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 .
Response to Arguments
Applicant's arguments, filed August 5, 2026, have been fully considered but they are not deemed to be fully persuasive. The following rejections and/or objections constitute the complete set presently being applied to the instant application.
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.
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.
Claims 14, 15, 17, 19, 20, 22, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Tenstad (WO 2010 066843) in view of Olberg et al. (WO 2010 114723).
This rejection is MAINTAINED for the reasons of record set forth in the Office Action mailed August 13, 2026 and those set forth herein.
The declaration under 37 CFR 1.132 filed August 5, 2026 is insufficient to overcome the rejection of claims 14, 15, 17, 19, 20, 22, and 23 based upon Tenstad and Olberg under U.S.C. 103 as set forth in the last Office action because Applicant’s assertions of unexpected results fail to satisfy the requisite legal criteria established under MPEP § 716.02. Objective evidence of unexpected results must be supported by an appropriate evidentiary showing, direct comparative data, and must be commensurate in scope with the claims. Applicant has failed to meet this burden based on the following criteria.
First, the alleged results are predictable, not truly unexpected. To establish unexpected results, the improvement or enhancement must significantly exceed what a person having ordinary skill in the art would have reasonably anticipated. Applicant asserts that the 18F-labeled radiotracer achieved surprisingly superior renal cortical contrast and practical spatial/functional PET-GFR resolution compared to the 124I-labeled tracers of Tenstad. Obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. It is a well-established physical fact to a POSITA that radioisotopes possess starkly different physical characteristics, imaging resolutions, and clinical target applications. Specifically, ¹⁸F is a short-lived, high-resolution isotope ideal for rapid metabolic imaging, whereas ¹²⁴I is a long-lived isotope uniquely suited for tracking slow biological processes. So, the enhancement represents a predictable result rather than an entirely new result that was unanticipated by the prior art. Olberg teaches an effective 18F-labeiling method, and a POSITA, seeking a high-resolution isotope for rapid metabolic imaging, would have been motivated to apply the Olberg method to prepare the 18F-labeled tracer. A POSITA relying on the combined teachings of the prior art would reasonably expect a clearer image from an 18F-labled tracer than from 124I-labeld tracer. Applicant did not address the predictable nature of an 18F-labeled tracer resulting from the combined teachings. Extending quantitative PET imaging to smaller animal models represents an optimization of routine testing techniques and image resolution attributable to the predictable physical advantages of 18F, rather than a patentable distinction in the chemical entity itself.
Second, Applicant fails to provide a direct comparison with the closest prior art (Tenstad and Olberg individually or in a baseline combination). The evidence of unexpected results must involve a direct, side-by-side comparison between the claimed invention and the closest prior art. Applicant just compared the claimed invention with the published data from Tenstad, which has different experimental conditions such as subjects. Applicant must provide direct comparative data under the same conditions about the prior art or combined prior art. Without a direct comparison showing that the actual performance of the claimed composition is significantly better than what would be predicted from a simple additive effect of Tenstad and Olberg, the showing is insufficient to rebut the prima facie case of obviousness.
Third, the results are not commensurate in scope of the claims. To effectively rebut a rejection of obviousness, the disclosure or evidence of unexpected results must be commensurate in scope with the claims to which the evidence is applied. Independent claim 14 broadly encompasses any protein that acts as a ligand for the megalin and/or cubilin receptor. However, Applicant’s arguments rely on narrow, specific examples such as cytochrome C and cystatin C in a specific subject. Applicant fails to provide examples of various claimed proteins in various subjects. The limited experimental data does not establish that the entire claimed genus would exhibit the same allegedly unexpected properties. The specification fails to provide any broad guidance or functional predictive model that would allow a POSITA to reasonably extrapolate the observed efficacy of cytochrome C and cystatin C to all claimed megalin/cubilin ligands. Showing allegedly unexpected results for a tiny fraction of a broadly claimed genus does not establish patentability for the entire scope of claim 14.
Accordingly, because the combination of teachings would have been obvious to one of ordinary skill in the art, and because the Applicant has not provided sufficient objective evidence to demonstrate unexpected results, the rejection is maintained.
Applicant argues that the claimed radiotracers provide improved characteristics that would not have been expected based on the cited references.
This argument is unpersuasive. Applicant’s assertions of unexpected results fail to satisfy the requisite legal criteria established under MPEP § 716.02. See the response to the Declaration above.
Conclusion
THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONG HWAN BAEK whose telephone number is (571)272-0670. The examiner can normally be reached Mon - Thu, 9 am - 3 pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael G Hartley can be reached at 571-272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JONG HWAN BAEK/Examiner, Art Unit 1618
/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618
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