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 .
Status of Claims
Claims 1-4, 9-12, 14, 17-21, and 23-28 are currently pending and under examination. Claims 5-8, 13, 15-16, and 22 are canceled. As per the amendments filed on 03/30/2026, claims 1, 3-4, 9-12, 14, 17-21, and 23-24 are amended and claims 25-28 are newly added.
Priority
The instant application (filed on 07/25/2022) is a national stage of PCT/EP2021/051250 (filed on 01/21/2021), filed under 35 USC 371. Acknowledgment is made of applicant's claim for foreign priority based on application EP20154351.9 (filed on 01/29/2020). Instant claims 1-4, 9-12, 14, 17-21, and 23-28 are sufficiently supported in the foreign application to receive an effective filing date of 01/29/2020 and all prior art will be evaluated with respect to this date.
Response to Arguments
Applicant's arguments, see Remarks pages 8-11 (Claim Rejections Under 35 U.S.C. § 103), filed 03/30/2026, with respect to the rejections of Claims 1-4, 7, 9-12, and 14-24 under 35 USC § 103 been fully considered. Claims 7, 15-16, and 22 are newly canceled. Regarding independent claims 1, 14, and 24, Applicant argues:
The Patent Office asserts that Cheng in view of one or more of Peng, Reynolds, Hayes-Gill, Yin, and Weinerth suggests or renders obvious a method or system in which a processor is adapted to determine a "coupling capacitance (Ce) from a combination of both the first and second outputs, and based on the first transfer function and the second transfer function." Specifically, the Patent Office asserts that Cheng discloses (emphasis in original):
a processor-adapted to determine the coupling capacitance (Ce) from a combination of both the first and second outputs, and based on the first transfer function and second transfer function electrodes ([0019] - the coupling capacitance is determined by the combination of the two channels, each with separate transfer functions), and based on an assumption that the sensed first and second signals are indicative of the same electrophysiological signal (Vbio) at the body surface, and based on an assumption that the coupling capacitance (C) between the electrode arrangement and the body surface during sensing of each of the first and second signals is the same ([0007-0008] - reference is made to a singular electrophysiological signal and singular coupling capacitance characterizing the body while the channels differ).
Although Applicant respectfully disagrees that these cited sections (including with the remainder of Cheng with or without Peng, Reynolds, Hayes-Gill, Yin, and Weinerth) disclose the cited step of determining a "coupling capacitance (Ce) from a combination of both the first and second outputs, and based on the first transfer function and the second transfer function," the claims have been amended to facilitate expeditious prosecution of the application. Specifically, the claims have been amended to recite:
"wherein the processor is adapted to estimate the coupling capacitance (Ce) from a combination of both the first and second outputs, and based on the first transfer function and the second transfer function, and wherein a speed and a duration of the switching of the switch arrangement are arranged such that the electrophysiological signal (Vbio) and the coupling capacitance (Ce) are constant during sensing of each of the first signal and the second signal."
Notably, Cheng while discloses a method for suppressing noise and recovering a bio signal of interest from a biosensor, it does not disclose first and second sensing circuits that generate outputs based on respective transfer functions, nor does it disclose determining/estimating a coupling capacitance based on the outputs from the two circuits. As acknowledged by the Patent Office, Cheng fails to suggest or render obvious a system comprising a shared sense electrode coupled to the surface of the body such that the shared sense electrode and the body define a coupling capacitance (Ce), and wherein the shared sense electrode comprises a single sense electrode, where the single sense electrode provides the first signal at the surface sent to the first sensing circuit and the second signal sent to the second sensing circuit. Thus, Cheng fails to suggest or render obvious a system comprising first and second sensing circuits that generate outputs based on respective transfer functions, and fails to suggest or render obvious a system that determines/estimates a coupling capacitance based on the outputs from the two circuits. While the Patent Office asserts that Cheng in view of Peng and/or Reynolds renders this obvious, Applicant addresses this assertion below. (03/30/2026 Remarks, pages 8-10)
This argument is overall persuasive. Neither Cheng, Peng, nor Reynolds teach “a duration of the switching of the switch arrangement are arranged such that the electrophysiological signal (Vbio) and the coupling capacitance (Ce) are constant during sensing of each of the first signal and the second signal." Therefore, the rejections of claims 1-4, 9-12, 14, 17-21, and 23-24 are withdrawn. However, it should be noted that Cheng does disclose “first and second sensing circuits that generate outputs based on respective transfer functions” and “determining/estimating a coupling capacitance based on the outputs from the two circuits.” Cheng [0019] states:
In preferred embodiments noise artifacts for a capacitive sensor are attenuated by employing a two-channel biopotential front-end with different transfer functions between channels, permitting a digital signal processor to solve a system of equations that can reconstruct both the noise-induced (such as motion induced) time-varying coupling capacitance, as well as the undistorted biopotential signal.
This is interpreted as using two channels with different transfer functions to create two equations with a common coupling capacitance and biopotential as the unknowns, where the unknowns can be solved from these equations.
Applicant additionally argues:
Further, Cheng does not disclose and fails to suggest or render obvious a system or method in which a processor is adapted to estimate a coupling capacitance (Ce) using a switch arrangement (Sl-S4) as defined in the independent claims. Specifically, Cheng does not disclose:
"wherein the processor is adapted to estimate the coupling capacitance (Ce) from a combination of both the first and second outputs, and based on the first transfer function and the second transfer function, and wherein a speed and a duration of the switching of the switch arrangement are arranged such that the electrophysiological signal (Vbio) and the coupling capacitance (Ce) are constant during sensing of each of the first signal and the second signal."
There is no mention of estimat(ing) the coupling capacitance from the first and second outputs analytically using the first and second transfer functions in Cheng, wherein a speed and a duration of the switching of the switch arrangement are arranged such that the electrophysiological signal (Vbio) and the coupling capacitance (Ce) are constant during sensing of each of the first signal and the second signal. Accordingly, Cheng (alone or in combination with one or more of Peng, Reynolds, Hayes-Gill, Yin, and Weinerth) fails to disclose or render obvious the claimed invention.
The Patent Office asserts that Cheng in view of Peng and/or Reynolds renders obvious a system comprising first and second sensing circuits that generate outputs based on respective transfer functions, and that determines/estimates a coupling capacitance based on the outputs from the two circuits. However, Cheng in view of Peng and/or Reynolds (with or without Hayes-Gill, Yin, and Weinerth) fails to disclose or render obvious estimat(ing) the coupling capacitance from the first and second outputs analytically using the first and second transfer functions AND wherein a speed and a duration of the switching of the switch arrangement are arranged such that the electrophysiological signal (Vbio) and the coupling capacitance (Ce) are constant during sensing of each of the first signal and the second signal. (03/30/2026 Remarks, pages 10-11)
This argument is persuasive. The teachings of Reynolds were previously relied upon for the switching function. However, the amendments now effectively require rapid switching with such frequency that each transfer function is exposed to virtually the same time-varying coupling capacitance and biopotential values. This rapid switching is not present in Cheng, Peng, or Reynolds. As previously stated, for this same reason, the rejections of claims 1-4, 9-12, 14, 17-21, and 23-24 are withdrawn. However, upon further consideration, a new ground(s) of rejection is made over Kamath (US 2005/0038350 A1).
Summary: The 35 U.S.C. § 103 rejections of claims 1-4, 7, 9-12, and 14-24 are withdrawn.
New 35 U.S.C. § 103 rejections for claims 1-4, 9-12, 14, 17-21, and 23-24 newly in view of Kamath (US 2005/0038350 A1) are added. 35 U.S.C. § 103 rejections for new claims 25-28 are added.
Claim Objections
The following claims are objected to because of the following informalities:
• Claims 4 and 25: The limitation “and based on a coupling capacitance (Ce) between the electrode arrangement and the body surface during sensing of each of the first and second signals is the same” is awkward where “is the same” would be more understandable as “being the same.”
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
Claim 12: “comprising an interface adapted to provide electrode contact quality information based on the coupling capacitance.” The limitation does not disclose sufficient structure for the “interface.” The “interface” is described as, “The system preferably further comprises an interface adapted to provide electrode contact quality information based on the coupling capacitance. This interface may be a user interface to inform a user that the measurement is not reliable and that the attachment of one or more capacitive electrodes needs to be improved. It may be an interface to a further processing system, to assist in the interpretation of the measured signals” (Specification, Page 5, Lines 10-14). Therefore, the interface is being interpreted as a user interface component for displaying and communicating sensed or computed information from the sensing system to the user.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 factual inquiries for establishing a background for determining obviousness under 35 U.S.C.
103 are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or non-obviousness.
Claims 1-4, 9, 12, 14, 17-18, and 21 are rejected under U.S.C 103 as being unpatentable over Cheng (US 2016/0256111 A1) in view of Peng (NPL, “Preamplifiers for Non-Contact Capacitive Biopotential Measurements”), Reynolds (PG Pub 2009/0033343 A1), and Kamath (US 2005/0038350 A1).
According Claim 1, Cheng discloses a sensing system for sensing an electrophysiological signal (Vbio) from the surface of a body ([0008] – capacitive sensing worn close to the skin), said system comprising:
• a capacitive sense electrode for coupling to the surface of the body such that the capacitive sense electrode and the body define a coupling capacitance (Ce), and wherein the capacitive sense electrode comprises a sense electrode ([0007], [0018-0019] – coupling capacitance determined by measurements for separate biosignal channels),
• a first sensing circuit, comprising a first sensing circuit arranged to sense a first signal at the surface via the sense electrode arrangement and generate a first output (VOUT_VA) based on a first transfer function for the first sensing circuit ([0018-0019] – reference to the first channel with its own isolated electrode arrangement and transfer function producing a voltage);
• a second sensing circuit, comprising a second sensing circuit and arranged to sense a second signal at the surface via sense electrode arrangement and generate a second output (VOUT_VA) based on a second transfer function for the second sensing circuit, wherein the second transfer function is different to the first transfer function ([0018-0019] – reference to the second channel with its own isolated electrode arrangement and transfer function producing a voltage, different transfer function mentioned in [0019] between the two channels),
• a processor ([0019] – processor with reconstruction functions);
• wherein the processor is adapted to estimate the coupling capacitance Ce from a combination of both the first and second outputs, and based on the first transfer function and the second transfer function ([0007-0008] – reference is made to a singular electrophysiological signal and singular coupling capacitance characterizing the body while the channels differ, [0019] – a two channel arrangement with a different transfer function equation for each channel is used to solve for unknown common time-varying capacitance and undistorted biosignal).
Cheng discloses: “After decades of research in non-contact sensing, the ECG and EEG wet electrodes remain important because the non-contact sensing still suffers from excessive noise due to movement between the subject and sensor and because of triboelectricity” ([0006]). Cheng additionally discloses a shield layer to isolate the first and second channels ([0028]). However, Cheng does not disclose: a voltage amplifier in the first sensing circuit or a charge amplifier in the second sensing circuit with the second sensing circuit comprising a charge amplifier and the second signal being a current signal.
Peng, in the same field of endeavor of biosignal monitoring using capacitive sensing, teaches non-contact biopotential sensing (Abstract and Introduction, Page 1). Peng teaches that both charge and voltage amplifiers are useful for improving performance of non-contact biopotential sensors (Introduction, Pages 1-2), where voltage and charge amplifiers can be applied to sensing channels (Fig. 1, pages 2-3 discuss comparisons of the different transfer functions for voltage and charge amplifiers).
Peng discloses:
Traditionally, non-contact sensors have been built with a high input impedance voltage follower amplifier (VA), [1] and [3]. Due to the small source capacitance, the input capacitance of the front-end VA must be kept extremely small or otherwise neutralized, however this can degrade the noise performance [4]. To cope with small bioelectric signals, a charge amplifier (CA) design is a promising option because its gain is independent of the input capacitance of the preamplifier [5]. Furthermore, shielding in the CA configuration is straightforward and the low-frequency cutoff is independent of the source capacitance. However, the challenge of using a CA is that its gain depends on the source capacitance, which may be modulated by the relative motion of the subject and the electrodes. (Introduction, Page 2)
Peng also discloses the use of the amplifier circuits in concert:
PNG
media_image1.png
304
1176
media_image1.png
Greyscale
Peng, Fig. 1 - “A generic differential amplifier where the two input channels may be implemented as either a voltage amplifier or a charge amplifier”
Peng summarizes the benefits and drawbacks of the voltage and charge amplifiers:
The VA and CA are both viable options for biopotential preamplifiers. In summary, see Table I for a comparison, at higher source capacitor values (greater than 100pF), the VA may be preferred due to its better CMRR, stable gain, and low noise. For lower source capacitance values, the CA is an attractive alternative due to its linear gain response, CMRR value nearly the same as that of the VA, and noise performance for small CA feedback capacitor values that is comparable to that of the VA. Finally, in our implementation of a non-contact ECG sensor [9] we monitor the source capacitance value and then compensate the output for motion induced gain modulation, which is greatly facilitated by the linear response characteristics of the CA configuration. (Conclusions, Page 6).
It would have been obvious to a person of ordinary skill in the art to alter Cheng’s two channel sensing system by incorporating the voltage and charge amplifier configurations taught by Peng. This would have been obvious because both Cheng and Peng discuss non-contact biopotential sensing response between two channels/circuits and Peng provides a solution/improvement of the benefits and drawbacks of conditioning with either voltage and charge amplifiers as known alternatives for capacitive coupling circuits with unique transfer functions (such as noted differences in noise, frequency response, CMRR, and sensitivity) when exposed to the same biosignal. Therefore, a person of ordinary skill in the art would be motivated to improve the system of Cheng by incorporating the voltage and charge amplifier channels of Peng.
However, Cheng does not disclose a shared single capacitive electrode in different electrical operating modes.
Reynolds, in the same field of endeavor of non-contact electrodes ([0004]), teaches two modes
for use with a combined guard and sensing electrode 120 in order to reduce noise in the system ([0020]). A processor switches between two modes (two circuits) connected to the electrode based on capacitive sensing measurements, which are used to determine whether an object is close enough to accurately sense a capacitive signal from an object ([0023]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter the two-channel capacitive sensing electrode system in Cheng by incorporating the switchable dual-mode sensing arrangement mechanism for an electrode in Reynolds. This would have been obvious because both Cheng and Reynolds teach capacitive sensors. Reynolds provides a solution/improvement of using a common electrode for different sensing operations, which reduces variations/noise from different properties or placement of separate electrodes (where a switch facilitates changing between sensing modes or channels based on changing coupling conditions). Therefore, a person of ordinary skill in the art would be motivated to improve the device in Cheng by incorporating the switchable dual-mode sensing arrangement mechanism for an electrode in Reynolds.
However, Cheng does not disclose:
• a switch arrangement configured to couple a selected one of the first sensing circuit and the second sensing circuit to the processor and to the shared sense electrode to generate the first output and the second output in a time sharing manner; and
• wherein a speed and a duration of the switching of the switch arrangement are arranged such that the electrophysiological signal (Vbio) and the coupling capacitance (Ce) are constant during sensing of each of the first signal and the second signal.
Note Reynolds was relied on to teach the switching function in the previous office action, but the amendments now require a more specific type of switching, which is taught by Kamath.
The biopotential signal source separation using source impedances (Abstract) in Kamath would be considered “reasonably pertinent” (see MPEP 2141.01(a)1) to the capacitive sensing for estimating capacitive coupling in the instant application because Kamath also obtains a common time-varying biopotential passed through different sensing-circuit conditions and addresses a common problem of maintaining a consistent biopotential signal when sampling between channels. Kamath teaches biosignal source separation based on measured differences in source impedance where a single electrode can rapidly switch between amplifiers provided at different impedance stages (Fig. 4A, [0058-0062]). Kamath teaches rapid switching between input impedance stages where “the switching may occur at a frequency much higher than any characteristic frequency of the constituent biopotential signals, so that the input signal may be assumed approximately constant across samples from the same switching/sampling cycle” ([0061]). This switching arrangement is used to estimate the source impedance based on the different responses of the respective amplifier pathways to the same source signal ([0063]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter the two-channel capacitive sensing electrode system in Cheng, as modified by Peng and Reynolds, by incorporating the rapid switching between channels to different circuit pathways where a common signal responds differently based on impedance properties of each amplifier circuit, as taught by Kamath. This would have been obvious because both Cheng and Kamath teach a biopotential sensor using a comparison of the same input signal under different sensing conditions/pathways. Kamath provides a solution/improvement of rapidly switching between amplifier pathways with different impedance properties so the input signal can be assumed as approximately constant among the different pathways (which standardizes the input signal to each channel for greater accuracy when solving for unknown values using the transfer functions). Therefore, a person of ordinary skill in the art would be motivated to improve the device in Cheng, as modified by Peng and Reynolds, by incorporating the rapid switching between channels to different circuit pathways where a common signal responds differently based on impedance properties of each amplifier circuit, as taught by Kamath.
According Claim 14, Cheng discloses a method for sensing an electrophysiological signal (Vbio) from the surface of a body ([0008] – capacitive sensing method with device worn close to the skin), comprising:
• sensing a first signal at the body surface via a capacitive sense electrode comprising a first sensing circuit, coupled to the surface of the body such that the capacitive sense electrode and the body define a coupling capacitance (Ce), and generating a first output (VOUT_VA) based on a first transfer function for the a first sensing circuit ([0018-0019] – reference to the first channel with its own isolated electrode arrangement and transfer function producing a voltage);
• sensing a second signal at the body surface via a second sensing circuit of the capacitive sense electrode and generating a second output (VOUT_CA) based on a second transfer function for the second sensing circuit, wherein the second transfer function is different to the first transfer function ([0018-0019] – reference to the second channel with its own isolated electrode arrangement and transfer function producing a voltage, different transfer function mentioned in [0019] between the two channels);
• estimating the coupling capacitance (Ce) from a combination of both the first and second outputs, and based on the first transfer function and the second transfer functions ([0007-0008] – reference is made to a singular electrophysiological signal and singular coupling capacitance characterizing the body while the channels differ, [0019] – a two channel biopotential with different transfer functions for each channel used to solve for unknown common time-varying capacitance and undistorted biosignal).
Cheng discloses: “After decades of research in non-contact sensing, the ECG and EEG wet electrodes remain important because the non-contact sensing still suffers from excessive noise due to movement between the subject and sensor and because of triboelectricity” ([0006]). Cheng additionally discloses a shield layer to isolate the first and second channels ([0028]). However, Cheng does not disclose: a voltage amplifier in the first sensing circuit or a charge amplifier in the second sensing circuit with the second signal being a current signal.
Peng, in the same field of endeavor of biosignal monitoring using capacitive sensing, teaches non-contact biopotential sensing (Abstract and Introduction, Page 1). Peng teaches that both charge and voltage amplifiers are useful for improving performance of non-contact biopotential sensors (Introduction, Pages 1-2), where voltage and charge amplifiers can be applied to sensing channels (Fig. 1, pages 2-3 discuss comparisons of the different transfer functions for voltage and charge amplifiers).
Peng discloses:
Traditionally, non-contact sensors have been built with a high input impedance voltage follower amplifier (VA), [1] and [3]. Due to the small source capacitance, the input capacitance of the front-end VA must be kept extremely small or otherwise neutralized, however this can degrade the noise performance [4]. To cope with small bioelectric signals, a charge amplifier (CA) design is a promising option because its gain is independent of the input capacitance of the preamplifier [5]. Furthermore, shielding in the CA configuration is straightforward and the low-frequency cutoff is independent of the source capacitance. However, the challenge of using a CA is that its gain depends on the source capacitance, which may be modulated by the relative motion of the subject and the electrodes. (Introduction, Page 2)
Peng also discloses the use of the amplifier circuits in concert:
PNG
media_image1.png
304
1176
media_image1.png
Greyscale
Peng, Fig. 1 - “A generic differential amplifier where the two input channels may be implemented as either a voltage amplifier or a charge amplifier”
Peng summarizes the benefits and drawbacks of the voltage and charge amplifiers:
The VA and CA are both viable options for biopotential preamplifiers. In summary, see Table I for a comparison, at higher source capacitor values (greater than 100pF), the VA may be preferred due to its better CMRR, stable gain, and low noise. For lower source capacitance values, the CA is an attractive alternative due to its linear gain response, CMRR value nearly the same as that of the VA, and noise performance for small CA feedback capacitor values that is comparable to that of the VA. Finally, in our implementation of a non-contact ECG sensor [9] we monitor the source capacitance value and then compensate the output for motion induced gain modulation, which is greatly facilitated by the linear response characteristics of the CA configuration. (Conclusions, Page 6).
It would have been obvious to a person of ordinary skill in the art to alter Cheng’s two channel sensing system method by incorporating the voltage and charge amplifier configurations taught by Peng. This would have been obvious because both Cheng and Peng discuss non-contact biopotential sensing response between two channels/circuits and Peng provides a solution/improvement of the benefits and drawbacks of conditioning with either voltage and charge amplifiers as known alternatives for capacitive coupling circuits with unique transfer functions (such as noted differences in noise, frequency response, CMRR, and sensitivity) when exposed to the same biosignal. Therefore, a person of ordinary skill in the art would be motivated to improve the method of Cheng by incorporating the voltage and charge amplifier channels of Peng.
However, Cheng does not disclose a shared single capacitive electrode in different electrical operating modes.
Reynolds, in the same field of endeavor of non-contact electrodes ([0004]), teaches two modes for use with a combined guard and sensing electrode 120 in order to reduce noise in the system ([0020]). A processor switches between two modes (two circuits) connected to the electrode based on capacitive sensing measurements, which are used to determine whether an object is close enough to accurately sense a capacitive signal from an object ([0023]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter the two-channel capacitive sensing electrode system method in Cheng by incorporating the switchable dual-mode sensing arrangement mechanism for an electrode in Reynolds. This would have been obvious because both Cheng and Reynolds teach capacitive sensors. Reynolds provides a solution/improvement of using a common electrode for different sensing operations, which reduces variations/noise from different properties or placement of separate electrodes (where a switch facilitates changing between sensing modes or channels based on changing coupling conditions). Therefore, a person of ordinary skill in the art would be motivated to improve the method in Cheng by incorporating the switchable dual-mode sensing arrangement mechanism for an electrode in Reynolds.
However, Cheng does not disclose:
• switching, via a switch arrangement coupling each of the first and second sensing circuits to the processor and to shared sense electrode voltage amplifier and the charge amplifier to alternatively activate the voltage amplifier and the charge amplifier to generate the first output and the second output in a time sharing manner; and
• wherein a speed and a duration of the switching of the switch arrangement are arranged such that the electrophysiological signal (Vbio) and the coupling capacitance (Ce) are constant during sensing of each of the first signal and the second signal.
Note Reynolds was relied on to teach the switching function in the previous office action, but the amendments now require a more specific type of switching, which is taught by Kamath. Peng was previously shown to teach the voltage and charge amplifier components, but not the rapid switching.
The biopotential signal source separation using source impedances (Abstract) in Kamath would be considered “reasonably pertinent” (see MPEP 2141.01(a)1) to the capacitive sensing for estimating capacitive coupling in the instant application because Kamath also obtains a common time-varying biopotential passed through different sensing-circuit conditions and addresses a common problem of maintaining a consistent biopotential signal when sampling between channels. Kamath teaches biosignal source separation based on measured differences in source impedance where a single electrode can rapidly switch between amplifiers provided at different impedance stages (Fig. 4A, [0058-0062]). Kamath teaches rapid switching between input impedance stages where “the switching may occur at a frequency much higher than any characteristic frequency of the constituent biopotential signals, so that the input signal may be assumed approximately constant across samples from the same switching/sampling cycle” ([0061]). This switching arrangement is used to estimate the source impedance based on the different responses of the respective amplifier pathways to the same source signal ([0063]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter the two-channel capacitive sensing electrode system method in Cheng, as modified by Peng and Reynolds, by incorporating the rapid switching between channels to different circuit pathways where a common signal responds differently based on impedance properties of each amplifier circuit, as taught by Kamath. This would have been obvious because both Cheng and Kamath teach a biopotential sensor using a comparison of the same input signal under different sensing conditions/pathways. Kamath provides a solution/improvement of rapidly switching between amplifier pathways with different impedance properties so the input signal can be assumed as approximately constant among the different pathways (which standardizes the input signal to each channel for greater accuracy when solving for unknown values using the transfer functions). Therefore, a person of ordinary skill in the art would be motivated to improve the method in Cheng, as modified by Peng and Reynolds, by incorporating the rapid switching between channels to different circuit pathways where a common signal responds differently based on impedance properties of each amplifier circuit, as taught by Kamath.
Regarding Claim 2, the sensing system according to Claim 1 is obvious over Cheng in view of Peng, Reynolds, and Kamath, as indicated hereinabove. Cheng further discloses the processor is further adapted to process the first and/or second outputs (VoutvA, Vout cA) thereby to determine the electrophysiological signal (Vbio) at the body surface ([0022] – the biological signals without motion artifact are calculated: “The sensor provides a pair of physically-interleaved capacitive channels designed to have different amounts of parasitic input capacitance, which create a channel-specific outputs that depend on the input coupling capacitance itself. Differences in output channel results can then be reconstructed with a digital filter to re-create the original bio potential with attenuated motion artifacts”). As stated in claim 1, the proposed combination with Peng yields the voltage and charge amplifiers for the processing of VoutvA and Vout cA.
Regarding Claims 3 and 17, the sensing system and method according to Claims 2 and 14 are obvious over Cheng in view of Peng, Reynolds, and Kamath, as indicated hereinabove. Cheng discloses determining the electrophysiological signal at the body surface further taking into account the estimated coupling capacitance, thereby to provide body motion compensation ([0017-0019] – removal of motion-induced noise during the process of calculating the skin biosignal and coupling capacitance from the two channels).
Regarding Claim 4, the sensing system according to Claim 1 is obvious over Cheng in view of Peng, Reynolds, and Kamath, as indicated hereinabove. Cheng further discloses wherein the processor is further adapted to estimate the coupling capacitance based on an assumption that the sensed first and second signals are indicative of the same electrophysiological signal (Vbio) at the body surface, and based on a coupling capacitance (Ce) between the electrode arrangement and the body surface during sensing of each of the first and second signals is the same ([0007-0008] – reference is made to a singular electrophysiological signal and singular coupling capacitance characterizing the body while the channels properties differ; [0018-0019] – a two channel biopotential with different transfer functions for each channel is used to solve for unknown common time-varying capacitance and undistorted biosignal).
Regarding Claims 9 and 18, the sensing system and method according to Claims 1 and 14 are obvious over Cheng in view of Peng, Reynolds, and Kamath, as indicated hereinabove. Cheng further discloses the electrophysiological signal comprises an electrocardiogram (ECG) signal ([0020, 0044] – ECG specified).
Regarding Claims 12 and 21, the sensing system according to Claims 1 and 14 are obvious over Cheng in view of Peng, Reynolds, and Kamath, as indicated hereinabove. Cheng further discloses an interface adapted to provide electrode contact quality information based on the estimated coupling capacitance ([0043-0044] – the error of the outputs involving the coupling capacitance are arrived at – raw data exported to a computing device [0023] - and plotted – as seen in Figs. 6A-B and 7A-C).
Claims 10 and 19 are rejected under U.S.C 103 as being unpatentable over Cheng (US 2016/0256111 A1) in view of Peng (NPL, “Preamplifiers for Non-Contact Capacitive Biopotential Measurements”), Reynolds (US 2009/0033343 A1), Kamath (US 2005/0038350 A1), and Hayes-Gill (US 2011/0306862 A1).
Regarding Claims 10 and 19, the sensing system and method according to Claims 9 and 18 are obvious over Cheng in view of Peng, Reynolds, and Kamath, as indicated hereinabove. Cheng discloses application of the system for monitoring ECG measurements with non-contact sensors ([0005-0006]), which could include placement for collection of adult ECG. Cheng discloses: “After decades of research in non-contact sensing, the ECG and EEG wet electrodes remain important because the non-contact sensing still suffers from excessive noise due to movement between the subject and sensor and because of triboelectricity” ([0006]). Cheng does not disclose the application of a non-contact sensor to measure fetal ECG signals.
Hayes-Gill, in the same field of endeavor of biosignal monitoring ([0006]), teaches the positioning of ECG electrodes to measure a fetal ECG signal ([0001-0002]). Hayes-Gill teaches: “The reduction of noise on the detected fECG signal is therefore of great importance. This noise on a detected fECG signal varies considerably and is typically caused by one or more of the following” ([0008]) and “Alternatively, other varieties of electrode such as hydrogel electrodes, dry electrodes and non contact electrodes may be used to detect ECG signals” ([0006]). Cheng is primarily concerned with reducing biosignal noise ([0006]) while Hayes-Gill is concerned with reducing noise in fetal ECG signals ([0008]).
It would have been obvious to a person of ordinary skill in the art to alter Cheng’s system, which is for adult placement using non-contact ECG electrodes, by integrating the placement of non-contact fetal ECG specified in Hayes-Gill in parallel to the adult placement. This would have been obvious because both Cheng and Hayes-Gill discuss biopotential sensing suffering from noise and Hayes-Gill provides a solution/improvement to noise during the acquisition of fetal ECG (pregnant patients being a subset of the population which could be monitored using non-contact electrodes). Therefore, a person of ordinary skill in the art would be motivated to improve the system of Cheng by incorporating the parallel non-contact electrode placement scheme for monitoring fetal ECG in Hayes-Gill.
Claims 11 and 20 are rejected under U.S.C 103 as being unpatentable over Cheng (US 2016/0256111 A1) in view of Peng (NPL, “Preamplifiers for Non-Contact Capacitive Biopotential Measurements”), Reynolds (US 2009/0033343 A1), Kamath (US 2005/0038350 A1), and Yin (US 2011/0137200 A1).
Regarding Claims 11 and 20, the sensing system and method according to Claims 1 and 14 are obvious over Cheng in view of Peng, Reynolds, and Kamath, as indicated hereinabove. Cheng discloses application of the system to ECG and EEG signals ([0005-0006]). Cheng does not disclose electromyography (EMG) as an electrophysiological signal.
Yin, in the same field of endeavor of non-contact biosignal monitoring, teaches a capacitive sensing electrode and a system for removing motion artifact being applied to ECG, EEG, and EMG biosignals ([0002]).
It would have been obvious to a person of ordinary skill in the art to alter Cheng’s system, which only explicitly teaches ECG and EEG, by integrating the electrode placement and signal collection needed to measure EMG in Yin. This would have been obvious because both Cheng and Yin discuss techniques for reduction in noise using non-contact, capacitive biopotential sensing and Yin provides a solution/improvement to noise during the acquisition of capacitive sensing EMG (thereby improving the collection of electrophysiologic parameters and the diagnostic capabilities of the device). Therefore, a person of ordinary skill in the art would be motivated to improve the system of Cheng by incorporating electrode placement and signal collection needed to measure EMG in Yin.
Claims 23-27 are rejected under U.S.C 103 as being unpatentable over Cheng (US 2016/0256111 A1) in view of Peng (NPL, “Preamplifiers for Non-Contact Capacitive Biopotential Measurements”), Reynolds (US 2009/0033343 A1), Kamath (US 2005/0038350 A1), and Weinerth (US 2017/0364184 A1).
Regarding Claim 23, the method for sensing an electrophysiological signal according to Claim 14 is obvious over Cheng in view of Peng, Reynolds, and Kamath, as indicated hereinabove. Cheng discloses first and second channel electrodes to assess the coupling capacity with the biosignal source via assessments of noise and strength of the underlying biosignal ([0018]). However, Cheng does not clearly disclose wherein the sense electrode arrangement comprises an array of electrodes, and wherein the processor is adapted to determine which electrodes of the array have a proper coupling to the body based on the respective coupling capacitance. Note the term “proper” is being interpreted broadly because “proper” may vary based on the applications of the device.
Weinerth, in the same field of endeavor of non-contact electrodes ([0032]), teaches an array of sensor electrodes arranged in a matrix to produce a capacitive image of an object in proximity to the array ([0050]). Weinerth teaches a determination module which quantifies the coupling capacitance between the electrode and the object in proximity to the electrode or between electrodes ([0004] - “The determination module is further configured to determine, using the first sensor electrode, a first capacitive coupling between the first sensor electrode and an input object in a sensing region of the input device. The determination module is further configured to determine, using the first sensor electrode and the second sensor electrode, a second capacitive coupling between the first sensor electrode and the second sensor electrode”). The processing unit determines the input state of the sensor (which includes a determination of excessive noise) based on the coupling capacity measurements ([0040]), where a result is to increase the signal-to-noise ratio of the capacitive sensing ([0138]).
It would have been obvious to a person of ordinary skill in the art to alter the electrode arrangement in the method of Cheng, as modified by Peng, Reynolds, and Kamath, by incorporating the electrode array capable of assessing local coupling capacitance with a capacitive image in Weinerth. This would have been obvious because both Cheng and Weinerth teach capacitive sensors and Weinerth provides a solution/improvement mechanism for allowing localized assessment of coupling capacitance with an object based on an object’s position in proximity to each electrode of an electrode array. A person of ordinary skill in the art would have been motivated to improve the method of Cheng by incorporating the electrode array capable of assessing local coupling capacitance with a capacitive image in Weinerth.
Regarding Claim 24, Cheng discloses a sensing system for sensing an electrophysiological signal from the surface of a body ([0008] – capacitive sensing worn close to the skin), said system configured to be coupled, when in use, to
• a capacitive sense electrode for coupling to the surface of the body such that the capacitive sense electrode and the body define a coupling capacitance (Ce) ([0007], [0018-0019] – coupling capacitance determined by measurements for separate biosignal channels);
• a first sensing circuit, comprising a first sensing circuit and arranged to sense a first signal at the surface via the capacitive sense electrode and generate a first output (VOUT_VA) based on a first transfer function for the first sensing circuit ([0018-0019] – reference to the first channel with its own isolated electrode arrangement and transfer function producing a voltage);
• a second sensing circuit, comprising a second sensing circuit and arranged to sense a second signal at the surface via the capacitive sense electrode and generate a second output (VOUT_CA) based on a second transfer function for the second sensing circuit, wherein the second transfer function is different to the first transfer function ([0018-0019] – reference to the second channel with its own isolated electrode arrangement and transfer function producing a voltage, different transfer functions mentioned in [0019] between the two channels);
• a processor ([0019] – processor with reconstruction functions);
• wherein the processor is adapted to estimate the coupling capacitance Ce from a combination of both the first and second outputs, and based on the first transfer function and the second transfer function ([0007-0008] – reference is made to a singular electrophysiological signal and singular coupling capacitance characterizing the body while the channels differ, [0019] – a two channel biopotential with different transfer functions for each channel used to solve for unknown common time-varying capacitance and undistorted biosignal).
Cheng discloses: “After decades of research in non-contact sensing, the ECG and EEG wet electrodes remain important because the non-contact sensing still suffers from excessive noise due to movement between the subject and sensor and because of triboelectricity” ([0006]). Cheng additionally discloses a shield layer to isolate the first and second channels ([0028]). However, Cheng does not disclose: a voltage amplifier in the first sensing circuit or a charge amplifier in the second sensing circuit with the second sensing circuit comprising a charge amplifier and the second signal being a current signal.
Peng, in the same field of endeavor of biosignal monitoring using capacitive sensing, teaches non-contact biopotential sensing (Abstract and Introduction, Page 1). Peng teaches that both charge and voltage amplifiers are useful for improving performance of non-contact biopotential sensors (Introduction, Pages 1-2), where voltage and charge amplifiers can be applied to sensing channels (Fig. 1, pages 2-3 discuss comparisons of the different transfer functions for voltage and charge amplifiers).
Peng discloses:
Traditionally, non-contact sensors have been built with a high input impedance voltage follower amplifier (VA), [1] and [3]. Due to the small source capacitance, the input capacitance of the front-end VA must be kept extremely small or otherwise neutralized, however this can degrade the noise performance [4]. To cope with small bioelectric signals, a charge amplifier (CA) design is a promising option because its gain is independent of the input capacitance of the preamplifier [5]. Furthermore, shielding in the CA configuration is straightforward and the low-frequency cutoff is independent of the source capacitance. However, the challenge of using a CA is that its gain depends on the source capacitance, which may be modulated by the relative motion of the subject and the electrodes. (Introduction, Page 2)
Peng also discloses the use of the amplifier circuits in concert:
PNG
media_image1.png
304
1176
media_image1.png
Greyscale
Peng, Fig. 1 - “A generic differential amplifier where the two input channels may be implemented as either a voltage amplifier or a charge amplifier”
Peng summarizes the benefits and drawbacks of the voltage and charge amplifiers:
The VA and CA are both viable options for biopotential preamplifiers. In summary, see Table I for a comparison, at higher source capacitor values (greater than 100pF), the VA may be preferred due to its better CMRR, stable gain, and low noise. For lower source capacitance values, the CA is an attractive alternative due to its linear gain response, CMRR value nearly the same as that of the VA, and noise performance for small CA feedback capacitor values that is comparable to that of the VA. Finally, in our implementation of a non-contact ECG sensor [9] we monitor the source capacitance value and then compensate the output for motion induced gain modulation, which is greatly facilitated by the linear response characteristics of the CA configuration. (Conclusions, Page 6).
It would have been obvious to a person of ordinary skill in the art to alter Cheng’s two channel sensing system by incorporating the voltage and charge amplifier configurations taught by Peng. This would have been obvious because both Cheng and Peng discuss non-contact biopotential sensing response between two channels/circuits and Peng provides a solution/improvement of the benefits and drawbacks of conditioning with either voltage and charge amplifiers as known alternatives for capacitive coupling circuits with unique transfer functions (such as noted differences in noise, frequency response, CMRR, and sensitivity) when exposed to the same biosignal. Therefore, a person of ordinary skill in the art would be motivated to improve the system of Cheng by incorporating the voltage and charge amplifier channels of Peng.
However, Cheng does not disclose a shared single capacitive electrode in different electrical operating modes.
Reynolds, in the same field of endeavor of non-contact electrodes ([0004]), teaches two modes for use with a combined guard and sensing electrode 120 in order to reduce noise in the system ([0020]). A processor switches between two modes (two circuits) connected to the electrode based on capacitive sensing measurements, which are used to determine whether an object is close enough to accurately sense a capacitive signal from an object ([0023]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter the two-channel capacitive sensing electrode system in Cheng by incorporating the switchable dual-mode sensing arrangement mechanism for an electrode in Reynolds. This would have been obvious because both Cheng and Reynolds teach capacitive sensors. Reynolds provides a solution/improvement of using a common electrode for different sensing operations, which reduces variations/noise from different properties or placement of separate electrodes (where a switch facilitates changing between sensing modes or channels based on changing coupling conditions). Therefore, a person of ordinary skill in the art would be motivated to improve the device in Cheng by incorporating the switchable dual-mode sensing arrangement mechanism for an electrode in Reynolds.
However, Cheng does not disclose:
• a switch arrangement configured to couple a selected one of the first sensing circuit and the second sensing circuit to the processor and to the shared sense electrode to generate the first output and the second output in a time sharing manner; and
• wherein a speed and a duration of the switching of the switch arrangement are arranged such that the electrophysiological signal (Vbio) and the coupling capacitance (Ce) are constant during sensing of each of the first signal and the second signal.
Note Reynolds was relied on to teach the switching function in the previous office action, but the amendments now require a more specific type of switching, which is taught by Kamath.
The biopotential signal source separation using source impedances (Abstract) in Kamath would be considered “reasonably pertinent” (see MPEP 2141.01(a)1) to the capacitive sensing for estimating capacitive coupling in the instant application because Kamath also obtains a common time-varying biopotential passed through different sensing-circuit conditions and addresses a common problem of maintaining a consistent biopotential signal when sampling between channels. Kamath teaches biosignal source separation based on measured differences in source impedance where a single electrode can rapidly switch between amplifiers provided at different impedance stages (Fig. 4A, [0058-0062]). Kamath teaches rapid switching between input impedance stages where “the switching may occur at a frequency much higher than any characteristic frequency of the constituent biopotential signals, so that the input signal may be assumed approximately constant across samples from the same switching/sampling cycle” ([0061]). This switching arrangement is used to estimate the source impedance based on the different responses of the respective amplifier pathways to the same source signal ([0063]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter the two-channel capacitive sensing electrode system in Cheng, as modified by Peng and Reynolds, by incorporating the rapid switching between channels to different circuit pathways where a common signal responds differently based on impedance properties of each amplifier circuit, as taught by Kamath. This would have been obvious because both Cheng and Kamath teach a biopotential sensor using a comparison of the same input signal under different sensing conditions/pathways. Kamath provides a solution/improvement of rapidly switching between amplifier pathways with different impedance properties so the input signal can be assumed as approximately constant among the different pathways (which standardizes the input signal to each channel for greater accuracy when solving for unknown values using the transfer functions). Therefore, a person of ordinary skill in the art would be motivated to improve the device in Cheng, as modified by Peng and Reynolds, by incorporating the rapid switching between channels to different circuit pathways where a common signal responds differently based on impedance properties of each amplifier circuit, as taught by Kamath.
Cheng discloses first and second channel electrodes to assess the coupling capacity with the biosignal source via assessments of noise and strength of the underlying biosignal ([0018]). However, Cheng does not clearly disclose wherein the sense electrode arrangement comprises an array of electrodes, and wherein the processor is adapted to determine which electrodes of the array have a proper coupling to the body based on the respective coupling capacitance. Note the term “proper” is being interpreted broadly because “proper” may vary based on the applications of the device.
Weinerth, in the same field of endeavor of non-contact electrodes ([0032]), teaches an array of sensor electrodes arranged in a matrix to produce a capacitive image of an object in proximity to the array ([0050]). Weinerth teaches a determination module which quantifies the coupling capacitance between the electrode and the object in proximity to the electrode or between electrodes ([0004] - “The determination module is further configured to determine, using the first sensor electrode, a first capacitive coupling between the first sensor electrode and an input object in a sensing region of the input device. The determination module is further configured to determine, using the first sensor electrode and the second sensor electrode, a second capacitive coupling between the first sensor electrode and the second sensor electrode”). The processing unit determines the input state of the sensor (which includes a determination of excessive noise) based on the coupling capacity measurements ([0040]), where a result is to increase the signal-to-noise ratio of the capacitive sensing ([0138]).
It would have been obvious to a person of ordinary skill in the art to alter the electrode arrangement of Cheng, as modified by Reynolds and Kamath, by incorporating the electrode array capable of assessing local coupling capacitance with a capacitive image in Weinerth. This would have been obvious because both Cheng and Weinerth teach capacitive sensors and Weinerth provides a solution/improvement mechanism for allowing localized assessment of coupling capacitance with an object based on an object’s position in proximity to each electrode of an electrode array. A person of ordinary skill in the art would have been motivated to improve the system of Cheng by incorporating the electrode array capable of assessing local coupling capacitance with a capacitive image in Weinerth.
It would have been obvious to a person of ordinary skill in the art to alter the electrode arrangement in Cheng, as modified by Peng, Reynolds, and Kamath, by incorporating the electrode array capable of assessing local coupling capacitance with a capacitive image in Weinerth. This would have been obvious because both Cheng and Weinerth teach capacitive sensors and Weinerth provides a solution/improvement mechanism for allowing localized assessment of coupling capacitance with an object based on an object’s position in proximity to an electrode array. A person of ordinary skill in the art would have been motivated to improve the system of Cheng by incorporating the electrode array capable of assessing local coupling capacitance with a capacitive image in Weinerth.
Regarding Claim 25, the sensing system according to Claim 24 is obvious over Cheng in view of Peng, Reynolds, Kamath, and Weinerth, as indicated hereinabove. Cheng further discloses wherein the processor is further adapted to estimate the coupling capacitance based on an assumption that the sensed first and second signals are indicative of the same electrophysiological signal (Vbio) at the body surface, and based on a coupling capacitance (Ce) between the electrode arrangement and the body surface during sensing of each of the first and second signals is the same ([0007-0008] – reference is made to a singular electrophysiological signal and singular coupling capacitance characterizing the body while the channels differ; [0018-0019] – a two channel biopotential with different transfer functions for each channel is used to solve for an unknown common time-varying capacitance and undistorted biosignal).
Regarding Claim 26, the sensing system according to Claim 24 is obvious over Cheng in view of Peng, Reynolds, Kamath, and Weinerth, as indicated hereinabove. Cheng further discloses the processor is further adapted to process the first and/or second outputs (VoutvA, Vout cA) thereby to determine the electrophysiological signal (Vbio) at the body surface ([0022] – the biological signals without motion artifact are calculated: “The sensor provides a pair of physically-interleaved capacitive channels designed to have different amounts of parasitic input capacitance, which create a channel-specific outputs that depend on the input coupling capacitance itself. Differences in output channel results can then be reconstructed with a digital filter to re-create the original bio potential with attenuated motion artifacts”). As stated in claim 24, the proposed combination with Peng yields the voltage and charge amplifiers for the processing of VoutvA and Vout cA.
Regarding Claim 27, the sensing system according to Claim 26 is obvious over Cheng in view of Peng, Reynolds, Kamath, and Weinerth, as indicated hereinabove. Cheng further discloses wherein the processor is further configured to use the determined coupling capacitance, to provide body motion compensation ([0017-0019] – removal of motion-induced noise during the process of calculating the skin biosignal and coupling capacitance from the two channels).
Claim 28 is rejected under U.S.C 103 as being unpatentable over Cheng (US 2016/0256111 A1) in view of Peng (NPL, “Preamplifiers for Non-Contact Capacitive Biopotential Measurements”), Reynolds (US 2009/0033343 A1), Kamath (US 2005/0038350 A1), Weinerth (US 2017/0364184 A1), and Hayes-Gill (US 2011/0306862 A1).
Regarding Claim 28, the sensing system according to Claim 24 is obvious over Cheng in view of Peng, Reynolds, Kamath, and Weinerth as indicated hereinabove. Cheng discloses application of the system for monitoring ECG measurements with non-contact sensors ([0005-0006]), which could include placement for collection of adult ECG. Cheng discloses: “After decades of research in non-contact sensing, the ECG and EEG wet electrodes remain important because the non-contact sensing still suffers from excessive noise due to movement between the subject and sensor and because of triboelectricity” ([0006]). Cheng does not disclose wherein the electrophysiological signal comprises a fetal ECG signal and a maternal ECG signal.
Hayes-Gill, in the same field of endeavor of biosignal monitoring ([0006]), teaches the positioning of ECG electrodes to measure a fetal ECG signal ([0001-0002]). Hayes-Gill teaches: “The reduction of noise on the detected fECG signal is therefore of great importance. This noise on a detected fECG signal varies considerably and is typically caused by one or more of the following” ([0008]) and “Alternatively, other varieties of electrode such as hydrogel electrodes, dry electrodes and non-contact electrodes may be used to detect ECG signals” ([0006]). Cheng is primarily concerned with reducing biosignal noise ([0006]) while Hayes-Gill is concerned with reducing noise in fetal ECG signals ([0008]).
It would have been obvious to a person of ordinary skill in the art to alter Cheng’s system, which is for adult placement using non-contact ECG electrodes, by integrating the placement of non-contact fetal ECG specified in Hayes-Gill in parallel to the adult placement. This would have been obvious because both Cheng and Hayes-Gill discuss biopotential sensing suffering from noise and Hayes-Gill provides a solution/improvement to noise during the acquisition of fetal ECG (pregnant patients being a subset of the population which could be monitored using non-contact electrodes). Therefore, a person of ordinary skill in the art would be motivated to improve the system of Cheng by incorporating the parallel non-contact electrode placement scheme for monitoring fetal ECG in Hayes-Gill.
Conclusions
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.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Examiner Benjamin Schmitt, whose telephone number is 703-756-1345. The examiner can normally be reached on Monday-Friday from 9:00 am to 5:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at 571-270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Benjamin A. Schmitt/
Examiner
Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796
