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 .
Status of the Claims
Claims 1 – 8, 12 – 26 and the newly added claims 57 – 63 are pending.
Claims 1, 3, 5, 12 – 13, 18 and 20 are rejected.
Claims 6 – 7 and 19 are objected.
Claims 2, 4, 8, 14 – 17, 21 – 26 and 57 – 63 are withdrawn.
Response to Applicant’s Remarks
Applicant’s amendments and remarks filed on October 22, 2025 have been fully considered.
The Improper Markush Grouping rejection of claims 1, 3, 5 – 7, 18 – 20 as containing an improper Markush grouping of alternatives is withdrawn in view of amendment to delete the scope of the compound of Formula I, wherein Q is Q-1 and Q-2, in claim 1. Claim 44 has been cancelled.
The rejection under 35 U.S.C. 102(a)(1) of claims 1, 3, 5 – 7, 12 – 13 and 20 as being anticipated by Wang et al. CN 109369554 A is withdrawn in view of amendment to recite the proviso that when Q is Q-3, R is hydrogen, in claim 1. Claim 44 has been cancelled.
Regarding the provisional nonstatutory double patenting rejection of claims 1, 3, 5 – 7, 18 and 20 as being unpatentable over claims 1 – 2, 4, 6 and 14 – 18 of copending Application No. 18/280,158, Applicant state that there has been no indication of allowable subject matter and requested to hold the rejection in abeyance. Since the claims are not yet patentable, the rejection is maintained. The rejection has only been amended to address the claims pending in the present application.
Examination: Applicant’s amendments necessitate extending the search in accordance with MPEP §803.02. The search has been extended to include the scope, wherein:
R5 is aryl or heteroaryl;
Q is
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or
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;
G is -O- or -S-; and
G2 is =N- or =C(R3b)-.
Election/ Restriction
Newly added claims 57 – 61 are directed to a compound of Formula I, wherein Q is Q-1 and Q-2.
Newly added claim 62 is directed to a pharmaceutical composition comprising the compound of claim 57, or a pharmaceutically acceptable salt or solvate thereof, and a pharmaceutically acceptable carrier.
Newly added claim 63 is directed to a method of treating cancer in a subject in need thereof, the method comprising administering to the subject a therapeutically effective amount of the compound of claim 57, or a pharmaceutically acceptable salt or solvate thereof.
Pursuant to Federal Register, Vol. 76, No. 27, dated February 9, 2011, page 7166 (middle column):
“Under principles of compact prosecution, the examiner should also require the applicant to elect a species or group of indistinct species for search and examination (i.e., an election of species). If the examiner does not find the species or group of indistinct species in the prior art, then the examiner should extend the search to those additional species that fall within the scope of a permissible Markush claim. In other words, the examiner should extend the search to the species that share a single structural similarity and a common use. The improper Markush claim should be examined for patentability over the prior art with respect to the elected species or group of indistinct species…within the scope of a proper Markush claim.”
Subject matter not embraced by the elected embodiment or the scope searched is therefore withdrawn from further consideration. Claims 2, 4, 8, 14 – 17, 21 – 26 and 57 – 63 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected invention/ species, there being no allowable generic or linking claim.
Noncompliant Amendment
The Amendment filed on October 22, 2025 is not compliant with the requirements of 37 CFR 1.121(c)(1) which states in part that “The claim listing shall commence on a separate sheet of the amendment document and the sheet(s) that contain the text of any part of the claims shall not contain any other part of the amendment”. The status identifiers of claims 2, 4, 8, 14 – 17, 21 – 26 and 57 – 63 are incorrect. Claims 2, 15, 17 and 22 – 25 are indicated as “Original”, claims 4, 14, 16 and 26 are indicated as “Previously Presented”, claims 8 and 21 are indicated as “Currently Amended”, and claims 57 – 63 are indicated as “New”. The correct status identifier for each of the claims should be “withdrawn”. Since Applicant’s reply appears bona fide, the amendment has been entered; however, appropriate correction is required in replying to this Office Action.
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, 12 – 13, 18 and 20 are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Kapoor et al. WO 2011082098 A1 (publ. July 7, 2011; effectively filed December 30, 2009).
Kapoor et al. teach Compound 6 as presented below:
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. See, e.g., pg. 29, paragraph [0094],
and page 39, Table.
The compound anticipates the instant claims as presented below:
Claims 1, 12 – 13 and 18, directed to a compound of Formula I:
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, wherein:
R is hydrogen;
E is =C(R1a)-;
E1 is =C(R5)-;
E2 is =C(R1b)-;
E3 is =C(R1c)-;
E4 is =C(R1d)-;
R1a, R1b, R1c and R1d are each hydrogen;
R5 is heteroaryl (indolyl) substituted with phenyl;
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With respect to claim 20, Kapoor teaches that a starting compound, methyl-3-hydroxy-isoxazole-5-carboxylate, is reacted with 1-[3-(bromomethyl)phenyl]-4-phenyl-1H-indole in the presence of dimethylformamide (DMF) and sodium hydride as base. Ester hydrolysis is performed using 2 equivalents 1 N aqueous sodium hydroxide in ethanol heated at 60 °C to obtain said compound. See, e.g., pg. 29, paragraph [0094]. Ethanol is considered a pharmaceutically acceptable carrier (according to Official Notice).
Claims 1, 5, 18 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Li et al., J. Med. Chem. 2017, 60, 2697-2717 (publ. March 9, 2017).
Li et al. teach Compound 37 as presented below:
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. See, e.g., pg. 2701, Scheme 6.
The compound anticipates the instant claims as presented below:
Claims 1, 5 and 18, directed to a compound of Formula I:
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, wherein:
R is hydrogen;
E is =C(R1a)-;
E1 is =C(R5)-;
E2 is =C(R1b)-;
E3 is =C(R1c)-;
E4 is =C(R1d)-;
R1a, R1b, R1c and R1d are each hydrogen;
R5 is aryl (phenyl) substituted with two C1 alkyl;
Q is
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;
G is -S-;
G1 is =C(R3a)-;
G2 is =C(R3b)-; and
R3a and R3b are each hydrogen.
With respect to claim 20, Li teaches that a starting compound, 2-((2′,6′-Dimethylbiphenyl-3-yl)methoxy)thiophene, is mixed with 8 mL of anhydrous tetrahydrofuran (THF), cooled, reacted with ”BuLi, cooled overnight and quenched to obtain said compound. See, e.g., pg. 2713, 15th paragraph. Tetrahydrofuran is considered a pharmaceutically acceptable carrier (according to Official Notice).
Claims 1, 3, 12 – 13, 18 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAS Registry RN 1509103-03-0 (Entered STN date: January 1, 2014).
CAS Registry RN 1509103-03-0 teach the compound as presented below:
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. See, e.g., pg. 1.
The compound anticipates the instant claims as presented below:
Claims 1, 12 – 13 and 18, directed to a compound of Formula I:
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, wherein:
R is hydrogen;
E is =C(R5)-;
E1 is =C(R1a)-;
E2 is =C(R1b)-;
E3 is =C(R1c)-;
E4 is =C(R1d)-;
R1a, R1b, R1c and R1d are each hydrogen;
R5 is heteroaryl (imidazolyl);
Q is
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;
G is -S-;
G1 is =C(R3a)-;
G2 is =C(R3b)-; and
R3a and R3b are each hydrogen.
Claim 3, directed to the compound of Formula III:
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, wherein:
R is hydrogen;
R1a, R1b, R1c and R1d are each hydrogen;
R5 is heteroaryl (imidazolyl);
Q is
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;
G is -S-;
G1 is =C(R3a)-;
G2 is =C(R3b)-; and
R3a and R3b are each hydrogen.
With respect to claim 20, the experimental and predicted properties of CAS RN 1509103-03-0 discloses a composition comprising 0.36 grams of said compound in 1 Liter of unbuffered water. See Mass solubility data, e.g., page 2, lines 15-17. Water is considered a pharmaceutically acceptable carrier (according to Official Notice).
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, 5, 12 – 13, 18 and 20 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 2, 4, 6 and 14-18 of copending Application No. 18/280,158 (U.S. Publication 2024/0174658 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 1 in US ‘158 claims a compound of Formula I:
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.
Claim 14 in US ‘158 specifically claims the compound:
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.
The claims in US ‘158 render the instant claims 1 – 5 unpatentable for anticipatory-type double patenting as presented below:
Claims 1, 5, 12 – 13 and 18, directed to a compound of Formula I:
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, wherein:
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R5 is an unsubstituted heteroaryl (pyridyl);
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Claim 3, directed to the compound of Formula III:
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, wherein:
R is hydrogen,
R1a, R1b, R1c and R1d are each hydrogen,
R5 is an unsubstituted heteroaryl (pyridyl),
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With respect to claim 20, claim 15 in US ‘158 specifically claims a pharmaceutical composition comprising the compound, or a pharmaceutically acceptable salt or solvate thereof, and a pharmaceutically acceptable carrier.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Allowable Subject Matter
Claims 6 – 7 and 19 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.
Conclusion
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 Sagar Patel whose telephone number is (571)272-1317. The examiner can normally be reached Monday - Friday: 9am to 5pm EST.
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, Amy L. Clark can be reached at (571) 272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Sagar Patel/Examiner, Art Unit 1626
/KAMAL A SAEED/Primary Examiner, Art Unit 1626