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 1-19 and 21 are currently pending in the instant application. Applicants have amended claims 17 and 21 and canceled claims 20 and 22-41 in an amendment filed on January 21, 2025. Claims 1-19 and 21 are rejected in this Office Action.
I. Priority
The instant application is a 371 of PCT/AU2022/051593, filed on December 23, 2022 and claims benefit of Foreign Application AUSTRALIA 2021904274, filed on December 24, 2021.
II. Information Disclosure Statement
The information disclosure statements (IDS) submitted on May 5, 2025, May 23, 2025 and January 29, 2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner.
III. Rejections
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless -
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 7, 8, 14-16, 17, 18 and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Slassi, et al. (WO 98/23587 (A1)). The instant invention claims
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and all other variables are as defined in claim 1.
The Slassi, et al. reference teaches indole derivatives as 5-HT1D receptor ligands such as
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(See page 46, example 17b) wherein R9 is C6 cycloalkyl; R6, R7, R8, R10, R11 to R4 are H; L is C1 alkylene; R1 and R2 together form pyrrolidine. This species of compound anticipates the genus compound of the instant invention, wherein the genus structure and its definitions are stated above.
Claims 1, 2, 7, 14-16, 17, 18 and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Olson, et al. (WO 2020/176599 (A1)). The instant invention claims
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and all other variables are as defined in claim 1.
The Olson, et al. reference teaches indole derivatives as 5-HT2A receptor ligands such as
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(See page 33, paragraph 0111) wherein R8 is methyl; R10 is methoxy; R6, R7, R9, R11 to R4 are H; L is C1 alkylene; R1 or R2 and R7 together form a C6 heterocycloalkyl; the other R1 or R2 is methyl. This species of compound anticipates the genus compound of the instant invention, wherein the genus structure and its definitions are stated above.
Claims 1, 7, 8, 11, 12, 14-16, 17, 18 and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sard, et al. (Bioorganic & Medicinal Chemistry Letters 15 (2005) 4555-4559). The instant invention claims
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and all other variables are as defined in claim 1.
The Sard, et al. reference teaches indole derivatives as 5-HT2C receptor agonist such as psilocybin
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(See page 33, paragraph 0111) wherein R8 is OP(O)(OH)2l; R6, R7, R9, R10, R11, R3 and R4 are H; L is C1 alkylene; R1 and R2 are methyl. Psilocybin is a hallucinogenic component of the Mexican mushroom Psilocybe Mexicana. This species of compound anticipates the genus compound of the instant invention, wherein the genus structure and its definitions are stated above.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 7, 8, 11, 12, 14-16, 17, 18 and 21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The non-statutory subject matter is psilocybin represented by formula
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wherein R8 is -OP(O)(OH)2, R1 and R2 is methyl, L is C1 alkyl and all other variables are H found in claim 1. According to the original disclosure, psilocybin is a natural compound produced by more than many species of mushrooms known collectively as psilocybin mushrooms or “magic mushrooms” (See page 2, lines 4-7 in the specification). The reference Morgan, et al. (Bioorg. Med. Chem. 2010) also teaches that
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is a natural product (See page 33, paragraph 0111). Since psilocybin is a natural product and the hand of man is not involved in the production of the compounds, Applicants cannot receive a patent for a natural product. See MPEP 2106.04(b).
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 USPQ 2d 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 1-19 and 21 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claim 1 of copending Application No. 18/723,719. Although the conflicting claims are not identical, they are not patentably distinct from each other because the instant claims 1-19 and 21 provide products which generically overlap with the copending application’s claimed products which are obvious over the copending application’s claimed invention.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Claim Rejections - 35 USC § 112, 2nd paragraph
The following is a quotation of the second paragraph of 35 U.S.C. 112:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 19 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Specifically, the limitation in claim 19 which is drawn to “selected from any one of the compounds of Table 1” do not clearly define the structure or name of each compound. The examiner must refer to the specification to find the structures of the various compounds being referred in claim 19. A claim referring to the specification is improper except in rare instances and fails to particularly point out the subject matter that applicant regards as the invention. Ex parte Fressola, 27 USPQ 2d 1608 (1993). To overcome the rejection, Applicants need to insert the structures of each ligand disclosed in claim 19. The structures are found on pages 124-127 of the specification.
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
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