Ex Parte Pilch et alDownload PDFPatent Trial and Appeal BoardAug 22, 201611850955 (P.T.A.B. Aug. 22, 2016) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 111850,955 0910612007 23909 7590 08/24/2016 COLGATE-PALMOLIVE COMPANY 909 RIVER ROAD PISCATAWAY, NJ 08855 FIRST NAMED INVENTOR Shira Pilch 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 ATTORNEY DOCKET NO. CONFIRMATION NO. 8147-00-0C 8412 EXAMINER SIMMONS, CHRIS E ART UNIT PAPER NUMBER 1629 NOTIFICATION DATE DELIVERY MODE 08/24/2016 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): Patent_Mail@colpal.com uspto@thebellesgroup.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte SHIRA PILCH and JAMES GERARD MASTERS 1 Appeal2015-000605 Application 11/850,955 Technology Center 1600 Before JOHN G. NEW, RICHARD J. SMITH, and RY ANH. FLAX, Administrative Patent Judges. SMITH, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to a method of treating dry mouth that have been rejected as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. STATEMENT OF THE CASE Background "Dry mouth, clinically called xerostomia ... can cause discomfort and lead to pathological conditions" depending on its severity. (Spec. i-f 1.) 1 According to Appellants, the real party in interest is Colgate-Palmolive Company. (Br. 2.) Appeal2015-000605 Application 11/850,955 Claims on Appeal Claims 1, 2, 4, 6, 8-12, 16-19, 21, 22, 24, and 27 are on appeal. 2 (Claims Appendix, Br. 14--15.) Independent claim 1 is illustrative and reads as follows: 1. A method of treating dry mouth comprising administering to a subject in need thereof an effective amount of a composition comprising at least one surfactant; at least one anti-microbial agent; and at least one glycoaminoglycan polysaccharide. 3 Examiner's Rejection Claims 1, 2, 4, 6, 8-12, 16-19, 21, 22, 24, and 27 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Pinol4 as evidenced by Talwar,5 the Translation6 as evidenced by Ialenti,7 and Svirkin.8 (Ans. 2.) Claims 1, 2, 4, 6, 8-12, 16-19, 21, 22, 24, and 27 were not separately argued, and we therefore limit our consideration to claim 1. See 37 C.F.R. § 41.37(c)(l)(iv). 2 The claims are subject to an election of species/restriction requirement. See Response to Restriction Requirement dated July 26, 2011. 3 The elected species of claim 1 are composition-mouthwash, surfactant- cocoamidopropyl betaine, and anti-microbial agent---cetylpyridinium chloride, and glycoaminoglycan polysaccharide is the adhesive. (Br. 3.) 4 Pinol et al., US 2004/0247532 Al, published Dec. 9, 2004 ("Pinol"). 5 Talwar et al., US 4,945,087, issued July 31, 1990 ("Talwar"). 6 JIA et al., New Formulation of Drug Controlled Release, Chemical Industry Press, 243-44 (2005) ("the Translation"). 7 Ialenti et al., 3 Mediators of Inflammation 4, Hindawi Publishing Corp., 287-89 ( 1994) ("Ialenti"). 8 Svirkin et al., US 2006/0094643 Al, published May 4, 2006 ("Svirkin"). 2 Appeal2015-000605 Application 11/850,955 FINDINGS OF FACT We adopt as our own the Examiner's findings and analysis concerning the scope and content of the prior art. The following findings are included for emphasis and reference convenience. FF 1. Pinol teaches compositions for the relief of xerostomia (dry mouth) that may be in the form of a mouthwash. (Pinol Abstract.) FF 2. Pinol teaches an example of a mouthwash composition that includes an antifungal/antimicrobial agent (triclosan) and a surfactant. (Id. i-f 57.) FF 3. Pinol teaches use of the surfactant cocoamidopropyl betaine and the anti-microbial cetylpyridinium chloride. (Pinol i-f 59, Abstract.) FF 4. The Examiner finds that the compositions contemplated by Pinol are for topical use and can be formulated in the form of mouthwashes, sprays, oral gels, and toothpastes, with the help of the conventional ingredients used for these topical forms, well known by those skilled in the art .... Oral gels include polymers that gel the compositions, which allows direct, stable application to the oral cavity'. (Ans. 4, citing Pinol i-fi-128, 52.) FF. 5. The Translation teaches use of an adhesive polymer "as carrier and long time attaching to mucous membrane via bioadhesion ... so as to extend the resident time and release time of the drug at the attached position and achieve the purpose of targeted administration." Also taught are conventional bioadhesives, including hyaluronic acid. 9 (Translation 243--44.) 9 Hyaluronic acid is a type or example of glycoaminoglycan polysaccharide. (Br. 9 and Br. 14, claim 11.) 3 Appeal2015-000605 Application 11/850,955 FF 6. Svirkin teaches oral compositions, including mouthwash, for treating dry mouth. The composition may include free hyaluronic acid. (Svirkin i-fi-f 10, 12, 188.) FF 7. The Examiner finds that the composition taught by Svirkin provides an alternative to the continual and frequent application of therapeutic agents for the treatment of . . . dry mouth . . . the efficacy of hyaluronic acid in alleviating . . . dry mouth can be enhanced by covalently attaching hyaluronic acid to the affected body surface or tissue. Such attachment reduces the need for repeated and frequent application of . . . dry mouth agents because the hyaluronic acid is less likely to be rinsed away in the process of ... swallowing. (Ans. 6, citing Svirkin i-f 10.) ISSUE Whether a preponderance of the evidence of record supports the Examiner's conclusion of obviousness under 35 U.S.C. § 103(a). ANALYSIS The Examiner concluded that the claimed invention would have been prima facie obvious to one skilled in the art because Pinol and Svirkin teach oral compositions, such as mouthwash, for treating dry mouth. (Ans. 6; FF 1-3, 6.) Pinol also teaches that oral gels may include polymers which allow direct, stable application to the oral cavity (FF 4 ), and the Translation teaches bioadhesives, such as hyaluronic acid (i.e., glycosaminoglycan), for attaching drugs to mucous membranes "so as to extend the resident time and release time of the drug at the attached position and achieve the purpose of targeted administration" (FF 5). (Ans. 6.) Svirkin also teaches that alleviating dry mouth can be enhanced by using hyaluronic acid so as to reduce the need for repeated and frequent application of dry mouth agents 4 Appeal2015-000605 Application 11/850,955 that may otherwise be rinsed away in the process of swallowing. (Id. at 7; FF 7.) We find that the Examiner has satisfied the burden of showing "some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness." KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007). In particular, we find that Pinol teaches and suggests the use of a composition (e.g., mouthwash) for treating dry mouth, including elected species cocoamidopropyl betaine and cetylpyridinium chloride (FF 1--4), and the Translation and Svirkin teach and suggest, and provide the motivation for including, hyaluronic acid in the mouthwash of Pinol (FF 5-7). Accordingly, the Examiner has established a prima facie case of obviousness and, as discussed below, Appellants have not overcome that prima facie case. Elected Species Appellants contend that the Examiner's rejection is in error because it does not address the patentability of Appellants' elected species, but rather the patentability of the broader generic claim. (Br. 4.) Appellants rely on Ex parte Ohsaka, 2 USPQ2d 1460, 1461 (BPAI 1987), as support for this argument. We are not persuaded by this argument, and find no error in the Examiner's rejection based on the elected species. (See Ans. 9-13.) Moreover, the specific issue presented for review is whether Appellants' claimed method, conducted with the elected species of claim 1, would have been obvious under 35 U.S.C. § 103(a). See Ohsaka, 2 USPQ2d at 1461. In this case, all of the elected species of claim 1 are taught by the cited references, and we conclude claim 1 would have been obvious. 5 Appeal2015-000605 Application 11/850,955 Lead-Modification Analysis Appellants argue that the Examiner is required to follow "a 'lead- modification' analysis similar to that involving novel compounds." (Br. 9.) We are not persuaded by this argument, and find no error in the Examiner's rejection. Claim 1 is not directed to a novel compound, but rather to a method of treating dry mouth comprising the administration of a composition comprising at least one of three specific components. (Br. 14.) Accordingly, the test for obviousness is what the combined teachings of Pinol, the Translation, and Svirkin would have suggested to one of ordinary skill in the art. See In re Keller, 642 F.2d 413, 425 (CCPA 1981) (citing cases). Here, the prior art teaches treating dry mouth using a mouthwash comprising the surfactant cocoamidopropyl betaine, the anti-microbial cetylpyridinium chloride, and the adhesive glycoaminoglycan polysaccharide. 10 1'vf otivation Appellants argue that there is no motivation or reasoning to select cetylpyridinium chloride as the anti-microbial agent, to combine it with hyaluronic acid (glycoaminoglycan polysaccharide ), and to further combine both of those components with cocoamidopropyl betaine as the surfactant. (Br. 10.) 10 We acknowledge, but are unpersuaded by, Appellants' contention that, while there is no limit on the number of references that can be relied upon, the number of references in this case suggest that the Examiner used the claims "as the answer key." (Br. 5.) We note Appellants' statement that the rejection is based on only three references (id. at 9) and further note that the Examiner points to specific disclosures in those references that support the obviousness rejection. (Ans. 2-9.) 6 Appeal2015-000605 Application 11/850,955 We are not persuaded by those arguments, and find no error in the Examiner's rejection. As an initial matter, we note that selection of components from a group of possible components is permissible in an obviousness rejection. See In re Arkley, 455 F.2d 586, 587 (CCPA 1972) ("picking and choosing may be entirely proper in the making of a 103, obviousness rejection"); see also Merck & Co., Inc. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989) ("That the [prior art] patent discloses a multitude of effective combinations does not render any particular formulation less obvious"). Here, Pinol suggests the use of a mouthwash comprising cetylpyridinium chloride as the anti-microbial agent and cocoamidopropyl betaine as the surfactant and, as the Examiner makes clear, both the Translation and Svirkin provide the motivation to include hyaluronic acid in Pinol's mouthwash composition. 11 (Ans. 6-7.) Charge-charge Interaction Appellants argue that "Pinol, the Translation and Svirkin also fail to provide any motivation or reasoning for the specific 'charge-charge interaction' species between the glycosaminoglycan polysaccharide and the cetylpyridinium chloride." (Br. 10.) We are not persuaded. As an initial matter, the "charge-charge interaction" is not a limitation of claim 1 (see claim 27), and because the claims have been argued as a group we have limited our consideration to claim 1. See 37 C.F.R. § 41.37(c)(l)(iv). Nevertheless, even if "charge-charge interaction" was a limitation of claim 1, we would still be unpersuaded. 11 Contrary to Appellants' contentions, the rejection is not based on substituting the oral mucosa protective agent of Pinol with hyaluronic acid, and Svirkin teaches the use of free hyaluronic acid. (Ans. 14--15.) 7 Appeal2015-000605 Application 11/850,955 The motivation for combining glycoaminoglycan polysaccharide and cetylpyridinium chloride based on the prior art is addressed above, and we are not persuaded by Appellants' arguments to the contrary. Moreover, Appellants acknowledge Ialenti's teaching that hyaluronic acid has a negative charge and Talwar' s teaching that cetylpyridinium chloride has a positive charge. (Br. 9.) However, Appellants argue that "there is still no reasonable expectation that the required charge-charge interaction would have occurred" and that "the proposed modification or combination of the prior art would change the principle of operation of the prior art invention." (Br. 11-12.) Such attorney argument is unpersuasive. See In re Pearson, 494 F.2d 1399, 1405 (CCPA 1974) ("[a]ttorney's argument in a brief cannot take the place of evidence"). Here, we are persuaded by the Examiner's position that the negatively charged hyaluronic acid and positively charged cetylpyridinium chloride would be expected to have at least some charge- charge interaction. (Ans. 13, 15.) Additional Matters Appellants take issue with a statement by the Examiner regarding the Translation, and particularly whether Appellants acknowledged the Translation as prior art. (Br. 12.) Appellants do not argue that the Translation is not prior art, but request us to direct the Examiner "to correct this misstatement." (Id.) Appellants also request that we direct the Examiner "to return their POTO/SB/08a forms with an indication that these references have been considered." (Id. at 13.) These matters do not relate to the merits of the rejection on appeal. However, Appellants may seek to address these matters by petition to the 8 Appeal2015-000605 Application 11/850,955 Director of the U.S. Patent and Trademark Office. See Jn re Hengehold, 440 F.2d 1395, 1403(CCPA1971). CONCLUSION A preponderance of evidence of record supports the Examiner's conclusion that claim 1 is obvious under 35 U.S.C. § 103(a). Claims 2, 4, 6, 8-12, 16-19, 21, 22, 24, and 27 were not argued separately and fall with claim 1. SUMMARY We affirm the rejection of all claims on appeal. 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). AFFIRMED 9 Copy with citationCopy as parenthetical citation