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 1-15 are pending in the present application file.
Election/Restrictions
Applicant’s election of Group I (claims 1-4; directed to compound represented by Formula (I), or a pharmaceutically acceptable salt thereof) and a species of instant formula (I) without traverse in the reply filed August 17, 2026 is acknowledged.
As per MPEP 803.02, the examiner will determine whether the entire scope of the claims is patentable. Applicants' elected species of present 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species found not allowable, the Markush-type claim shall be rejected and claims to the nonelected invention held withdrawn from further consideration.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 35 U.S.C. 102, which are not allowable.
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has been found not allowable, the Markush-type claims have been rejected and claims to the nonelected invention held withdrawn from further consideration.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 1-4 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subject matter not embraced by the elected embodiment or the above identified nonelected species is therefore withdrawn from further consideration.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 5-15 do not read on the presently searched and examined subject matter. Therefore, claims 5-15 are withdrawn from consideration by the Examiner under 37 CFR 1.142(b) as being drawn to a non-elected invention.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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Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The Information Disclosure Statement(s) filed June 24, 2024 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.
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.
Claims 1-4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAS Registry No. 1630155-58-6 (which entered STN October 27, 2014).
CAS Registry No. 1630155-58-6 is drawn to 1,1-Dimethylethyl N-[4-[[4-[(5-chloro-2-benzoxazolyl)amino]phenyl]amino]-4-oxobutyl]carbamate which has the following structure:
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CAS Registry No. 1630155-58-6 corresponds to a compound of Formula (I) where X is CR1, R1 is hydrogen, R2 is hydrogen, R3 is hydrogen, R4 is halogen (chloro), R5 is hydrogen, R6 is hydrogen, R7 is hydrogen, R8 is hydrogen and R9 is tert-butoxycarbonylaminopropylcarbonylamino. See instant claims 1-3. CAS Registry No. 1630155-58-6 corresponds to compound 64 of instant claim 4; tert-butyl 4-(4-(5-chlorobenzo[d]oxazol-2-ylamino)phenylamino)-4-oxobutylcarbamate.
Claims 1-4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAS Registry No. 2335569-99-6 (which entered STN June 19, 2019).
CAS Registry No. 2335569-99-6 is drawn to 5-fluoro-N-(3-nitrophenyl)-1,3-benzoxazol-2-amine which has the following structure:
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CAS Registry No. 2335569-99-6 is drawn to a compound of Formula (I) where X is CR1, R1 is hydrogen, R2 is hydrogen, R3 is hydrogen, R4 is halogen (fluoro), R5 is hydrogen, R6 is hydrogen, R7 is hydrogen, R8 is hydrogen and R9 is nitro. See instant claims 1-3. CAS Registry No. 2335569-99-6 corresponds to compound 2 of instant claim 4.
Claims 1-4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Huaiqing (Zhao, Huaiqing, et al. "Copper‐Catalyzed Intermolecular Amination of Acidic Aryl C H Bonds with Primary Aromatic Amines." Advanced Synthesis & Catalysis 352.8 (2010): 1301-1306.).
The prior art teaches compound 7g as 2-(4-Nitrophenylamino)-5-chloro-benzoxazole having the following structure:
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This compound is embraced by the instant variables of formula (I) where X is CR1, R1 is hydrogen, R2 is hydrogen, R3 is hydrogen, R4 is halogen (chloro), R5 is hydrogen, R6 is hydrogen, R7 is hydrogen, R8 is hydrogen and R9 is nitro. See instant claims 1-3. Compound 7g of the prior art corresponds to compound 8 of instant claim 4.
Claims 1-4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAS Registry No. 218622-16-3 (which entered STN January 29, 1999).
CAS Registry No. 218622-16-3 is drawn to 6-Chloro-N-(2-methoxy-4-nitrophenyl)-2-benzoxazolamine which has the following structure:
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CAS Registry No. 218622-16-3 is drawn to a compound of Formula (I) where X is CR1, R1 is hydrogen, R2 is hydrogen, R3 is hydrogen, R4 is halogen (chloro), R5 is hydrogen, R6 is hydrogen, R7 is C1 alkoxy (methoxy), R8 is hydrogen and R9 is nitro. See instant claims 1-3. CAS Registry No. 218622-16-3 corresponds to compound 10 of instant claim 4.
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 1-4 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over at least claims 1, 3 and 8 of copending Application No. 19/115,423 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they are drawn to the same subject matter.
Claim 1 of the ‘423 application teaches a compound represented by the following Formula 1, or a pharmaceutically acceptable salt thereof:
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.
Claim 3 of the ‘423 teach the compound of Formula 1 of the ‘423 where the compound includes compound 11, tert-butyl 4-(3-methoxy-4-(5-methylbenzo[d]oxazol-2-ylamino)phenylamino)-4-oxobutylcarbamate, compound 13, tert-butyl 4-(4-(5-tert-butylbenzo[d]oxazol-2-ylamino )-3-methoxyphenylamino)-4-oxobutylcarbamate, and compound 24, 4-amino-N-(3-methoxy-4-(5-methoxybenzo[d]oxazol-2-ylamino)phenyl)butanamide. Compounds 11, 13 and 24 of claim 3 of the ‘423 application correspond to compounds 66, 65 and 67 of claim 4 of the instant application, respectively.
Compound 10 of claim 8 of the ‘423 application also corresponds to compound 66 of claim 4 of the instant application. Compound 11 of claim 8 of the ‘423 application also corresponds to compound 65 of claim 4 of the instant application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1-4 are rejected.
Claims 5-15 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.
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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
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