DETAILED ACTION
Status of Claims
The amendment submitted February 10, 2026 has been entered.
Claims 1-20 and 215 are pending and under consideration.
Claims 22-214 are cancelled by Applicant.
Claim 215 is new.
Claims 3, 7-8, 10-20 are withdrawn are withdrawn in the instant office action as explained below in the Election/Restriction section
Claims 1-2, 4-6, 9, and 215 are under consideration in the instant office action as explained below in the Election/Restriction section
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 .
Election/Restrictions
Applicant’s election of Group I, claims 1-10, drawn to a compound of Formula (II) in the reply filed on February 10, 2026 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)).
New claim 215 depends on claim 1 and is drawn to a compound of Formula (II); therefore, it is included in Group I and is also elected.
Applicant’s election of example 82; compound 1557 as a species of compound of Formula (II) in the reply filed on February 10, 2026 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)).
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The election reads on claims 1-2, 4-6, 9, and 215 where X is N, Y is NR8, R8 is H, Z is CH, R2 is methyl, J1 to J5 are CR7, R7 is H for J5, J4, J2, and R7 is CH3 for J1 and F for J3.
Claims 3, 7-8, 10-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on February 10, 2026.
Claims 1-2, 4-6, 9 and 215 are under consideration and the subject of this Office Action.
Information Disclosure Statement
One information disclosure statements (IDS) submitted on July 10, 2024 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Specification
Abstract Objections
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
The abstract of the disclosure is objected to because the abstract is less than 50 words. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Rejections - 35 USC § 103
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.
Claims 1-2, 4-6, 9 and 215 are rejected under 35 U.S.C. 103 as being obvious over Poslusney et al. (USPN 12,234,221 B2) in view of Flynn et al. (Flynn, G. L., and Samuel H. Yalkowsky. "Correlation and prediction of mass transport across membranes I: Influence of alkyl chain length on flux‐determining properties of barrier and diffusant." Journal of pharmaceutical sciences 61, no. 6 (1972): 838-852).
The applied reference has a common inventor and applicant with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Poslusney discloses compounds similar to the instantly claimed invention of formula (1) (column 3, first structure).
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More specifically, at column 110, Poslusney discloses example 115, which only differs from the instantly claimed invention based on a methyl substituent para to the nitrogen atom instead of a hydrogen substituent as shown below.
[AltContent: textbox (Example 115, Poslusney)][AltContent: rect]
Consequently, Poslusney meets the limitations of claims 1-2, 4-6, 9 and 215 where X is N, Y is NR8, R8 is H, Z is CH, R2 is methyl, J1 to J5 are CR7, R7 is H for J5, J4, J2, and R7 is CH3 for J1 and F for J3, excepting for the hydrogen vs. methyl substituent as aforementioned.
Both Poslusney and the compounds of the instant invention are directed towards compounds for inhibiting the identical target, NAV1.8.
As per MPEP 2144.09.I: “A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979).”
Therefore, it is reasonable to conclude an ordinarily-skilled artisan would modify Poslusney to access instant elected compound as part of standard structure-activity relationship studies with a reasonable expectation of success in achieving similar properties.
Additionally, as per MPEP 2144.09.II “Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977).”
Again, the difference between Poslusney and instant elected species is a hydrogen vs a methyl substituent.
Flynn additionally teaches that membrane permeability, an important pharmacological property (page 838 first paragraph) can be optimized based on replacing hydrogen with a methyl group (page 843, column 2, paragraph 2), which shows correlations with increasing membrane permeability and increasing alkyl chain length.
Consequently, it would have been prima facie obvious before the effective filing date of the claimed invention to modify Poslusney to access the instant elected species because Poslusney teaches an identical compound differing only by a hydrogen vs methyl substituent and because Flynn teaches that membrane permeability can be optimized through replacing hydrogen with methyl and optimizable via alkyl chain length.
Therefore, a person of ordinary skill in the art would be motivated to modify Poslusney’s compound to access instant invention as a highly predictable result with a reasonable expectation of success to optimize the pharmacological properties as part of structure-activity relationship studies and standard drug candidate development process.
Therefore, claims 1-2, 4-6, 9 and 215 are rejected as being obvious based on the beneficial teachings of Poslusney and Flynn.
Conclusion
Claims 1-2, 4-6, 9, and 215 are under consideration and are rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAROLYN L. LADD whose telephone number is (703)756-5313. The examiner can normally be reached M-Th, 7:00 am to 5:30 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James H. Alstrum-Acevedo can be reached at 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.L.L./Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
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