DETAILED ACTION
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 .
Claims 1, 2, 8, 11, 12, 20, 21, 24, 28, 31, 35, 38, 44, 45, 48, 57, 59, 60, and 62-65 are pending in the instant application. Claims 1, 2, 8, 11, 12, 20, 21, 24, 28, 31, 35, 38, 44, 45, 48, 57, 59, 60, and 62-65 are rejected.
Information Disclosure Statement
The information disclosure statement filed on February 27, 2026 has been considered and a signed copy of form 1449 is enclosed herewith.
Response to Amendment and Arguments/Remarks
The amendment and arguments/remarks filed on February 27, 2026 have been fully considered and entered into the application. With regards to the 35 U.S.C. 112(a) rejection, Applicant argues “As these references show, a person of ordinary skill in the art would recognize the disorders recited in claims 64 and 65 as being treatable via inhibition of NLRP3. As noted above, the data in Table 2 of the present application show representative compounds of structure (I) inhibit NLRP3 and one skilled in the art would recognize that inhibition of NLRP3 as a means for treating the diseases and disorders listed in claims 63-65 given the disclosures described above.” In view of the submitted references, this argument is found to be fully persuasive and the rejection has been withdrawn. With regards to the nonstatutory double patenting rejection as being unpatentable over copending Application No. 17/998,135, Applicant argues that “The present claims are patentably distinct from the reference claims because the present claims recite a specific compound of structure (I) and the claims of the reference application recite, inter alia, a method of treating or preventing a disease or disorder by administering a NEK7 small molecule inhibitor. Accordingly, the present claims are non-obvious over the claims of co-pending Application No. 17/998,135, which recite methods of treatment.” This argument is not found to be persuasive because, as mentioned in the previous Office Action, the specific compound of structure (I) instantly claimed is used in the methods of treatment claimed in the reference (i.e., compounds of the Structure (Ib) used in the method of the reference application have the same scope as the compounds of the instant structure (I) even though the variables are labeled differently). Therefore, the examiner is still of the belief that it would have been obvious to one of ordinary skill in the art at the time of the invention through routine experimentation to arrive at the compounds having structure (I), pharmaceutical compositions thereof and method of treating a NLRP3-mediated disorder of the instant claims in view of the reference with a reasonable expectation of success. Therefore, the rejection is maintained and described below.
Maintained 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 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1, 2, 8, 11, 12, 20, 21, 24, 28, 31, 35, 38, 44, 45, 48, 57, 59, 60, and 62-65 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over at least claims 1, 106, 115, 116, 230, and 233 of copending Application No. 17/998,135 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other for the reasons given below.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Copending Application No. 17/998,135 claims a method of treating or preventing a disease or disorder, the method comprising administering a NEK7 small molecule inhibitor compound to a subject in need thereof (see claim 1) wherein the NEK7 small molecule inhibitor compound can have the Structure (Ib) (see claim 106). Compounds of the Structure (Ib) used in the method of the reference application have the same scope as the compounds of the instant structure (I) even though the variables are labeled differently (i.e., R5b has the same definition in the reference application as R3 of the instant claims). Also, a method of treating a NLRP3-mediated disorder, comprising administering a therapeutically effective amount of a compound having the structure (I) is instantly claimed and it is disclosed in the reference that the NEK7 inhibitors can be used to treat or prevent diseases or disorders via modulation of NLRP3 inflammasome activity (e.g. see abstract). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention through routine experimentation to arrive at the compounds having structure (I), pharmaceutical compositions thereof and method of treating a NLRP3-mediated disorder of the instant claims in view of the reference with a reasonable expectation of success. The motivation would have been to find the optimal compounds for the above-mentioned pharmaceutical use. Thus, a prima facie case of obviousness has been established.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTIN ANN VAJDA whose telephone number is (571)270-5232. The examiner can normally be reached Mon-Fri 6:00-4:00.
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/KRISTIN A VAJDA/Primary Examiner, Art Unit 1622
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