpreted
`
`to mean the concentration ofadenosine in the composition thatis topically
`
`applied to the unbroken epidermallayer ofa region ofthe skin containing the
`
`dermalcells is 10° M to 10°’M (i.e., 0.00265 to 0.00000265 wt %).
`
`V.
`
`CLAIMS1, 3, 5-7, AND 9 OF THE ‘327 PATENT ARE NOT
`NOVEL IN VIEW OFDE ‘107
`
`37.|DE‘107 discloses cosmetic compositions containing adenosine for
`
`care and prevention ofsigns of aging of the skin. (Ex. 1003, p. 1, ll. 1-39).
`
`«|7-
`
`
`
`DECLARATIONOF DR. R. RANDALL WICKETT
`REGARDINGU.S. PATENT NO.6,423,327
`Specifically, DE’107 teaches that the adenosine compositions can be applied to the
`
`skin to treat damageresulting from aging, such as wrinkling and drying out of the
`
`skin. (/d., ll. 20,29.) DE’107’s compositions contain adenosine in an amount
`
`ranging from 0.001% to 10% by weight. (Id., p. 14,ll. 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 amountranging from 0.001% to 10%, by weight. DE ‘107 also discloses
`
`application ofthe 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:
`
`-18-
`
`
`
`(Ex. 1004,p. 2, line 30to p. 3, line 5,
`
`(d) Limited regenerative turnoverin
`the epidermis in conjunction with
`abnormal formation of the horny
`layer (hornification) that leads to
`drying out of the skin.” (Ex. 1004,p.
`1, lines 27-29).
`
`DECLARATIONOF DR. R. RANDALL WICKETT
`REGARDINGU.S. PATENT NO.6,423,327
`
`DE ‘107 discloses a cosmetic
`product for the prevention and
`therapy of cosmetic or
`dermatological skin changes suchas,
`for example, skin aging. (Ex. 1004,
`p. 1, lines 3-9)
`
`DE ‘107 discloses cosmetic
`processesfor protection ofthe skin
`against oxidative and photoxidative
`processes. (Ex. 1004,p. 14,lines 10-
`15)
`
`DE ‘107 doesnot disclose the
`treatment of woundsor brokenskin,
`so a skilled artisan would understand
`DE‘107 to include treatment of
`unbrokenskin.
`
`DE ‘107 discloses application to
`human skin. (Ex. 1004,p.2, lines 1-
`
`4 “
`
`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 dermalcell
`proliferation,
`
`Discussed below—inherently
`disclosed
`
`the method comprising topically
`
`applying to the skin
`
`DE ‘107 discloses cosmetic
`compositions for topical application.
`
`
`
`DECLARATION OF DR. R. RANDALL WICKETT
`REGARDINGU.S. PATENT NO.6,423,327
`
`DE‘107 discloses cosmetic
`compositions for topical application
`containing an amountof adenosine
`ranging from 0.001% to 10%:
`
`a composition comprising a
`concentration of adenosine in an
`amounteffective to enhance the
`condition of the skin without
`increasing dermalcell proliferation,
`wherein the adenosine concentration
`applied to the dermalcells is 10“*M
`to 107M.
`
`“According to the use as described in
`the invention, cosmetic or
`dermatological formulations can be
`composedas 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 weight,
`of the active substance combinations
`relative to the total weight of the
`product.” (Ex. 1004,at p.2, line 28
`to p. 3, line 5, emphasis added).
`
`lines 10-20, emphasis added).
`
`“The present invention also includes
`a cosmetic methodofprotecting the
`skin and the hair against oxidative
`and photo-oxidative processes,
`whichis characterized in that a
`cosmetic composition; which
`contains an effective concentration
`of adenosine,in a sufficient amount
`is applied to the skin orhair.
`Preferably, the amountof
`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,
`
`
`
`DECLARATIONOF DR. R. RANDALL WICKETT
`REGARDINGU.S. PATENT NO.6,423,327
`In myreview ofthefile history of the ‘327 patent, I note that the
`
`39.
`
`Examinerrejected certain claims ofthe application as anticipated by DE ‘107. The
`
`Examinerstated 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.
`
`Inresponse, the inventors amended the claimsto specify the
`
`adenosine concentration range of 10M to 10°’M,and submitted a Declaration
`
`describing testing of adenosine at 104M (10°M) and 100nM (10M) on human
`
`fibroblasts in culture. (Ex. 1009, p. 81-92 and 107-111). Theresults ofthe testing
`
`concludedthat there was noproliferation of the fibroblasts. (/d.)
`
`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 arguedthat their test results showed that “low concentrations of
`
`adenosine do notincrease dermalcell proliferation,” supposedly contrary to DE
`
`‘107’s disclosure. (/d.) It is important to note, however,that the data the inventors
`
`submitted waslimited to fibroblasts, which are only one ofthe cell types in the
`
`skin in addition to othercells in the epidermal, dermal, and sub-dermallayers.
`
`Bt.
`
`
`
`DECLARATION OF DR. R. RANDALL WICKETT
`REGARDINGU.S. PATENT NO.6,423,327
`42. However, I note that DE ‘107states that its compositions are useful
`
`for treating a variety of dermatological skin changes associated with skin aging
`
`including problemsassociated with “limited regenerative turnover in the epidermis
`
`in conjunction with abnormal formation of the horny layer (hornification) that
`
`leads to drying out ofthe skin” and “Abnormalregulation ofcell division
`
`(proliferation) and cell maturation (differentiation) in the epidermis resulting in
`
`atypicalcells and polarity loss.” (Ex. 1004,at p. 1, lines 27-34, emphasis added).
`
`Thus, DE ‘107’s disclosureofcell proliferation at any particular concentration of
`
`adenosineis not limited to fibroblasts or other cells ofthe dermal layer. Further, a
`
`skilled artisan in 1998 would have understood that enhancing epidermalcell
`
`“turnover” was desirable in order to overcome the slowdown in epidermal
`
`“turnover” rate that was known to occurwith age. (Ex. 1021).
`
`43.
`
`Inother 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 dermalcells. Rather, the skilled artisan would have
`
`understood that DE ‘107 wasdiscussing skin cell proliferation without limitation to
`
`any particular type of skin cell including proliferation of epidermalcells.
`
`44.
`
`Importantly, if the inventors’ data showsthat concentrations of
`
`adenosine of 104M (10°M)and 100M (10“M)doesnotincrease proliferation of
`
`fibroblasts, then a skilled artisan would understand that the overlapping range of
`
`2.
`
`
`
`DECLARATION OF DR. R. RANDALL WICKETT
`REGARDINGU.S. PATENT NO.6,423,327
`adenosine disclosed by DE ‘107 necessarily does not promoteproliferation 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 dermalcell
`
`proliferation,” evenif that result would not have been appreciated bya skilled
`
`artisan at the time of the invention. Likewise, the inventors’ extrapolation
`
`regarding the lack of proliferation of dermalcells 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 dermalcell proliferation” is necessarily disclosed through the
`
`overlapping ranges of adenosine disclosed in DE ‘107.
`
`46.
`
`In view ofthe foregoing,it is my opinion that a skilled artisan would
`
`have understood that DE ‘107 discloses each elementof 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 107*M to 10°°M.
`
`As discussed above regarding claim 1, DE ‘107 discloses cosmetic compositions
`
`for topical application containing an amountof 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
`
`-53.
`
`
`
`DECLARATIONOF DR. R. RANDALL WICKETT
`REGARDINGU.S. PATENT NO.6,423,327
`the inventors in their declaration, the lower limit of the adenosine amount of DE
`
`‘107 (0.001%) corresponds to 3.8 x 10°M adenosine, which falls within the range
`
`of claim 3. (Ex. 1009, at p. 89-92 and 107-111). Thus, because DE ‘107 discloses
`
`each elementofclaim 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, Il. 18-26). The *327 patent
`
`further states “emollients help to maintain the soft, smooth, and pliable appearance
`
`of skin and function by remaining on the skin surfaceor in the stratum corneum to
`
`act as lubricants, to reduce flaking, and to improvethe skin's appearance...
`
`humectantsact to increase the water contentof the top layers of the skin...
`
`occlusive agents inhibit the evaporation of water from skin,thereby increasing the
`
`water contend[sic] of the skin.” (Jd. Col. 4,Il. 35-45).
`
`49. DE ‘107 discloses “[i]In keeping with the use according to the
`
`invention, cosmetic and dermatological preparations can contain cosmetic
`
`adjuvants as conventionally used in such pr
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