10599779 (B.P.A.I. Jun. 7, 2012)

Ex Parte Ho

Board of Patent Appeals and InterferencesJun 7, 2012

10599779 (B.P.A.I. Jun. 7, 2012)

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. 10/599,779 06/28/2007 Thienna Ho 70063.00004 4440 58688 7590 06/07/2012 CONNOLLY BOVE LODGE & HUTZ LLP P.O. BOX 2207 WILMINGTON, DE 19899 EXAMINER YU, GINA C ART UNIT PAPER NUMBER 1617 MAIL DATE DELIVERY MODE 06/07/2012 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 THIENNA HO __________ Appeal 2011-012254 Application 10/599,779 Technology Center 1600 __________ Before DEMETRA J. MILLS, FRANCISCO C. PRATS, and JEFFREY N. FREDMAN, Administrative Patent Judges. Opinion for the Board filed by Administrative Patent Judge FREDMAN. Concurring opinion filed by Administrative Patent Judge PRATS. FREDMAN, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to a method for lightening the natural skin tone of a user. The Examiner rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. Appeal 2011-012254 Application 10/599,779 2 Statement of the Case “The invention provides a method for skin lightening that is effective in lightening the natural skin tone of a user, and which is safe when topically applied to human skin” (Spec. 1). “[M]ethyl sulfonyl methane is delivered to an individual in an effective amount over an extended period of time, such as several months or longer, or until the desired degree of skin lightening is achieved” (Spec. 2). The Claims Claims 1, 4-6, 9-11, 13, 15, 17, and 19 are on appeal. Claim 1 is representative and reads as follows: 1. A method for causing a person to develop a skin tone noticeably lighter than the person‟s natural skin tone, comprising delivering an effective amount of methyl sulfonyl methane to a person for developing a lighter skin tone by ingestion of the effective amount, at least until the person develops a skin tone noticeably lighter than before commencement of the delivery step, wherein the effective amount comprises orally administered doses in an amount of at least 133 mg of methyl sulfonyl methane per kilogram of body weight per day continuing for not less than three months. The issue The Examiner rejected claims 1, 4-6, 9-11, 13, 15, 17, and 19 under 35 U.S.C. § 103(a) as obvious over Herschler, 1 Webster‟s Dictionary, 2 and Salim 3 (Ans. 5-7). 1 Herschler, R., US 4,296,130, issued Oct. 20, 1981. 2 Webster's Ninth New Collegiate Dictionary 296 (1991). 3 Salim, M., WO 94/05279 A1, published Mar. 17, 1994. Appeal 2011-012254 Application 10/599,779 3 The Examiner finds that Herschler teaches methyl sulfonyl methane (MSM) can be included in a cosmetic or other preparations applied to the skin, and beautifies the complexion, improves the condition of the scalp and hair and help to make the body of the user more flexible and comfortable. The reference also teaches MSM can be administered orally (Ans. 5). The Examiner finds that “Salim teaches a method of treating and improving skin condition by administering methyl sulfonyl methane and a sulfur-containing amino acid. The reference teaches the composition may be administered topically, orally or parenterally” (id.). The Examiner finds that the “applicant‟s claim of development of „a skin tone noticeably lighter than the person‟s natural skin tone‟ by administering MSM to the patient would naturally flow from practicing the Herschler method, which would have been obviously observed by one of ordinary skill in the art” (id. at 6). Appellant contends that “the entire disclosure of Herschler shows absolutely no recognition or conception that MSM has any effect on skin tone” (App. Br. 7). Appellant contends that “a reasonable reading of Salim leads to the conclusion that Salim taught maximum oral doses of MSM significantly less than claimed” (id. at 9). Appellant contends that “neither reference contains any hint that MSM could be used to lighten natural skin tone, and neither reference discloses any dose of MSM that would have inherently caused a lighter skin tone” (Reply Br. 2). Appeal 2011-012254 Application 10/599,779 4 Appellant contends that “MSM‟s skin lightening effects would not have been considered expected or predictable at the time these effects were first reported by [A]ppellant in the present application” (App. Br. 10). The issue with respect to this rejection is: Does the evidence of record support the Examiner‟s conclusion that Herschler, Webster‟s Dictionary and Salim render obvious a method of lightening skin tone with methyl sulfonyl methane as required by claim 1? Findings of Fact 1. Herschler teaches that “compositions containing methylsulfonylmethane (MSM) can be used effectively to soften skin” (Herschler, col. 2, ll. 18-20). 2. Herschler teaches that “MSM has proved to have varied and useful properties when applied to any animal tissue subject to undesired chemical bond formation including cross-linking. It has been observed to beautify the complexion” (Herschler, col. 2, ll. 29-32). 3. Webster‟s Dictionary defines complexion as “the hue or appearance of the skin and esp. of the face” (Webster‟s Dictionary 269). 4. Salim teaches “a synergistic pharmaceutical composition comprising methyl sulphonylmethane and a sulphur containing amino acid” (Salim 1). 5. Salim teaches that “[w]hen presented in unit dose form, each unit dose preferably contains from 100 to 500 mg of each of its ingredients. This dosage may be given once or more daily preferably at intervals of from 2 to 8 hours, most preferably every 6 hours” (Salim 7). Appeal 2011-012254 Application 10/599,779 5 6. Salim teaches that: Women with obvious facial wrinkles were randomized to receive the formulation described in Example 1.D or to the control group and were treated twice daily for 6 months then once daily (overnight application) for 18 months. The wrinkles were mapped on special charts and any improvements in their appearance, in terms of making them less visible, were calculated as percentage improvements. While the control group (n = 45, age range 50 to 59 years, mean 54) had after six months a 5% improvement, the active therapy group (n = 48, age range 48 to 59 years, mean 56) achieved a 71% improvement over this time period. At the end of the study (2 years) the percentage improvement in the control group has extended to 10% but this improvement had reached 89% in the active therapy group. (Salim 18.) Principles of Law “In rejecting claims under 35 U.S.C. § 103, the examiner bears the initial burden of presenting a prima facie case of obviousness. Only if that burden is met, does the burden of coming forward with evidence or argument shift to the applicant.” In re Rijckaert, 9 F.3d 1531, 1532 (Fed. Cir. 1993). “[R]ejections on obviousness grounds cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007). Analysis The Examiner finds that the “applicant‟s claim of development of „a skin tone noticeably lighter than the person‟s natural skin tone‟ by Appeal 2011-012254 Application 10/599,779 6 administering MSM to the patient would naturally flow from practicing the Herschler method, which would have been obviously observed by one of ordinary skill in the art” (Ans. 6). We are not persuaded. We agree with Appellant that “the entire disclosure of Herschler shows absolutely no recognition or conception that MSM has any effect on skin tone” (App. Br. 7). While Herschler certainly used the word “complexion,” the ordinary artisan would have understood Herschler to teach MSM as a skin softener, which would improve complexion (FF 1). There is also no teaching or suggestion in Salim to treat patients with MSM in order to change the hue of the patient‟s skin. Salim teaches treatment of wrinkles (FF 6). In addition, we agree that the doses required by Appellant‟s claims far exceed the doses used by Herschler or Salim for their purposes. Even when the Examiner stretches these disclosures to the utmost to argue dosing of 200 mg/day by taking the maximum 500 mg pill four times a day, the Examiner finds a maximum dosage of 44 mg/kg/day (Ans. 10), which is still only about 1/3 of the 133 mg/kg/day required by claim 1. There is no reason given in the prior art to triple the doses, nor is there any expectation that this would impact the hue of skin. We have considered the Barashkov 4 and Backman 5 Declarations, but find their disclosure simply supports our position that the claims are not obvious over the cited prior art by confirming the ordinary understanding of the word “complexion” and the difference in dosing of MSM. 4 Declaration of Dr. Nikolay N. Barashkov, filed Dec. 7, 2009. 5 Declaration of Sherilee J. Backman, filed Jan. 22, 2010. Appeal 2011-012254 Application 10/599,779 7 Conclusion of Law The evidence of record does not support the Examiner‟s conclusion that Herschler, Webster‟s Dictionary and Salim render obvious a method of lightening skin tone with methyl sulfonyl methane as required by claim 1. SUMMARY In summary, we reverse the rejection of claims 1, 4-6, 9-11, 13, 15, 17, and 19 under 35 U.S.C. § 103(a) as obvious over Herschler, Webster‟s Dictionary, and Salim. REVERSED cdc Appeal 2011-012254 Application 10/599,779 8 PRATS, Administrative Patent Judge, concurring. I agree with my colleagues‟ decision to reverse the appealed rejection. However, I would limit the grounds for reversal to the significant and unobvious difference, discussed above by the majority, between the dosage required by the claims and the dosages described in the prior art.