Ex Parte Estrela Ariquel et alDownload PDFPatent Trials and Appeals BoardMay 23, 201915041013 - (D) (P.T.A.B. May. 23, 2019) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 15/041,013 02/10/2016 44955 7590 05/28/2019 SQUIRE PB (SFR Office) 275 BATTERY STREET, SUITE 2600 SAN FRANCISCO, CA 94111-3356 FIRST NAMED INVENTOR Jose Marfa Estrela Ariquel 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. 117430.00003 3807 EXAMINER PHAN, DOANTHI-THUC ART UNIT PAPER NUMBER 1613 NOTIFICATION DATE DELIVERY MODE 05/28/2019 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): sfripdocket@squirepb.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte JOSE MARIA ESTRELA ARIQUEL and MIGUEL A. ASENSI MIRALLES 1 Appeal2018-003423 Application 15/041,013 Technology Center 1600 Before DEBORAH KATZ, ULRIKE W. JENKS, and JOHN G. NEW, Administrative Patent Judges. NEW, Administrative Patent Judge. DECISION ON APPEAL 1 Appellants identify the real party-in-interest as Green Molecular, S.L. App. Br. 1. Appeal2018-003423 Application 15/041,013 SUMMARY Appellants file this appeal under 35 U.S.C. § I34(a) from the Examiner's Final Rejection of claims 30, 34, 39, 47, 51, and 53 as unpatentable under 35 U.S.C. § I03(a) as obvious over Maes et al. (US 2009/0047309 Al, February 19, 2009) ("Maes"), Majeed et al. (US 2010/0240767 Al, September 23, 2010) ("Majeed"), Morariu (US 2006/0216251 Al, September 28, 2006) ("Morariu"), and R. Casagrande et al., Protective Effect of Topical Formulations Containing Quercetin against UVB-Induced Oxidative Stress in Hairless Mice, 84 J. PHOTOCHEM. PHOTOBIO. B: BIO. 21-27 (2006) ("Casagrande"). We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. NATURE OF THE CLAIMED INVENTION Appellants' invention is directed to the use of pterostilbene ("PTER") for the manufacture of pharmaceutical compositions for preventing and treating skin diseases. See Spec. p. 4, 11. 7-10. REPRESENTATIVE CLAIM Claim 30 is representative of the claims on appeal and recites: 30. A method for decreasing or reducing the risk of skin cancer induced by exposure to UVB radiation in a subject in need thereof, said method comprising topically administering to said subject an effective amount of a composition comprising pterostilbene (PTER), or any acceptable 2 Appeal2018-003423 Application 15/041,013 salt thereof, and a dermatologically acceptable excipient, thereby decreasing or reducing risk of skin cancer induced by exposure to UVB in the subject, wherein said composition is administered prior to exposure to radiation. App. Br. 15. ISSUES AND ANALYSIS We agree with, and expressly adopt, the Examiner's findings, reasoning, and conclusion that the claims are obvious over the combined prior art. We address below the arguments raised by Appellants. Issue 1 Appellants argue the prior art does not teach or suggest topical application of pterostilbene to decrease or reduce the risk of skin cancer when administered prior to exposure to radiation. App. Br. 9. Analysis The Examiner finds Maes teaches a method for reducing the adverse effects of sun exposure on human skin by applying a topical composition containing resveratrol or a derivative thereof, e.g., pterostilbene, and cosmetically acceptable ingredients. See Ans. 4 (citing Maes ,r,r 6, 11, 12, 37, 42-51). Cosmetically acceptable ingredients include sunscreen agents. Id. at 5, citing Maes ,r 46. The Examiner finds Maes teaches "the topical composition can be applied to the skin on an as-needed basis." Id. at 4 (citing Maes ,r 64). The Examiner finds Maes teaches Examples of treating human keratinocyte cells with resveratrol prior to exposure to UVB radiation. Id. ( citing Maes ,r,r 68-80). 3 Appeal2018-003423 Application 15/041,013 The Examiner finds Majeed teaches a topical composition of pterostilbene that has photo-protective and melanogenesis inhibitory properties. See Ans. 5 (citing Majeed ,r,r 2--4, 10, 14). The Examiner finds Majeed provides "a study of pterostilbene for UV protection, showing the administration of pterostilbene to mouse fibroblast cells (normal cells) before exposure to UVB and Majeed found that pterostilbene provided significant UVB protection in said treated cells." Id. at 15 (citing Majeed ,r 18). The Examiner finds "[ o ]ne of ordinary skill in the art would have reasonable expectation of success of reducing the risk of the skin from skin cancer or precancerous skin damage by topically applying to the skin prior to exposure to UVB radiation a composition containing pterostilbene of Maes" in view of the photo-protective effects taught by Majeed. Id. at 5. Appellants argue "[n]either Maes nor Majeed, alone or in combination, teach or suggest the use of PTER as a topical to decrease or reduce the risk of skin cancer when administered prior to exposure to radiation." App. Br. 9. Appellants argue "[s]ince Maes discloses a cell survival assay, it would not teach reduction of the risk of skin cancer, since the reduction of skin cancer relates to the reduction of carcinogenesis whereas cell survival would promote viability and perhaps carcinogenesis." Id. Appellants argue "Majeed teaches the use of PTER for inhibition and reduction of melanogenesis ... [which] would increase, not inhibit, tumorigenesis and increase the risk of skin cancer.... Accordingly, Majeed teaches or suggests that PTER ... would increase the risk of skin cancer." Id. at 10. In addition to the lack of express teaching in Maes and Majeed, Appellants argue that a method for decreasing or reducing the risk of skin 4 Appeal2018-003423 Application 15/041,013 cancer "would not be the natural result from the operation taught by Maes or Majeed." See id. at 12. We are not persuaded by Appellants' arguments. We begin with construing claim 30. We agree with the Examiner that "the limitation 'for decreasing or reducing the risk of skin cancer induced by exposure to UVB radiation'" recited in the preamble and the body of the claim is merely a recitation of purpose and intended result. See Ans. 9. As discussed below, we find that the expression does not impose a limitation upon the recited steps of the claim. See Bristol-Myers Squibb Co. v. Ben Venue Laboratories, Inc., 246 F.3d 1368, 1375-1376 (Fed. Cir. 2001). We find that the claim includes two steps: 1) topically administering an effective amount of PTER and a dermatologically acceptable excipient, and 2) administering prior to exposure to radiation. The steps in the method are performed in the same way regardless whether or not the subject experiences a decrease or reduction in the risk of skin cancer, and thus the language of the claim recites a structurally complete invention. See Bristol- Myers, 246 F.3d at 1375 ("steps of the three-hour infusion method are performed in the same way regardless whether or not the patient experiences a reduction in hematologic toxicity"); see also Rowe v. Dror, 112 F.3d 473, 478 (Fed. Cir. 1997) ("[W]here a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention"). As discussed above in the Examiner's findings, the combined prior art teaches applying topical compositions including pterostilbene for its photo- protective activity, specifically pterostilbene' s significant UV protective activity. The combined prior art teaches topical compositions including 5 Appeal2018-003423 Application 15/041,013 dermatologically acceptable excipients, and other ingredients, such as sunscreen agents. The prior art teaches topically applying the compositions as needed and prior to exposure with UVB radiation. Therefore, the prior art teaches all of the steps of claim 30. With respect to the intended result, i.e., decreasing or reducing the risk of skin cancer, "merely discovering and claiming a new benefit of an old process cannot render the process again patentable." In re Huai-Hung Kao, 639 F.3d 1057, 1070 (Fed. Cir. 2011). Therefore, we are not persuaded that the Examiner erred by finding the prior art teaches or suggests the claimed method. Issue 2 Appellants argue the prior art teaches away from the claimed method. App. Br. 10. Analysis Appellants argue that: [T]he disclosure and data found in the specification and examples of the prior art teaches away from the instantly claimed invention as the examples and resulting data do, indeed, criticize, discredit, and otherwise discourage one skilled in the art from using PTER as a topical to decrease or reduce the risk of skin cancer when administered prior to exposure to radiation. Reply Br. 4 (citing In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004)). As discussed above, Appellants argue that Maes' s teaching of a cell survival assay indicates promoting "viability and perhaps carcinogenesis." App. Br. 9. With respect to the data and examples of Maes, Appellants argue that Tables 1--4 of Maes indicate that resveratrol, alone, has no effect on cell 6 Appeal2018-003423 Application 15/041,013 survival against UVB toxicity. Id. at 9-10. Appellants further argue "Majeed teaches away from the method set forth in Claim 30" by teaching or suggesting "a method that would increase the risk of skin cancer induced by exposure to UVB radiation in a subject in need thereof by reducing the amount of melanin." Id. at 10-11 (emphasis in original). With respect to the data and examples of Majeed, Appellants argue "[ c Jells disclosed in Majeed as test cells, B16Fl cells, have high melanin and the object in Majeed was to reduce melanin, not tumorigenesis. So, inhibition of melanogenesis, and reduction of melanin, as in Majeed, would increase, not inhibit, tumorigenesis and increase the risk of skin cancer." Id. at 10. We are not persuaded by Appellants' arguments. As shown by the Examiner, Example III of Majeed teaches pterostilbene has photo-protective activity, and in particular, shows significant UV protection against exposure to UVA and UVB radiation. Ans. 15. The photo-protective activity of pterostilbene is identical to that described by Appellants in the Specification. See id. at 15-16 (citing Spec. p. 13, 11. 22-26). Appellants fail to cite to any portion of Majeed that suggests pterostilbene would be unlikely to provide photo-protective activity or that criticizes, discredits, or otherwise discourages topically administering a pterostilbene containing composition to reduce UVB radiation exposure. See In re Mouttet, 686 F.3d 1322, 1334 (Fed. Cir. 2012). Moreover, Appellants do not submit any substantive evidence that Majeed teaches topically applying pterostilbene would increase the risk of skin cancer. See In re Pearson, 494 F.2d 1399, 1405 (C.C.P.A. 1974) ("Attorney's argument in a brief cannot take the place of evidence.") We therefore agree with the Examiner that there is no teaching away by the prior art. In the absence of persuasive evidence of teaching 7 Appeal2018-003423 Application 15/041,013 away, we agree with the Examiner's conclusion that the claims would have been prima facie obvious to a person of ordinary skill to apply a topical composition containing pterostilbene to the skin prior to exposure to UVB radiation to reduce the risk of skin cancer. Issue 3 Appellants argue that the claimed method yields superior and unexpected results that would rebut a finding of prima facie obviousness. App. Br. 12. Analysis Appellants argue "topically administered PTER is superior and shows unexpected results for decreasing or reducing the risk of skin cancer induced by exposure to UVB when administered prior to exposure to radiation." App. Br. 12. Appellants point to Example 10 on pages 46-48 of the Specification that "directly evaluated PTER compared to resveratrol and other commercial skin creams" for preventing precancerous lesions in mice. Id. Appellants argue the results show "90% of the mice treated with PTER remained tumor free during the course of the study. Close to 90% of the mice treated with PTER and QUER during the course of the study remained tumor free." Id. at 13. In contrast, Appellants argue "[n]one of the other compounds tested showed such remarkable results .... less than 10% of the mice treated with resveratrol, the compound cited in Maes, remained tumor free for the course of the study." Id. Appellants further submit a Declaration by Dr. Jose M. Estrela, dated September 8, 2016, and an article by J. A. Sirerol et al., Topical Treatment with Pterostilbene, a Natural 8 Appeal2018-003423 Application 15/041,013 Phytoalexin, Effectively Protects Hairless Mice against UVB Radiation- Induced Skin Damage and Carcinogenesis, 85 FREE RADICAL BIOLOGY AND MEDICINE 1 (2015) ("Sirerol") to support their assertion of unexpected results. See id. at 5. We are not persuaded by Appellants' arguments and evidence with respect to the allegedly unexpected results. We agree that the Specification, the Estrela Declaration, and the Sirerol article provide evidence that topically applying pterostilbene decreases UVB radiation-induced skin damage and carcinogenesis. However, "[t]o be particularly probative, evidence of unexpected results must establish that there is a difference between the results obtained and those of the closest prior art, and that the difference would not have been expected by one of ordinary skill in the art at the time of the invention." Bristol-Myers Squibb Co. v. Teva Pharms. USA, Inc., 752 F.3d 967, 977 (Fed. Cir. 2014). As discussed below, we find that Appellants do not provide persuasive evidence of either requirement. We begin with the comparison to the closest prior art. Appellants argue that in Example 10 "[l]ess than 70% of the mice treated with Vichy; less than 60% of the mice treated with Heliocare; and less than 20% of the mice treated with Isdin showed significant results." App. Br. 13. The Specification refers to "commercial creams: Vichy (VICHY Capital Soleil 50+ UVB+UV A), Heliocare (Heliocare ultra 90 UVB/UV A) and Isdin (ISDIN Extrem 40 high protection UVA and UVB)." Spec. p. 17, 11. 5-7. Neither the Specification nor Appellants describe the contents of the commercial creams, in particular their active components. Therefore, there is no indication that improved results as compared to the commercial creams are relevant as compared to the prior art cited by the Examiner. 9 Appeal2018-003423 Application 15/041,013 We next compare the evidence of unexpected results to the closest prior art cited by the Examiner. Appellants argue, "less than 10% of the mice treated with resveratrol, the compound cited in Maes, remained tumor free for the course of the study." App. Br. 13. We find the comparison with resveratrol to be more relevant than the commercial creams, as Maes teaches that pterostilbene is a resveratrol derivative. Maes ,r 37. However, as Appellants argue, "Maes teach[ es] that resveratrol, alone, has no effect on cell survival" when protecting cells from UVB induced toxicity. App. Br. 9-10. Therefore, it is not unexpected that resveratrol is inferior to pterostilbene in decreasing UVB radiation-induced skin damage and carcinogenesis. Rather, as shown by the Examiner, Majeed teaches that the superior results of pterostilbene in decreasing UVB radiation-induced skin damage and carcinogenesis would have been expected given pterostilbene's significant protective activity against UV A and UVB exposure. Ans. 18. Because Appellants do not provide persuasive evidence of unexpected results as compared to the closest prior art, we do not find the evidence sufficient to overcome the Examiner's determination of prima facie obviousness. Appellants do not argue the dependent claims separately, relying on their arguments for claim 30. We consequently affirm the Examiner's rejection of claims 30, 34, 39, 47, 51, and 53. DECISION The Examiner's rejection of claims 30, 34, 39, 47, 51, and 53 under 35 U.S.C. § 103(a) is affirmed. 10 Appeal2018-003423 Application 15/041,013 No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(l)(iv). AFFIRMED 11 Copy with citationCopy as parenthetical citation