DETAILED ACTION
1. 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
2. Information Disclosure Statements filed 4/9/2025 and 6/25/2026 are acknowledged.
DOUBLE PATENTING
3. 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 132-251 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-31 of U.S. Patent No. 11759425. Although the claims at issue are not identical, they are not patentably distinct from each other because both are drawn to methods for treating pulmonary hypertension by administering a dry powder composition containing Treprostinil prodrug. The difference being R1 is a tetradecyl, pentadecyl hexadecyl heptadecyl or octadecyl in the instant application whereas it was hexadecyl in the ‘425 patent which overlaps in scope.
Claims 132-251 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12201725. Although the claims at issue are not identical, they are not patentably distinct from each other because both are drawn to a dry powder composition containing Treprostinil prodrug. The difference being the instant case uses the composition is for a method of treating pulmonary hypertension by administration of the composition. The same composition is used for the treatment which is accomplished via administering the composition.
Claims 132-251 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-48 of U.S. Patent No. 11458098. Although the claims at issue are not identical, they are not patentably distinct from each other because both are drawn to a dry powder composition containing Treprostinil prodrug. The difference being the instant case further recites a weight ratio of the DSPE-PEG2000 to the compound of formula I. The amounts of the compound of Formula I and the DSPE-PEG2000 overlap.
Claims 132-251 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-48 of U.S. Application 18513377. Although the claims at issue are not identical, they are not patentably distinct from each other because both are drawn to a dry powder composition containing Treprostinil prodrug. The claimed subject matter in the instant application is fully disclosed in the ‘377 application. The difference being the instant case recites 0.1 wt % to 3 wt % of the compound of Formula I which overlaps with the wt % of the copending application. Furthermore, hexadecyl is defined as R1 and the leucine is in overlapping amounts.
Claims 132-251 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-48 of U.S. Patent 9469600. Although the claims at issue are not identical, they are not patentably distinct from each other because both are drawn to a composition containing Treprostinil prodrug. The difference being the instant case recites methods of treatment however, the ‘600 patent overlaps in scope as it is drawn to a composition comprising PEGylated lipid compound which overlaps with the compound of Formula I of the instant application.
Claims 132-251 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent 9255064. Although the claims at issue are not identical, they are not patentably distinct from each other because both are drawn to a composition containing Treprostinil prodrug. The claimed subject matter in the instant application is fully disclosed in the ‘064 patent. The difference being the instant case recites methods of treatment however, the ‘064 patent overlaps in scope as it is drawn to a composition comprising prostacyclin compound which overlaps with the compound of Formula I of the instant application.
Claims 132-251 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-107 of U.S. Patent 10010518. Although the claims at issue are not identical, they are not patentably distinct from each other because both are drawn to a composition containing Treprostinil prodrug. The claimed subject matter in the instant application is fully disclosed in the ‘518 patent. Both are drawn to methods of treating pulmonary hypertension via administration of a composition containing compound that is formula II in the ‘518 patent and Formula I in the instant application.
Claims 132-251 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-41 of U.S. Patent 10526274. Although the claims at issue are not identical, they are not patentably distinct from each other because both are drawn to a composition containing Treprostinil prodrug. The claimed subject matter in the instant application is fully disclosed in the ‘274 patent. Both are drawn to a method of treating pulmonary disorder (hypertension vs fibrosis) via administration of a composition containing compound that is formula II in the ‘274 patent and Formula I in the instant application.
Claims 132-251 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-41 of U.S. Patent 10995055. Although the claims at issue are not identical, they are not patentably distinct from each other because both are drawn to a composition containing Treprostinil prodrug. The claimed subject matter in the instant application is fully disclosed in the ‘055 patent. Both are drawn to methods of treating pulmonary hypertension via administration of a composition containing compound that is formula II in the ‘055 patent and Formula I in the instant application.
Claims 132-251 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-41 of U.S. Patent 11795135. Although the claims at issue are not identical, they are not patentably distinct from each other because both are drawn to a composition containing Treprostinil prodrug. The claimed subject matter in the instant application is fully disclosed in the ‘135 patent. Both are drawn to methods of treating pulmonary hypertension via administration of a composition containing compound that is formula II in the ‘135 patent and Formula I in the instant application.
Claims 132-251 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-48 of U.S. Patent 11759425. Although the claims at issue are not identical, they are not patentably distinct from each other because both are drawn to methods for treating pulmonary hypertension containing Treprostinil prodrug. The claimed subject matter in the instant application is fully disclosed in the ‘425 patent. The difference being the instant case recites 0.1 wt % to 3 wt % of the compound of Formula I which overlaps with the wt % of the copending patent. Furthermore, hexadecyl is defined as R1 and the leucine is in overlapping amounts.
Claims 132-251 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-48 of U.S. Patent 12201725. Although the claims at issue are not identical, they are not patentably distinct from each other because both are drawn to a composition containing Treprostinil prodrug. The claimed subject matter in the instant application is fully disclosed in the ‘725 patent. The difference being the instant case recites methods of treatment however, the ‘725 patent overlaps in scope as it is drawn to a composition comprising prostacyclin compound which overlaps with the compound of Formula I of the instant application.
Claims 132-251 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 226, 229-230, 232, 235-242, 245-247, 249-250, 254-256 and 262 of U.S. Application No. 18513377. Although the claims at issue are not identical, they are not patentably distinct from each other because both are drawn to a method for treating pulmonary hypertension containing Treprostinil prodrug. The claimed subject matter in the instant application is fully disclosed in the ‘377 application. Both are drawn to method of treating pulmonary hypertension via administration of a composition containing compound that is formula I. The claimed amounts of the prostacyclin compound and leucine overlap.
CORRESPONDENCE
4. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Danah Al-awadi whose telephone number is (571) 270-7668. The examiner can normally be reached on 9:00 am - 6:00 pm; M-F (EST).
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Robert A. Wax can be reached on (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANAH AL-AWADI/ Primary Examiner, Art Unit 1615
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