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 .
Status of Claims
Claims 2-23 are rejected. Claim 1 is canceled.
Response to Arguments
Specification
The previous specification objection has been withdrawn in view of the amendment.
Claim Objections
The previous claim objection of claim 21 has been withdrawn in view of the amendment.
Claim Rejections - 35 USC § 112
The previous 112(b) rejections have been withdrawn in view of the amendment.
Claim Rejections - 35 USC § 101
The previous 101 human organism rejection of claim 12 has been withdrawn in view of the amendment.
Claim Rejections - 35 USC § 103
Applicant's arguments filed 7/1/26 have been fully considered but they are not persuasive.
Applicant asserts that Bolea and Testerman, either alone, or in combination fail to teach or suggest the features recited by independent claims 2 and 14 including "determine a sleep-wake status based on the sensed physiologic information, wherein the sleep-wake status comprises a probability of sleep and a probability of wakefulness; initiate stimulation therapy in response to the probability of sleep exceeding a sleep-detection threshold for a delay period; pause stimulation therapy in response to the probability of wakefulness exceeding a wake-detection threshold by a predetermined percentage for a predetermined duration; and resume stimulation therapy, after the pause in stimulation therapy, in response to the probability of sleep exceeding the sleep-detection threshold for the delay period;" and the similar features recited by independent claim 18. However, the Examiner disagrees. Testerman teaches the following:
wherein the sleep-wake status comprises a probability of sleep (col. 13 and lines 28-31-a signal from the activity sensor can be monitored and if predetermined amplitude and duration thresholds are satisfied, that would constitute a detected arousal; col. 13 and lines 9-10-an awakening arousal is in essence a sleep stage; if the arousal detection is not met, that indicates a probability of sleep)
and a probability of wakefulness (col. 13 and lines 28-31-a signal from the activity sensor can be monitored and if predetermined amplitude and duration thresholds are satisfied, that would constitute a detected arousal);
initiate stimulation therapy in response to the probability of sleep exceeding a sleep-detection threshold for a delay period (col. 14 and lines 30-31-the patient is allowed to get to sleep before the onset of stimulation; col. 14 and lines 59-60-a delay of 15 minutes may be used to allow the patient to get to sleep initially; if the arousal detection is not met, that indicates a probability of sleep);
pause stimulation therapy in response to the probability of wakefulness exceeding a wake-detection threshold by a predetermined percentage for a predetermined duration (col. 13 and lines 29-31-if predetermined amplitude and duration thresholds are satisfied, that would constitute a detected arousal; col. 13 and lines 24-26-this detected arousal could be used to delay the onset of stimulus until the patient has returned to sleep; col. 13 and lines 34-36-if both the activity sensor and the respiratory waveform indicate arousal, then the stimulation to the patient is disabled; if the threshold is triggered there is a probability that the patient is awake and that is above the threshold to pause the stimulation. Based on the threshold there is essentially a 0% or 100% output, (binary output). When it goes to 100%, it is above a “unspecified probability” (above 50%) that indicates wakefulness); and
resume stimulation therapy, after the pause in stimulation therapy, in response to the probability of sleep exceeding the sleep-detection threshold for the delay period (col. 13 and lines 24-26-this detected arousal could be used to delay the onset of stimulus until the patient has returned to sleep; col. 13 and lines 29-31-if predetermined amplitude and duration thresholds are satisfied, that would constitute a detected arousal; col. 14 and lines 51-53-the stimulus delay controller 400 must then determine when and in what manner to resume stimulation if the arousal detection is not met, that indicates a probability of sleep).
Applicant further asserts that Testerman fails to disclose that the absence of an arousal necessarily means that the patient is asleep. However, the Examiner disagrees. As noted by Applicant, “the detection of such an arousal event yields a binary outcome (either an arousal is detected or an arousal is not detected)” (Remarks, page 9). As noted above, if the arousal detection is not met, that indicates a probability of sleep.
Applicant asserts that Testerman fails to disclose initiating stimulation therapy in response to the probability of sleep exceeding a sleep-detection threshold for a delay period. However, the Examiner disagrees. Testerman teaches that the patient is allowed to get to sleep before the onset of stimulation (col. 14 and lines 30-31); and a delay of 15 minutes may be used to allow the patient to get to sleep initially (col. 14 and lines 59-60), if the arousal detection is not met, that indicates a probability of sleep.
Applicant asserts that Testerman fails to disclose pausing stimulation therapy in response to the probability of wakefulness exceeding a wake-detection threshold by a predetermined percentage for a predetermined duration. However, the Examiner disagrees. Testerman teaches if predetermined amplitude and duration thresholds are satisfied, that would constitute a detected arousal (col. 13 and lines 29-31); this detected arousal could be used to delay the onset of stimulus until the patient has returned to sleep (col. 13 and lines 24-26); if both the activity sensor and the respiratory waveform indicate arousal, then the stimulation to the patient is disabled (col. 13 and lines 34-36). If the threshold is triggered there is a probability that the patient is awake and that is above the threshold to pause the stimulation. Based on the threshold there is essentially a 0% or 100% output, (binary output). When it goes to 100%, it is above a “unspecified probability” (above 50%) that indicates wakefulness).
Applicant asserts that Testerman fails to disclose resuming stimulation in response to the probability of sleep exceeding the sleep-detection threshold for the delay period. However, the Examiner disagrees. Testerman teaches this detected arousal could be used to delay the onset of stimulus until the patient has returned to sleep (col. 13 and lines 24-26); if predetermined amplitude and duration thresholds are satisfied, that would constitute a detected arousal (col. 13 and lines 29-31); the stimulus delay controller 400 must then determine when and in what manner to resume stimulation (col. 14 and lines 51-53), if the arousal detection is not met, that indicates a probability of sleep.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
stimulation element in claims 18 and 21.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
For “a stimulation element” in claims 18 and 21, the specification recites “the microstimulator 2133 also may incorporate and/or include the stimulation electrode 2112” (¶132; ¶158). Therefore, the Examiner is interpreting a stimulation element to be a stimulation electrode, or any equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 2-6, 9-10, 12-15, 17-19, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Bolea (US 20140228905 filed on 2/11/14 as cited in the IDS) in view of Testerman (US 5483969 filed on 9/21/94 as cited in the IDS).
Regarding claim 2, Bolea teaches a device comprising: an implantable sensor to sense physiologic information (¶128-the implanted components 20 (shown faded) of the neurostimulator system 10 are implanted in a patient P with the INS 50 disposed in a subcutaneous pocket, respiration sensing; ¶137-INS 50 may include an activity sensor (not shown) for sensing the activity of a patient, including the amount of activity of the patient); a stimulation electrode to apply stimulation therapy to a tissue (¶128-the nerve cuff electrode 64 disposed on a nerve (e.g., hypoglossal nerve (HGN)) innervating a muscle (e.g., genioglossus muscle, not shown) controlling the upper airway); and a controller (¶132-patient controller 40) configured to: determine a sleep-wake status based on the sensed physiologic information (¶137-INS 50 may include an activity sensor (not shown) for sensing the activity of a patient, including the amount of activity of the patient; ¶138-data corresponding to a patient's motion may be used to determine whether a patient is sleeping or awake. For example, when a patient's activity level falls below a predetermined threshold, it may be assumed that the patient is sleeping. Conversely, when the patient's activity level rises above the predetermined threshold, it may be assumed that the patient is awake). However, Bolea does not explicitly teach wherein the sleep-wake status comprises a probability of sleep and a probability of wakefulness; initiate stimulation therapy in response to the probability of sleep exceeding a sleep-detection threshold for a delay period; pause stimulation therapy in response to the probability of wakefulness exceeding a wake-detection threshold by a predetermined percentage for a predetermined duration; and resume stimulation therapy, after the pause in stimulation therapy, in response to the probability of sleep exceeding the sleep-detection threshold for the delay period.
Testerman relates to medical devices which employ electrical stimulation in the treatment of sleep apnea (col. 1 and lines 8-10). Testerman further teaches the invention using the following steps:
wherein the sleep-wake status comprises a probability of sleep (col. 13 and lines 28-31-a signal from the activity sensor can be monitored and if predetermined amplitude and duration thresholds are satisfied, that would constitute a detected arousal; col. 13 and lines 9-10-an awakening arousal is in essence a sleep stage; if the arousal detection is not met, that indicates a probability of sleep) and a probability of wakefulness (col. 13 and lines 28-31-a signal from the activity sensor can be monitored and if predetermined amplitude and duration thresholds are satisfied, that would constitute a detected arousal); initiate stimulation therapy in response to the probability of sleep exceeding a sleep-detection threshold for a delay period (col. 14 and lines 30-31-the patient is allowed to get to sleep before the onset of stimulation; col. 14 and lines 59-60-a delay of 15 minutes may be used to allow the patient to get to sleep initially; if the arousal detection is not met, that indicates a probability of sleep); pause stimulation therapy in response to the probability of wakefulness exceeding a wake-detection threshold by a predetermined percentage for a predetermined duration (col. 13 and lines 29-31-if predetermined amplitude and duration thresholds are satisfied, that would constitute a detected arousal; col. 13 and lines 24-26-this detected arousal could be used to delay the onset of stimulus until the patient has returned to sleep; col. 13 and lines 34-36-if both the activity sensor and the respiratory waveform indicate arousal, then the stimulation to the patient is disabled; if the threshold is triggered there is a probability that the patient is awake and that is above the threshold to pause the stimulation. Based on the threshold there is essentially a 0% or 100% output, (binary output). When it goes to 100%, it is above a “unspecified probability” (above 50%) that indicates wakefulness); and resume stimulation therapy, after the pause in stimulation therapy, in response to the probability of sleep exceeding the sleep-detection threshold for the delay period (col. 13 and lines 24-26-this detected arousal could be used to delay the onset of stimulus until the patient has returned to sleep; col. 13 and lines 29-31-if predetermined amplitude and duration thresholds are satisfied, that would constitute a detected arousal; col. 14 and lines 51-53-the stimulus delay controller 400 must then determine when and in what manner to resume stimulation if the arousal detection is not met, that indicates a probability of sleep).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Bolea to include wherein the sleep-wake status comprises a probability of sleep and a probability of wakefulness; initiate stimulation therapy in response to the probability of sleep exceeding a sleep-detection threshold for a delay period; pause stimulation therapy in response to the probability of wakefulness exceeding a wake-detection threshold by a predetermined percentage for a predetermined duration; and resume stimulation therapy, after the pause in stimulation therapy, in response to the probability of sleep exceeding the sleep-detection threshold for the delay period of Testerman in order to employ electrical stimulation in the treatment of sleep apnea (Testerman, col. 1 and lines 9-10). Since stimulation of the upper airway can have very distinct sensations that disturb the patient, it is very important that the patient is allowed to get to sleep before the onset of stimulation and, if aroused, is able to return to sleep without feeling the effects of stimulation (Testerman, col. 14 and lines 28-32).
Regarding claim 3, the combination of Bolea and Testerman teaches the device of claim 2, wherein the sensed physiologic information comprises a respiratory rate (Bolea, ¶473-respiratory period variability; ¶129-stimulation may be thus triggered as a function of respiration as detected by respiration sensing lead 70 in a closed-loop feedback system).
Regarding claim 4, the combination of Bolea and Testerman teaches the device of claim 3, wherein the sensed physiologic information comprises a respiratory rate variability (Bolea, ¶473-respiratory period variability; ¶129-stimulation may be thus triggered as a function of respiration as detected by respiration sensing lead 70 in a closed-loop feedback system).
Regarding claim 5, the combination of Bolea and Testerman teaches the device of claim 3, wherein the sensed physiologic information comprises a respiratory rate stability (Bolea, ¶302- analyzing the sensed respiratory signal to determine whether the signal includes “noise” caused by a patient's movement ( 4702 b ), whether the signal is sub-threshold (e.g., has a relatively low amplitude) ( 4702 c ), whether the signal is sufficiently stable ( 4702 d ), and whether the inversion detection is possible with the sensed signal ( 4702 e ); ¶556-a respiratory sensing vector may be selected based on signal strength and stability; ¶520).
Regarding claim 6, the combination of Bolea and Testerman teaches the device of claim 2, wherein the sensed physiologic information comprises a first respiratory period corresponding to inspiration (Bolea, ¶466-inspiratory phase; ¶563-the bottom trace #7 in FIGS. 72A and 72B correspond to a respiratory flow signal wherein the negative portion of the trace corresponds to inspiration, and the positive portion of the trace corresponds to expiration) and a second respiratory period corresponding to expiration (Bolea, ¶466-expiratory phase; ¶563-the bottom trace #7 in FIGS. 72A and 72B correspond to a respiratory flow signal wherein the negative portion of the trace corresponds to inspiration, and the positive portion of the trace corresponds to expiration).
Regarding claim 9, the combination of Bolea and Testerman teaches the device of claim 2, wherein the sensed physiologic information comprises temperature (Bolea, ¶379-a temperature sensor to detect the difference between cool inspired air versus warmed expired air).
Regarding claim 10, the combination of Bolea and Testerman teaches the device of claim 2, wherein the sensed physiologic information comprises posture (Bolea, ¶417-a sensor inside the INS (or elsewhere in system implanted) may detect body position and automatically shut off stimulation when patient sits up or stands up; ¶488).
Regarding claim 12, the combination of Bolea and Testerman teaches the device of claim 2, wherein the implantable sensor is configured to be implanted within a neck region of a patient (Bolea, ¶18-implantable neurostimulator (INS); ¶136-the INS (or the receiver, unit of the ENS) may be implanted and optionally anchored in a number of different locations including a subcutaneous pocket in the pectoral region, the dorsal neck region, or cranial region behind the ear, for example; ¶137-INS 50 may include an activity sensor; ¶156).
Regarding claim 13, the combination of Bolea and Testerman teaches the device of claim 2, wherein the controller is configured to initiate stimulation therapy in a closed-loop manner such that delivered stimulation is based on the sensed physiologic information (Bolea, ¶129-stimulation may be thus triggered as a function of respiration as detected by respiration sensing lead 70 in a closed-loop feedback system).
Regarding claim 14, Bolea teaches a device comprising: an implantable sensor to sense physiologic information (¶128-the implanted components 20 (shown faded) of the neurostimulator system 10 are implanted in a patient P with the INS 50 disposed in a subcutaneous pocket, respiration sensing; ¶137-INS 50 may include an activity sensor (not shown) for sensing the activity of a patient, including the amount of activity of the patient); a stimulation electrode to apply stimulation therapy to an upper airway patency-related tissue (¶128-the nerve cuff electrode 64 disposed on a nerve (e.g., hypoglossal nerve (HGN)) innervating a muscle (e.g., genioglossus muscle, not shown) controlling the upper airway); and a controller (¶132-patient controller 40) configured to: determine a sleep-wake status based on the sensed physiologic information (¶137-INS 50 may include an activity sensor (not shown) for sensing the activity of a patient, including the amount of activity of the patient; ¶138-data corresponding to a patient's motion may be used to determine whether a patient is sleeping or awake. For example, when a patient's activity level falls below a predetermined threshold, it may be assumed that the patient is sleeping. Conversely, when the patient's activity level rises above the predetermined threshold, it may be assumed that the patient is awake), and wherein the sensed physiologic information comprises a respiratory rate (¶409-the stimulation level (i.e., voltage amplitude, pulse width, frequency) may be adjusted based on changes in respiration rate), and wherein the controller is configured to initiate stimulation therapy in a closed-loop manner such that delivered stimulation is based on the respiratory rate (¶129-stimulation may be thus triggered as a function of respiration as detected by respiration sensing lead 70 in a closed-loop feedback system). However, Bolea does not explicitly teach wherein the sleep-wake status comprises a probability of sleep and a probability of wakefulness; initiate stimulation therapy in response to the probability of sleep exceeding a sleep-detection threshold for a delay period; pause stimulation therapy in response to the probability of wakefulness exceeding a wake-detection threshold by a predetermined percentage for a predetermined duration and resume stimulation therapy, after the pause in stimulation therapy, in response to the probability of sleep exceeding the sleep-detection threshold for the delay period.
Testerman teaches wherein the sleep-wake status comprises a probability of sleep (col. 13 and lines 28-31-a signal from the activity sensor can be monitored and if predetermined amplitude and duration thresholds are satisfied, that would constitute a detected arousal; col. 13 and lines 9-10-an awakening arousal is in essence a sleep stage; if the arousal detection is not met, that indicates a probability of sleep) and a probability of wakefulness (col. 13 and lines 28-31-a signal from the activity sensor can be monitored and if predetermined amplitude and duration thresholds are satisfied, that would constitute a detected arousal); initiate stimulation therapy in response to the probability of sleep exceeding a sleep-detection threshold for a delay period (col. 14 and lines 30-31-the patient is allowed to get to sleep before the onset of stimulation; col. 14 and lines 59-60-a delay of 15 minutes may be used to allow the patient to get to sleep initially; if the arousal detection is not met, that indicates a probability of sleep); pause stimulation therapy in response to the probability of wakefulness exceeding a wake-detection threshold by a predetermined percentage for a predetermined duration (col. 13 and lines 29-31-if predetermined amplitude and duration thresholds are satisfied, that would constitute a detected arousal; col. 13 and lines 24-26-this detected arousal could be used to delay the onset of stimulus until the patient has returned to sleep; col. 13 and lines 34-36-if both the activity sensor and the respiratory waveform indicate arousal, then the stimulation to the patient is disabled; if the threshold is triggered there is a probability that the patient is awake and that is above the threshold to pause the stimulation. Based on the threshold there is essentially a 0% or 100% output, (binary output). When it goes to 100%, it is above a “unspecified probability” (above 50%) that indicates wakefulness); and resume stimulation therapy, after the pause in stimulation therapy, in response to the probability of sleep exceeding the sleep-detection threshold for the delay period (col. 13 and lines 24-26-this detected arousal could be used to delay the onset of stimulus until the patient has returned to sleep; col. 13 and lines 29-31-if predetermined amplitude and duration thresholds are satisfied, that would constitute a detected arousal; col. 14 and lines 51-53-the stimulus delay controller 400 must then determine when and in what manner to resume stimulation if the arousal detection is not met, that indicates a probability of sleep).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Bolea to include wherein the sleep-wake status comprises a probability of sleep and a probability of wakefulness; initiate stimulation therapy in response to the probability of sleep exceeding a sleep-detection threshold for a delay period; pause stimulation therapy in response to the probability of wakefulness exceeding a wake-detection threshold by a predetermined percentage for a predetermined duration and resume stimulation therapy, after the pause in stimulation therapy, in response to the probability of sleep exceeding the sleep-detection threshold for the delay period of Testerman in order to employ electrical stimulation in the treatment of sleep apnea (Testerman, col. 1 and lines 9-10). Since stimulation of the upper airway can have very distinct sensations that disturb the patient, it is very important that the patient is allowed to get to sleep before the onset of stimulation and, if aroused, is able to return to sleep without feeling the effects of stimulation (Testerman, col. 14 and lines 28-32).
Regarding claim 15, the combination of Bolea and Testerman teaches the device of claim 14, wherein the sensed physiologic information further comprises at least one of a respiratory rate variability, a respiratory rate stability, an inspiratory period, an expiratory period, a ratio of the inspiratory period relative to the expiratory period, an arterial motion, or a temperature (Bolea, ¶473-respiratory period variability; ¶520-signal stability outputs; Abstract-identifying an inspiratory phase of the respiratory cycle; ¶129-expiration).
Regarding claim 17, the combination of Bolea and Testerman teaches the device of claim 14, wherein the sensor comprises at least one of an accelerometer, a temperature sensor, an acoustic sensor, an impedance sensor, or a pressure sensor (Bolea, ¶137-an internal accelerometer; ¶134-impedance sensing electrodes).
Regarding claim 18, Bolea teaches a method comprising: implanting a sensor to sense physiologic information (¶128-the implanted components 20 (shown faded) of the neurostimulator system 10 are implanted in a patient P with the INS 50 disposed in a subcutaneous pocket, respiration sensing; ¶137-INS 50 may include an activity sensor (not shown) for sensing the activity of a patient, including the amount of activity of the patient) and a stimulation element to apply stimulation therapy to a tissue within a patient (¶128-the nerve cuff electrode 64 disposed on a nerve (e.g., hypoglossal nerve (HGN)) innervating a muscle (e.g., genioglossus muscle, not shown) controlling the upper airway); and determining a sleep-wake status based on the sensed physiologic information (¶137-INS 50 may include an activity sensor (not shown) for sensing the activity of a patient, including the amount of activity of the patient; ¶138-data corresponding to a patient's motion may be used to determine whether a patient is sleeping or awake. For example, when a patient's activity level falls below a predetermined threshold, it may be assumed that the patient is sleeping. Conversely, when the patient's activity level rises above the predetermined threshold, it may be assumed that the patient is awake). However, Bolea does not explicitly teach the sleep-wake status comprising a probability of sleep and a probability of wakefulness; initiating stimulation therapy via the stimulation element in response to the probability of sleep exceeding a sleep-detection threshold for a delay period; pausing stimulation therapy in response to the probability of wakefulness exceeding a wake-detection threshold by a predetermined percentage for a predetermined duration; and resuming stimulation therapy, after the pause in stimulation therapy, in response to the probability of sleep exceeding the sleep-detection threshold for the delay period.
Testerman teaches the sleep-wake status comprising a probability of sleep (col. 13 and lines 28-31-a signal from the activity sensor can be monitored and if predetermined amplitude and duration thresholds are satisfied, that would constitute a detected arousal; col. 13 and lines 9-10-an awakening arousal is in essence a sleep stage; if the arousal detection is not met, that indicates a probability of sleep) and a probability of wakefulness (col. 13 and lines 28-31-a signal from the activity sensor can be monitored and if predetermined amplitude and duration thresholds are satisfied, that would constitute a detected arousal); initiating stimulation therapy via the stimulation element in response to the probability of sleep exceeding a sleep-detection threshold for a delay period (col. 14 and lines 30-31-the patient is allowed to get to sleep before the onset of stimulation; col. 14 and lines 59-60-a delay of 15 minutes may be used to allow the patient to get to sleep initially; if the arousal detection is not met, that indicates a probability of sleep); pausing stimulation therapy in response to the probability of wakefulness exceeding a wake-detection threshold by a predetermined percentage for a predetermined duration (col. 13 and lines 29-31-if predetermined amplitude and duration thresholds are satisfied, that would constitute a detected arousal; col. 13 and lines 24-26-this detected arousal could be used to delay the onset of stimulus until the patient has returned to sleep; col. 13 and lines 34-36-if both the activity sensor and the respiratory waveform indicate arousal, then the stimulation to the patient is disabled; if the threshold is triggered there is a probability that the patient is awake and that is above the threshold to pause the stimulation. Based on the threshold there is essentially a 0% or 100% output, (binary output). When it goes to 100%, it is above a “unspecified probability” (above 50%) that indicates wakefulness); and resuming stimulation therapy, after the pause in stimulation therapy, in response to the probability of sleep exceeding the sleep-detection threshold for the delay period (col. 13 and lines 24-26-this detected arousal could be used to delay the onset of stimulus until the patient has returned to sleep; col. 13 and lines 29-31-if predetermined amplitude and duration thresholds are satisfied, that would constitute a detected arousal; col. 14 and lines 51-53-the stimulus delay controller 400 must then determine when and in what manner to resume stimulation if the arousal detection is not met, that indicates a probability of sleep).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Bolea to include the sleep-wake status comprising a probability of sleep and a probability of wakefulness; initiating stimulation therapy via the stimulation element in response to the probability of sleep exceeding a sleep-detection threshold for a delay period; pausing stimulation therapy in response to the probability of wakefulness exceeding a wake-detection threshold by a predetermined percentage for a predetermined duration; and resuming stimulation therapy, after the pause in stimulation therapy, in response to the probability of sleep exceeding the sleep-detection threshold for the delay period of Testerman in order to employ electrical stimulation in the treatment of sleep apnea (Testerman, col. 1 and lines 9-10). Since stimulation of the upper airway can have very distinct sensations that disturb the patient, it is very important that the patient is allowed to get to sleep before the onset of stimulation and, if aroused, is able to return to sleep without feeling the effects of stimulation (Testerman, col. 14 and lines 28-32).
Regarding claim 19, the combination of Bolea and Testerman teaches the method of claim 17, the sensed physiologic information comprises at least one of a respiratory rate, a respiratory rate variability, a respiratory rate stability, an inspiratory period, an expiratory period, a ratio of the inspiratory period relative to the expiratory period, an arterial motion, or a temperature (Bolea, ¶473-respiratory period variability; ¶520-signal stability outputs; Abstract-identifying an inspiratory phase of the respiratory cycle; ¶129-expiration).
Regarding claim 21, the combination of Bolea and Testerman teaches the method of claim 17, wherein implanting the sensor and the stimulation element comprising implanting the sensor and the stimulation element within a neck region of the patient (Bolea, ¶18-implantable neurostimulator (INS); ¶136-the INS (or the receiver, unit of the ENS) may be implanted and optionally anchored in a number of different locations including a subcutaneous pocket in the pectoral region, the dorsal neck region, or cranial region behind the ear, for example; ¶137-INS 50 may include an activity sensor; ¶156).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Bolea in view of Testerman as applied to claims 2 and 6 above, and further in view of Pu (US 20080319513 filed on 6/25/07 as cited in the IDS).
Regarding claim 7, the combination of Bolea and Testerman teaches the device of claim 6. However, the combination of Bolea and Testerman does not teach wherein the sensed physiologic information further comprises a ratio of the first respiratory period relative to the second respiratory period.
Pu teaches wherein the sensed physiologic information further comprises a ratio of the first respiratory period relative to the second respiratory period (¶28-a measure of variability of a respiratory parameter (an inspiratory/expiratory ratio)).
Pu relates generally to medical devices and, more particularly, to systems, devices and methods for delivering neural stimulation (¶1).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Bolea to include wherein the sensed physiologic information further comprises a ratio of the first respiratory period relative to the second respiratory period of Pu in order for stimulation adjustment in response to at least the detection of a respiratory disorder by the respiratory disorder detector (Pu, ¶78).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Bolea in view of Testerman as applied to claim 2 above, and further in view of Patangay (US 7678058 filed on 6/22/06 as cited in the IDS).
Regarding claim 8, the combination of Bolea and Testerman teaches the device of claim 2. However, the combination of Bolea and Testerman does not teach wherein the sensed physiologic information comprises arterial motion.
Patangay teaches wherein the sensed physiologic information comprises arterial motion (col. 5 and lines 3-4-a pulmonary artery pressure sensor).
Patangay relates to implantable medical devices, and more particularly, but not by way of limitation, to a method and apparatus for determining the type of sleep apnea in a patient (col. 1 and lines 6-9).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Bolea to include wherein the sensed physiologic information comprises arterial motion of Patangay in order to detect obstructive sleep apnea (Patangay, col. 5 and lines 7-10).
Claims 11, 16, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Bolea in view of Testerman as applied to claims 2, 14, and 18 above, and further in view of Ferree (US 20170312515 filed on 7/13/17 as cited in the IDS).
Regarding claim 11, the combination of Bolea and Testerman teaches the device of claim 2. However, the combination of Bolea and Testerman does not teach wherein the controller is configured to determine the sleep-wake status based on the sensed physiologic information and a time of day.
Ferree teaches wherein the controller is configured to determine the sleep-wake status based on the sensed physiologic information and a time of day (¶98-real-time clock 505 of user state detector 500 allows assigning a nontrivial a priori probability of the sleep-wake state at any given time of the day in order to further refine the sleep-wake state classification results obtained by the aforementioned analysis of leg orientation and leg motion data (i.e., a user is more likely to be asleep at 3:00 am and less likely to be asleep at 4:00 pm); ¶97).
Ferree relates generally to Transcutaneous Electrical Nerve Stimulation (TENS) devices that deliver electrical currents across the intact skin of a user via electrodes so as to provide symptomatic relief of pain. More specifically, this invention relates to a TENS device worn during sleep, and a method for controlling the timing and the intensity of TENS therapeutic stimulation based on continuous real-time sleep analysis (¶25).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Bolea to include wherein the controller is configured to determine the sleep-wake status based on the sensed physiologic information and a time of day of Ferree in order to further refine the sleep-wake state classification results (Ferree, ¶98).
Regarding claim 16, the combination of Bolea and Testerman teaches the device of claim 14. However, the combination of Bolea and Testerman does not teach wherein the controller is configured to determine the sleep-wake status based on the sensed physiologic information and a time of day.
Ferree teaches wherein the controller is configured to determine the sleep-wake status based on the sensed physiologic information and a time of day (¶98-real-time clock 505 of user state detector 500 allows assigning a nontrivial a priori probability of the sleep-wake state at any given time of the day in order to further refine the sleep-wake state classification results obtained by the aforementioned analysis of leg orientation and leg motion data (i.e., a user is more likely to be asleep at 3:00 am and less likely to be asleep at 4:00 pm); ¶97).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Bolea to include wherein the controller is configured to determine the sleep-wake status based on the sensed physiologic information and a time of day of Ferree in order to further refine the sleep-wake state classification results (Ferree, ¶98).
Regarding claim 20, the combination of Bolea and Testerman teaches the method of claim 18. However, the combination of Bolea and Testerman does not teach wherein determining the sleep-wake status comprises determining the sleep-wake status based on the sensed physiologic information and a time of day.
Ferree teaches wherein determining the sleep-wake status comprises determining the sleep-wake status based on the sensed physiologic information and a time of day (¶98-real-time clock 505 of user state detector 500 allows assigning a nontrivial a priori probability of the sleep-wake state at any given time of the day in order to further refine the sleep-wake state classification results obtained by the aforementioned analysis of leg orientation and leg motion data (i.e., a user is more likely to be asleep at 3:00 am and less likely to be asleep at 4:00 pm); ¶97).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Bolea to include wherein determining the sleep-wake status comprises determining the sleep-wake status based on the sensed physiologic information and a time of day of Ferree in order to further refine the sleep-wake state classification results (Ferree, ¶98).
Claims 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Bolea in view of Testerman as applied to claim 2 above, and further in view of Bandyopadhyay (WO 2017040331 filed on 8/26/16), hereinafter referred to as Band.
Regarding claim 22, the combination of Bolea and Testerman teaches the device of claim 2. However, the combination of Bolea and Testerman does not explicitly teach wherein the probability of sleep is determined based on a plurality of sensed sleep-wake determination parameters derived from the physiologic information.
Band teaches wherein the probability of sleep is determined based on a plurality of sensed sleep-wake determination parameters derived from the physiologic information (¶13-signals can be passed along with ground truth to the training system to generate a sleep stage evaluation engine, which can evaluate new input signals to produce a prediction of sleep stage; ¶16-EKG data, motion data, breathing rate data and sound data, are provided as input to the engine; ¶122-if it is a REMWake stage prediction, the probability of REMVsWakepx is checked. If this is above a threshold, such as 0.5 in some implementations, the stage is considered a Wake stage else a REM stage).
Band relates to systems to monitor and analyze the quality and quantity of a person's sleep (¶3).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Bolea to include wherein the probability of sleep is determined based on a plurality of sensed sleep-wake determination parameters derived from the physiologic information of Band in order to produce a more accurate result (Band, ¶115) for analysis of sleep data to detect disorders (Band, ¶99).
Regarding claim 23, the combination of Bolea, Testerman, and Band teaches the device of claim 22, wherein the sleep-wake determination parameters comprise respiratory rate, heart rate, and body movement (Band, ¶13-signals can be passed along with ground truth to the training system to generate a sleep stage evaluation engine, which can evaluate new input signals to produce a prediction of sleep stage; ¶16-EKG data, motion data, breathing rate data and sound data, are provided as input to the engine; ¶122-if it is a REMWake stage prediction, the probability of REMVsWakepx is checked. If this is above a threshold, such as 0.5 in some implementations, the stage is considered a Wake stage else a REM stage).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Bolea to include wherein the sleep-wake determination parameters comprise respiratory rate, heart rate, and body movement of Band in order to produce a more accurate result (Band, ¶115) for analysis of sleep data to detect disorders (Band, ¶99).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20180200512: which relates to devices, systems and associated methods for treating sleep disordered breathing. More particularly, the inventions described here relate to devices, systems and methods for treating obstructive sleep apnea (¶2).
THIS ACTION IS MADE FINAL. 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 LAURA HODGE whose telephone number is (571) 272-7101. The examiner can normally be reached M-F: 8:00 am-5:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, UNSU JUNG can be reached at (571) 272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/L.N.H./Examiner, Art Unit 3792
/AMANDA L STEINBERG/Examiner, Art Unit 3792
Prosecution Insights