Ex Parte Maitra et alDownload PDFPatent Trial and Appeal BoardMar 11, 201612132359 (P.T.A.B. Mar. 11, 2016) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 12/132,359 06/03/2008 23909 7590 03/15/2016 COLGATE-PALMOLIVE COMPANY 909 RIVER ROAD PISCATAWAY, NJ 08855 FIRST NAMED INVENTOR Prithwiraj Maitra 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 ATTORNEY DOCKET NO. CONFIRMATION NO. 7472-01-0C 7579 EXAMINER ROBERTS, LEZAH ART UNIT PAPER NUMBER 1612 NOTIFICATION DATE DELIVERY MODE 03/15/2016 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 PRITHWIRAJ MAITRA, LYNETTE ZAIDEL, SUMAN K. CHOPRA, GUISHENG PAN, MICHAEL PRENCIPE, and SYED IBRAHIM 1 Appeal2014-003185 Application 12/132,359 Technology Center 1600 Before ERIC B. GRIMES, JOHN G. NEW, and ROBERT A. POLLOCK, Administrative Patent Judges. POLLOCK, Administrative Patent Judge. DECISION ON APPEAL Appellants appeal under 35 U.S.C. § 134(a) from the final office action dated October 2, 2012, and in light of claim amendments entered January 3, 2014. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. 1 Appellants identify the Real Party in Interest as Colgate-Palmolive Company. App. Br. 2. Appeal2014-003185 Application 12/132,359 STATEMENT OF THE CASE Appellants' invention relates to oral care compositions comprising a tooth whitening agent and an acrylic film forming polymer. Spec. Abstract, i-fi-19-10. "In certain embodiments, the polymer is a terpolymer." Id. i125. Claims 1, 2, 4--25, and 36 are on appeal. 2 Independent claim 1 is illustrative: 1. An oral care composition, comprising: (a) a whitening agent; (b) a terpolymer wherein the terpolymer comprises a polymer of a first monomeric unit and at least two different second monomeric units; and ( c) a silicone polymer selected from the group consisting of silicone adhesives, silicone elastomers, silicone fluids, silicone resins, silicone gums and mixtures thereof. Claims 1, 2, 4--6, 8, 9, 11,12, and 15-17 stand rejected under 35 U.S.C. 103(a) as unpatentable over the combination ofMirajkar3 and Miranda.4 Claims 1,2, 4--25, and 36 stand rejected under 35 U.S.C. 103(a) as unpatentable over the combination of Singh, 5 Marchant, 6 and Miranda. The double patenting rejection in view of claims 1, 2, and 16-20 of Application No. 10/870,848 was withdrawn in the final office action of October 2, 2012, and is not before us. See Ans. 26. 2 We note that claims 1, 2, and 7 were amended in Appellants' response of Feb. 4, 2013. The Examiner has indicated that the amendments were entered. (Advisory Action mailed Jan. 7, 2014.) 3 Mirajkar et al., US 5,800,803, issued Sept. 1, 1998. 4 Miranda et al., US 5,656,286, issued Aug. 12, 1997. 5 Singh et al., US 2003/0152528 Al, published Aug. 14, 2003. 6 Marchant et al., US 6,297,337 Bl, issued Oct. 2, 2001. 2 Appeal2014-003185 Application 12/132,359 ANALYSIS We have reviewed Appellants' contentions that the Examiner erred in rejecting claims 1, 2, 4--25, and 36 as unpatentable over the cited art. (Br. 3- 16.) We disagree with Appellants' contentions and adopt the findings concerning the scope and content of the prior art set forth in the Examiner's Answer. For emphasis, we highlight and address the following: FF 1. Mirajkar discloses oral compositions such as dentifrices, gels, mouthwashes, chewing gums and lozenges, useful for increasing the uptake of non-cationic antibacterial agents in dental tissue and thereby reducing plaque. Mirajkar, Title, Abstract, 1:59-2:7, 2:24--29. The oral compositions comprise anionic copolymers derived from hydrophilic- type and hydrophobic-type monomers. Id. at 1 :59-2:7. The polymers may be derived from monomers of acrylic acid, methacrylic acid, ethyl methacrylate, ethyl acrylate, t-butyl acrylate, and substituted acrylamides such as tertbutyl acrylamide. Id. at 2:62-3:2; 3:11-25; 35-37. In a preferred embodiment, the copolymers are terpolymers, having "the general formula ABC, wherein: A is styrene, B is methylacrylate and C is selected from a mixture of acrylic acid and AMPS [acrylamidomethylpropylsulfonic acid]" Id. at 3:5-8, 38--41. "A representative and especially preferred anionic copolymer is the sodium salt of a methylacrylate/styrene/ AMPS/acrylic acid copolymer (hereinafter AMPS terpolymer salt)." Id. at 2:6-17. FF2. Mirajkar further discloses that the oral compositions may include thickeners such as polyvinylpyrrolidone [PVP], tooth whitening agents such as hydrogen peroxide, and silicones. Id. at 5:33--41, 63----67. 3 Appeal2014-003185 Application 12/132,359 FF3. Miranda discloses a drug delivery system comprising a pressure- sensitive adhesive composition having "at least two polymers, or at least one polymer and a soluble polyvinylpyrrolidone, in combination with a drug." Miranda, Abstract; see id. at 1 :24--34. "In a particularly preferred embodiment of the invention, the multiple polymer adhesive system comprises a pressure-sensitive adhesive blend of an acrylic polymer, a silicone polymer, and a soluble PVP." Id. at 9:34--37; see id. at 11 :30- 32, 44--53; see also id. at 6:35--42 ("[T]he term 'pressure-sensitive adhesive' refers to a viscoelastic material which adheres instantaneously to most substrates with the application of very slight pressure and remains permanently tacky."). The "soluble [PVP] can be used to prevent crystallization of the drug, without affecting the rate of drug delivery from the pressure-sensitive adhesive composition." Id. Abstract. FF4. Although Miranda is generally directed to the delivery of drugs to the skin (see e.g., id. at 1 :24--34), the reference broadly discloses the delivery of a wide variety of compounds (e.g., "pesticides, insect repellents, sun screens, cosmetic agents") to both plants and animals (see id. at 6:60-66). In particular, Miranda makes clear that the disclosed composition is applicable to oral use for the delivery of dental analgesics such as "Chlorobutanol, Clove, and Eugenol," and "[d]ental carries [sic, caries] prophylactics such as Sodium Fluoride." Id. at 12:49-50, 28:19. FF5. Singh discloses a tooth whitening composition comprising "a water- swellable, water-insoluble polymer, a blend of a hydrophilic polymer and a complementary oligomer capable of hydrogen bonding to the hydrophilic polymer, and a whitening agent, preferably a peroxide." Singh, Abstract. "When the water-swellable, water-insoluble polymer is 4 Appeal2014-003185 Application 12/132,359 an acrylate polymer or copolymer, a composition is provided that is generally substantially nontacky prior to contact with water, but becomes tacky upon contact with a moist surface." Id. at i-f 58. Acrylate-based copolymers may comprise a mixture of "acrylic acid, methacrylic acid, methyl acrylate, ethyl acrylate, methyl methacrylate, ethyl methacrylate and/or other vinyl monomers." Id. at i-f 62; see id. at claim 7. FF6. Marchant discloses bioadhesive polymer compositions comprising "homopolymer, copolymer, terpolymer, or interpolymer hydrogels," useful as pharmaceutical controlled release excipients. Marchant, Title, Abstract, 2:65-3: 10; 22: 1---6; 23:56---61. "The polymers for use in the invention may be homopolymers, copolymers, and block copolymers, including diblock, triblock, multiblock, graft, or starblock copolymers, and interpolymers with other hydrophilic polymers so long as the polymers are crosslinked to form a gel network and are swellable." Id. at 6: 17-22. Monomers used to make the polymers include mixtures combining vinyl esters, methacrylic acid, ethyl acrylate and isobutyl acrylate. See generally, id. at cols. 6-8; Rejection in view of Mirajkar and Miranda The Examiner finds that Mirajkar discloses an oral care composition comprising a whitening agent and a terpolymer, whereas Miranda discloses a pressure-sensitive adhesive composition comprising silicone polymer such as the "silicone adhesives, silicone elastomers, silicone fluids, silicone resins, silicone gums and mixtures thereof," required by claim 1. See Ans. 5. The Examiner concludesthat one of ordinary skill in the art would have found it obvious to combine the oral care composition of Mirajkar with the silicone adhesives of Miranda "motivated by the desire to use a component 5 Appeal2014-003185 Application 12/132,359 that would provide controlled delivery of the active to the teeth." Id. at 5; see id. at 16. Moreover, because Mirajkar teaches that the oral care composition may include silicones, one of ordinary skill in the art would look to the prior art to determine what silicone compounds would be suitable. Miranda specially [sic, specifically?] discloses that the silicone adhesive may be mixed with acrylate polymers and polyvinyl pyrrolidone and help control the release of the active. Therefore one would be motivated to use the silicones of Miranda as the silicones of Mirajkar because they are compatible with acrylate polymers, which are disclosed by Mirajkar, and would help control the release of the whitening agent to the teeth. Id. at 12; see id. at 13. Appellants argue that the Examiner has failed to articulate sufficient rationale for combining the oral care composition of Mirajkar with the silicone compounds of Miranda because Miranda "is directed toward transdermal drug delivery systems for the delivery of a drug through the skin." Br. 6. We do not find Appellants' argument persuasive. As noted by the Examiner, although Miranda discloses "transdermal delivery as the preferred embodiment, the reference clearly teaches oral care components are added to the delivery systems." Ans. 9-10; see FF4. In particular, because Miranda teaches the addition of "dental caries prophylactic sodium fluoride," "[ o ]ne of ordinary skill in the art would conclude that the delivery compositions may be used in the mouth because in order for the sodium fluoride to be effective, it must be applied to the teeth." Ans. 10; FF4. Appellants argue that the Examiner's rejection is in error because neither Mirajkar nor Miranda teach "a whitening agent as the main active component of their invention." Br. 7. We do not find this argument 6 Appeal2014-003185 Application 12/132,359 persuasive. Mirajkar discloses oral compositions comprising anionic antibacterials and whitening agents. FF 1, 2. Appellants' claims are set forth using comprising language, which does not foreclose additional, unrecited elements. Appellants present no argument or evidence suggesting that the claims on appeal exclude any of the components of oral compositions taught by Mirajkar, including the use of an anionic antibacterial. Appellants further argue that the Examiner errs in combining Mirajkar and Miranda because "the invention of Miranda is not isolated to the use of polysiloxane alone, but to the use of soluble polyvinylpyrrolidone (PVP) to prevent crystallization of the drug which is necessary within the context of Miranda's invention in order to provide the proper drug flux ... " Br. 6; see also id. at 13 (regarding propriety of combining Singh with Miranda). As above, we note that the comprising language of Appellants' claims in no way precludes the addition of PVP. Moreover, we accept the Examiner's reasoning that if the active components of the invention as claimed do not require PVP to prevent crystallization, "one of ordinary skill in the art would not add PVP," or would add PVP as a thickening agent as taught by Mirajkar. See Ans. 10-11; FF2. Appellants further contend the combination of Mirajkar and Miranda represents an infinite number of permuations for the types of active ingredients which can be used as well as the types of polymers which can be used of which there is no specific direction to arrive at the simultaneous combination of an oral care composition which comprises of a whitening agent, a terpolymer and a silicone polymer. Br. 9. Appellants argue that this is particularly true for claims 6 and 8, which specify that the terpolymer is comprised of selected monomer units 7 Appeal2014-003185 Application 12/132,359 (acrylic acid, t-butyl acrylate, ethyl acrylate, methacrylic acid, and N- tertbutyl acrylamide ). Id. at 1 O; see id. at 16. We do not find Appellants' argument persuasive. Under KSR, a "combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results." KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). Similarly, the Federal Circuit has long held that it is obvious for one of ordinary skill in the art to select a particular component from among many disclosed by the prior art as long as the prior art teaches that the selection will result in the disclosed effect (see Merck & Co., Inc. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989) ("That the '813 patent discloses a multitude of effective combinations does not render any particular formulation less obvious."); In re Corkill, 771F.2d1496, 1500 (Fed. Cir. 1985) (obviousness rejection affirmed in light of prior art teaching that "hydrated zeolites will work" in detergent formulations, even though "the inventors selected the zeolites of the claims from among 'thousands' of compounds")). The Examiner in the present case has identified each of the claimed elements in the cited references and provided an adequate rationale for combining those teachings as set forth in the claims on appeal. Appellants neither persuade us that any of these elements (including those recited in claims 6 and 8) would not work for their intended purpose, nor present evidence of secondary considerations to rebut the Examiner's prima facie case. Accordingly, we agree with the Examiner that one would be motivated to use the silicones of Miranda as the silicones of Mirajkar because they are compatible with acrylate polymers, which are disclosed by 8 Appeal2014-003185 Application 12/132,359 Mirajkar, and would help control the release of the whitening agent to the teeth. Rejection in view of Singh, Marchant, and Miranda The Examiner finds that Singh teaches oral hydrogel compositions comprising whiteners and acrylic based copolymers made from mixtures of monomers including acrylic acid, methacrylic acid, methyl acrylate and/or ethyl acrylate (see Ans. 6); Marchant teaches terpolymer compositions useful as bioadhesive and pharmaceutical controlled release excipients (id. at 7); and "Miranda discloses systems for delivering drugs to parts of the body such as the teeth using a combination of a pressure sensitive polymer and a soluble polyvinyl pyrrolidine" (id.). The Examiner finds that it would have been obvious to use the terpolymers of Marchant in the oral whitener compositions of Singh "motivated by the desire to make delivery systems with improved bioadhesiveness as taught by iviarchant." Id. The Examiner finds that it would have been further obvious to include the silicone pressure sensitive adhesives of Miranda "motivated by the desire to use a component that would adhere instantaneously to most substrates with the application of very slight pressure, remain permanently tacky and provide controlled delivery of the active to the teeth." Id. at 7-8. Appellants contend that the Examiner errs in the rejection for much the same reasons discussed with respect to the rejection in view of Mirajkar and Miranda. In both cases, the Examiner's explanation provides sufficient factual basis and technical reasoning to support a determination of obviousness, which Appellants have not rebutted. 9 Appeal2014-003185 Application 12/132,359 Accordingly, for the reasons set forth above, and in the Examiner's Answer, the rejections of record are affirmed. SUMMARY We affirm the rejection of claims 1, 2, 4---6, 8, 9, 11-12, and 15-17 under 35 U.S.C. 103(a) as unpatentable over the combination of Mirajkar and Miranda. We affirm the rejection of claims 1, 2, 4--25, and 36 under 35 U.S.C. 103 (a) as unpatentable over the combination of Singh, Marchant, and Miranda. 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). AFFIRivIED 10 Copy with citationCopy as parenthetical citation