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 .
Acknowledgments and Claim Status
The Examiner acknowledges receipt of the amendment filed 4/1/2026 wherein claims 1-13, 15-66, 68, 70, 85, and 87 were canceled and the specification and claims 14, 67, 69, 71-84, 86, and 88-90 were amended. In addition, the Examiner acknowledges receipt of the amendment filed 12/19/2025.
Note(s): Claims 14, 67, 69, 71-84, 86, and 88-90 are pending.
The Examiner acknowledges the replacement drawing filed 4/1/2026.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 1/20/2026 has been entered.
Priority
This application is a CON of 16/179,817 filed 11/2/2018 (now US Patent No. 11,857,648); 16/179,817 is a CON of PCT/US2017/030662 filed 5/2/2017;
PCT/US2017/030662 claims benefit to PRO 62/373,036 filed 8/10/2016;
PCT/US2017/030662 claims benefit to PRO 62/346,783 filed 6/7/2016; and
PCT/US2017/030662 claims benefit to PRO of 62/330,622 filed 5/2/2016.
Note(s): The pending invention is fully supported by provisional application 62/330,622. Thus, the earliest benefit date is 5/2/2016.
Response to Applicant’s Arguments and/or Amendment
The Applicant's arguments and/or amendment filed 4/1/2026 to the rejection of claims 14, 71-84, 86, and 88-90 made by the Examiner under 35 USC 112 first and second paragraphs have been fully considered and deemed persuasive because Applicant amended the claims to overcome the rejections. Therefore, the said rejections are hereby WITHDRAWN.
Rejoining of Claims
Claims 14, 69, 71-84, 86, and 88-90 are directed to an allowable product (Note(s): Applicant has to address the double patenting rejections below). Pursuant to the procedures set forth in MPEP § 821.04(B), claim 67, directed to the process of making or using an allowable product, previously withdrawn from consideration as a result of a restriction requirement, is hereby rejoined and fully examined for patentability under 37 CFR 1.104.
Because all claims previously withdrawn from consideration under 37 CFR 1.142 have been rejoined, the restriction requirement as set forth in the Office action mailed on 1/7/2025 is hereby withdrawn. In view of the withdrawal of the restriction requirement as to the rejoined inventions, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
NEW GROUNDS OF REJECTIONS
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.
Claims 14, 67, 69, and 73-80 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 12,029,798. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to compounds comprising a first and second peptides each conjugated to a spacer and chelator. In addition, the claims disclosed overlapping peptides that may be conjugated thereto (see patented claim 1). While the pending claims use the terminology “chelator”, the patented claims use “bioorthogonal ligation moiety” which as indicated by Richter et al (Nature Chemistry, 2023, Vol. 15, pages 1422-1430) are known in the art as the component that enables carbonyl and alkyne functionalized amino acids to interact (Richter et al, page 1422, left and right columns, bridging paragraph). Also, according to Richter et al, tetrazine conjugation may be applied to produce a radiolabel chelator-target complex (page 1422, abstract). In addition, both invention allow for the presence of a detectable label (see patented claim 3) and active agents (see patented claims 7). The patented claims do not exclude the presence of a spacer group which may be CH2, carboxyl, or alkyne moiety attached between the chelator and peptide. Thus, the skilled artisan would recognize that the inventions disclose overlapping subject matter.
In regards to the method of imaging (pending claim 67), the skilled artisan would recognize that the presence of a detectable moiety (see patented claims 3, 8, and 9) that are identical to those in pending claim 77 (e.g., 68Ga, 18F, 67Cu, 177Lu, 90Y, 212Bi, 131I, 211At, 225Ac, 188Re, and 111In) inherently indicates that the compound may be used for imaging purposes like the pending invention.
For the reasons set forth herein, the inventions disclose overlapping subject matter.
Claims 14, 67, 69, 75-79, 81-84, and 88-90 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 11-13, and 15-21 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 delivery compounds comprising bioorthogonal ligation moieties, at least two active agents, at least two spacers, and a detectable moiety (e.g., radionuclide). The claims differ in that the copending application is not limited to a PEG spacer. In addition, the copending invention discloses overlapping radionuclides (e.g., 68Ga, 18F, 67Cu, 177Lu, 90Y, 212Bi, 131I, 211At, 225Ac, 188Re, and 111In) which inherently indicates that the compound may be used for imaging purposes like the pending invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Objections
Claims 71, 72, and 86 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Information Disclosure Statement
The information disclosure statements filed 3/3/2026 and 3/20/2026 were considered.
Comments/Notes
For clarity of claim 67, it is respectfully suggested that Applicant insert “and generating an imaging” at the end of the claim (before the period).
It should be noted that no prior art is cited against the pending invention. However, Applicant must address and overcome the double patenting rejections supra. In particular, the claims are distinguished over the prior art because the prior art neither anticipates nor renders obvious a multivalent drug delivery compound comprising a first peptide-spacer-chelator complex with a second peptide-spacer bound thereto wherein the first and second peptides bind different biomarkers. The closest art is Applicant’s own work (US Patent No. 11,857,648 and 12,029,798).
Conclusion
Claims 14, 67, 69, 73-84, and 88-90 are rejected. Claims 71, 72, and 86 are objected.
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 23, 2026
Prosecution Insights