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 .
Receipt is acknowledged of IDS filed on 01/18/2024 and 02/24/2023.
Claims 1-19 are pending.
Claims 3-19 are withdrawn.
Election/Restrictions
Applicant's election with traverse of Group I and the species yersiniabactin labeled with copper-64, E. Coli UT189 (gram-negative) bacteria and used to monitor treatment response, progression, or both in antibiotic resistant E. coli. in the reply filed on 08/05/2025 is acknowledged. The traversal is on the ground(s) that However, Applicant notes that the claims of the present application are not directed simply to a "metallophore" and a "radionuclide." Rather, each of independent claims 1, 6, and 15 recite yersiniabactin labeled with either 64Cu or 89Zr, or staphylopine labeled with either 64Cu or 89Zr. This is not taught by Zhai. As noted by the Examiner, Zhai teaches 68Ga - but does not cite any teaching of Zhai directed to the combination of either 64CU or 89Zr combined with yersiniabactin (i.e., the actual recitation of the claims). In view of the fact that the cited Zhai reference does not teach the limitation of the claims directed to the use of either 64Cu or 89Zr, Applicant submits that this is a special technical feature, and respectfully requests withdrawal of the restriction requirement based on a lack of unity objection. This is not found persuasive because as discussed below and in the restriction technical feature is not a special technical feature as it does not make a contribution over the prior art in view of ZHAI (P-365 Imaging of occult bacterial infection using 68Ga-Yersiniabactin targeting siderophore transport. May 1, 2019.) The reference teaches a probe made from a metallophore, such as yersiniabactin and a radionuclide such as 68-Ga (methods). PETRIK teaches gallium-68 and copper-64 are both commonly used as PET radiopharmaceuticals (Introduction, paragraph 1). It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate copper-64. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because gallium-68 and copper-64 are functional equivalents of PET radiopharmaceuticals commonly used in radiolabeled siderophores for PET imaging.
The requirement is still deemed proper and is therefore made FINAL.
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.
Claims 1 and 2 are rejected under 35 U.S.C. 103 as being unpatentable over ZHAI (P-365 Imaging of occult bacterial infection using 68Ga-Yersiniabactin targeting siderophore transport. May 1, 2019.) in view of PETRIK (Siderophores for molecular imaging applications. Clin Transl Imaging. 2017.).
ZHAI teaches a position emission tomography (PET) probe comprised of a siderophore, such as yersiniabactin, labeled with the radiolabel gallium-68 to image infections (objective).
ZHAI does not teach specifically labeling Yersiniabactin with copper-64.
PETRIK teaches radiolabeling siderophores for PET imaging (abstract). Gallium-68 and copper-64 are both commonly used as PET radiopharmaceuticals (Introduction, paragraph 1). PETRIK further teaches that siderophores, such as yersiniabactin is able to bind extracellular copper (Page 18, paragraph 2).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate copper-64. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because gallium-68 and copper-64 are functional equivalents of PET radiopharmaceuticals commonly used in radiolabeled siderophores for PET imaging and PETRIK teaches that yersiniabactin is able to bind extracellular copper.
Conclusion
No claims are allowable.
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/S.L.M./Examiner, Art Unit 1618 /JAKE M VU/Primary Examiner, Art Unit 1618