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 .
Priority
This application filed 06/24/2024, is a national stage application of PCT/AU2022/051592, filed 12/23/2022, which claims the benefit of a foreign application filed in Australia, AU2021904274, on 12/24/2021.
Information Disclosure Statement
Information Disclosure Statements (IDS) submitted on 5/16/2025, 5/23/2025, and 1/29/2026 are being considered by the examiner.
Drawings
The drawings submitted on 6/24/2024 are objected to because Figures 1, 2, and 3 have font that isn’t legible. Please correct Figures 1, 2, and 3.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
Claim Status
Claims rejected: 1
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
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.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Jiang (Xi-Ling Jiang et al. “Modification of 5-methoxy-N, N-dimethyltryptamine-induced hyperactivity by monoamine oxidase A inhibitor harmaline in mice and the underlying serotonergic mechanisms” Pharmacological Reports 68, Pb. Date February 5 2016, Pgs. 608-615) in view of Sun (Shaoyi Sun et al. “Methyl-containing pharmaceuticals: Methylation in drug design”, Bioorganic and Medicinal Chemistry Letters, Volume 28, Issue 20, Pub. Date: November 1, 2018, Pgs. 3283-3289).
Jiang discloses 5-Methoxy-N, N-dimethyltryptamine, herein 5-MeO-DMT,
bottom left, as a synthesis compound used pharmaceutically (Abstract). To map 5-MeO-DMT disclosed in Jiang, with compound P-50 of Formula (I) in the instant application, R1 is a C1 alkyl, R2 is a C1 alkyl, R3 is hydrogen, R6 is a hydrogen, R7 is a hydrogen, R8 is a hydrogen, R9 is a C1 alkoxy group, and R10 is a hydrogen.
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5-MeO-DMT in Jiang does not teach an additional methyl group at position R11.
Sun teaches that adding a methyl group to a compound increases drug potency, selectivity, and solubility and plays an important role in drug design (Abstract).
It would have been obvious for one of ordinary skill in the art before the effective filing date to take 5-MeO-DMT disclosed in Jiang, and add a methyl group to arrive at Compound P-50 disclosed in the present application because Sun teaches methylation of compounds was known in the art of pharmaceutics and methylation has increased benefits of potency, selectivity, and solubility of drugs. It would have been obvious to add a methyl group at position R11 in the present application, because there are a finite number of positions that a methyl group can be added in Compound P-50, and one of ordinary skill in the art would be motivated by the increase potency, selectivity, and solubility for pharmaceutical use of methylation known in the art.
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 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 1 of copending Application No. 18/723,836 (reference application).
Claim 1 in the present application, bottom left, and Claim 1 in copending application ‘836, bottom right, both disclose compounds of the same genus, Formula (I).
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R1-R11 and L are defined identically in present claim 1, and Copending application ‘836.
Therefore Claim 1 in the present application as written is claiming the same invention as Claim 1 in copending application ‘836.
This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
Conclusion
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/C.M.R./ Examiner, Art Unit 1627
/Kortney L. Klinkel/ Supervisory Patent Examiner, Art Unit 1627
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