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 .
Acknowledgment and Claim Status
The Examiner acknowledges receipt of the amendment filed 5/27/2026 wherein claims 1, 5, 8-11, and 21 were amended and claim 14 was canceled.
Note(s): Claims 1-13 and 15-21 are pending.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 5/27/2026 has been entered.
Priority
This application is a DIV of 16/179,785 filed 11/2/2018 (now US Patent No. 12,029,798);
16/179,785 is a CON of PCT/US2017/030652 filed 5/2/2017;
PCT/US2017/030652 claims benefit to PRO 62/373,036 filed 8/10/2016;
PCT/US2017/030652 claims benefit to PRO 62/346,783 filed 6/7/2016; and PCT/US2017/030652 claims benefit to PRO 62/330,622 filed 5/2/2016.
Note(s): The earliest effective filing date is 5/2/2016 as the invention is fully supported by provisional application 62/330,622.
Response to Applicant’s Amendment and/or Arguments
Applicant's arguments and/or amendment filed 5/27/2026 to the rejection of claims 1-3, 5-8, 10-13, and 15-21 made by the Examiner under 35 USC 103 and/or double patenting have been fully considered and deemed persuasive-in-part for the reasons set forth below.
103 Rejection
The claims were amended to overcome the 103 rejection. Thus, the rejection is WITHDRAWN.
Double Patenting Rejections
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.
(I) Claims 1-13 and 15-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14, 69, 70-84, 86, and 88-90 of copending Application No. 18/515,076 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to at least one biorthogonal ligation moieties, at least one active agent, a polymer spacer, and a radionuclide as set forth in pending independent claim 1. The claims differ in that the copending claims (see independent claim 1) are not limited to a particular polymer spacer or any particular biorthogonal ligation or active agent. Thus, the claims of the copending application are encompassed by the instant invention. Copending claim 69 discloses a biorthogonal ligation moiety. Copending claims 75 and 77-80 discloses active agents. Copending claim 77 discloses radionuclides. Copending claim 82 disclose a spacer (e.g., polyethylene glycol). Thus, the inventions disclose overlapping subject matter.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
APPLICANT’S ASSERTION
Applicant has requested that the double patenting rejection be held in abeyance until allowable subject matter is identified.
EXAMINER’S RESPONSE
The Examiner acknowledges the request that the double patenting rejection be held in abeyance. The double patenting rejection is still deemed proper.
(II) Claims 1-13 and 15-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 11,857,648. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to a compound comprising at least one biorthogonal ligation moiety, at least one active agent, a polymer spacer, and a radionuclide. The claims differ in that the patented invention (see claims 1, 2, and 6) does not disclose all of the biorthogonal moieties in pending claim 1. However, the specific structure disclosed in patented claim 1 is a biorthogonal litigation moiety like the pending invention. Thus, the inventions disclose overlapping subject matter as the patented invention is not limited to a particular bioorthogonal ligation moiety.
APPLICANT’S ASSERTION
Applicant has requested that the double patenting rejection be held in abeyance until allowable subject matter is identified.
EXAMINER’S RESPONSE
The Examiner acknowledges the request that the double patenting rejection be held in abeyance. The double patenting rejection is still deemed proper.
Comments/Notes
The full scope of the pending invention was searched. It should be noted that no prior art is cited against the pending invention. In particular, the prior art neither anticipates nor renders obvious compositions as set forth in the pending invention. The closest art is that of Rahim et al (Bioconjugate Chem., 2015, Vol. 26, pages 352-360) which was cited in the previous office action. However, the pending claims were amended to overcome Rahim et al.
Conclusion
Claims 1-13 and 15-21 are rejected.
Future Correspondences
Any inquiry concerning this communication or earlier communications from the examiner should be directed to D L Jones whose telephone number is (571)272-0617. The examiner can normally be reached M-F.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael G. Hartley can be reached at (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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/D. L. Jones/
Primary Patent Examiner
Art Unit 1618
June 27, 2026
Prosecution Insights