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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 April 23, 2026 has been entered.
Response to Arguments
The Applicant filed a Request for Continued Examination, Amendments to the Claims, and Remarks on April 23, 2026 in response to the Examiner’s Final Office Action, mailed January 23, 2026.
Amendments to the Claims
At this time, claims 1-8 and 10-27 are pending. Claims 4-6, 11, and 14 have been amended. Claims 28-41 and 77-80 have been cancelled. The Applicant has added no new claims. The Applicant asserts that no new matter is added. Claim 1 is in independent form. (Remarks, pg. 7)
Claim Objections
Claims 14 and 36 were previously objected under due to typographical errors . The Applicant has submitted amended claim 14 and cancelled claim 36 accordingly. (Remarks, pg. 7)
Applicant’s arguments with respect to claims 14 and 36 have been fully considered and are persuasive. The claim objection of January 23, 2026 has been withdrawn.
Claim Rejections - 35 U.S.C. § 112
Claims 4-6 and 11 were previously rejected under 35 U.S.C. 112(b). (Remarks, pg. 7)
Applicant’s arguments with respect to claims 14 and 36 have been fully considered and are persuasive. The 35 U.S.C. 112(b) rejection of January 23, 2026 has been withdrawn.
Claim Rejections - 35 U.S.C. § 102 and 103
Moot Claim Rejections
Claims 28-37 and 40-41 were previously rejected under 35 U.S.C. 102(a)(2) as being anticipated by Dieken (previously cited). (Remarks, pg. 10)
These claims were canceled; thus the 35 U.S.C. 102(a)(2) rejection is rendered moot.
Claims 38-41 were previously rejected under 35 U.S.C. 103 in view of Dieken in view of Cho (previously cited). (Remarks, pg. 12)
These claims were canceled; thus 35 U.S.C. 103 rejection is rendered moot.
Traversed Claim Rejections
Claims 1-8, 10, 12-15, 27-30, 33-36, and 77-80 were previously rejected under 35 U.S.C. 102(a)(2) as being anticipated by Mashiach (previously cited). (Remarks, pg. 8-9)
The rejection is moot with respect to claims 28-30, 33-36, and 77-80 which have been canceled. The Applicant respectfully traverses the rejection in regards to pending claims 1-8, 10, 12-15, and 27, making the argument that Mashiach fails to anticipate claim 1 because it does not meet "implanting the housing portion in subcutaneous tissue under the patient's chin" as recited in claim 1. The Applicant argues that Mashiach does not discloses implanting the electrode led and the housing portion “at different anatomical depths” (emphasis added by Applicant), with the electrode lead being implanted in the genioglossus muscle and the housing portion being implanted in subcutaneous tissue.
Claim 11 was previously rejected under 35 U.S.C. 103 in view of Mashiach in view of O’Connor (previously cited). (Remarks, pg. 10-11)
The Applicant has respectfully traversed this rejection for the reason of O’Connor not remedying the argued deficiencies of Mashiach, as discussed in Remarks, pg. 8-9.
Claims 16-19 and 22 were previously rejected under 35 U.S.C. 103 in view of Mashiach in view of Dieken (previously cited). (Remarks, pg. 11)
The Applicant has respectfully traversed this rejection for the reason of Dieken not remedying the argued deficiencies of Mashiach, as discussed in Remarks, pg. 8-9.
Claims 20-21 and 23-26 were previously rejected under 35 U.S.C. 103 in view of Mashiach in view of Dieken and further in view of Cho (previously cited). (Remarks, pg. 11-12)
The Applicant has respectfully traversed this rejection for the reason of Cho not remedying the argued deficiencies of Mashiach, as discussed in Remarks, pg. 8-9.
Applicant’s arguments with respect to the rejection(s) of claim(s) 1-8 and 10-27 under 35 U.S.C. 102(a)(2) and 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new grounds of rejection is made in view of Mashiach, O’Connor, Dieken, and Cho.
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 1-8, 10, 12-15, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Mashiach et al. (US 9, 463,318, hereinafter referred to as Mashiach).
Regarding independent claim 1, Mashiach discloses treatment of sleep apnea via bilateral stimulation. Mashiach further discloses a method of treating sleep apnea in a patient, the method comprising:
A) acquiring a neurostimulator implant (implant unit 110 in Figs. 1-3, 10-13a) comprising a housing portion ([col. 24, li. 33-37]: “…all or some of the circuitry components included in implant 110 may be housed in a rigid housing, as illustrated in FIGS. 13a-b. Rigid housing 1305 may provide the components of implant 110 with additional mechanical and environmental protections.”) and a flexible elongate electrode lead (flexible carrier 161 in Figs. 10-13a) extending from the housing portion ([col. 24, li. 60-62]: “Rigid housing 1305 may include one or more conductive feedthroughs 1308 to make contact with circuitry on flexible carrier 161.”) and having an electrode ([col. 22, li. 25-27]: “…field-generating electrodes 158a and 158b may include two sets of four circular electrodes, provided on flexible carrier 161…”);
B) implanting the electrode lead in the genioglossus muscle of the patient ([col. 44, li. 15-17]); and
D) operating the implanted neurostimulator implant (implant unit 110 in Figs. 1-3, 10-13a) to stimulate a branch of the hypoglossal nerve of the patient ([col. 44, li. 50-58]: “In some embodiments, implant unit 110, including at least one pair of modulation electrodes, e.g. electrodes 158a, 158b, and at least one circuit may be configured for implantation through derma (i.e. skin) on an underside of a subject's chin. When implanted through derma on an underside of a subject's chin, an implant unit 110 may be located proximate to medial terminal fibers 1054 of the medial branch 1052 of a subject's hypoglossal nerve 1051. An exemplary implant location 1070 is depicted in FIG. 19.”).
Though not all embodiments of Mashiach are specific to C) implanting the housing portion in subcutaneous tissue under the patient's chin, it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention that a modified embodiment shown in Mashiach Fig. 20 can teach C) implanting the housing portion in subcutaneous tissue under the patient's chin. Mashiach’s Fig. 20 depicts a flexible carrier 161 (having electrodes) of the implant, with portions of the overall device being implanted at different anatomical depths ([col. 45, li. 52-58]: “…at least a portion of a flexible carrier 161 of the implant is located at a position between the genioglossus muscle 1060 and the geniohyoid muscle 1061. Flexible carrier 161 may be further configured to permit at least one pair of electrodes arranged on flexible carrier 161 to lie between the genioglossus muscle 1060 and the myelohyoid muscle.”). Prior paragraphs of Mashiach show that rigid housing 1305 of implant unit 110 is a separate but connected component to flexible carrier 161. ([col. 24, li. 45-53]; [col. 24, li. 60-62]: “Rigid housing 1305 may include one or more conductive feedthroughs 1308 to make contact with circuitry on flexible carrier 161.”) It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the implant unit 110 of Mashiach to instead be positioned such that the housing portion is implanted in subcutaneous tissue under the chin, while the electrode lead remains implanted in the genioglossus muscle of the patient.
Regarding claim 2, Mashiach discloses operating the implanted neurostimulator implant (implant unit 110 in Figs. 1-3, 10-13a) to stimulate the genioglossus nerve branch and/or the genioglossus muscle ([col. 5, li. 63-67]: “In treating a sleep breathing disorder, implant unit 110 may be located on a genioglossus muscle of a patient. Such a location is suitable for modulation of the hypoglossal nerve, branches of which run inside the genioglossus muscle. “).
Regarding claim 3, Mashiach discloses that the implanted neurostimulator implant (implant unit 110 in Figs. 1-3, 10-13a) is operated to stimulate the genioglossus nerve branch with a first stimulation signal and to stimulate the genioglossus muscle with a second stimulation signal ([col. 5, li. 63-67]; [col. 22, li. 5-12]: “Additionally, implant unit 110 may include electrodes located at a plurality of locations, for example on an end of both a first extension 162a and a second extension 162b of elongate arm 162, as illustrated, for example, in FIG. 11a. Positioning electrodes on two extensions of elongate arm 162 may permit bilateral hypoglossal nerve stimulation, as discussed further below”).
Regarding amended claim 4, Mashiach discloses that the implanted neurostimulator implant (implant unit 110 in Figs. 1-3, 10-13a) is operated to stimulate the genioglossus muscle with a stimulation signal ([col. 5, li. 63-67]: “In treating a sleep breathing disorder, implant unit 110 may be located on a genioglossus muscle of a patient. Such a location is suitable for modulation of the hypoglossal nerve, branches of which run inside the genioglossus muscle. “) having a frequency of between about 2Hz and about 150Hz ([col. 35, li. 52-53]: “…sub-pulses 1030 occur at a frequency of between 25 and 100 Hz.”).
Regarding amended claim 5, Mashiach discloses that the stimulation signal stimulating the genioglossus muscle ([col. 5, li. 63-67]: “In treating a sleep breathing disorder, implant unit 110 may be located on a genioglossus muscle of a patient. Such a location is suitable for modulation of the hypoglossal nerve, branches of which run inside the genioglossus muscle. “) has a peak amplitude of between 0.1mA and 10mA, more specifically between 0.1mA and 5mA ([col. 31, li. 50-55]: “…modulation of a nerve using less than 1.6 mA of current, less than 1.4 mA of current, less than 1.2 mA of current, less than 1 mA of current, less than 0.8 mA of current, less than 0.6 mA of current, less than 0.4 mA of current, and even less than 0.2 mA of current passed between modulation electrodes 158a, 158b.”).
Regarding amended claim 6, Mashiach discloses the implanted neurostimulator implant (implant unit 110 in Figs. 1-3, 10-13a) is operated to stimulate the genioglossus nerve branch ([col. 5, li. 63-67]: “In treating a sleep breathing disorder, implant unit 110 may be located on a genioglossus muscle of a patient. Such a location is suitable for modulation of the hypoglossal nerve, branches of which run inside the genioglossus muscle. “) with a stimulation signal having a frequency of between about 20Hz and about 1500Hz ([col. 35, li. 52-53]: “…sub-pulses 1030 occur at a frequency of between 25 and 100 Hz.”).
Regarding claim 7, Mashiach discloses that the stimulation of the genioglossus nerve branch and/or the genioglossus muscle ([col. 5, li. 63-67]: “In treating a sleep breathing disorder, implant unit 110 may be located on a genioglossus muscle of a patient. Such a location is suitable for modulation of the hypoglossal nerve, branches of which run inside the genioglossus muscle. “), each pulse having a pulse width of between 30 microseconds and 2,000 microseconds ([col. 35, li. 21-23]: “…stimulation control signals may include a pulse duration of greater than about 50 microseconds…”).
Regarding claim 8, Mashiach discloses that B) comprises implanting the electrode lead in the genioglossus muscle proximal to the genioglossus nerve branch of the patient ([col. 5, li. 63-67]: “In treating a sleep breathing disorder, implant unit 110 may be located on a genioglossus muscle of a patient. Such a location is suitable for modulation of the hypoglossal nerve, branches of which run inside the genioglossus muscle. “).
Regarding claim 10, Mashiach discloses transferring wireless power from an external device (external unit 120) to the implanted neurostimulator implant (implant unit 110 in Figs. 1-3, 10-13a; [col. 33, li. 1-63]: “Processor 144 may be configured to limit an amount of energy transferred from external unit 120 to implant unit 110.”; [col. 19, li. 36-43]).
Regarding claim 12, Mashiach discloses detecting, by a sensor, at least one of any of the following physiological parameters ([col. 16, li. 56-61]: “In some embodiments, processor 144 may be configured to monitor a feedback signal provided by alternative means, such as electromyography electrodes, thermistors, accelerometers, microphones, piezoelectric sensors, etc., as previously described. Each of these means may provide a feedback signal that may be indicative of a subject's breathing.”):
a respiration rate of the patient ([col. 16, li. 67] – [col. 17, li. 5]: “An accelerometer may provide a signal indicative of breathing by measuring a speed or rate at which parts of the subject's body, such as a chest or chin, moves. Microphones may be used to provide feedback signals, for example, by detecting acoustic variations coincident with a breathing pattern.”),
an electromyograph, EMG, of the patient ([col. 16, li. 64-67]: “Electromyography electrodes may provide a feedback signal indicative of breathing based on the detection of muscle contractions.”),
an electrocardiogram, ECG, of the patient ([col. 18, li. 40-49]: “That is, processor 144 may determine modulation parameters based on information about a patient's sleep disordered breathing characteristics. In some embodiments, such information may be determined by physicians, for example through the use of sleep lab equipment such as EKGs, EEGs, EMGs, breathing monitors, blood oxygen monitors, temperature monitors, brain activity monitors, cameras, accelerometers, electromyography equipment, and any other equipment useful for monitoring the sleep of a patient…”),
an oxygen saturation of the patient ([col. 18, li. 40-49]: “That is, processor 144 may determine modulation parameters based on information about a patient's sleep disordered breathing characteristics. In some embodiments, such information may be determined by physicians, for example through the use of sleep lab equipment such as …blood oxygen monitors …”),
a body temperature of the patient ([col. 16, li. 62-64]: “A thermistor, for example, may provide a signal that relates to a temperature of a subject's expired air, inspired air, or a subject's skin, which may be indicative of breathing.”),
a heart rate of the patient,
a blood pressure of the of the patient.
Regarding claim 13, Mashiach discloses detecting, by a sensor ([col. 16, li. 67] – [col. 17, li. 2]: “An accelerometer may provide a signal indicative of breathing by measuring a speed or rate at which parts of the subject's body, such as a chest or chin, moves.”), at least one of any of the following patient movements:
a respiratory movement of the patient ([col. 16, li. 67] – [col. 17, li. 2]: “…a signal indicative of breathing by measuring a speed or rate at which parts of the subject's body, such as a chest or chin, moves.”),
a mandibular movement of the patient ([col. 16, li. 67] – [col. 17, li. 2]: “…a signal indicative of breathing by measuring a speed or rate at which parts of the subject's body, such as a chest or chin, moves.”),
a thoracic movement of the patient,
a diaphragm movement of the patient ([col. 42, li. 46-51]: “…an accelerometer located on, or otherwise associated with external unit 120 may be utilized as the feedback signal to detect snoring. Located on the neck, ribs, or diaphragm, an accelerometer, by measuring external body movements, may detect a subject's breathing patterns.”).
Regarding amended claim 14, Mashiach discloses detecting, by a sensor, at least one of any of the following physiological parameters of the patient indicative of sleep apnea ([col. 16, li. 56-61]: “In some embodiments, processor 144 may be configured to monitor a feedback signal provided by alternative means, such as electromyography electrodes, thermistors, accelerometers, microphones, piezoelectric sensors, etc., as previously described. Each of these means may provide a feedback signal that may be indicative of a subject's breathing.”):
a lapse in respiratory rate ([col. 16, li. 67] – [col. 17, li. 5]: “An accelerometer may provide a signal indicative of breathing by measuring a speed or rate at which parts of the subject's body, such as a chest or chin, moves. Microphones may be used to provide feedback signals, for example, by detecting acoustic variations coincident with a breathing pattern.”),
an electromyograph, EMG, profile indicative of sleep apnea ([col. 16, li. 64-67]: “Electromyography electrodes may provide a feedback signal indicative of breathing based on the detection of muscle contractions.”),
an electrocardiogram, ECG, profile indicative of sleep apnea ([col. 18, li. 40-49]: “That is, processor 144 may determine modulation parameters based on information about a patient's sleep disordered breathing characteristics. In some embodiments, such information may be determined by physicians, for example through the use of sleep lab equipment such as EKGs, EEGs, EMGs, breathing monitors, blood oxygen monitors, temperature monitors, brain activity monitors, cameras, accelerometers, electromyography equipment, and any other equipment useful for monitoring the sleep of a patient…”),
a decrease in oxygen saturation ([col. 18, li. 40-49]: “That is, processor 144 may determine modulation parameters based on information about a patient's sleep disordered breathing characteristics. In some embodiments, such information may be determined by physicians, for example through the use of sleep lab equipment such as …blood oxygen monitors …”),
an increase in body temperature ([col. 16, li. 62-64]: “A thermistor, for example, may provide a signal that relates to a temperature of a subject's expired air, inspired air, or a subject's skin, which may be indicative of breathing.”),
an increase in heart rate,
an increase in blood pressure, or
a respiratory, mandibular, thoracic or diaphragm movement ([col. 16, li. 67] – [col. 17, li. 2]; [col. 42, li. 46-51]: “…an accelerometer located on, or otherwise associated with external unit 120 may be utilized as the feedback signal to detect snoring. Located on the neck, ribs, or diaphragm, an accelerometer, by measuring external body movements, may detect a subject's breathing patterns.”).
Regarding claim 15, Mashiach discloses controlling the neurostimulator implant (implant unit 110 in Figs. 1-3, 10-13a) to stimulate the genioglossus nerve branch and/or the genioglossus muscle ([col. 5, li. 63-67]: “In treating a sleep breathing disorder, implant unit 110 may be located on a genioglossus muscle of a patient. Such a location is suitable for modulation of the hypoglossal nerve, branches of which run inside the genioglossus muscle. “) in response to the detected at least one physiological parameter of the patient and/or the detected at least one movement of the patient ([col. 18, li. 40-42]: “…processor 144 may determine modulation parameters based on information about a patient's sleep disordered breathing characteristics.”).
Regarding claim 27, Mashiach discloses that the sensor is integrated with the neurostimulator implant ([col. 43, li. 58-65]: “…a processor associated with implant unit 110 may be configured to receive a control signal prompting the implant controller to turn on and cause a modulation signal to be applied to the implant electrodes for modulating a nerve. Such a processor may also be configured to monitor various sensors associated with the implant unit and to transmit this information back to and external unit.”).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Mashiach in view of O'Connor et al. (US 2022/0134102, hereinafter referred to as O'Connor).
Regarding amended claim 11, Mashiach discloses that the wireless power transferred to the implanted neurostimulator implant (implant unit 110 in Figs. 1-3, 10-13a; [col. 33, li. 1-63]: “Processor 144 may be configured to limit an amount of energy transferred from external unit 120 to implant unit 110.”; [col. 19, li. 36-43]; [col. 43, li. 65-67])
Mashiach is silent to the wireless power transferred comprising a frequency of between 300MHz and 3GHz.
However, O’Connor teaches implantable electrodes with remote power delivery for treating sleep apnea. O’Connor further teaches the wireless power transferred having a frequency of between 300MHz and 3GHz ([0053]: “In operation, the receiver antenna 133 receives power wirelessly from the power source 109 carried by the associated wearable device 101 (FIGS. 3A and 3B, and described in further detail below with reference to FIGS. 5A-6). In at least some embodiments, the power received at the receiver antenna 133 is in a “midfield” range, for example, a radio frequency in a range of from about 300 MHz to about 6 GHz, e.g., about 600 MHz to about 2.45 GHz, or about 900 MHz to about 1.2 GHz.”).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the invention of Mashiach to include controlling the frequency of the wireless power transferred in order to provide safe and effective treatment to a patient with sleep apnea, as well as to provide power to the implanted neurostimulator implant without the need for an implanted battery.
Claims 16-19 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Mashiach in view of Dieken (cited previously).
Regarding claim 16, Mashiach discloses detecting, by a sensor, a respiratory rate of the patient ([col. 16, li. 67] – [col. 17, li. 5]: “An accelerometer may provide a signal indicative of breathing by measuring a speed or rate at which parts of the subject's body, such as a chest or chin, moves. Microphones may be used to provide feedback signals, for example, by detecting acoustic variations coincident with a breathing pattern.”), and stimulating the genioglossus nerve branch and/or the genioglossus muscle ([col. 5, li. 63-67]: “In treating a sleep breathing disorder, implant unit 110 may be located on a genioglossus muscle of a patient. Such a location is suitable for modulation of the hypoglossal nerve, branches of which run inside the genioglossus muscle. “)
Mashiach is silent to stimulating the genioglossus nerve branch and/or the genioglossus muscle synchronously with the detected respiratory rate (FIG. 18A is a diagram schematically representing an example method of treating sleep apnea, including stimulation during specific phases of a respiratory cycle.; [0274]: “In some examples, information sensed via one of the sensors in FIG. 35, such as but not limited to motion information, can be used in a training mode of an implantable neurostimulation system (as described herein) to correlate the patient's respiration with the sensed motion.”).
However, Dieken teaches stimulating the genioglossus nerve branch and/or the genioglossus muscle synchronously with the detected respiratory rate (FIG. 18A is a diagram schematically representing an example method of treating sleep apnea, including stimulation during specific phases of a respiratory cycle.; [0274]: “In some examples, information sensed via one of the sensors in FIG. 35, such as but not limited to motion information, can be used in a training mode of an implantable neurostimulation system (as described herein) to correlate the patient's respiration with the sensed motion.”).
Dieken teaches a similar pursuit to that of Mashiach and the instant application in teaching respiratory control for sleep apnea treatment. It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the invention of Mashiach to include stimulating synchronously with the detected respiratory rate in order to safely and effectively regulate the respiratory rate of the patient.
Regarding claim 17, in view of the Mashiach/Dieken combination, Mashiach is silent to stimulating the genioglossus nerve branch and/or the genioglossus muscle at the start of an inhalation cycle of the patient.
However, Dieken teaches stimulating the genioglossus nerve branch and/or the genioglossus muscle at the start of an inhalation cycle of the patient (method 320 in Fig. 10: “synchronizing the stimulation, via the first stimulation element, of the upper airway patency-related first nerve relative to at least an inspiratory phase of a respiratory cycle.”).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the invention of Mashiach to include stimulating synchronously with the detected respiratory rate in order to safely and effectively regulate the respiratory rate of the patient.
Regarding claim 18, in view of the Mashiach/Dieken combination, Mashiach discloses determining, from the detected at least one physiological parameter and/or at least one movement of the patient ([col. 41, li. 36-41]: “Monitoring the degree of coupling can also provide such physiologic data as whether a patient's tongue is moving or vibrating (e.g., whether the patient is snoring), by how much the tongue is moving or vibrating, the direction of motion of the tongue, the rate of motion of the tongue, etc.”).
Mashiach is silent to a classification of sleep apnea, in particular whether the detected sleep apnea comprises obstructive sleep apnea, OSA, central sleep apnea, CSA, or a combination of OSA and CSA.
However, Dieken teaches a classification of sleep apnea ([0068]-0071] discuss “recognizing” obstructive sleep apnea (OSA) and central sleep apnea (CSA).), in particular whether the detected sleep apnea comprises obstructive sleep apnea, OSA, central sleep apnea, CSA, or a combination of OSA and CSA (FIG. 17 is a diagram schematically representing an example method of treating sleep apnea, including stimulation of both a central sleep apnea (CSA) related nerve and an obstructive sleep apnea (OSA) related nerve. Figs. 15 and 16 describe treating a “multiple-type apnea event”.).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to determine a classification of sleep apnea in order to provide the safest and most effective treatment to a patient based on their detected symptoms.
Regarding claim 19, in view of the Mashiach/Dieken combination, Mashiach is silent to operating a second implanted neurostimulator implant to stimulate a phrenic nerve and/or an ansa cervicalis nerve of the patient.
However, Dieken discloses operating a second implanted neurostimulator implant to stimulate a phrenic nerve and/or an ansa cervicalis nerve of the patient ([0105]: “As further shown in FIG. 6, in some examples, a stimulation element 142 is implanted subcutaneously in proximity to a target nerve 146. Stimulation of the target nerve 146 via stimulation element 142 causes contraction of at least some muscles innervated via the target nerve 146. In some examples, the target nerve 146 comprises a central sleep apnea-related nerve, such as but not limited to the phrenic nerve which innervates diaphragm 141.”).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify Mashiach to include stimulating a phrenic nerve and/or an ansa cervicalis nerve of the patient in order to more effectively treat a patient in response to varying apneic events.
Regarding claim 22, in view of the Mashiach/Dieken combination, Mashiach is silent to operating the neurostimulator implant and/or the second neurostimulator implant and/or the CPAP device based on the determined classification of sleep apnea.
Dieken teaches operating the neurostimulator implant and/or the second neurostimulator implant and/or the CPAP device based on the determined classification of sleep apnea ([0068]-0071] discuss “recognizing” obstructive sleep apnea (OSA) and central sleep apnea (CSA).; [0072]: “It will be understood that in some examples, the various example elements, example devices, and example methods for delivering stimulation to the upper airway patency-related nerve can be performed solely to treat obstructive sleep apnea without intentionally attempting to treat central sleep apnea… in some examples, the various example elements, example devices, and example methods for delivering stimulation to the central sleep apnea-related nerve can be performed solely to treat central sleep apnea without intentionally attempting to treat obstructive sleep apnea.”).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to determine a classification of sleep apnea in order to provide the safest and most effective treatment to a patient based on their detected symptoms.
Claims 20-21 and 23-26 are rejected under 35 U.S.C. 103 as being unpatentable over the Mashiach/Dieken combination and further in view of Cho et al. (US 2004/0138719, hereinafter referred to as Cho) (cited previously).
Regarding claim 20, in view of the Mashiach/Dieken combination, the Mashiach/Dieken combination is silent to operating a continuous positive air pressure, CPAP, device to provide positive air pressure to the patient's airways.
However, Cho teaches operating a continuous positive air pressure, CPAP, device to provide positive air pressure to the patient's airways ([0023]: “In an automatic CPAP system, controller 8 provides output to positive airway pressure (PAP) source 3 which generates positive pressure in response to sensed signal information that indicates apnea or hypopnea is imminent or occurring.”).
Cho teaches a similar pursuit to that of Mashiach and the instant application in teaches treatment of sleep apnea. It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to utilize a CPAP device in order to more effectively treat a patient in response to a detected apneic event.
Regarding claim 21, in view of the Mashiach/Dieken/Cho combination, the Mashiach/Dieken combination is silent to controlling the or each neurostimulator implant, and optionally the CPAP device, based on the detected at least one physiological parameter of the patient and/or the detected at least one movement of the patient.
However, Cho teaches controlling the or each neurostimulator implant (IMD 10 in Fig. 1A), and optionally the CPAP device (PAP source 3), based on the detected at least one physiological parameter of the patient and/or the detected at least one movement of the patient ([0040]: “Sensor signals [of activity senor 62 in Fig. 2] that may be used for detecting a sleeping state may include an activity sensor, a respiration sensor, a posture sensor, a blood temperature sensor, etc.”).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to utilize a CPAP device with a feedback signal of physiological parameters in order to more effectively treat a patient in response to a detected apneic event.
Regarding claim 23, in view of the Mashiach/Dieken/Cho combination, Mashiach is silent to when the classification of sleep apnea is determined to be obstructive sleep apnea, OSA, operating the neurostimulator device to stimulate the genioglossus nerve branch and/or the genioglossus muscle.
However, Dieken discloses that when the classification of sleep apnea is determined to be obstructive sleep apnea, OSA ([0068]-0071] discuss “recognizing” obstructive sleep apnea (OSA) and central sleep apnea (CSA).), operating the neurostimulator device to stimulate the genioglossus nerve branch and/or the genioglossus muscle ([0072]: “It will be understood that in some examples, the various example elements, example devices, and example methods for delivering stimulation to the upper airway patency-related nerve can be performed solely to treat obstructive sleep apnea without intentionally attempting to treat central sleep apnea.”; ([0106]: “… the stimulation elements 132, 142 may be positioned in location to directly stimulate a target muscle (e.g. genioglossus muscle, etc. or diaphragm 141) instead of stimulating an associated nerve.”).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to determine a classification of sleep apnea in order to provide an appropriate and effective stimulation to an appropriate location of a patient based on their detected symptoms.
Regarding claim 24, in view of the Mashiach/Dieken/Cho combination, Mashiach is silent to when the classification of sleep apnea is determined to be central sleep apnea, CSA, operating the second neurostimulator implant to stimulate the phrenic nerve and/or ansa cervicalis nerve.
Dieken discloses that when the classification of sleep apnea is determined to be central sleep apnea, CSA ([0068]-0071] discuss “recognizing” obstructive sleep apnea (OSA) and central sleep apnea (CSA).), operating the second neurostimulator implant to stimulate the phrenic nerve and/or ansa cervicalis nerve ([0072]: “… in some examples, the various example elements, example devices, and example methods for delivering stimulation to the central sleep apnea-related nerve can be performed solely to treat central sleep apnea without intentionally attempting to treat obstructive sleep apnea.”; [0105]: “Stimulation of the target nerve 146 via stimulation element 142 causes contraction of at least some muscles innervated via the target nerve 146. In some examples, the target nerve 146 comprises a central sleep apnea-related nerve, such as but not limited to the phrenic nerve which innervates diaphragm 141.”).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to determine a classification of sleep apnea in order to provide an appropriate and effective stimulation to an appropriate location of a patient based on their detected symptoms.
Regarding claim 25, in view of the Mashiach/Dieken/Cho combination, Mashiach is silent to when the classification of sleep apnea is determined to be obstructive sleep apnea, OSA, operating the CPAP device to provide positive air pressure to the patient.
However, Dieken teaches determining when the classification of sleep apnea is obstructive sleep apnea, OSA ([0068]-0071] discuss “recognizing” obstructive sleep apnea (OSA) and central sleep apnea (CSA).).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the system of Mashiach to include classifying the type of sleep apnea being experienced by the patient, as taught by Dieken, in order to determine the best treatment method(s) for the patient.
The Mashiach/Dieken combination is silent to operating the CPAP device to provide positive air pressure to the patient.
Cho discloses operating the CPAP device to provide positive air pressure to the patient ([0023]: “Controller 8 executes algorithms for analyzing sensed signals for detecting SRDB patterns. In an automatic CPAP system, controller 8 provides output to positive airway pressure (PAP) source 3 which generates positive pressure in response to sensed signal information that indicates apnea or hypopnea is imminent or occurring.”).
Cho teaches a similar pursuit to that of Mashiach and the instant application in teaches treatment of sleep apnea. It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to utilize a CPAP device in order to more effectively treat a patient in response to a detected apneic event.
Regarding claim 26, in view of the Mashiach/Dieken/Cho combination, Mashiach is silent to if the classification of sleep apnea is determined to be a combination of obstructive sleep apnea and central sleep apnea, operating:
the neurostimulator device to stimulate the genioglossus nerve branch and genioglossus muscle, and at least one of:
the second neurostimulator implant to stimulate the phrenic nerve and/or ansa cervicalis nerve, and
the CPAP device to provide positive air pressure to the patient.
Dieken teaches the classification of sleep apnea ([0068]-0071] discuss “recognizing” obstructive sleep apnea (OSA) and central sleep apnea (CSA).) being a combination of obstructive sleep apnea and central sleep apnea (FIG. 17 is a diagram schematically representing an example method of treating sleep apnea, including stimulation of both a central sleep apnea (CSA) related nerve and an obstructive sleep apnea (OSA) related nerve. Figs. 15 and 16 describe treating a “multiple-type apnea event”.) and operating the second neurostimulator implant to stimulate the phrenic nerve and/or ansa cervicalis nerve ([0105]: “As further shown in FIG. 6, in some examples, a stimulation element 142 is implanted subcutaneously in proximity to a target nerve 146. Stimulation of the target nerve 146 via stimulation element 142 causes contraction of at least some muscles innervated via the target nerve 146. In some examples, the target nerve 146 comprises a central sleep apnea-related nerve, such as but not limited to the phrenic nerve which innervates diaphragm 141.”).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the system of Mashiach to include classifying the type of sleep apnea being experienced by the patient, as taught by Dieken, in order to determine the best treatment method(s) for the patient. Additionally, it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the invention of Mashiach to include an additional implanted neurostimulator implant, as taught by the multiple stimulation elements and electrode placements of Dieken, in order to expand the treatment capabilities of the device and provide the option of treating multiple types of sleep apnea, as treating different types of sleep apnea requires stimulating different nerves/muscles.
The Mashiach/Dieken combination is silent to the CPAP device to provide positive air pressure to the patient.
Cho teaches the CPAP device to provide positive air pressure to the patient ([0023]: “…positive airway pressure (PAP) source 3 which generates positive pressure in response to sensed signal information that indicates apnea or hypopnea is imminent or occurring.”).
Cho teaches a similar pursuit to that of Mashiach and the instant application in teaches treatment of sleep apnea. It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to utilize a CPAP device in order to more effectively treat a patient in response to a detected apneic event.
Conclusion
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/M.G.S./Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796
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