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
This Office Action is response to the Response to Election/Restriction and Amendment filed 04/17/2026, wherein claims 1-3, 6-7, 9 and 14-15 are amended, and claims 4-5, 8, and 10-13 are cancelled.
Claims 1-3, 6-7, 9, and 14-19 are pending.
Priority
This application claims the following priority:
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Information Disclosure Statement
The information disclosure statement filed 04/24/2025, NPL No. 1, fails to comply with 37 CFR 1.98(a)(3)(i) because it does not include a concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of each reference listed that is not in the English language. It has been placed in the application file, but the information referred to therein has not been considered.
Election/Restrictions
Applicant's election with traverse of Group I, in the reply filed on 07/17/2026, is acknowledged. The traversal is on the ground(s) that Groups I and II possess unity and should be examined together without any undue burden being placed on the examiner.
This argument has been fully considered, but is not found persuasive. It is respectfully pointed out that the claims have been amended since the 03/02/2026 Restriction Requirement. The Restriction Requirement and evidence of lack of unity was properly applied. Further, in view of the amendment to the claims, Groups I and II, continue to lack unity.
WO 2020/061162 to Ledeboer (PTO-892) teaches
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(pg. 23), which meets the limitations of instant formula (P-1) when:
R1 is Cl
R2 is C1alkyl substituted with OH
Rc is F and C1alkyl substituted with 3 halogens.
While Ledeboer does not teach instant L as S, but as O, Patani (PTO-892) teaches S and O as known bioisosteres (pg. 3159), and US2023/0257382 to Li (IDS) teaches either S or O in the instant L position of compounds with similar pyridazinone structures (pg. 17, Col. 1; pgs. 63-65, claim 1). As such, an ordinary skilled artisan would have been motivated to substitute the O at the instant L position of Ledeboer with S, to arrive at instant formula P-1, to predictably achieve a compound with similar or more potent activity, for the inhibition of TRPC5 (Ledeboer pgs. 2, 31, 32, 37-39, 103-106).
As such the technical feature of formula P-I is not a special technical feature, and Groups I and II lack unity of invention.
Applicant’s election without traverse of species WX012,
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, in the reply filed on 04/17/2026 is acknowledged.
Claims 15, 17 and 19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention and species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 04/17/2026.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-3, 6-7, 9, 14, 16 and 18 are examined on the merits herein.
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 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.
Claims 1-3, 6-7, 9, 14, 16 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2020/061162 to Ledeboer (published 03/2020) in view of US20230257382 to Li (effectively filed 06/23/2021, IDS of 08/19/2024) and Patani (Bioisosterism: A Rational Approach in Drug Design, published 1996, PTO-892).
Ledeboer teaches:
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, which meets the limitations of instant formula (P-1) when:
R1 is Cl
R2 is C1alkyl substituted with OH
Rc is F and C1alkyl substituted with 3 halogens.
Regarding claims 1-3, 6-7, 9 and 14, Ledeboer differs from that of instant formula P-1 in that it does not teach the “L” position as S.
Li teaches structurally similar halogen substituted pyridazinone compounds:
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(pg. 17, Col. 1), which meets the limitations of instant formula (P-1) when:
L is S
R1 is Cl
R2 is C1alkyl substituted with OH
Rc is F and C1alkyl substituted with 3 halogens.
Patani teaches bioisosterism as a tool for the medicinal chemist for the rational modification of lead compounds into safer and more clinically effective agents (pg. 3147, “Introduction”). The ability of a group of bioisosteres to elicit similar biological activity is attributed to common physicochemical properties. Bioisosteres provide opportunities for the medicinal chemist to gain more specific insight into the quantitative structure-activity relationships associated with a specific class of drugs. Bioisosteric replacements often provide the foundation for the development of QSAR in drug design (pg. 3148, Col. 1).
Patani teaches -O- and -S- as divalent bioisosteres that are attached to two different substituents. Patani teaches that these types of bioisosteric substitutions have been used extensively in the study of the structure-activity relationships of various pharmacologically active agents (pgs. 3155-3156, B).
In conclusion, Patani teaches that bioisosteres modulate biological activity by virtue of subtle differences in their physicochemical properties. Systematic correlation of physicochemical parameters with observed biological activity is very effective in highlighting subtle differences within bioisosteric groups which often increases activity. This systematic approach facilitates the use of bioisosteric replacements in structure-activity studies.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed, to substitute the -O- at the instant L position of
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, to arrive at
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, the elected species. One of ordinary skill in the art would have been motivated to make such a substitution, with a reasonable expectation of success, because:
-both Ledeboer and Li teach structurally similar pyridazinone compounds for use as antagonists or inhibitors of TRPC5 (Ledeboer pgs. 2, 31, 32; Li abstract, [0013]),
-Li teaches exemplifies compounds with -S- at the instant L position, and teaches that the instant L position can be -O- or -S- (pgs. 63-69, claims 1-2, 5, 6), and
-Patani teaches -O- and -S-as bivalent bioisosteres,
As such, an ordinary skilled artisan would have been motivated to make such a substitution, to predictably arrive at a structurally and functionally similar compound that is therapeutically effective to inhibit TRPC5, and associated diseases.
Regarding claims 16 and 18, Ledeboer teaches its compounds as antagonists or inhibitors of TRPC5 (Ledeboer pgs. 2, 31, 32, 37-39, 103-106).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN WELLS whose telephone number is (571)272-7316. The examiner can normally be reached M-F 7:00-4:30.
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/LAUREN WELLS/Examiner, Art Unit 1622
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