Colgate-Palmolive CompanyDownload PDFPatent Trials and Appeals BoardDec 2, 20212020006263 (P.T.A.B. Dec. 2, 2021) 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. 15/840,046 12/13/2017 Mahmoud Hassan T11205-00-US-01-OC 1090 23909 7590 12/02/2021 COLGATE-PALMOLIVE COMPANY 909 RIVER ROAD PISCATAWAY, NJ 08855 EXAMINER WEBB, WALTER E ART UNIT PAPER NUMBER 1612 NOTIFICATION DATE DELIVERY MODE 12/02/2021 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 MAHMOUD HASSAN, XIANG CHEN, SHYAMALA PILLAI, GUOFENG XU, LATONYA KILPATRICK-LIVERMAN, SUMAN CHOPRA, ROBERT DICOSIMO, and MARK S. PAYNE __________ Appeal 2020-006263 Application 15/840,046 Technology Center 1600 __________ Before JEFFREY N. FREDMAN, ULRIKE W. JENKS, and CYNTHIA M. HARDMAN, Administrative Patent Judges. FREDMAN, Administrative Patent Judge. DECISION ON APPEAL This is an appeal1 under 35 U.S.C. § 134 involving claims to a two- phase oral care whitening composition. The Examiner rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. 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 (see Appeal Br. 2). We have considered the Specification of Dec. 13, 2017 (“Spec.”); Non-Final Office Action of Nov. 26, 2019 (“Non-Final Action”); Appeal Brief of Apr. 27, 2020 (“Appeal Br.”); Examiner’s Answer of July 2, 2020 (“Ans.”); and Reply Brief of Sept. 2, 2020 (“Reply Br.”). Appeal 2020-006263 Application 15/840,046 2 Statement of the Case Background “While oral care whitening gels including hydrogen peroxide have proven to be effective for oral care whitening teeth, different chromophores on the surfaces are often oxidized at varying rates and/or via varying mechanisms” (Spec. ¶ 2). “Accordingly, oral care whitening gels including a single oral care whitening agent (e.g., hydrogen peroxide) may require relatively longer periods of treatment to appreciably whiten the teeth” (id.). “While the oral care products incorporating a variety of oral care whitening agents have demonstrated increased efficacy in oral care whitening teeth,” these may be unstable so “the oral care products are often provided as a two- component oral care whitening system, which may be maintained separate from one another until the time of use, where they may be mixed with one another to generate the oral care whitening agents” (id. ¶ 3). The Claims Claims 1, 7–20, and 22 are on appeal. Claim 1 is an independent claim, is representative and reads as follows: 1. A two-phase oral care whitening composition, comprising: a hydrophobic phase comprising a source of hydrogen peroxide; a nonionic surfactant; and an acyl donor; and a hydrophilic phase comprising an amphoteric surfactant; an enzyme that catalyzes the generation of peracetic acid between the source of hydrogen peroxide and the acyl donor, and wherein when the hydrophobic phase and the hydrophilic phase are combined the resulting oral care product has a viscosity of from about 75,000 cP to about 200,000 cP. Appeal 2020-006263 Application 15/840,046 3 The Rejection2 The Examiner rejected claims 1, 7–10, 12–20, and 22 under 35 U.S.C. § 103(a) as obvious over Wieland,3 Butterick,4 and Zaidel5 (Non-Final Act. 3–9). The issue with respect to this rejection is: Does a preponderance of the evidence of record support the Examiner’s conclusion that the prior art suggests the composition of claim 1? Findings of Fact 1. Butterick teaches “oral care compositions and methods are provided that use a CE-7 perhydrolase to enzymatically produce a peracid benefit agent for use in oral care applications such as oral cavity surface bleaching, teeth whitening” (Butterick ¶ 20). 2. Butterick teaches “certain personal care applications may benefit from the ability to target/focus the peracid benefit agent to the desired body surface by localizing peracid production on or near the desired target body surface” (Butterick ¶ 8). 3. Butterick teaches: the terms “tooth whitening” and “tooth bleaching” are used interchangeably, to refer to improving the brightness (e.g., whitening) of a tooth or teeth. It is intended that the term encompass any method suitable for whitening teeth, including 2 We note that the Examiner withdrew the rejection of claim 11 in the Examiner’s Answer (Ans. 3) and that a terminal disclaimer was filed in copending US 15/840,050, mooting the provisional double patenting rejection. 3 Wieland et al., US 2005/0281773 A1, published Dec. 22, 2005. 4 Butterick et al., US 2012/0328534 A1, published Dec. 27, 2012. 5 Zaidel et al., US 2006/0045854 A1, published Mar. 2, 2006. Appeal 2020-006263 Application 15/840,046 4 the present invention, as well as chemical treatment, mild acid treatment, abrasive tooth whitening, and laser tooth whitening. In particularly preferred embodiments, the present invention provides a perhydrolase and perhydrolase-containing compositions suitable for whitening teeth. (Butterick ¶ 313). 4. Butterick teaches the “personal care product formulation will be comprised of at least two components that remain separated until use. Mixing of the components rapidly forms an aqueous peracid solution. Each component is designed so that the resulting aqueous peracid solution comprises an efficacious peracid concentration” (Butterick ¶ 385). 5. Butterick teaches: The type and amount of the various ingredients used within two component formulation should to be carefully selected and balanced to provide (1) storage stability of each component, especially the perhydrolysis activity of the enzyme catalyst and (2) physical characteristics that enhance solubility and/or the ability to effectively form the desired aqueous peroxycarboxylic acid solution (e.g., ingredients that enhance the solubility of the ester substrate in the aqueous reaction mixture and/or ingredients that modify the viscosity and/concentration of at least one of the liquid components . . . ). (Butterick ¶ 387). 6. Butterick teaches “[o]ne requirement for long term storage stability of the enzyme in triacetin is that there is not a significant reaction of the triacetin with any water that might be present” and the excipient “must provide stability of the enzyme in the organic substrate for the enzyme under conditions where acetic acid might be generated due to the presence of low concentrations of water in the formulation” (Butterick ¶ 405). Appeal 2020-006263 Application 15/840,046 5 7. Butterick teaches the “dried enzyme powder may be stored as a formulation in the organic compound that is a substrate for the at least one enzyme” (Butterick ¶ 405). 8. Butterick teaches a two-step application in Example 16 where: A solution of 10 μM of each enzyme in 10 mM phosphate buffer, pH 7.2 was prepared and 500 μL of solution was incubated with each enamel substrate for 60 min. The enzyme solution was removed and each well was rinsed three times with an additional 500 μL of buffer. The enamel blocks were placed in a fresh well for the whitening process. A solution with a final concentration of 40 mM triacetin, 100 mM H202 in 50 mM phosphate pH 7.2 buffer was freshly prepared and 500 μL of solution was added to each enamel block. Over the course of 1 hr the enamel blocks were removed and a color measurement was obtained and then each was returned to the solution in the well plate. (Butterick ¶ 556). 9. Wieland teaches “mouth, teeth and denture care products” that comprise “perhydrolases, a hydrogen peroxide source and a substrate for the perhydrolase” (Wieland ¶¶ 90, 93). 10. Wieland teaches “perhydrolases are combined in the agent according to the invention with one or several of the following ingredients: nonionic, anionic or cationic surfactants” (Wieland ¶ 115) as well as “zwitterionic surfactants can be used as emulsifiers” (Wieland ¶ 256). 11. Wieland teaches, in the context of dental care products, that “materials suitable to control viscosity include layered silicates, for example Appeal 2020-006263 Application 15/840,046 6 montinorillonite, colloidal swelling silicas, e.g. aerogel silicas or pyrogenic silicas” (Wieland ¶ 347). 12. Wieland teaches that “[h]ydrophobic bases are particularly suitable as additives for paste and liquid products” (Wieland ¶ 366). 13. Zaidel teaches “oral care compositions comprising: (a) a peroxide complex . . . (b) whitening agent; and . . . (c) an orally acceptable non-aqueous carrier . . . Nonaqueous hydrophilic polymers useful in the practice of the present invention preferably provide a viscosity for the composition in the range between about 10,000 cps to 600,000 cps” (Zaidel ¶¶ 46–49). Principles of Law A prima facie case for obviousness “requires a suggestion of all limitations in a claim,” CFMT, Inc. v. Yieldup Int’l Corp., 349 F.3d 1333, 1342 (Fed. Cir. 2003), and “a reason that would have prompted a person of ordinary skill in the relevant field to combine the elements in the way the claimed new invention does.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007). Analysis Appellant contends “simply because Wieland may teach that ‘hydrophobic bases are particularly suitable additives for paste and liquid products’ . . . this does not motivate one skilled in the art to invent an oral care composition comprising two-phases, one hydrophilic and one hydrophobic” (Appeal Br. 3). Appellant also contends “Butterick may report the use of a multi-component system and that the perhydrolytic enzyme may be stored in an aqueous solution . . . However, Butterick fails to Appeal 2020-006263 Application 15/840,046 7 teach a two-phase system comprising a hydrophobic and hydrophilic phase” (id.). The Examiner responds: Since Weiland et al. teaches “[h]ydrophobic bases” (p. 28, para. [0366]) as suitable additives, and Butterick et al. teaches that the perhydrolytic enzyme is stable in aqueous solution (p. 14, para. [0323]), one would have reasonably inferred a hydrophobic phase and hydrophilic phase to be suitable as storage media in the two-phase system for the perhydrolase enzyme and hydrogen peroxide source. (Ans. 4). We find Appellant has the better position. Not only does the Examiner lack a teaching or example of any hydrophobic phase, much less in a two-phase whitening or dentrifice composition, but the Examiner’s reason is not persuasive. The Examiner presumes that a second phase for an aqueous phase perhydrolytic enzyme in Butterick would be a hydrophobic phase, but the two examples in Butterick were both combinations of liquid/solid phases (Butterick ¶¶ 389–390). When Butterick discusses “multiple active fluids (liquid-liquid) systems [that] typically use multi- chamber dispenser bottles or two-phase systems” (Butterick ¶ 381), the Examiner does not identify any disclosure in Butterick or prior art cited therein that uses or directly suggests a hydrophobic phase, much less in a dentrifice. And when Wieland discusses “hydrophobic bases”, Wieland is generally discussing additives to pastes and liquids (FF 12), but does not suggest that the phase in entirety is hydrophobic, nor does Wieland teach or suggest a two-phase system with hydrophobic and hydrophilic phases. We therefore agree with Appellant that this rejection relies on hindsight. “We must still be careful not to allow hindsight reconstruction of Appeal 2020-006263 Application 15/840,046 8 references to reach the claimed invention without any explanation as to how or why the references would be combined to produce the claimed invention.” Innogenetics, N.V. v. Abbott Labs., 512 F.3d 1363, 1374 n.3 (Fed. Cir. 2008). Conclusion of Law A preponderance of the evidence of record does not support the Examiner’s conclusion that the prior art suggests the composition of claim 1. DECISION SUMMARY In summary: Claim(s) Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1, 7–10, 12–20, 22 103 Wieland, Butterick, Zaidel 1, 7–10, 12–20, 22 REVERSED Copy with citationCopy as parenthetical citation