Joziak, Marilou et al.

Patent Trials and Appeals BoardAug 14, 2019

12053222 - (D) (P.T.A.B. Aug. 14, 2019)

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. 12/053,222 03/21/2008 Marilou Joziak 8397-00-US-01-OC 3810 23909 7590 08/14/2019 COLGATE-PALMOLIVE COMPANY 909 RIVER ROAD PISCATAWAY, NJ 08855 EXAMINER ROBERTS, LEZAH ART UNIT PAPER NUMBER 1612 NOTIFICATION DATE DELIVERY MODE 08/14/2019 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 MARILOU JOZIAK and JASON NESTA1 __________ Appeal 12/053,222 Application 2019-003113 Technology Center 1600 __________ Before ERIC B. GRIMES, RICHARD M. LEBOVITZ, and RICHARD J. SMITH, Administrative Patent Judges. GRIMES, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to a dentifrice composition, which have been rejected as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. STATEMENT OF THE CASE “Foaming agents containing anionic surfactants, such as sodium lauryl sulfate . . . have traditionally been used in consumer care products, oral products, e.g., dentifrices, due to their low cost and ability to foam.” Spec. ¶ 1. However, “anionic surfactants tend to irritate the oral cavity.” Id. “Such 1 Appellants identify the Real Party in Interest as Colgate-Palmolive Company. Appeal Br. 2. Appeal 12/053,222 Application 2019-003113 2 irritation is especially undesirable, especially in people suffering from, or predisposed to[,] various conditions, such as xerostomia (dry mouth).” Id. The Specification discloses “a foaming agent comprising a non-ionic surfactant, a zwitterionic surfactant, and [] free of anionic surfactants.” Id. ¶ 4. Preferred zwitterionic surfactants include cocoamidopropyl betaine. Id. ¶ 13. Preferred non-ionic surfactants include poly(oxyethylene)-poly(oxypropylene) copolymers, known commercially as poloxamers; a “preferred poloxamer is Poloxamer 407, sold under the trade name PLURONIC F127.” Id. ¶ 14. “The oral care compositions . . . preferably contain fluoride ions.” Id. ¶ 17. “Antibacterial agents can be used if reduction of microorganisms is desired, and can include known antibacterial agents used in dentifrice formulations such as, e.g., benzoic acid, sodium benzoate, . . . cetylpyridinium chloride,” etc. Id. ¶ 26. Claims 9–11 and 14–17 are on appeal. Claim 17 is illustrative and reads as follows: 17. A dentifrice composition for use in the treatment and/or alleviation of xerostomia, comprising: about 0.2% to about 5% of cocoamidopropyl betaine, and about 0.5% to about 10% of a poly(oxyethylene)- poly(oxypropylene) copolymer, said dentifrice composition being free of anionic surfactants, said dentifrice composition further comprising an antibacterially effective amount of cetylpyridinium chloride, an antibacterially effective amount of sodium benzoate, and a fluoride ion source sufficient to provide about 5000 ppm fluoride ions, wherein the fluoride ion source is sodium fluoride. Appeal 12/053,222 Application 2019-003113 3 The claims stand rejected as follows: Claims 9–11 and 14–17 under 35 U.S.C. § 103(a) as obvious based on Boyd2 and Morgan3 (Ans. 3) and Claims 9–11 and 14–17 under 35 U.S.C. § 103(a) as obvious based on Szeles4 and Morgan (Ans. 5). I The Examiner has rejected all of the claims on appeal as obvious based on Boyd and Morgan. The Examiner finds that Boyd discloses a toothpaste that includes a nonionic surfactant, such as a poly(oxyethylene)- poly(oxypropylene) copolymer, and a zwitterionic surfactant, such as cocoamidopropyl betaine, in a total amount of 0.1–5% of the composition. Ans. 3. “The reference does not disclose the use of anionic surfactants.” Id. The Examiner also finds that Boyd discloses a fluoride ion source, preferably sodium fluoride, providing up to 5000 ppm fluoride ions, and an antibacterial agent. Id. at 3–4. The Examiner finds that Boyd “does not disclose using cetylpyridinium chloride in the compositions.” Id. at 4. However, the Examiner finds that Morgan discloses an antiplaque oral care composition comprising an antibacterial agent and “cetylpyridinium chloride as a stabilizer and a component that enhances anti-plaque efficacy.” Id. The Examiner finds that Morgan also teaches that “[s]urfactants that are 2 US 2004/0258631 A1, published Dec. 23, 2004. 3 US 7,220,404 B2, issued May 22, 2007. 4 US 2003/0211053 A1, published Nov. 13, 2003. Appeal 12/053,222 Application 2019-003113 4 compatible with enzymes may also be used,” including Poloxamer 407 and cocoamidopropyl betaine, in amounts of 2–10% by weight. Id. The Examiner concludes that it would have been obvious “to have incorporated cetylpyridinium chloride or the combination comprising cetylpyridinium chloride (CPC, reducing agent and enzyme) in the compositions of Boyd motivated by the desire to make a third composition used for the very same purpose, to treat plaque.” Id. at 5. The Examiner also concludes that the amount of surfactants in Boyd’s composition is a result- effective variable that would have been obvious to optimize. Id. Appellants argue that “the relevant question” in this appeal “is whether it would be obvious to add an antibacterially effective amount of sodium benzoate into Boyd’s antiplaque oral composition.” Appeal Br. 5–6. Appellants argue that Morgan would not have prompted a skilled artisan to include sodium benzoate in Boyd’s composition. Id. at 6–7. In response to Appellants’ argument on this point, the Examiner notes that, “although Boyd does not disclose sodium benzoate, it disclose[s] preservatives and Morgan discloses sodium benzoate as a preservative.” Ans. 9. The Examiner concludes that “[t]herefore it would have been obvious to have added a preservative such as sodium benzoate in the compositions of Morgan.” Id. We agree with the Examiner that the composition of claim 17 would have been obvious based on Boyd and Morgan. Boyd discloses a dentifrice composition comprising an antibacterial arginine-derived compound. Boyd ¶ 10. Boyd states that “[s]urfactants useful in the practice of the present invention include nonionic and zwitterionic surfactants.” Id. ¶ 30. Boyd does not identify anionic surfactants as useful in its invention. See id. Boyd states Appeal 12/053,222 Application 2019-003113 5 that suitable nonionic surfactants include poly(oxyethylene)- poly(oxypropylene) copolymers and suitable zwitterionic surfactants include cocoamidopropyl betaine. Id. ¶¶ 30–31. The surfactants are used in a range of about 0.1–5% by weight. Id. ¶ 32. Boyd discloses that its composition “may also contain a source of fluoride ions . . . in amount sufficient to supply about 25 ppm to 5,000 ppm of fluoride ions. . . . Sodium fluoride is preferred.” Id. ¶ 37. Boyd also discloses that “[v]arious other materials may be incorporated in the dentifrice compositions of [its] invention, including desensitizers . . . ; whitening agents; preservatives;” etc. Id. ¶ 46. Morgan discloses that “cetyl pyridinium chloride and a reducing agent can provide enhanced stability and antiplaque efficacy in enzyme containing oral compositions.” Morgan 2:11–13. “The enzymes useful in the practice of [Morgan’s] invention include carbohydrases such as glucoamylase and enzymes extracted from natural fruit products such as proteases.” Id. at 2:26–29. Morgan discloses that its composition comprises the same types of surfactants, in the same amounts, as Boyd’s composition, and also comprises the same amount of sodium fluoride. Id. at 5:30 to 6:4. Morgan also discloses that “[v]arious other materials may be incorporated in the oral compositions of [its] invention, including desensitizers . . . ; whitening agents . . . ; preservatives;” etc. Id. at 6:65 to 7:3. Morgan provides working examples in which “the sugar level and viscosity methods were used to compare the effects of cetyl pyridinium chloride, the reducing agents ammonium sulfate and potassium stannate and preservative agents sodium benzoate, and parabens on cellulase activity.” Id. at 9:64 to 10:1 (emphasis added). Appeal 12/053,222 Application 2019-003113 6 It would have been obvious to modify Boyd’s dentifrice composition by adding an enzyme (such as glucoamylase or a protease), cetyl pyridinium chloride, and a reducing agent because Morgan discloses that this combination enhances stability and antiplaque efficacy in oral compositions. It would also have been obvious to modify the composition to include sodium benzoate, because Boyd expressly suggests incorporating preservatives in its composition, and Morgan uses sodium benzoate as a preservative in its exemplary compositions. Thus, a skilled artisan would have recognized that sodium benzoate is a suitable preservative for use in oral compositions. In addition, while Boyd does not disclose the specific amounts of surfactants recited in claim 17, it suggests both of the recited surfactants and suggests a total amount of about 0.1–5% by weight, which includes the amounts recited in claim 17. “[W]here 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.” In re Aller, 220 F.2d 454, 456 (CCPA 1955). Appellants argue that “Morgan discloses two compositions comprising sodium benzoate (Compositions B and D in Table I)” but only “for the purpose of comparison to [inventive] Composition A, and does not teach or suggest that sodium benzoate would be compatible with enzymes in an oral care composition.” Appeal Br. 6. Appellants argue that “Morgan’s data show that the addition of sodium benzoate into a composition comprising an enzyme has an unwanted effect on cellulase activity.” Id. This argument is not persuasive. Morgan states that its results showed that sodium benzoate is not as effective as the combination of a reducing Appeal 12/053,222 Application 2019-003113 7 agent (potassium stannate) and cetyl pyridinium chloride in delaying—i.e., inhibiting—cellulase activity. Morgan 10:17–22. Cellulase is a contaminant. Id. at 1:46–51. Morgan does not describe its results as showing that sodium benzoate had any effect on the desired glucoamylase or protease activities in its compositions. In fact, Morgan shows that its Composition D, comprising enzymes (papain and glucoamylase), cetyl pyridinium chloride, and sodium benzoate, reduced bacteria more effectively than “a commercial dentifrice which contained cetyl pyridinium chloride but no enzymes.” Id. at 10:35–41, 52–55. The increased effectiveness of the enzyme-containing composition is evidence that sodium benzoate did not inhibit the desired glucoamylase or protease activities. Appellants also argue that “Morgan shows that Compositions B and D containing sodium benzoate are less effective in delaying cellulase activity . . . than Composition A, which contains EDTA as a preservative (Morgan, column 9, lines 17-19). Thus, one of skill in the art would be at most motivated to add EDTA as a preservative.” Appeal Br. 7. This argument is also unpersuasive. Morgan discloses using both EDTA and sodium benzoate as preservatives in its exemplary compositions. See Morgan 9:18 (“a preservative (EDTA)”) and 9:67 to 10:1 (“preservative agent[] sodium benzoate”). Thus, based on Boyd’s express suggestion to include preservatives in its composition, it would have been obvious to use either EDTA or sodium benzoate, or both, in Boyd’s composition. We affirm the rejection of claim 17 under 35 U.S.C. § 103(a) based on Boyd and Morgan. Claims 9–11 and 14–16 have not been argued separately and therefore fall with claim 17. 37 C.F.R. § 41.37(c)(1)(iv). Appeal 12/053,222 Application 2019-003113 8 II The Examiner rejected all of the claims on appeal as obvious based on Szeles and Morgan. The Examiner finds that Szeles discloses antibacterial dentifrice compositions comprising a cationic anti-bacterial compound such as cetylpyridinium chloride and 2–10% by weight surfactants, where preferred surfactants include poloxamer 407 and cocoamidopropyl betaine. Ans. 5–6. The Examiner finds that Szeles’ composition also includes a fluoride ion source, preferably sodium fluoride, providing up to 5000 ppm fluoride ions, and can include other optional ingredients. Id. at 6. The Examiner finds that Szeles does not disclose sodium benzoate as a component of its dentifrice, but Morgan discloses an antiplaque oral care composition comprising cetylpyridinium chloride and surfactants such as Poloxamer 407 and cocoamidopropyl betaine. Id. “The compositions also comprise preservatives including sodium benzoate (Examples).” Id. at 7. The Examiner concludes that it would have been obvious “to have used sodium benzoate in the compositions of Szeles et al. because is a suitable preservative[] for compositions comprising cetylpyridinium chloride.” Id. We agree with the Examiner that the composition of claim 17 would have been obvious based on Szeles and Morgan. Szeles discloses a dental composition comprising an antibacterial compound and a proteolytic enzyme. Szeles ¶ 9. Szeles states that “[c]ationic antibacterial agents useful in the practice of the present invention are well known in the art” and include cetyl pyridinium chloride. Id. ¶¶ 11, 12. Szeles discloses that “[a]nionic surfactants such as higher alkyl sulfates such as sodium lauryl sulfate are not compatible with enzymes.” Id. ¶ 39. “Examples of enzyme compatible surfactants include nonanionic Appeal 12/053,222 Application 2019-003113 9 polyoxyethylene surfactants such as Polyoxamer 407 . . . and amphoteric surfactants such as cocamidopropyl betaine.” Id. “Preferred surfactants include a combination of Pluronic F127, Polyoxamer 407, Polysorbate 20, and cocamidopropyl betaine at a total surfactant concentration in the dentifrice composition of between about 2 to about 10% by weight.” Id. Szeles discloses that its composition “may also contain a source of fluoride ions . . . in amount sufficient to supply about 25 ppm to 5,000 ppm of fluoride ions. . . . Sodium fluoride is preferred.” Id. ¶ 41. Szeles also discloses that “[v]arious other materials may be incorporated in the dentifrice compositions of [its] invention, including desensitizers . . .; whitening agents; preservatives;” etc. Id. ¶ 53. As discussed above with regard to the rejection based on Boyd and Morgan, Morgan provides exemplary compositions that include sodium benzoate as a preservative. Morgan 9:64 to 10:1. It would have been obvious to modify Szeles’ dental composition by adding sodium benzoate, because Szeles expressly suggests incorporating preservatives in its composition, and Morgan uses sodium benzoate as a preservative in its exemplary compositions. Thus, a skilled artisan would have recognized that sodium benzoate is a suitable preservative for use in oral compositions. In addition, while Szeles does not disclose the specific amounts of surfactants recited in claim 17, it suggests a combination of surfactants that includes Pluronic F127 and cocamidopropyl betaine, in a total amount of about 2–10% by weight, which includes the amounts recited in claim 17. “[W]here 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.” In re Aller, 220 F.2d at 456. Appeal 12/053,222 Application 2019-003113 10 As with the rejection based on Boyd and Morgan, Appellants argue that “Morgan’s data show that the addition of sodium benzoate into a composition comprising an enzyme has an unwanted effect on cellulase activity. There is no teaching or suggestion in Morgan that sodium benzoate would be a suitable preservative for a composition comprising enzymes and CPC [cetyl pyridinium chloride].” Appeal Br. 8–9. As discussed above, however, Morgan’s results regarding cellulase inhibition are not predictive of any effect of sodium benzoate on the activity of the protease in Szeles’ composition. In fact, Morgan shows that its Composition D, comprising glucoamylase, papain, cetyl pyridinium chloride, and sodium benzoate, reduced bacteria more effectively than “a commercial dentifrice which contained cetyl pyridinium chloride but no enzymes.” Morgan 10:35–42, 52–55. The increased effectiveness of the enzyme-containing composition is evidence that sodium benzoate did not inhibit the enzymes’ activities. Appellants also argue again that Morgan shows that Compositions B and D containing sodium benzoate are less effective in delaying cellulase activity upon the dentifrice composition than Composition A, which contains EDTA as a preservative (Morgan, column 9, lines 17-19). Thus, one of skill in the art would be at most motivated to add EDTA as a preservative into a composition comprising CPC and enzymes. Appeal Br. 9. As discussed above, however, Morgan’s disclosure that EDTA and sodium benzoate are suitable preservatives for use in dental compositions would have provided a reason to use either of them, or both, in Szeles’ composition, based on Szeles’ suggestion to include preservatives. Appeal 12/053,222 Application 2019-003113 11 We affirm the rejection of claim 17 under 35 U.S.C. § 103(a) based on Szeles and Morgan. Claims 9–11 and 14–16 have not been argued separately and therefore fall with claim 17. 37 C.F.R. § 41.37(c)(1)(iv). SUMMARY We affirm both of the rejections on appeal. 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). AFFIRMED