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 without traverse of Group I, claims 1, 4, 17, 20, 24, 26, 38, 48, 58, 75, 79, 80 in the reply filed on 12/12/2025 is acknowledged. Election of species of SEQ ID NOs: 1887-1891, 1893-1896, 1903 is acknowledged.
Claims 84, 88-90, 98, 102 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group, there being no allowable generic or linking claim.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 12/12/2025.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed applications, Application No. 63/082,566 and 63/152,900, fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Disclosures of ‘566 and ‘900 do not recite double stranded nucleic acids targeting instant SEQ ID NO: 6. Therefore, the effective filing date of instant claims is the filing date of PCT/US2021/051663, which is 09/23/2021.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 38, 48 and 58 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 38 recites the limitation "one or more lipophilic moieties" in first and second lines. There is insufficient antecedent basis for this limitation in the claim. Claim 48 is rejected based on dependency on claim 38.
For the purpose of examination it will be considered that claim 38 depends on claim 17, but appropriate correction is required.
Claim 58 recites the limitation "the lipophilic moiety" in first and second lines. There is insufficient antecedent basis for this limitation in the claim.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 4, 17, 20, 24, 26, 38, 48, 58, 75, 79-80 is/are rejected under 35 U.S.C. 103 as being unpatentable over Naito et al (US 2008/0113351, May 2008) and in further view of Nair et al (WO 2019/217469, November 2019, cited from IDS).
Naito teach double stranded ribonucleic acids, siRNAs, comprising sense and antisense strands complementary to each other (see paragraphs [0002, 0004, 0062]). One of such siRNAs, of SEQ ID NO: 183391, targets DPP4 (see paragraph [0061], sequence listing and search result below):
PNG
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731
1350
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Greyscale
SEQ ID NO: 183391 is 19 nucleotides long and is fully complementary to nucleotides 3-21 of instant SEQ ID NO: 1887 and identical to nucleotides 1206-1224 of instant SEQ ID NO: 6:
SEQ ID NO: 1887 1 TAAACTTTACAGTTGGATTCACAG 23
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SEQ ID NO: 183391 19 TGAAATGTCAACCTAAGTG 1
Complementary sequence to SEQ ID NO: 183391 comprises nucleotides 3-21 of instant SEQ ID NO: 1887. Further Naito teach that nucleotides of siRNAs can be modified and can comprise deoxy nucleotides (see paragraph [0106]), siRNAs can be a part of pharmaceutical composition (see paragraph [0006]) and can be introduced in a cell (see paragraph [0126]).
Naito do not teach that both strands of the siRNA are fully modified, or sense strand is conjugated at internal positions 4-8 or 13-18 of sense strand to lipophilic moiety containing C4-C30 hydrocarbon chain, or siRNA comprises phosphorothioate internucleotide linkages or phosphate at 5’ end of antisense strand.
Nair teach improvements in delivery of siRNAs in vivo (see paragraph [0005]) by siRNA modifications such as fully modified siRNA (see paragraph [0377]) and by conjugation of lipophilic moieties to internal positions at positions 4-8 and 13-18 on the sense strand (see paragraph [0182]), such lipophilic moiety can be C4-C30 hydrocarbon chain (see paragraph [0371]). Nair teach that siRNA can comprise phosphorothioate internucleotide linkages (see paragraph [0047]) and phosphate at 5’ end of antisense strand (see paragraph [0471]).
It would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to include modifications taught by Nair into siRNA taught by Naito, arriving at instant invention. One of the ordinary skill in the art would be motivated to do so in order to improve in vivo delivery of siRNA taught by Naito as taught by Nair.
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