DETAILED ACTION
The Applicant’s response, received 12 June 2026, has been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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.
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
This application claims benefit of 62/948,129, filed 13 December 2019.
Therefore, unless otherwise noted, the effective filing date of the claimed invention is 13 December 2019.
Double Patenting
The provisional rejection of claim 1, and those claims dependent therefrom, on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 19/409,591 (not docketed) in the Office action mailed 12 March 2026 has been withdrawn in view of copending claim 1 having been canceled.
The Applicant’s amendment received 12 June 2026 has been fully considered, however after further consideration, new grounds of nonstatutory double patenting rejection are raised in view of the amendment to copending Application No. 19/409,591 (not docketed), as noted below.
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 claims 2 and 16 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. Claims 2 and 16 of the ‘591 application recite ‘a metastatic disease status’ and ‘generate a corresponding probability score’ which are species of the instant claim 1 limitations reciting ‘a cancer condition’ and ‘determine the cancer condition,’ respectively. Thus, practicing claim 1 of the instant application is comprised within the breadth of claims 2 and 16 of copending Application No. 19/409,591.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
The Applicant’s arguments/remarks received 12 June 2026 have been fully considered but are not persuasive.
The Applicant states on page 15 of the Remarks that the claims of the present application are patentably distinct over the claims of the ‘591 application, and accordingly, the double patenting rejection is moot.
These arguments/remarks are not persuasive, because new grounds of nonstatutory double patenting rejection have been raised in view of the amendment to copending Application No. 19/409,591 (not docketed), as noted in the above rejection.
Conclusion
No Claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEVEN W. BAILEY whose telephone number is (571)272-8170. The examiner can normally be reached Mon - Fri. 1000 - 1800.
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/S.W.B./Examiner, Art Unit 1687
/Joseph Woitach/Primary Examiner, Art Unit 1687
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