The Procter & Gamble CompanyDownload PDFPatent Trials and Appeals BoardJul 29, 20202020000039 (P.T.A.B. Jul. 29, 2020) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O. Box 1450 Alexandria, Virginia 22313-1450 www.uspto.gov APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 15/206,623 07/11/2016 Cheri Lynn SWANSON 11241RD 2201 27752 7590 07/29/2020 THE PROCTER & GAMBLE COMPANY GLOBAL IP SERVICES CENTRAL BUILDING, C9 ONE PROCTER AND GAMBLE PLAZA CINCINNATI, OH 45202 EXAMINER WHEELER, THURMAN MICHAEL ART UNIT PAPER NUMBER 1619 NOTIFICATION DATE DELIVERY MODE 07/29/2020 ELECTRONIC Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address(es): centraldocket.im@pg.com mayer.jk@pg.com pair_pg@firsttofile.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte CHERI LYNN SWANSON, TOMOHIRO HAKOZAKI, and LEO TIMOTHY LAUGHLIN II __________ Appeal 2020-000039 Application 15/206,623 Technology Center 1600 __________ Before ERIC B. GRIMES, LINDA M. GAUDETTE, and FRANCISCO C. PRATS, Administrative Patent Judges. PRATS, Administrative Patent Judge. DECISION ON APPEAL Pursuant to 35 U.S.C. § 134(a), Appellant 0F1 appeals from the Examiner’s decision to reject claims 1, 3–6, 8–11, and 13–18. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies the real party in interest as The Procter & Gamble Company of Cincinnati, Ohio. Appeal Br. 1. Appeal 2020-000039 Application 15/206,623 2 STATEMENT OF THE CASE The sole rejection before us for review is the Examiner’s rejection of claims 1, 7, and 20 under 35 U.S.C. § 103(a) as being unpatentable over Millikin1F2 and Baldo.2F3 Final Act. 2–8. 3F4 Appellant’s claim 1 is representative and reads as follows: 1. A method of boosting the ability of a vitamin B3 compound and an N-acyl amino acid compound to inhibit PAR2 activation of keratinocytes, comprising: a. identifying a target portion of skin comprising one or more keratinocytes exhibiting a hyperpigmentation condition; and b. applying a cosmetic composition to the target portion of skin, wherein the cosmetic composition contains about 0.5% to about 10% by weight of the composition of niacinamide, about 0.02% to about 2.5% by weight of the composition of N- undecylenoyl-L-phenylalanine, and about 0.00006% to about 0.25% by weight of the composition of a Laminaria Saccharina extract to the target portion of skin during a treatment period, and the amount of Laminaria Saccharina extract is sufficient to boost the ability of the vitamin B3 compound and N-acyl amino acid compound to inhibit PAR2 activation of keratinocytes by at least 10% relative 2 US 2008/0069784 A1 (published Mar. 20, 2008). 3 US 2008/0119527 A1 (published May 22, 2008). 4 Final Action entered September 10, 2018. The rejection in the Final Action was directed to claims 1–4, 7, and 20. See Final Act. 2–8. After the Final Action, Appellant filed an amendment, which the Examiner entered, leaving only claims 1, 7, and 20 pending. See Amendment After Final Office Action (filed December 13, 2018); see also Advisory Action entered January 23, 2019 (entering Amendment After Final Office Action). Appeal 2020-000039 Application 15/206,623 3 to the same composition without the Laminaria Saccharina extract, and wherein a ratio of Laminaria Saccharina extract to N- acyl amino acid compound is between 1:100 and 1:20. Appeal Br. 7 (some indentation added). DISCUSSION The Examiner’s Prima Facie Case In rejecting Appellant’s representative claim 1, the Examiner cited Millikin as disclosing a process of treating hyperpigmentation by applying to the skin a composition containing two of the three ingredients recited in claim 1—niacinamide (vitamin B3) and N-undecylenoyl-L-phenylalanine— the composition containing those ingredients at concentration ranges overlapping the concentration ranges recited in claim 1. Final Act. 3–4. The Examiner conceded that Millikin differs from representative claim 1 in that Millikin does not disclose an extract of Laminaria saccharina as an ingredient in its administered composition. Final Act. 4. The Examiner cited Baldo as evidence that extracts of Laminaria saccharina, at concentration ranges encompassing the range recited in Appellant’s claim 1, were known in the art to be useful in compositions for treating acne-associated excessive pigmentation, as well for as treating oily skin. Final Act. 4–5, 7–8. Based on the references’ combined teachings, the Examiner concluded that it would have been obvious to include an extract of Laminaria saccharina in Millikin’s compositions: One skilled in the art would have recognized the benefit of including luminaria saccharina in the composition because the composition could then be used to also treat darkening of Appeal 2020-000039 Application 15/206,623 4 the skin caused by acne. Moreover, by adding laminaria saccharina to the composition as taught by Millik[i]n the composition could further be used to treat greasy skin. The inhibiting of PAR2 activation of keratinocytes [recited in claim 1] would be an intrinsic property provided by the composition comprising vitamin B3, a N-acyl amino acid compound and laminaria saccharina as [] taught by Millik[i]n and Baldo, as a whole. Final Act. 5–6. Analysis As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992): [T]he examiner bears the initial burden . . . of presenting a prima facie case of unpatentability. . . . After evidence or argument is submitted by the applicant in response, patentability is determined on the totality of the record, by a preponderance of evidence with due consideration to persuasiveness of argument. Having carefully considered all of the arguments and evidence advanced by Appellant and the Examiner, Appellant does not persuade us that a preponderance of the evidence fails to support the Examiner’s conclusion that the process of Appellant’s representative claim 1 would have been obvious in view of Millikin and Baldo. As recited in claim 1, Millikin describes processes of treating skin hyperpigmentation by applying to the skin a composition that contains a primary ingredient and “at least one additional skin and/or hair care active selected from . . . vitamin B3, . . . N-acyl amino acid compounds, . . . and/or combinations thereof . . . .” Millikin ¶ 5. As recited in Appellant’s claim 1, Millikin discloses that niacinamide is a preferred vitamin B3 compound. Millikin ¶ 80. Appeal 2020-000039 Application 15/206,623 5 Millikin discloses that a “preferred N-acyl Amino Acid is N- undecylenoyl-L-phenylalanine,” the phenylalanine derivative recited in representative claim 1. Millikin ¶ 90. Millikin discloses that “N- undecylenoyl-L-phenylalanine is commercially available under the tradename Sepiwhite® from SEPPIC.” Id. Millikin discloses that the additional skin care ingredients, which include the niacinamide and N-undecylenoyl-L-phenylalanine recited in Appellant’s representative claim 1, can be present in the hyperpigmentation- treating compositions at concentrations “preferably . . . from about 0.0001% to about 50%, more preferably from about 0.001% to about 20%, even more preferably from about 0.01% to about 10%, by weight of the composition.” Millikin ¶ 72. Each of Millikin’s ranges of preferred concentrations of its additional active ingredients, including 0.01–10% by weight, entirely encompassesthe range recited in representative claim 1 for both niacinamide (0.5% to about 10% (Appeal Br. 7)) and N-undecylenoyl-L-phenylalanine (0.02% to about 2.5% (id.)). Millikin thus describes treating hyperpigmentation with a composition that contains two of the three ingredients recited in Appellant’s representative claim 1, at concentration ranges that include the ranges recited in claim 1. While Millikin does not disclose including the Laminaria saccharina extract of Appellant’s representative claim 1 in its compositions, Millikin discloses that it is useful to include ingredients for treating oily skin, resulting from excessive sebum secretion, in its compositions. See Millikin ¶¶ 20, 60. Appeal 2020-000039 Application 15/206,623 6 As the Examiner found, Baldo discloses compositions for application to the skin to address sebum-related oiliness and hyperpigmentation: The present invention relates to a cosmetic composition for correcting or preventing disorders associated with greasiness of a dark skin, especially by the action of reducing the secretion of sebum while at the same time imparting depigmenting properties . . . . [T]his process makes it possible to combat both hyperseborrhoea and localized hyperpigmentation that may occur at the site of cicatrization of acne lesions on dark skin. Baldo ¶ 2; see also id. ¶ 4 (“Greasy skin is hyperseborrhoeic and characterized by an exaggerated secretion and excretion of sebum.”). Baldo discloses that “[p]referred anti-seborrhoeic active agents . . . include . . . extracts of the alga Laminaria saccharina, such as the product sold under the name Phlorogine® by the company Biotechmarine.” Baldo ¶¶ 82–86. Baldo discloses that useful concentrations of its anti-seborrhoeic agents are “from 0.1% to 10% by weight, preferably from 0.1% to 5% by weight and preferentially from 0.5% to 3% by weight relative to the total weight of the composition.” Baldo ¶ 102. Baldo’s broadest range of concentrations of its anti-seborrhoeic agents, from about 0.1% to 10% by weight, overlaps the range recited in representative claim 1 for the Laminaria saccharina extract (0.00006% to about 0.25% (Appeal Br. 7)). Thus, given Baldo’s teaching that Laminaria saccharina extracts were useful as anti-seborrhoeic agents in skin-applied hyperpigmentation-treating compositions, we agree with the Examiner that a skilled artisan had a good reason for, and a reasonable expectation of success in, including Laminaria saccharina extracts in Millikin’s skin-applied hyperpigmentation-treating Appeal 2020-000039 Application 15/206,623 7 compositions. In particular, given Millikin’s teaching that it was useful to include ingredients for treating oily skin resulting from excessive sebum secretion in its compositions, and given Baldo’s teaching that Laminaria saccharina extracts were useful for that purpose, we agree with the Examiner that a skilled artisan would have considered it obvious to include Laminaria saccharina extracts in Millikin’s compositions. Moreover, because the useful concentration ranges taught in Millikin and Baldo for niacinamide, N-undecylenoyl-L-phenylalanine, and Laminaria saccharina extracts encompass or overlap the ranges recited in Appellant’s representative claim 1, we also agree with the Examiner that the concentrations of those ingredients recited in claim 1 would have been prima facie obvious. See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003) (“In cases involving overlapping ranges, we and our predecessor court have consistently held that even a slight overlap in range establishes a prima facie case of obviousness.”). We acknowledge, as Appellant contends, that representative claim 1 recites a specific range of ratios of amounts (1:100 to 1:20) of the Laminaria saccharina extract and the N-undecylenoyl-L-phenylalanine. See Appeal. Br. 7. Appellant does not persuade us, however, that it would have been unobvious to include amounts of Laminaria saccharina extract and N- undecylenoyl-L-phenylalanine, encompassed by the range of ratios recited in claim 1, in the hyperpigmentation-treating compositions suggested by Millikin and Baldo. See Appeal Br. 3–4; Reply Br. 1–2. Specifically, as discussed above, Baldo discloses that useful concentrations of Laminaria saccharina extracts range from 0.1% to 10% by weight of the skin-applied compositions (Baldo ¶ 102), and Millikin Appeal 2020-000039 Application 15/206,623 8 discloses that preferred concentrations of N-undecylenoyl-L-phenylalanine range from about 0.01–10% by weight of the compositions (Millikin ¶ 72). Thus, viewed in combination, Baldo and Millikin teach that useful amounts of Laminaria saccharina extract and N-undecylenoyl-L-phenylalanine include relative proportions that are encompassed by the range of ratios recited in representative claim 1. Appellant does not persuade us, therefore, that Baldo and Millikin fail to suggest a composition in which the combined amounts of Laminaria saccharina extract and N-undecylenoyl-L- phenylalanine are encompassed by claim 1’s ratio. Appellant also does not persuade us that the Examiner erred in determining that the concentration of Laminaria saccharina extract taught in Baldo would inherently boost the inhibition of PAR2 activation of keratinocytes by at least 10%, as recited in Appellant’s representative claim 1. See Appeal Br. 4–5; Reply Br. 2–3; see also Appeal Br. 7 (claim 1 reciting that “the amount of Laminaria Saccharina extract is sufficient to boost the ability of the vitamin B3 compound and N-acyl amino acid compound to inhibit PAR2 activation of keratinocytes by at least 10% relative to the same composition without the Laminaria Saccharina extract”). Inherency is appropriate in an obviousness analysis “when the limitation at issue is the ‘natural result’ of the combination of prior art elements.” PAR Pharm., Inc. v. TWI Pharms., Inc., 773 F.3d 1186, 1195 (Fed. Cir. 2014) (quoting In re Oelrich, 666 F.2d 578, 581 (CCPA 1981)). In the present case, while representative claim 1 requires the claimed composition to contain a Laminaria saccharina extract in an amount that boosts the inhibition of PAR2 activation by the other ingredients by 10%, Appeal 2020-000039 Application 15/206,623 9 claim 1 also recites that the composition must contain about 0.00006% to about 0.25% by weight of the Laminaria saccharina extract. Appeal Br. 7. Although Appellant’s Specification does not state expressly what absolute amounts of the Laminaria saccharina extract boost the PAR2 inhibitory effect, Appellant’s Specification discloses that the Laminaria saccharina extract is useful in the inventive compositions at a wide range of concentrations, consistent with the concentration range recited in representative claim 1. See Spec. 6 (“The composition of the present invention therefore may contain a Laminaria Saccharina extract in an amount from about 0.00001% to about 1.25%, in one embodiment from about 0.00006% to about 0.5%, in another embodiment from about 0.002% to about 0.25%, by weight of the composition.”). Because the concentration of Laminaria saccharina extract taught in Baldo as being useful in hyperpigmentation-treating compositions significantly overlaps the concentrations of the extract recited both in representative claim 1 and in Appellant’s Specification, we find that the Examiner had a reasonable basis for determining that Baldo suggests using an amount of Laminaria saccharina that naturally results in the claimed 10% boost in PAR2 inhibitory effect recited in Appellant’s representative claim 1. Appellant does not persuade us, therefore, that the Examiner erred in finding that the amount of Laminaria saccharina extract taught by Baldo inherently meets the functionally defined amount of that ingredient recited in claim 1. Appellant also does not persuade us that it has advanced evidence of unexpected results sufficient to outweigh the prior art evidence of obviousness presented by the Examiner. See Appeal Br. 5 (citing Spec. 19); Reply Br. 2. In particular, we agree with the Examiner’s determination that Appeal 2020-000039 Application 15/206,623 10 Appellant’s evidence of unexpected results is not commensurate in scope with the subject matter encompassed by representative claim 1. See Final Act. 11–12. The Specification describes a comparison of different combinations of niacinamide, N-undecylenoyl-L-phenylalanine (“Sepiwhite”), and an extract of Laminaria saccharina (“Phlorigine”), in relation to the capacity to inhibit PAR2 activation in cells. See Spec. 17–19. The Specification describes the ingredients in the compared compositions as follows: Stock compositions of 1% Phlorogine (i.e., composition comprises approximately 0.025% - 0.01 % Laminaria Saccharina extract), 1% Sepiwhite, 5% niacinamide, and combinations thereof are prepared and diluted prior to use. Test runs are performed at dilution factors of 0.045, 0.023, and 0.006. For clarity purposes, the 1% Sepiwhite composition diluted at a factor of 0.045 yields a test compositing [sic, composition?] comprising 0.045% Sepiwhite. Spec. 18. The results of the comparison are presented in the following table (see Spec. 18–19): The Specification explains that a “value of 100% represents inhibition of PAR2 activation equivalent to the control where no trypsin initiator is present.” Spec. 18. Based on the results shown above, the Specification states as follows: Appeal 2020-000039 Application 15/206,623 11 The test compositions comprising Phlorogine alone show little to no inhibitory effect. Sepiwhite and niacinamide individually demonstrate an inhibitory effect which is pronounced at higher dilutions. Sepiwhite and niacinamide together demonstrate a prominent inhibitory effect especially at higher dilutions. The combination of Sepiwhite, niacinamide, and Phlorogine demonstrate an even greater inhibitory effect than the combination of Sepiwhite and niacinamide. This result[] is unexpected given that Phlorogine alone provides little to no inhibitory effect. Spec. 19 (emphasis added). While we acknowledge the Specification’s assertion regarding the unexpectedness of the results shown in the table spanning pages 18 and 19 of the Specification, Appellant’s representative claim 1 encompasses concentrations of each of the claimed ingredients significantly higher than the highest dilution factor of 0.045 for which data are presented. See Appeal Br. 7 (representative claim 1 recites about 0.5% to about 10% by weight of the composition of niacinamide, about 0.02% to about 2.5% by weight of the composition of N-undecylenoyl-L-phenylalanine, and about 0.00006% to about 0.25% by weight of the composition of a Laminaria saccharina extract). We note, moreover, that as the concentrations of the ingredients in the compared compositions increases, the boosting effect of the Phlorigine decreases. See Spec. 18–19. Because the data supporting the Specification’s assertion of unexpectedness is limited to compositions containing relatively low concentrations of ingredients (substantially less than 1%), whereas Appellant’s representative claim 1 encompasses ingredient concentrations significantly higher than the concentrations upon which the assertions of unexpectedness are based, we agree with the Examiner that the evidence of Appeal 2020-000039 Application 15/206,623 12 unexpectedness advanced by Appellant is not commensurate in scope with the subject matter recited in claim 1. In that regard we note, moreover, that claim 1 encompasses the use of any extract of Laminaria saccharina, whereas the assertion of unexpected results is based only on the Phlorigine product. Because claim 1 encompasses the use of Laminaria saccharina extracts for which no unexpected potentiation effect has been shown, such as the HG 657 product from Ennagram, France (see Spec. 5), we find that the evidence of unexpected results advanced by Appellant is not commensurate in scope with claim 1 on this basis also. In sum, for the reasons discussed, Appellant does not persuade us that the Examiner erred in determining that Millikin and Baldo would have suggested performing a process having all of steps and features recited in Appellant’s representative claim 1. For the reasons discussed, Appellant also does not persuade us that it has advanced evidence of unexpected results sufficient to outweigh the prior art evidence of obviousness presented by the Examiner in relation to claim 1. Because the preponderance of the evidence therefore supports the Examiner’s conclusion of obviousness as to claim 1, we affirm the Examiner’s rejection of claim 1 over Millikin and Baldo. Claims 7 and 20 fall with claim 1. See 37 C.F.R. 41.37(c)(1)(iv). Appeal 2020-000039 Application 15/206,623 13 CONCLUSION In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1, 7, 20 103(a) Millikin, Baldo 1, 7, 20 TIME PERIOD FOR RESPONSE No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R. § 1.136(a)(1)(iv). AFFIRMED Copy with citationCopy as parenthetical citation