10439856 (P.T.A.B. Dec. 19, 2012)

Ex Parte Hong et al

Patent Trial and Appeal BoardDec 19, 2012

10439856 (P.T.A.B. Dec. 19, 2012)

UNITED STATES PATENT AND TRADEMARKOFFICE 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. 10/439,856 05/15/2003 Keelung Hong 056367-1551 8223 88984 7590 12/19/2012 FOLEY & LARDNER LLP 3000 K STREET N.W. SUITE 600 WASHINGTON, DC 20007-5109 EXAMINER KISHORE, GOLLAMUDI S ART UNIT PAPER NUMBER 1612 MAIL DATE DELIVERY MODE 12/19/2012 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 PATENT TRIAL AND APPEAL BOARD __________ Ex parte KEELUNG HONG, WEI-WEN ZHENG, DARYL C. DRUMMOND, DMITRI B. KIRPOTIN, and MARK EAMON HAYES __________ Appeal 2011-001267 Application 10/439,856 Technology Center 1600 __________ Before DONALD E. ADAMS, STEPHEN WALSH, and ULRIKE W. JENKS, Administrative Patent Judges. WALSH, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134(a) from the rejection of claims directed to a process for preparing a microparticulate complex. The Patent Examiner rejected the claims for obviousness. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. Appeal 2011-001267 Application 10/439,856 2 STATEMENT OF THE CASE Claims 135 and 136 are on appeal. Claim 135 is representative and reads as follows: 135. A process for preparing a microparticulate complex of a nucleic acid component and a lipid composition, which process comprises: combining, at a temperature of from 30° to 80°C, the lipid composition, said lipid composition comprising cationic and non-cationic lipids, and the nucleic acid component in an aqueous/organic solvent system consisting essentially of a single liquid phase comprising water and a water- miscible organic solvent in an amount from 40 % to about 55% by volume of said liquid phase to form a mixture wherein the lipid composition and the nucleic acid component are independently molecularly or micellarly soluble in said liquid phase, and wherein said organic solvent is an alcohol and is essentially free from a halogenated hydrocarbon, and the ionic strength of the solvent system is less than that of about 50 mM NaCl whereby a monophasic system is formed,-and reducing the amount of the organic solvent in the monophasic system, whereby the formation of the microparticulate complex of the nucleic acid component and the lipid composition occurs. Claims 135 and 136 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Wheeler et al. (US 5,976,567); and under 35 U.S.C. § 103(a) as unpatentable over Wheeler and Minchey et al. (US 5,415,867). OBVIOUSNESS Appellants contend that the claimed method is distinguished from Wheeler’s by, among other points, that Wheeler “does not disclose the ionic strength of the solvent system let alone an ionic strength of less than 50 mM sodium chloride.” (App. Br. 14.) Neither of the rejections addresses the fact that claim 135 specifies an “aqueous/organic solvent system” and “the ionic strength of the solvent system is less than that of about 50 mM NaCl.” The Appeal 2011-001267 Application 10/439,856 3 Examiner responds that the ionic strength limitation “would read on even distilled water taught by Wheeler in examples.” (Ans. 8.) We find the Examiner’s conclusory response lacks an evidentiary foundation. First, the Examiner did not identify an example taught by Wheeler in which the aqueous/organic solvent system is distilled water, nor did the Examiner explain how it could be possible for distilled water to be an aqueous/organic solvent system. Next, in our review, we find Wheeler’s Examples 1-3 involve adding distilled water to a cefazolin sodium stock solution (Wheeler, cols. 19-21), and Examples 5 and 6 involve adding cephapirin sodium to distilled water (id. at col. 22). It is not evident from those bare facts that Wheeler taught or suggested an aqueous/organic solvent system having an ionic strength less than that of about 50 mM NaCl. “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.” In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006), cited with approval in KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417-18 (2007). For at least the limitation specifying the ionic strength of the solvent system, the rejections under review lack articulated reasoning based on a rational underpinning and are therefore reversed. Appeal 2011-001267 Application 10/439,856 4 SUMMARY We reverse the rejection of claims 135 and 136 under 35 U.S.C. § 103(a) as unpatentable over Wheeler. We reverse the rejection of claims 135 and 136 under 35 U.S.C. § 103(a) as unpatentable over Wheeler and Minchey. REVERSED dm