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 .
Status of the Claims
Claims 12 and 22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 09/11/2025.
Claim 15 has been amended.
Claims 1-3, 5, 7-9, 11, 15, 26, 28, 31, 33, 38-39, 42, 46, and 49 are pending and are examined herein.
Priority
This application, filed 08/23/2022, is a 371 of PCT/CA2021/050270, filed 03/02/2021, which claims benefit of PRO 62/984,080, filed 03/02/2020, and PRO 63/035,338, filed 06/05/2020. This benefit is acknowledged for claims 1-3, 5, 7-9, 11, 15, 26, 28, 31, 33, 38-39, 42, and 49 and they are treated as having an effective filing date of 03/02/2020. Claim 46 does not get benefit of 62/984,080 because of the inclusion of SARS-CoV-2 spike protein, but does get benefit of 63/035,338, filed 06/05/2020. Therefore, the effective filing date of claim 46 is 06/05/2020.
Withdrawn Objections/Rejections
The rejection of claims 1-3,5,7-9,11,15,26,28,31,33,38-39,42,46 and 49 under 35 U.S.C. 112(b) is withdrawn in view of Applicant’s arguments.
The rejection of claim 15 under 35 U.S.C. 112(b) is withdrawn in view of Applicant’s amendment.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 5, 7-9, 11, 26, 28, 31, 33, 38-39, 42 and 49 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by US 2004/0146909 A1, “SIGNAL DETECTION TECHINQUES FOR THE DETECTION OF ANALYTES” (published 07/29/2004, referred to herein as Duong).
Regarding claims 1, 2, and 3, Duong teaches an electrochemical biosensor (para. 0021, lines 1-3) comprising an electrode (para. 0047, lines 1-4) and a plurality of iMPs, i.e. a self-assembled monolayer (para. 0047, lines 5-9). Duong teaches that the iMPs comprise a linker, i.e. a conductive oligomer species (para. 0059, lines 1-3), a receptor for the target analyte (para. 0136, lines 1-3) bound to the conductive oligomer (para. 0140, lines 1-5), resulting in a conductive oligomer species linker bound to the electrode on one end and the receptor on the other end (para. 0145, lines 5). Duong teaches that a redox reporter, i.e. a redox active molecule (RAM), is bound to the linker (para. 0355, lines 1-5. System 3). Duong teaches that the assay measures the faradaic impedance based on electron transfer between the redox molecule and the electrode, which depends on the distance between the redox molecule and the electrode (para. 0376, lines 1-4). Duong teaches that the faradaic impedance changes in response to binding of the analyte (para. 0355, lines 5-9).
Regarding claims 5 and 7, these claims are considered functional limitations of the biosensor. In this case, any biosensor with the claimed structural components of claim 1 is considered to be capable of doing the functions recited in claims 5 and 7, i.e. having a change in electron transfer rate from the redox reporter to the electrode in response to movement of the reporter toward or away from the electrode. Duong teaches the biosensor structure characterized by an electrode, linker, redox reporter, and receptor as described regarding claim 1. Further, Duong teaches movement of the redox reporter towards and away from the electrode in response to being in a bound or unbound state as described regarding claims 2 and 3; therefore, the structure taught by Duong anticipates the functional limitations of claims 5 and 7 for being capable of performing the claimed functions.
Regarding claim 8, Duong teaches that the redox reporter, i.e. the ETM, contacts the electrode where it can then be detected (para. 0028, lines 13-20).
Regarding claim 9, Duong teaches that the redox reporter is covalently bound to the linker (System 3, para. 0354, lines 6-12).
Regarding claim 11, Duong teaches that the linker comprises double stranded DNA (para. 0042, lines 1-4).
Regarding claim 26, Duong teaches that the receptor, i.e. the binding ligand, will depend on the analyte and could comprise an antibody, an aptamer, a receptor, or an enzyme (para. 0138, lines 27-33).
Regarding claim 28, Duong teaches that the receptor is an IL-6 receptor protein (para. 0138, lines 41-43).
Regarding claim 31, Duong teaches that the electrode comprises a gold electrode (para. 0047, lines 1-4).
Regarding claim 33, Duong teaches a method providing the electrochemical biosensor, contacting the biosensor with a sample containing the analyte, and detecting the electrochemical signal to indicate the presence of the target analyte (para. 0010, lines 1-11).
Regarding claim 38, Duong teaches the target analyte is a protein (para. 0138, line 17).
Regarding claim 39, Duong teaches the target analyte is troponin T protein (para. 0034, line 44).
Regarding claim 42, Duong teaches that the target analyte is an anti-coronavirus antibody (para. 0034, lines 15-19).
Regarding claim 49, Duong teaches a device comprising a collector for receiving the sample (para. 0514, lines 1-4) comprising the biosensor electrode (para. 0514, lines 3-6) connected to a measuring electrode (para. 0514, lines 3-6) to allow contact between the biosensor and the sample (para. 0514, lines 7-10).
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.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Duong.
Regarding claim 15, Duong teaches that the linker can be a double-stranded (para. 0042, lines 1-3) peptide-nucleic acid strands (para. 0041, lines 1-2). Duong teaches that the linker can be modified with recruitment polymers containing lysine (para. 0248, lines 3-7). Duong teaches that the recruitment polymer can be used to attach the electron transfer molecule (ETM), i.e. methylene blue (para. 0190, line 13) to the linker (para. 0246, lines 1-4).
However, Duong does not directly teach these components in a single embodiment.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the double stranded PNA with a lysine recruitment polymer to attach methylene blue. An artisan would be motivated to combine these components in a biosensor because the use of a PNA duplex modified with lysine with a methylene blue reporter in a biosensor for the detection of analytes is consistent with the expected purpose and function of each component taught by Duong. An artisan would have a reasonable expectation of success because Duong teaches that these components can be combined to make a biosensor to detect analytes and an artisan would be reasonable motivated to pick and choose components taught by Duong based on availability.
Claim 46 is rejected under 35 U.S.C. 103 as being unpatentable over Duong in view of Song et al., “Discovery of Aptamers Targeting Receptor-Binding Domain of the SARS-CoV-2 Spike Glycoprotein” ChemRxiv (published 04/04/2020, referred to herein as Song).
Regarding claim 46, Duong teaches a biosensor with a duplex (para. 0042, lines 1-3) PNA (para. 0041, lines 1-2) with a methylene blue redox reporter (para. 0190, line 13). Duong teaches that this biosensor can have a receptor for detecting coronavirus (para. 0034, lines 15-19).
Duong does not teach a biosensor with a receptor for the specific detection of the SARS-CoV-2 spike protein.
However, Song teaches an aptamer for the detection of SARS-CoV-2 spike protein (p.1, col. 2, para. 2, lines 1-2). Song teaches that detection of the SARS-CoV-2 spike protein is a key target for the diagnosis of SARS-CoV-2 infection (p. 1, col. 1, para. 2, lines 9-11).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the biosensor taught by Duong by using the SARS-CoV-2 spike protein detection aptamer taught by Song. Doing so would enable the detection of SARS-CoV-2 in a sample, which is important for the diagnosis of SARS-CoV-2 infection, as taught by Song (p. 1, col. 1, para. 2, lines 9-11). An artisan would have a reasonable expectation of success because aptamer-based detection of proteins is routine in the art of biochemical protein detection.
Response to Arguments
Applicant's arguments filed 02/19/2026 have been fully considered but they are not persuasive for the following reasons:
Regarding the remarks on pages 8 and 9 regarding the rejections under 35 U.S.C. 112(b), the rejections are been withdrawn in view of Applicant’s amendment and arguments.
Regarding the remarks on pages 7 regarding the withdrawal of claim 12, the election of the redox reporter species comprising methylene blue in the reply dated 09/11/2025 without traverse was indicated in the previous Office Action. As currently elected, claim 12 is not directed to the invention as elected comprising methylene blue. Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 12 is withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
The election of the methylene blue redox reporter shall be treated as a final election; although election of a redox reporter in claim 12 could have been proper when selecting PNA/PNA as the linker species. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Regarding the remarks on pages 10 and 11, Applicant argues that Duong does not teach charged, field-responsive pendulums that enable states with differing electron field transfer rates under an applied electric field.
This argument is not persuasive. Duong teaches an electrochemical biosensor comprising a plurality of structures with a charged linker bound to an electrode surface, a receptor for a target analyte bound to the linker, and a redox reporter bound to the linker, as described in detail above in the rejection under 35 U.S.C. 102. The use of an electric field, whether described in the prior art or not, is considered an intended use without conveying any structural significance. In this case, the nucleic acid linker attached to an electrode, an antibody, and a methylene blue reporter, as described by Duong, is considered to be the same as the claimed device and is considered to be able to function in the same way. Applicant is respectfully reminded that the claims are directed to the structure of the biosensor and not a method of using the structure.
Further regarding the remarks on page 11, Applicant argues that the functional characteristics of the linker and redox active molecules described by Duong is different than presented in the claims.
This argument is not persuasive. The nucleic acid linker and the methylene blue redox molecules taught by Duong are structurally identical to the claimed structure and is considered to be able to have the same function.
Regarding the remarks on pages 11 and 12, Applicant argues that Duong teaches a mechanism utilizing faradaic impedance-based state-dependent rates rather than dynamic displacement under an applied field.
This argument is not persuasive. This argument is directed to a difference in the method of using the claimed device rather than illustrating a difference in the structure of the device taught in the prior art.
Conclusion
No claims are allowable.
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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/C.E./Examiner, Art Unit 1677
/BAO-THUY L NGUYEN/Supervisory Patent Examiner, Art Unit 1677 March 24, 2026