DETAILED ACTION
This Office Action is responsive to the Amendment filed 06 April 2026. Claims 1 - 10 are now pending. The Examiner acknowledges the amendments to claims 1 – 7 and 10.
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 4 is objected to because of the following informalities:
Claim 4, line 2, “induce corresponding neural” should read --induce the corresponding neural--.
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.
Claim 10 is 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.
Claim 10, lines 3 – 4, it is unclear if the limitation “adapted to operatively connect the two audio devices” applies to just the “transceiver” or “said sound generator, said sound generator controller, a transceiver”.
Claim Rejections - 35 USC § 103
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 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 – 3, and 6 - 9 are rejected under 35 U.S.C. 103 as being unpatentable over Stauch et al (US 20190388020 A1, hereinafter “Stauch”) in view of Elberling et al (2008; hereinafter “Elberling (2008)”; NPL: U) and Elberling et al (2010; hereinafter “Elberling (2010)”; NPL: V).
Regarding claim 1, Stauch teaches an audio system (“a system and method that enhances the effect of gamma frequency entrainment by stimulating an individual's brain using sensory stimulation” [0005]) comprising:
- a sound generator (“set of loudspeakers, headphones, or ear buds configured to output the auditory stimuli” [0033]; [0018], [0022] – [0023]) configured to provide an auditory stimulation comprising a plurality of cochlear dispersion ([0033]; [0018], [0022] – [0023]) compensated chirps (“auditory stimuli can include sounds such as tones, beats, and chirps,” [0073];),
the chirps adapted to induce neural oscillations for therapeutic alleviation of a neurological pathology ([0017] - [0018], [0022] – [0023], [0033]); ([0033]; [0018], [0022] – [0023])
- a sleep monitor (“EEG device 20” [0074]) configured to determine a sleep stage of a user of the audio system (“EEG feedback information is also used to determine the sleep-stage of the individual” [0068]); and
- a sound generator controller (“control computer 150” [0102]) configured to:
(i) initiate the auditory stimulation, only in response to a determination that the user is in a sleep stage (“the EEG feedback information is also used to determine the sleep-stage of the individual. Thus, in these embodiments, the EEG device 20 is also configured to measure the individual's other brain waves (i.e., alpha waves, beta waves, delta waves, and theta waves) in addition to the gamma waves, so that the information representing those other signals can be included in the EEG feedback information. The EEG feedback information can then be used as input into a control program that controls the manner in which the stimuli is provided to the individual during sleep. For example, the control program may, in one embodiment, control lights to flash on and off at a specified frequency, control the volume and/or tone of auditory stimuli” [0068]), and
(ii) withhold initiation of said auditory stimulation when the user is awake (“the EEG feedback information is also used to determine the sleep-stage of the individual. Thus, in these embodiments, the EEG device 20 is also configured to measure the individual's other brain waves (i.e., alpha waves, beta waves, delta waves, and theta waves) in addition to the gamma waves, so that the information representing those other signals can be included in the EEG feedback information. The EEG feedback information can then be used as input into a control program that controls the manner in which the stimuli is provided to the individual during sleep. For example, the control program may, in one embodiment, control lights to flash on and off at a specified frequency, control the volume and/or tone of auditory stimuli” [0068]; Examiner interprets that the control program can withhold/stop initiation when the user is awake due to “controls the manner in which the stimuli is provided to the individual”.);
wherein the cochlear dispersion compensated chirps are provided only during sleep for therapeutic neural entrainment (“controls the manner in which the stimuli is provided to the individual during sleep”[0068]; “chirps” [0073]).
Stauch does not teach wherein the chirps comprise a plurality of pure-tone components with relative phases selected to compensate cochlear dispersion such that neural synchrony is enhanced during said sleep stage therapeutic stimulation.
However, Elberling (2008) discloses “a chirp has previously been designed from estimates of the cochlear delay based on derived-band auditory brain-stem response (ABR) latencies” and teaches the chirps comprise a plurality of pure-tone components selected to compensate cochlear dispersion (bridging paragraph between pages 3022 and 3023, page 3023 right column; Examiner interprets numerous experiments had been carried out that clearly linked the difference in travelling wave delay in the human cochlea and the behaviour of tone burst and chirp signals in the delay introduced by the travelling waves and effects on the individual areas of the cochlear partition.).
The limitation “such that neural synchrony is enhanced during said sleep stage therapeutic stimulation” is intended use. Since Elberling teaches the device can be modulated (page 3024 right column), the device of Elberling is capable of performing the intended use as claimed.
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 system of Stauch such that wherein the chirps comprise a plurality of pure-tone components selected to compensate cochlear dispersion such that neural synchrony is enhanced during said sleep stage therapeutic stimulation, as taught by Elberling, for the benefit of “compensating for the temporal dispersion in the cochlea related to the traveling wave delay” (Elberling: page 3022, left column paragraph 1).
The modified invention of Stauch and Elberling does not teach each pure tone with a specific relative phase.
However, Elberling (2010) discloses “auditory brainstem responses (ABRs) evoked by chirps” (abstract) and discloses each pure tone with a specific relative phase (page 2963, left column second paragraph).
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 audio system of Stauch and Elberling (2008) to incorporate each pure tone with a specific relative phase, as taught by Elberling (2010), for the benefit of providing the most efficient chirp for users (page 2963, left column second paragraph).
Regarding claim 2, Stauch, Elberling (2008) and Elberling (2010) teach all limitations of claim 1. The modified invention of Stauch, Elberling (2008) and Elberling (2010) discloses “auditory stimuli can include sounds such as tones, beats, and chirps, and may be modulated at any desired rate and rendered at any desired frequency” (Stauch: [0073]).
Stauch does not teach the auditory stimulation is adapted to compensate the cochlear dispersion by adding the plurality of pure tones, each with a specific relative phase.
However, Elberling (2008) discloses “a chirp has previously been designed from estimates of the cochlear delay based on derived-band auditory brain-stem response (ABR) latencies” and teaches an auditory stimulation is adapted to compensate the cochlear dispersion by adding the plurality of pure tones (bridging paragraph between pages 3022 and 3023, page 3023 right column; Examiner interprets numerous experiments had been carried out that clearly linked the difference in travelling wave delay in the human cochlea and the behaviour of tone burst and chirp signals in the delay introduced by the travelling waves and effects on the individual areas of the cochlear partition.).
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 audio system of Stauch such that the auditory stimulation is adapted to compensate the cochlear dispersion by adding the plurality of pure tones, as taught by Elberling, for the benefit of “compensating for the temporal dispersion in the cochlea related to the traveling wave delay” (Elberling: page 3022, left column paragraph 1).
The modified invention of Stauch and Elberling does not teach each pure tone with a specific relative phase.
However, Elberling (2010) discloses “auditory brainstem responses (ABRs) evoked by chirps” (abstract) and discloses each pure tone with a specific relative phase (page 2963, left column second paragraph).
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 audio system of Stauch and Elberling (2008) to incorporate each pure tone with a specific relative phase, as taught by Elberling (2010), for the benefit of providing the most efficient chirp for users (page 2963, left column second paragraph).
Regarding claim 3, Stauch, Elberling (2008) and Elberling (2010) teach all limitations of claim 2. The modified invention of Stauch, Elberling (2008) and Elberling (2010) teaches the relative phases depend on the auditory stimulation level (Elderling (2010): page 2963, left column second paragraph).
Regarding claim 6, Stauch, Elberling (2008) and Elberling (2010) teach all limitations of claim 1. The modified invention of Stauch, Elberling (2008) and Elberling (2010) teaches the audio system (Stauch: “a system and method that enhances the effect of gamma frequency entrainment by stimulating an individual's brain using sensory stimulation” [0005]) comprising an EEG monitor (Stauch: “EEG device 20” [0074], [0029] – [0031]) adapted to at least one of:
measure a level of induced neural oscillations at 40 Hz,
to measure a level of slow wave sleep (Stauch: “the EEG device 20 is also configured to measure the individual's other brain waves (i.e., alpha waves, beta waves, delta waves, and theta waves) in addition to the gamma waves, so that the information representing those other signals can be included in the EEG feedback information.” [0068], [0076], [0089], [0095] – [096], [0102]),
to measure EEG data for determining at least one stage of sleep (Stauch: “the EEG device 20 is also configured to measure the individual's other brain waves (Stauch: i.e., alpha waves, beta waves, delta waves, and theta waves) in addition to the gamma waves, so that the information representing those other signals can be included in the EEG feedback information.” [0068], [0076], [0089], [0095] – [096], [0102]), and
to measure EEG data for evaluating an efficiency with respect to alleviating the neurological pathology (Stauch: [0017] - [0018], [0022] – [0023], [0033]); ([0033]; [0018], [0022] – [0023]).
Regarding claim 7, Stauch, Elberling (2008) and Elberling (2010) teach all limitations of claim 1. The modified invention of Stauch, Elberling (2008) and Elberling (2010) teaches the audio system (Stauch: “a system and method that enhances the effect of gamma frequency entrainment by stimulating an individual's brain using sensory stimulation” [0005]) further comprising:
- an arousal detector (Stauch: “EEG device 20” [0074], [0029] – [0031]) based on a measured bio-electrical signal selected from a group of bio-electrical signals comprising EEG (Stauch: “the EEG device 20 is also configured to measure the individual's other brain waves (i.e., alpha waves, beta waves, delta waves, and theta waves) in addition to the gamma waves, so that the information representing those other signals can be included in the EEG feedback information.” [0068], [0076], [0089], [0095] – [096], [0102]) and EMG signals; and
wherein the sound generator controller (Stauch: “control computer 150” [0102]) is configured to adapt the auditory stimulation level (“control the volume and/or tone of auditory stimuli” [0068], [0067]) in response to a detected arousal level (Stauch: [0068], [0076], [0089], [0095] – [096], [0102]).
Regarding claim 8, Stauch, Elberling (2008) and Elberling (2010) teach all limitations of claim 1. The modified invention of Stauch, Elberling (2008) and Elberling (2010) teaches the audio system (Stauch: “a system and method that enhances the effect of gamma frequency entrainment by stimulating an individual's brain using sensory stimulation” [0005]) comprising a user health estimator (Stauch: “determine the sleep-stage of the individual” [0068]; [0076], [0089], [0095] – [096], [0102]; Examiner interprets sleep-stage relates to a user’s health.),
wherein the sound generator controller (Stauch: “control computer 150” [0102]) is configured to adapt at least one characteristic (Stauch: “control the volume and/or tone of auditory stimuli” [0068]) of at least one type of auditory stimulation (Stauch: “control the volume and/or tone of auditory stimuli” [0068]) based on at least one user health estimate provided by the user health estimator (Stauch: “adjust one or more parameters associated with the stimuli” [0069]; [0067] - [0068]).
Regarding claim 9, Stauch, Elberling (2008) and Elberling (2010) teach all limitations of claim 1. The modified invention of Stauch, Elberling (2008) and Elberling (2010) teaches a first type of auditory stimulation is not provided (Stauch: “auditory stimuli can include sounds such as tones, beats, and chirps,” [0073], “volume and/or tone of auditory stimuli” [0067] – [0068], Examiner interprets no sound is a type of auditory stimulation.) and
a second type of auditory stimulation (Stauch: “auditory stimuli can include sounds such as tones, beats, and chirps,” [0073], “volume and/or tone of auditory stimuli” [0067] – [0068]) is only provided when a sleep stage comprising slow waves has been determined (Stauch: “generated EEG feedback information indicates that individual P is returning to, or entering, a more stable or deeper sleep-stage, control computer 150 can begin to adjust or return the visual, auditory, and/or somatosensory stimuli SDD 80 to previous levels.” [0076]; [0068], [0089], [0095] – [096], [0102]).
Claims 4 - 5 are rejected under 35 U.S.C. 103 as being unpatentable over Stauch.
Regarding claim 4, Stauch, Elberling (2008) and Elberling (2010) teach all limitations of claim 1. The modified invention of Stauch, Elberling (2008) and Elberling (2010) does not explicitly teach a first type of auditory stimulation is adapted to induce corresponding neural oscillations at a frequency of 40 Hz.
However, Stauch discloses “inducing gamma activity in the brains of humans with AD, especially at the 40 Hz frequency” ([0018]), “kinds of sensory stimuli can be presented to an individual to induce such gamma activity in the individual” ([0035], Figure 2), “control the volume and/or tone of auditory stimuli” ([0068]) and (“auditory stimuli can include sounds such as tones, beats, and chirps” [0073]).
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 audio system of Stauch such that a first type of auditory stimulation is adapted to induce corresponding neural oscillations at a frequency of 40 Hz, as taught by Stauch, for the benefit of “treating and preventing cognitive diseases, such as Alzheimer's disease, through the entrainment of the human brain to produce gamma activity” ([0017]).
Regarding claim 5, Stauch teaches all limitations of claim 4. Stauch teaches a second type of auditory stimulation is provided by at least one chirp (“auditory stimuli can include sounds such as tones, beats, and chirps” [0073]).
Stauch does not teach the second type of auditory stimulation adapted to be in phase with a slow wave of slow wave sleep ([0090]).
Stauch discloses “control computer 150 is configured to generate and utilize the EEG feedback information to both optimize a strength of the gamma entrainment, as well as to synchronize the gamma stimulation parameters to align with the sleep patterns of the individual P.” ([0090]; [0076)].
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 audio system of Stauch such that a second type of auditory stimulation is adapted to be in phase with a slow wave of slow wave sleep, for the benefit of “ensur[ing] that the individual's P sleep is not interrupted” ([0076]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Stauch Elberling (2008) and Elberling (2010), as applied in claim 1, in view of Alferness et al (WO 2016176668 A1, hereinafter “Alferness”).
Regarding claim 10, Stauch, Elberling (2008) and Elberling (2010) teach all limitations of claim 1. The modified invention of Stauch, Elberling (2008) and Elberling (2010) teaches the audio system, said sound generator (“set of loudspeakers, headphones, or ear buds configured to output the auditory stimuli” [0033]; [0018], [0022] – [0023]), said sound generator controller (“control computer 150” [0102]).
Stauch does not teach a first audio device and a second audio device, wherein each of the first audio device and the second audio device comprises said sound generator, said sound generator controller, and a transceiver, said transceiver adapted to operatively connect the two audio devices, and wherein said sound generator controller is adapted to synchronize in time the auditory stimulations provided by the two audio devices, whereby a diotic presentation of the auditory stimulation is provided.
However, Alferness discloses “systems and methods for diagnosing and treating breathing disorders of humans and other mammals” ([0012]) and teaches a first audio device and a second audio device (“a pair of such devices could be used, with one device positioned at and/or in each ear to increase the system effectiveness, with the two devices in communication with each other and/or with a separate computing device and/or smart phone” [0092]),
wherein each of the first audio device and the second audio device ([0092])comprises a sound generator (“separate computing device and/or smart phone” [0092]; Examiner interprets there is a speaker/sound generator within the “computing device and/or smart phone” of [0092].), a sound generator controller (“separate computing device and/or smart phone” [0092]), and a transceiver (“separate computing device and/or smart phone” [0092]; Examiner interprets there is a transceiver within the “computing device and/or smart phone” of [0092].),
said transceiver adapted to operatively connect the two audio devices (“with the two devices in communication with each other and/or with a separate computing device and/or smart phone” [0092]; Examiner interprets the devices include a transceiver in order to communicate with each other.), and
wherein said sound generator controller (“separate computing device and/or smart phone” [0092]) is adapted to synchronize in time the auditory stimulations provided by the first audio device and the second audio device ([0092]),
whereby a diotic presentation of the auditory stimulation is provided ([0092]).
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 audio system of Stauch to incorporate a first audio device and a second audio device, wherein each of the first audio device and the second audio device comprises said sound generator, said sound generator controller, and a transceiver, said transceiver adapted to operatively connect the two audio devices, and wherein said sound generator controller is adapted to synchronize in time the auditory stimulations provided by the first audio device and the second audio device, whereby a diotic presentation of the auditory stimulation is provided, as taught by Algerness, for the benefit of “monitor[ing], diagnos[ing], treat[ing] and/or alleviat[ing] the symptoms of Obstructive Sleep Disordered Breathing, other breathing disorders, including sleep apnea, Cheyne-Stokes breathing and Sudden Infant Death Syndrome (SIDS), as well as other non-breathing disorder conditions” ([0002]).
Response to Arguments
Applicant’s arguments, see page 5, filed 06 April 2026, with respect to claim objections have been fully considered and are persuasive in light of the amendments. The claim objections for 1 – 2, 6 – 7 and 10 of 05 January 2026 have been withdrawn.
Applicant’s arguments, see pages 5 - 6, filed 06 April 2026, with respect to 35 U.S.C. 112(b) rejections have been fully considered and are persuasive in light of the amendments. The 35 U.S.C. 112(b) rejections for claims 1 – 10 of 05 January 2026 has been withdrawn except for claim 10 below.
Claim 10, lines 3 – 4, it is unclear if the limitation “adapted to operatively connect the two audio devices” applies to just the “transceiver” or “said sound generator, said sound generator controller, a transceiver”.
Applicant’s arguments with respect to claim(s) 1 – 10 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant's arguments filed 06 April 2026 have been fully considered but they are not persuasive. Applicant contends “Eldering (2008) does not disclose the claimed combination of therapeutic application and sleep-dependent delivery” and “Elberling (2010) remains confined to diagnostic testing and does not extend its teachings to therapeutic neural entrainment or sleep-stage triggered applications”. However, Stauch, in combination, of Elberling & Don (2008) and Elberling & Don (2010) reads on the claims. 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 system of Stauch, as taught by Elberling (2008), for the benefit of “compensating for the temporal dispersion in the cochlea related to the traveling wave delay” (Elberling: page 3022, left column paragraph 1) and as taught by Elberling (2010), for the benefit of providing the most efficient chirp for users (page 2963, left column second paragraph). See rejections above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Cho et al (2015) discloses “Pure-tone audiometry and click-and CE-Chirp evoked ABRs exams were conducted for all ears” (abstract).
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.
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/JULIE THI TRAN/Examiner, Art Unit 3791
/ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791
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