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 II in the reply filed on 6/3/26 is acknowledged. Claims 4,21-31,35 and 36 are canceled in the amendment filed 5/8/26. The claims 39-43 are newly added in the amendment filed 6/3/26, were searched and are therefore joined to the claims of group II.
Claim Objections
Claims 32 and 39 are objected to because of the following informalities: the structures
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appear to be cutoff as they do not fully contain the terminal amino groups. Appropriate correction is required.
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) 32-34 and 37-43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Roivainen et al. (J Nucl Med 2013; 54:867-872) in view of Cappelletti et al. (US 2011/0052491A1) and in further view of Tweedle et al. (US 5,846,519).
Roivainen et al. (J Nucl Med 2013; 54:867-872) discloses the gastrin-releasing peptide antagonist 68Ga-BAY 86-7548 (68Ga-DOTA-4-amino -1-carboxymethylpiperidine-D-Phe-Gln-Trp-Ala-Val-Gly-His-Sta-Leu-NH2, RM2)
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(p867, left column, third paragraph; p870, Discussion).
Roivainen et al. does not disclose Me-Trp.
Cappelletti et al. (US 2011/0052491A1) discloses compounds for targeting GRP receptors
comprising M-N-O-P-G wherein M is a metal chelator, N-O-P comprises an amino acid linker and G is a GRP targeting receptor peptide (p2, [0013-0014],[0016-0019]; p39, [0244]).
M comprises DOTA, etc. (p2, [0014]; p8, [0148]; p9, [0153]).
The G moiety GRP targeting receptor peptide comprises D-Phe-Q-αMeWAVGHLM-NH2 (SEQ ID NO: 30) (p27, Table 3; L410, Table 4A; claim 108).
It would have been obvious to one of ordinary skill in the art to substitute the tryptophan (Trp, W) of 68Ga-BAY 86-7548 with the Me-Trp (αMeW) of Cappelletti et al. as the substitution as one known amino acid for another known and comparable amino acid predictably provides an analogous GRP peptide targeting compound with a reasonable expectation of success.
Roivainen et al. does not disclose 177Lu or a pharmaceutically acceptable carrier, excipient or diluent.
Cappelletti et al. further discloses that the metal chelators may be complexed with a radionuclide, such as 68Ga, 177Lu, etc. (p2, [0014]; p9, [0154]).
The compounds for targeting GRP receptors can be administered as a composition comprising excipients, diluents, carriers, etc. that are all well-known in the art (p39, [0243]).
It would have been obvious to one of ordinary skill in the art to substitute the 68Ga of Roivainen et al. for the 177Lu of Cappelletti et al. as the substitution of one known radionuclide for another known radionuclide predictably provides an analogous GRP peptide targeting compound used for radiotherapy with a reasonable expectation of success.
It would have been obvious to one of ordinary skill in the art to prepare the resulting GRP peptide targeting compound in a composition comprising excipients, diluents and/or carriers of Cappelletti et al. for effective administration for GRP targeting for the advantage of radiotherapy with a reasonable expectation of success.
Roivainen et al. does not explicitly disclose the chelator
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.
Cappelletti et al. further discloses of the metal chelators, such as DOTA, etc. (p7, [0146]; p9, [0153]) and those incorporated by reference, such as US 5,846,519 (p8, [0148]).
Tweedle et al. (US 5,846,519) discloses macrocyclic chelating agents comprise
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wherein Y is NR1; R1 is
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, etc.; R2 is H, etc. that are used to chelate metal ions, such as 68Ga, etc. (column 2, lines 48-58; column 4, lines 1+).
It would have been obvious to one of ordinary skill in the art to substitute the DOTA chelator of Roivainen et al. for the macrocyclic chelator (DOTA derivative) of Tweedle et al. as the substitution of one known DOTA chelator for another known DOTA chelator derivative predictably provides an analogous GRP peptide targeting compound chelated to a radionuclide, such as 68Ga for the advantage of radiotherapy with a reasonable expectation of success.
Conclusion
No claims are allowed at this time.
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/MELISSA J PERREIRA/ Examiner, Art Unit 1618
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