Robinson, Richard Scott. et al.Download PDFPatent Trials and Appeals BoardMay 8, 20202019005367 (P.T.A.B. May. 8, 2020) 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. 12/866,786 08/09/2010 Richard Scott Robinson 8569-00-US-01-OC 4463 23909 7590 05/08/2020 COLGATE-PALMOLIVE COMPANY 909 RIVER ROAD PISCATAWAY, NJ 08855 EXAMINER MILLIGAN, ADAM C ART UNIT PAPER NUMBER 1612 NOTIFICATION DATE DELIVERY MODE 05/08/2020 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 RICHARD SCOTT ROBINSON, DIANE CUMMINS, RICHARD J. SULLIVAN, and ROGER ELLWOOD __________ Appeal 2019-005367 Application 12/866,786 Technology Center 1600 __________ Before JEFFREY N. FREDMAN, CHRISTOPHER G. PAULRAJ, and JAMIE T. WISZ, Administrative Patent Judges. FREDMAN, Administrative Patent Judge. DECISION ON APPEAL This is an appeal1,2 under 35 U.S.C. § 134(a) involving claims to a method of treating early enamel caries. The Examiner rejected the claims as obvious. 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 Company (see Appeal Br. 2). 2 We have considered and refer to the Specification of Aug. 9, 2010 (“Spec.”); Final Action of Aug. 10, 2018 (“Final Act.”); Appeal Brief of Jan. 14, 2019 (“Appeal Br.”); Examiner’s Answer of May 7, 2019 (“Ans.”); and Reply Brief of July 8, 2019 (“Reply Br.”). We note that the Examiner was affirmed in Appeal 2012-012158, the previous appeal in this application. Appeal 2019-005367 Application 12/866,786 2 Statement of the Case Background “Arginine 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” (Spec. ¶ 3). “Combining these basic amino acids with minerals having oral care benefits, e.g., fluoride and calcium, to form an oral care product having acceptable long term stability, however, has proven challenging” (Spec. ¶ 3). The Claims Claims 1, 3, 7, 11, 20, 21, 26, and 27 are on appeal3. Claim 1 is representative and reads as follows: 1. A method of treating early enamel caries comprising: applying an effective amount of a dentifrice composition to the oral cavity, the dentifrice composition having a base formulation comprising dicalcium phosphate dihydrate, the dentifrice composition further comprising arginine, in free or salt form, and an effective amount of sodium monofluorophosphate, wherein the arginine is provided in the amount of from 1 to 10 wt % based on the total weight of the dentifrice composition; and wherein the sodium monofluorophosphate is present in an amount of from 0.01 wt% to 2 wt % of the composition. The Issues A. The Examiner rejected claims 1, 7, 11, 20, 21, 26, and 27 under 35 U.S.C. § 103(a) as obvious over Kleinberg4 and Norfleet5 (Final Act. 3–5). 3 Claims 2, 5, 6, 8–10, 12–19, 22, and 25 were cancelled and claims 4, 23, and 24 are withdrawn (see Appeal Br., Claims Appendix). 4 Kleinberg et al., US 6,217,851 B1, issued Apr. 17, 2001. Appeal 2019-005367 Application 12/866,786 3 B. The Examiner rejected claim 3 under 35 U.S.C. § 103(a) as obvious over Kleinberg, Norfleet, and Stookey6 (Final Act. 5–6). A. 35 U.S.C. § 103(a) over Kleinberg and Norfleet The Examiner finds Kleinberg teaches that one “method to prevent the formation of cavities is to reduce the acids present in the oral cavity” and “[a]nother strategy is to reduce the dissolution and demineralization of enamel using fluoride” (Final Act. 3). The Examiner finds “Kleinberg teaches using a composition comprising arginine, calcium and a cariostatic anion for these purposes” (id.). The Examiner acknowledges that “[w]hile emphasizing the importance of calcium phosphate generally, Kleinberg does not explicitly teach the addition of calcium phosphate dihydrate” (Final Act. 4). The Examiner finds that “Norfleet teaches that it was known in the art to formulate desensitizing anti-tartar dentifrices using calcium phosphates, specifically calcium phosphate dihydrate as a polishing agent” (id.). The Examiner also finds that Norfleet teaches incorporation of sodium fluoride (id. at 5). The Examiner finds it obvious for “the dentifrice of Kleinberg to incorporate the ingredients of Norfleet, given that the ingredients are taught to be used for the same purpose, i.e. to provide oral anti-tartar and desensitizing” (Final Act. 5). 5 Norfleet et al., US 5,505,933, issued Apr. 9, 1996. 6 Stookey et al., US 2004/0202356 A1, published Oct. 14, 2004. Appeal 2019-005367 Application 12/866,786 4 The issues with respect to this rejection are: (i) Does the evidence of record support the Examiner’s conclusion that Kleinberg and Norfleet render the claims prima facie obvious? (ii) If so, has Appellant provided evidence of unexpected results that outweighs the evidence supporting the prima facie case of obviousness? Findings of Fact 1. Kleinberg teaches “a method of reducing dental caries comprising delivering a therapeutically effective amount of the oral compositions . . . capable of retarding or preventing dental caries” (Kleinberg, 5:53–59). 2. Kleinberg teaches that: “Fluoride has been found to inhibit the dissolution of enamel by dental plaque acids by reducing the rate of solubilization, increasing remineralization” (Kleinberg 2:15–17). 3. Kleinberg teaches that a “therapeutic amount of calcium, arginine and a cariostatic anion as defined by this invention is an amount of these anti-caries agents sufficient to . . . reduce demineralization or increase remineralization of the dental enamel” (Kleinberg, 4:24–29). 4. Kleinberg teaches that In one preferred embodiment, the oral compositions contain calcium in an amount ranging from 5 µg/mg to 200 µg/mg, arginine in an amount ranging from 5 µg/mg to 700 µg/mg . . . In a more preferred embodiment, the oral compositions further contain fluoride in an amount ranging from 200 to 1500 ppm. (Kleinberg, 4:35–43; emphasis added). 5. The Examiner finds that Kleinberg’s arginine range overlaps that recited in claim 1, specifically teaching that in Kleinberg “arginine is Appeal 2019-005367 Application 12/866,786 5 present from 5 μg/mg to 700 μg/mg (i.e. 0.5% to 70%), and the instant application recites that arginine is present at 2–10% by weight” (Final Act. 5). 6. Kleinberg teaches that the “‘cariostatic’ denotes agents which are capable of retarding or preventing dental caries including remineralization of caries lesions” (Kleinberg, 4:1–3). 7. Kleinberg teaches the “[c]ariostatic anions may . . . provide an organic phosphate source to act as a surface covering or ‘poison’ or to be hydrolyzed by the plaque bacteria” (Kleinberg 3:6–10). Kleinberg teaches the “anti-caries agents are also referred to as calcium arginine phytate (CAP) salts” (Kleinberg 6:44–46). 8. Kleinberg teaches that “[d]entifrice pastes or gels may contain, for example . . . a conventional abrasive such as . . . insoluble alkali metal metaphosphates and the like in a standard amount of 20–60% wt” (Kleinberg 5:27–31). 9. Norfleet teaches “the oral composition is a desensitizing anti- tartar toothpaste or gel which, when the teeth are brushed with it, aids in removal of at least some tartar and prevents its reappearance, and at the same time diminishes any tooth pain that the brusher would otherwise experience due to such brushing” (Norfleet, abstract). 10. Norfleet teaches “polishing agents may be employed too, including . . . calcium phosphate dihydrate, anhydrous dicalcium phosphate” (Norfleet 6:21–25). 11. Norfleet teaches that “the useful sources of fluoride ions are water soluble alkali metal fluorides, such as . . . sodium and potassium monofluorophosphates . . . or a mixture thereof” (Norfleet 4:55–65). Appeal 2019-005367 Application 12/866,786 6 12. Norfleet teaches that the “the desired fluoride ion will usually be in the range of 0.03 to 0.7%” (Norfleet 8:22–23). 13. The Specification teaches, in Example 1, an experiment comparing an undefined amount of dicalcium phosphate dehydrate, 1.5% neutralized arginine and 1450 ppm of sodium monofluorophosphate with a composition lacking the arginine and finds that the three part composition results in a % mineral change of +8.27 while the two part composition lacking arginine results in % mineral change of -1.87 (see Spec. ¶ 84). Principles of Law “The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). Analysis Prima facie obviousness We adopt the Examiner’s findings of fact and reasoning regarding the scope and content of the prior art (Ans. 3–5; FF 1–12) and agree that Kleinberg and Norfleet render the claims obvious. We address Appellant’s arguments below. Appellant contends “[t]here is no teaching or suggestion in Kleinberg of a dentifrice composition comprising the specific combination of arginine, sodium monofluorophosphate and dicalcium phosphate dihydrate for treating early enamel caries” (Appeal Br. 5). Appellant contends “neither dicalcium phosphate dihydrate nor sodium monofluorophosphate is contained in any exemplary formulations in Norfleet. Neither Kleinberg nor Norfleet teach or suggest the use of dicalcium phosphate dihydrate, sodium monofluorophosphate and arginine in an oral care composition for treating Appeal 2019-005367 Application 12/866,786 7 early enamel caries” (id.). Appellant also contends that “Kleinberg provides no motivation to employ any other polishing agent. Kleinberg contains only a single reference to a polishing agent, and merely identifies calcium carbonate as a known polishing agent” and “Kleinberg does not disclose or suggest dicalcium phosphate dihydrate as a calcium-containing compound” (id. at 6). We find Appellant’s arguments unpersuasive because “[n]on- 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). Here, Kleinberg teaches a method of treating caries using oral compositions (FF 1) that include arginine in amounts overlapping those recited in claim 1 (FF 4–5), fluoride containing components in amounts overlapping claim 1 (FF 2, 4), and polishing agents composed of alkali metal phosphates (FF 8). Norfleet also teaches a method of treating caries using oral compositions (FF 9) that include sodium monofluorophosphate as a useful source of fluoride ions in an overlapping range with claim 1 (FF 11– 12) and an alkali metal phosphate polishing agent like calcium phosphate dihydrate (FF 10). We agree with the Examiner that the ordinary artisan would have found it obvious to select Norfleet’s useful fluoride source of sodium monofluorophosphate and polishing agent of calcium phosphate dehydrate for fluoride ion and polishing agents in Kleinberg because “a person of ordinary skill has good reason to pursue the known options within his or her Appeal 2019-005367 Application 12/866,786 8 technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.” KSR, 550 U.S. at 421. Also, to the extent that Appellant argues neither Kleinberg nor Norfleet have examples anticipating the claims, “a reference is not limited to the disclosure of specific working examples.” In re Mills, 470 F.2d 649, 651 (CCPA 1972). Appellant contends: There is no teaching or suggestion in Kleinberg that inorganic phosphate has cariostatic activities. If dicalcium phosphate dihydrate is added into Kleinberg’s composition, one of skill in the art might well expect that inorganic phosphate released from dicalcium phosphate dihydrate might interfere with the formation of calcium/arginine/cariostatic anion complex. Similarly, one of skill in the art might well expect that monofluorophosphate (an inorganic phosphate) released from sodium monofluorophosphate might interfere with the formation of calcium/arginine/cariostatic anion complex. Thus, one of skill in the art would not be motivated to replace calcium carbonate (which contains a cariostatic anion) with dicalcium phosphate dihydrate (which does not contain a cariostatic anion). (Appeal Br. 7). We find this argument unpersuasive for several reasons. First, claim 1 does not exclude the use of multiple fluoride ions and therefore encompass the use of sodium monofluorophosphate along with other fluoride ion sources. Indeed, Kleinberg teaches that fluoride sources result in remineralization of enamel (FF 2) and Norfleet expressly teaches that mixtures of fluoride compounds can be used (FF 11). Second, the arguments relating to interference of different ions are entirely attorney speculation without any evidentiary support. However, “attorney argument Appeal 2019-005367 Application 12/866,786 9 [is] not the kind of factual evidence that is required to rebut a prima facie case of obviousness.” In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997). Unexpected Results Appellant contends: The data in Example I . . . shows that the addition of arginine into the dicalcium phosphate dihydrate /sodium monofluorophosphate formulation not only reduces demineralization but also increases remineralization. Neither Kleinberg nor Norfleet teaches or suggests this technical effect. . . . There is no teaching or suggestion anywhere in Kleinberg that arginine, dicalcium phosphate dihydrate or fluoride, much less the combination of them, would enhance tooth remineralization. Kleinberg at most teaches that the calcium/arginine/cariostatic anion complex would increase remineralization. Thus, the data in Example 1 of the present application is unexpected. (Appeal Br. 9). Appellant also points to a post-filing date publication by Kraivaphan7 that shows “adding arginine and calcium salt to fluoride toothpaste makes it more effective in preventing dental caries than simply providing fluoride alone” (id. at 10). Appellant further contends, regarding these asserted results, that the results are commensurate in scope with the evidence because a “skilled artisan could ascertain a trend in the exemplified data that would allow him to reasonably extend the probative value thereof to the claimed method as recited in claims 1 and 7” (Appeal Br. 10). 7 Kraivaphan et al., Two-Year Caries Clinical Study of the Efficacy of Novel Dentifrices Containing 1.5% Arginine, an Insoluble Calcium Compound and 1,450 ppm Fluoride, 4 Caries Res. 582–90 (2013). Appeal 2019-005367 Application 12/866,786 10 We find the argument that Kleinberg does not teach remineralization unpersuasive because Kleinberg specifically teaches that fluoride compositions are capable of “retarding . . . dental caries” (FF 1). Kleinberg further teaches that fluoride containing compositions may “increase remineralization of the dental enamel” (FF 2) and that the particular composition described may assist in “remineralization of caries lesions” (FF 6). Thus, Kleinberg expressly disclosed remineralizing dental caries as well as preventing dental caries (FF 1, 2, 6). We also find the assertion of unexpected results unpersuasive for several reasons. First, Appellant acknowledges that Kraivaphan teaches “dentifrices containing 1.5% arginine, an insoluble calcium compound and 1,450 ppm F provide significantly greater protection against caries lesion cavitation, in a low to moderate caries risk population, than dentifrices containing 1,450 ppm F alone” (Kraivaphan 582, abstract; Appeal Br. 10). Thus, Kraivaphan is consistent with Kleinberg’s composition, which may contain calcium arginine phytate and fluoride (FF 4, 7) and where Kleinberg teaches that the combination will be effective (FF 2, 3). Thus, we find that results in the Specification (FF 13) and Kraivaphan are the expected results based on the prior art disclosure, not unexpected results. See In re Skoner, 517 F.2d 947, 950 (CCPA 1975) (“Expected beneficial results are evidence of obviousness of a claimed invention.”) Second, we are not persuaded that the results of either Example 1 of the Specification, or Kraivaphan, which are both limited to a single composition composed of 1.5% arginine, 1450 ppm sodium monofluorophosphate, and an undisclosed amount of dicalcium phosphate dihydrate, are commensurate in scope with the recitation in claim 1 of Appeal 2019-005367 Application 12/866,786 11 arginine from 1–10 wt% and sodium monofluorophosphate from 0.01 wt% (100 ppm) to 2 wt% (20,000 ppm). And of course, there is no limitation on the amount of dicalcium phosphate dehydrate in claim 1, and the Specification teaches that there may be anywhere from “about 15 wt.% to about 70 wt.%” of this component (Spec. 7). Consequently, this single example selecting single values from three different large ranges of composition components does not establish that the unexpected result is commensurate in scope with claim 1. See E.I. DuPont de Nemours & Co. v. Synvina C.V., 904 F.3d 996, 1012 (Fed. Cir. 2018) (“[O]nly a single pressure of 20 bars (4.2 bars PO2) was tested in the experiments disclosed in table 1, so any unexpected results demonstrated . . . were not commensurate with the scope of the claims.”) Appellant’s cited case, In re Clemens, 622 F.2d 1029 (CCPA 1980), also does not support Appellant’s position because Clemens explains that a single variable temperature range, tested using comparative tests conducted at two temperatures, was “not a case in which the probative value of a narrow range of data can be reasonably extended to prove the unobviousness of a broader claimed range.” Id. at 1036. Here, where there is not a single variable of temperature tested at two different values, but rather three different variable ranges of composition, each range tested at only a single value in a single experiment, the evidence is even less capable of extension to the broader range than the situation in Clemens. Unexpected results must be “commensurate in scope with the degree of protection sought by the claimed subject matter.” In re Harris, 409 F.3d 1339, 1344 (Fed. Cir. 2005). Third, given the direct suggestion by Kleinberg of a composition comprising arginine, calcium, and fluoride (FF 4) combined with Appeal 2019-005367 Application 12/866,786 12 Kleinberg’s teaching of remineralization (FF 2, 6) and Kleinberg’s teaching that an exemplified composition, when added to the tooth powder resulting in a “regain of the 20% loss” (Kleinberg 15:5) balanced against the approximately 10% remineralization change disclosed in Example 1 of Appellant’s Specification (FF 13), we conclude that even if there is some showing of unexpected results, the showing is insufficient to overcome the strong showing of obviousness in this case. See Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1372 (Fed. Cir. 2007) (“[W]e hold that even if Pfizer showed that amlodipine besylate exhibits unexpectedly superior results, this secondary consideration does not overcome the strong showing of obviousness in this case. Although secondary considerations must be taken into account, they do not necessarily control the obviousness conclusion”). Claim 7 Appellant does not provide any arguments specific to claim 7, but relies upon arguments we found unpersuasive with regard to claim 1 for the reasons discussed above. Conclusions of Law (i) The evidence of record supports the Examiner’s conclusion that Kleinberg and Norfleet render the claims prima facie obvious. (ii) Appellant has not provided evidence of unexpected results that outweighs the evidence supporting the prima facie case of obviousness. B. Kleinberg, Norfleet and Stookey Appellant does not argue separately claim 3 in this obviousness rejection, instead relying upon overcoming Kleinberg (see Appeal Br. 9). Having found no deficiency in the combination of Kleinberg and Norfleet as Appeal 2019-005367 Application 12/866,786 13 it relates to Appellant’s claim 1, we are not persuaded by Appellant’s contention to the contrary. CONCLUSION In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1, 7, 11, 20, 21, 26, 27 103 Kleinberg, Norfleet 1, 7, 11, 20, 21, 26, 27 3 103 Kleinberg, Norfleet, Stookey 3 Overall Outcome 1, 3, 7, 11, 20, 21, 26, 27 No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). AFFIRMED Copy with citationCopy as parenthetical citation