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 82-94, in the reply filed on 01/15/2026 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)).
Claims 95-98 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group, there being no allowable generic or linking claim.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 01/15/2026.
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:
SEQ ID NO: 217 1 AAGACGGCAGAAUGGAAAGAGGC 23
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AD-1707060.1 antisense 1 AAGACGGCAGAAUGGAAAGAGGC 23
SEQ ID NO: 71 1 CUCUUUCCAUUCUGCCGUCUU 21
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AD-1707060.1 sense 1 CUCUUUCCAUUCUGCCGUCUU 21
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). Deaton presents AD-1707060.1 duplex with those modifications on page 366 of Table 20 (see explanation for abbreviations in the Table on pages 144-146):
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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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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).
Conclusion
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/EKATERINA POLIAKOVA-GEORGANTAS/Primary Examiner, Art Unit 1637