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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 9/17/24 was filed in a timely manner. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being 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, 2, 6, 7, 8, 10, 14-16, 18, 19, 23-27, rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 9, 12-14, 16-23 of U.S. Patent No. 11,654,115. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to a tablet for peroral administration of N-butyloxycarbonyl-3-(4-imidazol-l-ylmethylpehnyl)-5-iso-butylthiophene-2-sulfonamide as the sole active agent in the formulation and an enteric coating. The formulation is essentially salt free and comprises the same salts and can also be used to treat the same conditions including pulmonary fibrosis. The claims differ in the scope in the at the instant claims recite specific excipients an carriers, while the 115 claims are of broader scope not reciting specific carriers, however they do recite broader enteric polymers for use in the coating. The claims would render each other obvious and cannot be allowed together.
Claims 1, 2, 6, 14, 18, 19, 23 and 27 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 6, 15 and 16 of U.S. Patent No. 12,121,614. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims recite a method for treating pulmonary fibrosis comprising administering to the gastrointestinal tract a peroral formulation comprising N-butyloxycarbonyl-3-(4-imidazol-l-ylmethylpehnyl)-5-iso-butylthiophene-2-sulfonamide as the sole active agent in the formulation. The claims overall in scope in that the 614 claims recite a range for the active agent awhile the instant claims are silent, however the optimization of workable ranges would have been obvious to those of ordinary skill in the art. For these reason, the claims would act as obviating art over each other and cannot be allowed together.
Claims 1-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 12,605,341. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to a pharmaceutical formulations comprising N-butyloxycarbonyl-3-(4-imidazol-l-ylmethylpehnyl)-5-iso-butylthiophene-2-sulfonamide as the sole active agent in the formulation. The claims both recite similar carriers and excipients as well as enteric polymers for the coating. The claims differ in that the instant claims recite a broader range of particle sizes, though the scopes overlap and would render each other obvious. The claims cannot be allowed together.
Claim 1-6, 9-12 and 15-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-18 of copending Application No. 19/331,702 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to a pharmaceutical formulations comprising N-butyloxycarbonyl-3-(4-imidazol-l-ylmethylpehnyl)-5-iso-butylthiophene-2-sulfonamide as the sole active agent in the formulation. The claims both recite similar carriers and excipients as well as enteric polymers for the coating. The claims differ in that the instant claims recite a broader range of particle sizes, though the scopes overlap and would render each other obvious. The claims cannot be allowed together.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 19/575,135 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to a pharmaceutical formulations comprising N-butyloxycarbonyl-3-(4-imidazol-l-ylmethylpehnyl)-5-iso-butylthiophene-2-sulfonamide as the sole active agent in the formulation. The claims differ in that the instant claims recite a broader range of particle sizes, though the scopes overlap and would render each other obvious. The claims cannot be allowed together.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Vicore et al (WO 2016/139475) discloses an oral dosage form comprising Compound 21 in gelatin capsules.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICAH PAUL YOUNG whose telephone number is (571)272-0608. The examiner can normally be reached Monday through Friday, 9:00 am to 5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached at 5712720616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICAH PAUL YOUNG/Primary Examiner, Art Unit 1618
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