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 .
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-4, 6-7, 9-12, 16, 18-24, and 26-27 are rejected under 35 U.S.C. 103 as being unpatentable over Toth et al. (US 20150351690 A1- Previously cited), hereinafter Toth, and further in view of Markowitz et al. (US 20110106203 A1- Previously cited), hereinafter Markowitz.
Regarding claims 1 and 18, Toth teaches a system for monitoring one or more physiological parameters (see ABSTRACT), comprising: a plurality of patches positionable at a plurality of locations on a surface of a body, wherein the plurality of patches are isolated from each other (¶ [0163,
0309] and fig. 1a) whereby no direct electrical communication is permitted between each of the plurality of patches (¶ [0133], the patch need not communicate directly with other patches, rather to a host device);
wherein a first patch of the plurality of patches comprises a transmitter/generator configured to inject electrical signal into the body at a first location on the surface of the body, and wherein the bio-impedance signal is induced within the body by the electrical signal injected from the first patch which is electrically isolated from the second patch (¶ [0109,0163], “In aspects wherein one or more patch/module pairs are equipped with a pulse generator and one or more electrodes suitable for emitting one or more pulses into the subject” and “The processor, gate array, digital signal processor, or an associated microcircuit, configured to analyze the captured signals to determine a bioimpedance of the nearby tissues” indicating that the pulse generator injects an electrical signal by a first patch at a first location while being electrically isolated from the second patch); and whereby wired electrical communication between the first patch and second patch external the body is restricted (¶ [0102,0133], each patch is wirelessly connected to each other and/or to the host device).
Toth fails to teach wherein a second patch of the plurality of patches comprises a sensor configured to detect a bio-impedance signal at a second location on the surface of the body that is spaced from the first location, and wherein the bio-impedance signal is induced within the body by the electrical signal injected from the first patch which is electrical isolated from the second patch.
Markowitz teaches a system and method for evaluating electrode positioning and spacing over time via an electrode potential or bioimpedance tracking system (see ABSTRACT). Markowitz teaches that that electrode based patch is configured to inject current into the patient and be received by another patch, thereby defining an axis (¶ [0029-30], “a first x-axis patch 58a and a second x-axis patch 58b can be connected with the patient 26 to create a x-axis (such as an axis that is generally medial-lateral of a patient) with a voltage gradient substantially along the x-axis between the patches 58a and 58d and a corresponding x-axis current flowing between patches 58a and 58b”, “Although a voltage can be sensed, an impedance can also be calculated or measured to determine a location in a similar manner” and “The induced current can be of a different frequency for each of the related patch pairs to allow for distinguishing which axis is being measured”).
As such, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Toth, such that a second patch detects the bio-impedance signal at a second location spaced from the first location, as taught by Markowitz, because Toth requires determining bio-impedance of nearby tissues, but fails to provide details, and Markowitz teaches it can be accomplished by injecting an electrical signal between two electrode based patches.
It follows, Toth-Markowitz teach the only direct communication between the plurality of patches being communication that extends through the body (¶ [0029-30] of Markowitz).
Regarding claim 2, Toth-Markowitz teach a transmitter of the first patch is configured to inject an alternating current at a first frequency (¶ [0163] of Toth, “the signal generator configured so as to provide a signal between two or more of the electrodes (e.g. in a frequency range of generally between 1 hertz (Hz) and 10 GHz, 1 kHz and 10 MHz, 5 kHz and 1 MHz, or the like, at multiple frequencies, swept over a range of frequencies, etc.), while the bioamps are configured to capture one or more signals from two or more of the electrodes”);
the sensor of the second patch is configured to detect the bio-impedance signal from a voltage induced by the injected alternating current (¶ [0030] of Markowitz, “The current applied between the related patches generates a small or micro-current, which can be about 1 microampere (.mu.A) to about 100 milliamperes (mA), in the patient along the axis between the respective patch pairs. The induced current can be of a different frequency for each of the related patch pairs to allow for distinguishing which axis is being measured. The current induced in the patient 26 will generate a voltage gradient across different portions, such as the heart, that can be measured with a position element. The position element can be an electrode, as discussed in further detail herein. The sensed voltage can be used to identify a position along an axis (whereby each axis can be identified by the particular frequency of the current being measured) to generally determine a position of an electrode along each of the three axes” indicating that the receiving patch is configured to sense the sense the bio-impedance signal);
and the second patch comprises a transmitter configured to inject an alternating current at a second frequency (¶ [0030-32,0035] of Markowitz, “By positioning the reference patches 62a,b at these locations, respiration may be monitored by measuring the relative voltage or impedance difference between the two reference electrodes 62a,b” and “the multiple driving or voltage patches 56a-60b are used to inject current in the patient to create voltage potentials within the patient 26 that can be sensed by electrodes” indicating that each patch is capable of injecting a current at a frequency thus requiring a transmitter/generator).
Toth-Markowitz fail to teach wherein the second frequency is different from the first frequency. However, Markowitz teaches “The induced current can be of a different frequency” and “the current generated can include different frequencies along the different x, y, and z axes to distinguish the x, y, and z-axes” indicating that by varying the frequency one can determine which patch is injecting the signal to determine impedance location. Additionally, Toth teaches that the patch electrodes are configured to provide a signal between two or more of the electrodes in a plurality of frequency ranges to aid in determining the bioimpedance of the tissue (¶ [0163]).
It would have been obvious to obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Toth-Markowitz, such that the second patch injects an alternating current at a second frequency that is different from the first frequency, as taught by Toth, to aid in determining the bioimpedance of the subjects tissue, or as taught by Markowitz, to aid in distinguishing the patches.
Regarding claim 3, Toth-Markowitz teaches wherein the first patch comprises sensor configured to detect a bioimpedance signal from the body that is induced by the alternating currents injected from the first patch and the second patch (¶ [0163,0242-243] of Toth, “bioamps are configured to capture one or more signals” and “one or more patches may relay a combination of an energy signal (e.g. to determine a physiologic parameter) as well as to communicate an information signal to one or more patches” indicating that a first patch can be configured to receive/detect induced signals from the first patch and/or multiple patches e.g., second, etc.; “the patch may include two or more electrode elements to be placed into electrical contact with the subject during a monitoring session. The processor may, via the electrode elements and/or signal conditioning or test electronics attached thereto, estimate the impedance between the electrodes and the body of the subject”).
Regarding claims 4 and 20, Toth-Markowitz teaches a controller coupled to the second patch to estimate the one or more physiological parameters based on the bioimpedance signal (¶ [0103,0248] of Toth, “In aspects, the energy signal may be emitted into the body of the subject by a first patch and simultaneously monitored by one or more patches to determine a physiologic parameter of the subject”).
Regarding claim 6, Toth-Markowitz teach wherein at least one of the one or more physiological parameters estimated by the controller corresponds to at least one of heart activity and respiratory activity of a patient (¶ [0158,0233,0243,0302] of Toth, heart rate and respiration).
Regarding claims 7 and 16, Toth-Markowitz teach wherein the one or more physiological parameters comprises a plurality of physiological parameters (¶ [0233] of Toth, “monitor one or more physiologic…parameters”), and wherein the controller is configured to apply a source separation algorithm on the bio-impedance signal to separate a first physiological parameter from the plurality of physiological parameters (¶ [0059] of Toth, “an algorithm…to separate the signals into pre impact and post impact portions”).
Regarding claims 9-10 and 19, Toth-Markowitz teach wherein each of the plurality of patches are independently electrically grounded to the body and a ground electrode in electrical contact with the surface of the body (see fig. 1a and ¶ [0219] of Toth, one skilled in the art understands that basic electrode configuration requires a ground electrode so as to determine the potential difference/voltage, this would be required for an isolated electrode patch, while not explicitly stated that each patch is grounded with a ground electrode, this structure is conventional in the art, e.g., recording electrode, ground electrode, reference electrode; ¶ [0041,0234] of Toth, the ground plane is considered the ground electrode; moreover, this limitation does not make a contribution over Manera cited below).
Regarding claim 11, Toth-Markowitz teach wherein at least one of the plurality of patches comprises a sensor configured to independently detect a bio-impedance signal from the body induced by the electrical signal injected from the second patch (¶ [0242-243] of Toth, “one or more patches may relay a combination of an energy signal (e.g. to determine a physiologic parameter) as well as to communicate an information signal to one or more patches” indicating that a first patch can be configured to receive/detect induced signals from the first patch and/or multiple patches e.g., second, etc.; For clarification, Toth teaches a plurality of patches and the modification with Markowitz arrives to a plurality of patches capable of transmitting and receiving voltage/impedance signals).
Regarding claim 12, Toth-Markowitz teach a transmitter of the first patch is configured to inject an alternating current at a first frequency (¶ [0163] of Toth, “the signal generator configured so as to provide a signal between two or more of the electrodes (e.g. in a frequency range of generally between 1 hertz (Hz) and 10 GHz, 1 kHz and 10 MHz, 5 kHz and 1 MHz, or the like, at multiple frequencies, swept over a range of frequencies, etc.), while the bioamps are configured to capture one or more signals from two or more of the electrodes”);
the sensor of the second patch is configured to detect the bio-impedance signal from a voltage induced by the injected alternating current (¶ [0030] of Markowitz, “The current applied between the related patches generates a small or micro-current, which can be about 1 microampere (.mu.A) to about 100 milliamperes (mA), in the patient along the axis between the respective patch pairs. The induced current can be of a different frequency for each of the related patch pairs to allow for distinguishing which axis is being measured. The current induced in the patient 26 will generate a voltage gradient across different portions, such as the heart, that can be measured with a position element. The position element can be an electrode, as discussed in further detail herein. The sensed voltage can be used to identify a position along an axis (whereby each axis can be identified by the particular frequency of the current being measured) to generally determine a position of an electrode along each of the three axes” indicating that the receiving patch is configured to sense the sense the bio-impedance signal);
and the second patch comprises a transmitter configured to inject an alternating current at a second frequency (¶ [0030-32,0035] of Markowitz, “By positioning the reference patches 62a,b at these locations, respiration may be monitored by measuring the relative voltage or impedance difference between the two reference electrodes 62a,b” and “the multiple driving or voltage patches 56a-60b are used to inject current in the patient to create voltage potentials within the patient 26 that can be sensed by electrodes” indicating that each patch is capable of injecting a current at a frequency thus requiring a transmitter/generator).
Toth-Markowitz fail to teach wherein the second frequency is different from the first frequency. However, Markowitz teaches “The induced current can be of a different frequency” and “the current generated can include different frequencies along the different x, y, and z axes to distinguish the x, y, and z-axes” indicating that by varying the frequency one can determine which patch is injecting the signal to determine impedance location (¶ [0030]). Additionally, Toth teaches that the patch electrodes are configured to provide a signal between two or more of the electrodes in a plurality of frequency ranges to aid in determining the bioimpedance of the tissue (¶ [0163]).
Thus, Toth-Markowitz teach wherein the first patch comprises a sensor configured to detect a bioimpedance signal from the body that is induced by the alternating currents injected from the first patch and the second patch (¶ [0242-243] of Toth, “one or more patches may relay a combination of an energy signal (e.g. to determine a physiologic parameter) as well as to communicate an information signal to one or more patches” indicating that a first patch can be configured to receive/detect induced signals from the first patch and/or multiple patches e.g., second, etc.; “the patch may include two or more electrode elements to be placed into electrical contact with the subject during a monitoring session. The processor may, via the electrode elements and/or signal conditioning or test electronics attached thereto, estimate the impedance between the electrodes and the body of the subject”).
Regarding claims 21 and 27, Toth-Markowitz fail to explicitly teach wherein each patch in the plurality of patches is configured to inject an electrical signal at a unique frequency to distinguish the electrical signals of the plurality of patches signals based on their unique frequency.
Markowitz teaches “The induced current can be of a different frequency” and “the current generated can include different frequencies along the different x, y, and z axes to distinguish the x, y, and z-axes” indicating that by varying the frequency one can determine which patch is injecting the signal to determine impedance location (¶ [0030]). Additionally, Toth teaches that the patch electrodes are configured to provide a signal between two or more of the electrodes in a plurality of frequency ranges to aid in determining the bioimpedance of the tissue (¶ [0163]).
It would have been obvious to obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Toth-Markowitz, such that the each patch in the plurality of patches is configured to inject an electrical signal at a unique frequency to distinguish the electrical signals of the plurality of patches signals based on their unique frequency, as taught by Toth, to aid in determining the bioimpedance of the subjects tissue, and/or as taught by Markowitz, to aid in distinguishing the axis/positioning of the patches.
Regarding claim 22, Toth-Markowitz teaches a controller in signal communication with the plurality of patches to correlate the bio-impedance signal with a specific patch of the plurality of patches responsible for inducing the bio-impedance signal (¶ [0030] of Markowitz, “The induced current can be of a different frequency” and “the current generated can include different frequencies along the different x, y, and z axes to distinguish the x, y, and z-axes” indicating that by varying the frequency the controller can determine which patch is injecting the signal to determine impedance location).
Regarding claim 23, Toth-Markowitz teach wherein the controller is configured to identify the specific patch by decoding the unique frequency associated with the specific patch (¶ [0035] of Markowitz, “The current generated can include different frequencies along the different x, y, and z axes to distinguish the x, y, and z-axes” indicating that the patches associated with each axes can be determined based on their unique frequency).
Regarding claim 24, Toth-Markowitz teach wherein the controller is configured to determine spatial locations of the plurality of patches on the surface of the body based on the unique frequencies (¶ [0030-31] and figs. 1-2 of Markowitz, “the position of the electrode with respect to each of the three axes can be used as map data to be illustrated on the display device 38” “reference patches or electrodes can be interconnected with the patient 26 for reference of guiding or mapping with the instrument relative to the patient 26” indicating that spatial locations of the patches are determined based on frequencies).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Toth-Markowitz, such that the controller is configured to determine spatial locations of the plurality of patches on the surface of the body based on the unique frequencies, as taught by Markowitz, to determine relative location of instruments used during medical procedures and navigating instruments (¶ [0023-24] of Markowitz).
Regarding claim 26, Toth-Markowitz teach positioning the plurality of patches at locations on the surface of the body to provide distributed sensing coverage of multiple physiological regions, including regions associated with cardiac and respiratory activity (see fig. 1a of Toth).
Claims 5, 8, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Toth in view of Markowitz, as applied to claims 4, 7 and 16, and further in view of Banet et al. (US 20160106366 A1- Previously cited), hereinafter Banet.
Regarding claim 5, Toth-Markowitz fail to teach wherein the controller is configured to adjust/modulate at least one of a frequency of the electrical signal injected by the transmitter.
Banet teaches a system for monitoring one or more physiological parameters (see ABSTRACT), comprising: a plurality of patches, wherein the first patch comprises a transmitter configured to inject an electrical signal in the body in a first location, and wherein a second patch (116) to detect the bioimpedance signal at a second location (S1,S2) that is spaced from the first location. The frequency is modulated/adjusted to aid in monitoring the subject’s physiology (¶ [0095]).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Toth-Banet, such that the frequency of the electrical signal injected is adjusted, as taught by Banet, to aid in monitoring the subjects physiology.
Regarding claim 8, Toth-Markowitz fail to wherein the controller is configured to apply a demodulation algorithm to the bio-impedance signal prior to the application of the source separation algorithm to the bio-impedance signal,
Banet teaches that the voltage signals are processed through a demodulator to use the demodulated signal for bioimpedance measurement (¶ [0122-123] ).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Toth-Markowitz, such that a demodulation algorithm is applied to the voltage signal prior to further processing, as taught by Banet, to aid in measuring bioimpedance.
Regarding claim 17, Toth-Markowitz fail to teach wherein the controller is configured to adjust/modulate at least one of a frequency of the electrical signal injected by the transmitter.
Banet teaches a system for monitoring one or more physiological parameters (see ABSTRACT), comprising: a plurality of patches, wherein the first patch comprises a transmitter configured to inject an electrical signal in the body in a first location, and wherein a second patch (116) to detect the bioimpedance signal at a second location (S1,S2) that is spaced from the first location. The frequency is modulated/adjusted to aid in monitoring the subject’s physiology (¶ [0095]).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Toth-Banet, such that the frequency of the electrical signal injected is adjusted, as taught by Banet, to aid in monitoring the subjects physiology.
Claims 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Toth in view of Markowitz, Banet, and Manera (US 2018031779).
Regarding claim 13, Toth teaches a system for monitoring one or more physiological parameters (see ABSTRACT), comprising: a plurality of patches positionable at a plurality of locations on a surface of a body, wherein the plurality of patches are isolated from each other (¶ [0163,
0309] and fig. 1a) whereby no direct electrical communication is permitted between each of the plurality of patches (¶ [0133], the patch need not communicate directly with other patches, rather to a host device);
wherein a first patch of the plurality of patches comprises a transmitter/generator configured to inject electrical signal into the body at a first location on the surface of the body, and wherein the bio-impedance signal is induced within the body by the electrical signal injected from the first patch which is electrically isolated from the second patch (¶ [0109,0163], “In aspects wherein one or more patch/module pairs are equipped with a pulse generator and one or more electrodes suitable for emitting one or more pulses into the subject” and “The processor, gate array, digital signal processor, or an associated microcircuit, configured to analyze the captured signals to determine a bioimpedance of the nearby tissues” indicating that the pulse generator injects an electrical signal by a first patch at a first location while being electrically isolated from the second patch); and whereby wired electrical communication between the first patch and second patch external the body is restricted (¶ [0102,0133], each patch is wirelessly connected to each other and/or to the host device).
Toth fails to teach wherein a ground electrode that is separate from the transmitter and in electrical contact with the surface of the body to electrically ground the first patch directly to the body at the first location.
Manera teaches an electrode patch for sensing electrical signals (abstract). The patch comprises a negative, positive, and ground electrode (¶[0019-25], “This allows the technician or physician to get the necessary EKG information from a single patch design as shown”).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system of Toth, such that a ground electrode that is separate from the transmitter and in electrical contact with the surface of the body to electrically ground the first patch directly to the body at the first location, as taught by Manera, to aid in providing sensor information using a single patch design.
Toth fails to teach wherein a second patch of the plurality of patches comprises a sensor configured to detect a bio-impedance signal at a second location on the surface of the body that is spaced from the first location, and wherein the bio-impedance signal is induced within the body by the electrical signal injected from the first patch which is electrical isolated from the second patch.
Markowitz teaches a system and method for evaluating electrode positioning and spacing over time via an electrode potential or bioimpedance tracking system (see ABSTRACT). Markowitz teaches that that electrode based patch is configured to inject current into the patient and be received by another patch, thereby defining an axis (¶ [0029-30], “a first x-axis patch 58a and a second x-axis patch 58b can be connected with the patient 26 to create a x-axis (such as an axis that is generally medial-lateral of a patient) with a voltage gradient substantially along the x-axis between the patches 58a and 58d and a corresponding x-axis current flowing between patches 58a and 58b”, “Although a voltage can be sensed, an impedance can also be calculated or measured to determine a location in a similar manner” and “The induced current can be of a different frequency for each of the related patch pairs to allow for distinguishing which axis is being measured”).
As such, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Toth-Manera, such that a second patch detects the bio-impedance signal at a second location spaced from the first location, as taught by Markowitz, because Toth requires determining bio-impedance of nearby tissues, but fails to provide details, and Markowitz teaches it can be accomplished by injecting an electrical signal between two electrode based patches.
It follows, Toth-Manera-Markowitz teach the only direct communication between the plurality of patches being communication that extends through the body (¶ [0029-30] of Markowitz).
Regarding claim 14, Toth-Manera-Markowitz teach wherein the plurality of patches (see fig. 1a and ¶ [0219] of Toth) comprises are plurality of ground electrodes in electrical contact with the surface of the body (¶[0020-25] of Manera. In view of the combination with Manera above, the patches of Toth result in each comprising its own ground electrode, as seen in Manera’s patch).
Regarding claim 15, Toth-Manera-Markowitz teach a transmitter of the first patch is configured to inject an alternating current at a first frequency (¶ [0163] of Toth, “the signal generator configured so as to provide a signal between two or more of the electrodes (e.g. in a frequency range of generally between 1 hertz (Hz) and 10 GHz, 1 kHz and 10 MHz, 5 kHz and 1 MHz, or the like, at multiple frequencies, swept over a range of frequencies, etc.), while the bioamps are configured to capture one or more signals from two or more of the electrodes”);
the sensor of the second patch is configured to detect the bio-impedance signal from a voltage induced by the injected alternating current (¶ [0030] of Markowitz, “The current applied between the related patches generates a small or micro-current, which can be about 1 microampere (.mu.A) to about 100 milliamperes (mA), in the patient along the axis between the respective patch pairs. The induced current can be of a different frequency for each of the related patch pairs to allow for distinguishing which axis is being measured. The current induced in the patient 26 will generate a voltage gradient across different portions, such as the heart, that can be measured with a position element. The position element can be an electrode, as discussed in further detail herein. The sensed voltage can be used to identify a position along an axis (whereby each axis can be identified by the particular frequency of the current being measured) to generally determine a position of an electrode along each of the three axes” indicating that the receiving patch is configured to sense the sense the bio-impedance signal);
and the second patch comprises a transmitter configured to inject an alternating current at a second frequency (¶ [0030-32,0035] of Markowitz, “By positioning the reference patches 62a,b at these locations, respiration may be monitored by measuring the relative voltage or impedance difference between the two reference electrodes 62a,b” and “the multiple driving or voltage patches 56a-60b are used to inject current in the patient to create voltage potentials within the patient 26 that can be sensed by electrodes” indicating that each patch is capable of injecting a current at a frequency thus requiring a transmitter/generator).
Toth-Markowitz fail to teach wherein the second frequency is different from the first frequency. However, Markowitz teaches “The induced current can be of a different frequency” and “the current generated can include different frequencies along the different x, y, and z axes to distinguish the x, y, and z-axes” indicating that by varying the frequency one can determine which patch is injecting the signal to determine impedance location (¶ [0030]). Additionally, Toth teaches that the patch electrodes are configured to provide a signal between two or more of the electrodes in a plurality of frequency ranges to aid in determining the bioimpedance of the tissue (¶ [0163]).
Thus, Toth-Manera-Markowitz teach wherein the first patch comprises a sensor configured to detect a bioimpedance signal from the body that is induced by the alternating currents injected from the first patch and the second patch (¶ [0242-243] of Toth, “one or more patches may relay a combination of an energy signal (e.g. to determine a physiologic parameter) as well as to communicate an information signal to one or more patches” indicating that a first patch can be configured to receive/detect induced signals from the first patch and/or multiple patches e.g., second, etc.; “the patch may include two or more electrode elements to be placed into electrical contact with the subject during a monitoring session. The processor may, via the electrode elements and/or signal conditioning or test electronics attached thereto, estimate the impedance between the electrodes and the body of the subject”).
Response to Arguments
Applicant's arguments filed 02/19/2026 have been fully considered but they are not fully persuasive.
Applicant contends that Toth does not describe detecting by the additional patch/modules a bio-impedance signal induced in the subject by an electrical signal injected from the first patch, on page 14 of the Remarks. Examiner agrees. Toth is not relied upon to teach patches communicating with each other via injected electrical signals, Markowitz is (pgs. 5-6 of Non Final Office Action- 09/19/2025).
It appears that Applicant’s entire argument was not included Remarks because the argument section is cutoff (see page 14 of the Remarks, “the Office Action asserts that it”).
Applicant’s arguments with respect to amended claim 13 and dependent claims thereof have been considered but are moot because amendments require new grounds of rejection.
Applicant contends that the Toth and Markowitz fail to teach claim 18, but fails to argue why on pages 16-17 of the Remarks. Toth is used to teach a plurality of patches that are independent from each other (¶ [0102,0133] of Toth) and Markowitz is used to teach patches that inject electrical signals to each other to determine impedance values (¶[0029-30] of Markowitz). As such, the analysis is maintained. It is further noted, separate electrodes can inject signals through tissue to each other to measure impedance (see Ollmar below).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Ollmar teaches the two injection electrodes can be placed at two different positions on the body of the subject, in order to measure impedance of one or more body segments (e.g. a portion of an arm or a leg) or the whole body. In other words, each pair of injection and sensing electrodes can be located at two different positions. US 20070161881
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 MARTIN NATHAN ORTEGA whose telephone number is (571)270-7801. The examiner can normally be reached M-F 7:10 am - 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert (Tse) Chen can be reached at (571) 272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARTIN NATHAN ORTEGA/Examiner, Art Unit 3791 /TSE CHEN/Supervisory Patent Examiner, Art Unit 3791
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