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 17/292,881 filed on 05/11/2021 claims benefit as follow:
CONTINUING DATA:
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Status of the Application
Claims 408, 411 and 412 are pending.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/13/2025 has been entered.
Information Disclosure Statement
All references from IDS documents received 05/11/2021, 10/26/2022, 08/11/2023, 01/11/2024, 08/09/2024, 03/25/2025 and 10/13/2025 have been considered unless marked with strikethrough.
Response to Arguments/Amendments
The amendment filled on 10/13/2025 has been entered.
Applicant canceled claims 1, 29, 57, 337, 397-407, 409 and 410.
Applicant amended claim 408. Applicant deleted the general Formula AA and limited claim 408 to specific compounds that modulate NLRP activity.
Applicant added new claims 411 and 412.
Regarding the 103 rejection and the double patenting rejection Applicant's arguments filed on 10/13/2025 have been fully considered but they are not persuasive.
Applicant argues that “a prima facie case of obviousness of a chemical compound requires "some motivation that would have led one of ordinary skill in the art to select and then modify a known compound (i.e., a lead compound) in a particular way to achieve the claimed compound." Applicant submitted that “The Federal Circuit has defined a lead compound as "a compound in the prior art that would be most promising to modify in order to improve upon….” has been fully considered but is not persuasive because the instant compounds does not show improvement over the compounds recited in Franchi (U.S. Patent No. 11,203,579).
MPEP 2143 teaches that it should be noted that the lead compound cases do not stand for the proposition that identification of a single lead compound is necessary in every obviousness rejection of a chemical compound. For example, one might envision a suggestion in the prior art to formulate a compound having certain structurally defined moieties, or moieties with certain properties. If a person of ordinary skill would have known how to synthesize such a compound, and the structural and/or functional result could reasonably have been predicted, then a prima facie case of obviousness of the claimed chemical compound might exist even without identification of a particular lead compound.
The compounds recited in Franchi (U.S. Patent No. 11,203,579) have structurally defined moieties that are combined to arrive at the instant compounds.
Franchi teaches e.g., compound 139 (see claim 13) and compound 141 (see column 861).
Applicant argument that nothing in Franchi teaches or suggest that the modification of compound 139 (introduction of pyridine moiety as in compound 141) would lead to a compound with better activity has been fully considered but is not persuasive because the instant compound 159 (the selected species) does not show improvement over compound 139 (see Table 30 in Franchi and instant Table B1).
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Franchi (U.S. Patent No. 11,203,579) Compound 139 and 141
Instant compound 159
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It is examiner position that a person of ordinary skill would expect some retention of activity after introduction of pyridine moiety (as presented below) because compounds bearing pyridine moiety have been disclosed by Franchi (U.S. Patent No. 11,203,579).
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The skilled person would have been motivated to prepare further examples of compounds useful in treatments of conditions associated with NLRP activity. The compounds recited in Franchi (U.S. Patent No. 11,203,579) have structurally defined moieties that are combined to arrive at the instant compounds.
However, Applicant is encouraged to present unexpected/superior results of instant compounds and discuss comparative data of instant compound 159 vs. compound 139 of U.S. Patent No. 11,203,579.
The 103 rejection and the double patenting rejection are maintained.
Election/Restrictions
With respect to species election, Applicant's election of compounds 129 in the reply filed on 08/09/2024 is acknowledged.
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Applicants' elected species, as shown above, does makes 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.
The search is now expanded to additional species (instant compound 159):
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recited in the claim 408.
Claim 412 is 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 08/09/2024.
Claim Objections
Claim 408 is objected to because of the following informalities:
It seems that compound 159 is recited twice (the fourth compound and the fifth compound look identical/see claims the last compound on page 2 and first compound on page 3).
Appropriate correction is required.
Claim 411, directed to the elected species, 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.
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.
Claim 408 is rejected under 35 U.S.C. 103 as being unpatentable over Franchi (U.S. Patent No. 11,203,579).
The applied reference has a common inventor 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 applies to the expanded species:
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Franchi (U.S. Patent No. 11,203,579) teaches Formula AA:
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Further, Franchi teaches and claims a pharmaceutical composition:
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Furthermore, Franchi teaches and claims compound 139 bearing pyrazolyl moiety in the position corresponding to ring A (see claim 13):
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The above compound differs from the instant Formula AA and from the expanded specie because it lacks a nitrogen atom in the B ring. Franchi fails to teach a compound bearing both pyrazolyl moiety and pyridine moiety.
However, Franchi teaches compound 141 bearing pyridine moiety in a position corresponding to ring B:
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Since Franchi teaches compound 141 bearing pyridine moiety in a position corresponding to B ring, starting from compound 139 and applying KSR prong (B) - Simple substitution of one known element for another to obtain predictable results -
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- 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 carbon by nitrogen and prepare the instant species bearing pyridine moiety with a reasonable expectation of success. One of ordinary skill in the art would expect retention of activity and would be motivated to prepare further examples of compounds useful in treatments of conditions associated with NLRP activity.
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.
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claim 408 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,203,579. (16/632,849).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims and the ‘579 patent claim similar and overlapping compounds.
The claims of Patent No. 11,203,579 recite Formula AA:
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Further, the claims of Patent No. 11,203,579 recite a pharmaceutical composition:
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Furthermore, the claims of Patent No. 11,203,579 recite compound 139 and compound 141 (claim 13):
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The claims of Patent No. 11,203,579 flail to recite a compound bearing both pyrazolyl moiety and pyridine moiety.
However, since claims of Patent No. 11,203,579 recite compound 141 bearing pyridine moiety at the same position, starting from compound 139:
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and 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 carbon by nitrogen and prepare the instant species bearing pyridine moiety, with a reasonable expectation of success. One of ordinary skill in the art would expect retention of activity and would be motivated to prepare further examples of compounds useful in treatments of conditions associated with NLRP activity.
Conclusion
Claim 408 is rejected.
Claim 411 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.
Claim 412 is withdrawn.
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 on (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
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621