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 .
DETAILED ACTION
Claims 1-13 are pending in the present application file.
Election/Restrictions
Applicant’s election of Group I (claims 1-11; directed to compound of formula (I)) and a species of instant formula (I) as pictured below without traverse in the reply filed September 02, 2026 is acknowledged.
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As per MPEP 803.02, the examiner will determine whether the entire scope of the claims is patentable. Applicants' elected species of instant formula (I) appears free of the prior art. Therefore, according to MPEP 803.02: should the elected species be found allowable, the examination of the Markush-type claim will be extended. If the examination is extended and a non-elected species found not allowable, the Markush-type claim shall be rejected and claims to the nonelected invention held withdrawn from further consideration. The examination of the Markush-type claims has been extended to include the species cited below under non-statutory double patent as well as the species of instant claim 9, which 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.
As a non-elected species has been found not allowable, the Markush-type claims have been rejected and claims to the nonelected invention held withdrawn from further consideration. Claims 1-6 and 9-11 have been examined to the extent that they embrace and are readable on the elected embodiment and the above identified nonelected species. Since the nonelected species has been found not allowable, subject matter not embraced by the elected embodiment or the above identified nonelected species is therefore withdrawn from further consideration.
Claims 7-8 and 12-13 do not read on the presently searched and examined subject matter. Therefore, claims 7-8 and 12-13 are withdrawn from consideration by the Examiner under 37 CFR 1.142(b) as being drawn to a non-elected invention.
Priority
The following continuity data is acknowledged in the present application file:
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Information Disclosure Statement
The Information Disclosure Statement(s) filed 02/25/2026 and 09/02/2026 have been acknowledged by the Examiner. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the Examiner.
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 1-6 and 10-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over at least claim 1 and 8-10 of copending Application No. 18362034 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they are directed to the same subject matter.
Claim 1 of the ‘034 application discloses a compound of formula (I) as follows:
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Claim 8 of the ‘034 application teaches specific compound of formula (I) of the ‘034 application of
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, which corresponds to a compound of formula (I) wherein, A is pyridinyl substituted with one R2, R1 is methyl, and R2 is halo (fluorine) (see instant claims 1-4). This compound of claim 8 corresponds to a compound of instant formula (I-a) wherein A is pyridinyl substituted with one R2, R1 is methyl, and R2 is halo (fluorine) (see instant claim 5).
This compound of claim 8 of the ‘034 application corresponds to a compound of instant formula (I-c) wherein, R1 is methyl (see instant claim 6).
The claims of ‘034 application also teach pharmaceutically acceptable salts of the compounds of formula (I) of the ‘034 application (see end of claim 8 of the ‘034 application on page 7 as well claim 9 of the ‘034 application; see instant claim 10).
Claim 10 of the ‘034 application teaches “A pharmaceutical composition comprising one or more compounds according to claim 1, or pharmaceutically acceptable salts thereof, optionally together with one or more inert carriers and/or diluents” (see instant claim 11).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1-6 and 10-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over at least claims 1 and 8-10 of copending Application No. 18542910 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they are directed to the same subject matter.
Claim 9 of the ‘910 application teaches specific compound of
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, which corresponds to a compound of formula (I) wherein, A is pyridinyl substituted with one R2, R1 is H, and R2 is halo (fluorine) (see instant claims 1-4). This compound of claim 9 of the ‘910 application corresponds to a compound of instant formula (I-a) wherein A is pyridinyl substituted with one R2, R1 is F1-fluoro-C1 alkyl, and R2 is halo (fluorine) (see instant claim 5).
This compound of claim 9 of the ‘910 application corresponds to a compound of instant formula (I-c) wherein, R1 is H (see instant claim 6).
The claims of ‘910 application also teach pharmaceutically acceptable salts of the compounds of claim 9 of the ‘910 application (see end of claim 9 of the ‘910 application on page 13 as well claim 10 of the ‘910 application; see instant claim 10).
Claim 11 of the ‘910 application teaches “A pharmaceutical composition comprising one or more compounds according to claim 9, or pharmaceutically acceptable salts thereof, optionally together with one or more inert carriers and/or diluents” (see instant claim 11).
Claim 1-6 and 10-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over at least claims 1 and 8-10 of copending Application No. 18789818 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they are directed to the same subject matter.
Claim 1 of the ‘818 application discloses a compound of formula (I) as follows:
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Claim 8 of the ‘818 application teaches specific compound of formula (I) of the ‘818 application of
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, which corresponds to a compound of formula (I) wherein, A is pyridinyl substituted with one R2, R1 is F1-fluoro-C1 alkyl, and R2 is halo (fluorine) (see instant claims 1-4). This compound of claim 8 of the ‘818 application corresponds to a compound of instant formula (I-a) wherein A is pyridinyl substituted with one R2, R1 is F1-fluoro-C1 alkyl, and R2 is halo (fluorine) (see instant claim 5).
This compound of claim 8 of the ‘818 application corresponds to a compound of instant formula (I-c) wherein, R1 is F1-fluoro-C1 alkyl (see instant claim 6).
The claims of ‘818 application also teach pharmaceutically acceptable salts of the compounds of formula (I) of the ‘818 application (see end of claim 8 of the ‘818 application on page 11 as well claim 9 of the ‘818 application; see instant claim 10).
Claim 10 of the ‘818 application teaches “A pharmaceutical composition comprising one or more compounds according to claim 1, or pharmaceutically acceptable salts thereof, optionally together with one or more inert carriers and/or diluents” (see instant claim 11).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Allowable Subject Matter
Claim 9 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 1-6 and 10-11 are rejected.
Claim 9 is objected to.
Claims 7-8 and 12-13 are withdrawn.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUINCY A MCKOY whose telephone number is (703)756-4598. The examiner can normally be reached Monday - Thursday 8:00 - 6:00.
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, Jeffrey Murray can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/QUINCY A. MCKOY/
Patent Examiner, Art Unit 1626
/KAMAL A SAEED/Primary Examiner, Art Unit 1626
Prosecution Insights