Gerhard Schmaus et al.

Patent Trials and Appeals BoardMar 3, 2021

2020003181 (P.T.A.B. Mar. 3, 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. 12/598,703 04/10/2010 Gerhard Schmaus 1507-22 2667 28249 7590 03/03/2021 DILWORTH & BARRESE, LLP Dilworth & Barrese, LLP 1000 WOODBURY ROAD SUITE 405 WOODBURY, NY 11797 EXAMINER BASQUILL, SEAN M ART UNIT PAPER NUMBER 1613 NOTIFICATION DATE DELIVERY MODE 03/03/2021 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): usptomail@dilworthbarrese.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte GERHARD SCHMAUS and RAVIKUMAR PILLAI ____________ Appeal 2020-003181 Application 12/598,703 Technology Center 1600 ____________ Before DONALD E. ADAMS, ULRIKE W. JENKS, and TIMOTHY G. MAJORS, Administrative Patent Judges. MAJORS, Administrative Patent Judge. DECISION ON APPEAL Appellant1 submits this appeal2 under 35 U.S.C. § 134(a) involving claims to an antimicrobial composition that includes 1,2-decanediol and at least one additional antimicrobial compound, which claims have been rejected for obviousness under 35 U.S.C. § 103. We have jurisdiction under 35 U.S.C. § 6. We AFFIRM. 1 “Appellant” refers to “applicant” as defined in 37 C.F.R. § 1.42(a). Appellant identifies Symrise AG as the real party-in-interest. Appeal Br. 4. 2 Appellant identifies as related our decision in Ex parte Schmaus, Appeal 2016-000057 (PTAB Jan. 20, 2017). Appeal Br. 5. Appeal 2020-003181 Application 12/598,703 2 STATEMENT OF THE CASE According to the Specification, “[t]he present invention relates to specific synergistic antimicrobial (cosmetic or pharmaceutical) preparations comprising a mixture comprising or consisting of . . . an antimicrobial active amount of 1,2-decanediol” and at least one further antimicrobial compound, such as ethanol, propan-2-ol [i.e., isopropyl alcohol] or benzalkonium chloride. Spec. 1:12–22. The Specification notes that in cosmetics, pharmaceuticals, and household-products, “there is an increasing demand for antimicrobial agents especially for hygiene products like antimicrobial liquid or solid soaps . . . for the treatment of hands and/or for the treatment of technical [e.g., surgical equipment] surfaces.” Id. at 1:23–2:3. Claims 17, 18, 23–28, and 30–34 are on appeal. Claim 17 is illustrative: 17. A composition consisting of: (a) an antimicrobial active amount of 1,2-decanediol of formula 1: and (b) an antimicrobial active amount of one or more compounds selected from the group consisting of propan-1-ol, propan-2-ol, benzethonium chloride, methylbenzethonium chloride and benzalkonium chloride. Appeal Br. 17 (Claims App.). Appeal 2020-003181 Application 12/598,703 3 Appellant seeks review of the Examiner’s rejection of claims 17, 18, 23–28, and 30–34 under 35 U.S.C. § 103 as obvious over Schmaus I3 and Schmaus II.4 Appeal Br. 12–16; Final Act.5 3–7; Ans. 3–7. Appellant’s arguments are addressed to the rejected claims as a group. Appeal Br. 12– 16. Accordingly, we focus our analysis below on claim 17, and the other claims stand or fall with claim 17. See 37 C.F.R. § 41.37(c)(iv). ANALYSIS An examiner “bears the initial burden . . . of presenting a prima facie case of unpatentability.” In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). If met, “the burden of coming forward with evidence or argument shifts to the applicant.” Id. And, if an applicant relies on unexpected results (e.g., unexpected synergy) in response to the examiner’s prima facie case, “it is well settled that unexpected results must be established by factual evidence. ‘Mere [attorney] argument or conclusory statements in the specification does not suffice.’” In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997) (quoting In re De Blauwe, 736 F.2d 699, 705 (Fed. Cir. 1984)). Ultimately, patentability of the claims is “determined on the totality of the record by a preponderance of the evidence.” Oetiker, 977 F.2d at 1445. Considering the record on appeal, we conclude the preponderance of the evidence supports the Examiner’s rejection for obviousness. Applicant provides insufficient persuasive argument or evidence that outweighs the evidence of obviousness cited by the Examiner. We explain below. 3 Schmaus et al., US 2003/0195263 A1, publ. Oct. 16, 2003. 4 Schmaus et al., US 2005/0222276 A1, publ. Oct. 6, 2005. 5 This citation refers to the Examiner’s Final Rejection dated May 13, 2019, and the substance of the rejection of the claims is also repeated in the Examiner’s Answer (“Ans.”) on appeal, entered December 12, 2019. Appeal 2020-003181 Application 12/598,703 4 The Examiner determines that claim 17 would have been obvious over Schmaus I, in view of Schmaus II. Final Act. 3–7. As the Examiner notes, claim 17 is “directed to compositions consisting of a combination of both 1,2-decanediol and a second antimicrobial active selected from a Markush- type list of alternatives which include, among others, benzethonium chloride, which is synonymous with hyamine.” Id. at 3. The Examiner finds that Schmaus I describes 1,2-decanediol compositions as useful for antimicrobial applications and inhibiting the growth of germs on skin. Id. at 4 (citing, e.g., Schmaus I, Abstr., ¶¶ 16–18, 23). The Examiner also cites Schmaus I’s teachings that additional active antimicrobial agents may be used in combination with 1,2-decanediol” to provide a “supraadditive antimicrobial effect.” Id. at 4 (citing Schmaus I, ¶¶ 32–35). Because Schmaus I does not expressly identify the additional, secondary antimicrobials that appear in claim 17’s Markush listing, the Examiner turns to Schmaus II. Id. at 5–6. According to the Examiner, Schmaus II discloses antimicrobial compositions that contain combinations of 1,2-alkanediols, such as 1,2- octanediol and 1,2-decanediol. Id. (citing Schmaus II, Abstr., ¶ 12). The Examiner finds that Schmaus II also teaches that, in compositions including the combined alkanediols, further antimicrobial active compounds may be added. Id. (citing Schmaus II, ¶¶ 54–60 (teaching “a further antimicrobial active compound that does not comprise a straight-chain 1,2-alkanediol” may be added)). Indeed, the Examiner finds that Schmaus II identifies hyamine (i.e., benzalkonium chloride) as a further antimicrobial agent for combination with the alkanediols. Id. (citing Schmaus II, ¶ 65 (teaching that one or more preservatives, including hyamine, may advantageously be added to “synergistic mixtures of 1,2-alkanediols”)). Appeal 2020-003181 Application 12/598,703 5 From this, the Examiner concludes it would have been obvious to add Schmaus II’s hyamine as a further antimicrobial agent in a composition of Schmaus I that includes 1,2-decanediol. Id. at 6. The Examiner reasons that the skilled artisan would have had reason to make this combination because Schmaus II evidences that hyamine and 1,2-decanediol are both useful and compatible antimicrobials, and that the skilled artisan would have further expected to see a supra-additive or synergistic effect to using multiple different antimicrobials as suggested in Schmaus I. Id. We agree with and adopt the Examiner’s findings and reasoning. Final Act. 3–7; Ans. 3–7; see also Ans. 7–10 (Resp. to Argument). As noted, Schmaus I teaches that 1,2-decanediol is a preferred and effective antimicrobial for use in topical compositions, such as compositions for use to inhibit bacteria and treat, for example, human skin with minimal irritation. Schmaus I, Abstr., ¶¶ 16–18, 32. Schmaus I further teaches that secondary antimicrobials can be added—“[a]lthough 1,2-decanediol already has an excellent action against the said organisms on its own, it is, of course, not precluded to add a further antimicrobial active compound to control these or other organism.” Id. ¶ 33. Schmaus I also suggests, as explained by the Examiner, that an additive or supra-additive effect may be realized by combining 1,2-decanediol with other antimicrobials. Id.; see Final Act. 4 (“[C]ombined with alternative or additional antimicrobial active agents, the antimicrobial activity of the composition as a whole is increased by at least a factor of 4.”). Schmaus II identifies hyamine as another antimicrobial active, and suggests it is compatible with 1,2-decanediol and other alkanediols in compositions similarly used to control bacteria on human skin. Schmaus II, ¶¶ 60, 65, 68. The idea of adding Schmaus II’s hyamine to Schmaus I’s 1,2-decanediol composition flows logically and obviously Appeal 2020-003181 Application 12/598,703 6 from the substantial overlap and interrelation of both references, and to predictably improve the antimicrobial effect of the resulting composition. “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). Appellant argues that the claimed subject matter provides unexpected results. More specifically, Appellant argues that “surprisingly” a composition of 1,2-decanediol and an antimicrobial active amount of one or more of the compounds recited in claim 17’s Markush limitation (b) “has synergistic disinfecting activity against bacteria.” Appeal Br. 12. Appellant further argues this alleged “synergistic effect” is significant in the relevant industries. Appeal Br. 12–13. We reject this argument for several reasons. First, “we attribute no magic status to synergism per se since it may be expected or unexpected.” In re Huellmantel, 324 F.2d 998, 1003 (CCPA 1963). Examiner provides evidentiary support from the prior art for the finding that a synergistic effect would have been expected when combining the recited antimicrobials. Appellant fails to rebut Examiner’s findings on this point. Quite the opposite, Appellant provides no persuasive evidence to establish what would have been expected, much less to establish that the synergy allegedly observed with the claimed subject matter would, in comparison, have been unexpected and nonobvious. See Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1371 (Fed. Cir. 2007) (holding patent owner’s “evidence must fail because the record is devoid of any evidence of what the skilled artisan would have expected”). Second, it was Appellant’s burden to provide factual evidence that supports the alleged unexpected synergy. Geisler, 116 F.3d at 1470. Appeal 2020-003181 Application 12/598,703 7 Appellant cites “page 34 of the specification” as support. This citation fails for the same reasons it did in Appellant’s prior appeal of four years ago. Ex parte Schmaus, Appeal 2016-000057, slip op. at 5–6. We pointed out then that “page 34 of the Specification . . . provides insufficient objective data supporting synergy,” and that “Appellants have not directed us to any data supporting the assertion of synergy itself (such as, the results of the calculations).” Id. Appellant has still not provided any persuasive data, such as results that show any alleged synergism. The table and accompanying text on pages 34–35 of the Specification identify a list of secondary antimicrobial agents that, when used with 1,2–decanediol, are said to provide “synergistic antimicrobial activity.” Spec. 34–35. But, as correctly pointed out by Examiner, no data is given to back up this vague and conclusory assertion of synergy. Ans. 7–8. Third, even if we gave some credit to the unsubstantiated assertions of synergy, many of the combinations the Specification’s Table 2 (page 35) are outside the scope of the present claims. Appellant has not shown persuasively that any synergy is commensurate with the scope of the claims and not a property also possessed in combinations of antimicrobials taught in the prior art, including prior art asserted here. To illustrate, the first row of the Specification’s Table 2 lists combinations of 1,2-decanediol and ethanol in various weight ratios. Spec. 35. Taking at face value Appellant’s argument that combinations identified on pages 34–35 of the Specification provide “synergistic antimicrobial activity,” that would mean the combinations of ethanol and 1,2-decanediol also provide this synergism. The problem for Appellant is that Schmaus I itself describes cosmetic compositions that contain 1,2-decanediol and ethanol (Final Act. 5; Ans. 5; see, e.g., Schmaus I ¶¶ 67–71 (describing a spray composition with 1% 1,2- Appeal 2020-003181 Application 12/598,703 8 decanediol and 10% ethanol, further diluted in an ethanol/water mixture)). Of course, to be probative of nonobviousness, evidence of unexpected results must be shown compared to the closest prior art, which Appellant has not endeavored to do. In re Baxter Travenol Labs., 952 F.2d 388, 392 (Fed. Cir. 1991) (“[W]hen unexpected results are used as evidence of nonobviousness, the results must be shown to be unexpected compared with the closest prior art.”). And, for the reasons explained above, if Schmaus I were treated as the closest prior art for comparison, the record here, if anything, suggests that such a comparison would not favor Appellant. Appellant also argues that, unexpected synergism aside, the Examiner’s prima facie case still fails. Appeal Br. 13–16. According to Appellant, Schmaus II mandates at least two alkanediols but the claims, by virtue of the “consisting of” transitional phrase in claim 17, allow only one alkanediol—1,2-decanediol. Id. at 14–15. Appellant contends modifying Schmaus II so that only one alkanediol remains would make Schmaus II unsatisfactory for its intended purpose and that “there is no suggestion or motivation to make such proposed modification of Schmaus II.” Id. at 15. This argument fares no better in rebutting the Examiner’s rejection. We agree that Schmaus II discloses and exemplifies compositions with a mixture of two or more 1,2-alkanediols. The Examiner is not, however, proposing that Schmaus II be changed so that any of those alkanediols are removed. As the Examiner highlights, Appellant’s argument advances an “application of the Schmaus II reference utterly absent from the record.” Ans. 10. Rather, the Examiner’s rejection relies on Schmaus II’s teaching that hyamine is a conventional and compatible secondary (non-alkanediol) antimicrobial (which Schmaus I generally teaches may be added to its 1,2- decanediol compositions). Id. at 9. As the Examiner explains, the Appeal 2020-003181 Application 12/598,703 9 expectation of a supra-additive effect of multiple antimicrobials finds evidentiary support in Schmaus I and “[t]he fact that Schmaus II additionally observes antimicrobial synergy by the combination of multiple 1,2 alkanediols is immaterial” to the rejection as actually framed. Id. We generally agree with the Examiner’s response on these points. Ans. 7–10.6 In sum, Appellant’s argument misconstrues the rejection of record and is therefore unpersuasive as a result. For the reasons above, we conclude that the preponderance of the evidence on this record supports the Examiner’s conclusion that claims 17, 18, 23–28, and 30–34 would have been obvious. CONCLUSION In summary: Claim(s) Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 17, 18, 23– 28, 30–34 103 Schmaus I, Schmaus II 17, 18, 23– 28, 30–34 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). AFFIRMED 6 Appellant did not file a Reply Brief in response to the Examiner’s Answer.