Detailed Action
The present office action is in response to the remarks filed on 18 Dec 2025.
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 .
Status
Claims 1-22 of the pending application have been examined on the merits. Claims 23-26 are withdrawn (see “Response to Applicant Election” below). Acknowledgement is made of the amendments filed 06 Feb 2024. Acknowledgement is made of the cancellation of claims 27-30.
Priority
Applicants identify the instant application, Serial #: 18/267,226, filed 14 Jun 2023, as a National Stage Entry of International Patent Application #: PCT/US2021/065208, filed 27 Dec 2021, which claims priority from U.S. Provisional Application #s: 63/131,084, filed 28 Dec 2020.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 06 Feb 2024, 01 May 2025, and 18 Dec 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Applicant Election
Applicant’s election without traverse of Group I, claims 1-22, and the species of Compound 12 (below) in the reply filed on 18 Dec 2025 is acknowledged.
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No prior art was found after a search for the elected compound. Examiner expanded the Markush search to the full scope of the generic Formula I. This search returned prior art and Group II, claims 23-26, is withdrawn.
Claims 23-26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 18 Dec 2025.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claims 12-13 and 18-21 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim Rejections - 35 USC § 112(b)
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.
Claims 1, 11, and 14-17 are 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.
Regarding claims 1, 11, and 14-17, the claims contain Markush groupings which do not have the coordinating conjunctions “and” or “or” to properly limit the alternatives defined in the list, or the claims contain the incorrect coordinating conjunction to properly limit the alternatives defined in the list. See MPEP § 2117(I). Specifically, claim 1 has no coordinating conjunction in the last line of the claim; claim 11 has the incorrect coordinating conjunction in the definition of variable X; and claims 14-17 do not contain a coordinating conjunction between the last two named compounds of each of the claims. Applicant may overcome this rejection by adding the proper coordinating conjunction to each Markush group in need of one.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 3-4, and 7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2009/0325970.
The instant claims are drawn to the following generic Formula I:
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The reference includes the following species which anticipate the instant claims (paragraph [0016]):
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Claim(s) 1 and 6-7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2011/097079 (provided in IDS 05/01/25).
The reference teaches the following formula which is a sub-genus of the instant generic Claim 1 (paragraph [0015]):
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Each species anticipates the instant claims.
Claim(s) 1-2 and 7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2012/031197.
The reference teaches the following species which anticipates the instant claims (pg. 106):
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Claim(s) 1-7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2012/123745 (provided in IDS 05/01/2025).
The reference teaches the following formula which anticipates the generic Formula I of the instant claims (paragraph [0055]):
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Claim(s) 1 and 5-7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2012/160464.
The reference teaches the following species which anticipate the instant claims:
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(pg. 126, Compound 120)
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(pg. 129, line 8)
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(pg. 130, Compound 130)
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(pg. 131, Compound 137)
Claim(s) 1-2 and 7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2013/127268.
The reference teaches the following species which anticipate the instant claims:
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(pg. 15, Compound 82)
Claim(s) 1-7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2014/081718 (provided in IDS 05/01/2025).
The reference teaches the following generic formula which anticipate the instant claims when X is CR3 (pg. 3, lines 10-16):
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Claim(s) 1 and 7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2014/196793.
The reference teaches the following species which anticipate the instant claims:
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(pg. 55, Intermediate 10)
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(pg. 95, Compound 98)
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(pg. 96, Compound 101)
Claim(s) 1-5, 7, and 22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2014/207260 (provided in IDS 12/18/25).
The reference teaches the following generic formula which anticipates the instant claims when reference variable R3 is -NR6R7:
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Claim(s) 1 and 7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2015/038417 (provided in IDS 02/06/24).
The reference teaches the following species which anticipate the instant compounds:
Compounds 6-8 (pgs. 182-183), 13 (pg. 184), 15-16 (pg. 185), 19-20 (pgs. 186-187), 22-27 (pgs. 187-189), 30-32 (pgs. 190-191), 97-98 (pgs. 212-213), 313 (pg. 289), 322 (pg. 292), 325 (pg. 293), 364 (pg. 309), 366 (pg. 310), 368 (pg. 310), 371 (pg. 312), 384-385 (pgs. 317-318), 393 (pg. 321), 397 (pg. 323), 616 (pg. 424), and 959-961 (pg. 560).
Claim(s) 1-10 and 22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2015/0079108.
The reference teaches the following generic formula which anticipates the generic Formula (I) when reference variable R3 is -NR7R6 (paragraph [0145]):
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The reference further teaches a pharmaceutical composition comprising at least one of the inventive compounds and a pharmaceutically acceptable carrier, excipient, binder, disintegrate, glidant, lubricant or solvent (paragraph [0045]).
Claim(s) 1-5 and 7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2016/166159 (provided in IDS 12/18/25).
The reference teaches the following species which anticipate the instant claims:
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(pg. 39)
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(Fig. 3A)
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(Fig. 6)
Claim(s) 1-5 and 7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2017/044623.
The reference teaches the following species which anticipate the instant claims:
Structures 305-311 (pgs. 91-92) and 590-593 (pg. 148).
Claim(s) 1-5 and 7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2017/109476.
The reference teaches species which anticipate the instant claims in Table 2 (pgs. 31-32).
Claim(s) is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2018/141855 (provided in IDS 02/06/24).
The reference teaches the following species which anticipate the instant claims (claim 14):
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Claim(s) 1-5 and 7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2019/080878.
The reference teaches the following species which anticipate the instant claims (pg. 117):
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Claim(s) 1 and 7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2019/080878.
The reference teaches the following species which anticipate the instant claims:
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(pg. 28)
Claim(s) 1-5 and 7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2020/021024 (provided in IDS 05/01/25).
The reference teaches the following species which anticipate the instant claims (pg. 93):
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Claim(s) 1 and 6-7 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by WO 2021/127166. The reference claims priority to U.S. Provisional Application #: 62/949,160, filed 17 Dec 2019.
The reference teaches the following generic formula which anticipates the generic Formula I when R4 is H:
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Claim(s) 1-3 and 6-7 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by WO 2021/148628. The reference claims priority from Foreign Application #: EP20153381.7, filed 23 Jan 2020.
The reference teaches the following species which anticipate the instant claims (pg. 37):
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Claim(s) 1 and 7 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by WO 2021/159993 (provided in IDS 05/01/25). The reference claims priority from Foreign Application #: PCT/CN2020/075387, filed 14 Feb 2020.
The reference teaches the following species which anticipate the instant claims:
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(pgs. 169-170)
Claim(s) 1 and 7 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by WO 2022/028556. The reference claims priority from Foreign Application #: CN202010789162.3, filed 07 Aug 2020.
The reference teaches the following species which anticipate the instant claims:
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(pg. 17)
Claim(s) 1-3 and 6-7 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by WO 2022/076975. The reference claims priority from U.S. Provisional Application #: 62/087,763, filed 05 Oct 2020.
The reference teaches the following species in reference claim 18 which anticipate the instant claims:
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Claim(s) 1 and 7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CN 111848506.
The reference teaches the following species which anticipate the instant claims (pg. 31):
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Claim(s) 1-5 and 7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Naud et al. (J Med Chem, 2013, 56:10045-10065).
The reference teaches the following species which anticipate the instant claims:
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(pg. 10049, Table 1)
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(pg. 10051-10052, Table 2)
Claim(s) 1-3 and 7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hanan et al. (J Med Chem, 2014, 57:10176-10191; provided in IDS 05/01/25).
The reference teaches the following species which read on the instant claims (pg. 10179, Table 2):
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Claim(s) 1-5 and 7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Li et al. (Eur J Med Chem, 2015, 93:523-538; provided in IDS 05/01/25).
The reference teaches the following species which read on the instant claims (pg. 532, Table 4):
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Claim(s) 1 and 7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zak et al. (J Med Chem, 2016, 59:8345-8368).
The reference teaches the following species which anticipates the instant claims (pg. 8349, Table 3):
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where X is NH2.
Claim(s) 1 and 7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chan et al. (J Med Chem, 2016, 59:9080-9093).
The reference teaches Compounds 9-10 and 12-13 which anticipate the instant claims (pg. 9084, Table 4):
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Claim(s) 1 and 7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pawar et al. (J Heterocyclic Chem, 2018, 55:1515-1821; provided in IDS 05/01/25).
The reference teaches the following species which anticipate the instant claims (pg. 1696, Scheme 1):
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Where R1 is –
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Claim(s) 1 and 7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Saini et al. (Chem Biol Drug Des, 2020, 96:921-930).
The reference teaches the following species which anticipates the instant claims (Fig. S1B):
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Conclusion
No claim is allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan D. Mahlum whose telephone number is (703)756-4691. The examiner can normally be reached 8:30 AM - 5:00 PM ET, M-F.
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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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/J.D.M./Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625