Richard Scott. Robinson et al.Download PDFPatent Trials and Appeals BoardMar 31, 202014649557 - (D) (P.T.A.B. Mar. 31, 2020) 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. 14/649,557 06/04/2015 Richard Scott ROBINSON 9849-00-US-01-OC 4845 23909 7590 03/31/2020 COLGATE-PALMOLIVE COMPANY 909 RIVER ROAD PISCATAWAY, NJ 08855 EXAMINER BROWE, DAVID ART UNIT PAPER NUMBER 1617 NOTIFICATION DATE DELIVERY MODE 03/31/2020 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 SCOTT ROBINSON and WILBENS JOSIAS Appeal 2019-0013881 Application 14/649,557 Technology Center 1600 Before ERIC B. GRIMES, RYAN H. FLAX, and CYNTHIA M. HARDMAN, Administrative Patent Judges. HARDMAN, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134(a) involving claims related to an oral care composition. The Examiner rejected the claims as obvious under 35 U.S.C. § 103(a). See Final Act. 3. 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. Appeal Br. 2. Appeal 2019-001388 Application 14/649,557 2 CLAIMED SUBJECT MATTER Claims 1–4, 6, 7, 13–22, 24, 25, 28, 31, 32, 35, 38, 55, and 56 are on appeal. Final Act. 2. The claims are directed to oral care compositions. Claim 1, reproduced below with spacing added for clarity, illustrates the claimed subject matter: 1. An oral care composition comprising an orally acceptable vehicle, a basic amino acid in free or salt form, calcium carbonate, a source of zinc ions, and at least one surfactant selected from a nonionic block copolymer surfactant and a betaine zwitterionic surfactant or a mixture thereof wherein the oral care composition does not comprise any anionic surfactant, wherein the basic amino acid in free or salt form comprises arginine, wherein the zinc ion source comprises zinc citrate, zinc oxide, or a mixture thereof, wherein the nonionic block copolymer surfactant has a polyoxypropylene molecular mass of from 3000 to 5000g/mol and a polyoxyethylene content of from 60 to 80 mol%, and wherein the betaine zwitterionic surfactant comprises a C8 – C16 amidopropyl betaine. Appeal Br. 14 (Claims Appendix). Appeal 2019-001388 Application 14/649,557 3 REFERENCES The prior art relied upon by the Examiner is: Name Reference Date Winston US 5,330,748 July 19, 1994 Prencipe WO 2009/099452 A1 Aug. 13, 2009 Joziak US 2009/0238769 A1 Sep. 24, 2009 REJECTION Claims 1–4, 6, 7, 13–22, 24, 25, 28, 31, 32, 35, 38, 55, and 56 stand rejected under pre-AIA 35 U.S.C. § 103(a) as being unpatentable over Prencipe, Joziak, and Winston. Final Act. 3. OPINION The Examiner found that Prencipe discloses a dentifrice composition for sensitive teeth comprising arginine bicarbonate (a basic amino acid), calcium carbonate, a zinc ion source, and Pluronic (i.e., Poloxamer) nonionic block copolymer surfactant, wherein the composition does not necessarily comprise an anionic surfactant. Final Act. 4. The Examiner found that Prencipe neither explicitly excludes anionic surfactants, nor discloses that the zinc ion source is specifically zinc oxide. Id. at 5. The Examiner found that Joziak and Winston teach this subject matter. Id. As to Joziak, the Examiner found that it discloses a dentifrice composition for sensitive teeth comprising a basic amino acid, carbonate salt abrasive particles, a zinc ion source, and Poloxamer 407 (i.e., a nonionic block copolymer surfactant), wherein the composition does not comprise any anionic surfactant. Final Act. 4–5. The Examiner further found that Joziak discloses that anionic surfactants can irritate the oral cavity, and that a foaming agent comprising a nonionic surfactant, free of any anionic Appeal 2019-001388 Application 14/649,557 4 surfactant, produces a foam quality that is just as good as, if not superior to, the foam produced with an anionic surfactant, and does not irritate the oral cavity. Final Act. 6. As to Winston, the Examiner found that it discloses a dentifrice composition comprising a calcium carbonate abrasive, zinc oxide (i.e., zinc ion source), and Pluronic nonionic block copolymer surfactant, wherein the composition does not necessarily comprise an anionic surfactant. Final Act. 5. The Examiner further found that Winston discloses that zinc oxide, unlike the more soluble zinc salts, exhibits enhanced plaque, tartar, and gingivitis fighting properties, without having a lingering unpleasant metallic and astringent taste. Final Act. 6. The Examiner found that one of ordinary skill in the art would have been motivated to employ e.g. Poloxamer 407 as the surfactant instead of an anionic surfactant, and zinc oxide as the zinc ion source in Prencipe’s dentifrice composition for sensitive teeth, with the reasonable expectation that the resulting dentifrice composition would successfully fight plaque, tartar, and gingivitis without irritating the oral cavity and without leaving any unpleasant metallic and astringent taste. Final Act. 6. We agree with and adopt the Examiner’s findings of fact, and determine that the Examiner has presented a prima facie case of obviousness with respect to the appealed claims. We address Appellant’s arguments below. Appellant argues that “the framework for analysis as to the obviousness of chemical formulations and their uses involves a ‘lead- modification’ analysis similar to that involving novel compounds.” Appeal Br. 5 (citing Unigene Labs., Inc. et al. v. Apotex, Inc., et al., 655 F.3d 1352, Appeal 2019-001388 Application 14/649,557 5 1361–1362 (Fed. Cir. 2011)). Appellant then characterizes the Examiner’s rejection as “(i) choos[ing] Prencipe as a lead reference, and then (ii) selectively chang[ing] the formulations in Prencipe to be more like a completely unrelated reference addressing a problem not identified at all in Prencipe,” which Appellant contends is not an obvious path, “without benefit of the map provided by the instant specification.” Id. at 6. We are not persuaded by Appellant’s arguments. As an initial matter, the court in Unigene merely stated that “[a] prima facie case of obviousness in the chemical arts is often based on a . . . ‘lead compound,”’ and that in the context of a composition or formulation patent, the “lead compound” might more appropriately be referred to as a “reference composition.” Unigene, 655 F.3d at 1361–62. There is no requirement, however, that the obviousness analysis for a composition claim must always be based on a motivation to modify a particular reference composition. Indeed, Unigene cannot run counter to the flexible analysis the Supreme Court set out in KSR, which recognizes the obviousness of pursuing known options within the technical grasp of the skilled artisan, e.g., known equivalents. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007). Additionally, Appellant mischaracterizes the Examiner’s rejection. The Examiner’s prima facie case was appropriately grounded in the teachings of the prior art. As summarized above, the Examiner found that Prencipe discloses a composition similar to that claimed, except it does not specifically exclude anionic surfactants, or specifically teach zinc oxide. Final Act. 5. However, Joziak and Winston respectively teach this subject matter, and respectively provide motivations for avoiding anionic surfactants and using zinc oxide. Final Act. 6. Where, as here, a patent claim “‘simply Appeal 2019-001388 Application 14/649,557 6 arranges old elements with each performing the same function it had been known to perform’ and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR Int'l Co., 550 U.S. at 417 (quoting Sakraida v. Ag Pro, Inc., 425 U.S. 273, 282 (1976)). Appellant additionally argues that neither Prencipe nor Joziak disclose or teach a composition comprising all limitations of the appealed claims. Appeal Br. 5, 8. We are not persuaded by these arguments, because the test for obviousness is not whether the claimed invention is expressly identified in any one of the references, but whether the claimed subject matter would have been obvious to those of ordinary skill in the art in light of the combined teachings of the prior art. See In re Keller, 642 F.2d 413, 425 (CCPA 1981). Appellant cannot show nonobviousness by attacking references individually as failing to teach all of the claimed limitations where, as here, the rejection is based on a combination of references, whose teachings together render obvious the claimed invention. Id. Appellant additionally argues that no exemplary formulation in Prencipe contains a zinc salt, and that all exemplary formulations in Prencipe contain an anionic surfactant. Appeal Br. 5–6. Appellant similarly argues that none of the exemplary formulations in Joziak contain a basic amino acid and/or a source of zinc ions, and that all of the examples in Winston contain anionic surfactants. Id. at 8. We are also not persuaded by these arguments, because “a reference is not limited to the disclosure of specific working examples.” In re Mills, 470 F.2d 649, 651 (CCPA 1972). Appellant argues that “the relevant question to be answered here is not whether a nonionic or zwitterionic surfactant can be added into Prencipe’s dentifrice, but is whether there is any teaching or suggestion in Prencipe or Appeal 2019-001388 Application 14/649,557 7 other cited references that would motivate one of skill in the art to add a surfactant system free of anionic surfactant as recited in claim 1 into a dentifrice containing a basic amino acid, a source of zinc ions, and calcium carbonate.” Appeal Br. 7. We are not persuaded by this argument, because the Examiner has answered the question formulated by Appellant, e.g., by finding that Prencipe teaches dentifrice compositions containing a basic amino acid, a source of zinc ions, calcium carbonate, and “anionic, cationic, nonionic or zwitterionic surfactants” (see, e.g., Prencipe ¶¶ 11, 19 (compositions 1.0.56 and 1.0.63), 60), and that Joziak provides a motivation to avoid anionic surfactants and opt for nonionic and zwitterionic surfactants in similar compositions (see, e.g., Joziak ¶ 4). Appellant argues that Prencipe teaches away from removing anionic surfactant, because it teaches that “the presence of a basic amino acid is also surprisingly found to reduce bacterial adhesion to the tooth surface, particularly when the basic amino acid is provided in combination with an anionic surfactant.” Appeal Br. 9 (citing Prencipe ¶ 17). We are not persuaded that Prencipe teaches away. “A reference does not teach away . . . if it merely expresses a general preference for an alternative invention but does not criticize, discredit, or otherwise discourage investigation into the invention claimed.” Galderma Labs., L.P. v. Tolmar, Inc., 737 F.3d 731, 738 (Fed. Cir. 2013) (citation omitted). Here, although Prencipe discloses a benefit of anionic surfactants, it neither criticizes nor discredits the use of nonionic or zwitterionic surfactants. And, as discussed previously, Joziak discloses that anionic surfactants can irritate the oral cavity, but a foaming agent comprising nonionic and zwitterionic surfactants, free of anionic surfactant, foams at least as well as an anionic surfactant, without irritating Appeal 2019-001388 Application 14/649,557 8 the oral cavity. See Joziak ¶¶ 1, 4. Thus, Joziak provides a reason for a skilled artisan to avoid anionic surfactants despite the benefit taught by Prencipe. See Winner Int’l Royalty Corp. v. Wang, 202 F.3d 1340, 1349 n.8 (Fed. Cir. 2000) (“The fact that the motivating benefit comes at the expense of another benefit . . . should not nullify its use as a basis to modify the disclosure of one reference with the teachings of another. Instead, the benefits, both lost and gained, should be weighed against one another.”). Appellant next asserts that it has demonstrated unexpected results, and that unexpected results “should be sufficient to rebut a prima facie case of obviousness.” Reply Br. 4, 6–7; Appeal Br. 10–13. Specifically, Appellant asserts that data in the Specification demonstrate that “the foam reduction effect of including both a basic amino acid and a zinc ion source in calcium carbonate-containing oral care compositions is mitigated by using a poloxamer nonionic surfactant and/or a betaine zwitterionic surfactant.” Reply Br. 5; see also Spec. 17 (Table 2) (reporting Foam Volume in various formulations). Appellant also argues that data in the Specification demonstrate that compositions comprising arginine, zinc ions, calcium carbonate, and the surfactant system used in the present invention increase zinc ion uptake as compared to compositions comprising an anionic surfactant. Appeal Br. 11 (citing Spec. 24 (Table 7)). We are not persuaded by Appellant’s arguments. As an initial matter, even assuming arguendo Appellant has demonstrated unexpected results, contrary to Appellant’s suggestions, any demonstration of unexpected results is not necessarily sufficient to overcome a strong prima facie case of obviousness. “Although secondary considerations must be taken into account, they do not necessarily control the obviousness conclusion.” Appeal 2019-001388 Application 14/649,557 9 Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1372 (Fed. Cir. 2007); see also id. (“Alternatively, we hold that even if Pfizer showed that amlodipine besylate exhibits unexpectedly superior results, this secondary consideration does not overcome the strong showing of obviousness in this case.”); Leapfrog Enters., Inc. v. Fisher-Price, Inc., 485 F.3d 1157, 1162 (Fed. Cir. 2007) (finding no error in district court’s conclusion that despite substantial evidence of commercial success, praise, and long-felt need, such evidence was inadequate to overcome the strong prima facie obviousness showing). “[T]he burden of showing unexpected results rests on [the party] who asserts them.” In re Klosak, 455 F.2d 1077, 1080 (CCPA 1972). Here, we agree with the Examiner that Appellant has not demonstrated that the foam volume results reported in the Specification are unexpected. Ans. 11–12. Appellant suggests that the results are unexpected because the beneficial effect of a poloxamer nonionic surfactant and/or a betaine zwitterionic surfactant in a composition containing calcium carbonate, a basic amino acid, and a zinc ion source is not taught or suggested by any of the cited references. Appeal Br. 10. We are not persuaded by this argument. Joziak expressly teaches that “a foaming agent comprising nonionic and zwitterionic surfactants may replace foaming agents containing anionic surfactants,” and that the foam from the nonionic and zwitterionic surfactants “is equivalent to, or may even be superior to, similar compositions containing one or more anionic surfactants.” Joziak ¶ 4. While Joziak does not expressly disclose foam results for a composition meeting all limitations of the claim, we agree with the Examiner that one of ordinary skill in the art would still expect the foam from the ionic [sic, nonionic] and zwitterionic surfactants to be equivalent to or superior to the foam from the anionic surfactant Appeal 2019-001388 Application 14/649,557 10 in such compositions, in view of the broad teaching in paragraph 0004. If the expectation is at least equivalent to or superior to, a finding of superior to is not necessarily such a dramatic surprise sufficient to overcome the compelling case of prima facie obviousness. Final Act. 13. We also agree with the Examiner that even assuming, arguendo, at least some aspect of surprise in the results set forth in the Specification, in weighing the evidence of prima facie obviousness against the evidence of unexpected results, the scales would appear to tip in favor of the case for prima facie obviousness. Indeed, one of ordinary skill in the art, in view of the teachings of Joziak, would be strongly compelled to employ e.g. a nonionic surfactant, or the combination of a nonionic surfactant and a zwitterionic surfactant, instead of an anionic surfactant, in the Prencipe dentifrice composition for sensitive teeth to eliminate the oral irritation caused by the use of anionic surfactants. Final Act. 12–13; see also Pfizer, Inc., 480 F.3d at 1372. Appellant additionally asserts that “Table 7 of the present specification further shows that when used in compositions comprising arginine, zinc ions, and calcium carbonate, the surfactant system used in the present invention increases zinc ion uptake as compared to an anionic surfactant.” Appeal Br. 11. We are not persuaded by Appellant’s argument. First, we agree with the Examiner that “the data pertains only to zinc oxide, but not to zinc citrate, which may or may not exhibit the same increase in uptake in the presence of the nonionic surfactant compared to the anionic surfactant.” Final Act. 13. Appellant has not provided a basis to support the conclusion that zinc citrate, which is also recited in claim 1, would also demonstrate the same behavior. See In re Huai-Hung Kao, 639 F.3d 1057, 1068 (Fed. Cir. 2011) (applicant must provide an adequate basis to support a Appeal 2019-001388 Application 14/649,557 11 conclusion that other embodiments falling within the claim would behave in the same manner). Second, unexpected results “must be shown to be unexpected compared with the closest prior art.” In re Baxter Travenol Labs., 952 F.2d 388, 392 (Fed. Cir. 1991). The composition designated as Comparative Example 7 lacks arginine or another basic amino acid (see Spec. 23), whereas the Examiner relied on compositions comprising arginine. See, e.g., Final Act. 4–5 (citing Prencipe at, e.g., ¶ 11, Example 3, and Joziak at, e.g., ¶¶ 11, 28). Accordingly, the comparison with Comparative Example 7 is not persuasive of unexpected results. To the extent inventive Example 5 shows more zinc uptake than Comparative Example 6 (a formulation which comprises, among other things, calcium carbonate, arginine bicarbonate, zinc oxide, and an anionic surfactant (sodium lauryl sulfate), see Spec. 23), we determine that the difference is merely a difference in degree, not kind. Galderma Labs., L.P., 737 F.3d at 739 (“Unexpected results that are probative of nonobviousness are those that are ‘different in kind and not merely in degree from the results of the prior art.’”) (quoting Iron Grip Barbell Co. v. USA Sports, Inc., 392 F.3d 1317, 1322 (Fed. Cir. 2004)). When differences based upon degree are asserted, the evidence must show that the claims and prior art “differed in such an appreciable degree that the difference was really unexpected.” In re Merck & Co., 800 F.2d 1091, 1099 (Fed. Cir. 1986). Here, the Specification reports a zinc uptake of 304 Mµg/disk for Example 5, and a zinc uptake of 235 Mµg/disk for Comparative Example 6. Spec. 24. On this record, Appellant has established neither that this difference in zinc uptake represents a difference in kind rather than in degree, nor that the results Appeal 2019-001388 Application 14/649,557 12 differed to such an appreciable degree that the difference was really unexpected. CONCLUSION We affirm the rejection of claims 1–4, 6, 7, 13–22, 24, 25, 28, 31, 32, 35, 38, 55, and 56 under 35 U.S.C. § 103(a) as being unpatentable over Prencipe, Joziak, and Winston. DECISION SUMMARY Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1–4, 6, 7, 13–22, 24, 25, 28, 31, 32, 35, 38, 55, 56 103(a) Prencipe, Joziak, Winston 1–4, 6, 7, 13–22, 24, 25, 28, 31, 32, 35, 38, 55, 56 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