GABA International Holding GmbHDownload PDFPatent Trials and Appeals BoardNov 23, 20212020005404 (P.T.A.B. Nov. 23, 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. 15/529,656 05/25/2017 Sylvia HESS 10116-00-US-01-GB 4016 23909 7590 11/23/2021 COLGATE-PALMOLIVE COMPANY 909 RIVER ROAD PISCATAWAY, NJ 08855 EXAMINER HOLLOMAN, NANNETTE ART UNIT PAPER NUMBER 1612 NOTIFICATION DATE DELIVERY MODE 11/23/2021 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 SYLVIA HESS, RUTH HINRICHS, STEPHANIE JAKUMEIT, TURAN MATUR, ANDRE BRUNELLA, and PETER REIFF Appeal 2020-005404 Application 15/529,656 Technology Center 1600 ____________ Before ERIC B. GRIMES, ULRIKE W. JENKS, and RACHEL H. TOWNSEND, Administrative Patent Judges. JENKS, Administrative Patent Judge. DECISION ON APPEAL Appellant1 submits this appeal under 35 U.S.C. § 134(a) involving claims directed to an oral care composition. 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(a). Appellant identifies the real party in interest as Colgate-Palmolive Company. Appeal Br. 2. Appeal 2020-005404 Application 15/529,656 2 STATEMENT OF THE CASE Claims 1, 3, 4, 7–12, 15, 16, 18, 19, and 21 are on appeal,2,3 and can be found in the Claims Appendix of the Appeal Brief. Claim 1, the sole independent claim, is representative of the claims on appeal, and reads as follows: 1. An oral care mouth rinse composition comprising (i) at least one source of ionic tin, wherein the at least one source of ionic tin comprises 0.02 to 0.08 weight % stannous fluoride, and (ii) polyvinylpyrrolidone wherein the polyvinylpyrrolidone is present in an amount of from 2.20 to 3.00 weight %, based on the total weight of the oral care mouth rinse composition and wherein the oral care mouth rinse composition further comprises 0.010 to 0.50 weight % amine fluoride based on the total weight of the oral care mouth rinse composition. Appeal Br. 9 (Claims Appendix). REJECTION Appellant requests review of Examiner’s rejection of claims 1, 3, 4, 7–12, 15, 16, 18, 19, and 21 under 35 U.S.C. § 103 over Scarlett-Smith.4 2 Herein we refer to the Specification filed May 25, 2017 (“Spec.”), Final Office Action mailed November 1, 2019 (“Final Act.”), Appeal Brief field March 2, 2020 (“Appeal Br.”), Examiner’s Answer mailed May 14, 2020 (“Ans.”), and Reply Brief filed July 14, 2020 (“Reply Br.”). 3 Appellant indicates that claims 2, 5, 6, 13, 14, 17, and 22 are cancelled and that claims 20 and 23–25 are withdrawn in light of a prior restriction/election requirement made by Examiner. Appeal Br. 2. 4 Scarlett-Smith, WO 97/45096, published Dec. 4, 1997. Appeal 2020-005404 Application 15/529,656 3 Obviousness The issue before us is whether the preponderance of evidence of record supports Examiner’s conclusion that the claims directed to an oral care composition are obvious. A. Findings of Fact (FF) FF1. Scarlett-Smith teaches that bacteriostatic stannous salt is associated with staining of teeth. Scarlett-Smith 4:37–5:1. Scarlett-Smith teaches oral hygiene compositions which comprise “a stannous salt and polyvinyl pyrrolidone, to counter the staining associated with use of a stannous salt.” Scarlett- Smith, Abstract. Scarlett-Smith teaches that the composition can be made into mouthwashes, gels, and dentifrices. See id. 4:17–23. FF2. Scarlett-Smith teaches that suitable stannous salts include stannous fluoride, stannous chloride, stannous pyrophosphate and stannous chlorofluoride and mixtures thereof. The stannous salt is present from 0.005 to 10% and more preferably 0.01 to 2% in the oral hygiene composition. Id. at 1:28–31. FF3. Scarlett-Smith teaches that polyvinyl pyrrolidone is “suitably present in at least 1%, preferably between 2 and 30%” and that the polyvinyl pyrrolidones have average molecular weights of 5000 to 100,000. Id. at 1:21–26. FF4. Scarlett-Smith teaches that the composition may optionally contain an ionic-fluorine compound. Oral hygiene compositions of the present invention may also usefully contain an ionic fluorine-containing compound. Suitable ionic fluorine-containing compounds Appeal 2020-005404 Application 15/529,656 4 include, for instance, fluoride salts such as amine fluorides and alkali metal fluoride salts, for example sodium fluoride, and monofluorophosphate salts such as alkali metal monofluorophosphate salts, for example sodium monofluorophosphate. Suitably the ionic fluorine-containing compound is incorporated into the composition to provide between 100 and 3000ppm, preferably between 500 and 2000ppm of fluoride ions. Scarlett-Smith 1:33–2:2 (emphasis added). FF5. Example 1 of Scarlett-Smith tests the ability of polyvinyl pyrrolidone (PVP) to prevent staining associated with the use of stannous fluoride. See id. at 5:27–6:20. Scarlett-Smith used stannous fluoride (0.4% w/v) and PVP (av. mol. wt. 40,000, at 1, 5, 10 and 20%). Id. 6:14–15. Scarlett-Smith teaches that the “[r]esults obtained demonstrated that PVP reduced 0.4% stannous fluoride induced stain formation on hydroxyapatite discs in a concentration dependent manner between 1% and 20% PVP. Stain was significantly reduced (P<0.05) by 27.4% and 24.5% for 10% and 20% PVP respectively.” Id. at 6:17–20. FF6. Example 3 of Scarlett-Smith teaches a toothpaste composition contain 1–1.5% stannous chloride, 0.454 % stannous fluoride, and 20% PVP in addition to other excipients. Id. at 7:1–13. FF7. Example 2 of Scarlett-Smith teaches a toothpaste composition contain 1% stannous fluoride, 0.22% sodium fluoride, and 20% PVP in addition to other excipients. Id. at 6:21–26. B. Analysis Examiner finds that Scarlett-Smith teaches oral care compositions containing polyvinyl pyrrolidone at a concentration of “at least 1%, [and] preferably between 2 and 30% by weight of the composition.” Ans. 3; see Appeal 2020-005404 Application 15/529,656 5 FF1, FF3, FF5. Examiner finds that Scarlett-Smith teaches the inclusion of stannous salts at a concertation range of 0.01 to 2%. Ans. 3; see FF1, FF2, FF5–FF7. In addition, Examiner finds that Scarlett-Smith teaches the inclusion of an ionic fluorine-containing compound, including amine fluorides, between 500 and 2000 ppm of fluoride ions. Ans. 3; FF4. Examiner finds that Scarlett-Smith exemplifies “a composition comprising 0.22% of an ionic fluorine-containing compound,” specifically, 0.22% sodium fluoride. Ans. 3; see FF4 and FF7. Appellant contends that Examiner erred in rejecting the claims based on the disclosure of Scarlett-Smith. Specifically, Appellant contends that (1) there is no reason to select the narrow ranges of components as presently claimed, (2) the rejection relies on hindsight, (3) the reference teaches away, and (4) the lower ranges of PVP as claimed show unexpected results. We have reviewed Appellant’s contentions that Examiner erred in rejecting the claims as obvious over Scarlett-Smith. Appeal Br. 2–8; Reply Br. 2–7. We disagree with Appellant’s contentions and address Appellant’s arguments below: 1. Narrow range Appellant contends that the reference encompasses a very large number of possible distinct compositions. Appeal Br. 3. “The only Example of a composition in the Scarlett-Smith reference that contained PVP is Example 2, which comprises 20% PVP.” Id. Appellant contends that “Scarlett-Smith not only fails to teach a composition that comprises both amine fluoride and stannous fluoride, but further fails to teach a mouth rinse composition that comprises amine fluoride, stannous fluoride and PVP at the Appeal 2020-005404 Application 15/529,656 6 claimed amounts.” Reply Br. 2. Appellant contends that the lower amount of PVP tested in Scarlett-Smith was ineffective. Id. at 3. We are not persuaded by Appellant’s contention. It is well settled that “in a section 103 inquiry, ‘the fact that a specific [embodiment] is taught to be preferred is not controlling, since all disclosures of the prior art, including unpreferred embodiments, must be considered.’” Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 807 (Fed. Cir. 1989) (quoting In re Lamberti, 545 F.2d 747, 750 (CCPA 1976)). Here, Examiner directs attention to teachings in Scarlett-Smith that suggest a composition that combines a stannous salt or mixture of stannous salts with PVP and optionally includes ionic fluorine-containing compounds selected from the group containing amine fluorides and alkali metal fluoride salts. See Ans. 3–4; FF2–FF4. Examiner finds that Scarlett-Smith teaches PVP at concentrations of 1, 5, 10, and 20% reduced the stannous fluoride stain formation in a concentration dependent manner. See Ans. 4; FF5. A teaching that 10 and 20% PVP significantly reduced staining does not detract from the teaching in Scarlett-Smith that 1 and 5% PVP also reduced staining. See FF5 (results showed “that PVP reduced 0.4% stannous fluoride induced stain formation on hydroxyapatite discs in a concentration dependent manner between 1% and 20% PVP.”). “A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.” In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003). Examiner acknowledges that Scarlett-Smith does not recite the specific endpoints set out in the claims but finds that the 1, 5, 10, and 20% PVP tested in Scarlett-Smith support the finding that Scarlett-Smith teaches a range that overlaps with the claimed Appeal 2020-005404 Application 15/529,656 7 ranges, thereby, rendering the claims prima facie obvious. See Ans. 4 (citing In re Peterson); FF5–FF7. We determine that Examiner has identified sufficient evidence in Scarlett-Smith from which to conclude that the presently claimed composition is obvious. 2. Hindsight Appellant contends that Examiner relies on hindsight to arrive at the presently claimed composition. Appeal Br. 4–6. Specifically, Appellant contends that “Examiner’s reliance on the 0.22% sodium fluoride concentration teaching of Scarlett-Smith to render obvious Appellant’s limitation of 0.010 to 0.50 weight % amine fluoride in claim 1 is not a reasonable extrapolation from Scarlett-Smith.” Appeal Br. 6. We are not persuaded. Here, Scarlett-Smith teaches that ionic fluorine-containing compounds can be selected from the group containing amine fluorides and alkali metal fluoride salts. FF4. Scarlett-Smith, therefore, identifies these compounds as equivalents. FF4. It is obvious to substitute one equivalent for another because such a combination is merely a “predictable use of prior art elements according to their established functions.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007); see Ans. 3 (“The reference discloses a composition comprising 0.22% of an ionic fluorine-containing compound, which would meet the limitation of 0.010 to 0.5% amine fluoride of instant claim 1.”). While we are fully aware that hindsight bias often plagues determinations of obviousness, Graham v. John Deere Co., 383 U.S. 1, 36 (1966), we are also mindful that the Supreme Court has clearly stated that 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. Appellant also has not directed us Appeal 2020-005404 Application 15/529,656 8 to information relied upon by Examiner that could only have been gleaned from Appellant’s disclosure. See In re McLaughlin, 443 F.2d 1392, 1395 (CCPA 1971). Thus, considering the totality of the evidence presented, we are not persuaded by Appellant’s hindsight argument. 3. Teaching away Appellant contends that Scarlett-Smith teaches away from the claimed compositions because “[t]he sole example of a composition in Scarlett-Smith containing PVP has PVP at a much higher concentration of 20%, further lending proof to the teaching of Scarlett-Smith that compositions with higher concentrations of PVP are preferred.” Appeal Br. 6. We are not persuaded by Appellant’s contention. “[A] reference will teach away when it suggests that the developments flowing from its disclosures are unlikely to produce the objective of the applicant’s invention. A statement that a particular combination is not a preferred embodiment does not teach away absent clear discouragement of that combination.” Syntex (U.S.A.) LLC v. Apotex, Inc., 407 F.3d 1371, 1380 (Fed. Cir. 2005) (citations omitted). As Examiner explains, Scarlett-Smith teaches “PVP at concentrations of 1, 5, 10 and 20% in example 1, which provided stain reduction.” Ans. 5; see also FF5 (“results obtained demonstrated that PVP reduced 0.4% stannous fluoride induced stain formation on hydroxyapatite discs in a concentration dependent manner between 1% and 20% PVP. Stain was significantly reduced (P<0.05) by 27.4% and 24.5% for 10% and 20% PVP respectively.”). We agree with Examiner that a fair reading of Scarlett- Smith is that stain reduction was observed at all concentrations including at 1% which represents the lower end of the range. The fact that PVP at higher concentration produces a more pronounced effect does not take away from Appeal 2020-005404 Application 15/529,656 9 the teaching that even at lower PVP concentrations, the stain preventing effect is still noticeable. 4. Unexpected results Appellant contends that the staining study of Example 2 in the Specification shows unexpected results. See Appeal Br. 6–7; Reply Br. 6. We are not persuaded and agree with Examiner that the evidence advanced by Appellant to show an unexpected result is not, when considered together with the evidence of obviousness, sufficient to demonstrate the claimed invention is non-obvious. “One way for a patent applicant to rebut a prima facie case of obviousness is to make a showing of ‘unexpected results,’ i.e., to show that the claimed invention exhibits some superior property or advantage that a person of ordinary skill in the relevant art would have found surprising or unexpected.” In re Soni, 54 F.3d 746, 750 (Fed. Cir. 1995). The unexpected results must be “different in kind and not merely in degree from the results of the prior art.” In re Applied Materials, Inc., 692 F.3d 1289, 1297 (Fed. Cir. 2012). “Moreover, the applicant’s showing of unexpected results must be commensurate in scope with the claimed range.” In re Peterson, 315 F.3d at 1330. Examiner explains that Scarlett-Smith discloses the results obtained demonstrated that PVP reduced 0.4% stannous fluoride induced stain formation in a concentration dependent manner between 1% and 20% PVP. While Scarlett-Smith provided data for 10% and 20% PVP having stain reduction of 27.4% and 24.5% respectively[,][t]here is also stain reduction at 1% as stated by Scarlett-Smith. Therefore, applicant’s results do not appear to be unexpected but concentration dependent as stated in Scarlett- Smith. Furthermore, applicant[’]s results show the greatest reduction of staining at 4.0% PVP, formulation I with a ∆E=12.40, which supports the concentration dependent results Appeal 2020-005404 Application 15/529,656 10 shown in Scarlett-Smith. The data shown in Table 4 [of the Specification] is concentration dependent with the exception of 3.5 wt.%. which appears to be an outlier based on the results shown in the table. Applicant also states, “the inclusion of PVP led to a concentration-dependent drop in ∆E, in the range of 1.5-4%”, which supports the findings in Scarlett-Smith. Ans. 6; see FF5. Table 2 of the Specification is reproduced below: Table 2 above shows that formulation A (a commercially available stannous containing mouth rinse comprising 0.30% PVP) produces greater staining (higher value of ∆E) than an equivalent formulation (B) comprising 2.4 % PVP. See Spec. ¶ 46. “The inclusion of 2.4 weight % PVP led to a significant drop in ∆E, demonstrating the reduced staining of this composition.” Id. Appeal 2020-005404 Application 15/529,656 11 Table 4 of the Specification is reproduced below: Table 4 shows formulas C–I each showing an increase in PVP concentration ranging from 0.3–4 wt.% PVP. See Spec. ¶¶ 47–48. In addition to PVP, the formulations each contain 0.85 wt.% xylitol, 0.054 wt.% stannous fluoride, 0.17 wt.% amine fluoride, and 0.25 wt.% emulsifier. Id. at ¶ 47. Higher ∆E values in the above tables mean more staining. We agree with Examiner that the data reported for formulation H, in table 4 above, appears to be an outlier because formulations C–G and I, which surround formulation H, show a trend of lower ∆E values with increasing concentration of PVP. A similar trend is seen between formulations A and B, from table 2 reproduced above, which also shows lower staining with higher PVP concentration. Appellant’s Specification confirms this conclusion, stating that “[f]ormulations C–I demonstrate the correlation between PVP concentration and reduced staining (lower value of ΔE). The inclusion of PVP led to a concentration-dependent drop in ΔE, in the range of 1.5–4%.” Spec. ¶ 48. Appeal 2020-005404 Application 15/529,656 12 Scarlett-Smith tested PVP at a concentration of 1, 5, 10, and 20%. FF5. The “[r]esults obtained [in Scarlett-Smith] demonstrated that PVP reduced 0.4% stannous fluoride induced stain formation on hydroxyapatite discs in a concentration dependent manner between 1% and 20% PVP. Stain was significantly reduced (P<0.05) by 27.4% and 24.5% for 10% and 20% PVP respectively.” FF5. We agree with Examiner’s interpretation that Scarlett-Smith teaches that stain reduction was observed at all points tested in a concentration dependent manner, meaning that as PVP concentration increased so did the stain reduction. This is the same trend observed in the present Specification. We determine that Appellant’s data presented in the Specification is not sufficient to establish that PVP concentrations between 2.20 to 3.00 weight % produce an unexpected results. Instead, we agree with Examiner that the data presented supports the same trend already disclosed in Scarlett- Smith that teaches increasing PVP concentrations show greater stain reduction in a dose dependent manner. After considering all the evidence anew before us, we conclude that Appellant has not provided sufficient evidence to establish non-obviousness of the claimed subject matter (In re Piasecki, 745 F.2d 1468, 1472 (Fed. Cir. 1984); In re Rinehart, 531 F.2d 1048, 1052 (CCPA 1976)), and, therefore, Appellant has not demonstrated an error in Examiner’s rejection. C. Conclusion We conclude that the preponderance of the evidence supports Examiner’s conclusion of obviousness with respect to claim 1, and Appellant has not provided sufficient rebuttal evidence or evidence of secondary considerations that outweighs the evidence supporting Examiner’s Appeal 2020-005404 Application 15/529,656 13 conclusion. As Appellant does not argue the claims separately, claims 3, 4, 7–12, 15, 16, 18, 19, and 21 fall with claim 1. 37 C.F.R. § 41.37 (c)(1)(iv). DECISION SUMMARY In summary: Claim(s) Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1, 3, 4, 7–12, 15, 16, 18, 19, 21 103 Scarlett-Smith 1, 3, 4, 7–12, 15, 16, 18, 19, 21 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)(1)(iv). AFFIRMED Copy with citationCopy as parenthetical citation