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 .
Acknowledgement of Receipt
Applicant’s Response, filed 9/24/2025, in reply to the Office Action mailed 3/24/2025, is acknowledged and has been entered. Claims 20, 24, 25, 27, 29-39, 43 and 44 are pending and are examined herein on the merits for patentability.
Response to Arguments
Applicant’s arguments have been fully considered. The rejection of claims 20, 24, 25 and 44 under 35 U.S.C. 103 as being unpatentable over Kobayashi et al. (Anal. Chem., 2011, 83, p. 9123-9130) in view of Lehmann et al. (US 2012/0064002) has been withdrawn in view of Applicant’s argument that Kobayashi does not teach a metal complex that is not bound to an antibody. The rejection of claims 20, 24, 25, 27, 29-39, 43 and 44 under 35 U.S.C. 103 as being unpatentable over Kobayashi et al. (Anal. Chem., 2011, 83, p. 9123-9130) in view of Lehmann et al. (US 2012/0064002), in further view of Driver (US 2017/0296684) and Kratz (US 2015/0023912) is maintained.
The Examiner’s response to Applicant’s arguments is incorporated below.
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 20, 24, 25, 27-39, 43 and 44 are rejected under 35 U.S.C. 103 as being unpatentable over Kobayashi et al. (Anal. Chem., 2011, 83, p. 9123-9130) in view of Lehmann et al. (US 2012/0064002), in further view of Driver (US 2017/0296684) and Kratz (US 2015/0023912), for reason set forth in the previous Office Action.
Response to arguments
Applicant argues that Kobayashi does not disclose, teach or suggest an 111In labeled EMCS-Bz-DTPA that is not bound to an antibody, nor does Kobayashi teach or suggest the specific compounds recited in the instant claims. Applicant asserts that the antibody-maleimide conjugate in Kobayashi is not a conjugate acid and nothing in Lehmann remedies the deficiencies of Kobayashi. Applicant further argues that nothing in Driver and Kratz remedies the deficiencies of Kobayashi and Lehmann. Applicant asserts that Driver does not teach or suggest the specific metal complexes as recited in the instant claims, and that while Kratz discloses various therapeutic agents, it does not teach or suggest any metal complexes, let alone the specific metal complexes as recited in the instant claims. Moreover, Applicant has demonstrated that upon administration of the instantly recited complexes, they are detected in tumor tissues. Applicant asserts that nothing in the combination of Kobayashi, Lehmann, Driver and Kratz would have led the skilled worker to the specific metal complexes and methods of use thereof as recited in the instant claims.
Applicant’s arguments have been fully considered but are not found to be persuasive. While it is acknowledged that Kobayashi does not teach a 111In labeled EMCS-Bz-DTPA or conjugate acid thereof that is not bound to an antibody, it is respectfully submitted that Driver is incorporated to teach provision of a radiolabeled proconjugate comprising a reactive maleimide moiety, see in particular an exemplary proconjugate comprising a radiolabeled chelator and maleimide for reaction with a protein shown on page 13 of Driver. Lehman teaches enantiomeric resolution of DTPA derivatives. With regard to the argument that Kratz does not remedy the deficiencies of Kobayashi and Driver, Applicant's arguments have been fully considered but are not found to be persuasive because Kratz teaches administration of a maleimide bearing active agent in order to bind the Cys-34 position of circulating albumin and accumulation in solid tumors due to passive targeting for tumor detection and monitoring. While the active agent bearing a reactive maleimide groups are not the same active agent in Kobayashi/Driver and Kratz, it is considered that one of ordinary skill in the art would have recognized that a given active agent bearing a reactive maleimide would be capable of reacting with albumin as shown by Kratz using an active agent bearing a reactive maleimide for the desired purpose of targeting for albumin and accumulation in tumor for detection and monitoring; for example Kratz teaches that a drug may be radioactive.
Conclusion
No claims are allowed at this time.
THIS ACTION IS MADE FINAL. 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.
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/LHS/
/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618