Ex Parte SHAPIRO et alDownload PDFBoard of Patent Appeals and InterferencesFeb 23, 201109110409 (B.P.A.I. Feb. 23, 2011) 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. 09/110,409 07/06/1998 STANLEY S. SHAPIRO JBP-430 4653 7590 02/23/2011 AUDLEY A CIAMPORCERO JR JOHNSON AND JOHNSON ONE JOHNSON AND JOHNSON PLAZA NEW BRUNSWICK, NJ 089337003 EXAMINER WEDDINGTON, KEVIN E ART UNIT PAPER NUMBER 1614 MAIL DATE DELIVERY MODE 02/23/2011 PAPER 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. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES __________ Ex parte STANLEY S. SHAPIRO, MIRI SEIBERG, SUSAN NIEMEC, JOHN KUNG, and MICHAEL J. COSTANZO __________ Appeal 2010-011042 Application 09/110,409 Technology Center 1600 __________ Before TONI R. SCHEINER, ERIC GRIMES, and JEFFREY N. FREDMAN, Administrative Patent Judges. FREDMAN, Administrative Patent Judge. DECISION ON APPEAL1 This is an appeal under 35 U.S.C. § 134 involving claims to a method of effecting changes in skin pigmentation. The Examiner rejected the claims as anticipated and/or obvious. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. 1 The two-month time period for filing an appeal or commencing a civil action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing, as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE” (paper delivery mode) or the “NOTIFICATION DATE” (electronic delivery mode) shown on the PTOL-90A cover letter attached to this decision. Appeal 2010-011042 Application 09/110,409 2 Statement of the Case The Specification teaches “a method for affecting changes in mammalian skin pigmentation comprising topically applying to the skin of a mammal a compound which affects the PAR-2 pathway” (Spec. 3, ll. 8-10). According to the Specification, compositions “may contain . . . PAR-2 agonists, for increase in pigmentation” (Spec. 3, ll. 11-12). The Specification teaches that alternate compositions “may contain one or more compounds that act . . . as PAR-2 pathway inhibitors or as a PAR-2 antagonist for decrease in pigmentation” (Spec. 3, ll. 13-15). The Claims Claims 79, 82-91, 94, and 96 are on appeal. Claim 79 reads as follows: 79. A method of effecting changes in mammalian skin pigmentation comprising administering to a mammal a pigmentation- changing effective amount of a composition which affects the PAR-2-pathway wherein said composition comprises soybean extracts in which proteins have not been denatured and which comprise soy trypsin inhibitory activity. The issue The Examiner rejected claims 79, 82-91, and 96 under 35 U.S.C. § 102(b) as anticipated by, or in the alternative, under 35 U.S.C. § 103(a) as obvious over Gupta2 (Ans. 3-4). The Examiner finds that “Gupta et al. teach the preparation of soybean extract for food without denaturing proteins (see the abstract). Note the 2 Gupta et al., US 4,915,972, issued Apr. 10, 1990. Appeal 2010-011042 Application 09/110,409 3 undenaturated soybean extract is consumed by humans; therefore, the consumption of the undenaturated soybean extract would inherently effect the changes in the human skin pigmentation” (Ans. 4). The Examiner finds that “the cited reference does not teach the applicants’ preferred amount of the soybean extract set forth in claims 86-89. However, to determine an amount having the optimum effectiveness to change mammalian skin pigmentation is well within the level of one having ordinary skill in the art” (Ans. 4). Appellants “submit that Gupta et al. very clearly indicates that it is important to deactivate undesirable enzyme activity, including trypsin inhibitors, in the soybean materials utilized therein. Appellants respectfully contend that Gupta et al. neither explicitly nor implicitly describes the methods or compositions of appellants’ claims” (App. Br. 7). Appellants contend that “nowhere does Gupta et al. suggest or describe soy-derived compositions that have not been denatured. Nor, notably, does Gupta et al. suggest or direct one to place the compositions that are described topically on the skin” (App. Br. 7). The issue with respect to this rejection is: Does the evidence of record support the Examiner’s conclusion that Gupta teaches or suggests the limitations of claim 79? Findings of Fact 1. The Specification teaches, in the “Summary of the Invention” section, that “we have found a method for affecting changes in mammalian skin pigmentation comprising topically applying to the skin of a mammal a compound which affects the PAR-2 pathway” (Spec. 3, ll. 8-10). Appeal 2010-011042 Application 09/110,409 4 2. The Specification teaches that the “compounds which are active in the compositions and methods of this invention may be delivered topically by any means known to those of skill in the art” (Spec. 13, ll. 1-2). 3. The Specification teaches that if the “delivery parameters of the topically active pharmaceutical or cosmetic agent so require, the topically active composition of this invention may preferably be further composed of a pharmaceutically or cosmetically acceptable vehicle capable of functioning as a delivery system to enable the penetration of the topically active agent into the skin” (Spec. 13, ll. 3-7). 4. The Specification teaches that as “used herein ‘amount effective’ shall mean an amount sufficient to cover the region of skin surface where a change in pigmentation is desired” (Spec. 14, ll. 29-31). 5. Gupta teaches: A method is disclosed for producing protein foods and edible oils from protein and oil containing seeds which comprises disintegrating the seeds in an oxygen-free environment, such that air is prevented from entering in and mixing with said environment, to prevent seed enzymes from producing off-flavors and bitter taste without heat treating seeds to inactivate the enzymes and concomitantly insolubilize the seed proteins. Artificial milk extracted from soybeans using this method has no-beany flavor, bitter taste, or chalkiness. Flaking of soybeans employing this method gives bland flakes without denaturing proteins. Such flakes are suitable for making highly functional palatable protein foods. (Gupta, abstract). Appeal 2010-011042 Application 09/110,409 5 6. Gupta teaches that “inactivating enzymes for the purpose of controlling off-flavors after disintegrating the seeds is not necessary in the present invention” (Gupta, col. 3, ll. 35-37). 7. Gupta teaches that “[h]owever, inactivating enzymes in the disintegrated seed products at a convenient step in processing is recommended to improve the nutritional quality of the foods and to simultaneously get rid of any residual undesirable enzyme activity” (Gupta, col. 3, ll. 38-41). 8. Example 6 of Gupta teaches preparation of soymilk where “the slurry transferred to a pressure cooker and the slurry cooked for a few minutes at 15 p.s.i. pressure to inactivate trypsin inhibitor” (Gupta, col. 6, ll. 18-20). 9. Embodiment 5 of Gupta teaches “heating the extracted oil sufficiently to inactivate lipoxygenase enzyme” (Gupta, col. 4, ll. 36-38). 10. Embodiment 6 of Gupta teaches “heating the extracted oil sufficiently to inactivate lipoxygenase enzyme” (Gupta, col. 4, ll. 47-48). Principles of Law “[A]nticipation of a claim under § 102 can be found only if the prior art reference discloses every element of the claim ….” In re King, 801 F.2d 1324, 1326 (Fed. Cir. 1986) (citing Lindemann Maschinenfabrik GMBH v. American Hoist and Derrick Co., 730 F.2d 1452, 1457 (Fed. Cir. 1984)). “Inherency … 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.” MEHL/Biophile Int’l. Corp. v. Milgraum, Appeal 2010-011042 Application 09/110,409 6 192 F.3d 1362, 1365 (Fed. Cir. 1999) (quoting In re Oelrich, 666 F.2d 578, 581 (CCPA 1981)). An invention “composed of several elements is not proved obvious merely by demonstrating that each of its elements was, independently, known in the prior art….[I]t can be important to identify a reason that would have prompted a person of ordinary skill in the relevant field to combine the elements in the way the claimed new invention does.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007). Analysis Claim interpretation is at the heart of patent examination because before a claim is properly interpreted, its scope cannot be compared to the prior art. In this case, the issue is whether the requirement of claim 79 of “administering to a mammal a pigmentation-changing effective amount” is limited to topical administration. Appellants contend that “[n]or, notably, does Gupta et al. suggest or direct one to place the compositions that are described topically on the skin” (App. Br. 7). During prosecution, claim terms are given their broadest reasonable interpretation as they would be understood by persons of ordinary skill in the art in the light of the Specification. Therefore, we first turn to the Specification to determine whether the meaning of the phrase “administering to a mammal a pigmentation-changing effective amount” can be discerned. The Specification solely teaches topical administration (FF 1-4). The Specification expressly teaches that the “compounds which are active in the compositions and methods of this invention may be delivered topically by any means known to those of skill in the art” (Spec. 13, ll. 1-2; FF 2; Appeal 2010-011042 Application 09/110,409 7 emphasis added). The Specification teaches that as “used herein ‘amount effective’ shall mean an amount sufficient to cover the region of skin surface where a change in pigmentation is desired” (Spec. 14, ll. 29-31; FF 4). The Examiner does not specifically address claim interpretation, but instead contends that “consumption of the undenatured soybean extract would inherently effect the changes in the human skin pigmentation” (Ans. 4). The Examiner therefore implicitly argues for an interpretation of “administering” which encompasses oral consumption. We find that Appellants have the better position. The Specification is entirely devoted to topical administration and the phrase “effective amount” is expressly defined as an amount “sufficient to cover the region of skin surface where a change in pigmentation is desired” (Spec. 14, ll. 29-31; FF 4). This express definition makes sense only in the context of topical administration. Further, we are not persuaded by the Examiner’s inherency argument (Ans. 4). The Examiner provides no reason or evidence to think it even probable, much less necessary, that oral administration of soybean extract would result in the same change in skin pigmentation as topical administration. When relying upon a theory of inherency, the Examiner must provide a basis in fact and/or technical reasoning to reasonably support the Examiner’s determination that the allegedly inherent characteristic necessarily flows from the teachings of the applied prior art. Ex parte Levy, 17 USPQ2d 1461, 1463-64 (BPAI 1990). Here, the Examiner merely makes a determination without providing any basis in fact and/or technical reasoning (see Ans. 4). No factual support is provided by the Examiner, nor Appeal 2010-011042 Application 09/110,409 8 did the Examiner provide any technical reasoning to show that the oral administration of soy extract of Gupta would reasonably be expected to inherently result in the same changes in skin pigmentation which are caused by topical administration as in the instant Specification. While the Examiner rejected the claims under both 35 U.S.C. § 102(b) and 35 U.S.C. § 103(a), the Examiner provided no reasoning as to why topical administration would have been obvious over Gupta. Conclusion of Law The evidence of record does not support the Examiner’s conclusion that Gupta teaches or suggests the limitations of claim 79. SUMMARY In summary, we reverse the rejection of claims 79, 82-91, and 96 under 35 U.S.C. § 102(b) as anticipated by, or in the alternative, under 35 U.S.C. § 103(a) as obvious over Gupta. REVERSED dm AUDLEY A CIAMPORCERO JR JOHNSON AND JOHNSON ONE JOHNSON AND JOHNSON PLAZA NEW BRUNSWICK NJ 08933-7003 Copy with citationCopy as parenthetical citation