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 .
Current Status
This action is responsive to the amended claims of 01/30/2026. Claims 1-3, 7, 9, 11-12, 20-21, 25-28, 32-34, 36-37, 39, 41, 43, 45, 47, and 51-64 are pending. Claims 1-3, 7, 9, 11-12, 20-21, 25-28, 32-34, 36-37, 39, 41, 43, 45, 47, and 51-64 have been examined on the merits.
Priority
The effective filing date is 06/08/2020.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/30/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Arguments
Examiner acknowledges receipt of and has reviewed the amendments and remarks of 01/30/2026, no new matter is found.
The objection to claims 1, 3, and 20-21 over punctuation is withdrawn since Applicant has amended in line with Examiner’s suggestion. The same objection to the dependent claims 2, 7, 9, 11-12, 25-28, 32-34, 36-37, 39, 41, 43, 45, 47, and 51-63 is similarly withdrawn.
The objection to claim 1 over R2 “one more substituents” is withdrawn since Applicant has amended the statement to “one or more substituents”. The same objection to the dependent claims 2-3, 7, 9, 11-12, 20-21, 25-28, 32-34, 36-37, 39, 41, 43, 45, 47, and 51-63 is similarly withdrawn.
The 112b and 112d rejections of claim 3 are each withdrawn since the R2 limitation "C3-C8 heterocyclyl" is replaced with “3-8 membered heterocyclyl”. This limitation has antecedent basis in the claims and properly limits the parent claim.
The 112b and 112d rejections of claims 7 and 11 are each withdrawn since the limitations defining R2 as "dioxidotetrahydrothiophenyl" (i.e.,
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) have been struck. The remaining limitations all have antecedent basis in the claims and properly limit the parent claim.
The 112b and 112d rejections of claim 12 are each withdrawn since the list of moieties from which R3 is chosen has been replaced with specific structures taken from parent claim 1. These structures have antecedent basis in the claims and properly limit the parent claim.
Similarly, the 112b and 112d rejection of claim 20 are each withdrawn since the list of moieties from which R3 is chosen has been replaced with specific structures taken from parent claim 1. These structures have antecedent basis in the claims and properly limit the parent claim.
The 112b and 112d rejections of claim 57 are each withdrawn since the structure comprising
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has been struck from the claim. The remaining structure have antecedent basis in the claims and properly limit the parent claim.
Regarding the non-statutory double patenting rejections (¶29-30 of the action mailed 10/30/2025), Applicant's arguments filed 01/30/2026 have been fully considered but they are not persuasive. Thus, the rejections are both maintained, below.
Both rejections are over co-pending Application No. 17/998,135 (reference application – amended claims of 11/07/2022); the first (¶29) is anticipatory regarding the compound of structure (I) and claim 64, the second (¶30) is obviousness-type regarding the formulation of said compound in a composition further comprising an excipient.
Applicant argues: 1) the reference claims do not recite a specific compound of structure (I); and 2) the reference claims are drawn to a method of treatment administering a compound, since the Examiner previously restricted the instant compound and method claims based on lack of unity, the present claims are nonobvious over the method claims of the reference.
Regarding argument 1), Examiner respectfully disagrees. As explained in the previous action (¶29), the reference claims 115 and 230 teach multiple species of the instant structure (I) wherein every variable is explicitly defined. For example, structure 1 of claim 230:
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wherein R1 is H, X is N, R2 is C3 alkyl, A is phenyl unsubstituted, Y is NH, R4 is H, and R3 is
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. Further, the reference species
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, and
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which do not fall under structure (I) (claim 1) are found in instant independent claim 64. Thus, the reference claims explicitly teach species of the instant claims.
Regarding argument 2), Examiner respectfully disagrees. The reference claims are drawn to a method of using the compounds (reference claims 1, 104, and 115) and also to a composition comprising the compounds (reference claims 116 and 230).
Further, the double patenting rejection of ¶29 (claims 1-3, 7, 9, 11-12, 20-21, 25-28, 32-34, 37, 39, 41, 43, 45, and 51-64) is an anticipatory type rejection. MPEP 804(II)(B) states: “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).” Thus, there are two types of double patenting rejections: one where the reference claims act like an anticipatory (102-like) reference and one where the reference claims act like an obviousness-type (103-like) reference. For the rejection of ¶29 (prev. action), the reference claims act like an anticipatory type reference since the reference claims recite species of the instant structure (I) and claim 64. Thus, the argument that the instant claims are nonobvious over the reference claims does not apply here since the rejection is anticipatory.
Regarding the double patenting rejection of ¶30 (claims 1 and 47), this rejection is an obviousness-type rejection which aims to show how the addition of an excipient to the composition, as seen in the composition claims of the reference application, would make obvious the instant composition claim 47. The reference application is not related to the instant application as a parent or child due to a restriction requirement, thus, the application of double patenting rejections between the two applications is not prohibited. The instant method and compound groups were restricted on the basis that they lacked a special technical feature (i.e., the shared technical feature of structure (I) did not define a contribution over the prior art; see MPEP 1893.03(d)). Such analysis makes no indication as to whether the formulation of the instant compound with an excipient would be obvious in view of reference claims which teach a composition of such compounds wherein the reference also teaches the compounds as pharmaceutically useful (i.e., NEK7 inhibitors – ref. claims 116 & 230) and as useful in methods of treatment. Note, these teachings of the reference claims were relied upon in the previous action. Thus, the arguments are not found to be persuasive.
To overcome, Applicant may consider filing a terminal disclaimer over the reference application (see MPEP 804.02(II)). Note, the instant application does not have an earlier patent term filing date.
Maintained Rejections
Double Patenting – Maintained
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 1-3, 7, 9, 11-12, 20-21, 25-28, 32-34, 37, 39, 41, 43, 45, and 51-64 are provisionally rejected on the ground of anticipatory nonstatutory double patenting as being unpatentable over claims 1, 104, 115-116, and 230 of co-pending Application No. 17/998,135 (reference application – amended claims of 11/07/2022). Although the claims at issue are not identical, they are not patentably distinct from each other.
Reference claims 115 and 230 recite a method of treatment administering and a composition comprising, respectively, 61 compounds of the instant Formula (I). The first 61 compounds recited in both claims are species of the instant Formula (I) (instant claim 1 and the above dependent claims and independent claim 64) wherein A is phenyl or pyridinyl; X is N or CH; R1 is H; R2 is one or more of the structures recited in instant claim 11; R3 is one of the recited groups; R4 is H; and R5 is halogen, methyl, haloalkyl, or hydroxyalkyl. The reference claims also recite the 3 species in instant claim 64 that do not fall within the instant Formula (I):
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, and
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. Since reference claim 104 recites a genus formula which the compounds 1-61 of reference claims 115 and 230 fall under, reference claim 104 also anticipates the instant claims. Similarly, since reference claims 115 and 230 depend from reference claims 1 and 116, the parent claims also anticipate the instant claims. Regarding the method claims 1, 104, and 115, in order to practice the method of these claims the practitioner must be in possession of the compounds recited in the reference claims. Thus, these method claims anticipate the instant compound claims. Finally, each of the cited reference claims teaches the compounds as NEK7 small molecule inhibitors, thus the reference claims anticipate instant claim 45.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Note, this rejection is maintained and made final since Applicant’s arguments were not found persuasive and neither the reference nor instant claims have been amended to overcome this rejection.
Claims 1 and 47 are provisionally rejected on the ground of obviousness-type nonstatutory double patenting as being unpatentable over claims 1, 104, 115-116, and 230 of copending Application No. 17/998,135 (reference application – amended claims of 11/07/2022) as applied to claim 1, above, further in view of CHAUDHARI (Chaudhari, S.P. and Pradeep, S.P. IJAPBC, 2012, 1(1), 21-34; provided by Examiner 10/30/2025).
Determining the Scope and Contents of the Prior Art:
Reference claims 1, 104, 115-116, and 230 teach the compound of claim 1, as laid out in the anticipatory NSDP rejection above.
CHAUDHARI teaches dosage forms (i.e., pharmaceutical compositions)
comprising the active pharmaceutical ingredient and excipients are formulated together
to improve patient acceptance (Pg. 21 Abstract & Intro P1). CHAUDHARI teaches
excipients must be inert to the human body (Pg. 22 Right Col. P3), i.e., the excipients
are pharmaceutically acceptable.
Ascertaining the Differences Between the Prior Art and the Claims at Issue:
The reference application claims do not teach wherein the composition is a pharmaceutical composition further comprising a pharmaceutically acceptable excipient.
Resolving the Level of Ordinary Skill in the Pertinent Art:
The level of ordinary skill in the art is represented by an artisan who has sufficient background in the development of compositions useful for administration of NEK7 inhibitors for treatment of subjects in need and possesses the technical knowledge necessary to make adjustments to the composition to optimize/enhance the delivery and treatment. Said artisan has also reviewed the problems in the art regarding pharmaceutically acceptable compositions and excipients and understands the solutions that are widely-known in the art.
Considering Objective Evidence Present in the Application Indicating Obviousness or Nonobviousness:
The instant claims are prima facie obvious in light of the combination of references Application No. 17/998,135 in view of CHAUDHARI.
The artisan would be motivated to formulate the compound (1-61 above) of App. No. ‘135 in a pharmaceutical composition also comprising a pharmaceutically acceptable excipient in order to increase patient acceptance of the compound since the compound is claimed in a composition (reference claims 116 and 230) and is also taught as useful for a method of treatment (reference claims 1 and 115). The artisan would have an expectation of success since CHAUDHARI teaches formulations with excipients increase patient acceptance (Pg. 21 Abstract & Intro P1).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Note, this rejection is maintained and made final since Applicant’s arguments were not found persuasive and neither the reference nor instant claims have been amended to overcome this rejection.
Conclusion
Claims 1-3, 7, 9, 11-12, 20-21, 25-28, 32-34, 37, 39, 41, 43, 45, 47, and 51-64 are rejected.
Claim 36 is objected to due to its dependence on a rejected claim.
A search for the compounds of structure (I) (claim 1) and independent claim 64 did not retrieve any prior art (see SEARCH 6 of the attached search notes). See the action mailed 10/30/2025 for a discussion of the close art (Pg. 16 ¶33).
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 SARA ELIZABETH BELL whose telephone number is (703)756-5372. The examiner can normally be reached Monday-Friday 9:00-5:30.
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, Andrew Kosar can be reached at 571-272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/S.E.B./Examiner, Art Unit 1625
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625