DETAILED ACTION
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in Application 18/005,917 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 09/04/2026 has been entered.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(B) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 62, 66 and 81 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claim 62 is rejected under 35 U.S.C. 112(b) for being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention for the following reasons. First, claim 55 recites “wherein the sensor unit comprises a hyperventilation sensor…or wherein the sensor unit comprises a pressure sensor unit”. Claim 62 provides further limitations to pressure sensor recited in claim 55 in an optional manner. However, these limitations render the claims indefinite as the claim 55 never positively recites a pressure sensor. Therefore, Claim 62 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention. Examiner suggests amending claim 62 to --wherein
Claim 66 is rejected under 35 U.S.C. 112(b) for being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention for the following reasons. First, claim 64 recites “wherein the sensor unit comprises a hyperventilation sensor…or wherein the sensor unit comprises a pressure sensor unit”. Claim 66 provides further limitations to pressure sensor recited in claim 64 in an optional manner. However, these limitations render the claims indefinite as the claim 55 never positively recites a pressure sensor. Therefore, Claim 66 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention. Examiner suggests amending as suggested for claim 62 above.
Claim 81 is rejected under 35 U.S.C. 112(b) for being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention for the following reasons. First, claim 55 recites “wherein the sensor unit comprises a hyperventilation sensor…or wherein the sensor unit comprises a pressure sensor unit”. Claim 81 provides further limitations to pressure sensor recited in claim 55 in an optional manner. However, these limitations render the claims indefinite as the claim 55 never positively recites a pressure sensor. Therefore, Claim 81 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention. Examiner suggests amending as suggested for claim 62 above.
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 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 of this title, 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 55, 57, 59-64, 69-70, 72-77, 80, 82, 83 are rejected under 35 U.S.C. 103 as being unpatentable over Meyyappan et al. (Pub. No.: US 20150367127 A1, hereinafter referred to as “Meyyappan”) in view of Mechlenburg et al. (Pub. No.: US 20040193003 A1, hereinafter referred to as “Mechlenburg”).
As per independent Claim 55, Meyyappan discloses a stimulation arrangement (Meyyappan in at least fig. 1, fig. 4, fig. 14-15, fig. 32, abstract, [0012-0068], [0107], [0110], [0112-0114], [0116-0117], [0120], [0122-0130], [0132], [0141], [0143], [0146], [0154], [0156-0157], [0167], [0197] for example discloses relevant subject-matter. More specifically, Meyyappan in at least fig. 1, fig. 4, abstract, [0042], [0067], [0112] for example discloses stimulation arrangement 20 as shown in fig. 1, fig. 4. See at least Meyyappan [0112] “transvascular diaphragm pacing system… 20… includes a stimulator 24 coupled in electrical communication (e.g., wired or wireless) with one or more transvascular electrodes 28 suitable for placement in-vivo near the left and/or right phrenic nerves”) comprising:
an induction device having a field generator configured to generate a spatial field (Here, the induction device is being interpreted in light of instant specification as-filed at least [0039] as comprising electrodes with the spatial field generated by the field generator being an electric field. Meyyappan in at least fig. 1, fig. 4, [0112], [0123-0124] for example discloses an induction device 28 having a field generator configured to generate a spatial field. See at least Meyyappan [0112] “stimulator 24 is configured to transmit a stimulatory signal in the form of stimulation pulses to one or more of the electrodes 28. The electrodes 28, in turn, emit the stimulatory signal in the vicinity of a left and/or right phrenic nerve. Stimulation of the left and/or right phrenic nerve, in turn, aims to cause recruitment of the subject's diaphragm.”);
a sensor unit (Meyyappan in at least fig. 1, fig. 4, fig. 15, [0113], [0124] for example discloses sensor unit 48, 50. See at least Meyyappan [0113] “sensors 48 configured to sense various physiological parameters of the patient, some indicating diaphragm output, can provide feedback to the stimulator 24 for regulation of the administered therapy”); and
a control unit in communication with the induction device and the sensor unit (Meyyappan in at least fig. 1, fig. 4, [0141] for example discloses a control unit 60 in communication with the induction device 28 and the sensor unit 48, 50. See at least Meyyappan [0141] “stimulator 24 includes a controller 60, which receives signals sensed from one or more sensors 48 and/or the breath sensor 50…controller 60 is coupled to a pulse generation circuit 70, which delivers stimulation signals to one or more of the electrodes 28”), wherein
the field generator of the induction device is configured to be positioned at a human or animal patient in a manner that an inspiration muscular structure of the patient is stimulable by the spatial field (Meyyappan in at least [0041-0042], [0112-0113] for example discloses the field generator of the induction device 28 is configured to be positioned at a human or animal patient in a manner that an inspiration muscular structure of the patient is stimulable by the spatial field. See at least Meyyappan [0042] “diaphragm pacing system is provided for preventing or reversing diaphragm disuse atrophy in a patient…monitor the breath cycle signals and determine the inspiration phase …of the breath cycle; generate the stimulation signal according to the one or more pacing parameters and delivering the generated stimulation signal to the at least one… electrode at a preselected time of the ventilator breath cycle; and regulate the diaphragm output of the patient for each breath cycle”; [0112] “system 20 includes a stimulator 24 coupled in electrical communication (e.g., wired or wireless) with one or more … electrodes 28 … stimulator 24 is configured to transmit a stimulatory signal in the form of stimulation pulses to one or more of the electrodes 28… electrodes 28, in turn, emit the stimulatory signal in the vicinity of a left and/or right phrenic nerve… aims to cause recruitment of the subject's diaphragm”),
the sensor unit is configured to be positioned at the patient to sense a feedback from the patient or from a respiratory system of the patient (Meyyappan in at least fig. 1, fig. 4, fig. 15, [0042], [0113], [0141], [0156-0157] for example discloses sensor unit 48, 50 is configured to be positioned at the patient to sense a feedback from the patient or from a respiratory system of the patient. See at least Meyyappan [0113] “sensors 48 configured to sense various physiological parameters of the patient, some indicating diaphragm output, can provide feedback to the stimulator 24 for regulation of the administered therapy.”),
the control unit is configured to control the induction device to generate the spatial field and to receive a feedback signal from the sensor unit (Meyyappan in at least fig. 1, fig. 4, fig. 15, [0129], [0156-0157] for example discloses control unit 60 is configured to control the induction device 28 to generate the spatial field and to receive a feedback signal from the sensor unit 48, 50. See at least Meyyappan [0129] “stimulator 24 functions, in part, as a signal generator for providing therapy to the diaphragm in response to information received from the one or more of the sensors 48 and 50 …stimulator 24 delivers pulses to the endovascular electrodes 28 in accordance with one or more protocols”; [0157] “If the calculated diaphragm contribution resulting from the last administered stimulation signal differs from the target diaphragm contribution value by more than a preselected amount… system 20 operates in accordance with a “closed-loop” feedback scheme to regulate the diaphragm output during operation of the system 20”), and
the control unit is configured to evaluate the feedback signal received from the sensor unit, and to activate the field generator of the induction device based upon the feedback signal being indicative of an abnormality (Meyyappan in at least fig. 1, fig. 4, fig. 15, [0042], [0124], [0127], [0129], [0156-0157] for example discloses the control unit is configured to evaluate the feedback signal received from the sensor unit, and to activate the field generator of the induction device based upon the feedback signal being indicative of an abnormality. See at least Meyyappan [0042] “diaphragm pacing system … for preventing or reversing diaphragm disuse atrophy in a patient … controller coupled in electrical communication with the one or more sensors, the at least one input device, and the pulse generator…controller … is programmed to: receive input data indicative of one or more aspects of the therapy plan, wherein the input data includes sensed signals indicative of ventilator operation and one or more pacing parameters; monitor the breath cycle signals and determine the inspiration phase …generate the stimulation signal …and delivering the generated stimulation signal to the at least one transvascular electrode at a preselected time of the ventilator breath cycle; and regulate the diaphragm output of the patient for each breath cycle.”; [0124] “sensors 48 can be part of a feedback control scheme for regulating the stimulation administered to the patient.”; [0127] “breath sensor 50 can be part of …a feedback control scheme for regulating the stimulation administered to the patient”; [0129] “stimulator 24 with characteristics that deliver a suitable charge to the phrenic nerves in order to provide enough diaphragm recruitment to satisfy the selected diaphragm contribution” [0157] “If the calculated diaphragm contribution resulting from the last administered stimulation signal differs from the target diaphragm contribution value by more than a preselected amount, the stimulation parameters may be modified (e.g., amplitude and/or duration are increased) so as to maintain the diaphragm output within a desired range. Such a difference between the calculated diaphragm contribution responsive to the last administered stimulation signal and the programmed diaphragm contribution value can be seen as a change in either the pressure (in Volume-Controlled Modes/Ventilators) or as a change in tidal volume (in Pressure-Controlled Modes/Ventilators) or as a change in any signal sensed by one or more of the sensor(s) 48 or sensor 50… system 20 operates in accordance with a “closed-loop” feedback scheme to regulate the diaphragm output during operation of the system 20”),
wherein the sensor unit comprises a hyperventilation sensor to sense a presence of hyperventilation of the patient, and occurrence of the abnormality is based on a presence of hyperventilation of the patient being identified, wherein the hyperventilation sensor comprises at least one of: an airflow sensor configured to be arranged at the patient to sense an air flow in the respiratory system of the patient, wherein the feedback signal is an airflow signal, and the control unit is configured in a manner that the evaluated airflow signal represents hyperventilation based on a breathing frequency determined from the airflow signal exceeding a threshold frequency of 15 per minute or more, and a carbon dioxide sensor configured to be arranged at the patient to sense carbon dioxide levels in the air or blood of the patient, wherein the feedback signal is a carbon dioxide signal, and the control unit is configured in a manner that the evaluated carbon dioxide signal represents hyperventilation based on a carbon dioxide level determined from the carbon dioxide signal being below a carbon dioxide threshold of 22 milli-mol/liter (mmol/L) or less; or wherein the sensor unit comprises a pressure sensor unit to sense a pressure of a respiratory system of the patient, and wherein occurrence of the abnormality is based on a positive end-expiratory pressure (PEEP) being below a predefined pressure threshold, wherein the pressure sensor unit includes an airway pressure sensor, and the feedback signal is a pressure signal having an airway pressure component (Due to inclusion of the “or”, a broad yet reasonable interpretation would exclude the hyperventilation sensor features while including just --wherein the sensor unit comprises a pressure sensor unit to sense a pressure of a respiratory system of the patient, and wherein occurrence of the abnormality is based on a positive end-expiratory pressure (PEEP) being below a predefined pressure threshold, wherein the pressure sensor unit includes an airway pressure sensor, and the feedback signal is a pressure signal having an airway pressure component—. Meyyappan in at least [0063], [0124-125], [0127], [0196]. see at least Meyyappan [0124] “one or more sensors 48 can be part of a feedback control scheme for regulating the stimulation administered to the patient. The plurality of sensors 48 can transmit data to the stimulator 24 indicative of one or more of the following: …and/or other physiological or mechanical parameters.”; [0125] The term “pressure” as used herein includes, but is not limited to, Airway Pressure, Alveolar Pressure, Ventilator Pressure, Esophageal Pressure, Gastric Pressure, Transdiaphragmatic Pressure, Intra-Thoracic Pressure Positive End-Expiratory Pressure or Pleural Pressure”; [0127] “system 20 can additionally … include a breath sensor 50 for sensing parameters of the ventilator 32… breath sensor 50…can monitor and/or measure several ventilation parameters and communicate such parameters to the stimulator 24… breath sensor 50 can be part of …a feedback control scheme for regulating the stimulation administered to the patient. The sensed ventilation parameters may include, but not limited to, airflow (inspired and/or expired), volume, pressure (airway, esophageal, gastric, and/or some combination/derivative of the former)…other sensors may aid in the procurement of one or more ventilation parameters.”; [0196] “system 20 …may make use of any patient response signal (feedback) that will help indicate that pacing is required; these signals include, but are not limited to: oxygen saturation, end-tidal CO2 (EtCO2), airflow, heart rate, movement-detecting accelerometer signals, etc.”)
Meyyappan does not explicitly disclose wherein the field generator of the induction device comprises a coil design and the spatial field generated by the field generator is an electro-magnetic field.
However, in an analogous stimulation arrangement for assisting patient breathing field of endeavor, Mechlenburg discloses a stimulation arrangement (Mechlenburg in at least fig. 1, 3-4, abstract, [0002], [0012], [0014] for example discloses relevant subject-matter. More specifically, Mechlenburg in fig. 1, [0002], [0012] discloses a stimulation arrangement/magnetic stimulator 30. See at least Mechlenburg abstract “A device … for magnetic stimulation … for the relief of a breathing disorder… a sensor monitors a physiologic characteristic of the patient, a coil is energized to stimulate the appropriate muscles associated with the upper airway, a power supply provides power for energizing the coil, and a control system controls the application of power to the coil based on the output of the sensor.” ) comprising:
an induction device having a field generator configured to generate a spatial field, wherein the field generator of the induction device comprises a coil design and the spatial field generated by the field generator is an electro-magnetic field (Mechlenburg in fig. 1, fig. 4, abstract, [0002], [0012] for example discloses an induction device having a field generator configured to generate a spatial field, wherein the field generator of the induction device comprises a coil design 56 and the spatial field generated by the field generator is an electro-magnetic field. See at least Mechlenburg [0012] “stimulator for applying a magnetic field to… includes a plurality of loops of electrical wire and a power supply that selectively provides electrical power to the plurality of loops. Applying power to the loops produces the magnetic field used to stimulate ”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the stimulators used in stimulation arrangement as taught by Meyyappan, by further providing coil based electro-magnetic field stimulators, as taught by Mechlenburg. A person of ordinary skill would have been motivated to do so, with a reasonable expectation of success, for the advantage of providing non-invasive modalities that noninvasively stimulate the upper airway of the patient to treat a breathing disorder (Mechlenburg, [0002]).
As per dependent Claim 57, the combination of Meyyappan and Mechlenburg as a whole discloses stimulation arrangement wherein the inspiration muscular structure comprises a diaphragm of the patient, an external intercostal muscle of the patient, an accessory muscle of inspiration of the patient, or a combination thereof ( Meyyappan in [0129], [0132]. See at least Meyyappan [0129] “stimulator 24 functions, in part, as a signal generator for providing therapy to the diaphragm in response to information received from the one or more of the sensors 48 and 50 … pulses … are generated by the stimulator 24 with characteristics that deliver a suitable charge to the phrenic nerves in order to provide enough diaphragm recruitment”; [0132] “diaphragm is skeletal muscle, pacing may be accomplished by delivering one or more stimulation signals to produce a mechanically effective contraction of the diaphragm”).
As per dependent Claim 59, the combination of Meyyappan and Mechlenburg as a whole discloses stimulation arrangement wherein the control unit is configured to activate the induction device in a manner that the field generator generates pulses of the spatial field having a frequency of about 10 Hertz (Hz) to about 35 (Hertz) (Hz) (This limitation is being interpreted in light instant application specification as-filed at least [0038]. Meyyappan disclosure in [0041-0042], [0113], [0117], [0130], [0152], [0196] of control unit configured to activate the induction device such that the field generator generates pulses of the spatial field having a therapeutically effective frequency for achieving an efficient stimulation or activation of the muscular structure makes recited subject-matter matter obvious as a matter of mere routine optimization within prior art conditions or through routine experimentation (see MPEP 2144.05) . See at least Meyyappan [0041]” administering the stimulation signal includes delivery of the stimulation signal…with inspiration phase”; [0042] “controller … is programmed to: receive input data indicative of one or more aspects of the therapy plan, wherein the input data includes sensed signals indicative of ventilator operation and one or more pacing parameters; monitor the breath cycle signals and determine the inspiration phase … the breath cycle; generate the stimulation signal according to the one or more pacing parameters and delivering the generated stimulation signal to the at least one transvascular electrode at a preselected time of the ventilator breath cycle; and regulate the diaphragm output of the patient for each breath cycle.”; [0130] “stimulator 24 is configured to deliver fully programmable stimulation, including, but not limited to, the following: any number of pulses, any combination of the defined pulses, any order of delivery of the defined pulses, multiple instances of any defined pulse(s), any frequency of stimulation, and/or any delay between pulses (interpulse delay). Each pulse can be independently programmable (e.g., frequency, amplitude, duration, etc.). The stimulation pulse(s) and/or train(s) may or may not generate a repeatable pattern.”; [0196] “to detect and/or modify physiological response signals to determine whether a change in stimulation pattern, frequency, breath rate, intensity, type, and/or shape profile is required to elicit the expected response.”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the spatial field pulse frequency used by the stimulation arrangement as taught by Meyyappan, such that pulses of the spatial field have a frequency of about 10 Hz to about 35 Hz, as made obvious by Meyyappan. A person of ordinary skill would have been motivated to do so, with a reasonable expectation of success, for the advantage of determining what change in stimulation pattern, frequency, intensity, type, and/or shape profile is required to elicit the expected and desired diaphragmatic response ( Meyyappan, abstract, [0196]).
As per dependent Claim 60, the combination of Meyyappan and Mechlenburg as a whole discloses stimulation arrangement, wherein the field generator of the induction device is configured to be positioned at the patient in a manner that a Phrenic nerve is in the spatial field generated by the field generator while the induction device is activated (Meyyappan in at least fig. 1, fig. 4, [0112], [0123-0124] for example discloses an induction device/electrode 28 having a field generator configured to generate an electric spatial field. See at least Meyyappan [0112] “stimulator 24 is configured to transmit a stimulatory signal in the form of stimulation pulses to one or more of the electrodes 28. The electrodes 28, in turn, emit the stimulatory signal in the vicinity of a left and/or right phrenic nerve. Stimulation of the left and/or right phrenic nerve, in turn, aims to cause recruitment of the subject's diaphragm.”).
As per dependent Claim 61, the combination of Meyyappan and Mechlenburg as a whole discloses
stimulation arrangement wherein the induction device comprises a second field generator configured to generate a second spatial field ( Meyyappan in at least fig. 1, fig. 4, [0112], [0122-0124] for example discloses second field generator/electrodes 28 configured to generate a second spatial field. See at least Meyyappan [0112] “stimulator 24 is configured to transmit a stimulatory signal in the form of stimulation pulses to … electrodes 28”),
the second field generator of the induction device is configured to be positioned at the patient in a manner that an expiration muscular structure of the patient is stimulable by the second spatial field ( Meyyappan in at least fig. 1, fig. 4, [0042], [0112-0113], [0122-0124] for example discloses second field generator of the induction device is configured to be positioned at the patient in a manner that an expiration muscular structure of the patient is stimulable by the second spatial field. See at least [0112] “system 20 includes a stimulator 24 coupled in electrical communication (e.g., wired or wireless) with one or more …electrodes 28 … stimulator 24 is configured to transmit a stimulatory signal in the form of stimulation pulses to one or more of the electrodes 28… electrodes 28, in turn, emit the stimulatory signal in the vicinity of a left and… right phrenic nerve… aims to cause recruitment of the subject's diaphragm”),
the control unit is configured to operate the induction device in a manner that the field generator and the second field generator generate coordinated pulses of the spatial field and the second spatial field to coordinately stimulate the inspiration muscular structure of the patient and the expiration muscular structure of the patient one after the other ( Meyyappan in at least fig. 1, fig. 4, [0042], [0122-0124] for example discloses control unit 60 is configured to operate the induction device in a manner that the field generator and the second field generator generate coordinated pulses of the spatial field and the second spatial field to coordinately stimulate the inspiration muscular structure of the patient and the expiration muscular structure of the patient one after the other. See at least Meyyappan [0042] “diaphragm pacing system … comprises at least one …electrode configured to transmit a stimulation signal delivered thereto…a pulse generator coupled in electrical communication with the at least one … electrode… includes a controller coupled in electrical communication with the one or more sensors, the at least one input device, and the pulse generator. The controller … is programmed to: receive input data indicative of one or more aspects of the therapy plan, wherein the input data includes sensed signals indicative of ventilator operation and one or more pacing parameters; monitor the breath cycle signals and determine the inspiration phase and expiration phase of the breath cycle; generate the stimulation signal according to the one or more pacing parameters and delivering the generated stimulation signal to the at least one … electrode at a preselected time of the ventilator breath cycle; and regulate the diaphragm output of the patient for each breath cycle.”;),
the second field generator of the induction device comprises either a second electrode and the second spatial field generated by the second field generator is a second electric field, or a second coil design and the second spatial field generated by the second field generator is a second electro-magnetic field( Meyyappan in at least fig. 1, fig. 4, [0042], [0122-0124] for example discloses second field generator of the induction device comprises a second electrode and the second spatial field generated by the second field generator is a second electric field. See at least Meyyappan [0122] “While two electrodes are shown and described for stimulating each of the left and right phrenic nerves, it will be appreciated that other numbers of electrodes may be practiced with embodiments”), and
the control unit is configured to de-activate the second field generator of the induction device in a manner that the second spatial field is not generated based on the feedback signal received from the sensor unit being indicative of the abnormality (See at least Meyyappan fig. 1, fig. 4, fig. 14, [0042], [0122-0124], [0154] . see at least Meyyappan [0042] “diaphragm pacing system is provided for preventing or reversing diaphragm disuse atrophy in a patient. … comprises at least one …electrode configured to transmit a stimulation signal delivered thereto…a pulse generator coupled in electrical communication with the at least one … electrode… includes a controller coupled in electrical communication with the one or more sensors, the at least one input device, and the pulse generator. The controller … is programmed to: receive input data indicative of one or more aspects of the therapy plan, wherein the input data includes sensed signals indicative of ventilator operation and one or more pacing parameters; monitor the breath cycle signals and determine the inspiration phase and expiration phase of the breath cycle; generate the stimulation signal according to the one or more pacing parameters and delivering the generated stimulation signal to the at least one … electrode at a preselected time of the ventilator breath cycle; and regulate the diaphragm output of the patient for each breath cycle.”;[0154] “system may either stop ongoing stimulation, continue stimulating…next breath”).
As per dependent Claim 62, the combination of Meyyappan and Mechlenburg as a whole discloses wherein in case the sensor unit comprises the pressure sensor unit to sense the pressure of a respiratory system of the patient (Meyyappan in at least [0063], [0124-125], [0127], [0196]), the stimulation arrangement comprises an input structure configured to set the predefined pressure threshold, wherein the input structure comprises a user interface ( Meyyappan in at least fig. 4, [0146] discloses an input structure 86 configured to set the predefined pressure threshold and/or the predefined oxygenation threshold, wherein the input structure comprises a user interface. See at least Meyyappan [0146] “stimulator 24 includes one or more input devices 86. The input devices 86 may include switches, knobs, etc., supported by the housing of the stimulator, and/or computer style devices, such as a keyboard, a touchpad, etc. The input devices 86 provide for the input of data, such as the pacing parameters, ventilator parameters, etc., into the stimulator 24”).
As per dependent Claim 63, the combination of Meyyappan and Mechlenburg as a whole discloses stimulation arrangement further comprising: a constraining device configured to provide an airflow resistance in the respiratory system of the patient ( Meyyappan in at least fig. 1, [039],[0114], [0159], [0171], [0177] for example discloses providing an airflow resistance in the respiratory system of the patient); and an activator configured to manually activate the field generator of the induction device in a manner that the spatial field is generated ( Meyyappan in at least fig. 4, [0146], [0171], [0185]. See at least [0171] “sequence of pauses may…. be employed manually by the clinician,”), wherein the activator comprises a button accessible by the patient ( Meyyappan in at least fig. 4, [0146], [0185] discloses button input device ).
As per independent Claim 64, Meyyappan discloses a stimulation method of stimulating a human or animal patient to ventilate the patient or to assist breathing of the patient (Meyyappan in at least fig. 1, fig. 4, fig. 14-15, fig. 32, abstract, [0012-0068], [0107], [0110], [0112-0114], [0116-0117], [0120], [0122-0130], [0132], [0141], [0143], [0146], [0154], [0156-0157], [0167], [0197] for example discloses relevant subject-matter. More specifically, Meyyappan in at least fig. 1, fig. 4, fig. 14, abstract, [0042], [0067], [0112] for example discloses stimulation method of stimulating a human or animal patient to ventilate the patient or to assist breathing of the patient. See at least Meyyappan abstract “diaphragm pacing systems (TDPS) and methods are disclosed for providing respiratory therapy to a patient.”), comprising:
positioning a field generator of an induction device at the patient (Here, the induction device is being interpreted in light of instant specification as-filed at least [0039] as comprising electrodes with the spatial field generated by the field generator being an electric field. Meyyappan fig. 1, [0112] for example discloses positioning a field generator of an induction device 28 at the patient. See at least Meyyappan [0112] “stimulator 24 is configured to transmit a stimulatory signal in the form of stimulation pulses to one or more of the electrodes 28. The electrodes 28, in turn, emit the stimulatory signal in the vicinity of a left and/or right phrenic nerve. Stimulation of the left and/or right phrenic nerve, in turn, aims to cause recruitment of the subject's diaphragm.”),
the field generator being configured to generate a spatial field, in a manner that an inspiration muscular structure of the patient is stimulable by the spatial field (Meyyappan in at least [0041-0042], [0112-0113] for example discloses field generator being configured to generate a spatial field, in a manner that an inspiration muscular structure of the patient is stimulable by the spatial field. See at least Meyyappan [0042] “diaphragm pacing system is provided for preventing or reversing diaphragm disuse atrophy in a patient…monitor the breath cycle signals and determine the inspiration phase …of the breath cycle; generate the stimulation signal according to the one or more pacing parameters and delivering the generated stimulation signal to the at least one… electrode at a preselected time of the ventilator breath cycle; and regulate the diaphragm output of the patient for each breath cycle”; [0112] “system 20 includes a stimulator 24 coupled in electrical communication (e.g., wired or wireless) with one or more … electrodes 28 … stimulator 24 is configured to transmit a stimulatory signal in the form of stimulation pulses to one or more of the electrodes 28… electrodes 28, in turn, emit the stimulatory signal in the vicinity of a left and/or right phrenic nerve… aims to cause recruitment of the subject's diaphragm”),
positioning a sensor unit at the patient to sense a feedback from the patient or from a respiratory system of the patient (Meyyappan in at least fig. 1, fig. 4, fig. 15, [0042], [0113], [0141], [0156-0157] for example discloses positioning a sensor unit 48, 50 at the patient to sense a feedback from the patient or from a respiratory system of the patient. See at least Meyyappan [0113] “sensors 48 configured to sense various physiological parameters of the patient, some indicating diaphragm output”);
evaluating a feedback signal provided by the sensor unit (Meyyappan in at least fig. 14-15, [0113], [0154], [0156-0157] for example discloses evaluating a feedback signal provided by the sensor unit 48, 50. See at least Meyyappan [0113] “sensors 48 configured to sense various physiological parameters of the patient, some indicating diaphragm output”; [0154] “breath detection algorithm can use any of the monitored signals, such as flow, volume or pressure to evaluate a series of conditional expressions … algorithm may also facilitate the operation of the system in an event-predictive or in an event-triggered manner.”); and
activating the field generator of the induction device in a manner that the spatial field is generated based upon the feedback signal being indicative of an abnormality (Meyyappan in at least fig. 1, fig. 4, fig. 15, [0042], [0124], [0127], [0129], [0156-0157] for example discloses activating the field generator of the induction device such that the spatial field is generated when the feedback signal is indicative of an abnormality. see at least Meyyappan [0042] “diaphragm pacing system … for preventing or reversing diaphragm disuse atrophy in a patient … controller coupled in electrical communication with the one or more sensors, the at least one input device, and the pulse generator…controller … is programmed to: receive input data indicative of one or more aspects of the therapy plan, wherein the input data includes sensed signals indicative of ventilator operation and one or more pacing parameters; monitor the breath cycle signals and determine the inspiration phase …generate the stimulation signal …and delivering the generated stimulation signal to the at least one transvascular electrode at a preselected time of the ventilator breath cycle; and regulate the diaphragm output of the patient for each breath cycle.”; [0124] “sensors 48 can be part of a feedback control scheme for regulating the stimulation administered to the patient.”; [0127] “breath sensor 50 can be part of …a feedback control scheme for regulating the stimulation administered to the patient”; [0129] “stimulator 24 with characteristics that deliver a suitable charge to the phrenic nerves in order to provide enough diaphragm recruitment to satisfy the selected diaphragm contribution”; [0157] “If the calculated diaphragm contribution resulting from the last administered stimulation signal differs from the target diaphragm contribution value by more than a preselected amount, the stimulation parameters may be modified (e.g., amplitude and/or duration are increased) so as to maintain the diaphragm output within a desired range. Such a difference between the calculated diaphragm contribution responsive to the last administered stimulation signal and the programmed diaphragm contribution value can be seen as a change in either the pressure (in Volume-Controlled Modes/Ventilators) or as a change in tidal volume (in Pressure-Controlled Modes/Ventilators) or as a change in any signal sensed by one or more of the sensor(s) 48 or sensor 50… system 20 operates in accordance with a “closed-loop” feedback scheme to regulate the diaphragm output during operation of the system 20”),
wherein the sensor unit comprises a hyperventilation sensor to sense a presence of hyperventilation of the patient, and wherein occurrence of the abnormality is based on a presence of hyperventilation of the patient being identified, wherein the hyperventilation sensor comprises at least one of: an airflow sensor configured to be arranged at the patient to sense an air flow in the respiratory system of the patient, wherein the feedback signal is an airflow signal, and the evaluated airflow signal represents hyperventilation based on a breathing frequency determined from the airflow signal exceeding a threshold frequency of 15 per minute or more, and/or a carbon dioxide sensor configured to be arranged at the patient to sense carbon dioxide levels in the air or blood of the patient, wherein the feedback signal is a carbon dioxide signal, and the evaluated carbon dioxide signal represents hyperventilation based on a carbon dioxide level determined from the carbon dioxide signal being below a carbon dioxide threshold of 22 milli-mol/liter (mmol/L) or less; or wherein the sensor unit comprises a pressure sensor unit to sense a pressure of the respiratory system of the patient, and wherein occurrence of the abnormality is based on a positive end-expiratory pressure (PEEP) being below a predefined pressure threshold, the pressure sensor unit including an airway pressure sensor and the feedback signal is a pressure signal with an airway pressure component (Due to inclusion of the “or”, a broad yet reasonable interpretation would exclude the hyperventilation sensor features while including just --wherein the sensor unit comprises a pressure sensor unit to sense a pressure of the respiratory system of the patient, and wherein occurrence of the abnormality is based on a positive end-expiratory pressure (PEEP) being below a predefined pressure threshold, the pressure sensor unit including an airway pressure sensor and the feedback signal is a pressure signal with an airway pressure component—. Meyyappan in at least [0063], [0124-125], [0127], [0196]. see at least Meyyappan [0124] “one or more sensors 48 can be part of a feedback control scheme for regulating the stimulation administered to the patient. The plurality of sensors 48 can transmit data to the stimulator 24 indicative of one or more of the following: …and/or other physiological or mechanical parameters.”; [0125] The term “pressure” as used herein includes, but is not limited to, Airway Pressure, Alveolar Pressure, Ventilator Pressure, Esophageal Pressure, Gastric Pressure, Transdiaphragmatic Pressure, Intra-Thoracic Pressure Positive End-Expiratory Pressure or Pleural Pressure”; [0127] “system 20 can additionally … include a breath sensor 50 for sensing parameters of the ventilator 32… breath sensor 50…can monitor and/or measure several ventilation parameters and communicate such parameters to the stimulator 24… breath sensor 50 can be part of …a feedback control scheme for regulating the stimulation administered to the patient. The sensed ventilation parameters may include, but not limited to, airflow (inspired and/or expired), volume, pressure (airway, esophageal, gastric, and/or some combination/derivative of the former)…other sensors may aid in the procurement of one or more ventilation parameters.”; [0196] “system 20 …may make use of any patient response signal (feedback) that will help indicate that pacing is required; these signals include, but are not limited to: oxygen saturation, end-tidal CO2 (EtCO2), airflow, heart rate, movement-detecting accelerometer signals, etc.”)
Meyyappan does not explicitly disclose wherein the field generator of the induction device comprises a coil design and the spatial field generated by the field generator is an electro-magnetic field.
However, in an analogous stimulation arrangement for assisting patient breathing field of endeavor, Mechlenburg discloses a stimulation method of stimulating a human or animal patient to assist breathing of the patient (Mechlenburg in at least fig. 1, 3-4, abstract, [0002], [0012], [0014] for example discloses relevant subject-matter. More specifically, Mechlenburg in fig. 1, [0002], [0012], [0014] discloses stimulation method of stimulating a human or animal patient to assist breathing of the patient. See at least Mechlenburg abstract “A … method for magnetic stimulation … for the relief of a breathing disorder… a sensor monitors a physiologic characteristic of the patient, a coil is energized to stimulate the appropriate muscles associated with the upper airway, a power supply provides power for energizing the coil, and a control system controls the application of power to the coil based on the output of the sensor.”)
positioning a field generator of an induction device at the patient, the field generator being configured to generate a spatial field, wherein the field generator of the induction device comprises a coil design and the spatial field generated by the field generator is an electro-magnetic field (Mechlenburg in fig. 1, fig. 4, abstract, [0002], [0012] for example discloses an induction device having a field generator configured to generate a spatial field, wherein the field generator of the induction device comprises a coil design 56 and the spatial field generated by the field generator is an electro-magnetic field. See at least Mechlenburg [0012] “stimulator for applying a magnetic field to… includes a plurality of loops of electrical wire and a power supply that selectively provides electrical power to the plurality of loops. Applying power to the loops produces the magnetic field used to stimulate… A sensor monitors a condition of the patient … such as …the patient's respiration, to determine when to initiate stimulation and how to change the intensity of the stimulation, if necessary, during the therapy process. A control unit receives signals output by the sensor and controls the application of electrical power from the power supply to the plurality of loops of electrical wire. A positioning appliance secures the plurality of loops of electrical wire to the patient at a position relative to the targeted muscle or muscle group such that the magnetic field produced by applying electrical power to the plurality of loops of electrical wire induces tension in that muscle or muscle group to relieve ”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the stimulators used in stimulation method of stimulating a human or animal patient to ventilate the patient or to assist breathing of the patient as taught by Meyyappan, by further providing coil based electro-magnetic field stimulators, as taught by Mechlenburg. A person of ordinary skill would have been motivated to do so, with a reasonable expectation of success, for the advantage of providing non-invasive modalities that noninvasively stimulate the upper airway of the patient to treat a breathing disorder (Mechlenburg, [0002]).
As per dependent Claim 69, the combination of Meyyappan and Mechlenburg as a whole discloses stimulation method wherein the sensor unit comprises a sensor to sense an oxygen content of a gas supplied from the respiratory system to the patient, and wherein occurrence of the abnormality is based on the oxygen content being below a predefined oxygenation threshold ( Meyyappan in at least [0028], [0114], [0127-0128], [0196]. See at least Meyyappan [0127] “system 20 can additionally … include a breath sensor 50 for sensing parameters of the ventilator 32… breath sensor 50, by virtue of its location in the breathing circuit, can monitor and/or measure several ventilation parameters and communicate such parameters to the stimulator 24… sensed ventilation parameters may include, but not limited to, airflow (inspired and/or expired), volume, pressure (airway, esophageal, gastric, and/or some combination/derivative of the former). ….other sensors may aid in the procurement of one or more ventilation parameters.”; [0196] “a closed-loop operation to autonomously pace the diaphragm. This mode may make use of any patient response signal (feedback) that will help indicate that pacing is required; these signals include, but are not limited to: oxygen saturation… Pacing is administered continuously … an algorithm is used to detect and/or modify physiological response signals to determine whether a change in stimulation pattern, frequency, breath rate, intensity, type, and/or shape profile is required to elicit the expected response.”).
As per dependent Claim 70, the combination of Meyyappan and Mechlenburg as a whole discloses stimulation method wherein activating the field generator of the induction device comprises generating pulses of the spatial field, wherein the pulses of the spatial field have a frequency of about 10 Hertz (Hz) to about 35 Hertz (Hz) (This limitation is being interpreted in light instant application specification as-filed at least [0038]. Meyyappan disclosure in [0041-0042], [0113], [0117], [0130], [0152], [0196] activating the field generator of the induction device by generating pulses of the spatial field, wherein the pulses of the spatial field have a therapeutically effective frequency for achieving an efficient stimulation or activation of the muscular structure makes recited subject-matter matter obvious as a matter of mere routine optimization within prior art conditions or through routine experimentation (see MPEP 2144.05) . See at least Meyyappan [0041]” administering the stimulation signal includes delivery of the stimulation signal…with inspiration phase”; [0042] “controller … is programmed to: receive input data indicative of one or more aspects of the therapy plan, wherein the input data includes sensed signals indicative of ventilator operation and one or more pacing parameters; monitor the breath cycle signals and determine the inspiration phase … the breath cycle; generate the stimulation signal according to the one or more pacing parameters and delivering the generated stimulation signal to the at least one transvascular electrode at a preselected time of the ventilator breath cycle; and regulate the diaphragm output of the patient for each breath cycle.”; [0130] “stimulator 24 is configured to deliver fully programmable stimulation, including, but not limited to, the following: any number of pulses, any combination of the defined pulses, any order of delivery of the defined pulses, multiple instances of any defined pulse(s), any frequency of stimulation, and/or any delay between pulses (interpulse delay). Each pulse can be independently programmable (e.g., frequency, amplitude, duration, etc.). The stimulation pulse(s) and/or train(s) may or may not generate a repeatable pattern.”; [0196] “to detect and/or modify physiological response signals to determine whether a change in stimulation pattern, frequency, breath rate, intensity, type, and/or shape profile is required to elicit the expected response.”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the spatial field pulse frequency used in the stimulation method of stimulating a human or animal patient to ventilate the patient or to assist breathing of the patient as taught by Meyyappan, such that pulses of the spatial field have a frequency of about 10 Hz to about 35 Hz, as made obvious by Meyyappan. A person of ordinary skill would have been motivated to do so, with a reasonable expectation of success, for the advantage of determining what change in stimulation pattern, frequency, intensity, type, and/or shape profile is required to elicit the expected and desired diaphragmatic response ( Meyyappan, abstract, [0196]).
As per dependent Claim 72, the combination of Meyyappan and Mechlenburg as a whole discloses stimulation method wherein the induction device comprises a second field generator configured to generate a second spatial field ( Meyyappan in at least fig. 1, fig. 4, [0112], [0122-0124] for example discloses second field generator/electrodes 28 configured to generate a second spatial field. See at least Meyyappan [0112] “stimulator 24 is configured to transmit a stimulatory signal in the form of stimulation pulses to … electrodes 28”),
the second field generator of the induction device is configured to be positioned at the human or animal patient in a manner that an expiration muscular structure of the patient is stimulable by the second spatial field ( Meyyappan in at least fig. 1, fig. 4, [0042], [0112-0113], [0122-0124] for example discloses second field generator of the induction device is configured to be positioned at the patient in a manner that an expiration muscular structure of the patient is stimulable by the second spatial field. See at least [0112] “system 20 includes a stimulator 24 coupled in electrical communication (e.g., wired or wireless) with one or more …electrodes 28 … stimulator 24 is configured to transmit a stimulatory signal in the form of stimulation pulses to one or more of the electrodes 28… electrodes 28, in turn, emit the stimulatory signal in the vicinity of a left and… right phrenic nerve… aims to cause recruitment of the subject's diaphragm”),
the induction device is operated in a manner that the field generator and the second field generator generate coordinated pulses of the spatial field and the second spatial field to coordinately stimulate the inspiration muscular structure of the patient and the expiration muscular structure of the patient one after the other ( Meyyappan in at least fig. 1, fig. 4, [0042], [0122-0124] for example discloses induction device is operated in a manner that the field generator/electrodes and the second field generator/electrodes generate coordinated pulses of the spatial field and the second spatial field to coordinately stimulate the inspiration muscular structure of the patient and the expiration muscular structure of the patient one after the other. See at least Meyyappan [0042] “diaphragm pacing system … comprises at least one …electrode configured to transmit a stimulation signal delivered thereto…a pulse generator coupled in electrical communication with the at least one … electrode… includes a controller coupled in electrical communication with the one or more sensors, the at least one input device, and the pulse generator. The controller … is programmed to: receive input data indicative of one or more aspects of the therapy plan, wherein the input data includes sensed signals indicative of ventilator operation and one or more pacing parameters; monitor the breath cycle signals and determine the inspiration phase and expiration phase of the breath cycle; generate the stimulation signal according to the one or more pacing parameters and delivering the generated stimulation signal to the at least one … electrode at a preselected time of the ventilator breath cycle; and regulate the diaphragm output of the patient for each breath cycle.”;), and
the second field generator of the induction device comprises a second electrode and the second spatial field generated by the field generator is a second electric field, or the second field generator of the induction device comprises a second coil design and the second spatial field generated by the second field generator is a second electro-magnetic field ( Meyyappan in at least fig. 1, fig. 4, [0042], [0122-0124] for example discloses second field generator of the induction device comprises a second electrode and the second spatial field generated by the second field generator is a second electric field. See at least Meyyappan [0122] “While two electrodes are shown and described for stimulating each of the left and right phrenic nerves, it will be appreciated that other numbers of electrodes may be practiced with embodiments”).
As per dependent Claim 73, the combination of Meyyappan and Mechlenburg as a whole discloses stimulation method comprising de-activating the second field generator of the induction device in a manner that the second spatial field is not generated based on the feedback signal being indicative of the abnormality (See at least Meyyappan fig. 1, fig. 4, fig. 14, [0042], [0122-0124], [0154] . see at least Meyyappan [0042] “diaphragm pacing system is provided for preventing or reversing diaphragm disuse atrophy in a patient. … comprises at least one …electrode configured to transmit a stimulation signal delivered thereto…a pulse generator coupled in electrical communication with the at least one … electrode… includes a controller coupled in electrical communication with the one or more sensors, the at least one input device, and the pulse generator. The controller … is programmed to: receive input data indicative of one or more aspects of the therapy plan, wherein the input data includes sensed signals indicative of ventilator operation and one or more pacing parameters; monitor the breath cycle signals and determine the inspiration phase and expiration phase of the breath cycle; generate the stimulation signal according to the one or more pacing parameters and delivering the generated stimulation signal to the at least one … electrode at a preselected time of the ventilator breath cycle; and regulate the diaphragm output of the patient for each breath cycle.”;[0154] “system may either stop ongoing stimulation, continue stimulating…next breath”).
As per dependent Claim 74, the combination of Meyyappan and Mechlenburg as a whole discloses stimulation method comprising setting the predefined pressure threshold and/or the predefined oxygenation threshold, wherein a user interface is provided for setting the predefined pressure threshold and/or the predefined oxygenation threshold ( Meyyappan in at least fig. 4, [0146] discloses setting via a user interface the predefined pressure threshold and/or the predefined oxygenation threshold. See at least Meyyappan [0146] “stimulator 24 includes one or more input devices 86. The input devices 86 may include switches, knobs, etc., supported by the housing of the stimulator, and/or computer style devices, such as a keyboard, a touchpad, etc. The input devices 86 provide for the input of data, such as the pacing parameters, ventilator parameters, etc., into the stimulator 24”).
As per dependent Claim 75, the combination of Meyyappan and Mechlenburg as a whole discloses stimulation method comprising providing an airflow resistance in the respiratory system of the patient ( Meyyappan in at least fig. 1, [039],[0114], [0159], [0171], [0177] for example discloses providing an airflow resistance in the respiratory system of the patient).
As per dependent Claim 76, the combination of Meyyappan and Mechlenburg as a whole discloses stimulation method comprising manually activating the field generator of the induction device in a manner that the spatial field is generated ( Meyyappan in at least fig. 4, fig. 4, [0146], [0171], [0185]. See at least [0171] “sequence of pauses may … be employed manually by the clinician”), wherein the field generator of the induction device is activated by the patient pushing a button ( Meyyappan in at least fig. 4, [0146], [0185] discloses button input device accessible by user).
As per dependent Claim 77, the combination of Meyyappan and Mechlenburg as a whole discloses stimulation method wherein the field generator of the induction device is configured to be positioned at the patient in a manner that a Phrenic nerve is in the spatial field generated by the field generator based on the induction device being activated ( Meyyappan fig. 1, [0112] for example discloses the field generator of the induction device is configured to be positioned at the patient in a manner that a Phrenic nerve is in the spatial field generated by the field generator when the induction device is activated. See at least Meyyappan [0112] “stimulator 24 is configured to transmit a stimulatory signal in the form of stimulation pulses to one or more of the electrodes 28. The electrodes 28, in turn, emit the stimulatory signal in the vicinity of a left and/or right phrenic nerve. Stimulation of the left and/or right phrenic nerve, in turn, aims to cause recruitment of the subject's diaphragm.”).
As per dependent Claim 80, the combination of Meyyappan and Mechlenburg as a whole discloses stimulation method wherein the inspiration muscular structure comprises a diaphragm of the patient, an external intercostal muscle of the patient, an accessory muscle of inspiration of the patient, or a combination thereof (Meyyappan in [0129], [0132]. See at least Meyyappan [0129] “stimulator 24 functions, in part, as a signal generator for providing therapy to the diaphragm in response to information received from the one or more of the sensors 48 and 50 … pulses … are generated by the stimulator 24 with characteristics that deliver a suitable charge to the phrenic nerves in order to provide enough diaphragm recruitment”; [0132] “diaphragm is skeletal muscle, pacing may be accomplished by delivering one or more stimulation signals to produce a mechanically effective contraction of the diaphragm”)
As per dependent Claim 82, the combination of Meyyappan and Mechlenburg as a whole discloses stimulation arrangement wherein the sensor unit comprises a sensor to sense an oxygen content of a gas supplied from the respiratory system to the patient, and wherein occurrence of the abnormality is based on the oxygen content being below a predefined oxygenation threshold (Meyyappan in at least [0028], [0114], [0127-0128], [0196]. See at least Meyyappan [0127] “system 20 can additionally … include a breath sensor 50 for sensing parameters of the ventilator 32… breath sensor 50, by virtue of its location in the breathing circuit, can monitor and/or measure several ventilation parameters and communicate such parameters to the stimulator 24… sensed ventilation parameters may include, but not limited to, airflow (inspired and/or expired), volume, pressure (airway, esophageal, gastric, and/or some combination/derivative of the former). ….other sensors may aid in the procurement of one or more ventilation parameters.”; [0196] “a closed-loop operation to autonomously pace the diaphragm. This mode may make use of any patient response signal (feedback) that will help indicate that pacing is required; these signals include, but are not limited to: oxygen saturation… Pacing is administered continuously … an algorithm is used to detect and/or modify physiological response signals to determine whether a change in stimulation pattern, frequency, breath rate, intensity, type, and/or shape profile is required to elicit the expected response.”).
As per dependent Claim 83, the combination of Meyyappan and Mechlenburg as a whole discloses stimulation arrangement comprising an input structure configured to set the predefined oxygenation threshold, wherein the input structure comprises a user interface (Meyyappan in at least fig. 4, [0146] discloses an input structure 86 configured to set the the predefined oxygenation threshold, wherein the input structure comprises a user interface. See at least Meyyappan [0146] “stimulator 24 includes one or more input devices 86. The input devices 86 may include switches, knobs, etc., supported by the housing of the stimulator, and/or computer style devices, such as a keyboard, a touchpad, etc. The input devices 86 provide for the input of data, such as the pacing parameters, ventilator parameters, etc., into the stimulator 24”).
Claim 78-79 are rejected under 35 U.S.C. 103 as being unpatentable over Meyyappan and Mechlenburg and further in view of Yun (Pub. No.: US 20090024176 A1, hereinafter referred to as “Yun”).
As per dependent Claim 78, the combination of Meyyappan and Mechlenburg discloses stimulation method of claim 64 (see claim 64 above).
The combination of Meyyappan and Mechlenburg does not explicitly disclose abnormality is based on the rate or tidal volume of breathing eliminating more carbon dioxide than the body produces.
However, in an analogous stimulation method of stimulating a human or animal patient to ventilate the patient or to assist breathing of the patient field of endeavor, Yun discloses a stimulation method of stimulating a human or animal patient to ventilate the patient or to assist breathing of the patient (Yun in at least abstract, fig. 1, fig. 3, [0004], [0008], [0024], [0043-0044], [0064] for example discloses stimulation method of stimulating a human or animal patient to ventilate the patient or to assist breathing of the patient. See at least Yun abstract “electrically stimulating or sensing motion of the diaphragm, and electrically stimulating the heart in a subject in a manner effective to produce respiratory sinus arrhythmia.”; [0024] “stimulator may further include a pulse generator configured to deliver stimulating pulses, either to the same electrodes used for sensing or to additional stimulation electrodes. The stimulation electrodes may also be placed adjacent to the phrenic nerve at some point along its length to provide stimulation pulse to the nerves, which in turn innervate the diaphragm muscle causing contractions and resulting respiration.”),
wherein the abnormality is based on the rate or tidal volume of breathing eliminating more carbon dioxide than the body produces (This limitation is being interpreted in light of instant application specification as-filed para. [0023] which defines and states “hyperventilation of the patient occurs, e.g. when the rate or tidal volume of breathing eliminates more carbon dioxide than the body can produce”. Yun disclosure in at least fig. 1, fig. 3, [0024], [0043-0045], [0064] for example of indirect measure of recited hyperventilation during which breathing abnormality state the recited physiological conditions would occur makes recited subject-matter obvious. See at least Yun [0043] “Hyperventilation may be detected when the respiratory rate or frequency is above a programmed rate. Complete apnea or central apnea is defined as a condition where there is no effective EMG signal or phrenic nerve signal… device may be programmed to first detect the hyperventilation and wait for a preprogrammed time to be considered apnea.”; [0044] “Phrenic nerve or EMG activity sensed … may indicate the onset of …hyperventilation…Similarly, diaphragm EMG …. may be used to determine …hyperventilation”;).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the stimulation method of stimulating a human or animal patient to ventilate the patient or to assist breathing of the patient as taught by Meyyappan as modified by Mechlenburg, by further using presence/occurrence of hyperventilation or abnormality wherein the rate or tidal volume of breathing eliminates more carbon dioxide than the body can produce in a patient, and wherein the abnormality is when a presence of hyperventilation of the patient is identified, the hyperventilation sensor unit, as taught by Yun. A person of ordinary skill would have been motivated to do so, with a reasonable expectation of success, for the advantage of to determine if certain breathing disorders like hyperventilation are present, and when and how to stimulate respiration in the presence of low oxygenation condition such as hyperventilation disorders (Yun, [0044]).
As per dependent Claim 79, the combination of Meyyappan and Mechlenburg discloses stimulation arrangement of claim 55 (see claim 55 above).
The combination of Meyyappan and Mechlenburg does not explicitly disclose wherein the abnormality is based on the rate or tidal volume of breathing eliminating more carbon dioxide than the body produces.
However, in an analogous stimulation method of stimulating a human or animal patient to ventilate the patient or to assist breathing of the patient field of endeavor, Yun discloses a stimulation arrangement (Yun in at least abstract, fig. 1, fig. 3, [0004], [0008], [0024], [0043-0044], [0064] for example discloses stimulation arrangement. See at least Yun abstract “electrically stimulating or sensing motion of the diaphragm, and electrically stimulating the heart in a subject in a manner effective to produce respiratory sinus arrhythmia.”; [0024] “stimulator may further include a pulse generator configured to deliver stimulating pulses, either to the same electrodes used for sensing or to additional stimulation electrodes. The stimulation electrodes may also be placed adjacent to the phrenic nerve at some point along its length to provide stimulation pulse to the nerves, which in turn innervate the diaphragm muscle causing contractions and resulting respiration.”),
wherein the abnormality is based on the rate or tidal volume of breathing eliminating more carbon dioxide than the body produces (This limitation is being interpreted in light of instant application specification as-filed para. [0023] which defines and states “hyperventilation of the patient occurs, e.g. when the rate or tidal volume of breathing eliminates more carbon dioxide than the body can produce”. Yun disclosure in at least fig. 1, fig. 3, [0024], [0043-0045], [0064] for example of indirect measure of recited hyperventilation during which breathing abnormality state the recited physiological conditions would occur makes recited subject-matter obvious. See at least Yun [0043] “Hyperventilation may be detected when the respiratory rate or frequency is above a programmed rate. Complete apnea or central apnea is defined as a condition where there is no effective EMG signal or phrenic nerve signal… device may be programmed to first detect the hyperventilation and wait for a preprogrammed time to be considered apnea.”; [0044] “Phrenic nerve or EMG activity sensed … may indicate the onset of …hyperventilation…Similarly, diaphragm EMG …. may be used to determine …hyperventilation”;).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the stimulation arrangement as taught by Meyyappan as modified by Mechlenburg, by further using presence/occurrence of hyperventilation or abnormality wherein the rate or tidal volume of breathing eliminates more carbon dioxide than the body can produce in a patient, and wherein the abnormality is when a presence of hyperventilation of the patient is identified, the hyperventilation sensor unit, as taught by Yun. A person of ordinary skill would have been motivated to do so, with a reasonable expectation of success, for the advantage of to determine if certain breathing disorders like hyperventilation are present, and when and how to stimulate respiration in the presence of low oxygenation condition such as hyperventilation disorders (Yun, [0044]).
Contingently Allowable Subject-Matter
As per dependent claims 66, 81, dependent claims 66, 81 would be contingently allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and by further including all of the limitations of the base claims and any intervening claims in addition to overcoming any other rejections/objections enumerated above.
As per dependent claims 66, 81, dependent claims 66, 81 are being objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims in addition to overcoming any other rejections/objections enumerated above.
The following is a statement of reasons for the indication of allowable subject matter:
As per dependent Claim 66, none of the prior art discloses stimulation method wherein the sensor unit comprises the pressure sensor unit to sense the pressure of the respiratory system of the patient the pressure sensor unit includes an esophageal pressure sensor and the pressure signal has an esophageal pressure component, and wherein evaluating the feedback signal includes evaluating the pressure signal provided by the pressure sensor unit and comprises calculating a transpulmonary pressure by subtracting the esophageal pressure component of the pressure signal from the airway pressure component of the pressure signal including all of the limitations, features, steps, combination and arrangement of features and steps of their respective base claim and any intervening claims.
As per dependent Claim 81, none of the prior art discloses stimulation arrangement wherein, the sensor unit comprises the pressure sensor unit to sense the pressure of the respiratory system of the patient, the pressure sensor unit includes an esophageal pressure sensor and the pressure signal has an esophageal pressure component, wherein the control unit is configured to evaluate the pressure signal by calculating a transpulmonary pressure by subtracting the esophageal pressure component of the pressure signal from the airway pressure component of the pressure signal including all of the limitations, features, steps, combination and arrangement of features and steps of their respective base claim and any intervening claims.
Prior art US 20150367127 A1 to Meyyappan et al. discloses Transvascular diaphragm pacing systems (TDPS) and methods for providing respiratory therapy to a patient. The systems and methods make best use of the contractile properties of the diaphragm muscle and prevent muscle disuse and muscle atrophy. This can be carried out by engaging the phrenic nerves using patterned functional electrical stimulation applied to endovascular electrodes that are temporarily and reversibly inserted in central veins of the patient, such as the left subclavian vein and the superior vena cava. The TDPS can be designed to seamlessly interface with any commercially available positive-pressure ventilatory assistance/support equipment such as is commonly in use in hospital intensive care units (ICU) for treating critically ill patients with breathing insufficiencies, pain, trauma, sepsis or neurological diseases or deficits.
Prior art US 20160310730 A1 to Martins discloses a medical stimulation system to stimulate a phrenic nerve to effectuate a diaphragm of a patient similar to that disclosed. More specifically, Martins discloses apparatus for reducing ventilation induced diaphragm disuse in a patient receiving ventilation support from a mechanical ventilator (MV), including: an electrode array of first and second types and comprising a plurality of electrodes configured to stimulate a phrenic nerve of the patient; and at least one controller configured to: identify a type of electrode array from at least two different types, generate a stimulus signal for stimulating a phrenic nerve of the patient based upon the identity of the electrode type.
Prior art US 20040193003 A1 to Mechlenburg et al. discloses an apparatus and method for noninvasive stimulation of muscles in the upper airway similar to that disclosed. More specifically, Mechlenburg discloses a magnetic stimulation device and a method of using the device to apply pulsed magnetic fields to the muscles in the neck area of a patient to induce tension in such muscles, thereby relieving the obstructive sleep apnea caused by a relaxation of such muscles.
However, none of the subject-matter discloses subject-matter of method claim 66 and system claim 81.
Response to Amendment
According to the Amendment, filed 09/04/2026, the status of the claims is as follows:
Claims 55, 59-62, 64, 66, 69-70, 73, 77-79 are currently amended;
Claims 57, 63, 72, 74-76 are previously presented;
Claims 80-83 are new; and
Claims 1-54 are cancelled.
By the current amendment, as a result, claims 55, 57, 59-64, 66, 69-70, 72-83 are now pending in this application and are being examined on the merits.
Response to Arguments
Issues Raised and Arguments/Remarks to Rejections/Objections Not Based On Prior Art presented on Pages 10-11 of Applicant’s Amendment dated 09/04/2026
The Examiner agrees with the Applicant, and in light of the amendments/arguments, withdraws the following non prior art related objections/rejections raised in Office Action dated 06/15/2026: [1] The objection to claims is withdrawn in view of the amendment and arguments, filed 09/04/2026; [3] The 35 U.S.C. 112(b), rejections to claims is withdrawn in view of the amendment, filed 09/04/2026.
Issues Raised and Arguments/Remarks to Rejections Based On Prior Art presented on Pages 10-14 of Applicant’s Amendment dated 09/04/2026 where Applicant’s’ remarks inter alia that:
35 U.S.C. § 103 Rejection of the Amended Independent Claim 55 and Claim 64
[A] The Office rejected claims 55-57, 59, 60-65, 69, 70, and 72-77 under 35 U.S.C. § 103 as being obvious over U.S. Pat. App. Pub. No. US 2015/0367127 Al to Meyyappan et al. ("Meyyappan") in view of U.S. Pat. App. Pub. No. US 2004/0193003 Al to Mechlenburg et al. ("Mechlenburg"). These rejections are respectfully traversed regarding the present claims as previously presented, and are also traversed insofar as the rejections are applicable to the present claims.
[B] The Office determined that claims 58 and 68 recited allowable subject matter and would be allowable if rewritten in independent form to include the features of their respective base and intervening claims and to address the outstanding formal objections. Amended independent claim 55 incorporates the allowable subject matter of claim 58, and amended independent claim 64 incorporates the allowable subject matter of claims 67 and 68. The amendments also address the formal objections identified by the Office. Accordingly, the outstanding § 103 rejection of the previously presented versions of claims 55 and 64 is rendered moot, and withdrawal of the rejection and allowance of present independent claims 55 and 64 are respectfully requested.
[C] In addition, present independent claim 55 recites, inter alia, "the sensor unit comprises a pressure sensor unit to sense a pressure of a respiratory system of the patient, and wherein occurrence of the abnormality is based on a positive end-expiratory pressure (PEEP) being below a predefined pressure threshold, wherein the pressure sensor unit includes an airway pressure sensor, and the feedback signal is a pressure signal having an airway pressure component." Independent method claim 64 recites corresponding features and recites activating the field generator based on such an abnormality.
[D] Accordingly, neither Meyyappan nor Mechlenburg discloses or suggests the claimed combination of: (1) an airway-pressure sensor providing an airway-pressure component; (2) determining from that pressure signal that PEEP is below a predefined pressure threshold; and (3) activating the field generator based on that below-threshold PEEP abnormality.
[E] In view of the foregoing amendments and remarks, Applicant respectfully submits that all claims in the application are now in condition for allowance. Accordingly, withdrawal of the rejections and allowance of all the claims is respectfully requested. Because the cited references do not disclose all the features of present independent claims 55 and 64, the claims are allowable over Meyyappan nor Mechlenburg under 35 U.S.C. § 103.
[F] According, allowance of present independent claims 55 and 64 is respectfully requested.
Applicants’ arguments [A-F] with respect to the above claim limitations in Claim 55 and claim 64 have been considered but are not persuasive for the following reasons:
First, with respect to Applicants arguments [B-F] above, amended independents claim 55 recites “wherein the sensor unit comprises a hyperventilation sensor to sense a presence of hyperventilation of the patient, and occurrence of the abnormality is based on a presence of hyperventilation of the patient being identified, … or wherein the sensor unit comprises a pressure sensor unit to sense a pressure of a respiratory system of the patient, and wherein occurrence of the abnormality is based on a positive end-expiratory pressure (PEEP) being below a predefined pressure threshold, wherein the pressure sensor unit includes an airway pressure sensor, and the feedback signal is a pressure signal having an airway pressure component” (emphasis added). Due to inclusion of the “or”, a broad yet reasonable interpretation would exclude the hyperventilation sensor features while including just --wherein the sensor unit comprises a pressure sensor unit to sense a pressure of a respiratory system of the patient, and wherein occurrence of the abnormality is based on a positive end-expiratory pressure (PEEP) being below a predefined pressure threshold, wherein the pressure sensor unit includes an airway pressure sensor, and the feedback signal is a pressure signal having an airway pressure component—which is obvious over Meyyappan in at least [0063], [0124-125], [0127], [0196] as detailed above. More specifically, Meyyappan [0124] discloses “one or more sensors 48 can be part of a feedback control scheme for regulating the stimulation administered to the patient. The plurality of sensors 48 can transmit data to the stimulator 24 indicative of one or more of the following: …and/or other physiological or mechanical parameters.”; and in [0125] discloses “The term “pressure” as used herein includes, but is not limited to, Airway Pressure, Alveolar Pressure, Ventilator Pressure, Esophageal Pressure, Gastric Pressure, Transdiaphragmatic Pressure, Intra-Thoracic Pressure Positive End-Expiratory Pressure or Pleural Pressure”; and in [0127] discloses “system 20 can additionally … include a breath sensor 50 for sensing parameters of the ventilator 32… breath sensor 50…can monitor and/or measure several ventilation parameters and communicate such parameters to the stimulator 24… breath sensor 50 can be part of …a feedback control scheme for regulating the stimulation administered to the patient. The sensed ventilation parameters may include, but not limited to, airflow (inspired and/or expired), volume, pressure (airway, esophageal, gastric, and/or some combination/derivative of the former)…other sensors may aid in the procurement of one or more ventilation parameters.” and in [0196] “system 20 …may make use of any patient response signal (feedback) that will help indicate that pacing is required.” (emphasis added), and thus, Meyyappan as a whole makes obvious wherein the sensor unit comprises a pressure sensor unit to sense a pressure of a respiratory system of the patient, and wherein occurrence of the abnormality is based on a positive end-expiratory pressure (PEEP) being below a predefined pressure threshold, wherein the pressure sensor unit includes an airway pressure sensor, and the feedback signal is a pressure signal having an airway pressure component as now explicitly, positively and specifically recited by the Applicants in independent claim 55.
Second, with respect to Applicants arguments [B-F] above, amended independents claim 64 recites “wherein the sensor unit comprises a hyperventilation sensor to sense a presence of hyperventilation of the patient, and wherein occurrence of the abnormality is based on a presence of hyperventilation of the patient being identified… or wherein the sensor unit comprises a pressure sensor unit to sense a pressure of the respiratory system of the patient, and wherein occurrence of the abnormality is based on a positive end-expiratory pressure (PEEP) being below a predefined pressure threshold, the pressure sensor unit including an airway pressure sensor and the feedback signal is a pressure signal with an airway pressure component” (emphasis added). Due to inclusion of the “or”, a broad yet reasonable interpretation would exclude the hyperventilation sensor features while including just --wherein the sensor unit comprises a pressure sensor unit to sense a pressure of the respiratory system of the patient, and wherein occurrence of the abnormality is based on a positive end-expiratory pressure (PEEP) being below a predefined pressure threshold, the pressure sensor unit including an airway pressure sensor and the feedback signal is a pressure signal with an airway pressure component—which as detailed above is obvious over Meyyappan in at least [0063], [0124-125], [0127], [0196] and thus, Meyyappan as a whole also makes obvious wherein the sensor unit comprises a pressure sensor unit to sense a pressure of a respiratory system of the patient, and wherein occurrence of the abnormality is based on a positive end-expiratory pressure (PEEP) being below a predefined pressure threshold, wherein the pressure sensor unit includes an airway pressure sensor, and the feedback signal is a pressure signal having an airway pressure component as now explicitly, positively and specifically recited by the Applicants in independent claim 64.
With respect to Applicants’ argument [B] above, stating “Amended independent claim 55 incorporates the allowable subject matter of claim 58, and amended independent claim 64 incorporates the allowable subject matter of claims 67 and 68. The amendments also address the formal objections identified by the Office…the outstanding § 103 rejection of the previously presented versions of claims 55 and 64 is rendered moot, and withdrawal of the rejection and allowance of present independent claims 55 and 64 are respectfully requested”, Examiner notes that Applicant additionally, added “wherein the sensor unit comprises a pressure sensor unit to sense a pressure of the respiratory system of the patient” features as a mutually exclusive option using the term “or”. As detailed above, this “wherein the sensor unit comprises a pressure sensor unit to sense a pressure of the respiratory system of the patient’ feature is rendered obvious over Meyyappan in at least [0063], [0124-125], [0127], [0196]. Examiner suggests merging claim 81 into claim 55 and claim 66 into claim 64 to overcome prior art.
As per Applicants, independent claim 64 as amended, recite similar limitations as noted above with respect to Claim 55. Therefore, the reasons discussed and proffered above with respect to Claim 55, also apply to independent claim 64.
For the above reasons, the 35 U.S.C. § 103 rejection of claims 55 and 64 as now explicitly, positively and specifically recited by the Applicants still applies and is being maintained at this time. Please also cross-reference detailed claims 55 and claim 64 interpretations, claim limitation mapping to prior art disclosed features and method steps and detailed explanations above. Examiner suggests merging claim 81 into claim 55 and claim 66 into claim 64 to overcome prior art.
Issues Raised and Arguments/Remarks to Rejections Based On Prior Art presented on Pages 14-15 of Applicant’s Amendment dated 09/04/2026 where Applicant’s’ remarks inter alia that:
35 U.S.C. § 103 Rejection of Dependent Claims 57, 59-63, 66, 69-70, 72-83.
[a] Dependent claims 57, 59-63, 66, 69-70, and 72-79 depend, directly or through intervening claims, from their respective allowable independent claims 55 and 64. If an independent claim is nonobvious under 35 U.S.C. § 103, then any claim depending therefrom is nonobvious. MPEP § 2143.03 (citing In re Fine, 837 F.2d 1071 (Fed. Cir. 1988)). Thus, dependent claims 57, 59-63, 66, 69-70, and 72-79 are allowable at least due to their dependence on allowable independent claim and for the additional features they recite, which are not disclosed by the cited references.
[b] Accordingly, claim 80 is patentable at least by virtue of its dependency from allowable independent claim 64, as well as for the additional features it recites, which are not disclosed by the cited references.
[c] Accordingly, claim 81 is patentable at least by virtue of its dependency from allowable independent claim 56, as well as for the additional features it recites, which are not disclosed by the cited references.
[d] Accordingly, claim 82 is patentable at least by virtue of its dependency from allowable independent claim 55, as well as for the additional features it recites, which are not disclosed by the cited references.
[e] Accordingly, claim 83 is patentable at least by virtue of its dependency from allowable independent claim 55, as well as for the additional features it recites, which are not disclosed by the cited references.
[f] In view of the foregoing amendments and remarks, Applicant respectfully submits that all claims in the application are now in condition for allowance. Accordingly, withdrawal of the rejections and allowance of all the claims is respectfully requested.
Applicants’ arguments with respect to dependent claims 57, 59-63, 66, 69-70, 72-83 solely based on their dependency on respective independent claims been considered but are not persuasive. Applicants’ arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the dependent claims 57, 59-63, 66, 69-70, 72-83 define a patentable invention based on their dependency on base claims without specifically pointing out how the language of the dependent claims patentably distinguishes them from the references.
Conclusion
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/SUNITA REDDY/Primary Examiner, Art Unit 3791
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