Ex Parte Bryson

Patent Trial and Appeal BoardAug 15, 2013

11699809 (P.T.A.B. Aug. 15, 2013)

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. 11/699,809 01/30/2007 Israel ben David Bryson 56959-338294 7696 13778 7590 08/15/2013 Leak & Schroeder, PLLC 301 N. Main Street Suite 2405 Winston-Salem, NC 27101 EXAMINER THOMAS, TIMOTHY P ART UNIT PAPER NUMBER 1628 MAIL DATE DELIVERY MODE 08/15/2013 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 ISRAEL BEN DAVID BRYSON __________ Appeal 2012-000131 Application 11/699,809 Technology Center 1600 __________ Before DEMETRA J. MILLS, JOHN A. EVANS, and ULRIKE W. JENKS, Administrative Patent Judges. MILLS, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134. The Examiner has rejected the claims for obviousness. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. Appeal 2012-000131 Application 11/699,809 2 STATEMENT OF CASE The current standard of therapy for treating cardiovascular and other patient classes is to continue to increase one statin dose to the maximal recommended dose in order to further reduce LDL cholesterol levels. However, this increase in dosage has led to LDL cholesterol decreases that are small (6 to maybe 10% maximal). Moreover, when taking higher doses of the statins, the side effect rates easily double (varies per statin and patient). The inventor of the present invention believes that no one has made compositions comprising one or more statins from two different groups, 1) one or more lipophilic statins and 2) one or more hydrophilic statins. (Spec. 3.) The following claim is representative. 1. A cholesterol lowering composition comprising one or more lipophilic statins and one or more hydrophilic statins wherein the composition lowers LDL cholesterol level to about or less than 100 mg/dL. Cited References Black WO 00/18395 Apr. 06, 2000 Grounds of Rejection Claims 1, 3-5, 7, 21-23, and 28-33 are rejected under 35 U.S.C. § 103(a) as being unpatentable over Black. FINDINGS OF FACT The Examiner’s findings of fact are set forth in the Answer at pages 4- 8. Appeal 2012-000131 Application 11/699,809 3 Discussion It is noted that the elected subject matter, under examination, was drawn to the elected combination of atorvastatin and fluvastatin, i.e., the subject matter recited in claim 32. (Ans. 4.) When the examiner has required the applicant to elect single chemical species for examination, the issue on appeal is the patentability of the single elected species. It is appropriate to limit discussion to that single issue and take no position respecting the patentability of the broader generic claims, including the remaining, non-elected species. See Ex parte Ohsaka, 2 USPQ2d 1461 (BPAI 1987). ISSUE The Examiner concludes that It would have been obvious to one of ordinary skill in the art at the time of the invention to prepare a composition containing the two statins, atorvastatin and fluvastatin for administration in the method of treating patients with coronary artery disease for aggressive LDL cholesterol reduction. The motivation to combine the two statin drugs would have been the art-recognized equivalent activity of both ingredients in aggressive LDL cholesterol reduction. The disease risk reduction/reversal properties recited in claims 28-29 would have been an inherent property of a composition with the elected drugs included at dosage levels for aggressive LDL cholesterol reduction. (Ans. 5.) Appellant argues that Black does not distinguish between lipophilic and hydrophilic statins. (App. Br. 8.) Appellant argues that the Examiner has not presented a prima facie case of obviousness because Black does not Appeal 2012-000131 Application 11/699,809 4 disclose a composition comprising a combination of any statins, let alone a combination of one or more lipophilic statins and one or more hydrophilic statins wherein the composition lowers LDL cholesterol level to about or less than 100 mg/dL as is claimed in claim 1. (App. Br. 4.) In addition, Appellant argues that their Declaration evidence is secondary consideration evidence of non-obviousness. The issue is: Does the Examiner’s cited prior art support the Examiner’s conclusion that the claimed subject matter is prima facie obvious? PRINCIPLES OF LAW “In rejecting claims under 35 U.S.C. § 103, the examiner bears the initial burden of presenting a prima facie case of obviousness. Only if that burden is met, does the burden of coming forward with evidence or argument shift to the applicant.” In re Rijckaert, 9 F.3d 1531, 1532 (Fed. Cir. 1993) (citations omitted). In order to determine whether a prima facie case of obviousness has been established, we consider the factors set forth in Graham v. John Deere Co., 383 U.S. 1, 17 (1966): (1) the scope and content of the prior art; (2) the differences between the prior art and the claims at issue; (3) the level of ordinary skill in the relevant art; and (4) objective evidence of nonobviousness, if present. ANALYSIS We do not find that the Examiner has provided evidence to support a prima facie case of obviousness. The Examiner argues that Appeal 2012-000131 Application 11/699,809 5 It would have been obvious to one of ordinary skill in the art at the time of the invention to prepare a composition containing the two statins, atorvastatin and fluvastatin for administration in the method of treating patients with coronary artery disease for aggressive LDL cholesterol reduction. The motivation to combine the two statin drugs would have been the art-recognized equivalent activity of both ingredients in aggressive LDL cholesterol reduction. (Ans. 5.) In support of this reasoning, the Examiner cites MPEP § 2144.06 I as follows: It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose .... [T]he idea of combining them flows logically from their having been individually taught in the prior art. In re Kerkhoven, 626 F.2d 846,850,205 USPQ 1069, 1072 (CCPA 1980) (citations omitted). (Ans. 5-6.) While we would have been persuaded under a Kerkoven analysis if the claims were directed to a combination of any two statin drugs, we find that the claims before us are more than just a mere combination of two known statin drugs. The claims and the specification before us require a particular selection and preference of a lipophilic statin and a hydrophilic statin, from which atorvastatin and fluvastatin have been elected. We find no suggestion in Black to make or limit the particular selection from the listed statins (Black, page 4, ll. 24-30), to a lipophilic statin in combination with a hydrophilic statin. In other words, we find that the claims require a specific preference or selection of a combination statins be made, which is Appeal 2012-000131 Application 11/699,809 6 not provided by Black. Thus we do not find that Black alone1 supports a prima facie case of obviousness and the obviousness rejection is reversed. We do not reach Appellant’s evidence of secondary considerations, as no prima facie case has been presented. CONCLUSION OF LAW The cited references do not support the Examiner’s obviousness rejection with respect to the elected species. We take no position respecting the patentability of the broader generic claims, including the remaining, non- elected species. See Ex parte Ohsaka, 2 USPQ2d 1461 (Bd. Pat. App. Int. 1987). REVERSED dm 1 See also, Vasilos Athyros, Atorvastatin Plus Pravastatin for the treatment of Heterozygous Familial Hypercholesterolaemia – A Pilot Study, 17 CURRENT MEDICAL RESEARCH AND OPINION 267-272 (2001) of record.