Ex Parte KRISHNADATHDownload PDFPatent Trials and Appeals BoardMay 16, 201913624884 - (D) (P.T.A.B. May. 16, 2019) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 13/624,884 09/21/2012 21089 7590 05/20/2019 PAUL D. YASGER VYSIS, INC (ABBOTT MOLECULAR) 100 ABBOTT PARK ROAD DEPT. 377/AP6C-1 ABBOTT PARK, IL 60064-6008 FIRST NAMED INVENTOR Kausilia K. KRISHNADATH 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. 10999US01 1835 EXAMINER SITTON, JEHANNE SOUAY A ART UNIT PAPER NUMBER 1634 NOTIFICATION DATE DELIVERY MODE 05/20/2019 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): molecularpatents@abbott.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte KAUSILIA K. KRISHNADATH Appeal2018-008057 Application 13/624,884 Technology Center 1600 Before JEFFREY N. FREDMAN, JOHN G. NEW, and JAMIE T. WISZ, Administrative Patent Judges. WISZ, Administrative Patent Judge. DECISION ON APPEAL Pursuant to 35 U.S.C. § 134(a), Appellant1 seeks review of claims 6 and 9. We have jurisdiction under 35 U.S.C. § 6(b). For the reasons set forth below, we AFFIRM. STATEMENT OF THE CASE The Specification describes a method of prognosticating progression of Barrett's esophagus in a patient by detecting in a sample of esophageal cells at least one abnormality selected from the group consisting of p 16 loss, p53 loss, chromosome 7 aneuploidy, and chromosome 17 aneuploidy. Spec. 1 Appellant identifies the Real Parties in Interest as Academisch Medisch Centrum and Abbott Molecular, Inc. App. Br. 1. Appeal2018-008057 Application 13/624,884 6. The method can further comprise detecting in the sample at least one abnormality selected from the group consisting of 20q gain, C-myc gain, and Her2 gain. Id. A set of probes and a kit are also provided. Id. Claim 6, which is illustrative, is set forth below: 6. A set of detectably labeled probes consisting of a probe for p16, which hybridizes to p21 on human chromosome 9, a probe for p53, which hybridizes to p13 on human chromosome 17, a centromeric probe for human chromosome 7, a centromeric probe for human chromosome 17, and a probe for Her2, which hybridizes to q 11 on human chromosome 1 7, wherein each probe is detectably labeled with a distinct fluorophore. App. Br. 7-8 (Claims Appendix). Claim 9 recites a kit consisting of the same probes as recited in claim 6, along with instructions and "optionally ... one or more items selected from the group consisting of a blocking agent, a label, a labeling agent, a reagent for hybridization, a buffer, and a metaphase spread." Id. at 8. The Examiner rejected claim 6 under 35 U.S.C. § 103(a) as being obvious over Halling2 in view of Brien3 and rejected claim 9 as being obvious over Halling in view of Brien and further in view of Ahem. 4 2 Halling et al., WO 2006/089163 A2, published Aug. 24, 2006 ("Halling"). 3 Brien et al., HER-2/neu Gene Amplification by FISH Predicts Poor Survival in Barrett's Esophagus-Associated Adenocarcinoma, 31 Human Pathology 35-39 (2000) ("Brien"). 4 Holly Ahem, Biochemical, Reagent Kits Offer Scientists Good Return on Investment, 9 The Scientist, 1-5 (1995), http://www.the- scientist.library.upenn.edu/yr1995/july/tools_950724.html ("Ahem"). 2 Appeal2018-008057 Application 13/624,884 ISSUES AND ANALYSIS We affirm the Examiner's obviousness rejections. We address the arguments raised by Appellant below. Obviousness The Examiner finds that "Halling teaches a set of probes for detecting esophageal cancer including a chromosome enumeration probe for chromosome 7 (CEP7), a chromosome enumeration probe for chromosome 17 (CEPl 7), a probe for 9p21 (p16) and a probe for 17pl3.1 (p53) (see table 3, table 4, page 45, and claims)." Final Act. 3. According to the Examiner, Halling also teaches that the probes are labeled with distinct fluorescent label containing moieties and that FISH is preferably employed. Id. ( citing Halling ,r 25, p. 16). The Examiner concedes that Halling does not teach a probe for detecting Her2 amplification but finds that "Brien teaches that Her2 amplification was assessed using FISH and that it was associated with shortened survival time and poor outcome in Barrett's esophagus associated adenocarcinoma." Id. The Examiner concludes: Id. Therefore, it would have been prima facie obvious to the ordinary artisan at the time the invention was made to construct a probe set consisting of a probe for p 16 which hybridizes to 9p21, a probe for p53 which hybridizes to 17p13, a centromeric probe for human chromosome 7, and a centromeric probe for human chromosome 17, and to include a probe for Her2 which hybridizes to [ q 11] as taught by Brien for the purpose of providing a comprehensive set of probes for esophageal cancer. It was routine in the art at the time the invention was made to select optimal combinations of probes to be used in FISH for cancer diagnosis and prognosis and label the probes with distinct fluorophores. 3 Appeal2018-008057 Application 13/624,884 With regard to claim 9, the Examiner finds that Halling teaches blocking agents, buffers, labeling agents, and reagents for hybridization for use with the probes and "Ahem teaches that packaging reagents in kits with instructions save researchers time." Id. at 4. The Examiner concludes that "it would have been prima facie obvious to the ordinary artisan at the time the invention was made to package the probe set taught by Halling and Brien in kit format with instructions, as taught by Ahem, for convenience and ease of use." Id. Appellant asserts that one of skill in the art would not have been motivated to combine the cited disclosures to arrive at the invention because Halling does not disclose or suggest a probe set consisting of the claimed probes and Brien does not disclose or suggest combining a Her2 probe with probes to other chromosomal regions for the detection or prognosis of Barrett's esophagus. App. Br. 5. Therefore, Appellant argues that the Examiner has not properly made out a prima facie case of obviousness and, even if the Examiner had done so, "the combination of Halling and Brien would result in a probe set comprising a Her2 probe and a combination of locus-specific and centromeric probes for chromosomes 5, 7, 8, 9, 17, 20, and Y that differs from the combination required by claims 6 and 9." Id. at 6. With regard to claim 9, Appellant asserts that Ahem does not compensate for the deficiencies of Halling and Brien because it does not teach the claimed probes. Id. at 5. The Examiner responds by explaining that "Halling teaches that for 9p21, 17p, CEP7, and CEP 17, the sharpest increase in percent cells showing gain came with progression from HGD to EA (page 46)." Ans. 6. The Examiner further finds that, because Brien teaches that Her2 amplification 4 Appeal2018-008057 Application 13/624,884 was assessed using FISH, it would have been obvious to construct a probe set with the claimed probes disclosed in Halling with a probe for Her2, as disclosed in Brien, for the purpose of providing a comprehensive set of probes for esophageal cancer. Id. The Examiner also explains that Halling teaches multiple probe sets that use less than all of the probes described therein and "found that the sensitivity of FISH was significantly enhanced when a combination of at least three probes were used to simultaneously detect chromosomal gains as diagnostic of cancer, as compared to the use of a single probe." Id. at 7. The Examiner further finds that Halling exemplifies the routine optimization in the art for constructing probe sets with different combinations of probes and selection of optimal probe sets would have required routine experimentation because the FISH methodology was known in the art. Id. at 8 ( citing Halling tables 5A-C and 6A-C). The Examiner concludes that, "the use of the combination of probes would have been predictable since the prior art teaches the benefits of each probe and the prior art teaches the benefit of using at least combinations of probes to increase the sensitivity of FISH for esophageal cancer including Barrett's Esophagus associated adenocarcinoma." Id. We are not persuaded by Appellant's arguments. As found by the Examiner, Halling and Brien disclose the use of fluorescently-labeled probes for determining the progression of Barrett's-associated esophageal adenocarcinoma. Final Act. 3. It would have been obvious to a person of ordinary skill in the art to use the probes disclosed in Halling (i.e., chromosome enumeration probe for chromosome 7 (CEP7), a chromosome enumeration probe for chromosome 17 (CEP 17), a probe for 9p21 (p 16) and 5 Appeal2018-008057 Application 13/624,884 a probe for 17pl3.1 (p53)), with the Her2 probe, as disclosed in Brien. "The combination of familiar elements 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). Furthermore, the selection of optimal probe sets would have required only routine experimentation because "the FISH methodology and parameters that affect the sensitivity and specificity of cancer detection assays based on FISH were well known in the art at the time the invention was made." Ans. 8. Obviousness under 35 U.S.C. § 103 requires an inquiry into "'whether the improvement is more than the predictable use of prior-art elements according to their established functions."' Monolithic Power Sys., Inc. v. Micro Int'! Ltd., 558 F.3d 1341, 1352 (Fed. Cir. 2009) (quoting KSR, 550 U.S. at 417). Applying this standard, we conclude that the Examiner did not err in determining that the claims would have been obvious to an ordinarily-skilled artisan over the cited prior art. With regard to Appellant's argument regarding Ahem, Appellant is improperly arguing the references individually rather than as a combination. "Non-obviousness cannot be established by attacking references individually where the rejection is based upon the teachings of a combination of references. . . . [The reference] must be read, not in isolation, but for what it fairly teaches in combination with the prior art as a whole." In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986). As presented by the Examiner, the claimed probes are disclosed by Halling and Brien, the blocking agents, buffers, labeling agents, and reagents are disclosed by Halling, and the use of instructions is disclosed by Ahem. Therefore, for the reasons discussed above for claim 6, it would have been 6 Appeal2018-008057 Application 13/624,884 obvious to one of skill in the art to combine these references to arrive at the elements of claim 9. For the reasons described herein and those already of record, we affirm the Examiner's rejection of claim 6 under 35 U.S.C. § I03(a) as being obvious over Halling in view of Brien. We also affirm the rejection of claim 9 as being obvious over Halling in view of Brien and further in view of Ahem. CONCLUSION We affirm the Examiner's obviousness rejections of claims 6 and 9. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(l )(iv). AFFIRMED 7 Copy with citationCopy as parenthetical citation