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 . 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.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-3, 5-6, 8-9, 12 and 14-15, in the reply filed on 11/03/2025, is acknowledged.
Applicant’s election without traverse of (species), in the reply filed on 11/03/2025, is acknowledged:
1. Chelator. Structure (VIII) of claim 3 wherein X₁ is =0, X₂ is N, L is 4-amino-
(1-carboxymethyl) piperidine-norleucine as shown in structure (14), and R₁ is
an α-melanocyte-stimulating hormone (αMSH) targeting peptide as shown in
structure (14).
2. Radiometal. 225Ac.
3. Targeting moiety. A peptide.
4. Biological targeting moiety. α-melanocyte-stimulating hormone (αMSH) targeting peptide.
5. Biological target. MC1R (melanocortin-1 receptor).
6. Type of radiation. Alpha-radiation.
Claims 2, 5, 18-21, 25-26, 28, 30-31, 34, 36, 38-39, 42 and 44-46 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species or invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/03/2025.
Claim Objections
Claim 14 is objected to because of the following informalities: Claim 14, line four ends in two commas. Appropriate correction is required.
Claim Rejections - 35 USC § 112 – Lack of Antecedent Basis,
Indefiniteness and Broad Limitation followed by Narrow Limitation
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 9, 12 and 14-15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding lack of antecedent basis, claim 9 recites the limitation "the radiometal" in line two. There is insufficient antecedent basis for this limitation in the claim. The Applicant is encouraged to depend claim 9 from claim 8.
Regarding indefiniteness, claim 12 is unclear. The claim recites, at line two, “the targeting moiety”. It is unclear if the claim refers to the biological targeting moiety of claim 1, or to another targeting moiety. Clarification of the claim scope is required.
Regarding broad to narrow limitations, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
In the present instance, claims 14 and 15 recite the broad recitations, and the claims also recite the narrower statements of the range/limitation in parentheses. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
The Applicant is encouraged to remove the parentheses from claims 14-15, at each instance of occurrence.
Claim Rejections - 35 USC § 103 - Obviousness
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) 1, 3, 6, 8-9, 12 and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al (Journal of Nuclear Medicine, 2018, 59 (supplement 1), 611), as evidenced by Zeisler et al (WO 2019/222851 A1).
The Examiner notes that the Applicant’s instantly elected compound is:
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250
550
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[see Compound 14 at page 32 of the Instant Specification].
Zhang taught the radiolabeled compound 68Ga-CCZ01099, which comprises a DOTA chelator [see Methods and Results].
Zhang did not teach the elected radiometal 225Ac.
Nevertheless, Zeisler evidenced Ac-225 as an exemplary isotope that binds DOTA [Table 1].
At paragraph [00122], Zeisler evidenced that the structure of CCz01099 is:
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815
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Since Zhang taught CCz01099, which comprises within its structure, DOTA, it would be prima facie obvious to the ordinarily skilled artisan to label the compound with 225Ac. The ordinarily skilled artisan would be motivated by Zeisler’s evidence that 225Ac is an exemplary isotope that binds DOTA [see Zeisler at Table 1].
Zhang, as evidenced by Zeisler, reads on claims 1, 3, 6, 8-9, 12 and 14-15.
Conclusion
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/CELESTE A RONEY/Primary Examiner, Art Unit 1612