12295616 (P.T.A.B. Sep. 22, 2016)

Ex Parte Senin et al

Patent Trial and Appeal BoardSep 22, 2016

12295616 (P.T.A.B. Sep. 22, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 12/295,616 09/30/2008 23373 7590 09/26/2016 SUGHRUE MION, PLLC 2100 PENNSYLVANIA A VENUE, N.W. SUITE 800 WASHINGTON, DC 20037 FIRST NAMED INVENTOR Paolo Senin 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. Ql 10371 9113 EXAMINER RAGHU, GANAPATHIRAM ART UNIT PAPER NUMBER 1652 NOTIFICATION DATE DELIVERY MODE 09/26/2016 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): PPROCESSING@SUGHRUE.COM sughrue@sughrue.com USPTO@sughrue.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte PAOLO SENIN, IVO SETNIKAR, and LUIGI ANGELO ROVATI 1 Appeal2015-001485 Application 12/295,616 Technology Center 1600 Before ERIC B. GRIMES, TIMOTHY G. MAJORS, and DEVON ZASTROW NEWMAN, Administrative Patent Judges. NEWMAN, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. Â§ 134 involving claims to a composition for oral administration having a beneficial effect on the cardiovascular system, which have been rejected as obvious and directed to non-statutory subject matter. We have jurisdiction under 35 U.S.C. Â§ 6(b ). We reverse. 1 Appellants identify the Real Party in Interest as ROTTAPHARM S.P.A. App. Br. 2. Appeal2015-001485 Application 12/295,616 STATEMENT OF THE CASE Background The Specification discloses: The present invention relates to a formulation for oral administration, in the form of tablets or of powder for extemporaneous use, which is able to exert a beneficial effect on the cardiovascular system, owing to a combination of activities such as eulipidaemic, cholesterol-lowering and triglyceride-lowering, antioxidant and protective of the vasal endothelium and others connected with these directly or indirect! y. Spec. 1: 1-5. The Claims Claims 1-14 and 1 7-21 are on appeal. Claim 1 is illustrative and reads as follows: 1. A composition for oral administration having a beneficial effect on the cardiovascular system, comprising as active principles policosanol, red yeast and astaxanthin, characterized in that it further comprises berberine or an extract containing berberine. App. Br. 19. 2 Appeal2015-001485 Application 12/295,616 The following rejections are before us to review: A. Claims 1, 3-9, 11-14, and 17-21 are rejected under 35 U.S.C. Â§ 103(a) as being unpatentable over Setnikar,2 Gouni-Berthold,3 and Jiang. 4 Ans. 2. B. Claims 1-12 and 17-21 are rejected under 35 U.S.C. Â§ 101 as directed to patent ineligible subject matter. Ans. 12. OBVIOUSNESS The Examiner finds that Setnikar discloses the "additive or potentiated effects and cardiovascular benefit of a composition comprising active principles policosanol, red yeast rice extract[] fermented with Monascus purpureus and astaxanthin," along with "patho-physiology of cardiovascular disease," "mode of action" and dosage of the principle components. Ans. 3. The Examiner also finds that Setnikar discloses "treatment regimen assays related to determining the efficacy of administered composition including statistical analysis of assay results" and a "teaching, suggestion and motivation for combining different active principles having different modes of action and their cardiovascular benefit in lowering serum cholesterol (TC) and low-density lipoprotein cholesterol (LDL)." Id. at 3. The Examiner cites Gouni-Berthold for the teaching of the therapeutic benefit of policosanol as a lipid-lowering agent and dosages for 2 Ivo Setnikar et al., Antiatherosclerotic Efficacy of Policosanol, Red Yeast Rice Extract and Astaxanthin in the Rabbit, 55 DRUG RES. (6) 312-17 (2005). 3 Ionanna Gouni-Berthold et al., Policosanol: Clinical pharmacology and therapeutic significance of a new lipid-lowering agent, 142 AM. HEART J., (2) 356-365 (2002). 4 Jiang et al., WO 2006/029577 Al, published Mar. 23, 2006. 3 Appeal2015-001485 Application 12/295,616 such use as well as evidence that "policosanol potentiates the antithrombotic effects of other drugs such as fibrate and aspirin." Id. at 4. The Examiner notes neither reference teaches the claimed composition further comprising berberine but cites Jiang for its disclosure of methods and compositions comprising berberine, red yeast rice extract, and other compounds useful in treating hyperlipidemia and providing cardiovascular benefits. Id. The Examiner concludes that it would have been obvious to a person of ordinary skill in the art to modify the teachings of Setnikar and Gouni-Berthold to add berberine and other beneficial compounds as taught by Jiang. Id. at 5. We agree with the Examiner that, based on the cited references, it would have been prima facie obvious to make a composition for the purpose of combining the beneficial cardiovascular effects of policosanol, red yeast, astaxanthin, and berberine or a berberine related or derivative compound. The primary references disclose use of policosanol, red yeast, and/or astaxanthin for the purpose of treating cardiovascular disease models and/or hyperlipidemia (Setnikar Abstract, p. 313, i-fi-12-3, col. 2; Gouni-Berthold Abstract, pp. 358-360). Setnikar teaches the additive or potentiated effects realized by combining these compounds. Setnikar p. 317, i13. Jiang discloses compositions containing a berberine compound for the prevention and treatment of hyperlipidemia, elevated cholesterol and/or cardiovascular disease in mammals. Jiang Abstract, i-fi-123, 123-125. Thus, it would have been obvious to add berberine to policosanol, red yeast, and astaxanthin to achieve cardiovascular benefits in addition to those demonstrated in Setnikar. Appellants argue, however, that the Declaration of Ivo Setnikar ("Setnikar Dec.") "has established that unexpectedly superior results are 4 Appeal2015-001485 Application 12/295,616 obtained by the claimed formulation" and thereby rebut the Examiner's prima facie case. App. Br. 7. We agree with Appellants that the Specification provides evidence that the composition provided synergistic effects to recipients that were significantly greater than would have been expected from adding the known effects of the respective individual compounds, and the Examiner has not provided an adequate basis to show that the increased effect would have been expected. Tables 1 and 2 of the Setnikar Dec. are reproduced below: TABLE 1 â€¢ % rt~ductfr:m blo~.~ uanuncfors (witJ1 .. te,;,pect to Ath,feed} ~ h::~;~~~~Â·::::hiB1'.~~Â·~~~:b~~~~~~~Â·::k1~~~\::::1 e'): Slgnificam \vifh re~pect to Ath.feefl'X~t to Berb, WO mid i\.:>:>. (cf TABLE 2) Setnikar Dec. i-f 14. Table 1 shows the percentage reduction in blood levels of cholesterol (CT), low density lipoproteins (LDL) and triclycerides (TG) induced by the claimed composition (COMB), and of the same principal components taken individually (identified as ASS, Berb 30 and Berb 100) on rabbits that were rendered hypercholesterolemic and hypertriglyceridaemic prior to testing (ASS is "a composition for oral administration based on policosanol, red yeast (RY) and an antioxidant selected from astaxanthin and folic acid" Spec. 3: 15-17). Setnikar Dec. i-f 13. 5 Appeal2015-001485 Application 12/295,616 TAHLE 2 ~ Almllute blood levels r--(:f;~;;~-;~o!)iYT-!j)i_(_;~~~~~~ljf)--T---------;f(;~-----------: l ! ! (mmo111) ! c:-::;: SJgnificaHt \.'rdtb n~~pe,'.: to i\th..feed (~:-~-)~ SJgnific~~ns: "'~Â·itb f(-:spet~ to tJ~:tb. l 00 ~Hid i\s.s.. H-): Not :oignitl.cimt