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 .
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.
Election/Restrictions
Applicant's election with traverse of in the reply filed on 30 March 2026, is acknowledged. The traversal is on the ground(s) that all the species have a common property or activity. This is not found persuasive because the Examiner properly cited justifications for the Election of Species Requirement (see, for example, pages 5-6).
The requirement is still deemed proper and is therefore made FINAL.
Applicants provided a compliant species election:
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, wherein R1 and R2 together with the carbon atoms to which they are attached form a benzene group; Ra is methyl; Rb and Rc together with the N atom and the carbon atom to which they are attached, form a group selected from a 5-memberted cyclic amide; and R7 is H. The Examiner interprets this compound as:
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.
The Examiner did not find prior art on the elected species. However, Examiner extended the Markush search to the compound:
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, which is a species of genus formula I of instant claim 1, wherein: R1 and R2 together with the C atoms to which they are attached, form a 1H-indole group which is substituted with one chlorine atom; Ra and Rb together with the C and N atom to which they are attached, form a 6-membered cyclic amide; Rc is H; and R7 is H. This search retrieved prior art.
Therefore, the Markush search will not be extended unnecessarily to additional species of genus formula I in this Office Action.
The extended Markush search reads on claims 1-5 and 14-21.
Claims 6-13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 30 March 2026.
Current Status of 18/553,471
This Office Action is responsive to the amended claims of 30 March 2026.
Claims 1-5 and 14-21 have been examined on the merits. Claims 1, 3, 14-15, and 21 are previously presented. Claims 2 and 5 are original. Claims 4 and 16-20 are current amended.
Priority
The effective filing date is 31 March 2021.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 31 March 2026; 8 August 2025; 7 December 2023; and 29 September 2023, are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Specification
The title of the application contains “Novel”. The title of the invention is not descriptive. Furthermore, words such as “New”, “Improvement”, and “Improvement of” are not permitted in the title of an application. See MPEP 606. A new title is required that is clearly indicative of the invention to which the claims are directed. Please delete “Novel”.
The following title is suggested: -- [[Novel]] Heterocyclic Compounds and Their Use as Medicaments to treat CNS Disorders -- .
Claim Objections
Claims 2-5 and 14 are dependent claims. These claims currently begin with “A” but dependent claims should begin with -- The -- .
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 1-5 and 14-21 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.
Claim 1 recites the limitations "R3, R4, R5, and R6". There is insufficient antecedent basis for this limitation in the claim.
As drafted, the limitations "R3, R4, R5, and R6" render the metes and bounds of claim 1 undefined (hence rendering claim 1 indefinite under 35 USC 112(b)). The artisan does not know which part of the phenyl ring (of the 1H-indole or benzene) each of these variables "R3, R4, R5, and R6" belongs.
Claims 2-5 and 14-21 are similarly rejected as indefinite under 35 USC 112(b) since these claims refer back to claim 1 but do not remedy the rationale underpinning the basis for rejecting claim 1.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-5 and 14-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by:
KARAM (U.S. 6,048,868, provided by Applicants and referenced in IDS of 29 September 2023).
The prior art reference KARAM teaches the compound of Example 42:
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(see Example 42 within col. 28), or a pharmaceutically acceptable salt thereof (col. 3), which is a species of genus formula I of instant claim 1, wherein: R1 and R2 together with the C atoms to which they are attached, form a 1H-indole group which is substituted with one chlorine atom; Ra and Rb together with the C and N atom to which they are attached, form a 6-membered cyclic amide; Rc is H; and R7 is H. This anticipates instant claim 1.
This also anticipates formula Ia and Ib of instant claim 2; this anticipates Id (wherein “n” is 2) of instant claims 3-5; and anticipates instant claim 14.
Lines 40-55 of col. 61 teach the pharmaceutical composition of instant claim 15.
Reference claim 18 teaches “pharmaceutically acceptable carrier” of instant claims 16-17.
Reference claim 19 teaches the method of instant claim 18.
Reference cols. 1 and 61 each teach instant claims 19-20.
Conclusion
Claims 1-5 and 14-21 are not presently allowable as written.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN S KENYON whose telephone number is (571)270-1567. The examiner can normally be reached Monday-Friday 10a-6p.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew D Kosar can be reached at (571) 272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625
Prosecution Insights