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 1-21 are currently pending in the instant application. Claims 1-21 are rejected in this Office Action.
I. Priority
The instant application is a CON of 18/317,169, filed on May 15, 2023 PAT 12,077,499 which is a CON of 17/801,552, filed on August 23, 2022 PAT 11,780,808 which is a 371 of PCT/US2021/019893, filed on February 26, 2021 which claims benefit of US Provisional Application 62/982,441, filed on February 27, 2020.
II. Information Disclosure Statement
The information disclosure statements (IDS) submitted on July 23, 2024, October 4, 2024 and September 11, 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
Claim Rejections - 35 USC § 112
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.
Claims 1-21 are 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 term “derivatives” found in claims 1 and 3 renders the products indefinite as the term “derivatives” can be considered open-ended language when not clearly defined and therefore is including additional subject matter in the pharmaceutical composition that is not described in the instant specification and is not particularly pointed out or distinctly claimed. It is unclear what compounds are considered “derivatives” of the second serotonergic drugs listed in the claims. One of ordinary skill in the art would not know the metes and bounds of this limitation and therefore the claims are considered indefinite. This rejection can be overcome by deleting the term “derivatives” in claims 1 and 3.
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 1-21 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 12,077,499. Although the conflicting claims are not identical, they are not patentably distinct from each other because:
Applicants claim
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342
781
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473
786
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Determining the Scope and Content of the Issued Patent
Claims 1-3 of the issued patent are the following:
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366
425
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Ascertaining the Differences Between the Instant Application and the Issued Patent
The difference between the instant application and the issued patent’s claims is the presence of a second serotonergic drug in the pharmaceutical composition with the crystalline bis(hydroxy-N-methyl-N-isopropyltryptammonium) fumarate whereas the issued patent’s claims only administer the above crystalline form.
Finding Prima Facie Obviousness
In Kerkhoven, 626 F. 2d 846, 205 USPQ 1069 (CCPA 1980), it was established that it is obvious to combine two compositions taught by the prior art to be useful for the same purpose to form a third composition that is used for the very same purpose. Both the instant claimed invention and the issued patent claim the same method of use administering a crystalline bis(hydroxy-N-methyl-N-isopropyltryptammonium) fumarate. The compound crystalline bis(hydroxy-N-methyl-N-isopropyltryptammonium) fumarate is taught in the instant specification and the issued patent to be a serotonergic agent. Therefore, it would be obvious to use a composition comprising two serotonergic agents for the purpose of treating the same utility of treating a brain disorder, for example, with a reasonable expectation for success. 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.
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).
/SHAWQUIA JACKSON/Primary Examiner, Art Unit 1626
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