Ex Parte Huang et alDownload PDFPatent Trial and Appeal BoardNov 30, 201211094496 (P.T.A.B. Nov. 30, 2012) 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. 11/094,496 03/30/2005 Lei Huang KCX-949 (21052) 1471 22827 7590 11/30/2012 DORITY & MANNING, P.A. POST OFFICE BOX 1449 GREENVILLE, SC 29602-1449 EXAMINER WEBB, WALTER E ART UNIT PAPER NUMBER 1612 MAIL DATE DELIVERY MODE 11/30/2012 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 PATENT TRIAL AND APPEAL BOARD __________ Ex parte LEI HUANG and SHU-PING YANG __________ Appeal 2012-000816 Application 11/094,496 Technology Center 1600 __________ Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and ERICA A. FRANKLIN, Administrative Patent Judges. FRANKLIN, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134(a) involving claims to a method for inhibiting and/or treating infection caused by Candida albicans. The Patent Examiner rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm-in-part. STATEMENT OF THE CASE Claims 7, 9-12, 15-16, 20-28, 46 and 53-54 are on appeal. Claims 21, 53 and 54 are representative and read as follows: Appeal 2012-000816 Application 11/094,496 2 21. A method for inhibiting and/or treating infection caused by Candida albicans, the method comprising administering a treatment composition into a vagina of a female who has a vaginal infection caused by Candida albicans, the treatment composition comprising from about 1 to about 100 milligrams per milliliter of a saccharide that consists of a nonionic alkyl glycoside, wherein the alkyl glycoside has the following formula: wherein, Z is a residue of glucose, fructose, maltose, maltotriose, lactose, galactose, mannose, dextrose, xylose, sucrose, leucrose, or combinations thereof; n is from about 1 to about 1000; and R is an alkyl group having 8 to 30 carbon atoms. wherein the treatment composition is free of additional anti-microbial agents effective against Candida albicans. 53. The method of claim 21, wherein the treatment composition is free of additional anti-microbial agents effective against Candida albicans. 54. The method of claim 21, wherein the treatment composition is free of additional anti-microbial agents. The following grounds of rejection are presented for review in this appeal: • claims 7, 9-12, 15, 16, 20-24, 26-28, 46, 53, and 54 under 35 U.S.C. § 103(a) as unpatentable over Resheski-Wedepohl; 1 • claims 7, 9-12, 20-23 and 26-28 under 35 U.S.C. § 103(a) as unpatentable over Resheski-Wedepohl and Liu; 2 1 Patent No. US 6,531,435 B1 issued to Kim L. Resheski-Wedepohl et al., Mar. 11, 2003. Appeal 2012-000816 Application 11/094,496 3 • claims 15, 16 and 24 under 35 U.S.C. § 103(a) as unpatentable over Resheski-Wedepohl and Liu; Appellants have not appealed the rejection of claim 25 under 35 U.S.C. § 103(a) as unpatentable over Resheski-Wedepohl and Wright 3 or the rejection of claim 25 under 35 U.S.C. § 103(a) over as unpatentable over Resheski-Wedepohl, Liu and Wright. (See Final Rejection 2-3, dated Oct. 12, 2010; App. Br. 3; Reply Br. 3.) We therefore summarily affirm both of these unappealed rejections. MANUAL OF PATENT EXAMINING PROCEDURE § 1205.02 (―If a ground of rejection stated by the examiner is not addressed in the appellant’s brief, that ground of rejection will be summarily sustained by the Board.‖); see also, Ex parte Frye, 2010 WL 889747 *4 (BPAI 2010) (precedential) (―If an appellant fails to present arguments on a particular issue—or, more broadly, on a particular rejection—the Board will not, as a general matter, unilaterally review those uncontested aspects of the rejection‖). OBVIOUSNESS I. The Rejection of Claims 7, 9-12, 15, 16, 20-24, 26-28, 46, 53, and 54 over Resheski-Wedepohl The Examiner’s position is that Resheski-Wedepohl taught a vaginal cleanser comprising an alkyl polyglycoside and a pharmaceutically 2 Hui Liu et al., Interaction between chitosan and alkyl β-D-glucopyranoside and its effect on their antimicrobial activity, 56 CARBOHYDRATE POLYMERS, 243-250 (2004). 3 US Patent No. 2,649,398 issued to John H. Wright, Aug. 18, 1953. Appeal 2012-000816 Application 11/094,496 4 acceptable carrier. (Ans. 5.) The Examiner found that Resheski-Wedepohl disclosed Glucopon 600 as a suitable alkyl polyglycoside, which has a structure that satisfies the structure set forth by the claimed invention. (Id.) The Examiner also found that Resheski-Wedepohl taught that its composition may optionally additionally comprise antimicrobial agents and/or anti-inflammatory agents, and may be formulated as a douche. (Id.) The Examiner found that Resheski-Wedepohl taught that microorganisms such as Candida albicans and Trichomonas vaginalis are generally associated with vaginitis, i.e., inflammation, or venereal disease, but did not teach administering its cleanser into a vagina of a female who has an infection caused by Candida albicans. (Id.) According to the Examiner, it would have been obvious to a person of ordinary skill in the art at the time the invention was made to have administered the cleanser of Resheski-Wedepohl into the vagina of a female who has an infection caused by Candida albicans ―since the cleanser would be expected to clean the infected area as well as prevent further exacerbation of inflammation via production of TSST-1 [4] .‖ (Id. at 6.) The Examiner found that an ―artisan would have also reasonably expected success in treating the infection since the cleanser may also comprise active materials such as antimicrobials, anti-parasitic agents, anti-pruritics, local anesthetics, and anti-inflammatory agents.‖ (Id.) Further, the Examiner found that the artisan would have reasonably expected that a composition comprising such active materials would be able to treat inflammation caused by Candida albicans. (Id.) 4 Toxic Shock Syndrome Toxin-1, a Staphylococcus aureus associated toxin (Resheski-Wedepohl, col. 1, l. 57-62). Appeal 2012-000816 Application 11/094,496 5 Appellants contend that a skilled artisan would not be lead to use the composition of Resheski-Wedepohl to treat a vaginal infection caused Candida albicans by the reference teachings that (a) its composition may comprise anti-inflammatory agents and (b) Candida albicans may be responsible for inflammation. (App. Br. 4.) Appellants assert that at most a skilled artisan would have been motivated to administer such anti- inflammatory agents alone, i.e., without the alkyl polyglycoside of Resheski- Wedepohl. (Id. at 5.) According to Appellants, There would be no reason at all to administer the alkyl polyglycoside of Resheski-Wedepohl et al. in conjunction with the anti-inflammatory agents because this compound is said to only have the effect of reducing the production of exoprotein toxins by Gram positive bacteria – not in inhibiting and/or killing Candida albicans (a yeast). (Id.) Thus, Appellants assert that based upon the disclosure of Resheski- Wedepohl, a skilled artisan would not have had a reasonable expectation of successfully inhibiting and/or killing Candida albicans by administering the composition of Resheski-Wedepohl. (Id.) After considering the evidence and arguments, we conclude that the Examiner has not made a prima facie case of obviousness. Specifically, for the reasons discussed by Appellants, we agree that Resheski-Wedepohl did not teach or suggest the claimed method for inhibiting and/or treating infection caused by Candida albicans, comprising administering its composition disclosed as useful for inhibiting the production of TSST-1 and enterotoxins from bacteria. In particular, what is missing from the rejection is a teaching or suggestion that the alkyl polyglycoside cleanser of Resheski- Wedepohl would inhibit and/or treat a Candida albicans vaginal infection. Appeal 2012-000816 Application 11/094,496 6 That is, while Resheski-Wedepohl teach the use of the alkyl polyglycoside cleanser in a patient population with S. aureus infection, there is no reason given to necessarily apply the alkyl polyglycoside cleanser to a patient population which has active Candida albicans vaginal infections. There is also no reason given to demonstrate that these patient populations would necessarily overlap. Accordingly, we reverse the rejection of claims 7, 9-12, 15-16, 20-24, 26-28, 46, and 53-54 over Resheski-Wedepohl. II. The Rejection of Claims 7, 9-12, 15-16, 20-24, and 26-28 over Resheski-Wedepohl and Liu In addition to the findings set forth above for Resheski-Wedepohl, the Examiner additionally found that Liu taught that the nonionic surfactant, alkyl β-D-glucopyranoside (AG) has antifungal activity. (Ans. 8.) Specifically, the Examiner found that Liu taught that the AG Glucopon 600 inhibited Candida albicans in vitro. (Id.) According to the Examiner, it would have been obvious to a person of ordinary skill in the art at the time the invention was made to have used the composition of Resheski-Wedepohl to inhibit or treat an infection caused by Candida albicans because that composition comprised Glucopon 600 which Liu disclosed as having antifungal activity against Candida albicans. (Id.) Appellants contend, in the Reply Brief, that Liu teaches only that AG is a relatively poor inhibitor of Candida albicans in comparison with complexes formed between AG and chitosan. (Reply Br. 6.) According to Appellants, ―one skilled in the art reading Liu, et al. would not be lead to believe that the AG of Liu, et al. would be effective against Candida Appeal 2012-000816 Application 11/094,496 7 albicans, particularly when administered in vivo into the vagina of a female.‖ (Id.) We are not persuaded by Appellants’ contention. As the Examiner correctly found, Liu disclosed that the AG Glucopon 600 showed biocidal activity against Candida albicans. (Ans. 8; Liu 248.) Liu also disclosed that the combination, i.e., ―dynamic association mixture‖ of chitosan, a natural antimicrobial agent, and AG ―showed obviously stronger biocidal activity than chitosan and AG, respectively.‖ (Liu 248.) However, we do not find that this disclosure comparing AG alone with the dynamic association mixture of AG and a known antimicrobial agent would have led a skilled artisan away from using AG to inhibit a Candida albicans. Rather, Liu’s disclosure merely provided an enhanced alternative for such activity without criticizing, discrediting, or otherwise discouraging the use of AG to inhibit Candida albicans. See In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004). In addition, Appellants’ claim 21 does not exclude the administration of a complex formed between AG and chitosan, but instead requires a treatment composition comprising a nonionic alkyl glycoside, such as AG (see Appellants’ claim 21). Accordingly, we affirm the rejection of independent claim 21 over Resheski-Wedepohl and Liu. Appellants have not raised separate arguments for the rejection of dependent claims 7, 9-12, 15-16, 20- 24, and 26-28over Resheski-Wedepohl and Liu. Accordingly, these claims fall with claim 21. See 37 C.F.R. § 41.37(c)(1)(vii). Appeal 2012-000816 Application 11/094,496 8 SUMMARY We reverse the rejection of claims 7, 9-12, 15-16, 20-24, 26-28, 46, and 53-54 under 35 U.S.C. § 103(a) as unpatentable over Resheski- Wedepohl; we affirm the rejection of claims 7, 9-12, 20-23, and 26-28 under 35 U.S.C. § 103(a) as unpatentable over Resheski-Wedepohl and Liu; we affirm the rejection of claims 15, 16 and 24 under 35 U.S.C. § 103(a) as unpatentable over Resheski-Wedepohl and Liu; we affirm the rejection of claim 25 under 35 U.S.C. § 103(a) as unpatentable over Resheski-Wedepohl and Wright we affirm the rejection of claim 25 under 35 U.S.C. § 103(a) and as unpatentable over Resheski-Wedepohl, Liu and Wright. 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-IN-PART cdc Copy with citationCopy as parenthetical citation