Colgate-Palmolive CompanyDownload PDFPatent Trials and Appeals BoardDec 20, 20212021000619 (P.T.A.B. Dec. 20, 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. 15/805,219 11/07/2017 Carl Myers 11343-00-US-01-OC 2617 23909 7590 12/20/2021 COLGATE-PALMOLIVE COMPANY 909 RIVER ROAD PISCATAWAY, NJ 08855 EXAMINER WEBB, WALTER E ART UNIT PAPER NUMBER 1612 NOTIFICATION DATE DELIVERY MODE 12/20/2021 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 CARL MYERS Appeal 2021-000619 Application 15/805,219 Technology Center 1600 Before RICHARD M. LEBOVITZ, DEBORAH KATZ, and RACHEL H. TOWNSEND, Administrative Patent Judges. TOWNSEND, Administrative Patent Judge. DECISION ON APPEAL Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision to reject claims to a two phase composition that includes a copolymerized product of a mixture of acrylic acid, methacrylic acid, and anionic 2-hydroxyethyl methacrylate phosphate polymer for being of improper dependent form, as being obvious, 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. Appellant identifies the real party in interest as Colgate-Palmolive Co. (Appeal Br. 2.) Appeal 2021-000619 Application 15/805,219 2 STATEMENT OF THE CASE “Dental plaque is a biofilm that adheres to tooth and other oral surfaces, particularly at the gingival margin, and is implicated in the occurrence of gingivitis, periodontitis, caries and other forms of periodontal disease.” (Spec. ¶ 2.) “Anaerobic bacteria in plaque metabolize sugar to produce acids that dissolve tooth minerals, damaging the enamel and eventually forming dental caries.” (Id.) “Various antibacterial agents can retard the growth of bacteria and thus reduce the formation of biofilm on oral surfaces.” (Id. ¶ 3.) “In many cases, these antibacterial agents are cationic.” (Id.) Discoloration of the tooth surface can occur from the use of tobacco products, and eating or drinking certain foods and beverages. (Id. ¶ 4.) The “color causing substances in these materials become part of the pellicle layer and can permeate the enamel layer.” (Id.) “[T]he compounds that stain the teeth are typically anionic materials.” (Id. ¶ 6.) “[C]ationic antibacterial agents can cause or enhance staining by facilitating the deposit of chromogens or by forming salts with minerals.” (Id.) “One approach to reducing staining and erosion as well as reducing biofilm formation is the use of anionic polymers that help coat and protect the enamel, discouraging bacterial attachment and repelling chromagens.” (Spec. ¶ 7.) These polymers “can interact with cationic antimicrobial agents . . ., particularly in high water formulations, such as mouthwashes, and [can] inhibit[] delivery of the antimicrobial agent and/or the polymer.” (Id.) Appellant’s claimed invention is directed to “aqueous biphasic compositions useful for combining and delivering poorly compatible ingredients, for example to deliver effective levels of cationic antibacterial Appeal 2021-000619 Application 15/805,219 3 agents in combination with polymers that protect against erosion and staining.” (Id. ¶ 1.) Claims 1, 5, 6, and 8–18 are on appeal. Claim 1, reproduced below, is illustrative of the claimed subject matter: 1. A composition comprising an aqueous solution of a) an acidic polymer, wherein the acidic polymer is selected from a combination of i) 1:4 to 4:1 copolymers of maleic anhydride or acid with another polymerizable ethylenically unsaturated monomer, wherein some or all of the anhydride moieties are hydrolyzed to provide free carboxyl groups, and ii) co-polymerized products of a mixture of acrylic acid, methacrylic acid, and 2-hydroxyethyl methacrylate phosphates of Formula 1: wherein n is 0, 1 or 2; b) a nonionic polymer selected from polyethylene glycol having a molecular weight of 5kD to 35kD; c) optionally an effective amount of cationic active agent; d) a stabilizing amount of lysine, in free or salt form, wherein the lysine is present in an amount of about 1 to 10% by weight, relative to the total weight of the composition; e) water; and f) an orally acceptable carrier; Appeal 2021-000619 Application 15/805,219 4 wherein the solution comprises two distinct aqueous phases having different composition and density. (Appeal Br. 10 (Claims App.).) The prior art relied upon by the Examiner is: Name Reference Date Montgomery US 6,475,469 B1 Nov. 5, 2002 Mello et al. US 2013/0078197 A1 Mar. 28, 2013 Prencipe et al. US 2009/0202451 A1 Aug. 13, 2009 Kigawa H et al.2 JP2005-145889 A June 9, 2005 Zaidel WO 2015/094332 A1 June 25, 2015 lsbu Water Structure and Behavior: Aqueous biphasic system, available at www.water.lsbu.ac.uk/water/aque ous_biphasic.html 2006 The following grounds of rejection by the Examiner are before us on review: Claim 17 under 35 U.S.C. § 112(d), as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends. Claims 1, 5, 6, and 8–18 under 35 U.S.C. § 103 as unpatentable over Mello, lsbu, Zaidel, Prencipe, and Montgomery. Claims 1, 5, 6, and 8–18 under 35 U.S.C. § 103 as unpatentable over Kigawa H, Mello, lsbu, Zaidel, and Montgomery. 2 The Examiner relied on the DERWENT Translation (Final Action 7), as do we. Appeal 2021-000619 Application 15/805,219 5 Claims 1, 5, 6, and 8–18, provisionally, on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3–16, and 18 of copending Application No. 15/366,327. Claims 1, 5, 6, and 8–18, provisionally, on the ground of nonstatutory double patenting as being unpatentable over claims 1–20 of copending Application No. 15/668,913. Claims 1, 5, 6, and 8–18, provisionally, on the ground of nonstatutory double patenting as being unpatentable over claims 1–17 of copending Application No. 15/806,400. DISCUSSION Appellant does not contest the Examiner’s rejection of claim 17 under 35 U.S.C. § 112(d) or the Examiner’s provisional nonstatutory double patenting rejections. Nor has Appellant filed a terminal disclaimer to obviate the obviousness-type double patenting rejections. Accordingly, we summarily affirm each of these rejections. Hyatt v. Dudas, 551 F.3d 1307, 1314 (Fed. Cir. 2008) (“When the appellant fails to contest a ground of rejection to the Board, . . . the Board may treat any argument with respect to that ground of rejection as waived.”). I. Obviousness: Mello, lsbu, Zaidel, Prencipe, Montgomery The Examiner found that Mello teaches oral care compositions that include arginine and a mucoadhesive polymer and provides a specific mouthwash composition that includes an acidic polymer that is a copolymer of methyl vinyl ether/maleic anhydride (0.65% gantrez, in which the copolymer is from 1:4 to 4:1 methyl vinyl ether to maleic anhydride), 0.8% arginine, 1.2% PEG40, and 4% propylene glycol, with the balance of the Appeal 2021-000619 Application 15/805,219 6 composition being water. (Final Action 3 (citing Mello Table 1, formula 1).) The Examiner explained that “[b]ecause this embodiment comprises water and a nonionic polymer, i.e. polyethylene glycol, it has an aqueous biphase, as evidenced by lsbu.” (Id. at 4.) The Examiner states that “[a]lthough PEG is inherently denser than water, it occupies the upper layer.” (Id.) The Examiner noted that Mello also teaches that the composition can include cetylpyridinium chloride (CPC) from 0.01–10%, as well as anionic surfactants, and poloxamers from 0.01–10%. (Final Action 4.) The Examiner also found that Mello teaches the oral compositions can include less than 5% hydrophobic ingredients. (Id.) The Examiner recognized that Mello does not teach inclusion of the copolymer of Formula 1 (Final Action 4), or that the polyamine is lysine (id. at 6), or that the PEG has a molecular weight within 5 kilodaltons (kDa) to 35 kDa (id.). However, the Examiner finds that the inclusion of these materials in an oral composition would have been obvious to one of ordinary skill in the art in light of the teachings of Zaidel, Prencipe, and Montgomery. (Id. at 5–7.) In particular, the Examiner found that Zaidel teaches a mouth rinse formulation that includes Gantrez S-97 and the claimed anionic polymer of Formula 1 and that the Gantrez may help to deposit the phosphate/acrylate copolymer on a dental surface and the phosphate/acrylate copolymer is useful for treating or inhibiting “chemical stain, plaque, and/or tartar on a dental surface.” (Id. at 5 (citing Zaidel ¶¶ 36, 54).) The Examiner found that Prencipe teaches an oral care composition, including a mouthwash, that can include a basic amino acid, such as lysine (Lys), which basic amino acid is “useful for ‘combating cavity formation and tooth sensitivity’.” (Id. at 6 (citing Principe ¶¶ 3, 8).) The Examiner also found Appeal 2021-000619 Application 15/805,219 7 that Prencipe teaches that the combination of basic amino acids and fluoride unexpectedly promotes reminerlization, repairing pre-carious lesions, and enhances oral health better than either compound separately. (Id. (citing Prencipe ¶ 19).) The Examiner found that Montgomery teaches an oral care composition for removing stains, including a mouthwash, that includes a complexing agent that has an “affinity for the disassociated chromogen,” such as PEG that preferably has a molecular weight between 2 kDa and 10 kDa. (Id. at 7 (citing Montgomery Abstr., 4:44–49, and 5:52).) The Examiner explained that it would have been obvious to one having ordinary skill in the art to have provided a PEG in the Mello mouthwash composition having a molecular weight within the claimed range in light of Montgomery’s teaching of the advantages of PEGs having a molecular weight between 2 kDa and 10 kDa, namely, providing for stain removal by complexing with a staining chromagen. (Id. at 7.) The Examiner also explained that it would have been obvious to one having ordinary skill in the art to have added a phosphate/acrylate copolymer of Formula 1 in the Mello mouthwash composition in light of Zaidel’s teaching of the advantage that such a phosphate copolymer has and Zaidel’s teaching that Gantrez, such as used in Mello, can help the phosphate/acrylate copolymer of Formula 1 deposit on the dental surface. (Id. at 5.) In addition, the Examiner explained that it would have been obvious to one having ordinary skill in the art to have substituted lysine for arginine in the Mello composition for the advantages that Prencipe teaches lysine would provide. (Id. at 6.) Appellant has argued claim 1 and claim 6 separately. We address claim 1 first. We agree with the Examiner’s conclusion of obviousness. Appeal 2021-000619 Application 15/805,219 8 Claim 1 Claim Construction During prosecution, we interpret terms in a claim using the broadest reasonable interpretation in light of the Specification. In re Morris, 127 F.3d 1048, 1055 (Fed. Cir. 1997). Claim 1 recites the following with respect to the components of the composition: “A composition comprising . . . a) an acidic polymer . . . b) a nonionic polymer selected from polyethylene glycol . . . c) optionally an effective amount of cationic active agent d) a stabilizing amount of lysine . . . , e) water; and f) an orally acceptable carrier . . . .” (Appeal Br. 10 (emphasis added).) Notably, the plain language of the claim indicates that inclusion of a “cationic active agent” is optional. Cadence Pharms. Inc. v. Exela PharmSci Inc., 780 F.3d 1364, 1372 (Fed. Cir. 2015) (“The plain and ordinary meaning of ‘optionally . . . topped . . . and placed’ is that both the topping and placing steps are optional.”) Appellant’s Specification teaches that staining and erosion, as well as reducing biofilm formation can be reduced by the use of anionic polymers, and describes compositions without cationic active agents. (Spec. ¶¶ 7, 9, 11.) Consequently, we do not find Appellant’s statement that “by any reading of the claims, the cationic active agents are represented in claim 1” persuasive to establish that a cationic active agent is required by claim 1. Thus, to find claim 1 obvious, the Examiner need not have established the prior art teaches inclusion of a cationic agent. Obviousness Analysis As the Examiner noted in the Final Action, Table 1 of Mello discloses a mouthwash composition that includes “Gantrez” (a copolymer of polyvinylmethylether/maleic anhydride), arginine, PEG 40, and water. Appeal 2021-000619 Application 15/805,219 9 (Mello ¶ 70 (Table 1); see also id. ¶ 30 (describing Gantrez brand copolymers).) Moreover, Mello discloses that Gantrez S-97 is a preferred Gantrez mucoadhesive polymer. (Id. ¶ 30.) Although Mello Table 1 does not specifically identify Gantrez S-97 was used, in light of Mello teaching this is a preferred Gantrez copolymer of polyvinylmethylether/maleic anhydride for use, we conclude that either the Gantrez identified in Table 1 that was used was Gantrez S-97 or it would have been obvious to have used it in the compositions disclosed in Table 1. Also included are a number of ingredients that Appellant’s Specification describes as “orally acceptable carriers” (Spec. ¶¶ 26, 42, 43), e.g., flavor, sweeteners (sucralose, saccharin), humectant (glycerin, sorbitol, propylene glycol) (Mello Table 1). Mello states that “[a]rginine and other basic amino acids have been proposed for use in oral care and are believed to have significant benefits in combating cavity formation and tooth sensitivity” and notes that combining basic amino acids in oral care compositions has proven challenging. (Id. ¶ 8.) Mello also notes that in mouthwash compositions in particular, “[w]hile a variety of agents can be included . . . , their concurrent use may not be possible due to interactivity, adverse reactions among reactive agents, resulting in loss of activity.” (Id. at 9.) However, the purpose of Mello is to provide a mouthwash composition that includes a variety of ingredients to treat a variety of dental conditions, “including for example, dentinal hypersensitivity, anticaries, bad breath, plaque formation, tartar control, stain prevention/whitening, dry mouth, erosion, gingivitis, etc.” (Id., see also id. ¶ 10.) Mello states that “[t]he compositions provide mucoadhesivity and film-forming properties that can be used to address hypersensitivity, dry mouth, acid resistance, deminerialization, and the like. (Mello ¶ 23.) Mello Appeal 2021-000619 Application 15/805,219 10 also states that inclusion of a surfactant, such as a nonionic surfactant, in the composition is provided to “compatibilize other components of the composition and thereby provide enhanced stability.” (Id. ¶ 56.) The Examiner provided adequate evidence that lsbu establishes that a composition with PEG and water, which the Mello composition described in Table 1 includes, would necessarily form an aqueous biphasic system which is required by claim 1 (“wherein the solution comprises two distinct aqueous phases”). Thus, as the Examiner explained, what is not taught in the composition of Mello that is claimed, is a phosphate/acrylate copolymer of Formula 1, a PEG having a molecular weight within the claimed range, and lysine. We find that the Examiner has provided sufficient evidence in the record to establish a reason to provide a phosphate/acrylate copolymer of Formula 1 to the composition of Mello from the teachings of Zaidel. “In determining whether the subject matter of a patent claim is obvious, neither the particular motivation nor the avowed purpose of the patentee controls. What matters is the objective reach of the claim. If the claim extends to what is obvious, it is invalid under § 103.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 419 (2007). Zaidel explains regarding the use of phosphate/acrylate copolymer, which refers to “a mixture of acrylic acid, methacrylic acid, and 2- hydroxyethyl methacrylate phosphates of Formula l” (Zaidel ¶ 15), which is identical to the recitation in claim 1 (ii), in mouthwash compositions: The phosphate side group of a phosphate/acrylate co-polymer, as disclosed herein, may function as an anchor to deposit the co-polymer onto the tooth surface thereby forming a physical layer on the tooth surface that may inhibit staining and/or Appeal 2021-000619 Application 15/805,219 11 biofilm formation. The copolymer may also prevent bacteria from sticking together. (Id. ¶ 23.) In addition, Zaidel teaches that combining such a phosphate/acrylate copolymer with a polyvinylmethylether/maleic anhydride (PVME/MA) copolymer such as Gantrez S-97, which is taught to be used in the oral compositions of Mello, “may help phosphate/acrylate co-polymer deposit on a dental surface due to its film forming property even though the phosphate group as the side group in the phosphate/acrylate co-polymer can anchor itself as well.” (Id. ¶ 54.) Consequently, the teachings of Mello and Zaidel provide one of ordinary skill in the art with a reason to include the claimed phosphate/acrylate copolymer in the composition of Mello that includes the basic amino acid arginine, which is believed to help combat tooth sensitivity, and the mucoadhesive polymer Gantrez, which is used to “enhance the delivery and retention of the agents to, and retention thereof on oral surfaces” (Mello ¶ 30). In addition, we find that the Examiner has provided sufficient evidence in the record from the teachings of Montgomery for adding a PEG within the molecular weight range recited by claim 1. Montgomery teaches that PEG having a molecular weight between 2 kDa and 10 kDa “does not contribute significantly to the viscosity of the oral care composition” but is suitable for use as a complexing agent so as to be able to complex with phenolic chromogenic substances which form tooth stain when present on pellicle on a surface of a tooth. (Montgomery 3:13–15, 44–60, 4:44–54.) Finally, we conclude that Prencipe teaches the equivalence of arginine and lysine in oral care compositions for their use in combating tooth sensitivity that include an anionic surfactant such as a copolymer of methyl vinyl ether and maleic anhydride, e.g., Gantrez S 97. (Prencipe ¶¶ 3, 15, 20, Appeal 2021-000619 Application 15/805,219 12 47, 75, 142–143, 183.) It is obvious to those skilled in the art to substitute one known equivalent for another. See In re Omeprazole Patent Litigation, 483 F.3d 1364, 1374 (Fed. Cir. 2007) (“[T]his court finds no . . . error in [the] conclusion that it would have been obvious to one skilled in the art to substitute one ARC [alkaline reactive compound] for another.”). The fact that arginine or lysine may be part of the composition for a different purpose (Appeal Br. 6) does not counsel against a finding of nonobviousness. In re Lintner, 458 F.2d 1013, 1016 (CCPA 1972) (“The fact that appellant uses sugar for a different purpose does not alter the conclusion that its use in a prior art composition would be prima facie obvious from the purpose disclosed in the references.”). “[I]nterrelated teachings of multiple patents; the effects of demands known to the design community or present in the marketplace; and the background knowledge possessed by a person having ordinary skill in the art, all [should be considered] in order to determine whether there was an apparent reason to combine the known elements in the fashion claimed.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007). Here, the Examiner has relied on prior art teachings of ingredients that are known to be used in mouthwash compositions to provide specific benefits to establish a reason to include all of the claimed elements recited by claim 1, and which address stated features that Mello desires to provide in a therapeutic oral composition. (Mello ¶ 10.) Thus, the fact that the prior art does not recognize the problem to be solved is not determinative of non-obviousness in this case. Consequently, we do not find Appellant’s reliance on Leo Pharmaceutical Products, Ltd. v. Rea, 726 F.3d 1346 (Fed. Cir. 2013) (Appeal Br. 5), which presented a very different factual scenario than Appeal 2021-000619 Application 15/805,219 13 presented here, establishes error in the Examiner’s rejection. In Leo Pharmaceutical, prior art discouraged combining vitamin D analogs and corticosteroids in a single formulation because of stability problems, thus teaching away from mixing topical Vitamin D formulations with other drugs. Leo Pharm., 726 F.3d at 1353. Other prior art relied on by the Examiner in the rejection combined Vitamin D and corticosteroid but not with the solvents claimed and Leo Pharmaceuticals presented experimental evidence to the Board that demonstrated that the solvents that were used, “harmed the storage stability of the vitamin D analog and corticosteroid combination.” Id. at 1354. Beyond the foregoing, the prior art references teaching the combination of Vitamin D and corticosteroid did not recognize the storage stability problems. Id. There is no evidence here that the prior art taught away from the combination of acidic polymers with a basic amino acid. Nor is there evidence that the combination of acidic polymers with a basic amino acid has some formulation problem. Appellant also argues against the conclusion of obviousness by asserting that the composition has an unexpected advantage. (Appeal Br. 4– 7.) In particular, Appellant notes that the acidic phosphate/acrylate co- polymer claimed that has a phosphate side group has a stability problem in a composition that also includes a cationic active agent, which problem “has unexpectedly been solved by the addition of a polyamine.” (Id. at 5.) Appellant states that “[i]t was not known at the time of the invention that the claimed polyacrylic acid polymer would deactivate the cationic active agent through precipitation.” (Id.) Appellant further notes that “this unexpected stabilization effect is established by data in the application.” (Id.) In particular, Appellant points Appeal 2021-000619 Application 15/805,219 14 to Example 3, compositions 2 and 3, which differ only by the absence or presence of lysine. (Id.) Appellant explains that composition 2 included 6 wt. % PEG, 2.5 wt. % of the claimed polyacrylic acid polymer and 0.075 wt. % CPC, and showed precipitation by the fact that only 15% CPC was taken up on hydroxyapatite discs, but when lysine was added to the composition, i.e., composition 3, “CPC uptake reached the maximum set by the control containing CPC but no polyacrylic acid polymer (Composition 1).” (Id.) Appellant further notes that “when glutamic acid was used in place of lysine (Composition 6), CPC uptake was decreased dramatically.” (Id.) Appellant states that the “composition containing lysine showed a 37% improvement over the composition containing glutamic acid” which “results were unexpected, and they establish that lysine uniquely stabilized the present composition.” (Id.) We do not find Appellant’s argument and test data persuasive to establish non-obviousness of claim 1. Claim 1, as just discussed, does not require the presence of a cationic active agent, much less CPC. Thus, even if an unexpected result regarding the stabilization of CPC might be demonstrated by Appellant’s data, that data does not establish non- obviousness with respect to a claimed composition that does not require a cationic active agent be present. The Examiner has provided an adequate reason to include lysine rather than arginine in the composition of Mello that does not include CPC. Appellant’s data does not establish that lysine would not have been considered an equivalent alternative to arginine in a mouth wash composition of Mello that does not include CPC. “In determining whether the subject matter of a patent claim is obvious, neither the particular motivation nor the avowed purpose of the patentee controls. What matters is Appeal 2021-000619 Application 15/805,219 15 the objective reach of the claim. If the claim extends to what is obvious, it is invalid under § 103.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 419 (2007). In light of the foregoing, we affirm the Examiner’s rejection of claim 1 as being obvious from Mello, lsbu, Zaidel, Prencipe, and Montgomery. Claims 8–15 and 18 have not been argued separately and therefore fall with claim 1. 37 C.F.R. § 41.37(c)(1)(iv). Claims 5, 6, 16, and 17 We next address Appellant’s arguments as they relate to claims requiring the presence of a cationic agent. Claim 5 depends from claim 1 and requires that the oral composition of claim 1 further includes a cationic agent selected from various groups. Claim 6 requires that the oral composition of claim 1 include a cationic agent selected from several different specified agents, of which CPC is but one. Dependent claims 16 and 17 require the presence of at least CPC as the cationic agent. First, we note that Zaidel teaches that an antibacterial agent such as CPC can be included in the composition that has both Gantrez, the claimed polymer of i) of the claim,and a polymer of Formula 1, the claimed polymer of ii) if the claim. Thus, there is a reasonable expectation of success in achieving a composition having the claimed ingredients recited by these claims. Thus, we conclude that the Examiner has established a prima facie case of obviousness for these claims, just as was done for claim 1. We also conclude, as the Examiner did, that Appellant’s results are not commensurate in scope with the claims so as to establish unexpected results. Moreover, with respect to claims 5, 6, 16, and 17, we conclude that Appeal 2021-000619 Application 15/805,219 16 the comparison was not to the closest prior art, and that there is no evidence that the results even with respect to what was tested were unexpected. Appellant’s Specification and data only describe an incompatibility of CPC with anionic polymers like DV8801 “because of the resulting precipitation of both components.” (Spec. ¶ 67.) The group of cationic active agents recited in claims 5 and 6, however, is much broader in scope than CPC. For example, the category includes cationic amino acids and metal cations, as well as chlorhexidine digluconate, all of which are very different in chemical structure from each other and from CPC. “Commensurate in scope” means that the evidence provides a reasonable basis for concluding that untested embodiments encompassed by the claims would behave in the same manner as the tested embodiment. See In re Lindner, 457 F.2d 506, 508 (CCPA 1972). Here there is no such evidence. See id. (“Here, only one mixture of ingredients was tested. . . . The claims, however, are much broader in scope, . . . and we have to agree with the Patent Office that there is no ‘adequate basis for reasonably concluding that the great number and variety of compositions included by the claims would behave in the same manner as the [single] tested composition.’”); see also In re Kollman, 595 F.2d 48, 56 (Fed. Cir. 1979) (one data point is insufficient to “to ascertain a trend in the exemplified data which would allow [one having ordinary skill in the art] to reasonably extend the probative value thereof.”). We note that Appellant’s Specification has a general statement that “anionic polymers that help coat and protect the enamel” “can interact with cationic antimicrobial agents, leading to formulation incompatibilities, particularly in high water formulations” (Spec. ¶ 7) and it further states that Appeal 2021-000619 Application 15/805,219 17 chlorhexidine and CPC, which “are cationic in charge,” “typically” are rendered inactive in combination “with anionic polymers such as phosphate- containing DV8801 (Mirapol 8801) or Gantrez . . . through complexation or precipitation” (id. ¶ 68). However, Appellant’s Specification does not provide any test data to demonstrate that chlorhexidine is stabilized by the addition of Lys like CPC is. Appellant’s Specification only indicates that “[t]he addition of Lys provides needed stability and competition between the acid functionality of the polymer[, DV8801,], the acid and the amine of Lys and CPC – each act to free CPC and make it more available for interaction with bacteria.” (Id. ¶ 67.) Appellant does not provide evidence that such would necessarily be the case with chlorhexidine, which is a biguanide compound not a cationic quaternary ammonium compound, which CPC is. Moreover, Appellant does not provide evidence that any other of the identified cationic active agents in claim 6, or the category of all cationic amino acids, or all metal cations as recited in claim 5, would complex with anionic polymers like DV8801 or that Lys would compete with the acid functionality of the polymer with them to prevent complexation and thus stabilize the composition. Furthermore, it is not clear that Appellant has provided a comparison to the closest prior art. Mello teaches a composition that includes arginine, gantrez and PEG in Table 1, and teaches that cationic active agents can be included in such a composition (see Mello ¶ 35). Appellant’s comparisons in Examples 2 and 3 are of formulations that include (1) CPC and PEG as a control, (2) CPC with DV and PEG, and then (3) CPC with DV, Lys (or Glu, or Lys and Glu), and PEG. We assume from Appellant’s Specification that Gantrez and DV are both “incompatible” with CPC without Lys. (See Spec. Appeal 2021-000619 Application 15/805,219 18 ¶¶ 12, 67.) The closest prior art for comparison would have been Mello’s compositions in Table 1 (preferred embodiments) that teach arginine (a basic amino acid just as Lys is3), and Gantrez, with PEG and the teaching at Mello paragraph 35 indicating “[t]he compositions of the preferred embodiments also may optionally contain one or more antibacterial agents . . . [which] may be selected from . . . bisguanide antiseptics (e.g., chlorhexidine . . .), quaternary ammonium compounds (e.g., cetylpyridinium chloride . . . metal ions (e.g., zinc salts . . . ).” Furthermore, there is a fundamental requirement that “any superior property must be unexpected to be considered as evidence of non- obviousness.” Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1371 (Fed. Cir. 2007). However, other than statements by the Attorney (see, e.g., Appeal Br. 4, 5), Appellant provides no evidence that the results of adding CPC to an aqueous biphasic composition that includes gantrez and a basic amino acid, such as Arginine, as taught by Mello, is unexpected. We note that an electronic word search of the Specification does not find any usage of either the terms “unexpected,” “synergistic,” or “surprising.” No declaration or affidavit has been submitted to show that the stabilizing effect with the presence of the basic amino acid Lysine or the efficacy of CPC uptake would have been surprising or unexpected to one of ordinary skill in the art. We note that the statement that the presence “of Lys provides needed stability and competition between the acid functionality of the polymer, the acid and the amine of Lys, and CPC – each act to free CPC and make it more available for interaction with bacteria” (Spec. ¶ 67. see also ¶ 68 3 Glu is a basic amino acid at a neutral pH. Appeal 2021-000619 Application 15/805,219 19 (“Biofilm removal increases when amino acids Lys (and Glu) are added, which act to free CPC from the anionic polymer through competing charge interaction, thereby increasing its efficacy.”)) does not suggest the results are unexpected. Therefore, the only indication that the results constitute an unexpected result is naked attorney argument in the Appeal Brief and these statements are not evidence. In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997); In re Pearson, 494 F.2d 1399, 1405 (CCPA 1974) (“Attorney’s argument in a brief cannot take the place of evidence.”). As Geisler explains in distinguishing In re Soni, 54 F.3d 746 (Fed. Cir. 1995), in Soni the applicants stated “in their application that the improved properties exhibited by the claimed compositions were ‘much greater than would have been predicted,’ . . . while Geisler made no such assertion in his application. Nor did Geisler submit any such statement through other evidentiary submissions, such as an affidavit or declaration.” Geisler, 116 F.3d at 1470–71 (citation omitted). Geisler concluded that “naked attorney argument is ‘insufficient to establish unexpected results.’” Id. at 1471 (citing Soni, 54 F.3d at 750). In light of the foregoing, we affirm the Examiner’s rejection of claims 5, 6, 16, and 17 as being obvious from Mello, lsbu, Zaidel, Prencipe, and Montgomery. II. Obviousness: Kigawa H, Mello, lsbu, Zaidel, and Montgomery The Examiner found that Kigawa H teaches a mouthwash formulation having excellent disinfectant effect on oral cavities comprising 1% lysine, ethanol, glycerol, polyoxyethylene-60-castor oil (nonionic polymer), l- menthol, fragrance, and purified water. (Final Action 7–8.) The Examiner Appeal 2021-000619 Application 15/805,219 20 further found that Kigawa H teaches in general that the compositions can include cationic surfactants such as CPC, anionic surfactants, and nonionic surfactants, and that the lysine can be present in from 0.01 to 20%. (Id. at 8 (citing Kigawa H ¶¶ 30, 39, 41).) As with Mello, the Examiner found that because Kigawa H teaches a “mouthwash that comprises a nonionic surfactant, polyethylene glycol, and water[,] it is an aqueous biphasic system as evidenced by lbsu.” (Id.) The Examiner found that it would have been obvious to add to the Kigawa H mouthwash the 1:4 to 4:1 copolymer of mal[ei]c [anhydride] or acid and the mixture of acrylic acid, methacrylic acid, and 2-hydroxyethyl methacrylate phosphates of Formula 1 as taught by Mello and Zaidel “for the advantage of the treatment and/or inhibition of a chemical stain, plaque, and/or tartar on a dental surface, as taught by Zaidel et al.” (Id.) The Examiner relies on the teachings of Montgomery for the obviousness of adding PEG within the claimed molecular weight for the same reasons as in the rejection based on Mello. (Id. at 9.) We agree with the Examiner’s conclusion of obviousness. Appellant argues that the rejection is in error because Kigawa H does not teach the use of an acidic polymer, and there “can be no motivation to combine” the reference with either one of Mello or Zaidel “because the relevant problem to be solved (combination of an acidic polymer and a cationic surfactant) is not presented.” (Appeal Br. 7.) We do not find this argument persuasive. The Examiner recognized that Kigawa H does not teach the use of an acidic polymer, and relied on the teachings of Mello and Zaidel’s teachings of using such polymers in mouthwash compositions to teach the obviousness of adding such a polymer to the mouthwash of Appeal 2021-000619 Application 15/805,219 21 Kigawa H. “Non-obviousness cannot be established by attacking references individually where the rejection is based upon the teachings of a combination of references. . . . [The reference] must be read, not in isolation, but for what it fairly teaches in combination with the prior art as a whole.” In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986). Appellant’s argument that there is no motivation to combine is unpersuasive because the references need not recognize the problem solved by the Appellant for a prima facie case of obviousness to be established. See In re Kemps, 97 F.3d 1427, 1430 (Fed. Cir. 1996); In re Beattie, 974 F.2d 1309, 1312 (Fed. Cir. 1992). The Examiner provided sufficient reason from the prior art references to add the acidic polymer and the claimed phosphate polymer to the mouthwash composition of Kigawa H. Appellant also argues that lysine is present in the Kigawa H composition to provide a substrate for lysyl oxidase which is “hardly instructive for using lysine in order to stabilize incompatibilities between ingredients.” (Appeal Br. 7.) We do not find this argument persuasive of nonobviousness. “When determining the patentability of a claimed invention which combines two known elements, ‘the question is whether there is something in the prior art as a whole to suggest the desirability, and thus the obviousness, of making the combination.’” In re Beattie, 974 F.2d 1309, 1311–12 (Fed. Cir. 1992) (quoting Lindemann Maschinenfabrik GMBH v. American Hoist & Derrick Co., 730 F.2d 1452, 1462 (Fed. Cir. 1984)). That lysine is present in Kigawa H at the claimed amount for a different intended purpose does not establish nonobviousness of the use of lysine in the Kigawa H composition. Accord Lintner, 458 F.2d at 1016. The fact that the ingredient is taught to be part of a mouthwash composition in an Appeal 2021-000619 Application 15/805,219 22 amount in the range claimed together with a PEG nonionic polymer and water is sufficient. And as just discussed the prior art as a whole suggests the desirability of adding the acidic polymer combination claimed. The stabilization that lysine would provide to the composition that also included the acidic polymer and CPC would be an inherent result of its presence in the composition given that it is taught to be present in the claimed range.. “What is important regarding properties that may be inherent, but unknown, is whether they are unexpected. All properties of a composition are inherent in that composition, but unexpected properties may cause what may appear to be an obvious composition to be nonobvious.” Honeywell International Inc. v. Mexichem Amanco Holding SA DE C.V., 865 F.3d 1348, 1355 (Fed. Cir. 2017). Appellant’s additional arguments regarding the unexpected results against this ground of rejection are the same as those discussed in section I. above. (See Appeal Br. 3–7.) For the reasons discussed in the Mello based rejection, we do not find those arguments persuasive of non-obviousness as to claim 1, which does not require a cationic active agent. We also conclude that with respect to claims 5 and 6, Appellant’s results are not commensurate in scope with the claims so as to establish unexpected results. Moreover, with respect to claims 5, 6, 16, and 17, we conclude that the comparison was not to the closest prior art, and that there is no evidence that the results even with respect to what was tested were unexpected. Here again claims 8–15 and 18 have not been argued separately and therefore fall with claim 1. 37 C.F.R. § 41.37(c)(1)(iv). Appeal 2021-000619 Application 15/805,219 23 In view of the foregoing, we affirm the Examiner’s rejection of claims 1, 5, 6, and 8–18 as being obvious over Kigawa H, Mello, lsbu, Zaidel, and Montgomery. DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 17 112(d) Improper Dependency 17 1, 5, 6, 8–18 103 Mello, lsbu, Zaidel, Prencipe, Montgomery. 1, 5, 6, 8–18 1, 5, 6, 8–18 103 Kigawa H, Mello, lsbu, Zaidel, Montgomery 1, 5, 6, 8–18 1, 5, 6, 8–18 Provisional Nonstatutory Double Patenting Application No. 15/366,327 1, 5, 6, 8–18 1, 5, 6, 8–18 Provisional Nonstatutory Double Patenting Application No. 15/668,913 1, 5, 6, 8–18 1, 5, 6, 8–18 Provisional Nonstatutory Double Patenting Application No. 15/806,400 1, 5, 6, 8–18 Overall Outcome 1, 5, 6, 8–18 Appeal 2021-000619 Application 15/805,219 24 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) (2019). AFFIRMED Copy with citationCopy as parenthetical citation