Ex Parte Borgman et al

Patent Trial and Appeal BoardJan 9, 2019

14728190 (P.T.A.B. Jan. 9, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 14/728,190 06/02/2015 2387 7590 01/11/2019 Olson & Cepuritis, LTD. 20 NORTH WACKER DRIVE 36THFLOOR CHICAGO, IL 60606 FIRST NAMED INVENTOR Robert J. Borgman 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 ATTORNEY DOCKET NO. CONFIRMATION NO. CRTK-111 1169 EXAMINER SULLIVAN, DANIELLE D ART UNIT PAPER NUMBER 1617 NOTIFICATION DATE DELIVERY MODE 01/11/2019 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): docket@olsonip.com firm@olsonip.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte ROBERT J. BORGMAN and JAMES E. JUUL 1 Appeal2017-005121 Application 14/728, 190 Technology Center 1600 Before DONALD E. ADAMS, ERIC B. GRIMES, and RYAN H. FLAX, Administrative Patent Judges. FLAX, Administrative Patent Judge. DECISION ON APPEAL This is a decision under 35 U.S.C. Â§ 134(a) involving claims directed to an aqueous terconazole composition and method of preparing the same. Claims 1-11 are on appeal as rejected under 35 U.S.C. Â§ 103. We have jurisdiction under 35 U.S.C. Â§ 6(b ). We reverse. 1 Appellants identify the Real Party in Interest as "Curatek Pharmaceuticals Holding, Inc." Appeal Br. 1. Herein we reference the Specification of June 2, 2015 ("Spec."); Final Office Action of Dec. 2, 2015 ("Final Action"); Appeal Brief of July 28, 2016 ("Appeal Br."); Examiner's Answer of Dec. 13, 2016 ("Answer"); and Reply Brief of Feb. 13, 2017 ("Reply Br."). Oral argument was heard on Jan. 3, 2019; the transcript of the hearing will be made a part of the record on appeal. Appeal2017-005121 Application 14/728, 190 STATEMENT OF THE CASE Independent claim 1 is representative and is reproduced below: 1. An aqueous terconazole composition comprising at least about 0.4 percent by weight of terconazole dissolved in water containing at least 35 mole percent of citric acid based on the number of moles of terconazole present in the composition; the composition being free from terconazole crystals at an ambient temperature of about 20Â° C or greater. Appeal Br. 12 (Claims Appendix). The following rejection is considered on appeal: Claims 1-11 stand rejected under 35 U.S.C. Â§ I03(a) over Ahmad2 and Golding. 3 Final Action 3. DISCUSSION "[T]he examiner bears the initial burden, on review of the prior art or on any other ground, of presenting aprimafacie case ofunpatentability. If that burden is met, the burden of coming forward with evidence or argument shifts to the applicant." In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). "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). However, "rejections on obviousness grounds cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness." Id. at 2 US 2003/0130225 Al (published July 10, 2003) ("Ahmad"). 3 WO 2005/087270 Al (published Sept 22, 2005) ("Golding"). The Examiner has called this reference "Golding," therefore, we follow suit. However, we note that Golding identifies the applicant or agent in this PCT application, not the named inventor(s). 2 Appeal2017-005121 Application 14/728, 190 418 (quoting In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006)). Always, but "[ e ]ven 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 re Kotzab, 217 F.3d 1365, 1370 (Fed. Cir. 2000). The "mere fact that the prior art may be modified in the manner suggested by the Examiner does not make the modification obvious unless the prior art suggested the desirability of the modification." In re Fritch, 972 F.2d 1260, 1266 (Fed. Cir. 1992). The Examiner determined claims 1-11 would have been obvious over the combination of Ahmad and Golding, where Ahmad was determined to teach the majority of the claim limitations ( e.g., an aqueous gel solution with at least 0.4 wt.% of the antifungal agent terconazole and an acid to adjust pH and enhance solubility of the active agent) and Golding was combined with Ahmad for its teaching of using citric acid as a pH adjuster. See Final Action 3---6 and Answer 2-3. For the recited claim element requiring citric acid to be provided in an amount of "at least 35 mole percent ... based on the number of moles of terconazole present in the composition," the Examiner relied on the skilled artisan's motivation to adjust the amount of citric acid to increase the molar concentration thereof to form a gel or foam formulation, which would require complete dissolution of terconazole and, hence (so it appears to be argued by the Examiner), more citric acid than expressly disclosed by Golding. Final Action 5. Appellants present several arguments, including that "[ t ]here is no reason, and the Examiner has failed to provide any, why one of ordinary skill would have adjusted in Example 4 [ of Golding as applied to Ahmad] 3 Appeal2017-005121 Application 14/728, 190 the amount of citric acid upwardly from 16 mole percent to 35 mole percent," as claimed. Appeal Br. 7. Appellants contend: Id. One of ordinary skill would have readily recognized that any increase in the mole concentration of citric acid in Example 4 would necessarily reduce the pH of the cream composition to a value below 4 [as formulated in Ahmad]. Thus, even the impermissible combined teachings of Ahmad et al. and Golding fail to suggest the claimed invention. Relevant to this argument we note that Ahmad does not require its disclosed gel (aqueous) formulations to have an active agent completely dissolved in solution. Ahmad indicates that this is one choice, but also states that its gel compositions can have the active agent "suspended in the gel vehicle as in the case of miconazole nitrate." Ahmad ,r 40. This calls into question whether the skilled artisan would have been motivated to "optimize" the citric acid amount from what Appellants and the Examiner agree to be disclosed as 16 mole percent in Golding, to the claimed at least 35 mole percent based on the amount of terconazole, as claimed, even were it obvious to substitute Golding's citric acid for Ahmad's lactic acid. If a gel solution was not required and the desired pH would have been obtained using far less acid, why add more? Here, the Examiner's rationale for motivation to make such a modification was that: One of ordinary skill would have been motivated to adjust the amount of acid to least 35 mole percent of citric acid since the examples show terconazole in an amount of 2% with about 16 mole percent of citric acid was a cream formulation [ and because] adjusting the formulation to increase the moles of acid 4 Appeal2017-005121 Application 14/728, 190 would have aided in forming gel and/ or foam formulations which require complete dissolution of the terconazole. Final Action 4--5. This, however, is evidenced to be incorrect based on the prior art relied on by the Examiner. As noted above, Ahmad indicates that its gels may have completely dissolved antifungal compounds, i.e., a solution, or not completely dissolved fungal compounds, i.e., merely suspended. Ahmad ,r 40. So, having completely dissolved terconazole in a formulation of Ahmad would not be required even if a gel was desired. Thus, we find insufficient evidence on the record to support the conclusion that a skilled artisan would have added citric acid to the compositions of Ahmad, based on Golding, and then also modified the amount of citric acid to be the claimed mole percentage thereof. Therefore, we find the Examiner has not established a prima facie case for obviousness. SUMMARY The obviousness rejection is reversed. REVERSED 5