Ex Parte Muller et alDownload PDFBoard of Patent Appeals and InterferencesMar 29, 201110856192 (B.P.A.I. Mar. 29, 2011) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES __________ Ex parte CHRISTOPHER A. MULLER, JANET K. CHEETHAM, TERESA H. KUAN, and DAVID F. POWER __________ Appeal 2011-001915 Application 10/856,192 Technology Center 1600 __________ Before DEMETRA J. MILLS, ERIC GRIMES, and LORA M. GREEN, Administrative Patent Judges. GREEN, Administrative Patent Judge. DECISION ON APPEAL This is a decision on appeal under 35 U.S.C. § 134 from the Examiner’s rejection of claims 1-16. We have jurisdiction under 35 U.S.C. § 6(b). STATEMENT OF THE CASE Claims 1 and 2 are representative of the claims on appeal, and read as follows: 1. An aqueous topical ophthalmic composition comprising from 0.35% to 0.45% ketorolac tromethamine. Appeal 2011-001915 Application 10/856,192 2 2. The aqueous topical ophthalmic composition of claim 1 comprising 0.4% ketorolac tromethamine. In addition, each of claims 4-6 and 9-16 are drawn to compositions and methods requiring 0.4% ketorolac tromethamine. The following ground of rejection is before us for review: Claims 1-16 stand rejected under 35 U.S.C. § 103(a) as being rendered obvious by Fu.1 We affirm as to claims 1, 3, 7, and 8, but reverse as to claims 2, 4-6, and 9-16. ISSUE Have Appellants presented evidence of unexpected results, that when weighed with the evidence of obviousness, is sufficient to demonstrate the unobviousness of a 0.4% ketorolac composition? FINDINGS OF FACT FF The Examiner’s statement of the rejection may be found at pages 3-4 of the Answer. We adopt the Examiner’s findings of fact and conclusion regarding the prima facie case of obviousness as our own. PRINCIPLES OF LAW One way for a patent applicant to rebut a prima facie case of obviousness is to make a showing of “unexpected results,” i.e., to show that the claimed invention exhibits some superior property or advantage that a person of ordinary skill in the relevant art would have found surprising or unexpected. The 1 Fu et al., US 5,414,011, issued May 9, 1995. Appeal 2011-001915 Application 10/856,192 3 basic principle behind this rule is straightforward-that which would have been surprising to a person of ordinary skill in a particular art would not have been obvious. In re Soni, 54 F.3d 746, 750 (Fed. Cir.1997). “When prima facie obviousness is established and evidence is submitted in rebuttal, the decision-maker must start over.” In re Rinehart, 531 F.2d 1048, 1052 (CCPA 1976); In re Hedges, 783 F.2d 1038, 1039 (Fed. Cir. 1986) (“If a prima facie case is made in the first instance, and if the applicant comes forward with reasonable rebuttal, whether buttressed by experiment, prior art references, or argument, the entire merits of the matter are to be reweighed”). In addition, “when unexpected results are used as evidence of nonobviousness, the results must be shown to be unexpected compared with the closest prior art.” In re Baxter-Travenol Labs., 952 F.2d 388, 392 (Fed. Cir. 1991). A showing of unexpected results must also be commensurate in scope with the breadth of the claims. In re Grasselli, 713 F.2d 731, 743 (Fed. Cir. 1983). ANALYSIS Appellants do not argue the prima facie case, but assert that “a 0.4% ketorolac composition provides unexpected results . . . over the 0.5%, 0.25% and 0.10% w/v ketorolac formulations as taught in Fu” (App. Br. 3). As Appellants do not argue the broader claims, of which claim 1 is representative, we conclude that the Examiner has set forth a prima facie case of obviousness as to those claims, which has not been rebutted, and thus affirm the rejection of those claims, that is, claims 1, 3, 7, and 8. Appeal 2011-001915 Application 10/856,192 4 As to the 0.4 % ketorolac composition, Appellants cite the Sandoval paper to demonstrate that the 0.4% solution is just as effective as the 0.5% solution, but has significantly less side effects (id. at 4). With respect to the 0.25% and 0.1% ketorolac compositions taught by Fu, Appellants cite the Declaration of Mayssa Attar (Attar Declaration), attached to the Appeal Brief as Exhibit B. The Declaration states that based on their pharmacokinetic data and mathematical models using that data, a 0.1% ketorolac composition would have to be administered 15 times a day, and a 0.25% ketorolac composition would have to be administered 7 times a day, to provide an equivalent amount of ketorolac as the 0.4% ketorolac composition provides when administered 4 times a day (Attar Declaration, ¶¶5-7; see also App. Br. 4-5). In response to the above data, the Examiner concludes that it would have been well within the level of skill of the ordinary artisan to administer a higher concentration of an active agent less frequently. The Examiner also asserts that the “data are not commensurate in scope with the claimed language. Such data are done at one concentration, however the independent claims are not limited to one concentration” (Ans. 5). The Examiner’s response, however, does not address why the ordinary artisan would have expected the lower concentration compositions taught by Fu have to be administered more frequently than would be suggested by just the difference in concentrations. That is, why a 0.25% ketorolac composition would have to be administered 7 times a day to deliver the same amount of active as a 0.4% ketorolac composition, and why a 0.1% ketorolac composition would have to be administered 15 times a day Appeal 2011-001915 Application 10/856,192 5 to deliver the same amount of active as a 0.4% ketorolac composition administered 4 times a day. The Examiner also does not address the statements in the declaration that that administration 7 or 15 times a day would not be acceptable for treating ocular inflammation in a patient (see (Attar Declaration, ¶¶10, 12). Moreover, the Examiner did not address the evidence in the Sandoval paper, or provide any evidence or persuasive reason to expect a 0.4% ketorolac composition to provide the same effectiveness, but fewer side effects, compared to a 0.5% solution. As to the Examiner’s statement that the claims are not commensurate in scope, claims 2, 4-6, and 9-16 are limited to a 0.4% ketorolac composition. CONCLUSION OF LAW We conclude that Appellants have presented evidence of unexpected results, that when weighed with the evidence of obviousness, is sufficient to demonstrate the unobviousness of a 0.4% ketorolac composition. Thus, as to the rejection of claims 1-16 under 35 U.S.C. § 103(a) as being rendered obvious by Fu, we affirm the rejection as to claims 1, 3, 7, and 8, but reverse as to claims 2, 4-6, and 9-16. Appeal 2011-001915 Application 10/856,192 6 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-IN-PART alw Copy with citationCopy as parenthetical citation