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 Objections
Claim 1 is objected to because of the following informalities: “a wearable member audio” should be “a wearable member”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 10 -11 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 10-11 merely restate the subject matter that is previously described in lines 14 and 15 of claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 1, 2, 5-17, 19-21, and 24-27 are rejected are rejected under 35 U.S.C. 103 as being unpatentable over Mackellar (US 20190246982 A1 - previously cited) in view of Campbell (US 20210314692 A1).
In regards to claim 1, Mackellar teaches a portable device for monitoring hearing sensitivity ([0138]) the device comprising:
a wearable member used to deliver user-selected playback audio ([0022] “an audio sample transmitted based on instructions extracted from a collected audio signal input of the user” audio is selected based on user input signal);
a stimulator integrated into the wearable member ([0069] speaker);
a sensor integrated into the wearable member, the sensor comprising a plurality of electrodes ([0100] Fig 6 one or more EEG sensors 210, common mode sensors 222, and one or more DRL electrodes 224);
and a controller operably coupled to the stimulator and the sensor ([0137] electronics subsystem 250), the controller being configured to: deliver a stimulation signal to a subject's ear using the stimulator that is delivered with the user-selected playback audio ([0137]);
and receive an electrophysiological response signal of the subject in response to the stimulation signal, the electrophysiological response signal being recorded by the sensor ([0022] [0094]).
Mackellar fails to teach electrodes that are configured to optimize recording of cochlear microphonic and related early auditory potentials from the ear canal/pinna region; and a system wherein the electrophysiological response signal comprises an early auditory potential from inner-ear sensory epithelia. Campbell teaches electrodes that are configured to optimize recording of cochlear microphonic and related early auditory potentials from the ear canal/pinna region; and a system wherein the electrophysiological response signal comprises an early auditory potential from inner-ear sensory epithelia. ([0050] “AEP is a type of EEG signal emanating from the brain through the scalp in response to an acoustical stimulus. The sensor 320 can measure any AEP, such as auditory brainstem response, mid latency response, cortical response, acoustic change complex, auditory steady state response, complex auditory brainstem response, electrocochleography, cochlear microphonic, or cochlear neurophonic AEP.”). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the electrodes of Mackellar to detect cochlear microphonics like the sensors of Campbell.
In regards to claim 2, Mackellar teaches the device of claim 1, wherein the wearable member is configured to be worn around a portion of the subject's head, the wearable member comprising at least one ear-covering member (Mackellar Fig 3 Device covers ear).
In regards to claim 5, Mackellar teaches the device of claim 1, wherein the sensor is an electroencephalography (EEG) sensor (Campbell [0050] sensor detects EEG).
In regards to claim 6, Mackellar teaches the device of claim 1, wherein the plurality of electrodes are skin surface electrodes (Mackellar [0090] EEG sensors contact skin in ear canal, Campbell [0049] “sensor 320 placed into contact with a user's skin”).
In regards to claim 8, Mackellar teaches the device of claim 1, wherein the plurality of electrodes comprise an active electrode, a reference electrode, and a ground electrode (Mackellar [0107] [0109] EEG sensors 210 are active, DRL is reference, Common Mode sensor is ground).
In regards to claim 9, Mackellar teaches the device of claim 1, wherein the controller is further configured to generate the stimulation signal (Mackellar [0137]).
In regards to claim 10. Mackellar teaches device of claim 1, wherein electrophysiological response signal comprises physiological activity of the subject's inner ear sensory epithelia (Campbell [0050]).
In regards to claim 11 modified Mackellar teaches device of claim 1, wherein the electrophysiological response signal comprises an early auditory potential (Campbell [0050]).
In regards to claim 12, modified Mackellar teaches the device of claim 11, wherein the early auditory potential comprises at least one of the cochlear microphonic (CM) response, the auditory nerve neurophonic, the auditory nerve overlapped waveform, the summating potential of the cochlea, or the compound action potential (Campbell [0050]).
In regards to claim 13, Mackellar teaches the device of claim 1, wherein the controller further comprises an analog-to-digital converter (ADC) configured to convert the electrophysiological response signal into a digital signal (Mackellar [0125-0126]).
In regards to claim 14, Mackellar teaches the device of claim 1, wherein the controller further comprises a wireless transceiver (Mackellar [0132]).
In regards to claim 15, Mackellar teaches the device of claim 14, wherein the wireless transceiver is a low-power wireless transceiver (Mackellar [0132] Zigbee and RF are low power).
In regards to claim 16, Mackellar teaches the device of claim 1, wherein the controller further comprises signal conditioning circuity (Mackellar [0130]).
In regards to claim 17, Mackellar teaches the device of claim 1, wherein the controller comprises a microprocessor (Mackellar [0124]).
In regards to claim 19, Mackellar teaches the device of claim 1, wherein the controller is integrated into the wearable member (Mackellar Fig 4a controller 250 is in the wearable member).
In regards to claim 20, Mackellar teaches the device of claim 1, wherein the stimulator is an electroacoustic transducer and the stimulation signal is an acoustic stimulation signal, the controller being configured to actuate the electroacoustic actuator transducer to deliver the acoustic stimulation signal to the subject's ear (Mackellar [0069] speaker).
In regards to claim 21, Mackellar teaches the device of claim 20, wherein the acoustic stimulation signal is configured to activate the subject's inner ear (Mackellar [0069] speaker).
In regards to claim 24, Mackellar teaches a system for monitoring hearing sensitivity, the system comprising: the device of claim 1 (see the above rejection of claim 1); and a computing device operably coupled to the controller of the device, the computing device comprising a processor and a memory, the memory having computer-executable instructions stored thereon that, when executed by the processor, cause the processor to: receive, from the controller of the device, the electrophysiological response signal; and analyze the electrophysiological response signal (Mackellar [0144]).
In regards to claim 25, Mackellar teaches the system of claim 24, wherein the memory has further computer-executable instructions stored thereon that, when executed by the processor, cause the processor to generate a warning in response to analyzing the electrophysiological response signal (Mackellar [0084] generates alert).
In regards to claim 26, Mackellar teaches the system of claim 24 , wherein analyzing the electrophysiological response signal comprises: converting the electrophysiological response signal into a frequency domain; and calculating a statistical measure of the frequency-domain electrophysiological response signal (Mackellar [0130] [0143]).
In regards to claim 27, Mackellar teaches the system of claim 26, wherein the statistical measure of the frequency-domain electrophysiological response signal is at least one of a mean, a standard deviation, a confidence interval, or a noise floor level (Mackellar [0143] confidence level).
Claims 3 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over by Mackellar (US 20190246982 A1 - previously cited) in view of Campbell (US 20210314692 A1) as applied to claim 1, further in view of Jin (US 20180056083 A1 - previously cited).
In regards to claim 3. Mackellar teaches the device of claim 1, including an earbud ([0021] Fig 4a 206 is an earbud). Mackellar fails to teach clip on electrode. Jin teaches clip-on electrodes that attach to a user’s ear ([0070]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the reference electrode of Mackellar with be a clip on electrode like the reference electrodes of Jin. Doing so would merely be a simple substitution of one known electrode type for another to obtain predictable results.
In regards to claim 4. modified Mackellar teaches the device of claim 3, wherein the pair of clip electrodes are configured to detachably couple to an external portion of the subject's ear or ears (Jin [0070]).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over by Mackellar (US 20190246982 A1 - previously cited) in view of Campbell (US 20210314692 A1) as applied to claim 1, further in view of Orron (US 20180279952 A1 - previously cited).
In regards to claim 18, modified Mackellar teaches device of claim 1, comprising receiving temperature data (Mackellar [0092]). Modified Mackellar fails to teach a temperature sensor. Orron teaches an audio headset with a temperature sensor ([0058]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the earphone of modified Mackellar to include a temperature sensor like the earphone of Orron. Doing so would merely be choosing from a finite number of identified, predictable solutions (different placements for temperature sensors), with a reasonable expectation of success in order to obtain the temperature data. Alternatively, it would have been obvious because modified Mackellar teaches the receipt of temperature data and Orron teaches one way to receive such temperature data.
Claims 22 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over by Mackellar (US 20190246982 A1 - previously cited) in view of Campbell (US 20210314692 A1) as applied to claim 1, further in view of Soulet de Brugiere (US 20170340855 A1 - previously cited).
In regards to claim 22, modified Mackellar teaches the device of claim 1, wherein the controller is configured to deliver a stimulation signal to a subject's ear using the stimulator ([0137]). Modified Mackellar fails to teach a device wherein the stimulator is a bone oscillator and the stimulation signal is a bone conduction stimulation, the controller being configured to actuate the bone oscillator to deliver the bone conduction stimulation to the subject's ear. Soulet de Brugiere teaches a bone oscillator and the stimulation signal is a bone conduction stimulation that is actuated to deliver the bone conduction stimulation to the subject's ear ([0026]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to substitute the speaker of modified Mackellar with the bone conduction device of Soulet de Brugiere. Doing so would merely be a simple substitution of one known stimulus device for another to obtain predictable results.
In regards to claim 23, modified Mackellar teaches the device of claim 22, wherein the bone conduction stimulation is configured to activate the subject's inner ear (Soulet de Brugiere [0026]).
Claims 28, 32, and 33 are rejected under 35 U.S.C. 103 as being unpatentable over by Mackellar (US 20190246982 A1 - previously cited) in view of Campbell (US 20210314692 A1) as applied to claim 24, in view of Das (US 20160242699 A1 - previously cited).
In regards to claim 28, modified Mackellar teaches the system of claim 24, wherein analyzing the electrophysiological response signal comprises calculating a cognitive metric (Mackellar [0070]). Mackellar fails to teach calculating a score based on the electrophysiological response signal. Das teaches determining a cognitive score using EEG signals ([0048-0049]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the computing device of modified Mackellar to determine a cognitive score like the device of Das. Doing so would allow for “real-time personalized content generation for distant learning, customize and test various applications on mobile devices, and many other areas related to human interactions” (Das [0003]).
In regards to claim 32, modified Mackellar teaches the system of claim 28, wherein the memory has further computer-executable instructions stored thereon that, when executed by the processor, cause the processor to store the score (Mackellar [0084] [00133-0135] to convert and transmit data to an output the communication module must inherently store data). It would be prima facie obvious to a person of ordinary skill in the art to have the communication module store the score in order to transmit it to a display.
In regards to claim 33, modified Mackellar teaches the system of claim 28, wherein the memory has further computer-executable instructions stored thereon that, when executed by the processor, cause the processor to generate display data comprising the score (Mackellar [0084] [0100] device comprises a display for displaying output, cognitive score is the output).
Claims 29-30 are rejected under 35 U.S.C. 103 as being unpatentable over by Mackellar (US 20190246982 A1 - previously cited) in view of Campbell (US 20210314692 A1) in view of Das (US 20160242699 A1 - previously cited) as applied to claim 28, further in view of Kraus (US 20120197153 A1 - previously cited).
In regards to claim 29 modified Mackellar in view of Das teaches the system of claim 28. Modified Mackellar in view of Das fails to teach wherein calculating the score comprises comparing an amplitude measure of the electrophysiological response signal to a reference value, wherein the reference value is the subject's electrophysiological response at an earlier point in time. Kraus teaches comparing an amplitude measure of the electrophysiological response signal to a reference value, wherein the reference value is the subject's electrophysiological response at an earlier point in time in order to validate the signal ([0230]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the calculation method of modified Mackellar on view of Das to include a step of comparing EEG peaks like the method of Kraus in order to determine the stimulus response is valid.
In regards to claim 30 modified Mackellar teaches the system of claim 29, wherein the score is based on a difference between the amplitude measure of the electrophysiological response signal and the reference value (Kraus [0230] Obvious to determine score based on only valid amplitudes).
Allowable Subject Matter
Claim 31 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The following is a statement of reasons for the indication of allowable subject matter. In regards to claim 31, none of the prior art teaches or suggests, either alone or in combination, a device comprising an amplitude measure that is a normalized decibel power level of the electrophysiological response signal, in combination with the other claimed elements.
Response to Arguments
Applicant’s arguments, see remarks, filed 01/20/2026, with respect to the rejection(s) of claim(s) 1, 2, 5-10, 13-17, 19-21, and 24-27 under 35 U.S.C. 102(a)(1) and dependent claims under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Mackellar (US 20190246982 A1 - previously cited) in view of Campbell (US 20210314692 A1).
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 LUCY EPPERT whose telephone number is (571)270-0818. The examiner can normally be reached M-F 7:30-5:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Robertson can be reached at (571) 272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LUCY EPPERT/ Examiner, Art Unit 3791
/ADAM J EISEMAN/ Primary Examiner, Art Unit 3791
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