DETAILED ACTION
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 .
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.
Claims 1, 3-4, 6-7, 12, 16-17, 19-21, 23, 27, 33-35, 39 and 43 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 21-26, 39-41 of copending Application No. 19/028,462 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claims from ‘462 recite RNAi constructs comprising sense and antisense strands from Tables 1 and 2, such Tables comprise all the same sense and antisense strands as instantly claimed, with the same sequence identifiers. Limitations of instant dependent claims are also recited in dependent claims of ‘462.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 3-4, 6-7, 12, 16-17, 19-21, 23, 27, 33-35, 39 and 43 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9, 11-13, 15-16, 18-35, 41-43 of copending Application No. 19/029,290 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claims from ‘290 recite RNAi constructs comprising sense and antisense strands from Tables 1 and 2, such Tables comprise at least some of the instantly claimed sequences. For example, ‘290 recites RNAi construct comprising SEQ ID NOs: 805 and 806 in Table 1, which are respectively identical to instantly claimed SEQ ID NOs: 1933 and 1934. Further, ‘290 recites RNAi construct comprising SEQ 1D NOs: 647 and 648 in Table 1, which are respectively identical to instantly claimed SEQ ID NOs: 1967 and 1968. Limitations of instant dependent claims are also recited in dependent claims of ‘290.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed 10/30/2025 have been fully considered but they are not persuasive.
Concerning double patenting rejection over application 19/028462 Applicant argues that ‘462 application is a divisional from instant application, therefore no double patenting rejection is proper. In response claims of ‘462 encompass all instantly claim sequences, therefore double patenting rejection is appropriate. It is suggested to amend claims of ‘462 to exclude all the instantly claimed sequences to overcome the rejection.
Concerning double patenting rejection over application 19/029290 Applicant argues that it is later filed than instant one. In response the rejection over ‘290 application will be dropped after that rejection is the only one left. As stated above, there is another double patenting rejection present, therefore double patenting rejection over ‘290 application is maintained.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EKATERINA POLIAKOVA whose telephone number is (571)270-5257. The examiner can normally be reached Mon-Fri 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Dunston can be reached at (571)272-2916. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EKATERINA POLIAKOVA-GEORGANTAS/Primary Examiner, Art Unit 1637