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 .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on December 8, 2025 has been entered. By this amendment, claims 1, 10, 12, 18, 19, 21, 30, and 31 are amended, claims 17 and 22-24 are cancelled, and claims 1-4, 7-16, 18-21, 30, and 31 are now pending in the application, with claims 22-24 withdrawn from further consideration as being drawn to a non-elected invention.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on June 13, 2025 has/have been acknowledged and is/are being considered by the Examiner.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-4, 7-10, 13-16, 19-21, 30, and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Bolea (U.S. 2012/0089199, previously cited) in view of Douglas et al. (U.S. 2018/0189989), and further in view of Arnold et al. (U.S. 2015/0165200). Regarding claim 1, Bolea discloses a system for aiding a user in breathing during a sleep session of the user (“the present invention provides, in exemplary non-limiting embodiments, devices, systems and methods for nerve stimulation for OSA therapy”, paragraph [0007]), the system comprising: a respiration monitoring device (respiration sensors 74) configured to be positioned inside the user adjacent to a thoracic cavity of the user (see Figure 2 and “the respiration sensors 74 disposed adjacent lung tissue and/or intercostal muscles outside the pleural space”, paragraph [0039]), the respiration monitoring device including a sensor 74 configured to generate respiration data associated with respiration of the user (“the respiration sensors 74 disposed adjacent lung tissue and/or intercostal muscles outside the pleural space”, paragraph [0039]); a stimulation device 64 configured to be positioned inside the user adjacent to a tongue of the user (see Figure 2 and “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”, paragraph [0039]), the stimulation device including a stimulator that is configured to provide electrical stimulation to one or more branches of a nerve of the user that are adjacent to the tongue of the user (“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”, paragraph [0039]), the stimulation device being physically separated from the respiration monitoring device (see Figure 2) and communicatively coupled with the respiration monitoring device via a wireless communication protocol (“Generally, the respiratory sensor(s) may be internal/implanted or external, and may be connected to the neurostimulator via a wired or wireless link.”, paragraph [0054]); an external sensor configured to be positioned outside the user, the external sensor configured to generate physiological data (“the respiration sensors) may comprise a variety of different design embodiments, both implanted and external, and may be positioned at different anatomical sites. Generally, the respiratory sensor(s) may be internal/implanted or external, and may be connected to the neurostimulator via a wired or wireless link.”, paragraph [0054] and “external respiratory effort sensors 916/918”, paragraph [0197]); a memory storing machine-readable instructions (“The INS may contain a microprocessor and memory for storing and processing data and algorithms.”, paragraph [0046]); and a control system 20 including one or more processors configured to execute the machine- readable instructions (“The INS may contain a microprocessor and memory for storing and processing data and algorithms.”, paragraph [0046]) to: determine, based at least in part on the generated respiration data associated with the respiration of the user, a respiration signal for the user (“the closed-loop process 400 may include the initial step of sensing respiration 350 using bio-Z, for example, and optionally sensing other parameters 360 indicative of respiration or other physiologic process.”, paragraph [0137]); identify, within the respiration signal, one or more inhalation portions (“a default algorithm may be provided to predict onset of inspiration from fiducial data ”, paragraph [0163]) and one or more exhalation portions (“detecting expiratory onset from the sensed signal”, claim 75); based at least in part on the identified one or more inhalation portions, determine a predicted start time for a future inhalation of the user; and cause the stimulation device to provide electrical stimulation to the one or more branches of the nerve at a stimulation time that is based at least in part on the predicted start time for the future inhalation of the user ( stimulation of the hypoglossal nerve may be triggered to occur during the inspiratory phase of respiration”, paragraph [0161]). However, Bolea fails to disclose determining that the generated data associated with the respiration of the user is valid based on the generated physiological data, in other words, Bolea fails to disclose using the data from the external sensor to validate the data obtained from the internal sensor. Douglas teaches a sensor device 200 configured to measure physiological parameters, including respiratory rate (“data from electromyography (EMG) sensors, temperature sensors, elevation sensors, light intensity sensors, pressure sensors, force sensors, and electrical sensors may be correlated with health information, such as blood-glucose levels, heartrate, blood pressure, oxygen saturation levels, body temperature, respiratory rate, and/or gait”, paragraph [0039]), wherein the sensor device includes both internal sensors 342 and external sensors 344 (see Figure 2), where the external sensors are used to verify data from internal sensors 342 (“In some embodiments, external sensor(s) 344 may be used to verify data from internal sensor(s) 342.”, paragraph [0064]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Bolea to include determining that the generated data associated with the respiration of the user is valid based on the generated physiological data, as taught by Douglas, in order to ensure that the data from the internal sensors are an accurate representation of a user’s respiration.
Further, Bolea fails to disclose that the control system is configured to analyze the generated respiration data to determine a number of respiration events the user experienced over a period of time during the sleep session and based at least in part on the number of respiration events, determine one or more parameters for an electrical stimulation to be provided to the one or more branches of the nerve. Arnold teaches a method and system to detect a respiratory pattern of a patient, identify an apnea event, and provide neuro-stimulation in response to the identification of the apnea event (see Abstract). Arnold teaches that the control system is configured to analyze the generated respiration data to determine a number of respiration events the user experienced over a period of time during the sleep session and based at least in part on the number of respiration events, determine one or more parameters for an electrical stimulation to be provided to the one or more branches of the nerve (see Figure 4 and “physiologic conditions of the patient during each AE (e.g., sleep state, respiratory pattern, time when AE begins/ends, duration of AE, a count of the number of AEs during one sleep cycle or one evening, a number of AE occurring in a select period of time, a duration of at least one AE, The AET-NS therapy information may include the parameter values for the therapy as delivered, when the therapy was delivered, whether adjustments were made to the therapy, how many therapy attempts were made, include a number of times that the AET-NS therapy is delivered, a count of a success rate of the AET-NS therapy, and the like). The termination results may indicate whether the AET-NS therapy was successful in terminating the AE, what physiologic state the patient was in or changed to upon termination of the AE, and the like. For example, the method may record the sleep state of the patient after the AE is terminated.”, paragraph [0102]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Bolea in view of Douglas to include that the control system is configured to analyze the generated respiration data to determine a number of respiration events the user experienced over a period of time during the sleep session and based at least in part on the number of respiration events, determine one or more parameters for an electrical stimulation to be provided to the one or more branches of the nerve, as taught by Arnold, in order to tailor the electrical stimulation to the apnea events that are occurring during each sleep session and as it has been held that combining prior art elements according to known methods to yield predictable results requires only routine skill in the art. KSR Int'l Co. v. Teleflex Inc., 127 S.Ct. 1727, 1742, 82 USPQ2d 1385, 1396 (2007).
Regarding claim 2, Bolea discloses that the stimulation time is the predicted start time for the future inhalation of the user (“the hypoglossal nerve is triggered about 300 mS before inspiration. Accordingly, a predictive algorithm may be used to predict the inspiratory phase, and deliver stimulation accordingly”, paragraph [0161]).
Regarding claim 3, Bolea discloses that the stimulation is “triggered about 300 mS before inspiration” (see paragraph [0161]) and, thus, the stimulation time is at least about 50 milliseconds prior to the predicted start time for the future inhalation of the user.
Regarding claim 4, Bolea discloses the invention substantially as claimed, but fails to disclose that the stimulation time is within 100 milliseconds of the predicted start time for the future inhalation of the user, instead the stimulation is “triggered about 300 mS before inspiration” (see paragraph [0161]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Bolea in view of Douglas such that the stimulation time is within 100 milliseconds of the predicted start time for the future inhalation of the user, as it has been held that discovering an optimum value of a result effective variable (the time of stimulation prior to inspiration) involves only routine skill in the art. MPEP 2144.05
Regarding claim 7, Bolea discloses that the future inhalation of the user is a next inhalation of the user (“the hypoglossal nerve is triggered about 300 mS before inspiration. Accordingly, a predictive algorithm may be used to predict the inspiratory phase, and deliver stimulation accordingly”, paragraph [0161]).
Regarding claim 8, it is respectfully submitted that inhalation by definition “corresponds to the user breathing in” and expirations by definition “correspond to the user breathing out”. As such, Bolea is considered to disclose the invention as claimed.
Regarding claim 9, Bolea discloses that the nerve is a hypoglossal nerve (“the nerve cuff electrode 64 disposed on a nerve (e.g., hypoglossal nerve (HGN))”, paragraph [0039]).
Regarding claim 10, Bolea discloses that the control system is further configured to execute the machine-readable instructions to: compare the determined number of respiration events with a threshold, wherein the determining the one or more parameters is based at least in part on the determined number of respiration events exceeding the threshold (“Generally, if the CV is greater than 0.20 over a one minute period then person is awake. Also generally, if the CV is less than 0.20 over a one-minute period then person is asleep. These events may be flagged for the step of fiducial extraction 378 wherein data (e.g., event duration, CV, PP range, PPmin, PPmax, etc.) may be time stamped and stored with an event identifier. If CV is greater than 1.00 over a 20 second period then body movement is affecting the bio-Z signal. By way of example, not limitation, if body movement is detected, then (a) stimulation may be delivered in an open loop fashion (e.g., based on historical respiratory data); (b) stimulation may be delivered constantly the same or lower level; or (c) stimulation may be turned off during the period of movement. The selected stimulation response to detected movement may be preset by the physician programmer or by the patient control device. Other stimulation responses may be employed as will be described hereinafter.”, paragraph [0149]).
Regarding claim 13, Bolea discloses that the one or more parameters of the electrical stimulation include an amount of time during a breath that the electrical stimulation is provided, a percentage of an amount of time during a breath when the electrical stimulation is provided, a percentage of an amount of time during inhalation when the electrical stimulation is provided, a percentage of an amount of time during exhalation when the electrical stimulation is provided, frequency, intensity, duration, dwell time, rise time in a pulse, a ratio of on-time to an off-time, or any combination thereof (“stimulation may be delivered in an open loop fashion (e.g., based on historical respiratory data); (b) stimulation may be delivered constantly the same or lower level; or (c) stimulation may be turned off during the period of movement”, paragraph [0149]).
Regarding claim 14, Bolea discloses that the control system is coupled to a belt configured to be worn by the user (Bolea discloses an alternative embodiment including an implanted device 910 adjacent the thoracis cavity, but with an external control system 920 located adjacent the waist and capable of being coupled to a belt, see Figures 51A-51B and paragraphs [0188]-[0190]).
Regarding claim 15, Bolea discloses a power supply coupled to the belt, the power supply being configured to wirelessly power the respiration monitoring device (“Because power is supplied to the internal components via an inductive link, the internal components may be chronically implanted without the need for replacement of an implanted battery,”, paragraph [0192]).
Regarding claim 16, Bolea discloses that respiration monitoring device includes a built-in power supply (“One of several different embodiments of the neurostimulator may be implemented. For example, the neurostimulator may be an internal/implanted neurostimulator (INS) powered by a long-life primary battery or rechargeable battery, or an external neurostimulator (ENS) wirelessly linked (e.g., inductive) to an implanted receiver unit connected to the leads.”, paragraph [0046]).
Regarding claim 19, Bolea discloses a method for aiding a user in breathing during a sleep session, the method comprising: receiving respiration data associated with respiration of a user from a respiration monitoring device, the respiration monitoring device being positioned inside the user adjacent to a thoracic cavity of the user (see Figure 2 and “the respiration sensors 74 disposed adjacent lung tissue and/or intercostal muscles outside the pleural space”, paragraph [0039]); receiving physiological data from an external sensor, the external sensor being positioned outside the user (“the respiration sensors) may comprise a variety of different design embodiments, both implanted and external, and may be positioned at different anatomical sites. Generally, the respiratory sensor(s) may be internal/implanted or external, and may be connected to the neurostimulator via a wired or wireless link.”, paragraph [0054] and “external respiratory effort sensors 916/918”, paragraph [0197]); determining, based at least in part on the respiration data associated with respiration of the user, a respiration signal for the user (“the closed-loop process 400 may include the initial step of sensing respiration 350 using bio-Z, for example, and optionally sensing other parameters 360 indicative of respiration or other physiologic process.”, paragraph [0137]); determining, based at least in part on the respiration signal, a predicted start time for a future inhalation of the user (“a default algorithm may be provided to predict onset of inspiration from fiducial data ”, paragraph [0163]); and causing a stimulation device to provide electrical stimulation to one or more branches of a nerve of the user at the predicted start time (“stimulation of the hypoglossal nerve may be triggered to occur during the inspiratory phase of respiration”, paragraph [0161]), the stimulation device being positioned inside the user adjacent to a tongue of the user and being physically separated from the respiration monitoring device (see Figure 2 and “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”, paragraph [0039]) and communicatively coupled with the respiration monitoring device via a wireless communication protocol (“Generally, the respiratory sensor(s) may be internal/implanted or external, and may be connected to the neurostimulator via a wired or wireless link.”, paragraph [0054]). However, Bolea fails to disclose determining that the respiration data associated with the respiration of the user is valid based on the physiological data, in other words, Bolea fails to disclose using the data from the external sensor to validate the data obtained from the internal sensor. Douglas teaches a sensor device 200 configured to measure physiological parameters, including respiratory rate (“data from electromyography (EMG) sensors, temperature sensors, elevation sensors, light intensity sensors, pressure sensors, force sensors, and electrical sensors may be correlated with health information, such as blood-glucose levels, heartrate, blood pressure, oxygen saturation levels, body temperature, respiratory rate, and/or gait”, paragraph [0039]), wherein the sensor device includes both internal sensors 342 and external sensors 344 (see Figure 2), where the external sensors are used to verify data from internal sensors 342 (“In some embodiments, external sensor(s) 344 may be used to verify data from internal sensor(s) 342.”, paragraph [0064]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Bolea to include determining that the respiration data associated with the respiration of the user is valid based on the physiological data, as taught by Douglas, in order to ensure that the data from the internal sensors are an accurate representation of a user’s respiration.
Further, Bolea fails to disclose analyzing the respiration data to determine a number of respiration events the user experienced over a period of time during the sleep session and based at least in part on the number of respiration events, determining one or more parameters for an electrical stimulation to be provided to the one or more branches of a nerve of the user. Arnold teaches a method and system to detect a respiratory pattern of a patient, identify an apnea event, and provide neuro-stimulation in response to the identification of the apnea event (see Abstract). Arnold teaches analyzing the respiration data to determine a number of respiration events the user experienced over a period of time during the sleep session and based at least in part on the number of respiration events, determining one or more parameters for an electrical stimulation to be provided to the one or more branches of a nerve of the user (see Figure 4 and “physiologic conditions of the patient during each AE (e.g., sleep state, respiratory pattern, time when AE begins/ends, duration of AE, a count of the number of AEs during one sleep cycle or one evening, a number of AE occurring in a select period of time, a duration of at least one AE, The AET-NS therapy information may include the parameter values for the therapy as delivered, when the therapy was delivered, whether adjustments were made to the therapy, how many therapy attempts were made, include a number of times that the AET-NS therapy is delivered, a count of a success rate of the AET-NS therapy, and the like). The termination results may indicate whether the AET-NS therapy was successful in terminating the AE, what physiologic state the patient was in or changed to upon termination of the AE, and the like. For example, the method may record the sleep state of the patient after the AE is terminated.”, paragraph [0102]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Bolea in view of Douglas to include analyzing the respiration data to determine a number of respiration events the user experienced over a period of time during the sleep session and based at least in part on the number of respiration events, determining one or more parameters for an electrical stimulation to be provided to the one or more branches of a nerve of the user, as taught by Arnold, in order to tailor the electrical stimulation to the apnea events that are occurring during each sleep session and as it has been held that combining prior art elements according to known methods to yield predictable results requires only routine skill in the art. KSR Int'l Co. v. Teleflex Inc., 127 S.Ct. 1727, 1742, 82 USPQ2d 1385, 1396 (2007).
Regarding claim 20, Bolea discloses that the respiration signal includes one or more inhalation portions and one or more exhalation portions (“a default algorithm may be provided to predict onset of inspiration from fiducial data ”, paragraph [0163] and “detecting expiratory onset from the sensed signal”, claim 75).
Regarding claim 21, Bolea discloses that the determining the predicted start time for the future inhalation of the user is based at least in part on the one or more inhalation portions of the respiration signal (“a default algorithm may be provided to predict onset of inspiration from fiducial data ”, paragraph [0163]).
Regarding claim 30, Bolea discloses a second respiration monitoring device 74, wherein data from the second respiration monitoring device is combined with the generated respiration data to determine the respiration signal for the user (see Figure 1 and “Generally, the impedance electrodes 74A-74D may comprise current emitting electrodes and voltage sensing electrodes for detecting respiration by changes in bio-impedance. The number, spacing, anatomical location and function of the impedance electrodes will be described in more detail hereinafter.”, paragraph [0055]).
Regarding claim 31, it is respectfully submitted that because the respiration sensors 74 are each distinct electrodes, both the second respiration monitoring device and the respiration monitoring device are provided in separate housings and configured to be positioned inside the user adjacent to the thoracic cavity of the user.
Claims 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Bolea (U.S. 2012/0089199, previously cited) in view of Douglas et al. (U.S. 2018/0189989) and Arnold et al. (U.S. 2015/0165200) as applied to claims 1-4, 7-10, 13-16, 19-21, 30, and 31 above, and further in view of Meadows et al. (U.S. 2011/0112601, previously cited). Bolea in view of Douglas and Arnold discloses the invention substantially as claimed, including measuring obstructive sleep apnea (OSA) events over time (“A clean respiratory waveform may then be extracted 376 along with other waveforms indicative of specific events such as obstructive sleep apnea (OSA), central sleep apnea (CSA), hypopnea, sleep stage, etc. Specific fiducial points may then be extracted and identified (e.g., type, time, and value).”, paragraph [0138]), but fails to disclose that the events are measured over the period of an hour or that the threshold is ten respiration events per hour. Meadows teaches that the severity of OSA is “determined by dividing the number of episodes of apneas and hypopneas lasting ten seconds or more by the number of hours of sleep” and an index “between 5 and 10 is low, between 10 and 15 is mild to moderate, over 15 is moderately severe, and anything over 30 indicates severe sleep apnea.” (paragraph [0006]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Bolea in view of Douglas and Arnold to observe the events over the course of an hour with ten respiration events per hour being a threshold for changing to the stimulation parameters, as taught by Meadows, in order to accurately detect and treat sleep apnea events.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Bolea (U.S. 2012/0089199, previously cited) in view of Douglas et al. (U.S. 2018/0189989) and Arnold et al. (U.S. 2015/0165200) as applied to claims 1-4, 7-10, 13-16, 19-21, 30, and 31 above, and further in view of Kent (U.S. 2019/0117966, previously cited). Bolea in view of Douglas and Arnold discloses the invention substantially as claimed, but fails to disclose that the wireless communication protocol is Bluetooth. Kent teaches systems and methods for treating sleep disordered breathing (Abstract) that includes wireless communication between an external device 14 and an implantable neurostimulator 12 and utilizes Bluetooth, WIFI, or MICS wireless communication (see paragraph [0028]). It would have been obvious to one having ordinary skill in the art before the effective filing date to modify the invention of Bolea in view of Douglas and Arnold to include Bluetooth, as taught by Kent, as it has been held that choosing from a finite number of identified, predictable solutions (the wireless protocols recited by Kent), with a reasonable expectation of success requires only routine skill in the art. KSR Int'l Co. v. Teleflex Inc., 127 S.Ct. 1727, 1742, 82 USPQ2d 1385, 1396 (2007).
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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/TAMMIE K MARLEN/Primary Examiner, Art Unit 3796