12866780 (P.T.A.B. Oct. 31, 2016)

Ex Parte Prencipe et al

Patent Trial and Appeal BoardOct 31, 2016

12866780 (P.T.A.B. Oct. 31, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 12/866,780 08/09/2010 23909 7590 11/02/2016 COLGATE-PALMOLIVE COMPANY 909 RIVER ROAD PISCATAWAY, NJ 08855 FIRST NAMED INVENTOR Michael Prencipe 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. 8572-00-0C 4442 EXAMINER PEEBLES, KATHERINE ART UNIT PAPER NUMBER 1617 NOTIFICATION DATE DELIVERY MODE 11/02/2016 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 PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte MICHAEL PRENCIPE, RICHARD SCOTT ROBINSON, RAJNISH KOHLI, and RICHARD J. SULLIV AN 1 Appeal2015-001487 Application 12/866,780 Technology Center 1600 Before JEFFREY N. FREDMAN, TA WEN CHANG, and DEVON ZASTROW NEWMAN, Administrative Patent Judges. NEWMAN, Administrative Patent Judge. DECISION ON APPEAL This appeal under 35 U.S.C. Â§ 134 involves claims to a dental whitening agent. The Examiner entered final rejections for obviousness. We have jurisdiction under 35 U.S.C. Â§ 6(b). We affirm-in-part. STATEMENT OF THE CASE Background The Specification discloses: 1 Appellants identify the Real Party in Interest as Colgate-Palmolive Company. App. Br. 2. Appeal2015-001487 Application 12/866,780 The present invention is directed to compositions and devices which deliver basic amino acids, e.g., arginine, to the oral cavity together with a whitening agent to whiten teeth and, e.g., (i) reduce or inhibit formation of dental caries, (ii) reduce, repair or inhibit pre-carious lesions of the enamel, e.g., as detected by quantitative light-induced fluorescence (QLF) or electrical caries measurement (ECM), (iii) reduce or inhibit demineralization and promote remineralization of the teeth, (iv) reduce hypersensitivity of the teeth, (v) reduce or inhibit gingivitis, (vi) promote healing of sores or cuts in the mouth, (vii) reduce levels of acid producing bacteria, (viii) to increase relative levels of arginolytic bacteria, (ix) inhibit microbial biofilm formation in the oral cavity. (x) raise and/or maintain plaque pH at levels of at least pH 5.5 following sugar challenge, (xi) reduce plaque accumulation, (xii) clean the teeth and oral cavity, (xiii) immunize the teeth against cariogenic bacteria, (xiv) promote systemic health, including cardiovascular health, e.g., by reducing potential for systemic infection via the oral tissues, (xv) reduce erosion and/or (xv) treat, relieve or reduce dry mouth. Spec. i-f 5. Arginine and other basic amino acids have been proposed for use in oral care and are believed to have significant benefits in combating cavity formation and tooth sensitivity. It is believed that basic amino acids in the oral cavity are metabolized by certain types of bacteria ... [leading to] demineraliz[ ation of] the teeth, ultimately leading to cavities. Basic amino acids, e.g., arginine, moreover promote remineralization of the teeth, helping to repair erosion, and plugging microtubules implicated in dentinal sensitivity. Many patients complain of hypersensitive teeth following bleaching treatments, possibly because the whitening chemicals irritate the nerve endings in the microtubules. Id. at i-f 6. 2 Appeal2015-001487 Application 12/866,780 The Issues The following rejections are before us to review (App. Br. 3--4). A. Claims 1, 7, 9, 10, 13, 19-21, 23-25, 27, 29, 31-34, and 38--40 are rejected as obvious under 35 U.S.C. Â§ 103(a) over Sharma,2 van Lune,3 and Kleinberg '504.4 B. Claims 1, 7, 9, 10, 13, 19-21, 23-25, 27, 29, 31-34, and 38--40 are rejected as obvious under 35 U.S.C. Â§ 103(a) over Chen5 and Kleinberg '504. C. Claim 8 is rejected as obvious under 35 U.S.C. Â§ 103(a) over Chen, Kleinberg '504, and Dewis. 6 D. Claim 22 is rejected as obvious under 35 U.S.C. Â§ 103(a) over Chen, Kleinberg '504, and Kleinberg '813. 7 E. Claim 26 is rejected as obvious under 35 U.S.C. Â§ 103(a) by Chen, Kleinberg '504, and Chadwick.8 2 Deepak Sharma and Jenette Suh Edelstein, US 2007/0231276 Al, published Oc. 4, 2007 ("Sharma") 3 Harry van Lune and Johan Jochem Bruggeman, EP 1 724 359 Al, published Nov. 22, 2006 ("van Lune") 4 Israel Kleinberg, et al., US 2002/0064504 Al, published May 30, 2002 ("Kleinberg '504") 5 Tianming Chen, U.S. Pat. No. 6,500,408 B2, issued Dec. 31, 2002 ("Chen") 6 Mark L. Dewis, et al., US 2006/0057268 Al, published Mar. 16, 2006 ("Dewis") 7 Israel Kleinberg, U.S. Pat. No. 4,154,813, issued May 15, 1979 ("Kleinberg '813 ") 8 Thomas C. Chadwick and Heather L. Hunt, US 2003/0170592 Al, published Sept. 11, 2003 ("Chadwick"). 3 Appeal2015-001487 Application 12/866,780 F. Claim 30 is rejected as obvious under 35 U.S.C. Â§ 103(a) by Chen, Kleinberg '504 and Witt. Claim 1 illustrates the appealed subject matter and reads as follows: 1. A composition comprising an effective amount of a dental whitening agent, and from about 0.1 % to about 50% by weight of arginine in salt form; and the composition further comprising a matrix material wherein the dental whitening agent and arginine are dispersed within said matrix material. App. Br. Appx. 18. OBVIOUSNESS Rejection over Sharma, van Lune, and Kleinberg '504 Does the preponderance of evidence of record support the Examiner's finding that Sharma, van Lune, and Kleinberg '504 suggest the invention of claims 1, 7, 9, 10, 13, 19-21, 23-25, 27, 29, 31-34, and 38--40? FACTUAL FINDINGS (FF) FF 1. Sharma discloses: At least one zwitterionic stabilizer is added to the compositions of the present invention to provide improved physical and/ or chemical stability to the composition compared to a similar composition that does not contain the zwitterionic stabilizer. While not intending to be limited by the following, in aqueous solutions at pH of between about 4.5 to about 7.5, certain molecules or compounds possess zwitterionic properties and possess functional groups that can act as a proton donor as well as an acceptor in hydrogen bonding interactions. Sharma, i-f 10. 4 Appeal2015-001487 Application 12/866,780 FF 2. Sharma discloses FF 3. The pH of dental whitening compositions is typically adjusted with strong bases, such as sodium hydroxide, potassium hydroxide, and the like. The final pH is typically from about 4 to about 7. With the compositions of the present invention, in addition to stabilizing the composition, the zwitterionic stabilizing compound may also serve as a buffering agent and help maintain pH under chemical stress. Id. at i-f 14. Kleinberg '504 discloses: [T]he present invention relates to a method of reducing or preventing tooth hypersensitivity by delivering into the oral cavity an oral composition containing a therapeutically effective amount of arginine bicarbonate and calcium carbonate distributed in an oral vehicle. The amount of arginine bicarbonate and calcium carbonate sufficient to reduce or prevent dentinal hypersensitivity is an amount sufficient to promote dentinal plugging. It has been discovered that arginine bicarbonate and calcium carbonate promote the formation of and provide particles in the oral cavity for plugging the dentinal tubules of teeth. By plugging the dentinal tubules, the oral compositions used in the method of this invention are capable of reducing dentinal hypersensitivity. A mixture of arginine bicarbonate, which is highly soluble, with poorly soluble calcium carbonate (or calcium phosphate) yields a composition that gives a pH of about 8.0 to 9.0, which is ideal for tubule plugging. Kleinberg i-f 31. FF 4. Kleinberg '504 discloses "[a]rginine bicarbonate [is] well suited for promoting dentinal plugging for a number of reasons ... 5 Appeal2015-001487 Application 12/866,780 arginine bicarbonate surprising has adhesive properties particularly useful at a pH ranging from about 7.5 to about 9.5, and preferably 8 to about 9 or 9.5." Id. at i-fi-131 and 34. FF 5. Kleinberg '504 Figure 2 demonstrates that very little aggregate formation (i.e., dental plug formation) occurs at a pH of less than 8.5 in a solution of arginine bicarbonate/calcium carbonate mixture. f : g 'l.~Â·:J .j l- ' FIG, 2 ' .4 t .. I ~ ' ,_g l!, ~Â· \.-.::.. f It"' l ! J