11519326 (B.P.A.I. Jan. 23, 2012)

Ex Parte Borgman et al

Board of Patent Appeals and InterferencesJan 23, 2012

11519326 (B.P.A.I. Jan. 23, 2012)

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. 11/519,326 09/12/2006 Robert J. Borgman CRTK-106 6477 2387 7590 01/23/2012 Olson & Cepuritis, LTD. 20 NORTH WACKER DRIVE 36TH FLOOR CHICAGO, IL 60606 EXAMINER SULLIVAN, DANIELLE D ART UNIT PAPER NUMBER 1617 MAIL DATE DELIVERY MODE 01/23/2012 PAPER 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. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES __________ Ex parte ROBERT J. BORGMAN and JAMES E. JUUL __________ Appeal 2010-010650 Application 11/519,326 Technology Center 1600 __________ Before TONI R. SCHEINER, ERIC GRIMES, and STEPHEN WALSH, Administrative Patent Judges. GRIMES, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims related to nitroimidazole compositions, which the Examiner has rejected as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. STATEMENT OF THE CASE The Specification discloses that the nitroimidazoles metronidazole and tinidazole are antimicrobial agents with limited solubility in water (Spec. 1: 9-11, 19-29). “[C]ompositions containing metronidazole at Appeal 2010-010650 Application 11/519,326 2 concentrations of about 1 percent by weight or greater, generally include insoluble metronidazole crystals or must include organic co-solvents, cyclodextrins or water-soluble vitamins to aid in the solubilization” (id. at 1: 22-25). The Specification discloses that organic acids, including polybasic acids, aid in the solubilization of metronidazole and tinidazole (see id. at 3: 21 to 4: 7). Claims 1, 3-6, 8-23, and 25-30 are on appeal. Claim 1 is representative and reads as follows: 1. An aqueous nitroimidazole composition comprising a nitroimidazole selected from the group consisting of metronidazole, tinidazole, and a combination thereof, the composition including at least 1 percent by weight metronidazole and a metronidazole crystallization- inhibiting amount of at least one organic acid which is an organic polybasic acid, the composition being free from organic co-solvents, water-soluble vitamins, and cyclodextrins; and free from metronidazole crystals at an ambient temperature of about 20ºC. Claims 17 and 23, the only other independent claims, also require a “metronidazole crystallization-inhibiting amount” (claim 17) or a “nitroimidazole crystallization-inhibiting amount” (claim 23) of a polybasic organic acid. The Specification states that the “concentration of organic acid in the solution preferably is in the range of about 50 to about 150 mole percent based on the molar amount of metronidazole in the composition” (Spec. 6: 4-6). The Examiner has rejected all of the claims on appeal under 35 U.S.C. § 103(a) as obvious based on Goodman1 and Fawzi2 (Answer 3). The 1 Goodman et al., US 6,348,203 B1, Feb. 19, 2002 Appeal 2010-010650 Application 11/519,326 3 Examiner finds that Goodman exemplifies a composition comprising 0.75% metronidazole and (polybasic) citric acid (id. at 4) but Goodman’s composition does not have at least about 1% metronidazole or a crystallization-inhibiting amount of citric acid (id.). The Examiner finds that Fawzi discloses compositions comprising up to 5% metronidazole or tinidazole “in admixture with mono or di-hydroxy- benzoic acid (page 1, lines 16-18, 29-34). The amount of acid depends on identity and final concentration required (page 1, lines 71-76). . . . Example 18 teaches a ratio of acid and nitroimidazole of 1:1.” (Answer 5.) The Examiner concludes that it would have been obvious to increase the concentration of metronidazole in Goodman’s composition to at least 1% based on Fawzi’s disclosure of compositions having 5% metronidazole (id.). The Examiner also concludes that: It would have been obvious to one of ordinary skill in the art at the time of the invention to utilize the teachings of Goodman et al. and Fawzi et al. to further include the amount of polybasic acid and metronidazole in a 1:1 ratio. One would have been motivated to manipulate ranges during routine experimentation to discover the optimum or workable range. Therefore, one would have been motivated to adjust the amount of polybasic acid, relative to the nitroimidazole to 1:1 because Fawzi et al. teaches in Example 18 a ratio of acid to nitroimidazole of 1:1 and also discloses that acid may be added to neutralize the solution to give a pH in a physiological range. (Id. at 6.) Appellants argue that Goodman’s composition contains citric acid only as a buffering agent, in combination with sodium citrate (Reply Br. 3), 2 Fawzi, GB 2 000 025 A, Jan. 4, 1979 Appeal 2010-010650 Application 11/519,326 4 and Fawzi’s teaching of mono- or di-hydroxybenzoic acid “has nothing to do with polybasic organic acids” (id.). Appellants argue that the “use of hydroxy-substituted benzoic acids by Fawzi could not have led one of ordinary skill to polybasic organic acids in any event” (id.). We agree with Appellants that the Examiner has not shown that the cited references would have made obvious the claimed compositions and methods. As Appellants point out, Goodman’s composition includes citric acid only as a buffering agent to adjust the pH (see Goodman, col. 4, ll. 25- 42). Fawzi discloses that a mono- or di-hydroxy benzoic acid improves the solubility of nitroimidazoles in aqueous media (see Fawzi 1: 5-33). Fawzi discloses that the “amount of hydroxybenzoic acid . . . required depends on the identity and final concentration required of the nitroimidazole used, as well as on the nature of the particular hydroxybenzoic acid” (id. at 1: 71-75, emphasis added). The Examiner has pointed to nothing in the cited references that would lead a person of ordinary skill in the art to expect that the citric acid used by Goodman, as a component of a buffering system, would increase the solubility of nitroimidazoles, as Fawzi teaches is true of hydroxybenzoic acids. Nor has the Examiner provided a reasoned explanation to show that the knowledge of those skilled in the art would have provided such an expectation. Thus, the Examiner has not provided an adequate basis, in evidence or in sound technical reasoning, to conclude that a person of ordinary skill in the art would have considered it obvious to apply Fawzi’s teachings, which relate to hydroxybenzoic acids, to polybasic organic acids, as required by the claims. Appeal 2010-010650 Application 11/519,326 5 SUMMARY We reverse the rejection of claims 1, 3-6, 8-23, and 25-30 under 35 U.S.C. § 103(a) as obvious based on Goodman and Fawzi. REVERSED lp