Ex Parte SunDownload PDFPatent Trial and Appeal BoardDec 8, 201411726603 (P.T.A.B. Dec. 8, 2014) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte ALEXANDER S. SUN __________ Appeal 2012-010698 Application 11/726,603 Technology Center 1600 __________ Before DONALD E. ADAMS, DEMETRA J. MILLS, and CHRISTOPHER G. PAULRAJ, Administrative Patent Judges. PAULRAJ, Administrative Patent Judge. DECISION ON APPEAL This is an appeal1 under 35 U.S.C. § 134 involving claims to a method to ameliorate an effect of non-small cell lung cancer. The Examiner rejected the claims on obviousness grounds. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. STATEMENT OF THE CASE Background According to the Specification: This invention relates to treatments effective in treating malignancies and restoring CD4+ cell levels, and also to dietary 1 Appellant identifies the Real Party in Interest as Sun Farm Corporation (see App. Br. 1). Appeal 2012-010698 Application 11/726,603 2 supplements that improve immune functions. In particular, it concerns compositions that are derived from plants, foods and extracts thereof, that are used in a particular combination as dietary supplements, which are effective against malignancies and depressed immune functions and which improve overall immune function. (Spec. ¶ 2.) The Claims Claims 11–14 are on appeal. Claim 11, the sole independent claim, is representative, and reads as follows: 11. A method to ameliorate at least one effect of non-small cell lung cancer (NSCLC), which method comprises: administering to a subject in need thereof an effective amount of a dietary supplement comprising at least one phytoestrogen, at least one β- glucan, at least one saponin, inositol hexaphosphate, and at least one lectin, wherein said dietary supplement is administered periodically for a time sufficient to ameliorate at least one effect of NSCLC. The Rejection The Examiner has rejected the claims under 35 U.S.C. § 103(a) as obvious over the combination of Sun2 and Lei,3 as further evidenced by Kataria.4 FINDINGS OF FACT We adopt the Examiner’s findings of fact set forth in the Answer (Ans. 5). We add the following findings for emphasis. 2 Sun, US 5,437,866, issued Aug. 1, 1995. 3 Lei et al., EGF-Dependent and Independent Programmed Cell Death Pathways in MCI-H596 Nonsmall Cell Lung Cancer Cells, 245 BIOCHEMICAL AND BIOPHYSICAL RESEARCH COMMC’NS 939–45 (1998). 4 Kataria et al., Antinutrients in amphidiploids (black gram X Mung bean): varietal differences and effect of domestic processing and cooking, 39 PLANT FOODS FOR HUMAN NUTRITION 257–266 (1989). App App FF1. FF2. eal 2012-0 lication 11 Table (Spec Lei is Cell D Cells NSCL signa “[t]he thera and g prolif 10698 /726,603 1 of the S . ¶ 4). directed t eath Path ” (Lei, Tit C is over ling pathw refore EG py in NSC enistein [p eration, E pecificatio o “EGF-D ways in N le). Lei tea expression ay may be FR may b LC” (id., p hytoestrog GFR phos 3 n is repro ependent CI-H596 N ches that “ of EGFR involved e an impor . 943). L en], a tyro phorylatio duced belo and Indepe onsmall [a] comm , suggestin in lung ca tant target ei “evaluat sine kina n and its d w: ndent Pro Cell Lung on occurre g that the rcinogene for antica ed the eff se inhibito ownstream grammed Cancer nce in EGFR sis” and ncer ect of EGF r, on cell signal Appeal 2012-010698 Application 11/726,603 4 MAP kinase activation and investigated the involvement of these processes in programmed cell death in a human pulmonary adenosquamous carcinoma cell line, NCI-H596” (id., Abstract) (emphasis omitted). Lei further teaches that “[g]enistein abolished the ability of EGF to induce EGFR phosphorylation, to activate MAP kinase and to increase cell proliferation” (id.). FF3. Kataria teaches the presence of saponin in mung bean (Kataria, Abstract). PRINCIPLES OF LAW Once a prima facie case of obviousness has been established, objective evidence of secondary considerations must be considered in making an obviousness decision. See Stratoflex, Inc. v. Aeroquip Corp., 713 F.2d 1530, 1538–39 (Fed. Cir. 1983). See also In re Rinehart, 531 F.2d 1048, 1052 (CCPA 1976); In re Eli Lilly & Co., 902 F.2d 943, 945 (Fed. Cir. 1990). A “nexus” must be established between the merits of the claimed invention and the evidence of secondary considerations in order for the evidence to be given substantial weight. See In re GPAC, Inc., 57 F.3d 1573, 1580 (Fed. Cir. 1995). The scope of the “objective evidence of non- obviousness must be commensurate in scope with the claims which the evidence is offered to support.” In re Tiffin, 448 F.2d 791, 792 (CCPA 1971); see also In re Peterson, 315 F.3d 1325, 1329–31 (Fed. Cir. 2003). Further, in order to prove unexpected results, the invention must be compared with the closest prior art. In re Baxter Travenol Labs., 952 F.2d 388, 392 (Fed. Cir. 1991). Appeal 2012-010698 Application 11/726,603 5 ANALYSIS The Examiner finds that “Sun teaches a method of treating non-small lung cancer using a composition that comprises mung bean and the mushroom Lentinus edodes . . . prepared as extracts” (Ans. 5). Based on Table I of Appellants’ Specification, the Examiner finds that “inositol hexaphophate and lectins are found in mung bean and that lentinan is found in mushrooms” and further finds that “Kataria teaches that saponins are found in mung beans (id.; FF1, FF3). The Examiner therefore concludes that “the composition taught by Sun would naturally include lentinan, saponins, inositol hexaphosphate, and phytohemagglutinin,” but acknowledges that “Sun does not teach adding genistein to the treatment composition” (Ans. 5). To make up for this deficiency, the Examiner relies upon Lei’s teaching “that genistein inhibits the proliferation of non-small lung cancer cells” and asserts that “an artisan of ordinary skill would have a reasonable expectation that a combination of the substances would also be useful in creating compositions to treat non-small cell lung cancer” (id. at 5– 6). We agree that the Examiner made a prima facie showing of obviousness. “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 which is to be used for the very same purpose.” In re Kerkhoven, 626 F.2d 846, 850 (CCPA 1980). We have considered Appellant’s arguments but do not find them persuasive. Appellant first argues that “[b]ecause Lei is simply a mechanistic study of the effect of genistein on a cell line representing NSCLC, and does not consider the effects of genistein when administered in vivo, appellant Appeal 2012-010698 Application 11/726,603 6 believes no prima facie case has been made” (App. Br. 4). We are not convinced. Given Lei’s teaching that “EGFR may be an important target for anticancer therapy in NSCLC” and that “[g]enistein abolished the ability of EGF to induce EGFR phosphorylation, to activate MAP kinase and to increase cell proliferation,” a skilled artisan would have a strong incentive to utilize genistein in an anticancer therapy targeting NSCLC. Lei p. 943; Abstract (emphasis omitted.) Even though Lei does not conclusively demonstrate efficacy through in vivo results, “[c]onclusive proof of efficacy is not necessary to show obviousness. . . . All that is required is a reasonable expectation of success.” Hoffmann-La Roche Inc. v. Apotex Inc., 748 F.3d 1326, 1331 (Fed. Cir. 2014). We therefore find that a skilled artisan would have a reasonable expectation of success combining genistein (photoestrogen) with other claimed ingredients found in a mung bean/Lentinus edodes extract in a therapy targeting NSCLC in view of the teachings of Sun and Lei. Appellant further argues that they demonstrated unexpected results sufficient to overcome a prima facie case of obviousness. In particular, Appellant asserts: To summarize the results set forth in the application itself, animals that were fed a 5% wt/wt of the three-component SV mixture containing the active components set forth in the claims and animals fed a 20% wt/wt composition of the two- component mushroom/mung bean diet of Sun lacking phytoestrogens showed comparable inhibitions in tumor growth. Because the levels of active components were much lower in SV, the addition of the third component, supplying phytoestrogen, is shown to provide synergistic results. Appeal 2012-010698 Application 11/726,603 7 (App. Br. 4.) In addition to the results described in the Specification, Appellant also cites to results published in Sun, et al., Phase I/II Study of Stage III and IV Non-Small Cell Lung Cancer Patients Taking a Specific Dietary Supplement Nutrition and Cancer (1999) 34:62-69 and Sun, et al., Pilot Study of a Specific Dietary Supplement in Tumor-Bearing Mice and in Stage IIIB and IV Non-Small Cell Lung Cancer Patients, Nutrition and Cancer (2001) 39:85-95 (App. Br. 4). We do not find that Appellant has demonstrated unexpected results commensurate in scope with the claimed invention that are sufficient to overcome the prima facie case of obviousness. In particular, the results described in the Specification show that administering a selected vegetable (SV) composition improved survival time and Karnofsky performance status (KPS) in patients suffering from stage III- IV non-small cell lung cancer compared with those patients treated with “conventional therapies” (Spec. ¶ 27). The SV composition includes “soybean, mushroom, and mung bean as the active components,” i.e., wherein the “active components in the SV comprise phytoestrogens, β- glucans, saponin, inositol hexaphosphate, and lectins” (id. ¶¶ 15, 25). According to the Specification, “[t]he remainder of the components, red date, scallion, garlic, lentil bean, leek, hawthorn fruit, onion, ginseng, angelica root, licorice, dandelion root, Senegal root, ginger, olive, sesame seed, and parsley are added for flavor” (id. ¶ 15). The other published articles cited by Appellant report similar results in different studies. As an initial matter, we agree with the Examiner that Appellant has not provided objective evidence, such as in the form of a declaration, to support their assertion that any additional ingredients present in the SV Appeal 2012-010698 Application 11/726,603 8 composition would not have contributed to the reported improvement in NSCLC patients. Appellant’s conclusory statements that only soybean, mushrooms, and mung bean contribute to the “active components” of the SV composition are insufficient in our view. As In re Lindner makes clear, Appellants’ rebuttal evidence of unexpected results must be objective: The affidavit and specification do contain allegations that synergistic results are obtained with all the claimed compositions, but . . . mere lawyers’ arguments unsupported by factual evidence are insufficient to establish unexpected results. Likewise, mere conclusory statements in the specification and affidavits are entitled to little weight when the Patent Office questions the efficacy of those statements. . . . [W]e agree with the board that there is insufficient evidence to overcome the case of prima facie obviousness found to exist here. 457 F.2d 506, 508–09 (CCPA 1972) (emphasis added) (citations omitted). See also In re De Blauwe, 736 F.2d 699, 705 (Fed. Cir. 1984) (“It is well settled that unexpected results must be established by factual evidence. Mere argument or conclusory statements in the specification does not suffice.”); In re Wood, 582 F.2d 638, 642 (CCPA 1978) (“Mere lawyer’s arguments and conclusory statements in the specification, unsupported by objective evidence, are insufficient to establish unexpected results.”). Furthermore, even assuming that only the claimed ingredients are the “active components” in the SV composition, the alleged unexpected results relied upon by Appellant are only based on a comparison to “conventional therapies,” i.e., radiation, surgery, and/or chemotherapy (Spec. ¶ 61). “However, when unexpected results are used as evidence of nonobviousness, the results must be shown to be unexpected compared with the closest prior art.” Baxter Travenol Labs., 952 F.2d at 392 (emphasis added). Appellant Appeal 2012-010698 Application 11/726,603 9 has not shown any unexpected results associated with the SV composition when compared to the closest prior art, which in this case is the Sun reference teaching administration of a mung bean/Lentinus edodes extract composition comprising all the claimed ingredients except for phytoestrogen. In other words, Appellant has not demonstrated that the addition of phytoestrogen to the prior art mung bean/Lentinus edodes extract composition resulted in an unexpected improvement in the treatment of NSCLC. See Wm. Wrigley Jr. Co. v. Cadbury Adams USA LLC, 683 F.3d 1356, 1362 (Fed. Cir. 2012) (“Evidence that a combination of known components results in an effect greater than the predicted additive effect of the components can support a finding of nonobviousness.”)(Emphasis added.) We therefore cannot conclude, based on the record before us, that there are any unexpected “synergistic results” associated with the addition of phytoestrogen given Lei’s express teaching that phytoestrogen (genistein) can beneficially play a role in the treatment of NSCLC (FF2). SUMMARY We affirm the claim rejection under 35 U.S.C. §103(a). No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). 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