DETAILED ACTION
This Office action is a second Non-final action because upon an updated inventor search, the copending application 19/409,591, filed 04 December 2025, has been identified, requiring a new rejection on the grounds of nonstatutory double patenting, as set forth below.
The present application would otherwise be in condition for allowance in view of the Patent Trial and Appeal Board (PTAB) decision mailed 04 December 2025, and in view of the outstanding objections having been withdrawn, as set forth below.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 1-6, 8-11, 13, 14, 18, 20, 21, 25, 28, 29, 34, 35, 38, 40, 42, 44, 51-53, and 55 are pending.
Claims 1-6, 8-11, 13, 14, 18, 20, 21, 25, 28, 29, 34, 35, 38, 40, 42, 44, 51-53, and 55 are rejected.
Priority
Claims 1-6, 8-11, 13, 14, 18, 20, 21, 25, 28, 29, 34, 35, 38, 40, 42, 44, 51-53, and 55 claim benefit of Provisional Application No. 62/948,129, filed 13 December 2019.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Independent claim 1, and those claims dependent therefrom, are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 19/409,591 (not docketed). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of the ‘591 application recites essentially the same limitations as claim 1 of the instant application, as evidenced below:
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This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Objection to the drawings:
The objection to the drawings in the Office Action mailed 01 December 2023 is withdrawn in view of further consideration of the Applicant’s arguments/remarks received 29 February 2024.
Objection to the claims:
The objection to claim 21 in the Office Action mailed 01 December 2023 is withdrawn in view of the amendment received 29 February 2024.
35 U.S.C. § 101:
In the Patent Trial and Appeal Board (PTAB) decision mailed 04 December 2025, the rejection of claims 1-6, 8-11, 13, 14, 18, 20, 21, 25, 28, 29, 34, 35, 38, 40, 42, 44, 51-53, and 55 under 35 U.S.C. 101 was the only remaining rejection of record, and was reversed by the Board. At Step 2A Prong Two, the Board found that the Applicant’s claims, when considered as a whole and read in light of its Specification, integrate the abstract idea(s) into a practical application. In particular, the Board found that the claimed invention provides “tools for early detection of cancer in subjects” that have “improved specificity and sensitivity over existing classification techniques by applying deep learning classification techniques to methylation fragment data, specifically vision classification techniques.”
35 U.S.C. § 102/103:
An updated search and consideration of the relevant art has been performed. Claims 1-6, 8-11, 13, 14, 18, 20, 21, 25, 28, 29, 34, 35, 38, 40, 42, 44, 51-53, and 55 have been found free of the prior art.
Conclusion
No Claims are allowed.
This Office action is a Non-final action. A shortened statutory period for reply to this action is set to expire THREE MONTHS from the mailing date of this application.
Inquiries
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/S.W.B./Examiner, Art Unit 1687
/Joseph Woitach/Primary Examiner, Art Unit 1687