DETAILED ACTION
This office action is in response to applicant’s filing dated January 28, 2026.
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 Claims
Claims 82-98 and 102-107 are pending in the instant application. Acknowledgement is made of Applicant's remarks and amendments filed January 28, 2026. Acknowledgement is made of Applicant's amendment of claim 96; and cancelation of claims 1-81 and 99-101.
Election/Restrictions
Applicant’s election without traverse of Group II, drawn to composition comprising a compound of Formula I or I(a) or a pharmaceutically acceptable salt thereof in an enantiomeric purity of at least 95% in the reply filed on January 28, 2026 is acknowledged.
Claims 81-95 and 102-107 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on January 28, 2026.
Applicant’s election without traverse of Compound B:
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in the reply filed on January 28, 2026 is acknowledged.
Compound B is a compound of formula (Ia) wherein R1 and R2 are each hydrogen; R3 and R4 are each hydrogen; R5 is C3 alkyl, propyl; R6 is C4haloalkyl; and R7 and R8 are each independently hydrogen and C1alkyl.
Compound B has been found free of prior art. Thus, examination has been expanded to encompass the full scope of compounds of formula (Ia).
Claims 96-98 are presently under examination as they relate to the elected species:
Compound B and Compounds of Formula (Ia)
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Priority
The present application is a CON of US Application No. 17/542,908 filed on December 6, 2021, which is a CON of US Application No. 16/852,272 filed on April 17, 2020, which is a CON of US Application No. 16/391,686 filed on April 23, 2019, which is a CON of US Application No. 15/764,988 filed on March 30, 2018, which is a 371 of PCT/US16/54549 filed on September 29, 2016, which claims benefit of US Provisional Application No. 62/235,900 filed on October 1, 2015.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on January 12, 2024 and January 28, 2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner, except where marked with a strikethrough.
Drawings
Acknowledgement is made of the drawings received on May 2, 2023. These drawings are accepted.
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 96-98 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 10,292,971 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant claims are directed to a composition comprising a compound of Formula (Ia) in an enantiomeric purity of at least 95%:
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The previously granted claims are directed to a composition comprising a compound of of formula (I) including a compound of formula I(a):
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which is the same as the instantly claimed formula I(a) and
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which is the same as the instantly elected compound. The compounds of the previously granted claims have the same stereochemistry as the instantly claimed compounds. It would have been prima facie obvious to one of ordinary skill in the art to arrive at a composition comprising a compound of Formula (Ia) and no other stereoisomers (i.e. enantiomeric purity of 100%) from the previously granted claims with a reasonable expectation of success since the previously granted claims are directed to compounds having this specific stereochemistry.
Claims 96-98 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 10,624,878 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant claims are directed to a composition comprising a compound of Formula (Ia) in an enantiomeric purity of at least 95%:
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The previously granted claims are directed to method of treating a subject suffering from a cancer comprising administering a compound of formula (I) including:
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which is the same as the instantly elected compound. The compounds of the previously granted claims have the same stereochemistry as the instantly claimed compounds. Moreover the copending claims teach administering the claimed compounds in combination with an anti-cancer agent. It would have been prima facie obvious to one of ordinary skill in the art to arrive at a composition comprising a compound of Formula (Ia) and no other stereoisomers (i.e. enantiomeric purity of 100%) from the previously granted claims with a reasonable expectation of success since the previously granted claims are directed to compounds having this specific stereochemistry.
Claims 96-98 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,229,630 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant claims are directed to a composition comprising a compound of Formula (Ia) in an enantiomeric purity of at least 95%:
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The previously granted claims are directed to method of preventing recurrence of a cancer comprising administering a compound of of formula (I) including a compound of formula I(a):
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which is the same as the instantly claimed formula I(a) and
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which is the same as the instantly elected compound wherein the compounds are administered as an adjunctive therapy. The compounds of the previously granted claims have the same stereochemistry as the instantly claimed compounds. It would have been prima facie obvious to one of ordinary skill in the art to arrive at a composition comprising a compound of Formula (Ia) and no other stereoisomers (i.e. enantiomeric purity of 100%) from the previously granted claims with a reasonable expectation of success since the previously granted claims are directed to compounds having this specific stereochemistry.
Conclusion
Claims 96-98 are rejected.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAYNA B RODRIGUEZ whose telephone number is (571)272-7088. The examiner can normally be reached 8am-5:00pm, Monday - Thursday.
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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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/Rayna Rodriguez/ Primary Examiner, Art Unit 1628
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