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 .
Response to Amendment
2. This office action is responsive to the preliminary amendment filed on February 3, 2026. As directed by the amendment: claims 1, 6, 9, 12, 26, and 53 have been amended, no claims have been cancelled, and claim 58 has been added. Thus, claims 1-13, 26-27, 40, 53-54, and 58 are presently pending in this application.
Information Disclosure Statement
3. The information disclosure statements filed April 7, 2025 and October 14, 2022 fail to comply with the provisions, of 37 CFR 1.97, 1.98 and MPEP § 609 because a translation or concise explanation of relevance is not provided for all the foreign patent documents, see 37 CFR 1.98(3). It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
Drawings
4. The drawings are objected to because:
Regarding figs. 1A-1D and 2A-2D, "When possible, a drawing should be so complete that the purpose and operation of the invention may be readily understood by one skilled in the art by means of a mere inspection of said drawing. The necessity of reading the specification in connection with the drawing should be avoided, if possible." See Ex Parte Hartley, 1901 C.D. 247 (Comm'r Pat. 1901). Figs. 1A-1D and 2A-2D has boxes and other shapes with lines connecting the shapes together and the use of a label or legend is necessary because it is believed that such will facilitate a clear understanding of the drawings without undue reliance on the specification for understanding of the subject matter depicted therein as currently there is reliance on the specification for understanding the subject matter depicted therein. It is suggested to replace reference numerals 12 and 14 in figs. 1A-1D with labels and replace reference numerals 19, 21, 22, 23, 24, 25, 26, 28, and 29 in figs. 2A-2D with labels to facilitate a clear understanding of the drawings.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 101
5. 35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
6. Claims 1-4, 6, 9-12, 27, and 53 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: the claim falls under the 4 statutory categories of invention
Claims 1-4, 6, 9-12, and 27 recite a device comprising an interface arrangement and control unit. Therefore, the claims are a manufacture or a machine which falls under the 4 statutory categories of invention.
Claim 53 recites method steps. Therefore, the claims are a process which falls under the 4 statutory categories.
Step 2A, Prong One: a judicial exception is recited
For claim 1, the limitation “determining one or more state parameters for the respiratory muscles based on the stimulation signal and on the activation signal” could be human activity. The claimed determining step can be performed with human mind calculation. The recitation of a control unit in this claim does not negate the mental nature of these limitations because the claim uses the control unit to perform the otherwise mental thought process.
The limitations of “determine an activatability of the respiratory muscles” in claim 4; “determine” in claim 6; “determine an indicator of a maximum possible breathing effort of the patient” in claim 9; the determining step is expanded in claim 10; “determine one or more of an indicator” in claim 11; the determining step is expanded in claim 12 can be done by human activity such as human mind evaluation or calculation.
For claim 53, the limitation “determining one or more state parameters for the respiratory muscles based on the stimulation signal and on the activation signal” could be human activity. The claimed determining step can be performed with human mind calculation.
Step 2A, Prong Two: not integrated into a practical application
Claims 1-4, 6, 9-12, and 27 recite additional elements an interface that can detect signals and a control unit for stimulating muscles of a patient and detect signals. The control unit and interfaces are also recited at a high level of generality, i.e., performing generic computer functions of receiving, detecting, or calculating. Further, these additional elements are well-known in the art see Bolser et al. (US 2012/0245482) paragraph [0003] regarding nerve stimulators being conventional in existing gas delivery devices. See Hanrahan et al. (US 2018/0193579) paragraph [0024] regarding a sensor for sensing a voltage in a mechanical ventilation device.
Claim 53 recites additional steps of “stimulating the respiratory the respiratory muscles of the patient with a stimulation signal” and “detecting an activation signal as a response the stimulation”. These additional steps can be accomplished by well-known in the art see Bolser paragraph [0003] regarding nerve stimulators being conventional in existing gas delivery devices. See Hanrahan paragraph [0024] regarding a sensor for sensing a voltage in a mechanical ventilation device.
Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limitation practicing the abstract idea beyond linking it to a particular technological environment. Thus, these claims are directed to the abstract idea.
Step 2B: Claim provides an inventive concept? No
As discussed in Step 2A Prong two, the additional elements are not sufficient to amount to significantly more than the judicial exception. In addition, the control unit and interfaces are claimed in a merely generic manner. The other additional elements are well known in the art: for nerve stimulators see Bolser paragraph [0003], for sensor units that detect an activation signal see Goldstone et al. (US 5,024,228) which describes a conventional EMG processing machine used in detecting muscle activation in an endotracheal tube.
Since the additional limitations do not provide improvements to any other technical field, applying the judicial exception with, or by use of a particular machine, or applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, and they do not integrate the Judicial Exception into practical application at Step 2A or provide an inventive concept in Step 2B. Thus, the claims are ineligible.
Claim Rejections - 35 USC § 102
7. 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.
8. 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.
9. Claim(s) 1-9, 11-13, 26-27, 40, 53-54, and 58 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);
detect an 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 activation signal detecting 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
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).
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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]) with one or more stimulation pulses (fig. 3, pulses 1031a-1031h).
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 4, the system of Evans discloses the limitations of claim 1 and further discloses the control unit (fig. 15, controller) is configured to determine an activatability of the respiratory muscles ([0204] states that a lung gas distribution can be adjusted, see figs. 18A-18C) of the patient with the determination of the one or more state parameters ([0068] states that the control unit adjusts stimulation parameters if the measured lung gas parameter deviates from a desired value).
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);
detecting an 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 activation signal detecting 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).
Claim Rejections - 35 USC § 103
10. 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.
11. 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
Regarding the information disclosure statements, updated annotated IDS forms with proper strikethroughs are provided.
12. Applicant’s arguments with respect to claim(s) 1-13, 26-27, 40, and 53-54 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.
13. Applicant's arguments filed 02/03/2026 have been fully considered but they are not persuasive.
Regarding the rejection to claims 1-4, 6, 9-12, 27, and 53 under 35 USC 101 presented in “Remarks” on page 11 paragraph 3, the applicant argues that processing of signals cannot be done by the human mind, however, the limitation “determine one or more state parameters for the respiratory muscles based on the stimulation signal” in claim 1 lines 10-11 and similar language in claim 53 lines 7-8 seem to suggest a mathematical calculation for finding the “state parameters” which can be accomplished by the human mind. Further, the state parameters are not used to adjust therapy so the limitation is not integrated into a practical application. The 101 rejection has been updated to clarify this position.
Regarding the rejection to claims 1-9, 11-13, 26, 27, 40, and 53-54 under 35 USC 102 and the rejection to claim 10 under 35 USC 103 presented in “Remarks” on page 11 paragraph 5 through page 14 paragraph 1, the applicant argues that the impedance measurement performed by Evans is not the same as the activation signal of the present invention, however, in the specification paragraph [0045] the activation signal is suggested to encompass electrical impedance myogram among other methods for detecting muscle activation such as EMG. Evans discloses in paragraph [0013] that a stimulation signal is delivered to cause contraction of a respiratory muscle, and a bioelectrical impedance is measured. Evans further discloses that the system can use EMG signals (see Evans [0077], [0097] which states the leads can detect EMG depending on placement, and [0185]).
Conclusion
14. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Meyyappan et al. (US 2026/0102617) discloses a transvascular diaphragm pacing system that uses a ventilator, stimulator, and sensors to regulate patient breathing while administering therapy.
15. 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.
16. 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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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