Toshihiko Hibino et al.Download PDFPatent Trials and Appeals BoardDec 10, 201914004977 - (D) (P.T.A.B. Dec. 10, 2019) 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. 14/004,977 09/13/2013 Toshihiko Hibino 053466-0556 7122 22428 7590 12/10/2019 FOLEY & LARDNER LLP 3000 K STREET N.W. SUITE 600 WASHINGTON, DC 20007-5109 EXAMINER HOFFMAN, SUSAN COE ART UNIT PAPER NUMBER 1655 NOTIFICATION DATE DELIVERY MODE 12/10/2019 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): ipdocketing@foley.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte TOSHIHIKO HIBINO, SHOKO YAMADA, and HIDEKAZU FUKUSHIMA Appeal 2019-000566 Application 14/004,977 Technology Center 1600 Before DONALD E. ADAMS, RICHARD M. LEBOVITZ, and JOHN S. SCHNEIDER, Administrative Patent Judges. LEBOVITZ, Administrative Patent Judge. DECISION ON APPEAL Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision to reject claims 4, 6, and 7. 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(a). Appellant identifies the real party in interest as SHISEIDO COMPANY, LTD. Br. 3. Appeal 2019-000566 Application 14/004,977 2 STATEMENT OF THE CASE The Examiner finally rejected the claims as follows: 1. Claims 4 and 6 under 35 U.S.C. § 102(b) (2006) as anticipated by Voegel (US 2010/0324111, published Dec. 23, 2010) (“Voegel”). Final Act. 2. 2. Claims 4 and 6 under 35 U.S.C. § 103(a) (2006) as obvious in view of Voegel. Final Act. 3. 3. Claims 4, 6, and 7 pre-AIA 35 U.S.C. 103(a) as obvious in view of Voegel and Kamata (Bleomycin Hydrolase Is Regulated Biphasically in a Differentiation- and Cytokine-dependent Manner, J. Biol. Chem., 2011, Vol. 286 (10), 8204−12) (“Kamata”). Final Act. 4. Independent claim 4 is representative and reproduced below: 4. A method for improving or preventing dry skin caused by atopic dermatitis, comprising: applying a bleomycin hydrolase production promoter comprising as an active ingredient thereof one or more ingredients selected from the group consisting of chestnut rose extract, benzenesulfonyl GABA and erythritol to a non-lesion area of a subject in need of improvement or prevention of dry skin caused by atopic dermatitis. 1. ANTICIPATION REJECTION Claim 4 is directed to a method for improving or preventing dry skin caused by atopic dermatitis. The method comprises applying a bleomycin hydrolase production promoter “to a non-lesion area of a subject in need of improvement or prevention of dry skin caused by atopic dermatitis.” The elected promoter is “erythritol.” Final Act. 2. The Examiner found that Voegel describes preventing and treating atopic dermatitis with a composition that comprises erythritol. Final Act. 3. The Examiner found that Voegel does not specifically disclose applying the Appeal 2019-000566 Application 14/004,977 3 erythritol composition to a non-lesion area of skin as required by the claim, but the Examiner found “by teaching the prevention of atopic dermatitis,” Voegel “is implicitly teaching that the erythritol composition should be applied to skin prior to the outbreak of the lesion, i.e. non-lesioned skin.” Id. Therefore, the Examiner concluded Voegel “is considered to teach applying the erythritol to non-lesioned skin of a patient who suffers from atopic dermatitis,” anticipating the claim. Id. Appellant contends that “nowhere does Voegel disclose or suggest that the non-lesion skin area is by any means associated with atopic dermatitis, let alone, imply that there is any preventive role for erythritol to play in the non-lesion region.” Appeal Br. 7. Appellant argues that Voegel “only presents the fact that atopic dermatitis is characterized by ‘lesions.’” Id. Appellant further argues that “Voegel implies that the non-lesion area is not affected by atopic dermatitis. So assuming, arguendo, that Voegel taught treatment of dry skin with erythritol, the only inherent teaching ‘necessarily flow[ing]’ from Voegel is that erythritol can be applied to the ‘lesion,’ but not to ‘non-lesion area,’ to prevent atopic dermatitis characterized by dry skin.” Id. at 7–8. FINDINGS OF FACT (“FF”) FF1. The present invention relates to combinations which are particularly suitable for the treatment and/or prevention of atopic dermatitis. Voegel ¶ 1. FF2. Atopic dermatitis is a common condition in individuals of both sexes, often from the age of three months, which is characterized by repeating outbreaks of eczema on skin Appeal 2019-000566 Application 14/004,977 4 characterized by dry, squamous and highly pruriginous lesions. It has been noted that dryness of the skin is one of the predominant factors in the generation of atopic dermatitis. Voegel ¶ 4. FF3 In fact, the application of a combination or composition containing pyrrolidone-5-carboxylic acid and at least one compound from citrulline, arginine and asparagine, in racemic or isomer form, and also salts thereof, has a moisturizing action on this part of the skin, thereby leading to a significant effect for the treatment of atopic dermatitis. Voegel ¶ 8. FF4. A subject of the present invention is also the use of the composition according to the invention in the preparation of a medicament for use in the prevention and/or treatment of atopic dermatitis (or eczema). Voegel ¶ 15. FF5. The composition according to the invention is generally suitable for topical application to the skin and it therefore contains a physiologically acceptable medium, i.e. a medium that is compatible with the skin. Voegel ¶ 33. FF6. Humectants and moisturizers having the role of increasing the water content of upper layer of skin such as Sodium PCA and Arginine (both NMFs/Filaggrin breakdown produ[c]ts ), Glycerol; Sorbitol; Aloe vera; Betaine; caprylyl glycol, chitosan, cholesterol, Erythritol . . . Voegel ¶ 49. Appeal 2019-000566 Application 14/004,977 5 FF7. The moisturizing lotion according to the present is a non greasy creamy oil in water emulsion, without preservative, allergens and fragrance. It is designed to allow the dry skin to recover its essential functions and healthy aspect. Voegel ¶ 81. FF8. 6. A method for treating and or preventing atopic dermatitis wherein a composition according to claims 1 to 4 is administrated to a subject in need thereof. 7. A method according to claim 6, wherein said composition is administrated topically and/or applied on the skin surface. Voegel, p. 8. Discussion Under 35 U.S.C. § 102 a claim is anticipated “if each and every limitation is found either expressly or inherently in a single prior art reference.” Celeritas Techs. Ltd. v. Rockwell Int’l Corp., 150 F.3d 1354, 1361 (Fed. Cir. 1998). When inherency is a basis of anticipation, it “may not be established by probabilities or possibilities. The mere fact that a certain thing may result from a given set of circumstances is not sufficient.” In re Robertson, 169 F.3d 743, 745 (Fed. Cir. 1999) (internal citation and quotation marks omitted). A “prior art reference may anticipate without disclosing a feature of the claimed invention if that missing characteristic is necessarily present, or inherent, in the single anticipating reference.” SmithKline Beecham Corp. v. Apotex Corp., 403 F.3d 1331, 1343 (Fed. Cir. 2005). The issue in this rejection is whether following Voegel’s disclosure to prevent atopic dermatitis would necessarily result in “applying . . . erythritol Appeal 2019-000566 Application 14/004,977 6 to a non-lesion area of a subject in need of improvement or prevention of dry skin caused by atopic dermatitis” as recited in claim 1. The Examiner’s determination that the claim is anticipated by Voegel is based on the finding that “by teaching the prevention of atopic dermatitis, the reference is implicitly teaching that the erythritol composition should be applied to skin prior to the outbreak of the lesion, i.e. non-lesioned skin.” Final Act. 3. The Examiner’s reasoning is supported by a preponderance of the evidence. Voegel describes applying its composition topically to the skin to treat and prevent atopic dermatitis (FF1, FF4, FF5, FF8). Appellant did not dispute that the composition can contain erythritol (FF6). Voegel teaches treating atopic dermatitis by applying its composition “on this part of the skin” (FF3). This “part” of the skin would be understood to be at least the “dry, squamous and highly pruriginous lesions” which is characteristic of atopic dermatitis. We reach this conclusion because the lesions are indicative of atopic dermatitis (FF2) and therefore would be the part of the skin when treatment is desired. Voegel also teaches prevention of atopic dermatitis (FF1, FF4, FF8). As indicated by the Examiner, Voegel does not explicitly disclose where to topically apply the composition to the skin to prevent atopic dermatitis. However, because the disease is characterized by “outbreaks of . . . dry, squamous and highly pruriginous lesions” (FF2), the only logical conclusion is that the composition would be applied to non-lesion skin to prevent the outbreak of the characteristic pruriginous lesions. Appeal 2019-000566 Application 14/004,977 7 Appellant argues that there is no teaching in Voegel that “the non- lesion skin area is by any means associated with atopic dermatitis” and “the only inherent teaching ‘necessarily flow[ing]’ from Voegel is that erythritol can be applied to the ‘lesion,’ but not to ‘non-lesion area,’ to prevent atopic dermatitis characterized by dry skin.” Appeal Br. 7–8. We find this argument unpersuasive because to apply the composition to lesions which have already appeared would be considered treatment of atopic dermatitis because it would be ameliorating symptoms of the disease. However, Voegel also discloses prevention of atopic dermatitis (FF1, FF4). Appellant has not identified where the composition would be applied to the skin to prevent the outbreak of the lesions characteristic of atopic dermatitis, if not to non-lesioned areas. Appellant states that “Voegel implies that the non-lesion area is not affected by atopic dermatitis” (Appeal Br. 7), but does not explain what would be the appearance of the skin prior to the outbreak of lesions. Appellant has not directed us to a definition of “non-lesion” skin area that would distinguish it from the skin area in Voegel that the composition is applied to prevent “outbreaks of eczema on skin characterized by dry, squamous and highly pruriginous lesions” (FF2). Appellant, citing Perricone v. Medicis Pharm. Corp., 432 F.3d 1368 (Fed. Cir. 2005), argues “a reference disclosing generalized topical administration of skin care preparations cannot inherently teach a method directed to a specific area of skin that the reference does not teach.” Appeal Br. 9. The anticipation rejection here is distinguishable because the Examiner is not relying on a general teaching to apply the composition to the skin, but rather a specific disclosure in Voegel to apply the composition Appeal 2019-000566 Application 14/004,977 8 topically to prevent atopic dermatitis, which necessarily would mean applying it to skin which is not experiencing an outbreak of lesions. The Examiner further found that Voegel discloses the same composition as claimed and thus would also “inherently have to result in the promotion of bleomycin hydrolase” as claimed (Final Act. 4), in reference to claim 4 of applying a bleomycin hydrolase production promoter and claim 6 of “promoting bleomycin hydrolase production.” Appellant contends that the Examiner improperly relied on the disclosure in the Specification to establish a link between erythritol and atopic dermatitis in making this rejection. Appeal Br. 9–10; Reply Br. 2–3. This argument does not persuade us that the Examiner erred. Claim 6 is directed to a “method for promoting bleomycin hydrolase production.” There is one recited step in the claim which comprises administering erythritol “to a non-lesion area of a subject suffering from atopic dermatitis and in need of promoting bleomycin hydrolase production.” It is well-established that merely recognizing a new benefit of an old process is insufficient to render the old process again patentable. In re Woodruff, 919 F.2d 1575 (Fed. Cir. 1990); MEHL/Biophile Int’l Corp. v. Milgraum, 192 F.3d 1362, 1365 (Fed. Cir. 1999); In re Cruciferous Sprout Litig., 301 F.3d 1343, 1351 (Fed. Cir. 2002); In re Omeprazole Patent Litig., 483 F.3d 1364, 1373 (Fed. Cir. 2007). In MEHL, 192 F.3d at 1365, the patentee claimed a “method of hair depilation” utilizing steps which had been described in a prior art publication. The prior art method did not perform the steps for the purpose of hair depilation, but it was determined that hair depilation would have been Appeal 2019-000566 Application 14/004,977 9 a necessary, albeit unrecognized and inherent, consequence of carrying out the method. MEHL, 192 F.3d at 1366. Although the claim preamble expressly required the method to be performed for the purpose of hair depilation, the court did not find it necessary that the article’s authors “appreciate the results” of their process to constitute an anticipation of the claimed process. Id. Here, while the claim preamble recites that the method is for promoting bleomycin hydrolase production, the steps are the same as those disclosed in Voegel and thus necessarily the same result is achieved. Appellant has not provided evidence to rebut the Examiner’s fact-based determination. The same rationale applies to claim 4. Accordingly, we conclude that the Examiner correctly determined that application of the claimed composition to non-lesion skin is “necessarily present” in Voegel when its prevention is carried out. SmithKline Beecham Corp. v. Apotex Corp., 403 F.3d at 1343. The rejection of claims 4 and 6 as anticipated by Voegel is affirmed. 2. OBVIOUSNESS BASED ON VOEGEL The Examiner found that Voegel also renders the claimed subject matter obvious to one of ordinary skill in the art at the time of the invention. The Examiner found, as discussed above, that Voegel teaches that atopic dermatitis is characterized by lesions on the skin. Final Act. 4. The Examiner further found that Voegel disclose that “skin dryness is a predominant factor in the generation of atopic dermatitis.” Id. The Examiner found that the skilled worker “would reasonably expect that the prevention and treatment of atopic dermatitis could be carried out by applying the erythritol composition to dry skin associated with atopic Appeal 2019-000566 Application 14/004,977 10 dermatitis prior to the development of lesions on the skin.” Id. The Examiner concluded that this “reasonable expectation of success would motivate the artisan to improve or prevent dry skin caused by atopic dermatitis by applying the erythritol composition to non-lesioned areas of the skin to prevent the development of the lesions” as required by the claims. Id. Appellant states that the Examiner is improperly relying on inherency to establish obviousness. Appeal Br. 11. This is argument does not identify an error in the Examiner’s rejection. The Examiner found that the skilled worker, knowing that the composition is useful to treat and prevent dry skin associated with atopic dermatitis, would have found it obvious to apply it to dry skin prior to the appearance of lesions, i.e., for the prevention of an outbreak of lesions. Final Act. 4. Appellant has not identified a defect in this reasoning other than to assert that it is based on the same faulty finding in the anticipation rejection. Appeal Br. 11. However, this is not correct. The Examiner clearly set forth a different basis for the obviousness rejection, namely, that a skilled worker would have had reason to apply the composition to non-lesion skin; inherency was not invoked. For the foregoing reasons, the rejection of claims 4 and 6 as obvious in view of Voegel is affirmed. 3. OBVIOUSNESS BASED ON VOEGEL AND KAMATA Claim 7 depends from independent claim 4, and further recites “evaluating the expression level of bleomycin hydrolase to identify a subject in need of improvement or prevention of dry skin.” Appeal 2019-000566 Application 14/004,977 11 The Examiner acknowledged that Voegel does not describe the claimed step, but found that “Kamata teaches that a loss of bleomycin hydrolase leads to a deficiency in skin’s natural moisturizing factors which leads to dry skin and atopic dermatitis.” Final Act. 5. The Examiner further stated: Thus, an individual with a lowered expression level of bleomycin hydrolase would be recognized as an individual in need of improvement or treatment of dry skin and atopic dermatitis. An artisan of ordinary skill would be motivated to treat this individual with known compositions for treating dry skin and atopic dermatitis for improvement and would be motivated to perform the evaluation to determine patients that are in need of treatment for dry skin and atopic dermatitis. Therefore, an artisan of ordinary skill would be motivated to perform this evaluation prior to the dry skin and dermatitis treatment taught by Voegel. Final Act. 5. Appellant makes the same unpersuasive argument about Voegel not disclosing applying its composition to non-lesion skin. Appeal Br. 12. Appellant also argues “there is no indication in Kamata that erythritol compositions can elevate the production of bleomycin hydrolase in the recited ‘non-lesion’ area.” Appeal Br. 12. Appellant’s argument ignores the express language in the claim. Claim 7 does not require knowledge that the erythritol is a bleomycin hydrolase promoter. The claim only requires that expression is evaluated. The Examiner gave a well-reasoned statement as to why one of ordinary skill would have had reason to evaluate bleomycin hydrolase expression after application of the composition described in Voegel. Appellant did not identify a deficiency in the Examiner’s rejection and we find none. Appeal 2019-000566 Application 14/004,977 12 For the foregoing reasons, the rejection of claims 4, 6, and 7 as obvious in view of Voegel and Kamata is affirmed. SUMMARY For the foregoing reasons, the obviousness rejection of claim 1, and dependent claims 4, 6, and 7 is affirmed. DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 4, 6 102(b) Voegel 4, 6 4, 6 103(a) Voegel 4, 6 4, 6, 7 103(a) Voegel, Kamata 4, 6, 7 Overall Outcome 4, 6, 7 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