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 .
Response to Amendment
The amendments filed 31st March 2026 have been entered. Claims 1-20 are pending. Claims 21-24 are canceled.
Response to Arguments
Applicant's arguments filed 31st March 2026 have been fully considered but they are not persuasive. In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references (see Pg. 6-8 of Remarks), the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Sheppard explicitly teaches a multiple analyte sensor with at least two working electrodes (Fig. 4a, items 414 & 418; Para. [0023], [0035]) operating in conjunction with shared or switchable control circuitry for redundancy, continuous operation, differential/ratiometric measurements, and controlled switching between electrodes. The reference emphasizes the advantages of using multiple working electrodes with simplified/shared amplifier control in Para. [0023]. Examiner did not ignore the structural distinctions in Sheppard’s embodiments (separate transimpedance amplifiers 406 & 408 and differential amplifiers 426 & 428 per electrode). Rather, the rejection properly relies on the obviousness of modifying that system to use a single transimpedance amplifier receiving signals from both working electrodes and a single differential amplifier to handle the combined output. This is a predictable variation that flows directly from Sheppard’s own teachings on operating multiple electrodes with reduced circuitry for redundancy and continuous monitoring. Combining signals from two electrodes into one transimpedance (effectively multiplexing /handling the two signals through shared amplification) is a routine optimization when the goal is to simplify the analog front-end while maintaining the ability to derive analyte values. The differential stage then subtracts the bias offset, as already shown in Sheppard’s per-electrode differential outputs.
Applicant argues that Sheppard distinguishes “control amplifiers” from transimpedance and differential amplifiers, and that this prevents any motivation to consolidate the latter amplifiers. This argument is unpersuasive. The functional role of the amplifiers in the claimed device (current to voltage conversion via transimpedance, and differential subtraction of bias) overlaps substantially with the signal processing and control functions described in Sheppard for multi-electrode operations. Sheppard’s teaching is the benefit of simplified/shared amplification across multiple electrodes, modifying the separate transimpedance paths into a combined path is obvious to for the same reasons while achieving the same result of monitoring analyte values. The proposed modification is a simple consolidation of parallel paths taught by Sheppard into a shared path. The bias offset subtraction via differential amplifier remains unchanged in purpose and result. Sheppard’s Fig. 4a along with related paragraphs already show signals from two working electrodes being processed in parallel and then compared/differentially handled. Consolidating the front-end conversion step using the teachings provided through Para. [0023] is a straightforward modification that doesn’t require hindsight but follows from the reference’s teachings.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.3
Claim Objections
Claim 17, ‘the received signal’, should likely read ‘the received signals’.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 13 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 13 recites ‘the negative poise bias amplifier is configured to receive a reference signal from the reference electrode and a positive poise reference’, but the specification provides no disclosure of the negative poise bias amplifier being configured for receiving a positive poise reference. This appears to be new matter. Examiner interprets the limitation as either ‘a positive poise bias amplifier is configured to receive … a positive poise reference’ or ‘the negative poise bias amplifier is configured to receive… a negative poise reference’ as previously recited.
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 19 & 20 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.
Claims 19 & 20 recite ‘the variable residual’, there is insufficient antecedent basis for this limitation in these claims.
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.
Claim(s) 1, 6, 8-17, 19, & 20 are rejected under 35 U.S.C. 103 as being unpatentable over US 20110089957 A1 to Sheppard in view of US 20080249385 A1 to Phan.
Regarding Claim 1, Sheppard discloses an analyte monitoring device (Sheppard: Abstract), comprising: a multiple analyte sensor (Sheppard: Para. [0035]; Fig. 4A) comprising
a first working electrode (Sheppard: Fig. 4A, item 414),
a second working electrode (Sheppard: Fig. 4A, item 418),
a counter electrode (Sheppard: Fig. 4A, item 412), and
a reference electrode (Sheppard: Fig. 4A, item 416),
wherein each of the first working electrode and the second working electrode is configured to receive a signal indicative of a presence of a respective analyte (Sheppard: Para. [0023] ‘Each of the respective working electrodes is utilized as part of a biosensor (or alternatively, a chemical/electrochemical sensor) for detecting or measuring an analyte, in vitro or in vivo.’), and
a transimpedance amplifier configured to receive a first signal of the received signals from the first working electrode (Sheppard: Fig. 4A item 406; Para. [0045] ‘the first working electrode 414 is electrically connected to the inverting input of the first transimpedance amplifier 406.’ ) and a second signal of the received signals from the second working electrode (Sheppard: Fig. 4A item 408; Para. [0046] ‘the second working electrode 418 is electrically connected to the inverting input of the second transimpedance amplifier 408.’),
wherein the transimpedance amplifier converts the received first signal and the received second signal to an output including a bias offset (Sheppard: Para. [0046]; Fig. 4A items working electrode set point 1 & working electrode set point 2);
a differential amplifier configured to subtract the bias offset from the output to generate a modified output (Sheppard: Fig. 4A, items 426 sensor 1 output & 428 sensor 2 output; Para. [0045] ‘The working electrode set point associated with the first transimpedance amplifier 406 may likewise be provided to an inverting input of the differential amplifier 426. Accordingly, an output of the differential amplifier 426 may produce a voltage that is proportional to the working electrode 414 current.’; Para. [0046] ‘The working electrode set point associated with the second transimpedance amplifier 408 may likewise be provided to an inverting input of the differential amplifier 428. Accordingly, an output of the differential amplifier 428 may produce a voltage that is proportional to the working electrode 418 current.’).
a processor configured to generate data indicative of an analyte value from the modified output (Sheppard: Fig. 7 [0052]).
Sheppard does not explicitly disclose a single transimpedance amplifier configured to receive both the first signal of the received signals from the first working electrode and the second signal of the received signals from the second working electrode and a single differential amplifier to subtract the bias offset from the output to generate a modified output.
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the transimpedance amplifiers and differential amplifiers of Sheppard to be a single transimpedance amplifier and a single differential amplifier, as Sheppard teaches the operability of at least two working electrodes with a single control amplifier for redundancy, controlled switching, differential or ratiometric operation between available working electrodes for continuous operation (Sheppard: Para. [0023] ‘The operability of at least two working electrodes with a single control amplifier can advantageously allow for redundancy, controlled switching between, differential or ratiometric operation between available working electrodes, thereby allowing for continuous operation of the biosensors.’).
Sheppard does not explicitly disclose wherein a signal at the counter electrode is a sum of the received signal of each of the first working electrode and the second working electrode.
However, Phan teaches wherein a signal at the counter electrode is a sum of the received signal of each of the first working electrode and the second working electrode (Phan: Para. [0025] ‘the potentiostat 33 holds the counter electrode 21 at a voltage level with respect to the reference electrode 19 to provide a return path for the electrical current to the bloodstream, such that the returning current balances the sum of currents drawn in the working electrodes 15 and 17.’);
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the counter electrode(s) of Sheppard to include a counter electrode that is a sum of the received signal of each of the first working electrode and the second working electrode as taught by Phan, the combination motivated by the need to provide a return path for the electrical current to the bloodstream (Phan: Para. [0025] ‘Another function of the potentiostat is receiving electrical current signals from the working electrodes 15 and 17 for output to a controller, As the potentiostat 33 works to maintain a constant voltage for the working electrodes 15 and 17, current flow through the working electrodes 15 and 17 may change. The current signals indicate the presence of an analyte of interest in blood. In addition, the potentiostat 33 holds the counter electrode 21 at a voltage level with respect to the reference electrode 19 to provide a return path for the electrical current to the bloodstream, such that the returning current balances the sum of currents drawn in the working electrodes 15 and 17.’).
Regarding Claim 6, Sheppard in view of Phan discloses the device of Claim 1, Sheppard further discloses wherein the device is configured to detect blood ketone levels, blood glucose levels, or blood lactate levels (Sheppard: Para. [0035] ‘glucose’, ‘lactate’).
Regarding Claim 8, Sheppard in view of Phan discloses the device of Claim 1, wherein the analyte comprises glucose (Sheppard: Para. [0035] ‘glucose’’).
Regarding Claim 9, Sheppard in view of Phan discloses the device of Claim 1, wherein the analyte comprises lactate (Sheppard: Para. [0035] ‘lactate’).
Regarding Claim 10, Sheppard in view of Phan discloses the device of Claim 1, Sheppard further discloses wherein the bias offset is determined based on a first analyte associated with the first working electrode or a second analyte associated with the second working electrode (Sheppard: Para. [0044] ‘the outputs of control amplifiers 402, 404 are measured during operation so that reference electrode set points and working electrode set points can be adjusted as necessary to keep the feedback control loop operational.’; Para. [0045]).
Regarding Claim 11, Sheppard in view of Phan discloses the device of Claim 1, Sheppard further discloses further comprising: a negative poise bias amplifier configured to subtract a predetermined voltage from the reference electrode to generate a first working electrode bias to bias the first working electrode (Sheppard: Para. [0044] ‘reference electrode set points’).
Regarding Claim 12, Sheppard in view of Phan discloses the device of Claim 11, Sheppard further discloses wherein the predetermined voltage is determined based on a first analyte associated with the first working electrode or a second analyte associated with the second working electrode (Sheppard: Para. [0044] Note: Any reference electrode set point would be predetermined based on analyte measurement by its respective working electrode to ensure stable potential.).
Regarding Claim 13, Sheppard in view of Phan discloses the device of Claim 11, wherein the negative poise bias amplifier is configured to receive a reference signal from the reference electrode and a positive poise reference (Sheppard: Para. [0044] ‘The first reference electrode 416 is electrically connected to the inverting input of the first control amplifier 402’; Fig. 4A reference electrode set point 1; Note: See interpretation of Claim 13 in the rejection under 35 U.S.C. § 112(a) above.).
Regarding Claim 14, Sheppard in view of Phan discloses the device of Claim 1, Sheppard further discloses wherein the differential amplifier is further configured to subtract out a bias dependent residual and a common-mode op-amp characteristic from the output to generate the modified output (Sheppard: Para. [0045]; Para. [0057]).
Regarding Claim 15, Sheppard in view of Phan discloses the device of Claim 14, wherein the bias dependent residual is determined based on a two-point offset calibration for one of the first working electrode or the second working electrode (Sheppard: Para. [0045]; Para. [0057]).
Regarding Claim 16, Sheppard in view of Phan discloses the device of Claim 14, Sheppard further discloses wherein the common-mode op-amp characteristic is determined based on a three-point calibration (Sheppard: Para. [0060]).
Regarding Claim 17, Sheppard in view of Phan discloses the device of Claim 1, Sheppard further discloses wherein the first signal of the received signal is a first current signal (Sheppard: Para. [0045] ‘Sensor current flow in the first working electrode 414 is detected by a first current measurement circuitry’), and wherein the second signal of the received signals is a second current signal (Sheppard: Para. [0046] ‘sensor current flow in the second working electrode 418 is detected by a second current measurement circuitry’).
Regarding Claim 19, Sheppard in view of Phan discloses the device of Claim 1, Sheppard further discloses wherein the processor is further configured to generate the data indicative of the analyte value using a calibration function configured to adjust the generated data based on the variable residual (Sheppard: Para. [0063]).
Regarding Claim 20, Sheppard in view of Phan discloses the device of Claim 1, Sheppard further discloses wherein the processor is further configured to generate the data indicative of the analyte value using a calibration function configured to adjust the generated data to remove the variable residual (Sheppard: Para. [0059]).
Claim(s) 2-5, 7 & 18 are rejected under 35 U.S.C. 103 as being unpatentable over Sheppard in view of Phan in further view of US 20210379370 A1 to Windmiller et al. (hereinafter, Windmiller).
Regarding Claim 2, Sheppard in view of Phan discloses the device of Claim 1, Sheppard does not explicitly state further comprising: an analog to digital converter configured to convert the modified output to a digital output.
However, Windmiller teaches further comprising: an analog to digital converter configured to convert the modified output to a digital output (Windmiller: Para. [0142] ‘At block 1205, the signal subsequently undergoes analog-to-digital conversion at an ADC to convert the analog signal to a digital bitstream.’).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the output methods of Sheppard to specify including an analog to digital converter to convert the modified output of Sheppard to a digital output as taught by Windmiller, as the combination allows for interfacing with digital display devices (Windmiller: Para. [0142]; Fig. 27).
Regarding Claim 3, Sheppard in view of Phan in further view of Windmiller discloses the device of Claim 2, Sheppard further discloses wherein the subtraction of the bias offset from the output reduces the modified output (Sheppard: Para. [0045] ‘The working electrode set point associated with the first transimpedance amplifier 406 may likewise be provided to an inverting input of the differential amplifier 426. Accordingly, an output of the differential amplifier 426 may produce a voltage that is proportional to the working electrode 414 current. A microcontroller can measure the output voltage of the differential amplifier 426 to determine information regarding the sensor current detected by the first working electrode 414. In an embodiment of the invention, additional signal conditioning or signal processing can be applied to output of the differential amplifier in order to facilitate measurement by the microcontroller’)
Sheppard does not explicitly disclose an analog to digital converter.
However, Windmiller teaches configuring modified outputs into a range of an analog to digital converter (Windmiller: Para. [0156]; Para. [0157]).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the output methods of Sheppard to specify including an analog to digital converter, configuring the modified output of Sheppard to be reduced into a range of an analog to digital converter as taught by Windmiller, as the combination allows for interfacing with digital display devices (Windmiller: Para. [0142]; Fig. 27).
Regarding Claim 4, Sheppard in view of Phan in further view of Windmiller discloses the device of Claim 2,
Sheppard does not explicitly disclose further comprising: a communication module configured to process the digital output into measurement results.
However, Windmiller teaches further comprising: a communication module configured to process the digital output into measurement results (Windmiller: Para. [0142] ‘At block 1206, the signal is routed to a wireless transmitter or transceiver (BLUETOOTH, WiFi, RFID/NFC, Zigbee, Ant+) 1207 for transmission of the signal (corresponding to the level of the biochemical analyte) to a mobile communication device 1208 for further information processing, interpretation, display, archiving, and trending.’).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the output methods of Sheppard to include a communication module configured to process the digital output into measurement results as taught by Windmiller, as the combination allows for interfacing with digital display devices (Windmiller: Para. [0142]; Fig. 27)
Regarding Claim 5, Sheppard in view of Phan in further view of Windmiller discloses the device of Claim 4, Sheppard does not explicitly disclose wherein the communication module is further configured to provide the measurement results to a receiving device for display via wireless communication.
However, Windmiller teaches wherein the communication module is further configured to provide the measurement results to a receiving device for display via wireless communication (Windmiller: Fig. 27 item 1206 & 1208; Para. [0142] ‘At block 1206, the signal is routed to a wireless transmitter or transceiver (BLUETOOTH, WiFi, RFID/NFC, Zigbee, Ant+) 1207 for transmission of the signal (corresponding to the level of the biochemical analyte) to a mobile communication device 1208 for further information processing, interpretation, display, archiving, and trending.’).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the output methods of Sheppard to include a communication module configured to provide the measurement results to a receiving device for display via wireless communication as taught by Windmiller, as the combination allows for interfacing with digital display devices (Windmiller: Para. [0142]; Fig. 27)
Regarding Claim 7, Sheppard in view of Phan discloses the device of Claim 1, Sheppard does not explicitly disclose wherein the analyte comprises ketone.
However, Windmiller teaches wherein the analyte comprises ketone (Windmiller: Para. [0198]).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the detected analytes of Sheppard to include ketone as taught by Windmiller, as one known analyte among many potential analytes that could be measured in an analyte sensing device (Windmiller: Para. [0198]).
Regarding Claim 18, Sheppard in view of Phan discloses the device of Claim 17, Sheppard does not explicitly disclose wherein a single transimpedance amplifier converts the first and second current signals into output voltage. Instead, Sheppard discloses a transimpedance amplifier configured to receive a first signal of the received signals from the first working electrode (Sheppard: Fig. 4A item 406; Para. [0045] ‘the first working electrode 414 is electrically connected to the inverting input of the first transimpedance amplifier 406.’ ) and a second signal of the received signals from the second working electrode (Sheppard: Fig. 4A item 408; Para. [0046] ‘the second working electrode 418 is electrically connected to the inverting input of the second transimpedance amplifier 408.’).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the transimpedance amplifiers of Sheppard to be a single transimpedance amplifier, as Sheppard teaches the operability of at least two working electrodes with a single control amplifier for redundancy, controlled switching, differential or ratiometric operation between available working electrodes for continuous operation (Sheppard: Para. [0023] ‘The operability of at least two working electrodes with a single control amplifier can advantageously allow for redundancy, controlled switching between, differential or ratiometric operation between available working electrodes, thereby allowing for continuous operation of the biosensors.’).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHAWN CURTIS BROUGHTON whose telephone number is (571)272-2891. The examiner can normally be reached Monday - Friday, 8am-4pm EST..
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/SHAWN CURTIS BROUGHTON/Examiner, Art Unit 3791
/PATRICK FERNANDES/Primary Examiner, Art Unit 3791
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