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 .
Response to Amendment
The amendment filed 4/16/2025 has been entered.
Response to Arguments
Applicant’s argument that claims 54, 78 and 79 should not be withdrawn is found persuasive and these claims have been rejoined herein.
Any previous rejection not reiterated herein has been withdrawn.
New Grounds of Rejection
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 7, 9, 11, 54, 78 and 79 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12258339 in view of Wilson WO 2018/183906.
The ‘339 patent, in claim 1, discloses a species that is directly within the scope of the instant claims, for example, see claim 9 of the instant invention.
The only difference is that the instant claims are complexed with a radiometal.
However, complexing these types of macrocyclic ligands with a radiometal is well known as shown by Wilson ‘906, see abstract and entire document. The complexing of these ligands with a radiometal provides the advantage of making them useful for radiotherapy, see at least para. [0070].
It would have been obvious to one or ordinary skill in the art to conjugate the ligand of claim 1 of the US12258339 patent with a radiometal since it is well known in the art that this is a main purpose of such ligands to provide for useful radiotherapeutic agents as disclosed by Wilson.
Conclusion
No claims are allowed at this time.
It is noted that at least 11279698 and 12103922 were considered for obviousness-type double patenting but were not considered at this time due to the claims of these patents requiring a targeting ligand (i.e., antibody, etc.) that was restricted out of the originally filed claims in, for example, Group IV of the restriction filed 3/31/2024.
Also it is further noted that upon overcoming the double patenting rejection, (e.g., an appropriate terminal disclaimer is filed) all present claims depending on claim 7 will be rejoined as long as no new claims are added.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael G Hartley whose telephone number is (571)272-0616. The examiner can normally be reached 10-6:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Michener can be reached at 5712721424. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618