DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims and Response to Amendments
The amendments filed on June 16, 2026 have been acknowledged and entered.
Claims 1-3, 10-27, 29, 30, 33, and 34 are pending. Claims 22-27 and 29 are withdrawn. Claims 4-9, 28, 31, and 32 are cancelled.
Withdrawn Rejections
Applicant is notified that any outstanding rejection or objection that is not expressly maintained in this office action has been withdrawn or rendered moot in view of Applicant’s amendments and/or remarks.
Status of Priority
The present application is a 35 U.S.C. § 371 national stage patent application of International patent application PCT/US2020/024702, filed on March 25, 2020. This application also claims the benefits of United States Provisional Patent Application No. 62/823,384, filed on March 25, 2019.
Election/Restrictions
As a reminder, Applicant elected, without traverse, Group (I) which is drawn to a compound or composition having the structure represented by Formula (I) according to claims 1-21, 28, and 30-34. Note: claims 4-9, 28, 31, and 32 are now cancelled.
Specification - Disclosure
The 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 1 and 3 are objected to because of the following informalities:
In claim 1 on pg. 7:
the structures corresponding to formulae XXI and XXII are not present (below is what the Examiner sees):
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310
665
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Please ensure that these structures are included in the claim.
In claim 1 on pg. 8:
the 2nd and 3rd compounds listed are the same;
to avoid repetition, please remove one of the structures.
In claim 3:
the structures corresponding to formulae VIII and IX are not present (below is what the Examiner sees):
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298
662
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Please ensure that these structures are included in the claim.
Appropriate correction is required.
-------------------------------- Maintained rejections --------------------------------
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 1-3, 10-14, and 16-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over:
claims 1-5, 9, 11, 15-17, and 19-25 of U.S. Patent Application No. 18/178,192.
Although the claims at issue are not identical, they are not patentably distinct from each other because there is significant overlap in compound species between the instant claims and the claim set from the co-pending application. For example, compounds A-1, A-5, A-20, A-95, A-106, A-124 through A-127, A-212, and A-217 of U.S. Patent Application No. 18/178,192 are also species of the instant claim set.
The co-pending application discloses agents for the treatment of diseases by inhibition of FOXO1. Since:
there is overlap between the compound species disclosed in the instant application and those disclosed in the co-pending application, and
the instant application teaches compounds that can selectively inhibit the FOXO1 transcription factor
it would be reasonable for one of ordinary skill in the art to conclude that the compounds of the co-pending application that overlap with the instant application likewise exhibit selective FOXO1 transcription factor inhibition. Hence, instant claim 14 is also provisionally rejected on the ground of nonstatutory double patenting.
-------------------------------- Added rejections --------------------------------
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 30, 33, and 34 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over:
claims 1-5, 9, 11, 15-17, and 19-25 of U.S. Patent Application No. 18/178,192 (‘192).
Although the claims at issue are not identical, they are not patentably distinct from each other because there is significant overlap in compound species between the instant claims and the claim set from the co-pending application. See the Maintained “Double Patenting” Rejection above for an explanation why instant claims 1-3, 10-14, and 16-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over ‘192. Note: instant claims 30, 33, and 34 are directed towards a pharmaceutical composition comprising a compound that is encompassed by instant claims 1-3, 10-14, and 16-21.
Even though ‘192 does not have claims directed to pharmaceutical compositions, a POSITA would have found it obvious to take any one of the overlapping compounds encompassed by the instant claims and the claims of ‘192 application and formulate it into a pharmaceutical composition as recited in instant claims 30, 33, and 34. The ‘192 application explicitly:
identifies specific compounds that overlap between the instant claim set and the claim set of ‘192 (see Table 1 starting on pg. 99 of specification of ‘192 for a list of compounds) and
states that a “pharmaceutical composition of the disclosure can be a combination of any pharmaceutical compounds described herein [including those that are also encompassed by the instant claims] with other chemical components, such as carriers, … diluents, … and/or excipients” (see specification of ‘192, pg. 83, para. 00153, 1st sentence). “For the purpose of oral therapeutic administration, the active agent can be incorporated with excipients and used in the form of tablets… or capsules” (pg. 87, para. 00167, 2nd sentence).
In view of these teachings, a POSITA would have been motivated to formulate the overlapping compounds into the instantly claimed pharmaceutical compositions. Accordingly, instant claims 30, 33, and 34 are not patentably distinct from the claims of the co-pending application, ‘192.
----------------------------- Rejections necessitated by the amended claims -----------------------------
Note on 35 USC § 102 and § 103 Rejections
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.
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.
102 Rejection part 1:
Claims 1 and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by
Adachi et al. (Adachi) (Adachi, I. et al. Studies on Dihydropyridines. II. Synthesis of 4,7-Dihydropyrazolo[3,4-b]-pyridines with Vasodilating and Antihypertensive Activities. Chem. Pharm. Bull. 1987, 35, 3235-3252.)
Adachi discloses the following compound:
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(herein, referred to as Adachi-compound-28; general structure of Adachi-compound-28 is provided on pg. 3236, chart 1 [see general structure representing compounds 1-33]; on pg. 3246-3247, the section titled “5-Amino-1-methyl-3-R3-pyrazoles (1-28)” discloses Adachi-compound-28 with its structure shown above).
This compound reads on instant claims 1 and 21 wherein:
b = 0 (i.e., the cyclic moiety, A, is absent)
c = 0 (i.e., R3 is absent)
a = 0 (i.e., R2 is absent)
R1 = C1 alkyl
d = 0 (i.e., R4 is absent)
e = 1
R5 = C1 alkyl
R6 = R7 = H
102 Rejection part 2:
Claims 1, 21, 30, and 33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by
STN registry entry, RN 2249013-09-8, entered into the database on November 18, 2018 in view of:
Product no. Z2957696520; Enamine. https://enaminestore.com/catalog/Z2957696520. (Accessed July 24, 2026).
The STN entry for compound 2249013-09-8 is shown below:
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645
777
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This compound reads on instant claims 1 and 21 wherein:
b = 0 (i.e., the cyclic moiety, A, is absent)
c = 0 (i.e., R3 is absent)
a = 0 (i.e., R2 is absent)
R1 = C1 alkyl
d = 0 (i.e., R4 is absent)
e = 1
R5 = C1 alkyl
R6 = H
R7 = a moiety represented by Formula III:
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145
218
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wherein
X = C
g = 0 (i.e., the “B” moiety is absent)
R9 = C1 alkyl
f = 5
three R8 substituents are H, one R8 substituent is a C1 alkyl, one R8 substituent is OMe.
According to the STN entry, this compound can be purchased from the company, Enamine (see “Source of Registration” line from STN output).
According to the Enamine company webpage, compound 2249013-09-8 can be purchased in the form of a solution wherein the compound is dissolved in DMSO:
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585
871
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DMSO is a known excipient that can be used as a diluent (See McKim et al. Pharmaceutical Technology. 2008, 32; 1st sentence of article). Therefore, this composition comprising compound 2249013-09-8 and DMSO reads on instant claims 30 and 33.
102 Rejection part 3:
Claims 1, 16, and 18-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by
STN registry entry, RN 1580735-20-1, entered into the database on April 6, 2014.
The STN entry for compound 1580735-20-1 is shown below:
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553
755
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This compound reads on instant claims 1, 16, and 18-21 wherein:
b = 0 (i.e., the cyclic moiety, A, is absent)
c = 0 (i.e., R3 is absent)
a = 0 (i.e., R2 is absent)
R1 = C1 alkyl
d = 0 (i.e., R4 is absent)
e = 1
R5 = C1 alkyl
R6 = H
R7 = a moiety represented by Formula II:
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186
170
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wherein
X = C
g = 0 (i.e., the “B” moiety is absent)
f = 5
three R8 substituents are H, one R8 substituent is a C1 alkyl, one R8 substituent is an amine moiety
wherein the amine moiety is represented by Formula X:
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81
125
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and R16 = R17 = H.
Allowable Subject Matter
Claim 15 is 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.
Conclusion
Claims 1-3, 10-14, 16-21, 30, 33, and 34 are rejected. Claim 15 is objected to. Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTEN ROMERO whose telephone number is (571)272-6478. The examiner can normally be reached M-F 9:30 AM - 6:00 PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JEFFREY H. MURRAY can be reached at (571) 272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KRISTEN W ROMERO/Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624
Prosecution Insights