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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 18 March 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 18, 21-23, and 31 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Any analysis of whether a particular claim is supported by the disclosure in an application requires a determination of whether that disclosure, when filed, contained sufficient information regarding the subject matter of the claims as to enable one skilled in the pertinent art to make and use the claimed invention. The standard for determining whether the specification meets the enablement requirement was cast in the Supreme Court decision of Minerals Separation Ltd. v. Hyde, 242 U.S. 261, 270 (1916) which postured the question: is the experimentation needed to practice the invention undue or unreasonable? The factors to be considered when determining whether any necessary experimentation is undue have been set forth by the courts in the Wands factors (see MPEP 2164.01(a)) and In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
These factors are:
(1) the breadth of the claims; (2) the nature of the invention; (3) the state of the prior art (3); (4) the level of one of ordinary skill; (5) the level of predictability in the art; (6) the amount of direction provided by the inventor; (7) the existence of working examples; and (8) the quantity of experimentation needed to make or use the invention based on the content of the disclosure.
(1) Breadth of the claims:
The claims of the instant invention are drawn to a method of treating a disease or condition comprising administering to an individual either a besylate or lactate salt of psilocin. Claims 21-23 and 31 further limit the salt of psilocin and the stability of the psilocin salt. As there is no limitation to the disease or condition to be treated in claims 18, 21-23, and 31, the claims at issue are drawn to a very broad method of treating any number of unspecified diseases and conditions.
(2) Nature of the invention; (3) State of the prior art; and (5) Level of predictability in the art:
It is evidenced by the instant specification and further evidenced by Lowe et al. (Molecules, 2021, Vol. 26, 2948) that psilocin is the active metabolite of psilocybin (Lowe et al. pg. 10) and psilocin can be utilized as a 5HT2A, 5HT2C, and 5HT1A agonist for any condition that psilocybin is administered for (Instant specification at par. [80]). The instant specification and Lowe et al. disclose that these conditions include anxiety disorders, depression, headache disorder, obsessive compulsive disorder, personality disorders, stress disorders, addictions, autism, and neurodegenerative disorders (Instant Specification at par. [80]; Lowe et al. at Table 1). And as further evidenced by Felsing et al. serotonin receptors 5HT2A and 5HT2C are implicated in neuropsychiatric disorders (Abstract), not disclosing any other disorders related to the 5HT receptors. However, little to no data exists demonstrating psilocin or psilocybin treatment of any conditions unrelated to the above listed neuropsychiatric disorders.
As such, the level of predictability in the art is low outside of the above listed neuropsychiatric disorders, as one of ordinary skill in the art would not have any amount of data to base a prediction on.
(4) The level of one of ordinary skill:
The level of skill to practice the art of the instantly claimed invention is high and requires a variety of skill usually found in institutions and companies that employ highly trained and skill scientists to carry out these tasks.
(6) Amount of direction provided by the inventor; and (7) Existence of working examples:
The direction provided by the inventor is limited to generalized statements of dosages and dosage forms without providing any preferred embodiments or guidance to the efficacy of excipients, dosage forms, or dosing schedules (Instant Specification at pars. [073-79]). Further, there are not any working examples disclosed by the inventor of treating a disease or condition by administration of psilocin.
(8) Quantity of experimentation needed to use the invention based on the content of the disclosure:
Based on the limited direction provided in the disclosure of the invention, and the lack of any working examples, a very large number of experiments would need to be carried out to determine what conditions psilocin could be used to treat, as well as the required dosages, dosage forms, and dosing schedules. As such, one of ordinary skill in the art would not be able to treat conditions commensurate with the scope of the claims without undue experimentation.
As such, claims 18, 21-23, and 31 are rejected.
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 18-19, and 21-38 are rejected under 35 U.S.C. 103 as being unpatentable over Nichols et al. (US 11,312,684 effectively filed 10 February 2021, cited on Applicant’s IDS filed 18 March 2025) in view of Blumstock et al. (WO 2020/157569 cited on Applicant’s IDS filed 18 March 2025).
Claim 18 is drawn to a method of treating a disease or condition, comprising administering to an individual a composition comprising psilocin besylate salt or psilocin lactate salt.
Claim 23 is drawn to the method of claim 18, wherein the individual is administered psilocin besylate salt.
Claim 31 is drawn to the method of claim 18, wherein the individual is administered psilocin lactate salt.
Nichols et al. teach pharmaceutically acceptable salts of psilocin for use to treat a disease or condition (Abstract), further teaching benzoate, tartrate, succinate, and naphthalene disulfonate salts (Col. 1 lines 20-35), indicating a plurality of pharmaceutically suitable salts of psilocin.
Nichols et al. do not teach the psilocin salt comprising a besylate salt or a lactate salt.
However, Blumstock et al. teach treatment of disorders by administering a 5HT agonist (Abstract) such as psilocin and salts thereof (Par. [7]), further teaching benzenesulfonic acid (i.e., besylate ion), benzoic acid (i.e., benzoate ion), lactic acid (i.e., lactate ion), naphthalene disulfonic acid (i.e., naphthalene disulfonate ion), succinic acid (i.e., succinate ion), and tartaric acid (i.e., tartrate ion) as forming pharmaceutically acceptable salts (Par. [232]).
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Nichols et al. to utilize a besylate or lactate salt of psilocin as taught by Blumstock et al. It would have been obvious to substitute one pharmaceutically acceptable salt of psilocin for another, with a reasonable expectation of success.
As such, claims 18, 23, and 31 are rejected as prima facie obvious.
Claim 19 is drawn to the method of claim 18, wherein the disease or condition is an anxiety disorder, depression, headache disorder, obsessive compulsive disorder, personality disorder, stress disorder, drug disorder, addiction, pain, neurodegenerative disorder, autism spectrum disorder, eating disorder, or neurological disorder.
Claim 24 is drawn to the method of claim 23, wherein the disease or condition is an anxiety disorder (claim 26), depression (claim 25), headache disorder, obsessive compulsive disorder (claim 29), personality disorder, stress disorder (claim 27), drug disorder, addiction, pain (claim 28), neurodegenerative disorder, autism spectrum disorder, eating disorder, or neurological disorder.
Claim 30 is drawn to the method of claim 24, wherein the disease or condition is drug disorder, addiction, eating disorder, headache disorder, personality disorder, neurodegenerative disorder, autism spectrum disorder, or neurological disorder.
Claim 32 is drawn to the method of claim 31, wherein the disease or condition is an anxiety disorder (claim 34), depression (claim 33), headache disorder, obsessive compulsive disorder (claim 37), personality disorder, stress disorder (claim 35), drug disorder, addiction, pain (claim 36), neurodegenerative disorder, autism spectrum disorder, eating disorder, or neurological disorder.
Claim 38 is drawn to the method of claim 32, wherein the disease or condition is drug disorder, addiction, eating disorder, headache disorder, personality disorder, neurodegenerative disorder, autism spectrum disorder, or neurological disorder.
Nichols et al. further teach the disease or condition being treated including anxiety, depression, headache disorder, compulsive behavior, post-traumatic stress disorder, addiction, chronic pain, neurodegenerative disease, eating disorder, or neurological conditions (Col. 2 lines 51 – col. 3 lines 16).
Nichols et al. do not specifically teach OCD and are silent to autism spectrum disorder and personality disorder.
However, Blumstock et al. teach that psilocin is useful as a 5HT agonist (par. [7]) and HT agonism facilitating treatment of autism spectrum disorder, OCD, and personality disorder (Par. [76]).
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art to utilize the method of Nichols et al. to treat OCD, autism spectrum disorder, and personality disorder. It would have been obvious to use one a known method of psilocin treatment to treat a condition known to be treatable with psilocin, with a reasonable expectation of success.
As such, claims 19, 24-30, and 32-38 are rejected as prima facie obvious.
Claim 21 is drawn to the method of claim 18, wherein the composition is stable.
Claim 22 is drawn to the method of claim 21, wherein stable includes being shelf-stable, being stable in cold storage, or being stable in storage under inert conditions.
Nichols et al. and Blumstock et al. are silent as to the stability of psilocin besylate salts and psilocin lactate salts.
However, as discussed in MPEP 2112.01(II), "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
In the instant case, the instantly claimed stability, shelf-stability, stability and cold storage, and stability under inert conditions are properties inherent to the besylate and lactate salts of psilocin as evidenced by the instant specification. As Nichols et al. in view of Blumstock et al. teach using psilocin besylate and psilocin lactate, the instantly claimed stability is necessarily present.
As such, claims 21-22 are rejected as prima facie obvious.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Paul Hoerner whose telephone number is (571)270-0259. The examiner can normally be reached Monday - Friday 9:00am - 5:00pm eastern.
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, Bethany Barham can be reached at (571)272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/PAUL HOERNER/Examiner, Art Unit 1611
/CRAIG D RICCI/Primary Examiner, Art Unit 1611
Prosecution Insights