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, 8, 11, 16, 21, 24-30, 40, 41, 76, in the reply filed on 05/22/2026 is acknowledged. Election of species as in claim 1 is acknowledged.
Claims 47, 58, 60 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group, there being no allowable generic or linking claim.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 05/22/2026.
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, 8, 11, 16, 21, 24-30, 40-41, 76 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 Erbe et al (WO 2019/014530, January 2019, cited from IDS).
Naito teach a number of siRNAs (dsRNAs) comprising sense and antisense strands complementary to each other (see paragraphs [0002-0003, 0057-0059]), including siRNA targeting PRODH2 with a sense strand of SEQ ID NO: 225752 (see paragraph [0061], sequence listing, search result below), which is identical to nucleotides 943-961 of instant SEQ ID NO: 1 (SEQ ID NO: 1 is shown first below, SEQ ID NO: 225752 is shown second):
PNG
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966
1511
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Greyscale
It is inherent that siRNA comprises antisense strand complementary to SEQ ID NO: 225752 and nucleotides 943-961 of instant SEQ ID NO: 1. Such siRNA has a double-stranded region of 19 nucleotides, with each strand 19 nucleotides in length.
Naito further teach that nucleotides of siRNAs can comprise modifications such as methylation of sugar hydroxyl groups (see paragraph [0106]) and overhangs of two nucleotides at 3’ end (see paragraph [0081]). Naito teach cells comprising the siRNAs (see paragraph [0127]), pharmaceutical compositions and kits comprising siRNAs (see paragraphs [0065, 0276]).
Naito do not teach all modified nucleotides of the sense strand, or 3’ end of sense strand conjugated to trivalent GalNAc ligand as in claims 27-29, or at least one phosphorothioate linkage.
Erbe teach siRNAs (dsRNAs) improvements such as modifications, comprising 2’-O-methyl, of all nucleotides in sense strand (see lines 30-38 on page 3, page 4, lines 21-23 on page 43) and conjugation of siRNA through 3’ end of sense strand to trivalent GalNAc ligand, same as in claims 27-29, to enhance siRNA delivery in vivo (see pages 4 and 5, lines 8-10 on page 96). Erbe teach that siRNAs can comprise phosphorothioate linkages (see line 27 on page 4).
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 improvements taught by Erbe into siRNA targeting PRODH2 taught by Naito, arriving at instant invention. One of the ordinary skill in the art would be motivated to do so to further improve siRNA taught by Naito as taught by Erbe.
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
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