Joseph Sung et al.

Patent Trials and Appeals BoardNov 15, 2021

2021001155 (P.T.A.B. Nov. 15, 2021)

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. 12/646,839 12/23/2009 Joseph Jao Yiu Sung 080015-0780481-000200US 1846 20350 7590 11/15/2021 Kilpatrick Townsend & Stockton LLP - West Coast Mailstop: IP Docketing - 22 1100 Peachtree Street Suite 2800 Atlanta, GA 30309 EXAMINER POHNERT, STEVEN C ART UNIT PAPER NUMBER 1634 NOTIFICATION DATE DELIVERY MODE 11/15/2021 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): KTSDocketing2@kilpatrick.foundationip.com ipefiling@kilpatricktownsend.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte JOSEPH JAO YIU SUNG, JUN YU, and KIN FAI ____________ Appeal 2021-001155 Application 12/646,839 Technology Center 1600 ____________ Before DONALD E. ADAMS, ERIC B. GRIMES, and JEFFREY N. FREDMAN, Administrative Patent Judges. ADAMS, Administrative Patent Judge. DECISION ON APPEAL Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from Examiner’s decision to reject claims 1, 6, 7, 12, and 21–24 (Appeal Br. 3). We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 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 “The Chinese University of Hong Kong, Hong Kong Special Administrative Region, CHINA” (Appellant’s May 22, 2020, Appeal Brief (Appeal Br.) 3). Appeal 2021-001155 Application 12/646,839 2 STATEMENT OF THE CASE Appellant’s disclosure relates to “markers for gastric cancer, and methods for the inhibition of gastric cancer” (Spec.2 1). Appellant’s claim 1, the only independent claim on appeal, is reproduced below: 1. A method for assessing likelihood of mortality from gastric cancer, the method comprising the steps of: (a) treating genomic DNA isolated from a gastric cancer sample with a bisulfite, wherein the gastric cancer sample is taken from a human patient diagnosed with stage I-III gastric cancer; (b) performing a polymerase chain reaction (PCR) to amplify the treated genomic DNA following step (a) with primers consisting of the nucleotide sequences of SEQ ID NO:43 and SEQ ID NO:44; (c) determining nucleotide sequence of the amplified DNA from step (b) to detect DNA that has been amplified from a methylated version of the genomic DNA; and (d) determining, based on the presence of the amplified methylated genomic DNA from step (c), a higher likelihood of mortality for the patient compared with another stage I-III gastric cancer human patient whose gastric cancer sample shows absence of amplified methylated genomic DNA after being processed through steps (a) to (c). (Appeal Br. 10.) 2 Appellant’s December 23, 2009, Specification. Appeal 2021-001155 Application 12/646,839 3 Grounds of rejection before this Panel for review: I. Claims 1, 6, 7, and 243 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Cheung,4 Freije,5 Dieffenbach,6 and Roux.7 II. Claims 12, 21, and 22 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Cheung, Freije, Dieffenbach, Roux, and Hogan.8 III. Claim 23 stands rejected under 35 U.S.C. § 103(a) as unpatentable over Cheung, Freije, Dieffenbach, Roux, Hogan, and Yao.9 3 Examiner’s statement of the rejection includes a harmless typographical error, listing Appellant’s claim 23, instead of claim 24, as part of this rejection (see Examiner’s October 7, 2020, Answer (Ans.) 3; cf. Ex parte Sung et al., 2019 WL 2208890 (PTAB April 25, 2019) (Decision) n.2; Appeal Br. 3, n. 1). We, therefore, address the merits of this rejection as it relates to claims 1, 6, 7, and 24. 4 Cheung et al., Epigenetic Characterization of a Novel Tumor Suppressor Gene, Rnf180, in Gastric Cancer and Its Application in Noninvasive Cancer Detection, 134 GASTROENTEROLOGY A-382 (2008). 5 Freije et al., WO 2007/102891 A2, published Sept. 13, 2007. 6 Dieffenbach et al., General Concepts for PCR Primer Design, 3 PCR METHODS APPL. 30–37 (1993). 7 Roux, Optimization and Troubleshooting in PCR, 4 PCR METHODS APPL. 185–194 (1995). 8 Hogan et al., US 5,541,308, issued July 30, 1996. 9 Yao et al., Evaluation of Minor Groove Binding Probe and Taqman Probe PCR Assays: Influence of Mismatches and Template Complexity on Quantification, 20 MOLECULAR & CELLULAR PROBES 311–316 (2006). Appeal 2021-001155 Application 12/646,839 4 This is the second Appeal of Appellant’s claimed invention (see Decision *1). The prior art rejections before this Panel are the same as those affirmed by the prior Panel (see id. at *1–*4). The “prosecution history is not disputed” (Reply Br.10 2). The only difference between this Appeal and the prior Appeal is “the Rule 132 declaration that was signed by inventor Dr. Jun Yu [(Yu Decl.)] and submitted with Appellant’s response of June 24, 2019, to provide information not before the PTAB at the time of the appeal and therefore not considered during the [prior] appeal process (Appeal Br. 6 (emphasis omitted)). ISSUE Does the preponderance of evidence relied upon by Examiner support a conclusion of obviousness? ANALYSIS We adopt the prior Panel’s factual findings and reasoning as it relates to the combination of references set forth in each of Rejections I–III on this record. For emphasis we note that the prior Panel found: Frieje [sic] as a whole explores the correlation between methylation of certain genes and cancer, as indicated by its title: “Materials and Methods for Assaying for Methylation of CpG Islands Associated with Genes in the Evaluation of Cancer.” Further, as the Examiner explains, addressing both Frieje [sic] and Cheung: the prior art of Cheung specifically teaches RNF180 is a tumor suppressor in gastric cancer and implicates the methylation of the RNF180 core promoter (sequence amplified by claimed primers) as a biomarker, while Freije teach SEQ ID NO 183 10 Appellant’s December 1, 2020, Reply Brief. Appeal 2021-001155 Application 12/646,839 5 which comprises the RNF180 core promoter and the sequences or complement of SEQ ID NO 43 and SEQ ID NO 44. Further Frieje [sic] teaches, “The invention also provides methods of prognosticating cancer by assaying for the methylation of one or more genes that are indicative of the grade or stage of the cancer, and/or the length of disease-free survival following treatment for cancer” (0025, page 10 of Frieje). Ans. 16. Thus, the combination of references relied upon by the Examiner provides a reasonable expectation of successfully predicting the likelihood of patient mortality relative to another stage I-III gastric cancer human patient based on methylation state of the amplified genomic DNA. (Decision *3–*4.) Yu declares: The Board’s reasoning is incorrect because it fails to take into consideration an important scientific fact: albeit somewhat related, the initial onset of a disease and its progression are two biological processes involving substantially different molecular mechanisms. At or just prior to the initial stage of disease emergence, a series of relevant molecular events take place in an environment that is still relatively normal or under near physiological conditions. In contrast, at a later stage of disease development a different set of molecule events contribute to disease progression, up to and including mortality, under severely abnormal or pathological conditions. The divergence of diagnostic markers and prognostic markers can be better understood considering how different subpopulations of patients emerge after the initial diagnosis: while these patients may share some of the common molecular events responsible for the disease occurrence, they undergo different subsequent molecular changes, which are responsible for different courses of disease progression, e.g., differences in mortality. As such, there is a substantial likelihood that a biomarker useful for diagnosing gastric cancer cannot serve as a suitable biomarker for predicting patient mortality. Appeal 2021-001155 Application 12/646,839 6 (Yu Decl. ¶ 5; see also Appeal Br. 7 (citing Yu Decl. ¶ 5); Reply Br. 4 (citing Yu Decl. ¶ 5.)) Declarant failed to direct attention to an evidentiary basis supporting the foregoing statements. Nonetheless, even if we assume, for the purposes of this Appeal, that Yu’s statements are factually correct, we find that the preponderance of evidence on this record falls in favor of Examiner’s rejections. As Examiner explains, “the declaration provides no evidence that RNF180 promoter methylation detection in gastric cancer[, as is suggested by the combination of prior art relied upon by Examiner,] is not correlated with mortality” (Ans. 12; cf. Decision *4 (The prior Panel found that “the combination of references relied upon by the Examiner provides a reasonable expectation of successfully predicting the likelihood of patient mortality relative to another stage I-III gastric cancer human patient based on methylation state of the amplified genomic DNA”)). Stated differently, even if Yu’s broad generic statements regarding molecular modifications that may generically occur during disease progression are correct, Yu’s testimony fails to specifically address the specific disclosures of the prior art relating to, and making obvious, the specific method set forth in Appellant’s claimed invention. Similarly, Yu’s generic unsupported statements regarding “observed diagnostic markers [that] turn out to be very poor or completely unusable as prognostic markers” and discussion of markers that are outside the scope of the combination of prior art on this record fails to outweigh Examiner’s prima facie case of obviousness that relies on a combination of prior art that addresses and makes obvious the use of the specific marker required by Appeal 2021-001155 Application 12/646,839 7 Appellant’s claimed method (see Yu Decl. ¶ 6; see also Appeal Br. 7 (citing Yu Decl. ¶ 6);Reply Br. 4 (citing Yu Decl. ¶ 6); cf. Decision *1–*4). For the foregoing reasons, having reconsidered the evidence relied upon by Examiner, and the prior Panel, in the context of the Yu Declaration, we find that the preponderance of evidence on this record fails to support Yu’s statement that “there is no reasonable expectation that RNF180 will turn out to be a suitable marker for predicting mortality. Only actual experimentation can provide the definitive answer whether or not RNF180 is a usable marker for predicting gastric cancer mortality” (Yu Decl. ¶ 7; see also Appeal Br. 7–8; Reply Br. 4–5; cf. Decision *4 (The prior Panel found that “the combination of references relied upon by the Examiner provides a reasonable expectation of successfully predicting the likelihood of patient mortality relative to another stage I-III gastric cancer human patient based on methylation state of the amplified genomic DNA”)). “Appellant agrees that the law does not require absolute predictability” (Reply Br. 3). Having found no deficiency in the combination of Cheung, Freije, Dieffenbach, and Roux, we are not persuaded by Appellant’s contention that Hogan or Yao fail to make up for Appellant’s asserted deficiency in Cheung, Freije, Dieffenbach, and Roux (see Appeal Br. 8). We decline to address arguments presented for the first time in Appellant’s Reply Brief. See Ex parte Borden, 93 USPQ2d 1473, 1474 (BPAI 2010) (informative) (“[T]he reply brief [is not] an opportunity to make arguments that could have been made in the principal brief on appeal to rebut the Examiner’s rejections, but were not.”). Appeal 2021-001155 Application 12/646,839 8 CONCLUSION The preponderance of evidence relied upon by Examiner supports a conclusion of obviousness. Rejection I: The rejection of claim 1 under 35 U.S.C. § 103(a) as unpatentable over Cheung, Freije, Dieffenbach, and Roux is affirmed. Claims 6, 7, and 24 are not separately argued and fall with claim 1. Rejection II: The rejection of claim 12 under 35 U.S.C. § 103(a) as unpatentable over Cheung, Freije, Dieffenbach, Roux, and Hogan is affirmed. Claims 21 and 22 are not separately argued and fall with claim 12. Rejection III: The rejection of claim 23 under 35 U.S.C. § 103(a) as unpatentable over Cheung, Freije, Dieffenbach, Roux, Hogan, and Yao is affirmed. DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1, 6, 7, 24 103 Cheung, Freije, Dieffenbach, Roux 1, 6, 7, 24 12, 21, 22 103 Cheung, Freije, Dieffenbach, Roux, Hogan 12, 21, 22 23 103 Cheung, Freije, Dieffenbach, Roux, Hogan, Yao 23 Overall Outcome 1, 6, 7, 12, 21–24 Appeal 2021-001155 Application 12/646,839 9 TIME PERIOD FOR RESPONSE No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R. § 1.136(a)(1)(iv) (2019). AFFIRMED