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 .
Status of the Claims
Claims 1-27 are pending.
Claims 5, 10, 17, 19-22, and 27 are withdrawn (see election/restriction).
Priority
Applicant’s claim for benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged. This application claims priority to PRO application number 63/429,615, filed 12/02/2022.
Information Disclosure Statement
All references from IDS(s) received on 10/23/2024, 11/14/2025, and 07/20/2026 have been considered unless marked with a strikethrough.
Elections/Restrictions
Applicant’s election of Group I with traverse in the reply filed on 6/16/2026 is acknowledged.
Claim 27 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as
being drawn to a nonelected method of use, there being no allowable generic or linking claim.
Applicant’s election of species of the Compound below elected with traverse in the reply filed on 6/16/2026 is acknowledged.
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Applicants reason for traversal includes the plurality of compounds have a significant structural
element and have a common property or activity. The Examiner does not find this argument persuasive because the Applicant has not provided any data (such as an IC50) to show that the different embodiments of the compounds would lead to similar activity.
The requirement is deemed proper and is therefore made FINAL.
Claims 5, 10, 17, 19-22 are withdrawn as not reading on the elected species.
Claims 1-4, 7-9, 11-16, 18, and 23-26 will be examined on their merits.
No anticipatory art was found of the elected species, so the Examiner expanded the species
pursuant to MPEP 803.02. The expanded specie reads, where in Formula II: X,Y,Z are C, R1 is a C1 alkyl chain, U is O, V is C(R4) where R4 is a methyl group, and R2 is a heteroaryl, specifically a pyridine. The Examiner has provided a structure for reference below:
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(Expanded Species)
No art was found for the elected species and reasons a 103 rejection could not be made can be found below.
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, 8, 13, 14, 26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Grant, J. et al. (Bioorg. Med. Chem. 18 (2010) 909–921; “Grant”).
This rejection applies to the expanded species.
Grant teaches an overlapping genus structure with instant Formula(I).
Grant explicitly teaches a structural example of the expanded species.
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(Grant, Compound 5a)
Therefore, Grant anticipates independent claim 1 and dependent claims 8, 13, 14, 26.
Claim Objections/Allowable Subject Matter
Claims 2-4, 7, 9, 11-12, 15-16, 18, and 23-25 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The closest prior art and the reasoning for not being used in a rejection can be found below:
The elected species and the remaining claims require one or more of the following:
1. A core structure where the 5-membered ring of the bicyclic core has 2 nitrogen atoms (as seen below) (Claims 2,3):
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2. A core structure where the 6-membered ring of the bicyclic core has at least one heteroatom (Claim 18)
3. R1 is a heteroaryl (claims 4, 7) that may be substituted with R6 (Claim 15)
4. R2 is a 6-membered heterocycle with 1 sulfur heteroatom (Claim 9) or another type of heterocycle (Claims 11,12) that may be substituted with R7 (Claim 16)
5. Or all of the above (Elected Species, Claims 23-25)
The closest prior art includes:
Hong, H. et al. (WO2009065131A1). Hong teaches an overlapping genus structure with instant formula I and that taught by Grant. Hong also teaches where R2 is a 6-memebred heterocycle, as required by instant claims 9, 11, 12, and 16.
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However, Hong teaches the compounds as activators of the AMPK and fails to teach anything about DGAT2. Therefore, a person skilled in the art would not be motivated to combine the teachings of Grant and Hong and 103 rejection was not made.
Futatsugi, K. et al. (Medchemcomm. 2016 Nov; 8(4): 771–779.): Futatsugi teaches an overlapping genus structure with instant Formula I for use as a DGAT2 inhibitor and meets the additional limitations of claims 2, 3, 18.
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However, Futatsugi fails to teach the amide bond as well as the -OR group off the bicyclic in the genus structure of instant formula I. The Examiner could not find other art with a similar structure for a DGAT inhibitor including the necessary amide bond. Therefore, Futatsugi was not used in a 102 or 103 rejection.
Hugelshofer, C. et al. (Org. Lett. (2021) 23 (3): 943–947.) Hugelshofer teaches cyclic sulfones as an important building block in medicinal chemistry and for drug discovery. Hugelshofer fails to mention anything about DGAT2 and therefore, was not used in a 103 rejection.
Conclusion
Claims 1, 8, 13, 14, 26 are rejected.
Claims 2-4, 7, 9, 11-12, 15-16, 18, and 23-25 are objected to.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLA MARIA BAUER whose telephone number is (703)756-1269. The examiner can normally be reached Monday-Friday 7:30-5 EST.
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/N.M.B./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621