Michael Prencipe et al.Download PDFPatent Trials and Appeals BoardJun 22, 20212020006149 (P.T.A.B. Jun. 22, 2021) 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. 12/058,209 03/28/2008 Michael Prencipe 8272-00-US-01-OC 2695 23909 7590 06/22/2021 COLGATE-PALMOLIVE COMPANY 909 RIVER ROAD PISCATAWAY, NJ 08855 EXAMINER SIMMONS, CHRIS E ART UNIT PAPER NUMBER 1629 NOTIFICATION DATE DELIVERY MODE 06/22/2021 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, RAVI SUBRAMANYAM, SARITA V. MELLO, DONGHUI WU, SUMAN CHOPRA, ANDRE M. MORGAN, DIANE CUMMINS, RICHARD J. SULLIVAN, RALPH PETER SANTARPIA III, LYNETTE ZAIDEL, QIN WANG, GARY EDWARD TAMBS, VIRGINIA MONSUL BARNES, RAJNISH KOHLI, RICHARD SCOTT ROBINSON, SERGIO LEITE, and ERIC A. SIMON __________ Appeal 2020-006149 Application 12/058,209 Technology Center 1600 __________ Before DONALD E. ADAMS, ERIC B. GRIMES, and JEFFREY N. FREDMAN, Administrative Patent Judges. FREDMAN, Administrative Patent Judge. DECISION ON APPEAL This is an appeal1 under 35 U.S.C. § 134 involving claims to an oral care composition. The Examiner rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies the real party in interest as Colgate- Palmolive Company (see Appeal Br. 2). We have considered the Specification of Mar. 28, 2008 (“Spec.”); Final Action of Sept. 20, 2018 (“Final Act.”); Appeal Brief of Apr. 17, 2019 (“Appeal Br.”); Examiner’s Answer of June 26, 2020 (“Ans.”); and Reply Brief of Aug. 26, 2020 Appeal 2020-006149 Application 12/058,209 2 Statement of the Case Background “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” (Spec. ¶ 3). “Combining these basic amino acids with minerals having oral care benefits, e.g., fluoride and calcium, to form an oral care product having acceptable long term stability, however, has proven challenging” (id.). The Claims Claims 1, 2, 4, 7, 10–15, 25–27, and 31–34 are on appeal.2 Independent claim 1 is representative and reads as follows: 1. An oral care composition comprising a. L-arginine in an amount of about 1.5% by weight of the composition; b. a zinc salt, comprising zinc citrate, in an amount of 0.01 to 5% by weight of the composition; c. a surfactant mixture comprising sodium lauryl sulfate and cocoamidopropyl betaine, wherein the surfactant mixture in an amount of 0.1 to 5% by weight of the composition; and d. an anionic polymer in an amount of 0.05 to 5% by weight of the composition; and e. phosphoric acid; wherein the composition has a pH of 6.8 to 7.2. (“Reply Br.”). We note the Examiner affirmed the claims in Appeal 2013- 010567, the previous appeal in this application. 2 Claims 16, 17, and 48 are identified as withdrawn (see Appeal Br. 12–14). Appeal 2020-006149 Application 12/058,209 3 The Issues A. The Examiner rejected claims 1, 2, 4, 7, 10–13, 15, and 25–27 under 35 U.S.C. § 103(a) as obvious over Doyle,3 Kleinberg I,4 Kleinberg II,5 and Montgomery6 (Final Act. 3–11). B. The Examiner rejected claims 1, 2, 4, 7, 10–15, 25–27, and 31–34 under 35 U.S.C. § 103(a) as obvious over Doyle, Kleinberg I, Kleinberg II, Montgomery, and Fujisawa7 (Final Act. 11–14). A. 35 U.S.C. § 103(a) over Doyle, Kleinberg I, Kleinberg II, and Montgomery The issue with respect to this rejection is: Does a preponderance of the evidence of record support the Examiner’s conclusion that the combination of prior art renders claim 1 obvious? Findings of Fact 1. Doyle teaches “oral care compositions comprising the combination of particular antibacterial agents with agents having anti- inflammatory activity” (Doyle ¶ 16). 2. Doyle teaches that “[s]uitable antibacterial agents include . . . zinc ion agent” (Doyle ¶ 69). 3 Doyle et al., US 2007/0053849 A1, published Mar. 8, 2007 (“Doyle”). 4 Kleinberg et al., US 6,217,851 B1, issued Apr. 17, 2001 (“Kleinberg I”). 5 Kleinberg et al., US 2002/0064504 A1, published May 30, 2002 (“Kleinberg II”). 6 Montgomery, R., US 2001/0021374 A1, published Sept. 13, 2001 (“Montgomery”). 7 Fujisawa, K., US 2004/0146465 A1, published July 29, 2004 (“Fujisawa”). Appeal 2020-006149 Application 12/058,209 4 3. Doyle teaches “copolymers of maleic anhydride with methyl vinyl ether having a molecular weight (M.W.) of about 30,000 to about 1,000,000. These copolymers are available for example as Gantrez AN 139 (M.W. 500,000), AN 119 (M.W. 250,000) and S-97” (Doyle ¶ 107). 4. Doyle teaches, in Example II, exemplary dentrifice compositions as shown below: . . . . . . ” Doyle exemplifies a dentrifice IID containing zinc citrate in an amount of 0.400 weight percent that is within the range cited by claim 1; amount of SLS (sodium lauryl sulfate) of 2.8 weight percent; and amount of the anionic polymer Gantrez S97 of 1 weight percent (Doyle ¶ 143; see also Spec. ¶ 70 (Gantrez S97 is a “synthetic anionic polymeric polycarboxylate[]”). 5. Doyle teaches the “compositions may also comprise surfactants . . . . The surfactant may be anionic, nonionic, amphoteric, zwitterionic, cationic, or mixtures thereof” (Doyle ¶ 126). Doyle specifically teaches “[a]nionic surfactants useful herein include . . . Sodium lauryl sulfate” and “suitable amphoteric surfactants are betaines, specifically cocamidopropyl Appeal 2020-006149 Application 12/058,209 5 betaine” (Doyle ¶¶ 127, 129). Doyle teaches the “composition typically comprises one or more surfactants each . . . most preferably from about 1% to about 6%, by weight of the composition” (Doyle ¶ 129). 6. Doyle teaches “[b]uffering agents, as used herein, refer to agents that can be used to adjust the pH of the compositions to a range of about pH 3.0 to about pH 10” (Doyle ¶ 114). 7. The Examiner states that “Doyle does not expressly teach 1) L- arginine, 2) cocamidopropyl betaine together with SLS, 2) phosphoric acid or 3) the specific pH range claimed” (Final Act. 4; italics omitted). 8. Kleinberg I teaches “oral compositions containing therapeutic amounts of calcium, arginine and a cariostatic anion distributed in an oral vehicle. In one preferred embodiment, the oral composition is supplemented with fluoride. The present invention further relates to a method of preparing oral compositions containing anti-caries agents” (Kleinberg I 3:20–27). Kleinberg I teaches “the arginine component of the composition described herein attacks the first stage of the Miller process” (Kleinberg I 2:59–61). 9. Kleinberg I teaches that in “one preferred embodiment, the oral compositions contain . . . arginine in an amount ranging from 5 µg/mg to 700 µg/mg” (Kleinberg I 4:35–43). The Examiner finds that Kleinberg I’s arginine range overlaps that recited in claim 1, specifically teaching that in Kleinberg I “the oral compositions contain arginine in an amount ranging from 5 to 700 micrograms/milligram, i.e., 0.5 to 70 %” (Final Act. 5). 10. Kleinberg I teaches the “pH of the oral compositions of the present invention generally ranges from about 6.0 to about 9.0. In one embodiment, the pH of the oral composition ranges from about 7.0 to about 8.0” (Kleinberg I 5:47–50). Appeal 2020-006149 Application 12/058,209 6 11. Montgomery teaches: The compositions of the present invention may also contain a buffer to provide a specific pH for optimal penetration of the composition into tooth enamel . . . . Acid buffers, such as . . . phosphoric acid, and others may also be used alone or in conjunction with an alkaline buffer to obtain the desirable pH and to provide buffering capacity. (Montgomery ¶ 40). Principles of Law “The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). “If a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability.” Id. at 417. Analysis We adopt the Examiner’s findings of fact and reasoning regarding the scope and content of the prior art (Ans. 3–11; FF 1–11) and agree that claim 1 is rendered obvious by Doyle, Kleinberg I, and Montgomery.8 We address Appellant’s arguments below. Appellant contends: Kleinberg II teaches the use of the basic pH range from about 7.5 to about 9.5 for its composition containing arginine bicarbonate and calcium carbonate. There is no teaching or suggestion in Kleinberg II that would motivate one of skill in the art to decrease the pH of Kleinberg’s composition 8 We note the Board may rely on less than all of the references applied by the Examiner in an obviousness rationale without designating it as a new ground of rejection. In re Bush, 296 F.2d 491, 496 (CCPA 1961). Here, we do not rely upon Kleinberg II or its benefit of reducing dental sensitivity at a particular pH because it is unnecessary for the obviousness rejection. Appeal 2020-006149 Application 12/058,209 7 containing arginine bicarbonate and calcium carbonate to the claimed range (6.8-7.2). (Appeal Br. 6). We find this argument unpersuasive because we do not, and need not, rely upon Kleinberg II for the obviousness analysis. Doyle suggests oral care compositions containing zinc citrate in amounts within the claimed range (FF 1, 2, 4); containing surfactants including sodium lauryl sulfate and cocamidopropyl betaine9 in overlapping amounts (FF 4, 5); containing an anionic polymer in overlapping amounts (FF 3, 4) and the use of buffering agents to generate a pH between 3 and 10 (FF 6). While Doyle does not teach the use of either arginine or phosphoric acid, Kleinberg I suggests that oral compositions contain therapeutic amounts of arginine in overlapping amounts (FF 8, 9) as well as an overlapping pH range of 7 to 8 (FF 10). Montgomery teaches that phosphoric acid is a buffer that may be used both to obtain the desired pH and to provide buffering capacity (FF 11). Thus, these three references suggest an oral care composition that comprises all of the claimed components, with the arginine of Kleinberg I incorporated into Doyle’s oral care composition to inhibit caries formation (FF 8) and the phosphoric acid of Montgomery incorporated to both modify the pH to Kleinberg I’s preferred range and to further function as a pH buffer (FF 11). “[A] person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the 9 Claim 1 recites “cocoamidopropyl betaine” but the Specification uses “cocamidopropyl betaine” and “cocoamidopropyl betaine” interchangeably. See, e.g., Spec. ¶ 62, 100. Appeal 2020-006149 Application 12/058,209 8 anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.” KSR, 550 U.S. at 421. Appellant contends Kleinberg I’s composition contains a cariostatic anion. Kleinberg I teaches that cariostatic anions may provide buffering which enhances the acid neutralizing activity of the arginine, as well as neutralizing the acid itself (column 3, lines 6-8). Kleinberg I does not teach or suggest the use of additional buffers in addition to cariostatic anions. The Examiner has not provided any articulated reason why one of skill in the art would be motivated to incorporate phosphoric acid as a buffer into the oral care composition already containing a cariostatic anion which acts as a buffer. (Appeal Br. 7). We do not find this argument persuasive as the Examiner states: “Buffering agents are used to adjust the pH of the compositions. . . . One of ordinary skill in the art would understand that the composition may be adjusted to a suitable pH that falls within the range described by Doyle” (Final Act. 8–9). Kleinberg I does not exclude the use of other buffering agents and does prefer that the oral composition pH values range between 7 and 8 (FF 10). Thus, the Examiner provides articulated reasoning for including a buffer such as phosphoric acid in order to both buffer the composition and ensure the pH falls in the range desired by Doyle or Kleinberg I (FF 6, 10). The “combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” KSR, 550 U.S. at 416. See also In re Kerkhoven, 626 F.2d 846, 850 (CCPA 1980) (“It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the Appeal 2020-006149 Application 12/058,209 9 same purpose, in order to form a third composition which is to be used for the very same purpose.”). Appellant contends There is no teaching or suggestion in Kleinberg I that inorganic phosphate has cariostatic activities. If inorganic phosphate (e.g., phosphoric acid) is added into Kleinberg’s composition, inorganic phosphate might interact with calcium and arginine. Thus, one of skill in the art would expect that inorganic phosphate might interfere with the formation of calcium/arginine/cariostatic anion complex. Similarly, one of skill in the art would expect that citrate (which is also not taught to be cariostatic by Kleinberg I) and a competing divalent soluble metal ion (zinc from zinc citrate) might interfere with the formation of calcium/arginine/cariostatic anion complex. (Appeal Br. 8–9). Appellant also contends the “Examiner has not provided any articulated explanation why one of skill in the art would not expect that the presence of inorganic phosphate, citrate and zinc would affect the formation of Kleinberg I’s calcium/arginine/cariostatic anion complex” (id. at 9). We find this argument unpersuasive because Appellant misplaces the burden in this situation. The Examiner has established a prima facie case of obviousness over Doyle, Kleinberg I, and Montgomery as discussed above. In response to that prima facie case, Appellant introduces speculation regarding possible interactions that might occur, without providing any citations to the cited prior art or any other evidence of record that support the stated concerns regarding interactions. However, “an examiner is entitled to reject claims . . . without conducting an inquiry into whether or not that prior art reference is enabling . . . the burden shifts to the applicant to submit rebuttal evidence of nonenablement.” In re Antor Media Corp., 689 F.3d Appeal 2020-006149 Application 12/058,209 10 1282, 1289 (Fed. Cir. 2012). And it is clear that rebuttal does require evidence because “attorney argument [is] not the kind of factual evidence that is required to rebut a prima facie case of obviousness.” In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997). Conclusion of Law A preponderance of the evidence of record supports the Examiner’s conclusion that the combination of prior art renders claim 1 obvious. B. 35 U.S.C. § 103(a) over Doyle, Kleinberg I, Kleinberg II, Montgomery, and Fujisawa Appellant does not substantively separately argue this obviousness rejection, instead relying upon their arguments to overcome the above rejection (see Appeal Br. 10). The Examiner provides sound fact-based reasoning for combining these references with Fujisawa (see Final Act. 12– 13). Having affirmed the obviousness rejection of claim 1 over Doyle, Kleinberg I, Kleinberg II, and Montgomery for the reasons given above, we also find that the further combination with Fujisawa renders the rejected claims obvious for the reasons given by the Examiner. CONCLUSION In summary: Claim(s) Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1, 2, 4, 7, 10– 13, 15, 25–27 103 Doyle, Kleinberg I, Kleinberg II, Montgomery 1, 2, 4, 7, 10–13, 15, 25–27 Appeal 2020-006149 Application 12/058,209 11 Claim(s) Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1, 2, 4, 7, 10– 15, 25–27, 31– 34 103 Doyle, Kleinberg I, Kleinberg II, Montgomery, Fujisawa 1, 2, 4, 7, 10–15, 25–27, 31–34 Overall Outcome 1, 2, 4, 7, 10–15, 25–27, 31–34 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 Copy with citationCopy as parenthetical citation