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 .
Election/Restrictions
Applicant's election with traverse of Group I (Claims 1-2, 4-9, 15-16, and 33) in the reply filed on 4 December 2025 is acknowledged. The traversal is on the ground(s) that the office has not shown that a serious burden would be required to examine all pending claims. Applicant claims that a lack of unity of invention was not raised in the examination of the PCT application upon which this application is based and thus, all compound and methods claims were searched together. The Examiner respectfully disagrees. There is a lack of unity of species due to the presence of compounds which read on the compounds of Group I, as explained in the restriction requirement. Thus, there is no unity of invention.
The requirement is still deemed proper and is therefore made FINAL.
Applicant further elects a species of the compound of Claim 1 wherein A1 through A6 are each C, R1 and R2 combine to form unsubstituted heterocycloalkyl, R3 is substituted heteroaryl, R4 is hydrogen, R5 is hydrogen, R6 is substituted aryl, and X and Y are N. This species reads on Claims 1, 2, 4, 16, and 33. This election is not fully responsive as Applicant has not fully and specifically defined each variable. However, this election was sufficient to begin a search. A search was performed for a species wherein variables A1 through A6 are each C, R1 and R2 combine to form a 3, 4, 5, and 6-membered heterocycloalkyl (substituted or unsubstituted), variable R3 as heteroaryl, R4 and R5 as hydrogen, R6 as substituted aryl, and X and Y as N. No art was retrieved. The search was expanded for all options for variables R3 through R6, with prior art retrieved. The search was then stopped (See STN Search, Search Notes).
Claims 5-9, 15, 18-27, and 29-31 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 4 December 2025.
Claims 1, 2, 4, 16, and 33, submitted on 4 December 2025, represent all claims currently under consideration.
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.
Priority
This application is a 371 of PCT/US2021/034128, filed 26 May 2021, which claims priority to provisional US 63/030,085, filed 26 May 2020. The effective filing date is 26 May 2020.
Information Disclosure Statement
One Information Disclosure Statement (IDS), submitted 24 April 2023, is acknowledged and has been considered.
Specification
The Title is objected to because it contains the word “NOVEL”. All patentable inventions are necessarily novel, so such words should not be included in the title (See MPEP § 606). The word “NOVEL” has been deleted from the title. No further action is required on Applicant’s part.
Claim Rejections - 35 USC § 102
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.
Claims 1, 2, 4, 16, and 33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Luk (WO 00/35920; Publication Date: 22 June 2000).
Luk discloses novel 4,5-azolo-oxindoles which inhibit cyclin-dependent kinases (Abstract). The present invention is directed to pharmaceutical compositions comprising a compound of the invention (Page 14, Lines 5-8). Anticipatory compounds include Example 16 (Page 32)
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, Example 19 (Page 33)
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, and Example 20 (Page 34)
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. These compounds have variables A1-A6 each as C, variable R1 and R2 coming together to form a substituted heterocycloalkyl, variables R3, R4, and R5 each as hydrogen, and variable R6 as substituted aryl, with substituents including OH and substituted alkyl, meeting the limitations of Claims 1, 2, 4, 16, and 33.
Claims 1, 2, 4, 16, and 33 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Schiller (US 2022/0213089; Publication Date: 7 July 2022; Priority to 15 March 2019).
Schiller discloses inhibitors of the CBP/p300 of bromodomains (Abstract). Schiller discloses several anticipatory compounds, including
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(Figure 1, Sheet 56),
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(Figure 1, Sheet 57),
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(Figure 1, Sheet 77),
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(Figure 1, Sheet 77),
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(Figure 1, Sheet 78),
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(Figure 1, Sheet 82),
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(Figure 1, Sheet 83), and
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(Figure 1, Sheet 85). These compounds have variables A1-A6 each as C, variable R1 and R2 coming together to form a substituted heterocycloalkyl, variables R3 and R4 as hydrogen, variable R5 as substituted alkyl, and variable R6 as aryl substituted with substituted alkyl, alkoxy, and/or halogen. Another aspect of the present disclosure relates to a pharmaceutical composition comprising a compound of the invention and a pharmaceutically acceptable carrier (Paragraph 0024).
Claims 1, 2, 4, 16, and 33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chen (WO 2018/002848; Publication Date: 4 January 2018).
Chen discloses compounds having drug and bio-affecting properties, their pharmaceutical compositions, and methods of use (Abstract). The compounds of the invention and set forth are generally given as pharmaceutical compositions. These compositions are comprised of a therapeutically effective amount of a compound of the invention and a pharmaceutically acceptable carrier (Page 26, Lines 30-33). Compound 100 (Page 232)
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has variables A1-A6 each as C, variable R1 and R2 coming together to form a substituted heterocycloalkyl, variables R3 and R4 as hydrogen, variable R5 as hydrogen, and variable R6 as aryl substituted with substituted alkyl. Compounds A298 (Page 173)
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and A303 (Page 174)
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have variables R2 and R3 coming together to form an unsubstituted or substituted heterocycloalkyl.
Claims 1, 2, 4, 16, and 33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Simoneau (WO 2005/042530; Publication Date: 12 May 2005) .
Simoneau discloses compounds useful in the manufacture of a medicament for the treatment or prevention of respiratory syncytial virus infection (Abstract). The present invention relates to compounds and pharmaceutical compositions comprising such compounds (Page 1, Lines 6-7). Anticipatory compounds include compound 1132 (Page 26)
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, compound 1059 (Page 29)
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, and Compound 2007 (Page 35)
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. Table 1 (Page 37) lists several anticipatory compounds wherein the aryl ring in the analogous variable R6 is substituted with groups such as chlorine, trifluoromethyl, nitro, methyl, and cyano, and the analogous variable R4 position is substituted with groups such as halogen, ethyl, amine, alkylene, OH, and substituted amine. Table 2 lists more anticipatory compounds, with similar substituents. Each of these compounds have variables A1-A6 each as C, variable R1 and R2 coming together to form a substituted heterocycloalkyl, variable R3 as hydrogen, variable R4 as hydrogen or other groups such as halogen, amine, alkylene, or alkyl, variable R5 as H, and variable R6 as substituted aryl.
Claims 1, 2, 4, and 33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Deshmukh (Dyes and Pigments, 113, 2015, 189-199).
Deshmukh discloses several anticipatory compounds. Compounds 8’a, 8’b, and 8’c
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(Scheme 1, Page 191) have variable R’ as N(Et)2, H, and OH, respectively. These compounds meet the limitations of the compounds of Claims 1, 2, and 33. Each of these compounds have variables A1-A6 each as C, variable R1 and R2 coming together to form a substituted heterocycloalkyl, variable R3 as hydrogen, variable R4 as hydrogen, variable R5 as H, and variable R6 as substituted aryl.
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, 2, 4, 16, and 33 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 5, and 10 of copending Application No. 19/140,283 (Amended Claims of 22 July 2025) (‘283).
Claim 1 of ‘283 is directed to a compound of structure 1A or 1B
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wherein X and Y are selected from C or N;
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. Claim 3 of ‘283 is directed to the compound of Claim 1 represented by formula IIA
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or IIB
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. Claim 5 of ‘283 claims the compound of claim 3 wherein R1 and R2 connect to form a five-membered, six-membered, seven-membered, or eight-membered ring; and/or R4 and R5 are connected to form a five-membered, six-membered, seven-membered, or eight-membered ring; and/or R4 and R6 five-membered, six-membered, seven-membered, or eight-membered ring. Claim 10 is directed to a pharmaceutical composition comprising the compound according to claim 1 and a pharmaceutically acceptable carrier, adjuvant, or excipient.
The claims are not identical but are not patentably distinct because the compounds of Claim 5 read on the species of the examined application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1, 2, 4, 16 and 33 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHILLIP MATTHEW RZECZYCKI whose telephone number is (703)756-5326. The examiner can normally be reached Monday Thru Friday 730AM-5PM EST.
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/P.M.R./Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625