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 .
Claim Rejections - 35 USC § 112
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 6 recites the limitation "blanking duration" in line 3. It is unclear what qualifies a blanking duration in regards to the method and system. The term blanking could refer to a period of holding breath before the exhalation or the period after exhalation. Due to lack of clarity the claim is rendered indefinite.
Claim 7 recites the limitation "blanking duration" in line 5. It is unclear what qualifies a blanking duration in regards to the method and system. The term blanking could refer to a period of holding breath before the exhalation or the period after exhalation. Due to lack of clarity the claim is rendered indefinite.
Claim 39 recites the limitation "blanking duration" in line 1. It is unclear what qualifies a blanking duration in regards to the method and system. The term blanking could refer to a period of holding breath before the exhalation or the period after exhalation. Due to lack of clarity the claim is rendered indefinite.
Claim 40 recites the limitation "blanking duration" in line 1. It is unclear what qualifies a blanking duration in regards to the method and system. The term blanking could refer to a period of holding breath before the exhalation or the period after exhalation. Due to lack of clarity the claim is rendered indefinite.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-3, 6, 39-44, and 47-49 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being unpatentable by Bolea(WO 2015123360 A1).
Regarding claim 1, Bolea discloses the a method for controlling delivery of a neurostimulation therapy, the method comprising: identifying an onset of an exhalation phase of a respiratory cycle of a patient; initiating a timer at the onset of the exhalation phase, wherein the timer is configured to identify expiration of a therapy withholding duration; and in response to the expiration of the therapy withholding duration, providing neurostimulation therapy in coordination with an onset of an inspiration phase of the respiratory cycle of the patient(After explained in more detail below, in order to deliver a stimulus to a patient in accordance with the principles of the present disclosure, a start of stimulation may be calculated by first predicting the time intervals between the start of expiration (or the end of inspiration) for subsequently occurring respiratory cycles[0111]. To reduce nerve and muscle fatigue, the stimulus may be delivered for only a portion of the respiratory cycle, such as during inspiration which corresponds to negative pressure in the upper airway. Stimulation may be thus triggered as a function of respiration as detected by respiration sensing lead 70 in a closed-loop feedback system. By way of example, the stimulus may be triggered to turn on at the end of expiration (or at the beginning of inspiration), and triggered to turn off at the beginning of expiration (or at the end of inspiration).[051]. According to another aspect of the present disclosure, a method of applying a sleep apnea nerve stimulation therapy to a subject may include detecting a respiratory waveform of the subject with a sensor coupled to the subject. The respiratory waveform may include at least one peak magnitude and at least one respiratory cycle both corresponding to a respiratory time period. The method may also include identifying an inspiration portion of the at least one respiratory cycle corresponding to at least one of an inspiration or an attempted inspiration of the subject, the inspiration portion corresponding to an inspiratory time period. The method may also include comparing the inspiratory time period to the respiratory time period to indicate a disordered breathing event. The method may also include commencing a corrective nerve stimulation therapy[020]).
Regarding claim 2, Bolea discloses the method of claim 1, wherein the therapy withholding duration is based on a sensed respiratory rate of the patient(According to other aspects of the disclosure, the method above may include one or more of the following features. The subject may be a simulated subject and the respiratory waveform of the subject may be provided by a respiratory waveform simulator configured to generate the respiratory waveform. Commencing an initial nerve stimulation therapy during the time period and prior to the commencing of the corrective nerve stimulation therapy, the corrective nerve stimulation therapy having a greater amplitude than the initial stimulation therapy. Transitioning from the corrective nerve stimulation therapy to the initial nerve stimulation therapy at a time subsequent to the future projected time. Commencing an initial setting of a nerve stimulation device, the initial setting configured to withhold therapy during at least a portion of the time period prior to the commencing of the corrective nerve stimulation therapy[017]).
Regarding claim 3, Bolea discloses the method of claim 2, further comprising sensing a respiratory rate of the patient using an acceleration signal from an accelerometer when the accelerometer is implanted in a submandibular region of the patient(In another exemplary embodiment, a signal from an implanted accelerometer may indicate the presence of disordered breathing or the presence of arousals, which can be used to increase or decrease the stimulation amplitude to mitigate arousals[0163]. As can be appreciated, the measurement technique used to acquire the respiratory waveform, and the selection of the threshold, may require calibration based on a baseline related to the normal or usual respiratory effort for the patient, and to account for the configuration of the impedance, airflow, pressure, accelerometer, or other sensors measuring the respiratory effort[0124]. As shown in FIG. 2, and by way of example, not limitation, the implanted components 20 of the neurostimulator system 10 are implanted in a patient P with the INS 50 disposed in a subcutaneous pocket, the stimulation lead body 62 disposed in a subcutaneous tunnel, the nerve cuff electrode 64 disposed on a nerve (e.g., hypoglossal nerve (HGN)) innervating a muscle (e.g., genioglossus muscle, not shown) controlling the upper airway, the respiration sensing lead body 72 disposed in a subcutaneous tunnel, and the respiration sensors 74 disposed adjacent lung tissue and/or intercostal muscles outside the pleural space[050]).
Regarding claim 6, Bolea discloses the method of claim 1, comprising determining the therapy withholding duration based on a measured duration of an exhalation phase and a blanking duration(As can be appreciated, the end of inspiration and the beginning of expiration may be separated from each other by an insignificant time when exhalation immediately follows inhalation, or be separated by a longer time corresponding to the holding of a breath or the obstruction of an exhalation. The waveform 5500 can also define an expiration period or phase EP which is a time period over which air exits the lungs, with the boundaries of the expiration period EP defined by an expiration start EP1 (or M) and an expiration end (EP2). Likewise, the waveform 5500 can define an inspiration period or phase IP which is a time period over which air enters the lungs and includes attempts to bring air into the lungs (such as during obstructed or disordered breathing events), with the boundaries of the inspiration period IP defined by an inspiration start IP1 and an inspiration end IP2 (or M). As stated previously, the peak M can indicate inspiration end IP2 as well as indicate expiration start EP1 when the time between inspiration end IP2 and expiration start EP1 is zero or insignificant. As also state previously, the peak M can be expressed as a plateau when there is a difference in the timing of inspiration end IP2 and expiration start EP1 representing a holding or obstruction of an exhalation for said different in the timing[0114]. As can also be appreciated, when an anticipated disordered breathing event is treated with a therapy delivered prior to the anticipated or detected intersection point 5504 and 5514, the subject may no longer cross the threshold 5502 or 5512 due to the effectiveness of the corrective nerve stimulation therapy and/or the effectiveness of an increase in the existing application of a nerve stimulation therapy. In such a situation, the application of the corrective nerve stimulation therapy or the increase in the level of existing therapy can be timed to terminate when an estimated duration of the anticipated disordered breathing event has passed[0128]).
Regarding claim 39, Bolea discloses the method of claim 6, further comprising determining the blanking duration based on an intensity of the neurostimulation therapy(The following amplitude parameters can be adjusted: stimulation amplitude, stimulation intensity, current, voltage, pulse width, and frequency of pulse train. The signals used to indicate that stimulation amplitude may be increased or decreased to optimize therapy can include signals from a bio-impedance detector, which may identify disordered breathing and allow adjustments that cause the progressively incremental increase of stimulation levels until a pre-set maximum level is reached or until the disordered breathing is no longer detected[0162]).
Regarding claim 40, Bolea discloses the method of claim 6, further comprising determining the blanking duration based on a duration of one or more previous respiratory cycles of the patient(In the exemplary embodiment illustrated in FIG. 14A, the respiratory waveform 5500 can be defined by a number of respiratory cycles measured over time, such as a respiratory cycle A RCA and/or a respiratory cycle B RCB as illustrated in FIG. 14A. The respiratory cycles A and B illustrated in FIG. 14A represent one or more such cycles distributed over a time period. The respiratory cycles A and B can be obtained by measurements of respiration movements, such as those described previously, and can be determined by calculations based on earlier measured respiratory cycle[0112]).
Regarding claim 41, Bolea discloses a system comprising: first housing configured for implantation in a submandibular region or cervical region of a patient; a first electrode lead coupled to the first housing and configured to be disposed in the submandibular region, wherein at least one electrode on the first electrode lead is configured to be disposed at or near a first branch of a hypoglossal nerve of the patient to provide a first neurostimulation therapy that is configured to treat a sleep disorder or breathing disorder of the patient; a processor circuit configured to: identify an onset of an exhalation phase of a respiratory cycle of a patient; initiate a timer at the onset of the exhalation phase, wherein the timer is configured to identify expiration of a therapy withholding duration; and in response to the expiration of the therapy withholding duration, provide a control signal to a signal generator circuit to provide neurostimulation therapy in coordination with an onset of an inspiration phase of the respiratory cycle of the patient(According to another aspect of the present disclosure, an implantable nerve stimulation system may be configured to deliver a stimulation therapy. The system may include a sensor configured to detect a respiration signal of the subject. The respiration signal may define a respiratory waveform of the subject. The system may also include a stimulation electrode configured to deliver the stimulation therapy to a hypoglossal nerve of the subject. The system may also include a processor communicating with the sensor and the stimulation electrode. The processor may be configured to receive an input including the respiratory waveform and further configured to generate a therapy signal responsive to the input. The therapy signal may include the stimulation therapy. The respiratory waveform may include a plurality of respiratory cycles each corresponding to at least one of a breath and an attempted breath of the subject. The respiratory waveform may further include a breathing pattern over a period of time. The breathing pattern may include a repeating pattern of a plurality of respiratory cycles followed by at least one respiratory cycle corresponding to a disordered breathing event. The therapy signal may include a series of stimulation pulses. The series of stimulation pulses may be coordinated with the breathing pattern[010]).
Regarding 42, Bolea discloses the system of claim 41, further comprising one or more physiological sensors configured to measure a corresponding one or more physiological parameters of the patient(The respiratory sensor(s) may measure, for example, respiratory airflow, respiratory effort (e.g., diaphragmatic or thoracic movement), intra-pleural pressure, lung impedance, respiratory drive, upper airway EMG, changes in tissue impedance in and around the lung(s) including the lungs, diaphragm and/or liver, acoustic airflow or any of a number other parameters indicative of respiration[066]).
Regarding claim 43, Bolea discloses the system of claim 42, wherein the one or more physiological sensors comprises an accelerometer configured to provide an acceleration signal that includes information about the respiratory cycle of the patient(In another exemplary embodiment, a signal from an implanted accelerometer may indicate the presence of disordered breathing or the presence of arousals, which can be used to increase or decrease the stimulation amplitude to mitigate arousals[0163]. As can be appreciated, the measurement technique used to acquire the respiratory waveform, and the selection of the threshold, may require calibration based on a baseline related to the normal or usual respiratory effort for the patient, and to account for the configuration of the impedance, airflow, pressure, accelerometer, or other sensors measuring the respiratory effort[0124]. As shown in FIG. 2, and by way of example, not limitation, the implanted components 20 of the neurostimulator system 10 are implanted in a patient P with the INS 50 disposed in a subcutaneous pocket, the stimulation lead body 62 disposed in a subcutaneous tunnel, the nerve cuff electrode 64 disposed on a nerve (e.g., hypoglossal nerve (HGN)) innervating a muscle (e.g., genioglossus muscle, not shown) controlling the upper airway, the respiration sensing lead body 72 disposed in a subcutaneous tunnel, and the respiration sensors 74 disposed adjacent lung tissue and/or intercostal muscles outside the pleural space[050]).
Regarding claim 44, Bolea discloses the system of claim 43, wherein the processor circuit is further configured to identify the onset of the exhalation phase of the respiratory cycle of the patient based on the acceleration signal(The breathing pattern may be determined from a detection of at least one of a signal peak, a signal minimum, an expiration detection, and an inspiration detection. The breathing pattern may include a trend defined by at least one of the plurality of respiratory cycles, a plurality of peak magnitudes of the plurality of respiratory cycles, a plurality of minima magnitudes of the plurality of respiratory cycles, a plurality of expiration detections of the plurality of respiratory cycles, and a plurality of inspiration detections of the plurality of respiratory cycles[009]).
Regarding 47, Bolea discloses a method for controlling delivery of a neurostimulation therapy, the method comprising: determining a respiratory rate of the patient; identifying an onset of an exhalation phase of a respiratory cycle of a patient; initiating a timer at the onset of the exhalation phase; and in response to the expiration of the timer, providing neurostimulation therapy in coordination with an onset of an inspiration phase of the respiratory cycle of the patient(After explained in more detail below, in order to deliver a stimulus to a patient in accordance with the principles of the present disclosure, a start of stimulation may be calculated by first predicting the time intervals between the start of expiration (or the end of inspiration) for subsequently occurring respiratory cycles[0111]. To reduce nerve and muscle fatigue, the stimulus may be delivered for only a portion of the respiratory cycle, such as during inspiration which corresponds to negative pressure in the upper airway. Stimulation may be thus triggered as a function of respiration as detected by respiration sensing lead 70 in a closed-loop feedback system. By way of example, the stimulus may be triggered to turn on at the end of expiration (or at the beginning of inspiration), and triggered to turn off at the beginning of expiration (or at the end of inspiration).[051]. According to another aspect of the present disclosure, a method of applying a sleep apnea nerve stimulation therapy to a subject may include detecting a respiratory waveform of the subject with a sensor coupled to the subject. The respiratory waveform may include at least one peak magnitude and at least one respiratory cycle both corresponding to a respiratory time period. The method may also include identifying an inspiration portion of the at least one respiratory cycle corresponding to at least one of an inspiration or an attempted inspiration of the subject, the inspiration portion corresponding to an inspiratory time period. The method may also include comparing the inspiratory time period to the respiratory time period to indicate a disordered breathing event. The method may also include commencing a corrective nerve stimulation therapy[020]).
Regarding claim 48, Bolea discloses the method of claim 47, further comprising withholding neurostimulation therapy until the expiration of the timer(The therapy can be started when the patient falls asleep, after the activation of a timer, or after a preset period of time[0134]).
Regarding claim 49, Bolea discloses the method of claim 48, wherein the expiration of the timer corresponds to the expiration of a therapy withholding duration, and wherein the therapy withholding duration is based on the determined respiratory rate of the patient(According to other aspects of the disclosure, the method above may include one or more of the following features. The subject may be a simulated subject and the respiratory waveform of the subject may be provided by a respiratory waveform simulator configured to generate the respiratory waveform. Commencing an initial nerve stimulation therapy during the time period and prior to the commencing of the corrective nerve stimulation therapy, the corrective nerve stimulation therapy having a greater amplitude than the initial stimulation therapy. Transitioning from the corrective nerve stimulation therapy to the initial nerve stimulation therapy at a time subsequent to the future projected time. Commencing an initial setting of a nerve stimulation device, the initial setting configured to withhold therapy during at least a portion of the time period prior to the commencing of the corrective nerve stimulation therapy. Transitioning from the corrective nerve stimulation therapy to recommence the initial setting at a time subsequent to the future projected time[017]).
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, 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Bolea in view of Schipper(US 20220095952 A1).
Regarding claim 7, Bolea discloses the method of claim 6, but fails to disclose comprising: sensing the respiratory rate of the patient using an acceleration signal from an accelerometer when the accelerometer is implanted in a submandibular region of the patient; and determining the blanking duration based on interpolated values of the acceleration signal.
However, Schipper teaches “FIG. 12 shows a possible implementation of a system based on a neural network. Signals input to the neural network 90 are the 1D respiratory effort signal 92 and an instantaneous heart rate (IHR) signal 94 which has been derived from an inter-beat interval detector 96. This signal is for example interpolated at a fixed sampling rate[0172]. The example above is obtains both a respiratory signal and a respiration rate from the 3D acceleration signal. The processing to obtain the respiration rate is optional (step 74 in FIG. 6), and there are other possible uses of the preceding respiratory signal, which may be considered to represent a 1D respiratory effort signal[0159]. The third plot shows output probabilities for apnea and hypopnea events as determined by the neural network, and the fourth plots shows that, after using predefined thresholds, the intervals corresponding to the duration of the events can be established[0176]”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the sleep apnea nerve stimulation therapy of Bolea with the interpolated data of the respiration detection system of Schipper. Doing so would specify data manipulation to determine parameters of the stimulation.
Claim(s) 37, 38, and 45 are rejected under 35 U.S.C. 103 as being unpatentable over Bolea in view of Thorp(WO 2022020489 A1).
Regarding claim 37, Bolea discloses method of claim 3, but fails to explicitly state wherein sensing the respiratory rate of the patient includes: determining a moving average of the acceleration signal over a first duration; determining a moving standard deviation based on the moving average; determining a first specified threshold based on the moving standard deviation; identifying respiration phase transitions based on a relationship between the first specified threshold and the acceleration signal; and determining the respiratory rate based on the identified respiration phase transitions.
However, Thorp teaches “In some examples, the sensed changes (e.g. an increase or decrease) in chest wall movement may be due to increased respiratory effort or changes in motion shape due to the changes in motion (resulting in different harmonic content or other non-linear behavior). [00318] In some examples, the values and/or fiducials of the sensed respiratory motion may comprise at least one of: (A) a standard deviation of an amplitude of a respiratory motion signal, wherein the difference between the second value and the first value comprises an increase in the standard deviation; and (B) a signal-to-noise ratio in respiration signal, wherein the difference between the second value and the first value comprises a decrease[00317]. With further reference to FIG. 53A, in some examples the disease burden indicator 4040 may be expressed as quantitative value, and may comprise an index, rating, etc. regarding the particular disease. In some examples, the disease burden indicator 4040 may be expressed with regard to a reference value, threshold, criteria, etc. or without regard to a reference value, threshold, criteria, etc. In some examples, the disease burden indicator 4040 may be expressed with regard to changes (e.g. increase, decrease, no change) relative to a baseline value of disease burden or without regard to a baseline value of disease burden[00463]”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the sleep apnea nerve stimulation therapy of Bolea with the metric values of the disease burden indication unit of Thorp. Doing so would specify the average and standard deviation values obtained for the respiratory signals and measuring how they compare to the threshold to check for irregularities.
Regarding claim 38, Bolea in view of Thorp teaches the method of claim 37, wherein identifying the respiration phase transitions includes identifying respective times when a value of the acceleration signal meets or exceeds the first specified threshold(Bolea - The amplitude of the impedance peaks M of respiratory waveform 5501, or the peaks P of respiratory waveform 551 1, can be compared to a threshold value 5502 or 5512 to determine the level of effort required during a respiratory cycle. A high or otherwise significant level of respiratory effort is indicated when an impedance peak value M exceeds or surpasses (rises above) a threshold 5502, which can identify disordered or atypical breathing indicative of an obstructive sleep apnea event[0124]).
Regarding claim 45, Bolea discloses the system of claim 43, but fails to explicitly state wherein: the therapy withholding duration is based on a respiratory rate of the patient; and wherein the processor circuit is configured to determine the respiratory rate of the patient by: determining a moving average of the acceleration signal over a first duration; determining a moving standard deviation based on the moving average; determining a first specified threshold based on the moving standard deviation; identifying respiration phase transitions based on a relationship between the first specified threshold and the acceleration signal; and determining the respiratory rate based on the identified respiration phase transitions.
However, Thorp teaches “In some examples, the sensed changes (e.g. an increase or decrease) in chest wall movement may be due to increased respiratory effort or changes in motion shape due to the changes in motion (resulting in different harmonic content or other non-linear behavior). [00318] In some examples, the values and/or fiducials of the sensed respiratory motion may comprise at least one of: (A) a standard deviation of an amplitude of a respiratory motion signal, wherein the difference between the second value and the first value comprises an increase in the standard deviation; and (B) a signal-to-noise ratio in respiration signal, wherein the difference between the second value and the first value comprises a decrease[00317]. With further reference to FIG. 53A, in some examples the disease burden indicator 4040 may be expressed as quantitative value, and may comprise an index, rating, etc. regarding the particular disease. In some examples, the disease burden indicator 4040 may be expressed with regard to a reference value, threshold, criteria, etc. or without regard to a reference value, threshold, criteria, etc. In some examples, the disease burden indicator 4040 may be expressed with regard to changes (e.g. increase, decrease, no change) relative to a baseline value of disease burden or without regard to a baseline value of disease burden[00463]”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the sleep apnea nerve stimulation therapy of Bolea with the metric values of the disease burden indication unit of Thorp. Doing so would specify the average and standard deviation values obtained for the respiratory signals and measuring how they compare to the threshold to check for irregularities.
Allowable Subject Matter
Claims 4, 5, and 46 are 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIA CATHERINE ANTHONY whose telephone number is (703)756-4514. The examiner can normally be reached 7:30 am - 4:30 pm, EST, M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CARL LAYNO can be reached at (571) 272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARIA CATHERINE ANTHONY/Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796
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