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
RESPONSE TO ELECTION/RESTRICTION
Applicant’s election without traverse of the elected species (compound 2) in the reply filed on 10/13/2025 is acknowledged.
The requirement is still deemed proper and is therefore made FINAL.
Claims 170,172-173,175,177, and 179-181 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
An action on the merits of claims 168-169,171,174,176,178 and 182 is contained herein.
Priority
This application is a continuation of 18/316,994 and claims priority under 35 U.S.C. § 119(e) to U.S. Provisional Patent App No. 63/341,975, filed 5/13/2022.
Specification
The disclosure is objected to for minor informalities such as the Example 1 synthetic scheme at page 98 which appears to be missing a chloro atom on the pyridazine ring (see read arrow):
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. Correction is required and throughout where necessary.
Claim Objections
Claims 178 and 182 are objected to because of the following informality:
The preamble of claim 178 should incorporate proper alternative Markush language such as “wherein the compound is selected from the group consisting of” or something similar thereof. Thus the claim and claims dependent on it are objected to. Correction is required.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 168-169,171,174,176,178, and 182 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 2, 20-22, 93, 153, 162, 163, and 166 of copending Application No. 18/316,994. Although the conflicting claims are not identical, they are not patentably distinct from each other because there is significant overlap between the two applications.
The claimed elected species, compositions thereof, and other species of instant claim 178 are also recited in the copending application (see claim 153 for example, compound 2). These species also would anticipate the claimed genus structure of the instant application (claim 1) and instant claims. Thus the claimed subject matter would have been anticipated by the copending application and the claims would not be considered independent and distinct.
Additionally, the claimed genus is subgeneric to what is described in copending claim 1 (in particular wherein X = -NRa) where the scope of the prior art genus is substantially small that one of ordinary skill would have readily arrived at the claimed subject matter. In reference to methods of using the claimed compounds; there was not in place any restriction between the compounds themselves and methods of using. Since specification describes these methods of modulating and subsequently treating diseases associated with NLRP3 inflammasome (see page 2, lines 15-25) using the claimed compounds, the compounds and subsequent methods of using would have been considered obvious
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made or effectively filed to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claims 168-169,171,174,176,178, and 182 are rejected under pre-AIA 35 U.S.C. 103(a) as being obvious over WO 2022/166890.
Applicant’s elected species is the following compound below:
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WO 2022/166890 teaches the following compound and compositions thereof (see page 133, 2nd row for compound and English translation for compositions under the term “pharmaceutically acceptable” at page 3):
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wherein R1 = alkyl, R11 = methyl, and R2,4,5,12,Ra = H.
The only difference between Applicant’s compound and the compound in the prior art document stems from variable R1 (hydrogen vs alkyl).
However, MPEP states the following:
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).
Additionally, the genus formula shows an equivalency teaching for the latter, wherein R1 may be hydrogen (see claim 1, page 122, line 8). Thus the two compounds would have been considered obvious.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN E MCDOWELL whose telephone number is (571)270-5755. The examiner can normally be reached on 8:30-6 MF.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached at 571-272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN E MCDOWELL/Primary Examiner, Art Unit 1624
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