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
RESPONSE TO ELECTION/RESTRICTION
Applicant’s election without traverse of group I, drawn to compositions comprising formula I and elected species:
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in the reply filed on 3/6/2026 is acknowledged.
The requirement is still deemed proper and is therefore made FINAL.
Claims 3, 5-6, 42-53, 58 and 61 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
An action on the merits of claims 1-2,4,9-11,15-29,32-34 and 39-40 is contained herein.
Priority
This application claims the benefit of U.S. Provisional Application No. 63/189,449 filed
May 17, 2021.
Information Disclosure Statement
The examiner has considered the references cited in the information disclosure statements filed of record. References that do not have a publication year have been crossed out by the examiner as a publication year is required.
Specification
Applicant is reminded of the proper content of an Abstract of the Disclosure, see MPEP 608.01(b).
In chemical patent abstracts for compounds or compositions, the general nature of the compound or composition should be given as well as its use, e.g., "The compounds are of the class of alkyl benzene sulfonyl ureas, useful as oral anti-diabetics." Exemplification of a species could be illustrative of members of the class. For processes, the type reaction, reagents and process conditions should be stated, generally illustrated by a single example unless variations are necessary.
It is recommended that the structure of Formula I be inserted into the abstract to accurately illustrate the claimed invention. Additionally the abstract of the disclosure does not commence on a separate sheet in accordance with 37 CFR 1.52(b)(4) and 1.72(b). A new abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text.
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 1-2,4,9-11,15-29,32-34 and 39-40 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 10, 11, 15, 16, 18, 19, 22-24, 27-30, 32, and 39 of copending Application No. 18/867,231. Although the conflicting claims are not identical, they are not patentably distinct from each other because there is significant overlap between the two applications.
The genus structure of the instant application may fully encompass the claimed compositions of the copending application. For instance in the copending application, the compositions comprise a polymer and the same formula I in amorphous form where it is stated that the purity must be greater than 97%. Dependent claims reciting specific polymers and inherent features are also described in both applications. Despite the latter recitation reciting purity, the compositions fall within the scope of the compositions of the instant application and subsequently are anticipated.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
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 of this title, 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 1-2,4,9-11,15-29,32-34 and 39-40 are rejected under 35 U.S.C. 103(a) as being unpatentable over WO 2021/003467 in view of WO 2020/148442 and in further view of GREENAN et al., "Preparation and Characterization of Novel Crystalline Solvates and Polymorphs of Psilocybin and Identification of Solid Forms Suitable for Clinical Development", Retrieved online from ResearchGate: https://www.researchgate.net/publication/339238710, 29 page – (all mentioned in IDS).
The instant claims are drawn to compositions comprising dispersions of the compound of formula I (in particular the elected species psilocybin) in amorphous form along with a polymer and salts, stereoisomers, tautomers, and solvates thereof. Some dependent claims recite specific weight percentages of components, polymer types, additional excipients known in the art, and inherent characteristics regarding said compositions.
WO 2021/003467 teaches generically compositions comprising psychedelic compounds and a polymer wherein said compounds may be chose from psilocybin (see claims 1-2) at page 45 of document. The document teaches tablets for oral administration of the latter (see claim 8) and starting at pages 26-28 teach varying amounts of active agent employed, specific polymers, and preservatives. The document does not state the psilocybin being in an amorphous form.
GREENAN et al. teaches that various forms of psilocybin are known in the art including the recited and claimed amorphous forms (see abstract). Lastly, WO 2020/148442 teaches methods of preparing solid dispersions of known pharmaceuticals stating that amorphous forms of these dispersions are often pursued due to improving dissolution performance and dissolution rates over their crystalline form (see page 4 of document, lines 24-35). Thus based on these teaching, one skilled in the art would have been motivated to prepare the solid dispersion compositions described in WO 2021/003467 comprising the known amorphous forms of psilocybin due to their suspected advantageous properties. Thus the claimed compositions would have been considered obvious.
Dependent claims reciting specific weight percentages of components, polymer types not explicitly taught, additional excipients known in the art, and inherent characteristics regarding said compositions do not tip the scales towards patentability since this would have been viewed as routine optimization or inherent properties of an obvious composition. Generally, differences in these variables will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN E MCDOWELL whose telephone number is (571)270-5755. The examiner can normally be reached on 8:30-6 MF.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey 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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BRIAN E MCDOWELL/Primary Examiner, Art Unit 1624
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