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
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 4/1/2026 has been entered.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objects are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Notes and Comments
No prior art was found against 4, 9-10, 13-16, 18-20, and 22.
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 4, 9-10, 13-16, 18-20, and 22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 9-21, and 26-31 of U.S. Patent No. 9,273,059. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to macrocycles comprising a chelating agent, a linker, a targeting agent, and optionally, a metal. The claims differ in that those of the patented invention are directed to a specific macrocycle structure whereas the instant invention is directed to one or more chelating agents, a linker groups, and a targeting moiety. While the patented invention does not specifically disclose that the teachings of the patented invention is directed to PSMA or LHRH ligands and a somatostatin receptor binding agent, it should be noted that peptides as taught in the patented invention, for example, include somatostatin receptor binding agents are art recognized peptides (see specification, page 6, paragraph 19). Also, page 47, paragraph 217 of the instant invention disclose that the targeting moieties includes peptides Likewise, PSMA ligands include peptides and peptidomimetics (see specification, page 2, paragraph 12). Thus, the skilled artisan would recognize that the instant invention encompasses the invention of the patented claims.
Applicant’s arguments have been fully considered but are not found persuasive. Regarding applicant’s argument that the position of L8 in the structure of U.S. Patent No. 9,273,059 is patentably distinct from present structure, the examiner’s response is that the position of L8 in the structure of U.S. Patent No. 9,273,059 is not patentably distinct from the present structure, as L8 is a substituted heteroalkyl (claim 1), which encompasses the present invention.
Claims 4, 9-10, 13-16, 18-20, and 22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 15, 16, 18-24 of U.S. Patent No. 8,507,199. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to macrocycles comprising a chelating agent, a linker, a targeting agent, and optionally, a metal. The claims differ in that those of the patented invention are directed to a specific macrocycle structure whereas the instant invention is directed to a chelating agent, a linker groups, a targeting moiety, and optionally, a metal. While the patented invention does not specifically disclose that the teachings of the patented invention is directed to PSMA or LHRH ligands and a somatostatin receptor binding agent, it should be noted that peptides as taught in the patented invention, for example, include somatostatin receptor binding agents are art recognized peptides (see specification, page 6, paragraph 19). Also, page 47, paragraph 217 of the instant invention disclose that the targeting moieties includes peptides. Likewise, PSMA ligands include peptides and peptidomimetics (see specification, page 2, paragraph 12). Thus, the skilled artisan would recognize that the instant invention encompasses the invention of the patented claims.
Applicant’s arguments have been fully considered but are not found persuasive. Regarding applicant’s argument that the position of L8 in the structure of No 8,507,199. is patentably distinct from present structure, the examiner’s response is that the position of L8 in the structure of U.S. Patent No. 8,507,199 is not patentably distinct from the present structure, as L8 is a substituted heteroalkyl (claim 1), which encompasses the present invention.
Claims 4, 9-10, 13-16, 18-20, and 22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 5-24 of U.S. Patent No. 10,273,256. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to macrocycles comprising a chelating agent, a linker, a targeting agent, and optionally, a metal. The claims differ in that those of the patented invention are directed to a specific macrocycle structure whereas the instant invention is directed to one or more chelating agents, a linker groups, and a targeting moiety. While the patented invention does not specifically disclose that the teachings of the patented invention is directed to PSMA or LHRH ligands and a somatostatin receptor binding agent, it should be noted that peptides as taught in the patented invention, for example, include somatostatin receptor binding agents are art recognized peptides (see specification, page 6, paragraph 19). Also, page 47, paragraph 217 of the instant invention disclose that the targeting moieties includes peptides.Likewise, PSMA ligands include peptides and peptidomimetics (see specification, page 2, paragraph 12). Thus, the skilled artisan would recognize that the instant invention encompasses the invention of the patented claims.
Applicant’s arguments have been fully considered but are not found persuasive. Regarding applicant’s argument that the position of B3 in the structure of U.S. Patent No. 10,273,256 is patentably distinct from present structure, the examiner’s response is that the position of B3 in the structure of U.S. Patent No. 10,273,256 is not patentably distinct from the present structure, as B3 is a substituted heteroalkyl (claim 1), which encompasses the present invention.
Conclusion
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL W DICKINSON whose telephone number is (571)270-3499. The examiner can normally be reached on M-F 9 AM to 7:30 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached on 571-272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PAUL W DICKINSON/Primary Examiner, Art Unit 1618
April 4, 2026