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 .
Election/Restrictions
Applicant’s election of Group I, claims 1-10, in the reply filed on 12/19/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim 11 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/19/2025.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sierant et al (New Journal of Chemistry, 2010, 34: 918-924).
Concerning claims 1-8 Sierant disclose siRNAs comprising gemcitabine within the antisense strand (marked Gem10, Gem8, Gem5) and in the 5’ end of one strand marked Gem1, such siRNAs also comprising deoxyribonucleotides in the overhangs and ribonucleotides (see page 919, Figure 2):
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Concerning claim 9 Sierant disclose pharmaceutical compositions of such siRNAs (see Section 4.2 on page 923).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sierant et al, above, as applies to claims 1-9, and in further view of Lu et al (US 2019/0030187, January 2019).
Teachings of Sierant are discussed above.
Sierant do not teach pharmaceutical composition of siRNA comprising histidine-lysine copolymer.
Lu teach that histidine-lysine copolymer enhances delivery of siRNA in vivo (see paragraph [0028]).
It would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to create a pharmaceutical composition of siRNA taught by Sierant comprising histidine-lysine copolymer based on teachings of Lu. One of the ordinary skill in the art would be motivated to do so in order to enhances delivery of the siRNA in vivo as taught by Lu.
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 1-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 53-56, 60, 65, 88-91 of copending Application No. 17/713025 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claims from ‘025 recite siRNAs comprising gemcitabine and their pharmaceutical compositions comprising histidine-lysine copolymer, anticipating instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-6, 9-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-5, 8-9, 11-13, 17, 20-21, 25 of copending Application No. 17/187678 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claims from ‘678 recite recombinant orthopox virus comprising synthetic DNA. According to specification of ‘678 such synthetic DNA can comprise nucleoside analogs (see paragraph [0067] from ‘678 specification). Thus such recombinant virus anticipates instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/909519 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claims from ‘519 recite siRNAs comprising gemcitabine and their pharmaceutical compositions comprising histidine-lysine copolymer, anticipating instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 19/098292 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claims from ‘292 recite siRNAs comprising gemcitabine and their pharmaceutical compositions comprising histidine-lysine copolymer, anticipating instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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