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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/08/2026 has been entered.
Response to Amendment
Regarding the Office action mailed 10/08/2025, all rejections set forth therein are withdrawn in view of the amendment. New grounds of rejection are set forth below.
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.
Claims 1, 2, 3, 8, 13, 16, 17, 18, 21, 26, 27, 37, 72 and 88 are rejected under 35 U.S.C. 103 as being unpatentable over Dudani (WO 2019/075292 A1).
Dudani disclosed a nanosensor library comprised of peptide substrates, each peptide conjugated to FRET pair (FAM and CPQ2; claims 3, 8, 13) for detecting protease activity. See page 35, last paragraph and page 36, Table 6, first row, indicating the 58 peptide substrates and the general structure. See figure 3, illustrating how, when the peptide (which is 11 amino acids in this case; see also peptide substrates disclosed on page 3; claims 17 and 18) binds to a protease (which is a protein; claim 16), the peptide is cleaved and fluorescence of FAM is unquenched (i.e., FRET from the donor (FAM) to the acceptor (CPQ2) decreases or stops; claims 1 and 2). At page 37, Dudani notes: “For use in vivo, the peptides maybe conjugated to a nanoparticle having robust accumulation in the prostate abilities.” To that end, Dudani tested three such particles: a multivalent PEG and two iron oxide carriers, noting that “a multivalent PEG polymer accumulated more in the prostate, and less in spleen and liver. Thus, the peptide substrates were conjugated to a PEG core and their cleavage profile was tested.” As shown in Table 7 (pages 37-38), each peptide substrate was conjugated to its own PEG carrier (see also page 2, lines 3-6). Thus, for a given sensor, all of the TBMs of the sensor system bind to the same target (claim 21). The purpose of the library of sensors was for diagnosis and classification of prostate cancer (page 35). Thus, the protease targets of the peptides represent gene products indicative or predictive of cancer (claims 26 and 27).
Dudani disclosed the substrate could be attached to the scaffold (such as PEG) directly (e.g. via a peptide bond, which is a covalent bond; claim 37), though Dudani also contemplated non-covalent linkage (page 20, lines 25-32).
Figure 5 illustrates the in vivo study with the 40 kDa “Multiam [sic, Multi-arm] PEG” and the two differently-sized iron oxide particles. See also page 6, lines 6-9.
Dudani disclosed the multi-arm PEG could comprise from 2-20 arms (page 2, lines 23-29; paragraph spanning pages 11-12), and a particular example of 8 arms (figure 6).
Dudani disclosed administering the nanosensors to a subject, and obtaining a sample from the subject containing the detectable markers released by the prostate protease nanosensors (page 3, last paragraph). See also figure 1A, where nanosensors are injected into a subject (thus, “implanted”; claim 72). See also page 39, where an in vivo protease activity imaging study was performed using a red-shifted FRET pair, and see page 4, line 23 where Dudani disclosed the detection could be performed by “optical imaging” (which means the signal was detectable by an optical camera; claim 88).
The only reason this rejection is not being made under 35 USC 102(a)(1) is because, in the particular example discussed on page 37, Dudani did not explicitly state that the peptide substrates were conjugated to a three-arm, four-arm or 8-arm PEG.
However, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the application to use three-arm, four-arm or 8-arm PEG for conjugating the peptides, since these were within the range taught by Dudani. MPEP 2144.05: “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists.”
Conclusion
Claims 4, 10, 11, 31, 32 and 89 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL C WOOLWINE whose telephone number is (571)272-1144. The examiner can normally be reached 9am-5:30pm.
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/SAMUEL C WOOLWINE/Primary Examiner, Art Unit 1681