Ex Parte LEHRER et alDownload PDFPatent Trial and Appeal BoardAug 29, 201812621408 (P.T.A.B. Aug. 29, 2018) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 12/621,408 11/18/2009 7590 08/29/2018 Collabrx Inc. 2225 East Bayshore Road, Suite 200 Palo Alto, CA 94303 FIRST NAMED INVENTOR Raphael LEHRER 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. 663022000100 2403 EXAMINER BORIN, MICHAEL L ART UNIT PAPER NUMBER 1631 MAIL DATE DELIVERY MODE 08/29/2018 PAPER 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. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte RAPHAEL LEHRER and ROBERT COOPERSMITH Appeal 2016-007941 Application 12/621,408 Technology Center 1600 Before DONALD E. ADAMS, ULRIKE W. JENKS, and TA WEN CHANG, Administrative Patent Judges. JENKS, Administrative Patent Judge. DECISION ON APPEAL Pursuant to 35 U.S.C. § 134(a), Appellants 1 appeal from the Examiner's decision to reject claims as being directed to non-statutory subject matter. We have jurisdiction under 35 U.S.C. § 6(b ). We REVERSE. STATEMENT OF THE CASE Appellants disclose "analysis of tumor tissue of individual patients to determine irregularities in gene expression that leads to identifying suitable treatments." Spec. ,r 2 1 Appellants identify the real party in interest as CollabRx. Inc. Appeal Br. 1. Appeal 2016-007941 Application 12/621,408 Claims 1, 3--4 and 7-15 are on appeal, and can be found in the Claims Appendix of the Appeal Brief. Independent claim 1 reads as follows: 1. A method to identify at least one therapeutic target in an individual cancer patient, which method consists essentially of: (a) assaying multiple characteristics of the genome and/or multiple characteristics of the molecular phenotype in a biopsy of the cancer afflicting said patient to obtain one or more first data sets wherein each data set consists of a single type of characteristic and assaying said characteristics in normal tissue from said individual patient to obtain one or more second data sets, wherein said multiple characteristics represent a sufficient fraction of the networks of interacting genes and their corresponding proteins in any said patient to permit identification of at least one dysregulated pathway; (b) identifying characteristics from (a) in said one or more first data sets which differ from those in said one or more second data sets to obtain differentiated characteristics; and ( c) matching said differentiated characteristics of (b) to pathways to identify one or more pathways dysregulated in said cancer biopsy as compared to normal tissue for therapeutic intervention wherein (i) each pathway comprises a multiplicity of interacting proteins curated from the literature; (ii) the differentiated characteristics are used to identify dysregulated pathways by applying statistical approaches based on triangulation to each pathway as a whole; and (iii) whereby one or more pathways is determined to be dysregulated in said individual patient's cancer as compared to the patient's normal tissue; and ( d) identifying at least one therapeutic target wherein interaction with said target would overcome dysregulation of said pathway; wherein step (b) and/ or the step ( c) is performed by a computer; and wherein each said identified dysregulated pathway contains a sufficient number of independent data points to 2 Appeal 2016-007941 Application 12/621,408 overcome statistical limitations of one or two samples and exhibits a coherent pattern whereby gene products are dysregulated in accordance with the pathway itself; and said target is responsive to approved or investigational drugs or biologics. Appeal Br. 13. Claims 1, 3--4 and 7-15 stand rejected under 35 U.S.C. § 101. Issue Does the evidence of record support Examiner's finding that Appellants' claimed invention is directed to patent ineligible subject matter? Analysis Examiner finds that Appellants' claimed invention is a computational method of analyzing genotype or phenotype data to identify a pathway dysregulated compared to normal tissue. As such, the claims are directed to processing and correlating information and converting one form of numerical representation into another. Thus, the claims are directed to an abstract idea which is a judicial exception. Final Act. 2 2. Examiner acknowledges that "the method steps while providing, arguably, improvement to analysis of data, do not demonstrate an improvement to the field of treatment of cancer." Ans. 2; see also Final Act. 3 ("The claims do not recite inventive steps outside of data manipulation."). In addition, Examiner asserts that those elements of Appellants' claimed invention that are directed using drugs or biologics for treating the patient "consist of well-understood, routine, conventional activity of designing a treatment protocol using drugs or biologics of interest." Ans. 3; see Final Act. 3. 2 Final Office Action mailed July 15, 2015 ("Final Act.")> 3 Appeal 2016-007941 Application 12/621,408 Appellants contend that the claims are "not directed to number- crunching, but to real measurements and identification of real pathways that exist in nature." Reply Br. 2. Furthermore, Appellants contend that the claims are not routine in the field of cancer treatment. See Reply Br. 4; see Appeal Br. 9 ("The limitations in claim 1 are not routine in the field of cancer treatment."). "Whether something is well-understood, routine, and conventional to a skilled artisan at the time of the patent is a factual determination." Berkheimer v. HP Inc., 881 F.3d 1360, 1369 (Fed. Cir. 2018). On this record, Examiner failed to establish an evidentiary basis to support a conclusion that elements of Appellants' claimed invention were well- understood, routine, and conventional in this field prior to Appellants' claimed invention. CONCLUSION The evidence of record fails to support Examiner's finding that Appellants' claimed invention is directed to patent ineligible subject matter. The rejection of claims 1, 3--4 and 7-15 under 35 U.S.C. § 101 is reversed. REVERSED 4 Copy with citationCopy as parenthetical citation