Ex Parte Yang et al

Patent Trials and Appeals BoardMar 25, 2019

14002809 - (D) (P.T.A.B. Mar. 25, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 14/002,809 11/13/2013 23413 7590 03/27/2019 CANTOR COLBURN LLP 20 Church Street 22nd Floor Hartford, CT 06103 FIRST NAMED INVENTOR Zhi-hong Yang 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. YUA0025US 6729 EXAMINER YOO,SUNJAE ART UNIT PAPER NUMBER 1626 NOTIFICATION DATE DELIVERY MODE 03/27/2019 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): usptopatentmail@cantorcolbum.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Exparte ZHI-HONG YANG, HIROKO MIYAHARA, SHUHEI TAKEMURA, and AKIMASA HATANAKA 1 Appeal2018-002951 Application 14/002,809 Technology Center 1600 Before DONALD E. ADAMS, RYAN H. FLAX, and DAVID COTTA, Administrative Patent Judges. FLAX, Administrative Patent Judge. DECISION ON APPEAL This is a decision on appeal under 35 U.S.C. Â§ 134(a) involving claims to a method of raising blood adiponectin concentrations, and lessening TNF-a concentration. The Examiner's rejection of claims 6-8, 12, and 15-20 under 35 U.S.C. Â§ 103(a) is appealed. 2 We have jurisdiction under 35 U.S.C. Â§ 6(b). We reverse. 1 The Real Party in Interest is identified as "NIPPON SUISAN KAISHA, LTD." Appeal Br. 2. 2 Claims 1-5, 9-11, 13, and 14 have been cancelled. Appeal Br. 9-11 (Claims Appendix). Appeal2018-002951 Application 14/002,809 STATEMENT OF THE CASE The claimed invention is directed to a treatment for raising blood adiponectin concentrations and lowering TNF-a concentrations. The Specification states that "metabolic syndrome amelioration comprises raising blood adiponectin concentrations, lessening adipocytokine resistin and TNF-a concentrations, improving insulin tolerance, suppressing expression of SCD-1 ( stearoyl CoA desaturase-1 ), which is a fatty acid synthesis system gene in adipose tissue, and lessening the amount of visceral fat." Spec. ,r 32. The Specification further states that "[t]he metabolic syndrome ameliorating agent in the present invention is a C22: 1 and/or C20:1 [monounsaturated fatty acids or MUFAs], or a salt, or ester comprising these as constituent fatty acids. The metabolic syndrome ameliorating agent also includes oils derived from natural materials such as oils of marine products and microorganisms containing these C22: 1 and/ or C20: 1 [MUFAs], or the salt or the ester." Id. ,r 24; see also id. 9--10 ( describing 20 carbon and 22 carbon long-chain monounsaturated fatty acids (MUF As)). The Specification describes saury raw fish oil, as processed, as containing a "total weight of MUFA at 50.1 % by weight." Id. ,r 26. Independent claim 6, reproduced below, is representative: 6. A method of ra1smg blood adiponectin concentrations, and lessening TNF-a concentration comprising administering, to a patient in need thereof, an oil comprising an effective amount of at least one selected from (a) a monounsaturated fatty acid having 22 carbons, or a salt or an ester thereof, and (b) a monounsaturated fatty acid having 20 carbons, or a salt or an ester thereof, wherein total amount of (a) the monounsaturated fatty acid having 22 carbons, or a salt or ester thereof, and (b) the 2 Appeal2018-002951 Application 14/002,809 monounsaturated fatty acid having 20 carbons, or a salt or an ester thereof is at least 5 0% by weight of total amount of all fatty acids present in the oil. Appeal Br. 9 (Claims Appendix). The following rejection is on appeal: Claims 6-8, 12, and 15-20 stand rejected under 35 U.S.C. Â§ 103(a) over Lindqvist3 and Neschen. 4 Final Action 3. DISCUSSION "[T]he examiner bears the initial burden, on review of the prior art or on any other ground, of presenting aprimafacie case ofunpatentability. [ Only once] that burden is met, [does] the burden of coming forward with evidence or argument shift[] to the applicant." In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). "The combination of familiar elements [ or steps] according to known methods is likely to be obvious when it does no more than yield predictable results." KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398,416 (2007). However, "obviousness requires a suggestion of all limitations in a claim." CFMT, Inc. v. Yieldupint'l Corp., 349 F.3d 1333, 1342 (Fed. Cir. 2003) (citing In re Royka, 490 F.2d 981,985 (CCPA 1974). "Even when obviousness is based on a single prior art reference, there must be a showing of a suggestion or 3 H. Lindqvist et al., Influence of Herring (Clupea harengus) and Herring Fractions on Metabolic Status in Rats Fed a High Energy Diet, 196 ACTA PHYSIOL. 303-14 (2009) ("Lindqvist"). 4 S. Neschen et al., Fish Oil Regulates Adiponectin Secretion by a Peroxisome Proliferator-Activated Receptor-Gamma-Dependent Mechanism in Mice, 55(4) Diabetes 924--28, abstract (2006) ("Neschen"). 3 Appeal2018-002951 Application 14/002,809 motivation to modify the teachings of that reference." In re Kotzab, 217 F.3d 1365, 1370 (Fed. Cir. 2000). "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." [In re] Aller, 220 F.2d [824,] [] 456 [(CCPA 1955)]. [However,] [t]his rule is limited to cases in which the optimized variable is a "result-effective variable." In re Antonie, 559 F.2d 618, 620 (CCPA 1977). In re Applied Materials, Inc., 692 F.3d 1289, 1295 (Fed. Cir. 2012). The Examiner determined that Lindqvist disclosed administering herring oil, that herring oil contains about 40% monounsaturated fatty acids in the form of gadoleic acid and cetoleic acid, and that administering the oil to animals resulted in blood adiponectin increases. Final Action 3. Although the Examiner acknowledged that Lindqvist did not disclose the claimed 50% MUFA in oil, the Examiner cited Neschen as teaching that upon administering menhaden fish oil (to mice), the plasma adiponectin concentration was dose-dependent. Id. Thus, the Examiner reasoned that it would have been obvious for the skilled artisan to optimize Lindquist's dose ofMUFA (as a purified and isolated agent) to reach the claimed 50% amount present in the administered oil. Appellants argue that the Examiner's rationale for optimizing the MUF As disclosed by Lindquist to add 10% more thereof to its administered oil is in error. Appeal Br. 6. Appellants argue Lindqvist does not identify what components of its disclosed fish oil, or combination of components, could be expected to cause an increase in blood adiponectin concentrations. Id. Relatedly, Appellants argue that, because "the amount of monounsaturated fatty acids has not been recognized as a result-effective 4 Appeal2018-002951 Application 14/002,809 variable in cited references (Lindqvist and Neschen), a person ordinarily skilled in the art does not have any motivation to optimize the amount of the monounsaturated fatty acids." Id. at 7 (italics removed). Appellants' argument is persuasive. Lindqvist is, at best, vague regarding how gadoleic acid and cetoleic acid (the MUFAs in herring oil) might effect a patient's biology. See generally Lindqvist. Although these MUFAs are included in herring oil, it is not clear from either Lindqvist's or Neschen's disclosures that these fatty acids, specifically, have any biological effect relative to, in addition to, or synergistically with the other components of herring oil (e.g., eicosapentaenoic acid, docosahexaenoic acid, and other, non-fatty acid components). It is also not clear from Lindqvist's disclosure that gadoleic and cetoleic fatty acid-containing herring oil produces any increase in adiponectin because, even in view of the difference in the numbers provided in Lindqvist's Table 6, Lindqvist expressly states, "adiponectin and blood pressure did not differ between groups." Lindqvist 310. Moreover, Neschen may disclose that fish oil feeding raises adiponectin concentrations in a dose-dependent manner, but this does not suggest that any particular component of fish oil, and we know from the Examiner-cited potions of Lindqvist that there are several, specifically matters for such results. See Neschen. Thus, we agree with Appellants that there is no indication in the cited prior art that MUF A concentration (% by weight in oil) is a result effective optimizable variable, nor is there any evidence that the skilled artisan would have been motivated to increase the % by weight ofMUFAs in Lindqvist's herring oil composition. 5 Appeal2018-002951 Application 14/002,809 For the above reasons we conclude that the Examiner has not established a prima facie case that the appealed claims would have been obvious over Lindqvist and Neschen. 5 SUMMARY The obviousness rejection is reversed. REVERSED 5 Although it was not argued by Appellants, we also note that the claims require "an oil comprising an effective amount" for "lessening TNF-a concentration." Although, based on the rationale presented in the final rejection and Appellants' arguments there-over, the claimed increasing adiponectin concentrations is the claim element of focus on appeal, the Examiner's rejection and rationale there-for fails to mention the additional claim element relating to TNF-a concentration. See Final Action 3--4. As noted supra, "obviousness requires a suggestion of all limitations in a claim." CFMT, 349 F.3d at 1342. 6