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
Claims 34-53 are currently pending in the instant application. Applicants have canceled claims 1-33 and added new claims 34-53 in an amendment filed on May 28, 2024. Claims 34-53 are rejected in this Office Action.
I. Priority
The instant application is a 371 of PCT/US2022/015897, filed on February 10, 2022 which claims benefit of US Provisional Applications 63/276,096, filed on November 5, 2021 and 63/148,052, filed on February 10, 2021.
II. Information Disclosure Statement
The information disclosure statements (IDS) submitted on May 28, 2024 and July 24, 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner.
III. Rejections
35 USC § 103 - OBVIOUSNESS REJECTION
The following is a quotation of 35 U.S.C. § 103(a) that forms the basis for all
obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Graham v. John Deere Co. set forth the factual inquiries necessary to determine obviousness under 35 U.S.C. §103(a). See Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966). Specifically, the analysis must employ the following factual inquiries:
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.
Claims 34-36 and 39-53 are rejected under 35 U.S.C. § 103(a) as being unpatentable over Guertin (WO 2015/127558 A1) in view of Blumstock, et al. (WO 2020/157569 A1). Applicants claim
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The Scope and Content of the Prior Art (MPEP §2141.01)
Guertin teaches the use of psilocin or a pharmaceutically acceptable derivative as a 5-HT2/3 receptor agonist (see page 2). The prior art defines the term “pharmaceutically acceptable derivative” as the following:
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(see page 8).
And then defines the term “pharmaceutically acceptable salt” as the following:
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(see page 9).
Blumstock, et al. teaches the use of psilocin or a salt thereof as a 5HT agonist useful for the treatment of disorders that include psychological, cognitive, behavioral and/or mood disorder (see pages 10-11).
The Difference Between the Prior Art and the Claims (MPEP §2141.02)
The difference between the prior art of Guertin and the instant invention is that the prior art teaches broadly pharmaceutically acceptable salts of psilocin which includes salts derived from salicylic acid whereas the instant invention has prepared specific psilocin salicylate salts.
Prima Facie Obviousness-The Rational and Motivation (MPEP §2142-2413)
In In re Williams, 89 USPQ 396 (CCPA 1951), it was well established that it is obvious to form salts from known acids. The prior art teaches pharmaceutically acceptable salts of psilocin being used as a 5-HT2/3 receptor agonist and defines salts to include salicylic acid (see page 9). So it would have been within the skill of a person having ordinary skill in the art to prepare various salts of psilocin for the purpose of using them as 5HT2/3 receptor agonists as taught in the Guerin reference. Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was made to prepare different pharmaceutically acceptable salts based on the teachings of the prior art. For example, a skilled artisan would have been motivated to prepare a pharmaceutically acceptable salt of psilocin when the prior art teaches broadly pharmaceutically acceptable salts of psilocin and it pharmaceutical use. As such, a prima facie case of obviousness has been established.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 34-53 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11,312,684. Although the conflicting claims are not identical, they are not patentably distinct from each other because: Applicants claim:
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Determining the Scope and Content of the Issued Patent
Claim 1 of the issued patent claims
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Ascertaining the Differences Between the Instant Application and the Issued Patent
The instant application claims a salicylate salt of psilocin whereas the issued patent claims a benzoate salt of psilocin.
Finding Prima Facie Obviousness
The issued patent claims a benzoate salt form of psilocin and it would have been prima facie obvious to, and within the skill of, one of ordinary skill in the art to prepare other salt forms of psilocin such as salicylate which is well known and used salt form in the art. One of ordinary skill the art would have been motivated to prepare other salt forms such as salicylate for finding more stable forms of psilocin for treating anxiety, chronic pain, etc. The claims are rejected under obviousness-type double patenting.
Claims 34-53 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 40-46 of copending application 18/142,662. Although the conflicting claims are not identical, they are not patentably distinct from each other because:
Applicants claim
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Determining the Scope and Content of the Copending Application
Claim 40 of the copending application claims
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Ascertaining the Differences Between the Instant Application and the Copending Application
The instant application claims a salicylic acid of psilocin whereas the copending application claims a tartrate salt, succinate salt and 1,5-naphthalenedisulfonic acid of psilocin.
Finding Prima Facie Obviousness
The copending application claims a tartrate salt, succinate salt and 1,5-naphthalenedisulfonic acid form of psilocin and it would have been prima facie obvious to, and within the skill of, one of ordinary skill in the art to prepare other salt forms of psilocin such as salicylate salt which are well used salt forms in the art. One of ordinary skill the art would have been motivated to prepare other salt forms such as salicylate to find more or additional stable forms of psilocin for treating anxiety, chronic pain, etc. As a result, the claims are rejected under obviousness-type double patenting.
IV. Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Shawquia Jackson whose telephone number is 571-272-9043. The examiner can normally be reached on 7:00 AM-3:30PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Adam Milligan can be reached on 571-270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHAWQUIA JACKSON/ Primary Examiner, Art Unit 1626