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
This application, filed 02/17/2023 is a Continuation of PCT/US21/46778, filed 08/19/2021.
PCT/US21/46778 Claims Priority from Provisional Application 63067726, filed 08/19/2020; Priority from Provisional Application 63074302, filed 09/03/2020; Priority from Provisional Application 63094759, filed 10/21/2020; and Priority from Provisional Application 63129306, filed 12/22/2020.
Status of Claims
Claims 1-53 are pending as of the response filed on 10/20/25.
Applicant’s election without traverse of invention II, claims 17-40 and 50-53; HATU as the benzotriazole based activator, DIPEA as the base, step (a) performed in dichloromethane, step (b) performed in isopropyl acetate, and compound 1 further converted to a hemisulfate salt in the reply filed on 10/20/25 is acknowledged. Applicants have submitted the elected species read on claims 17-18, 20, 23, 25-26, 28-35, 39-40, and 50-53.
Upon further consideration, the species requirement is withdrawn, while the restriction between inventions I, II, and III is maintained for reasons of record. Therefore, claims 17-40 and new claims 50-53 were included for examination.
Claims 1-16 and 41-49 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/20/25.
Claims 17-40 and 50-53 were examined and are rejected.
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.
Claims 17-40 and 50-53 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.
Claim 17 refers to a nucleotide of Formula XVI, however the structure of Formula XVI is not shown or described in the claim. The claim is therefore indefinite, as the metes and bounds aren’t clear. Claims 18-40 and 50-53 are similarly rejected as these claims depend either directly or indirectly from claim 17 and don’t provide further clarity as to the structure of Formula XVI.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter: with the exception of the issue under 35 USC 112(b) as discussed previously, elected claims 17-40 and 50-53 would be in condition for allowance. Tran, WO 2014008236, cited in an IDS represents the closest prior art. Tran teaches processes of preparing diastereomerically enriched phosphoramidate derivatives. Although Tran teaches several similar process steps, Tran doesn’t teach or suggest contacting a nucleoside compound with the dihydroquinine salt of isopropyl (hydroxy(phenoxy)phosphoryl)-L-alaninate, as required by the instant claims.
Information Disclosure Statement
The IDS filed on 10/26/23 and 10/20/23 have been considered.
Correspondence
Claims 17-40 and 50-53 were examined and are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH PIHONAK whose telephone number is (571)270-7710. The examiner can normally be reached Monday-Friday 9:00-5:30 EST.
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SARAH . PIHONAK
Primary Examiner
Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627