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
Claims 1-30 and 58-63 are pending in the instant application.
Claims 4, 8-12, 22-25, and 60-63 are withdrawn from consideration.
Claims 1-3, 5-7, 13-21, 26-30, and 58-59 are examined herein.
Priority
The instant application claims benefit of priority to U.S. Provisional Application No. 63/336,183, filed on 28 April 2022; U.S. Provisional Application No. 63/389,237, filed on 14 July 2022; and U.S. Provisional Application No. 63/456,342, filed on 31 March 2023 . The claims to the benefit of priority are acknowledged. As such, the effective filing date of the claims is 28 April 2022.
Information Disclosure Statement
The information disclosure statements (IDS), submitted on 18 August 2023, 03 November 2023, and 19 November 2025, are acknowledged and considered. The submissions are in compliance with the provisions of 37 CFR 1.97.
Response to Election/Restrictions
Applicant’s election of Group I, claims 1-30 and 58-59, without traverse, in the reply filed on 19 November 2025 is acknowledged. In addition the specie election of N-(4-(4-(6-(4,4-difluoropiperidin-1-yl)-5-fluoropyridin-2-yl)-1H-1,2,3-triazol-1-yl)-3-(6-azaspiro[2. 5]octan-6-yl)phenyl)-2-hydroxyethane-1-sulfonamide (pictured below), is acknowledged. Claims 1-3, 5-7, 13-21, 26-30, and 58-59 read on the elected species, therefore claims 4, 8-12, 22-25, and 60-63 are withdrawn from consideration.
PNG
media_image1.png
350
364
media_image1.png
Greyscale
If the elected species is not identified in the art, the search will be expanded to additional species per MPEP 802.03.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 58 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 58 references Table 1 of the specification which renders the claim indefinite as claims are to complete in themselves. See MPEP 2173.05(s).
Improper Markush
Claims 1-3, 5-7, 13-21, 26-30, and 58-59 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of B1, B2, R4, R3, X, Z, and A are improper because the alternatives defined by the Markush grouping do not share both a single structural similarity, as there is no common core, and a common use, as the specification fails to use a combination of these variables for the use as KIF18A inhibitors.
The possible substitution patterns set forth in claim 1 create a genus of compounds that spans classifications due to the changing core. Without a representative number of structures, expressing the range of variability, disclosed in the specification or shown in the prior art, the instant application does not show all the possible structure subtypes to be functionally equivalent and have a common use. The specification sets forth 166 embodiments. Of these B1 is CH in 163 embodiments, B2 is CH in all 166 embodiments, R3 is piperidinyl in 158 embodiments, R4 is NRc5S(O)2Rc6 in 165 embodiments, X is N or CH in 156 embodiments, Z is N or CH in 165 embodiments, and A is a six membered ring in 139 embodiments. All other substitution patterns set forth for these groupings are either not represented in the specification or inadequately represented such that one cannot deem them functionally equivalent.
For example Onogi et al. (WO2009020198A1) disclose aniline compounds with anti-DNA virus activity. Preferred embodiment KP1153 (page 78) and KP1153 (page 81) share a core that overlaps with the instant genus when the instant V is N; X is N; Z is N; W is C; Y is CH; B1 is CH; and B2 is CRB, wherein RB is halogen. Onogi shows a core of the instant genus with an alternate use, demonstrating that all possible structure substitutions presented in the instant claims do not share a common use. And without a representative number of species one would not assume all the possible structural substitutions to be functionally equivalent.
PNG
media_image2.png
164
140
media_image2.png
Greyscale
PNG
media_image3.png
166
140
media_image3.png
Greyscale
Claim 29, is the closest to a proper Markush grouping, as it represents the majority of the preferred embodiments. Setting B1 as CH, B2 as CH, and R4 as NRc5S(O)2Rc6, would result in a proper Markush grouping.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
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(s) 1-3, 5-7, 13-21, 26-30, and 58-59 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (US2025/0214965A1, priority date 25 June 2021) in view of Bonandi et al. (Drug Discovery Today.2017;22(1):1572-1581).
Regarding claims 1, 7, and 29-30, Zhang discloses KIF18A inhibitors of Formula (I) (claim 1) (pictured below) which overlaps with the instant genus when:
A is -Y-R1; wherein Y is a bond; wherein R1 is a 6 membered heterocycle substituted with halo
X1 is N
X2 is CRC; wherein RC is halo
X3 is CRC; wherein RC is hydrogen
X4 is CRC; wherein RC is hydrogen
L is a 5 membered heteroaryl
B is Formula (Ib) (pictured below)
Z1 is CRm; wherein Rm is hydrogen
Z2 is CRm; wherein Rm is hydrogen
Z3 is CRm; wherein Rm is hydrogen
R5 is Q-R8; wherein Q is -NRaS(O)2-; wherein Ra is hydrogen; wherein R8 is alkyl substituted
R6 and R7 form a 3 membered ring with the carbon to which they are attached
k is 2
n is 2
PNG
media_image4.png
158
144
media_image4.png
Greyscale
PNG
media_image5.png
206
358
media_image5.png
Greyscale
Zhang does not disclose a preferred embodiment where L is a 5-membered heterocycle.
Zhang discloses several embodiments where with one modification the compound is a species of the instant genus. Such as compound 85 (page 24) (pictured below). Modification of L from an amide to a 5-membered heteroaryl results in a species of the instant genus. As this modification is within the provided substituents for L, one skilled in the art would be motivated to make the change because structurally similar compounds are expected to have similar properties and in this case the genus teaches that both an amide and a 3-6 membered heterocycle and heteroaryl group substituted in the same position would be expected to have similar properties.
PNG
media_image6.png
229
359
media_image6.png
Greyscale
Zhang does not specifically suggest a 1,2,3-triazole as a substituent for L in paragraph [0099]).
Bonandi teaches 1,2,3-triazole as a bioisostere of amides (page 1572).
It would be prima facie obvious to one of ordinary skill in the art, guided by the teaching of Bonandi, to modify the amide bonds seen in the preferred embodiments of Zhang to the 1,2,3-triazole of the instant elected species. Zhang teaches L can be substituted with a 3-6 membered heteroaryl group but does not specifically suggest a triazole. As Bonandi teaches this is the most common amide bond isostere the skilled artisan would be motivated to make the modification as the isosteric change would result in a structurally similar compound which is expected to have similar properties.
Regarding claims 2 and 3, X and Z correspond to the reference L, when L is a 5-membered heteroaryl the substituents corresponding to X and Z can be N (claim 1).
Regarding claims 5 and 6, Zhang teaches L can be a 5-membered heteroaryl (claim 1), which encompasses the species recited in instant claims 5 and 6.
Regarding claims 13-15, Zhang discloses the same moiety corresponding to the instant A (pictured below) (claim 1).
PNG
media_image4.png
158
144
media_image4.png
Greyscale
Regarding claims 16 and 17, the instant R1 corresponds to the reference A. Zhang teaches when A is Y-R1 and Y is a bond, R1 can be heterocycloalkyl (claim 1).
Regarding claims 18 and 19, the instant ring corresponds to the reference Formula (Ib) (pictured above). Where Z1 is N or CRm, Z2 is N or CRm, and Z3 is CRm (claim 1).
Regarding claims 20 and 21, Zhang teaches the reference substituent corresponding to the instant R3 can is piperidinyl when k and n are 2 (claim 1).
Regarding claims 26-28, Zhang teaches the reference substituent R5 which corresponds to the instant R4. The reference R5 is Q-R8, wherein Q is -NRaS(O)2- and Ra is hydrogen, wherein R8 is alkyl substituted.
Regarding claim 58, Applicant elected the species pictured below. Zhang teaches the preferred embodiment 85 (pictured below) which is the elected species when L is modified to a triazole and X3, which is CRC, is modified so RC is hydrogen, not methyl.
Zhang does not specifically guide the skilled artisan to a triazole as this moiety is not recited in the heteroaryl suggestions of paragraph [0099].
Bonandi teaches 1,2,3-triazole as a bioisostere of amides (page 1572).
It would be prima facie obvious to one of ordinary skill in the art, guided by the teaching of Bonandi, to modify the amide bonds seen in the preferred embodiments of Zhang to the 1,2,3-triazole of the instant elected species. Zhang teaches L can be substituted with a 3-6 membered heteroaryl group but as a triazole is not specifically suggested the teaching on Bonandi guides the artisan to a triazole. As Bonandi teaches this is the most common amide bond isostere the skilled artisan would be motivated to make the modification as the isosteric change would result in a structurally similar compound which is expected to have similar properties.
PNG
media_image1.png
350
364
media_image1.png
Greyscale
PNG
media_image6.png
229
359
media_image6.png
Greyscale
Regarding claim 59, Zhang teaches a pharmaceutical composition comprising a compound of Formula (I) and a pharmaceutically acceptable carrier (claim 13).
Conclusion
Claims 1-3, 5-7, 13-21, 26-30, and 58-59 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jerica K Wilson whose telephone number is (703)756-4690. The examiner can normally be reached Monday-Friday 9:00-5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached at (571)270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/J.K.W./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
Prosecution Insights