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 .
Priority
The instant application, filed 04/14/2023, is a 371 filing of PCT/US21/54921, filed 10/14/2021, which claims domestic priority to provisional U.S. application number 63/092,935 filed 10/16/2020.
Amendments and Claim Status
The following amendment filed on 04/28/2026 is acknowledged and entered.
Claim 6 is amended;
Claims 8-11, 13, and 15-19 are cancelled;
Claims 7 and 20-23 remain withdrawn according to 37 CFR § 1.142(b), as being drawn to a non-elected invention and species;
Claims 1-7, 12, 14, and 20-23 are pending and are under prosecution.
Information Disclosure Statement
The Information Disclosure Statement filed on 04/28/2026 acknowledged and found to be in compliance with the provisions of 37 CFR § 1.97. Accordingly, the information disclosure statement is considered.
Telephonic communication
in an effort to facilitate compact prosecution, a telephone call was made to Applicant’s agent of record, Dr. Austin C. Hachey, Ph.D. on 06/16/2026 wherein Applicant was made aware that the statement of common ownership was not proper according to MPEP § 706.07(a). Secondly, in order to overcome the nonstatutory double patenting rejection, applicant would need to file a terminal disclaimer. In an effort to avoid the instant final rejection, Examiner recommended (i) cancellation of the withdrawn claims, or (ii) amendment to avoid rejections discussed under 35 U.S.C. § 112 (a). Upon communication, Applicant elected to refrain from amendment, and to not file the terminal disclaimer. Instead, requiring further time to deliberate the changes required by Examiner, Applicant elected to receive another office action. As such, Examiner has issued the instant Final Rejection on the grounds already presented in the office action filed 01/28/2026.
Claim Interpretation
The instant claims are subject to the following claim interpretation:
Claims 1-6, 12, and 14 are drawn to a phenyl, naphthyl, or heteroaryl group at position R6. According to the broadest reasonable interpretation of the claims set forth in MPEP § 2111, these are all aromatic substituents. With respect to a phenyl group, this is interpreted to be solely a phenyl group, i.e. an aromatic and fully unsaturated system of 6 carbon atoms. With respect to naphthyl, this is interpreted to be solely a naphthalene group, which is two fused benzene rings, i.e., an aromatic and fully unsaturated system of 10 carbon atoms. Finally, with respect to a heteroaryl group, the term heteroaryl is interpreted, according to the instant specification (page 12 lines 10-14), to be a monocyclic, bicyclic, or tricyclic aromatic ring system having 5-14 ring atoms, containing 1-4 heteroatoms selected from oxygen, nitrogen, and sulfur. As a general rule, well-known to a person of ordinary skill in the art, all carbon atoms within an aromatic system—including heteroaryl—must be sp2 hybridized in order to be considered aromatic. This is because sp3 hybridization eliminates the aromatic character within a ring system. Furthermore, aromatic systems are cyclic, planer, and conjugated. All atoms within the aromatic ring systems must have a p-orbital to allow π-electrons to delocalize over the entire structure. Finally, an aromatic system must contain (4𝑛+2) π-electrons, where 𝑛 denotes the number of electrons which may be any non-negative integer (e.g., 2, 6, 10, or 14 electrons).
Response to arguments
Applicant’s arguments filed 04/28/2026 with respect to the claim rejections under 35 U.S.C. §§ 112(b) and (d) and 103, and nonstatutory double patenting have been fully considered.
With respect to the rejection of claim 6 under 35 U.S.C. § 112(b) as being indefinite, the correction of the IUPAC names of the compounds is sufficient to overcome the rejection. Accordingly, the rejection is hereby withdrawn.
With respect to the rejection of claim 6 under U.S.C. § 112(d) as being of improper dependent form, the removal of the dependence of the claim on claim 1 is sufficient to overcome the rejection. Accordingly, the rejection is hereby withdrawn.
With respect to the rejection of claims 1-6, 12, and 14 under 35 U.S.C. § 103 as being unpatentable over Bouche et al. (WO 2020216701 A1, effectively filed April 25, 2019 for the purposes of § 102(a)(2)), cited on Applicant IDS dated 05/08/2023), hereinafter Bouche, the arguments made by Applicant are herein addressed.
Applicant argues that the prior art the used for the grounds of the rejection was commonly owned, and thus, does not qualify as prior art, alluding to a possible exception under 35 USC § 102 (b) (2) (C) or a statement of common ownership at the time the invention.
Applicant’s argument is unconvincing because the statement submitted by applicant is not proper. According to MPEP § 706.07(a), a statement disqualifying prior art on the basis of common ownership must state that the inventions were commonly owned "not later than the effective filing date of the claimed invention." Absent this very important detail of the timing of the common ownership, the prior art is still available for use in a prior art rejection. Accordingly, the obviousness rejection is hereby maintained.
With respect to the rejection of claims 1-6 and 12 on the ground of nonstatutory double patenting as being unpatentable over claims 1-12, 14, and, 15 of U.S. Patent No. US 12,357,603 B2. The arguments made by applicant are herein addressed as follows.
Applicant argues that the patented claims do not focus upon the 4-membered ring formed by joining Ra and Rb, in the patented Formula (I), and thus, a person of ordinary skill would have been motivated to arrive at the present claim scope.
Applicant’s argument is unconvincing, because the teachings of a heterocycle formed by joining Ra and Rb are explicitly taught within the patented claims. As such, a person of ordinary skill in the art would be directly motivated to create such compounds, although they are not synthesized as an explicit embodiment in the patented disclosure.
Applicant further argues that the instant application experimentally demonstrates that numerous compounds within the claim scope have excellent activity in the KAT6A and KAT6B assays, and cancer cell proliferation assays, and that a person of ordinary skill in the art would not have been able to predict these beneficial properties.
Applicant’s argument is unconvincing because the teachings of the patented document already disclose KAT6A and KAT6B assays (Abstract), and cancer cell proliferation assays (Table 6). Therefore, person of ordinary skill in the art, following the teachings of the patented application would reasonably expect that the patented compounds, which encompass a 4-membered heterocycle formed by joining Ra and Rb would have equally excellent activity in the KAT6A and KAT6B assays, and cancer cell proliferation assays.
In order to overcome the rejection, Applicant is required to file a terminal disclaimer disclaiming the terminal portion of U.S. Patent No. US 12,357,603 B2. Absent such a filing, the nonstatutory double patenting rejection is maintained.
Status of Claims
Claims 1-7, 12, 14, and 20-23 are pending in the instant application. Claims 7 and 20-23 are withdrawn from further consideration pursuant to 37 CFR § 1.142(b), as being drawn to a non-elected invention and species. Therefore, claims 1-6, 12, and 14 read on the elected invention and species and are therefore under examination herein.
Claim Rejections - 35 U.S.C. § 103
The following is a quotation of pre-AIA 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.
Claims 1-6, 12, and 14 are rejected under 35 U.S.C. § 103 as being unpatentable over Bouche et al. (WO 2020216701 A1, effectively filed April 25, 2019 for the purposes of § 102(a)(2)), cited on Applicant IDS dated 05/08/2023), hereinafter Bouche.
The instant claims are drawn to a compound of Formula (I) elected to be the species,
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, and a pharmaceutical composition thereof, further comprising an anticancer agent.
Bouche teaches a compound of Formula (I) (claim 1 of Bouche, see instant claims 1-6), and a pharmaceutical composition thereof (claim 19 of Bouche, see instant claim 12), further comprising an anticancer agent (claim 21 of Bouche, see instant claim 14).
Regarding claims 1-6, Bouche renders obvious the elected species wherein,
R1, R2, R4, and R5 are hydrogen
R3 is fluoro
Ra and Rb together with the nitrogen atom to which they are attached form a 4-membered nitrogen-containing heterocycloalkyl
R6 is phenyl substituted with a 2-ethoxy group.
The prior art is not anticipatory insofar as these combinations must be selected from various lists/locations in the reference. It would have been prima facie obvious, however, to make the combination since all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art (see MPEP § 2143 (I)(A)).
The interest of brevity, and because the claims are largely repetitive, the outlined teachings are herein applied to each claim individually and the claims collectively, thus, stand rejected.
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 1-6 and 12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12, 14, and, 15 of U.S. Patent No. US 12,357,603 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the elected species is encompassed by limitations of the patented claims. The patented claims (claims 1-12) teach a compound of Formula (I) would anticipate the elected species wherein,
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X is Oxygen (see instant claims 1-6)
R1, R2, R4, and R5 are hydrogen (see instant claims 1-6)
R3 is fluoro (see instant claims 1-6)
Ra and Rb together with the nitrogen atom to which they are attached form a 4-membered nitrogen-containing heterocycloalkyl (see instant claims 1-6)
R6 is phenyl substituted with a 2-ethoxy group (see instant claims 1-6)
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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sophia P. Hirakis whose telephone number is +1 (571) 272-0118. The examiner can normally be reached within the hours of 5:00 am to 5:00pm EST, Monday through Friday.
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, Adam C. Milligan can be reached on +1 (571) 270-7674. The fax phone number for the organization where this application or proceeding is assigned is +1 (571) 273-8300.
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/SOPHIA P HIRAKIS/Examiner, Art Unit 1623
/KARA R. MCMILLIAN/Primary Examiner, Art Unit 1623
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