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 .
Amendments
Applicants amendments to the claims filed 7/17/2026 have been entered.
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) 120-123 and 125-126 and 128-152 is/are rejected under 35 U.S.C. 103 as being unpatentable over Muller et al. “Structure-Based Design of High-Affinity Fluorescent Probes for the Neuropeptide Y Y₁ Receptor”, J. Med. Chem. 2022, 65, 4832-4853, cited by applicants, in view of CHATENET et al., “Novel Dimeric DOTA-Coupled Peptidic Y1-Receptor Antagonists for Targeting of Neuropeptide Y Receptor-Expressing Cancers”, EJNNMI Research 1(21):21 (2011), cited by applicants, for the reasons set forth in the previous action filed 4/20/2026.
Response to Arguments
Applicant's arguments filed 7/17/2026 have been fully considered but they are not persuasive.
Applicants assert Muller and Chatenet. describe antagonist from entirely different design paradigms with different SAR analysis. Therefore, applicants surmise there is no basis for predicting how site selection and spacer lessons would transfer to unrelated scaffolds.
To briefly recapitulate, the primary reference teaches all that is claimed, including the ligand and spacer, the missing feature is the metal chelate DOTA. However, since DOTA was already known to be attachable to Y1 ligand receptors as taught by Chatenet the examiner found a person of ordinary skill would have a very high expectation of success in making such a modification. The purpose of each ligand is not really germane as the examiner is only using one piece from the secondary reference DOTA. Since the references are generally related in their teachings of Y1 ligands and have similar reactive moieties one of ordinary skill would have a high expectation of success in substituting fluorescent probe of Muller with DOTA through routine chemical synthesis. Reason to make such a substitution would be to treat tumors and image them with the radiolabeled compound with the advantageous high binding affinity from the Y1 receptor.
Applicants assert the examples seen at table A in their specifcation show that DOTA conjugation uniformly retains high NPY1R affinity, showed high tumor accumulation, low accumulation in healthy tissue and favorable pharmacokinetics. Applicants assert these properties could not be predicted based on the combination of Muller and Chatenet.
The relevance of this assertion is unclear for a number of reasons. The first is the features listed above are not claimed. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Secondly, even if applicants added functional limitations in the claims on the tumor binding affinity and pharmacokinetics it follows such features would naturally occur once the Muller and Chatenet references are combined.
Conclusion
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael 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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/JAMES W ROGERS/Primary Examiner, Art Unit 1618
