PATENT
`Attorney Docket No.: EXCTD-35239.307
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In re Application of:
`Serial No.:
`Filed:
`Entitled:
`
`Confirmation: 2966
`Joost Louwagie
`Group No.:
`1634
`18/179,945
`Examiner:
`Ethan C. Whisenant
`03/07/2023
`FECAL SAMPLE PROCESSING AND ANALYSIS COMPRISING
`DETECTION OF BLOOD
`
`AMENDMENT AND RESPONSE TO NON-FINAL
`OFFICE ACTION MAILED 07/06/2023
`
`EFS WEB FILED
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`This paperis responsive to the Office Action mailed 07/06/2023, with response due by
`
`10/06/2023. Applicant respectfully requests reconsideration in view of the remarks hereinbelow.
`
`The Commissioneris authorized by this paper to charge any fees during the entire
`
`pendency ofthis application, including fees due under 37 C.F.R. §§ 1.16 and 1.17 that may be
`
`required, including any required extension of time fees, or credit any overpayment to Deposit
`
`Account 50-4302, referencing Attorney Docket No.: EXCTD-35239.307. This paragraphis a
`
`CONSTRUCTIVE PETITION FOR EXTENSION OF TIME in accordance with 37 C.F.R. §
`
`1.136(a)(3).
`
`Amendmentto the Claims begins on Page 2;
`
`Remarksbegin on Page6.
`
`]
`
`Geneoscopy Exhibit 1019, Page 1
`
`Geneoscopy Exhibit 1019, Page 1
`
`

`

`PATENT
`Attorney Docket No.: EXCTD-35239.307
`
`AMENDMENTSTO THE CLAIMS:
`
`This listing of the claims will replace all prior listings and versions of claims in the
`
`application:
`
`1.
`
`(original) A method of processing a freshly-collected fecal sample without freezing, the
`
`method comprising:
`
`a)
`
`collecting a fecal sample from a human subject, wherein the fecal sample is
`
`collected at home by the humansubject;
`
`
`
`b) in a sealable vessel, combiningafirst portion of the fecal sample with a
`
`stabilizing buffer, and sealing the sealable vessel; and
`
`)
`
`in a sealable container, combining a second portion of the fecal sample with a
`
`solution that prevents denaturation or degradation of blood proteins found in a
`
`fecal sample, and sealing the sealable container.
`
`(original) The method of claim 1, further comprising delivering the sealable vessel
`
`containing the first portion of the fecal sample and the stabilizing buffer and the sealable
`
`container containing the second portion of the fecal sample and the solution to a medical
`
`diagnostics laboratory.
`
`(canceled)
`
`(original) A method of processing a fecal sample, the method comprising:
`
`a)
`
`obtaining a pair of portions of a fecal sample collected from a humansubject, the
`
`pair of portions comprising:
`
`i)
`
`a sealed sealable vessel containing a first portion of a fecal sample
`
`and a stabilizing buffer; and
`
`ii)
`
`a sealed sealable container containing a second portion of a fecal
`
`sample and a solution that prevents denaturation or degradation of
`
`blood proteins found in a fecal sample,
`
`2
`
`Geneoscopy Exhibit 1019, Page 2
`
`Geneoscopy Exhibit 1019, Page 2
`
`

`

`PATENT
`Attorney Docket No.: EXCTD-35239.307
`
`b)
`
`c)
`
`wherein the pair of portions are obtained by the method of claim 1;
`
`extracting nucleic acid from the first portion of the fecal sample;
`
`testing nucleic acid extracted from the first portion of the fecal sample for an
`
`amount of a human nucleic acid; and
`
`d)
`
`testing the second portion of the fecal sample for an amountof a blood protein
`
`present in the second portion of the fecal sample.
`
`(original) The method of claim 4, wherein testing the nucleic acid comprises determining
`
`expression from a human gene.
`
`(original) The method of claim 5, wherein determining expression from the human gene
`
`comprises testing the nucleic acid for presence of human DNAhaving an epigenetic
`
`modification.
`
`(original) The method of claim 6, wherein testing the nucleic acid for the presence of
`
`human DNAhaving an epigenetic modification comprises measuring an amountof a
`
`methylated human DNA.
`
`(original) The method of claim 6, wherein the epigenetic modification comprises aberrant
`
`methylation.
`
`(original) The method of claim 8, wherein the aberrant methylation comprises
`
`hypermethylation.
`
`10.
`
`(original) The method of claim 6, wherein the human DNAhavingan epigenetic
`
`modification comprises a gene and/or a promoter region of a gene.
`
`3
`
`Geneoscopy Exhibit 1019, Page 3
`
`Geneoscopy Exhibit 1019, Page 3
`
`

`

`PATENT
`Attorney Docket No.: EXCTD-35239.307
`
`11.
`
`(original) The method of claim 10, wherein the geneis selected from the group consisting
`
`of PHACTR3, NDRG4, FOXE1, GATA4, GPNMB, TFPI2, SOX17, SYNE1, LAMA,
`
`MMP2?, OSMR, SFRP2, and CDO1.
`
`12.
`
`(original) The method of claim 6, wherein testing the nucleic acid for the presence of
`
`human DNAhaving an epigenetic modification comprises modifying the nucleic acid
`
`with bisulfite ions under conditions wherein unmethylated cytosine is converted to uracil.
`
`13.
`
`(original) The method of claim 5, wherein determining expression from the human gene
`
`comprises measuring an amount of RNA expressed from the humangene.
`
`14.
`
`(original) The method of claim 13, wherein measuring an amount of RNA expressed
`
`from the human gene comprises reverse transcriptase polymerase chain reaction (RT-
`
`PCR).
`
`15.
`
`(original) The method of claim 4, wherein testing for an amountof a blood protein
`
`present in the second portion comprisestesting for a concentration of hemoglobin in the
`
`second portion, wherein a concentration of hemoglobin is indicative of a presence of
`
`blood in the fecal sample.
`
`16.
`
`(original) The method of claim 15, wherein testing for the concentration of hemoglobin
`
`comprises immunochemical detection of hemoglobin.
`
`17.
`
`(original) The method of claim 15, wherein the second portion of the fecal sample is
`
`considered positive for the presence of blood when the concentration of hemoglobin
`
`detected in the second portionis at least 5 ng/ml.
`
`18.
`
`(original) The method of claim 15, wherein the second portion of the fecal sample is
`
`considered positive for the presence of blood when the concentration of hemoglobin
`
`detected in the second portion is at least 10 ng/ml.
`
`4
`
`Geneoscopy Exhibit 1019, Page 4
`
`Geneoscopy Exhibit 1019, Page 4
`
`

`

`PATENT
`Attorney Docket No.: EXCTD-35239.307
`
`19.
`
`(original) The method of claim 15, wherein the second portion of the fecal sample is
`
`considered positive for the presence of blood when the concentration of hemoglobin
`
`detected in the second portion is at least 20 ng/ml.
`
`20.
`
`(original) The method of claim 15, wherein the second portion of the fecal sample is
`
`considered positive for the presence of blood when the concentration of hemoglobin
`
`detected in the second portion is at least 50 ng/ml.
`
`5
`
`Geneoscopy Exhibit 1019, Page 5
`
`Geneoscopy Exhibit 1019, Page 5
`
`

`

`PATENT
`Attorney Docket No.: EXCTD-35239.307
`
`REMARKS
`
`Information Disclosure Statements
`
`Claims 1-20 are pending in the present application. Applicant notes with appreciation that
`
`the Examinerhas considered the references disclosed by the Applicant in the Information
`
`Disclosure Statements filed in this matter on 03/07/2023 and 06/08/2023.
`
`Claim Amendments
`
`For business reasons and without acquiescing to Examiner arguments, and reserving the
`
`right to prosecute the original or similar claims in one or more future applications, Applicant
`
`herein cancels claim 3 without prejudice.
`
`Office Action
`
`In an Office Action mailed 07/06/2023, the Examiner provisionally rejected all claims on
`
`the grounds of non-statutory obviousness-type double patenting over claims 1-19 of co-pending
`
`Application Ser No. 18/179,961.
`
`The Examineradditionally rejects Claims 1-20 over claims 1-20 of U.S. Patent No.
`
`11,634,781.
`
`Solely in the interest of expediting prosecution, Applicant herewith files terminal
`
`disclaimers over Application Ser. No. 18/179,961 and USPatent No. 11,634,781 to obviate the
`
`present rejections. Applicant notes thatthe filing of a terminal disclaimer to obviate a rejection
`
`based on non-statutory double patenting is not an admission of the propriety of the rejection.
`
`6
`
`Geneoscopy Exhibit 1019, Page 6
`
`Geneoscopy Exhibit 1019, Page 6
`
`

`

`PATENT
`Attorney Docket No.: EXCTD-35239.307
`
`CONCLUSION
`
`It is respectfully submitted that all grounds for rejection have been addressed and
`
`Applicant’s claims should be passed to allowance. Should the Examinerbelieve that a telephone
`
`interview would aid in the prosecution of this application, Applicant encourages the Examinerto
`
`call the undersigned at (608) 662-1277.
`
`
`
` Dated: October 6, 2023
`
`/Mary Ann D. Brow/
`
`Mary Ann D. Brow
`Registration No. 42,363
`
`CASIMIR JONES, S.C.
`2275 Deming Way,Suite 310
`Middleton, Wisconsin 53562
`608.662.1277
`
`7
`
`Geneoscopy Exhibit 1019, Page 7
`
`Geneoscopy Exhibit 1019, Page 7
`
`

`

`PTO/AIA/26 (04-14)
`Approvedfor use through 05/31/2024. OMB 0651-0031
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Underthe Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unlessit displays a valid OMB control number.
`TERMINAL DISCLAIMER TO OBVIATE A DOUBLE PATENTING
`Docket Number(Optional)
`REJECTION OVERA “PRIOR” PATENT
`EXCTD-35239.307
`
`In re Application of: Joost Louwagie
`
`Application No.: 18/1 79,945
`
`Filed: 7 March 2023
`
`For: FECAL SAMPLE PROCESSING AND ANALYSIS COMPRISING DETECTION OF BLOOD
`
`percentinterest in the instant application hereby
`100
`, owner of
`The applicant, Exact Sciences Corporation
`disclaims, except as provided below, the terminal part of the statutory term of any patent granted on the instant application which would extend
`beyond the expiration date of the full statutory term of prior patent No. 11,634,781
`as the term of said prior patent is presently
`shortened by any terminal disclaimer. The applicant hereby agrees that any patent so granted on the instant application shall be enforceable
`only for and during suchperiod that it and the prior patent are commonly owned. This agreement runs with any patent granted on the instant
`application and is binding upon the grantee, its successors or assigns.
`
`In making the abovedisclaimer, the applicant does not disclaim the terminal part of the term of any patent granted on the instant application
`that would extend to the expiration date of the full statutory term of the prior patent, “as the term of said prior patent is presently shortened by
`any terminal disclaimer," in the event that said prior patentlater:
`expires for failure to pay a maintenancefee;
`is held unenforceable;
`is found invalid by a court of competentjurisdiction;
`is statutorily disclaimed in whole or terminally disclaimed under 37 CFR 1.321;
`hasall claims canceled by a reexamination certificate;
`is reissued; or
`is in any manner terminated prior to the expiration of its full statutory term as presently shortened by any terminal disclaimer.
`
`be included on this form. Provide credit card information and authorization on PTO-2038.
`
`Checkeither box 1 or 2 below,if appropriate.
`1. [| The undersignedis the applicant.
`If the applicant is an assignee, the undersigned is authorized to act on behalf of the assignee.
`
`| hereby acknowledge that any willful false statements made are punishable under 18 U.S.C. 1001 by fine or imprisonment of not more
`than five (5) years, or both.
`
`2.
`
`The undersigned is an attorney or agent of record. Reg. No._42363
`
`/Mary Ann D. Brow/
`Signature
`
`10/06/2023
`Date
`
`Mary Ann D. Brow
`Typed or printed name
`
`Attorney
`Title
`
`608-662-1277
`Telephone Number
`
`Terminal disclaimer fee under 37 CFR 1.20(d) included.
`
`WARNING: Information on this form may becomepublic. Credit card information should not
`
`A Federal agency may not conduct or sponsor, and a personis not required to respond to, nor shall a person be subject to a penalty for failure to comply with an
`information collection subject to the requirements of the Paperwork Reduction Act of 1995, unless the information collection has a currently valid OMB Control
`Number. The OMB Control Number for this information collection is 0651-0031. Public burden for this form is estimated to average 12 minutes per response,
`including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the
`information collection. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this
`burden to the Chief Administrative Officer, United States Patent and Trademark Office, P.O. Box 1450, Alexandria, VA 22313-1450 or email
`InformationCollection@uspto.gov. DO NOT SEND FEES OR COMPLETED FORMS TO THIS ADDRESS. If filing this completed form by mail, send to:
`Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313-1450.
`
`_
`If you need assistance in completing the form, call 1-800-PTO-9199 and select option 2.
`Geneoscopy Exhibit 1019, Page 8
`
`Geneoscopy Exhibit 1019, Page 8
`
`

`

`Privacy Act Statement
`
`The Privacy Act of 1974 (P.L. 93-579) requires that you be given certain information in connection
`with your submission of the attached form related to a patent application or patent. The United States
`Patent and Trademark Office (USPTO) collects the information in this record under authority of 35
`U.S.C. 2. The USPTO’s system of records is used to manage all applicant and owner information
`including name, citizenship, residence, post office address, and other information with respect to
`inventors and their legal representatives pertaining to the applicant's/owner’s activities in connection
`with the invention for which a patent is sought or has been granted. The applicable Privacy Act
`System of Records Notice for the information collected in this form is COMMERCE/PAT-TM-7 Patent
`Application Files, available in the Federal Register at 78 FR 19243 (March 29, 2013). https://
`www.govinfo.gov/content/pkg/FR-201 3-03-29/pdf/2013-07341 .pdf
`
`Routine uses of the information in this record may include disclosure to: 1) law enforcement, in the
`event that the system of records indicates a violation or potential violation of law; 2) a Federal, state,
`local, or international agency, in response to its request; 3) a contractor of the USPTO having need
`for the information in order to perform a contract; 4) the Departmentof Justice for determination of
`whether the Freedom of Information Act (FOIA) requires disclosure of the record; 5) a Member of
`Congress submitting a request involving an individual to whom the record pertains, when the
`individual has requested the Member's assistance with respect to the subject matter of the record; 6)
`a court, magistrate, or administrative tribunal, in the course of presenting evidence, including
`disclosures to opposing counsel in the course of settlement negotiations; 7) the Administrator,
`General Services Administration (GSA), or their designee, during an inspection of records conducted
`by GSA under authority of 44 U.S.C. 2904 and 2906, in accordance with the GSA regulations and any
`other relevant (i.e., GSA or Commerce) directive, where such disclosure shall not be used to make
`determinations about individuals; 8) another federal agency for purposes of National Security review
`(35 U.S.C. 181) and for review pursuant to the Atomic Energy Act (42 U.S.C. 218(c)); 9) the Office of
`Personnel Management (OPM) for personnel research purposes; and 9) the Office of Management
`and Budget (OMB)for legislative coordination and clearance.
`
`If you do not furnish the information requested on this form, the USPTO maynot be able to process
`and/or examine your submission, which may result in termination of proceedings, abandonmentof the
`application, and/or expiration of the patent.
`
`Additional Uses
`
`Additional USPTO usesof the information in this record mayinclude disclosureto: 1) the International
`Bureau of the World Intellectual Property Organization, if the record is related to an international
`application filed under the Patent Cooperation Treaty; 2) the public i) after publication of the
`application pursuant to 35 U.S.C. 122(b), ii) after issuance of a patent pursuant to 35 U.S.C. 151, iii) if
`the record wasfiled in an application which became abandonedor in which the proceedings were
`terminated and which application is referenced by either a published application, an application open
`to public inspections, or an issued patent, or iv) without publication of the application or patent under
`the specific circumstances provided for by 37 CFR 1.14(a)(1)(v)-(vii); and/or 3) the National Archives
`and Records Administration, for inspection of records.
`
`Geneoscopy Exhibit 1019, Page 9
`
`Geneoscopy Exhibit 1019, Page 9
`
`

`

`PTO/AIA/25 (04-13)
`Approved for use through 05/31/2024. OMB 0651-0031
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Underthe Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unlessit displays a valid OMB control number.
`TERMINAL DISCLAIMER TO OBVIATE A PROVISIONAL DOUBLE PATENTING_|Docket Number (Optional)
`REJECTION OVERA PENDING “REFERENCE” APPLICATION
`EXCTD-35239.307
`
`In re Application of: Joost Louwagie
`
`Application No.: 18/179,945
`
`Filed: 7 March 2023
`
`be included on this form. Provide credit card information and authorization on PTO-2038. A
`
`For: FECAL SAMPLE PROCESSING AND ANALYSIS COMPRISING DETECTION OF BLOOD
`
`percent interest in the instant application hereby
`100
`, ownerof
`The applicant, Exact Sciences Corporation
`of
`part
`the statutory term of any patent granted on the instant application which would extend
`disclaims, except as provided
`below, the terminal
`beyond the expiration date of the full statutory term of any patent granted on pending reference Application Number 18/1 79,961
`filed, 7 March 2023
`, as the term of any patent granted on said reference application may be shortened by any terminal disclaimer
`filed prior to the grant of any patent on the pending reference application. The applicant hereby agrees that any patent so granted on the instant
`application shall be enforceable only for and during suchperiod that it and any patent granted on the reference application are commonly
`owned. This agreement runs with any patent granted on the instant application and is binding upon the grantee, its successors or assigns.
`
`In making the abovedisclaimer, the applicant does not disclaim the terminal part of any patent granted on the instant application that would
`extend to the expiration date of the full statutory term of any patent granted on said reference application, “as the term of any patent granted on
`said reference application may be shortened by any terminal disclaimerfiled prior to the grant of any patent on the pending reference
`application,” in the event that: any such patent granted on the pending reference application expires for failure to pay a maintenancefee, is
`held unenforceable, is found invalid by a court of competentjurisdiction, is statutorily disclaimed in whole or terminally disclaimed under 37
`CFR 1.321, hasall claims canceled by a reexamination certificate, is reissued, or is in any mannerterminated prior to the expiration ofits full
`statutory term as shortened by any terminal disclaimer filed prior to its grant.
`
`Checkeither box 1 or 2 below, if appropriate.
`1. L] The undersignedis the applicant.
`If the applicant is an assignee, the undersigned is authorized to act on behalf of the assignee.
`
`| hereby acknowledge that anywillful false statements made are punishable under 18 U.S.C. 1001 byfine or imprisonment of not more than
`five (5) years, or both.
`
`2.
`
`The undersigned is an attorney or agent of record. Reg. No. 42363
`
`/Mary Ann D. Brow/
`Signature
`
`10/06/2023
`Date
`
`Mary Ann D. Brow
`Typed or printed name
`
`Attorney —___—608-662-1277
`Title
`Telephone Number
`
`Terminal disclaimer fee under 37 CFR 1.20(d) is included.
`
`WARNING: Information on this form may becomepublic. Credit card information should not
`
`an
`failure to comply with
`to a penalty for
`required to respond to, nor shall a person be subject
`or sponsor, and a personis not
`Federal agency may not conduct
`information collection subject to the requirements of the Paperwork Reduction Act of 1995, unless the information collection has a currently valid OMB Control
`Number. The OMB Control Numberfor this information collection is 0651-0031. Public burden for this form is estimated to average 12 minutes per response,
`including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the
`information collection. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this
`burden to the Chief Administrative Officer, United States Patent and Trademark Office, P.O. Box 1450, Alexandria, VA 22313-1450 or email
`InformationCollection@uspto.gov. DO NOT SEND FEES OR COMPLETED FORMS TO THIS ADDRESS. If filing this completed form by mail, send to:
`Commissionerfor Patents, P.O. Box 1450, Alexandria, VA 22313-1450.
`
`If you need assistance in completing the form, call 1-800-PTO-9199 and select option 2.
`
`Geneoscopy Exhibit 1019, Page 10
`
`Geneoscopy Exhibit 1019, Page 10
`
`

`

`Privacy Act Statement
`
`The Privacy Act of 1974 (P.L. 93-579) requires that you be given certain information in connection
`with your submission of the attached form related to a patent application or patent. The United States
`Patent and Trademark Office (USPTO) collects the information in this record under authority of 35
`U.S.C. 2. The USPTO’s system of records is used to manage all applicant and owner information
`including name, citizenship, residence, post office address, and other information with respect to
`inventors and their legal representatives pertaining to the applicant's/owner’s activities in connection
`with the invention for which a patent is sought or has been granted. The applicable Privacy Act
`System of Records Notice for the information collected in this form is COMMERCE/PAT-TM-7 Patent
`Application Files, available in the Federal Register at 78 FR 19243 (March 29, 2013). https://
`www.govinfo.gov/content/pkg/FR-201 3-03-29/pdf/2013-07341 .pdf
`
`Routine uses of the information in this record may include disclosure to: 1) law enforcement, in the
`event that the system of records indicates a violation or potential violation of law; 2) a Federal, state,
`local, or international agency, in response to its request; 3) a contractor of the USPTO having need
`for the information in order to perform a contract; 4) the Departmentof Justice for determination of
`whether the Freedom of Information Act (FOIA) requires disclosure of the record; 5) a Member of
`Congress submitting a request involving an individual to whom the record pertains, when the
`individual has requested the Member's assistance with respect to the subject matter of the record; 6)
`a court, magistrate, or administrative tribunal, in the course of presenting evidence, including
`disclosures to opposing counsel in the course of settlement negotiations; 7) the Administrator,
`General Services Administration (GSA), or their designee, during an inspection of records conducted
`by GSA under authority of 44 U.S.C. 2904 and 2906, in accordance with the GSA regulations and any
`other relevant (i.e., GSA or Commerce) directive, where such disclosure shall not be used to make
`determinations about individuals; 8) another federal agency for purposes of National Security review
`(35 U.S.C. 181) and for review pursuant to the Atomic Energy Act (42 U.S.C. 218(c)); 9) the Office of
`Personnel Management (OPM) for personnel research purposes; and 9) the Office of Management
`and Budget (OMB)for legislative coordination and clearance.
`
`If you do not furnish the information requested on this form, the USPTO maynot be able to process
`and/or examine your submission, which mayresult in termination of proceedings, abandonmentof the
`application, and/or expiration of the patent.
`
`Additional Uses
`
`Additional USPTO usesofthe information in this record mayinclude disclosure to: 1) the International
`Bureau of the World Intellectual Property Organization, if the record is related to an international
`application filed under the Patent Cooperation Treaty; 2) the public i) after publication of the
`application pursuant to 35 U.S.C. 122(b), ii) after issuance of a patent pursuant to 35 U.S.C. 151, iii) if
`the record wasfiled in an application which became abandonedor in which the proceedings were
`terminated and which application is referenced by either a published application, an application open
`to public inspections, or an issued patent, or iv) without publication of the application or patent under
`the specific circumstances provided for by 37 CFR 1.14(a)(1)(v)-(vii); and/or 3) the National Archives
`and Records Administration, for inspection of records.
`
`Geneoscopy Exhibit 1019, Page 11
`
`Geneoscopy Exhibit 1019, Page 11
`
`