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 .
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 82-94 is/are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Deaton et al (WO 2023/003922, 26 January 2023, cited from IDS).
Concerning claims 82-86 Deaton disclose double-stranded ribonucleic acids, dsRNAs, targeting INHBE gene (see Abstract). One of such dsRNA comprises sense and antisense strands, of duplex AD-1707060.1 in Table 19 on page 339, wherein antisense strand is 100% identical to instant SEQ ID NO: 217 and sense strand is 100% identical to instant SEQ ID NO: 71:
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Further Deaton disclose that dsRNAs of the invention can include modifications (see lines 5-15 on page 32) such as 2'-O-methyl modifications and phosphorothioate linkages (see lines 25-35 on page 15) and can comprise GalNAc targeting ligands (see lines 33-37 on page 18). Thus, Deaton disclose dsRNAs satisfying structural requirements of claims 82-86.
Concerning claims 87 and 92 Deaton disclose in preferred embodiment that antisense strand can comprise overhang on 3' end (see line 16 on page 76).
Concerning claims 88-89 Deaton disclose that all nucleotides of dsRNA can be modified (see lines 1-5 on page 53), also modified AD-1707060.1 duplex on page 366 of Table 20 shows modifications in both strands:
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While this example of modified dsRNA includes 2’- deoxyribonucleotides, this is just one specific example of modified dsRNAs disclosed.
Concerning claims 90-92 Deaton disclose that GalNAc ligand can be at 5' end of the sense strand (see lines 27-28 on page on page 80).
Concerning claims 93-94 Deaton disclose pharmaceutical composition of dsRNAs further comprising pharmaceutically acceptable diluents (see lines 12-17 on page 19).
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) 82-94 is/are rejected under 35 U.S.C. 103 as being unpatentable over Deaton et al, above.
Teachings of Deaton are discussed above.
Deaton do not specifically exemplify modified dsRNA comprising instant SEQ ID NOs: 217 and 71 without 2’-deoxyribonucleotide modifications.
It would have been obvious to one of the ordinary skill in the art before the effective filing date of instant invention to create a number of modified dsRNAs comprising instant SEQ ID NOs: 217 and 71 and 2’-O-methoxy and phosphorothioate modifications only based on teachings of Deaton, arriving at instant invention. One of the ordinary skill in the art would be motivated to do so, because Deaton suggest such modifications of dsRNA and does not specifically require 2’-deoxyribonucleotide modification to be present in modified dsRNA. Deaton teach a range of modified dsRNAs which encompass instantly claimed dsRNAs (see MPEP 2144.05, I : “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists.”)
Response to Arguments
Applicant's arguments filed 05/05/2026 have been fully considered but they are not persuasive.
Concerning 102 rejection based on Deaton reference Applicant argues that the reference does not teach modified dsRNA without 2’-deoxyribonucleotide modifications. In response the reference presents unmodified dsRNA comprising instant SEQ ID NOs: 217 and 71 and further teaches that such dsRNA can comprise 2’-O-methoxy and phosphorothioate modifications, therefore teaching a genus of modified dsRNAs, many of which satisfy structural requirements of instant claims. The reference indeed provides one example of modified dsRNA, which includes 2’- deoxyribonucleotide modifications, but nowhere in the reference such modifications are taught to be required to be present in the modified dsRNA.
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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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
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