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 .
Receipt is acknowledged of Applicant’s Amendment and Arguments filed on 03/03/2026.
Claim 1 has been amended.
Claim 2 has been cancelled. Accordingly, claims 1 and 3-6 are pending and presented for examination.
Any previous rejections and/or objections not reiterated herein have been withdrawn in view of arguments filed on 03/03/2026. The following rejections and/or objections constitute the complete set presently being applied to the instant application.
Response to Declaration under C.F.R. s1.132
The Declaration under 37 CFR 1.132 filed 04/03/2026 is sufficient to overcome the rejection of claims 1-6 based upon 103 rejections.
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.
Claim(s) 1 and 2-6 are rejected under 35 U.S.C. 103 as being unpatentable over Conti et al. (US 9,403,875) in view of Sushil Tripathi et al. ( Nucl Med Biol, 51, 55-61, 2017) .
Conti discloses a kit having a bifunctional chelator/targeting moiety conjugate with instructions for complexing a metal to the bifunctional chelator/targeting moiety conjugate (Col. 4 line 14-18). In one embodiment discloses Sarcophagine based bifunctional chelators (BFCs) containing a hexa-aza cage for labeling with metals having either imaging, therapeutic or contrast applications radiolabeling and one or more linkers (A) and (B). The compounds have the general formula
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, wherein A and B is a functional group selected from amine, a carboxylic acid, and an ester (abstract). In one embodiment, compound is
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, in which a bifunctional chelator is conjugated to a targeting moiety, for example, RGD (reads on BaBaSar-RGD₂,), In these complexes, metal resides within the Sar cage and is bonded to one or more nitrogen, preferably, the metal may be 64Cu (Col. 3 and 4).
Conti fails to disclose buffer salt sodium acetate in the kit.
Sushil a freeze-dried diaminedithiol-peptide (N2S2-TP3805) kit and its evaluation for the preparation of 64Cu labeled TP3805. Parameters such as pH, temperature and incubation time were examined that influenced the radiolabeling efficiency and stability of the product (abstract). Kits were made with varying amounts of peptide Fig 1 (5, 10, 15, 20 and 25 µg), using increasing amounts of the stock solution 4 µg/ul in 0.1 M sodium acetate at pH 4.5. To these kits, the amount of 64Cu was added in 30 µl, 0.1M HCl and all other kit ingredients were constant regardless of the amount of peptide used (page 3, 2.2). Additional disclosure includes that the kit remained stable for 18 months (stored at -10oC), the longest time studied, All the kits complied with self-determined criteria of radiochemical purity (≥ 95%) (page 6, paragraph 7).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to incorporate sodium acetate buffer into Conti’s kit composition. The person of ordinary skill in the art would have been motivated to make those modification because Sushil teaches the single vial freeze dried kits, which can be radiolabeled with 64Cu with a high degree of reproducibility, provide a convenient and reliable method for facile preparation of 64Cu-TP3805 BPH DAR Histology Benign Prostate Tissue, “101-4P” for clinical use (page 8). Therefore, one of ordinary skill in the art would have a reasonable expectation of success because Sushil established a simple and robust practical kit formulation for 64Cu labeling and evaluated its characteristics for long term clinical applications.
Note: With respect to first vial containing a lyophilized powder of BaBaSar-RGD, buffer and second vial containing 64Cu solution and instructions to provide for clear use of the kit, one of ordinary skill in the art would be motivated to generate a kit for diagnostic and/or therapeutic purposes which utilizes a chelate-peptide conjugate (BaBaSar-RGD₂) and 64CuCl2 because of the ever-present need for such kits in hospitals, clinics, or other medical facilities. Thus, a skilled practitioner in the art would be motivated to place the agent(s) in one or more containers to be labeled at a desired time for use with the subject. In addition, a skilled artisan would be able to apply the procedures for generating a diagnostic and/or therapeutic kit found in Sushil et al., since the kits of Conti as modified by Sushil would have the same components as the instantly claimed kits, they would be expected to have the same properties, of shelf life as instantly claimed, since a composition and its properties are inseparable. Also, it would have been obvious to include instructions to provide for clear use of the kit.
Conclusion
No claims are allowed at this time.
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/J.R.S/Examiner, Art Unit 1618
/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618
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