DETAILED ACTION
Response to Amendment
This office action is responsive to the amendment filed on June 8, 2026. As directed by the amendment: claim(s) 1, 7, 9, 12, 14, 19 and 23-24 have been amended, claim(s) 6, 11, 13, and 22 have been cancelled, and claim(s) 26-28 have been added. Thus, claims 1-5, 7-10, 12, 14-21, and 23-28 are currently pending in the application.
Response to Arguments
Applicant’s arguments, see pg. 10, filed June 8, 2026, with respect to the 35 U.S.C. 112(b) rejection of claim 9 have been fully considered and are persuasive. The 35 U.S.C. 112(b) rejection of claim 9 has been withdrawn.
The Non-Final Rejection mailed on 1/16/26 designated claims 6-7, 9, 12, and 14-15 as allowable subject matter; however, upon further search the examiner has found new art to reject the claims. Applicant’s arguments with respect to claims 1-5, 7-10, 12, 14-21, and 23-28 have been considered but the arguments do not apply to the combination of the references being used in the new grounds of rejection set forth above; therefore, the examiner has applied a new combination of prior art to reject the claims.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 14-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Martins (US 2016/0310730 A1)
Regarding claim 14, Martins discloses a system for electrically stimulating a nerve to cause muscle contraction (e.g. “…an electrode array of a first and second types and comprising a plurality of electrodes configured to stimulate a phrenic nerve…” (abstract)), comprising: a plurality of electrodes configured to be positioned in electrical contact with the skin simultaneously, the electrodes being configured to allow electrical stimulation to be directed independently towards a plurality of different stimulation regions below the skin via a corresponding plurality of combinations of the electrodes (e.g. [0148] “array of electrode elements 1356 …may be coupled to the selector 1354…so as to receive drive signals from the selector…” ); and a controller (e.g. controller 1350) configured to: for each combination of electrodes, apply a test stimulation using the combination of electrodes and measure a response to the test stimulation (e.g. [0164] “…the system or the clinician may proceed to test electrodes of that particular region of the electrode array as follows: electrode pairs 3-5, then 4-5, then 3-4, then 4-6, then 5-6. The testing may also include inversion of which electrode gives a better response as an anode or cathode…”); select one or a subset of stimulation regions based on the measured responses (e.g. [0164] “…Once it's determined which half of the array gives the better stimulation, for example as determined by observing the contractions of the diaphragm caused by the stimulation, by visual observation, through use of a sensor patch as described herein, palpation, using ultrasounds, fluoroscopy, etc., then testing can focus on the electrodes of that particular region of the electrode array…”); and apply a therapy stimulation to each selected stimulation region using the combination of electrodes corresponding to the selected stimulation region (e.g. [0168] “…The stimulator may be capable of stimulating for example in five different stimulation modes (SMs) as will be discussed below although other modes of operation are also envisioned. After the electrode combination that provides better results is determined (e.g., better contraction of the diaphragm and/or little or no collateral contraction of collateral muscles), three amplitudes for example may be established to support different modes of operation as described herein …”), wherein the controller is further configured to synchronize the application of the therapy stimulation with the breathing cycle (e.g. [0010]; [0014]-[0017]; [0099]), and wherein the controller is configured to apply the therapy stimulation only within a predetermined portion of the breathing cycle of a subject (e.g. [0183]; [0203]; [0253]; [0260]-[0262]).
Regarding claim 15, Martins discloses wherein a majority of the predetermined portion of the breathing cycle is in the first half of the inspiration phase of assisted ventilation to the subject (e.g. [0183]; [0203]; [0253]; [0259]-[0262]).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-5, 7-8, 10, 16-17, 20 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Martins in view of Netherly (US 6,007,532 A).
Regarding claims 1 and 23, Martins discloses a system and method for electrically stimulating a nerve to cause muscle contraction (e.g. “…an electrode array of a first and second types and comprising a plurality of electrodes configured to stimulate a phrenic nerve…” (abstract)), comprising: a plurality of electrodes configured to be positioned in electrical contact with the skin simultaneously, the electrodes being configured to allow electrical stimulation to be directed independently towards a plurality of different stimulation regions below the skin via a corresponding plurality of combinations of the electrodes (e.g. [0148] “array of electrode elements 1356 …may be coupled to the selector 1354…so as to receive drive signals from the selector…” ); and a controller (e.g. controller 1350) configured to: for each combination of electrodes, apply a test stimulation using the combination of electrodes and measure a response to the test stimulation (e.g. [0164] “…the system or the clinician may proceed to test electrodes of that particular region of the electrode array as follows: electrode pairs 3-5, then 4-5, then 3-4, then 4-6, then 5-6. The testing may also include inversion of which electrode gives a better response as an anode or cathode…”); select one or a subset of stimulation regions based on the measured responses (e.g. [0164] “…Once it's determined which half of the array gives the better stimulation, for example as determined by observing the contractions of the diaphragm caused by the stimulation, by visual observation, through use of a sensor patch as described herein, palpation, using ultrasounds, fluoroscopy, etc., then testing can focus on the electrodes of that particular region of the electrode array…”); and apply a therapy stimulation to each selected stimulation region using the combination of electrodes corresponding to the selected stimulation region (e.g. [0168] “…The stimulator may be capable of stimulating for example in five different stimulation modes (SMs) as will be discussed below although other modes of operation are also envisioned. After the electrode combination that provides better results is determined (e.g., better contraction of the diaphragm and/or little or no collateral contraction of collateral muscles), three amplitudes for example may be established to support different modes of operation as described herein …”).
Martins is silent regarding wherein the controller is further configured to perform a contact quality check comprising measuring an electrical impedance associated with a contact between an electrode and the skin for each of the plurality of combinations of the electrodes.
However, Netherly discloses a method and apparatus for detecting loss of contact of biomedical electrodes with patient skin wherein the controller is further configured to perform a contact quality check comprising measuring an electrical impedance associated with a contact between an electrode and the skin for each of the plurality of combinations of the electrodes (e.g. Netherly abstract col 6 lines 1-19).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system of Martins to incorporate the teachings of Netherly wherein the controller is further configured to perform a contact quality check comprising measuring an electrical impedance associated with a contact between an electrode and the skin for each of the plurality of combinations of the electrodes for the purpose of ensuring proper contact between the electrodes and the user (e.g. Netherly abstract col 6 lines 1-19).
Regarding claim 2, modified Martins discloses wherein each measured response comprises information about a physiological response to the corresponding test stimulation (e.g. Martins [0163] “…During use, testing (e.g., in accordance with the EPTM discussed above) can start with electrodes 1 (cathode) and 4 (anode). The stimulus amplitude can be set to a value that typically generates a contraction that is visible and/or measurable, although it doesn't have to generate a full-breath contraction. The desired contraction may be some contraction that is visible and/or can be measurable (e.g., through use of a motion sensor)…”).
Regarding claim 3, modified Martins discloses wherein the physiological response comprises a physiological response of the diaphragm (e.g. Martins [0164] “…Once it's determined which half of the array gives the better stimulation, for example as determined by observing the contractions of the diaphragm caused by the stimulation, by visual observation, through use of a sensor patch as described herein, palpation, using ultrasounds, fluoroscopy, etc.…”).
Regarding claim 4, modified Martins discloses wherein the controller is configured such that the selection of the one or a subset of the stimulation regions comprises selecting the stimulation region for which the measured response to the respective test stimulation is the highest (e.g. Martins [0164] “…if it is determined that electrode pair 1-4 gives better stimulation than electrode pair 3-6, then the system or the clinician (for example by pressing a key that selects the next pair of electrodes of the same group) may proceed testing electrodes within that particular region (e.g., in the region of electrode pair 1-4) of the electrode array such as electrode pairs 1-3, then 1-2, then 2-3, then 2-4, and then 3-4. If, on the other hand, the electrode pair 3-6 is determined to give better stimulation than electrode pair 1-4, the system or the clinician may proceed to test electrodes of that particular region…”).
Regarding claim 5, modified Martins discloses wherein the controller is configured such that the selection of the one or a subset of the stimulation regions is performed based on whether the respective measured response is, or respective measured responses are, higher than a predetermined response threshold (e.g. Martins [0168] “…after the electrode combination that provides better results is determined; e.g. better contraction of the diaphragm…”).
Regarding claim 7, modified Martins discloses wherein the controller is configured to output an alert or exclude a stimulation region from the selection when the measured electrical impedance for one or more of the contacts is higher than a predetermined threshold (e.g. Netherly abstract col 6 lines 1-19).
Regarding claim 8, modified Martins discloses wherein: the therapy stimulations are applied at intervals separated by one or more breathing cycle periods (e.g. Martins [0183] “…It is also envisioned that stimulation may also occur for one period of time and thereafter be discontinued for another period of time which periods may be the same or different..”); and a separate instance of the test stimulation is performed before each application of the therapy stimulation (e.g. Martins [0164] “…if it is determined that electrode pair 1-4 gives better stimulation than electrode pair 3-6, then the system or the clinician (for example by pressing a key that selects the next pair of electrodes of the same group) may proceed testing electrodes within that particular region…”).
Regarding claim 10, modified Martins discloses wherein the test stimulation is applied using each of the combinations of electrodes one after another (e.g. Martins [0164] “…if it is determined that electrode pair 1-4 gives better stimulation than electrode pair 3-6, then the system or the clinician (for example by pressing a key that selects the next pair of electrodes of the same group) may proceed testing electrodes within that particular region…” ).
Regarding claim 16, modified Martins discloses wherein: the plurality of electrodes comprises a plurality of first electrodes configured to be brought simultaneously into contact with respective different locations on the skin; and one or more second electrodes configured to contact one or more respective further locations on the skin (e.g. Martins [0246]“…at least one skin electrode may be placed on the sternum of the patient (e.g., a reference electrode), and two additional skin electrodes, one on each side of the intercostal area of the patient and which may provide information related to potentials across the corresponding areas of the anatomy of the patient in a manner similar to the skin pads…” ), and to have different polarity to the first electrodes during operation of the system (e.g. Martins Figure 16A-D depicts cathodes and anodes).
Regarding claim 17, modified Martins discloses wherein each combination of electrodes corresponding to a stimulation region includes at least one of the first electrodes and one of the second electrodes (e.g. Martins [0246] “…at least one skin electrode may be placed on the sternum of the patient (e.g., a reference electrode), and two additional skin electrodes, one on each side of the intercostal area of the patient and which may provide information related to potentials across the corresponding areas of the anatomy of the patient in a manner similar to the skin pads…”).
Regarding claim 20, modified Martins discloses wherein at least one of the combinations of electrodes comprises a plurality of at least the first electrodes, and the controller is configured to drive that combination to provide the therapy stimulation by applying different respective electrical stimulations simultaneously via the plurality of first electrodes, the therapy stimulation resulting from interference between the different respective electrical stimulations (e.g. Martins [0158] “…Start with a first electrode pair (e.g., electrode 1 as the cathode and electrode 6 as the anode). Increase stimulation amplitude until a contraction is visible. If the stimulation achieves a discernible contraction, this electrode pair may be selected. If there is collateral stimulation then select another electrode pair using any suitable method such as by selecting another cathode such as by deselecting a current cathode (e.g., electrode 1 in current example) and selecting another electrode (e.g., electrode 2 in the current example) as the cathode…”).
Regarding claim 25, modified Martins discloses wherein the nerve is a phrenic nerve (e.g. Martins “…a plurality of electrodes configured to stimulate a phrenic nerve of the patient…” (abstract)).
Claim(s) 9 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Martins in view of Stuerzinger (US 2008/0215114 A1).
Regarding claim 9, Martins discloses a system for electrically stimulating a nerve to cause muscle contraction (e.g. “…an electrode array of a first and second types and comprising a plurality of electrodes configured to stimulate a phrenic nerve…” (abstract)), comprising: a plurality of electrodes configured to be positioned in electrical contact with the skin simultaneously, the electrodes being configured to allow electrical stimulation to be directed independently towards a plurality of different stimulation regions below the skin via a corresponding plurality of combinations of the electrodes (e.g. [0148] “array of electrode elements 1356 …may be coupled to the selector 1354…so as to receive drive signals from the selector…” ); and a controller (e.g. controller 1350) configured to: for each combination of electrodes, apply a test stimulation using the combination of electrodes and measure a response to the test stimulation (e.g. [0164] “…the system or the clinician may proceed to test electrodes of that particular region of the electrode array as follows: electrode pairs 3-5, then 4-5, then 3-4, then 4-6, then 5-6. The testing may also include inversion of which electrode gives a better response as an anode or cathode…”); select one or a subset of stimulation regions based on the measured responses (e.g. [0164] “…Once it's determined which half of the array gives the better stimulation, for example as determined by observing the contractions of the diaphragm caused by the stimulation, by visual observation, through use of a sensor patch as described herein, palpation, using ultrasounds, fluoroscopy, etc., then testing can focus on the electrodes of that particular region of the electrode array…”); and apply a therapy stimulation to each selected stimulation region using the combination of electrodes corresponding to the selected stimulation region (e.g. [0168] “…The stimulator may be capable of stimulating for example in five different stimulation modes (SMs) as will be discussed below although other modes of operation are also envisioned. After the electrode combination that provides better results is determined (e.g., better contraction of the diaphragm and/or little or no collateral contraction of collateral muscles), three amplitudes for example may be established to support different modes of operation as described herein …”).
Martins is silent regarding wherein each test stimulation comprises a biphasic waveform.
However, Stuerzinger discloses a system for stimulation of skeletal or smooth muscles wherein each test stimulation comprises a biphasic waveform (e.g. [0124]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system of Martins to incorporate the teachings of Stuerzinger wherein each test stimulation comprises a biphasic waveform for the purpose of ensuring the proper signal to achieve a particular muscle contraction (e.g. Stuerzinger [0124]).
Regarding claim 26, newly modified Martins discloses wherein each test stimulation comprises a biphasic rectangular wave (e.g. Stuerzinger [0124]).
Claim(s) 12 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Martins in view of Lu (US 2019/0381313 A1) and Stuerzinger.
Regarding claim 12, Martins discloses a system for electrically stimulating a nerve to cause muscle contraction (e.g. “…an electrode array of a first and second types and comprising a plurality of electrodes configured to stimulate a phrenic nerve…” (abstract)), comprising: a plurality of electrodes configured to be positioned in electrical contact with the skin simultaneously, the electrodes being configured to allow electrical stimulation to be directed independently towards a plurality of different stimulation regions below the skin via a corresponding plurality of combinations of the electrodes (e.g. [0148] “array of electrode elements 1356 …may be coupled to the selector 1354…so as to receive drive signals from the selector…” ); and a controller (e.g. controller 1350) configured to: for each combination of electrodes, apply a test stimulation using the combination of electrodes and measure a response to the test stimulation (e.g. [0164] “…the system or the clinician may proceed to test electrodes of that particular region of the electrode array as follows: electrode pairs 3-5, then 4-5, then 3-4, then 4-6, then 5-6. The testing may also include inversion of which electrode gives a better response as an anode or cathode…”); select one or a subset of stimulation regions based on the measured responses (e.g. [0164] “…Once it's determined which half of the array gives the better stimulation, for example as determined by observing the contractions of the diaphragm caused by the stimulation, by visual observation, through use of a sensor patch as described herein, palpation, using ultrasounds, fluoroscopy, etc., then testing can focus on the electrodes of that particular region of the electrode array…”); and apply a therapy stimulation to each selected stimulation region using the combination of electrodes corresponding to the selected stimulation region (e.g. [0168] “…The stimulator may be capable of stimulating for example in five different stimulation modes (SMs) as will be discussed below although other modes of operation are also envisioned. After the electrode combination that provides better results is determined (e.g., better contraction of the diaphragm and/or little or no collateral contraction of collateral muscles), three amplitudes for example may be established to support different modes of operation as described herein …”); wherein each application of the therapy stimulation comprises a plurality of therapy waveforms (e.g. [0170]; [0182]-[0183]). wherein the therapy stimulation satisfies a duration of the therapy stimulation is in the range of 0.5s to 2s (e.g. [0172]; [0183]; [0185]).
Martins is silent regarding wherein the therapy stimulation satisfies each of one or more of the following in any combination: each therapy waveform is biphasic; a peak current amplitude in each therapy waveform is in the range of 1-200mA; or a phase width of each therapy waveform is in the range of 50 microseconds to 2ms. Martin does disclose that the signal may be altered (e.g. [0258]).
However, Lu discloses a stimulation system wherein the therapy stimulation satisfies each of one or more of the following in any combination: a peak current amplitude in each therapy waveform is in the range of 1-200mA (e.g. [0047]); or a phase width of each therapy waveform is in the range of 50 microseconds to 2ms (e.g. [0042] 100 microseconds up to about 1 ms).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system of Marting to incorporate the teachings of Lu wherein the therapy stimulation satisfies each of one or more of the following in any combination: a peak current amplitude in each therapy waveform is in the range of 1-200mA; or a phase width of each therapy waveform is in the range of 50 microseconds to 2ms for the purpose of utilizing known parameters for the desired stimulation.
Additionally, Stuerzinger discloses a system for) stimulation of skeletal or smooth muscles wherein each test stimulation comprises a biphasic waveform (e.g. [0124]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system of Martins to incorporate the teachings of Stuerzinger wherein each test stimulation comprises a biphasic waveform for the purpose of ensuring the proper signal to achieve a particular muscle contraction (e.g. Stuerzinger [0124]).
Regarding claim 27, modified Martins discloses wherein each therapy waveform is a biphasic rectangular wave (e.g. Stuerzinger [0124]).
Claim(s) 18-19 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Martins in view of Netherly as applied to claim 16 above, and further in view of Minogue (WO 2010/067145).
Regarding claims 18 and 19, modified Martins discloses a stimulation device but fails to describe where the second electrode surrounds a skin contact region of the first electrodes.
Minogue describes a stimulation apparatus and depicts in Figure 2A, the second electrode 16b partially surrounding first electrode 16a [e.g. page 10: lines 3-5].
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system of Martins to include a second electrode surrounding a first electrode as taught by Minogue, since such a modification would provide the predictable results of being able to maximize stimulation across the skin.
Regarding claim 28, newly modified Martins discloses wherein at least one of the second electrodes is configured such that the skin contact regions of at least two of the first electrodes surrounded by the skin contact region of the second electrode are not separated from each other by a portion of the skin contact region of the second electrode (e.g. Minogue Figure 2A, the second electrode 16b partially surrounding first electrode 16a [e.g. page 10: lines 3-5] ).
Claim(s) 21 is rejected under 35 U.S.C. 103 as being unpatentable over Martins in view of Netherly as applied to claim 16 above, and further in view of Lu (US 2019/0381313 A1)
Modified Martins discloses stimulation device but fails to describe an automated defibrillation unit to measure output from the heart and deliver a shock to the patient and further stimulate a contraction of the diaphragm. Lu discloses an automated defibrillation unit configured to measure an electrical output from a patient's heart and selectively deliver an electrical shock to the patient to restore normal heart function (e.g. Lu [0247] “…An automated external defibrillator (AED) is a portable device that can check the heart rhythm and can send an electric shock to the heart to try to restore a normal rhythm…”) and the system of an claim 1 configured to stimulate contraction of the diaphragm to restore normal breathing function (e.g. Lu [0425] “…Electrical stimulation of the dorsal cord at C3/4 resulted in diaphragm EMG bursts and productive inhalation…”). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system of Martins, to include an automated defibrillation unit as taught by Lu, since such a modification would provide the predictable results of allowing the Martins system to provide multiple functions such as restoring heart and breathing functions.
Claim(s) 24 is rejected under 35 U.S.C. 103 as being unpatentable over Martins in view of Netherly as applied to claim 23 above, and further in view of Minogue (WO 2010/067145).
Regarding claim 24, modified Martins discloses wherein the plurality of electrodes comprises: a plurality of first electrodes simultaneously in contact with respective different locations on the skin [e.g. “array of electrode elements 1356 …may be coupled to the selector 1354…so as to receive drive signals from the selector…” (paragraph 0148)]; one or more second electrodes to contact locations on the skin and to have different polarity to the first electrodes during operation of the system [e.g. Figure 16A-D depicts cathodes and anodes]. Martins discloses a stimulation device but fails to describe where the second electrode surrounds a skin contact region of the first electrodes. Minogue describes a stimulation apparatus and depicts in Figure 2A, the second electrode 16b partially surrounding first electrode 16a [e.g. page 10: lines 3-5]. It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system of Martins to include a second electrode surrounding a first electrode as taught by Minogue, since such a modification would provide the predictable results of being able to maximize stimulation across the skin.
Conclusion
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Jessandra Hough September 11, 2026
/J.F.H./Examiner, Art Unit 3796
/William J Levicky/Primary Examiner, Art Unit 3796
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