DETAILED ACTION
Response to Amendment
This is a final office action in response to a communication filed on November 7, 2025. Claims 1-23 are pending in the application.
Status of Objections and Rejections
All rejections from the previous office action are withdrawn in view of Applicant’s amendment.
New grounds of rejection are presented as follows.
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.
Claim(s) 1-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Heikenfeld (WO 2022/066979) in view of Plaxco (US 2021/0196161), and further in view of Nebling (US 2011/0156722), and further in view of Sasaki (US 2009/0145780).
Regarding claim 1, Heikenfeld teaches a target molecule detection system (Fig. 6A: device 600; ¶70) comprising:
a chamber configured to contain a solution (claim 14: one or more interior chambers containing sensor fluid; Fig. 6A: sensor fluid 18) having redox tags (Fig. 6A; ¶70: redox label 640) and capture agents (Fig. 6A; ¶70: aptamer 670) bound to the redox tags (¶71: an aptamer 670 with attached redox tag 640), the redox tags are present in the solution (Fig. 6A: ¶70: redox tags 640, free in solution) in a reduced state and/or an oxidized state (¶70: electron transfer that can occur between redox tags 640 and the first and second electrodes 650, 652; i.e., the redox tags being either in reduced state or in oxidized state), the capture agents configured to bind to target molecules introduced into the solution (¶71: the redox tag 640 is less available for electron transfer with the electrodes 650, 652 in the absence of analyte binding to aptamer (left side of FIG. 6B), because of a longer diffusion time between the first and second electrodes 650, 652 where the analyte can undergo redox recycling (e.g., one electrode is a reducing electrode, one electrode is an oxidizing electrode);
an oxidation electrode (¶71: one electrode is an oxidizing electrode) configured to oxidize the redox tags present in the solution in the reduced state into the oxidized state, the oxidation electrode configured to output a first oxidation current profile in response to a first oxidation voltage pulse applied to the oxidation electrode when the solution does not contain the target molecules, the oxidation electrode configured to output a second oxidation current profile in response to a second oxidation voltage pulse applied to the oxidation electrode when the solution contains the target molecules (¶70: electron transfer 698 from the redox tags 640 in an increased amount, or frequency, or rate, when analyte 19 is bound to the aptamer 670; Examiner notes here the designation “configured to…” is deemed to be functional limitation and does not further limit the structure of the detection system); and
a reduction electrode (¶71: one electrode is a reducing electrode) spaced apart from the oxidation electrode (Fig. 6A: electrodes 650 and 652 are spaced apart) and configured to reduce the redox tags present in the solution in the oxidized state into the reduced state, the reduction electrode configured to output a first reduction current profile in response to a first reduction voltage pulse applied to reduction electrode when the solution does not contain the target molecules (¶71: the redox tag 640 is less available for electron transfer with the electrodes 650, 652 in the absence of analyte binding to aptamer (left side of FIG. 6B), because of a longer diffusion time between the first and second electrodes 650, 652 where the analyte can undergo redox recycling; ¶75: the diffusion time during each voltage pulse that is applied), the reduction electrode configured to output a second reduction current profile in response to a second reduction voltage pulse applied to the reduction electrode when the solution contains the target molecules (¶70: aptamer binding to analyte can provide changes in electron transfer and redox current (compared to baseline transfer and current - i.e., transfer/current in the absence of analyte binding), one or more electrical properties of the first and second oxidation current profiles and the first and second reduction current profiles are indicative of a presence of the target molecules (since the change in electron transfer is due to the analyte binding, thus the current profiles of the oxidation current profiles would indicate the presence of the target analyte; Examiner notes here the designation “configured to…” is deemed to be functional limitation and does not further limit the structure of the detection system).
Heikenfeld further discloses interplays of sensors, electronics, microfluidics, algorithms, computing, software, system etc. (¶7), but fails to teach a controller.
However, Plaxco teaches measurement of analytes using electrochemical sensors (title), for example, using electrochemical aptamer-based (EA-B) sensors use redox-reporter-modified, electrode-bound aptamers, wherein binding-induced conformational changes in the aptamer result in measurable changes in electron flows between the redox reporter and electrode (¶3). The system of the analyte concentration measurements include electrochemical sensors, controller which deliver electrical signals to generate current, and computer for calculating the target concentration based on the acquired, stored, and processed current decay data (¶90).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Heikenfeld by incorporating a controller for delivering electrical signals as taught by Plaxco. Here, the claimed limitations are obvious because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results. MPEP 2143(I)(A).
Heikenfeld and Plaxco do not teach the controller being programmed to determine a difference between at least one of the one or more electrical properties of the first oxidation current profile and the second oxidation current profile and between at least one of one or more electrical properties of the first reduction current profile and the second reduction current profile to detect the presence of the target molecules.
However, Nebling teaches a process for detecting one or more chemical or biological species based on a redox reaction, wherein current generated by said redox reaction is detected at at least one electrode position (¶1). The measurement principle, e.g., redox cycling, is to apply an oxidation potential and reduction potential to the two electrodes (¶11). The two currents, which are generated directly by the oxidation or reduction of the redox molecules at the electrodes, are measured (Fig. 2c; ¶11). The change over time in the added-up total current signal (sum of the amounts of oxidation current and reduction current, resulting in an increase in current over time), which corresponds to a change in the concentration of the redox mediator (¶17). Further, Sasaki teaches the substance to be detected in the sample solution can be quantitatively determined by comparing the recorded oxidation current value with a result of measurement of the oxidation current values of a standard sample (¶128).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Heikenfeld and Plaxco by programming the controller using oxidation currents of the sample and standard solution, i.e., with the presence and absence of the sample, for detecting the target as taught by Nebling and Sasaki because oxidation current is a part of the redox current (Nebling, ¶17) and used for quantitative determination of the substance to be detected (Sasaki, ¶128). Here, the claimed limitations are obvious because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results. MPEP 2143(I)(A). The combined controller of Heikenfeld, Plaxco, Nebling, and Sasaki would arrive the claimed invention of claim 1, for determining a difference between at least one of the one or more electrical properties of the first oxidation current profile and the second oxidation current profile and between at least one of one or more electrical properties of the first reduction current profile and the second reduction current profile to detect the presence of the target molecules.
Regarding claim 2, the designation “wherein a signaling process is configured to start from the oxidation electrode when the redox tags are stable in the reduced state as an initial state, or the signaling process is configured to start from the reduction electrode when the redox tags are stable in the reduced state as an initial state” is deemed to be functional limitation in apparatus claims. MPEP 2114 (II). "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). Here, Heikenfeld in view of Plaxco, Nebling, and Sasaki teaches all structural limitations of the presently claimed target molecule detection system comprising an oxidation electrode and a reduction electrode, and thus the redox tags is capable of starting from its reduced state or its oxidized state as an initial state from the oxidation electrode or the reduction electrode, respectively.
Regarding claim 3, the designation “wherein the first and second oxidation voltage pulses are equal and the first and second reduction voltage pulses are equal, and the first and second oxidation pulses are different than the first and second reduction pulses” is deemed to be functional limitation in apparatus claims. MPEP 2114 (II). "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). Here, Heikenfeld in view of Plaxco, Nebling, and Sasaki teaches all structural limitations of the presently claimed target molecule detection system comprising an oxidation electrode and a reduction electrode, and thus they are capable of being applied with equal and different voltage pulses.
Regarding claims 4-5, the designations “wherein the first and second oxidation voltage pulses are greater than an oxidation potential of the redox tags” in claim 4 and “wherein the first and second reduction voltage pulses are less than a reduction potential of the redox tags” in claim 5 are deemed to be functional limitations in apparatus claims. MPEP 2114 (II). "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). Here, Heikenfeld in view of Plaxco, Nebling, and Sasaki teaches all structural limitations of the presently claimed target molecule detection system comprising an oxidation electrode and a reduction electrode, and thus the oxidation electrode is capable of being applied with oxidation voltage pulses greater than the oxidation potential of the redox tag molecule and the reduction electrode is capable of being applied with reduction voltage pulses less than the reduction potential of the redox tag molecule.
Regarding claim 6, Heikenfeld teaches wherein the oxidation electrode and the reduction electrode are spaced apart a fixed distance (¶71: one electrode is a reducing electrode, one electrode is an oxidizing electrode, Fig. 6A: electrodes 650 and 652 are spaced apart a fixed distance).
Regarding claims 7-8, the designations “wherein the one or more electrical properties of the first and second oxidation current profiles includes a time delay onset oxidation current and a steady state oxidation current level” in claim 7 and “wherein the one or more electrical properties of the first and second reduction current profiles includes a time delay onset reduction current and a steady state reduction current level” in claim 8 are deemed to be functional limitations in apparatus claims. MPEP 2114 (II). "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). Here, Heikenfeld in view of Plaxco, Nebling, and Sasaki teaches all structural limitations of the presently claimed target molecule detection system comprising an oxidation electrode and a reduction electrode that are capable of outputting oxidation current profiles and reduction current profiles, respectively, and thus those current profiles would naturally include a time delay onset and a steady state.
Regarding claim 9, the designation “wherein the solution has a first redox tag concentration when the solution does not contain the target molecules and a second redox tag concentration when the solution contains the target molecules, and the first and second redox tag concentrations are equal” is deemed to be functional limitation in apparatus claims. MPEP 2114 (II). "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). Here, Heikenfeld in view of Plaxco, Nebling, and Sasaki teaches all structural limitations of the presently claimed target molecule detection system comprising an oxidation electrode and a reduction electrode that are capable of outputting two oxidation current profiles when the solution does not contain or contains the target molecules and two reductions current profiles when the solution does not contain or contains the target molecules, and thus they are capable of being used to detect the target molecules using the same redox tag concentration when the solution does not contain or contains the target molecules.
Regarding claim 10, the designation “wherein the one or more electrical properties of the first and second oxidation current profiles and the first and second reductions current profiles are indicative of an amount of the target molecules” is deemed to be functional limitation in apparatus claims. MPEP 2114 (II). "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). Here, Heikenfeld in view of Plaxco, Nebling, and Sasaki teaches all structural limitations of the presently claimed target molecule detection system comprising an oxidation electrode and a reduction electrode that are capable of outputting two oxidation current profiles and two reductions current profiles when the solution does not contain or contains the target molecules, and thus the output oxidation and reduction current profiles would necessarily provide the electrical property indicative of an amount of the target molecules.
Claim(s) 7-8 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Heikenfeld in view of Plaxco, Nebling, and Sasaki, and further in view of Wilsey (US 2013/0284610).
Regarding claims 7-8, Heikenfeld, Plaxco, Nebling, and Sasaki disclose all limitations of claim 1 as applied to claim 1, but fails to teach wherein the one or more electrical properties of the first and second oxidation current profiles includes a time delay onset oxidation current and a steady state oxidation current level (claim 7) or wherein the one or more electrical properties of the first and second reduction current profiles includes a time delay onset reduction current and a steady state reduction current level (claim 8).
However, Wilsey teaches determination of the glucose concentration using test strips (¶2) using electrochemical sensors (¶10). The sensor includes a mediator that is either reduced or is oxidized (¶51). Mediator electrooxidized at the working electrode can therefore diffuse rapidly to the adjacent counter electrode via radial diffusion where it is once again reduced, and oxidized mediator reduced at the counter electrode can migrate to the working electrode for electrooxidation to the oxidized form. This migration between the fingers produces a constant or 'steady state' current between the electrodes, after a short time delay, which is measured and correlated to the amount of analyte in the sample (¶51).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Heikenfeld, Plaxco, Nebling, and Sasaki by outputting the oxidation current profiles and reduction current profiles including a time delay onset followed with a steady state current level as taught by Wilsey because the oxidized and reduced mediator would have to diffuse to the reduction electrode and oxidization electrode before being reduced and oxidized once again (¶51). Here, the claimed limitations are obvious because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results. MPEP 2143(I)(A).
Regarding claim 10, Heikenfeld, Plaxco, Nebling, and Sasaki disclose all limitations of claim 1 as applied to claim 1, but fails to teach wherein the one or more electrical properties of the first and second oxidation current profiles and the first and second reductions current profiles are indicative of an amount of the target molecules.
However, Wilsey teaches determination of the glucose concentration using test strips (¶2) using electrochemical sensors (¶10). The sensor includes a mediator that is either reduced or is oxidized (¶51), and the electroactive reactions is used to detect or quantify the electroactive reaction product, which allows correlation of the amount of electroactive reaction product with the presence or concentration of analyte in the original sample (¶52).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Heikenfeld, Plaxco, Nebling, and Sasaki by using the redox reaction of the mediator, i.e., the redox molecule, for detecting presence and determining concentration of the analyte as taught be Wilsey because the electrochemical sensors using electroactive reaction of the mediator are suitable for determining presence and concentration of the analyte (¶52). Here, the claimed limitations are obvious because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results. MPEP 2143(I)(A).
Response to Arguments
Applicant’s arguments have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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 extension fee 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 CAITLYN M SUN whose telephone number is (571)272-6788. The examiner can normally be reached M-F: 8:30am - 5:30pm.
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/C. SUN/Primary Examiner, Art Unit 1795
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