Micropure, Inc.Download PDFPatent Trials and Appeals BoardNov 15, 20212021001148 (P.T.A.B. Nov. 15, 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. 16/133,359 09/17/2018 Jaiprakash G. Shewale 70878.00800 6546 20322 7590 11/15/2021 SNELL & WILMER L.L.P. (Main) 400 EAST VAN BUREN ONE ARIZONA CENTER PHOENIX, AZ 85004-2202 EXAMINER ROBERTS, LEZAH ART UNIT PAPER NUMBER 1612 NOTIFICATION DATE DELIVERY MODE 11/15/2021 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): IPDOCKET@swlaw.com chauff@swlaw.com dgiancaterin@swlaw.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte JAIPRAKASH G. SHEWALE, WILLIAM E. COOLEY, JAMES L. RATCLIFF, and ESMERALDA ANN GARCIA-SMITH1 Appeal 2021-001148 Application 16/133,359 Technology Center 1600 Before ERIC B. GRIMES, RICHARD M. LEBOVITZ, and RACHEL H. TOWNSEND, Administrative Patent Judges. GRIMES, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134(a) involving claims to a composition (e.g., an oral care composition), which have been rejected as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 1 Appellant identifies the real party in interest as Micropure, Inc. Appeal Br. 2. “Appellant” refers to “applicant” as defined in 37 C.F.R. § 1.42. Appeal 2021-001148 Application 16/133,359 2 STATEMENT OF THE CASE The Specification describes a “multi-component composition compris[ing] an aliphatic anionic compound and an oxidative compound.” Spec. ¶ 8. The aliphatic anionic compound can be an N-acyl sarcosinate such as sodium lauroyl sarcosinate. Id. ¶¶ 10–11. The oxidative compound can be sodium chlorite. Id. ¶ 12. The composition can be formulated as “a mouth rinse, a gum, a gel, a paste, a cream, [or] a lozenge.” Id. ¶ 13. Claims 1–3, 5–11, 13, 14, 16–24, and 31–33 are on appeal. Claims 1 and 31, reproduced below, are illustrative: 1. A single phase composition comprising: from about 0.01% to about 5.0% of an aliphatic anionic compound, based on a total weight of the single phase composition; from about 0.001 to about 8.0% of an oxidative compound, based on a total weight of the single phase composition; a buffering system, wherein pH of the single phase composition is between 6.0 and 8.0; and water, wherein the aliphatic anionic compound provides enhanced stability for the oxidative compound, wherein the oxidative compound is sodium chlorite. 31. The single phase composition of claim 1, wherein the buffering system comprises disodium hydrogen phosphate and sodium dihydrogen phosphate. Appeal 2021-001148 Application 16/133,359 3 The claims stand rejected as follows: Claims 1–3, 5–11, 13, 14, 16–18, and 20–24 under 35 U.S.C. § 103 as obvious based on Witt2 (Final Action3 4) and Claims 19 and 31–33 under 35 U.S.C. § 103 as obvious based on Witt and Pilch4 (Final Action 6). OPINION Obviousness: Claims 1–3, 5–11, 13, 14, 16–18, and 20–24 Claims 1–3, 5–11, 13, 14, 16–18, and 20–24 stand rejected as obvious based on Witt. The Examiner finds that Witt teaches single and dual phase “oral care compositions comprising chlorite” that “are formulated into toothpastes, gels, mouth rinses and lozenges.” Final Action 4. The Examiner finds that “[t]he pH of the final composition is greater than 7” and “[t]he compositions may comprise a buffer.” Id. The Examiner also finds that “[a]nionic surfactants may be used and include sodium lauryl sulfate and sodium lauroyl sarcosinates. The surfactant typically comprises from about 0.1% to about 5%.” Id. The Examiner finds that Witt exemplifies a “single phase composition compris[ing] water, sodium chlorite (3.750%) . . . [and] sodium alkyl sulfate (4.00% of a 27.9% solution),” among other things. Id. The Examiner reasons that “[t]he sodium lauroyl sarcosinate is an aliphatic anionic compound recited by the instant claims and may be used in place of the sodium alkyl 2 US 2001/0006624 A1; published July 5, 2001. 3 Office Action mailed Dec. 27, 2019. 4 US 8,980,229 B2; issued Mar. 17, 2015. Appeal 2021-001148 Application 16/133,359 4 sulfate of Witt.” Id. at 4–5. “Therefore when sodium lauroyl sarcosinates is used, it should enhance the stability of the oxidative compound.” Id. at 5. The Examiner concludes that “[t]he prior art is not anticipatory insofar as these combinations must be selected from various lists/locations in the reference. It would have been obvious, however, to make the combination since each component is taught as being useful in making the compositions of the prior art.” Id. We agree with the Examiner that the composition of claim 1 would have been obvious to a person of ordinary skill in the art based on the teachings of Witt, which discloses “oral care compositions, including therapeutic rinses, especially mouth rinses, as well as toothpastes, . . . comprising an effective amount of chlorite ion.” Witt ¶ 1. Witt discloses that its “compositions . . . can be dual phase compositions or single phase compositions.” Id. ¶ 58. Witt states that, preferably, its “oral care compositions comprising chlorite ion [have] relatively alkaline pHs, e.g. at pHs above 7, whereby no (or only very low levels of) chlorine dioxide or chlorous acid is generated or is present in the oral care composition at the time of use.” Id. ¶ 20. “For dual phase compositions the pH is measured after the two phases are mixed together.” Id. ¶ 54. Witt discloses that, for its dual phase compositions, “[p]referably the first phase, in addition to chlorite, comprises one (or more) compatible binder, humectant, buffer and/or preservative. Preferably, the second phase, which comprises no chlorite, comprises flavorant, surfactant, fluoride ion, and/or abrasive.” Id. ¶ 61 (emphasis added). Appeal 2021-001148 Application 16/133,359 5 Witt states that “[t]he chlorite ion can come from any type of chlorite salt. Examples include alkali metal chlorites,” etc. Id. ¶ 35. “Sodium chlorite is particularly preferred.” Id. Witt states that suitable surfactants include anionic surfactants such as sodium alkyl sulfates. Id. ¶¶ 83, 89. “Other suitable anionic surfactants are sarcosinates, such as sodium lauroyl sarcosinate.” Id. ¶ 89. Witt discloses that its “composition typically comprises an anionic surfactant at a level of from about 0.025% to about 9%, . . . most preferably from about 0.1% to about 5%.” Id. Witt exemplifies a single-phase dentifrice composition comprising, among other things, water (62.777 wt%), sodium chlorite (3.750 wt%), and sodium alkyl sulfate (4.000 wt% of a 27.9% solution). Id. ¶ 138 (Example 3). Witt does not disclose the pH of this composition. However, Witt also exemplifies a dual-phase dentifrice composition in which the dentifrice phase comprises water (22.180 wt%) and sodium alkyl sulfate (8.000 wt% of a 27.9% solution), among other things, and the chlorite phase comprises water (91.07 wt%), 80% sodium chlorite (2.5 wt%), sodium carbonate (0.53 wt%), and sodium bicarbonate (0.42 wt%). Id. ¶ 137 (Example 2). Witt states that, “[a]fter phases mixed in a 1:1 vol./vol. Ratio, pH approximately 7.5.” Id. We conclude that the composition of claim 1 would have been obvious in view of Witt, which discloses dentifrice compositions that comprise water, sodium chlorite, and sodium alkyl sulfate, in amounts that are encompassed by claim 1. Witt, ¶¶ 137–138. Witt also suggests sodium lauroyl sarcosinate as a suitable anionic surfactant (id. ¶ 89); thus, Appeal 2021-001148 Application 16/133,359 6 substituting sodium lauroyl sarcosinate for the sodium alkyl sulfate in Witt’s exemplary compositions would have been an obvious modification. Witt also discloses that its composition should have a pH above 7.0 (id. ¶ 20), a pH range that overlaps the one recited in claim 1. Witt discloses using a buffer in its composition. Id. ¶ 61. Thus, it would have been obvious to a skilled artisan to use a buffer in Witt’s composition in order to maintain a pH above 7.0; e.g., between 7.0 and 8.0. Witt in fact discloses that, after the two phases of its exemplary dual-phase composition are mixed, the pH of the resulting (single-phase) composition is “approximately 7.5.” Id. ¶ 137. Regarding the first “wherein” clause of claim 1—“wherein the aliphatic anionic compound provides enhanced stability for the oxidative compound”—the composition made obvious by Witt includes the same components in the same amounts as the composition defined by claim 1. Thus, the composition made obvious by Witt should have the same properties as the composition of claim 21. Appellant argues that, “[a]lthough Witt mentions stable compositions with pH values of greater than 7 (which would overlap the claimed pH range), Witt provides absolutely no teaching to support any such composition. All of the examples for which Witt provided pH values had a pH of about 10.” Appeal Br. 8. Appellant also argues that Witt’s specification, in fact, suggests that, in addition to a high pH, the best approach is to keep chlorite and other ingredients in separate phases (and not a single phase as is claimed here) until the time of use. Thus, Witt teaches away from combining chlorite, a buffer system, and an aliphatic anionic compound at a pH of 6.0 to 8.0 in a single phase composition. Id. at 8–9. Appeal 2021-001148 Application 16/133,359 7 This argument is unpersuasive. Regarding Appellant’s argument based on Witt’s examples, Witt does state that the chlorite phase of its Example 2 has a pH of 10, but it also states that, after the phases were mixed in a 1:1 ratio, the mixed (single-phase) composition had a pH of about 7.5. Witt ¶ 137. Claim 1 does not require any particular degree of enhanced stability, or stability for any particular length of time, and therefore reads on the single-phase composition created by mixing the two phases of a dual- phase composition, even if that mixing happens just before the composition is used. Thus, Witt does not teach away from a single-phase composition comprising sodium chlorite, a buffer system, and an aliphatic anionic compound at a pH of 6.0 to 8.0. Appellant also argues that “[t]he Examiner points to Example 3 of Witt,” but “Example 3 does not teach a buffer, let alone a buffer contained in the same phase as the sodium chlorite and sodium alkyl sulfate.” Appeal Br. 9. Appellant argues that, “[g]iven that there is no buffering system taught in Witt’s Example 3, it is impossible to determine what the pH might be. . . . Whatever the initial pH of Example 3 might have been, it is surely not inherent in Example 3 that the pH is, or is close to, the claimed range of 6.0 to 8.0 of the pending claims.” Id. at 10. This argument is also unpersuasive because the rejection on appeal is based on obviousness, not anticipation. Even though Witt does not disclose all of the limitations of claim 1 in a single exemplified embodiment of its composition, it would have made the claimed composition obvious because it discloses all of the limitations of claim 1 and provides a reason to combine Appeal 2021-001148 Application 16/133,359 8 them in the manner claimed; i.e., in a single-phase composition with a pH between 7.0 and 8.0. Appellant argues that “[i]t is also not inherent that any of the compositions disclosed by Witt are stable, since there is no data that demonstrates stability. Facts must be shown to support the Examiner’s premise that the compositions are stable.” Appeal Br. 10. This argument does not persuade us that the Examiner erred. First, as mentioned above, claim 1 does not require stability of any particular degree or for any particular length of time. Appellant’s Specification states that “a single phase multi-component composition, comprising for example the combination of an oxidative compound and an aliphatic anionic compound (e.g., an N-acyl sarcosinate compound), such composition may resist significant degradation of the oxidative compound.” Spec. ¶ 122. Witt teaches a single phase composition comprising an oxidative compound and an aliphatic anionic compound (Witt ¶ 138), and suggests using sodium lauroyl sarcosinate instead of sodium alkyl sulfate (id. ¶ 89). Thus, the compositions disclosed and made obvious by Witt meet the Specification’s conditions for enhancing stability. See In re Best, 562 F.2d 1252, 1255 (CCPA 1977): Where . . . the claimed and prior art products are identical or substantially identical . . . the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. Whether the rejection is based on ‘inherency’ under 35 U.S.C. § 102, on ‘prima facie obviousness’ under 35 U.S.C. § 103, jointly or alternatively, the burden of proof is the same. Appellant’s arguments regarding claim 13 (Appeal Br. 11–13) are unpersuasive for the same reasons discussed above with regard to claim 1. Appeal 2021-001148 Application 16/133,359 9 Appellant also argues that “Witt teaches nothing specific about improving stability and provides no stability data. In contrast, Appellant has demonstrated unexpected stability for chlorite compositions comprising a buffer and an aliphatic anionic compound at a pH from 6.0 to 8.0.” Appeal Br. 13. Appellant argues that, “[i]n Example 2 of the present specification, stability of prior art Toothpastes A and B (which Appellant submits is closer prior art than Witt) and the stability of Toothpastes C and D, representing the claimed compositions, were compared.” Id. Appellant points to Table 3 in the Specification as evidence that “Toothpaste C and Toothpaste D are significantly more stable than the prior art Toothpaste A and Toothpaste B.” Id. at 14. Appellant states that “[t]his demonstrates a significant, and wholly unexpected, improvement in stability of the claimed compositions as compared to the closest prior art.” Id. at 15. Appellant also points to Table 4 in the Specification as providing stability data for Toothpastes E, F, and G. Id. Appellant states that the table shows that “Toothpaste E lost 9.3% and Toothpaste F lost 0% of stabilized chlorine dioxide after 3 months of accelerated stability testing. Even Toothpaste G, which contained sodium lauroyl sarcosinate and sorbitol—a known destabilizing agent—lost only 9.5% activity after 3 months of accelerated testing.” Id. at 16. Appellant argues that these results “demonstrate the long-term shelf stability of the claimed compositions.” Id. We have considered the data in the Specification but do not agree that it shows that the claimed combination of components results in unexpected stability of the oxidative compound. Appellant points to the data shown in Appeal 2021-001148 Application 16/133,359 10 the Specification’s Tables 1–4, which pertain to Toothpastes A–H. Of these, Toothpastes A, B, and H are outside the scope of claim 1. Toothpastes C–G appear to be closest to the composition of claim 1, although all of the exemplified toothpastes include stabilized chlorine dioxide, not sodium chlorite, as the chlorite ion source, and the Specification does not disclose the pH of any of the toothpastes. Spec. ¶ 156 (Table 1). Appellant argues that the data show that Toothpastes C and D are significantly more stable than Toothpastes A and B: “a significant, and wholly unexpected, improvement in stability of the claimed compositions as compared to the closest prior art.” Appeal Br. 14–15. This conclusion is not supported by the data. First, as discussed above, Toothpastes C and D are not “the claimed compositions,” because they do not include sodium chlorite as the oxidative compound, as required by claim 1. In addition, the comparison of Toothpastes C and D to Toothpastes A and B cannot be relied upon to show that an aliphatic anionic compound enhances the stability of the oxidative compound, because Toothpaste A contains glycerin and sorbitol, and Toothpaste B contains sorbitol, as humectants. Spec. ¶ 156 (Table 1). Toothpastes C and D do not contain either glycerin or sorbitol. Id. Appellant’s Specification states that “polyhydroxy compounds such as sorbitol and glycerin react with chlorite salts thereby resulting in unstable compositions.” Id. ¶ 170. Thus, the enhanced stability of Toothpastes C and D, relative to Toothpastes A and B, appears to be due to the presence of glycerin and/or sorbitol in Toothpastes A and B rather than the presence of sodium lauroyl sarcosinate in Toothpastes C and D. Appeal 2021-001148 Application 16/133,359 11 This conclusion is supported by a comparison of Toothpaste C to Toothpaste H, which are identical except that Toothpaste C includes sodium lauroyl sarcosinate, and Toothpaste H does not include any aliphatic anionic compound. Spec. ¶ 156 (Tables 1, 2). The results showed that Toothpaste H—with no aliphatic anionic compound and no humectant—lost 9.5% of its stabilized chlorine dioxide (SCD) activity after 3 months, while Toothpaste C—with sodium lauroyl sarcosinate and no humectant—lost 16.6% of its SCD activity after 3 months. Id. ¶ 169. In other words, in the absence of a polyhydroxy compound like glycerin or sorbitol, the inclusion of sodium lauroyl sarcosinate decreased the stability of Toothpaste C relative to an identical composition lacking sodium lauroyl sarcosinate (Toothpaste H). For the reasons discussed above, the evidence of record does not support the statements in the Appeal Brief and in the Specification that aliphatic anionic compounds or N-acyl sarcosinate compounds enhance the stability of oxidative compounds, unexpectedly or otherwise. Appellant also argues that “[t]he inventive compositions also provide unexpectedly superior efficacy,” with regard to stimulating fluoride uptake, stimulating remineralization, pellicle cleaning ability, and oxidizing salivary biomolecules. Appeal Br. 16–19. Appellant relies on data from the Specification comparing the performance of Toothpaste C with that of Toothpaste B. Id.5 5 The Specification also includes some data for Crest 3D White Mild Mint and Colgate Total Advanced Whitening toothpastes, the US Pharmacopoeia Reference Standard dentifrice, and the American Dental Association reference dentifrice, but does not include any description of the composition of these toothpastes. Spec. ¶¶ 176, 196–202, 211, 212. Appeal 2021-001148 Application 16/133,359 12 We are not persuaded that the cited data provide evidence of unexpected results that outweigh the evidence favoring obviousness. First, as discussed above, Toothpaste C includes stabilized chlorine dioxide rather than sodium chlorite as the oxidative compound, and therefore is not encompassed by claim 1. See Spec. ¶ 12 (listing sodium chlorite and stabilized chlorine dioxide as different oxidative compounds). Second, as also discussed above, Toothpastes B and C differ not only by the presence or absence of sodium lauroyl sarcosinate but also by the presence or absence of sorbitol, which is known to react with oxidative compounds such as stabilized chlorine dioxide. Spec. ¶¶ 5, 170. Finally, and even if the results for Toothpaste C were extrapolated to the claimed compositions, and even if comparing Toothpastes B and C was assumed to be a valid comparison, Toothpaste C is only a single composition, providing a single data point with respect to all of the compositions that are encompassed by Appellant’s claim 1. Toothpaste C includes sodium lauroyl sarcosinate, while claim 1 encompasses any aliphatic anionic compound; Toothpaste C includes 2.5 wt% sodium lauroyl sarcosinate and 0.14 wt% stabilized chlorine dioxide, and has an undisclosed pH, while claim 1 encompasses 0.01–5.0 wt% of an aliphatic anionic compound, 0.001 to about 8.0 wt% of an oxidative compound, and a pH between 6.0 and 8.0. Appellant has not pointed to an evidentiary basis in the record to show that any results seen for Toothpaste C are representative of other claimed embodiments, and therefore commensurate with the scope of claim 1. See In re Huai-Hung Kao, 639 F.3d 1057, 1068 (Fed. Cir. 2011) (“If an Appeal 2021-001148 Application 16/133,359 13 applicant demonstrates that an embodiment has an unexpected result and provides an adequate basis to support the conclusion that other embodiments falling within the claim will behave in the same manner, this will generally establish that the evidence is commensurate with [the] scope of the claims.”). In summary, we affirm the rejection of claims 1 and 13 under 35 U.S.C. § 103(a) based on Witt. Claims 2, 3, 5–11, 14, 16–18, and 20–24 were not argued separately, and therefore fall with claims 1 and 13. 37 C.F.R. § 41.37(c)(1)(iv). Obviousness: Claims 19 and 31–33 Claims 19 and 31–33 stand rejected as obvious based on Witt and Pilch. Appellant argues these claims as a group. Appeal Br. 20–23. We select claim 31 as representative of the rejected claims. 37 C.F.R. § 41.37(c)(1)(iv). The Examiner finds that Witt does not disclose the specific buffering system recited in claim 31, but Pilch discloses, in the context of a dentifrice, that “[b]uffer[s] are used to maintain the pH between 4 and 10 and include disodium hydrogen phosphate and sodium dihydrogen phosphate.” Final Action 6. The Examiner concludes that “[i]t would have been obvious to have used a combination of disodium hydrogen phosphate and sodium dihydrogen phosphate as the buffer in Witt et al. because the combination is suitable for toothpaste compositions.” Id. We agree with and adopt the Examiner’s fact-finding and conclusion. Appellant argues that “Pilch fails to make up for the shortcomings of Witt.” Appeal Br. 20. Appellant argues that “Pilch teaches an entirely different, unrelated solution to the problem of providing an improved Appeal 2021-001148 Application 16/133,359 14 dentifrice, and thus fails to complement or make up for the shortcomings of Witt.” Id. at 21. For the reasons discussed above, however, we do not agree that Witt is deficient in suggesting the composition of claim 1. Appellant’s argument based on Pilch is therefore unpersuasive. Appellant also revisits the arguments based on allegedly unexpected results. Appeal Br. 22. Appellant’s unexpected result argument is addressed above and is no more persuasive with respect to the rejection based on the combination of Witt and Pilch. Finally, Appellant argues that “the Examiner provides no rationale as to why one of ordinary skill in the art would combine Pilch with Witt,” and the rejection is based on hindsight. Appeal Br. 20–21, 22–23. This argument is unpersuasive as well. The Examiner pointed to Pilch’s disclosure of disodium hydrogen phosphate and sodium dihydrogen phosphate as a buffer system and concluded that it would have been obvious to use that system in Witt’s composition because Witt suggests using a buffer and Pilch teaches that the disodium hydrogen phosphate/sodium dihydrogen phosphate combination is suitable for toothpaste compositions. Final Action 6. We see no error in the Examiner’s reasoning. In summary, we affirm the rejection of claim 31 under 35 U.S.C. § 103(a) based on Witt and Pilch. Claims 19, 32, and 33 fall with claim 31 because they were not argued separately. 37 C.F.R. § 41.37(c)(1)(iv). Appeal 2021-001148 Application 16/133,359 15 DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1–3, 5–11, 13, 14, 16– 18, 20–24 103 Witt 1–3, 5–11, 13, 14, 16– 18, 20–24 19, 31–33 103 Witt, Pilch 19, 31–33 Overall Outcome 1–3, 5–11, 13, 14, 16– 24, 31–33 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 Copy with citationCopy as parenthetical citation