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 .
Priority
Instant application 18/607,196 filed on 03/15/2024 claims benefit as follows:
CONTINUING DATA:
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Status of the Application
The amendment filled on 08/12/2026 has been entered.
Claims 1, 2, 5, 6, 18-20, 23, 26, 27, 57-59, 62, 65, 89, 90-93, 96, 102, 106, 107 are pending.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/15/2024 was in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 08/12/2026 is acknowledged.
91-93, 96, 102, 106, 107 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention there being no allowable generic or linking claim.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 08/12/2026.
Regarding species election, Applicant’s election without traverse of Example 9-1 in the reply filed on 08/12/2026 is acknowledged.
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Examination will begin with the elected species. In accordance with the MPEP 803.02, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species, the search of the Markush-type claim will be extended. If prior art is then found that anticipates or renders obvious the non-elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be reexamined. Id. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. Id. In the event prior art is found during reexamination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final. Id.
As per MPEP 803.02, the Examiner will attempt to determine whether the entire scope of the claims is patentable. Applicants' elected species, as shown above, does make a contribution over the prior art. Therefore, according to MPEP 803.02: should the elected species appear allowable; the search of the Markush-type claim will be extended. The search and examination should be continued until either (1) prior art is found that anticipates or renders obvious a species that falls within the scope of a proper Markush grouping that includes the elected species, or (2) it is determined that no prior art rejection of any species that falls within the scope of a proper Markush grouping that includes the elected species can be made. The Examiner need not extend the search beyond a proper Markush grouping.
Species Election
A careful review of the prior art has indicated that elected species is free of the prior art. A claim directed to the elected species in independent form would be free of prior art.
The examiner has moved onto alternative species embodied within the general formula (IIIa) recited in the instant claim 18, and subsequent examination is based on this species expansion.
Claims 1, 2, 5, 6, 19-20, 57-59, 62, 65 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. Election was made without traverse in the reply filed on 08/12/2026.
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 (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.
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.
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 18, 27 and 90 are rejected under 35 U.S.C. 103 as being unpatentable over RN-958568-54-2 (Entered to STN 18 Dec 2007) evidenced by Emory Chemical Biology Discovery Center website (printed 10/07/2026) in view of Bauer (Bauer et al., RSC Med. Chem., 2021, 12, 448–471).
RN-958568-54-2 teaches the following structure:
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Compound RN-958568-54-2 differs from instant Formula (IIIa):
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wherein:
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R3 is alkoxy, Ra is hydrogen, n is 1 and p is 1, only in one position.
RN-958568-54-2 bears cyclopropyl (R7 and R8 are alkyls joined together to form cycloalkyl ring) whereas the compounds of instant formula (IIIa) recited in instant claim 18 (B) require R7 and R8 independently selected from H and alkyl.
However, Bauer teaches cyclopropyl is an isostere of isopropyl (see page 449, last paragraph and Fig. 3 on page 450).
Applying KSR prong (B) - Simple substitution of one known element for another to obtain predictable results - it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute cyclopropyl moiety with isopropyl moiety to arrive at the instant Formula I, wherein R7 and R8 are both methyl groups, with a reasonable expectation of success. One of ordinary skill would have been motivated to prepare additional compounds for the screening library.
Regarding instant claim 90, as evidenced by Emory University Molecular Library Center website, Emory University Molecular Library Center is “a nationally recognized academic high throughput screening center involved in local, national and international drug discovery programs”.
Since compound RN-958568-54-2 is registered in the screening library, one of ordinary skill in the art would formulate the compound RN-958568-54-2 into a pharmaceutical composition comprising said compound and the pharmaceutically acceptable carrier DMSO in order to test the efficacy of said screening library compound on a variety of diseases. (See also MPEP 2131.02 III).
Further, it should be noted that MPEP 2128(I)(B) states that electronic publications on the internet or on an online database are considered to be publicly available as of the date the item was publicly posted.
Claims 18, 23, 89 and 90 are rejected under 35 U.S.C. 103 as being unpatentable over RN-1381433-40-4 (entered to STN 04 Jul 2012) evidenced by Asinex website (Asinex.com - Home, printed 10/7/2026).
RN-1381433-40-4 teaches the following structure:
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The above compound is an isomer of a compound falling under instant Formula
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wherein R3 is alkoxy, p is 1, R7 and R8 are join together to form a cycloalkyl ring, Ra is H, R2 is H, R1 is H and R2 is alkyl (methyl).
Regarding claim 89, it should be noted that the RN-1381433-40-4 compound is an isomer of instant Example 4-2.
The only difference between RN-1381433-40-4 and instant Example 4-2 is the position of the methyl group attached to the pyridazine ring.
Instant claim 89 recites (Example 4-2)
RN-1381433-40-4 discloses
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The case law states that “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).” (MPEP 2144.09 -Close Structural Similarity Between Chemical Compounds (Homologs, Analogues, Isomers).
A skilled artisan would expect isomers to have similar properties and would have been motivated to move the methyl group around the pyridazine ring in order to prepare additional compounds for the screening library.
Regarding claim 90, as evidenced by Asinex website, Asinex is a screening library that provides “biologically-relevant molecular structures”.
Since RN-1381433-40-4 compound is registered in the screening library, one of ordinary skill in the art would formulate the said compound into a pharmaceutical composition comprising said compound and the pharmaceutically acceptable carrier DMSO in order to test the efficacy of said screening library compound on a variety of diseases. (See also MPEP 2131.02 III).
Further, it should be noted that MPEP 2128(I)(B) states that electronic publications on the internet or on an online database are considered to be publicly available as of the date the item was publicly posted.
Allowable Subject Matter
Claim 26 is objected to as being dependent upon a rejected base claim but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
No claim is allowed
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IZABELA SCHMIDT whose telephone number is (703)756-4787. The examiner can normally be reached Monday - Friday from 9 am to 5 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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/I.S./Examiner, Art Unit 1621
/GEORGE W KOSTURKO/Primary Examiner, Art Unit 1621
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