Colgate-Palmolive CompanyDownload PDFPatent Trials and Appeals BoardOct 20, 20212020005829 (P.T.A.B. Oct. 20, 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. 15/954,784 04/17/2018 Richard Robinson 9100-00-US-D1-OC 9933 23909 7590 10/20/2021 COLGATE-PALMOLIVE COMPANY 909 RIVER ROAD PISCATAWAY, NJ 08855 EXAMINER WEBB, WALTER E ART UNIT PAPER NUMBER 1612 NOTIFICATION DATE DELIVERY MODE 10/20/2021 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 RICHARD ROBINSON, RICHARD SULLIVAN, and RAJNISH KOHLI Appeal 2020-005829 Application 15/954,784 Technology Center 1600 BEFORE DONALD E. ADAMS, TAWEN CHANG, and JOHN E. SCHNEIDER, Administrative Patent Judges. SCHNEIDER, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision to reject claims 12 and 18–29. 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(a). Appellant identifies the real party in interest as Colgate-Palmolive Company. Appeal Br. 2. Appeal 2020-005829 Application 15/954,784 2 CLAIMED SUBJECT MATTER The claims are directed to an oral care composition comprising: an effective amount of a basic amino acid, in free or salt form; and an effective amount of a water soluble strontium salt selected from strontium acetate, strontium chloride, strontium nitrate, strontium lactate, strontium bromide and mixtures thereof. In some embodiments, the basic amino acid is arginine. In some embodiments, the compositions further comprise a fluoride ion source. Claim 12, reproduced below, is illustrative of the claimed subject matter: 12. A method to reduce, repair or inhibit early enamel lesions, comprising applying an effective amount of an oral composition to a surface of the oral cavity of a subject in need thereof, the oral care composition comprising a. an effective amount of a basic amino acid, in free or salt form; b. an effective amount of a water soluble strontium salt; and c. an effective amount of a fluoride ion source; wherein the oral care composition is in the form of a dentifrice or a mouth rinse, wherein the basic amino acid is arginine, or a salt thereof, wherein the water soluble strontium salt is selected from strontium acetate; strontium chloride; strontium nitrate; strontium lactate; strontium bromide; and a combination of two or more thereof, wherein the water soluble strontium salt is present in an amount of from 0.1 to 15% by weight of the dentifrice or from 0.01 to 2% by weight of the mouthwash, and wherein the composition has a pH of 6.5 to 7.4. Appeal 2020-005829 Application 15/954,784 3 REFERENCES The prior art relied upon by the Examiner is: Name Reference Date Neirinckx US 4,990,327 Feb. 5, 1991 Hughes US 6,004,538 Dec. 21, 1999 Hill US 2009/0208428 A1 Aug. 20, 2009 Deckner US 2010/0135932 A1 June 3, 2010 Rohit GB 201011074 D0 Aug. 18, 2010 REJECTIONS The Examiner has rejected the pending claims as follows: Claims 12, 18–21, 25–27, and 29 have been rejected under 35 U.S.C. § 103 as unpatentable over Rohit in view of Neirinckx. Claims 22–24 have been rejected under 35 U.S.C. § 103 as unpatentable over Rohit in view of Neirinckx in further view of Hill. Claims 22 and 28 have been rejected under 35 U.S.C. § 103 as unpatentable over Rohit in view of Neirinckx in further view of Hughes. Claims 12, 18–22, 25, 26, 28, and 29 have been rejected under 35 U.S.C. § 103 as unpatentable over Deckner. Claims 23 and 24 have been rejected under 35 U.S.C. § 103 as unpatentable over Deckner in view of Hughes. Claims 12, 18–22, and 25–29 have been rejected under 35 U.S.C. § 103 as unpatentable over Deckner in view of Neirinckx. OPINION Obviousness Based on Rohit Combined with Neirinckx The issue with respect to this rejection is whether a preponderance of the evidence supports the Examiner’s conclusion that the subject matter of claims 12, 18–21, 25–27, and 29 would have been obvious to one of Appeal 2020-005829 Application 15/954,784 4 ordinary skill in the art at the time the invention was made over Rohit combined with Neirinckx. The Examiner finds that Rohit teaches an oral care composition comprising arginine, fluoride and strontium chloride. Final Act. 3. The Examiner also finds that oral care patients are generally in need of “reducing, repairing or inhibiting early enamel lesions,” and that the “use of the toothpaste and mouthwash formulations addresses the limitation of applying an effective amount to a surface of the oral cavity of a subject in need thereof.” Id. The Examiner find that Rohit does not teach the amounts of strontium chloride of the pH range recited in the claims. Id. The Examiner finds that Neirinckx teaches an oral care composition having a strontium containing phase and a fluoride containing phase. Id. The Examiner finds that Neirinckx teaches that the strontium containing phase has a pH of from 3 to 7 in order to maintain the solubility of the strontium. Id. at 4. The Examiner also finds that Neirinckx teaches that the strontium is present in amounts ranging from 0.1 to about 12%. Id. The Examiner concludes: It would have been obvious to a person having ordinary skill in the art to modify the amount of strontium chloride in the compositions of Rohit et al. since strontium chloride is recognized in the art as a desensitizing agent, as taught by Neirinckx. Because suitable amounts of strontium chloride fall within the range of about 0.1 and about 12 weight percent, also taught by Neirinckx, it would have been obvious to modify the strontium chloride within this range. Accordingly, having amounts of strontium chloride within the claimed range of from 0.1 to 15% or from 0.001 to 2%, would have been obvious. Since Neirinckx teaches a preferred pH range of about 5 and 7 for solubilizing strontium ion, it would have been obvious modify the pH of the compositions of Rohit et al. within that Appeal 2020-005829 Application 15/954,784 5 range. Accordingly, having a pH of 6.5 to 7.4, as claimed, would have been obvious. Id. Appellant contends that Rohit is silent as to the amounts of strontium and as to the pH of the composition. Appeal Br. 5. Appellant also contends that Rohit is directed to an oral care composition and not a method to reduce, repair or inhibit early enamel lesions. Id. Appellant contends that, although Neirinckx teaches a strontium containing phase having a pH of from 3 to 7, one skilled in the art would not combine the teachings of Neirinckx with Rohit as Neirinckx teaches that the strontium phase should be kept separate from the fluoride phase to prevent the formation of strontium fluoride. Id. at 5–8. We adopt the Examiner’s findings of fact, reasoning on scope and content of the prior art, and conclusions set out in the Final Action and Answer regarding this rejection. We find the Examiner has established a prima facie showing that the subject matter of the claims would have been obvious over Rohit combined with Neirinckx to a person of ordinary skill in the art at the time the invention was made. Appellant has not produced evidence showing, or persuasively argued, that the Examiner’s determinations on obviousness are incorrect. Only those arguments made by Appellant in the Briefs have been considered in this Decision. Arguments not presented in the Briefs are waived. See 37 C.F.R. § 41.37(c)(1)(iv) (2015). We have identified claim 12 as representative; therefore, all claims fall with claim 12. We address Appellant’s arguments below. Appellant contends that Rohit does not teach or suggest the amounts of strontium recited in the claims nor does it suggest the pH range recited in the claims. Appeal Br. 5. We are not persuade by this argument. Appellant is Appeal 2020-005829 Application 15/954,784 6 attacking the teachings of the individual reference. “Non-obviousness cannot be established by attacking references individually where the rejection is based upon the teachings of a combination of references. . . . [The reference] must be read, not in isolation, but for what it fairly teaches in combination with the prior art as a whole.” In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986). Neirinckx supplies the necessary teachings regarding the amount of strontium and the pH of the composition. Neirinckx, col. 2, ll. 21– 30. Appellant argues that the present claims are directed to a method for reducing, repairing or inhibiting early enamel lesions and that Rohit does not mention enamel lesions. Appeal Br. 5. Appellant contends not all persons using oral care products have enamel lesions therefore the claimed method is not suggested by Rohit’s teaching of oral care products. Id. We have considered Appellant’s argument and the evidence of record and we are not persuaded that the rejection is in error. As the Examiner points out, the claims are directed to reducing, repairing or inhibiting early enamel lesions. Ans. 3–4. We agree with the Examiner that “individuals in need” of reduction, repair, or inhibition of early enamel lesions include the general population and not merely those who already have lesions. Id. The instant claims are analogous to the claims at issue in Perricone v. Medicis Phram. Corp., 432 F.3d 1368 (Fed. Cir. 1005). Several of the claims at issue in Perricone were directed to a method for preventing sunburn damage comprising topically applying to skin surfaces a specific composition. Id. at 1378. The prior art disclosed topical application of the same composition. Id. at 1379. The Federal Circuit found that the method of applying the composition to the skin to prevent sunburn was encompassed by the prior art’s teaching of topical application. Id. Appeal 2020-005829 Application 15/954,784 7 We find that the same logic applies here. The method of inhibiting enamel lesion by applying a composition containing arginine, strontium and fluoride is encompassed by the method of applying the same composition for oral care. Appellant contends that Neirinckx teaches forming separate strontium compositions and fluoride compositions to prevent formation of strontium fluoride which is inactive. Appeal Br. 6–8. Appellant contends that this teaching would lead on skilled in the art way from applying the teachings of Neirinckx to Rohit’s composition. Id. Again we have considered Appellant’s argument and are not persuaded. While we agree with Appellant that Neirinckx teaches keeping the strontium component separate from the fluoride component, Neirinckx also teaches that the two components are admixed just before use. Neirinckx, col. 1, ll. 15–23; col. 5, ll. 39–41; col. 6, ll. 54–58. The instant claims only call for applying a composition containing the recited ingredients to the teeth, it does not preclude creation of the composition just before application as taught by Neirinckx. See Appeal Br. 14 (Claims App.) Given that both Rohit and Neirinckx teach compositions containing strontium and that Neirinckx teaches that the concentration levels and pH ranges improve the solubility of the strontium, we agree with the Examiner that one skilled in the art would have been led to combine the teachings of these references with a reasonable expectation of success. See Final Act. 4. Based on the foregoing we conclude that a preponderance of the evidence supports the Examiner’s conclusion that the subject matter of claims 12, 18–21, 25–27, and 29 would have been obvious to one of ordinary skill in the art at the time the invention was made over Rohit combined with Neirinckx. Appeal 2020-005829 Application 15/954,784 8 Obviousness Based on Deckner The issue with respect to this rejection is whether a preponderance of the evidence supports the Examiner’s conclusion that the subject matter of claims 12, 18–22, 25, 26, 28, and 29 would have been obvious to one of ordinary skill in the art at the time the invention was made over Deckner. The Examiner finds Deckner teaches oral care compositions and methods for reducing hypersensitivity of teeth. Final Act. 8. The Examiner finds that Deckner teaches that the composition may comprise a strontium ion source such as strontium chloride, arginine and potassium fluoride. Id. The Examiner finds that Deckner teaches that the composition will have a pH of from about 3 to about 10. Id. The Examiner concludes: It would have been obvious to a person having ordinary skill in the art at the time of applicant’s invention to administer an oral care composition having an effective amount of a basic amino acid comprising arginine, a fluoride ion source, and an effective amount of a water soluble strontium salt, e.g. strontium chloride given their plain enumeration in the prior art. Deckner et al. does not teach a concentration range for the strontium ion source. However, “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation” (see MPEP 2144.05 IIA quoting In re Aller, 220 F.2d 454, 456 (105 USPQ 233)). Since the strontium ion source of Deckner et al. functions as an [sic] tubule occluding and desensitizing agent, it would have been obvious to optimize amounts of the strontium ion source consistent with these functions. Id. at 8–9. Appeal 2020-005829 Application 15/954,784 9 Appellant contends that while Deckner discloses the use of strontium, aginine and fluoride, “[n]one of them is essential component of Deckner’s composition.” Appeal Br. 8–9. Appellant contends that there is no motivation to combine the ingredients to form the composition used in the claimed method. Id. at 9. Appellant contends that the present claims are directed to a method “to reduce, repair or inhibit early enamel lesions. Deckner does not teach or suggest anything regarding a method of reducing, repairing or inhibiting early enamel lesions.” Id. Appellant also contends that Deckner does not teach or suggest the specific pH range recited in the claim. Id. Appellant argues that while Deckner teaches a pH range of from 3 to 10, the range is so broad as to encompass almost any oral care composition. Id. at 10. Appellant contends that the specific composition taught by Deckner all have a pH of less than 6. Id. at 10–11. Appellant contends that this would lead one skilled in the art to use a pH below the claimed range of 6.5 to 7.4. Id. at 11. We adopt the Examiner’s findings of fact, reasoning on scope and content of the prior art, and conclusions set out in the Final Action and Answer regarding this rejection. We find the Examiner has established a prima facie showing that the subject matter of the claims would have been obvious over Deckner to a person of ordinary skill in the art at the time the invention was made. Appellant has not produced evidence showing, or persuasively argued, that the Examiner’s determinations on obviousness are incorrect. Only those arguments made by Appellant in the Briefs have been considered in this Decision. Arguments not presented in the Briefs are waived. See 37 C.F.R. § 41.37(c)(1)(iv) (2015). We have identified claim 12 Appeal 2020-005829 Application 15/954,784 10 as representative; therefore, all claims fall with claim 12. We address Appellant’s arguments below. Appellant contends that Deckner does not teach that arginine, strontium and fluoride are “essential components” of Deckner’s composition and then none of the examples contain arginine. Appeal Br. 9. We are not persuaded by this argument. The test of obviousness is “whether the teachings of the prior art, taken as a whole, would have made obvious the claimed invention.” In re Gorman, 933 F.2d 982, 986 (Fed. Cir. 1991). As Appellant acknowledges, Deckner teaches the inclusion of arginine, strontium, and fluoride in an oral care composition. Appeal Br. 8; Deckner ¶ 83. Thus Deckner teaches the basic composition recited in the claims. Appellant contends that Deckner does not teach the claimed method to reduce, repair or inhibit early enamel lesions. Appeal Br. 9. Appellant contends that while the composition of Deckner may be capable of being used in the claimed method, Deckner does not render that method obvious. Id. We have considered Appellant’s arguments and the evidence of record and are not persuaded that the rejection is in error. As discussed above, the claimed method includes inhibiting enamel lesions. Appeal Br. 14 (Claims App.). Like Neirinckx and Rohit, Deckner teaches an oral care composition that is used to promote oral health. See Deckner ¶¶ 3–5. As discussed above, Appellant’s method of inhibiting enamel lesions is encompassed within Deckner’s teaching of using the disclosed composition for oral care. Perricone, 432 F.3d at 1379. Appeal 2020-005829 Application 15/954,784 11 Appellant contends that Deckner’s broad range of pH combined with the specific teaching of using a pH of 6 or less would not lead one skilled in the art to the claimed range of from 6.5 to 7.4. Appeal Br. 9–11. Again, we have considered Appellant’s argument and are not persuaded that the rejection is in error. “[W]here there is a range disclosed in the prior art, and the claimed invention falls within that range, there is a presumption of obviousness. But the presumption will be rebutted if it can be shown: (1) That the prior art taught away from the claimed invention, In re Geisler, 116 F.3d 1465, 1471 (Fed. Cir. 1997); or (2) that there are new and unexpected results relative to the prior art, In re Woodruff, 919 F.2d 1575, 1578 (Fed. Cir. 1990).” Iron Grip Barbell Co. v. USA Sports, Inc., 392 F.3d 1317, 1322 (Fed. Cir. 2004). Deckner teaches a pH range of from 3 to 10, which overlaps with the range of 6.5 to 7.4 recited in the claims. Deckner ¶ 102. Appellant has not produced any persuasive evidence to show that the claimed range produces any new and unexpected results. To the extent Deckner teaches that a pH of 6 or less is preferred, this does not constitute a teaching away from the broader range. Expressed preference for certain embodiments within disclosed genus does not teach away from rest of embodiments within genus. In re Susi, 440 F.2d 442, 446 n.3 (CCPA 1971). Based on the foregoing we conclude that a preponderance of the evidence supports the Examiner’s conclusion that the subject matter of claims 12, 18–22, 25, 26, 28, and 29 would have been obvious to one of ordinary skill in the art at the time the invention was made over Deckner. Appeal 2020-005829 Application 15/954,784 12 The Remaining Rejections Appellant argues the remaining rejections together. Appeal Br. 12. Appellant contends that none of the additional references cited in the remaining rejections teach or suggest “a method to reduce, repair or inhibit early enamel lesions and there is no teaching or suggestion in the cited references that would motivate one of skill in the art to modify the pH of a composition containing arginine, strontium and fluoride to within the claimed range.” Id. As discussed above, the primary references or combination of references teach these elements. Therefore we affirm the remaining rejections. CONCLUSION The Examiner’s rejections are AFFRIMED. More specifically, The rejection of claims 12, 18–21, 25–27, and 29 under 35 U.S.C. § 103 as unpatentable over Rohit in view of Neirinckx is affirmed. The rejection of claims 22–24 under 35 U.S.C. § 103 as unpatentable over Rohit in view of Neirinckx in further view of Hill is affirmed. The rejection of claims 22 and 28 under 35 U.S.C. § 103 as unpatentable over Rohit in view of Neirinckx in further view of Hughes is affirmed. The rejection of claims 12, 18–22, 25, 26, 28, and 29 have been rejected under 35 U.S.C. § 103 as unpatentable over Deckner is affirmed. The rejection of claims 23 and 24 under 35 U.S.C. § 103 as unpatentable over Deckner in view of Hughes is affirmed. The rejection of claims 12, 18–22, and 25–29 under 35 U.S.C. § 103 as unpatentable over Deckner in view of Neirinckx is affirmed. Appeal 2020-005829 Application 15/954,784 13 DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 12, 18–21, 25–27, 29 103 Rohit, Neirinckx 12, 18–21, 25–27, 29 22–24 103 Rohit, Neirinckx, Hill 22–24 22, 28 103 Rohitm Neirinckx, Hughes 22, 28 12, 18–22, 25, 26, 28, 29 103 Deckner 12, 18–22, 25, 26, 28, 29 23, 24 103 Deckner, Hughes 23, 24 12, 18–22, 25–29 103 Deckner, Neirinckx 12, 18–22, 25–29 Overall Outcome 12, 18–29 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). See 37 C.F.R. § 1.136(a)(1)(iv). AFFIRMED Copy with citationCopy as parenthetical citation