Case 1:17-cv-12194-MLW Document 32-1 Filed 03/01/18 Page 1 of 11
`Case 1:17-cv—12194-MLW Document 32-1 Filed 03/01/18 Page 1 of 11
`
`EXHIBIT 1
`EXHIBIT 1
`
`

`

`Case 1:17-cv-12194-MLW Document 32-1 Filed 03/01/18 Page 2 of 11
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`PATENT
`Attorney Docket No. 37901-713.305
`
`In re application of:
`
`Confirmation No.: 1199
`
`Inventors: Daniel D. VON HOFF et al.
`
`Group Art Unit: 1631
`
`Serial No.: 14/473,871
`
`Filed: August 29, 2014
`
`Examiner: LIN, JERRY
`
`Customer No. 96600
`
`For: SYSTEM AND METHOD FOR
`DETERMINING INDIVIDUALIZED MEDICAL
`INTERVENTION FORA DISEASE STATE
`
`ELECTRONICALLY FILED JANUARY 21, 2015
`
`Mail Stop Amendment
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`Sir/Madam:
`
`Introductory Comments:
`
`RESPONSE TO FINAL OFFICE ACTION
`
`This Response is in response to the Final Office Action dated September 3, 2015 (the "Office
`
`Action"). The shortened statutory period for response expired on December 3, 2015. Therefore,
`
`Applicant submits fees for a two-month extension with the filing of this Response.
`
`Applicant respectfully requests reconsideration of the above-referenced application in view of the
`
`following amendments and remarks.
`
`Remarks begin on page 2 of this Response.
`
`Docket No. 37901-713.305
`
`

`

`Case 1:17-cv-12194-MLW Document 32-1 Filed 03/01/18 Page 3 of 11
`
`U.S. Serial No. 14/473,871
`Response to Final Office Action of Sept. 3, 2015
`
`REMARKS
`
`With this Response, no claims are amended. Thus, Applicant believes no search is required and
`
`respectfully requests reconsideration of the pending claims based on the following remarks.
`
`I.
`
`Information Disclosure Statement
`
`Applicant thanks the Examiner for acknowledging the Supplemental IDS statement filed August
`
`7, 2015. Applicant has submitted an additional Supplemental IDS statement herewith.
`
`II. Examiner Interview
`
`Applicant is very appreciative to the Examiner for attending the telephonic interview on
`
`September 10, 2015. Examiner Lin and Applicant's representatives Ray Akhavan and Jeff Thomas were
`
`in attendance. The rejection under 35 U.S.C. § 101 was discussed. The Examiner's remarks were very
`
`helpful to Applicant in preparing this Response.
`
`III. Claim Rejections under 35 U.S.C. § 101
`
`The Examiner rejected claims 1-14 under 35 U.S.C. § 101 as allegedly "directed to a judicial
`
`exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more."
`
`Office Action, p. 2. The Examiner alleges that the claims "are directed to the abstract idea of identifying a
`
`therapeutic agent for an individual with a cancer." Id. The Examiner reasons that "[t]he device for
`
`assaying molecular targets is a data-gathering device that is routine, conventional, and well-known for
`
`gathering molecular profile test data" and that "computer code and computer database are also routine,
`
`conventional, and well-known, tools of implementing an abstract idea." Id. at p. 3. Applicant respectfully
`
`traverses the rejection.
`
`On December 16, 2014, the USPTO guidance issued updated guidelines for determining subject
`
`matter eligibility under 35 U.S.C. 101 in view ofrecent decisions by the U. S. Supreme Court (the
`
`"Guidance"). The Guidance provides "a number of considerations [identified by the Supreme Court] for
`
`determining whether a claim with additional elements amounts to significantly more than the judicial
`
`exception itself." Guidance, p. 21. In the instant application, the claims provide "[i]mprovements to
`
`another technology or technical field" and thus recite eligible subject matter. See id. at p. 21 (citation
`
`removed).
`
`-2-
`
`Docket No. 37901-713.305
`
`

`

`Case 1:17-cv-12194-MLW Document 32-1 Filed 03/01/18 Page 4 of 11
`
`U.S. Serial No. 14/473,871
`Response to Final Office Action of Sept. 3, 2015
`
`Applicant submits herewith a Declaration under 3 7 CFR § 1.13 2 from medical oncologist
`
`Sandeep K. Reddy, M.D. (the "Reddy Declaration"). In the declaration, Dr. Reddy states that the system
`
`of the invention has been implemented in the real world and used to assist treating physicians in the care
`
`of patients having various cancers by suggesting therapeutic agents as having likely benefit for those
`
`patients. See Reddy Declaration,~~ 5-6. The Reddy Declaration provides evidence that the claimed
`
`invention effects an improvement in the treatment of cancer victims. See id.
`
`Accordingly, Applicant submits evidence herewith that the claimed system provides an
`
`improvement in another technology or technical field, namely in the medical field and specifically in the
`
`treatment of cancer victims. See Reddy Declaration, ~ 7. Accordingly, the claims recite "significantly
`
`more" than any alleged judicial exception. See Guidance, p. 21. Applicant respectfully requests that the
`
`Examiner reconsider and withdraw this rejection and allow all claims.
`
`IV. Claim Rejections under 35 U.S.C. § 103(a)
`
`Applicant thanks the Examiner for withdrawing the prior rejection under 35 U.S.C. § 103(a).
`
`-3-
`
`Docket No. 37901-713.305
`
`

`

`Case 1:17-cv-12194-MLW Document 32-1 Filed 03/01/18 Page 5 of 11
`
`U.S. Serial No. 14/473,871
`Response to Final Office Action of Sept. 3, 2015
`
`CONCLUSION
`
`Applicant submits that this Response fully addresses the Final Office Action dated September 3,
`
`2015. Applicant believes that the pending claims are under condition for allowance. Applicant
`
`respectfully solicits the Examiner to expedite the prosecution of this patent application to issuance.
`
`FEE AUTHORIZATION
`
`The Commissioner is authorized to charge any additional fees which may be required, including
`
`petition fees and extension of time fees, to Deposit Account No. 50-4961 (Docket No. 37901-713.305).
`
`Respectfully submitted,
`
`CARIS MPI, INC.
`
`/Ramin Akhavan/
`Ramin Akhavan
`Registration No. 58,120
`
`Date:
`
`January 21, 2016
`
`Caris MPI, Inc.
`6655 N. MacArthur Blvd.
`Irving, TX 75039
`Customer No. 96600
`
`-4-
`
`Docket No. 37901-713.305
`
`

`

`Case 1:17-cv-12194-MLW Document 32-1 Filed 03/01/18 Page 6 of 11
`
`U.S. Serial No. 14/473,871
`Response to Final Office Action of Sept. 3, 2015
`
`REMARKS
`
`With this Response, no claims are amended. Thus, Applicant believes no search is required and
`
`respectfully requests reconsideration of the pending claims based on the following remarks.
`
`I.
`
`Information Disclosure Statement
`
`Applicant thanks the Examiner for acknowledging the Supplemental IDS statement filed August
`
`7, 2015. Applicant has submitted an additional Supplemental IDS statement herewith.
`
`II. Examiner Interview
`
`Applicant is very appreciative to the Examiner for attending the telephonic interview on
`
`September 10, 2015. Examiner Lin and Applicant's representatives Ray Akhavan and Jeff Thomas were
`
`in attendance. The rejection under 35 U.S.C. § 101 was discussed. The Examiner's remarks were very
`
`helpful to Applicant in preparing this Response.
`
`III. Claim Rejections under 35 U.S.C. § 101
`
`The Examiner rejected claims 1-14 under 35 U.S.C. § 101 as allegedly "directed to a judicial
`
`exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more."
`
`Office Action, p. 2. The Examiner alleges that the claims "are directed to the abstract idea of identifying a
`
`therapeutic agent for an individual with a cancer." Id. The Examiner reasons that "[t]he device for
`
`assaying molecular targets is a data-gathering device that is routine, conventional, and well-known for
`
`gathering molecular profile test data" and that "computer code and computer database are also routine,
`
`conventional, and well-known, tools of implementing an abstract idea." Id. at p. 3. Applicant respectfully
`
`traverses the rejection.
`
`On December 16, 2014, the USPTO guidance issued updated guidelines for determining subject
`
`matter eligibility under 35 U.S.C. 101 in view ofrecent decisions by the U. S. Supreme Court (the
`
`"Guidance"). The Guidance provides "a number of considerations [identified by the Supreme Court] for
`
`determining whether a claim with additional elements amounts to significantly more than the judicial
`
`exception itself." Guidance, p. 21. In the instant application, the claims provide "[i]mprovements to
`
`another technology or technical field" and thus recite eligible subject matter. See id. at p. 21 (citation
`
`removed).
`
`-2-
`
`Docket No. 37901-713.305
`
`

`

`Case 1:17-cv-12194-MLW Document 32-1 Filed 03/01/18 Page 7 of 11
`
`U.S. Serial No. 14/473,871
`Response to Final Office Action of Sept. 3, 2015
`
`Applicant submits herewith a Declaration under 3 7 CFR § 1.13 2 from medical oncologist
`
`Sandeep K. Reddy, M.D. (the "Reddy Declaration"). In the declaration, Dr. Reddy states that the system
`
`of the invention has been implemented in the real world and used to assist treating physicians in the care
`
`of patients having various cancers by suggesting therapeutic agents as having likely benefit for those
`
`patients. See Reddy Declaration,~~ 5-6. The Reddy Declaration provides evidence that the claimed
`
`invention effects an improvement in the treatment of cancer victims. See id.
`
`Accordingly, Applicant submits evidence herewith that the claimed system provides an
`
`improvement in another technology or technical field, namely in the medical field and specifically in the
`
`treatment of cancer victims. See Reddy Declaration, ~ 7. Accordingly, the claims recite "significantly
`
`more" than any alleged judicial exception. See Guidance, p. 21. Applicant respectfully requests that the
`
`Examiner reconsider and withdraw this rejection and allow all claims.
`
`IV. Claim Rejections under 35 U.S.C. § 103(a)
`
`Applicant thanks the Examiner for withdrawing the prior rejection under 35 U.S.C. § 103(a).
`
`-3-
`
`Docket No. 37901-713.305
`
`

`

`Case 1:17-cv-12194-MLW Document 32-1 Filed 03/01/18 Page 8 of 11
`
`U.S. Serial No. 14/473,871
`Response to Final Office Action of Sept. 3, 2015
`
`CONCLUSION
`
`Applicant submits that this Response fully addresses the Final Office Action dated September 3,
`
`2015. Applicant believes that the pending claims are under condition for allowance. Applicant
`
`respectfully solicits the Examiner to expedite the prosecution of this patent application to issuance.
`
`FEE AUTHORIZATION
`
`The Commissioner is authorized to charge any additional fees which may be required, including
`
`petition fees and extension of time fees, to Deposit Account No. 50-4961 (Docket No. 37901-713.305).
`
`Respectfully submitted,
`
`CARIS MPI, INC.
`
`/Ramin Akhavan/
`Ramin Akhavan
`Registration No. 58,120
`
`Date:
`
`January 21, 2016
`
`Caris MPI, Inc.
`6655 N. MacArthur Blvd.
`Irving, TX 75039
`Customer No. 96600
`
`-4-
`
`Docket No. 37901-713.305
`
`

`

`Case 1:17-cv-12194-MLW Document 32-1 Filed 03/01/18 Page 9 of 11
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`PATENT
`Attorney Docket No. 37901-713.305
`
`In re application of:
`
`Confirmation No.: 1199
`
`Inventors: Daniel D. VON HOFF et al.
`
`Group Art Unit: 1631
`
`Serial No.: 14/473,871
`
`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
`
`I, Sandeep K. Reddy, M.D., declare and state that:
`
`1.
`
`I am a Medical Oncologist and am board certified in Medical Oncology by the American
`
`Board oflntemal Medicine. I have practiced in this field for over 12 years and have
`
`prescribed chemotherapeutic treatment for hundreds of patients. I recently left my personal
`
`practice to serve as Senior Vice President and Chief Medical Officer of Caris MPI, Inc.
`
`("Caris"), the Assignee of the above referenced patent application.
`
`2. Prior to my current position at Caris, I was Chief of Staff at Los Alamitos Medical Center
`
`and actively practiced clinical hematology and oncology. I hold an adjunct faculty position at
`
`the Geffen/UCLA School of Medicine as a clinical instructor at Harbor-UCLA Medical
`
`Center, where I was awarded the distinguished teaching award for clinical faculty in 2006. I
`
`am a member of the Los Angeles Biomedical Institute, American Society of Clinical
`
`Oncology (ASCO), and International Association for the Study of Lung Cancer (IASLC). My
`
`Attorney Docket No. 37901-713.305
`
`

`

`Case 1:17-cv-12194-MLW Document 32-1 Filed 03/01/18 Page 10 of 11
`
`U.S. Serial No. 14/473,871
`Response to Final Office Action of Sept. 3, 2015
`
`medical training includes a fellowship in hematology and medical oncology and therapeutics
`
`research at the City of Hope National Medical Center, and Internal Medicine residency at
`
`Harbor-UCLA Medical Center. I received my M.D. from the Geffen/UCLA School of
`
`Medicine after receiving my B.S. in biomedical sciences at the University of California,
`
`Riverside.
`
`3. I have reviewed the pending claims and Office Action mailed on September 3, 20I5 (the
`
`"Office Action"). The invention is directed to a system for generating a report identifying at
`
`least one therapeutic agent for an individual with cancer. The system includes a device
`
`configured to assay the molecular targets EGFR, KIT, TOPI, MLHI, PTEN, PDGFRA and
`
`ERRB2 and computer instructions to identify at least one therapeutic agent based on the
`
`assay results. The system also includes computer instructions to generate a report identifying
`
`the therapeutic agent of likely benefit.
`
`4.
`
`It is my understanding that the claimed invention was rejected in part as abstract. However, I
`
`believe that the claimed invention provides a concrete improvement in the practice of
`
`medicine by identifying therapeutic agents that are of likely benefit to an individual with
`
`cancer.
`
`5. Caris provides a tumor molecular profiling service known as Caris Molecular Intelligence™
`
`("CMI"). The CMI service includes devices to assay the biomarkers EGFR, KIT, TOPI,
`
`MLHI, PTEN, PDGFRA and ERRB2 in a sample from an individual with cancer, and
`
`computer technology to identify therapeutic agents of likely benefit for the cancer based on
`
`the assay results and to generate a report identifying such therapeutic agents. Thus, this
`
`system includes the components in the claimed invention.
`
`6. To date, Caris has performed the CMI service on over 75,000 cancer patient samples from
`
`practically all common tumors and many, if not all, rare tumors. We have assayed EGFR,
`
`KIT, TOPI, MLHI, PTEN, PDGFRA and ERRB2 in thousands of cancer samples, and have
`
`used these results in providing reports to treating physicians that recommend therapeutic
`
`agents as having likely benefit or lack of benefit for the patients. Indeed, treating physicians
`
`have used these reports in the real world to assist in the treatment of their cancer patients.
`
`-2-
`
`Attorney Docket No. 37901-713.305
`
`

`

`Case 1:17-cv-12194-MLW Document 32-1 Filed 03/01/18 Page 11 of 11
`
`U.S. Serial No. 14/473,871
`Response to Final Office Action of Sept. 3, 20 15
`
`7. In sum, it is my expert medical opinion that the system of the claimed invention provides
`
`improvements in the practice of medicine by identifying therapeutic agents that are of likely
`
`benefit to an individual with cancer. This result cannot be determined by mere phenotypic
`
`parameters and can only be determined using the specific analytes and informatics contained
`
`within the invention.
`
`8. I declare that all statements made herein of my own knowledge are true and that all
`
`statements were made on information and belief are believed to be true; and further that these
`
`statements were made with the knowledge that willful false statements and the like to made
`
`are punishable by fine or imprisonment, or both, under 18 U.S.C. § 1001 and that willful
`
`false statements may jeopardize the validity of this application and any patent issuing
`
`therefrom.
`
`Sandeep K. Reddy, M.D.
`
`Signed this day 21 of January, 2015
`
`-3-
`
`Attorney Docket No. 37901-713.305
`
`