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 .
Claim Status
Currently, claims 1-5, 7-8, 11, 13, 18, 22-23 and 25 are pending in the instant application. Claims 6, 9-10, 12, 19-21, and 24 have been canceled and claims 22-23 and 25 are withdrawn. This action is written in response to applicant’s correspondence submitted 11/17/2025. All the amendments and arguments have been thoroughly reviewed but were found insufficient to place the instantly examined claims in condition for allowance. The following rejections are either newly presented, as necessitated by amendment, or are reiterated from the previous office action. Any rejections not reiterated in this action have been withdrawn as necessitated by applicant’s amendments to the claims. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action. This action is Final.
Election/Restrictions
The response traverses the restriction requirement and asserts that the claims make a contribution over the cited art including Linardy and therefore the claims do not lack unity. As addressed previously the claimed DNA ensemble is not a contribution over the cited art of record, as addressed below Bi (Angew. Chem, Int, Ed, 2015, 54:8144-8148) who teaches the claimed DNA ensemble. This was previously addressed and was make final in the previous office action.
Claims 1-5, 7-8, 11, 13, and 18 are under examination.
Withdrawn Objections/Rejections
The objection to claims 2-9, 11-16, and 18-19 is withdrawn in view of the amendment to the claims.
The rejection of claims 1-9, 11-16, and 18-19 under 35 USC 112(b) is withdrawn in view of the amendment tot eh claims.
The rejection of claims 1-9, 11-16, 18-19 rejected under 35 U.S.C. 101 is withdrawn in view of the amendment to the claims.
The rejection of claims 1-9, 11-16 and 18-19 rejected under 35 U.S.C. 102(a)(1) as being anticipated by Reeve (US 6399364) is withdrawn in view of the amendment to the claims.
The rejection of claims 1-6, 8-9, 11, 13-16, and 18-19 rejected under 35 U.S.C. 102(a)(1) as being anticipated by Linardy (2016, cited on IDS) is withdrawn in view of the amendment to the claims.
Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to show 18 in figure 1, as described in the specification. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Response to Arguments
The response asserts enclosed page 1 of the figures element 18 has been added in para 49. However there is no amendment to the specification included with the response. For these reasons the objection is maintained.
New Grounds of Rejection – Necessitated by Amendment to the Claims
Claim Rejections - 35 USC § 102
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 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 1-6, 8-9, 11, 13-16, and 18-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bi (Angew. Chem. Int. Ed. 2015, 54:8144-8148)
Bi teaches two super hairpin species, SH1 and SH2, two hairpins (H1 and H2) and two single stranded assistant species (AS1 and AS2). Bi teaches a DNA initiator that comprises a trigger sequence to detect target DNA (see pg. 8145). Bi teaches the hairpins coexist with single stranded species, AS1 and AS2 until trigged by initiator. Bi teaches I-SH1 which is a detector comprising a probe strand (SH1) hybridized to a trigger DNA sequence (I). Bi teaches amplifier sequences having g hairpin configuration and a region for hybridization with a trigger DNS sequence (H1). Bi teaches a second amplifier having a hairpin configuration and a region for hybridization with open configuration of first amplifier sequence (H2). Bi teaches a key holder DNA sequence hybridized to a key sequence and comprises a region for hybridization with open configuration of first amplifier DNA sequence (SH2). Bi further teaches H1 and H2 are responders comprising a reporter for producing a single detectable to an observer and a DNA capture formation having a first configuration in which prevents activity of the reporter and second configuration in which it does not prevent activity of the reporter. Bi teaches each of the formations are attached to a common body (see scheme 1) (claims 2- 5).
With regard to claim 7, this claim limits the intended use of the claim and does not limit any structural features of the DNA formations, as such Bi anticipates the claim.
With regard to claim 8, Bi teaches a plurality of regions in the detector (SH1) for hybridization with a plurality of targets (see scheme 1).
With regard to claim 13 and 18, Bi teaches the amplifier comprises a amplifier DNA sequence, second amplifier DNA sequence and a key holder DNA sequence (see H1 and H2, scheme 1). Bi teaches release of a first and second key DNA sequence (see scheme 1).
Claims 1-5, 7-8, 11, and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yang (Analytical Chemistry, 2013, vol 85, pp. 11518-11523).
Yang teaches amplifiers comprising hairpin sequences (see H1 and H2). Yang teaches a blocking probe (I). Yang teaches a DNA nanostructure assembly based on toehold mediated DNA strand displacement using HCR with a long nicked dsDNA molecules is formed by an initiator DNA (see table 1 and pg. 11519). Yang teaches a detector comprising a probe strand hybridized to a trigger DNA sequence (see figure 1B, aptamer and blocking probes). Yang teaches adding hairpin probes (amplifiers comprising DNA sequence with hairpin configuration and comprising a key holder DNA hybridized to a key DNA sequence). Yang teaches a responder (see fluorophore for producing a signal) (aptamer, table 1) (see fig 1). Yang teaches blocking probes (claim 13) (see figure 1). Yang teaches each of the formations on a DNA formation (claims 2-5) (figure 1B).
With regard to claim 7, this claim limits the intended use of the claim and does not limit any structural features of the DNA formations, as such Yang anticipates the claim.
With regard to claim 8, Yang teaches a plurality of regions in the detector for hybridization with a plurality of targets (see fig 1B).
With regard to claim 13 and 18, Yang teaches the amplifier comprises a amplifier DNA sequence, second amplifier DNA sequence and a key holder DNA sequence (see aptamer 1-5). Yang teaches release of a first and second key DNA sequence (see fig 1B).
Conclusion
No claims are allowable.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAE L BAUSCH whose telephone number is (571)272-2912. The examiner can normally be reached M-F 9a-4p.
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/SARAE L BAUSCH/ Primary Examiner, Art Unit 1699