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 .
Status of the Application
Claims 1-28 are pending in the application as of the preliminary amendment submitted 09/21/2023. Claims 1-28 are examined herein.
Priority
This application is a 371 of PCT/US2022/021625 filed 03/24/2022 which claims priority to PRO 63/166,520 filed 03/26/2021. The effective filing date of claims 1-28 is 03/26/2021.
Information Disclosure Statement
The information disclosure statements filed on 01/10/2025 and 09/21/2023 has been considered. The submissions are in compliance with the provisions of 37 CFR 1.97.
Claim Rejections - 35 USC § 112
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.
Claims 2-9 and 18-19 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.
Regarding instant claim 2, the claim recites “A compound according to claim 1 of Formula (II)” having the following structure.
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However, there is no recitation of what constitutes variable “A” in claim 2. This renders the metes and bounds of the claim indefinite.
For the purposes of applying prior art, the variable “A” has been interpreted as “each A is independently N or CH, provided when one A is N the other is CH” as supported by the only definition appearing in page 5 of the instant specification.
Regarding instant claims 3-9, the structures of the compounds represented by Formula (III), Formula (IIIa), Formula (IIIb), Formula (IIIc), Formula (IIId), Formula (IIIe), Formula (IIIf), respectively, are identical to the compound of Formula (II), yet being represented by different formulae. This poses some clarity issues.
For examination purposes, compounds of claims 3-9 have been labeled as represented by Formula (II), Formula (IIa), Formula (IIb), Formula (IIc), Formula (IId), Formula (IIe), Formula (IIf), respectively, for clarity.
Regarding claim 18-19, the claims depends from claim 1 and recite “wherein A is N, provided when one A is N the other is CH” and “wherein A is CH”, respectively. However, claim 1 doesn’t recite a structure with a variable “A”. There is insufficient antecedent basis for this limitation in the claim.
For the purpose of applying prior art, claims 18-19 have been interpreted to depend from claim 2 to provide sufficient antecedent basis to the limitation “A” appearing in the claims.
Specification
The disclosure is objected to because of the following informalities:
Applicants are required to amend the specification in response to the 35 U.S.C. 112(b) rejection of claims 3-9, as noted above.
Appropriate correction is required.
Allowable Subject Matter
The compounds of Formula (I) as in claim 1 have been found to be free of prior art.
The following is a statement of reasons for the indication of allowable subject matter:
The instant application relates to a compound of Formula (I) or a pharmaceutically acceptable salt thereof, with variables as defined in claim 1, a pharmaceutical composition and method of use thereof.
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The closest prior art of record is Anderson et al. (US 2020/0369610 A1, 26 November 2020, hereinafter Anderson, in the IDS). Anderson teaches N-alkylaryl-5-oxyaryl octadihydrocyclopenta[c]pyrrole negative allosteric modulators of NR2B receptors useful in the treatment of neurological diseases having the Formula I (Paras. [0006]-[0008]).
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Anderson teaches an exemplary compound, shown below (Para. [0081], first compound).
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The above compound of Anderson overlaps the scope of Formula (I) of instant claim 1, wherein
R1 is phenyl substituted with two R5, each R5 being a halogen (fluoro);
R4 is H;
R3 is O;
n is 0;
B is CRx, Rx is H.
The above compound of Anderson differs from the compound of the instant claims in the presence of a -H vs -OH in the bridgehead position of the bicyclic hexahydrocyclopenta[c]pyrrolyl ring. The conversion of a hydrogen atom to a hydroxyl group at a bridge position, especially bridgehead position in a bicyclic, non-aromatic heterocycle is not an obvious substitution owing to the strain and unique electronic properties of the bridgehead position. There is no teaching or suggestion in the prior art regarding such a transformation.
Therefore, compounds of the instant invention are novel and non-obvious variants of the compounds taught in the prior art.
Except for the 35 U.S.C. 112(b) rejection above, all claims would be allowable.
Conclusion
Claims 2-9 and 18-19 are rejected.
Claims 1, 10-17 and 20-28 are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PADMAJA S RAO whose telephone number is (571)272-9918. The examiner can normally be reached 9:00-5:30pm EDT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney L Klinkel can be reached on (571) 270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/P.S.R./Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627