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 § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-10 and 15-19 are rejected under 35 U.S.C. 103 as being unpatentable over Schulhauser et al (U.S. Patent Application Publication Number: US 2021/0290957 A1, hereinafter “Schulhauser”- APPLICANT CITED) in view of Dieken et al (U.S. Patent Application Publication Number: US 2020/0147376 A1, hereinafter “Dieken”- APPLICANT CITED).
Regarding claims 1 and 15, Schulhauser teaches a system (e.g. 10 Fig. 1) and method for treatment of Central Sleep Apnea (CSA) and Obstructive Sleep Apnea (OSA) in a subject (e.g. [0002]), comprising:
an implantable pulse generator (IPG) (e.g. 16 Fig.1) coupled to a first electrode and a second electrode, wherein the first electrode is configured to stimulate a hypoglossal nerve (HGN) (e.g. 11 Fig.1, [0032]) of the subject and the second electrode is configured to stimulate a phrenic nerve (PN) (e.g. 27 Fig.1) of the subject (e.g. [0023] -[0025]); and
a controller comprising a processor (e.g. 57 Fig.5) and memory (e.g. 60 Fig.5), communicatively linked to the IPG and configured to:
command the first electrode to deliver a stimulation signal to stimulate the HGN which innervates an upper airway muscle for alleviating an obstruction caused by OSA (e.g. [0028]: OSA and CSA and Mixed OSA and CSA therapies are delivered), and
command the second electrode to deliver an inspiration stimulation signal to stimulate the PN based on a duty cycle for treating CSA by driving a respiration pace for the subject (e.g. [0028], [0026]: Synchronous therapy by synchronizing or coordinating therapy with a patient's breathing, [0092]: stimulation is only applied during inspiration in a ramping pattern to produce a smooth diaphragm contraction). Schulhauser teaches synchronous therapy by synchronizing or coordinating therapy with a patient's breathing and providing stimulation for treating a combination of OSA by stimulating the HGN and CSA by stimulating the PN but does not specifically teach that the first electrode is commanded to deliver the stimulation signal to stimulate the HGN according to the respiration pace driven by the inspiration stimulation signal (provided to the PN).
In a similar field of endeavor, Dieken teaches a system and method to treat multiple type sleep apnea and that the upper airway patency target nerve (e.g. 130 Fig. 6) is the HGN (e.g. [0104]) to treat OSA and the PN (e.g. [0091] : stimulation of the central sleep apnea-related nerve (e.g. phrenic nerve) generally coincides with (e.g. is synchronous with) the inspiratory phase of a respiratory cycle.) to treat CSA and further teaches triggering the delivery of the stimulation of the upper airway patency-related nerve relative to the delivery of stimulation to the central sleep apnea-related second nerve (e.g. [0101]). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Schulhauser so that the first electrode is commanded to deliver the stimulation signal to stimulate the HGN according to the respiration pace driven by the inspiration stimulation signal (provided to the PN) as taught by Dieken in order to provide the predictable results of a more reliable basis on which to trigger stimulation of the upper airway patency-related nerve, and thereby ensure patency of the upper airway.
Regarding claims 2 and 16, Schulhauser in view of Dieken teaches the claimed invention as discussed above and Schulhauser teaches the controller is further configured to: provide a signal for when to start and stop commanding the first electrode (e.g. [0027]: processing circuitry of system 10 may control the delivery of therapy, e.g., turn the stimulating therapy on and off, based on sensing feedback from sensing circuitry 56 (FIG. 5)).
Regarding claims 4 and 18, Schulhauser in view of Dieken teaches the claimed invention as discussed above and Schulhauser teaches wherein both the first electrode is commanded to deliver the stimulation to the HGN and the second electrode is commanded to deliver the inspiration stimulation signal to the PN to treat CSA without detection or classification of an apneic event (e.g. [0026]: asynchronous mode, [0027]: default or safety mode).
Regarding claims 5 and 19, Schulhauser in view of Dieken teaches the claimed invention as discussed above and Schulhauser teaches the controller is further configured to: detect whether a sleep disordered breathing (SDB) is likely to occur in the subject based on sensor data obtained from one or more sensors, wherein the second electrode is commanded to deliver the inspiration stimulation signal to the PN based on a determination that the SDB is likely to occur in the subject based on the sensor data (e.g. [0026] : synchronous mode. [0092]: stimulation is only applied during inspiration in a ramping pattern to produce a smooth diaphragm contraction; 56 Fig.5: sensing circuitry [0069], [0074]-[0077]: Sensing circuitry 56 may include a variety of additional or alternative circuitry for sensing a respiration signal, or other signals indicative of apnea or useful for distinguishing between “healthy/normal”, OSA, CSA, and mixed OSA/CSA respiration).
Regarding claim 6, Schulhauser in view of Dieken teaches the claimed invention as discussed above and Schulhauser teaches a microphone configured to determine information indicative of snoring(e.g. [0077]: Sensing circuitry 56 includes acoustical sensors or a microphone for detecting vibrations in upper airway 48 which may be indicative of the onset of OSA) but does not specifically teach that the SDB is determined likely to occur in the subject based on a presence of snoring.
In a similar field of endeavor, Dieken teaches an accelerometer utlitization engine 1800 comprises an acoustic engine 1850 to determine if snoring is occurring per snoring function (e.g. [0221]) which may be indicative to sleep quality, sleep disordered breathing events (e.g. [0272],[273]). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Schulhauser to further include the accelerometer utilization engine for determining snoring to determine SDB as taught by Dieken in order to provide the predictable results of more accurately determining the state of the patient.
Regarding claim 7, Schulhauser in view of Dieken teaches the claimed invention as discussed above and Schulhauser teaches a posture sensor (e.g. [0069],[0074] : sensors configured to sense posture or position of patient 14, IMD 16 may include one or more accelerometers, such as a 3-axis accelerometer 84, to determine a posture of patient 14), but does not specifically teach that the SDB is determined likely to occur in the subject based on a determination that the body position of the subject is laying facing supine.
In a similar field of endeavor, Dieken teaches an accelerometer utilization engine 1800 that comprises a posture function 1840 to identifying whether a patient is in a generally vertical position or a lying down position, such as a supine position ( e.g. [0212]) as soon as possible which may be more likely to produce sleep disordered breathing (e.g. [0218],[0219]). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Schulhauser to further include the accelerometer utilization engine to determine a supine body position to determine SDB as taught by Dieken in order to provide the predictable results of more accurately determining the state of the patient.
Regarding claim 8, Schulhauser in view of Dieken teaches the claimed invention as discussed above and Schulhauser teaches sensing electrocardiogram (e.g. [0069]), but does not specifically teach a heart rate sensor configured to determine heart rate of the subject, wherein the SDB is determined likely to occur in the subject based on a determination that the heart rate of the subject is slow.
In a similar field of endeavor, Dieken teaches a heart rate sensor configured to determine heart rate of the subject and wherein the SDB is determined likely to occur in the subject based on a determination that the heart rate of the subject is slow (e.g. [0145],[0146],[0147]: during central apnea events where no respiratory effort is present, RSA is reduced or is absent). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Schulhauser to include heart rate sensing and determining that SDB is likely to occur based on determination of a slow heart rate as taught by Dieken in order to provide the predictable results of increasing reliability of inspiration detection and/or detection of central and/or obstructive sleep apneas.
Regarding claim 9, Schulhauser in view of Dieken teaches the claimed invention as discussed above except for the one or more sensors being configured to determine sleep stages, wherein the SDB is determined likely to occur in the subject based on a determination that the subject is in a rapid eye movement (REM) stage.
In a similar field of endeavor, Dieken teaches determining sleep stages, wherein the SDB is determined likely to occur in the subject based on a determination that the subject is in a rapid eye movement (REM) stage (e.g. [0228]: sleep stage determination engine, [0229], [0238]). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Schulhauser to include sleep stage determination to determine SDB is likely to occur based on REM stage as taught by Dieken in order to provide the predictable results of increasing reliability of detection and treatment of central and/or obstructive sleep apneas.
Regarding claim 10, Schulhauser in view of Dieken teaches the claimed invention as discussed above and Schulhauser teaches an electromyography sensor (EMG) configured to detect signals generated by muscles of a subject (e.g. [0077]) except for the SDB is determined likely to occur in the subject based on a determination that the detected signals sent from the PN to a diaphragm are waning.
In a similar field of endeavor, Dieken teaches sensing EMG, the SDB is determined likely to occur in the subject based on a determination that the detected signals sent from the PN to a diaphragm are waning (e.g. EMG 2240 Fig.35, [0265]: whether the apnea is obstructive or central in origin, etc. For instance, central apneas may show no respiratory EMG effort). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Schulhauser to include EMG sensing and determination of SDB based on EMG as taught by Dieken in order to provide the predictable results of increasing reliability of detection of central and/or obstructive sleep apneas.
Regarding claim 3 and 17, Schulhauser in view of Dieken teaches the claimed invention as discussed above except for delivering, via the first electrode, the stimulation signal to the HGN at least 500 milliseconds before delivering, via the second electrode, the inspiration stimulation signal to a diaphragm via the PN or motor point to produce inspiration. It would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the teachings of Schulhauser in view of Dieken with the stimulation to the HGN at least 500 milliseconds before delivering the stimulation signal to a diaphragm via the PN or motor point, because Applicant has not disclosed that the time range of 0-500 milliseconds provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with stimulation to the HGN and PN as taught by Schulhauser in view of Dieken, because it provides increased reliability of detection and treatment of central and/or obstructive sleep apneas and since it appears to be an arbitrary design consideration which fails to patentably distinguish over Schulhauser in view of Dieken. Therefore, it would have been an obvious matter of design choice to modify Schulhauser in view of Dieken to obtain the invention as specified in the claims.
Claims 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Schulhauser et al (U.S. Patent Application Publication Number: US 2021/0290957 A1, hereinafter “Schulhauser”- APPLICANT CITED) in view of Dieken et al (U.S. Patent Application Publication Number: US 2020/0147376 A1, hereinafter “Dieken”- APPLICANT CITED) and further in view of Rondoni et al (U.S. Patent Application Publication Number: US 2023/0095780 A1, hereinafter “Rondoni”).
Regarding claims 11 and 12, Schulhauser in view of Dieken teaches the claimed invention as discussed above except for the controller being further configured to: generate a probabilistic function based on a data source that includes predictive data indicative of apnea and hypopnea events determined based on a sleep study, wherein the probabilistic function is generated or tuned based on machine learning algorithms, wherein the SDB is determined likely to occur in the subject based on the probabilistic function and wherein a determination that SDB is likely to occur is further determined using probabilistic indicators corresponding to one or more of blood oxygen level, blood pressure, heart rate, heart rate variability, electrocardiogram (ECG) data, electroencephalogram (EEG) data, electromyography (EMG) results, impedance, cardiothoracic impedance, sleep state, accelerometer data, or auscultation, and combinations thereof.
Rondoni teaches a controller being further configured to: generate a probabilistic function based on a data source that includes predictive data indicative of apnea and hypopnea events determined based on a sleep study, wherein the probabilistic function is generated or tuned based on machine learning algorithms, wherein the SDB is determined likely to occur in the subject based on the probabilistic function using probabilistic indicators corresponding to one or more of heart rate, heart rate variability, electrocardiogram (ECG) data, electroencephalogram (EEG) data, electromyography (EMG) results, sleep state, accelerometer data and combinations thereof ( e.g.[0258], [0281], [0353]-[0359]). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to further modify the controller in the teachings of Schulhauser in view of Dieken to use a trained machine learning algorithms that generate a probabilistic function based on probabilistic indicators as taught by Rondoni in order to provide the predictable results of more granular controls of a patient's individual signals, which may enable balancing simple control with the capability of complex control when desired.
Claims 13, 14 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Schulhauser et al (U.S. Patent Application Publication Number: US 2021/0290957 A1, hereinafter “Schulhauser”- APPLICANT CITED) in view of Dieken et al (U.S. Patent Application Publication Number: US 2020/0147376 A1, hereinafter “Dieken”- APPLICANT CITED) and further in view of Koh et al (U.S. Patent Number: US 7636600 B1, hereinafter “Koh”).
Regarding claim 13, 14 and 20, Schulhauser in view of Dieken teaches the claimed invention as discussed above except for the IPG is further coupled to a third electrode, wherein the third electrode is configured to stimulate an additional target related to a body organ of the subject, wherein the controller is further configured to: monitor one or more common comorbidities associated with the OSA and/or the CSA; and command the third electrode to deliver a stimulation to the additional target related to the body organ to alleviate or treat comorbid indications, wherein the additional body organ is one of a carotid baroreceptor, a vagus nerve, a target on or near a heart, a target on or near a liver, a target on or near a pancreas, a carotid sinus, or a target on or near a stomach of the subject and wherein the system further comprises one or more sensors configured to determine sensor data indicative of one or more of atrial fibrillation, acute heart failure, reduced blood oxygen levels, elevated glucose levels, and combinations thereof, wherein the controller is further configured to sound an alarm, generate an event record, deliver bioelectric therapy, deliver a medication or therapeutic compound, or combinations thereof, based on the sensor data being determined to be indicative of one or more of atrial fibrillation, acute heart failure, reduced blood oxygen levels, elevated glucose levels, and combinations thereof.
In a similar field of endeavor, Koh teaches a system and method for detecting and treating OSA and CSA (e.g. Fig.11) and also teaches that the stimulation device is configured to monitor for arrhythmia and fibrillation associated with the OSA and/or the CSA; and delivering, via a third electrode that is part of the IPG, a stimulation to an additional target on the heart (e.g. Col. 7 lines 4-23). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Schulhauser in view of Dieken to have a third electrode as part of the IPG and configure the controller to monitor for arrhythmia and fibrillation and deliver therapy as taught by Koh in order to provide the predictable results of providing a more effective therapy.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Ternes et al (U.S. Patent Application Publication Number: US 2015/0283383 A1, hereinafter “Ternes”) teaches a system and method for determining and treating obstructive sleep apnea (OSA) by stimulating the HGN and central sleep apnea (CSA) by applying phrenic nerve stimulation in combination with using a CRM device (e.g. [0027],[0028]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MALLIKA DIPAYAN FAIRCHILD whose telephone number is (571)270-7043. The examiner can normally be reached Monday- Friday 8 am-5pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, BENJAMIN KLEIN can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MALLIKA D FAIRCHILD/Primary Examiner, Art Unit 3792