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 1-14, 17-18, 23-26, 50-51, 54-55 are pending in this application. Claims 1, 2 and 26 are independent claims.
Copious amount of art was found that teaches the use of psilocybin to treat treatment resistant depression.
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.
Claims 1-14, 17-18, 23-26, 50-51 and 54-55 are rejected under 35 U.S.C. 103 as being unpatentable over Lyons et al. (Journal of Psychopharmacology (London, United Kingdom) (2018), 32(7), 811-819). The reference teaches the usefulness of psilocybin in treating treatment resistant depression (TRD). The claims differ by requiring that that the subject did not respond to a first dose of psilocybin and specifying a time period for administering a second dose of psilocybin. However, it is routine experimentation to determine when a second dose should be administered and TRD is, by definition, a disease that did not respond to a first dose. One skilled in the art would therefore be motivated to administer a second dose of psilocybin to a TRD patient who did not respond to any known anti-depressant, including psilocybin itself because the reference teaches the usefulness of psilocybin to treat TRD. The crystalline form of claim 23 was disclosed in Applicant’s previous US application 16/920,223. The clinical rating scales are routine in the art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRUCK KIFLE whose telephone number is (571)272-0668. The examiner can normally be reached 8 AM - 6 PM, M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey H. Murray can be reached at 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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July 23, 2026
/BRUCK KIFLE/Primary Examiner, Art Unit 1624
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