DETAILED ACTION
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 .
Election/Restrictions
Applicant’s election without traverse of group I and the species 61Cu in the reply filed on 6/23/26 is acknowledged.
The search was expanded to include 67Cu and therefore the claims 89-95 were examined.
Claims 101-104 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected groups, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/23/26.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 75-95,98 and 99 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by
Bernabeu et al. (Eur. J. Nucl. Med. Mol. Imaging Vol. 48, Suppl. 1, October 20-23, 2021).
Bernabeu et al. (Eur. J. Nucl. Med. Mol. Imaging Vol. 48, Suppl. 1, October 20-23, 2021) teaches of
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that anticipates the
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of the instant claims (p5-6).
The NODAGA moiety
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anticipates the NODAGA moiety
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of the instant claims.
The 61Cu anticipates the 61Cu of the instant claims.
The L moiety
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anticipates the L moiety
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of the instant claims.
The V moiety
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anticipates the V moiety Lys-Urea-Glu
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of the instant claims.
The
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anticipates the compounds of the instant claims, has the same properties and is capable of the same functions, such as having a radiochemical purity of ≥95%.
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.
Claim(s) 75-100 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lim et al. (KR 20220006286A and translation) in view of Lee et al. (Cancer Biother. Radiopharm. Volume 37, Number 6, 2022, 417-423) and Lin et al. (US 2021/0338851A1).
Lim et al. (KR 20220006286A and translation) discloses the radiolabeled PSMA compound for the diagnosis and/or treatment of cancer ([0001]; [0061]; [0067])
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( [0020-0021] and p4).
The radiolabeled PSMA compound comprises a composition including diluents or excipients ([0069]) that encompasses the pharmaceutically acceptable excipient of the instant claims.
The
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moiety encompasses the
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moiety of the instant clams wherein the L comprises
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, and V is Lys-Urea-Glu
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.
Lim et al. does not disclose the chelator NODAGA, or the radioisotopes 61Cu or 67Cu.
Lee et al. (Cancer Biother. Radiopharm. Volume 37, Number 6, 2022, 417-423) discloses the PSMA imaging and therapy agent 64Cu-PSMA I&T (abstract).
NOTA and NODAGA were envisioned as chelators for the 64Cu labeled PSMA agents (p418, left column, first full paragraph).
Lin et al. (US 2021/0338851A1) discloses radiolabeled PSMA imaging or therapeutic agents for PSMA-expressing diseases/conditions comprising the formula
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(abstract; p1, [0007]) wherein R7 comprises and Rx chelator moiety (p2, [0020]; p3, [0024]).
The PSMA-targeting moiety comprises
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wherein R0 is O; R1a, R1b and R1c are -CO2H and R3 is a linker (p6, [0060-0066]).
The Rx chelator moieties comprise DOTAGA, NODAGA, etc. (p33, [0282]).
The radioisotopes comprise 61Cu, 64Cu of PET or SPECT imaging of PSMA expressing tumors and 64Cu or 67Cu for therapy of PSMA expressing tumors (p51, [0300-0301).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the DOTAGA of Lim et al. for the NODAGA of Lin et al. with a reasonable expectation of success as Lee et al. envisioned the binding a NODAGA to a PSMA I&T moiety in order to chelate a copper radioisotope and Lin et al. teaches that DOTAGA and NODAGA chelators are used to chelate different copper radioisotopes to PSMA targeting agents depending on the desired methods of use, such as imaging and/or therapy.
The substitution of one known copper radioisotope chelator for another known copper radioisotope chelator predictable provides for the methods of imaging or therapy depending on the copper radioisotope and chelator combination.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the 64Cu of Lim et al. for the 61Cu or 67Cu of Lin et al. depending on the desired method of use, such as imaging and/or therapy as Lin et al. teaches that imaging and/or therapy use different radioisotopes and 64Cu is substituted for 61Cu for the method of imaging and 64Cu is substituted for 67Cu for the method of therapy.
Lim et al. does not disclose the radiochemical purity of ≥ 95%.
The compounds of the combined disclosures comprise a
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moiety bound to NODAGA in order to chelate 61Cu or 67Cu and encompasses the compounds of the instant claims, have the same properties and are capable of the same properties, such as having a radiochemical purity of ≥95%.
Claim(s) 75-100 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bernabeu et al. (Eur. J. Nucl. Med. Mol. Imaging Vol. 48, Suppl. 1, October 20-23, 2021) in view of Lim et al. (KR 20220006286A and translation).
Bernabeu et al. (Eur. J. Nucl. Med. Mol. Imaging Vol. 48, Suppl. 1, October 20-23, 2021) discloses
teaches of
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as a 0.5 nm composition (p6) as well as that stated above.
Bernabeu et al. does not disclose the pharmaceutically acceptable excipient of the instant claims.
Lim et al. (KR 20220006286A and translation) discloses the radiolabeled PSMA compound for
the diagnosis and/or treatment of cancer as well as that stated above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the [61Cu]Cu-NODAGA-PSMA I&T with a pharmaceutically acceptable excipient as Bernabeu et al. teaches that the [61Cu]Cu-NODAGA-PSMA I&T is used as a 0.5 nm composition and Lim et al. teaches of combining radiolabeled PSMA compound with a pharmaceutically acceptable excipient for preparing a formulation for administration to a subject (Lim et al. [0069].
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 § 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 75-100 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-69 of U.S. Patent No. 12,527,885B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the compounds
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and
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comprising a pharmaceutically acceptable
excipient of U.S. Patent No. 12,527,885B2 encompass the
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and
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comprising a pharmaceutically acceptable excipient of the instant claims.
The compounds of Formula A of the instant claims encompasses the compounds of U.S. Patent No. 12,527,885B2, has the same properties and is capable of the same functions, such as 61Cu is obtained by deuteron irradiation of natNi or 60Ni on a niobium backing or by proton irradiation of 61Ni on a niobium backing.
The compounds of Formula A of the instant claims encompasses the compounds of U.S. Patent No. 12,527,885B2, has the same properties and is capable of the same functions, such as generating an imaging of a subject, detecting PSMS-receptor-expressing tumors, a theranostic method or a method of treating a cancer that expresses a PSMS receptor.
The compound of Formula A of the instant claims encompasses the compounds of U.S. Patent No. 12,527,885B2, has the same properties and is capable of the same functions, such as having radiochemical purity, end of synthesis by sum of radionuclide impurities, activity concentration, and radionuclide purity of U.S. Patent No. 12,527,885B2.
Claims 75-100 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1,2,13,15,18-21,24,25,27,44,49,58,72 and 75-85 of copending Application No. 18/474,218 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the radiotracer comprising 61Cu or 67Cu chelated to a NODAGA that is bound to a PSMA targeting moiety via a linker of copending Application No. 18/474,218 encompasses the compound of Formula A comprising 61Cu or 67Cu chelated to a NODAGA that is bound to a PSMA targeting moiety via a linker of the instant claims.
The compound of Formula A of the instant claims encompasses the radiotracer of copending Application No. 18/474,218, has the same properties and is capable of the same functions, such as generating an imaging of a subject, detecting a disease and monitoring or determining the effect of cancer treatment.
The compound of Formula A of the instant claims encompasses the radiotracer of copending Application No. 18/474,218, has the same properties and is capable of the same functions, such as having a radiochemical purity, activity concentration, molar activity, and radionuclide purity of
copending Application No. 18/474,218.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 75-100 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 75-104 of copending Application No. 19/452,054 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the compound of Formula A of copending Application No. 19/452,054 comprises
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and
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encompasses the
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and
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of the instant claims.
The compound of Formula A of the instant claims encompasses the compound of Formula A of
copending Application No. 19/452,054, has the same properties and is capable of the same functions, such as generating an imaging of a subject, detecting PSMS-receptor-expressing tumors, a theranostic method or a method of treating a cancer that expresses a PSMS receptor.
The compound of Formula A of the instant claims encompasses the compound of Formula A of copending Application No. 19/452,054, has the same properties and is capable of the same functions, such as having a radiochemical purity, end of synthesis by sum of radionuclide impurities, activity concentration, and radionuclide purity of copending Application No. 19/452,054.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed at this time.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA JEAN PERREIRA whose telephone number is (571)272-1354. The examiner can normally be reached M9-3, T9-3, W9-3, Th9-2, F9-2.
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/MELISSA J PERREIRA/ Examiner, Art Unit 1618
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