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 .
Priority
This application is a continuation of US Application no. 17/474,646, now US Patent no. 12,029,903 filed 14 September 2021, which is a continuation of US Application no. 15/837,519, now Abandoned, filed 11 December 2017.
Response to Amendment
The preliminary amendment filed 3 June 2024 has been acknowledged. Claims 39-58 are pending, wherein claims 39-58 are new.
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.
Claim(s) 39-41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hewson (US Patent no. 4,683,890 – disclosed by Applicant) in view of Lurie et al. (US Patent no. 6,463,327 – disclosed by Applicant).
In regard to claim 39, Hewson discloses a stimulation system comprising:
an esophageal tube 18 comprising a first electrode figures 1 and 3, col 2 lines 39-59 and col 3 lines 11-37);
a transcutaneous stimulation array comprising a second electrode 12, 14 (figures 1 and 2, col 2 lines 40-54, and col 3 lines 28-49); and
a control unit 16 configured to deliver stimulation (col 3 lines 50-64).
Hewson sets forth a system the provides esophageal stimulation and transcutaneous stimulation, however does not teach:
Delivering stimulation to a first respiratory muscle via the first electrode; and delivering stimulation to a second respiratory muscle via the second electrode.
Lurie et al. teaches that respiratory muscles may be stimulated to contract to enhance ventilation and/or alter intrathoracic pressures wherein the muscles includes the intercostal muscles and abdominal muscles (col 9 lines 50-54).
Lurie et al. teaches a known improvement to respiratory stimulation therapy by recruiting different muscle groups in a coordinated manner in order to closely replicate natural respiratory mechanics, and Hewson provides suitable respiratory stimulation platform onto which that known improvement may be implemented. Therefore, one of ordinary skill in the art would have found it obvious to modify the system of Hewson to stimulate multiple muscle groups as taught by Lurie et al. in order to improve ventilation effectiveness and closely replicate natural respiratory mechanics. The modification would include pertain to the application of a known technique to a known device to improve the effectiveness of respiratory therapy.
In regard to claims 40 and 41, Lurie et al. explicitly teaches that respiratory muscles may be stimulated to contract to enhance ventilation and/or alter intrathoracic pressures wherein the muscles includes the intercostal muscles and abdominal muscles (col 9 lines 50-54).
Claim(s) 42, 43, and 46 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hewson (US Patent no. 4,683,890 – disclosed by Applicant) in view of Lurie et al. (US Patent no. 6,463,327 – disclosed by Applicant), further in view of Jung (US Publication no. 2016/0287877). In regard to claims 42 and 43, Hewson in view of Lurie et al. are considered to substantially suggest the invention as claimed, however do not teach that the control unit is configured to deliver stimulation to the first respiratory muscle during inspiration only. Jung is directed to controlled stimulation of respiratory muscles and nerves. Jung uses a closed loop electrical stimulation to for natural and efficient ventilatory assist and for rehabilitation therapy of the muscles to prevent disuse atrophy, wherein stimulation is provided in an optimal sequence between intercostal muscles for inspiration and to abdominal muscles for expiration. This sequence of delivering stimulation to the intercostals (i.e., first respiratory muscle) during inspiration and then delivering stimulation to the abdominal muscles (i.e., the second respiratory muscle) during expiration can stabilize the rib cage to avoid movement during diaphragmatic pacing (para 31). Therefore, it is considered to have been obvious to one of ordinary skill in the art at the time of the invention to control delivery of stimulation to the intercostals (i.e., first respiratory muscle) during inspiration and then control delivery of stimulation to the abdominal muscles (i.e., the second respiratory muscle) during expiration since it is explicitly taught by Jung to provide natural and efficient ventilatory assist and for rehabilitation therapy of the muscles and stabilizing movement of the rib cage.
In regard to claim 46, Hewson in view of Lurie et al. are considered to substantially suggest the invention as claimed, however do not teach wherein the stimulation delivered to the first respiratory muscle, the second respiratory muscle, or both, comprises: a first set of stimulation trains, wherein each stimulation train of the first set of stimulation trains causes the respiratory muscle to contract and includes pulses delivered at a first frequency; and a second set of stimulation trains, wherein each stimulation train of the second set of stimulation trains causes the respiratory muscle to contract and includes pulses delivered at a second frequency; wherein the first frequency is different than the second frequency. Lurie et al. contains teachings suggestive of this. Lurie teaches that an electrode may be configured to deliver electrical stimulation at different frequencies, pulse widths, pulse trains and voltage outputs to optimize respiratory muscle stimulation (col 13 lines 35-38). Additionally, as Jung teaches stimulation of the intercostals during inspiration and the abdominals during expiration is considered to suggest that each muscle has would require its own separate electrode and stimulation parameters (i.e., pulses in a train and frequency of pulses) to properly evoke contraction of the muscle. In view of this, it is considered to have been obvious to one of ordinary skill in the art to control and direct the stimulation trains and frequency of the stimulation trains to the appropriate muscle to optimize targeted respiratory muscle stimulation.
Claim(s) 44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hewson (US Patent no. 4,683,890 – disclosed by Applicant) in view of Lurie et al. (US Patent no. 6,463,327 – disclosed by Applicant), further in view of Wall (US Patent no. 3,951,136).
In regard to claim 44, Hewson in view of Lurie et al. are considered to substantially suggest the invention as claimed, however do not teach that the control unit is further configured to receive sensor data from the first electrode, where the sensor data includes an ECG signal, a phrenic nerve signal, or vagus nerve activity. Wall discloses an esophageal probe similar to that of Hewson, wherein the probe of Wall has electrodes for providing pacing/stimulation and includes active electrodes mounted in the lower end to sense ECG signals (col 2 lines 21-28, and col 5 lines 1-2). Therefore modification of the probe of Hewson to sense a physiological signal such as ECG is considered to have been obvious to one of ordinary skill in the art since Wall explicitly shows the structure of an esophageal probe for both stimulation and sensing was known in the art, wherein the modification would include the use of a known element in a known device to yield a predictable result. Modification to substitute the ECG sensor with other electrical signal sensors such as EMG or nerve activity sensors is also considered obvious as a substitution of a known element for another requiring only routine skill in the art.
Claim(s) 45 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hewson (US Patent no. 4,683,890 – disclosed by Applicant) in view of Lurie et al. (US Patent no. 6,463,327 – disclosed by Applicant) and Wall (US Patent no. 3,951,136), further in view of Francois et al. (US Publication no. 2014/0142652).
In regard to claim 45, Hewson in view of Lurie et al. and Wall are considered to substantially suggest the invention as claimed, however do not teach that the control unit is further configured to adjust a timing or an amplitude of stimulation delivered to the first respiratory muscle, the second respiratory muscle, or both, based on the sensor data. Francois et al. is directed to electrical stimulation of muscle (e.g., the intercostals and abdominals) to elicit a contraction to assist a subject with breathing. Francois et al. teaches that the system uses feedback from a sensor to adjust or optimize stimulation parameters (para 59). Such parameters include the frequency, amplitude, pulse shape, pulse width, pulse duration (i.e., considered timing), etc. (para 54). It would have been obvious to one of ordinary skill in the art to incorporate physiological sensing into Hewson to optimize stimulation parameter amplitude and timing since Francois et al. demonstrates that physiologic feedback control was well known and routine in cardiac stimulation, neurostimulation, and respiratory pacing systems for optimizing and adjusting stimulation therapy.
Claim(s) 47 and 55 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hewson (US Patent no. 4,683,890 – disclosed by Applicant) in view of Lurie et al. (US Patent no. 6,463,327 – disclosed by Applicant), further in view of Hoffer et al. (US Publication no. 2015/0202448 – disclosed by Applicant).
In regard to claim 47, Hewson discloses a stimulation system comprising:
an esophageal tube 18 comprising a first electrode figures 1 and 3, col 2 lines 39-59 and col 3 lines 11-37);
a transcutaneous stimulation array comprising a second electrode 12, 14 (figures 1 and 2, col 2 lines 40-54, and col 3 lines 28-49); and
a control unit 16 configured to deliver stimulation (col 3 lines 50-64).
Hewson sets forth a system the provides esophageal stimulation and transcutaneous stimulation, however does not teach:
Delivering stimulation to a first respiratory muscle via the first electrode; and delivering stimulation to a second respiratory muscle via the second electrode.
Lurie et al. teaches that respiratory muscles may be stimulated to contract to enhance ventilation and/or alter intrathoracic pressures wherein the muscles includes the intercostal muscles and abdominal muscles (col 9 lines 50-54).
Lurie et al. teaches a known improvement to respiratory stimulation therapy by recruiting different muscle groups in a coordinated manner in order to closely replicate natural respiratory mechanics, and Hewson provides suitable respiratory stimulation platform onto which that known improvement may be implemented. Therefore, one of ordinary skill in the art would have found it obvious to modify the system of Hewson to stimulate multiple muscle groups as taught by Lurie et al. in order to improve ventilation effectiveness and closely replicate natural respiratory mechanics. The modification would include pertain to the application of a known technique to a known device to improve the effectiveness of respiratory therapy.
However, neither Hewson nor Lurie et al. teach the steps for:
determine a first combination of electrodes from the plurality of esophageal electrodes; determine a second combination of electrodes from the plurality of transcutaneous electrodes.
Hoffer et al. is directed to the use of electrical stimulation to restore breathing and other respiratory functions. Hoffer et al., is particularly directed to determining the optimum combination of electrodes for stimulation, wherein Hoffer et al. is considered to suggest the steps to determine a first combination of electrodes from the plurality of esophageal electrodes; determine a second combination of electrodes from the plurality of transcutaneous electrodes (para 29). Modification of the system suggested by Hewson and Lurie et al. to incorporate multiple electrodes from which a first and second combination of electrodes may be determined is considered to have been obvious to one of ordinary skill in the art as an improvement in view of the teachings in Hoffer et al. that selecting proper electrode combinations allow for lower and safer electrical charge and currents to be used to activate the targeted muscles, thus preventing overstimulation or unwanted activation of nearby structures such as other nerves, muscles, or the heart. The modification is considered to comprise the application of a known routine technique for stimulation optimization.
In regard to claim 48, Hewson in view of Lurie et al. are considered to substantially suggest the invention as claimed, however do not teach that the control unit is further configured to identify a threshold value for a charge required to stimulate the intercostal muscle via the first combination of electrodes. Hoffer et al. teaches that it is well known in the art to identify an activation threshold for when the muscle begins to respond to stimulation and to identify a charge level that is shown to activate the muscle (para 74). In view of this, it is considered to have been obvious to one of ordinary skill in the art to determine an activation threshold since Hoffer et al. explicitly teaches that it is routine in the art to generate stimulation parameters for use during therapy.
In regard to claim 55, Hewson discloses a stimulation system comprising:
an esophageal tube 18 comprising a first electrode figures 1 and 3, col 2 lines 39-59 and col 3 lines 11-37);
a transcutaneous stimulation array comprising a second electrode 12, 14 (figures 1 and 2, col 2 lines 40-54, and col 3 lines 28-49); and
a control unit 16 configured to deliver stimulation (col 3 lines 50-64).
Hewson sets forth a system the provides esophageal stimulation and transcutaneous stimulation, however does not teach:
Delivering stimulation to a first respiratory muscle via the first electrode; and delivering stimulation to a second respiratory muscle via the second electrode.
Lurie et al. teaches that respiratory muscles may be stimulated to contract to enhance ventilation and/or alter intrathoracic pressures wherein the muscles includes the intercostal muscles and abdominal muscles (col 9 lines 50-54).
Lurie et al. teaches a known improvement to respiratory stimulation therapy by recruiting different muscle groups in a coordinated manner in order to closely replicate natural respiratory mechanics, and Hewson provides suitable respiratory stimulation platform onto which that known improvement may be implemented. Therefore, one of ordinary skill in the art would have found it obvious to modify the system of Hewson to stimulate multiple muscle groups as taught by Lurie et al. in order to improve ventilation effectiveness and closely replicate natural respiratory mechanics. The modification would include pertain to the application of a known technique to a known device to improve the effectiveness of respiratory therapy.
Hewson in view of Lurie et al. are considered to substantially suggest the invention as claimed, however do not teach that the control unit is further configured to identify a threshold value for a charge required to stimulate the intercostal muscle via the first combination of electrodes and a threshold to stimulate the abdominal muscle via the second combination of electrodes. Hoffer et al. teaches that it is well known in the art to identify an activation threshold for when the muscle begins to respond to stimulation and to identify a charge level that is shown to activate the muscle (para 74). In view of this, it is considered to have been obvious to one of ordinary skill in the art to determine an activation threshold since Hoffer et al. explicitly teaches that it is routine in the art to generate stimulation parameters for use during therapy.
Claim(s) 49-54 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hewson (US Patent no. 4,683,890 – disclosed by Applicant) in view of Lurie et al. (US Patent no. 6,463,327 – disclosed by Applicant), Jung (US Publication no. 2016/0287877), and Hoffer et al. (US Publication no. 2015/0202448 – disclosed by Applicant), further in view of Franke et al. (US Publication no. 2015/0202437). In regard to claim 49, Hewson in view of Lurie et al. are considered to substantially suggest the invention as claimed, however do not teach wherein the stimulation delivered to the first respiratory muscle, the second respiratory muscle, or both, comprises: a first set of stimulation trains, wherein each stimulation train of the first set of stimulation trains causes the respiratory muscle to contract and includes pulses delivered at a first frequency; and a second set of stimulation trains, wherein each stimulation train of the second set of stimulation trains causes the respiratory muscle to contract and includes pulses delivered at a second frequency; wherein the first frequency is different than the second frequency. Lurie et al. contains teachings suggestive of this. Lurie teaches that an electrode may be configured to deliver electrical stimulation at different frequencies, pulse widths, pulse trains and voltage outputs to optimize respiratory muscle stimulation (col 13 lines 35-38). Additionally, as Jung teaches stimulation of the intercostals during inspiration and the abdominals during expiration is considered to suggest that each muscle has would require its own separate electrode and stimulation parameters (i.e., pulses in a train and frequency of pulses) to properly evoke contraction of the muscle. In view of this, it is considered to have been obvious to one of ordinary skill in the art to control and direct the stimulation trains and frequency of the stimulation trains to the appropriate muscle to optimize targeted respiratory muscle stimulation.
Hewson in view of Lurie et al. are considered to substantially suggest the invention as claimed, however do not teach that the control unit is further configured to identify a threshold value for a charge required to stimulate the intercostal muscle via the first combination of electrodes. Hoffer et al. teaches that it is well known in the art to identify an activation threshold for when the muscle begins to respond to stimulation and to identify a charge level that is shown to activate the muscle (para 74). In view of this, it is considered to have been obvious to one of ordinary skill in the art to determine an activation threshold since Hoffer et al. explicitly teaches that it is routine in the art to generate stimulation parameters for use during therapy.
However, neither Hewson nor Lurie et al., Jung, nor Hoffer et al. teach that the first set of stimulation trains is delivered at a charge of 150%-300% of threshold value and that the second set of stimulation parameters is delivered at about 100% of the threshold value. Franke et al. shows that pulse generators may generate stimulation charges at 100-200% of the nerve threshold (para 73).
Moreover, the present specification lacks a critical reason for stimulation charges at these levels, wherein it is considered that the recited charge levels are the result of routine optimization of stimulation parameters. The pulse generation means of Hewson, Lurie et al., Jung, and Hoffer et al. are considered structurally capable of outputting stimulation charges at these levels. Therefore, these limitations are considered to have been obvious to one of ordinary skill in the art as a matter of routine optimization of therapy parameters.
In regard to claim 50, Hewson is capable of delivering stimulation in the ranges as claimed (e.g., stimulation in the range of 10-18 cycles per minute, col 1 lines 56-65). Lurie et al. teach that common stimulation settings including stimulations per minute (col 25 lines 16-19). Moreover, the present specification lacks a critical reason for stimulation in these ranges, wherein it is considered that the recited ranges are the result of routine optimization of stimulation parameters. The pulse generation means of Hewson and Lurie et al., Jung, and Hoffer et al. are considered structurally capable of outputting stimulation charges at these levels. Therefore, these limitations are considered to have been obvious to one of ordinary skill in the art as a matter of routine optimization of therapy parameters.
In regard to claim 51, Hewson in view of Lurie et al. are considered to substantially suggest the invention as claimed, however do not teach that the control unit is further configured to identify a threshold value for a charge required to stimulate the abdominal muscle via the second combination of electrodes. Hoffer et al. teaches that it is well known in the art to identify an activation threshold for when the muscle begins to respond to stimulation and to identify a charge level that is shown to activate the muscle (para 74). In view of this, it is considered to have been obvious to one of ordinary skill in the art to determine an activation threshold since Hoffer et al. explicitly teaches that it is routine in the art to generate stimulation parameters for use during therapy.
In regard to claim 52, Hewson in view of Lurie et al. are considered to substantially suggest the invention as claimed, however do not teach wherein the stimulation delivered to the first respiratory muscle, the second respiratory muscle, or both, comprises: a first set of stimulation trains, wherein each stimulation train of the first set of stimulation trains causes the respiratory muscle to contract and includes pulses delivered at a first frequency; and a second set of stimulation trains, wherein each stimulation train of the second set of stimulation trains causes the respiratory muscle to contract and includes pulses delivered at a second frequency; wherein the first frequency is different than the second frequency. Lurie et al. contains teachings suggestive of this. Lurie teaches that an electrode may be configured to deliver electrical stimulation at different frequencies, pulse widths, pulse trains and voltage outputs to optimize respiratory muscle stimulation (col 13 lines 35-38). Additionally, as Jung teaches stimulation of the intercostals during inspiration and the abdominals during expiration is considered to suggest that each muscle has would require its own separate electrode and stimulation parameters (i.e., pulses in a train and frequency of pulses) to properly evoke contraction of the muscle. In view of this, it is considered to have been obvious to one of ordinary skill in the art to control and direct the stimulation trains and frequency of the stimulation trains to the appropriate muscle to optimize targeted respiratory muscle stimulation.
In regard to claim 53, Lurie et al. explicitly teaches that respiratory muscles may be stimulated to contract to enhance ventilation and/or alter intrathoracic pressures wherein the muscles includes the intercostal muscles and abdominal muscles (col 9 lines 50-54).
In regard to claim 54, Hewson in view of Lurie et al. are considered to substantially suggest the invention as claimed, however do not teach that the control unit is configured to deliver stimulation to the first respiratory muscle during inspiration only. Jung is directed to controlled stimulation of respiratory muscles and nerves. Jung uses a closed loop electrical stimulation to for natural and efficient ventilatory assist and for rehabilitation therapy of the muscles to prevent disuse atrophy, wherein stimulation is provided in an optimal sequence between intercostal muscles for inspiration and to abdominal muscles for expiration. This sequence of delivering stimulation to the intercostals (i.e., first respiratory muscle) during inspiration and then delivering stimulation to the abdominal muscles (i.e., the second respiratory muscle) during expiration can stabilize the rib cage to avoid movement during diaphragmatic pacing (para 31). Therefore, it is considered to have been obvious to one of ordinary skill in the art at the time of the invention to control delivery of stimulation to the intercostals (i.e., first respiratory muscle) during inspiration and then control delivery of stimulation to the abdominal muscles (i.e., the second respiratory muscle) during expiration since it is explicitly taught by Jung to provide natural and efficient ventilatory assist and for rehabilitation therapy of the muscles and stabilizing movement of the rib cage.
Claim(s) 56 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hewson (US Patent no. 4,683,890 – disclosed by Applicant) in view of Lurie et al. (US Patent no. 6,463,327 – disclosed by Applicant) and Hoffer et al. (US Publication no. 2015/0202448 – disclosed by Applicant), further in view of Wall (US Patent no. 3,951,136).
In regard to claim 56, Hewson in view of Lurie et al. are considered to substantially suggest the invention as claimed, however do not teach that the control unit is further configured to receive sensor data from the first electrode, where the sensor data includes an ECG signal, a phrenic nerve signal, or vagus nerve activity. Wall discloses an esophageal probe similar to that of Hewson, wherein the probe of Wall has electrodes for providing pacing/stimulation and includes active electrodes mounted in the lower end to sense ECG signals (col 2 lines 21-28, and col 5 lines 1-2). Therefore modification of the probe of Hewson to sense a physiological signal such as ECG is considered to have been obvious to one of ordinary skill in the art since Wall explicitly shows the structure of an esophageal probe for both stimulation and sensing was known in the art, wherein the modification would include the use of a known element in a known device to yield a predictable result. Modification to substitute the ECG sensor with other electrical signal sensors such as EMG or nerve activity sensors is also considered obvious as a substitution of a known element for another requiring only routine skill in the art.
Claim(s) 57 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hewson (US Patent no. 4,683,890 – disclosed by Applicant) in view of Lurie et al. (US Patent no. 6,463,327 – disclosed by Applicant), Hoffer et al. (US Publication no. 2015/0202448 – disclosed by Applicant), and Wall (US Patent no. 3,951,136), further in view of Francois et al. (US Publication no. 2014/0142652).
In regard to claim 57, Hewson in view of Lurie et al. and Wall are considered to substantially suggest the invention as claimed, however do not teach that the control unit is further configured to adjust a timing or an amplitude of stimulation delivered to the first respiratory muscle, the second respiratory muscle, or both, based on the sensor data. Francois et al. is directed to electrical stimulation of muscle (e.g., the intercostals and abdominals) to elicit a contraction to assist a subject with breathing. Francois et al. teaches that the system uses feedback from a sensor to adjust or optimize stimulation parameters (para 59). Such parameters include the frequency, amplitude, pulse shape, pulse width, pulse duration (i.e., considered timing), etc. (para 54). It would have been obvious to one of ordinary skill in the art to incorporate physiological sensing into Hewson to optimize stimulation parameter amplitude and timing since Francois et al. demonstrates that physiologic feedback control was well known and routine in cardiac stimulation, neurostimulation, and respiratory pacing systems for optimizing and adjusting stimulation therapy.
Claim(s) 58 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hewson (US Patent no. 4,683,890 – disclosed by Applicant) in view of Lurie et al. (US Patent no. 6,463,327 – disclosed by Applicant), Hoffer et al. (US Publication no. 2015/0202448 – disclosed by Applicant), Wall (US Patent no. 3,951,136), and Francois et al. (US Publication no. 2014/0142652), further in view of Jung (US Publication no. 2016/0287877).
In regard to claim 58, Hewson in view of Lurie et al., Hoffer et al., Wall, and Francois et al. are considered to suggest the invention as claimed, however does not teach that the stimulation is delivered to the second respiratory muscle during expiration only. Jung is directed to controlled stimulation of respiratory muscles and nerves. Jung uses a closed loop electrical stimulation to for natural and efficient ventilatory assist and for rehabilitation therapy of the muscles to prevent disuse atrophy, wherein stimulation is provided in an optimal sequence between intercostal muscles for inspiration and to abdominal muscles for expiration. This sequence of delivering stimulation to the intercostals (i.e., first respiratory muscle) during inspiration and then delivering stimulation to the abdominal muscles (i.e., the second respiratory muscle) during expiration can stabilize the rib cage to avoid movement during diaphragmatic pacing (para 31). Therefore, it is considered to have been obvious to one of ordinary skill in the art at the time of the invention to control delivery of stimulation to the intercostals (i.e., first respiratory muscle) during inspiration and then control delivery of stimulation to the abdominal muscles (i.e., the second respiratory muscle) during expiration since it is explicitly taught by Jung to provide natural and efficient ventilatory assist and for rehabilitation therapy of the muscles and stabilizing movement of the rib cage.
Conclusion
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/BRIAN T GEDEON/Primary Examiner, Art Unit 3796 10 June 2026
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