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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's amendments filed on 07/29/2025 have been entered based on the RCE request filed on 08/27/2025.
Status of Claims
Claims 1-4, 7, 9-12, and 14-24 are currently pending and under examination. As per the amendments filed on 07/29/2025, claims 1 and 14 are amended and claims 22-24 are newly added. Claims 5-6, 8, and 13 are canceled.
Response to Arguments
Applicant’s arguments, see Remarks pages 7-12 (Rejections under 35 U.S.C. § 103), filed 07/29/2025, with respect to the rejections of claims 1-5, 7, and 9-21 under 35 U.S.C. § 103 have been fully considered and are persuasive. Claims 5 and 13 are canceled. Regarding independent claim 1, Applicant argues:
Cheng in view of one or more of Peng, Weinerth, Hayes-Gill, and Yin fails to suggest or
render obvious a system comprising a sense electrode arrangement coupled to the surface of the body such that the sense electrode arrangement and the body define a coupling capacitance (Ce), and wherein the sense electrode arrangement 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. Cheng in view of one or more of Peng, Weinerth, Hayes-Gill, and Yin only suggests or renders obvious a system comprising a sense electrode arrangement with multiple sense electrodes. (page 8, 07/29/2025 Remarks)
When commenting on how Cheng is applied to the instant claims, Applicant argues:
Thus, Cheng discloses two channels each with "its own isolated electrode" arrangement. Indeed, Cheng discloses "at least two independent electrodes 14 a and 14 b, that each are formed from a plurality of symmetric pie shaped sections of conductors. The pie shape is preferred to form a circular biosensor, but other symmetrical shapes can also be used. The first and second electrodes should be substantially equal in area and symmetrical in shape. The goal is to create an active shield for each channel." Cheng, paragraph [0025].
Modifying Cheng to comprise a single electrode arrangement, 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, would completely change the structure and function of the bio sensor 10 disclosed in that reference. Further, the only motivation to modify Cheng to comprise a single electrode arrangement comes from Applicant's own disclosure, thus constituting impermissible hindsight. (pages 8-9, 07/29/2025 Remarks).
The Examiner finds this argument persuasive with respect to a single electrode being used to provide channel information in the electrode arrangement. Therefore, the 35 USC § 103 rejections of claim 1 and dependent claims 2-4, 7, and 9-12 are withdrawn. However, upon further consideration, a new ground(s) of rejection is made over Reynolds (PG Pub 2009/0033343 A1), see “Claim Rejections - 35 USC § 103” section.
Regarding independent claim 14, Applicant argues (with reference to a switch in claim 4):
Claim 14 has been amended to comprise the step of "switching, via a switch arrangement coupling each of the first and second sensing circuits to the processor and to a shared sense electrode of the sense electrode arrangement, between the sense electrode arrangement comprising the voltage amplifier and the sense electrode arrangement comprising the charge amplifier to alternatively activate the voltage amplifier and the charge amplifier, thereby creating fully independent first and second transfer functions." The Patent Office asserts that Cheng in view of one or more of Peng, Weinerth, Hayes-Gill, and Yin discloses switching. (pages 9-10, 07/29/2025 Remarks)
However, Cheng intentionally discloses a system comprising a sense electrode arrangement with multiple sense electrodes, each feeding a sensor signal to a different circuit. This is the solution provided in Cheng for "isolating signal channels for separate computation." Modifying the sense electrode arrangement with multiple sense electrodes of Cheng to remove the multiple electrodes reverses the solution. There is no motivation to reverse the sense electrode arrangement with multiple sense electrodes of Cheng to include switching as per Peng, in either the Cheng or Peng references. The only motivation to modify Cheng to reverse the sense electrode arrangement with multiple sense electrodes of Cheng comes from Applicant's own disclosure, thus constituting impermissible hindsight. (pages 10-11, 07/29/2025 Remarks)
The Examiner finds this argument persuasive regarding a switch being defined as being used to switch between circuits connected to a shared sense electrode. Therefore, the 35 USC § 103 rejection of claim 14 and dependent claims 15-21 are withdrawn. However, upon further consideration, a new ground(s) of rejection is made over Reynolds (PG Pub 2009/0033343 A1), see “Claim Rejections - 35 USC § 103” section.
Regarding newly added independent claim 24 (and by extension the same argument can apply to newly added claim 23), Applicant argues (referring to the rejection of claim 13, which relies on [0043] of Cheng):
The Patent Office asserts that Cheng in view of one or more of Peng, Weinerth, HayesGill,
and Yin discloses determining which electrodes of the array have a proper coupling to the
body based on the respective coupling capacitance (emphasis in original) […] This paragraph discloses detecting "the error between the reconstructed output and the biosignal which is scaled according to the gain of the channel." There is absolutely nothing disclosed regarding detecting "proper coupling to the body based on the respective coupling capacitance. (pages 11-12, 07/29/2025 Remarks)
Note the term “proper” is being interpreted broadly because “proper” may vary based on the applications of the device or the purpose of the user making the assessment. The Examiner is therefore interpreting Cheng [0043] as relating to an assessment of coupling capacity. However, while Cheng is interpreted as disclosing an array with its set of electrodes, the Examiner views Weinerth as more explicitly teaching electrode by electrode coupling capacitance in an array, see “Claim Rejections - 35 USC § 103” section.
Summary: The 35 U.S.C. § 103 rejections for claims 1-4, 7, 9-12, and 14-21 are withdrawn. New 35 U.S.C. § 103 rejections in view of Reynolds (PG Pub 2009/0033343 A1) are added (see “Claim Rejections - 35 USC § 103”). 35 U.S.C. § 103 rejections for new claims 22-24 are added (see “Claim Rejections - 35 USC § 103”).
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, 7, 9, 12, 14-18, and 21-22 are rejected under U.S.C 103 as being unpatentable over Cheng (US PG Pub 2016/0256111 A1, cited in IDS filed on 07/25/2022) in view of Peng (NPL, “Preamplifiers for Non-Contact Capacitive Biopotential Measurements”, see previously cited) and Reynolds (PG Pub 2009/0033343 A1, see “Notice of References Cited”).
According Claim 1, Cheng discloses a sensing system for sensing an electrophysiological signal from the surface of a body ([0008] – worn close to the skin), said system configured to be coupled, when in use, to a sense electrode arrangement for coupling to the surfacee) ([0007] – coupling capacitance determined by measurements for separate biosignal channels), and wherein there is a sense electrode arrangement ([0008]), wherein the sensing system comprises:
• a first sensing circuit, the first sensing circuit arranged to sense a first signal at the surface via the sense electrode arrangement and generate a first output (VoutvA) 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, the second sensing circuit arranged to sense a second signal at the surface via the sense electrode arrangement 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); and
• a processore) 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).
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]). Cheng does not disclose a voltage amplifier in the first sensing circuit or a charge amplifier in the second sensing circuit. Additionally, Cheng does not disclose wherein the sense electrode arrangement comprises a single sense electrode.
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 and Reynolds provides a solution/improvement mechanism for allowing an electrode to switch between different modes (or channels) dependent on capacitance measurements in order to adapt to sensing 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.
Peng, in the same field of endeavor of biosignal monitoring, 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).
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 system by incorporating the voltage and charge amplifier channels of Peng for conditioning of electrode outputs. This would have been obvious because both Cheng and Peng discuss that non-contact biopotential sensing suffers from noise and Peng provides a solution/improvement with different circuit modes based on the benefits and drawbacks of conditioning with voltage and charge amplifiers. 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 for conditioning of electrode outputs.
Therefore, Claim 1 is obvious over Cheng in view of Peng and Reynolds.
Regarding Claim 2, the sensing system according to Claim 1 is obvious over Cheng in view of Peng and Reynolds, 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”).
Therefore, Claim 2 is obvious over Cheng in view of Peng and Reynolds.
Regarding Claim 3, the sensing system according to Claim 2 is obvious over Cheng in view of Peng and Reynolds, as indicated hereinabove. Cheng further discloses 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).
Therefore, Claim 3 is obvious over Cheng in view of Peng and Reynolds.
Regarding Claim 4, the sensing system according to Claim 1 is obvious over Cheng in view of Peng and Reynolds, as indicated hereinabove. Cheng further discloses an arrangement for coupling a selected one of the first and second sensing circuits to the processor ([0019] – the sensing circuits of the two channels are coupled with the processor performing the analysis) and to a shared sense electrode ([0023] – “A separate electrode operates as driven-right-leg circuit to provide common-mode noise suppression”). Cheng does not explicitly disclose switches as part of the arrangement.
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 and Reynolds provides a solution/improvement mechanism for allowing an electrode to switch between different modes (or channels) dependent on capacitance measurements in order to adapt to sensing 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.
Therefore, Claim 4 is obvious over Cheng in view of Peng and Reynolds.
Regarding Claim 7, the sensing system according to Claim 1 is obvious over Cheng in view of Peng and Reynolds, as indicated hereinabove. Cheng further discloses the first and second sensing circuits each comprise an amplifier circuit (Figure 1C, [0026] – both channels measuring the biosignal are passed through a separate amplifier 26).
Therefore, Claim 7 is obvious over Cheng in view of Peng and Reynolds.
Regarding Claim 9, the sensing system according to Claim 1 is obvious over Cheng in view of Peng and Reynolds, as indicated hereinabove. Cheng further discloses the signal comprises an electrocardiogram (ECG) signal ([0020, 0044] – ECG specified).
Therefore, Claim 9 is obvious over Cheng in view of Peng and Reynolds.
Regarding Claim 12, the sensing system according to Claim 1 is obvious over Cheng in view of Peng and Reynolds, as indicated hereinabove Cheng further discloses an interface adapted to provide electrode contact quality information based on the 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).
Therefore, Claim 12 is obvious over Cheng in view of Peng and Reynolds.
According Claim 14, Cheng discloses a method for sensing an electrophysiological signal from the surface of a body ([0008] – worn close to the skin), comprising:
• sensing a first signal at the body surface via a sense electrode arrangement with the first sensing circuit, coupled to the surface of the body such that the sense electrode arrangement and the body define a coupling capacitance (Ce) ([0007] – coupling capacitance determined by measurements for separate biosignal channels); and generating a first output (VoutvA) 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);
• sensing a second signal at the body surface via the second sensing circuit of the sense electrode arrangement 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); and
• and determining 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 ([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 (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).
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]). Cheng does not disclose switching, via a switch arrangement coupling each of the first and second sensing circuits to the processor and to a shared sense electrode of the sense electrode arrangement, between the sense electrode arrangement comprising the voltage amplifier and the sense electrode arrangement comprising the charge amplifier to alternatively activate the voltage amplifier and the charge amplifier, thereby creating fully independent first and second transfer functions.
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 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 and Reynolds provides a solution/improvement mechanism for allowing an electrode to switch between different modes (or channels) dependent on capacitance measurements in order to adapt to sensing 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.
Peng, in the same field of endeavor of biosignal monitoring, 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).
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 method by incorporating the voltage and charge amplifier channels of Peng for conditioning of electrode outputs. This would have been obvious because both Cheng and Peng discuss that non-contact biopotential sensing suffers from noise and Peng provides a solution/improvement with different circuit modes based on the benefits and drawbacks of conditioning with voltage and charge amplifiers. 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 for conditioning of electrode outputs.
Therefore, Claim 14 is obvious over Cheng in view of Peng and Reynolds.
Regarding Claim 15, the method for sensing an electrophysiological signal according to Claim 14 is obvious over Cheng in view of Peng and Reynolds, as indicated hereinabove. Cheng further discloses coupling the sense electrode arrangement to the surface of the body such that the sense electrode arrangement and the body define a coupling capacitance (Ce) ([0007] – coupling capacitance determined by measurements for separate biosignal channels).
Therefore, Claim 15 is obvious over Cheng in view of Peng and Reynolds.
Regarding Claim 16, the method for sensing an electrophysiological signal according to Claim 14 is obvious over Cheng in view of Peng and Reynolds, as indicated hereinabove. Cheng further discloses determining the electrophysiological signal (Vbio) at the body surface from the first and/or second outputs ([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”).
Therefore, Claim 16 is obvious over Cheng in view of Peng and Reynolds.
Regarding Claim 17, the method for sensing an electrophysiological signal according to Claim 16 is obvious over Cheng in view of Peng and Reynolds, as indicated hereinabove. Cheng further discloses the processor is adapted to determine the electrophysiological signal (Vbio) at the body surface further taking into account the determined 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).
Therefore, Claim 17 is obvious over Cheng in view of Peng and Reynolds.
Regarding Claim 18, the method for sensing an electrophysiological signal according to Claim 14 is obvious over Cheng in view of Peng and Reynolds, as indicated hereinabove. Cheng further discloses the signal comprises an electrocardiogram (ECG) signal ([0020, 0044] – ECG specified).
Therefore, Claim 18 is obvious over Cheng in view of Peng and Reynolds.
Regarding Claim 21, the method for sensing an electrophysiological signal according to Claim 14 is obvious over Cheng in view of Peng and Reynolds, as indicated hereinabove. Cheng further discloses providing, via a user interface, electrode contact quality information based on the 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).
Therefore, Claim 21 is obvious over Cheng in view of Peng and Reynolds.
Regarding Claim 22, the method for sensing an electrophysiological signal according to Claim 14 is obvious over Cheng in view of Peng and Reynolds, as indicated hereinabove. Cheng further discloses wherein the sense electrode arrangement comprises a first electrode connected to the first sensing circuit and a second electrode connected to the second sensing circuit ([0018-0019] – reference to the second channel with its own isolated electrode arrangement and transfer function producing a voltage).
Therefore, Claim 22 is obvious over Cheng in view of Peng and Reynolds.
Claims 10 and 19 are rejected under U.S.C 103 as being unpatentable over Cheng (US PG Pub 2016/0256111 A1, cited in IDS filed on 07/25/2022) in view of Peng (NPL, “Preamplifiers for Non-Contact Capacitive Biopotential Measurements”, see previously cited), Reynolds (PG Pub 2009/0033343 A1, see “Notice of References Cited”), and Hayes-Gill (US PG Pub 2011/0306862 A1, see previously cited).
Regarding Claim 10, the sensing system according to Claim 9 is obvious over Cheng in view of Peng and Reynolds, 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 does not disclose the application of a non-contact sensor to measure fetal ECG signals. 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]).
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.
Therefore, Claim 10 is obvious over Cheng in view of Peng, Reynolds, and Hayes-Gill.
Regarding Claim 19, the method for sensing an electrophysiological signal according to Claim 18 is obvious over Cheng in view of Peng and Reynolds, 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 does not disclose the application of a non-contact sensor to measure fetal ECG signals. 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]).
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 method, 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 method of Cheng by incorporating the parallel non-contact electrode placement scheme for monitoring fetal ECG in Hayes-Gill.
Therefore, Claim 19 is obvious over Cheng in view of Peng, Reynolds, and Hayes-Gill.
Claims 11 and 20 are rejected under U.S.C 103 as being unpatentable over Cheng (US PG Pub 2016/0256111 A1, cited in IDS filed on 07/25/2022) in view of Peng (NPL, “Preamplifiers for Non-Contact Capacitive Biopotential Measurements”, see previously cited), Reynolds (PG Pub 2009/0033343 A1, see “Notice of References Cited”), and Yin (US PG Pub 2011/0137200 A1, see previously cited).
Regarding Claim 11, the sensing system according to Claim 1 is obvious over Cheng in view of Peng and Reynolds, as indicated hereinabove. Cheng discloses application of the system to ECG and EEG signals ([0005-0006]). Cheng does not disclose electromyography (EMG) as a biosignal.
Yin, in the same field of endeavor of 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.
Therefore, Claim 11 is obvious over Cheng in view of Peng, Reynolds, and Yin.
Regarding Claim 20, the method for sensing an electrophysiological signal according to Claim 14 is obvious over Cheng in view of Peng and Reynolds, as indicated hereinabove. Cheng discloses wherein the signal comprises an electromyography (EMG) signal ([0005-0006]). Cheng does not disclose electromyography (EMG) as a biosignal.
Yin, in the same field of endeavor of 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 sensor method, 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 sensor method of Cheng by incorporating electrode placement and signal collection needed to measure EMG in Yin.
Therefore, Claim 20 is obvious over Cheng in view of Peng, Reynolds, and Yin.
Claims 23-24 is rejected under U.S.C 103 as being unpatentable over Cheng (US PG Pub 2016/0256111 A1, cited in IDS filed on 07/25/2022) in view of Peng (NPL, “Preamplifiers for Non-Contact Capacitive Biopotential Measurements”, see previously cited), Reynolds (PG Pub 2009/0033343 A1, see “Notice of References Cited”), and Weinerth (US PG Pub 2017/0364184 A1, cited in IDS filed on 07/25/2022).
Regarding Claim 23, the method for sensing an electrophysiological signal according to Claim 14 is obvious over Cheng in view of Peng and Reynolds, 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 ([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 method in Cheng 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 method of Cheng by incorporating the electrode array capable of assessing local coupling capacitance with a capacitive image in Weinerth.
Therefore, Claim 23 is obvious over Cheng in view of Peng, Reynolds, and Weinerth.
Regarding Claim 24, Cheng discloses a sensing system for sensing an electrophysiological signal from the surface of a body ([0008] – worn close to the skin), said system configured to be coupled, when in use, to a sense electrode arrangement for coupling to the surface of the body such that the sense electrode arrangement and the body define a coupling capacitance (Ce) ([0007] – coupling capacitance determined by measurements for separate biosignal channels), wherein the sensing system comprises:
• a first sensing circuit, comprising the 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 the second sensing circuit arranged to sense a second signal at the surface via the sense electrode arrangement 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); and
• 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 the second transfer function ([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 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);
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]). Cheng does not disclose a voltage amplifier in the first sensing circuit or a charge amplifier in the second sensing circuit. Additionally, Cheng does not 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.
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 and Reynolds provides a solution/improvement mechanism for allowing an electrode to switch between different modes (or channels) dependent on capacitance measurements in order to adapt to sensing 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.
Peng, in the same field of endeavor of biosignal monitoring, 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).
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 system by incorporating the voltage and charge amplifier channels of Peng for conditioning of electrode outputs. This would have been obvious because both Cheng and Peng discuss that non-contact biopotential sensing suffers from noise and Peng provides a solution/improvement with different circuit modes based on the benefits and drawbacks of conditioning with voltage and charge amplifiers. 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 for conditioning of electrode outputs.
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 ([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 Cheng 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.
Therefore, Claim 24 is obvious over Cheng in view of Peng, Reynolds, and Weinerth.
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 8:30 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
/REX R HOLMES/Primary Examiner, Art Unit 3796