DETAILED ACTION
This Office action details a final action on the merits for the above referenced application No. Claims 1-5, 7-18, and 23-24 are pending in this application.
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 .
Status of Claims
Claims 1-3 are amended. Claims 6, 19-22, and 25-26 are cancelled.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 7 Jan. 2026 has been considered by the examiner.
Response to Amendment
The amendments filed on 14 Jan. 2026 have been entered.
Response to Arguments
In view of Applicants amendments, the rejection of claim 2 under 35 USC 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter is withdrawn.
In view of Applicants amendments, the rejection of claims 1-3, 6-11, 13-18, and 23-24 under 35 USC 102(a)(1) as being anticipated by Kelly et al. (Mol. Pharmaceutics; published 14 Apr. 2020) is withdrawn.
In view of Applicants amendments, the rejection of claims 1-3, 11, and 15-18 under 35 USC 102(a)(1) as being anticipated by Ponnala et al. (J. Nucl. Med.; published 1 May 2019) is withdrawn.
In view of Applicants amendments, the rejection of claims 1-3, 11, 16-18, and 23-24 under 35 USC 103 as being unpatentable over Zeisler et al. (WO 2019/222851 A1; published 28 Nov. 2019) is withdrawn.
In view of Applicants amendments, the rejection of claims 1-18 and 23-24 under 35 USC 103 as being unpatentable over Babich et al. (WO 2018/187631 A1; published 11 Oct. 2018), in view of Donnelly et al. (WO 2010/063069 A1; published 10 Jun. 2010) and Zeglis et al. (US 2016/0331852 A1; published 17 Nov. 2016) is withdrawn.
In view of Applicants amendments, the rejection of claims 1-3, 6-18, and 23-24 under 35 USC 103 as being unpatentable over Babich et al. (WO 2018/187631 A1; published 11 Oct. 2018), in view of Donnelly et al. (WO 2010/063069 A1; published 10 Jun. 2010) and Ponnala et al. (J. Nucl. Med.; published 1 May 2019) is withdrawn.
New Grounds of Rejection
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 15 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Instant claim 15 depends to claim 1 and claim 15 requires that the sarcophage-containing domain chelates 64Cu+2 or 67Cu2+; however, claim 1 does not allow for a metal complexes wherein the sarcophage-containing domain chelates a metal including one of 64Cu+2 or 67Cu2+. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. The Examiner suggests amending claim 15 to recited “further chelates”.
Claim Rejections - 35 USC § 103
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.
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.
Claim(s) 1-3, 7-18, and 23-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Babich et al. (WO 2018/187631 A1; published 11 Oct. 2018; see IDS filed on 31 Oct. 2022), in view of Donnelly et al. (WO 2010/063069 A1; published 10 Jun. 2010) and Berkman et al. (WO 2018/098390 A1; published 31 May 2018; see IDS filed on 7 Jul. 2026).
Babich et al. teach trifunctional constructs with tunable pharmacokinetics useful in imaging and anti-tumor therapies (see title). Babich et al. teach compounds for the treatment of for example prostate cancer (see abstract). Babich et al. teach the compound RPS-063 of the formula
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wherein n=2 having a PSMA IC50 (nM) of 1.5±0.3 and a max tumor uptake (%ID/g) of 30.0±6.9 ([0233], table 2, pg. 88).
This reads in part on a compound of instant formula (IV) or (V) wherein TTD is PSMA GUL tumor targeting domain,
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wherein P4=P5=P6=H and W4=-(CH2)s-NH-C(O)-, and s=2; X1 is absent; p=0; q=2; L1=-O(CH2CH2O)f’-CH2CH2C(O)-, f’=2; sarc=Lys-DOTA chelator containing domain; L2=absent; BBD is a blood protein binding domain of formula
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where Y1=Y2=Y4=Y5=H, w=1, v=1, X3=O, u=0, and t=2 and where the BBD comprises a 2-(4-iodophenyl)acetic acid.
Babich et al. teach compounds of formula (I)
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wherein ABD is an antigen binding domain and wherein R1-R3 are suitably for example
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wherein Tox is a cytotoxin containing domain or imaging agent containing domain and Alb is an albumin binding moiety (pg. 18). The antigen binding domain may be a tumor targeting moiety including PSMA, SSTR2, etc ([0084]). The albumin binding domain may be
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([0086]) or
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([0087]). Babich et al. teach chelators selected from the group consisting of NOTA, etc ([0090]). Metal ions for tox and/or rad may be 177Lu, etc ([0087]). Babich et al. teach a pharmaceutical composition comprising a pharmaceutically acceptable carrier and composition comprising an effective amount of a compound therein for detecting PSMA expressing cancer including prostate cancer or for treating cancer including prostate cancer (pgs 125-126). Babich et al. teach methods comprising administering to a subject an effective amount of the for imaging cancer and detecting radiation from the compound and methods of treating cancer overexpressing PSMA (pgs. 127-128).
Babich et al. do not teach a compound of instant formula (IV) or (V) comprising a sarcophagine containing domain, such as a domain of formula
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optionally chelating 64Cu+2 or 67Cu+2 or triazole linker of the claimed formula form by SPAAC reaction of a DBCO reagent or a composition comprising one of those compounds optionally in an effective amount for treating prostate cancer and a pharmaceutically acceptable carrier or methods of imaging/treating comprising administering to a subject an effective amount of one of those compounds and optionally subsequently detecting positron emission. Babich et al. do not further exemplify a compound wherein the blood protein binding domain is
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.
Donnelly et al. teach nitrogen containing macrocyclic conjugates as radiopharmaceuticals (see title). Donnelly et al. teach compounds that contain a molecular recognition moiety and coordinated to a suitable radionuclide. The coordinated compounds are useful in areas of radiotherapy and diagnostic imaging (see abstract). The caged compounds form remarkably stable complexes with metals such as Cu2+ and have fast complexation kinetics even at low concentrations of metal at ambient temperatures (see pg. 2). Donnelly et al. teach antibodies (pg. 3). Donnelly et al. teach 64Cu and 67Cu (pg. 17). Donnelly et al. teach the sarcophagine
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(R22=Me; pg. 29). Donnelly et al. teach molecular recognition moieties such as octreotate (pg. 34).
Berkman et al. teach albumin-binding PSMA inhibitors (see title). Berkman et al. teach imaging diagnostics and therapeutics for prostate cancer that capitalize of the potency and specific affinity of small-molecule inhibitors to PSMA (0005]). Berkman et al. teach pharmaceutical compositions comprising a pharmaceutically acceptable carrier ([0011]). Berkman et al. teach the triazole linking groups
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and
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(see [0046], [0047]). Berkman et al. teach dibenzocyclooctyne (pgs. 10, 43). Berkman et al. teach the compounds
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and
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([00102]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date to modify the compounds/compositions/methods of Babich et al. (compounds/compositions/methods using RPS-063 and optionally a pharmaceutically acceptable carrier) by substituting the DOTA-Bz-SCN chelator of RPS-063 with a sarcophagine chelator such as
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and optionally form a 64Cu+2 or 67Cu+2 complex with one of those compounds as taught by Donnelly et al. because the sarcophagine chelator would have been expected to enable remarkably fast and stable radiocopper complexes and because the 64Cu+2 and 67Cu+2 complexes would have been expected to advantageously enable PET imaging and radiotherapy of cancers such as prostate cancer.
It would have been obvious to a person of ordinary skill in the art before the effective filing date to further modify the compounds/compositions/methods of Babich et al. by further substituting the triazole linker with a triazole linker represented by
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or
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that attaches to a -NH- on the TTD as taught by Berkman et al. because those triazoles attached to the TTD would have been expected to provide equivalent triazole linkers suitable for use with PSMA conjugates and because those triazole linkers would have been expected to result from the advantageous click reaction by strain promoted azide-alkyne cycloaddition reaction using dibenzocyclooctyne. It would have been obvious to a person of ordinary skill in the art before the effective filing date to modify further substituting the blood protein binding domain with
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as taught by Babich et al. because that substituting would have been expected to provide an equivalent blood protein binding domain suitable for binding to albumin. Stereoisomers are generally prima facie obvious. See also In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978). It would have been obvious to a person of ordinary skill in the art before the effective filing date to further modify Babich et al. by further administering an effective amount of the obvious derivatives containing the 64/67Cu labeled sarcophagine to a subject for PET imaging and/or treating prostate cancer and optionally PET image (detect positrons) the subject as taught by Babich et al., Donnelly et al. and Berkman et al. because the administering would have been expected to advantageously enable in vivo imaging and therapy of cancer using remarkably stable radiocopper complexes.
Claim(s) 1-5, 7-18, and 23-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Babich et al. (WO 2018/187631 A1; published 11 Oct. 2018; see IDS filed on 31 Oct. 2022), in view of Donnelly et al. (WO 2010/063069 A1; published 10 Jun. 2010) and Berkman et al. (WO 2018/098390 A1; published 31 May 2018; see IDS filed on 7 Jul. 2026), in further view of Zeglis et al. (US 2016/0331852 A1; published 17 Nov. 2016).
Babich et al. teach as discussed above.
Babich et al. do not further teach a tumor targeting domain that comprises trastuzumab or bevacizimab.
Donnelly et al. teach as discussed above.
Berkman et al. teach as discussed above.
Zeglis et al. teach radioligands for pre-targeted PET imaging and methods of their therapeutic use (see title). Zeglis et al. teach Tz/TCO base pre-targeted strategies using a 64Cu-sarcophagine based tetrazine radioligand for pre-targeted PET imaging. The imaging strategies enable PET imaging of cancer ([0015]). Zeglis et al. teach that in certain embodiments the targeting moiety is an antibody selected as trastuzumab or bevacizumab ([0039]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date to further modify Babich et al. by further substituting the PSMA tumor targeting domain with a trastuzumab or bevacizumab tumor targeting domain as taught Zeglis et al. because the substituting would have been expected to enable targeting HER-2 or VEGF expressing cancer.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN R DONOHUE whose telephone number is (571)270-7441. The examiner can normally be reached on Monday - Friday, 8:00 - 5:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached on (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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/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618
/SEAN R. DONOHUE/
Examiner, Art Unit 1618