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 in reply to the Applicant’s Remarks filed 08 July 2026 for application 18/602,519 filed 12 March 2024. Claims 10 and 12-14 are canceled. Currently, claims 1-9 and 11 are pending.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 20 March 2024 and 25 June 2024 were filed after the mailing date of the application on 12 March 2024. The submission is 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 of Group I without traverse in the response filed 08 July 2026 is acknowledged.
Applicant’s election of Example 243, illustrated below, without prejudice in the response filed 08 July 2026 is acknowledged.
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Applicant’s cancellation of claims 13-14, rendering the species election of a neurological condition moot, is the response filed 08 July 2026 is acknowledged.
The elected species, per the Applicant’s Remarks, reads upon claims 1, 3-6, 8-9 and 11.
As such, claims 2 and 7 are withdrawn.
The elected species was found to be free of the prior art.
The search was expanded to other species and related claims.
Specification
The disclosure is objected to because of the following informalities: images in Table 1 and images on pgs. 205-210, 229, 232-233, 237-242, 244-245, 247-248, 249, 257, 260-261, 263-264, 266-267, 269-270, 293-294, 298-314, 322-371, 373-420, 423, 431-439, 444-446, 450-456, 461-463 and 466-472 are not well-resolved (i.e. too blurry). Images on pages not mentioned above may also contain similarly poor-quality images.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 4-5, 8, and 11 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Zhang et al.(Inhibitors of NLRP3, WO 2023/028534 A1, 2023; filed 24 August 2022; entered into the IDS on 20 March 2024).
Zhang discloses 2-(4-{3-[(dimethylamino)methyl]pyrrolidine-1-yl}phthalazin-1-yl)-5-(trifluoromethyl)phenol, illustrated below (pg. 50):
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Here n = 1, R1 is a halo C1-alkyl, R2 and R3 form a C6 carbocyclic ring fused to the pyridazine ring, R4 and R5 form a 5 membered monocyclic heterocycloalkyl ring substituted by a mono C3-alkylamino- group.
As such, Zhang anticipates claim 1.
Regarding the limitations of claim 4 are met as the compound disclosed by Zhang contains a trifluoromethoxy group.
Concerning the limitations of claim 5 are met as the compound disclosed by Zhang can be described by the general formula where n is 1 and R1 is meta on the phenyl with respect to the pyridazine ring.
With respect to the limitations of claim 8 are met as the compound disclosed by Zhang can be described by the general formula where R4, R5 and the nitrogen atom form a pyrrolidinyl ring substituted by a N(CH3)2-CH2- group.
With regards to the limitations of claim 11 are met as Zhang discloses possible formulations, including excipients (pg. 129, line 25 – pg. 135, line 16).
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 non-obviousness.
Claim 1, 4-5, 8, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Cheung et al. (1,4-disubstituted pyridazine analogs and methods for treating SMN-deficiency-related conditions, WO 2014/028459 A1, 2014; entered into the IDS on 20 March 2024) in view of Greene et al. (Protective groups in organic synthesis, Wiley Inc. 1999).
Cheung discloses (3aR,6aS)-tert-butyl 5-(6-(4-chloro-2-hydroxyphenyl)pyridazine-3-yl)hexahydropyrrolo[3,4-c]pyrrole-2(1H)-carboxylate, illustrated below (pg. 179, example 43-1, step 2):
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Here n = 1, R1 is halogen atom, R2 and R3 are hydrogen, R4 and R5 are an 8 membered bicyclic heterocycloalkyl ring substituted by a boc protecting group.
The boc carbamate, however, is not described within the limitations of claim 1.
Greene rectifies this deficiency by teaching the removal of boc protecting groups under several conditions (pg. 520-522), which would result in a structure that reads upon the limitations of claim 1 as an unsubstituted 8 membered bicyclic heterocycloalkyl ring for R4 and R5.
As such it would have been prima facie obvious, to a person of ordinary skill in the art, before the effective filing date, to consider boc deprotection to obtain a novel compound using any number of well-known reactions to do so as taught by Greene.
Regarding the limitations of claim 4 are met as the compound disclosed by Cheung contains a chlorine atom.
Concerning the limitations of claim 5 are met as the compound disclosed by Cheung can be described by the general formula where n is 1 and R1 is meta on the phenyl with respect to the pyridazine ring.
With respect to the limitations of claim 8 are met as the compound disclosed by Cheung can be described by the general formula where R4, R5 and the nitrogen atom form an unsubstituted hexahydropyrrolopyrrolyl ring.
With regards to the limitations of claim 11 are met as Cheung teaches different possible formulations including excipients (pg. 29, line 34 – pg. 32, line 6).
Allowable Subject Matter
Claims 3, 6, and 9 are 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.
Reasons for Allowable Subject Matter
The following is a statement of reasons for allowable subject matter: the limitations of claims 3 and 6 on formula I are not described in the prior art in a 100% embodiment. Similarly, the species described in claim 9 are free of the prior art. The closest prior art is described by Zhang et al.(Inhibitors of NLRP3, WO 2023/028534 A1, 2023; filed 24 August 2022; entered into the IDS on 20 March 2024) and Cheung et al. (1,4-disubstituted pyridazine analogs and methods for treating SMN-deficiency-related conditions, WO 2014/028459 A1, 2014; entered into the IDS on 20 March 2024) who disclose 2-(4-{3-[(dimethylamino)methyl]pyrrolidine-1-yl}phthalazin-1-yl)-5-(trifluoromethyl)phenol and (3aR,6aS)-tert-butyl 5-(6-(4-chloro-2-hydroxyphenyl)pyridazine-3-yl)hexahydropyrrolo[3,4-c]pyrrole-2(1H)-carboxylate, respectively.
Summary
Claims 1, 4-5, 8 and 11 are rejected under 35 U.S.C. 102(a)(2) and 35 U.S.C. 103. Claims 3, 6 and 9 are objected to being dependent on a rejected base claim.
Conclusion
Claims 1, 4-5, 8, and 11 are rejected. Claims 3, 6, and 9 are objected to.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Allen Chao whose telephone number is (571)272-7001. The examiner can normally be reached Monday - Friday 0700-1300.
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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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/ALLEN CHAO/Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
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