Ex Parte Boyd et alDownload PDFPatent Trial and Appeal BoardOct 18, 201611457610 (P.T.A.B. Oct. 18, 2016) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 111457,610 07/14/2006 23909 7590 10/20/2016 COLGATE-PALMOLIVE COMPANY 909 RIVER ROAD PISCATAWAY, NJ 08855 FIRST NAMED INVENTOR Thomas J. Boyd 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. 7937-00 7439 EXAMINER LAZARO, DOMINIC ART UNIT PAPER NUMBER 1611 NOTIFICATION DATE DELIVERY MODE 10/20/2016 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 THOMAS J. BOYD, RENSL DILLON, JEFFREY M. MILLER, DAVID B. VISCIO, and ABDUL GAFF AR Appeal2015-003995 Application 11/457,6101 Technology Center 1600 Before RICHARD M. LEBOVITZ, ULRIKE W. JENKS and DAVID COTTA, Administrative Patent Judges. COTT A, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to a method of making an oral care, personal care, cleansing and/ or home care composition. The Examiner rejected the claims on appeal as obvious under 35 U.S.C. § 103(a). We affirm-in-part. 1 The real party in interest is Colgate-Palmolive Company. Reel/frame 017936/0214; see also, App. Br. 2. Appeal2015-003995 Application 11/457 ,610 STATEMENT OF THE CASE Claims 3, 6, 8, 9, 12, 15-22, 28 and 29 are on appeal. Independent claims 12 and 29 read as follows: 12. A method of making an oral care, a personal care, a cleansing and/or a home care composition, the method compnsmg: introducing a film into a medium comprising an active ingredient, wherein the film is substantially free of the active ingredient; transferring at least a portion of the active ingredient from the medium to the film due to a concentration gradient of the active ingredient between the medium and the film, wherein the transferring occurs until the film comprises an effective amount of transferred active ingredient, so that the film is suitable for use as at least one of the oral care, the personal care, the cleansing and/ or the home care compositions; and preparing the composition by introducing the film comprising the transferred active ingredient into a carrier film, wherein a dissolution rate of the carrier film is greater than the dissolution rate of the film comprising the active ingredient, and wherein the film comprising the transferred active ingredient is stable during storage of the composition. 29. A method of making an oral care, a personal care, a cleansing and/or a home care composition comprising a film, the method comprising: submerging a film into a medium comprising an active ingredient, wherein the film is substantially free of the active ingredient wherein the active agent is a peroxide; and introducing at least a portion of the active ingredient from the medium into the film due to a concentration gradient of the active ingredient between the medium and the film, wherein the introduction of the 2 Appeal2015-003995 Application 11/457 ,610 active ingredient is performed until the film comprises an effective amount of introduced active ingredient, so that the film is suitable for use as at least one of the oral care, the personal care, the cleansing and/ or the home care compositions; and preparing the composition by introducing and dispersing the film comprising the introduced active ingredient into a carrier, wherein the film comprising the introduced active ingredient is stable during storage of the composition, wherein substantially free means that the active ingredient is absent from the film to the extent that it is not present at an efficacious level and/ or cannot be detected, wherein the film is porous; wherein an amount of the introduced active ingredient into the film is greater than 0.5% by weight of the film; and wherein the film comprises a polymer selected from the group consisting of cellulose ethers, acrylate polymers, methacrylate polymers, polyvinyl alcohol, polyalkylenes, polyalkylene okides, polystyrene, polyvinylpyrrolidone, polyvinylphosphonates, polysiloxanes, polyvinyl pyrrolidone-vinyl acetate copolymers, ethylene oxide graft copolymers of PV A, vinylcaprolactam/sodium acrylate polymers, maleic polyvinylalkyl ether-maleic acid copolymer, vinyl acetate and crotonic acid copolymers, terpolymers of acrylomethyl propyl sulphonic acid/methyl acrylate/styrene monomers, and mixtures thereof. The claims stand rejected as follows: Claims 3, 6, 9, 12, 15-18, 21, 22 and 28 under 35 U.S.C. § 103(a) as unpatentable over the combination of Wiesel2 and Boyd3 ("the First 2 Wiesel, U.S. Patent No. 6,287,120 Bl, issued Sept. 11, 2001 ("Wiesel"). 3 Boyd et al., U.S. Patent Publication No. 2004/0136924 Al, published July 15, 2004 ("Boyd"). 3 Appeal2015-003995 Application 11/457 ,610 Rejection"). Claims 8, 19, 20 and 29 under 35 U.S.C. § 103(a) as unpatentable over the combination of Wiesel, Boyd, and Moro4 ("the Second Rejection"). Claims 3, 6, 8, 9, 12, 15-22, and 28-29 under 35 U.S.C. § 103(a) as unpatentable over the combination of Kochinke5 and Boyd6 ("the Third Rejection"). Claims 19 and 20 under 35 U.S.C. § 103(a) as unpatentable over the combination of Kochinke, Boyd, and Christina-Beck7 ("the Fourth Rejection"). ANALYSIS WITH RESPECT TO CLAIMS 3, 6, 8, 9, 12, 15-22 AND 28 Claim 12 requires that there be two films: a film onto which an active ingredient is transferred (hereafter, "the Active Film"), and a film on which the Active Film is carried, i.e., a "carrier film." Each of the Examiner's four obviousness rejections relies on Boyd for the disclosure of a "carrier film." As a result of the Examiner's common reliance on Boyd; a single issue is dispositive with respect to all four of the Examiner's rejections as applied to claims requiring a "carrier film." Accordingly, we address all four rejections with respect to those claims together. The carrier film limitation of claim 12 requires "introducing the film comprising the transferred active ingredient into a carrier film, wherein a 4 Moro et al., U.S. Patent Publication No. 2004/0062724 Al, published Apr. 1, 2004 ("Moro"). 5 Kochinke, U.S. Patent Publication No. 2003/0185872 Al, published Oct. 2, 2003 ("Kochinke"). 6 Boyd et al., U.S. Patent Publication No. 2004/0136924 Al, published July 15, 2004 ("Boyd"). 7 Christina-Beck et al., U.S. Patent No. 5,766,574, issued June 16, 1998 ("Christina-Beck") 4 Appeal2015-003995 Application 11/457 ,610 dissolution rate of the carrier film is greater than the dissolution rate of the film comprising the active ingredient." With respect to the Examiner's First and Second Rejections, the Examiner found that Wiesel met all of the limitations of claim 12 with the exception that it did not disclose the "carrier film" limitation. Ans. 3--4, 7. In the Examiner's Third and Fourth Rejections, the Examiner similarly found that Kochinke met all of the limitations of claim 12 with the exception of the "carrier film" limitation. Id. at 9-11, 14. With respect to all four rejections, the Examiner found that Boyd taught the claimed "carrier film." The Examiner then concluded that it would have been obvious to modify the teeth whitening apparatus of Wiesel and the drug delivery system of Kochinke to include Boyd's carrier film. Id. at 4--5, 7, 11-12 and 14. The Examiner's explanation with respect to the First Rejection is representative: It would have been prima facie obvious to one of ordinary skill in the art at the time of the invention to entrain the impregnated film materials of Wiesel in a carrier film (e.g., a gel) as taught by Boyd (Boyd, par. [0085]). One would have been motivated to do so in order to provide a tooth whitening composition capable of sustained release of the whitening agent as taught by Boyd. Boyd, par. [0008] and [0009]. Id. at 5 (emphasis added). Appellants argue that entraining an Active Film in a gel, as taught in Boyd, is distinct from entraining an Active Film in a "carrier film" as recited in claim 12. App. Br. 10. We agree that the Examiner erred in finding that Boyd's gel meets the claimed limitation of a carrier film. The Examiner cites to several passages from Boyd, including passages teaching that the 5 Appeal2015-003995 Application 11/457 ,610 carrier can be "any material" and that the carrier can be "a liquid, a semi- solid or solid," as evidence that Boyd does not exclude films as possible carriers of its Active Film. Ans. 19-22. But the fact that Boyd does not exclude carrier films does not make it obvious to use a carrier film. This is particularly true where claim 12 requires not just any carrier film, but a carrier film with a dissolution rate that is "greater than the dissolution rate of the film comprising the active ingredient." The Examiner does not explain how or why it would have been obvious for the carrier film to have a greater dissolution rate than the Active Film. The Examiner states that "Appellants' specification provides no definition or indication that a film is distinguishable from a gel." Ans. 22. The Examiner then contends that "a gel carrier, taught by Boyd as a 'semi- solid' carrier, reasonably meets the requirement of the instant claims for a 'carrier film."' Id. at 23 (internal citations omitted). The Examiner, however, does not point to any portion of the Specification that indicates that the term "carrier film" should be given the same meaning as "gel." or "carrier gel." Moreover, the Specification discusses the use of a carrier film separately from discussing gels. Compare, Specification i-fi-1 94--94 with i-fi-1 72, 87 and 98. Claim 15 also separately recites a film and a gel, suggesting that they are different. The Specification also describes the "film" as a structure with a fixed thickness (at i-fi-179, 80-81). Consistent with this description, we interpret the recited "film" to be a layer of material with a specific structure. In contrast, the gel of Boyd is not described as having such a specific layer structure. Accordingly, we find that the Specification does not support the Examiner's position that a gel as described in Boyd meets the requirement of a "carrier film" as recited in claim 12. For this 6 Appeal2015-003995 Application 11/457 ,610 reason, and the reasons set forth above, we reverse all four of the Examiner's rejections with respect to claims 3, 6, 8, 9, 12, 15-22 and 28- i.e. all of the appealed claims that require a "carrier film." ANALYSIS WITH RESPECT TO CLAIM 29 Claim 29 does not require that the Active Film be introduced into a "carrier film." Instead, claim 29 requires "introducing and dispersing the film comprising the introduced active ingredient into a carrier, wherein the film comprising the active ingredient is stable during storage of the composition." Accordingly the error identified with respect to the Examiner's rejection of claims 3, 6, 8, 9, 12, 15-22 and 28 does not apply to claim 29. As discussed above, all four of the Examiner's rejections are premised on entraining an Active Film in Boyd's gel carrier. With respect to the First and Second Rejections, Appellants argue that entraining Wiesel's film in a gel carrier would "reduce the concentration of Wiesel's active ingredient mixture and render it useless for its intended purpose." App. Br. 8. Appellants further argue that Wiesel teaches away from the use of gels. App. Br. 8-9. We are not persuaded. Wiesel expressly contemplates using its film in connection with a gel. Wiesel states: In one embodiment, the carrier is coated or impregnated with a paste, gel, or solution which contains medicaments which decrease teeth sensitivity. In another embodiment, a carrier is coated or impregnated with a paste, gel, or solution which contains medicaments which promote the repair or remineralization of tooth enamel. In yet another embodiment, the carrier is coated or impregnated with a paste, gel, or solution which contains therapeutic medicaments such as antibiotics. 7 Appeal2015-003995 Application 11/457 ,610 Wiesel Abstract; see also, id. at col. 8, 11. 4--9. Wiesel specifically teaches that the carrier can be a tape, i.e., a film. Id. at col. 4, 11. 5-8; col. 5, 11. 1-8; Fig. 12. Boyd teaches the use of films entrained in a gel. Boyd if 85 ("if the composition is a dentifrice comprising both a gel and film fragments, a film fragment can be totally surrounded by the gel, or partially or totally exposed on the surface of the gel."). Boyd also teaches that its compositions allow for "controlled delivery of functional materials." Id. at if 9. We find that Appellants' argument that the use of a gel would render Wiesel's active ingredient useless for its intended purposes is not supported by persuasive evidence. Appellants' argument is also contradicted by Wiesel's teaching of multiple embodiments of films that can be used with gels and by Boyd's teaching that films may be entrained in a gel. We further find that a person of ordinary skill in the art would not have been discouraged from using a gel by Wiesel; s criticism of aspects of prior art gels at least because Wiesel expressly approves the use of gels with its film. Accordingly, we affirm the Examiner's First and Second Rejections as applied to claim 29. With respect to the Examiner's Third and Fourth Rejections, Appellants argue that entraining Kochinke's drug delivery system in a gel carrier would "enlarge Kochinke' s system and render it useless for its intended purpose." App. Br. at 12. Appellants further argue that incorporating Boyd's carrier would require "putting Kochinke' s system into a different system (i.e., Boyd's entrainment system)" which would serve to "make diffusion of the therapeutic agent more difficult to control." Id. at 13. We are not persuaded. 8 Appeal2015-003995 Application 11/457 ,610 Kochinke teaches that its drug delivery system may optionally contain inactive materials "such as buffering agents and pH adjusting agents ... degradation/release modifiers; drug release adjusting agents; emulsifiers; preservatives ... solubility adjusting agents; stabilizers; cohesion modifiers . . . and so forth." Kochinke i-f 97. Kochinke further teaches that "[a]dditional structural features can be added to the system to control the rate of diffusion of the therapeutic agent from the system." Id. at i-f 105. Finally, Kochinke teaches that its drug delivery system can be a "film or sheet." Id. at i-f 100. As discussed above, Boyd teaches that its compositions, which include films entrained in a gel, see Boyd i-f 85, allow for "controlled delivery of functional materials." Id. at i-f 9. We find that Appellants' argument that the use of a gel would render Kochinke' s drug delivery system useless for its intended purposes is not supported by persuasive evidence. Appellants' argument is also contradicted by Kochinke' s teaching that its drug delivery system can incorporate multiple types of inactive materials and that its system can include "additional structural features ... to control the rate of diffusion." We further find that a person of ordinary skill in the art would have been motivated to entrain Kochinke' s drug delivery system in a gel to control the rate of diffusion as taught by Boyd and as suggested by Kochinke. See Boyd at i-f 9, Kochinke at i-f 105. Accordingly, we affirm the Examiner's Third and Fourth Rejections as applied to claim 29. 9 Appeal2015-003995 Application 11/457 ,610 survnvIARY For the reasons set forth herein, the Examiner's final decision to reject claims 3, 6, 8, 9, 12, 15-22 and 28 is reversed. For the reasons set forth herein, and those set forth in the Examiner's Answer, the Examiner's decision to reject claim 29 is affirmed. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(l). AFFIRMED-IN-PART 10 Copy with citationCopy as parenthetical citation