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
The instant application is the national stage entry of PCT/EP2022/064778 filed 31 May 2022. Acknowledgement is made of the Applicant’s claim of foreign priority to application IN202111024601 filed 2 June 2021.
Election/Restrictions
Applicant’s election with traverse of Group I (Claims 1-16 and 20) in the reply filed on 26 December 2025 is acknowledged.
Applicant’s election with traverse of Example P15 (below) as the species of formula I in the reply filed on 26 December 2025 is acknowledged.
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Claims 2, 4-11, and 17-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 26 December 2025. The traversal is on the ground(s) that the ISA found the present claims to be both novel and inventive. This is not found persuasive because the Examiner has previously explained how the claimed groups lack unity of invention based on the disclosure of Edmunds et al. (WO 2020/084075).
The requirement is still deemed proper and is therefore made FINAL.
Status of the Claims
Claims 1-20 are pending.
Claims 2, 4-11, and 17-19 are withdrawn.
Claims 1, 3, 12-16, and 20 are rejected.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1, 3, 12-15, and 20 are rejected under 35 U.S.C. 102a1 as being anticipated by Edmunds et al. (WO 2020/084075).
Edmunds teaches the following structure P2 in a free form which anticipates the elected species of instant claims 1, 3, 12-15, and 20 (pg 68, lns 1-5). The structure of P2 is a racemic mixture and thus necessarily comprises both the R and the S configurations, by definition. Regarding instant claim 20, the claim comprises a product-by-process limitation. “If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” (See MPEP 2113 (I)).
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Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 1, 3, 12-16, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Edmunds et al. (WO 2020/084075).
Edmunds teaches the following structure P2 which reads on the racemic mixture of the elected species of instant claims 1, 3, 12-15, and 20 (pg 68, lns 1-5). The structure of P2 is a racemic mixture and thus necessarily comprises both the R and the S configurations, by definition, however Edmunds teaches that an enantiomer thereof can be prepared (pg 2, lns 8-9). The compounds of formula (I) can be in free form or the form of salts (pg 40, lns 8-9). The composition of Edmunds can comprise a compound of formula (I) (structure P2) or an enantiomer thereof as well as an auxiliary or diluent (pg 24, lns 10-15), thus rendering obvious instant claims 1, 3, 12-16, and 20.
Regarding instant claim 20, the claim comprises a product-by-process limitation. “If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” (See MPEP 2113 (I)).
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Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW S ROSENTHAL whose telephone number is (571)272-6276. The examiner can normally be reached M-F 8-5pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW S ROSENTHAL/ Primary Examiner, Art Unit 1613