2021000973 (P.T.A.B. Oct. 15, 2021)

COLGATE-PALMOLIVE COMPANY

Patent Trials and Appeals BoardOct 15, 2021

2021000973 (P.T.A.B. Oct. 15, 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. 15/100,990 06/02/2016 Ying YANG 10162-00-US-01-OC 5827 23909 7590 10/15/2021 COLGATE-PALMOLIVE COMPANY 909 RIVER ROAD PISCATAWAY, NJ 08855 EXAMINER ROBERTS, LEZAH ART UNIT PAPER NUMBER 1612 NOTIFICATION DATE DELIVERY MODE 10/15/2021 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): Patent_Mail@colpal.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte YING YANG, HARSH M. TRIVEDI, and GUOFENG XU1 Appeal 2021-000973 Application 15/100,990 Technology Center 1600 Before ERIC. B. GRIMES, JEFFREY N. FREDMAN, and JAMIE T. WISZ, Administrative Patent Judges. GRIMES, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134(a) involving claims to an oral care method, which have been rejected as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM but designate the affirmance a new ground of rejection. STATEMENT OF THE CASE The Specification states that 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 2021-000973 Application 15/100,990 2 [i]t has surprisingly been found that zinc ions can enhance the epithelial barrier function of oral soft tissues epithelial cells, such as gingival epithelial cells, and thus protect oral tissues from periodontal pathogen infection. By inhibiting pathogenic organisms from adhering to or invading the epithelial cells in the oral cavity, . . . a reduction in the occurrence and/or severity of periodontal diseases such as gingivitis and periodontitis [can be obtained]. Spec. ¶ 30. Claims 15, 19, 25–27, 44, 45, and 48 are on appeal. Claim 15, the only independent claim, is illustrative and is reproduced below: 15. A method for inhibiting the adherence to or invasion of oral soft tissue epithelial cells by a periodontal pathogen in a patient in need thereof, the method comprising applying a composition comprising a zinc ion source to the oral soft tissue epithelial cells of said patient, wherein the zinc ion source comprises a combination of zinc citrate in an amount of from 5 μM to 1.2 mM and zinc oxide in an amount of from 12 μM to 6 mM; wherein the oral soft tissue is gingival epithelial cells; and wherein the periodontal pathogen causes, transmits or exacerbates a periodontal disease selected from gingivitis and periodontitis and is one or more of Streptococcus mutans, Streptococcus sobrinus, Streptococcus sanguis, Streptococcus oralis, Porphyromonas gingivalis, Porphyromonas cangingivalis, Actinobacillus actinomycetemcomitans, Tannerella forsythia, Fusobacterium nucleatum and Treponema denticola. Appeal Br. 8 (Claims Appendix). Appeal 2021-000973 Application 15/100,990 3 OPINION Claims 15, 19, 25–27, 44, 45, and 48 stand rejected under 35 U.S.C. § 103 as obvious based on Mello.2 Final Action3 2. The Examiner finds that Mello discloses therapeutic oral compositions that comprise arginine and anti-bacterials such as zinc citrate and zinc oxide. Id. The Examiner finds that “[z]inc salts comprise 0.01 to 1% by weight of [Mello’s] compositions.” Id. The Examiner finds that Mello also discloses “a method of one or more of: . . . reducing or inhibiting gingivitis . . . comprising applying to the oral cavity of a patient in need thereof an oral care composition comprising arginine . . . , a mucoadhesive polymer, and at least one component selected from the group consisting of pyrophosphate compounds, zinc salts,” etc. Id. at 3. The Examiner concludes that [t]he instant claims recite 5 microMolar to 2.4 mM of zinc citrate and 12 microMolar to 24 mM [of] zinc oxide whereas the Mello et al. disclose 0.1 to 1% zinc salts (1.71 mM to 17.14 mM zinc citrate and []12 mM to 120 mM zinc oxide). In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists. MPEP 2144.05 A. Therefore the claims are obvious over Mello. Id. We agree with the Examiner that claim 15 would have been obvious based on Mello, but we disagree with the Examiner’s reasoning. We therefore affirm the rejection but designate the affirmance as a new ground of rejection under 37 C.F.R. § 41.50(b). 2 Mello et al., WO 2011/162756 A1, published Dec. 29, 2011. 3 Office Action mailed Jan. 27, 2020. Appeal 2021-000973 Application 15/100,990 4 The Examiner’s reasoning, quoted above, errs in two ways. First, claim 15 was amended to recite 5 μM to 1.2 mM (not 2.4 mM) zinc citrate and 12 μM to 6 mM (not 24 mM) zinc oxide. See Amendment filed March 29, 2019. Thus, the Examiner’s conclusion—that the ranges recited in the claims overlap ranges of 1.71 mM to 17.14 mM zinc citrate and 12 mM to 120 mM zinc oxide—is not consistent with the claims as they currently stand. The Examiner also erred in stating that Mello’s disclosed range for zinc salts is limited to 0.1 to 1% by weight. Mello in fact states that “[t]he zinc salts may be present in amounts within the range of from 0.01–5% by weight, more preferably from 0.1–1% of zinc salt weight, based on the total weight of the composition.” Mello ¶ 37 (emphasis added). Thus, Mello suggests using zinc salts in its composition at a concentration as low as 0.01% by weight, which is one-tenth the lowest concentration cited by the Examiner. According to the Examiner’s calculations (which Appellant does not dispute), 0.01% by weight corresponds to 0.171 mM zinc citrate and 1.2 mM zinc oxide. Thus, although the Examiner used the wrong data, she correctly concluded that Mello discloses ranges for zinc citrate and zinc oxide that overlap the ranges recited in claim 15 (5 μM to 1.2 mM for zinc citrate and 12 μM to 6 mM for zinc oxide). Appellant argues that “[a] method claim reciting ‘in need thereof’ language (as in this case) should be properly construed, such that the method is practiced on a particular patient population with the intent to reduce the particular disorder or symptom recited in the claim.” Appeal Br. 3. Appellant argues that the “claims are directed to treatment of soft oral tissue, Appeal 2021-000973 Application 15/100,990 5 specifically gingival epithelial cells, not to treatment of plaque as asserted by the Examiner” and, “while the Examiner argues that all people have plaque in their oral cavity, that does not mean that all people are in need of a treatment as claimed.” Id. at 4. Appellant also argues that “Mello does not at all disclose periodontitis” and “[p]eople suffering from [gingivitis or periodontitis] are not people who would be considered to be part of a ‘broad patient population’ or people who have ‘a little plaque.’” Id. at 5 (quoting Final Action 4). We are not persuaded by this argument. Claim 15 is not directed to a method of treating gingivitis or periodontitis; it is directed to a “method for inhibiting the adherence to or invasion of oral soft tissue epithelial cells by a periodontal pathogen in a patient in need thereof, . . . wherein the periodontal pathogen causes, transmits or exacerbates a periodontal disease selected from gingivitis and periodontitis.” Claim 15. Thus, the claimed method encompasses treating a healthy patient to inhibit adherence to or invasion of the oral epithelium by bacteria that cause gingivitis or periodontitis, thereby preventing the development of those conditions. This interpretation of the claim language is consistent with Appellant’s Specification, which states that “zinc ions can enhance the epithelial barrier function of oral soft tissues epithelial cells, . . . and thus protect oral tissues from periodontal pathogen infection.” Spec. ¶ 30 (emphasis added). The Specification also states that “[b]y inhibiting pathogenic organisms from adhering to or invading the epithelial cells in the oral cavity, oral care benefits can be obtained. These benefits can include for example a reduction Appeal 2021-000973 Application 15/100,990 6 in the occurrence . . . of periodontal diseases such as gingivitis and periodontitis.” Id. (emphasis added). The broadest reasonable interpretation of claim 15, in light of the Specification’s statements that zinc ions protect oral tissues from infection and result in a reduction in the occurrence of periodontal diseases, encompasses treating a healthy patient in order to prevent the occurrence of gingivitis or periodontitis. Mello discloses using its composition for “reducing or inhibiting gingivitis.” Mello ¶¶ 12, 67. Thus, like Appellant’s Specification, Mello describes its composition as useful in reducing the occurrence of gingivitis. Similarly, both Appellant’s Specification and Mello state that the compositions can be formulated as mouth rinses. Spec. ¶ 53; Mello ¶ 43. Appellant also argues that General Foods Corp. v. Studiengesellschaft Kohle mbH, 972 F.2d 1272 (Fed. Cir. 1992), supports its position. Appeal Br. 5. We disagree. General Foods addressed the issue of whether claims to a method of decaffeinating coffee, using supercritical carbon dioxide as a solvent, were invalid for obviousness-type double patenting based on claims to a method of recovering caffeine from the caffeine-containing solvent. General Foods, 972 F.2d at 1276. The court found that the claims of the patent in suit “define a process of decaffeinating raw coffee with supercritical water-moist carbon dioxide and recovering the decaffeinated coffee. They say nothing about what happens to the caffeine.” Id. at 1277–78. Claim 1 of the other patent, “relied on to show double patenting, defines a 9-step process of ‘obtaining caffein Appeal 2021-000973 Application 15/100,990 7 from green coffee.’ Anything less than a process with all 9 steps is not what is claimed, and is, therefore, not patented.” Id. at 1278. The court held that “[t]hese two inventions, decaffeination of coffee and recovery of caffeine, are separate, patentably distinct inventions between which there cannot be double patenting.” Id. In contrast to General Foods, Appellant’s claimed invention administers the same zinc-containing composition in the same way (to the oral epithelium) in the same patients (healthy people) for the same purpose (reduction in the occurrence of gingivitis) as is suggested by Mello. General Foods therefore does not support a conclusion of nonobviousness for Appellant’s claims. “Using the same composition claimed . . . in the same manner claimed . . . naturally results in the same claimed . . . benefits.” Perricone v. Medicis Pharm. Corp., 432 F.3d 1368, 1380 (Fed. Cir. 2005). Finally, Appellant argues that “Mello disclosing that its low amounts may be effective for the use of Mello . . . does not mean that it discloses amounts that would be effective for the same use as the Appellant’s.” Appeal Br. 5. Appellant calculates that the amount of zinc citrate in Mello’s mouthwash II, and the amount of zinc oxide in its mouthwash V, “do not fall within the ranges as recited in claim 15.” Id. at 5–6. Appellant concludes that “[t]he invention of Mello is directed to a different purpose than the invention here, and it is not reasonable to assume that the ranges disclosed by Mello would have a similar effect as the range recited by the instant claims.” Id. at 6. Again, we are not persuaded. As the Examiner pointed out (Ans. 9), Appellant’s calculations are based on Mello’s examples, but Mello’s Appeal 2021-000973 Application 15/100,990 8 teachings are not limited to its examples. “All the disclosures in a reference must be evaluated, including nonpreferred embodiments, and a reference is not limited to the disclosure of specific working examples.” In re Mills, 470 F.2d 649, 651 (CCPA 1972). Although Mello’s exemplary compositions contain zinc citrate or zinc oxide in concentrations that are higher than those recited in claim 15, Mello also suggests that concentrations of zinc salts “from 0.01–5% by weight” will be effective for its purposes, including “reducing or inhibiting gingivitis.” Mello ¶¶ 37, 67. “[A] prior art publication cited by an Examiner is presumptively enabling barring any showing to the contrary by a patent applicant.” In re Antor Media Corp., 689 F.3d 1282, 1288 (Fed. Cir. 2012). Appellant has not shown that Mello is not enabling for what it discloses. CONCLUSION The Examiner’s rejection is affirmed. Because we rely on additional fact-finding, however, we designate the affirmance a new ground of rejection. DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed New Ground 15, 19, 25–27, 44, 45, 48 103 Mello 15, 19, 25–27, 44, 45, 48 15, 19, 25–27, 44, 45, 48 Appeal 2021-000973 Application 15/100,990 9 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; 37 C.F.R. 41.50(b)