DETAILED ACTION
All rejections and objections not mentioned below have been withdrawn.
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 .
Election/Restrictions
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Applicant’s election without traverse of “Compound 133” in the reply filed on 09/30/2025 is acknowledged.
Applicant states claims 1-2, 9-14, 19-23, 25-27, 33-36, 43, 51-52, 62, 64, 68-75, 77, 80, 82-83, and 116 read on the elected species.
As per MPEP 803.02, the examiner will determine whether the entire scope of the claims is patentable. Applicants' elected species of compound 133 appears allowable. Therefore, according to MPEP 803.02: should the elected species be found allowable, the examination of the Markush-type claim will be extended. If the examination is extended and a non-elected species found not allowable, the Markush-type claim shall be rejected and claims to the nonelected invention held withdrawn from further consideration. The examination of the Markush-type claims has been extended to include the scope of claims 116, 82 and 14. Claims 116 and 82 were found to be allowable so the scope was expanded to claim 14. Claim 14 was found to be anticipated by the prior art so the expansion of the scope was halted at claim 14. Since a non-elected species has been found not allowable, examination has been limited to claims directed to the elected species, which are presently claims 1-2, 9-14, 19-23, 25-27, 33-36, 43, 51-52, 62, 64, 68-75, 77, 80, 82-83, and 116. Claims 1-2, 9-14, 19-23, 25-27, 33-36, 43, 51-52, 62, 64, 68-75, 77, 80, 82-83, and 116 have been examined to the extent that they are readable on the elected embodiment and the above identified nonelected species(the scope of claims 116, 82 and 14). Since the nonelected species has been found not allowable, subject matter not embraced by the elected embodiment or the above identified nonelected species is therefore withdrawn from further consideration.
Claims 3-8, 15-18, 24, 28-31, 53-55, 63, 65-67, 78 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention or species. Election was made without traverse in reply filed 09/30/2025.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed applications, Application No. 63/021,727 and 63/121,077, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. A claim my claim analysis indicated that 63/021,727 lacked several structures of claims 10, 11, 12, 13, 14, 15, 16, 17-20, 62, 63-70, 72, 73-75, 78. For example, the following structure lack priority:
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. Thus claims 10, 11, 12, 13, 14, 15, 16, 17-20, 62, 63-70, 72, 73-75, 78 were given a priority date of 12/03/2020. Claims 21, 22, 23, 24, 25, 26, 27, 28, 30, 31, 33, 34, 35, 36, 53, 54, 55, 71,77, 80, 82, 83, 116 lack support until the application PCT/US21/31386 for several structures including
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and so these claims were given a priority date of 05/07/2021. All remaining claims were given a priority date of 05/08/2020.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/05/2024, 05/19/2025, 07/24/2025, 11/06/2025, and 05/19/2026 are being considered by the examiner.
Claim Rejections - 35 USC § 112- New due to Amendment
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 26 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.
The scope of claim 26 is unclear because claim 26 depends from claim 25 which has very specific R1 requirements but the compounds of 26 have no location to place a R1 variable that is not H or methyl.
Claim Rejections - 35 USC § 102- New due to Amendment
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 9-10, 12,13, 20,21, 22, 23, 26, 33-36, 43, 51-52, 62, 72-73, 77, 120 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAS 2101281-80-3 CAS Registry File Accessed 6/22/2026 from STN, entered into STN 04 Jul 2017.
The STN reference CAS 2101281-80-3 teaches the following compound, wherein A is
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,
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R1’=Cl, n’=1, Q=O, Ra=H, Y1-Y4=CR2, R2=H, U= NRa, Ra=H, T=N, Z1-Z5=CR3, R3=H, V=absent, R4=C5 heterocycloalkyl. This anticipated claims 1, 9-10, 12,13, 20,21, 22, 23, 26, 33-36, 43, 51-52, 62, 72-73, 77, 120.
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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.
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, 9, 10, 11, 12, 13, 14, 19, 20, 21, 22, 23, 27, 33, 34, 35, 36, 43, 51, 52, 62, 64, 68, 69, 70, 71,72, 73, 74, 77 is/are rejected under 35 U.S.C. 103 as being unpatentable over CHOI, (CHOI et al., WO 2017/039318, 2017-03-09).
The reference CHOI teaches the following compound (page 44), wherein A is
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, R1=H, Q=NRa, Ra=H, Y1-Y4=CR2, R2=H, U= NRa, Ra=H, T=N, Z1-Z5=CR3, R3=H, V=NRa, Ra=H,, R4=heteroaryl substituted with R5, R5=C1 alkyl and -N(Ra)2, Ra=H. This helps to teach claims 1, 9, 10, 11, 12, 13, 14, 19, 20, 21, 22, 23, 27, 33, 34, 35, 36, 43, 51, 52, 62, 64, 68, 69, 70, 71,72, 73, 77.
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The reference CHOI teaches the following compound (page 45), wherein A is
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, R1=H, Q=NRa, Ra=H, Y1-Y4=CR2, R2=H, U= NRa, Ra=H, T=N, Z1-Z5=CR3, R3=H, V=NRa, Ra=H,, R4=heteroaryl substituted with R5, R5= -N(Ra)2, Ra=H. This helps to teach claims 1, 9, 10, 11, 12, 13, 14, 19, 20, 21, 22, 23, 27, 33, 34, 35, 36, 43, 51, 52, 62, 64, 68, 69, 70, 71,72, 73, 74, 77.
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The reference also teaches “The invention provides for DNA methylation inhibitors, and also methods and use of the compounds of the invention, by themselves or in combination with other therapies, for treating a disease in which DNA hypermethylation is found”(abstract).
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The reference CHOI teaches the following generic formula (formula I, reference claim 1), wherein:
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The reference CHOI does not teach a specific compound wherein R1’=CH3 (all claims).
It would be prima facie obvious to the person having ordinary skill in the art before the effective filing date of the instant invention to modify the reference CHOI by adding R1’=CH3 because CHOI teaches the lead compounds shown above that only differ in a single methyl group and the general formula of CHOI suggest adding a methyl group to that location. One would be motived to add the methyl group to see if any improvement in activity for treating a disease in which DNA hypermethylation would be found. One would have reasonable expectation of success because it is both a small change which would likely have similar structure and function and because it is a suggested change under the reference generic formula. Further, it is generally noted that the substitution of methyl for hydrogen on a known compound is not a patentable modification absent unexpected or unobvious results. In re Druey, 319 F.2d 237, 138 U.S.P.Q. 39 (C.C. P.A. 1963). Given that applicant did not provide unexpected or unobvious results of the invention, it is concluded that the normal desire of scientists or artisans to improve upon what is already generally known would provide the motivation to substitute the H group for a Me. 2144.08(II)(A)(4)(c)
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 1-2, 9-14, 19-23, 25-27, 33-36, 43, 51-52, 62, 64, 68-75, 77, 80, 82-83, and 116 -120 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-135 of copending Application No. 18/707,125 (reference application), over claim 1-104 of copending Application No. 18/707,109 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Application ‘125 claims:
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All other variables of the instant claims can be found in the reference claims of Application ‘125 nearly word for word and structure for structure. The above are just some of the examples. This anticipates claims 1-2, 9-14, 19-23, 25-27, 33-36, 43, 51-52, 62, 64, 68-75, 77, 80, 82-83, and 116-118.
Application ‘109 claims:
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All other variables of the instant claims can be found in the reference claims of Application ‘109 nearly word for word and structure for structure. The above are just some of the examples. This anticipates claims 1-2, 9-14, 19-23, 25-27, 33-36, 43, 51-52, 62, 64, 68-75, 77, 80, 82-83, and 116-118.
Response to Arguments
Applicant’s arguments with respect to the previous office action rejections have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Claims 1-2, 9-14, 19-23, 25-27, 33-36, 43, 51-52, 62, 64, 68-75, 77, 80, 82-83, and 116-120 are rejected. Claims 3-8, 15-18, 24, 28-31, 53-55, 63, 65-67, 78 are withdrawn.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 ALISON AZAR HASTINGS whose telephone number is (703)756-4584. The examiner can normally be reached Mon-Thurs 7:30am-5pm EST Friday 7:30-4pm EST (every other Friday off).
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, Kortney Klinkel can be reached at (571) 270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.A.H./ Examiner, Art Unit 1627
/Kortney L. Klinkel/ Supervisory Patent Examiner, Art Unit 1627
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