GABA International Holding GmbH

Patent Trials and Appeals Board

Mar 23, 2022

2021001324 (P.T.A.B. Mar. 23, 2022)

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. 15/529,680 05/25/2017 Ruth HINRICHS 10354-00-US-01-GB 1869 23909 7590 03/23/2022 COLGATE-PALMOLIVE COMPANY 909 RIVER ROAD PISCATAWAY, NJ 08855 EXAMINER LIU, TRACY ART UNIT PAPER NUMBER 1612 NOTIFICATION DATE DELIVERY MODE 03/23/2022 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 RUTH HINRICHS, TURAN MATUR, ANDRE BRUNELLA, and SYLVIA HESS Appeal 2021-001324 Application 15/529,680 Technology Center 1600 Before DEBORAH KATZ, JOHN G. NEW, and ROBERT A. POLLOCK, Administrative Patent Judges. POLLOCK, Administrative Patent Judge. DECISION ON APPEAL This appeal under 35 U.S.C. § 134(a) involves claims to oral care mouth rinse compositions containing ionic tin and at least one aliphatic di- or tri-carboxylic acid. See Abstr. Appellant1 seeks our review of the Examiner’s decision to reject the claims as obvious over the prior art and for non-statutory double patenting. 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 2021-001324 Application 15/529,680 2 STATEMENT OF THE CASE According to the Specification, oral care compositions, such as mouth rinses, incorporate stannous (tin) ions to provide anti-caries benefits and prevent gingivitis. Spec. ¶ 2. However, stannous ions may form insoluble stannic oxide that precipitates from liquid formulations during storage. See id. To address this problem, the Specification describes combining stannous ions with 0.05 to 0.30 weight % aliphatic di- or tri-carboxylic acid to provide a highly stable mouth rinse formulation. Id. ¶ 4. The Specification discloses specific components to be used in various exemplary embodiments. See id. ¶ 21. For example, the stannous ions may include stannous fluoride. Id. ¶ 27. The aliphatic carboxylic acid may include 0.10 to 0.25 weight % malic acid. Id. ¶ 31. The Specification describes additional components in the mouth rinse composition, including amine fluoride, e.g., N,N,Nʹ -tris(2-hydroxyethyl)-N' -octadecyl-1,3- diaminopropane dihydrofluoride), and a polymer, e.g. polyvinyl pyrrolidone. Id. ¶¶ 33, 41, 49. The Specification provides examples demonstrating that adding malic acid to liquid formulations containing stannous fluoride reduces turbidity and sediment. Id. ¶¶ 48-51. Claims 1, 6, 10-12, and 15-20 are on appeal of which claim 1 is independent. Claim 1 is reproduced below: 1. An oral care mouth rinse composition comprising (i) at least one stannous ion source in an amount from 0.01 to 0.10 weight % based on the total weight of the oral care mouth rinse composition; (ii) at least one aliphatic di- or tri-carboxylic acid in free or salt form wherein the at least one aliphatic di- or tri-carboxylic acid in free or salt form comprises 0.10 to 0.25 weight % malic acid based on the total weight of the oral care composition; Appeal 2021-001324 Application 15/529,680 3 (iii) amine fluoride in an amount corresponding to 45 to 1500 ppm fluoride based on the total weight of the composition; and (iv) polyvinyl pyrrolidone in an amount of 0.3 wt.% based on the total weight of the oral care mouth rinse composition. Appeal Br. 11. REJECTION UNDER 35 U.S.C. § 103 The Examiner rejects claims 1, 6, 10-12, and 15-20 under 35 U.S.C. § 103 as obvious in view of Fiscella,2 Mühlemann,3 and Gaffar4. Final Act. 3-13. Appellant contends that the prior art does not account for unexpected results demonstrated by the claimed compositions. See Appeal Br. 3-7. Appellant contends that, instead, the prior art teaches away from the claimed compositions. See id. Additionally, Appellant contends that the Examiner does not provide a rationale to combine the references. See id. at 7-8. Appellant separately argues for the patentability of dependent claim 16. See id. at 8. We do not find Appellant’s arguments persuasive. For the reasons set forth below, we affirm the Examiner’s rejection of independent claim 1 and dependent claim 16. We adopt the Examiner’s findings of fact and reasoning regarding the content and application of Fiscella, Mühlemann, and Gaffar. We emphasize the following findings of fact relevant to the contested elements. Findings of Fact (“FF”) 1. Fiscella discloses aqueous compositions, including mouth washes and dentifrices, containing stannous fluoride and a hydroxyl 2 Fiscella, US 3,282,792, issued Nov. 1, 1966. 3 Mühlemann et al., US 4,828, 822, issued May 9, 1989. 4 Gaffar et al., US 5,466,437, issued Nov. 14, 1995. Appeal 2021-001324 Application 15/529,680 4 substituted aliphatic di- and tri-carboxylic acid effective to prevent stannous ions from precipitating from solution. Fiscella 1:13-16, 52-58, 64-69. 2. Fiscella discloses that preferred aliphatic carboxylic acids include malic acid. Id. at 1:59-63. 3. Fiscella discloses that the carboxylic acid concentration is desirably between “about 0.05% to 10% by weight of the composition [and] [t]here is no criticality of concentrations in this range.” Id. at 2:51-60. 4. Fiscella discloses an example of a liquid dentifrice containing stannous fluoride (0.1 to 2.0 parts by weight), hydroxyl substituted aliphatic di- and tri-carboxylic acid (0.1 to 5 parts by weight), water (60.1 to 92 parts by weight), and binder or suspending agent (0.5 to 1.5 parts by weight), among other components. Id. at 5:1-11. 5. Mühlemann discloses that adding water-soluble diamine salts to aqueous tin(II) fluoride results in “stable, precipitate-free formulations for the care of the mouth and of the teeth.” Mühlemann 2:43-50. 6. Mühlemann discloses stabilizing solutions of tin(II) fluoride by adding “one or more water-soluble organic amine salts in a weight ratio of Sn : amine which is suitably from 1:10 to 10:1.” Id. at 2:51-56. 7. Mühlemann discloses a suitable diamine salt as “N,N,N' -tris- (2-hydroxyethyl)-N' -octadecyl-1,3-diaminopropane, which, in the form of the dihydrofluoride, is referred to as amine fluoride 297.” Id. at 3:10-35. 8. Mühlemann discloses example formulations including a mouthwash (Example 1) containing 0.14 % amine fluoride and 0.04 % Tin(II) fluoride, and a toothpaste (Example 3) containing 1.0 % amine fluoride and 0.2 % Tin(II) fluoride). Appeal 2021-001324 Application 15/529,680 5 9. Gaffar discloses liquid dentifrice oral compositions containing a natural or synthetic thickener or gelling agent, typically present in about 0.1 to about 10 %. Gaffar 11:36-39. 10. Gaffar discloses that suitable thickeners or gelling agents include polyvinylpyrrolidone. Id. at 11:47-49. Analysis The Examiner finds that Fiscella teaches liquid dentifrices containing 0.1 to 2.0 wt.% stannous fluoride, 0.1 to 5 wt.% malic acid, and water.5 Final Act. 3 (citing Fiscella 5:1-6, 1:59-60). The Examiner finds that Fiscella teaches that malic acid prevents stannous ions from precipitating from the solution. Id. (citing Fiscella 1:65-67). The Examiner finds that Mühlemann teaches combining stannous ions with water-soluble organic amine salts to stabilize the stannous ions and provide precipitate-free oral care compositions. Id. at 3-4 (citing Mühlemann Abstr., 2:43-50, 53-56). The Examiner finds that Mühlemann specifically teaches adding an amine fluoride, N,N,Nʹ-tris-(2-hydroxyethyl)-Nʹoctadecyl-1,3-diaminopropane difluoride, corresponding to an amount of 76 ppm of fluoride. See id. at 4, 6 (citing Mühlemann 3:10-33, 2:53-56). The Examiner finds that it would have been obvious to add Mühlemann’s amine fluoride to Fiscella’s composition to help stabilize stannous fluoride. Id. at 4. Finally, the Examiner finds that it would have been obvious to incorporate about 0.1 to about 10% polyvinyl pyrrolidone into the composition because Gaffar 5 The Examiner finds that one of ordinary skill in the art would have reasonably concluded that Fiscella’s examples disclose wt.% because the parts by weight total 100% by weight. See Ans. 5. Appeal 2021-001324 Application 15/529,680 6 teaches that polyvinyl pyrrolidone is a suitable thickener or gelling agent for liquid dentifrices. Id. at 5 (citing Gaffar 11:36-38, 49). Appellant argues that the Specification discloses that the claimed composition is unexpectedly stable, thereby demonstrating criticality of the claimed range of malic acid. Appeal Br. 3. Specifically, Appellant argues that Example 2, Table 4, shows that compositions containing 0.01 wt.% and 0.05 wt.% malic acid provided unacceptable precipitation (turbidity) as compared to the claimed minimum amount of 0.10 wt.%. Id. at 3 (citing Spec. ¶ 52). Appellant argues that the claimed range is unexpected in view of Fiscella’s teachings of a broad range of 0.05 to 10% by weight carboxylic acid. See id. at 4-7. Appellant contends that Fiscella’s teaching that “there is no criticality of concentrations in this range” should be interpreted as teaching the effectiveness of every value across the entire range, not of any narrower range within that entire range. See id. at 5-6 (emphasis omitted). Appellant argues that, when considering Fiscella as a whole, the disclosure of the broader range of 0.05 to 10% by weight carboxylic acid-with no criticality of concentrations-would have led one of ordinary skill in the art away from the amounts taught by Fiscella’s example formulations, containing 0.1 to 5 wt.% carboxylic acid. See id. We do not find Appellant’s argument persuasive. Under 35 U.S.C. § 103, a reference must be considered not only for what it expressly teaches, but also for what it fairly suggests. In re Lamberti, 545 F.2d 747, 750 (CCPA 1976). By disclosing preferred ranges within the broader range, Fiscella fairly suggests that some minimum amount of carboxylic acid would have been expected to prevent precipitation. Likewise, Fiscella’s broader range applies to various carboxylic acids so that identifying the Appeal 2021-001324 Application 15/529,680 7 optimum or workable ranges for specific carboxylic acids, e.g., malic acid, would have been routine experimentation. See In re Aller, 220 F.2d 454, 456 (CCPA 1955). Similarly, we are not persuaded that Fiscella teaches away from a minimum amount of 0.10 wt.% malic acid. Our reviewing court has held that “[t]he degree of teaching away will of course depend on the particular facts; in general, a reference will teach away if it suggests that the line of development flowing from the reference’s disclosure is unlikely to be productive of the result sought by the applicant.” In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994). We do not agree that Fiscella’s teaching of “no criticality of concentrations” within the broader range suggests that there is no minimum amount of malic acid required to stabilize stannous ions. Rather, as shown by Fiscella’s preferred embodiments, some amounts of carboxylic acid would have been expected to work better than others, depending on the composition. Appellant further argues that it would not have been obvious to combine Mühlemann’s amine fluoride with Fiscella’s malic acid. Appeal Br. 7. Appellant argues that the “Examiner does not address the potential formation of salts between the basic amine ion and the malic acid, or explain how the positively-charged amine ion would beneficially impact the complexing of the positively-charged stannous ion with the negatively- charged deprotonated malic acid to provide a stabilized configuration . . . .” Id. Appellant further argues that the Example 2 shows that compositions containing amine fluoride showed unacceptable instability in the absence of malic acid. See id. Appeal 2021-001324 Application 15/529,680 8 We do not find Appellant’s arguments persuasive. Appellant’s argument regarding the potential interaction of amine fluoride and malic acid is not supported by factual evidence. See Johnston v. IVAC Corp., 885 F.2d 1574, 1581 (Fed. Cir. 1989)(“Attorneys’ argument is no substitute for evidence.”). Moreover, Appellant’s argument that amine fluoride alone did not stabilize example compositions in the absence of malic acid does not address the combination of references. As discussed above, the Examiner cited Mühlemann’s amine fluoride in combination with Fiscella’s malic acid for improved stabilization of stannous ions. Non-obviousness cannot be established by attacking references individually where the rejection is based upon the teachings of a combination of references. In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986). Finally, Appellant argues that Gaffar does not teach the claimed amount of 0.3 wt.% polyvinyl pyrrolidone. Appeal Br. 8. Appellant argues that the Examiner does not provide a rationale for picking and choosing components from Fiscella, Mühlemann, and Gaffar, absent Appellant’s own specification. Id. We do not find Appellant’s arguments persuasive. The Examiner identified a reason to make the combination for each prior art reference, along with each specific component of the claimed composition. See Non- Final Act. 3-5. Accordingly, the Examiner provides articulated reasoning with rational underpinnings to support the obviousness rejection. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007). Moreover, the Examiner established that the improvement of the claimed invention is no more than the predictable use of prior art elements according to their established Appeal 2021-001324 Application 15/529,680 9 functions. See id. at 416. For these reasons, we are not persuaded that the Examiner erred in rejecting claim 1. Appellant argues claim 16 separately. See Non-Final Act. 8. Specifically, Appellant argues that “claim 16 specifically requires, in addition to the limitations of claim 1, 0.10 to 0.25 weight % malic acid, 0.04 to 0.08 weight % stannous fluoride and 0.10 to 0.25 weight % N,N,N'-tris(2- hydroxyethyl)N'-octadecyl-1,3-diaminopropane dihydrofluoride.” Id. Appellant argues that the Examiner fails to address these ingredients in combination. See id. We do not find Appellant’s arguments persuasive. The Examiner identified overlapping ranges in the prior art that encompass both the amounts of malic acid and N,N,N'-tris(2-hydroxyethyl)N'-octadecyl-1,3- diaminopropane dihydrofluoride. See Final Act. 3, 6. As discussed above, we find that Appellant did not overcome the presumption of obviousness as to the amount of malic acid falling with the known range. See In re Peterson, 315 F.3d 1325, 1330 (Fed. Cir. 2003)(“the existence of overlapping or encompassing ranges shifts the burden to the applicant to show that his invention would not have been obvious”). The Examiner further finds that the claimed amount of 0.08 wt.% stannous tin would have been obvious over Fiscella’s range of 0.1 to 2.0 wt.% stannous tin. See id. at 6, Ans. 9. Although the ranges do not overlap, we agree with the Examiner that the amounts are so close that “one of ordinary skill in the art would have reasonably expected them to have the same properties,” absent evidence to the contrary. See id.; see Peterson, 315 F.3d at 1329. We further note that Appeal 2021-001324 Application 15/529,680 10 Mühlemann’s Example 16 teaches a mouthwash containing 0.14% N,N,N'- tris(2-hydroxyethyl)N'-octadecyl-1,3-diaminopropane dihydrofluoride and 0.04% stannous fluoride, both of which fall within the claimed range. FF 8. Accordingly, Appellant does not show Examiner error in rejecting claim 16. DOUBLE PATENTING The Examiner provisionally rejects claims 1, 6, 10-12, and 15-20 on the ground of nonstatutory double patenting over claims 1, 5-18, 20, 21, and 23 of copending Application No. 15/529,565 and Fiscella. Final Act. 13-15. Because the non-statutory double patenting rejection is provisional, we conclude that it is premature to address the provisional rejection of the claims. See Ex parte Moncla, Appeal No. 2009-006448 (PTAB June 22, 2010) (precedential) (holding that it is premature to address a provisional rejection). Accordingly, we do not address the non-statutory double patenting rejection. CONCLUSION In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1, 6, 10-12, 15-20 103 Fiscella, Mühlemann, Gaffar 1, 6, 10-12, 15-20 1, 6, 10-12, 15-20 Provisional Obviousness-type Double Patenting7 6 Previously cited by the Examiner during prosecution. See Non-Final Action dated July 11, 2018. 7 As explained above, we do not reach this rejection per Ex parte Moncla. Appeal 2021-001324 Application 15/529,680 11 Overall Outcome 1, 6, 10-12, 15-20 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