DETAILED ACTION
Notice of 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 .
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 1/12/2026 is acknowledged. The requirement is still deemed proper and is therefore made FINAL.
Claims 20, 22-26, 29, 30-31, 33 and 35 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Applicant’s election without traverse of a single species in the reply filed on 1/12/2026 is also acknowledged.
The elected species read upon claims 1-3, 6 and 41. Claims 8-9, 13-14 and 16-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, 6 and 41 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nimmagadda et al (WO 2018/119313; of record).
Claims 1-3 are drawn to an imaging agent comprising a compound of formula (I) which embraces the following non-elected compound species:
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344
542
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wherein, in formula (I):
L is
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92
132
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wherein r is 2 (see claim 2); and A is the chelating agent NODA (1,4,7-triazacyclononane-1,4-diacetate) (see claim 3); or
L is
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100
128
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wherein q is 2 (see claim 2); and A is
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146
138
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(see claim 3).
Nimmagadda et al teach the instantly claimed compound as DK-A-222 (Figure 30).
Accordingly, claims 1-3 are anticipated.
Claim 6 is drawn to the imaging agent of claim 1, wherein the reporting moiety is a chelating agent and the chelating agent further comprises the radiometal 64Cu.
Nimmagadda et al teach [64Cu]DK-A-222 (Figure 31).
Accordingly, claim 6 is also anticipated.
Claim 41 is drawn to a kit for detecting PD-L1, the kit comprising the imaging agent of any of claims 1-3 and/or 6.
Nimmagadda et al teach “a kit for detecting Programmed Death Ligand 1 (PD-L1), the kit comprising an imaging agent” (Page 4, Lines 1-3), in particular “a presently disclosed imaging agent” (Page 29, Lines 32-33).
Accordingly, claim 41 is also anticipated.
Claim Rejections - 35 USC § 103
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.
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 1-3, 6 and 41 are rejected under 35 U.S.C. 103(a) as being unpatentable over Nimmagadda et al (WO 2018/119313; of record) in view of Shetty et al (Bioorg Med Chem 20:5941-5947, 2012).
Claims 1-3 and 6 are drawn to an imaging agent comprising a compound of formula (I) which embraces Applicant’s elected compound species:
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400
676
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wherein, in formula (I):
L is
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90
170
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wherein p is 1 (see claim 2); and A is the chelating agent NODA (1,4,7-triazacyclononane-1,4-diacetate) (see claim 3) further comprising the radiometal Al18F (see claim 6).
Nimmagadda et al teach “an imaging agent comprising a conjugate of a peptide having binding specificity for programmed death ligand 1 (PD-L1) and a reporting moiety, and optionally a linker” (Page 2, Lines 18-20), specifically disclosing the imaging agents DK-A-222 (Figure 30) and [64Cu]DK-A-222 (Figure 31), which differ from Applicant’s instantly elected compound in comprising a different linker and a different radiometal.
Yet, as further taught by Nimmagadda et al, “[i]n some embodiments, the substrate is labeled with 18F using the AlF method, for example, based on the chelation of aluminum fluoride by... NODA” (Page 19, Lines 15-17).
And Shetty et al teach “a bifunctional chelating agent containing isothiocyanate residue for one step F-18 labeling of peptides” (Title) as follows (Page 5942, Scheme 1):
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222
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which “can be conjugated to a target molecule containing an amino functional group under weak basic conditions by way of thiourea bond formulation” (Abstract). As further taught by Shetty et al, “[t]he conjugated peptide was labeled with the [18F]AlF method with high radiochemical efficiency” and “[b]iodistribution and microPET imaging studies... showed significant uptakes of the labeled peptide” (Page 5944, Column 1), specifically disclosing an Al18F-NODA-peptide as follows (Page 5943, Scheme 2):
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Based on all of the foregoing, it would have been prima facie obvious to formulate Applicant’s instantly elected compound species. In particular, it would have been prima facie obvious to modify DK-A-222 and/or [64Cu]DK-A-222 (taught by Nimmagadda et al) such that the peptide is labeled with the [18F]AlF method to comprise Al18F-NODA-peptide (based on Nimmagadda et al and Shetty et al) to arrive at the instantly elected compound species with a reasonable expectation of success. The simple substitution of one known radiolabeled chelating agent useful in peptide-specific PET imaging agents for another is prima facie obvious.
As such, claims 1-3 and 6 are rejected as prima facie obvious.
Claim 41 is drawn to a kit for detecting PD-L1, the kit comprising the imaging agent of any of claims 1-3 and/or 6.
Nimmagadda et al teach “a kit for detecting Programmed Death Ligand 1 (PD-L1), the kit comprising an imaging agent” (Page 4, Lines 1-3), in particular “a presently disclosed imaging agent” (Page 29, Lines 32-33).
Accordingly, claim 41 is also rejected as prima facie obvious.
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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-3, 6 and 41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-44 of U.S. Patent No. 11/607,466 alone or in view of Shetty et al (Bioorg Med Chem 20:5941-5947, 2012).
Although the claims at issue are not identical, they are not patentably distinct from each other. The ‘466 claims are drawn to compounds of DK-A-221-(L)n-Rpt (claim 1), including DK-A-222 (claim 7) and [64Cu]DK-A-222 (claim 8) and a kit thereof (claim 24), which reads on the instantly claimed compounds and wherein, in further view of Shetty et al, it would have been obvious to arrive at Applicant’s elected compound species.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to whose telephone number is (571) 270-5864. The examiner can normally be reached on Monday through Thursday, and every other Friday, 7:30 am - 5:00 pm ET. 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, Bethany Barham can be reached on (571) 272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CRAIG D RICCI/Primary Examiner, Art Unit 1611