DETAILED ACTION
Applicant’s amendment and remarks filed July 23, 2026 are acknowledged. Any prior objection or rejection that is not repeated or addressed below is either moot or withdrawn in view of Applicant’s amendment.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 3-5 and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yang et al. (WO 2015/007293 A1, cited in the IDS filed 7/26/2023, “Yang”). The claims are summarized above and correlated with the teachings of the prior art in bold font below.
Yang discloses stem-loop silver nanocluster probes that detect miRNA in biological samples (see abstract). The probe comprises a polycytosine loop sequence consisting of from 6-12 cytosine nucleotides that function as a scaffold for silver nanoclustering, a target complementary sequence comprising at least 21 nucleotides in length, and an anchoring sequence consisting of from 2-12 nucleotides, wherein part of the anchoring sequence is complementary to the target complementary sequence (see page 2, lines 5-19) (claims 1, 3 and 4). An example of Yang’s probe is in Figure 1, reproduced below:
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Yang’s probe comprises a template nucleotide sequence for AgQC formation (“loop for AgNC”), a target-recognition nucleotide sequence (“sensor for miRNA-21”), and nucleotide sequence for intra-molecular hybridization (“forms loop in the absence of miRNA”) which has a stem-loop structure in the absence of a target nucleotide sequence and whose structure is disturbed when the target nucleotide sequence binds the sensor for miRNA-21 (claim 1, aspect of stem-loop structure). Figure 3 shows a full stem-loop structure and two partial stem-loop structures in the absence of a target nucleotide sequence. Silver clusters are disclosed (see page 10, lines 9-11) (claim 5). Target nucleotide concentration detected is, for example, 0.1 µM (100 nM) (see page 5, lines 9-13) (claim 12).
Claim 1 now recites limitations about what will happen when the sensor is used. (Hybridization of the target nucleotide sequence with the at least one target-recognition nucleotide sequence triggers a shift in fluorescence intensity between two characteristic fluorescence maxima in fluorescence spectrum of the sensor caused by either opening of the stem-loop structure, or change in AgQC environment while maintaining the stem-loop structure of the sensor.) These limitations characterize the sensor in terms of what it will do when hybridization occurs. However, the claims are products, not methods of detecting a shift in fluorescence intensity between two characteristic fluorescence maxima (as in method claim 14). Therefore, since the prior art’s sensors meet the structural limitations of the instant claims, the claims remain rejected.
In Applicant’s remarks filed July 23, 2026, Applicant argues that Yang does not teach the new limitations in claim 1 as outlined in the paragraph above. Applicant does not note any structural difference between Yang’s sensor and the instantly claimed sensor, only an intended method of use and its implications down the line. Applicant’s arguments, as they pertain to the product claims, are not persuasive.
Conclusion
Claims 6-11 and 13-16 are objected to for being dependent on a rejected claim but would otherwise be allowable if rewritten in independent form.
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.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to Stacy B. Chen whose telephone number is 571-272-0896. The examiner can normally be reached on M-F (7:00-4:30). If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Visone, can be reached on 571-270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
/STACY B CHEN/Primary Examiner, Art Unit 1672
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