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 46, 55, 56, 68-70, 72, 89, 122, 125-128, 131-134 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 12,037,585 in view of Khvorova et al (US 2017/0312367, November 2017, of record). Claims from '585 recite divalent siRNAs targeting SEQ ID NO: 1, such sequence comprises instant SEQ ID NO: 5, therefore such siRNAs include instantly claimed siRNAs targeting instant SEQ ID NO: 5. Khvorova et al teach branched oligonucleotides exhibiting improvement in distribution and in vivo efficacy (see paragraph [0006]), comprising two or more nucleic acids 15-20 nucleotides long with complementarity to a target connected to each other by linker, spacer or branching point (see paragraphs [0007-0010]). Such nucleic acid can be double-stranded and can comprise sense and antisense strands with 5' and 3' ends each, which can comprise alternating 2'-methoxy and 2'-fluoro nucleotides and phosphorothioate modifications at positions 1-2 of 5' end and positions 1-7 of 3' end (see paragraphs [0012-0013]). Further Khvorova et al teach a compound of formula (1), identical to instant compound of formula (1), which can further comprise branch point B, a polyvalent organic species, and spacer S, which can be ethylene glycol chain (see paragraph [0016]), and compounds (I-1) and (I-2), identical to instant compounds (I-1) and (I-2) (see paragraph [0017]), wherein L can be of structure L1 (see paragraph [0026]), identical to instant structure L1 and the antisense strand can comprise terminal group such as R3 (see paragraph [0018]), identical to instant R3 structure, with a preferred embodiment where is L1, R is R3, n=2 (see paragraph [0026]). Khvorova et al teach compound of formula (II) (see paragraph [0019]), identical to instant formula (II). Khvorova et al teach that compounds of the invention can be included in compositions for therapeutic purposes (see paragraph [0083]), therefore inherently teaching pharmaceutical compositions. It would have been obvious to create divalent siRNAs targeting instant SEQ ID NO: 5, which is a portion of SEQ ID NO: 1 based on teachings of '585 and further modify and/or connect such siRNAs based on teachings of Khvorova et al with improved distribution and efficacy. Limitations of dependent claims 131- 134 do not need to be taught in the prior art, because they relate to the second option of complementarity to SEQ ID NO: 6 in independent claims 46, 55 and 69, while instant rejection is based on the first option of the independent claims of complementarity to SEQ ID NO: 5.
Claims 46, 55, 56, 68-70, 72, 89, 122, 125-128, 131-134 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 17-35, 37, 60-62 of copending Application No. 18/675,023 in view of Khvorova et al, above. Claims from '023 recite siRNAs targeting SEQ ID NO: 1, such sequence comprises instant SEQ ID NO: 5, therefore such siRNAs include instantly claimed siRNAs targeting instant SEQ ID NO: 5. Teachings of Khvorova et al are discussed above. It would have been obvious to create siRNAs targeting instant SEQ ID NO: 5, which is a portion of SEQ ID NO: 1 based on teachings of '023 and further modify and/or connect such siRNAs based on teachings of Khvorova et al with improved distribution and efficacy, arriving at instantly claimed branched oligonucleotides. Limitations of dependent claims 131- 134 do not need to be taught in the prior art, because they relate to the second option of complementarity to SEQ ID NO: 6 in independent claims 46, 55 and 69, while instant rejection is based on the first option of the independent claims of complementarity to SEQ ID NOs: 5.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed 12/10/2025 have been fully considered but they are not persuasive.
Previous 103 rejections and double patenting rejections based on U.S. Patent No. 11,279,930 and 11,492,619 are withdrawn in view of new amendments, arguments are moot.
Concerning double patenting rejection based on U.S. Patent No. 12,037,585 Applicant argues that ‘585 has a later patent term filing date. In response there is nothing in MPEP 1504.06 concerning prevention of double patenting rejection over US Patent with later filing date. Rejection is maintained.
Concerning double patenting rejection based on Application No. 18/675,023 Applicant argues that the rejection is the only one left, therefore it has to be withdrawn. In response there is still one double patenting rejection based on U.S. Patent No. 12,037,585 left, therefore rejection based on Application No. 18/675,023 is maintained.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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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/EKATERINA POLIAKOVA-GEORGANTAS/Primary Examiner, Art Unit 1637