DETAILED ACTION
This Office action is responsive to communications filed on 10/30/2025. Claims 1, 6-7, & 9-12 have been amended. Claims 4-5, 8, & 13-14 canceled. Claims 16-21 are newly added. Presently, Claims 1-3, 6-7, 9-12, & 15-21 remain pending and are hereinafter examined on the merits.
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 Arguments
Previous objections to the Drawings are withdrawn in view of the amendments filed on 10/30/2025.
Previous rejections under 35 USC § 112(b) are withdrawn in view of the amendments filed on 10/30/2025.
Previous claim objections are withdrawn in view of the amendments filed on 10/30/2025.
Applicant’s arguments with respect to claim(s) have been considered but are moot because the new ground of rejection does not rely on solely on Warner et al (US 2021/0212587 A1) as applied in the prior rejection of record under 35 USC § 102 for any teaching or matter specifically challenged in the argument. The new grounds of rejection now relies on Warner et al (US 2021/0212587 A1) in view of Warner et al (US 2015/0011901 A1, herein Warner ‘901).
Examiner Notes:
The Applicant arguments and Remarks filed on 10/30/2025 was submitted by an attorney, Blaine T. Bettinger, who is not the Applicant’s appointed Power of Attorney or an Agent of the Record on file in the present application. Proper and corrective action is needed.
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 1-3, 6-7, & 9-11 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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.
Claim 1: line 17, “apply, via a driving electrode, the driving output signal”. It is unclear if “a driving electrode” refers to or is separate from “a driving electrode” as recited in line 5. For examination purposes, the Examiner assumes the driving electrode is intended to be recited in at line 17. Consistent claim language is required when referring to the same term. Appropriate correction is required.
Claim 10: line 1, “an output signal”. It is unclear if “an output signal” refers to or is separate from the driving output signal. For examination purposes, the Examiner assumes an output signal is intended to recite the driving output signal. Consistent claim language is required when referring to the same term. Appropriate correction is required.
The dependent claims of the above rejected claims are rejected due to their dependency.
Claim Objections
The following claims are objected to because of the following informalities and should recite:
Claim 1, lines 19-21: “wherein the ARLD controller is operatively connected to a user interface, and the ARLD controller further includes instructions that, when executed by the at least one processor, performs one or more of the following:” Appropriate correction is required.
Claim 9, line 2: “[[a]]the user interface”. Consistent claim language is required when referring to the same term. Appropriate correction is required.
Claim 12, lines 13-15: “wherein the ARLD controller is operatively connected to a user interface, and the ARLD controller further includes instructions that, when executed by the at least one processor, performs one or more of the following:” Appropriate correction is required.
Claim 15, line 1: “non-magnetic resonance (MR) environment mode”. Appropriate correction is required.
Claim 20, line 2: “[[a]]the user interface”. Consistent claim language is required when referring to the same term. Appropriate correction is required.
Claims 15-21: preamble- “of claim 14”. Claim 14 is canceled. These claims are interpreted to depend from claim 12. Appropriate correction is required.
Claim Rejections - 35 USC § 103
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, 9-10, 12, 16-17, & 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Warner et al (US 2021/0212587 A1) in view of Warner et al (US 2015/0011901 A1, herein Warner ‘901).
Claim 1: Warner discloses: A system (FIG. 1) of adaptively measuring bio-potential signals (¶0030 – measurement of ECG signals from electrodes.) of a patient (patient 12, Fig. 1) in proximity to a noise source (¶0004 – “ECG leads encounter noise from a variety of sources” & ¶0005 & ¶0007 – “common mode noise from the electrodes”.), the system comprising:
-The system of Warner is adaptive because it actively monitors the performance of its noise-reduction circuitry, specifically the Right LEG Drive (RLD) and adjust its configuration based on the level of saturation detected, ¶Abstract, ¶0004-0007, ¶0008, ¶0030. There includes a number of RLD circuits utilized for different monitoring states. Based on a quality index that measures the saturation degree and duration, the system automatically selects the best setting optimal RLD circuit to effectively reduce noise, ¶Abstract, ¶0010, ¶0012, ¶0033. Warner further includes a programmable RLD that allows the CPU to selectively alter the operation of the RLD to maintain signal integrity under various use conditions, ¶0012, ¶0033.
one or more bio-potential signal sensors for measuring the bio-potential signals of the patient; (¶0028 – obtaining ECG from subject are 3-led, 5 led, 12-lead, or a 15 lead ECG, “commonly used for routine ECG monitoring at hospitals”; ¶0029 – electrodes attached to the patient 12)
-Warner explicitly mentions that these bio-potential signal measurements of the patient occur in challenging environments like electrophysiology labs, where the patient is in proximity to noise sources, ¶0026, ¶0028-0029.
a driving electrode (RL electrode, FIG. 2) for applying a driving output signal to the patient; (¶0029 – electrodes attached to the patient with RL electrode serving as an electrical ground; ¶0030 – Amplifier 22 is a right leg drive (RLD) amplifier that utilizes the RL electrode for equalizing the potential for the human body and the measurement electronics.)
-Warner’s system includes the right leg (RL) electrode. This serves as a driving electrode because the RLD circuit introduces a signal into the right left of the patient to cancel common-mode noise and equalize the potential of the human body with the measurement electronics, ¶0005, ¶0028, ¶0029, ¶0030.
an adaptive right leg drive (ARLD) circuit operatively connected to the one or more bio-potential signal sensors, the ARLD circuit comprising: (¶0030 – data acquisition system 10 for obtaining electrocardiogram (ECG) signals from a patient 12. The data acquisition system 10 includes a 3-lead ECG measurement unit 14 that measures ECG signals from electrodes RA, LA, LL and RL. As is well known, augmented leads aVR, aVL and aVF are calculated by comparing the measured voltage from each of the limb electrodes to a reference voltage and the CPU 28 executes a program of instructions to monitor the level of saturation of the RLD circuit 100 in sure to selected an appropriate reduction circuit.; ¶0033 - data acquisition system 10 featuring RLD circuits 100 to 100’’ and a modifiable or runnable RLD circuit 100 allows users to selectively alter the operation of the RLD circuit 100 using a switching circuit 200. This information provides realization of effectiveness of the traditional right leg drive, and when used in a programmable right-leg drive system, provide feedback on effectivity of the control algorithm under various use conditions.)
-Warner discloses the data acquisition system which is the entire comprehensive system comprising its subcomponent the RLD circuit contained within. The at least one RLD circuit 100 (along with its variance 100’ and 100’’) is an adaptive, programmable, tunable system, ¶0033. The at least one RLD circuit is operably connected between bio-potential signal sensors (i.e., the limb electrodes RA, LA, LL) and the driving electrode (RL electrode), ¶0015, ¶0030, Claim 1.
a feedback circuit (¶0033 – tunable RLD circuit 100) for receiving the bio-potential signals from the patient via the one or more bio-potential signal sensors (¶0030] – RA, LA, LL electrodes) and outputting a feedback signal (¶0030 – via RL electrode); and
-Warner discloses, a feedback circuit (i.e., the RLD amplifier of the tunable RLD circuit 100) receives input via the electrodes. It utilizes a measurement point to monitor the feedback voltage and output a signal used to determine saturation levels, ¶0015, ¶0013-0014, ¶0030, ¶0032, ¶0033, Claim 1.
an ARLD controller (¶0030 – Control unit 26) having at least one processor (¶0030 – control unit 26 to be processed by the CPU 28.) and memory (¶0030 – memory storage 20 contains the program of instructions used to execute the inventive method and system.) storing instructions that, when executed by the at least one processor (¶0030 – the CPU executes a program of instructions to monitor the level of saturation of the RLD circuit in use and to selected an appropriate noise reduction.), performs one or more of the following:
-Warner discloses features of the control unit 26 containing a CPU 28 and memory 20 that stores instructions for managing the RLD circuit, ¶0030, to perform one or more of the following task:
receive, from the feedback circuit, the feedback signal; (FIG. 5 – connection 20-26, ¶0030 – The A/D converted 24 converts the analog signal to a digital ECG signal that received by the control unit 26 to be processed by the CPU 28 within the control unit 26, CPU 28 executes a program of instructions to monitor the level of saturation of the RLD circuit to use and to select appropriate noise reduction circuit. Output from the control unit 26/CPU 28 can be presented on display and interacted with by the user though a user input 32 such as a touchscreen, mouse, or keyboard)
-Warner discloses, that the CPU monitors feedback voltage isolated from the patient to record the RLD’s function and identify saturation. This is done by measuring the actual output voltage via a voltmeter, ¶0013-0014, ¶0030, ¶0032, Claims 11-14.
construct, based on the feedback signal, the driving output signal; (¶0033 – tune the tunable RLD circuit)
Upon review of the limitation, under the broadest reasonable interpretation the claim states that “construct, based on [emphasis added] the feedback signal, the driving output signal”. The term “based on” is ambiguous and lacks precision. The term “based on” is a broad and ambiguous term that doesn’t clearly define the extent or nature of the relationship that claimed invention is intended to present. As such, the term “based on” implies that the claim invention is derived from or closely related to the feedback signal. There are not explicit steps or additional limitations recited in the claim that preclude this interpretation.
-Warner discloses, that the RLD amplifier of the tunable RLD circuit generates a signal to be introduced into the right leg to cancel common-mode noise, ¶0015. The controller’s algorithm determines the best setting for how the filter/signal should be based on the feedback, ¶0012, ¶0033.
change an operating mode of the ARLD circuit between a first operating mode and a second operating mode; and (¶0033 – select best RLD 100, 100’, 100’’)
-Warner discloses, that the system can alter the operation of the RLD circuit (i.e., RLD 100, 100’, 100’’), ¶0033. Specifically, it can change the different states or operating characteristics by switching circuit to select between different RLD circuits, (i.e., RLD 100, 100’, 100’’), ¶0033.
apply, via a driving electrode, the driving output signal; and (¶0030-0031, Claim 1)
-Warner discloses, the signal is applied to the patient via the right leg (RL) electrode, which acts as the driving electrode to equalize the potential between the body and the electronics, ¶0030-0031, Claim 1.
enable or disable the ARLD circuit;
-Warner discloses, the controller can select or choose a particular performance or strategy such as virtual RLD or using a switching circuit to alter which RLD circuit is in use. ¶0011, ¶0033, Claim 1-2.
Warner fails to disclose:
wherein the ARLD controller is operatively connected to a user interface, and further instructions that, when executed by the at least one processor, performs one or more of the following:
receive, via one or more secondary sensors, environmental information; and
receive, via the user interface, environmental configuration information; and
wherein the ARLD controller is further configured to construct the driving output signal based on at least one of the received environmental information and the received environmental configuration information.
However, Warner ‘901 in the context of right leg drive circuitry to eliminate common mode interference noise discloses,
wherein the ARLD controller is operatively connected to a user interface, and further instructions that, when executed by the at least one processor, performs the following:
-Warner ‘901 discloses, controller 50 of the ARLD controller, ¶0032-0034, that is operatively connected to the user interface 110, ¶0023, ¶0025-0026. Specifically, Warner ‘901 describes a system 10 for optimizing electrocardiography study performance that includes an amplifier, a controller 50, and a user interface, ¶0023, ¶0025-0026, wherein the controller includes a processor and memory containing instructions, Claim 19. Warner ‘901 explicitly states, “a user interface operatively connected to the controller.”, Claim 16, ¶0042.
receive, via the user interface, environmental configuration information; and
-Warner ‘901 discloses, receive, via a user interface, environmental configuration information. Note; the claim does not define what constitutes environmental configuration information. Warner ‘901 teaches study criteria which encompasses and constitutes as environment configuration information, which the processor receives via the user interface. Study criteria is defines as, see ¶0026: “Study criteria” as used herein refers generally to potential sources of noise or baseline wander including, but not limited to, the use of ablation equipment, the attachment of multiple medical devices to a subject, ungrounded electrical extension cords, electrical sockets, high-energy consumption equipment, and the like. Study criteria also include the type of study, e.g., ECG or other type of electronic signal monitoring systems, as well as desired levels of signal definition. As used herein, “appropriate” noise reduction circuits are those that will achieve optimal performance, e.g., signal measurement, given the study criteria that are on hand at the time the study is to be completed.”, see also ¶0022. The user interface is presented with, see ¶0031, “A user may also be presented with a questionnaire or separate input screen through interface 140 into which relevant information regarding the study may be entered.”
wherein the ARLD controller is further configured to construct the driving output signal based on the received environmental configuration information.
Upon review of the limitation, under the broadest reasonable interpretation the claim states that “wherein the ARLD controller is further configured to construct the driving output signal based on [emphasis added] the received environmental configuration information.”. The term “based on” is ambiguous and lacks precision. The term “based on” is a broad and ambiguous term that doesn’t clearly define the extent or nature of the relationship that claimed invention is intended to present. As such, the term “based on” implies that the claim invention is derived from or closely related to the received environmental configuration information. There are not explicit steps or additional limitations recited in the claim that preclude this interpretation.
-Warner ‘901 discloses, that the controller is configured to select, modify or tune the right leg drive (RLD) circuit, which generates the driving output signal, based on the received environmental information (i.e., study criteria). The RLD circuit functions to “introduce a signal into right leg of a patient to cancel common mode noise from the electrodes”, see ¶0007. The controller executes a program of instructions to, “select an appropriate noise reduction circuit.”, see ¶0024, or modify one based on the study criteria, ¶0011, ¶0024, ¶0042. Modifying the circuit constructs the driving output signal, for instance, a user can “with an input screen 160 [...] can tune the circuit by selecting or entering, for example, a specific frequency of the cut-off for the circuit”, see ¶0034. The controller can selected from multiple RLD circuits ensuring the driving signal is constructed appropriately for the specific environmental conditions, ¶0032-0033.
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the ARLD controller of Warner in view of the teachings of Warner ‘901. The motivation to do this yields predictable results such as improving “control and potentially minimizing interactions between multiple devices attached to a single subject”, as explicitly stated by Warner ‘901, ¶0034 of Warner ‘901.
Claim 2: Warner as modified discloses all the elements above in claim 1, Warner discloses, wherein the one or more bio-potential signal sensors include at least two electrodes operatively connected to the patient. (¶0030 – ECG signals from a patient 12 the data acquisition system 10 includes 3-lead ECG measurement units that measures ECG signals from electrodes RA, LA, LL, and RL.)
Claim 3: Warner as modified discloses all the elements above in claim 1, Warner discloses: wherein the driving electrode (RL electrode, FIG. 2) receives the driving output signal from the ARLD circuit and applies the driving output signal to the patient. (¶0029 – electrodes attached to the patient with RL electrode serving as an electrical ground; ¶0030 – Amplifier 22 is a right leg drive (RLD) amplifier that utilizes the RL electrode for equalizing the potential for the human body and the measurement electronics.)
Claim 9: Warner as modified discloses all the elements above in claim 1, Warner discloses: wherein the ARLD controller is operatively connected to a user interface, and includes further instructions that, when executed by the at least one processor, performs the following: receive, from the user interface, a user input including one or more user-selectable filters or parameters; and construct the driving output signal based on the user input. (¶0030 – Output from the control unit 26/CPU 28 can be presented on display and interacted with by the user though a user input 32 such as a touchscreen, mouse, or keyboard.; ¶0033, ‘in a data acquisition system 10 such as an ECG or specialist EP/HEMO system featuring multiple RLD circuits 100, 100′ and 100″ and/or a modifiable or tunable RLD circuit 100 that allows the user to selectively alter the operation of the RLD circuit 100 using a switching circuit 200, […], by providing the RLD saturation index, the system 10 provides both computer algorithm in the CPU 26, and/or the end user a manner of determining the performance of the particular RLD circuit 100, 100′ or 100″ that is currently in use through reporting by the system 10 of the degree of saturation of the RLD circuit 100, 100′ and 100″, and the period of saturation of the RLD circuit 100, 100′ and 100″ in the form of the RLD index to report these combined effects. This RLD index provides the CPU 26/end user with a ready means to know whether saturation is occurring, and amount of time on a standardized basis this is occurring. This data may also be used as a quality index in the data to highlight the deterioration in the recorded signal. Further, using the RLD index, the CPU 26 and algorithm (any examples of what this might ental?—perturbation function, transform function?) can automatically select the best RLD circuit 100, 100′ or 100″ with its particular associated feedback voltage value for optimal operation of the system 10 based upon how aggressive the RLD circuit 100, 100′ or 100″ should be in view of the current operating characteristics of the system 10. This information provides realization of effectiveness of the traditional right leg drive, and when used in a programmable right-leg drive system, provide feedback on effectivity of the control algorithm under various use conditions.’ & ¶0011-0012)
Claim 10: Warner as modified discloses all the elements above in claim 1, Warner discloses: wherein an output signal is constructed by the ARLD controller (¶0030 – Control unit 26) based on at least the bio-potential signal received from the patient. (¶0029 – electrodes attached to the patient with RL electrode serving as an electrical ground; ¶0030 – Amplifier 22 is a right leg drive (RLD) amplifier that utilizes the RL electrode for equalizing the potential for the human body and the measurement electronics. The A/D converted 24 converts the analog signal to a digital ECG signal that received by the control unit 26 to be processed by the CPU 28 within the control unit 26, CPU 28 executes a program of instructions to monitor the level of saturation of the RLD circuit to use and to select appropriate noise reduction circuit. Output from the control unit 26/CPU 28 can be presented on display and interacted with by the user though a user input 32 such as a touchscreen, mouse, or keyboard))
Claim 12: Warner discloses: An adaptive right leg drive (ARLD) circuit (¶0033), the ARLD circuit comprising:
-The system of Warner is adaptive because it actively monitors the performance of its noise-reduction circuitry, specifically the Right LEG Drive (RLD) and adjust its configuration based on the level of saturation detected, ¶Abstract, ¶0004-0007, ¶0008, ¶0030. There includes a number of RLD circuits utilized for different monitoring states. Based on a quality index that measures the saturation degree and duration, the system automatically selects the best setting optimal RLD circuit to effectively reduce noise, ¶Abstract, ¶0010, ¶0012, ¶0033. Warner further includes a programmable RLD that allows the CPU to selectively alter the operation of the RLD to maintain signal integrity under various use conditions, ¶0012, ¶0033.
a feedback circuit (¶0033 – tunable RLD circuit 100) for receiving bio-potential signals from a patient (patient 12, Fig. 1) via one or more bio-potential signal sensors (¶0030] – RA, LA, LL electrodes) and outputting a feedback signal (¶0030 – via RL electrode); and
-Warner discloses, a feedback circuit (i.e., the RLD amplifier of the tunable RLD circuit 100) receives input via the electrodes. It utilizes a measurement point to monitor the feedback voltage and output a signal used to determine saturation levels, ¶0015, ¶0013-0014, ¶0030, ¶0032, ¶0033, Claim 1.
an ARLD controller (¶0030 – Control unit 26) having at least one processor (¶0030 – control unit 26 to be processed by the CPU 28.) and memory storing (¶0030 – memory storage 20 contains the program of instructions used to execute the inventive method and system.) instructions that, when executed by the at least one processor, (¶0030 – the CPU executes a program of instructions to monitor the level of saturation of the RLD circuit in use and to selected an appropriate noise reduction.) performs one or more of the following:
-Warner discloses features of the control unit 26 containing a CPU 28 and memory 20 that stores instructions for managing the RLD circuit, ¶0030, to perform one or more of the following task:
receive, from the feedback circuit, the feedback signal; (FIG. 5 – connection 20-26, ¶0030 – The A/D converted 24 converts the analog signal to a digital ECG signal that received by the control unit 26 to be processed by the CPU 28 within the control unit 26, CPU 28 executes a program of instructions to monitor the level of saturation of the RLD circuit to use and to select appropriate noise reduction circuit. Output from the control unit 26/CPU 28 can be presented on display and interacted with by the user though a user input 32 such as a touchscreen, mouse, or keyboard)
-Warner discloses, that the CPU monitors feedback voltage isolated from the patient to record the RLD’s function and identify saturation. This is done by measuring the actual output voltage via a voltmeter, ¶0013-0014, ¶0030, ¶0032, Claims 11-14.
construct a driving output signal based on at least the feedback signal; (¶0033 – tune the tunable RLD circuit)
Upon review of the limitation, under the broadest reasonable interpretation the claim states that “construct, a driving output signal based on [emphasis added] at least the feedback signal, the driving output signal”. The term “based on” is ambiguous and lacks precision. The term “based on” is a broad and ambiguous term that doesn’t clearly define the extent or nature of the relationship that claimed invention is intended to present. As such, the term “based on” implies that the claim invention is derived from or closely related to the feedback signal. There are not explicit steps or additional limitations recited in the claim that preclude this interpretation.
-Warner discloses, that the RLD amplifier of the tunable RLD circuit generates a signal to be introduced into the right leg to cancel common-mode noise, ¶0015. The controller’s algorithm determines the best setting for how the filter/signal should be based on the feedback, ¶0012, ¶0033.
change an operating mode of the ARLD circuit between a first operating mode and a second operating mode; (¶0033 – select best RLD 100, 100’, 100’’)
-Warner discloses, that the system can alter the operation of the RLD circuit (i.e., RLD 100, 100’, 100’’), ¶0033. Specifically, it can change the different states or operating characteristics by switching circuit to select between different RLD circuits, (i.e., RLD 100, 100’, 100’’), ¶0033.
apply, via a driving electrode (RL electrode, FIG. 2), the driving output signal; and (¶0029 – electrodes attached to the patient with RL electrode serving as an electrical ground; ¶0030 – Amplifier 22 is a right leg drive (RLD) amplifier that utilizes the RL electrode for equalizing the potential for the human body and the measurement electronics.)
-Warner discloses, the signal is applied to the patient via the right leg (RL) electrode, which acts as the driving electrode to equalize the potential between the body and the electronics, ¶0030-0031, Claim 1.
enable or disable the ARLD circuit;
-Warner discloses, the controller can select or choose a particular performance or strategy such as virtual RLD or using a switching circuit to alter which RLD circuit is in use. ¶0011, ¶0033, Claim 1-2.
Warner fails to disclose:
wherein the ARLD controller is operatively connected to a user interface, and further instructions that, when executed by the at least one processor, performs one or more of the following:
receive, via one or more secondary sensors, environmental information; and
receive, via the user interface, environmental configuration information; and
wherein the ARLD controller is further configured to construct the driving output signal based on at least one of the received environmental information and the received environmental configuration information.
However, Warner ‘901 in the context of right leg drive circuitry to eliminate common mode interference noise discloses,
wherein the ARLD controller is operatively connected to a user interface, and further instructions that, when executed by the at least one processor, performs the following:
-Warner ‘901 discloses, controller 50 of the ARLD controller, ¶0032-0034, that is operatively connected to the user interface 110, ¶0023, ¶0025-0026. Specifically, Warner ‘901 describes a system 10 for optimizing electrocardiography study performance that includes an amplifier, a controller 50, and a user interface, ¶0023, ¶0025-0026, wherein the controller includes a processor and memory containing instructions, Claim 19. Warner ‘901 explicitly states, “a user interface operatively connected to the controller.”, Claim 16, ¶0042.
receive, via the user interface, environmental configuration information; and
-Warner ‘901 discloses, receive, via a user interface, environmental configuration information. Note; the claim does not define what constitutes environmental configuration information. Warner ‘901 teaches study criteria which encompasses and constitutes as environment configuration information, which the processor receives via the user interface. Study criteria is defines as, see ¶0026: “Study criteria” as used herein refers generally to potential sources of noise or baseline wander including, but not limited to, the use of ablation equipment, the attachment of multiple medical devices to a subject, ungrounded electrical extension cords, electrical sockets, high-energy consumption equipment, and the like. Study criteria also include the type of study, e.g., ECG or other type of electronic signal monitoring systems, as well as desired levels of signal definition. As used herein, “appropriate” noise reduction circuits are those that will achieve optimal performance, e.g., signal measurement, given the study criteria that are on hand at the time the study is to be completed.”, see also ¶0022. The user interface is presented with, see ¶0031, “A user may also be presented with a questionnaire or separate input screen through interface 140 into which relevant information regarding the study may be entered.”
wherein the ARLD controller is further configured to construct the driving output signal based on the received environmental configuration information.
Upon review of the limitation, under the broadest reasonable interpretation the claim states that “wherein the ARLD controller is further configured to construct the driving output signal based on [emphasis added] the received environmental configuration information.”. The term “based on” is ambiguous and lacks precision. The term “based on” is a broad and ambiguous term that doesn’t clearly define the extent or nature of the relationship that claimed invention is intended to present. As such, the term “based on” implies that the claim invention is derived from or closely related to the received environmental configuration information. There are not explicit steps or additional limitations recited in the claim that preclude this interpretation.
-Warner ‘901 discloses, that the controller is configured to select, modify or tune the right leg drive (RLD) circuit, which generates the driving output signal, based on the received environmental information (i.e., study criteria). The RLD circuit functions to “introduce a signal into right leg of a patient to cancel common mode noise from the electrodes”, see ¶0007. The controller executes a program of instructions to, “select an appropriate noise reduction circuit.”, see ¶0024, or modify one based on the study criteria, ¶0011, ¶0024, ¶0042. Modifying the circuit constructs the driving output signal, for instance, a user can “with an input screen 160 [...] can tune the circuit by selecting or entering, for example, a specific frequency of the cut-off for the circuit”, see ¶0034. The controller can selected from multiple RLD circuits ensuring the driving signal is constructed appropriately for the specific environmental conditions, ¶0032-0033.
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the ARLD controller of Warner in view of the teachings of Warner ‘901. The motivation to do this yields predictable results such as improving “control and potentially minimizing interactions between multiple devices attached to a single subject”, as explicitly stated by Warner ‘901, ¶0034 of Warner ‘901.
Claim 16: Warner as modified discloses all the elements above in claim 12, Warner discloses, wherein the one or more bio-potential signal sensors include at least two electrodes operatively connected to the patient. (¶0030 – ECG signals from a patient 12 the data acquisition system 10 includes 3-lead ECG measurement units that measures ECG signals from electrodes RA, LA, LL, and RL.)
Claim 17: Warner as modified discloses all the elements above in claim 12, Warner discloses: wherein the driving electrode (RL electrode, FIG. 2) receives the driving output signal from the ARLD circuit and applies the driving output signal to the patient. (¶0029 – electrodes attached to the patient with RL electrode serving as an electrical ground; ¶0030 – Amplifier 22 is a right leg drive (RLD) amplifier that utilizes the RL electrode for equalizing the potential for the human body and the measurement electronics.)
Claim 20: Warner as modified discloses all the elements above in claim 12, Warner discloses: wherein the ARLD controller is operatively connected to a user interface, and includes further instructions that, when executed by the at least one processor, performs the following: receive, from the user interface, a user input including one or more user-selectable filters or parameters; and construct the driving output signal based on the user input. (¶0030 – Output from the control unit 26/CPU 28 can be presented on display and interacted with by the user though a user input 32 such as a touchscreen, mouse, or keyboard.; ¶0033, ‘in a data acquisition system 10 such as an ECG or specialist EP/HEMO system featuring multiple RLD circuits 100, 100′ and 100″ and/or a modifiable or tunable RLD circuit 100 that allows the user to selectively alter the operation of the RLD circuit 100 using a switching circuit 200, […], by providing the RLD saturation index, the system 10 provides both computer algorithm in the CPU 26, and/or the end user a manner of determining the performance of the particular RLD circuit 100, 100′ or 100″ that is currently in use through reporting by the system 10 of the degree of saturation of the RLD circuit 100, 100′ and 100″, and the period of saturation of the RLD circuit 100, 100′ and 100″ in the form of the RLD index to report these combined effects. This RLD index provides the CPU 26/end user with a ready means to know whether saturation is occurring, and amount of time on a standardized basis this is occurring. This data may also be used as a quality index in the data to highlight the deterioration in the recorded signal. Further, using the RLD index, the CPU 26 and algorithm (any examples of what this might ental?—perturbation function, transform function?) can automatically select the best RLD circuit 100, 100′ or 100″ with its particular associated feedback voltage value for optimal operation of the system 10 based upon how aggressive the RLD circuit 100, 100′ or 100″ should be in view of the current operating characteristics of the system 10. This information provides realization of effectiveness of the traditional right leg drive, and when used in a programmable right-leg drive system, provide feedback on effectivity of the control algorithm under various use conditions.’ & ¶0011-0012)
Claim 21: Warner as modified discloses all the elements above in claim 12, Warner discloses: wherein an output signal is constructed by the ARLD controller (¶0030 – Control unit 26) based on at least the bio-potential signal received from the patient. (¶0029 – electrodes attached to the patient with RL electrode serving as an electrical ground; ¶0030 – Amplifier 22 is a right leg drive (RLD) amplifier that utilizes the RL electrode for equalizing the potential for the human body and the measurement electronics. The A/D converted 24 converts the analog signal to a digital ECG signal that received by the control unit 26 to be processed by the CPU 28 within the control unit 26, CPU 28 executes a program of instructions to monitor the level of saturation of the RLD circuit to use and to select appropriate noise reduction circuit. Output from the control unit 26/CPU 28 can be presented on display and interacted with by the user though a user input 32 such as a touchscreen, mouse, or keyboard))
Claims 6 & 18 are rejected under 35 U.S.C. 103 as being unpatentable over Warner et al (US 2021/0212587 A1) in view of Warner et al (US 2015/0011901 A1, herein Warner ‘901), as applied to claim 1 & 12, in further view of Liu et al (EP 3821799 A1).
Claim 6: Warner as modified discloses all the elements above in claim 1, Warner fails to disclose: wherein the environmental information includes at least one of local electromagnetic interference (EMI), local audible measurements, local mechanical measurements, and local temperature measurements.
However, Liu in the context of three-lead electrocardiography monitoring method and device, discloses, wherein environmental information includes local temperature measurements (¶0019, ‘a body temperature circuit […] These parameters may comprise but are not limited to: parameters such as electrocardiogram, respiration, body temperature, blood oxygen, non-invasive blood pressure, and invasive blood pressure.’)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the ARLD controller of modified Warner to include a body temperature circuit of Liu for the advantage of providing an improved apparatus being able to improve accuracy of a calculated electrocardiography parameter and analysis results when common-mode interference is present, ¶0053 of Liu.
Claim 16: Warner as modified discloses all the elements above in claim 12, Warner fails to disclose: wherein the environmental information includes at least one of local electromagnetic interference (EMI), local audible measurements, local mechanical measurements, and local temperature measurements.
However, Liu in the context of three-lead electrocardiography monitoring method and device, discloses, wherein environmental information includes local temperature measurements (¶0019, ‘a body temperature circuit […] These parameters may comprise but are not limited to: parameters such as electrocardiogram, respiration, body temperature, blood oxygen, non-invasive blood pressure, and invasive blood pressure.’)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the ARLD controller of modified Warner to include a body temperature circuit of Liu for the advantage of providing an improved apparatus being able to improve accuracy of a calculated electrocardiography parameter and analysis results when common-mode interference is present, ¶0053 of Liu.
Claims 7 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Warner et al (US 2021/0212587 A1) in view of Warner et al (US 2015/0011901 A1, herein Warner ‘901), as applied to claim 1 and 12 respectively, in further view of Centen et al (US 2019/0046069 A1)
Claim 7: Warner as modified discloses all the elements above in claim 1, Warner fails to disclose: wherein the environmental configuration information includes at least one of mains grid properties, magnetic resonance imaging (MRI) system type, MRI scan to be perform, and lead configurations.
However, Centen in the context of electrode arrangement for cardiovascular signal acquisition, discloses, wherein the environmental configuration information includes lead configurations.
-Centen discloses, de-noised signal components from noise components based on electro array configuration, ¶0070. The arrangement of the electrodes allows the system to distinguish between signal and noise, ¶0048-0051, ¶0065, ¶0071-0072.
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the environmental configuration information of modified warner to be configured to include the teachings of Centen for the advantage of providing an improved system to improve the signal to noise ration, as explicitly stated by Centen, ¶0041.
Claim 19: Warner as modified discloses all the elements above in claim 12, Warner fails to disclose: wherein the environmental configuration information includes at least one of mains grid properties, magnetic resonance imaging (MRI) system type, MRI scan to be perform, and lead configurations.
However, Centen in the context of electrode arrangement for cardiovascular signal acquisition, discloses, wherein the environmental configuration information includes lead configurations.
-Centen discloses, de-noised signal components from noise components based on electro array configuration, ¶0070. The arrangement of the electrodes allows the system to distinguish between signal and noise, ¶0048-0051, ¶0065, ¶0071-0072.
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the environmental configuration information of modified warner to be configured to include the teachings of Centen for the advantage of providing an improved system to improve the signal to noise ration, as explicitly stated by Centen, ¶0041.
Claims 11 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Warner et al (US 2021/0212587 A1) in view of Warner et al (US 2015/0011901 A1, herein Warner ‘901), as applied to claim 1 and 12 respectively, in further view of Cooke et al (US 2014/0018870 A1).
Claim 11: Warner as modified discloses all the elements above in claim 1:
Warner fails to disclose: wherein the first operating mode of the ARLD circuit is a non-magnetic resonance (MR) environment mode and the second operating mode of the ARLD circuit is a MR environment mode.
However, Cooke in the context of MRI operation modes for medical devices discloses: wherein the first operating mode of the circuit is a non-magnetic resonance (MR) environment mode and the second operating mode of the circuit is a MR environment mode. (¶0012, ‘The communication signals can include commands to switch or reprogram the CRM device between an MRI mode and a non-MRI mode. In one embodiment, the MRI mode can be a CRM device mode that allows the CRM device to switch from a normal operation mode to an MRI-safe operation mode in the presence of one or more MRI electromagnetic fields. Further, the non-MRI mode can be a CRM device mode that prohibits the CRM device from switching from the normal operation mode to the MRI-safe operation mode.’)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the ARLD circuit of modified Warner to include a first operating ode is a non-MR environment mode and the second operating mode is a MR environment mode in view of the teachings of Cooke for the advantage of improving the apparatus with such an apparatus being able to render medical devices safe in the presence of strong electro-magnetic interference, such as those produced by a magnetic resonance imaging (“MRI”) system, ¶0002 of Cooke.
Claim 15: Warner as modified discloses all the elements above in claim 12:
Warner fails to disclose: wherein the first operating mode of the ARLD circuit is a non-magnetic resonance (MR) environment mode and the second operating mode of the ARLD circuit is a MR environment mode.
However, Cooke in the context of MRI operation modes for medical devices discloses: wherein the first operating mode of the circuit is a non-magnetic resonance (MR) environment mode and the second operating mode of the circuit is a MR environment mode. (¶0012, ‘The communication signals can include commands to switch or reprogram the CRM device between an MRI mode and a non-MRI mode. In one embodiment, the MRI mode can be a CRM device mode that allows the CRM device to switch from a normal operation mode to an MRI-safe operation mode in the presence of one or more MRI electromagnetic fields. Further, the non-MRI mode can be a CRM device mode that prohibits the CRM device from switching from the normal operation mode to the MRI-safe operation mode.’)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the ARLD circuit of modified Warner to include a first operating ode is a non-MR environment mode and the second operating mode is a MR environment mode in view of the teachings of Cooke for the advantage of improving the apparatus with such an apparatus being able to render medical devices safe in the presence of strong electro-magnetic interference, such as those produced by a magnetic resonance imaging (“MRI”) system, ¶0002 of Cooke.
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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/N.A.R./Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798