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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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`17/936,335
`
`09/28/2022
`
`Joost Louwagie
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`EXCTD-35239.306
`
`1513
`
`CASIMIR JONES, S.C.
`2275 DEMING WAY,SUITE 310
`MIDDLETON, WI 53562
`
`WHISENANT, ETHAN C
`
`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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`01/11/2023
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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 1020, Page 1
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`Geneoscopy Exhibit 1020, Page 1
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`

`

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`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`5a) Of the above claim(s) ___ is/are withdrawn from consideration.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) The drawing(s) filed on
`is/are: a)() 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)1) 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)C All
`1... Certified copies of the priority documents have been received.
`2.1) Certified copies of the priority documents have beenreceived in Application No.
`3.1.) 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)
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`Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`2)
`Paper No(s)/Mail Date 28 SEP 2022.
`U.S. Patent and Trademark Office
`
`3)
`
`(LJ Interview Summary (PTO-413)
`Paper No(s)/Mail Date
`4) (J Other:
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`PTOL-326 (Rev. 11-13)
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`Office Action Summary
`
`Part of Paper No./Mail Date 20221219
`Geneoscopy Exhibit 1020, Page 2
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`Application No.
`Applicant(s)
`17/936 335
`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
`
`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).
`
`Status
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`1) Responsive to communication(s) filed on 28 SEP 2022.
`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.
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`Geneoscopy Exhibit 1020, Page 2
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`

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`Application/Control Number: 17/936 ,335
`Art Unit: 1634
`
`Detailed Action
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`Page 2
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`>
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`Claim(s) 1-20 as presented in the paper(s) filed 28 SEP 2022 is/are pending.
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`>
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`The present application is being examined under the pre-AlAfirst 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 under either status.
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`35 U.S.C. 112(b)/ 112 (pre-AlA), second paragraph
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`Sequence Rules
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`>
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`This application complies with the sequence rules and the sequence(s) have been
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`entered by the Scientific and Technical Information Center.
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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 preventthe unjustified or
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`improper timewise extension of the "right to exclude” granted by a patent and to prevent
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`possible harassment by 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 (CCPA 1969). A timelyfiled
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`terminal disclaimer in compliance with 37 CFR 1.321(c) may be used to overcomeanactual 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
`
`1.130(b).
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`Geneoscopy Exhibit 1020, Page 3
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`Geneoscopy Exhibit 1020, Page 3
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`

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`Application/Control Number: 17/936 ,335
`Art Unit: 1634
`
`Page 3
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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 timelyfiled terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may
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`be used to overcomean actual or 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 asa result of activities undertaken within the
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`scope of a joint research agreement.
`
`The USPTOInternet website contains terminal disclaimer forms which may be used.
`
`Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the
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`form is filed determines whatform (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA/25, or PTO/AIA/26)
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`should be used. A web-based eTerminal Disclaimer maybe filled out completely online using
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`web-screens. An eTerminal Disclaimer that meetsall requirements is auto-processed and
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`approved immediately upon submission. For more information about eTerminal Disclaimers,
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`refer to www. uspto.gov/patents/process/file/efs/guidance/eT D-info-l.jsp.
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`>
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`Claim(s) 1- 3, 5-11 and 14-20 is/are provisionally rejected underthe judicially created
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`doctrine of obviousness-type double patenting as being unpatentable over claims 82, 84, 87,
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`89-94 aand 96-100 of copending Application No. 15/634,607 — hereinafter “607’”. Although the
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`conflicting claims are notidentical, they are not patentably distinct from each other.
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`This is a provisional obviousness-type double patenting rejection because the conflicting
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`claims have not in fact been patented., they have been allowed.
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`Geneoscopy Exhibit 1020, Page 4
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`Geneoscopy Exhibit 1020, Page 4
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`

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`Application/Control Number: 17/936 ,335
`Art Unit: 1634
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`Page 4
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`>
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`Claim(s) 4 and 12-13 is/are provisionally rejected under the judicially created doctrine of
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`obviousness-type double patenting as being unpatentable over claims 82, 84, 87, 89-94 and 96-
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`100 of copending Application No. 15/634,607 as applied above and further in view of Ohlsson et
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`al. [Br. J. of Cancer 95:218(2006) — hereinafter “Ohlsson’].
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`Claim 4 is drawn to an embodiment of the method of Claim 1 wherein testing the nucleic
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`acid comprises determining expression from a human gene.
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`The Claims of the 607’ application reasonably suggest a method a comprising many but
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`notall of the limitations of Claim 4. For example, Claim 87 teach analyzing nucleic acid
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`extracted from the remaining portion but fail to teach testing the nucleic acid for expression of
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`ahuman gene. However, it was well known to analyze human nucleic acids in order to detect
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`CRC in human sample. For example, Ohlsson teach using quantitative RT -PCR to detect the
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`expression of select genes in order to detect the presence of occult tumour (i.e. CRC) cells in
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`said samples. Accordingly, absent an unexpected result it would have been prima facie obvious
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`to the PHOSITAat the time of the invention to modify the method of the claims of the 607’
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`application wherein the nucleic acids tested for are mRNA biomarkers as taught by Ohlsson
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`rather than or in addition to the epigenetic markers of 607’. The PHOSITA would have been
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`motivated by a desire to gather as muchdata as possible to insure a correct diagnosis.
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`Claim 12 is drawn to an embodimentof the method of Claim 4 wherein determining
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`expression from the human gene comprises measuring an amount of RNA from the gene.
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`Claim 13 is drawn to an embodimentof the method of Claim 12 wherein measuring an
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`amount of RNA from the gene comprises RT-PCR.
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`Ohlsson teach theselimitations, see at least the abstract.
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`Geneoscopy Exhibit 1020, Page 5
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`Geneoscopy Exhibit 1020, Page 5
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`

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`Application/Control Number: 17/936 ,335
`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 number is (571) 272-0754. The
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`examiner can normally be reached Monday-Friday from 8:30 am -5:30 pm ESTor anytime 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, Dave Nguyen, can be reached at (571) 272-0731.
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`The Central Fax number for the USPTOis (571) 273-8300. Please note thatthe 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
`
`may be obtained from either Private PAIR or Public PAIR. Status information for unpublished
`
`applications is available through Private PAIR only. For more information about the PAIR
`
`system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private
`
`PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197(toll-free). If you
`
`would like assistance from a USPTO Customer Service Representative or access to the
`
`automated information system, call 800-786-9199 (INUSA OR CANADA)or 571-272-1000.
`
`/ETHAN C WHISENANT/
`Primary Examiner, Art Unit 1634
`ethan.whisenant@uspto.gov
`
`Geneoscopy Exhibit 1020, Page 6
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`Geneoscopy Exhibit 1020, Page 6
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`

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`Application/Control Number: 17/936 ,335
`Art Unit: 1634
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`Page 6
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`EXAMINER SEARCH NOTES
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`19-30 DEC 2022- 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 and updated the searchin 15/634,607 , now allowed
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`Reviewed, the search(es), if any, performedby prior examinersincluding any international
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`examiners.
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`Planned Search
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`Search terms:
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`All Inventor(s) e.g. Louwagie J?/au
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`feces or stool or excrement or fecal
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`devid$5 or separate
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`Analyse or analyze or Analysis or test$4
`Methylation or aberrant methylation or hypermethylat$5 or hypomethylat$5
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`CRC or colorectal cancer
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`gene expression or aberrant gene expression
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`Geneoscopy Exhibit 1020, Page 7
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`Geneoscopy Exhibit 1020, Page 7
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`