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 .
Claims 35-57 are pending in the instant application. Claims 52-54, 56 and 57 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to non-elected subject matter. The withdrawn subject matter is patentably distinct from the elected subject matter as it differs in structure and element and would require separate search considerations. In addition, a reference which anticipates one group would not render obvious the other. Claims 35, 36, 40, and 43-48 are rejected. Claims 35, 37-39, 41, 42, 49, and 55 are objected. Claims 50 and 51 are allowed.
Information Disclosure Statements
The information disclosure statements filed on November 24, 2025 and November 14, 2025 have been considered and signed copies of form 1449 are enclosed herewith.
Election/Restrictions
Applicant’s election with traverse of Group III, claims 35-51 and new claim 55, in the response filed on November 14, 2025 is acknowledged. The traversal is on the ground(s): “a search of the compounds will readily uncover any methods of their use” or there is no undue burden. This not found to be persuasive because the inventions are independent and distinct because there is no patentable co-action between the groups and a reference anticipating one member will not render another obvious. Each group is directed to art recognized divergent subject matter which require different searching strategies for each group. Moreover, the examiner must perform a commercial database search on the subject matter of each group in addition to a paper search, which is quite burdensome to the examiner. Therefore, the restriction requirement is maintained and hereby made final.
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 35, 36, 40, and 43-48 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2012/0065209 A1.
US 2012/0065209 A1 discloses pharmaceutically acceptable salts of (R)-7-[3-aminio-4-(2,4,5-trifluorophenyl)-butyryl]-3-trifluoromethyl-5,6,7,8-tetrahydro-imidazo[1,5-a]pyrazine-1-formic acid and compositions thereof and their use as medicaments (see abstract), such as the compound
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122
206
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(see Example No. 3 on page 2) which anticipates a compound and pharmaceutical composition thereof of the claims wherein X3 is -O-; L3 is a bond; Z3 is H; m3 is 0; R10 is -CF3; p3 and q3 are 1; o3 is 3; and R11 is F.
Claim Objections
Claims 37-39, 41, 42, and 49 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.
Claim 35 is objected to because of the following informalities: the first compound listed in the excluded compounds or “methyl 2-((8-(3-aminopiperidin-1-yl)-7-(but-2-yn-1-yl)-3-methyl-2,6-dioxo-2,3,4,6-tetrahydro-1H-7λ4-purin-1-yl)methyl)nicotinate” does not fit within the scope of the compounds of formula (III). Appropriate correction is required and this objection can be overcome by deleting this compound from the claim.
Claim 55 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 51. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Allowable Subject Matter
Claims 50 and 51 are allowed. No prior art was found.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTIN ANN VAJDA whose telephone number is (571)270-5232. The examiner can normally be reached Mon-Fri 6:00-4:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Alstrum-Acevedo can be reached at 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KRISTIN A VAJDA/Primary Examiner, Art Unit 1622