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 .
Response to Amendment
The amendment filed June 23, 2026 has been entered.
Claims 1-8, 10-11, and 13-21 remain pending and examined in the application. Claim 22 is newly added and is pending and examined.
Applicant’s amendments to the Claims have overcome each and every objection and most of the 112(b) rejections previously set forth in the Non-Final Office Action mailed Mach 24, 2026. However, new claim objections have been raised, as detailed in the Claim Objections section in the instant Office Action below, and one 112(b) rejection remains outstanding, as detailed in the Claim Rejections-35 USC 112 section in the instant Office Action below.
Based on Applicant’s amendments and remarks, the previous prior art rejection has been modified to address the claim amendments.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 6/23/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 3, 16, and 20 are objected to because of the following informalities:
Regarding claim 3, Lns. 1-3 recite, “wherein the reactive sulphur group is a thiol and/or the reactive silicon group is a silane.” However, claim 1 recites “a reactive sulphur or silicon group”, not “a reactive sulphur and/or silicon group”. Therefore, the two phrases do not correspond grammatically. The above limitation needs to be amended to recite, “wherein the reactive sulphur group is a thiol or the reactive silicon group is a silane”.
Examiner’s Note: in order to overcome the above objection, claim 1 could be alternately amended to recite, “a reactive sulphur and/or silicon group”, and claim 3 can remain as currently constructed.
Regarding claim 16, Ln. 4 recites, “the biological agent”. While claim 1, which claim 16 depends on, provides sufficient antecedent basis for “the biological agent”, since this is the first time the biological agent has been recited within claim 16, which is a hybrid claim, this instance of biological agent in claim 16 should be recited as, “a biological agent”.
Regarding claim 20, Lns. 1-2 recite, “wherein the biological agent is a macromolecule, which is captured by the electrochemical biosensor is ACE-2…”, which is grammatically incorrect. The above limitation needs to be amended to recite, “wherein the biological agent which is captured by the electrochemical biosensors is a macromolecule that is ACE-2” to be grammatically correct.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 16-22 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 16, the claim states that it is a method of detecting a target analyte, but does not positively recite an actual step where the target analyte is bound to the biological agent. Rather, the claim merely recites, “the target analyte is capable of binding to the biological agent”. Therefore, it is unclear how the target analyte interacts with the biosensor, such that the biosensor is capable of detecting the target analyte. Further clarification is needed.
Examiner’s Note: the Examiner recommends amending claim 16 to recite, “and detecting the target analyte that has bound to the biological agent”, in order to overcome the above 112(b) rejection.
Claims 17-22 are rejected as depending on a rejected claim.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-8, 16-18, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Chou et al. (US Pub. No. 2016/0025634; hereinafter Chou; already of record) in view of Park et al. (US Pub. No. 2019/0331605; hereinafter Park; already of record).
Regarding claim 1, Chou discloses an electrochemical biosensor for use in detecting a target analyte ([0013], [[0078]). The biosensor comprises:
at least one detection electrode comprising a surface coated with a self-assembled monolayer (SAM), wherein the SAM comprises, consists essentially of, or consists of a molecule bound to the surface of the electrode through a reactive sulphur or silicon group present on the molecule ([0102], gold is an electrode, and is therefore capable of functioning as a detection electrode, [0142]-[0151]).
A biological agent captured by the SAM ([0039], [0142]-[0151]).
Chou fails to explicitly disclose that the molecule is a hydrofluorocarbon or fluorocarbon molecule.
Park is in the field of forming self-assembled monolayers on substrates (Park [0091]), and is therefore reasonably pertinent to the problem faced by the inventor. Park teaches a hydrofluorocarbon or fluorocarbon molecule having a reactive thiol group, where the fluorocarbon or hydrofluorocarbon molecule is 1H,1H,2H,2H-Perfluorodecanethiol (Park; [0091], [0095]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the biosensor of Chou with the teachings of Park so that the molecule is a hydrofluorocarbon or fluorocarbon molecule, where the fluorocarbon or hydrofluorocarbon molecule is 1H,1H,2H,2H-Perfluorodecanethiol, as Park teaches that 1H,1H,2H,2H-Perfluorodecanethiol can be used to form a self-assembled monolayer on a gold surface (Park; [0091], [0095]), and Chou is concerned with formed self-assembled monolayers on a gold surface (Chou; [0102], [0142]-[0151]). Further, hydrofluorocarbons/fluorocarbons such as 1H,1H,2H,2H-Perfluorodecanethiol are hydrophobic, and Chou teaches that a self-assembled monolayer may have a hydrophobic surface (Chou [0150]), such that using the 1H,1H,2H,2H-Perfluorodecanethiol as in Park may be desirably advantageous.
Note: with regards to the biosensor being an electrochemical biosensor for use in detecting a target analyte, see MPEP 2111.02, which states that, “if the body of a claim fully and intrinsically sets forth all the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction.”
Regarding claim 2, modified Chou discloses the electrochemical biosensor according to claim 1. Modified Chou further discloses that the hydrofluorocarbon or fluorocarbon molecule is a linear, branched or cyclic alkane, alkene or alkyne molecule having a single or multiple reactive sulphur or silicon groups (see Claim 1 above at Park teaching the claimed molecule in [0091], [0095]).
Regarding claim 3, modified Chou discloses the electrochemical biosensor according to claim 1. Modified Chou further discloses that the reactive sulphur group is a thiol and/or the reactive silane group is a silane group (see Claim 1 above at Park teaching the claimed molecule in [0091], [0095]).
Regarding claim 4, modified Chou discloses the electrochemical biosensor according to claim 1. Modified Chou further discloses that the fluorocarbon molecule is a linear fluoro alkanethiol, or a linear fluoro alkanesilane (see Claim 1 above at Park teaching the claimed molecule in [0091], [0095]).
Regarding claim 5, modified Chou discloses the electrochemical biosensor according to claim 4, wherein the linear fluoro alkanethiol, or linear fluoro alkanesilane is 1H,1H,2H,2H-Perfluorodecanethiol (see Claim 1 above at Park teaching the claimed molecule in [0091], [0095]).
Regarding claim 6, modified Chou discloses the electrochemical biosensor according to claim 4, wherein the linear fluoro alkanethiol is 1H,1H,2H,2H-Perfluorodecanethiol (see Claim 1 above at Park teaching the claimed molecule in [0091], [0095]).
Regarding claim 7, modified Chou discloses the electrochemical biosensor according to claim 1. Modified Chou further discloses that the electrode surface is formed from a glassy carbon; metal oxide; conducting polymer; or noble metal (Chou [0102]).
Regarding claim 8, modified Chou discloses the electrochemical biosensor according to claim 7. Modified Chou further discloses that the electrode surface is gold (Chou [0102]).
Regarding claim 16, modified Chou discloses the electrochemical biosensor according to claim 1. Modified Chou further discloses a method of detecting a target analyte, the method comprising incubating a sample comprising the target analyte with the electrochemical biosensor (Chou; [0039], [0142]-[0151], [0190]), The target analyte is capable of binding to a biological agent (Chou; [0039], [0142]-[0151], [0190]).
Regarding claim 17, modified Chou discloses the method according to claim 16. Modified Chou further discloses that the target analyte is a chemical or biological molecule (Chou [0084]).
Regarding claim 18, modified Chou discloses the method according to claim 16. Modified Chou further discloses that the target analyte is free within the sample, or is part of a cell, cell membrane, or virus coat, in which the target analyte is found in situ (Chou; [0084], [0190], the target proteins are free within the sample being analyzed).
Regarding claim 22, modified Chou discloses the method of claim 17. Modified Chou further discloses that the chemical is a hormone, narcotic or pollutant; and/or the biological molecule is a peptide, protein, glycoprotein, enzyme, glycolipid, cell surface receptor, cytokine, antibody, or nucleic acid (Chou [0084]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Chou in view of Park as applied to claims 1-8, 16-18, and 22 above, and further in view of Budach et al. (US Pat. No. 6,707,561; hereinafter Budach; already of record).
Regarding claim 10, modified Chou discloses the electrochemical biosensor according to claim 1.
Modified Chou fails to explicitly disclose that the biological agent is captured by physisorption to the SAM layer.
Budach is in the analogous field of sensors (Budach Col. 1 Lns. 5-14). Budach teaches a biological agent that captured by physisorption to a SAM layer (Budach; Col. 13 Lns. 21-48, specifically Lns. 30-33, Col. 13 Ln. 60-Col. 14 Ln. 2). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the electrochemical biosensor of modified Chou with the teachings of Budach so that the biological agent is captured by physisorption to the SAM layer, as Budach teaches that antibodies can be attached by physisorption to a SAM (Budach; Col. 13 Lns. 21-48, specifically Lns. 30-33, Col. 13 Ln. 60-Col. 14 Ln. 2), and Chou suggests that antibodies can be used as capture agents (Chou [0039]). Further, Budach teaches that hydrophobic alkyl chains can render a surface of a device hydrophobic and enable the physisorption of antibodies (Budach Col. 13 Ln. 60-Col. 14 Ln. 2), meaning that the 1H,1H,2H,2H-Perfluorodecanethiol taught by Park (Park [0095]), which is a hydrophobic alkyl chain, can be suitably used for the physisorption of antibodies, particularly as Chou teaches that a self-assembled monolayer may have a hydrophobic surface (Chou [0150]), such that using the 1H,1H,2H,2H-Perfluorodecanethiol as in Park would be desirably advantageous. The biosensor of Chou as modified by Park and Budach would therefore be capable of capturing biological agents by both covalent bonding and by physisorption, which is compatible with Budach, which teaches that capture molecules can be bound either covalently or by physisorption (Budach Col. 13 Lns. 21-48).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Chou in view of Park as applied to claims 1-8, 16-18, and 22 above, and further in view of Hanson (US Pub. No. 2009/0324834; already of record) and Budach.
Regarding claim 11, modified Chou discloses the electrochemical biosensor according to claim 1.
Modified Chou further discloses a method of making the electrochemical biosensor, the method comprising: providing an electrode and a hydrofluorocarbon or fluorocarbon molecule comprising a reactive sulphur or silicon group suitable for binding to the surface of the electrode (see Claim 1 above at Chou teaching the electrode in [0102], [0142]-[0151], and Park teaching the hydrofluorocarbon or fluorocarbon molecule in [0091], [0095]).
Modified Chou fails to explicitly disclose a method of making the electrochemical biosensor, the method comprising:
forming a SAM on a surface of at least one detection electrode, by contacting the surface of the at least one detection electrode with a solution comprising an organic solvent and the hydrofluorocarbon or fluorocarbon molecule, allowing the solvent to evaporate and the SAM to form on the surface of the at least one detection electrode, and contacting the SAM coated electrode with a solution comprising a biological agent and allowing the biological agent to be captured by the SAM layer coated on the electrode.
Hanson is in the field of forming coatings on metallic substrates (Hanson [0002]), and is therefore reasonably pertinent to the problem faced by the inventor. Hanson teaches a method comprising: forming a SAM on a surface of at least one substrate, by contacting the surface of the at least one substrate with a solution comprising an organic solvent and a hydrofluorocarbon or fluorocarbon, and allowing the solvent to evaporate and the SAM to form on the surface of the at least one substrate (Hanson; [0004]-[0009], [0038]-[0039]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the biosensor of modified Chou with the teachings of Hanson to include a method of making the electrochemical biosensor, the method comprising: forming a SAM on a surface of at least one detection electrode, by contacting the surface of the at least one detection electrode with a solution comprising an organic solvent and a hydrofluorocarbon or fluorocarbon molecule comprising a reactive sulphur or silicon group suitable for binding to the surface of the electrode, and allowing the solvent to evaporate and the SAM to form on the surface of the at least one detection electrode to form a SAM coated electrode. The motivation would have been to be able to form a substantially continuous coating of SAM on the detection electrode (Hanson; [0004]-[0009], [0038]-[0039]).
Modified Chou fails to explicitly disclose contacting the SAM coated electrode with a solution comprising a biological agent and allowing the biological agent to be captured by the SAM layer coated on the electrode.
Budach is in the analogous field of sensors (Budach Col. 1 Lns. 5-14). Budach teaches contacting a SAM coated substrate with a solution comprising a biological agent and allowing the biological agent to be captured by the SAM layer coated on the substrate (Budach Col. 24 Ln. 37-Col. 25 Ln. 10). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of modified Chou with the teachings of Budach so that the method includes contacting the SAM coated electrode with a solution comprising the biological agent and allowing the biological agent to be captured by the SAM layer coated on the electrode, as Budach teaches that this method can be used to immobilize an antibody to a SAM (Budach Col. 24 Ln. 37-Col. 25 Ln. 10), and Chou suggests that antibodies can be used as capture agents (Chou [0039]).
Claims 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Chou in view of Park as applied to claims 1-8, 16-18, and 22 above, and further in view of Bhansali et al. (US Pub. No. 2017/0059561; hereinafter Bhansali; already of record).
Regarding claim 13, modified Chou discloses the electrochemical biosensor according to claim 1.
Modified Chou fails to explicitly disclose at least one reference and/or counter electrode electrically coupled to said at least one detection electrode.
Bhansali is in the analogous field of electrochemical sensors (Bhansali [0009]). Bhansali teaches at least one reference and/or counter electrode electrically coupled to a detection electrode (Bhansali [0011]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the biosensor of modified Chou with the teachings of Bhansali to include at least one reference and/or counter electrode electrically coupled to said at least one detection electrode, as Bhansali teaches that such an arrangement can be used to create an electrochemical immunosensing substrate (Bhansali [0011]), particularly as Chou establishes that its device can be used to detect substances using electrochemiluminescence (Chou [0084]).
Regarding claim 14, modified Chou discloses the electrochemical biosensor according to claim 1.
Modified Chou fails to explicitly disclose that the biosensor further comprises at least one reference and/or counter electrode and wherein each electrode is provided on a substrate.
Bhansali teaches a biosensor that comprises at least one reference and/or counter electrode and that each electrode is provided on a substrate (Bhansali [0011]). Each electrode is in the form of a microelectrode (Bhansali; [0011], [0095]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the biosensor of modified Chou with the teachings of Bhansali so that the biosensor comprises at least one reference and/or counter electrode and that each electrode is provided on a substrate, and the sensor is provided in the form of microelectrodes, as Bhansali teaches that such an arrangement can be used to create an electrochemical immunosensing substrate (Bhansali; [0011], [0095]), particularly as Chou establishes that its device can be used to detect substances using electrochemiluminescence (Chou [0084]).
Regarding claim 15, modified Chou discloses the electrochemical biosensor according to claim 14. Modified Chou further discloses that each electrode is provided in the form of a microelectrode (see Claim 14 above at Bhansali teaching the electrodes in the biosensor being in the form of microelectrodes in [0011], [0095]).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Chou in view of Park as applied to claims 1-8, 16-18, and 22 above, and further in view of Holmes et al. (US Pub. No. 2011/0093249; hereinafter Holmes).
Regarding claim 19, modified Chou discloses the method according to claim 18.
Modified Chou fails to explicitly disclose that the target analyte is a virus coat protein.
Holmes is in the analogous field of virus detection (Holmes [0163]). Holmes teaches a virus coat protein as a target analyte (Holmes [0163]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of modified Chou with the teachings of Holmes so that the target analyte is a virus coat protein, as Holmes teaches that detecting a virus coat protein will allow for the detection of particular virus strains (Holmes [0163]).
Claims 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Chou in view of Park as applied to claims 1-8, 16-18, and 22 above, and further in view of Kim et al. (US Pub. No. 2023/0160895; hereinafter Kim; already of record).
Regarding claim 20, modified Chou discloses the method according to claim 16.
Modified Chou fails to explicitly disclose that the biological agent which is captured by the electrochemical biosensors is a macromolecule that is ACE-2 and the target analyte is SARS-CoV-2 or a coat protein thereof.
Kim is in the analogous field of biological detection kits (Kim [0001]). Kim teaches ACE-2 as a biological agent that is captured by a sensor (Kim; [0052]-[0053], [0094], see Fig. 1b), and SARS-CoV-2 as a target analyte, where the SARS-CoV-2 is COVID-19 (Kim; [0052]-[0053], [0059], [0094], see Fig. 1b). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of modified Chou with the teachings of Kim so that the biological agent which is captured by the electrochemical biosensors is a macromolecule that is ACE-2 and the target analyte is SARS-CoV-2 or a coat protein thereof, and that the SARS-CoV-2 is COVID-19. The motivation would have been that ACE-2 is a protein that can be used to detect COVID-19 (Kim; [0052]-[0053], [0059], [0094], see Fig. 1b), and Chou has previously established that proteins are suitable capture agents for target analyte detection (Chou [0039]). Further, being able to detect COVID-19 in an infected patient would allow for subsequent treatment of the patient.
Regarding claim 21, modified Chou discloses the method according to claim 20, wherein the SARS-CoV-2 is COVID-19 (see Claim 20 above at Kim teaching COVID-19 in [0052]-[0053], [0059], [0094], see Fig. 1b).
Response to Arguments
Applicant's arguments filed June 23, 2026 have been fully considered but they are not persuasive.
Applicant argues on Pgs. 10-13 of their Remarks that, as Chou teaches a SAM that comprises a head group that binds to the nanoparticle surface, a terminal group that binds to the capture agent, and a chain that acts as a spacer between the nanoparticle and capture agent, while Park is drawn to an SAM without the head group, terminal group, and spacer features, that Park cannot be combined with Chou to arrive at the claimed invention. The Applicant argues that the SAM of Park is not used for capturing biological agents as in Chou, and is therefore not suitable for combination with Chou. The Examiner respectfully disagrees. Park is not relied upon to teach the binding of the SAM to a capture agent, as this has previously been taught by Chou. Park is relied upon to teach different kinds of molecules that can be used in the SAMs, specifically as the spacer chain as in Chou. It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to try the SAMs of Park in the device of Chou, where the SAMs of Chou already teach the capture agent and functional group, for the reasons previously stated in the Non-Final Office Action, i.e. Chou teaches that a self-assembled monolayer may have a hydrophobic surface, such that using the 1H,1H,2H,2H-Perfluorodecanethiol as in Park may be desirably advantageous. Essentially, Park is relied upon to teach what the spacer is, and this spacer is incorporated into the SAM of the device of Chou, resulting in the claimed invention.
Further, regarding Applicant’s arguments on Pgs. 13-14 of their Remarks that the SAMs described in Budach as suitable for physisorption of capture elements do not have the functionality required by Chou to bind to a nanoparticle at one end and a capture agent at the other end. The Examiner respectfully disagrees, as Chou teaches that SAMs may be hydrophobic, and Budach teaches that hydrophobic alkyl chains can render a surface of a device hydrophobic and enable the physisorption of antibodies, which would mean that the 1H,1H,2H,2H-Perfluorodecanethiol taught by Park, which is a hydrophobic alkyl chain, can be suitable used for the physisorption of antibodies. The biosensor of Chou as modified by Park and Budach would therefore be capable of capturing biological agents by both covalent bonding and by physisorption, which is compatible with Budach, which teaches that capture molecules can be bound either covalently or by physisorption. For a more detailed explanation, please see the rejection of Claim 10 in the Claim Rejections-35 USC 103 section of this instant Office Action.
Conclusion
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.
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/JOHN MCGUIRK/Examiner, Art Unit 1798
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