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 response to communication filed on 03/19/2026.
Response to Amendment
Acknowledgment is made of the receipt and entry of the amendment filed on 03/19/2026, wherein claims 2-4, 8, 14, 15, and 18-21 are cancelled, and claim 1 is amended.
Election/Restriction
Applicant elected with traverse, Group I invention and compound species having structure shown below, on 12/04/2025.
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The traversal is on the ground “the single general inventive concept shared by the presently claimed compounds is the presence of a substituted pyrazolyl picolinamide group linked to a first substituted heteroaryl group as LRRK2 inhibitor compounds... present claims are all related to the same subject matter...no serious burden for examination”.
Applicant’s argument is NOT persuasive. Please note instant application is a 371 of PCT application and argument regarding search burden is not applicable to 371 applications, since the restriction requirement is based upon whether there is unity of an invention or not based on the prior art. Bothe (US 2016/0311833 A1) teaches compound species that read on the core structure of instant claimed compound of Formula I. The Restriction Requirement is made FINAL in last office action mailed on 03/02/2026.
The elected species disclosed in instant spec as Ex 1.56( See [0157], Table) is a compound of Formula I wherein,
A is pyridyl ring;
R1 is H;
R2 is pyrrolidinyl substituted with R4 (R 1-6 alkyl OH);
R3 is CF3.
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Claims 1, 5-7, 11-13, 16 and 17 read on the elected invention and species.
The elected species, compound Ex 1.56 (CAS# 2839870-49-2 , entered STN database on October 18, 2022 , See STN search note), is free of 102 prior art. The Examiner has expanded search/examination to non-elected species wherein A is pyridyl ring; R1 is H; R2 is pyrrolidinyl, R3 is H or CH3, R4 is H, alkyl, which are rejected as obvious over Taylor in view of Tso under 103 rejection on the record.
Other non-elected species recited in claim are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to non-elected species, there being no allowable generic or linking claim.
Status of Claims
Claims 1, 5-7, 9-13, 16 and 17 are pending in the instant application.
Claim 9-10 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.
Claims 1, 5-7, 11-13, 16 and 17 are under examination in this office action.
Response to Arguments
Applicant's remarks filed have been fully considered. Any objection and rejection found in the previous Office Action and not repeated herein has been withdrawn in view of amendment and Applicant’s remarks .The text of those sections of Title 35 U.S. Code not included in this action can be found in a prior Office action.
Applicant’s argument have been fully considered, but NOT persuasive to overcome rejections of claims 1,5-7,11-13 and 17 over Taylor in view of Tso under 35 USC 103.
Applicant argues : “There is no teaching or suggestion in the cited reference of the currently amended compounds. Neither Taylor or Tso teach or suggest the currently claimed compounds having nitrogen containing bridged or spirocyclic ring structures such as pyrrolidinyl, azaspiroheptanyl, tetrahydrofuranyl attached to the pyridyl ( "A") that act on the Leucine-Rich Repeat Kinase 2 (LRRK2) gene to treat Parkinson's disease... Even if the compounds of Taylor or Tso and the present invention were structurally similar, the Examiner has not cited any support for his assertion that one skilled in the art would have been motivated by either of the disclosures to make the specific modifications necessary to arrive at the compounds of the present invention for the claimed use.
RESPONSE: As the Applicant agrees, Taylor or Tso and the present invention were structurally similar. According to M.P.E.P. § 2144.09, "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979). Taylor collectively teaches pyrazolyl picolinamide wherein A moiety is pyridyl ring further substituted with heterocylcloalkyl group, wherein heterocylcloalkyl group could be piperidinyl or pyrrolidinyl. A skilled artisan could have further modified heterocylcloalkyl group taught by Taylor and arrived at instantly claimed compound comprising pyrrolidinyl as R2 with reasonably expectation of success. Tso’s compound I-72 could have been modified by substituting the pyrazole ring with pyridyl ring as taught by Taylor and arrive at instantly claimed compounds.
Applicant’s argument about Leucine-Rich Repeat Kinase 2 (LRRK2) activity is NOT persuasive. As noted, biological activity is the property of compound which do not necessarily add structural limitation/ patentable weight to the compound claims. Any biological activity that naturally flows from the core structure of pyrazolyl picolinamide are construed as the property of picolinamide compounds even though prior art might be silent about the particular biological activity. Further, instant specification does not disclose any working example comprising tetrahydrofuranyl, or diazaspirononanyl as R2 that exhibits LRRK2 activity. Instant specification discloses LRRK2 activity of compound species at vast range (See Table 20), for example, Ex 1.71. at 96.9 uM, Ex 6.7.at 294uM, Ex 6.19 is 178 uM. Thus, instant specification does not support full scope of compound of Formula I as recited in claim 1 as LRRK2 inhibitor. Applicant is advised to amend claims that commensurate with instant disclosure for allowable subject matter. Claim 16 comprises compound species that might be allowable.
Priority
The instant application 18/550,303 filed on 09/13/2023, is a 371 of PCT/US2022/020108 filed on 03/14/2022, which claims priority benefit of US provisional application No. 63/162,297 filed on 03/17/2021.
Claim Objections
Claim 1 and 16 are objected to because of the following informalities:
Claim 1 is amended to recite R2 is tetrahydrofuran or an N-linked heterocyclically.... The “tetrahydrofuronyl” from “said pyrrolidinyl,
Claim 16 recite compound names in different format (See page 12), wherein letter “l” (-yl or methyl, etc.) and number “1” are not distinguishable. Claim 16 still recites duplicate compound names, e.g. last compound on page 12 and first compound on page 13.
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The first compound on page 17 is followed by a period.
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Applicant' s cooperation is requested in correcting any possible errors of which applicant may become aware in the claims, including the chemical names.
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 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.
Claims 1, 5-7, 11-13, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Taylor et al. (US 20190002455 A1 ) in view of Tso et al. (US 20180111917A1).
Taylor disclosed amide compound of Formula I, II and subgenus thereof as kinases inhibitors, e.g. interleukin receptor-associated kinase (IRAK), composition comprising aforementioned compounds and method for treating diseases and conditions related to IRAK (e.g. neurodegenerative disorder, etc.) (See abstract, [0004]-[0020] , [0087]-[0088], [0147], Examples 3-171, claims 1-40).
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Regarding instantly claimed core structure, Taylor teaches Het-1 may be a 5 or 6- membered heteroaryl, e.g. pyridinyl, etc. (See [0004], [0016], claims 2-4) . Taylor embodiment comprising pyridinyl as Het-1 read on instant core structure of pyrazolyl picolinamide.
Regarding instant heteroaryl A moiety, Taylor teaches A is N , i.e. pyridinyl (See [0014], [0139]-[0140]), claim 1, 33 and 34)(which also reads on instant claims 12 and 13).
Regarding instant claimed R2 “N-linked heterocycloalkyl” , Taylor teaches
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moiety wherein linker is a bond, X may be O or NR9, and Y may be N or CH (See [0009]). For example, Taylor teaches
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is
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(See [0009], [0011], ) (which read on instant R2 is morpholinyl and piperazinyl group).
Taylor teaches R3 substituent on the A moiety wherein each R3 independently is C1-6 alkyl, C1-3 haloalkyl (See [0008]).
Taylor teaches compound species (See [0147], Example 21, 47, etc. ) that’s similar to instant claimed compounds.
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Taylor collectively teaches pyrazolyl picolinamide wherein A moiety is pyridyl ring, R1 is H; R2 is morpholinyl, piperazinyl and pyrrolidinyl, R3 is H or CH3, R4 is H, alkyl.
Tso teaches amide compound of formula 1-9 as interleukin receptor-associated kinase (IRAK) inhibitors, composition comprising aforementioned amide compounds and method for treating IRAK -associated diseases and conditions (See abstract, [0004]-[0011] , [0109]-[0116], Examples, claims 1-32).
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Regarding instant R2, Tso teaches Ring A maybe aryl, heteroaryl, 5-or 6 - membered heterocycloaliphatic , such as phenyl , pyridinyl, pyrazinyl, pyrrolidinyl, piperidinyl, or morpholino (See [0004], [0011], [0084]-[0098]).
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Tso teaches compound species comprising pyrazolyl picolinamide that’s similar to instant compound(See [0116] ).
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According to M.P.E.P. § 2144.09, a prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979).
It would have been prima facie obvious to one of ordinary skilled in the art before the effective filing date of instant application to explore more IRAK inhibitors based on combined teachings of Taylor and Tso, together with experimentation/optimization based on general knowledge of structure similarity and bioisosteric modification for SAR study of IRAK inhibitors, and arrive at instantly claimed invention with reasonable expectation of success. As stated in MPEP § 2144.08 II subsection II. A. 4.(c), "Structural relationships may provide the requisite motivation or suggestion to modify known compounds to obtain new compounds". A skilled artisan would be motivated to combine teachings of Taylor and Tso, because both teachings are directed to IRAK inhibitor/ modulators and both teach picolinamide core structure. Please note biological activity is the property of compound which do not necessarily add structural limitation/ patentable weight to the compound claims. Both Taylor and Tso teach compound species comprising core structure of picolinamide, any biological activity that naturally flows from the core structure of pyrazolyl picolinamide are construed as the property of picolinamide compounds even though prior art might be silent about the particular biological activity.
One of ordinary skill in the art would have had reasonable expectation of success in producing the claimed invention base on the combined teachings of prior art and further exploration/optimization based on general knowledge of structure similarity and bioisosteric modification for SAR study of IRAK inhibitors . Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
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.
Claims 1, 5-7, 11-13, and 17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending U.S. Patent application No. 18/549,223, in view of Taylor et al. (US 20190002455 A1 ).
Reference claims are directed to compound of Formula I.
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Reference claim 3 recites A is pyridyl which reads on instant picolinamide structure.
Reference claim 13 recites pyrazolyl ring attached to A moiety.
The difference of reference compounds and instant compounds are pyrazole ring verse pyridyl in instant A moiety. The collective teachings of Taylor is elaborated in preceding 103 rejection and applied as before. Taylor collectively teaches pyrazolyl picolinamide wherein A moiety is pyridyl ring further substituted with heterocylcloalkyl group.
According to M.P.E.P. § 2144.09, a prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979).
It would have been prima facie obvious to one of ordinary skilled in the art to explore more amide compounds based on combined teachings of reference claims and Taylor, together with experimentation/optimization based on general knowledge of structure similarity and bioisosteric modification, and arrive at instantly claimed invention with reasonable expectation of success.
The instant application shares at least one common inventor/applicant/assignee with reference patent. Based on the continuing data on the record, instant application is not related to the reference patent, thus no 35 USC 121 shield exists.
Conclusion
No claims are allowed.
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 LIYUAN MOU whose telephone number is (571)270-1791. The examiner can normally be reached Mon-Fri 9:00-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L Clark can be reached on (571)272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LIYUAN MOU/Examiner, Art Unit 1628
/JARED BARSKY/Primary Examiner, Art Unit 1628
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