Colgate-Palmolive CompanyDownload PDFPatent Trials and Appeals BoardMay 26, 202014960960 - (D) (P.T.A.B. May. 26, 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. 14/960,960 12/07/2015 Lyndsay Schaeffer-Korbylo 10711-00-US-01-OC 1021 23909 7590 05/26/2020 COLGATE-PALMOLIVE COMPANY 909 RIVER ROAD PISCATAWAY, NJ 08855 EXAMINER RONEY, CELESTE A ART UNIT PAPER NUMBER 1612 NOTIFICATION DATE DELIVERY MODE 05/26/2020 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 LYNDSAY SCHAEFFER-KORBYLO and LISA MANUS Appeal 2019-005987 Application 14/960,960 Technology Center 1600 Before DONALD E. ADAMS, ELIZABETH A. LAVIER, and JAMIE T. WISZ, Administrative Patent Judges. LAVIER, 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 1–21. 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 2019-005987 Application 14/960,960 2 CLAIMED SUBJECT MATTER The claims are directed to methods for using an oral care composition to treat a person with particular bacterial species in their oral cavities. Claims 1 and 7 are illustrative: 1. A method of promoting the aggregation and/or immune clearance of oral bacteria, the method comprising: a) selecting a person in need of treatment due to the presence of one or more of A. viscous, L. casei, S. oralis, V. parvula and F. nucleatum present in their oral cavities; b) administering to the oral cavity of the person in need of treatment, an oral care composition comprising a metal-amino acid complex, wherein said complex is a zinc(II)-amino acid complex selected from zinc-lysine and zinc-arginine complex; c) and maintaining the metal-amino acid complex in the oral cavity for a period of treatment greater than 5 minutes. 7. The method of claim 1, wherein the complex is a zinc lysine chloride complex having the chemical structure [Zn(C6H14N2O2)2Cl]+ Cl-, either in solution of the cationic cation and the chloride anion, or in solid salt form, optionally in mono- or dihydrate form. Appeal Br. 11–12 (Claims Appendix). Appeal 2019-005987 Application 14/960,960 3 REFERENCES The Examiner relies on the following references: Name Reference Date Ratcliff et al. US 2009/0016973 Al Jan. 15, 2009 Pan et al. WO 2014/098822 A1 June 26, 2014 Heimdahl et al. Detection and Quantitation by Lysis-Filtration of Bacteremia after Different Oral Surgical Procedures, Journal of Clinical Microbiology, 2205– 2209. Oct. 1990 REJECTIONS 1. Claims 1–21 stand rejected under 35 U.S.C. § 112(a) as failing to comply with the written description requirement. Final Action 2. 2. Claims 1–20 stand rejected under 35 U.S.C. § 103 as unpatentable over Pan and Ratcliff. Final Action 3. 3. Claim 21 stands rejected under 35 U.S.C. § 103 as unpatentable over Pan, Ratcliff, and Heimdahl. Final Action 9. OPINION Rejection 1 The written description rejection (see Final Action 2–3) pertains to the limitation in claim 1 of “maintaining the metal-amino acid complex in the oral cavity for a period of treatment greater than 5 minutes.” The Examiner acknowledges that the Specification provides in vitro bacterial aggregation data at five-minute intervals (see id. at 3 (discussing Spec. ¶¶ 60–64), but concludes that these data are inadequate to support treatment within the Appeal 2019-005987 Application 14/960,960 4 mouth (see id. at 3; see also Ans. 7–8). In vivo data are not necessarily required to satisfy the written description requirement for a method of treatment. Instead, the disclosure must demonstrate, with reasonable clarity, that the inventors were in possession of the claimed subject matter. See Purdue Pharma L.P. v. Faulding, Inc., 230 F.3d 1320, 1323 (Fed. Cir. 2000). Having reviewed the cited passages of the Specification, we agree with Appellant (see Appeal Br. 9) that the in vitro aggregation data, at time points up to 55 minutes, are sufficient to support the “period of treatment greater than 5 minutes” language in claim 1. Accordingly, we reverse Rejection 1. Rejection 2 1. Claim 1 With respect to illustrative claim 1, the Examiner finds that Pan teaches zinc amino acid complex mouthwashes that, inter alia, reduce bacterially-generated biofilm and plaque, and can be applied for an extended period of time, i.e., more than five minutes. See Final Action 3–4 (citing Pan ¶¶ 7, 18, 40–41, claims 13, 19). As Pan does not specify the particular types of bacteria involved, the Examiner turns to Ratcliff. See id. at 4. Ratcliff teaches mouthwash compositions for killing bacteria in the oral cavity, including several of the species recited in claim 1, namely A. viscous, S. oralis, and F. nucleatum. See id. (citing Ratcliff ¶¶ 6, 7, 28, 63, claim 15). The Examiner concludes: Since Pan disclosed antibacterial compositions for the reduction of oral bacteria, it would have been prima facie to one of ordinary skill in the art to have used said compositions to reduce A. viscous, F. nucleatum and S. oralis, as taught by Ratcliff. An ordinarily skilled artisan would have been so motivated because said bacteria are closely associated with biofilm and oral disease. Appeal 2019-005987 Application 14/960,960 5 Further, a skilled artisan would have been so motivated because there is a strong need in the art to inhibit the formation of bacterial plaque, by reducing the presence of A. viscous F. nucleatum and S. oralis, as taught by Ratcliff, at [0006-7 and 0063] and at claim 15. Final Action 4–5. Furthermore, the Examiner finds that administering the mouthwashes comprising [Zn(Cl6H14N2O2)2Cl]+Cl- as taught in Pan would be expected to have the same effect as the claimed oral compositions likewise comprising [Zn(Cl6H14N2O2)2Cl]+Cl-: The instant specification, at page 2 and sections [0007 and 0008], discloses that [Zn(Cl6H14N2O2)2Cl]+Cl-, existing in solution of the cationic cation and the chloride anion, or as a solid salt, promotes improved bacterial aggregation. Pan discloses mouthwashes (title and abstract) administered to humans that comprise [Zn(Cl6H14N2O2)2Cl]+Cl-, existing in solution of the cationic cation and the chloride anion, or as a solid salt. Pan further discloses methods of reducing bacterially-generated biofilm and plaque, and of treating enamel erosion. It appears that the compositions of the instant claims and those of the prior art would reasonably be expected to have substantially the same physical and chemical properties (e.g. promotion of the aggregation of oral bacteria). This is because Pan disclosed administering mouthwashes comprising [Zn(Cl6H14N2O2)2Cl]+Cl-, and the instant specification disclosed that oral compositions comprising [Zn(C15H14N2O2)2Cl]+Cl- promote the aggregation of oral bacteria. Final Action 5; cf. In re Spada, 911 F.2d 705, 708 (Fed. Cir. 1990) (“Products of identical chemical composition cannot have mutually exclusive properties.”). Appellant presents several arguments, none of which we find persuasive. First, Appellant asserts that they “have demonstrated that treatment for a novel and nonobvious patient-sub[]population with specific Appeal 2019-005987 Application 14/960,960 6 bacteria in their oral cavity” (Appeal Br. 5) whereas the Examiner’s rejection relies only on generalizations (see id. at 6). We disagree. The Examiner’s rejection is specific, and utilizes the combination of Pan and Ratcliff, not in isolation. In re Keller, 642 F.2d 413, 426 (CCPA 1981) (“But one cannot show non-obviousness by attacking references individually where, as here, the rejections are based on combinations of references.”). The Examiner explains: Pan clearly teaches the administration of zinc amino acid halide complexes, for reducing bacterially-generated oral biofilm, plaque, gingivitis, and caries, caused by normal oral bacteria (taught by Ratcliff), including Actinomyces viscosus, Streptococcus oralis and Fusobacterium nucleatum, and wherein said bacteria are basic and normal, rather than random, colonizers that cause biofilm, plaque, gingivitis and caries in the mouth. Ans. 10. Thus, we agree with the Examiner (see id.) that Pan’s teachings read on the claimed bacteria insofar as Pan teaches treatment of oral bacteria that cause plaque, gingivitis, and biofilm; Ratcliff adds clarity to this point by identifying some of the bacterial species recited in claim 1 as causal to these conditions. Appellant has, at best, identified the particular species of bacteria left unspecified, but nonetheless treated, by Pan. This is not inventive. Cf. In re Baxter Travenol Labs., 952 F.2d 388, 392 (Fed. Cir. 1991) (“Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention.”). Appellant also argues that because Pan is “primarily directed to reducing or treating hypersensitivity by occluding dentinal tubules and provide zinc to teeth enamel,” the ordinarily skilled artisan would not have looked to Pan to develop the claimed method. Appeal Br. 7; see also Reply Appeal 2019-005987 Application 14/960,960 7 Br. 6.2 But what Pan “primarily” teaches is not the issue, as a reference is prior art for all that it teaches. See In re Mills, 470 F.2d 649, 651 (CCPA 1972) (citations omitted) (“All the disclosures in a reference must be evaluated, including nonpreferred embodiments.”), In re Lemelson, 397 F.2d 1006, 1009 (CCPA 1968) (“The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain.”). As introduced above, Pan teaches using its compositions to “reduce bacterially-generated biofilm and plaque” as well as for treating hypersensitivity, enamel erosion, and other purposes. Pan ¶ 10; see also id. at ¶¶ 18, 44. Appellant’s assertion that the use of Pan’s compositions is “entirely different” because “the method here claims the act of rinsing out the entire [oral] cavity” (Appeal Br. 8) thus fails to account for the scope of Pan’s teachings.3 Relatedly, Appellant argues that the rejection fails to identify a teaching, motivation, or suggestion to combine the references, insofar as Ratcliff does indicate that the recited bacterial strains “can be treated by the complex in Pan,” and that there is “no link between the solution of stabilized chlorine dioxide” in Pan and the compositions recited in claim 1. Appeal Br. 6; see also Reply Br. 5. Appellant’s argument unpersuasively considers the 2 The Reply Brief is not paginated. We count seven pages, beginning from the title page. 3 This argument also fails because claim 1 simply recites “administering to the oral cavity” (Appeal Br. 11 (Claims Appendix)), not “rinsing out the entire cavity” as Appellant alleges (id. at 8). Indeed, claim 9, which depends from claim 1, further specifies that the composition may be in the form of, inter alia, a “strip[] or gum” (id. at 12), i.e., forms that are not rinses. Appeal 2019-005987 Application 14/960,960 8 references individually, not in tandem. See Keller, 642 F.2d at 426. As discussed above, both Pan and Ratcliff are directed to reducing oral bacteria and treating conditions caused thereby, such as plaque. The Examiner relies on Pan, not Ratcliff, for the bacteria-killing composition, and so there need not be a “link” between the compositions of Ratcliff and those used in claim 1. Appellant’s assertion that bacterial aggregation is unpredictable (see Appeal Br. 9) likewise misses the mark (see Ans. 17). Having considered Appellant’s arguments as properly presented in the Appeal Brief,4 we are not persuaded that the Examiner erred reversibly in rejecting claim 1. For the reasons described herein as well as those already of record, we affirm the rejection of claim 1. Claims 2–6, 8–16, and 18–20 are not argued separately, and fall with claim 1. See 37 C.F.R. § 41.37(c)(1)(iv). 4 In the Reply Brief, Appellant raises a new argument with respect to Rejection 2, namely that Pan does not teach or suggest administering its composition for greater than five minutes, as required by claim 1. See Reply Br. 4. A new argument not timely presented in the Appeal Brief will not be considered when filed in a Reply Brief, absent a showing of good cause explaining why the argument could not have been presented in the Appeal Brief. See 37 C.F.R. § 41.37(c)(1)(iv) (2015); see also Ex parte Borden, 2010 WL 191083 at *2 (BPAI 2010) (informative) (“Any bases for asserting error, whether factual or legal, that are not raised in the principal brief are waived.”). In addition to being improper, this new argument is unpersuasive. We discern no error in the Examiner’s finding (see Final Action 3–4; see also Ans. 10) that Pan’s teaching of “extended” treatment times reads on “greater than 5 minutes” as recited in claim 1. Appeal 2019-005987 Application 14/960,960 9 2. Claims 7 and 17 Appellant argues that unexpected results in the Specification support the patentability of the administration of the specific zinc lysine chloride complex recited in claims 7 and 17.5 See Appeal Br. 8 (discussing Spec. ¶¶ 60–61). The characterization of the results as “unexpected” (Appeal Br. 8) appears to be unsupported attorney argument. See Knorr v. Pearson, 671 F.2d 1368, 1373 (CCPA 1982) (“[A]rguments of counsel cannot take the place of evidence lacking in the record.”); see also In re Klosak, 455 F.2d 1077, 1080 (CCPA 1972) (“[I]t is not enough to show that results are obtained which differ from those obtained in the prior art: that difference must be shown to be an unexpected difference.”). Further, the cited data in the Specification do not support such an assertion. For example, the Examiner explains: “[t]he appellants have attempted to draw a conclusion of aggregation by comparing solutions of unequal concentrations, and because the solutions are not comparable to each other, they cannot be fairly compared for an improved aggregation, as alleged.” Ans. 18. Nor is it clear whether or how these data compare to the closest prior art. See In re Soni, 54 F.3d 746, 750 (Fed. Cir. 1995). We affirm the rejection of claims 7 and 17. Rejection 3 Appellant does not present any additional arguments with respect to claim 21. We affirm the rejection of claim 21. 5 Claim 17 mirrors the language of claim 7, except that claim 17 depends on claim 11, while claim 7 depends on claim 1. Compare Appeal Br. 12 (claim 7) with id. at 13. Appeal 2019-005987 Application 14/960,960 10 CONCLUSION Rejection 1 is reversed; Rejections 2 and 3 are affirmed. DECISION SUMMARY Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1–21 112(a) Written Description 1–21 1–20 103 Pan, Ratcliff 1–20 21 103 Pan, Ratcliff, Heimdahl 21 Overall Outcome 1–21 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). See 37 C.F.R. § 1.136(a)(1)(iv). AFFIRMED Copy with citationCopy as parenthetical citation