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 .
Claim Status
Claims 1, 3, 5, 7-9, 11-13, 16, 17, 19-21, 25, 26, and 42-44 are pending.
Claims 2, 4, 6, 10, 14, 15, 18, 22-24, 27, 29, 32-37, and 39-41 were previously cancelled
and claims 28, 30, 31, and 31 are cancelled.
Claims 1, 3, 5, 7-9, 11-13, 16, 17, 19-21, 25, 26 are currently amended.
Claims 42-44 are newly added.
Claims 1, 3, 5, 7-9, 11-13, 16, 17, 19-21, 25, 26, and 42-44 have been examined.
Claims 1, 3, 5, 7-9, 11-13, 16, 17, 19-21, 25, 26, and 42-44 are rejected.
Priority
Priority to 371 PCT/US21/47894 filed on 08/27/2021, which claims priority to application 63/074640 filed on 08/28/2020 is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/08/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Drawings
The drawings filed on 02/27/2023 are accepted.
Withdrawn Claim Rejections - 35 USC § 112
Response to Applicant’s Arguments
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
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.
The rejection of claims 11, 12, 19 and 20 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn in view of the amendments to the claims.
Withdrawn Claim Rejections - 35 USC § 102
Response to Applicant’s Arguments
The rejection of claim(s) 1, 5, 7-9, 11-13, 16, 17, 19-21, 25, and 26, under 35 U.S.C. 102(a)(1) as being anticipated by Griffith et al. (European Patent Application Publication 0279937, Published 08/31/1988) is withdrawn in view of the amendments to the claims.
The rejection of claim 28 under 35 U.S.C. 102(a)(1) as being anticipated by Griffith et al. (European Patent Application Publication 0279937, Published 08/31/1988) is moot since the claim is cancelled.
The rejection of claim(s) 30 and 38 under 35 U.S.C. 102(a)(1) as being anticipated by Johnson et al. (US Patent 5650443, Published 07/22/1997) is moot since the claims are cancelled.
The rejection of claim(s) 31 under 35 U.S.C. 102(a)(1) as being anticipated by Smith et al. (US Patent Application Publication 2013/0158112 A2, Published 06/20/2013) is moot since the claim is cancelled.
Withdrawn and New 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Response to Applicant’s Arguments
The rejection of claim(s) 1, 3, 5, 7-9, 11-13, 16, 17, 19-21, 25, and 26 under 35 U.S.C. 103 as being unpatentable over Griffith et al. (European Patent Application Publication 0279937, Published 08/31/1988) is withdrawn in view of the amendment to the claims.
The rejection of claim 28 under 35 U.S.C. 103 as being unpatentable over Griffith et al. (European Patent Application Publication 0279937, Published 08/31/1988) is moot since the claim is cancelled.
This is a new ground of rejection necessitated by the amendments to the claims.
Claim(s) 1, 3, 5, 7-9, 11-13, 16, 17, 19-21, 25, 26, and 42-44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Metcalf et al. (International Application Published Under the PCT WO 99/04779, Published 02/04/1999) in view of Mayeux et al. (International Application Published Under the PCT WO 2008/086452 A3, Published 07/17/2008).
Metcalf et al. teach a formulation comprising a compound of formula (I) or a salt thereof:
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(see page 1, lines 21-32). Metcalf et al. further teach, “the formulations of the invention are suitable for the treatment or prophylaxis of disease conditions where administration of an NMDA antagonist is beneficial … In a further aspect the invention therefore provides a formulation as defined herein for use in therapy, and particularly for the treatment and prophylaxis of epilepsy, Parkinson's disease and Huntingdon’s disease. Preferably the formulations of the invention are used for the treatment and prophylaxis of epilepsy” (page 4, lines 4-10).
Metcalf et al. lacks a preferred teaching of compound of instant formula (I). However, Metcalf et al. does render such a compound obvious. Metcalf et al. also lacks a teaching wherein the compound is administered for treatment of Alzheimer’s disease.
Mayeux et al. teach therapeutics used to treat Alzheimer's disease include, NMDA antagonist (paragraph 0032).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the instant invention to use the compound(s) of Metcalf et al. for the treatment of Alzheimer’s disease and have a reasonable expectation of success. One would have been motivated to do so since Metcalf et al. teach the compounds are NMDA antagonists and Alzheimer’s disease can be treated with NMDA antagonists. For the foregoing reasons the instant claims are rendered obvious by the teachings of the prior art.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614