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
Claim Status
Claims 1-25 and 30-31 were subject to Restriction Requirement & Election of Specie.
Upon Applicant’s Amendment, in response to the restriction requirement, Group I (claims 1-25) was elected.
Claims 1-25 are under examination.
Priority Status
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Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
All references have been considered in the two (2) IDS(s) filed 04/10/2023 & 10/05/2023 unless marked with a strikethrough.
Drawings
The one (1) drawing submission filed on 04/10/2023 has been accepted by the Examiner.
Response to Restriction/Election of Species
In Response to the Restriction and Species Election Requirement dated 11/10/2025:
Applicant elected Group I: Claims 1-25, drawn to compounds of the formula (I).
Claims 30-31, drawn to methods of preventing or treating a disease or medical disorder mediated by α2-GABAA, are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions
Applicant’s election of Group I: Claims 1-25 in the reply filed on 11/10/2025 is acknowledged.
Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Applicant further elected the specie Example 24 (4-Amino-8-(5-methoxy-4-methylpyridin-3-yl)-2-oxo-N-propyl-1,2-dihydroquinoline-3-carboxamide), as seen below:
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Claims 1-6, 10, 14, 21-25 read on the elected specie.
If the elected specie is not identified in the art, then Examiner will expand her search as per MPEP 802.03.
The elected specie was not identified in the art.
The elected specie would be allowable if claims were drafted to the elected specie alone.
Examiner expanded her search to the full extent of Claims 1-6, 10, 14, 21-25 as per MPEP 803.02.
No prior art was found.
Therefore Claims 1-6, 10, 14, 21-25, which read on the elected specie, are allowed.
Claims 7-9, 11-13, 15-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b).
Claim Rejections - 35 USC § 112
I. 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, 14, 20, and 24 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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.
Pg. 2 of 12: Claim 1.
Missing comma or semicolon.
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Claim 5: “substituted by p R3 groups”
It is unclear the phrase “substituted by p R3 groups”. It unclear if this means a particular number of p groups must be attached or if the specified R3 needs to be attached a specified amount of times.
Claim 14: for example, “e.g. R35 is F, or R35 is -OMe.”
the phrase "for example" and “e.g.” renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 20: “for example wherein R31 is selected from: halo and C1-4 alkyl, and R32 is selected from: H, halo, C1-4 alkyl, C1-4 haloalkyl, -O-C1-4 alkyl and -O-C1-4 haloalkyl.”, “optionally wherein R31 and R32 are…”.
the phrases "for example" and “optionally” render the claim indefinite because it is unclear whether the limitation(s) following the phrases are part of the claimed invention. See MPEP § 2173.05(d).
Claim 24: The compound according to claim 1, wherein the compound is selected from Compound List 1 in the description, or a pharmaceutically acceptable salt.
Applicants is instructed to copy the table contents into the claim itself.
See MPEP § 2173.05(s).
Dependent claims 2-4, 6-13, 15-19, 21-23 do not resolve these issues, since these claims do not further limit or provide further explanation towards the limitations. Accordingly, these claims are also rejected.
II. The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 22 rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim 22: wherein R4 is selected from
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Claim 22 has listed a structure with deuterium (D; enclosed in the picture above). As Claim 22 is dependent on Claim 1, there is no indication listed of “deuterated alkyl” being an option. In Claim 1, R4 does not include “deuterated compound thereof,” so as to indicate that deuteration of the compound is a possibility. Therefore, Claim 22 does not further limit claim 1.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter:
Closest Art: US 5430153 A (hereinafter “App’153”).
App’153 is considered as the closest prior art since it describes compounds with the same purpose. Table 3 lists 730 compounds (Cpds 223-953) tested as 4-amino-2-quinolines (Cpd. 904 as one; col. 119-120).
The Applicant Election specie differs structurally from the compounds of the prior art though they have similar quinoline cores through three areas (see circled areas below):
a di-substituted heteroaryl attached to position 8 of the quinoline core;
a carboxamide attached at position 3 of the quinoline core between the 2-oxo substituent and the primary amine; and
a primary amine attached at position 4 of the quinoline core.
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The prior art, though provides structurally relevant compounds (see below). There is no suggestion through the compounds listed in the prior art for a skilled artisan to specifically elect the Applicant’s specie. Though it is established the quinoline core is effective in the treatment of diseases mediated by the GABAA receptors.
As seen in the Compound listed (Cpd 904), though structurally similar to the Applicant’s election through the quinoline core, there is no motivation to want to have the specific di-substituted heteroaryl ring substituent (as seen in the Applicant election) versus having a benzyl substituent. There is also no motivation also for Applicant’s 4-amino substituent (as seen above) versus the prior art’s substituted phenyl with a CF3.
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In summary, the teachings of App’153 (closely-related art) does not teach, suggest or provide motivation to arrive at the structures in the instant claims. The species of the Instant Claims are distinct.
Conclusions
Claims 1-6, 10, 14, 21-24 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Josmalen M. Ramos-Lewis whose telephone number is (571)272-0084. The examiner can normally be reached M-F 9:30-5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton A. Brooks can be reached at (571) 270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSMALEN M. RAMOS-LEWIS, Ph.D./Patent Examiner, Art Unit 1621
/VALERIE RODRIGUEZ-GARCIA/Primary Examiner, Art Unit 1621 03/25/2026