DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
2. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07/29/2026 has been entered.
Response to Amendment
3. This office action is responsive to the amendment filed on 07/29/2026. As directed by the amendment: claims 1-2, 5, 53 have been amended, claim 4 has been cancelled, and claim 59 has been added. Thus, claims 1-3, 5-13, 26-27, 40, 53-54, and 58-59 are presently pending in this application.
Claim Rejections - 35 USC § 102
4. 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.
5. 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.
6. Claim(s) 1-3, 5-9, 11-13, 26-27, 40, 53-54, and 58-59 is/are rejected under 35 U.S.C. 102(a)/(b) as being anticipated by Evans et al. (US 2020/0360690).
Regarding claim 1, Evans discloses a device for determining a state of respiratory muscles of a patient (fig. 2, medical system 1000), the device comprising:
an interface arrangement comprising one or more interfaces (see annotated fig. 15 below which is a block diagram of the components of a respiratory muscle stimulation system), the interface arrangement being configured to detect patient signals (see annotated fig. 15 below where the interfaces are connected to sensors which detect patient signals) via a sensor unit (fig. 15, sensors on the left and right leads); and
a control unit (fig. 15, controller) configured to:
stimulate the respiratory muscles of the patient with a stimulation signal (fig. 16, step 1601 provides a stimulation signal) via a stimulation unit (fig. 15, stimulation modules 1 and 2), wherein the stimulation signal comprises a transient magnetic stimulation pulse ([0080] states that the stimulation includes delivery of magnetic energy where fig. 3, illustrates example stimulation trains which constitute a transient stimulation pulse) having an intensity sufficient to elicit a twitch contraction of the respiratory muscles for eliciting an activation signal ([0052] states that the stimulation delivered causes contraction of the respiratory muscle which constitutes a twitch, fig. 16, steps 1602 and 1603 measure the desired response which is the activation signal);
detect the activation signal as a response to the stimulation (fig. 16, steps 1602 and 1603 detect an impedance value and physiological response) via the sensor unit (fig. 15, sensors on each lead), the detected activation signal indicating a neuronal activation of the respiratory muscles ([0013] states that stimulation signal can cause contraction of a respiratory muscle, and a bioelectrical impedance is measured in response, and [0045] of the application specification states that the neuronal activation can be an electrical impedance myogram); and
determine one or more state parameters for the respiratory muscles based on the stimulation signal and on the activation signal ([0068] states that a lung gas parameter is determined based on volume and pressure signals which can be found in fig. 16, steps 1602 and 1603 which result from a stimulation in step 1601)
generate a signal based on the one or more state parameters for controlling ventilation of the patient (fig. 16, steps 1620 and 1630 comprise altering the stimulation parameters or external support parameters as a result of the measured value in steps 1602 and 1603).
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Regarding claim 2, the system of Evans discloses the limitations of claim 1 and further discloses the control unit (fig. 15, controller) is configured to generate the stimulation signal (fig. 3, stimulation signals may include a plurality of pulses 1031a-1031h in a stimulation train 1030b, see [0102]).
Regarding claim 3, the system of Evans discloses the limitations of claim 1 and further discloses the control unit (fig. 15, controller) is configured to detect the activation signal (fig. 16, steps 1602 and 1603 results from a stimulation being provided to the respiratory muscles) as a pulse response (fig. 3, the stimulation signal comprises pulses).
Regarding claim 5, the system of Evans discloses the limitations of claim 4 and further discloses the control unit (14) is configured to take into consideration an lower activation threshold for the stimulation signal during the determination of the activatability (fig. 16, step 1620 adjusts stimulation parameters which can include an amplitude and pulse width, see [0013], which inherently accounts for a changing activation threshold in the lung during subsequent activations), wherein an activation of the respiratory muscles takes place during a stimulation of the respiratory muscles above the activation threshold and an activation is at least reduced or is not performed in case of a stimulation of the respiratory muscles below the activation threshold (muscle activation inherently occurs after an absolute threshold and does not occur if an activation threshold is not met).
Regarding claim 6, the system of Evans discloses the limitations of claim 5 and further discloses the control unit is configured to determine at least one of:
a respiratory muscle pressure ([0054] states a respiratory pressure is sensed), Pstim, which is generated by stimulations (fig. 16, physiological response is monitored in step 1603);
a tidal volume ([0054] states a tidal volume is sensed), Volstim, which is generated by stimulation (fig. 16, physiological response is monitored in step 1603); and
a work of breathing of the patient ([0054] states a work of breathing is sensed), which is generated by stimulation (fig. 16, physiological response is monitored in step 1603).
Regarding claim 7, the system of Evans discloses the limitations of claim 1 and further discloses the control unit is further configured to signal the interface arrangement to perform a pneumatic diagnostic maneuver ([0077] states that the system can include a mechanical ventilator, see fig. 2, external respiratory support 1007 which inherently provides pneumatic therapy) for determining a pneumatic ventilation parameter (fig. 2, breath sensor 1009 can sense various ventilation parameters, see [0098]) and further to determine the one or more state parameters based on the basis of the pneumatic ventilation parameter (fig. 16, the parameters in 1610 can account for volume or pressure values from the breath sensor in step 1603).
Regarding claim 8, the system of Evans discloses the limitations of claim 7 and further discloses the pneumatic diagnostic maneuver comprises:
A variability in the breathing assistance of the patient ([0231] state that the system can facilitate weaning off of mechanical ventilation which is a variation in pneumatic breathing assistance).
Regarding claim 9, the system of Evans discloses the limitations of claim 1 and further discloses the control unit is further configured to determine an indicator of a maximum possible breathing effort of the patient (fig. 20, shows the maximum inspiratory pressure over various sessions).
Regarding claim 11, the system of Evans discloses the limitations of claim 1 and further discloses the control unit is configured to determine one or more of an indicator of a load-bearing capacity of the respiratory muscles of the patient ([0117] states that lung impedance can characterize respiratory condition of the patient) and an indicator of an efficiency of the respiratory muscles of the patient ([0083] states that higher amplitude pulses engage additional muscle fibers, see fig. 19, A4 shows increasing amplitudes results in greater muscle pressure and airflow).
Regarding claim 12, the system of Evans discloses the limitations of claim 11 and further discloses the indicator of efficiency comprises a ratio of tidal volume (fig. 19, the middle graph titled “charge response airflow in lungs” is based on the provided charge and resulting airflow) or respiratory muscle pressure (fig. 19, pressure) to the activation signal (fig. 19 charge envelope).
Regarding claim 13, the system of Evans discloses the limitations of claim 1 and further discloses the control unit is configured to output information on the one or more state parameters via the one or more interfaces (fig. 15, the display can communicate patient condition, see [0189]).
Regarding claim 26, the system of Evans discloses the limitations of claim 1 and further discloses
one or more interfaces of the interface arrangement, which are configured for an exchange of information with one or more of a ventilating unit (fig. 2, controller 1001 can communicate with internal sensors of respiratory support 1007, see [0098]), a stimulation unit (fig. 15, stimulation modules) and a sensor unit (fig. 15, sensors in right and left leads); and
wherein the control unit is configured (fig. 15, controller):
to detect an indicator of a component of the ventilation that is contributed by the patient's own efforts (fig. 16, step 1603 accounts for physiological response which can be an EMG according to [0097]) via the ventilating unit (fig. 2, breath sensor 1009 is extended from external respiratory support 1007 which measures various parameters to control unit 1001 which is used when accounting for physiological response);
to determine an indicator of a load-bearing capacity of the patient (fig. 16, step 1602 monitors gas distribution and lung impedance);
to influence the component contributed by the patient's own efforts and of the ventilation (fig. 16, step 1620 adjusts the stimulation parameters based on values in steps 1602 and 1603);
and to assist the patient during the ventilation via the ventilating unit (fig. 16, step 1630 uses adjusts external respiratory support parameters meaning that the external respiratory support is on throughout the process, [0008] states that positive pressure mechanical ventilation is a means of external respiratory support) based on the indicator of the component of the ventilation that is contributed by the patient's own efforts himself (fig. 16, step 1603 includes EMG data according to [0077]) and based on the indicator of the load-bearing capacity of the patient (fig. 16, step 1602 includes lung impedance and gas distribution).
Regarding claim 27, the system of Evans discloses the limitations of claim 1 and further discloses wherein the control unit is configured:
to determine a first piece of information on a desired respiratory muscle activation of the patient (fig. 16, step 1610 includes a predetermined range for the value);
to determine a second piece of information by means of an actual respiratory muscle activation of the patient (fig. 16, step 1603 monitors physiological response including EMG values which are considered when controlling stimulation parameters, see [0077]); and
to determine an indicator of a breathing assistance of the patient (fig. 16, steps 1620 and 1630 control breathing assistance provided to the patient) based on the basis of the first information and based on the basis of the second information (fig. 16, step 1610 compares measured values with predetermined values).
Regarding claim 40, the system of Evans discloses the limitations of claim 1 and further discloses
one or more interfaces of the interface arrangement, which are configured for an exchange of information with a ventilation unit (fig. 2, controller 1001 can communicate with internal sensors of respiratory support 1007, see [0098]) and with a sensor unit (fig. 15, sensors in right and left leads); and
wherein the control unit (fig. 15, controller), which is configured:
to detect information on a time course of an activation signal of the respiratory muscles of the patient ([0098] states that muscle activity can be sensed and used to sync muscle stimulation);
to stimulate the respiratory muscles in a chronological alignment with the activation signal for the muscular ventilatory assistance of the patient ([0098] states that a sensor can detect a breath attempt and delivers positive pressure ventilation and muscle stimulation).
Regarding claim 53, Evans discloses a process for determining a state of respiratory muscles of a patient, the process comprising the steps of:
stimulating the respiratory muscles of the patient with a stimulation signal (fig. 16, step 1601) via a stimulation unit (fig. 15, stimulation modules 1 and 2), wherein the stimulation signal comprises a transient magnetic stimulation pulse ([0080] states that the stimulation includes delivery of magnetic energy where fig. 3, illustrates example stimulation trains which constitute a transient stimulation pulse) having an intensity sufficient to elicit a twitch contraction of the respiratory muscles for eliciting an activation signal ([0052] states that the stimulation delivered causes contraction of the respiratory muscle which constitutes a twitch, fig. 16, steps 1602 and 1603 measure the desired response which is the activation signal);
detecting the activation signal as a response to the stimulation (fig. 16, steps 1602 and 1603) via a sensor unit (fig. 15, sensors on each lead), the detected activation signal indicating a neuronal activation of the respiratory muscles ([0013] states that stimulation signal can cause contraction of a respiratory muscle, and a bioelectrical impedance is measured in response, where [0045] of the application specification states that the neuronal activation can be an electrical impedance myogram); and
determining one or more state parameters for the respiratory muscles based on the stimulation signal and on the activation signal (fig. 16, a comparison is made in step 1610 to a predetermined value and parameters are subsequently adjusted in steps 1620 and 1630).
Regarding claim 54, the process of Evans discloses the limitations of claim 53 and further discloses
detecting an indicator of a component contributed by the patient themself to the ventilation (fig. 16, step 1603 monitors physiological responses which can include EMG according to [0097]);
determining an indicator of a load-bearing capacity of the patient (fig. 16, step 1602 includes lung impedance and gas distribution);
influencing the component contributed by the patient themself and of the ventilation (fig. 16, step 1620 adjusts the muscle stimulation parameters and step 1630 adjusts the ventilator parameters); and
assisting the patient during the ventilation based on the indicator of the component contributed by the patient themself to the ventilation (fig. 16, step 1603) and based on the indicator of the load-bearing capacity of the patient (fig. 16, step 1602).
Regarding claim 58, Evans discloses the device of claim 1 and further discloses the control unit is further configured to perform a pneumatic diagnostic maneuver ([0077] states that the system can include a mechanical ventilator, see fig. 2, external respiratory support 1007 which inherently provides pneumatic therapy) to determine a pneumatic ventilation parameter via the ventilator (fig. 2, breath sensor 1009 located on external respiratory support 1007 can sense various ventilation parameters, see [0098]) and to determine the one or more state parameters based on the pneumatic ventilation parameter (fig. 16, the parameters in 1610 can account for volume or pressure values from the breath sensor in step 1603).
Regarding claim 59, Evans discloses the process of claim 53 and further discloses generating a signal based on the one or more state parameters for controlling ventilation of the patient (fig. 16, steps 1620 and 1630 comprise altering the stimulation parameters or external support parameters for ventilation as a result of the measured value in steps 1602 and 1603).
Claim Rejections - 35 USC § 103
7. 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.
8. Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Evans in view of Reid, Jr. et al. (US 4,057,059).
Regarding claim 10, the system of Evans discloses the limitations of claim 9, but does not expressly disclose that the maximum possible breathing effort of the patient comprises a mouth closing pressure at the peak of inhalation.
However, Reid teaches of a ventilator that uses a control (fig. 1, 12) that limits the maximum pressure in the mouth during the inhalation phase (col. 3, lines 28-30) which requires a maximum pressure to be measured and set.
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to provide the controller of Evans with the control of Reid to indicate the end of inhalation and terminate an inhalation phase as a safety feature (col. 3, lines 28-30).
Response to Arguments
9. Applicant’s arguments with respect to claim(s) 1-3, 5-13, 26-27, 40, 53-54, and 58-59 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The updated rejections references Evans paragraph [0052] which states that the stimulation array is configured to deliver energy via energy sources known in the art such as electromagnetic and Evans paragraph [0080] states that stimulation can include delivery of magnetic energy to read on the device being able to produce a transient magnetic stimulation pulse.
Conclusion
10. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Lurie et al. (US 6,463,327) discloses a device for electrically stimulating the phrenic nerve which is performed by supplying a magnetic field to various nerve or muscle bundles.
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to THOMAS Z CHANG whose telephone number is (571)272-0432. The examiner can normally be reached Monday-Friday 9:00 am-5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Timothy Stanis can be reached at (571)272-5139. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THOMAS Z CHANG/Examiner, Art Unit 3785
/TIMOTHY A STANIS/Supervisory Patent Examiner, Art Unit 3785
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