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 .
This Office action is responsive to Applicant’s amendment and remarks, filed 13 July 2026, in which claims 1 and 3 are amended to change the scope and breadth of the claim, and new claims 5-10 are added.
This application is the national stage entry of PCT/JP2022/022556, filed 02 June 2022; and claims benefit of foreign priority document JAPAN 2021-092873, filed 02 June 2021. This foreign priority document is not in English.
Claims 1-10 are pending in the current application and are examined on the merits herein.
Rejections Withdrawn
Applicant’s amendment, filed 13 July 2026, with respect that claims 1-2 are rejected under 35 U.S.C. 103 as being unpatentable over McCuen et al. (J. Am. Chem. Soc., 2006, 128, p8138-8139, provided by Applicant in IDS filed 24 April 2025) in view of Roy et al. (Molecules, 2013, 18(11), p14268-14284, provided by Applicant in IDS filed 24 April 2025) has been fully considered and is persuasive, as amended claim 1 recites the nucleic oligomer comprising a nucleotide unit represented by General Formula (1); a nucleotide unit represented by General Formula (2); and a nucleotide unit represented by General Formula (3), and Applicant’s remarks are persuasive that McCuen et al. in view of Roy et al. does not provide sufficient guidance to combine the teachings of the prior art in a manner that would make obvious the nucleic oligomer comprising a phosphorothioate linkage, a boranophosphate linkage, and a phosphate linkage.
This rejection has been withdrawn.
Applicant’s remarks, filed 13 July 2026, with respect that claims 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over McCuen et al. (J. Am. Chem. Soc., 2006, 128, p8138-8139, provided by Applicant in IDS filed 24 April 2025) in view of Roy et al. (Molecules, 2013, 18(11), p14268-14284, provided by Applicant in IDS filed 24 April 2025) as applied to claims 1-2, and further in view of Sato et al. (J. Org. Chem., 2019, 84, p15032-15041, provided by Applicant in IDS filed 30 Nov 2023) and Zain et al. (J. Org. Chem., 1996, 61, p6617-6622, of record) has been fully considered and is persuasive regarding the combined teachings of the prior art as cited gave only general guidance as to the particular form of the claimed invention and merely suggestion to explore a general approach that seemed to be a promising field of experimentation, and Applicant notes that the teachings of Sato et al. also teach the chimeric DNA containing phosphate and boranophosphate as an improvement over phosphorothioate DNA, weighing against combining the prior art in order to modify the process steps of the method of making DNA in order to make a combined chimeric DNA containing phosphorothioate and boranophosphate.
This rejection has been withdrawn.
The following are new grounds of rejection necessitated by Applicant’s amendment, filed 13 July 2026, in which claims 1 and 3 are amended to change the scope and breadth of the claim, and new claims 5-10 are added.
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.
Amended Claims 3-4 and 8-10 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.
Amended independent Claim 3 recites a “method for producing a nucleic acid oligomer comprising:
a nucleotide unit represented by General Formula (1) below;
a nucleotide unit represented by General Formula (2) below; and
optionally a nucleotide unit represented by General Formula (3) below,”. However, claim 3 does not recite the structures of General Formula (1), (2), or (3). Claims 8-10 further clarify one of the structure of one General Formula, but do not clarify the structures of all 3 together. For example, claim 8 further recites the nucleotide unit represented by General Formula (1) is a nucleotide unit represented by General Formula (1’), however this claim does not clarify the structures of General Formula (2) or (3). Therefore each of claims 3-4 and 8-10 is indefinite because it is unclear what structure is required for the nucleic acid oligomer produced by the method.
Allowable Subject Matter
Claims 1-2 and 5-7 are allowed.
Claims 3-4 and 8-10 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter: The closest prior art is McCuen et al. (J. Am. Chem. Soc., 2006, 128, p8138-8139, provided by Applicant in IDS filed 24 April 2025) in view of Roy et al. (Molecules, 2013, 18(11), p14268-14284, provided by Applicant in IDS filed 24 April 2025), and further in view of Sato et al. (J. Org. Chem., 2019, 84, p15032-15041, provided by Applicant in IDS filed 30 Nov 2023) and Zain et al. (J. Org. Chem., 1996, 61, p6617-6622, of record).
The closest prior art does not teach or fairly suggest the claimed invention for the reasons detailed above.
Conclusion
Claims 1-2 and 5-7 are allowed.
The application is not currently in condition for allowance.
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 Jonathan S Lau whose telephone number is (571)270-3531. The examiner can normally be reached Monday-Friday 9a-5p Eastern.
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/JONATHAN S LAU/Primary Examiner, Art Unit 1693
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