Case 1:17-cv-00868-CFC-SRF Document 97 Filed 03/06/20 Page 1 of 90 PageID #: 2588
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`UNIVERSITY OF MASSACHUSETTS
`and CARMEL LABORATORIES, LLC,
`
`Plaintiffs,
`
`
`
`v.
`
`L’ORÉAL USA, INC.,
`
`Defendant.
`
`C.A. No. 17-868-CFC-SRF
`
`JOINT CLAIM CONSTRUCTION BRIEF
`
`
`
`

`

`Case 1:17-cv-00868-CFC-SRF Document 97 Filed 03/06/20 Page 2 of 90 PageID #: 2589
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`
`I.
`
`TABLE OF CONTENTS
`
`Plaintiffs’ Opening Position ............................................................................ 1
`A. Overview of the Patented Inventions .................................................... 3
`B. Defendant’s Construction Was Rejected by the PTO ........................... 7
`C. Defendant Attempts to Rewrite the Claims and Defies the
`Intrinsic Evidence with its Proffered Construction ............................. 10
`II. Defendant’s Answering Position ................................................................... 20
`A.
`Introduction ......................................................................................... 20
`B.
`Background ......................................................................................... 22
`C.
`The Intrinsic Evidence Compels Construing the Disputed
`Claim Term to Refer to the Concentration of Adenosine
`Applied to the Skin .............................................................................. 26
`1.
`The Claims of the Patents-in-Suit Support L’Oréal
`USA’s Proposed Construction .................................................. 27
`The Specification of the Patents-in-Suit Supports
`L’Oréal USA’s Proposed Construction .................................... 32
`L’Oréal USA’s Proposed Construction Is Confirmed
`by the Prosecution History ........................................................ 36
`a.
`The Prosecution Leading to the ’327 Patent................... 38
`b.
`The Prosecution Leading to the ’513 Patent................... 45
`c.
`The Prosecution of Related Patent Applications ............ 48
`III. Plaintiffs’ Reply Position ............................................................................... 52
`1.
`The PTO Correctly Decided This Dispute Long Ago .............. 53
`2.
`The Intrinsic Evidence Compels a Plain and Ordinary
`Meaning Construction ............................................................... 55
`
`2.
`
`3.
`
`
`
`
`i
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`Case 1:17-cv-00868-CFC-SRF Document 97 Filed 03/06/20 Page 3 of 90 PageID #: 2590
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`3.
`
`The Court Should Strike Defendant’s Expert
`Declaration ................................................................................ 65
`Conclusion ................................................................................ 68
`4.
`IV. Defendant’s Sur-Reply Position .................................................................... 68
`A.
`Introduction ......................................................................................... 68
`B.
`The Board’s Claim Construction Ruling Is Incorrect and
`Should Not Be Followed ..................................................................... 70
`The Intrinsic Evidence Supports L’Oréal USA’s Construction .......... 71
`1.
`The Claim Language ................................................................. 71
`2.
`The Specification ...................................................................... 73
`3.
`The Prosecution History ........................................................... 74
`D. Dr. Kasting’s Declaration Is Proper Claim Construction
`Evidence .............................................................................................. 77
`Conclusion ........................................................................................... 79
`
`C.
`
`E.
`
`
`
`
`
`
`
`
`ii
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`

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`Case 1:17-cv-00868-CFC-SRF Document 97 Filed 03/06/20 Page 4 of 90 PageID #: 2591
`
`TABLE OF AUTHORITIES
`
` Page(s)
`
`Cases
`01 Communique Lab., Inc. v. Citrix Sys., Inc.,
`889 F.3d 735 (Fed. Cir. 2018) ............................................................................ 51
`Abbott Labs. v. Sandoz, Inc.,
`566 F.3d 1282 (Fed. Cir. 2009) .......................................................................... 18
`ACCO Brands, Inc. v. Micro Sec. Devices, Inc.,
`346 F.3d 1075 (Fed. Cir. 2003) .................................................................... 43, 48
`Am. Calcar, Inc. v. Am. Honda Motor Co.,
`651 F.3d 1318 (Fed. Cir. 2011) .......................................................................... 29
`Amgen Inc. v. Coherus Biosciences, Inc.,
`931 F.3d 1154 (Fed. Cir. 2019) .............................................................. 42, 63, 76
`Aqua-Aerobic Sys., Inc. v. Aerators Inc.,
`211 F.3d 1241 (Fed. Cir. 2000) .......................................................................... 67
`Autogiro Co. of Am. v. United States,
`384 F.2d 391 (Ct. Cl. 1967) ................................................................................ 61
`Avid Tech., Inc. v. Harmonic Inc.,
`812 F.3d 1040 (Fed. Cir. 2016) .......................................................................... 28
`Bd. Of Regents of the Univ. of Tex. Sys. v. BENQ Am. Corp.,
`533 F.3d 1362 (Fed. Cir. 2008) .................................................................... 12, 72
`Biogen Idec, Inc. v. GlaxoSmithKline LLC,
`713 F.3d 1090 (Fed. Cir. 2013) .................................................................... 37, 51
`Biogen, Inc. v. Berlex Labs., Inc.,
`318 F. 3d 1132 (Fed. Cir. 2003) ................................................................... 44, 64
`CCS Fitness, Inc. v. Brunswick Corp.,
`288 F.3d 1359 (Fed. Cir. 2002) .................................................................. 2, 3, 56
`CIAS, Inc. v. All. Gaming Corp.,
`504 F.3d 1356 (Fed. Cir. 2007) .................................................................... 57, 59
`
`
`
`iii
`
`

`

`Case 1:17-cv-00868-CFC-SRF Document 97 Filed 03/06/20 Page 5 of 90 PageID #: 2592
`
`Cree, Inc. v. SemiLEDs Corp.,
`No. CIV.A. 10-866-RGA, 2012 WL 975697 (D. Del. Mar. 21, 2012) .............. 64
`Depuy Orthopaedics, Inc. v. Orthopaedic Hosp.,
`No. 12-299, 2016 WL 96164 (N.D. Ind. Jan. 8, 2016) ....................................... 26
`Desper Products, Inc. v. QSound Labs, Inc.,
`157 F.3d 1325 (Fed. Cir. 1998) .......................................................................... 37
`Dippin’ Dots, Inc. v. Mosey,
`476 F.3d 1337 (Fed. Cir. 2007) .................................................................... 71, 72
`Ecolab, Inc., v. FMC Corp.,
`569 F.3d 1335 (Fed. Cir. 2009) ...................................................................... 2, 19
`Engel Indus., Inc. v. Lockformer Co.,
`96 F.3d 1398 (Fed. Cir. 1996) ............................................................................ 37
`Eon Corp. IP Holdings v. Silver Spring Networks,
`815 F.3d 1314 (Fed. Cir. 2016) .......................................................................... 27
`Eon-Net LP v. Flagstar Bancorp,
`653 F.3d 1314 (Fed. Cir. 2011) .......................................................................... 34
`Fitness Anywhere LLC v. Woss Enters. LLC,
`No. 14-CV-01725-BLF, 2015 WL 7293659 (N.D. Cal. Nov. 19, 2015) ........... 54
`Griffin v. Bertina,
`285 F.3d 1029 (Fed. Cir. 2002) .......................................................................... 29
`Grober v. Mako Prods., Inc.,
`686 F.3d 1335 (Fed. Cir. 2012) .................................................................... 18, 62
`In re ICON Health & Fitness, Inc.,
`496 F.3d 1374 (Fed. Cir. 2007) .......................................................................... 70
`Johnson Worldwide Assocs., Inc. v. Zebco Corp.,
`175 F.3d 985 (Fed. Cir. 1999) .............................................................................. 2
`MasterMine Software, Inc. v. Microsoft Corp.,
`874 F.3d 1307 (Fed. Cir. 2017) .......................................................................... 48
`
`
`
`iv
`
`

`

`Case 1:17-cv-00868-CFC-SRF Document 97 Filed 03/06/20 Page 6 of 90 PageID #: 2593
`
`Medrad, Inc. v. MRI Devices Corp.,
`401 F.3d 1313 (Fed. Cir. 2005) .......................................................................... 37
`Merck & Co., Inc. v. Teva Pharm. USA, Inc.,
`395 F.3d 1364 (Fed. Cir. 2005) .......................................................................... 12
`NeoMagic Corp. v. Trident Microsystems, Inc.,
`287 F.3d 1062 (Fed. Cir. 2002) .......................................................................... 53
`Netcraft Corp. v. eBay, Inc.,
`549 F.3d 1394 (Fed. Cir. 2008) .......................................................................... 34
`NTP, Inc. v. Research in Motion, Ltd.,
`418 F.3d 1282 (Fed. Cir. 2005) .......................................................................... 28
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005) ...................................................................passim
`Purdue Pharma L.P. v. Endo Pharm. Inc.,
`438 F.3d 1123 (Fed. Cir. 2006) .................................................................... 15, 17
`Raytheon Co. v. Sony Corp.,
`727 F. App’x 662 (Fed. Cir. 2018) ..................................................................... 72
`Research Plastics, Inc. v. Federal Packaging Corp.,
`421 F.3d 1290 (Fed. Cir. 2005) .......................................................................... 30
`Salazar v. Procter & Gamble Co.,
`414 F.3d 1342 (Fed. Cir. 2005) .................................................................... 63, 64
`Serio-US Indus., Inc. v. Plastic Recovery Techs. Corp.,
`459 F.3d 1311 (Fed. Cir. 2006) .......................................................................... 70
`Shire Dev., LLC v. Watson Pharm., Inc.,
`787 F.3d 1359 (Fed. Cir. 2015) .......................................................................... 37
`Southwall Techs., Inc. v. Cardinal IG Co.,
`54 F.3d 1570 (Fed. Cir. 1995) ............................................................................ 51
`StrikeForce Techs., Inc. v. PhoneFactor, Inc.,
`No. CIV.A. 13-490-RGA, 2015 WL 3793726 (D. Del. May 26, 2015) ............ 54
`
`
`
`v
`
`

`

`Case 1:17-cv-00868-CFC-SRF Document 97 Filed 03/06/20 Page 7 of 90 PageID #: 2594
`
`Thorner v. Sony Computer Entm’t Am. LLC,
`669 F.3d 1362 (Fed. Cir. 2012) .................................................................... 18, 62
`Tuna Processors, Inc. v. Hawaii Int’l Seafood, Inc.,
`327 F. App’x 204 (Fed. Cir. 2009) ..................................................................... 28
`Vitronics Corp. v. Conceptronic, Inc.,
`90 F.3d 1576 (Fed. Cir. 1996) ............................................................................ 65
`Wilson Sporting Goods Co. v. Hillerich & Bradsby,
`442 F.3d 1322 (Fed. Cir. 2006) .............................................................. 24, 54, 70
`Wireless Protocol Innovations, Inc. v. TCT Mobile, Inc.,
`771 F. App’x 1012 (Fed. Cir. 2019) ................................................................... 34
`Wright Medical Tech., Inc. v. Osteonics Corp.,
`122 F.3d 1440 (Fed. Cir. 1997) .......................................................................... 30
`Statutes
`35 U.S.C. § 112 .................................................................................................. 20, 40
`Rules
`D. Del. LR 7.1.1 ....................................................................................................... 77
`Regulations
`37 C.F.R. § 42.71(c) ................................................................................................. 26
`
`
`
`vi
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`

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`Case 1:17-cv-00868-CFC-SRF Document 97 Filed 03/06/20 Page 8 of 90 PageID #: 2595
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`
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`Pursuant to Paragraph 16 of the Court’s Scheduling Order (D.I. 46) (as
`
`amended), Plaintiffs University of Massachusetts and Carmel Laboratories, LLC
`
`(together “Plaintiffs”) and Defendant L’Oréal USA,
`
`Inc.
`
`(“Defendant”)
`
`(collectively, the “Parties”) provide this Joint Claim Construction Brief.
`
`
`
`There is only one term in dispute, which is, “wherein the adenosine
`
`concentration applied to the dermal cells is . . . .” See U.S. Patent No. 6,423,327
`
`(“’327 Patent”), claim 1; Patent No. 6,645,513 (“’513 Patent”), claim 1 (D.I. 77 Ex. 1
`
`and 2, respectively).
`
`
`
`The Parties’ positions with respect to this term are below.
`
`Plaintiffs’ Construction
`Plain and ordinary meaning.
`
`Alternatively, if construed, “wherein the
`adenosine concentration that reaches the
`dermal cell layer is”
`
`Defendant’s Construction
`“wherein the adenosine concentration
`applied to the skin containing the
`dermal cells is”
`
`
`I.
`
`PLAINTIFFS’ OPENING POSITION
`
`
`
`Plaintiffs assert that Defendant infringes claims of the ’327 and ’513 Patents.
`
`Both patents disclose methods to enhance the condition of skin without increasing
`
`dermal cell proliferation, by applying recited ranges of adenosine “to the dermal
`
`cells.” ’327 Patent at claim 1; ’513 Patent at claim 1.
`
`
`
`Defendant proposes a strained construction that is inconsistent with the
`
`intrinsic evidence, relies on a misreading of the patent prosecution history, and
`
`ignores the plain meaning of ordinary words the asserted patents use unambiguously.
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`

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`At its core, Defendant wishes to interpret the claims in a manner inconsistent with
`
`basic science—that the “epidermis” is the same as the “dermis.” But even children
`
`know the difference between these structures. See, e.g., American Academy of
`
`Dermatology, What Kids Should Know About the Layers of Skin, available at
`
`https://www.aad.org/teach-healthy-habits/skin-layers (“Epidermis is the top layer of
`
`the skin, the part of the skin you see. Dermis is the second layer of skin. It’s much
`
`thicker and does a lot for your body.”); see also Phillips v. AWH Corp., 415 F.3d
`
`1303, 1314 (Fed. Cir. 2005) (“In some cases, the ordinary meaning of claim language
`
`as understood by a person of skill in the art may be readily apparent even to lay
`
`judges, and claim construction in such cases involves little more than the application
`
`of the widely accepted meaning of commonly understood words.”). And nothing in
`
`the prosecution history comes close to a “clear and unmistakable disclaimer” that
`
`would overcome this fundamental science. Ecolab, Inc., v. FMC Corp., 569 F.3d
`
`1335, 1342 (Fed. Cir. 2009).
`
`
`
`Plaintiffs, by contrast, propose either no construction or, if the Court is
`
`inclined to clarify this term, one based on its plain and ordinary meaning. CCS
`
`Fitness, Inc. v. Brunswick Corp., 288 F.3d 1359, 1366 (Fed. Cir. 2002) (“[W]e
`
`indulge a ‘heavy presumption’ that a claim term carries its ordinary and customary
`
`meaning.”) (quoting Johnson Worldwide Assocs., Inc. v. Zebco Corp., 175 F.3d 985,
`
`989 (Fed. Cir. 1999)).
`
`
`
`2
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`

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`
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`The Parties have already briefed the same claim construction issue for the
`
`same term, in conjunction with Defendant’s petitions for inter partes review of both
`
`asserted patents. The Patent and Trademark Office (“PTO”) agreed with Plaintiffs
`
`that this term needs no construction, and on that basis, denied Defendant’s petitions.
`
`As explained further below, this Court should do the same.
`
`A. Overview of the Patented Inventions
`The asserted patents teach that “[s]kin includes a surface layer, known as the
`
`
`
`epidermis, and a deeper connective tissue layer, known as the dermis.” ’327 Patent1
`
`at 1:19-20. “The dermis is composed of a variety of cells types, including
`
`fibroblasts.” Id. at 1:23-24. In other words, “the skin” is comprised of both the
`
`epidermis and the dermis; “dermal cells” are cells in the dermal layer of the skin,
`
`and may include dermal fibroblasts. “As skin ages, or is exposed to UV light and
`
`other environmental insults,” the “dermis becomes thinner and the number of skin
`
`fibroblasts declines.” Id. at 1:25-33. In turn, “products of the fibroblasts,” such as
`
`the proteins “collagen and proteoglycans,” decrease in “abundance and function,”
`
`and play a “major role in wrinkled and damaged skin.” Id.
`
`
`
`
`1 The asserted patents share a nearly identical specification, and Plaintiffs reference
`only the ’327 Patent specification for convenience.
`
`
`
`3
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`

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`Case 1:17-cv-00868-CFC-SRF Document 97 Filed 03/06/20 Page 11 of 90 PageID #: 2598
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`
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`David J. Wong and Howard Y. Chang, Skin Tissue Engineering (Harvard Stem Cell
`Institute 2008), available at https://www.ncbi.nlm.nih.gov/books/NBK27029/.
`
`
`
`Plaintiffs use this publicly-available diagram as an illustrative example, but
`
`
`
`countless other sources reiterate this basic scientific fact. See, e.g., Ex. 5 (Decision
`
`Denying Inter Partes Review of the ’327 Patent) (“’327 IPR Denial”) at 8
`
`(App’x A0179) (“There is no dispute that the skin is comprised of multiple layers.”)
`
`(depicting a figure illustrating “[t]he multiple layers of skin”).
`
`
`
`The inventors of the asserted patents—Doctors James G. Dobson, Jr. and
`
`Michael Ethier, both formerly of the University of Massachusetts—sought to
`
`address aging and damaged skin using their discoveries regarding adenosine.
`
`
`
`4
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`

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`Case 1:17-cv-00868-CFC-SRF Document 97 Filed 03/06/20 Page 12 of 90 PageID #: 2599
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`Adenosine is a naturally occurring purine nucleoside that plays an important role in
`
`a variety of biochemical processes. Prior inventions had disclosed using adenosine
`
`to treat human skin, but prior art taught using adenosine to increase dermal cell
`
`proliferation—i.e., treating the thinning dermis by increasing the number of dermal
`
`cells. But dermal cell proliferation can be detrimental and “cause scarring,
`
`discoloration, and a variety of other skin anomalies associated with hyperplasia.”
`
`Ex. 2 (excerpts of the file history of the ’327 Patent) (“’327 File History”) at 84
`
`(App’x A0078).
`
`
`
`Doctors Dobson and Ethier discovered that the benefits of adenosine could be
`
`harnessed without increasing dermal cell proliferation. Specifically, they discovered
`
`that low concentrations of adenosine applied to the dermal cells could be used to
`
`“enhance[e] the condition of skin” by “stimulat[ing] DNA synthesis, increas[ing]
`
`protein synthesis, and increas[ing] cell size” in “human skin fibroblasts,” but without
`
`“caus[ing] proliferation of the dermal cells.” ’327 Patent at 1:37-41; 1:59-60; 1:66-
`
`67. That is, in direct contrast to prior art, the claimed inventions teach that the best
`
`way to treat the thinning dermis with adenosine is not to increase the number of
`
`dermal cells, but to use a low concentration of adenosine to enhance the size and
`
`function of existing dermal cells.
`
`
`
`The patents disclose that their methods can be used, for example, to
`
`“enhance[e] the condition of aged skin,” on “subjects having otherwise damaged
`
`
`
`5
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`

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`Case 1:17-cv-00868-CFC-SRF Document 97 Filed 03/06/20 Page 13 of 90 PageID #: 2600
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`skin, e.g., wrinkled skin and skin with a non-proliferative disorder,” and
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`“prophylactically on a subject to minimize deterioration of skin condition associated
`
`with aging or environmental factors, such as photodamage.” Id. at 3:23-35. Both
`
`patents teach that adenosine may be “applied to the dermal cells” for these uses
`
`“preferably applied by topical routes,” where such “topical application” results in
`
`“the penetration of the adenosine into skin tissue.” Id. at 5:10-14. But in order to
`
`achieve the disclosed benefits of “stimulate[d] DNA synthesis, increase[d] protein
`
`synthesis, and increases in cell size” to “fibroblasts,” adenosine must by necessity
`
`penetrate to the dermal layer of skin. Id. at 1:37-41; see also id. at 9:5-51 (disclosing,
`
`for example, “increased cell size” from direct application to dermal fibroblasts of
`
`adenosine in the amount of 10-4 M). Simply put, while “the skin” includes both the
`
`epidermis and the dermis, id. at 1:19-24, the patents teach that the recited
`
`concentration of adenosine must penetrate “to the dermal cells” to obtain the claimed
`
`skin enhancement.
`
`
`
`The ’327 Patent issued first. Claim 1 of the ’327 Patent, the only independent
`
`claim, recites a 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 to the dermal cells is 10-4 M to 10-7 M.” The ’327
`
`Patent also discloses a number of dependent claims. The ’513 Patent issued second,
`
`
`
`6
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`

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`Case 1:17-cv-00868-CFC-SRF Document 97 Filed 03/06/20 Page 14 of 90 PageID #: 2601
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`and built on the inventorship of the ’327 Patent. Claim 1 of the ’513 Patent, the only
`
`independent claim, recites a 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 to the dermal cells is 10-3 M to 10-7 M.”
`
`The ’513 Patent also discloses a number of dependent claims.
`
`B. Defendant’s Construction Was Rejected by the PTO
`Defendant previously petitioned the PTO for inter partes review of both
`
`
`
`asserted patents. In its petitions, Defendant requested claim construction of the same
`
`term at issue now, and there, contended the term should be construed as reciting “a
`
`concentration of adenosine in the composition that is topically applied to an
`
`unbroken, epidermal layer of a region of skin containing the dermal cells.” ’327 IPR
`
`Denial at 8 (App’x A0179) (emphasis in original). Although Defendant has
`
`shortened its proffered construction of this term somewhat since its failed petitions,
`
`the construction’s import remains the same. Both in its petitions and now, “[t]he
`
`fundamental question presented by [Defendant] in connection with its proposed
`
`construction is whether the recited concentration [of adenosine] is applied to the
`
`dermal cells or the epidermal cells.” Id. at 9 (App’x A0180). To the extent Defendant
`
`now argues it does not intend to point to the epidermis with its construction, which
`
`calls for the recited concentrations of adenosine to be applied to “the skin containing
`
`
`
`7
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`

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`Case 1:17-cv-00868-CFC-SRF Document 97 Filed 03/06/20 Page 15 of 90 PageID #: 2602
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`the dermal cells,” its construction merely creates ambiguity and confusion where
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`there is none in the asserted claims. “[T]he skin” is comprised of both the epidermis
`
`and the dermis; only the dermis “contain[s] the dermal cells,” but the claims already
`
`plainly state that the recited concentration of adenosine is to be applied “to the
`
`dermal cells.”
`
`
`
`Plaintiffs argued to the PTO, and still maintain, that the term should be
`
`construed according to its plain and ordinary meaning, and that “the recited
`
`concentration is the concentration that is applied to the dermal cells.” See id. at 8
`
`(App’x A0179) (emphasis in original); see also Ex. 6 (Decision Denying Inter Partes
`
`Review of the ’513 Patent) (“’513 IPR Denial”) at 10 (App’x A0202) (same
`
`constructions).
`
`
`
`Defendant’s strained construction that the claims really mean “applied to the
`
`skin” (i.e., the epidermis) was squarely—and correctly—rejected by the PTO in its
`
`decisions denying inter partes review of both asserted patents. The three-judge IPR
`
`panel reviewed Defendant’s construction in “a district court-type claim construction
`
`like that provided in Phillips,” and found that “the disputed claim language is
`
`unambiguous [and] requires an adenosine concentration ‘applied to the dermal
`
`cells.’” ’327 IPR Denial at 6, 15 (App’x A0177, A0186); ’513 IPR Denial at 6, 14
`
`(App’x A0198, A0206). Accordingly, the PTO construed “the ‘concentration
`
`applied to the dermal cells’ to mean what it says—that the recited concentration is
`
`
`
`8
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`

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`Case 1:17-cv-00868-CFC-SRF Document 97 Filed 03/06/20 Page 16 of 90 PageID #: 2603
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`the concentration that is applied to the dermal cells.” ’327 IPR Denial at 15
`
`(App’x A0186); ’513 IPR Denial at 14 (App’x A0206). On that basis, the PTO
`
`denied Defendant’s petition for inter partes review because the prior art cited by
`
`Defendant had no “evidence reflecting the concentration of adenosine applied to the
`
`dermal cells,” and therefore Defendant did not have a reasonable likelihood of
`
`prevailing in its invalidity arguments. ’327 IPR Denial at 16-19 (App’x A0187-90);
`
`’513 IPR Denial at 15-18 (App’x A0207-10).
`
`
`
`Defendant sought reconsideration of that decision, but the PTO confirmed the
`
`claims mean exactly what they say:
`
`Our construction gives the term “dermal cells” its ordinary meaning by
`construing it to refer to “dermal cells”—i.e., the dermis or dermal layer.
`We do not find in the record, and Petitioner does not suggest, another
`way to interpret the limitation “concentration applied to the dermal
`cells” consistent with the ordinary meaning of the words “dermal cells.”
`. . . [T]here is no meaningful difference between the “epidermal layer
`of a region of the skin containing the dermal cells” recited in
`Petitioner’s proposed claim construction, and
`the epidermis.
`Petitioner’s proposed construction is, thus, contrary to the language of
`the claim, because it changes the meaning of “dermal cells” to
`“epidermal cells.” . . . [T]he Specification discloses not only that
`adenosine may be topically applied to the epidermal layer of the skin,
`but also that adenosine so applied will penetrate the epidermis to reach
`the dermal layer. . . Topical application of adenosine will, therefore,
`result in adenosine being brought in contact with both the epidermis
`and the dermis. . . . [T]he Specification provides examples in which a
`concentration of adenosine matching the high end recited in the claims
`(10-4 M) is applied directly to dermal cells (fibroblasts), suggesting that
`the inventors considered it desirable for the dermal cells to receive the
`claimed concentration of adenosine. In this context, the meaning of
`claim 1 is clear: adenosine is first topically applied to the epidermal
`layer of the skin and, only after it penetrates this outer skin layer, is a
`
`
`
`9
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`

`

`Case 1:17-cv-00868-CFC-SRF Document 97 Filed 03/06/20 Page 17 of 90 PageID #: 2604
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`specific concentration (10-4 M to 10-7 M) of the adenosine “applied” to
`the dermal cells.
`
`
`Ex. 7 (Decision Denying Reconsideration for
`
`the ’327 Patent) (“’327
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`Reconsideration Denial”) at 5-6 (App’x A0217-18) (emphasis added); see also Ex.
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`8 (Decision Denying Reconsideration for the ’513 Patent) (“’513 Reconsideration
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`Denial”) at 5-6 (App’x A0229-30) (same).
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`
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`Defendant now reprises the same twice-debunked claim construction
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`argument, hoping this Court will rewrite these unambiguous claims where the PTO
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`was unwilling to do so. The Court should instead affirm that the claims mean what
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`they say.
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`C. Defendant Attempts to Rewrite the Claims and Defies the
`Intrinsic Evidence with its Proffered Construction
`Both claims at issue recite that the claimed concentration of adenosine is
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`
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`“applied to the dermal cells.” ’327 Patent at claim 1, ’513 Patent at claim 1.
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`Defendant would rewrite the claims such that the adenosine is “applied to the skin
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`containing the dermal cells”—i.e., applied to the epidermis.
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`
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`Claim interpretation starts with the claim language itself. Phillips, 415 F.3d at
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`1312. In addition to the language of the claims, it is “entirely appropriate” for a court
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`“to rely heavily on the [specification] for guidance as to the meaning of the claims.”
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`Id. at 1317. Prosecution history may be helpful, but because it “represents an
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`ongoing negotiation between the PTO and the applicant, rather than the final product
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`Case 1:17-cv-00868-CFC-SRF Document 97 Filed 03/06/20 Page 18 of 90 PageID #: 2605
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`of that negotiation, it often lacks the clarity of the specification and thus is less useful
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`for claim construction purposes.” Id. (citations omitted). Courts may consider
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`extrinsic evidence as well, but “it is less significant than the intrinsic record in
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`determining the legally operative meaning of claim language.” Id. (citations and
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`quotations omitted).
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`
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`As already explained multiple times by the PTO, Defendant’s construction
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`contradicts the claim language, the specification, and the prosecution history, and
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`should be rejected in favor of the term’s plain and ordinary meaning.
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`
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`
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`The Claim Language
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`The claim language distinguishes between “the skin” and the “dermal cells.”
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`Claim 1 of the ’327 Patent recites:
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`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 to the dermal cells is 10-4
`M to 10-7 M.
`
`Claim 1 (emphasis added); see also claim 1 of the ’513 Patent (same, but the
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`“adenosine concentration applied to the dermal cells is 10-3 M to 10-7 M”). Thus, the
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`claim discloses a method whereby a composition containing adenosine is “topically
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`appl[ied] to the skin” and “the adenosine concentration applied to the dermal cells is
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`10-4 M to 10-7 M” (or, in the case of the ’513 Patent, 10-3 M to 10-7 M).
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`Case 1:17-cv-00868-CFC-SRF Document 97 Filed 03/06/20 Page 19 of 90 PageID #: 2606
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`The plain and ordinary meaning of “dermal cells” is dermal cells—i.e., cells
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`in the dermal layer of skin. No “elaborate interpretation” is needed for terms whose
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`ordinary meanings are apparent. Phillips, 415 F.3d at 1314 (citations and quotations
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`omitted). Defendant’s construction would change “the dermal cells” to “the skin
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`containing the dermal cells,” a bald attempt to avoid liability by turning the claim
`
`language on its head. The claim plainly distinguishes between “the skin” and “the
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`dermal cells” (a specific area of the skin), where a composition is “topically applied
`
`to the skin,” and the recited adenosine concentration is “applied to the dermal cells.”
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`If the inventors had wanted the adenosine to be applied “to the skin,” rather than “to
`
`the dermal cells,” they would have said so. See Bd. Of Regents of the Univ. of Tex.
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`Sys. v. BENQ Am. Corp., 533 F.3d 1362, 1371 (Fed. Cir. 2008) (“Different claim
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`terms are presumed to have different meanings.”); Merck & Co., Inc. v. Teva Pharm.
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`USA, Inc., 395 F.3d 1364, 1372 (Fed. Cir. 2005) (“A claim construction that gives
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`meaning to all the terms of the claim is preferred over one that does not do so.”);
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`’327 IPR Denial at 9-10 (App’x A0180-81) (“One would expect that if the Patent
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`Owner had intended both ‘applications’ recited in the claim 1 to be made to the same
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`cells, Patent Owner would have used the same term to describe both applications.”).
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`Defendant’s construction defies the words of the claim it proposes to construe, and
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`should be rejected.
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`The Specification
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`The specification further supports Plaintiffs’ plain and ordinary meaning
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`interpretation of this term. The specification is “[u]sually dispositive; it is the single
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`best guide to the meaning of a disputed term.” Phillips, 415 F.3d at 1315 (citations
`
`omitted). The very first sentence of the specification confirms the straightforward
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`fact that the skin is composed of multiple layers: “Skin includes a surface layer,
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`known as the epidermis, and a deeper connective tissue layer, known as the dermis.”
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`’327 Patent at 1:20-21. The specification explains that compositions containing
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`adenosine are “preferably applied by topical routes to exert local therapeutic results,”
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`but, as explained above, in order to achieve the disclosed benefits of “stimulate[d]
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`DNA synthesis, increase[d] protein synthesis, and increases in cell size” to
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`“fibroblasts,” adenosine must reach the dermal layer. Id. at 1:37-41; 5:10-13; see
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`also id. at 1:24-25 (“The dermis is composed of a variety of cell types, including
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`fibroblasts”); ’327 Reconsideration Denial at 6-7 (App’x A0218-19) (the “ordinary
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`meaning of ‘apply’” is “to bring into physical contact with or close proximity to”)
`