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 .
Summary
Claims 1-3 and 11-17 are pending in this office action. Claims 4-10 are cancelled. All pending claims are under examination in this application.
Priority
The current application was filed on May 14, 2024 is a 371 of PCT/CN2022/118207 filed on September 9, 2022. The current application claims foreign priority to CN2021113701238.7 filed on November 18, 2021.
Claim Objections
Claims 2 and 13-17 are objected to because of the following informalities:
Claims 2, 3 and 13-17: Please state all the acronyms in-full. Once defined within the claims all further references to the compound may use the acronym. Claim 3 is included because it does not cure the issue with claim 2.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 11-12 and 17 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.
Claim 11 is a generic scheme and is unclear. Please add details to the scheme such as reagents, conditions, and the solid-phase resin being used in the synthesis. Also, please include how the bifunctional chelating agent is coupled within step (b). [This is discussed with pages 4-5 and 8-11 of the instant specification.]
Claims 12 and 17 use the term “preferably.” The term "preferably" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 17 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. Claim 17 is written as a “use” claim and does not recite process steps. Additionally, claim 17 does not comply with the four statutory categories. It is therefore, indefinite.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 17 is directed to non-statutory subject matter. The claim 10 does not fall within at least one of the four categories of patent eligible subject matter because it is written as a “use” claim.
Prior Art
For record purposes only, it is noted that there were no prior art rejections of present claims 1-3 and 11-17 at this time. The Examiner has included a PTO-892 form with relevant prior art. [Bilcer et al. (WO2019/160916A1) is not included, as a file within this office action, due to the size.]
Allowable Subject Matter
Claims 1-3 and 11-17 contain allowable subject matter over the prior art. Bilcer et al. (WO2019/160916A1) is the closest prior art to the present application. But, the Bilcer et al. reference lacks a complete disclosure of the claimed analogue within instant claim 1.
Bilcer et al. disclose granzyme B directed imaging and therapy, and specifically discloses a method of imaging granzyme B in a cell or tissue, which comprises: i) contacting the cell or tissue sample with a compound of formula I, or administering to the subject a compound of formula I: [A-B-C] or a pharmaceutically acceptable salt thereof, and ii) imaging the cell or tissue using a suitable imaging technique, and thereby imaging granzyme B in the cell or tissue, wherein: (A) comprises one or more imaging agents; (B) is an optional linking group; and (C) is a group that binds to granzyme B.
Bilcer et al. also disclose a method of imaging an immune response in a cell or tissue sample or in a subject, a method of monitoring the treatment of a disease in a subject, and a method of monitoring an immune response in the treatment of a disease in a subject; wherein (C) is a small organic molecule that binds to granzyme B.
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(A) comprises a radioisotope; (B) is an optional linking group comprising one or more C1-30 alkylene groups, one or more amino groups, one or more amide groups, one or more C1-30 alkyleneoxy groups, one or more C1-30 thiol groups, or any combination thereof; and (C) is selected from a polypeptide that binds to granzyme B and a small organic molecule that binds to granzyme B. (A) comprises a radioisotope selected from the group consisting of: 3H, 11C, 64Cu, 67Cu, 67Ga, 68Ga, 89Zr, 90Y, 99mTc, 123I, 124I, 125I, 177Lu, 186Re, 188Re, 201Tl, 203Pb, 210At, 211At, 212Bi, 213Bi and 225Ac. (A) further comprises a chelating agent, and the chelating agent is selected from the group consisting of: 1,4,7-triazacyclononanetriacetic acid (NOTA), 1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraacetic acid (DOTA), 1,4,7-triazacyclononane-1-glutaric acid-4,7-diacetic acid (NODAGA), ethylene diamine tetra-acetic acid (EDTA), diethylene triaminepentaacetic acid (DTPA), etc. The disease for treatment is cancer (see abstract and claims 1-6, 59, 62, 64, 65, 67, 68 and 101; both within Bilcer et al.). However, this representative derivative disclosed by Bilcer et al. is only a portion of the claimed compound within the instant application. Motivation is lacking to complete the analogue because there are specific organic linkers between the disclosed molecule and the bifunctional chelating group.
Conclusion
Claim 1 is allowed.
Please address all non-prior art rejections and objections.
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/JOHN W LIPPERT III/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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