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 .
DETAILED ACTION
Election/Restrictions and Status of the Claims
Applicant’s election of Group I, comprising claims 1-15 in the response filed on December 16th 2025 is acknowledged. Applicant’s election of
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as the single specific compound in the response filed on December 16th 2025 is acknowledged. Claims 1-15 are pending. Claims 6-8 are withdrawn from further consideration as being directed towards nonelected species until a generic claim has been found allowable (note that claim 8 requires that R2 and R3 form a cycloalkyl group). Claims 1-5 and 9-15 are examined on their merits.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 120 is acknowledged. Applicant has complied with all conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 based on the date of the provisional application 63/416,243 filed on October 14th 2022.
Information Disclosure Statement
The Information Disclosure Statement filed on December 16th 2025, May 28th 2025, and January 26th 2024 are in compliance with the provisions of 37 CFR 1.97 and have been considered in full. A signed copy of references cited from the IDS is included with this Office Action.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 13-15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 13-15 are indefinite for the phrase “a disease associated with pain,” because one of ordinary skill in the art could not reasonably determine the metes and bounds of the claim. The phrase is not defined in the specification, and one of ordinary skill in the art would therefore interpret it as any disease in which pain is a factor and/or symptom. Such conditions are as varied as migraines, cancers, amputations, arthritis, and even allergies. As one of ordinary skill in the art could not reasonably determine the entire scope of “diseases associated with pain,” claims 13-15 are indefinite.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4 and 10-14 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Hagel (WO 2023/173227 published on September 21st 2023, effectively filed on March 18th 2022).
The claims are directed towards a compound of Formula (I):
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Hagel teaches compound D(IV),
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(Hagel, pg. 180).
Compound D(IV) is anticipatory of claims 1-4.
Claim 10 is directed to pharmaceutical compositions comprising the compound of claim 1. Hagel teaches pharmaceutical compositions (Hagel, paragraph [00403]), anticipating claim 10.
Claim 11 is directed to the treatment of conditions that are responsive to serotonin receptor activation. Hagel teaches treatment of depressive disorders (Hagel, paragraph [00408]) and that such disorders are responsive to serotonin activation (Hagel, paragraph [00152]). Hagel therefore anticipates claim 11.
Claims 12-14 are directed to the treatment of psychiatric disorders, such as borderline personality disorder, via administration of the compound of claim 1. Hagel teaches the treatment of psychiatric disorders including borderline personality disorder (Hagel, paragraph [00408]), anticipating claims 12-14.
Claim Rejections - 35 USC § 103
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.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Hagel (WO 2023/173227 published on September 21st 2023, effectively filed on March 18th 2022).
Claim 15 requires that the neurological disease treated in the method of claim 13 is pain or associated with pain. Hagel teaches modulation of the 5-HT2A receptor (Hagel, claim 61) and that the modulation of such a receptor is a treatment for migraines (Hagel, paragraph [00156]). One of ordinary skill in the art would therefore have a reasonable expectation of success in treating migraines with Hagel’s compounds, and claim 15 is prima facie obvious.
Claims 5, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Hagel in view of Brown (Brown, Bioisosteres in Medicinal Chemistry (2012)).
Claims 5 and 9 are directed towards applicant’s elected species of:
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Hagel teaches the substantially similar compound D(I):
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(Hagel, pg. 180).
Applicant has provided a proviso in claim 1, that the compound is not compound D(I). Therefore, compound D(I) is not anticipatory of applicant’s claims. However, compound D(I) differs from applicant’s elected species only in the replacement of a single hydrogen atom with a methyl group. This replacement is one of the most common bioisosteric substitutions performed in the field of drug discovery (Brown, pg. 17). One of ordinary skill in the art would therefore have a reasonable expectation of success in developing applicant’s elected species from Hagel’s compound D(I), and claims 5 and 9 are prima facie obvious.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anthony Seitz whose telephone number is (703)756-4657. The examiner can normally be reached 7:30 AM ET - 5:00 PM ET M-F.
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 Lundgren can be reached at (571)272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.J.S./Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
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