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 Claims and Response to Amendments
The amendments filed June 8, 2026 have been acknowledged and entered. Claims 1-12 and 14-24 are pending.
Information Disclosure Statements
Acknowledgement is made of the Information Disclosure Statement filed June 8, 2026 . All references have been considered except where marked with a strikethrough.
Withdrawn Rejections
Applicant is notified that any outstanding rejection or objection that is not expressly maintained in this Office Action has been withdrawn or rendered moot in view of Applicant’s amendments and/or
remarks.
Maintained Rejections
Claim Rejections - 35 USC § 112a
Claims 1-4, 6-12 and 14-24 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The reasons for this rejection were set forth in the previous Office Action mailed December 8, 2025 and are incorporated herein by reference.
Response to Arguments
Applicant’s arguments filed June 8, 2026 have been fully considered but they are not persuasive.
Applicant states without acquiescing to the rejection and solely to expedite prosecution,
Applicant amends claim 1 to be drawn to a crystalline form IV of a compound of formula 1, a pharmaceutically acceptable salt thereof, or a solvate thereof, which requires 5 or more characteristic peaks in its X-ray powder diffraction (XRPD) pattern, wherein R1 is C2-C5 alkyl. Applicant argues that the limitation requiring that the crystalline form IV share 5 or more characteristic peaks is valid and supported by the disclosure in the written description. Applicant submits that the amendments render the claims as demonstrating that the Applicant was in full possession of the invention at the time of filing.
This argument is not found persuasive for the reasons set forth previously. The claims are drawn to a genus of crystalline compounds, salts, or hydrates thereof; however, Applicant has very narrowly only described one single crystalline form (Form IV at [00139]-[00140], [00148] and Table 1 of the specification). A person skilled in the art would recognize that different crystalline compounds will have different X-ray powder diffraction patterns and that the single crystal form disclosed by Applicant is not representative of the genus claimed which embraces hundreds of different compounds, salts and solvates. The art is highly unpredictable and there is no reason to expect, nor is it possible to predict, that the full scope of compounds, salts or hydrates embraced by claim 1 will all have 5 or more of the claimed peaks.
A person skilled in the art would not recognize that Applicants were in possession of the invention as broadly claimed at the time the application was filed.
The rejection is still deemed proper and thus maintained.
The rejection could be overcome by amending the claims to be drawn to crystalline form IV of hydrate of N((3S,5S)-1-((3S,4R)-1-(tert-butyl)-4-(4- chlorophenyl)pyrrolidine-3-carbonyl)-5-(morpholine-4-carbonyl)pyrrolidin-3-yl)-N-((1s,4R)-4-methylcyclohexyl)isobutyramide hydrochloride
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Double Patenting
Claims 1-12 and 14-24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of copending Application No. 18/558,351; or claims 1-14 of copending Application No. 18/558,148; or claims 1-19 of copending Application No. 18/557,866; or claims 1-11 of copending Application No. 18/558,142; or claims 1-19 of copending Application No. 18/258,730; or claims 1-16 of copending Application No. 18/258,717; or claims 1-16 of copending Application No. 18/258,711; or claims 1-13 of copending Application No. 18/251,129; or claims 1-13 of copending Application No. 18/251,084; or claims 1-13 of copending Application No. 18/251,101. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the reference claims.
The reasons for this rejection were set forth in the previous Office Action mailed December 8, 2025 and are incorporated herein by reference.
Response to Arguments
Applicant’s arguments filed June 8, 2026 have been fully considered but they are not persuasive.
Applicant states they disagree and respectfully requests that the nonstatutory double patenting rejections be held in abeyance until there is a favorable indication of allowable subject matter.
This response is found not persuasive since a complete response to a nonstatutory double patenting (NSDP) rejection is either a reply by applicant showing that the claims subject to the rejection are patentably distinct from the reference claims or the filing of a terminal disclaimer in accordance with 37 CFR 1.321 in the pending application(s) with a reply to the Office action (see MPEP § 1490 for a discussion of terminal disclaimers). Such a response is required even when the nonstatutory double patenting rejection is provisional. As filing a terminal disclaimer, or filing a showing that the claims subject to the rejection are patentably distinct from the reference application’s claims, is necessary for further consideration of the rejection of the claims, such a filing should not be held in abeyance. Only objections or requirements as to form not necessary for further consideration of the claims may be held in abeyance until allowable subject matter is indicated. Thus, the previous double patenting rejection is hereby maintained.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. 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 KEVIN MARTIN whose telephone number is (571)270-0917. The examiner can normally be reached Monday - Friday 8 am - 5 pm.
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, Jeffrey Murray can be reached on (571) 272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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June 15, 2026
/K.S.M./Examiner, Art Unit 1624
/BRUCK KIFLE/Primary Examiner, Art Unit 1624
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