DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: figure 1 does not include the following reference signs 212, 213 mentioned in the description in at least [0143]; figure 1 does not include the following reference signs 11, 12, 13 mentioned in the description in at least [0145]; figure 1 does not include the following reference sign 53 mentioned in the description in at least [0147].
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. 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.
Specification
The disclosure is objected to because of the following informalities:
“…Such fields allow for directly stimulate muscular structures or indirectly stimulate muscular structures via the nervous system or via other muscular structures…” in para.[0012] needs to be corrected. A suggested correction is --Such fields
“…wherein the abnormality is when a positive end-expiratory pressure, PEEP, being below a predefined pressure threshold…” in para. [0024] needs to be corrected. A suggested correction is -- wherein the abnormality is when a positive end-expiratory pressure (PEEP)
“Thus, with the ventilation arrangement of the third aspect of the invention mechanical ventilation, e.g. by means of a breathing pump, or continuous positive airway pressure ventilation can be improved and provided more gently and efficient” in para. [0075] needs to be corrected. A suggested correction is -- Thus, with the ventilation arrangement of the third aspect of the invention mechanical ventilation, e.g. by means of a breathing pump, or continuous positive airway pressure ventilation can be improved and provided more gently and efficiently [[efficient]].—
“Alternatively, the induction device can comprise one or two electrodes for generate electrical fields for stimulate the nerve of the patient” in [00143] needs to be corrected. A suggested correction is -- Alternatively, the induction device can comprise one or two electrodes for [[generate]] generating electrical fields [[for]] to stimulate the nerve of the patient--.
“Alternatively or additionally, the sensor unit 4 can includes a pressure sensor for measure the positive end-expiratory pressure, PEEP. If that is below a predefined value” in [00149] needs to be corrected. A suggested correction is -- Alternatively or additionally, the sensor unit 4 can includes a pressure sensor for measure the positive end-expiratory pressure (PEEP)
“the field generator can receive an activation signal from the flow sensor 41 upon detection of detection of an abnormality” in [00150] needs to be corrected. A suggested correction is --the field generator can receive an activation signal from the flow sensor 41 upon detection of --.
Appropriate correction is required.
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant's cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Following claims are objected to because of the following informalities:
Each of claims 55, 58-61, 63-64, 72-73, 76-77 include at least one or more “such that” intended result limitations which needs to be corrected to avoid intended result/functional limitation interpretation (see MPEP 2111.04) which would raise question as to whether the limitation proceeding “such that” is even required or not required. For example amend claim 55 “wherein the field generator of the induction device is configured to be positioned at a human or animal patient such that an inspiration muscular structure of the patient is stimulable by the spatial field” to –wherein the field generator of the induction device is configured to be positioned at a human or animal patient [[such]] in a manner that an inspiration muscular structure of the patient is stimulable by the spatial field—and claim 64 “positioning a field generator of an induction device at the patient, the field generator being configured to generate a spatial field, such that an inspiration muscular structure of the patient is stimulable by the spatial field …activating the field generator of the induction device such that the spatial field is generated when the feedback signal is indicative of an abnormality” to ---positioning a field generator of an induction device at the patient, the field generator being configured to generate a spatial field, [[such]] in a manner that an inspiration muscular structure of the patient is stimulable by the spatial field …activating the field generator of the induction device [[such]] in a manner that the spatial field is generated when the feedback signal is indicative of an abnormality--.
Each of device claims 55-56, 58, 60-61 include at least one or more conditional limitations which needs to be corrected to avoid conditional limitation recitation based interpretation which would raise question as to what occurs when the condition is not met. As an example, examiner suggests amending claim 55 lines 12-14 “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 when the feedback signal is indicative of an abnormality” to -- 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 indicative of the occurrence of an abnormality—or --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 indicating the occurrence of an abnormality-- avoid conditional limitation recitation which would raise question as to what occurs when the condition is not met.
Each of method claims 64, 66-69, 73, 77 include at least one or more conditional limitations which needs to be corrected in light of MPEP 2111.04(II) which states the broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met. Here, in each of method claims 64, 66-69, 73, 77, method step limitations when broadly yet reasonably interpreted under MPEP 2111.04(II) qualify as a contingent limitation i.e. this step is not necessarily required to be performed if the conditions are not met and thus applied art need not necessarily disclose this contingent/conditional method step. As an example, examiner suggests, amending method claim 64 “activating the field generator of the induction device such that the spatial field is generated when the feedback signal is indicative of an abnormality” to -- activating the field generator of the induction device [[such]] in a manner that the spatial field is generated based upon the feedback signal indicative of the occurrence of an abnormality – or -- activating the field generator of the induction device [[such]] in a manner that the spatial field is generated based upon the feedback signal indicating the occurrence of an abnormality --.
Each of claim 56 and claim 66 recite “a positive end-expiratory pressure, PEEP,” which needs to be corrected. A suggested correction is --a positive end-expiratory pressure (PEEP), [[PEEP,]]—since PEEP is an acronym of positive end-expiratory pressure.
Each of claims 68, 70, 56, 58-59 include numerous acronyms/abbreviations. At least first occurrence of each acronym/abbreviation should be spelled out in full. Appropriate correction is required.
Appropriate correction is required.
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 55-77 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 55 recites “the feedback signal is indicative of an abnormality” which renders this claim unclear. More specifically, it is unclear as what qualifies as an abnormality in the absence of any comparative reference or any definition, whether it is objective, subjective, based on population metrics or patient historical data or based on predetermined/preset thresholds or something else.
Claim 64 recites “the feedback signal is indicative of an abnormality” which renders this claim unclear. More specifically, it is unclear as what qualifies as an abnormality in the absence of comparative reference or any definition, whether it is objective, subjective, based on population metrics or patient historical data or based on predetermined/preset thresholds or something else.
Claim 56 in line 11 recites “and/or” which renders this claim unclear. A broad yet reasonable interpretation “and/or” in the context used in claim 56 encompasses the interpretation of “and/or” as if reciting “or”. As recited it is unclear as which of limitations in claim 56 lines 2-14 are optional and which are required.
Claim 58 in line 10 recites “and/or” which renders this claim unclear. A broad yet reasonable interpretation “and/or” in the context used in claim 58 encompasses the interpretation of “and/or” as if reciting “or”. As recited it is unclear as which of limitations in claim 58 lines 2-16 are optional and which are required.
Dependent claims 57, 59-63, 65, 70-73, 75, 77 when analyzed as a whole are held to be patent ineligible under 35 U.S.C. 112(b) because the additional recited limitations fail to cure the 35 U.S.C. 112(b) issue in their respective base claims. Consequently, dependent claims 57, 59-63, 65, 70-73, 75, 77 are also rejected under 35 U.S.C. 112(b) based on their direct/indirect dependency on their respective base claims.
Claim Interpretation
Claims terms where relevant are being interpreted in light of definitions enumerated in instant application specification [0009], [0012-0013], [0017], [0020-0023], [0070], [0156].
Please note that USPTO personnel are to give claims their broadest reasonable interpretation in light of the supporting disclosure. In re Morris, 127 F.3d 1048, 1054-55, 44 USPQ2d 1023, 1027-28 (Fed. Cir. 1997). Limitations appearing in the specification but not recited in the claim should not be read into the claim. E-Pass Techs., Inc. v. 3Com Corp., 343 F.3d 1364, 1369, 67 USPQ2d 1947, 1950 (Fed. Cir. 2003) (claims must be interpreted "in view of the specification" without importing limitations from the specification into the claims unnecessarily). In re Prater, 415 F.2d 1393, 1404-05, 162 USPQ 541, 550-551 (CCPA 1969). See also In re Zletz, 893 F.2d 319, 321-22, 13 USPQ2d 1320, 1322 (Fed. Cir. 1989) ("During patent examination the pending claims must be interpreted as broadly as their terms reasonably allow.... The reason is simply that during patent prosecution when claims can be amended, ambiguities should be recognized, scope and breadth of language explored, and clarification imposed.... An essential purpose of patent examination is to fashion claims that are precise, clear, correct, and unambiguous. Only in this way can uncertainties of claim scope be removed, as much as possible, during the administrative process.").
Claim Rejections - 35 USC § 102
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 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.
Claims 55-57, 60-65, 69, 71-77 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Meyyappan et al. (Pub. No.: US 20150367127 A1, hereinafter referred to as “Meyyappan”).
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], [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 such 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 such 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] 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] 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”), 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 when the feedback signal is indicative of an abnormality ( Meyyappan in at least fig. 1, fig. 4, fig. 15, [0042], [0124], [0127], [0129] for example discloses control unit 60 is configured to evaluate the feedback signal received from the sensor unit 48, 50, and to activate the field generator of the induction device 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”).
As per dependent Claim 56, Meyyappan further discloses stimulation arrangement wherein the sensor unit comprises: a pressure sensor unit to sense a pressure of a respiratory system of the patient, and wherein the abnormality is when a positive end-expiratory pressure, PEEP, is below a predefined pressure threshold, the pressure sensor unit including at least one of an airway pressure sensor, and the feedback signal is a pressure signal having an airway pressure component, and 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; and/or a sensor to sense an oxygen content of a gas supplied from the respiratory system to the patient, and wherein the abnormality is when the oxygen content is below a predefined oxygenation threshold ( Meyyappan in at least [0063], [0124], [0127], [0196]. see at least Meyyappan “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.”).
As per dependent Claim 57, Meyyappan further 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 60, Meyyappan further discloses stimulation arrangement wherein the field generator of the induction device comprises an electrode and the spatial field generated by the field generator is an electric field, or a coil design and the spatial field generated by the field generator is an electro-magnetic field; and/or wherein the field generator of the induction device is configured to be positioned at the patient such that a Phrenic nerve is in the spatial field generated by the field generator when 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 a 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, Meyyappan further 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 such 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 such 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 such 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 such 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 such that the second spatial field is not generated when the feedback signal received from the sensor unit is 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, Meyyappan further discloses stimulation arrangement comprising an input structure configured to set the predefined pressure threshold and/or 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 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, Meyyappan further 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 such 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], [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, such 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, such 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] 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] 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 such that the spatial field is generated when the feedback signal is indicative of an abnormality ( Meyyappan in at least fig. 1, fig. 4, fig. 15, [0042], [0124], [0127], [0129] 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”).
As per dependent Claim 65, Meyyappan further 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 69, Meyyappan further 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 the abnormality is when the oxygen content is 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 71, Meyyappan further discloses stimulation method wherein the field generator of the induction device comprises: an electrode and the spatial field generated by the field generator is an electric field; or a coil design and the spatial field generated by the field generator is an electro-magnetic field ( 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 a 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 72, Meyyappan further 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 such 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 such 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 such 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 such 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, Meyyappan further discloses stimulation method comprising de-activating the second field generator of the induction device such that the second spatial field is not generated when the feedback signal is 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, Meyyappan further 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, Meyyappan further 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, Meyyappan further discloses stimulation method comprising manually activating the field generator of the induction device such 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, Meyyappan further discloses stimulation method wherein the field generator of the induction device is configured to be positioned at the patient such that a Phrenic nerve is in the spatial field generated by the field generator when the induction device is activated ( Meyyappan fig. 1, [0112] for example discloses the field generator of the induction device is configured to be positioned at the patient such 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.”).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 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.
Claims 59 and 70 are rejected under 35 U.S.C. 103 as being unpatentable over Meyyappan
As per dependent Claim 59, Meyyappan discloses stimulation arrangement of claim 55 (see Claim 55 analysis above),
Meyyappan does not necessarily require generating pulses of the spatial field having a frequency of about 10 Hz to about 35 Hz.
However, Meyyappan disclosure in light of instant application specification as-filed makes obvious stimulation arrangement control unit is configured to activate the induction device such that the field generator generates pulses of the spatial field having a frequency of about 10 Hz to about 35 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 70, Meyyappan discloses the stimulation method of claim 64 (see Claim 64 analysis above),
Meyyappan does not necessarily require generating pulses of the spatial field having a frequency of about 10 Hz to about 35 Hz.
However, Meyyappan disclosure in light of instant application specification as-filed makes obvious 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 Hz to about 35 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]).
Claim 67 is rejected under 35 U.S.C. 103 as being unpatentable over Meyyappan in view of Yun (Pub. No.: US 20090024176 A1, hereinafter referred to as “Yun”).
As per dependent Claim 67, Meyyappan discloses stimulation method of claim 64 (see claim 64 above).
Meyyappan does not explicitly disclose the hyperventilation sensor features i.e. hyperventilation sensor to sense a presence of hyperventilation of the patient, and wherein the abnormality is when a presence of hyperventilation of the patient is identified, the hyperventilation sensor unit.
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.”), comprising:
wherein the sensor unit comprises a hyperventilation sensor to sense a presence of hyperventilation of the patient (Yun in at least fig. 1, fig. 3, [0043-0045] for example discloses the sensor unit comprises a hyperventilation sensor to sense a presence of hyperventilation of the patient. 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”), and wherein the abnormality is when a presence of hyperventilation of the patient is identified, the hyperventilation sensor unit (Yun in at least fig. 1, fig. 3, [0024], [0043], [0064] for example discloses the sensor unit comprises a hyperventilation sensor to sense a presence of hyperventilation of the patient, and wherein the abnormality is when a presence of hyperventilation of the patient is identified, the hyperventilation sensor unit. See at least Yun [0043] “Hyperventilation may be detected when the respiratory rate or frequency is above a programmed rate … device may be programmed to first detect the hyperventilation and wait for a preprogrammed time to be considered apnea.”;).
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 sensor types 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, by further including hyperventilation sensor to sense a presence of hyperventilation of the 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 58, 66, 68, dependent claims 58, 66, 68 would be contingently allowable if rewritten 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 to include all of the limitations of the base claim and any intervening claims in addition to overcoming any other rejections/objections enumerated above.
Additionally, as per dependent claims 58, 66, 68, dependent claims 58, 66, 68 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 58, none of the prior art discloses stimulation arrangement … wherein the sensor unit comprises a hyperventilation sensor to sense a presence of hyperventilation of the patient, and the abnormality is when a presence of hyperventilation of the patient is identified, the hyperventilation sensor comprising 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 such that the evaluated airflow signal represents hyperventilation when a breathing frequency determined from the airflow signal exceeds a threshold frequency of 15 per minute or more… 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 such that the evaluated carbon dioxide signal represents hyperventilation when a carbon dioxide level determined from the carbon dioxide signal is below a carbon dioxide threshold of 22 mmol/L or less including all of the limitations, features, combination and arrangement of features of their respective base claim and any intervening claims.
As per dependent Claim 66, none of the prior art discloses a stimulation method of stimulating a human or animal patient to ventilate the patient or to assist breathing of the patient wherein the sensor unit comprises: a pressure sensor unit to sense a pressure of the respiratory system of the patient, and wherein the abnormality is when a positive end-expiratory pressure, PEEP, is 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, and 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 68, none of the prior art a stimulation method of stimulating a human or animal patient to ventilate the patient or to assist breathing of the patient 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 when a breathing frequency determined from the airflow signal exceeds 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 when a carbon dioxide level determined from the carbon dioxide signal is below a carbon dioxide threshold of 22 mmol/L or less 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 system claim 58 and method claim 66 and method claim 68.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure and/or the claims.
US 5857957 A to Lin discloses a device and a method for stimulating/recruting diaphragm muscles in a subject. More specifically, Lin discloses a device for stimulating diaphragm muscles in order to induce a cough function in a mammalian subject through electromagnetic induction and a method of treatment which provides a procedure which is non-invasive to individuals to stimulate cough functions in individuals including those individuals such as quadraplegic patients and in patients suffering from multiple sclerosis.
Prior art US 20150314133 A1 to Yamashiro discloses methods and devices comprising magnetic, radio frequency burst, and light stimulation to modulate muscle contraction. The magnetic stimulation may be delivered to the muscle using one or more coils similar to that disclosed.
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/SUNITA REDDY/Primary Examiner, Art Unit 3791