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`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and TrademarkOffice
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
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`18/179,945
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`03/07/2023
`
`Joost Louwagie
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`EXCTD-35239.307
`
`2966
`
`CASIMIR JONES, S.C.
`2275 DEMING WAY,SUITE 310
`MIDDLETON, WI 53562
`
`WHISENANT, ETHAN C
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`ART UNIT
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`1634
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`PAPER NUMBER
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`NOTIFICATION DATE
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`DELIVERY MODE
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`07/06/2023
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`ELECTRONIC
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`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`Thetime 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):
`DOCKETING @CASIMIRJONES.COM
`
`Genomic_docketing @ cardinal-ip.com
`
`PTOL-90A (Rev. 04/07)
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`Geneoscopy Exhibit 1018, Page 1
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`Geneoscopy Exhibit 1018, Page 1
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`

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`
`
`Application No.
`Applicant(s)
`18/179 ,945
`Louwagie, Joost
`
`Office Action Summary Art Unit|AIA (FITF) StatusExaminer
`Ethan C Whisenant
`1634
`No
`
`
`
`-- The MAILING DATEof this communication appears on the cover sheet with the correspondence address --
`Period for Reply
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`A SHORTENED STATUTORY PERIOD FOR REPLYIS SET TO EXPIRE 3 MONTHS FROM THE MAILING
`DATE OF THIS COMMUNICATION.
`Extensions of time may be available underthe provisions of 37 CFR 1.136(a). In no event, however, may a reply betimely filed after SIX (6) MONTHSfrom the mailing
`date of this communication.
`If NO period for reply is specified above, the maximum statutory period will apply and will expire SIX (6) MONTHSfrom the mailing date of this communication.
`-
`- Failure to reply within the set or extended period for reply will, by statute, cause the application to become ABANDONED (35 U.S.C. § 133).
`Any reply received by the Office later than three months after the mailing date of this communication, evenif timely filed, may reduce any earned patent term
`adjustment. See 37 CFR 1.704(b).
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`Status
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`1) Responsive to communication(s) filed on 07 MAR 2023.
`C) A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/werefiled on
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`2a)() This action is FINAL. 2b)¥)This action is non-final.
`3)02 An election was madeby the applicant in responseto a restriction requirement set forth during the interview
`on
`; the restriction requirement and election have been incorporated into this action.
`4)\0) Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
`closed in accordance with the practice under Exparte Quayle, 1935 C.D. 11, 453 O.G. 213.
`
`Disposition of Claims*
`1-20 is/are pending in the application.
`)
`Claim(s)
`5a) Of the above claim(s) ___ is/are withdrawn from consideration.
`Cj} Claim(s)
`is/are allowed.
`Claim(s) 1-20 is/are rejected.
`S)
`) © Claim(s)___is/are objected to.
`Cj) Claim(s
`are subjectto restriction and/or election requirement
`)
`S)
`* If any claims have been determined allowable, you maybeeligible to benefit from the Patent Prosecution Highway program at a
`participating intellectual property office for the corresponding application. For more information, please see
`http://Awww.uspto.gov/patents/init_events/pph/index.jsp or send an inquiry to PPHfeedback@uspto.gov.
`
`) )
`
`Application Papers
`10) The specification is objected to by the Examiner.
`11)0) The drawing(s) filedon__ is/are: a)(J accepted or b)( objected to by the Examiner.
`Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a).
`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121 (d).
`
`Priority under 35 U.S.C. § 119
`12)[VM. Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d)or (f).
`Certified copies:
`c)Z None ofthe:
`b)() Some**
`a) All
`1... Certified copies of the priority documents have been received.
`2.{¥} Certified copies of the priority documents have been received in Application No. 13147570.
`3.4.) Copies of the certified copies of the priority documents have been receivedin this National Stage
`application from the International Bureau (PCT Rule 17.2(a)).
`* See the attached detailed Office action for a list of the certified copies not received.
`
`Attachment(s)
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`1)
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`Notice of References Cited (PTO-892)
`
`(LJ Interview Summary (PTO-413)
`Paper No(s)/Mail Date
`4) (J Other:
`Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`2)
`Paper No(s)/Mail Date07MAR2023.
`U.S. Patent and Trademark Office
`
`3)
`
`PTOL-326 (Rev. 11-13)
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20230628
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`Geneoscopy Exhibit 1018, Page 2
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`Geneoscopy Exhibit 1018, Page 2
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`

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`Application/Control Number: 18/179,945
`Art Unit: 1634
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`Detailed Action
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`Page 2
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`>
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`>
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`Claim(s) 1-20 as presented in the paper(s) filed 07 MAR 2023 is/are pending.
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`The present application is being examined under the pre-AlA first to invent provisions.
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`In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102
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`and 103 (or as subject to pre-AlA 35 U.S.C. 102 and 103) is incorrect, any correction of the
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`statutory basis for the rejection will not be considered a new ground ofrejection if the prior art
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`relied upon, and the rationale supporting the rejection, would be the same undereitherstatus.
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`Non-Statutory Obviousness-type Double Patenting
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`>
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`The nonstatutory double patenting rejection is based on a judicially created doctrine
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`groundedin public policy (a policy reflected in the statute) so as to prevent the unjustified or
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`impropertimewise extension of the "right to exclude" granted by a patent and to prevent
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`possible harassmentby multiple assignees. See In re Goodman, 11 F.3d 1046, 29 USPQ2d
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`2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van
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`Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619
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`(CCPA 1970);and, In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA1969). A timelyfiled
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`terminal disclaimer in compliance with 37 CFR 1.321(c) may be used to overcome an actual or
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`provisional rejection based on a nonstatutory double patenting ground provided the conflicting
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`application or patent is shown to be commonly ownedwith this application. See 37 CFR
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`1.130(b).
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`Effective January 1, 1994, a registered attorney or agent of record may sign a terminal
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`disclaimer. A terminal disclaimer signed by the assignee mustfully comply with 37 CFR
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`3.73(b). A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may
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`be used to overcome an actualor provisional rejection based on nonstatutory double patenting
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`provided the reference application or patent either is shown to be commonly owned with the
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`examined application, or claims an invention made as a result of activities undertaken within the
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`scope of a joint research agreement.
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`The USPTOInternet website contains terminal disclaimer forms which may be used. Please
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`visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is
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`filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA/25, or PTO/AIA/26) should
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`Geneoscopy Exhibit 1018, Page 3
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`Geneoscopy Exhibit 1018, Page 3
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`

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`Application/Control Number: 18/179,945
`Art Unit: 1634
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`Page 3
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`be used. A web-based eTerminal Disclaimer may befilled out completely online using web-
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`screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved
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`immediately upon submission. For more information about eTerminal Disclaimers, refer to
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`www.uspto.gov/patents/process/file/efs/guidance/eT D-info-l.jsp.
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`Non-Statutory Obviousness-type Double Patenting Rejections
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`>
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`Claim(s) 1-20 is/are provisionally rejected underthe judicially created doctrine of
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`obviousness-type double patenting as being unpatentable over claims 1-19 of copending
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`Application No.18/179,961. Although the conflicting claims are not identical, they are not
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`patentably distinct. This is a provisional obviousness-type double patenting rejection
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`because the conflicting claims have not in fact been patented.
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`>
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`Claim(s) 1-20 is/are rejected underthe judicially created doctrine of obviousness-type
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`double patenting as being unpatentable over Claims 1-20 of U.S. Patent No. 11,634,781
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`(hereinafter “US -781”).
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`Although the conflicting claims are not identical, they are not patentably distinct from
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`each other. For example, Claim 1 of US-781 teach a method of processing a freshly-collected
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`fecal sample without freezing that comprises collecting a fecal sample from a human subject,
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`wherein the fecal sample is collected at home by the human subject; in a sealable vessel,
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`combiningafirst portion of the fecal sample with a stabilizing buffer, and sealing the sealable
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`vessel; and in a sealable container, combining a second portion of the fecal sample with a
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`solution that prevents denaturation or degradation of blood proteins found in a fecal sample, and
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`sealing the sealable container.
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`Geneoscopy Exhibit 1018, Page 4
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`Geneoscopy Exhibit 1018, Page 4
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`

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`Application/Control Number: 18/179,945
`Art Unit: 1634
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`Prior Art
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`Page 4
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`>
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`The Claims are allowable over the prior art of record becausethe prior art of recordfails
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`to teach dividing a feces/stool sample collected at home into at least two portions. One portion
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`of which is combined with a 1* stabilizing buffer (i.e. nucleic acid stabilizing buffer) while the
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`second portion is combined with a solution that prevents denaturation or degradation of blood
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`proteins found in the fecal sample. The closest prior art is considered to be Lapidus etal. [US
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`5,952,178 — hereinafter “Lapidus”] - cited by applicant. However, Lapidus does not teach or
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`reasonably suggest dividing a feces sample collected at home into at least two portions. One
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`portion of which is combined with a 1* stabilizing buffer (i.e. nucleic acid stabilizing buffer) while
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`the second portion is combined with a solution that prevents denaturation or degradation of
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`blood proteins found in the fecal sample. The teaching of Lapidus alone or in combination with
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`the otherprior art of record would have suggested to PHOSITAto place the a stool, ora
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`portion thereof, collected at home into a sealable container and to combine said stool or portion
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`thereof with a stabilizing buffer which stabilizing buffer stabilizes both nucleic acids and proteins
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`found within the stool sample or portion thereof. The claims clearly require the division of the
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`stool into two separate and distinct samples. A first for nucleic acid analysis and a second for
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`protein analysis. The prior art of record fails to teach this feature.
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`Geneoscopy Exhibit 1018, Page 5
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`Geneoscopy Exhibit 1018, Page 5
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`

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`Application/Control Number: 18/179,945
`Art Unit: 1634
`
`Conclusion
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`Page 5
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`C.
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`Anyinquiry concerning this communication or earlier communications from the examiner
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`should be directed to Ethan Whisenant whosetelephone numberis (571) 272-0754. The
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`examiner can normally be reached Monday-Friday from 8:30 am -5:30 pm ESTor any time via
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`voice mail.
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`If repeated attempts to reach the examiner by telephone are unsuccessful, the
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`examiner's supervisor, Wu-Cheng Winston Shen, can be reachedat (571) 272-3157.
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`The Central Fax number for the USPTOis (571) 273-8300. Please note that the faxing
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`of papers must conform with the Notice to Comply publishedin the Official Gazette, 1096 OG 30
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`(November 15, 1989).
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`Information regarding the status of an application may be obtained from the Patent
`
`Application Information Retrieval (PAIR) system. Status information for published applications
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`may be obtained from either Private PAIR or Public PAIR. Status information for unpublished
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`applications is available through Private PAIR only. For more information about the PAIR
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`PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you
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`would like assistance from a USPTO CustomerService Representative or access to the
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`automated information system, call 800-786-9199 (IN USA OR CANADA)or 571-272-1000.
`
`/ETHAN C WHISENANT/
`Primary Examiner, Art Unit 1634
`ethan.whisenant@uspto.gov
`
`Geneoscopy Exhibit 1018, Page 6
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`Geneoscopy Exhibit 1018, Page 6
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`Application/Control Number: 18/179,945
`Art Unit: 1634
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`Page 6
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`EXAMINER SEARCH NOTES
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`28 JUN 2023 - ECW
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`Databases searched: All available via PE2E SEARCH
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`CAplus, Medline and BIOSIS via STNext; and Google Scholar(note the search terms used
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`below)
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`Reviewed the parent(s), if any, and any search(es) performed therein : see the BIB data sheet
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`Reviewed, the search(es), if any, performed by prior examinersincluding any international
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`examiners. Reviewed the Search Report and Written opinion in PCT/GB2010/000180
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`Planned Search
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`Search terms:
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`All Inventor(s) e.g. Louwagie?/au
`Fecesor faeces or stool
`Process$
`Collect$
`divid$ or partion$ or portion$ or separat$
`sealable (vessel$ or container$)
`blood proteins
`colorectal cancer or CRC
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`>
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`See the Examiner's PE2E SEARCH notes/strategy in IFW
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`Geneoscopy Exhibit 1018, Page 7
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`Geneoscopy Exhibit 1018, Page 7
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