`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`UNIVERSITY OF
`MASSACHUSETTS and CARMEL
`LABO RA TORIES, LLC
`
`Plaintiffs,
`
`V.
`
`Civil Action No.17-0868-CFC-SRF
`
`L'OREAL USA, INC.
`
`Defendant.
`
`Brian E. Farnan, Michael J. Farnan, FARNAN LLP, Wilmington, Delaware;
`Beatrice Franklin, Nicholas C. Carullo, Tamar E. Lusztig, William C. Carmody,
`SUSMAN & GODFREY LLP, New York, New York; Davida Brook, SUSMAN
`& GODFREY LLP, Los Angeles, Califmnia; Justin A. Nelson, SUSMAN &
`GODFREY LLP, Houston, Texas
`
`Counsel for Plaintiffs
`
`Frederick L. Cottrell, III, Jason James Rawnsley, Katharine Lester Mowery,
`RICHARDS LAYTON & FINGER, PA, Wilmington, Delaware; Eric W.
`Dittmann, Bruce M. Wexler, Isaac S. Ashkenazi, Karthik R. Kasaraneni, Nicholas
`A. Tymoczko, PAUL HASTINGS, LLP, New York, New York; Joseph E. Palys,
`Naveen Modi, PAUL HASTINGS, LLP, Washington, District of Columbia;
`Dennis S. Ellis, Katherine F. Murray, Serli Polatoglu, BROWNE GEORGE ROSS
`O'BRIEN ANNAGUEY & ELLIS LLP, Century City, California
`
`Counsel for Defendant
`
`MEMORANDUM OPINION
`
`April 20, 2021
`Wilmington, Delaware
`
`
`
`Case 1:17-cv-00868-CFC-SRF Document 410 Filed 04/20/21 Page 2 of 15 PageID #: 22213
`
`OLME0NNOLLY
`UNITED STATES DISTRICT JUDGE
`
`Plaintiffs University of Massachusetts and Carmel Laboratories, LLC
`
`(collectively, UMass) have sued Defendant L'Oreal USA, Inc. for infringement of
`
`U.S. Patent Numbers 6,423,327 (the #327 patent) and 6,645,513 (the #513 patent).
`
`Pending before me is L'Oreal's Motion for Summary Jµdgment of Indefiniteness
`
`of the Skin Enhancement Claim Limitation (D.I. 278). L'Oreal argues that claims
`
`1, 3, 5, 6, 7, and 9 of the asserted patents are invalid for indefiniteness. D.I. 278
`
`at 1.
`
`I.
`
`BACKGROUND
`
`The asserted patents teach methods to treat skin using the organic compound
`
`adenosine. Each patent has a single independent claim-claim 1 in each patent.
`
`For purposes of the pending motion, the patents' independent claims and written
`
`descriptions are identical. In each patent, claim 1 recites:
`
`[a] method for enhancing the condition of unbroken skin
`of a mammal by reducing one or more of wrinkling,
`roughness, dryness, or laxity of the skin, without
`increasing dermal
`cell proliferation,
`the method
`comprising topically applying to the skin a composition
`comprising a concentration of adenosine in an amount
`effective to enhance the condition of the skin without
`increasing dermal cell proliferation, wherein
`the
`adenosine concentration applied to the dermal cells is [ a
`recited concentration range].
`
`
`
`Case 1:17-cv-00868-CFC-SRF Document 410 Filed 04/20/21 Page 3 of 15 PageID #: 22214
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`The two claim 1 s differ only with respect to the recited concentration range. In
`
`claim 1 of the #327 patent, the recited range of adenosine "applied to the dermal
`
`cells" is "10-4 M to 10-7 M." In claim 1 of the #513 patent, the recited range is
`
`"10-3 M to 10-7 M."
`
`In their jointly filed claim construction chaii, the parties identified the
`
`recited concentration range limitation (that is, "wherein the adenosine
`
`concentration applied to the dermal cells is [ within the recited ranges]") as the only
`
`claim term that required construction. D.I. 77 at 2. The parties outlined their
`
`respective positions with respect to the recited concentration range limitation in an
`
`82-page joint brief. UMass argued that the limitation should be given its plain and
`
`ordinary meaning. L'Oreal argued that the limitation should be construed to mean
`
`"wherein the adenosine concentration applied to the skin containing the dermal
`
`cells is [within the recited ranges]." D.I. 77 at 2.
`
`The parties' claim construction dispute turned on the meaning of "applied to
`
`the de1mal cells." L'Oreal argued that those words require the concentration of
`
`adenosine to be measured when the adenosine is topically applied to the surface
`
`(i.e., epidermal layer) of the skin. UMass argued that the concentration of
`
`adenosine is measured at the dermal cells underneath the surface of the skin when
`
`the adenosine is absorbed and reaches the dermal cells. I agreed with UMass and
`
`concluded that, based on the claim language and intrinsic evidence, the plain and
`
`2
`
`
`
`Case 1:17-cv-00868-CFC-SRF Document 410 Filed 04/20/21 Page 4 of 15 PageID #: 22215
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`ordinary meaning of the limitation required the concentration to be measured when
`
`the adenosine reached the dermal cells under the surface of the skin.
`
`II.
`
`LEGAL STANDARDS
`
`A.
`
`Indefiniteness
`
`Section 112(b) of the Patent Act requires that the claims of a patent
`
`"particularly point[] out and distinctly claim[] the subject matter which the
`
`inventor ... regards as the invention." 35 U.S.C. § l 12(b) (previously§ 112 ~ 2).
`
`To satisfy this requirement, a claim must be "sufficiently 'definite."' Allen Eng'g
`
`Cmp. v. Bartell Indus., Inc., 299 F.3d 1336, 1348 (Fed. Cir. 2002). "The primary
`
`purpose of the definiteness requirement is to ensure that the claims are written in
`
`such a way that they give notice to the public of the extent of the legal protection
`
`afforded by the patent, so that interested members of the public, e.g., competitors
`
`of the patent owner, can determine whether or not they infringe." Oakley, Inc. v.
`
`Sunglass Hut Int'!, 316 F.3d 1331, 1340 (Fed. Cir. 2003). "[A] patent is invalid for
`
`indefiniteness if its claims, read in light of the specification delineating the patent,
`
`and the prosecution history, fail to infonn, with reasonable certainty, those skilled
`
`in the art about the scope of the invention." Nautilus, Inc. v. Biosig Instruments,
`
`Inc., 572 U.S. 898, 901 (2014). "[A] patent does not satisfy the definiteness
`
`requirement of § 112 merely because 'a court can ascribe some meaning to a
`
`patent's claims."' Interval Licensing LLC v. AOL, Inc., 766 F.3d 1364, 1371 (Fed.
`
`3
`
`
`
`Case 1:17-cv-00868-CFC-SRF Document 410 Filed 04/20/21 Page 5 of 15 PageID #: 22216
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`Cir. 2014) (quoting Nautilus, 572 U.S. at 911). To comply with§ 112, a patent
`
`"must provide objective boundaries for those of skill in the art." Id. Thus, "[t]he
`
`scope of claim language cannot depend solely on the unrestrained, subjective
`
`opinion of a particular individual." Datamize, LLC v. Plumtree Software, Inc., 417
`
`F.3d 1342, 1350 (Fed. Cir. 2005), abrogated on other grounds by Nautilus, 572
`
`U.S. at 901.
`
`"Indefiniteness is a matter of claim construction, and the same principles
`
`that generally govern claim construction are applicable to determining whether
`
`allegedly indefinite claim language is subject to construction." Praxair, Inc. v.
`
`ATM], Inc., 543 F.3d 1306, 1319 (Fed. Cir. 2008), abrogated on other grounds by
`
`Nautilus, 572 U.S. at 901. Courts construe claims "as written, not as the patentees
`
`wish they had written [them]." Chef Am. Inc. v. Lamb-Weston, Inc., 358 F.3d
`
`1371, 1374 (Fed. Cir. 2004).
`
`B.
`
`Summary Judgment
`
`A court must grant summary judgment "if the movant shows that there is no
`
`genuine dispute as to any material fact and the movant is entitled to judgment as a
`
`matter of law." Fed. R. Civ. P. 56(a). Federal Circuit decisions, however, appear
`
`to confirm that I may grant summary judgment based on indefiniteness even when
`
`the parties present conflicting expert testimony about whether an artisan of
`
`ordinary skill would be able to understand disputed claim terms. See, e.g.,
`
`4
`
`
`
`Case 1:17-cv-00868-CFC-SRF Document 410 Filed 04/20/21 Page 6 of 15 PageID #: 22217
`
`Halliburton Energy Servs., Inc. v. M-I LLC, 514 F.3d 1244, 1249-50 (Fed. Cir.
`
`2008) (affirming grant of summary judgment of indefiniteness based on intrinsic
`
`evidence and noting in dictum that conflicting expert testimony does not preclude a
`
`finding of indefiniteness); Capital Sec. Sys., Inc. v. NCR Corp., 725 F. App'x 952,
`
`958-59 (Fed. Cir. 2018) (affirming district court's decision granting summary
`
`judgment of indefiniteness despite expert testimony that an artisan of ordinary skill
`
`would understand the disputed claim term with reasonable certainty); HIP, Inc. v.
`
`Hormel Foods Corp., 796 F. App'x 748 (Fed. Cir. 2020) (summarily affi1ming
`
`district court's decision granting summary judgment of indefiniteness despite
`
`expert testimony that an aiiisan of ordinary skill would understand the disputed
`
`claim term with reasonable ce1iainty).
`
`III. DISCUSSION
`
`L'Oreal argues that the patents' skin enhancement limitation-that is, the
`
`requirement that the composition applied to the skin contain "a concentration of
`
`adenosine in an amount effective to enhance the condition of the skin"-is
`
`indefinite and renders the patents invalid as a matter of law.
`
`The detennination of definiteness begins with "a construction of the claims
`
`according to the familiar canons of claim construction." Oakley, 316 F.3d at 1340.
`
`UMass argues that the skin enhancement limitation should be construed to mean
`
`the concentration ranges recited in the "wherein" clause of the asserted claims. See
`
`5
`
`
`
`Case 1:17-cv-00868-CFC-SRF Document 410 Filed 04/20/21 Page 7 of 15 PageID #: 22218
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`D.I. 315 at 3 (arguing that "'a concentration of adenosine in an amount effective to
`
`enhance the condition of skin' does not-as L' Oreal argues-refer to skin that is
`
`'in fact' enhanced, ... but 'refer[s] back to' the concentration, which is adenosine
`
`of 'ten to the negative 4M to ten to the negative 7M' for '327 claim 1" (alterations
`
`and emphasis in original) (citation omitted)); D.I. 315 at 4 (arguing that "[t]he
`
`concentration's 'effective' amount is plainly' 10-4 M to 10-7 M[]' in the [#]327
`
`[patent]"); D.I. 315 at 7 (arguing that "the language 'a concentration of adenosine
`
`in an amount effective to enhance the condition of the skin' means ... a
`
`concentration of the recited amount of adenosine"). According to UMass, I
`
`"ordered this construction months ago"-i.e., at the claim construction hearing.
`
`D.I.315at7.
`
`Truth be told, the parties did not dispute or present for my consideration at
`
`the claim construction hearing the skin enhancement limitation and I did not
`
`construe the term. UMass now seeks to collapse the skin enhancement limitation
`
`into the recited concentration range limitation. But the plain and unambiguous
`
`language of the asserted claims makes clear that the skin enhancement limitation is
`
`distinct from and independent of the recited concentration range limitation. The
`
`skin enhancement limitation requires that the concentration of the adenosine
`
`composition that is "topically appl[ied] to the skin" be "in an amount effective to
`
`enhance the condition of the skin." The recited concentration range limitation
`
`6
`
`
`
`Case 1:17-cv-00868-CFC-SRF Document 410 Filed 04/20/21 Page 8 of 15 PageID #: 22219
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`requires that the concentration of the adenosine that reaches and is "applied to the
`
`dermal cells" be in the recited ranges (i.e., 10-4 M to 10-7 M in the case of the #3 2 7
`
`patent and 10-3 M to 10-7 Min the case of #513 patent).
`
`UMass itself expressly noted the distinction between the two limitations in
`
`its claim construction briefing. In UMass's words:
`
`[T]he claim language twice refers to a "concentration" of
`adenosine and contrasts the different skin structures the
`concentration may be "applied" to: a "composition
`comprising a concentration of adenosine" is "topically
`applied to the skin," and "the adenosine concentration" is
`"applied to the dermal cells" in a specific numerical range.
`
`"In the patent claim context the term 'comprising' is well
`understood to mean 'including but not limited to."' CIAS,
`Inc. v. All. Gaming Corp., 504 F.3d 1356, 1360 (Fed. Cir.
`2007) ( discussing cases). Because the "composition"
`includes, but is not limited to, the recited adenosine
`concentration, it may also include other ingredients, such
`as more adenosine that is not ultimately "applied to the
`dermal cells." See Kasting Dec. ,I 17 (App'x A0251)
`( opining that only a portion of a topically applied
`composition "permeates to a particular layer within the
`skin"). The claims disclose a numerical range for only
`the adenosine that is "applied to the dermal cells," and
`not
`the amount of adenosine
`that
`is
`in
`the
`"composition" itself, except to say that the composition
`includes, but is not limited to, the amount of adenosine
`in the concentration that is "applied to the dermal
`cells." The claims are directed to what amount of
`adenosine will be applied to, and thus affect, the dermal
`cells.
`
`Had the inventors intended the "composition comprising a
`concentration of adenosine" to include the identical
`amount of adenosine as what is "applied to the dermal
`
`7
`
`
`
`Case 1:17-cv-00868-CFC-SRF Document 410 Filed 04/20/21 Page 9 of 15 PageID #: 22220
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`cells," they easily could have said so. They did not,
`instead carefully contrasting "the skin" and "the dermal
`cells," requiring the recited numerical concentration of
`adenosine to be "applied to the dermal cells." ...
`
`According to Defendant, because the claim language
`provides only one numerical range of adenosine (the
`"concentration"), but recites that the concentration will be
`"applied" to "the skin" (as part of the "composition") as
`well as "the dermal cells" (a layer of the skin), the claims
`equate the skin and the dermal cells. Defendant's
`argument defies logic. The claims disclose one numerical
`concentration of adenosine, which is "applied to the
`dermal cells." The composition applied "to the skin"
`need not be limited to only the recited adenosine
`concentration. Indeed, as Defendant recognizes, it often
`will not contain the same amount because not all
`adenosine will necessarily penetrate to the dermal layer.
`See Kasting Dec. ,r 17 (App'x A0251).
`Instead, the
`concentration applied "to the skin" includes the amount of
`adenosine that penetrates to the dermal cells, as well as
`other ingredients, such as more adenosine, that may not
`penetrate to the dermal cells. And the claim then specifies
`the range of the concentration "applied to the dermal
`cells."
`
`D.I. 97 at 57-59 (bold emphases added).
`
`UMass's claim construction briefing was spot on. The asserted claims do
`
`"carefully contrast[] 'the skin' and 'the dermal cells,'" and they do "require[ e] the
`
`recited numerical concentration of adenosine to be 'applied to the dermal cells,"'
`
`not the surface of the skin. UMass was right: The composition that is applied to
`
`the skin "need not be limited to only the recited adenosine concentration."
`
`8
`
`
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`Case 1:17-cv-00868-CFC-SRF Document 410 Filed 04/20/21 Page 10 of 15 PageID #: 22221
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`Precisely for that reason, the skin enhancement limitation does not mean "a
`
`concentration of the recited amount of adenosine."
`
`How, then, should the skin enhancement limitation be construed? (Although
`
`L'Oreal challenges UMass's proposed construction of the skin enhancement
`
`limitation, it does not offer an alternative construction.) The limitation requires
`
`that the composition applied to the skin have a concentration in an amount that is
`
`"effective to enhance the condition of the skin." Thus, the adenosine concentration
`
`applied to the skin must be in an amount sufficient to achieve the intended result of
`
`skin enhancement. Cf Abbott Lab 'ys v. Baxter Pharm. Prods., Inc., 334 F.3d
`
`1274, 1277 (Fed. Cir. 2003) (noting that "effective amount" has a customary usage
`
`meaning an "amount sufficient" for the intended result).
`
`The claims do not define what constitutes "enhance[ment] [ot] the condition
`
`of the skin"; nor do they describe how an artisan of ordinary skill is to ascertain
`
`whether a "topical[] appl[ication] to the skin [ ot] a composition comprising a
`
`concentration of adenosine" enhances the condition of the skin. There is a "heavy
`
`presumption that a claim term carries its ordinary and customary meaning," CCS
`
`Fitness, Inc. v. Brunswick Corp., 288 F.3d 1359, 1366 (Fed. Cir. 2002), and neither
`
`side suggests that an artisan of ordinary skill would have a different understanding
`
`of "enhancing the condition of the skin" than a lay person would. When "the
`
`ordinary meaning of claim language as understood by a person of skill in the art
`
`9
`
`
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`Case 1:17-cv-00868-CFC-SRF Document 410 Filed 04/20/21 Page 11 of 15 PageID #: 22222
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`may be readily apparent even to lay judges, ... claim construction ... involves
`
`little more than the application of the widely accepted meaning of commonly
`
`understood words." Phillips v. AWH Corp., 415 F.3d 1303, 1314 (Fed. Cir. 2005)
`
`(en bane). The commonly accepted meaning of the phrase "enhancing the
`
`condition of the skin"-i.e., improving or making better the quality or desirability
`
`of the skin-is clearly indefinite. Indeed, the determination of whether a person's
`
`skin is enhanced provides a paradigmatic example of indefiniteness. Beauty, after
`
`all, is "in the eyes of the beholder." The assessment of whether a person's skin has
`
`been improved is "purely subjective" and "depends on the unpredictable vagaries
`
`of any one person's opinion." Intellectual Ventures, 902 F.3d at 1381 (internal
`
`quotation marks, alterations, and citations omitted).
`
`There is, however, a good argument to be made that the skin enhancement
`
`limitation should not be given its plain and ordinary meaning but instead the
`
`definition provided in the patents' shared written descriptions. When the written
`
`description "reveal[ s] a special definition given to a claim term by the patentee that
`
`differs from the meaning [the term] would otherwise possess," "the inventor's
`
`lexicography governs." Phillips, 415 F.3d at 1316. In this case, the patents'
`
`written descriptions define "enhancement of skin condition" to mean "a noticeable
`
`10
`
`
`
`Case 1:17-cv-00868-CFC-SRF Document 410 Filed 04/20/21 Page 12 of 15 PageID #: 22223
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`decrease in the amount of wrinkling, roughness, dryness, laxity, sallowness, or
`
`pigmentary mottling in skin." #327 patent at 2:35-3 7, see also id. at 5 :44-48. 1
`
`The claims do not define or suggest what constitutes a "noticeable decrease"
`
`in "one or more of wrinkling, roughness, dryness, or laxity of the skin sallowness,
`
`or pigmentary mottling in skin." Nor do they describe how an artisan of ordinary
`
`skill would ascertain whether an application of the adenosine resulted in such a
`
`noticeable decrease. But here again, the written descriptions are informative.
`
`They provide that
`
`[m]ethods of measuring improvements in skin condition
`are well known in the art (see, e.g., Olsen et al., J. Amer.
`Acad. Dermatol. 26:215-24, 1992), and can include
`subjective evaluations by the patient or a second pmiy,
`e.g., a treating physician.
`
`#327 patent at 5 :48-52. Thus, the written descriptions expressly confirm that the
`
`determination of whether the skin enhancement condition is satisfied can be made
`
`by purely subjective evaluations of one or more persons. 2 Accordingly, even if I
`
`1 Because the written descriptions of the patents are identical in all material
`respects, I will follow the parties' lead and provide written description citations
`only for the #327 patent.
`
`2 I have also considered the patents' prosecution histories and specifically those
`pmiions of the histories cited by UMass at pages 5 and 6 of its brief in opposition
`to L'Oreal's motion. The prosecution histories neither clarify the scope of the skin
`enhancement limitation nor contradict the written descriptions' express
`confirmation that determining whether the skin enhancement condition is satisfied
`can be made by purely subjective evaluations. But even if they had, the written
`descriptions' express confirmation would neve1iheless control. See Phillips v.
`
`11
`
`
`
`Case 1:17-cv-00868-CFC-SRF Document 410 Filed 04/20/21 Page 13 of 15 PageID #: 22224
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`were to construe the skin enhancement limitation as the term is defined in the
`
`written descriptions, the asserted claims would be indefinite.
`
`UMass has effectively conceded that the skin enhancement condition is
`
`purely subjective. Its corporate designee, Dr. James Dobson, who is a named
`
`inventor of the asserted patents, testified at his deposition that a subjective
`
`assessment may be used to determine whether the adenosine has enhanced the
`
`condition of the skin within the meaning of the claims:
`
`Q.
`The fact that you used adenosine on your own skin
`and observed that there was a decrease in elasticity and a
`diminution of fine lines and wrinkles, would that have
`satisfied the patent claims in the [#]327 and [#]513 patent?
`
`A.
`
`Assuming so, yes.
`
`Q.
`Okay. And the point being is that a subject[ive]
`assessment of a diminution of fine lines and wrinkles or
`decrease in elasticity does satisfy or qualify as enhancing
`the condition of the skin, as you've defined it in the patent;
`correct? ...
`
`A.
`
`Yes.
`
`D.I. 286-1, Ex. 17 at 135:4-18. Perhaps because of this explicit testimony,
`
`UMass's expert, Dr. Bozena Michniak-Kohn, did not dispute in her expe1i rep01is
`
`AWH Corp., 415 F.3d 1303, 1317 (Fed. Cir. 2005) (en bane) (noting that "because
`the prosecution history represents an ongoing negotiation between the [Patent &
`Trademark Office] and the applicant, rather than the final product of that
`negotiation, it often lacks the clarity of the specification and thus is less useful for
`claim construction purposes").
`
`12
`
`
`
`Case 1:17-cv-00868-CFC-SRF Document 410 Filed 04/20/21 Page 14 of 15 PageID #: 22225
`
`that a subjective assessment may be used to determine whether the condition of the
`
`skin has been enhanced as required by the asserted claims.3
`
`In sum, whether I give the skin enhancement limitation its plain and ordinary
`
`meaning or the definition set forth in the asserted patents' written descriptions, the
`
`term is indefinite. See Vivid Techs., Inc. v. Am. Science & Eng'g, Inc., 200 F.3d
`
`795, 803, (Fed. Cir. 1999) ("[O]nly those terms need be const1ued that are in
`
`controversy, and only to the extent necessary to resolve the controversy."
`
`(emphasis added)). Artisans of ordinary skill seeking to avoid infringement of the
`
`asserted claims would have to guess about the opinions held by doctors, patients,
`
`and undefined others with respect to the qualities and desirability of skin
`
`conditions. The claims thus lack the requisite objective boundaries required by
`
`§ 112. See Datamize, 417 F.3d 1342, 1352-53 (Fed. Cir. 2005) ("Simply put, the
`
`definition of 'aesthetically pleasing' cannot depend on an undefined
`
`standard .... [Nor can it] depend on the defined views of unnamed persons, even
`
`if they are experts, specialists, or academics.").
`
`3 In its responsive concise statement of facts submitted in support of its opposition
`to L'Oreal's motion, UMass disputed L'Oreal's statement that Dr. Michniak-Kohn
`"has not disputed that a subjective assessment may be used to determine whether
`the condition of the skin has been enhanced." D.I. 319 at 3. UMass cited
`paragraph of 186 of Dr. Michniak-Kohn's rebuttal report in support of its position.
`Paragraph 186, however, says nothing about subjective evaluations.
`
`13
`
`
`
`Case 1:17-cv-00868-CFC-SRF Document 410 Filed 04/20/21 Page 15 of 15 PageID #: 22226
`
`IV. CONCLUSION
`
`For the reasons discussed above, the skin enhancement limitation, when
`
`viewed in light of the specifications and prosecution histories, fails to "inform
`
`those skilled in the art about the scope of the invention with reasonable certainty."
`
`Nautilus, 572 U.S. at 910. The independent claims of the asserted patents are
`
`therefore invalid for indefiniteness. As UMass did not argue that the patents'
`
`dependent claims provide clarity regarding the scope of the skin enhancement
`
`limitation that is lacking in the independent claims, those dependent claims are also
`
`invalid for indefiniteness.
`
`The Court will issue an Order consistent with this Memorandum Opinion.
`
`14
`
`