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 1-24 are currently pending in the instant application. Claims 1-24 are rejected in this Office Action.
I. Priority
The instant application is a CON of 18/604,747, filed on March 14, 2024 which is a CON of PCT/EP2023/057882, filed on March 27, 2023 and claims benefit of Foreign Application EPO 22000081.4, filed on March 27, 2022.
II. Information Disclosure Statement
The information disclosure statements (IDS) submitted on January 17, 2025, February 27, 2025, March 28, 2025, April 30, 2025, May 30, 2025, June 30, 2025, July 31, 2025, August 29, 2025, September 26, 2025, October 31, 2025, December 15, 2025, January 21, 2026 and February 23, 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
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 1 and 6 are rejected under 35 U.S.C. § 103(a) as being unpatentable over Feilding-Mellen (WO 2021/250435 A1). Applicants claim
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The Scope and Content of the Prior Art (MPEP §2141.01)
Feilding-Mellen teaches a crystalline form of 5MEODMT
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hydrochloride and a pharmaceutical composition comprising the crystalline form. The prior art broadly teaches various salt forms of the compound
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and that in one embodiment the salt is a benzoate, fumarate, citrate, acetate, succinate, halide, fluoride, chloride, bromide, iodide, oxalate, or triflate (see page 2, lines 22-23). The prior art further teaches that the 5MeODMT salt is amorphous or crystalline (see page 2, line 20) . These compounds are used for treating various disorders such as depression, anxiety, eating disorders, etc. (see page 3, lines 28-45).
The Difference Between the Prior Art and the Claims (MPEP §2141.02)
The difference between the prior art of Feilding-Mellen and the instant invention is that the instant invention specifically claims a crystalline 5MeODMT hydrobromide when the prior art specifically teaches a crystalline 5MeODMT hydrochloride but broadly teaches that the possible salts include bromide and are crystalline.
Prima Facie Obviousness-The Rational and Motivation (MPEP §2142-2413)
The prior art teaches that a crystalline bromide salt of 5MeODMT is included in the invention as a preferred embodiment. Therefore, it would be obvious to prepare another salt form of 5MeODMT (i.e. hydrobromide) when the art teaches a hydrochloride salt form with a reasonable expectation of success. Specifically, both hydrochloride and hydrobromide salts are well known salt forms and the preparation of these salts forms is well within one of ordinary skill in the art. Since the prior teaches bromide salts that are crystalline as a possible salt form for 5MeODMT, it would be obvious for one of ordinary skill in the art to prepare other crystalline salt forms taught by the prior art with a reasonable expectation for success. 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 other crystalline salt forms (i.e. bromide) based on the teachings of the preferred embodiments in the prior art. A strong prima facie 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 1-24 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 12,172,960. 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 are drawn to a broader genus of crystalline forms of 5-MeO-DMT hydrobromide whereas the issued patent is drawn to a crystalline form with specified x-ray diffraction peaks.
Finding Prima Facie Obviousness
The genus crystalline form of the instant application encompasses the narrower genus compound of the patented claims 1-22. The scope of the compounds in the patented claims 1-22 and the scope of the claims 1-24 of the instant application overlap and include patented subject matter in the instant claims. Therefore, one of ordinary skill in the art would be motivated to prepare and claim the scope of the compounds in the issued patent again in the instant application since the scope already patented falls within the full scope of the instant claims 1-24. 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
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