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 .
Response to Arguments
The Applicant filed Amendments to the Claims and Remarks on October 9, 2025 in response to the Examiner’s Non-Final Office Action, mailed July 10, 2025.
Amendments to the Claims
At this time, claims 1-8, 10-41, and 77-80 are pending. Claims 1, 4-6, 11-14, and 36 have been amended. Claim 9 has been cancelled, without prejudice. The Applicant has added new claims 77-80. The Applicant asserts that no new matter is added. (Remarks, pg. 11)
Claim Rejections - 35 U.S.C. § 112(b)
Applicant’s arguments, see Remarks, pg. 11, filed October 9, 2025, with respect to claims 4-6, 11-14, and 36 (regarding the phrase “for example”) have been fully considered and are persuasive. The 35 U.S.C. § 112(b) rejection of claims 4-6, 11-14, and 36 has been withdrawn. However, the indefiniteness of claims 4-6 and 11 still remains due to the claims consisting of a broad range together with a narrow range (in the same range).
Claim Rejections - 35 U.S.C. § 102 and § 103
Applicant’s arguments with respect to the rejections of claims 1-41 under 35 U.S.C. § 102 and § 103 have been fully considered and are persuasive. Therefore, the rejections have been withdrawn. However, upon further consideration and necessitated by amendments, new grounds of rejection are made in view of Mashiach et al. (US 9, 463,318, hereinafter referred to as Mashiach).
Claim Objections
Claims 14 and 36 are objected to because of the following informalities: Claim 14 contains the typographical error of "...a lapse is respiratory rate...". The Examiner believes this is meant to state the limitation "...a lapse in respiratory rate...". Claim 36 contains the same error. Appropriate correction is required.
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.
Claims 4-6 and 11 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 4-6 and 11, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
In the present instance, claim 4 recites the broad recitation "a stimulation signal having a frequency of between about 2Hz and about 150Hz", and the claim also recites "more specifically between about 2Hz and about 100Hz, for example more specifically between about 2Hz and about 50Hz, for example more specifically between about 2Hz and about 40Hz, for example more specifically between about 2Hz and about 30Hz, more specifically between about 2Hz and about 20Hz, more specifically between about 2Hz and about 15Hz, more specifically between about 2Hz and about 10Hz" which is the narrower statement of the range/limitation.
Claim 5 recites the broad recitation "the stimulation signal stimulating the genioglossus muscle has a peak amplitude of between 0.1mA and 1OmA", and the claim also recites "more specifically between 0.1mA and 5mA" which is the narrower statement of the range/limitation.
Claim 6 recites the broad recitation "a stimulation signal having a frequency of between about 20Hz and about 1500Hz", and the claim also recites “more specifically between about 20Hz and about 1000Hz, for example more specifically between about 20Hz and about 500Hz, for example more specifically between about 20Hz and about 400Hz, for "more specifically between about 20Hz and about 300Hz, more specifically between about 20Hz and about 200Hz, more specifically between about 20Hz and about 150Hz, more specifically between about 20Hz and about 100Hz" which is the narrower statement of the range/limitation.
Claim 11 recites the broad recitation "the wireless power transferred to the implanted neurostimulator implant comprises a frequency of between 300MHz and 3GHz", and the claim also recites "more specifically between 400MHz and 2.5GHz, more specifically between 433MHz and 2.4GHz" which is the narrower statement of the range/limitation.
The claims are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (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 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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-8, 10, 12-15, 27-30, 33-36, and 77-80 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Mashiach et al. (US 9, 463,318, hereinafter referred to as Mashiach).
Regarding amended, 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]);
C) implanting the housing portion in subcutaneous tissue under the patient's chin ([col. 44, li. 15-17]: “FIG. 19 depicts an implantation location in the vicinity of a genioglossus muscle 1060 that may be accessed through derma on an underside of a subject's chin.”); 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.”).
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, more specifically between about 2Hz and about 100Hz, more specifically between about 2Hz and about 50Hz, more specifically between about 2Hz and about 40Hz, more specifically between about 2Hz and about 30Hz, more specifically between about 2Hz and about 20Hz, more specifically between about 2Hz and about 15Hz, more specifically between about 2Hz and about 10Hz ([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, more specifically between about 20Hz and about 1000Hz, more specifically between about 20Hz and about 500Hz, more specifically between about 20Hz and about 400Hz, more specifically between about 20Hz and about 300Hz, more specifically between about 20Hz and about 200Hz, more specifically between about 20Hz and about 150Hz, more specifically between about 20Hz and about 100Hz ([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 amended 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 amended 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 amended 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 is 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.”).
Regarding independent claim 28, Mashiach discloses a system for treating sleep apnea of a patient, the system comprising a neurostimulator implant (implant unit 110 in Figs. 1-3, 10-13a) implantable proximal to a branch of the hypoglossal nerve of the patient and operable to stimulate the branch of the hypoglossal nerve ([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 29, Mashiach discloses that the implanted neurostimulator implant (implant unit 110 in Figs. 1-3, 10-13a) is operable to stimulate the genioglossus nerve branch and/or the genioglossus muscle 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 30, Mashiach discloses that the neurostimulator implant (implant unit 110 in Figs. 1-3, 10-13a) comprises 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…”) that is implantable within the genioglossus muscle proximal to a genioglossus nerve branch of the patient ([col. 5, li. 63-67]), and a signal generator (signal source 142 in Fig. 3) for generating a stimulation signal to stimulate the genioglossus nerve branch and/or the genioglossus muscle of the patient ([col. 5, li. 63-67]).
Regarding claim 33, Mashiach discloses a sensor arranged to detect at least one physiological parameter of the patient and/or at least one movement of the patient ([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.”).
Regarding amended claim 34, Mashiach discloses that the at least one physiological parameter comprises one or more of.
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 35, Mashiach discloses that the at least one movement of the patient comprises at least one of:
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 36, Mashiach discloses a controller ([col. 43, li. 55-62]: “A processor located on implant unit 110 may perform all or some of the processes described with respect to the at least one processor associated with an external unit. For example, 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.”) configured to determine the onset or occurrence of sleep apnea based on any of the following detected physiological parameter and/or the detected movement of the patient ([col. 16, li. 56-61]):
a lapse is 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 new, independent claim 77, Mashiach 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 ([col. 22, li. 25-27]: “…field-generating electrodes 158a and 158b may include two sets of four circular electrodes, provided on flexible carrier 161…”) extending from the housing portion 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 proximal to the genioglossus nerve branch of the patient ([col. 44, li. 15-17]);
C) implanting the housing portion proximal to a posterior edge of the patient's mandibular symphysis ([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.”); 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.”).
Regarding new claim 78, Mashiach discloses that the method comprises operating the implanted neurostimulator implant (implant unit 110 in Figs. 1-3, 10-13a) to stimulate the genioglossus nerve branch and 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 new claim 79, 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 new claim 80, 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. “).
Claims 28-37 and 40-41 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Dieken et al. (US 2020/0147376, hereinafter referred to as Dieken).
Regarding independent claim 28, Dieken discloses a system for treating sleep apnea of a patient (arrangement 121 in Fig. 6; device 1410 in Fig. 29), the system comprising a neurostimulator implant (stimulation elements 132, 142 in Fig. 6) implantable proximal to a branch of the hypoglossal nerve of the patient and operable to stimulate the branch of the hypoglossal nerve ([0104]: “In some examples, the target nerve 130 comprises an upper airway patency-related nerve, such as but not limited to the hypoglossal nerve.”).
Regarding claim 29, Dieken discloses that the implanted neurostimulator implant (stimulation elements 132, 142 in Fig. 6) is operable to stimulate the genioglossus nerve branch and/or the genioglossus muscle of the patient ([0106]: “With regard to FIG. 6, it will be understood …that in some examples the various stimulation elements 132, 142 may be positioned in locations adjacent other nerves responsible for treating obstructive sleep apnea and central sleep apnea and behaviors involving both obstructive and sleep apnea. In some examples, 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”).
Regarding claim 30, Dieken discloses that the neurostimulator implant (stimulation elements 132, 142 in Fig. 6 or IPG 1435 in Fig. 29) comprises an electrode ([0106]: “…elements 132, 142 may represent a cuff electrode or other types of electrodes, stimulation elements, etc., at least some of which are described later in association with FIGS. 30A-31.”; stimulation electrode 1445 in Fig. 29) that is implantable within the genioglossus muscle proximal to a genioglossus nerve branch of the patient, and a signal generator (IPG 1435 in Fig. 29; pulse generator 1510 in Figs. 30A-J) for generating a stimulation signal to stimulate the genioglossus nerve branch and/or the genioglossus muscle of the patient (Fig. 6 shows a second stimulation element 142 stimulating target nerve 146. [0104], [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”).
Regarding claim 31, Dieken discloses that the neurostimulator implant is a battery- less implant (No battery is mentioned in Dieken.) and comprises a wireless power receiver ([0163]: “In some examples, device 1410 [a pulse generator] is totally implantable… A few non-limiting examples of such non-implanted components include… an external power source… The communication pathway may comprise a radiofrequency (RF) telemetry link or other wireless communication protocols.”; [0174]-[0182] discuss that electrodes may be in wireless connection with pulse generator 1510, shown in Figs. 30C-30F and 30I-30J with a wavy arrow.).
Regarding claim 32, Dieken discloses an external device comprising a wireless power transmitter for transmitting wireless power to the neurostimulator implant ([0163]: “A few non-limiting examples of such non-implanted components include… an external power source…”) when the neurostimulator implant is implanted in the genioglossus muscle ([0106]: “With regard to FIG. 6, it will be understood …that in some examples the various stimulation elements 132, 142 may be positioned in locations adjacent other nerves responsible for treating obstructive sleep apnea and central sleep apnea and behaviors involving both obstructive and sleep apnea. In some examples, 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”).
Regarding claim 33, Dieken discloses a sensor (accelerometer-based sensor 1790 in Fig. 32; radiofrequency sensor 2230 in Fig. 35; Fig. 35 represents example sensor types 2200-2252.) arranged to detect at least one physiological parameter of the patient ([0158]: “…sensing to detect at least respiratory information and/or other physiologic information…”) and/or at least one movement of the patient ([0262]: “In some examples, radiofrequency sensor 2230 shown in FIG. 35 enables non-contact sensing of various physiologic parameters and information, such as but not limited to respiratory information, cardiac information, motion/activity, and/or sleep quality.”).
Regarding amended claim 34, Dieken discloses that the at least one physiological parameter ([0158]: “…sensing to detect at least respiratory information and/or other physiologic information…”) comprises one or more of.
a respiration rate of the patient (Figs. 26-28A mention sensing respiratory cycles.; [0103]: “…a respiratory rate may be determined by the period of the cyclical change in heart rate...”),
an electromyograph, EMG, of the patient (EMG 2240 in Fig. 35),
an electrocardiogram, ECG, of the patient (EKG 2242 in Fig. 35),
an oxygen saturation of the patient ([0263] discusses that optical sensor 2214 in Fig. 35 may sense heart rate and/or oxygen saturation via pulse oximetry, or for measuring oxygen saturation index (ODI).),
a body temperature of the patient,
a heart rate of the patient (heart rate 1934 in Fig. 34B; [0263] discusses that optical sensor 2214 in Fig. 35 may sense heart rate and/or oxygen saturation via pulse oximetry.),
a blood pressure of the of the patient.
Regarding claim 35, Dieken discloses that the at least one movement of the patient ([0262]: “In some examples, radiofrequency sensor 2230 shown in FIG. 35 enables non-contact sensing of various physiologic parameters and information, such as but not limited to respiratory information, cardiac information, motion/activity, and/or sleep quality.”) comprises at least one of:
a respiratory movement of the patient ([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.”),
a mandibular movement of the patient (accelerometer-based sensor 1790 in a head-neck region 1784),
a thoracic movement of the patient (accelerometer-based sensor 1790 in a thorax/abdomen region 1786),
a diaphragm movement of the patient (accelerometer-based sensor 1790 in a thorax/abdomen region 1786).
FIG. 32 is a diagram 1780 schematically representing accelerometer-based sensing, utilizing at least one accelerometer-based sensor 1790 in a head-neck region 1784, a thorax/abdomen region 1786, and/or a peripheral/other region 1788 of a patient's body ([0194]).
Regarding amended claim 36, Dieken discloses a controller (controller 3002 in Fig. 38A) configured to determine the onset or occurrence of sleep apnea based on any of the following detected physiological parameter and/or the detected movement of the patient ([0282]: “In some examples, control portion 3000 includes a controller 3002 and a memory 3010… The controller 3002 is electrically couplable to, and in communication with, memory 3010 to generate control signals to direct operation of at least some [components of the stimulation device]… In some examples, these generated control signals include, but are not limited to, employing instructions 3011… to at least direct and manage treatment of sleep disordered breathing such as obstructive sleep apnea and/or central sleep apnea, sensing physiologic information including but not limited to respiratory information, heart rate, and/or monitoring sleep disordered breathing, etc.…”):
a lapse is respiratory rate ([0090]; [0103]: “…in some examples sensed expiratory periods may be determined by a decrease in heart rate over the average of the previous period, a respiratory rate may be determined by the period of the cyclical change in heart rate, and the start of the inspiratory period may then be determined by a fraction of the respiratory period starting from the end of the expiratory period.”),
an electromyograph, EMG, profile indicative of sleep apnea (EMG 2240 in Fig. 35),
an electrocardiogram, ECG, profile indicative of sleep apnea (EKG 2242 in Fig. 35),
a decrease in oxygen saturation ([0263] discusses that optical sensor 2214 in Fig. 35 may sense heart rate and/or oxygen saturation via pulse oximetry, or for measuring oxygen saturation index (ODI).),
an increase in body temperature,
an increase in heart rate (heart rate 1934 in Fig. 34B; [0263] discusses that optical sensor 2214 in Fig. 35 may sense heart rate via pulse oximetry.),
an increase in blood pressure, or
a respiratory, mandibular, thoracic or diaphragm movement ([0194]: FIG. 32 is a diagram 1780 schematically representing accelerometer-based sensing, utilizing at least one accelerometer-based sensor 1790 in a head-neck region 1784, a thorax/abdomen region 1786, and/or a peripheral/other region 1788 of a patient's body.).
Regarding claim 37, Dieken discloses a second neurostimulator implant implantable 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.”).
Regarding claim 40, Dieken discloses that the controller (controller 3002 in Fig. 38A) is configured to determine, based the detected at least one physiological parameter ([0158]: “…sensing to detect at least respiratory information and/or other physiologic information…”) and/or the at least one movement of the patient ([0262]: “In some examples, radiofrequency sensor 2230 shown in FIG. 35 enables non-contact sensing of various physiologic parameters and information, such as but not limited to respiratory information, cardiac information, motion/activity, and/or sleep quality.”), 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”.).
Regarding claim 41, Dieken discloses that the controller (controller 3002 in Fig. 38A) is configured to operate the neurostimulator implant (stimulation elements 132, 142 in Fig. 6) 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.”).
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.
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, more specifically between 400MHz and 2.5GHz, more specifically between 433MHz and 2.4GHz.
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, more specifically between 400MHz and 2.5GHz, more specifically between 433MHz and 2.4GHz ([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.
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).
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.
Claims 38-41 are rejected under 35 U.S.C. 103 as being unpatentable over Dieken in view of Cho.
Regarding claim 38, Dieken is silent to a continuous positive air pressure, CPAP, device operable to provide positive air pressure to the patient.
However, Cho teaches a continuous positive air pressure, CPAP, device operable to provide positive air pressure to the patient ([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.”).
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 39, in view of the Dieken/Cho combination, Dieken discloses a controller (controller 3002 in Fig. 38A) configured to control the or each neurostimulator implant (stimulation elements 132, 142 in Fig. 6), and optionally the CPAP device (PAP source 3 in Fig. 1A; [0023]), based on the detected at least one physiological parameter of the patient ([0158]: “…sensing to detect at least respiratory information and/or other physiologic information…”) and/or the detected at least one movement of the patient ([0262]: “In some examples, radiofrequency sensor 2230 shown in FIG. 35 enables non-contact sensing of various physiologic parameters and information, such as but not limited to respiratory information, cardiac information, motion/activity, and/or sleep quality.”).
Dieken is silent to the CPAP device.
However, Cho teaches the CPAP device (PAP source 3 in Fig. 1A; [0023]).
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.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARY G SCHLUETER whose telephone number is (703)756-4601. The examiner can normally be reached M-F 9:00am-5:30pm EST.
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/M.G.S./Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796