DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 102
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-24 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Christensen et al. (USPN 2015/0080671-Cited by the Applicant)
Regarding claims 1, 23-24, a method of characterizing a neurodegenerative disorder (NDD), the method comprising using at least one hardware processor to: acquire physiological data for a subject, wherein the physiological data are obtained while the subject is sleeping ([0028]); derive one or more sleep biomarkers based on the physiological data ([0018], [0051]); apply a classifier to the one or more sleep biomarkers, wherein the classifier outputs a risk probability for each of one or more neurodegenerative disorders ([0041]-[0042], [0047]); assign a risk severity based on the risk probability for each of the one or more neurodegenerative disorders ([0041]-[0042], [0047]); and generate a report that indicates the risk severity for the subject ([0027]-[0040]).
Regarding claim 2, the one or more sleep biomarkers comprise a measure of time spent in rapid eye movement (REM) sleep ([0018], [0042], [0095]).
Regarding claim 3, the one or more sleep biomarkers comprise a measure of spindle activity ([0025]-[0035]).
Regarding claim 4, deriving the measure of spindle activity comprises: detecting each sleep spindle by identifying a spindle peak comprising a burst in both sigma-wave power and alpha-wave power, within the physiological data, determining a start time and an end time of the sleep spindle around the spindle peak based on at least one first threshold, determining a duration of the sleep spindle based on the start time and the end time, and detecting the sleep spindle when the duration of the sleep spindle satisfies at least one second threshold; and computing the measure of spindle activity based on the duration of each detected sleep spindle ([0142]-[0150]).
Regarding claim 5, the one or more sleep biomarkers comprise a measure of atypical slow-wave (AN3) sleep ([0064]).
Regarding claim 6, the one or more sleep biomarkers comprise a measure of non-rapid eye movement (NREM) hypertonia (NRH) ([0039], [0061]).
Regarding claim 7, deriving the measure of NREM hypertonia comprises automatically detecting one or more episodes of NREM hypertonia by: for each of a plurality of epochs, represented in the physiological data, determining whether or not the epoch exhibits an abnormal sleep characteristic based on signals, in the physiological data, representing delta-wave power without ocular activity, theta-wave power, sigma-wave power, and electromyographic (EMG) power, and determining whether or not a standard deviation of the EMG power satisfies a predefined threshold within a set of two or more epochs that includes the epoch; connecting two or more of the plurality of epochs, that each exhibits the abnormal sleep characteristic and for which the standard deviation of the EMG power satisfies the predefined threshold within the set of two or more epochs that includes the epoch, into an NRH block; extending one or more NRH blocks to include one or more surrounding epochs; and excluding any NRH block that satisfies one or more exclusion criteria, wherein the one or more episodes of NREM hypertonia consist of any non-excluded NRH blocks. See [0095]-[0099]
Regarding claim 8, determining whether or not the epoch exhibits an abnormal sleep characteristic comprises: determining that the epoch does not exhibit the abnormal sleep characteristic when the delta-wave power without ocular activity exceeds a first threshold; calculating a delta threshold based on a theta-EMG ratio of the theta-wave power and the EMG power; calculating a theta threshold based on a delta-EMG ratio of the delta-wave power without ocular activity and the EMG power; determining whether or not the delta-EMG ratio is within a first range based on the delta threshold; determining whether or not the theta-EMG ratio is within a second range based on the theta threshold; determining whether or not a sigma-EMG ratio of the sigma-wave power and the EMG power is within a third range; determining that the epoch does not exhibit the abnormal sleep characteristic when either the delta-EMG ratio is not within the first range, the theta-EMG ratio is not within the second range, or the sigma-EMG ratio is not within the third range; and determining that the epoch exhibits the abnormal sleep characteristic when the delta-EMG ratio is within the first range, the theta-EMG ratio is within the second range, and the sigma-EMG ratio is within the third range. See [0095]-[0099], ([0142]-[0150]).
Regarding claim 9, the one or more exclusion criteria comprise one or more of a presence of the NRH block within a predefined time duration immediately following sleep onset, the presence of the NRH block within a predefined time duration of uprightness, or the NRH block corresponding in time to a skin-electrode impedance greater than a predefined threshold impedance. See [0095]-[0099], ([0142]-[0150]).
Regarding claim 10, the one or more sleep biomarkers comprise a measure of autonomic activation ([0047], [0095]).
Regarding claim 11, the one or more sleep biomarkers comprise relative theta-wave power ([0049], [0061]).
Regarding claim 12, the one or more sleep biomarkers comprise a ratio of theta-wave power to alpha-wave power ([0049], [0061]).
Regarding claim 13, the one or more sleep biomarkers comprise a measure of sleep efficiency ([0040]).
Regarding claim 14, the one or more sleep biomarkers comprise sleep duration in a supine position ([0028]).
Regarding claim 15, the one or more sleep biomarkers comprise a measure of electroencephalographic (EEG) slowing ([0064]).
Regarding claim 16, the one or more sleep biomarkers comprise a measure of rapid eye movement (REM) sleep without atonia (RSWA) events ([0107]).
Regarding claim 17, deriving the measure of RSWA events comprises: detecting the RSWA events by, for each of a plurality of epochs, represented in the physiological data, filtering an electromyographic (EMG) signal in the physiological data for the epoch, extracting a measure of EMG power from the filtered EMG signal, computing baseline EMG power during REM sleep, and detecting the RSWA event based on the measure of EMG power and the baseline EMG power; and computing the measure of RSWA events based on the detected RSWA events. See [0107]
Regarding claim 18, the one or more sleep biomarkers comprise a pattern of oscillatory events ([0061]-[0063]).
Regarding claim 19, the one or more sleep biomarkers are derived further based on a health record of the subject ([0028]-[0035]).
Regarding claim 20, the one or more neurodegenerative disorders are a plurality of neurodegenerative disorders ([0028]-[0035]).
Regarding claim 21, the report comprises the risk severity, a two-way comparison of each pair of the plurality of neurodegenerative disorders, and an analysis of each of the one or more sleep biomarkers ([0028]-[0035]).
Regarding claim 22, the one or more sleep biomarkers are a plurality of sleep biomarkers ([0028]-[0035]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARJAN FARDANESH whose telephone number is (571)270-5508. The examiner can normally be reached Monday-Friday 9:00-17:00.
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/MARJAN FARDANESH/Primary Examiner, Art Unit 3791
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