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 .
According to paper filed on June 2, 2026, the applicants have canceled claims 4-5 and furthermore, have amended claims 1-3, 26 and 32.
Claims 1-3, 6-7, 20-24, 26, 28-29, 32, 35 and 40-42 are pending in the application. Claim 42 is withdrawn from further consideration as being directed to non-elected species.
Information Disclosure Statement
In the IDS filed on June 1, 2026, one reference was lined through since the date of publication was missing.
Response to Arguments
Applicant's arguments filed June 2, 2026 have been fully considered but they are not persuasive regarding enablement rejection of claims 1-3, 6-7, 20-24, 26, 28-29, 32, 35, 40 and 41 for solvates and prodrugs, enablement rejection of claims 28, 32 and 35 for treating various diseases and indefiniteness rejection of claim 32. The examiner agrees with applicant’s arguments on pages 14-16 regarding prior art rejections since the elected species was not disclosed in priority documents 63/026,939 and 63/114,738. Therefore, the cited two references do not constitute prior art references. However, it is of note that the elected species is claimed in claim 50 of the cited patent 11,242,318. Therefore, once all other issues are resolved, an interference will be declared against claim 50 of U.S. Patent 11,242,318.
Regarding solvates and prodrugs, the examiner does not agree with applicant’s arguments on pages 9-10 that the specification is enabling for preparing every known solvate and prodrug of the instant compounds of claim 1. The applicant’s attention is drawn to paragraph [0050] of the specification which teaches that molecules of a suitable solvent are incorporated in the crystal lattice. Therefore, specific solvents used, antisolvents used, specific temperatures used to prepare specific solvates and their characterization using various techniques such as XRPD are critical. There is no teaching in the specification for preparing any specific solvate and prodrug.
The examiner also does not agree with applicant’s arguments on pages 11-12 regarding enablement rejection of claims 28, 32 and 35 for treating various diseases by the instant compounds. The applicants have not provided any NPL documents showing well established utility of 5-HT2A receptor agonists for treating all the disease conditions listed in instant claims 28, 32 and 35.
Regarding indefiniteness rejection of claim 32, the examiner does not agree with the applicant’s arguments on pages 13-14 that claim is definite. It was clearly stated in the last office action that a broader limitation followed by a narrow limitation in the same claim renders it indefinite.
Conclusion
The enablement rejection of claims 1-3, 6-7, 20-24, 26, 28-29, 32, 35, 40 and 41 under 35 U.S.C. 112, 1st paragraph for solvates and prodrugs is maintained.
The enablement rejection of claims 28, 32 and 35under 35 U.S.C. 112, 1st paragraph for treating various diseases is maintained.
The indefiniteness rejection of claim 32 under 35 U.S.C. 112, 2nd paragraph is maintained.
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 CHARANJIT AULAKH whose telephone number is (571)272-0678. The examiner can normally be reached Monday-Friday 7:00-3:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton A Brooks can be reached at 571-270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHARANJIT AULAKH/ Primary Examiner, Art Unit 1621
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