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 .
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(a) 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 application, Application No. JP2020-127142, fails 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. Application '142 does not disclose any of instant SEQ ID NOs: 22-27. Therefore, effective filing date for claims 27-35 is the filing date of PCT/JP2021/026930, 07/19/2021.
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)(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) 1, 4, 7-9, 11, 13 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Freier et al (WO 2021/248027, claiming priority to 63/035516, filed 5 June 2020).
Concerning claims 1, 7-8, 13 Freier disclose oligonucleotides targeting and inhibiting ACE2 (see Abstract). One of such oligonucleotides is of SEQ ID NO: 26 (see Table 1 on page 54), which is 16 nucleotides long with nucleotides 2-16 identical to nucleotides 1-15 of instant SEQ ID NO: 14:
SEQ ID NO: 14 1 CGGAAAGCATCATTGATA 18
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SEQ ID NO: 26 1 ACGGAAAGCATCATTG 16
Further Freier disclose that the oligonucleotide comprises 2’-O-methyl modification (see lines 5-10 on page 4).
Concerning claim 4 Freier disclose that oligonucleotide can be 18 nucleotides long (see lines 8-9 on page 36).
Concerning claims 9 and 11 Freier disclose pharmaceutical compositions comprising oligonucleotide of the invention and pharmaceutically acceptable formulations (see lines 1-2 on page 51). Functional limitations of claim 11 are expected to happen in the absence of evidence to the contrary, because the oligonucleotide of SEQ ID NO: 26 satisfies structural requirements of the claim.
Claim(s) 27-35 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Jaschinski et al (WO 2022/144441, claiming priority to EP 20217970.1, filed 31 December 2020, Citations below are given from the priority document).
Concerning claims 27 and 33-34 Jaschinski disclose oligonucleotides targeting and inhibiting ACE2 (see lines 5-10 on page 1). One of such oligonucleotides is of SEQ ID NO: 24 (see Table 1 on page 10), 17 nucleotides long, with nucleotides 2-17 identical to nucleotides 1-16 of instant SEQ ID NO: 22:
SEQ ID NO: 22 1 TTGTCATTCAGACGGAAA 18
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SEQ ID NO: 24 1 GTTGTCATTCAGACGGA 17
Olihonucleotide of SEQ ID NO: 24 comprises modified nucleotides (see lines 1-10 on page 9).
Concerning claims 28 and 35 Jaschinski disclose that oligonucleotide can be 18 nucleotides long (see lines 10-12 on page 8).
Concerning claims 29-30 Jaschinski disclose that oligonucleotide can have 2’-O-methyl modifications (see lines 15-17 on page 6).
Concerning claims 31-32 Jaschinski disclose pharmaceutical compositions comprising oligonucleotide of the invention and pharmaceutically acceptable carriers (see lines 9-11 on page 18). Functional limitations of claim 32 are expected to happen in the absence of evidence to the contrary, because the oligonucleotide of SEQ ID NO: 24 satisfies structural requirements of the claim.
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, 4, 25-26 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rossomando et al (WO 2011/005765, January 2011).
Concerning claims 1, 4 and 25-26 Rossomando disclose a number of oligonucleotides (see paragraph [0014]), including an oligonucleotide of SEQ ID NO: 1605189 (see sequence listing), 19 nucleotides long, which comprises nucleotides 4-18 of instant SEQ ID NO: 6:
SEQ ID NO: 6 1 GGCTGTTGTCATTCAGAC 18
:|::|:||::|||||
SEQ ID NO: 1605189 1 AAUGUUGUCAUUCAGACAA 19
Further Rossomando disclose that oligonucleotides of the invention can comprise modified nucleotides (see paragraphs [0051-0052]).
Response to Arguments
Applicant's arguments filed 03/30/2026 have been fully considered but they are not persuasive.
Previous rejections are withdrawn in view of new amendments, arguments are moot.
New rejections are presented above.
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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