Daqing WuDownload PDFPatent Trials and Appeals BoardMar 31, 202015279866 - (D) (P.T.A.B. Mar. 31, 2020) Copy Citation 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. 15/279,866 09/29/2016 Daqing Wu 064466.025 4037 25461 7590 03/31/2020 SMITH, GAMBRELL & RUSSELL SUITE 3100, PROMENADE II 1230 PEACHTREE STREET, N.E. ATLANTA, GA 30309-3592 EXAMINER BARSKY, JARED ART UNIT PAPER NUMBER 1628 NOTIFICATION DATE DELIVERY MODE 03/31/2020 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): docketing@sgrlaw.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte DAQING WU __________ Appeal 2019-004367 Application 15/279,8661 Technology Center 1600 __________ Before DONALD E. ADAMS, RICHARD M. LEBOVITZ, and RACHEL H. TOWNSEND, Administrative Patent Judges. TOWNSEND, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to a composition of flavonoids and its use in treating solid tumor cancer, which have been rejected as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. STATEMENT OF THE CASE “Prostate cancer is the most common non-skin cancer in American men.” (Spec. 1.) “[D]ietary management of prostate cancer is being actively pursued due to low dose-limiting toxicities and negligible side 1 We use the word “Appellant” to refer to “Applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies the real party in interest as Augusta University Research Institute, Inc. (Appeal Br. 2.) Appeal 2019-004367 Application 15/279,866 2 effects.” (Id. at 1–2.) “[A] nutraceutical formulation with defined composition and potent anti-cancer activity is highly desired.” (Id. at 2.) Appellant’s invention is directed to such a composition. (Id. at 1.) Claims 1–18 are on appeal. Claims 1, 9, and 11 are representative and read as follows: 1. A composition comprising luteolin, quercetin and kaempferol at a molar ratio of 1: 1:2. 9. A method of inhibiting or killing cancer cells comprising: exposing the cancer cells to an inhibitory dose of the composition of any one of claim 1 to 8. 11. A method for treating a solid tumor in a mammalian subject comprising: administering to the subject a therapeutically effective dose of the composition according to any one of claim 1. (Appeal Br. 10–11.) The prior art relied upon by the Examiner is: Name Reference Date Lansky US 2002/0012710 A1 Jan. 31, 2002 Attardo US 7,709,477 B2 May 4, 2010 Cohen US 2010/0234310 A1 Sept. 16, 2010 Thomas Walle et al., Cancer chemopreventive properties of orally bioavailable flavonoids-methylated versus unmethylated flavones, 73(9) Biochem Pharmacol., 1288–1296 (2007) Lei Wang, Pomegranate Juice and Pomegranate Derived Natural Products as Alternative Treatment for Cancer Progression and Metastasis, UC Riverside Electronic Theses and Dissertations, (2013), available at https://escholarship.org/uc/item/8xn766zp Appeal 2019-004367 Application 15/279,866 3 The following grounds of rejection by the Examiner are before us on review: Claims 1–5, 7–15, and 18 under 35 U.S.C. § 103(a) as unpatentable over Lansky and Cohen. Claims 1–15 and 18 under 35 U.S.C. § 103(a) as unpatentable over Lansky, Cohen, and Walle. Claims 1–5, 7–15, and 18 under 35 U.S.C. § 103(a) as unpatentable over Lansky, Cohen, and Wang. Claims 1–5 and 7–18 under 35 U.S.C. § 103(a) as unpatentable over Lansky, Cohen, and Attardo. Claims 1–5 and 7–18 under 35 U.S.C. § 103(a) as unpatentable over Lansky, Cohen, Wang, Attardo. Claims 1–18 under 35 U.S.C. § 103(a) as unpatentable over Lansky, Cohen, Wang, Attardo, Walle. DISCUSSION Appellant argues a single issue is dispositive with respect to all of the Examiner’s obviousness rejections: Namely whether or not the Lansky reference or any of the other cited references teaches the ratio of luteolin, quercetin, and kaempferol recited in claim 1. (Appeal Br. 7–9.) As noted above in the recitation of rejections for review, all of the obviousness rejections rely on Lansky. In light of this, we will first address the Examiner’s rejection of claim 1 over Lansky and Cohen. Appellant has not argued the claims separately, and they, therefore, fall with claim 1. 37 C.F.R. § 41.37(c)(1)(iv). Appeal 2019-004367 Application 15/279,866 4 The Examiner finds that Lansky teaches a cancer chemopreventative mixture that includes an unspecified amount of luteolin, quercetin, and kaempferol isolated from pomegranate peel. (Final Action 5 (citing Lansky claim 11).) The Examiner further finds that Lansky teaches a solution that includes 260 μM luteolin, 280 μM quercetin, and 460 μM kaempferol. (Ans. 19 (citing Lansky ¶ 129 and Figures 65 A and B).) The Examiner notes that Lansky teaches the compositions can be used to treat prostate cancer, including hormone independent prostate cancer. (Final Action 5.) The Examiner also finds that Cohen teaches pharmaceutical compositions that include a therapeutically effective amount of luteolin, quercetin, and kaempferol, each of which are plant isolates that possess estrogen potential. (Id. (citing Cohen ¶¶ 7, 8, 112).) The Examiner further finds Cohen teaches administering these compositions, either by parenteral or oral means, to treat cancer, such as prostate cancer. (Id. (citing Cohen ¶¶ 23–30, 41).) The Examiner further finds that Cohen teaches administering the composition to a human in an amount from 10 mg to 30 g. (Id. (citing Cohen ¶ 242).) In light of the foregoing, the Examiner concludes that it would have been obvious to one having ordinary skill in the art to administer luteolin, quercetin, and kaempferol to a subject with hormone-independent prostate cancer. (Id. at 5–6; Ans. 18–19.) With respect to the specific ratio of luteolin, quercetin, and kaempferol recited in claim 1, the Examiner notes that “differences in concentration . . . will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration . . . is critical” because “it is not inventive to discover the optimum or workable ranges by routine experimentation” where Appeal 2019-004367 Application 15/279,866 5 the general condition is disclosed. (Final Action 6 (quoting In re Aller, 220 F.2d 454, 456 (CCPA 1955).) We agree with the Examiner’s findings as set forth above, and the Examiner’s conclusion of obviousness. On appeal, Appellant does not argue that the ratio of luteolin, quercetin, and kaempferol recited in claim 1 is critical to achieve any particular function, much less inhibiting or killing cancer cells or treatment of cancer as recited in claims 9 and 11. (See Ans. 18.) Rather, Appellant argues only that Lansky’s “[m]ass spectrometry data . . . suggests that the molar ratio of compounds in pomegranate seed extract are not 1:1:2 because Lan[s]ky discloses a ratio of luteolin:kaempferol that is 1:1, and is silent to the amount of quercetin.” (Appeal Br. 7 (citing Lansky ¶ 214 and Figures 62, 63, and 66).) Appellant further contends that “Cohen teaches using equivalent amounts of each of luteolin, quercetin, and kaempferol.” (Id.) In response to Appellant’s assertion regarding Lansky, the Examiner pointed out in the Answer that Figure 65 of Lansky, which is discussed in Lansky ¶ 214, but which Appellant does not make reference to, teaches a solution that has 260 μM luteolin, 280 μM quercetin, and 460 μM kaempferol, and teaches that such solution has bioactivity. (Ans. 19.) Thus, explains the Examiner, Lansky is not silent about quercetin in a luteolin and kaempferol composition and Lansky teaches more than a 1:1 luteolin to kaempferol ratio, noting that the ratio of luteolin:quercetin:kaempferol in the solution that includes 260 μM luteolin, 280 μM quercetin, and 460 μM kaempferol is 1:1.07:1.76 which is “almost identical to that claimed.” (Id.) Appeal 2019-004367 Application 15/279,866 6 The Examiner’s reasoning is supported by a preponderance of the evidence, and Appellant does not respond to the foregoing factual finding by the Examiner. Indeed, Appellant did not file a Reply Brief. We further agree with the Examiner that the near identity of the ratio disclosed in Lansky to that which is claimed is sufficient to establish a prima facie case of obviousness, particularly when, as here, the evidence relied upon by the Examiner suggests a composition comprising a therapeutically effective amount of luteolin, quercetin, and kaempferol, which may be determined through routine experimentation. See In re Brandt, 886 F.3d 1171, 1177 (Fed. Cir. 2018) (“prima facie rejections may be appropriate ‘where there is a teaching in the prior art that the end points of the prior art range are approximate, or can be flexibly applied”’) (citing In re Patel, 566 Fed. Appx. 1005, 1010 (Fed. Cir. 2014)). In light of the foregoing, we conclude that it does not matter that Cohen does not disclose the claimed ratio of luteolin:quercetin:kaempferol, and thus, do not find Appellant’s argument regarding Cohen to be persuasive of nonobviousness. Accordingly, we affirm the Examiner’s rejection of claims 1–5, 7–15, and 18 under 35 U.S.C. § 103(a) as unpatentable over Lansky and Cohen. Moreover, we note that Appellant’s argument regarding all the other obviousness rejections on appeal, is that none of the additionally cited prior art teach or suggest the claimed ratio of luteolin:quercetin:kaempferol, and thus the recited combination of references do not render obvious claim 1. (See Appeal Br. 7–9.) Because we conclude that the claimed ratio is rendered prima facie obvious by Lansky, we do not find Appellant’s Appeal 2019-004367 Application 15/279,866 7 argument persuasive. Accordingly we also affirm the Examiner’s rejection of: Claims 1–15 and 18 under 35 U.S.C. § 103(a) as unpatentable over Lansky, Cohen, and Walle, Claims 1–5, 7–15, and 18 under 35 U.S.C. § 103(a) as unpatentable over Lansky, Cohen, and Wang, Claims 1–5 and 7–18 under 35 U.S.C. § 103(a) as unpatentable over Lansky, Cohen, and Attardo, Claims 1–5 and 7–18 under 35 U.S.C. § 103(a) as unpatentable over Lansky, Cohen, Wang, Attardo, and Claims 1–18 under 35 U.S.C. § 103(a) as unpatentable over Lansky, Cohen, Wang, Attardo, Walle. DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed 1–5, 7–15, 18 103 Lansky, Cohen 1–5, 7–15, 18 1–15, 18 103 Lansky, Cohen, Walle 1–15, 18 1–5, 7–15, 18 103 Lansky, Cohen, Wang 1–5, 7–15, 18 1–5, 7–18 103 Lansky, Cohen, Attardo 1–5, 7–18 1–5, 7–18 103 Lansky, Cohen, Wang, Attardo 1–5, 7–18 1–18 103 Lansky, Cohen, Wang, Attardo, Walle 1–18 Appeal 2019-004367 Application 15/279,866 8 Overall Outcome 1–18 No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). AFFIRMED Copy with citationCopy as parenthetical citation