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 with traverse of group I in the reply filed on 1/29/2026 is acknowledged. The traversal is on the ground(s) that the Bleicher reference does not teach the entirety of the claimed invention as it only mentions 19F derivatives. This is not found persuasive because the prior art used to break unity only has to teach the general technical feature of the invention and does not have to be 102 type of reference on its own merit. Clearly as disclosed in the previous action ethyl 2-F-4-nitrobenzoate, the shared technical feature, was a known compound before the time of the claimed invention.
The requirement is still deemed proper and is therefore made FINAL.
Claims 14-15,17,19,22,36,38-39,41-43,45,49-50 and 54 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 Objections
Claims 1,7,11 are objected to because of the following informalities: the new limitations added by amendment are faint and should be darker. 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.
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.
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) 1,7,11 and 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bleicher et al. (US 2006/0276494), cited previously, in view of Blom et al. “[18F]/19F exchange in fluorine containing compounds for potential use in 18F-labelling strategies”, J. Label Compd. Radiopharm 2009, 52 504–511.
Bleicher teaches sulfonamides as L-CPT1 inhibitors and uses ethyl 2-F-4-nitrobenzoate as in intermediate in ethanol (reads on carrier) in the synthesis of the compounds. See abstract and example 38.
Bleicher is silent with respect use of the 18F isotope of the naturally occurring 19F isotope in the compounds and intermediates disclosed.
Blom is used for the teaching within on 18F/19F label exchange in various organofluorine compounds including fluorinated benzoate esters. Blom notes that 18F can be used in PET imagining.
Since Bleicher teaches benzoate esters and Blom teaches how to exchange 18F with 19F in fluorinated benzoate esters one of ordinary skill would have a high expectation of success in labeling ethyl 2-F-4-nitrobenzoate with 19F. It follows that some 18F would remain as unreacted side product as the reactions in Blom were not quantitative. Reason to make such a modification would be to label the L-CPT1 inhibitors of Bleicher such that delivery could be imaged with PET. The intermediate containing both 18F and 19F derivatives reads on applicants claimed composition.
Regarding the ratio of 18F to 19F recited in claims 2,7 and 11, the combination above is silent on a ratio within the claimed range. However, the preparation of compositions having variable amount labeled compounds for imaging is within the level of skill of one having ordinary skill in the art at the time of the invention. Clearly one of ordinary skill would adjust the amount of 19F sufficient for PET diagnostic imaging. It has also been held that the mere selection of proportions and ranges is not patentable absent a showing of criticality. See In re Russell, 439 F.2d 1228 169 USPQ 426 (CCPA 1971).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES W ROGERS whose telephone number is (571)272-7838. The examiner can normally be reached 9:30-6:00 PM.
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/JAMES W ROGERS/Primary Examiner, Art Unit 1618