Colgate-Palmolive Company

Patent Trials and Appeals BoardNov 2, 2021

2021001020 (P.T.A.B. Nov. 2, 2021)

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. 16/062,154 06/14/2018 Andre MORGAN 10642-00-US-01-OC 3792 23909 7590 11/02/2021 COLGATE-PALMOLIVE COMPANY 909 RIVER ROAD PISCATAWAY, NJ 08855 EXAMINER ROBERTS, LEZAH ART UNIT PAPER NUMBER 1612 NOTIFICATION DATE DELIVERY MODE 11/02/2021 ELECTRONIC Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address(es): Patent_Mail@colpal.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte ANDRE MORGAN, SARITA VERA MELLO, and MARIAN GEORGES1 Appeal 2021-001020 Application 16/062,154 Technology Center 1600 Before DONALD E. ADAMS, ERIC B. GRIMES, 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 dental varnish composition, which have been rejected as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM IN PART and enter a new ground of rejection. 1 Appellant identifies the real party in interest as Colgate-Palmolive Company. Appeal Br. 2. “Appellant” refers to “applicant” as defined in 37 C.F.R. § 1.42. Appeal 2021-001020 Application 16/062,154 2 STATEMENT OF THE CASE “[D]ental varnishes can be used to deliver fluoride directly to the surface of teeth for prolonged periods of time.” Spec. ¶ 3. The Specification discloses a dental varnish composition [that] can include a fluoride source, such as sodium fluoride. The dental varnish composition can also include a non-aqueous solvent, such as an ethanol. In addition, the dental varnish composition can include ethyl cellulose in an amount effective to achieve suspension of the fluoride source. . . . Further, the dental varnish composition can include one or more resins selected from mastic, colophonium, or a combination thereof. Id. ¶ 8. “Mastic can include a resin obtained from the mastic tree (Pistacia lentiscus) and colophonium can include a resin derived from the stumps or sap of various plants, e.g., certain pine and conifer species.” Id. ¶ 23. Claims 1, 3–8, and 12–16 are on appeal.2 Claims 1 and 14, the only independent claims, are illustrative and are reproduced below: 1. A dental varnish composition comprising: a fluoride source; a non-aqueous solvent: ethyl cellulose in an amount effective to achieve suspension of the fluoride source, and one or more resins selected from mastic, colophonium, or a combination thereof; wherein a high shear viscosity of the dental varnish composition is at least 1,500 centipoise (cps), and wherein the ethyl cellulose has a viscosity no greater than 45 centipoise (cps). 2 Claims 9, 10, and 17 are also pending but we understand the rejection of these claims to have been withdrawn. See footnote 6, infra. Appeal 2021-001020 Application 16/062,154 3 14. A dental varnish composition comprising: a non-aqueous solvent; a fluoride source; ethyl cellulose in an amount effective to achieve suspension of the fluoride source, the ethyl cellulose having a viscosity no greater than 45 centipoise (cps); and one or more resins selected from mastic, colophonium, or a combination thereof. The claims stand rejected as follows: Claims 1, 3–8, 12, and 13 under 35 U.S.C. § 103 as obvious based on Blanvalet3 (Final Action4 2) and Claims 14–16 under 35 U.S.C. § 103 as obvious based on Blanvalet and Pillai5 (Final Action 4, Ans. 46). OPINION Obviousness: Blanvalet Claims 1, 3–8, 12, and 13 stand rejected as obvious based on Blanvalet. The Examiner finds that Blanvalet discloses a tooth varnish composition comprising sodium fluoride, ethyl cellulose, colophonium, mastic, and ethanol (a non-aqueous solvent). Final Act. 2–3. The Examiner also finds that Blanvalet teaches that “[t]he ethyl cellulose has a viscosity of 3 WO 2015/076777 A1; published May 28, 2015. 4 Office Action mailed Nov. 15, 2019. 5 US 8,883,212 B2; published Nov. 11, 2014. 6 In the Final Action, this rejection was applied to claims 9, 10, and 14–17, but in the Answer it was only applied to claims 14–16. Thus, although the Examiner did not expressly say it, we understand the rejection of claims 9, 10, and 17 to have been withdrawn. Appeal 2021-001020 Application 16/062,154 4 50–200 cps” and “[t]he viscosity of the composition ranges from 4000 cps to 14,000 cps.” Id. at 3. The Examiner reasons that “a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close,” and “no more than 45 is close [to] the 50 cps disclosed by the reference.” Id. The Examiner concludes that “‘[t]he proportions are so close that prima facie one skilled in the art would have expected them to have the same properties.[’] Therefore the claims are obvious over Blanvalet.” Id. Appellant argues that [t]he Examiner has not provided any articulated reasoning why one of skill in the art, prima facie, would have considered th[e] 10% difference between the upper limit (45 cps) of the claimed range and the lower limit (50 cps) of the Blanvalet’s range to be not meaningful such that the person of skill in the art would have expected these ranges to have the same properties. Appeal Br. 5. That is, Appellant argues, “[t]he examiner bears the initial burden of factually supporting any prima facie conclusion of obviousness. . . . The Examiner has not demonstrated that the claimed ranges and the prior art are so close that one of skill in the art would have expected them to have the same properties.” Id. at 6. We agree with Appellant that the Examiner has not shown that Blanvalet’s teachings, or the background knowledge of those skilled in the art, would have led a skilled artisan to use ethyl cellulose with a viscosity of no greater than 45 centipoise (cps) in Blanvalet’s composition. Blanvalet states that “[p]referably, the ethyl cellulose has a viscosity of 50–200 cps, preferably from 80–120 cps, more preferably from 90–110 cps or 80–105 cps, for example about 100 cps.” Blanvalet ¶ 25. Appeal 2021-001020 Application 16/062,154 5 Notably, although Blanvalet states that a viscosity of 50–200 cps is “[p]referabl[e],” rather than required, the Examiner has not identified a broader range of ethyl cellulose viscosities in Blanvalet. As Appellant pointed out (Appeal Br. 6), the “examiner bears the initial burden of presenting a prima facie case of obviousness.” In re Huai-Hung Kao, 639 F.3d 1057, 1066 (Fed. Cir. 2011). Here, the Examiner points out that Appellant’s “specification discloses an example comprising an ethyl cellulose having a viscosity of 50 cps and . . . [t]he composition comprising 50 cps ethyl cellulose was seen to have no phase separation and therefore considered a suitable ethyl cellulose.” Ans. 6– 7. The Examiner reasons that under Titanium Metals Corp. of America v. Banner, 778 F.2d 775 (Fed. Cir. 1985), a claimed range can be obvious if it is close to a prior art range, even if it does not overlap. Id. at 7. The Examiner concludes that, “based on the cited precedent and the results disclosed by the instant specification, 45 cps would be obvious over 50 cps.” Id. We do not agree with the Examiner that the data in Appellant’s Specification can be relied on as evidence of obviousness. “Motivation to combine is a factual determination as to whether there is a known reason a skilled artisan would have been motivated to combine elements to arrive at a claimed combination.” Arctic Cat, Inc. v. Bombardier Recreational Prods., Inc., 876 F.3d 1350, 1359 (Fed. Cir. 2017) (emphasis added). See also In re Kotzab, 217 F.3d 1365, 1370 (Fed. Cir. 2000) (“Even when obviousness is based on a single prior art reference, there must be a showing of a suggestion or motivation to modify the teachings of that reference.”). In this case, we agree with Appellant (Appeal Br. 6) that the Examiner relied on impermissible hindsight in citing data from Appellant’s Appeal 2021-001020 Application 16/062,154 6 Specification to show that ethyl cellulose with a viscosity of 45 cps would perform similarly to ethyl cellulose with a viscosity of 50 cps in Blanvalet’s composition. A prima facie case of obviousness must be based on the knowledge of a hypothetical person of ordinary skill in the art at the time the invention was made, but the Examiner has not shown that the data in Appellant’s Specification would have been known to those skilled in the art prior to the effective filing date of the instant application. Thus, the Examiner has not shown that, at the time Appellant’s invention was made, those of ordinary skill in the art would have had a reason to use ethyl cellulose with a viscosity no greater than 45 cps in Blanvalet’s composition. Because the Examiner has not shown that a composition meeting all of the limitations of claim 1 would have been obvious to a person of ordinary skill in the art based on Blanvalet, we reverse the rejection of claim 1, and dependent claims 3–8, 12, and 13, under 35 U.S.C. § 103. Obviousness: Blanvalet and Pillai Claims 14–16 stand rejected as obvious based on Blanvalet and Pillai. The Examiner relies on Blanvalet for the same teachings discussed above with respect to claim 1. Final Action 4. The Examiner notes that Blanvalet “does not disclose the viscosity of the ethyl cellulose of less than 50% [sic, 50 cps].” Id. at 5. The Examiner finds, however, that Pillai discloses “a tooth film composition comprising ethyl cellulose polymers with viscosities ranging from 3 to 70 mPa.sec[7] such as Ethocel® E22 and E50. . . . The ethyl 7 One millipascal second (mPa.s) corresponds to the same viscosity as one centipoise. See The International System of Units (SI) - Conversion Factors for General Use, NIST Special Publication 1038, page 12 (2006), available at Appeal 2021-001020 Application 16/062,154 7 cellulose acts as a dispersant, is an additional film forming agent and enhance[s] the stain-protecting effect.” Id. The Examiner concludes that it would have been obvious “to have used an ethyl cellulose with a viscosity of 3 to 70 mPa.sec motivated by the desire to use an ethyl cellulose that is also used for varnishes and acts as a dispersant, is an additional film forming agent and has a stain-protecting effect.” Id. We agree with the Examiner that the combined teachings of Blanvalet and Pillai would have made the composition of claim 14 obvious to a person of ordinary skill in the art. However, we designate the affirmance a new ground of rejection under 37 C.F.R. § 41.50(b) in order to give Appellant a fair opportunity to respond to the reasoning set out below. In addition, we conclude that claim 1 would have been obvious based on Blanvalet and Pillai. We therefore enter the following new ground of rejection: Claim 1 is rejected under 35 U.S.C. § 103 as unpatentable based on Blanvalet and Pillai. As discussed above, Blanvalet discloses a tooth varnish composition meeting all of the limitations of claims 1 and 14 except for the requirement of ethyl cellulose having a viscosity no greater than 45 cps. Pillai discloses “a dental film-forming composition comprising i. an acrylate/octylacrylamide copolymer . . . ; ii. one or more alkyl cellulose ethers, e.g., ethyl cellulose . . . ; [and] iii. an orally acceptable solvent, for example ethanol.” Pillai 2:46–56. Pillai teaches that a suitable “ethyl cellulose ha[s] . . . a viscosity of from 3–70 mPa·sec . . . e.g. Ethocel® E7, Ethocel® E22 or Ethocel® E50.” nvlpubs.nist.gov/nistpubs/Legacy/SP/nistspecialpublication1038.pdf, last accessed Oct. 22, 2021. Appeal 2021-001020 Application 16/062,154 8 Id. at 2:27–32. Pillai states that ethyl cellulose is suitably used “in an amount by weight of 1–20%, e.g., about 5%.” Id. at 1:35. See also id. at 3:4–5 (“[E]thyl cellulose in an amount of 1–10%, e.g., 2–5%.”), 3:66 to 4:1 (“Unless otherwise specified, all percentages and amounts . . . refer to percentages by weight.”). Pillai exemplifies film-forming compositions comprising 5 wt% Ethocel® E7 (“E7”), combined with hydroxypropyl cellulose (“HPC”) and one of three film-forming polymers. Id. at 4:10–30 (Table 1). Pillai also states that “ethyl cellulose and hydroxypropyl cellulose, which act as dispersants, and in the case of ethyl cellulose, as additional film forming agent[], enhance the stain-protecting effect of the acrylate/ octylacrylamide copolymer formulation.” Id. at 5:34–38. In summary, Pillai discloses that ethyl cellulose having a viscosity of 3– 70 cps, including Ethocel® E7, acts as a dispersant and film-forming agent in a dental film-forming composition. Pillai also discloses that such ethyl cellulose is suitably used at concentrations of 1–20 wt% and exemplifies compositions comprising 5 wt% Ethocel® E7. We agree with the Examiner that, in view of Pillai’s teachings, it would have been obvious to a person of ordinary skill in the art to use 1–20 wt% (e.g., 5 wt%) ethyl cellulose with a viscosity of 3–70 cps in Blanvalet’s composition. Pillai provides a reason to do so, because it teaches that ethyl cellulose acts as a dispersant and film-forming agent. Similar to Pillai, Blanvalet teaches that ethyl cellulose is used in its composition “in an amount of up to 5%, preferably from 1% to 5%.” Blanvalet ¶ 12. Blanvalet also discloses that the ethyl cellulose in its composition “[p]referably . . . has a viscosity of 50–200 cps” (id. ¶ 25), but it Appeal 2021-001020 Application 16/062,154 9 does not state that a viscosity of at least 50 cps for the ethyl cellulose is required. Id. Blanvalet states that “it is believed that at the concentrations employed, the ethyl cellulose in the compositions of the invention functions, inter alia, as a suspending agent for the fluoride-containing active ingredient.” Id. ¶ 29. “Suspending” an agent in a liquid medium and “dispersing” an agent in a liquid medium are two ways of saying the same thing: the agent is dispersed throughout, or suspended in, the medium instead of forming a discrete layer (e.g., by settling on the bottom of the container). See, e.g., Appeal Br. 8 (“In the Blanvalet’s tooth varnish composition, ethyl cellulose is not only used as a dispersing agent but is also used to build viscosity.”) (emphasis added). Thus, Blanvalet and Pillai disclose that the ethyl cellulose in their respective compositions performs the same function. A skilled artisan would therefore have reasonably expected Pillai’s ethyl cellulose, with a viscosity of 3–70 cps, to function as a dispersing/suspending agent in Blanvalet’s composition, making it obvious to use ethyl cellulose with a viscosity no greater than 45 cps in Blanvalet’s composition. “A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.” In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003). Appellant argues that “Pillai’s dental film-forming composition contains an acrylate/octylacry[l]amide copolymer and does not contain a resin, whereas Blanvalet’s composition is a tooth varnish composition containing a colophonium/mastic based film forming component and does not contain an acrylate/octylacry[l]amide copolymer.” Appeal Br. 8. Appeal 2021-001020 Application 16/062,154 10 This argument is unpersuasive because a skilled artisan would recognize that ethyl cellulose performs the same suspending/dispersing function in both Blanvalet’s resin-containing composition and in Pillai’s copolymer-containing composition. Thus, it would be reasonable to expect that Pillai’s 3–70 cps ethyl cellulose would also function as a suspending/ dispersing agent in Blanvalet’s composition. Appellant argues that, in “Blanvalet’s tooth varnish composition, ethyl cellulose is not only used as a dispersing agent but is also used to build viscosity in the varnish composition.” Appeal Br. 8. However, Appellant argues, “Pillai does not mention anything regarding whether ethyl cellulose (e.g., Et[h]ocel E7) increases the viscosity of [its] dental film-forming compositions.” Id. at 9. Appellant argues that Pillai at most teaches the use of ethyl cellulose (e.g., Et[h]ocel E7) as a dispersant and additional film forming agent in a dental film forming composition comprising an acrylate/ octylacry[l]amide. There is no teaching . . . that one would consider using a composition identified as a dispersant and additional film forming agent in a non-resin formulation as a thickener in a resin-based varnish. Id. This argument is also unpersuasive, because Blanvalet discloses that the effectiveness of ethyl cellulose as a suspension agent (a.k.a., dispersion agent) is a result of its viscosity-increasing effect. See Blanvalet ¶ 29 (“It is surprising that ethyl cellulose at these relatively low concentrations imparts the requisite increased viscosity properties sufficient to allow its use as a suspension agent in the compositions of the invention.”). Because Pillai discloses that its 3–70 cps ethyl cellulose functions as a dispersing agent, just as Blanvalet’s 50–200 cps ethyl cellulose functions as a Appeal 2021-001020 Application 16/062,154 11 suspending agent, a person of ordinary skill in the art would reasonably expect that Pillai’s ethyl cellulose would also impart increased viscosity sufficient to allow its use as a suspension agent in Blanvalet’s composition. Appellant also argues that the claimed composition provides unexpected results. Appeal Br. 10. Appellant argues that “[t]he data in the present specification shows that lower viscosity ethyl celluloses falling within the scope of claim 1 provide[] a higher viscosity composition than a commercial formula including shellac (Example 1).” Id. Appellant also argues that the data in the Specification “shows that varnish formulations containing low viscosity ethyl cellulose provide[] improved varnish retention on enamel, improved fluoride uptake, improved appearance over the commercial formula (Examples 2–5).” Id. Appellant argues that these results “are unexpected, because one of skill in the art would expect that low viscosity ethyl celluloses cause a decrease in the viscosity of the overall dental varnish formulations, as explained in paragraph [0057] of the . . . specification.” Id. This argument is also unpersuasive. With respect to unexpected results, the cited paragraph from the Specification states: It is unexpected that the compositions of dental varnishes described herein provide rheological properties that achieve the substantially uniform suspension of a fluoride source without phase separation. In particular, the ethyl cellulose included in formulations described herein has viscosities that are less than those of previous compositions, which one of skill in the art would expect to cause a decrease in the viscosity of the overall dental varnish formulations. However, the lower viscosity ethyl cellulose . . . provides a higher viscosity composition than previous dental varnish compositions. . . . The improved rheological properties result in a substantially uniform Appeal 2021-001020 Application 16/062,154 12 distribution of a fluoride source in the dental varnish formulations described herein. Spec. ¶ 57. The statements in this passage, however, are not consistent with Blanvalet. The passage quoted above states that a skilled artisan would expect a lower-viscosity ethyl cellulose to result in a lower viscosity in the overall formulation. That result, in fact, is what is shown by the data in the record. The Specification’s “Composition 2” and Blanvalet’s “Composition 5” are very similar, and both compositions include 2.5 wt% ethyl cellulose, which has a viscosity of 50 cps in the Specification’s Composition 2 and 100 cps in Blanvalet’s Composition 5. See Spec. ¶ 61 (Table 1), Blanvalet ¶ 46 (Table 1).8 Blanvalet’s Composition 5 has a viscosity of 11,168 cps and the Specification’s Composition 2 has a viscosity of 3200 cps. Spec. ¶ 61 (Table 1), Blanvalet ¶ 46 (Table 1). In other words, the results are what would have been expected according to Appellant’s Specification: in otherwise nearly identical compositions, the viscosity of a composition with 50 cps ethyl cellulose is lower than that of a composition with 100 cps ethyl cellulose. Appellant’s Specification also describes “Composition 1” and “Composition 3,” which include ethyl cellulose with viscosities of 22 cps and 10 cps, respectively, and have overall viscosities of 3800 cps and 5500 cps, respectively. Spec. ¶ 61 (Table 1). Thus, compared to the Specification’s 8 Blanvalet’s composition includes “Ethyl Cellulose (N100PH),” which we interpret to mean ethyl cellulose with a viscosity of 100 cps. See Blanvalet ¶¶ 25–26 (“Preferably, the ethyl cellulose has a viscosity of 50–200 cps, preferably . . . for example about 100 cps. . . . One particularly preferred ethyl cellulose is N100PH.”). Appeal 2021-001020 Application 16/062,154 13 Composition 2, Compositions 1 and 3 show that lower-viscosity ethyl celluloses produced compositions with higher overall viscosities. These results, however, still fail to support the Specification’s statement that “the lower viscosity ethyl cellulose . . . provides a higher viscosity composition than previous dental varnish compositions.” Spec. ¶ 57. First, the overall viscosities of the Specification’s Compositions 1 and 3 are not “higher . . . than previous dental varnish compositions,” id., because Blanvalet’s Composition 5 has an overall viscosity of 11,668, which is higher than any of the compositions exemplified in Appellant’s Specification. In addition, the Specification’s Composition 1 includes 3.00 wt% ethyl cellulose (22 cps) and its Composition 3 includes 6.00 wt% ethyl cellulose (10 cps). Spec. ¶ 61 (Table 1). Both the Specification’s Composition 2 and Blanvalet’s Composition 5, however, only include 2.5 wt% ethyl cellulose. Thus, it is unclear from the data shown whether the increased viscosity in the Specification’s Compositions 1 and 3 (compared to Composition 2) is due to the viscosity of the ethyl cellulose or the concentration of ethyl cellulose in the compositions, or a combination of the two. The data therefore do not support a conclusion that using a lower-viscosity ethyl cellulose results in increased overall viscosity in the claimed composition. Finally, the claims encompass compositions comprising ethyl cellulose with a viscosity of 45 cps or less, but the data presented in the Specification only pertains to ethyl cellulose with a viscosity of either 10 cps or 22 cps (Composition 2, with its 50 cps ethyl cellulose, is outside the scope of the claims). The Specification does not provide evidence that shows the results with 10 cps ethyl cellulose and 22 cps ethyl cellulose would also be expected to apply to ethyl cellulose with a viscosity of less than 10 cps or with a Appeal 2021-001020 Application 16/062,154 14 viscosity of 23–45 cps. Thus, the data presented are not commensurate in scope with the claims. See In re Huai-Hung Kao, 639 F.3d 1057, 1068 (Fed. Cir. 2011) (“If an 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.”). CONCLUSION We reverse the rejection of claims 1, 3–8, 12, and 13 under 35 U.S.C. § 103 based on Blanvalet. We affirm the rejection of claim 14 under 35 U.S.C. § 103 based on Blanvalet and Pillai. Claims 15 and 16 fall with claim 14 because they were not argued separately. We designate the affirmance a new ground of rejection because we rely on additional fact-finding and reasoning. We also apply the new ground of rejection to independent claim 1. We take no position on whether the new ground of rejection is applicable to the rest of the claims, and leave it to the Examiner to make that determination in the event of further prosecution. Appeal 2021-001020 Application 16/062,154 15 DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed New Ground 1, 3–8, 12, 13 103 Blanvalet 1, 3–8, 12, 13 14–16 103 Blanvalet, Pillai 14–16 1, 14–16 103 Blanvalet, Pillai 1, 14– 16 Overall Outcome 14–16 3–8, 12, 13 1, 14– 16 TIME PERIOD FOR RESPONSE This decision contains a new ground of rejection pursuant to 37 C.F.R. § 41.50(b). 37 C.F.R. § 41.50(b) provides “[a] new ground of rejection pursuant to this paragraph shall not be considered final for judicial review.” 37 C.F.R. § 41.50(b) also provides that the Appellant, WITHIN TWO MONTHS FROM THE DATE OF THE DECISION, must exercise one of the following two options with respect to the new ground of rejection to avoid termination of the appeal as to the rejected claims: (1) Reopen prosecution. Submit an appropriate amendment of the claims so rejected or new Evidence relating to the claims so rejected, or both, and have the matter reconsidered by the examiner, in which event the proceeding will be remanded to the examiner. . . . (2) Request rehearing. Request that the proceeding be reheard under § 41.52 by the Board upon the same Record. . . . Further guidance on responding to a new ground of rejection can be found in the Manual of Patent Examining Procedure § 1214.01. AFFIRMED-IN-PART; 37 C.F.R. § 41.50(b)