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 .
Amendment Entered
In response to the amendment filed on January 8th, 2026, amended claims 1-3 and 11-12, and new claims 21-33 are entered. Claims 4-8 are canceled. Claims 1-3, 9-12, and 21-33 are currently pending and under examination.
Response to Arguments
Applicant's remarks and amendments with respect to the claim objections have been fully considered. The objections are withdrawn in view of the amendment.
Applicant's remarks and amendments with respect to the rejections under 35 U.S.C. 112(b) have been fully considered. The rejections are withdrawn in view of the amendment.
Applicant's arguments, filed on January 8th, 2026, with respect to the rejections under 35 U.S.C. 103 have been fully considered but they are not persuasive. The rejections have been maintained, and further clarified, in view of the amendment.
At Pg. 8 of the Reply, Applicant argues that “Clements mentions reference electrodes 122, but does not disclose or suggest the claimed ‘circuitry operatively coupled to the one or more reference electrodes and configured to generate the common mode reference output based on signals from the one or more reference electrodes.’ The feedback amplifier described in Clements at paragraph [0091] measures common-mode from a node inside the differential amplification circuitry rather than from ‘reference electrodes that are positioned and configured to measure activity from the same muscle group as the plurality of signal electrodes,’ as recited by amended claim 1”. Examiner respectfully disagrees. Clements clearly teaches one or more reference electrodes (the electrode array 104 includes one or more reference electrodes 122 (or ground electrode, driving electrode, etc.); [0060]; Figure 2). As shown in Figure 2 of Clements, the one or more reference electrodes 122 are included in the same electrode patch and placed adjacently to the signal electrodes; therefore, the one or more reference electrodes would be positioned and configured to measure activity from the same muscle group as the plurality of signal electrodes. Furthermore, Figure 2 clearly shows circuitry, equivalent to traces 118, operatively coupled to the one or more reference electrodes (the electrode patch 100 further includes a plurality of traces 118, where each of the traces extends between a respective electrode and a peripheral region 120 of the electrode patch 100…as shown in FIG. 2, the electrode array 104 includes one or more reference electrodes 122 (or ground electrode, driving electrode, etc.); [0060]; Figure 2).
Additionally, Clements clearly teaches circuitry configured to generate the common mode reference output based on signals from the one or more reference electrodes (as shown in FIG. 10A, the electronics module 150 includes a driven right leg circuit 155. The driven right leg circuit 155 is configured to measure the subject's common-mode, and force a ground of the electronics module 150 to the subject's common-mode. FIG. 10B illustrates the significant reduction in observed stimulation artifact achieved using the driven right leg circuit 155; [0070]; Examiner’s Note: Figure 10A shows wherein the reference electrode is used as an input for the operational amplifier “OA1”, which is part of the common-mode reference circuit; therefore, the common mode reference output would be based on the input, which includes the reference signal from the reference electrode). Therefore, the Examiner respectfully disagrees with these portions of the Applicant’s Reply. However, the Examiner agrees and acknowledges that Clements fails to specifically teach the newly amended limitation of wherein an amplifier of the plurality of amplifiers has: “a second input operatively coupled to a common mode reference output”.
However, Do Valle clearly teaches the newly added limitation of wherein an amplifier of the plurality of amplifiers has: “a second input operatively coupled to a common mode reference output” (FIG. 15 shows an exemplary configuration 1500 in which a common-mode feedback circuit 1502 is used to more effectively reduce the impact of common-mode noise on biopotential recordings made by electrodes 1202, as compared to configuration 1400. As shown, common-mode feedback circuit 1502 is configured to measure a common-mode signal Vcm between the amplified signals Vn1 and Vn2 output by amplifiers 1204 and provide Vcm to non-inverting operational amplifier circuits 1304. Non-inverting operational amplifier circuits 1304 are configured to use Vcm to generate the voltage-divided feedback signals used to generate amplified signals Vn1 and Vn2; [0117]; Figure 15).
Further at Pg. 8 of the Reply, Applicant argues that “Do Valle’s common-mode feedback circuit 1402 operates on signals output by amplifiers 1204-1 and 1204-2”, not from “one or more reference electrodes”. Although not specifically argued in the 103 rejection below, Examiner would like to clarify that Do Valle teaches “a reference signal associated with a reference electrode” ([0145]), and wherein “the signal processing unit is configured to: generate a plurality of differential signals representative of a difference between a different one of the plurality of amplified signals and a reference signal associated with a reference electrode; and generate a plurality of biopotential measurement signals based on the plurality of differential signals” ([0145]). Furthermore, the signals output by amplifiers 1204-1 and 1204-2 would be based on the signals from the electrodes, since each of the amplifiers corresponds to a different one of electrodes 1202 and receives input from them (Do Valle [0103]). Do Valle goes on to further designate a recording electrode that may be used to compare different signals (one of electrodes 1202 (e.g., electrode 1202-N) may be designated as a recording electrode. Signal processing unit 1208 may be configured to compare each of the signals generated by the other electrodes 1202 with the signal recorded by the recording electrode. For example, if electrode 1202-N is the recording electrode, signal processing unit 1208 may compare signals Vn1, Vn2, and other signals output by other non-inverting operational amplifier circuits 1304 with signal VnN, which is output by non-inverting operational amplifier circuit 1304-N; [0122]).
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:
“wearable structure” in Claims 1, 24, and 29: [0007] of the Applicant’s Specification recites wherein the “wearable structure” may comprise a “wrist-worn structure”
“wearable device” in Claims 24 and 29: [0029] of the Applicant’s Specification recites wherein the “wearable device” may comprise “a wrist-worn device (e.g., a smart watch, a fitness tracker, etc.) or an arm-worn device” and [0062] of the Applicant’s Specification further recites “an example wrist-worn device…includes a capsule 702, and a band portion 704”
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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 24-33 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 24 recites “a wearable device” in lines 2-3, and later recites “a wearable structure” in lines 3-4. It is unclear as to whether the “wearable structure” is referring to the same element as the previously introduced “wearable device”, or a separate element. Clarification is requested.
Claim 24 recites the limitation “the same muscle group” in lines 7-8. It is unclear as to whether this limitation is referring to the “muscle group” previously introduced in line 4 of Claim 24, or if the intended meaning of “same” in this limitation was meant to merely require each of the reference signals of the set to correspond to a singular muscle group (which then could be a different muscle group from that of line 4). For examination purposes, the Examiner will interpret the limitation “the same muscle group” in lines 7-8 of Claim 24 to be referring to the same “muscle group” previously introduced in line 4 of Claim 24.
Claim 29 recites “a wearable device” in line 2, and later recites “a wearable structure” in lines 5-6. It is unclear as to whether the “wearable structure” is referring to the same element as the previously introduced “wearable device”, or a separate element. Clarification is requested.
Claim 29 recites the limitation “the same muscle group” in lines 9-10. It is unclear as to whether this limitation is referring to the “muscle group” previously introduced in line 6 of Claim 29, or if the intended meaning of “same” in this limitation was meant to merely require each of the reference signals of the set to correspond to a singular muscle group (which then could be a different muscle group from that of line 6). For examination purposes, the Examiner will interpret the limitation “the same muscle group” in lines 9-10 of Claim 29 to be referring to the same “muscle group” previously introduced in line 6 of Claim 29.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-3, 9-10, 12, 21-26, 28-30, and 32-33 are rejected under 35 U.S.C. 103 as being unpatentable over Clements et al (U.S. Publication No. 2020/0138313; cited by Applicant) in view of Do Valle et al (U.S. Publication No. 2021/259638; cited by Applicant).
Regarding Claim 1, Clements discloses a device for sensing neuromuscular signals (electrode-based systems and devices for interfacing with biological tissue and related methods; Abstract), the device comprising:
a wearable structure configured to be worn by a user (The compression pad 114 can be configured to wrap around a portion of the patient's anatomy; [0063]; Figure 6);
a plurality of signal electrodes (The electrode array 104 includes a plurality of electrodes 106; [0055]) aligned along an interior portion of the wearable structure configured to be proximate to a skin surface of the user (A wrap or band can be provided to apply this pressure. The wrap or band may include the compression pad of FIGS. 8 and 9A. In some cases the wrap or band can incorporate a rigid member (e.g. flat, curved, or otherwise shaped to fit the underlying anatomy) overlying the electrode array designed to selectively apply pressure on the electrode array pushing it into the skin; [0113]), each signal electrode of the plurality of signal electrodes configured to detect neuromuscular signals (the systems and methods described herein can be used for fine assessment of the degree of neuromuscular function, e.g. as a measure of reinnervation be regenerating axons. Signals from nerve, muscles, and reflex pathways can all be used for these assessments, which can also inform the progression of a disease or other pathology or amelioration via treatment, therapy, or natural healing. Enhanced characterization of neuromuscular function in this way can provide more sensitive and discriminating quantitative measures to better inform intervention; [0204]);
a plurality of amplifiers (“DA1”, “DA2”…“DAn” in Figure 10A) operatively coupled to the plurality of signal electrodes (The electronics module 150 can include stimulating electronics for stimulating nerves and/or recording electronics such as filters, amplifiers, and/or analog-to-digital converters; [0066-0070]; Figure 10A shows n number of signal electrodes, each of which is connected to an amplifier: “DA1”, “DA2”…“DAn”), wherein an amplifier of the plurality of amplifiers has:
a first input operatively coupled to a corresponding signal electrode of the plurality of signal electrodes (Examiner’s Note: Figure 10A shows that each of the signal electrodes are operatively coupled to each of the amplifiers: “DA1”, “DA2”…“DAn”);
a second input (Examiner’s Note: Figure 10A shows that each amplifier (“DA1”, “DA2”…“DAn”) comprises two inputs); and
an output corresponding to a neuromuscular signal (In some implementations, the electronics module 150 is further configured for functional nerve imaging. FIG. 16A. illustrates spatial activity mapping. For example, the electronics unit 150 is configured to automatically manipulate and monitor nerves, and the electronics unit 150 can be configured to identify the electrodes in the electrode array that acquire signals with the highest amplitudes. The results can be displayed as a heat map. In some implementations, the electronics module 150 is further configured for a nerve conduction study. FIG. 16B is a still frame of signal propagation through the patient's median nerve, displayed as an animation or video. Different electrodes in the electrode array acquire the signal as it propagates along the nerve; [0071-0072]; The sensitivity, robust nature of an array-based system, and capabilities for automation or feedback to the operator allows clinicians or other health care providers with less specialized training or experience to administer screenings, diagnostics or therapies. For example, various types of stimulation or operant conditioning protocols can help patients overcome effects after neuromuscular injuries or disease; [0199]; the systems and methods described herein can be used for fine assessment of the degree of neuromuscular function, e.g. as a measure of reinnervation be regenerating axons. Signals from nerve, muscles, and reflex pathways can all be used for these assessments, which can also inform the progression of a disease or other pathology or amelioration via treatment, therapy, or natural healing. Enhanced characterization of neuromuscular function in this way can provide more sensitive and discriminating quantitative measures to better inform intervention; [0204]);
one or more reference electrodes (the electrode array 104 includes one or more reference electrodes 122 (or ground electrode, driving electrode, etc.); [0060]) positioned and configured to measure activity from a same muscle group as the plurality of signal electrodes (a short region of conduction velocity slowing (e.g., the median nerve at the wrist, as in carpal tunnel syndrome) can be clearly seen when the stimulus and recording electrodes lie directly on either side of that region; [0088]; [0113]; Figures 6 and 9A-9B; Examiner’s Note: The one or more reference electrodes are included in the same electrode patch and placed adjacently to the signal electrodes; therefore, the signals would be corresponding to the same muscle group); and
circuitry operatively coupled to the one or more reference electrodes (the electrode patch 100 further includes a plurality of traces 118, where each of the traces extends between a respective electrode and a peripheral region 120 of the electrode patch 100…as shown in FIG. 2, the electrode array 104 includes one or more reference electrodes 122 (or ground electrode, driving electrode, etc.); [0060]; Examiner’s Note: Figure 2 clearly shows the traces 118 connecting to the one or more reference electrodes 122) and configured to generate the common mode reference output based on the set of one or more reference signals (as shown in FIG. 10A, the electronics module 150 includes a driven right leg circuit 155. The driven right leg circuit 155 is configured to measure the subject's common-mode, and force a ground of the electronics module 150 to the subject's common-mode. FIG. 10B illustrates the significant reduction in observed stimulation artifact achieved using the driven right leg circuit 155; [0070]; Examiner’s Note: Figure 10A shows wherein the reference electrode is used as an input for the operational amplifier, which is part of the common-mode reference circuit; therefore, the common mode reference output would be based on the input, which includes the reference signal from the reference electrode).
Although Clements discloses a circuit configured to measure the subject’s common-mode ([0070], [0091]), Clements fails to specifically teach wherein an amplifier of the plurality of amplifiers has: a second input operatively coupled to a common mode reference output; and an output corresponding to a neuromuscular signal channel.
In a similar technical field, Do Valle teaches a biopotential measurement system including a plurality of electrodes each configured to record a different signal included in a plurality of signals representative of electrical activity of a target within a user (Abstract), comprising a plurality of amplifiers, wherein an amplifier of the plurality of amplifiers has:
a second input operatively coupled to a common mode reference output (FIG. 15 shows an exemplary configuration 1500 in which a common-mode feedback circuit 1502 is used to more effectively reduce the impact of common-mode noise on biopotential recordings made by electrodes 1202, as compared to configuration 1400. As shown, common-mode feedback circuit 1502 is configured to measure a common-mode signal Vcm between the amplified signals Vn1 and Vn2 output by amplifiers 1204 and provide Vcm to non-inverting operational amplifier circuits 1304. Non-inverting operational amplifier circuits 1304 are configured to use Vcm to generate the voltage-divided feedback signals used to generate amplified signals Vn1 and Vn2; [0117]; Figure 15);
an output corresponding to a neuromuscular signal channel (the outputs of amplifiers 1204-1 and 1204-2 are connected to a signal processing unit 1208 by way of conductive lines 1206-1 and 1206-2; [0105]; Figure 15).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the amplifier output teachings of Do Valle into the invention of Clements as the output is representative of the biopotential measurement signals (Do Valle [0107]).
Regarding Claim 2, Clements discloses wherein the one or more reference electrodes consist of a single reference electrode (the electrode array 104 includes one or more reference electrodes 122 (or ground electrode, driving electrode, etc.); [0060]), and wherein the single reference electrode is disposed along the interior portion of the wearable structure (A wrap or band can be provided to apply this pressure. The wrap or band may include the compression pad of FIGS. 8 and 9A. In some cases the wrap or band can incorporate a rigid member (e.g. flat, curved, or otherwise shaped to fit the underlying anatomy) overlying the electrode array designed to selectively apply pressure on the electrode array pushing it into the skin; [0113]; Figures 6 and 10A).
Regarding Claim 3, Clements discloses wherein the one or more reference electrodes comprise a plurality of reference electrodes (the electrode array 104 includes one or more reference electrodes 122 (or ground electrode, driving electrode, etc.); [0060]) disposed along the interior portion of the wearable structure (A wrap or band can be provided to apply this pressure. The wrap or band may include the compression pad of FIGS. 8 and 9A. In some cases the wrap or band can incorporate a rigid member (e.g. flat, curved, or otherwise shaped to fit the underlying anatomy) overlying the electrode array designed to selectively apply pressure on the electrode array pushing it into the skin; [0113]; Figures 6 and 10A).
Regarding Claim 9, Clements discloses wherein the wearable structure comprises a wrist-worn structure (FIG. 6 illustrates an electrode patch applied to a patient's lower arm according to implementations described herein; [0042]; A wrap or band can be provided to apply this pressure. The wrap or band may include the compression pad of FIGS. 8 and 9A. In some cases the wrap or band can incorporate a rigid member (e.g. flat, curved, or otherwise shaped to fit the underlying anatomy) overlying the electrode array designed to selectively apply pressure on the electrode array pushing it into the skin; [0113]; Figures 6 and 9A-9B).
Regarding Claim 10, Clements discloses, wherein the plurality of signal electrodes are disposed circumferentially around the interior portion of the wearable structure (A wrap or band can be provided to apply this pressure. The wrap or band may include the compression pad of FIGS. 8 and 9A. In some cases the wrap or band can incorporate a rigid member (e.g. flat, curved, or otherwise shaped to fit the underlying anatomy) overlying the electrode array designed to selectively apply pressure on the electrode array pushing it into the skin; [0113]; Figures 6 and 9A-9B).
Regarding Claim 12, Clements discloses wherein the plurality of signal electrodes aligned along the interior portion of the wearable structure are configured to be in contact with the skin surface of the user (A wrap or band can be provided to apply this pressure. The wrap or band may include the compression pad of FIGS. 8 and 9A. In some cases the wrap or band can incorporate a rigid member (e.g. flat, curved, or otherwise shaped to fit the underlying anatomy) overlying the electrode array designed to selectively apply pressure on the electrode array pushing it into the skin; [0113]; Figures 6 and 9A-9B).
Regarding Claim 21, Clements wherein the circuitry operatively coupled to the one or more reference electrodes comprises an operational amplifier (as shown in FIG. 10A, the electronics module 150 includes a driven right leg circuit 155. The driven right leg circuit 155 is configured to measure the subject's common-mode, and force a ground of the electronics module 150 to the subject's common-mode. FIG. 10B illustrates the significant reduction in observed stimulation artifact achieved using the driven right leg circuit 155; [0070]; Examiner’s Note: Figure 10A shows wherein the reference electrode is used as an input for the operational amplifier “OA1”, which is part of the common-mode reference circuit; therefore, the output would be based on the input, which includes the reference signal from the reference electrode).
Regarding Claim 22, Clements discloses wherein the one or more reference electrodes are coupled to a positive input of the operational amplifier (Figure 10A shows wherein “Reference Electrode” is coupled to the “+” input of operational amplifier “OA1”), and wherein the operational amplifier is configured as a closed-loop amplifier (as shown in FIG. 10A, the electronics module 150 includes a driven right leg circuit 155. The driven right leg circuit 155 is configured to measure the subject's common-mode, and force a ground of the electronics module 150 to the subject's common-mode. FIG. 10B illustrates the significant reduction in observed stimulation artifact achieved using the driven right leg circuit 155; [0070]; A feedback amplifier is used to measure the common-mode of the patient (normally extracted from a node inside the differential amplification circuitry) and apply a cancelling signal through an additional electrode, in order to force the measured common-mode to the desired reference (allowable patient current-leakage restrictions thus come into play); [0091]; Examiner’s Note: Figure 10A depicts wherein the “OA1” is configured as a closed-loop amplifier).
Regarding Claim 23, Clements discloses wherein the one or more reference electrodes each have a different shape than the plurality of signal electrodes (Examiner’s Note: Figure 2 shows a reference electrode 122 in an oblong, strip-like shape, which is a different shape than the plurality of signal electrodes 106).
Regarding Claim 24, Clements discloses a method for sensing neuromuscular signals (electrode-based systems and devices for interfacing with biological tissue and related methods; Abstract), the method comprising:
receiving a set of neuromuscular signals (the systems and methods described herein can be used for fine assessment of the degree of neuromuscular function, e.g. as a measure of reinnervation be regenerating axons. Signals from nerve, muscles, and reflex pathways can all be used for these assessments, which can also inform the progression of a disease or other pathology or amelioration via treatment, therapy, or natural healing. Enhanced characterization of neuromuscular function in this way can provide more sensitive and discriminating quantitative measures to better inform intervention; [0204]) via a plurality of signal electrodes (The electrode array 104 includes a plurality of electrodes 106; [0055]) of a wearable device (The compression pad 114 can be configured to wrap around a portion of the patient's anatomy; [0063]; Figure 6), the plurality of signal electrodes arranged along an interior portion of a wearable structure (A wrap or band can be provided to apply this pressure. The wrap or band may include the compression pad of FIGS. 8 and 9A. In some cases the wrap or band can incorporate a rigid member (e.g. flat, curved, or otherwise shaped to fit the underlying anatomy) overlying the electrode array designed to selectively apply pressure on the electrode array pushing it into the skin; [0113]), and the set of neuromuscular signals corresponding to a muscle group of a user of the wearable device (a short region of conduction velocity slowing (e.g., the median nerve at the wrist, as in carpal tunnel syndrome) can be clearly seen when the stimulus and recording electrodes lie directly on either side of that region; [0088]; [0113]; Figures 6 and 9A-9B);
receiving a set of one or more reference signals via one or more reference electrodes (one or more reference electrodes 122) of the wearable device (the electrode patch 100 further includes a plurality of traces 118, where each of the traces extends between a respective electrode and a peripheral region 120 of the electrode patch 100…as shown in FIG. 2, the electrode array 104 includes one or more reference electrodes 122 (or ground electrode, driving electrode, etc.); [0060]; Figure 2), the set of one or more reference signals corresponding to the same muscle group (Examiner’s Note: The one or more reference electrodes are included in the same electrode patch and placed adjacently to the signal electrodes; therefore, the signals would be corresponding to the same muscle group);
generating a common mode reference output based on the set of one or more reference signals (as shown in FIG. 10A, the electronics module 150 includes a driven right leg circuit 155. The driven right leg circuit 155 is configured to measure the subject's common-mode, and force a ground of the electronics module 150 to the subject's common-mode. FIG. 10B illustrates the significant reduction in observed stimulation artifact achieved using the driven right leg circuit 155; [0070]; Examiner’s Note: Figure 10A shows wherein the reference electrode is used as an input for the operational amplifier, which is part of the common-mode reference circuit; therefore, the output would be based on the input, which includes the reference signal from the reference electrode); and
generating, via a plurality of amplifiers of the wearable device (“DA1”, “DA2”, “DAn”, “OA1”, as shown in Figure 10A), a set of neuromuscular signal outputs (In some implementations, the electronics module 150 is further configured for functional nerve imaging. FIG. 16A. illustrates spatial activity mapping. For example, the electronics unit 150 is configured to automatically manipulate and monitor nerves, and the electronics unit 150 can be configured to identify the electrodes in the electrode array that acquire signals with the highest amplitudes. The results can be displayed as a heat map. In some implementations, the electronics module 150 is further configured for a nerve conduction study. FIG. 16B is a still frame of signal propagation through the patient's median nerve, displayed as an animation or video. Different electrodes in the electrode array acquire the signal as it propagates along the nerve; [0071-0072]; The sensitivity, robust nature of an array-based system, and capabilities for automation or feedback to the operator allows clinicians or other health care providers with less specialized training or experience to administer screenings, diagnostics or therapies. For example, various types of stimulation or operant conditioning protocols can help patients overcome effects after neuromuscular injuries or disease; [0199]; the systems and methods described herein can be used for fine assessment of the degree of neuromuscular function, e.g. as a measure of reinnervation be regenerating axons. Signals from nerve, muscles, and reflex pathways can all be used for these assessments, which can also inform the progression of a disease or other pathology or amelioration via treatment, therapy, or natural healing. Enhanced characterization of neuromuscular function in this way can provide more sensitive and discriminating quantitative measures to better inform intervention; [0204]) based on the set of neuromuscular signals and the common mode reference output (The electronics module 150 can include stimulating electronics for stimulating nerves and/or recording electronics such as filters, amplifiers, and/or analog-to-digital converters…in some implementations, as shown in FIG. 10A, the electronics module 150 includes a driven right leg circuit 155. The driven right leg circuit 155 is used to mitigate stimulation artifact. As described herein, the driven right leg circuit 155 uses a feed-forward based circuit design to increase bandwidth. The driven right leg circuit 155 is configured to measure the subject's common-mode, and force a ground of the electronics module 150 to the subject's common-mode. FIG. 10B illustrates the significant reduction in observed stimulation artifact achieved using the driven right leg circuit 155; [0066-0070]; A feedback amplifier is used to measure the common-mode of the patient (normally extracted from a node inside the differential amplification circuitry) and apply a cancelling signal through an additional electrode, in order to force the measured common-mode to the desired reference (allowable patient current-leakage restrictions thus come into play); [0091]; Figure 10A).
Regarding Claim 25, Clements discloses wherein the one or more reference electrodes consist of a single reference electrode (the electrode array 104 includes one or more reference electrodes 122 (or ground electrode, driving electrode, etc.); [0060]), and wherein the single reference electrode is disposed along the interior portion of the wearable structure (A wrap or band can be provided to apply this pressure. The wrap or band may include the compression pad of FIGS. 8 and 9A. In some cases the wrap or band can incorporate a rigid member (e.g. flat, curved, or otherwise shaped to fit the underlying anatomy) overlying the electrode array designed to selectively apply pressure on the electrode array pushing it into the skin; [0113]; Figures 6 and 10A).
Regarding Claim 26, Clements discloses wherein the wearable device comprises a wrist-wearable device, and wherein the wearable structure comprises a wristband (FIG. 6 illustrates an electrode patch applied to a patient's lower arm according to implementations described herein; [0042]; A wrap or band can be provided to apply this pressure. The wrap or band may include the compression pad of FIGS. 8 and 9A. In some cases the wrap or band can incorporate a rigid member (e.g. flat, curved, or otherwise shaped to fit the underlying anatomy) overlying the electrode array designed to selectively apply pressure on the electrode array pushing it into the skin; [0113]; Figures 6, 9A-9B, 10A).
Regarding Claim 28, Clements discloses wherein the common mode reference output is generated using a closed-loop amplifier (as shown in FIG. 10A, the electronics module 150 includes a driven right leg circuit 155. The driven right leg circuit 155 is configured to measure the subject's common-mode, and force a ground of the electronics module 150 to the subject's common-mode. FIG. 10B illustrates the significant reduction in observed stimulation artifact achieved using the driven right leg circuit 155; [0070]; A feedback amplifier is used to measure the common-mode of the patient (normally extracted from a node inside the differential amplification circuitry) and apply a cancelling signal through an additional electrode, in order to force the measured common-mode to the desired reference (allowable patient current-leakage restrictions thus come into play); [0091]; Examiner’s Note: Figure 10A depicts wherein the “OA1” is configured as a closed-loop amplifier).
Regarding Claim 29, Clements discloses a non-transitory computer-readable storage medium (It should be understood that the above-described subject matter may also be implemented as a computer-controlled apparatus, a computer process, a computing system, or an article of manufacture, such as a computer-readable storage medium; [0034]) including instructions that, when executed by a wearable device (electrode-based systems and devices for interfacing with biological tissue and related methods; Abstract) comprising one or more processors (processing unit 206) and memory (system memory 204; [0075]), causes the wearable device to perform operations for:
receiving a set of neuromuscular signals (the systems and methods described herein can be used for fine assessment of the degree of neuromuscular function, e.g. as a measure of reinnervation be regenerating axons. Signals from nerve, muscles, and reflex pathways can all be used for these assessments, which can also inform the progression of a disease or other pathology or amelioration via treatment, therapy, or natural healing. Enhanced characterization of neuromuscular function in this way can provide more sensitive and discriminating quantitative measures to better inform intervention; [0204]) via a plurality of signal electrodes (The electrode array 104 includes a plurality of electrodes 106; [0055]) of the wearable device, the plurality of signal electrodes arranged along an interior portion of a wearable structure (A wrap or band can be provided to apply this pressure. The wrap or band may include the compression pad of FIGS. 8 and 9A. In some cases the wrap or band can incorporate a rigid member (e.g. flat, curved, or otherwise shaped to fit the underlying anatomy) overlying the electrode array designed to selectively apply pressure on the electrode array pushing it into the skin; [0113]), and the set of neuromuscular signals corresponding to a muscle group of a user of the wearable device (a short region of conduction velocity slowing (e.g., the median nerve at the wrist, as in carpal tunnel syndrome) can be clearly seen when the stimulus and recording electrodes lie directly on either side of that region; [0088]; [0113]; Figures 6 and 9A-9B);
receiving a set of one or more reference signals via one or more reference electrodes (one or more reference electrodes 122) of the wearable device (the electrode patch 100 further includes a plurality of traces 118, where each of the traces extends between a respective electrode and a peripheral region 120 of the electrode patch 100…as shown in FIG. 2, the electrode array 104 includes one or more reference electrodes 122 (or ground electrode, driving electrode, etc.); [0060]; Figure 2), the set of one or more reference signals corresponding to the same muscle group (Examiner’s Note: The one or more reference electrodes are included in the same electrode patch and placed adjacently to the signal electrodes; therefore, the signals would be corresponding to the same muscle group);
generating a common mode reference output based on the set of one or more reference signals (as shown in FIG. 10A, the electronics module 150 includes a driven right leg circuit 155. The driven right leg circuit 155 is configured to measure the subject's common-mode, and force a ground of the electronics module 150 to the subject's common-mode. FIG. 10B illustrates the significant reduction in observed stimulation artifact achieved using the driven right leg circuit 155; [0070]; Examiner’s Note: Figure 10A shows wherein the reference electrode is used as an input for the operational amplifier, which is part of the common-mode reference circuit; therefore, the output would be based on the input, which includes the reference signal from the reference electrode); and
generating, via a plurality of amplifiers of the wearable device (“DA1”, “DA2”, “DAn”, “OA1”, as shown in Figure 10A), a set of neuromuscular signal outputs (In some implementations, the electronics module 150 is further configured for functional nerve imaging. FIG. 16A. illustrates spatial activity mapping. For example, the electronics unit 150 is configured to automatically manipulate and monitor nerves, and the electronics unit 150 can be configured to identify the electrodes in the electrode array that acquire signals with the highest amplitudes. The results can be displayed as a heat map. In some implementations, the electronics module 150 is further configured for a nerve conduction study. FIG. 16B is a still frame of signal propagation through the patient's median nerve, displayed as an animation or video. Different electrodes in the electrode array acquire the signal as it propagates along the nerve; [0071-0072]; The sensitivity, robust nature of an array-based system, and capabilities for automation or feedback to the operator allows clinicians or other health care providers with less specialized training or experience to administer screenings, diagnostics or therapies. For example, various types of stimulation or operant conditioning protocols can help patients overcome effects after neuromuscular injuries or disease; [0199]; the systems and methods described herein can be used for fine assessment of the degree of neuromuscular function, e.g. as a measure of reinnervation be regenerating axons. Signals from nerve, muscles, and reflex pathways can all be used for these assessments, which can also inform the progression of a disease or other pathology or amelioration via treatment, therapy, or natural healing. Enhanced characterization of neuromuscular function in this way can provide more sensitive and discriminating quantitative measures to better inform intervention; [0204]) based on the set of neuromuscular signals and the common mode reference output (The electronics module 150 can include stimulating electronics for stimulating nerves and/or recording electronics such as filters, amplifiers, and/or analog-to-digital converters…in some implementations, as shown in FIG. 10A, the electronics module 150 includes a driven right leg circuit 155. The driven right leg circuit 155 is used to mitigate stimulation artifact. As described herein, the driven right leg circuit 155 uses a feed-forward based circuit design to increase bandwidth. The driven right leg circuit 155 is configured to measure the subject's common-mode, and force a ground of the electronics module 150 to the subject's common-mode. FIG. 10B illustrates the significant reduction in observed stimulation artifact achieved using the driven right leg circuit 155; [0066-0070]; A feedback amplifier is used to measure the common-mode of the patient (normally extracted from a node inside the differential amplification circuitry) and apply a cancelling signal through an additional electrode, in order to force the measured common-mode to the desired reference (allowable patient current-leakage restrictions thus come into play); [0091]; Figure 10A).
Regarding Claim 30, Clements discloses wherein the one or more reference electrodes consist of a single reference electrode (the electrode array 104 includes one or more reference electrodes 122 (or ground electrode, driving electrode, etc.); [0060]), and wherein the single reference electrode is disposed along the interior portion of the wearable structure (A wrap or band can be provided to apply this pressure. The wrap or band may include the compression pad of FIGS. 8 and 9A. In some cases the wrap or band can incorporate a rigid member (e.g. flat, curved, or otherwise shaped to fit the underlying anatomy) overlying the electrode array designed to selectively apply pressure on the electrode array pushing it into the skin; [0113]; Figures 6 and 10A).
Regarding Claim 32, Clements discloses wherein the common mode reference output is generated using a closed-loop amplifier (as shown in FIG. 10A, the electronics module 150 includes a driven right leg circuit 155. The driven right leg circuit 155 is configured to measure the subject's common-mode, and force a ground of the electronics module 150 to the subject's common-mode. FIG. 10B illustrates the significant reduction in observed stimulation artifact achieved using the driven right leg circuit 155; [0070]; A feedback amplifier is used to measure the common-mode of the patient (normally extracted from a node inside the differential amplification circuitry) and apply a cancelling signal through an additional electrode, in order to force the measured common-mode to the desired reference (allowable patient current-leakage restrictions thus come into play); [0091]; Examiner’s Note: Figure 10A depicts wherein the “OA1” is configured as a closed-loop amplifier).
Regarding Claim 33, Clements discloses wherein the one or more reference electrodes each have a different shape than the plurality of signal electrodes (Examiner’s Note: Figure 2 shows a reference electrode 122 in an oblong, strip-like shape, which is a different shape than the plurality of signal electrodes 106).
Claims 11, 27, and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Clements and Do Valle as applied to claims 1, 24, and 29 above, and further in view of Strohmeier et al (WO 2019/043147 A1; cited by Applicant).
Regarding Claim 11, although Clements discloses wherein the same muscle group comprises wrist muscles (a short region of conduction velocity slowing (e.g., the median nerve at the wrist, as in carpal tunnel syndrome) can be clearly seen when the stimulus and recording electrodes lie directly on either side of that region; [0088]; [0113]; Figures 6 and 9A-9B), Clements and Do Valle fail to specifically teach wherein the same muscle group comprises one or more of: wrist extensor muscles, and wrist flexor muscles.
In a similar technical field, Strohmeier teaches a garment fabric for reading and writing muscle activity (Abstract), comprising electrodes for collecting EMG data of a user (array of 60 skin electrodes are sewn into the inner surface of sleeve…around the forearm of a user; Page 10 Lines 11-19; Figures 1-3) wherein the same muscle group comprises one or more of: wrist extensor muscles, and wrist flexor muscles (The target gestures were grouped into pairs based on shared muscle compartments: wrist-up and wrist-down, hand-left and hand-right, squeeze-fingers and index-point. For example, the extensor carpi ulnaris (on the top of the forearm), among other muscles, contracts to extend the wrist. In this case, it is an agonist muscle. The antagonist muscles, such as the flexor carpi ulnaris (on the bottom of the forearm), relax to enable wrist extension. When flexing the wrist, however, the role of these muscles is reversed. When holding a pose, co-activation of both agonist and antagonist muscles can occur, producing discernible signals for our EMG devices; Page 30 Lines 5-13).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the wrist extensor and/or flexor muscles teachings of Strohmeier into those of Clements and Do Valle in order to measure activity from muscles that actively work together (Strohmeier Page 30 Lines 5-13).
Regarding Claim 27, although Clements discloses wherein the same muscle group comprises wrist muscles (a short region of conduction velocity slowing (e.g., the median nerve at the wrist, as in carpal tunnel syndrome) can be clearly seen when the stimulus and recording electrodes lie directly on either side of that region; [0088]; [0113]; Figures 6 and 9A-9B), Clements and Do Valle fail to specifically teach wherein the same muscle group comprises one or more of: wrist extensor muscles, and wrist flexor muscles.
In a similar technical field, Strohmeier teaches a garment fabric for reading and writing muscle activity (Abstract), comprising electrodes for collecting EMG data of a user (array of 60 skin electrodes are sewn into the inner surface of sleeve…around the forearm of a user; Page 10 Lines 11-19; Figures 1-3) wherein the same muscle group comprises one or more of: wrist extensor muscles, and wrist flexor muscles (The target gestures were grouped into pairs based on shared muscle compartments: wrist-up and wrist-down, hand-left and hand-right, squeeze-fingers and index-point. For example, the extensor carpi ulnaris (on the top of the forearm), among other muscles, contracts to extend the wrist. In this case, it is an agonist muscle. The antagonist muscles, such as the flexor carpi ulnaris (on the bottom of the forearm), relax to enable wrist extension. When flexing the wrist, however, the role of these muscles is reversed. When holding a pose, co-activation of both agonist and antagonist muscles can occur, producing discernible signals for our EMG devices; Page 30 Lines 5-13).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the wrist extensor and/or flexor muscles teachings of Strohmeier into those of Clements and Do Valle in order to measure activity from muscles that actively work together (Strohmeier Page 30 Lines 5-13).
Regarding Claim 31, although Clements discloses wherein the same muscle group comprises wrist muscles (a short region of conduction velocity slowing (e.g., the median nerve at the wrist, as in carpal tunnel syndrome) can be clearly seen when the stimulus and recording electrodes lie directly on either side of that region; [0088]; [0113]; Figures 6 and 9A-9B), Clements and Do Valle fail to specifically teach wherein the same muscle group comprises one or more of: wrist extensor muscles, and wrist flexor muscles.
In a similar technical field, Strohmeier teaches a garment fabric for reading and writing muscle activity (Abstract), comprising electrodes for collecting EMG data of a user (array of 60 skin electrodes are sewn into the inner surface of sleeve…around the forearm of a user; Page 10 Lines 11-19; Figures 1-3) wherein the same muscle group comprises one or more of: wrist extensor muscles, and wrist flexor muscles (The target gestures were grouped into pairs based on shared muscle compartments: wrist-up and wrist-down, hand-left and hand-right, squeeze-fingers and index-point. For example, the extensor carpi ulnaris (on the top of the forearm), among other muscles, contracts to extend the wrist. In this case, it is an agonist muscle. The antagonist muscles, such as the flexor carpi ulnaris (on the bottom of the forearm), relax to enable wrist extension. When flexing the wrist, however, the role of these muscles is reversed. When holding a pose, co-activation of both agonist and antagonist muscles can occur, producing discernible signals for our EMG devices; Page 30 Lines 5-13).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the wrist extensor and/or flexor muscles teachings of Strohmeier into those of Clements and Do Valle in order to measure activity from muscles that actively work together (Strohmeier Page 30 Lines 5-13).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
In a similar technical field, Matthiessen et al (U.S. Patent No. 7,288,943) teaches electroimpedance tomograph with common-mode signal suppression (Abstract), comprising: one or more common-mode signal electrodes (common-mode signal electrodes 4 and 90); and circuitry configured to generate the common mode reference output based on signals from the one or more common-mode signal electrodes (The output of the voltage divider with the additional common-mode signal is connected to one of the two inputs of a differential amplifier 70 of a control loop circuit. The other input of the differential amplifier 70 is connected to a common-mode signal electrode 4, which can be placed on the patient's body. The output of the differential amplifier 70 is connected to another active common-mode signal electrode 90, which can be placed on the body. A common-mode signal corresponding to the additional common-mode signal is generated on the body in this manner by the analog control circuit with the differential amplifier 70; Column 5 Lines 41-56).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHANEL J YOON whose telephone number is (571) 272-2695. The examiner can normally be reached on Monday-Friday 9:00AM-5:00PM.
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/CHANEL J YOON/Examiner, Art Unit 3791
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