Ex Parte Hansenne et alDownload PDFBoard of Patent Appeals and InterferencesMar 6, 201212010897 (B.P.A.I. Mar. 6, 2012) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES __________ Ex parte ISABELLE HANSENNE, HANI FARES, MARC CORNELL, and SIDNEY P. FOLTIS __________ Appeal 2011-008225 Application 12/010,897 Technology Center 1600 __________ Before ERIC GRIMES, FRANCISCO C. PRATS, and STEPHEN WALSH, Administrative Patent Judges. WALSH, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134(a) from the rejection of claims directed to a method of peeling skin. The Patent Examiner rejected the claims for anticipation, obviousness, and nonstatutory obviousness-type double patenting. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. Appeal 2011-008225 Application 12/010,897 2 STATEMENT OF THE CASE Claims 1-7 and 9-20 are on appeal. Claim 1 is representative and reads as follows: 1. A method of peeling skin, comprising applying to skin to be peeled at least one salicylic acid derivative of formula (I): wherein R is a linear aliphatic group containing from 6 to 10 carbon atoms; R' is a hydroxyl group or an ester functional group of formula wherein R1 is a linear or branched saturated or unsaturated aliphatic group having from 1 to 18 carbon atoms, and salts thereof; in an amount sufficient, and for a time sufficient, to provide a superficial, medium or deep chemical peel. Claim 4, which is dependent on claim 1, defines the salicylic acid derivative as 5-n-octanoyl-salicylic acid. The Examiner rejected the claims as follows: claims 1-4, 9, and 12-17 under 35 U.S.C. § 102(b) as anticipated by Gueret;1 claims 5, 7, 10, and 11 under 35 U.S.C. § 103(a) as unpatentable over Gueret; claims 1-7 and 9-20 under 35 U.S.C. § 103(a) as unpatentable over Jacquet2 and Gueret; 1 Jean-Louis Gueret, US 2002/0051796 A1, published May 2, 2002. Appeal 2011-008225 Application 12/010,897 3 claims 18-20 under 35 U.S.C. § 103(a) as unpatentable over Jacquet and Kligman;3 claims 1-7 and 9-17 under the judicially created doctrine of obviousness-type double patenting over claims 1-10 of Jacquet in view of Gueret; claims 18-20 under the judicially created doctrine of obviousness-type double patenting over claims 1-10 of Jacquet in view of Gueret and Kligman; and claims 1-7 and 9-20 under the judicially created doctrine of obviousness-type double patenting over claims 6, 7, 9-12, 14-17, 19- 22, 24, 25, and 27-42 of copending application 10/367,700 in view of Jacquet and Gueret. ANTICIPATION The Issue Appellants contend that Gueret did not anticipate the invention because “no expectation would exist that sufficient active agent would be delivered to skin to effect peeling” by Gueret’s method. (App. Br. 5-6.) Thus, Appellants dispute the Examiner’s finding that Gueret’s exfoliation method peeled skin, contending that “[p]eeling involves removal of skin layer(s). (See, Specification at page 10, lines 15-20),” but “[i]n contrast, cleansing/exfoliation indicate removal of dead cells from the skin's surface. (See, about.com: acne, printed November 1, 2010).” (Id. at 6.) 2 Bernard Jacquet et al., US 4,767,750, issued Aug. 30, 1988. 3 Douglas E. Kligman et al., WO 97/28786, published Aug. 14, 1997. Appeal 2011-008225 Application 12/010,897 4 The issue is whether the evidence supports the rejection’s finding that Gueret’s exfoliation method peeled skin. Findings of Fact 1. We adopt the Examiner’s findings concerning the scope and content of the Gueret disclosure. 2. Appellants’ Specification states: The composition according to the present invention may be applied in any manner, for example, by pasting, spraying, wiping, dispensing, etc. (hereinafter “applying”) . . . . This can typically be accomplished with, for example, a spray bottle, an absorbent cotton swab wetted with the concentrated solution, with a solution-wetted sable brush or by gentle wiping with a solution-wetted absorbent fibrous material such as a gauze square or nonwoven pad, but other solution application techniques that coat the skin with the solution, preferably in a uniform manner, are also feasible. The application serves as a peel, the degree of which depends upon the amount or concentration of acid compound and time of application, all of which is within the skill of the ordinary artisan in view of this disclosure. (Spec. 8, ll. 13-23.) 3. Appellants’ Specification states: The applied compound or composition is normally allowed to air dry over a relatively short period of time, preferably being less than 15 minutes and, with the preferred ethanol solvent, typically being in the range of about 3 to 10 minutes. (Id., ll. 25-27.) 4. Appellants’ Specification states: While not bound by theory, it is believed that the invention method can remove the epidermis (mainly the cuticle) of the skin and impose influences upon the cells of the stratum spinosum epidermidis and the stratum basale epidermidis of the epidermis, and cause the reproduction of the fibroblast of the corium. The aged corium portion can be replaced with the reproduced fibroblast. At the same time, the Appeal 2011-008225 Application 12/010,897 5 cuticle of the hair follicle can also be peeled off and the accumulated cuticle can be removed. (Id. at 10, ll.15-20.) 5. The ordinary meaning of keratolytic includes: “a substance that promotes the softening and peeling of epidermis-eg, diluted topical salicylic acid to [reduce] the thickness of laminated keratin or hyperkeratotic scales-eg, in psoriasis” (McGraw-Hill Concise Dictionary of Modern Medicine. © 2002 by The McGraw- Hill Companies, Inc.).4 Principles of Law To support anticipation, “the reference need not satisfy an ipsissimis verbis test.” In re Gleave, 560 F.3d 1331, 1334 (Fed. Cir. 2009). “[A] reference may anticipate even when the relevant properties of the thing disclosed were not appreciated at the time.” Abbott Labs. v. Baxter Pharm. Products, Inc., 471 F.3d 1363, 1367 (Fed. Cir. 2006). “The general principle that a newly-discovered property of the prior art cannot support a patent on that same art is not avoided if the patentee explicitly claims that property.” Id. at 1368. See also, W.L. Gore & Assocs., Inc. v. Garlock, Inc., 721 F.2d 1540, 1548, 1554 (Fed. Cir. 1983) (“irrelevant that those using the invention may not have appreciated the results . . . . Were that alone enough to prevent anticipation, it would be possible to obtain a patent for an old and unchanged process”). 4 http://medical-dictionary.thefreedictionary.com/keratolytic, accessed March 1, 2012. Appeal 2011-008225 Application 12/010,897 6 Analysis The Examiner correctly found that Gueret described applying, via patch, a 3 wt % 5-n-octanoylsalicylic acid solution to skin for between 15 seconds and 20 minutes. (Ans. 4.) The finding is explicitly supported in Gueret, and is undisputed. Appellants speculate that more information would be needed to prove that Gueret’s method applied an amount sufficient, for a time sufficient, to achieve a peel as claimed. This argument is unpersuasive because Appellants’ Specification evidences that no more information is needed to support the Examiner’s position. The Specification states that any manner of application may be used (FF 2), and the preferred time period for application is less than 15 minutes (FF 3). To distinguish exfoliation from peeling, Appellants rely on an “About.com” definition of exfoliation, but the definition does not define peeling and does not purport to distinguish exfoliation from peeling. Because Gueret taught applying the same composition to the same patients for an even longer time than Appellants prefer, the evidence is sufficient to support the Examiner’s finding that Gueret’s method peeled skin. Further, the Examiner directed attention to Gueret’s description of 5-n- octanoylsalicylic acid as a keratolytic agent, and the ordinary meaning of keratolytic is “a substance that promotes the softening and peeling of epidermis.” (FF 5.) Finally, Appellants’ reliance on its Specification page 10 disclosure is not persuasive of what layers of skin are or are not removed in its process because it states that the invention is not bound by the theory stated. (FF 4.) In sum, we find the rejection’s evidence and the Examiner’s Response to Argument persuasive. (Ans. 14-16.) Appeal 2011-008225 Application 12/010,897 7 Claims 2-4, 9, and 12-17 have not been argued separately and therefore fall with claim 1. 37 C.F.R. § 41.37(c)(1)(vii). OBVIOUSNESS A. The rejection of claims 5, 7, 10, and 11 over Gueret The Issue Appellants do not dispute that Gueret suggested treating skin with a combination of 5-n-octanoyl-salicylic acid and glycolic acid or other agents listed in claims 5, 7, 10, and 11. Instead, Appellants contend that “Gueret’s disclosure is silent concerning skin peels and how to peel skin, so this disclosure would not lead one of ordinary skill in the art to practice the invention peeling methods. Accordingly, Gueret's disclosure would not render the invention methods obvious.” (App. Br. 6-7.) “At any rate, the unexpected properties associated with the invention peeling methods (as demonstrated in the Rule 132 declaration submitted in this case) are more than sufficient to establish non-obviousness of the invention peeling methods.” (Id. at 7.) The issues with respect to this rejection are: whether Gueret’s description of its method without using the word peel means that practicing Gueret’s method would not necessarily result in peeling; and if so, whether the Rule 132 Declaration establishes unexpected properties of Appellants’ method weighing in favor of nonobviousness. Further Findings of Fact 6. We adopt the Examiner’s findings concerning the scope and content of the Gueret disclosure. Appeal 2011-008225 Application 12/010,897 8 7. Appellants rely on the “Declaration Under 37 C.F.R. 1.132” signed by Sidney P. Foltis on August 5, 2009. 8. The Foltis Declaration states that observations and experiments were carried out on salicylic acid derivatives designated “short chain (C4),” “long chain (C18),” “C8 with carbonyl,” and “C8 without carbonyl.” (Decl. ¶ 3.) 9. The Foltis Declaration states that “the salicylic acid derivatives containing a C8 chain, regardless of whether there was a carbonyl functionality associated with the chain, yielded vastly superior properties (as represented by change in fusion temperature) as compared to the other compounds analyzed.” (Decl. ¶ 7.) 10. According to the Foltis Declaration, the results were “surprising and unexpected given the similarity of the structures and/or activities of these compounds.” (Decl. ¶ 9.) 11. Gueret’s preferred keratolytic agent, 5-n-octanoyl-salicylic acid, is a C8 salicylic acid derivative of the kind referred to in the Foltis Declaration. Principles of Law “Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention.” In re Baxter Travenol Labs., 952 F.2d 388, 392 (Fed. Cir. 1991). See In re Woodruff, 919 F.2d 1575, 1577-78 (Fed. Cir. 1990) (obviousness rejection affirmed where using claimed elements in the manner suggested by the prior art necessarily resulted in claim-recited effect). Appeal 2011-008225 Application 12/010,897 9 Analysis Appellants first repeat the argument that Gueret’s method would not result in peeling. For the reasons given in the Anticipation Analysis section above, that argument remains unpersuasive. Appellants next argue that unexpected properties demonstrated in the Foltis Declaration suffice to establish non-obviousness. The Examiner found this argument unpersuasive (Ans. 16-17), and we agree that the Examiner properly weighed all the evidence. The Foltis Declaration confirms what Gueret disclosed and exemplified: 5-n-octanoyl-salicylic acid was a preferred salicylic acid derivative keratolytic agent. Its use according to Gueret’s instructions would have necessarily produced the peeling result Appellants achieve because Appellants’ method follows Gueret’s instructions. Although the Declaration states that the result of comparing a C8 derivative to derivatives such as C4 or C18 was surprising and unexpected (FF 10), Gueret had already identified the C8 derivative 5-n- octanoyl-salicylic acid as preferred, and exemplified its use for exfoliating. The totality of the evidence, including Appellants’ demonstration of the superior effectiveness of C8 salicylic acid derivatives and Gueret’s earlier disclosure of the same fact, leads to the conclusion that the claimed subject matter would have been obvious. B. The rejections of claims 1-7 and 9-20 over Jacquet and Gueret, and of claims 18-20 over Jacquet and Kligman. The Issues Appellants contend that because “Jacquet discloses frequent, prolonged application of his compositions to skin, Jacquet cannot teach or Appeal 2011-008225 Application 12/010,897 10 suggest applying the claimed salicylic acid derivatives ‘in an amount sufficient, and for a time sufficient, to provide a superficial, medium or deep chemical peel’ as required by the claims.” (App. Br. 7.) Regarding claims 13-15 which refer to treating hyperpigmentation, wrinkled skin, and photodamaged skin, respectively, Appellants argue that Jacquet treats acne, a different condition. (Id.) “Because Gueret also fails to disclose the required peeling methods,” the combination of these references would not lead to the claimed peeling methods, and the unexpected properties of the invention demonstrated in the Foltis Declaration establish non-obviousness. (Id. at 8.) Appellants contend that Kligman “does not compensate for Jacquet’s deficiencies,” and “relates to salicyclic acid, not the required compounds.” (Id. at 8.) The Examiner responds that “the only deficiency of Jacquet is the method steps in peeling treatment, and such was known in the art, according to Gueret.” (Ans. 17.) According to the Examiner, “Jacque[t] teaches that keratolytic agents are known to treat ‘diseases affecting the horny layer in man’. See col. 1, lines 17-21. The treatment results of hyperpigmentation, wrinkled skin, and photodamaged skin as presently claimed in claims 13-15 would have been obvious.” (Id. at 18.) The issues with respect to these rejections are: whether Jacquet’s disclosure is properly limited solely to treating acne; whether the combination of Jacquet and Gueret would not have led to the claimed peeling methods; and whether the Foltis Declaration presented evidence of unexpected results. Appeal 2011-008225 Application 12/010,897 11 Further Findings of Fact 12. We adopt the Examiner’s findings concerning the scope and content of the Jacquet, Gueret, and Kligman disclosures. Principles of Law “The entirety of the evidence must be reviewed in order to determine whether the claimed invention as a whole would have been obvious to a person of ordinary skill in the art.” In re Kumar, 418 F.3d 1361, 1369 (Fed. Cir. 2005). Each reference “must be read, not in isolation, but for what it fairly teaches in combination with the prior art as a whole.” In re Merck & Co., Inc., 800 F.2d 1091, 1097 (Fed. Cir. 1986) (citation omitted). Analysis The rejection directed attention to evidence that Jacquet expressly taught (1) that keratolytic products were sought for peeling, (2) that one of Jacquet’s preferred embodiments consisted of masks for peeling compositions, and (3) that Jacquet exemplified preparations of 5-n- octanoylsalicylic acid. Appellants’ contentions that Jacquet’s preparations could not have been used for peeling are thus inconsistent with Jacquet’s teachings, and unpersuasive because they provide no evidence that Jacquet’s teachings were mistaken. We conclude that the references were properly combined and that the totality of the evidence supports the conclusion of obviousness. For the reasons explained above, the evidence presented in the Foltis Declaration confirms the Gueret and Jacquet preference for 5-n- octanoylsalicylic acid, rather than showing that the properties of 5-n- Appeal 2011-008225 Application 12/010,897 12 octanoylsalicylic acid derivative were unexpected. As to treating hyperpigmentation, wrinkled skin, and photodamaged skin, the Examiner correctly points out that Jacquet disclosed that keratolytic products were used for treating diseases affecting the horny layer in man. This evidence is sufficient to suggest applying Gueret’s methods to those diseases and the conditions named in claims 13-15. We also find the Examiner’s assessment of the arguments (Ans. 17-19) consistent with the entirety of the evidence. NONSTATUTORY OBVIOUSNESS-TYPE DOUBLE PATENTING A. The rejections over Jacquet’s claims 1-10 in view of Gueret, and over Jacquet’s claims 1-10 in view of Gueret and Kligman. The Examiner’s position is that because Jacquet claimed a method using a composition comprising salicylic acid derivatives of Formula I as a beauty mask, and Gueret taught a method of exfoliating, i.e., peeling, skin, by applying a mask comprising 3 wt % 5-n-octanoylsalicylic acid for a period between 15 seconds and 20 minutes, the method defined in the appealed claims 1-7 and 9-17 would have been obvious and these claims should be rejected for obviousness-type double patenting. (Ans. 10-11.) Based on the additional disclosures of Kligman, the Examiner reached a similar conclusion regarding claims 18-20. (Id. at 11-12.) Appellants contend that (i) “Jacquet does not teach or suggest using the required salicylic acid compounds in the invention peeling methods,” (ii) “Gueret's disclosure is silent concerning skin peels and how to peel skin,” (iii) the combination of these references would not lead one of ordinary skill in the art to practice the invention peeling methods using the required salicylic acid derivatives,” (iv) Kligman does not compensate for Appeal 2011-008225 Application 12/010,897 13 these deficiencies, and (v) the Rule 1.132 Declaration is sufficient to establish non-obviousness. (App. Br. 9-10.) Jacquet’s claims 6 and 10 are directed to methods using a salicylic acid derivative in a “beauty mask with a keratolytic . . . effect.” (Jacquet, claim 1.) Because the ordinary meaning of keratolytic includes peeling, and because Jacquet’s claims define their invention with that term, and Gueret uses that term, Appellants’ arguments about peeling are unpersuasive. Appellants’ Formula I and Jacquet’s Formula I overlap, and Appellants do not show that Gueret’s 5-n-octanoylsalicylic acid derivative would not have been an obvious choice from the Formula I genera, given Gueret’s disclosure of that derivative as preferred. B. The rejection over copending claims in Application No. 10/367,700 in view of Jacquet and Gueret. The Examiner’s position is that claims of the copending application require “at least one keratolytic agent be present in the claimed composition, suggesting the use of the composition as a keratolytic agent.” (Ans. 13.) According to the Examiner, the copending claims and the appealed claims require applying to the body the same salicylic acid derivatives, “wherein the effective amount is within the overlapping range.” (Id. at 12.) Although the copending claims do not claim Appellants’ method, Jacquet and Gueret were found to have taught and suggested the claimed methods, and the Examiner concluded that the claimed subject matter would have been obvious. (Id. at 13.) Appellants maintain that “Jacquet and Gueret do not render the claimed methods obvious. The asserted ‘700 application claims do not Appeal 2011-008225 Application 12/010,897 14 compensate for their deficiencies.” (App. Br. 10.) According to Appellants, “the ‘700 application claims are directed to methods for enhancing the activity of active ingredients by combining the active ingredients with the claimed salicylic acid derivatives - they do not claim using the salicylic acid compounds as active agents, let alone as active agents in the claimed methods.” (Id.) The copending application claims compositions comprising an active agent and a salicylic acid derivative “present in an amount and a form effective to enhance the penetration of the active agent into skin,” (claim 16) “wherein the salicylic acid derivative is 5-n-octanoyl-salicylic acid” (claim 17). Appellants do not dispute the Examiner’s finding that the amounts of salicylic acid derivative used to enhance active agent penetration overlap with the amounts of 5-n-octanoyl-salicylic acid taught by Jacquet or Gueret. As the methods of Jacquet and Gueret included applying active agents in addition to the salicylic acid derivative, the evidence supports the Examiner’s position. SUMMARY We affirm the rejection of claims 1-4, 9, and 12-17 under 35 U.S.C. § 102(b) as anticipated by Gueret. We affirm the rejection of claims 5, 7, 10, and 11 under 35 U.S.C. § 103(a) as unpatentable over Gueret. We affirm the rejection of claims 1-7 and 9-20 under 35 U.S.C. § 103(a) as unpatentable over Jacquet and Gueret. We affirm the rejection of claims 18-20 under 35 U.S.C. § 103(a) as unpatentable over Jacquet and Kligman. Appeal 2011-008225 Application 12/010,897 15 We affirm the rejection of claims 1-7 and 9-17 under the judicially created doctrine of obviousness-type double patenting over claims 1-10 of Jacquet in view of Gueret. We affirm the rejection of claims 18-20 under the judicially created doctrine of obviousness-type double patenting over claims 1-10 of Jacquet in view of Gueret and Kligman. We affirm the rejection of claims 1-7 and 9-20 under the judicially created doctrine of obviousness-type double patenting over claims 6, 7, 9-12, 14-17, 19-22, 24, 25, and 27-42 of copending application 10/367,700 in view of Jacquet and Gueret. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). AFFIRMED lp Copy with citationCopy as parenthetical citation