DETAILED ACTION
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 .
Election/Restrictions
Applicant’s election of Group I and Species A1 and B1, claims 1-5, 7-9, 12, 16-19, and 28-29 in the reply filed on June 3, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Information Disclosure Statement
It should be noted that the Applicant has submitted an exorbitant amount of prior art on numerous PTO-1449's which, on initial consideration, do not all appear to have relevancy or pertinence to the instant invention as claimed. The Applicant is requested in response to this office action to point out which of these numerous prior art are pertinent or relevant to the patentability of the invention as claimed in this instant application. It should be noted that it would be advantageous to the Applicant to provide a concise explanation of why each of the prior art is being submitted and how it is understood to be relevant. "Concise explanations are helpful to the Office, particularly where documents are lengthy and complex and Applicant is aware of a section that is highly relevant to patentability or where a large number of documents are submitted and Applicant is aware that one or more are highly relevant to patentability." (See MPEP 609 under subheading "A. CONTENT" and 37 CFR 1.98(b)(5)).
Claim Objections
Claim(s) 7 is/are objected to because of the following informalities:
Claim 7, lines 6-7: “if the biosensing readout system” should be “of the biosensing readout system”
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.
Claim(s) 1-5, 7-9, 12, 16-19, and 28-29 is/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 pre-AIA the applicant regards as the invention.
Claim 1 recites the limitation "isolate the reference electrode" in line 8. It is unclear how a core potentiostat circuit isolates the reference electrode. In light of the specification, the core potentiostat circuit comprises a voltage follower (VF) that is used to isolate and prevent the flow of current through the RE, thereby ensuring the RE to provide a stable reference (PGpub ¶169). It is suggested to be “prevent the flow of current through the reference electrode” to avoid the confusion on whether the RE is physically isolated or not.
Claim 1 recites “various different types of excitation signals” in line 12. It is unclear how many and what types of excitation signals are included.
Dependent claim(s) 2-5, 7-9, 12, 16-19, and 28-29 is/are rejected based on rejected claim 1.
Claim 4 contains the trademark/trade name Arduino. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe the microcontroller unit and, accordingly, the identification/description is indefinite.
Claim 7 recites “various integrated circuits” in line 6. It is unclear how many and what integrated circuits are included.
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 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claim(s) 1, 3, 17, and 28-29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hall (US 2018/0303386) in view of Prasad (US 2015/0114850).
Regarding claim 1, Hall teaches a portable biosensing readout system (¶5: a smartphone or wearable device comprising an integrated reconfigurable biosensor) for analyzing a sample (¶5: for performing test), the portable biosensing readout system comprising:
a biosensor comprising a working electrode, a reference electrode and a counter electrode (Fig. 14(a): the part of biosensor comprising RE, CE, and WE1-2; ¶139);
a core potentiostat circuit coupled to the biosensor (Fig. 14(a): Potentiostat), the core potentiostat circuit having one or more amplifiers (Fig. 14(a): showing one amplifier) configured to:
inject an excitation signal into the biosensor (Fig. 11; ¶147: a voltage signal is applied to the three electrode sensor between the RE and the WE, with the CE supplying the current to set the solution potential);
isolate the reference electrode (¶148: the input bias current of the RE circuitry must be minimized; chosen specifically for the potentiometric mode); and
an output signal from the biosensor (¶147: generates a current signal in the solution that is measured at the WE; also see ¶149: in the potentiometric mode, the voltage generated between two electrodes in a solution is measured);
a microcontroller unit in communication with the core potentiostat circuit (Fig. 14(a): µC; ¶153: microcontroller), the microcontroller unit being configured to:
generate various different types of excitation signals that are transmitted to the core potentiostat circuit and, subsequently, to the biosensor (¶153: the microcontroller configures the potentiostat with the proper settings; and thus the biosensor; also see Fig. 14(a); the measurement is from electrodes of the biosensor, e.g., ¶150: small signal voltage sinusoids can be applied);
receive the output signal from the core potentiostat circuit (¶117: the microcontroller handles communication and controls the potentiostat to run electrochemical technique, e.g., ¶151: VOUT is read by the ADC); and
communicate the output signal to an external computing device (¶117: the microcontroller handles communication; ¶108: the reconfigurable biosensor may be capable of high-speed communication with its host device (smartphone or wearable) and may have the flexibility to interface with external test chips or electrodes functionalized for a specific task); and
a peripheral instrument for processing the sample, the peripheral instrument being in communication with the microcontroller unit to receive instructions from the microcontroller that control the peripheral instrument (¶105: external bio-sensing peripherals for smartphones that interface via the I/O ports).
Hall discloses the potentiostat configuration for amperometric mode, a generated current signal is measured at the WE (¶147), and in the potentiometric mode, the voltage generated between two electrodes in a solution is measured (¶149). Hall does not disclose converting current of an output signal from the biosensor to voltage.
However, Prasad teaches a flowchart of detection using a handheld potentiostat (Fig. 9; ¶76). The microcontroller applies an electrical signal to the working electrode and reference electrode (Fig. 9; ¶76: step 402); and receives a reference signal from the working electrode (Fig. 9; ¶76: step 404). The read current signal from step 406 is amplified and converted to voltage signal (Fig. 9; ¶76: step 408), which is then converted to digital voltage signal (Fig. 9; ¶76: step 410) to be compared with the calibration data (Fig. 9; ¶76: step 412).
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 Hall measuring a current signal using a potentiostat to be converted into a voltage signal as taught by Prasad because it is known in the art for molecular detection using potentiostat via converting an amplified current signal to a voltage signal. 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 3, Hall teaches wherein the output signal from the biosensor is an electrochemical signal (¶10: the biosensor comprising the potentiostat adapted to perform a plurality of electrochemical detection techniques).
Regarding claim 17, Hall teaches wherein the core potentiostat circuit is configured to perform multiplexed measurements (Fig. 3(a); ¶126: strategically placed multiplexers allow the circuit to be switched at nodes that do not affect performance).
Further, the limitation “configured to perform multiplexed measurements” is functional limitation in apparatus claims. MPEP 2114 (II). 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).
Regarding claim 28, Hall teaches wherein the analyzing of the sample is by square wave voltammetry (¶13).
Regarding claim 29, Hall teaches wherein the microcontroller unit is configured to control a sampling rate of the excitation signal (¶153: The microcontroller controls the potentiostat during testing by updating and sampling from the proper DAC and ADC channels respectively).
Claim(s) 2 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hall in view of Prasad, and further in view of Hassibi (US 2019/0323070).
Regarding claims 2 and 19, Hall and Prasad discloses all limitations of claim 1. Hall further discloses the potentiostat has two working electrodes (WE) and two tests can be run in parallel simultaneously on the same sample to compensate for factors such as temperature variation (¶125), but fail to teach wherein the peripheral instrument is a heater (claim 2) or wherein the peripheral instrument is a heater configured to heat the sample (claim 19).
However, Hassibi teaches an example system comprises a biosensor array, heating and cooling modules and a temperature sensor, a temperature controller, and a computer to which sensor data is sent from the biosensor array (Fig. 31; ¶394), which allow the user to interact with the reaction, e.g., add reagents, change the temperature, change the pH, dilution, etc. (¶400).
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 Hall and Prasad by incorporating a heating module, e.g., a heater configured to heat the sample, as taught by Hassibi because it enables the user to change the temperature of the sample to be sensed by the biosensor and thus compensate the temperature variation. 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).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hall in view of Prasad, and further in view of Cordova-Huaman (A. Cordova-Huaman, Low-cost smartphone-controlled potentiostat based on Arduino for teaching electrochemistry fundamentals and applications, Heliyon, 2021(7), e06259, pp. 1-7).
Regarding claim 4, Hall and Prasad discloses all limitations of claim 1, but fails to teach wherein the microcontroller unit comprises an Arduino device that processes the output from the core potentiostat circuit.
However, Cordova-Huaman teaches a low-cost, portable electrochemical workstation that integrates an open-source potentiostat based on Arduino and a smartphone application ([Abstract]). Arduino microcontroller boards have expanded the functionality of electronic-controlled potentiostats allowing an increment in the number of methodologies addressed with these while maintaining an affordable price (p. 1, col. 2, para. 2).
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 Hall and Prasad by substituting the microcontroller with the Arduino one as taught by Cordova-Huaman because Arduino microcontroller boards have expanded the functionality of electronic-controlled potentiostats allowing an increment in the number of methodologies addressed with these while maintaining an affordable price (p. 1, col. 2, para. 2). 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).
Claim(s) 5 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hall in view of Prasad, and further in view of Stefani (S. Stefani, MINICOMPUTER-BASED INSTRUMENTATION FOR ELECTROANALYTICAL TECHNIQUES, Analytica Chimica Acta, 1986(187), pp. 213-222).
Regarding claim 5, Hall and Prasad discloses all limitations of claim 1. Hall further discloses wherein the microcontroller unit is coupled to a digital-to-analog converter (Fig. 2). Hall and Prasad fail to teach a reconstruction filter.
However, Stefani teaches a home-made electrochemical interface which includes digital/analog and analog/digital conversion circuits, a potentiostat, and porgrammable timers allowing fast data transfer ([Summary]). When the waveform comprises small potential steps as in linear sweep or cyclic voltammetry, the impedance characteristics of the electrochemical cell make it important to use a DAC with a small differential linearity and to keep spurious transients arising when the DAC output changes to a minimum (p. 220, para. 2). Moreover, the insertion of a low-pass filter in the output of the DAC, as a “reconstruction filter” meeting the Nyquist criterion, allows the generation of continuously varying potential waveforms (p. 220, para. 2).
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 Hall and Prasad by incorporating a low-pass filter in the output of the DAC as a reconstruction filter as taught by Stefani because the reconstruction filter allows the generation of continuously varying potential waveforms (p. 220, para. 2). 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 7, Hall teaches wherein the microcontroller unit is further configured to (Fig. 2; ¶117: an onboard microcontroller controls the potentiostat to run electrochemical techniques):
generate a voltammetric excitation signal (¶117: to apply appropriate signals to the chip);
compute a voltammetric excitation series ((¶117: to make measurements on the biological sample; i.e., to measure current, voltage, or impedance spectrum; e.g., ¶151: the complex impedance is computed);
read the output signal received from the core potentiostat circuit (e.g., ¶151: VOUT is the voltage read by the ADC);
configure settings of various integrated circuits if the biosensing readout system (Fig. 2; ¶117: an onboard microcontroller uses the specific parameters set by the user application); and
communicate with the external computing device (Fig. 2; ¶117: an onboard microcontroller handles communication with the specific high-speed bus of the host device).
Claim(s) 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hall in view of Prasad, and further in view of Tong (J. Tong, Ultra-low-power wireless anchor load monitoring system based on internet of things technology, IOP Conference Series: Materials Science and Engineering, 2019 (615), 012107, pp. 1-8), and further in view of Bowers (US 5368706).
Regarding claim 8, Hall and Prasad discloses all limitations of claim 1. Hall further discloses the portable biosensing readout system further comprises: a multiplexer (¶124: the potentiostat must be able to run multiple types of techniques; ¶126: placed multiplexers), an analog-to-digital converter (Fig. 2; ¶124: ADC); and the plurality of amplifiers includes a transimpedance amplifier (¶73: the reconfigurable electrochemical biosensing circuit comprises two working electrodes and two resistive feedback transimpedance amplifiers (TIAs) connected to a respective working electrode).
Hall and Prasad fail to teach a dual output voltage reference.
However, Tong teaches a circuit is power by a voltage regulator which is controlled by a microcontroller to achieve optimized power usage (p. 3, para. 4). A low-drift, dual-output voltage reference is integrated to provide a stable voltage VREF = 2.5V to excite the bridge circuit and also be the rail-to-rail reference voltage for ADC (analog-to-digital) converter (p. 3, para. 4).
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 Hall and Prasad by incorporating a dual output voltage reference as taught by Tong because the integration of the dual output voltage reference would provide stable voltage with low drift. 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).
Hall and Prasad fail to teach wherein the plurality of amplifiers also includes a control amplifier and a voltage follower.
However, Bowers teaches an amperometric detection cell (title) with an electrical circuit as shown in Fig. 5. The circuit includes a control amplifier 106 which controls the current that flows between the counter electrode 86 and the working electrode 90 (Fig. 5; col. 4, ll. 48-51). The potential between the reference electrode 88 and the working electrode 90 is maintained using a feedback arrangement between the reference electrode 88, the voltage follower 114, and the input to the control amplifier 106 (Fig. 5; col. 4, ll. 51-56).
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 Hall and Prasad by incorporating a control amplifier and a voltage follower as taught by Bowers because they enable both current control and potential maintenance through a feedback loop for the amperometric detection of a three-electrode system. 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 9, Hall teaches wherein the multiplexer is configured to toggle between two or more working electrodes (Fig. 3: WE1, WE2, ¶126: strategically placed multiplexers allow the circuit to be switched at nodes that do not affect performance).
The designation “to perform sequential measurements of dual-signal assays or multi-channel assays” is 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, Hall teaches the multiplexer would allow the circuit to be switched for simultaneous measurement (Fig. 3; ¶37), and thus is capable of performing sequential measurements of dual-signal assays or multi-channel assays.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hall in view of Prasad, Tong, and Bowers, and further in view of Wang (US 2013/0065257).
Regarding claim 12, Hall, Prasad, Tong, and Bowers discloses all limitations of claim 8, but fails to teach wherein the plurality of amplifiers further comprises a precision operational amplifier.
However, Wang teaches an potentiostatic unit consists of two LMP2234 precision instrumentation operational amplifiers (OA) (Fig. 58B; ¶454). The use of precision instrumentation amplifiers possessing 20 fA of input bias current enables unabated operation to the sub-picoampere level, which is suitable for nearly all electrochemical studies ([0454]).
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 Hall, Prasad, Tong, and Bowers by incorporating a precision operational amplifier as taught by Wang because it would enable unabated operation to the sub-picoampere level, which is suitable for nearly all electrochemical studies ([0454]). 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).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hall in view of Prasad, Tong, and Bowers, and further in view of Martinez (US 2020/0297255).
Regarding claim 16, Hall, Prasad, Tong, and Bowers discloses all limitations of claim 8, but fails to teach wherein the core potentiostat circuit includes a dual impedance converter/network analyzer chip.
However, Martinez teaches a paper-based smart bandage device (title) of a wearable potentiostat used for wireless chronic would monitoring (Fig. 6; ¶18). AD5933 chip is used to perform impedance spectroscopy (¶18), which is a high precision impedance analyzer (AD5933, Analog Devices Inc) (¶52). Since the prior art discloses the same high precision impedance converter system, AD 5933 (PGpub ¶28), the AD5933 high precision impedance converter system would include a dual impedance converter/network analyzer chip.
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 Hall, Prasad, Tong, and Bowers by incorporating a dual impedance converter/network analyzer chip, e.g., a AD5933 high precision impedance converter system, as taught by Martinez for impedance spectroscopy measurement because it is a high precision impedance analyzer that provides high precision measurements. 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).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hall in view of Prasad, and further in view of Gordon (US 2018/0106791).
Regarding claim 18, Hall and Prasad discloses all limitations of claim 1, but fails to teach wherein the biosensor includes a biorecognition moiety immobilized onto a surface of the working electrode to recognize a presence of an analyte in the sample, the biorecognition moiety comprising a DNAzyme.
However, Gordon teaches and electrochemical biosensor for detecting ultra-low levels of biological analyte in a rapid, simple, and inexpensive way ([Abstract]). To be used in DNA electrochemical biosensors, guanine quadruplex structures immobilized on the working electrode surface as recognition probe for detecting analytes by electrochemical aptasensors or hemin/DNAzyme electrochemical biosensors (¶66).
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 Hall and Prasad by incorporating a biorecognition moiety, e.g., a DNAzyme or an aptamer, as taught by Gordon for detecting analyte because the biorecognition moiety, e.g., a DNAzyme or an aptamer, immobilized on the working electrode surface would enable detecting analytes. 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).
Conclusion
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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