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 11/11/2025 wherein claims 1 and 4-6 were amended; claims 2, 3, 7-11, 13, 15-30, 34, 37, 38, 40-45, 47-60, and 62-73 were canceled; and claim 79 was added.
Note(s): Claims 1, 4-6, 12, 14, 31-33, 35, 36, 39, 46, 61, and 74-79 are pending.
Priority
This application is a 371 of PCT/US2020/057198 filed 10/23/2020 and PCT/US2020/057198 claims benefit to PRO 62/924,997 filed 10/23/2019.
Note(s): The earliest effective filing date is 10/23/2020 as the pending invention is fully supported in PCT/US2020/057198.
Response to Applicant’s Amendment and/or Arguments
The Applicant's arguments and/or amendment filed 11/11/2025 to the rejection of claims 1-4, 7, 8, 12, 25, 31, 33, 35, and 75 made by the Examiner under 35 USC 102, 112, and/or improper Markush have been fully considered and deemed persuasive because Applicant amended the claims to overcome the rejections. Therefore, the said rejections are hereby WITHDRAWN.
Applicant’s Election
Once again, Applicant's election with traverse of Group I (claims 1-8, 12, 14, 25, 31-36, and 74-78) filed 5/14/2025 is acknowledged. The restriction requirement was still deemed proper and made FINAL.
Once again, it is noted that Applicant elected the following single disclosed species for initial examination:
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wherein R4 is copper-64, C4 is
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, AA-CP4 is Y-e-C-Hyp-Y(3-Cl)-G-L-C-H-I-q, y is 1, and z is 0. It was noted that no prior art was cited against the elected species. The search was expanded previously, prior art cited, and the claims amended to overcome that rejection. Thus, the search is once again extended. Prior art (see rejection below) is once again found and cited against the pending invention. As a result, the search was not extended beyond Koerner et al.
Withdrawn Claims
Claims 4, 12, 31-33, 36, 39, 46, 61, and 74-79 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention/species.
Information Disclosure Statement
The information disclosure statement filed 11/11/2025 was considered.
NEW GROUNDS OF REJECTIONS
103 Rejection
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 5, 6, 14, and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Koerner et al (US Patent No. 6,991,775) in view of Tornesello et al (Molecules, 2017, Vol. 22, No. 1282, pages 1-21).
Independent claim 1 is directed to compounds of formula
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wherein the variables are defined therein.
Claim 5 is directed to radioisotopes selected from technetium-99m, terbium-155, and lead-203.
Claim 6 is directed to radioisotopes selected from scandium-47, copper-67, yttrium-90, samarium-153, terbium-161, holmium-166, lutetium-177, rhenium-188, lead-212, bismuth-213, radium-223, actinium-225, and thorium-227.
Claim 14 is directed to various chelators including
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.
Claim 35 is directed to pharmaceutical compositions comprising compounds of claim 1.
Koerner et al is directed to peptides and peptide targeted contrast agents for radionuclide imaging. A single peptide can function both as a targeting group and a point of attachment for a chelate at the N- and C-terminus (see entire document, especially, abstract; column 2, lines 13-17). In particular, Koerner et al disclose SEQ ID No. 5 in column 3, line 7, which the same as Applicant’s SEQ ID No. 7 in claim 1, line 37 (see also column 40, lines 35-36; column 41, 18th species from the bottom of the page).
In column 8, the precursor chelate
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wherein L is a leaving group and R may be OH (see also column 50, line 1, second species). This structure corresponds to that in Applicant’s claim 1, line 13, third species when the leaving group leaves.
In column 13, lines 59-63, it is disclosed that metal ions may be selected from Mn(II) and III), Cu(II), and m Tb(III and IV). In column 33, lines 59-61, it is disclosed that one may have radionuclides selected from 90Y, 99mTc, 111In, 47Sc, 67Ga, 67Cu, 188Re, 177Lu, and 203Pb.
In column 32, lines 15-24, it is disclosed that the radionuclide contrast agents may have a chelator attached directly to both ends of the peptide (see also column 23, line 55; column 25, line 1). Pharmaceutical compositions comprising the compounds and pharmaceutically acceptable excipients, carriers, adjuvants, or vehicles may be generated (column 32, lines, 40-43; column 119, lines 16-21).
Koerner et al disclose that suitable peptides for use with their invention include those capable of specifically binding to the targets of vasoactive intestinal peptides (VIP) receptors, somatostatin receptors, chemotactic peptide receptors, bombesin, gastrin release peptide receptors, and integrin receptors. In addition, it is disclosed that the peptides may be used for tumor/cancer imaging (column 38, lines 25-42).
Thus, the difference between the pending invention and that of Koerner et al is that Koerner et al disclose that their compounds/compositions may be multimers since a chelator may be attached to both ends of the peptide.
Tornesello et al is directed to designing bioactive peptides and chelating agent for imaging and therapy in oncology (cancers/tumors). Chemical modifications alter the biological activity, the stability, and efficacy of peptide analogues employed as anti-cancer drugs or molecular imaging tracers (see entire document, especially, abstract). Also, modifications at the C- or N-terminus, multimerization, cyclization, and so forth are chemical modification that alter peptide properties (page 1, second complete paragraph).
In Figure 1, (page 2), Tornesello et al discos that a linear, multimeric, and cyclic peptide. It should be noted that while the peptide orientations vary (linear, multimeric, and cyclic), the components (nuclide, chelator, linker, and peptide) to generate the peptides are the same.
In Table 1 (pages 2-3), the various targeting receptors are disclosed. Those receptors, like that of Koerner et al, target somatostatin, VIP, gastrin, bombesin, RGD, and chemotactic receptors. Depending upon the desired purpose and target, the skilled artisan would be motivated to vary the spacer, chelator, radionuclide, or peptide (pages 2-3, Table 1 and pages 8-21).
While Koerner et al disclose that one may have a chelator on each end of the peptide present, it would have be obvious to one of ordinary skill in the art prior to the effective filing date of the pending invention to generate a non-multimeric peptide as well for the following reasons. (1) Koerner et al disclose that it is well known in the art to have a multimer comprising all the components (chelator, radionuclide, and peptide) of Applicant’s claimed invention. (2) Tornesello et al disclose that it is well known in the art to modify peptides depending upon the desired function/properties needed for a particular task. In addition, Tornesello et al disclose that multimers do not always result in a product with the best/most desired properties. Specifically, Tornesello et al disclose that mono-, di-, and trimeric conjugated αvβ6 integrins were synthesized. While the multimers improved αvβ6 integrin affinity, the multimers did not exhibit in superior tumor accumulation in PET scans and showed inferior pharmacokinetics compared to respective monomers (page 5, second complete paragraph). Thus, the skilled artisan would be motivated to generate a non-multimer peptide from a known multimer such as that disclosed by Koerner et al known to be effective for the same purpose as that of the prior art (tumor/cancer imaging and therapy).
Since both Koerner et al and Tornesello et al are directed to overlapping peptide populations that target cancers/tumors and chelators, the references may be considered to be within the same field of endeavor. Thus, the reference teachings are combinable.
For the reasons set forth herein, Koerner et al in combination with Tornesello et al render obvious the pending invention.
Comments/Notes
It should be noted that the full scope of Group I was not searched.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
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.
Conclusion
Claims 1, 5, 6, 14, and 35 are rejected and claims 4, 12, 31-33, 36, 39, 46, 61, and 74-79 are withdrawn.
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.
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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
March 4, 2026