Case 1:17-cv-12194-MLW Document 32-2 Filed 03/01/18 Page 1 of 8
`Case 1:17-cv—12194-MLW Document 32-2 Filed 03/01/18 Page 1 of 8
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`EXHIBIT 2
`EXHIBIT 2
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`Case 1:17-cv-12194-MLW Document 32-2 Filed 03/01/18 Page 2 of 8
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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
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`PATENT
`Attorney Docket No. 37901-713.306
`
`In re application of:
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`Confirmation No.: 1038
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`Inventors: Daniel D. VON HOFF et al.
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`Group Art Unit: 1631
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`Serial No.: 14/473,881
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`Filed: August 29, 2014
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`Examiner: LIN, JERRY
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`Customer No. 96600
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`For: SYSTEM AND METHOD FOR
`DETERMINING INDIVIDUALIZED MEDICAL
`INTERVENTION FORA DISEASE STATE
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`ELECTRONICALLY FILED JANUARY 21, 2016
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`Mail Stop Amendment
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
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`Sir/Madam:
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`Introductory Comments:
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`RESPONSE TO FINAL OFFICE ACTION
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`This communication is in response to the Final Office Action dated September 4, 2015 (the
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`"Office Action"). The shortened statutory period for response expired on December 4, 2015. Therefore,
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`Applicant submits fees for a two-month extension with the filing of this Response.
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`Applicant respectfully requests reconsideration of the above-referenced application in view of the
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`following amendments and remarks.
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`Remarks begin on page 2 of this Response.
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`Docket No. 37901-713.306
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`Case 1:17-cv-12194-MLW Document 32-2 Filed 03/01/18 Page 3 of 8
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`U.S. Serial No. 14/473,881
`Response to Final Office Action of Sept. 4, 2015
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`REMARKS
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`With this Response, no claims are amended. Thus, Applicant believes no search is required and
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`respectfully requests reconsideration of the pending claims based on the following remarks.
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`I.
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`Information Disclosure Statement
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`Applicant thanks the Examiner for acknowledging the Supplemental IDS statement filed August
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`7, 2015. Applicant has submitted an additional Supplemental IDS statement herewith.
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`II. Claim Rejections under 35 U.S.C. § 101
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`The Examiner rejected claims 1-14 under 35 U.S.C. § 101 as allegedly "directed to a judicial
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`exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more."
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`Office Action, p. 2. The Examiner alleges that the claims "are directed to the abstract idea of identifying a
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`therapeutic agent for an individual with a cancer." Id. The Examiner reasons that "[t]he device for
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`assaying molecular targets is a data-gathering device that is routine, conventional, and well-known for
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`gathering molecular profile test data" and that "computer code and computer database are also routine,
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`conventional, and well-known, tools of implementing an abstract idea." Id. at p. 3. Applicant respectfully
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`traverses the rejection.
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`On December 16, 2014, the USPTO guidance issued updated guidelines for determining subject
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`matter eligibility under 35 U.S.C. 101 in view ofrecent decisions by the U. S. Supreme Court (the
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`"Guidance"). The Guidance provides "a number of considerations [identified by the Supreme Court] for
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`determining whether a claim with additional elements amounts to significantly more than the judicial
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`exception itself." Guidance, p. 21. In the instant application, the claims provide "[i]mprovements to
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`another technology or technical field" and thus recite eligible subject matter. See id. at p. 21 (citation
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`removed).
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`Applicant submits herewith a Declaration under 3 7 CFR § 1.13 2 from medical oncologist
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`Sandeep K. Reddy, M.D. (the "Reddy Declaration"). In the declaration, Dr. Reddy states that the system
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`of the invention has been implemented in the real world and used to assist treating physicians in the care
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`of patients having various cancers by suggesting therapeutic agents as having likely benefit for those
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`patients. See Reddy Declaration,~~ 5-6. The Reddy Declaration provides evidence that the claimed
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`invention effects an improvement in the treatment of cancer victims. See id.
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`-2-
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`Docket No. 37901-713.306
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`Case 1:17-cv-12194-MLW Document 32-2 Filed 03/01/18 Page 4 of 8
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`U.S. Serial No. 14/473,881
`Response to Final Office Action of Sept. 4, 2015
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`Accordingly, Applicant submits evidence herewith that the claimed system provides an
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`improvement in another technology or technical field, namely in the medical field and specifically in the
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`treatment of cancer victims. See Reddy Declaration, ~ 7. Accordingly, the claims recite "significantly
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`more" than any alleged judicial exception. See Guidance, p. 21. Applicant respectfully requests that the
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`Examiner reconsider and withdraw this rejection and allow all claims.
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`III. Claim Rejections under 35 U.S.C. § 103(a)
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`Applicant thanks the Examiner for withdrawing the prior rejection under 35 U.S.C. § 103(a). See
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`Office Action, p. 5.
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`-3-
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`Docket No. 37901-713.306
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`Case 1:17-cv-12194-MLW Document 32-2 Filed 03/01/18 Page 5 of 8
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`U.S. Serial No. 14/473,881
`Response to Final Office Action of Sept. 4, 2015
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`CONCLUSION
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`Applicant submits that this Response fully addresses the Final Office Action dated September 4,
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`2015. Applicant believes that the pending claims are under condition for allowance. Applicant
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`respectfully solicits the Examiner to expedite the prosecution of this patent application to issuance.
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`FEE AUTHORIZATION
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`The Commissioner is authorized to charge any additional fees which may be required, including
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`petition fees and extension of time fees, to Deposit Account No. 50-4961 (Docket No. 37901-713.306).
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`Respectfully submitted,
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`CARIS MPI, INC.
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`/Ramin Akhavan/
`Ramin Akhavan
`Registration No. 58,120
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`Date:
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`January 21, 2016
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`Caris MPI, Inc.
`6655 N. MacArthur Blvd.
`Irving, TX 75039
`Customer No. 96600
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`-4-
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`Docket No. 37901-713.306
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`Case 1:17-cv-12194-MLW Document 32-2 Filed 03/01/18 Page 6 of 8
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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`PATENT
`Attorney Docket No. 37901-713.306
`
`In re application of:
`
`Confirmation No.: 1038
`
`Inventors: Daniel D. VON HOFF et al.
`
`Group Art Unit: 1631
`
`Serial No.: 14/473,881
`
`Filed: August 29, 2014
`
`Examiner: LIN, JERRY
`
`Customer No. 96600
`
`For: SYSTEM AND METHOD FOR
`DETERMINING INDIVIDUALIZED MEDICAL
`INTERVENTION FORA DISEASE STATE
`
`Mail Stop Amendment
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`DECLARATION OF SANDEEP K REDDY, M.D., UNDER 37 CFR § 1.132
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`I, Sandeep K. Reddy, M.D., declare and state that:
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`1.
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`I am a Medical Oncologist and am board certified in Medical Oncology by the American
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`Board oflntemal Medicine. I have practiced in this field for over 12 years and have
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`prescribed chemotherapeutic treatment for hundreds of patients. I recently left my personal
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`practice to serve as Senior Vice President and Chief Medical Officer of Caris MPI, Inc.
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`("Caris"), the Assignee of the above referenced patent application.
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`2. Prior to my current position at Caris, I was Chief of Staff at Los Alamitos Medical Center
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`and actively practiced clinical hematology and oncology. I hold an adjunct faculty position at
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`the Geffen/UCLA School of Medicine as a clinical instructor at Harbor-UCLA Medical
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`Center, where I was awarded the distinguished teaching award for clinical faculty in 2006. I
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`am a member of the Los Angeles Biomedical Institute, American Society of Clinical
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`Oncology (ASCO), and International Association for the Study of Lung Cancer (IASLC). My
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`Attorney Docket No. 37901-713.305
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`Case 1:17-cv-12194-MLW Document 32-2 Filed 03/01/18 Page 7 of 8
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`U.S. Serial No. 14/473,871
`Response to Final Office Action of Sept. 3, 2015
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`medical training includes a fellowship in hematology and medical oncology and therapeutics
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`research at the City of Hope National Medical Center, and Internal Medicine residency at
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`Harbor-UCLA Medical Center. I received my M.D. from the Geffen/UCLA School of
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`Medicine after receiving my B.S. in biomedical sciences at the University of California,
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`Riverside.
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`3. I have reviewed the pending claims and Office Action mailed on September 4, 2015 (the
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`"Office Action"). The invention is directed to a system for generating a report identifying at
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`least one therapeutic agent for an individual with cancer. The system includes a device
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`configured to assay the molecular targets AR, EGFR, HER2, KIT, MLHI, PTEN, and
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`PDGFRA and computer instructions to identify at least one therapeutic agent based on the
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`assay results. The system also includes computer instructions to generate a report identifying
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`the therapeutic agent of likely benefit.
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`4.
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`It is my understanding that the claimed invention was rejected in part as abstract. However, I
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`believe that the claimed invention provides a concrete improvement in the practice of
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`medicine by identifying therapeutic agents that are of likely benefit to an individual with
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`cancer.
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`5. Caris provides a tumor molecular profiling service known as Caris Molecular Intelligence™
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`("CMI"). The CMI service includes devices to assay the biomarkers AR, EGFR, HER2, KIT,
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`MLHI, PTEN, and PDGFRA in a sample from an individual with cancer, and computer
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`technology to identify therapeutic agents of likely benefit for the cancer based on the assay
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`results and to generate a report identifying such therapeutic agents. Thus, this system
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`includes the components in the claimed invention.
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`6. To date, Caris has performed the CMI service on over 75,000 cancer patient samples from
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`practically all common tumors and many, if not all, rare tumors. We have assayed AR,
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`EGFR, HER2, KIT, MLHI, PTEN, and PDGFRA in thousands of cancer samples, and have
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`used these results in providing reports to treating physicians that recommend therapeutic
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`agents as having likely benefit or lack of benefit for the patients. Indeed, treating physicians
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`have used these reports in the real world to assist in the treatment of their cancer patients.
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`-2-
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`Attorney Docket No. 37901-713.306
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`Case 1:17-cv-12194-MLW Document 32-2 Filed 03/01/18 Page 8 of 8
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`U.S. Serial No. 14/473,871
`Response to Final Office Action of Sept. 3, 2015
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`7.
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`In sum, it is my expert medical opinion that the system of the claimed invention provides
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`improvements in the practice of medicine by identifying therapeutic agents that are of likely
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`benefit to an individual with cancer. This result cannot be determined by mere phenotypic
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`parameters and can only be determined using the specific analytes and informatics contained
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`within the invention.
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`8.
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`I declare that all statements made herein of my own knowledge are true and that all
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`statements were made on information and belief are believed to be true; and further that these
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`statements were made with the knowledge that willful false statements and the like to made
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`are punishable by fine or imprisonment, or both, under 18 U.S.C. § 1001 and that willful
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`false statements may jeopardize the validity of this application and any patent issuing
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`therefrom.
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`Sandeep K. Reddy, M.D.
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`Signed this day 18 of January, 2016
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`-3-
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`Attorney Docket No. 37901-713.306
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