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 of Group I, claims 1-11, in the reply filed on 10/06/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 12-26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Andrews et al., (WO 2000/12083, cited in IDS) in view of Gennadievich et al., (WO 2020/031136).
Andrews et al. teaches hydroxamate metalloprotease inhibitors having the following structure, as per the instant claim 1, shown below:
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192
479
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(p. 3, lines 23-26).
Andrews et al. teaches a specific embodiment, as per claim 11:
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84
817
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(p. 80, lines 16-17, Example 1).
The prior art teaches “where R1 is methyl, ethyl, isopropyl 4-methyl-1-pentyl . . .” (p. 113, lines 11), as per claims 2-3; “R2 is . . . 3-phenyl-1-propyl . . . “(p. 113, line 18), as per claim 4; “R4 is tert-butyl” (p. 114, lines 13), as per claim 5; “R6 is methyl” (p. 115, line 8), as per claims 6-7.
Andrews et al. teaches, “Compounds which inhibit activities of one or more of the matrix metalloproteases are recognized as having therapeutic benefit in one or more pathologies where MMP activity is upregulated, such as: . . . “diseases of cancer and malignancy, including but not limited to cancers of the oral cavity and pharynx (lip, tongue, mouth, pharynx), esophagus, stomach, small intestine, large intestine, rectum, liver . . . lung, bone, connective tissue . . . colon, breast, cervix uteri . . . “ (p. 2, lines 19-27 through p. 3, line 4).
Andrews et al. teaches attaching an “affinity reagent” to the formulas “which does not affect its in vitro biological activity, allowing the compound to bind to a target, yet such a group binds strongly to a third component allowing a) characterization of the target as to localization within a cell or other organism component, perhaps by visualization by fluorescence or radiography” (p. 51, lines 11-15).
Andrews et al. does not teach wherein the N-hydroxamide is radiolabled with a radionucleotide.
Gennadievich et al., “Integration of targeted therapy and diagnostics have created a new field of treatment called theranostics. The main task of the discipline is the potential ability to track the progress of target delivery of drugs or other pharmaceutically acceptable derivatives using molecular imaging in the study subjects” (p. 1, 2nd paragraph).
Gennadievich et al. further teaches “making SANPs-theranostics with adjuvant effect turned to therapy and diagnostic of prostate cancer and possible ways of usage” (p. 2, last paragraph). “In the application to therapy and diagnosis of prostate cancer the first ‘theranostic’-alike delivery methods used the well-known readioactive labels to detect the accumulation of drug” (p. 1, last paragraph). For example, Gennadievich et al. teaches use of iodine-123 as radionuclide theranostic in its method of treating prostate cancer (see p. 6, last paragraph).
It would have been obvious to a person having ordinary skill in the art at the time of applicant’s filing to use theranostics, of Gennadievich et al., to treat cancers of Andrews et al. since Andrews teaches cancer treatment as well as localization of its compounds within a cell or other organism for visualization by radiography. Since Andrews et al. teaches where R2 is “3-(4-chlorophenyl)-1-propyl” (p. 114, line 1), it would have been reasonable for the artisan to take advantage of neophilic halogen exchange and substitute the chloro- atom with iodine-123, thus creating a radiolabeled compound for radiography and treatment via theranostics.
Technological Background
The prior art made of record is considered pertinent to applicant's disclosure Cuthbertson et al., (US 2007/0104644, cited in IDS). Cuthbertson et al. is pertinent for teaching “imaging agents which comprise a specific type of matrix metalloprotease inhibitors (MMPi’s) of the sulphonamide hydroxamate class labelled with an imaging moiety, are useful diagnostic imaging agents for in vivo imaging and diagnosis of the mammalian body” (Abstract).
Conclusion
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to WALTER E WEBB whose telephone number is (571)270-3287 and fax number is (571) 270-4287. The examiner can normally be reached from Mon-Fri 7-3:30.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Frederick F. Krass can be reached (571) 272-0580. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Walter E. Webb
/WALTER E WEBB/Primary Examiner, Art Unit 1612