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
This is a response to Applicant’s communication filed on February 4, 2026. Application No. 18/274,896, is a 371 of PCT/CA2022/050121, filed January 28, 2022, and claims the benefit of U.S. Provisional applications Nos.: 63/273,612, filed October 29, 2021; 63/187,681, filed May 12, 2021; 63/143,695, filed January 29, 2021; 63/143,679, filed January 29, 2021; and 63/143,688, filed January 29, 2021. In a preliminary amendment filed July 28, 2023, Applicant cancelled claims 3, 4, 9, 11, 12, 27 and 28. In an amendment filed February 4, 2026, Applicant added new claims 32-39. Claims 1, 2, 5-8, 10, 13-26, and 29-39 are pending.
Election/Restrictions
Applicant's election with traverse of the invention of group I in the reply filed on February 4, 2026, is acknowledged. The traversal is on the grounds that the International Search Authority determined that the subject matter of claim 1, the “salts” of N, N-dimethyltryptamine (DMT), pamoate and nicotinate, are novel and inventive. This is not persuasive because the salts of the present invention would have been obvious to the ordinary artisan at the time of the invention. See the 35 U.S.C. 103, Rejection below.
The requirement is still deemed proper and is therefore made FINAL.
Claims 2, 5-8, 10, 13-26, and 29-39 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention. Applicant timely traversed the restriction (election) requirement in the reply filed on February 4, 2026.
Claim 1 is examined below.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 1 is ejected under 35 U.S.C. 103 as being unpatentable over Perez Castillo et al., U.S. Patent No. 11,723,894, in view of Gu, US2020/0230103 A1. Perez-Castillo teaches that DMT binds and regulates serotonin receptors including the sigma-1 receptor. Perez-Castillo et al., ‘894 patent, Col. 1, lns. 53-67. The sigma-1 receptor is also a target for treating neurodegenerative diseases and stroke. Id. However, DMT, itself, is also associated with some undesirable effects. Therefore a combination drug or salt, potentially reducing side effects, and increasing the benefits toward treating neurodegenerative diseases is desired. Id., Col. 2., lns. 49-54.
Gu teaches pamoate salts of monoamine anti-Parisons agents. Gu, ‘103 publc’n, Abstract. Gu also teaches that the pamoate salts provide an alternative and more desirable dosing regimen for treating patients suffering from Parkinson’s disease. Id., p. 4 para. [0047]. The pamoate salts also have a superior drug absorption and distribution profile compared to the existing oral drug products by providing a continuous delivery of drug, which maintain plasma drug concentration ratios during dosing intervals, ultimately improving the safety profile and enhancing the clinical effectiveness.
It would have been obvious to the ordinary artisan at the time of the invention to combine DMT with a pamoate salt with a reasonable expectation of success. The ordinary artisan would have been motivated by teaching of the prior art to improve its safety profile and enhance its clinical effectiveness.
Conclusion
Claim 1 is not allowed.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIMOTHY R ROZOF whose telephone number is (571)270-5992. The examiner can normally be reached on Monday - Friday, 9:00 a.m. -5:00 p.m..
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached on (571) 272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TIMOTHY R ROZOF/
Primary Examiner, Art Unit 1625