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 .
Election/Restrictions
Claims 1-12, 24-26 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/17/2026.
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(s) 13-23, 27-29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fadem (USPN 2014/0128763) in view of Thai-Van et al. (USPN 2016/0262651) in view of Burton et al. (WO 2006/122349).
Regarding claims 13, 27-29, FADEM discloses a method for determining a condition of a subject ([0003]), the method comprising: recording auditory brain stem (ABS) electrical signal data (signals as produced by elements 16, 16', 16") in a subject (20) in response to an auditory signal (signals as produced by elements 16, 16', 16") delivered to the subject (20) (FIG. 1, FIG. 5, [0121]- The gain, filters, and A/D conversion settings may thus be different to accommodate the differences in signal characteristics. In particular, the high frequency electrode(s) 16 may be used to capture low amplitude, high frequency brainwaves as in auditory brainstem response (ABR) testing for hearing defects;[0122]- The memory 54 is also preloaded or uploaded with a testing protocol and stores a number of testing session data records so that the headset 10 may be repeatedly used prior to uploading results); determining first data that indicates a property of peaks in the ABS electrical signal, wherein peaks occur in a first portion of the ABS electrical signal away from a different second portion that includes a set of one or more vertices (signals as produced by elements 16, 16', 16") ([0019]- For auditory stimuli, N1 has a maximum amplitude over frontocentral areas or the vertex. More recent studies differentiated it into three different components with maximum amplitudes over temporal areas (latency 75 ms and 130 ms) and over vertex (latency 100 ms). Based upon review of the three components of N1, it was proposed that the early temporal and vertex components reflect sensory and physical properties of the stimuli (e.g., intensity, location, timing in regard to other stimuli) while the later temporal component appears to be less specific in its response and reflects transient arousal. However, most of the studies reviewed in the present manuscript treated N1 as a single component occurring at 100 ms after stimulus onset with maximum amplitude at the vertex electrode.; para [0024]- P2 often occurs together with N1, yet the two peaks can be dissociated. The distribution of the P2 is less localized than that of the N1 and has the highest amplitude over the central region. Also, the temporal peak of the P2 can occur over a broader latency range than the preceding peaks with latency ranging from 150-275 ms and can be double-peaked. Like N1, P2 has been consistently identified by PCA factor scores, baseline to peak amplitude, and baseline to peak latency analysis procedures). FADEM fails to teach or suggest micropeaks and wherein each vertex indicates a response from a different anatomical location from the cochlea to the auditory cortex of the subject; and determining a condition of the subject based on a distance of the property of the micropeaks from a predetermined set of values for the property of the micropeaks in a population of control individuals. THAI-VAN ET AL. discloses wherein each vertex indicates a response from a different anatomical location from the cochlea to the auditory cortex of the subject (para [0005]-[0006]- high-frequency responses (above about 80 hertz (Hz)), of origin that is assumed to be sub-cortical (coming in particular from the brainstem), and thus generally referred to in the literature as speech auditory brainstem response ("speech ABR"). The physical characteristics of speech ABRs serve not only to verify that the delivered speech sound is detected by the auditory nervous system, but also that it is properly coded and that the coding enables the auditory nervous system to discriminate it from another speech sound; and low-frequency responses (below about 80 Hz), of origin that is assumed to be essentially cortical. These responses are generally labeled by their sign and by the latency in milliseconds at the vertex: P50, N100, P200, etc.; FIG. 1, para [0066]- the central unit 1 is connected to an electro- or magneto-encephalographic amplifier 5 (referred to below as an EG amplifier). This EG amplifier 5 is connected to electro-encephalographic electrodes or to magneto-encephalographic sensors 6 arranged in contact with or in the proximity of the head of the individual 4.; FIGS. 2C-2G, para [0077]- The data was recorded at the Cz electrode (placed at the vertex), referenced to the average of two pickup electrodes placed on the mastoids. The speech ABRs were obtained from 3000 individual tests, with rejection of artifacts, averaging of tests that did not present artifacts, and bandpass filtering in the range 80 Hz to 1000 Hz). Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention before the effective filling date of the invention to incorporate the teaching of that each vertex indicates a response from a different anatomical location from the cochlea to the auditory cortex of the subject as taught by Thai-Van et al. into the device of Fadem, since such modification would provide additional information in order to obtain more accurate physiological parameters. Fadem in view of THAI-VAN ET AL. fails to determining a condition of the subject based on a distance of the property of the micropeaks from a predetermined set of values for the property of the micropeaks in a population of control individuals. BURTON ET AL. does disclose ABS electrical signals with recorded vertices (Pg. 1, In 28-Pg. 2, In 2- measuring consciousness incorporate measurement of auditory evoked potentials (AEPs), which are measurable biosignals appearing in an EEG measurement resulting from an auditory stimulus. AEPs are brain responses "evoked" as a result of auditory stimulus presentation. Techniques are available for the extraction of wanted auditory evoked potentials from the background random EEG signal. The AEP waveform is visually identified by a number of waveform peaks and troughs, and is described by the AEPs latency and amplitude characteristics.; Pg. 8, In 30- Pg. 9, In 4- The method includes the use of any combination of latency band and related functions including first latency AEP signals (0-5 ms); anatomy of the cochlear, eighth nerve, eighth nerve compound action potential (CAP); fast latency AEP signals (2-20 ms); auditory brainstem response (ABR) waves I, II, 111, IV, V; early cortical or middle-latency signals (10-100 ms): MLAEP: Na, Pa, TP41, Pb, Nb);slow "Vertex" latency AEP signals (50-300 ms); P1, N1, P2, N2, and late latency AEP signals (150-1000 ms); mismatched negativity (MMN), processing negativity (Nd), N2b, P3a, P3b, N400, P600). Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention before the effective filling date of the invention to incorporate the teaching of determining a condition of the subject based on a distance of the property of the micropeaks from a predetermined set of values for the property of the micropeaks in a population of control individuals. as taught by Burton et al. into the device of Fadem in view of Thai-Van et al., since such modification would provide additional information in order to obtain more accurate physiological parameters.
Regarding claim 14, the population of control individuals includes a plurality of populations of control individuals, each population having a different set of values for the property of the micropeaks and associated with a different neurodevelopmental condition (Thai-Van et al. [0066]-[0077]).
Regarding claim 15, the plurality of populations of control individuals, includes first population associated with normal development and different second population associated with autism spectrum disorder (ASD) (Thai-Van et al. [0066]-[0077]).
Regarding claim 16, the property of the micropeaks includes a prominence for each micropeak (Thai-Van et al. [0066]-[0077]).
Regarding claim 17, the property of the micropeaks includes a width for each micropeak (Thai-Van et al. [0066]-[0077]).
Regarding claim 18, the property of the micropeaks includes an amplitude for each micropeak (Thai-Van et al. [0066]-[0077]).
Regarding claim 19, the first data indicates a distribution of the property for each micropeak over a plurality of micropeaks; and the distance is a distance between the distribution of the property of the subject to the distributions of the property in the plurality of populations of control individuals (Thai-Van et al. [0066]-[0077]).
Regarding claim 20, the distance is an Earthmover's distance between distributions (Thai-Van et al. [0066]-[0077]).
Regarding claim 21, the different set of values for the property of the micropeaks are indicated by a different set of values for parameters of a probability density function for the property (Thai-Van et al. [0066]-[0077]).
Regarding claim 22, the probability density function is a Gamma Function and the parameters of the Gamma Function include scale and shape (Thai-Van et al. [0066]-[0077]).
Regarding claim 23, the parameters of the probability density function include mean, variance and skewness (Thai-Van et al. [0066]-[0077]).
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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