13969736 (P.T.A.B. May. 31, 2018)

Ex Parte Jenkins et al

Patent Trial and Appeal BoardMay 31, 2018

13969736 (P.T.A.B. May. 31, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE FIRST NAMED INVENTOR 13/969,736 08/19/2013 Gail Jenkins 201 7590 06/04/2018 UNILEVER PATENT GROUP 700 SYLVAN AVENUE A4 ENGLEWOOD CLIFFS, NJ 07632-3100 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 ATTORNEY DOCKET NO. CONFIRMATION NO. J9242US1 5715 EXAMINER MILLER, DALE R ART UNIT PAPER NUMBER 1673 NOTIFICATION DATE DELIVERY MODE 06/04/2018 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): patentgroupus@unilever.com pair_unilever@firsttofile.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte GAIL JENKINS, JOHN CASEY, and JULIA SARAH ROGERS Appeal2017-008383 1 Application 13/969, 73 62 Technology Center 1600 Before TONI R. SCHEINER, JAMES A. WORTH, and JOHN E. SCHNEIDER, Administrative Patent Judges. WORTH, Administrative Patent Judge. DECISION ON APPEAL Appellants appeal under 35 U.S.C. Â§ 134(a) from the Examiner's Final Rejection of claims 1-15. We have jurisdiction under 35 U.S.C. Â§Â§ 134 and 6(b ). We affirm. 1 Our Decision refers to Appellants' Appeal Brief ("Br.," filed Apr. 22, 2016), and the Examiner's Final Office Action ("Final Act.," mailed Nov. 25, 2015) and Answer ("Ans.," mailed Nov. 1, 2016). 2 According to Appellants, the real party in interest is "Conopco, Inc., d/b/a UNILEVER, a corporation of the State ofNew York. Conopco, Inc. is owned by Unilever United States, Inc., which is a member of the group of companies, which includes parents Unilever, N.V and Unilever PLC." Br. 3. Appeal2017-008383 Application 13/969,736 STATEMENT OF THE CASE Background Appellants' application relates "to a composition suitable for oral consumption and a method for improving skin characteristics with such composition." Spec. 1 :2-3. According to the Specification, "[ w ]hile topical creams and lotions are popular, such topical products have limitations and deal primarily with dead surface (external) layers of the skin." Id. at 1:13-14. "It is known that certain ingredients can provide improvements in skin appearance and texture subsequent to being ingested" and can act from the interior of the skin. Id. at 1:15-18. The Specification discloses in particular (a) a carotenoid, (b) a PP AR ligand, ( c) an oestrogen receptor binding agent, ( d) an agent involved in post translational modification of collagen, and ( e) an antioxidant. Id. at 3:8-12. The Representative Claim Claim 1, the sole independent claim on appeal, is reproduced below and is representative of the subject matter on appeal: 1. A composition comprising: a) a carotenoid comprising beta-carotene, lycopene or a mixture thereof; b) a PP AR ligand comprising omega-3 fatty acids from DHA, EPA or both; c) an oestrogen receptor binding agent comprising genistein where from about 8 to about 125 mg of genistein is delivered in about a daily dose of the composition; d) an agent involved in post translational modification of collagen comprising Vitamin C; and e) an antioxidant comprising Vitamin E 2 Appeal2017-008383 Application 13/969,736 wherein the agent involved in post translational modification of collagen and antioxidant are present at a daily dosage amount (x) that is from about 0.02 to about 23 times a daily dosage amount (y) that is the daily dosage amount of carotenoid, PP AR ligand and oestrogen receptor binding agent in the composition further wherein the antioxidant daily dosage amount/ carotenoid daily dosage amount within the composition is from about 0.008 to about 300, the composition being one capable of delivering from about 45 to about 2000 mg PP AR ligand, from about 0.5 to about 120 mg carotenoid, from about 45 to about 1100 mg of an agent involved in post translational modification of collagen and from about 0.85 to about 310 mg antioxidant in about a daily dosage, and further wherein the composition is a capsule or tablet for oral consumption. Br., Claims App. The Issues A. The Examiner rejected claims 1-13 under 35 U.S.C. Â§ I03(a) as being unpatentable over Goralczyk3â€¢ B. The Examiner rejected claim 14 under 35 U.S.C. Â§ I03(a) as being unpatentable over Goralczyk and Patel 4â€¢ C. The Examiner rejected claim 15 under 35 U.S.C. Â§ I03(a) as being unpatentable over Goralczyk and Capella 5. 3 Goralczyk, US 2010/0080762 Al, pub. Apr. 1, 2010. 4 Sarsvatkumar Patel et al., Compression Physics in the Formulation Development of Tablets, 23(1) CRITICAL REVIEWSâ„¢ IN THERAPEUTIC DRUG CARRIER SYSTEMS 1---65 (2006) (hereinafter, "Patel"). 5 Capella Enterprises, Capsules - overview (Feb. 5, 2012) (retrieved Nov. 18, 2015) (http://web.archive.org/web/20150205152624/http://capella- enterprises.com/Capsules) (hereinafter, "Capella"). 3 Appeal2017-008383 Application 13/969,736 A. 35 USCÂ§ 103(a) rejection over Goralczyk Claims 1-13 The Examiner finds that paragraph 225 of Goralczyk discloses an example of a capsule containing the following ingredients and amounts: !ii.'d!,tlcâ€¢ Vit::i.emro C: l{i~_l {llg l'<'..l wg ,~(i~) {Ug 1 tJn UJ_g fpri..-:-vi.d.C'.~ 6 ff~g J:i(-Â·,,lyp~~i:T!C:-fo ~u-:~i Z..S n:g faych\.i;i,;yry-:t\;.."tdf 3,){i Âµg ?{1 n\s; \.=:fi>:) mg A LL-Q cKÂ· 1\1% l ... ~\.:-i:.hJ:11 &:s ~n~x(:d. s{:,::..:L~~:-a(1 4fl {rtg phlA:r,i~la~~,i~'i;: Final Act. 5 (citing Goralczyk ,r 225). Tocopherol acetate is Vitamin E. Goralczyk ,r 165. ROPUFAÂ® 75 n-3 '75'EE is an ethyl ester containing a minimum of 72% n-3 fatty acid ethyl ester. Goralczyk ,r,r 21, 224. With respect to fatty acids, Goralczyk describes that polyunsaturated fatty acids of the n-3 series are preferred, e.g., eicosapenta-5,8,11,14,17- enoic acid (EPA) and docosahexa-4,7,10,13,16,19-enoic acid (DHA), and arachidonic acid (ARA), as well as ethyl ester derivatives of polyunsaturated ethyl esters. See Goralczyk ,r,r 17-18. The Examiner finds that TEA VIGO is a green tea extract containing 94% EGCG, which is (-)-Epigallocatechin gallate. Final Act. 5 (citing Goralczyk ,r,r 48, 76, 128); see Goralczyk ,r 35. The Examiner concludes that one of ordinary skill in the art would have been motivated to substitute genistein (another polyphenol) for EGCG, or add genistein in addition to EGCG, in order to improve skin barrier function, as taught by Goralczyk. See Final Act. 5, 7 (citing Goralczyk ,r,r 48, 76, 128); Ans. 8-9. Indeed, 4 Appeal2017-008383 Application 13/969,736 Goralczyk discloses that biotin, vitamin E, and genistein support skin barrier function. Goralczyk ,r,r 47--48. The Examiner correctly finds that paragraph 154 of Goralczyk discloses that kits are presented to users, or potential users, with information on benefits and information on preferred daily dosage. Final Act. 6. The Examiner correctly finds that paragraphs 91-108 of Goralczyk disclose the following preferred daily dosages: 1) PUPA- 50 mg to 8g; 2) Genistein - 20 mg to 60 mg; 3) Beta-carotene - 1 mg to 30 mg; 4) Vitamin E - 10 mg to 2 g; and 5) Vitamin C - 50 mg to 5 g Id. The Examiner's findings are supported by the evidence. Goralczyk discloses as follows: [0091] According to the present invention it is advantageous to administer the active ingredients in a way that their effective daily amounts ("daily dosages") are in the ranges given below. It is thereby irrelevant if the daily dosage is applied all at once (by a single dosage) or in multiple dosages. [0092] PUFA(s), in particular n-3 polyunsaturated fatty acids and/or its derivatives (especially triglycerides): daily dosage for humans (70 kg person): from 50 mg to 8 g, preferred daily dosage for humans (70 kg person) from 300 mg to 2000 mg. [0094] Genistein: is daily dosage for humans (70 kg person): 1 to 150 mg, preferred daily dosage for humans (70 kg person) 20 to 60 mg, more preferred from 20 to 40 mg. [0097] B-Carotene: daily dosage for humans (70 kg person): 0.1 to 50 mg, preferred daily dosage for humans (70 kg person): 1 and 30 mg, more preferred daily dosage for humans (70 kg person): 2 to 7 mg. 5 Appeal2017-008383 Application 13/969,736 [0102] Vitamin E: For humans (70 kg person) the daily dosage preferably may vary for vitamin E between 10 mg and 2 g, more preferably between 15 and 500 mg. [0103] Vitamin C: For humans (70 kg person) the daily dosage preferably may vary for vitamin C between 50 mg and 5 g, more preferably between 200 mg and 1.5 g. Goralczyk ,r,r 91-92, 94, 97, 102---03. The Examiner determines that the instant claims are prima facie obvious over the teachings of the prior art, reasoning that where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. Final Act. 8-9 ( quoting In re Wertheim, 541 F.2d257, 267 (CCPA 1976); citing In re Woodruff, 919 F.2d 1575 (Fed. Cir. 1990)). Appellants argue that "genistein is a phytoestrogen and while EGCG is reported to be suitable to bind to estrogen receptors, it is also reported as not estrogenic in vivo. Therefore, the two are not obvious substitutes for each other. Appellants have specifically defined in the claims specific genistein amounts whereby the same are not, even remotely, suggested in the '762 reference." Br. 10. Appellants further argue that "[a]ttention is, again, respectfully directed to the Examples which demonstrate, among other things, reduced wrinkle depth and smooth skin surface results subsequent to using the composition of this invention." Id. The issue with respect to this rejection is: Does a preponderance of the evidence of record support the Examiner's conclusion that Goralczyk renders obvious claims 1-13? In view of Goralczyk's express teaching that genistein improves skin barrier function, we agree with the Examiner that it would have been obvious to add genistein to the composition of paragraph 225 of Goralczyk 6 Appeal2017-008383 Application 13/969,736 for this purpose. As the Examiner observes, independent claim 1 uses the transitional term "comprising" and, therefore, does not limit the composition to the recited ingredients. Ans. 7. Accordingly, we agree with the Examiner that it would have been obvious, based on the above teachings of Goralczyk, for a user to take supplements containing B-carotene, Vitamin C, Vitamin E, n-fatty acids (DHA, EPA, or both) and/or their derivatives, ECGC, and genistein. As to Appellants' argument that Goralczyk does not disclose the claimed amount of genistein, the Examiner correctly finds that Goralczyk discloses a preferred daily amount of genistein of 20-60 mg. Goralczyk ,r 94. We agree with the Examiner that, based on the teaching of Goralczyk (e.g., ,r,r 91, 154), it would have been obvious for a user to take capsules containing genistein and the other recited constituents at the total daily dosage disclosed in Goralczyk (e.g., ,r,r 91-108). We further agree with the Examiner that Appellants are essentially claiming a range of amounts of the supplements that overlaps with known amounts, and that this creates a prima facie case of obviousness. In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003). The Examiner's findings are amply supported by the record evidence, as set forth above. "[ A ]n applicant may overcome a prima facie case of obviousness by establishing 'that the [ claimed] range is critical, generally by showing that the claimed range achieves unexpected results relative to the prior art range."' Peterson, 315 F .3d at 1330 ( emphasis in original) (internal citation omitted). An applicant may also overcome a prima facie case of obviousness by demonstrating an optimization of values. Id. 7 Appeal2017-008383 Application 13/969,736 Appellants assert an unexpected decrease in wrinkle line depth based on Examples 1-5 of the Specification. Br. 10. However, we agree with the Examiner that Example 5 of the Specification, which reports a decrease in wrinkle depth over placebo, does not compare the claimed composition to the prior art of Goralczyk and, therefore, does not establish unexpected results with respect to the relevant prior art. See Ans. 1 O; Spec. 20-21. We, therefore, sustain the Examiner's rejection underÂ§ 103(a) of independent claim 1. Claims 2-13, which were not separately argued, fall with claim 1. See 37 C.F.R. Â§ 4I.37(c)(l)(iv); cf In re Lovin, 652 F.3d 1349, 1357 (Fed. Cir. 2011) ("[T]he Board [has] reasonably interpreted Rule 41.37 to require more substantive arguments in an appeal brief than a mere recitation of the claim elements and a naked assertion that the corresponding elements were not found in the prior art"). B.-C. 35 US.C. Â§ 103(a) rejections over Goralczykfurther in view of one of Patel and Capella Appellants argue that Patel and Capella do not remedy the argued deficiency in Goralczyk. Having found no deficiency therein, we sustain the Examiner's rejections of claims 14 and 15 under 35 U.S.C. Â§ 103(a) over Goralczyk further in view of one of Patel and Capella. DECISION The Examiner's decision to reject claims 1-15 under 35 U.S.C. Â§ 103(a) is affirmed. 8 Appeal2017-008383 Application 13/969,736 No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. Â§ 1.136(a). See 37 C.F.R. Â§ 1.136(a)(l )(iv). AFFIRMED 9