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 .
Information Disclosure Statement
The listing of references in the PCT international search report is not considered to be an information disclosure statement (IDS) complying with 37 CFR 1.98. 37 CFR 1.98(a)(2) requires a legible copy of: (1) each foreign patent; (2) each publication or that portion which caused it to be listed; (3) for each cited pending U.S. application, the application specification including claims, and any drawing of the application, or that portion of the application which caused it to be listed including any claims directed to that portion, unless the cited pending U.S. application is stored in the Image File Wrapper (IFW) system; and (4) all other information, or that portion which caused it to be listed. In addition, each IDS must include a list of all patents, publications, applications, or other information submitted for consideration by the Office (see 37 CFR 1.98(a)(1) and (b)), and MPEP § 609.04(a), subsection I. states, “the list ... must be submitted on a separate paper.” Therefore, the references cited in the international search report have not been considered. Applicant is advised that the date of submission of any item of information in the international search report will be the date of submission of the IDS for purposes of determining compliance with the requirements for the IDS with 37 CFR 1.97, including all timing statement requirements of 37 CFR 1.97(e). See MPEP § 609.05(a).
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-7, 14-15, 17-19 and 23-28 are 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.
Regarding claim 1, it is unclear how one could choose between an audio waveform and an electromagnetic waveform separately in second Markush group of the claim when choosing the type of device provided being a visual or an audio device would therefore set the type of signal. Clarity in the claim is needed. For examination purposes, the selection of the device provided in the first Markush group will set the waveform in the second Markush group.
Regarding claim 3, it is unclear if claim 3 limits claim 1 by providing a second device and second type of waveforms or if claim 3 is limiting the device and therefore waveforms provided as claimed in claim 1. The invention appears to be only one device being used at a time versus multiple. It appears that claim 3 may be better suited as a more detailed independent claim or rewritten to limit the limitations of claim 1 in wherein clauses. For example, “wherein the device provided in claim one is an AVS device”. For examination purposes, claim 3 is taken as limited the device in claim 1 rather than introducing a second device provided.
Regarding claims 2-7, 14-15, 17-19 and 23-28, the dependent claims are rejected similarly to claim 1 due to their dependency from claim 1.
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.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], 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.
Claim 28 is 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. Claim 28 recites the same limitation as claim 1 based on the “…apply to the subject, or to induce the formation of in the subject, at least one nested waveform selected from the group consisting of audio waves and electromagnetic waves” limitation. Claim 28 states the apply to the subject limitation, however claim 1 can be interpreted as only being that limitation. Therefore, claim 28 is seen as not further limiting 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 § 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 4-7, 15, 23-26 and 28 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lizarazu, “Phase-amplitude coupling between theta and gamma oscillations adapts to speech rate.” Ann N Y Acad Sci. 2019 Oct;1453(1):140-152. doi: 10.1111/nyas.14099. Epub 2019 Apr 24. PMID: 31020680; PMCID: PMC6850406, herein referred to “Lizarazu”.
Regarding Claim 1, Lizarazu teaches: A method for performing brainwave entrainment on a subject (Neural entrainment analysis, page 143, para 5), comprising: providing a signal source selected from the group consisting of audio signal sources and video signal sources (To address this issue, we recorded magnetoencephalography (MEG) signals from participants listening to a speech at various rates: decelerated, normal, and accelerated... The original speech was digitized at 44.1 kHz using a digital recorder... and audio files (*.wav) were segmented... During MEG recording, sentences were presented auditorily to the participants, page 142, paras 2-5); and using the signal source to apply to the subject, or to induce the formation of in the subject, at least one nested waveform selected from the group consisting of audio waves and electromagnetic waves (To address this issue, we recorded magnetoencephalography (MEG) [electromagnetic waves] signals from participants listening to a speech at various rates, page 142, para 2; The frequency-adaptive nested gamma response [nested electromagnetic wave] to the fine-grain structure of the auditory signal could explain experimental evidence suggesting that auditory cortical entrainment influences word recognition, page 149, para 4).
Regarding Claim 4, Lizarazu teaches: the method of claim 1, wherein the nested waveform is a theta-nested gamma waveform (Theta/gamma phase-amplitude coupling, caption of Fig. 4 [seen in originally claim 26 of Applicants specs- wherein the nested band is formed by phase-amplitude coupling of the first and second waves]).
Regarding Claim 5, Lizarazu teaches: the method of claim 1, wherein the nested waveform is a composite waveform of a first waveform having a first frequency, and a second waveform having a second frequency (Theta [first waveform with first frequency/gamma [second waveform with second frequency] phase-amplitude coupling, caption of Fig. 4 [see claim 26 of Applicants specs- wherein the nested band is formed by phase-amplitude coupling of the first and second waves]).
Regarding Claim 6, Lizarazu teaches: the method of claim 5, wherein the first and second waveforms are selected from the group consisting of delta waves, theta waves, alpha waves, beta waves and gamma waves (Theta [first wave]/gamma [second wave] phase-amplitude coupling, caption of Fig. 4).
Regarding Claim 7, Lizarazu teaches: the method of claim 5, wherein the first frequency is within the range of 0.5 Hz to 2 Hz (For decelerated speech, significantly higher coherence values (compared with surrogate data) were found in the 0.5-2 Hz (delta) band, page 144, para 7).
Regarding Claim 15, Lizarazu teaches: the method of claim 1, wherein the nested waveform is a composite waveform of a first waveform having a first frequency, a second waveform having a second frequency and a third waveform having a third frequency (Furthermore, we measured thee maximum MI value (Mlmax) and the phase (fphase) and amplitude (famp) frequency values of Mimax for the MIcluster (theta [first waveform]-beta [second waveform]/gamma [third waveform]), for each condition and ROI (Table 2), page 146, para 1 and furthermore, we measured the maximum MI value (Mlmax) and the phase (fphase) and amplitude (famp) frequency values of Mlmax for the MI cluster (theta-beta/gamma), for each condition and ROI (Table 2), page 146, para 1)).
Regarding Claim 23, Lizarazu discloses the method of claim 1, wherein the nested waveform is a composite of a first wave selected from a first frequency band, and a second wave selected from a second frequency band which is distinct from the first frequency band, and wherein the first and second frequency bands are selected from the group consisting of the delta band, theta band, alpha band, mu-rhythm band, beta band and gamma band (Theta [first waveform with first frequency -4-7.5 Hz]/gamma [second waveform with second frequency -30-40 Hz] phase-amplitude coupling, caption of Fig. 4 [see claim 26 of Applicants specs- wherein the t nested band is formed by phase-amplitude coupling of the first and second waves]).
Regarding Claim 24, Lizarazu discloses the method of claim 23, wherein the nested band is formed by cross-frequency coupling of the first and second waves (Table 2. Cross-frequency phase-amplitude coupling analysis, caption of Table. 2 [first wave is theta or beta, second wave is gamma]).
Regarding Claim 25, Lizarazu discloses the method of claim 23, wherein the nested band is formed by phase coupling of the first and second waves (Theta [first wave]/gamma [second wave] phase-amplitude coupling, caption of Fig. 4).
Regarding Claim 26, Lizarazu discloses the method of claim 23, wherein the nested band is formed by phase-amplitude coupling of the first and second waves (Theta/gamma phase-amplitude coupling, caption of Fig. 4).
Regarding Claim 28, Lizarazu discloses the method of claim 1, wherein the signal source is used to apply to the subject at least one nested waveform selected from the group consisting of audio waves and electromagnetic waves (To address this issue, we recorded magnetoencephalography (MEG) signals from participants listening to a speech at various rates: decelerated, normal, and accelerated... The original speech was digitized at 44.1 kHz using a digital recorder... and audio files (*.wav) were segmented... During MEG recording, sentences were presented auditorily to the participants, page 142, paras 2-5).
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) 2-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lizarazu in view of Tang, “Open-Loop Audio-Visual Stimulation (AVS): A Useful Tool for Management of Insomnia? Appl Psychophysiol Biofeedback”. 2016 Mar;41(1):39-46. doi: 10.1007/s10484-015-9308-7. PMID: 26294268, herein referred to as "Tang".
Regarding Claim 2, Lizarazu does not explicitly disclose the method of claim 1, wherein said brainwave entrainment is open-loop audio visual stimulation (AVS) brainwave entrainment.
Tang discloses: wherein said brainwave entrainment is open-loop audio visual stimulation (AVS) brainwave entrainment (AVS entrainment... We recently conducted two pilot studies, using the open-loop light and sound stimulation technique, with an AVS program that participants used at home, page 6, para 2).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify Lizarazu to include the open-loop AVS as described in Tang for the purpose of using a non-pharmacological intervention that has been used for both performance enhancement and symptom management (see Tang, Abstract).
Regarding Claim 3, Lizarazu discloses the method of claim 1, further comprising: providing a stimulation device; and using the stimulation device to apply to the subject, or to induce the formation in the brain of the subject, at least one nested waveform selected from the group consisting of audio waves and electromagnetic waves (To address this issue, we recorded magnetoencephalography (MEG) [electromagnetic waves] signals from participants listening to a speech at various rates, page 142, para 2; The frequency-adaptive nested gamma response [nested electromagnetic wave] to the fine-grain structure of the auditory signal could explain experimental evidence suggesting that auditory cortical entrainment influences word recognition, page 149, para 4).
Lizarazu does not explicitly disclose wherein the stimulation device is an audio-visual stimulation (AVS) device.
Tang discloses wherein the stimulation device is an audio-visual stimulation (AVS) device. (AVS entrainment... We recently conducted two pilot studies, using the open-loop light and sound stimulation technique, with an AVS program that participants used at home, page 6, para 2).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify Lizarazu to include the open-loop AVS as described in Tang for the purpose of using a non-pharmacological intervention that has been used for both performance enhancement and symptom management (see Tang, Abstract).
Claim(s) 14, 17-19, 21-22 and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lizarazu in view of Chang, US 20100056854, herein referred to as Chang.
Regarding Claim 14, Lizarazu fails to disclose the method of claim 5, wherein the second waveform is a higher harmonic of the first waveform.
Chang discloses: wherein the second waveform is a higher harmonic of the first waveform ('Harmonic relationships' among the entrainment frequencies are maximized to enhance global harmony and to amplify entrainment in the brain. An example is an entrainment with target frequencies 13 and 20, auxiliary frequencies 10, 7.83 and 4, and a binding frequency 40. These have the following harmonic relations: 4×2.5=10, 4×5=20, 4×10=40; 7.83×5=39.15 (40); 10×2=20, 10×4=40; 13x3=39 (40): 20×2=40., para 0032).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify Lizarazu to include the higher harmonic of a waveform as taught in Chang for the purpose of enhancing global harmony and amplifying brain entrainment (see Chang, para 0032).
Regarding Claim 17, Lizarazu fails to disclose the method of claim 16, wherein the third waveform is a higher harmonic of the first waveform.
Chang discloses wherein the third waveform is a higher harmonic of the first waveform ('Harmonic relationships' among the entrainment frequencies are maximized to enhance global harmony and to amplify entrainment in the brain. An example is an entrainment with target frequencies 13 and 20, auxiliary frequencies 10, 7.83 and 4, and a binding frequency 40. These have the following harmonic relations: 4×2.5=10, 4×5=20, 4×10=40; 7.83×5=39.15 (40); 10×2=20, 10x4=40; 13×3=39 (40); 20×2=40., para 0032).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify Lizarazu to include the higher harmonic of a waveform as taught in Chang for the purpose of enhancing global harmony and amplifying brain entrainment (see Chang, para 0032).
Regarding Claim 18, Lizarazu fails to disclose the method of claim 15, wherein the second and third waveforms are higher harmonics of the first waveform.
Chang discloses: wherein waveforms are higher harmonics of other waveforms ('Harmonic relationships' among the entrainment frequencies are maximized to enhance global harmony and to amplify entrainment in the brain. An example is an entrainment with target frequencies 13 and 20, auxiliary frequencies 10, 7.83 and 4, and a binding frequency 40. These have the following harmonic relations: 4×2.5=10, 4×5=20, 4×10=40; 7.83×5=39.15 (40); 10×2=20, 10×4=40; 13x3=39 (40); 20×2=40., para 0032).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify Lizarazu to include the higher harmonic of a waveform as taught in Chang for the purpose of enhancing global harmony and amplifying brain entrainment (see Chang, para 0032).
Regarding Claim 19, Lizarazu discloses the method of claim 1, wherein the nested waveform is a composite waveform of a first waveform having a first frequency, a second waveform having a second frequency, a third waveform having a third frequency (Furthermore, we measured the maximum MI value (Mimax) and the phase (fphase) and amplitude (famp) frequency values of Mlmax for the MI cluster (theta [first waveform]-beta [second waveform]/gamma [third waveform]), for each condition and ROI (Table 2), page 146, para 1) and Lizarazu discloses wherein the first, second, third waveforms are selected from the group consisting of delta waves, theta waves, alpha waves, beta waves and gamma waves (Furthermore, we measured the maximum MI value (Mlmax) and the phase (fphase) and amplitude (famp) frequency values of Mlmax for the MI cluster (theta-beta/gamma), for each condition and ROI (Table 2), page 146, para 1).
Lizarazu fails to explicitly disclose a fourth waveform having a fourth frequency.
Chang discloses: a fourth waveform with a fourth frequency (Table 2 below provides some other examples of brain entrainment modulation sets. The first column ("Target Task") lists the type of brain entrainment desired. The second column ("Main Target Freq") lists the main target frequency according the particular brain entrainment set. Similarly, the third, fourth and fifth columns identify the secondary target frequencies, the auxiliary frequencies and the binding frequencies (if any) of the particular brain entrainment sets, para 0051).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify Lizarazu to include a fourth waveform with a fourth frequency as taught in Chang for the purpose of obtaining the required brain entrainment sets (see Chang, para 0051).
Regarding Claim 21, Lizarazu discloses the method of claim 19, wherein the nested waveform is a composite waveform of a first waveform having a first frequency, a second waveform having a second frequency, a third waveform having a third frequency (Furthermore, we measured the maximum MI value (Mlmax) and the phase (fphase) and amplitude (famp) frequency values of Mimax for the MI cluster (theta [first waveform]-beta [second waveform]/gamma [third waveform]), for each condition and ROI (Table 2). page 146, para 1).
Lizarazu fails to explicitly disclose a fourth waveform having a fourth frequency.
Chang discloses: a fourth waveform having a fourth frequency and a fifth waveform having a fifth frequency (Table 2 below provides some other examples of brain entrainment modulation sets. The first column ("Target Task") lists the type of brain entrainment desired. The second column ("Main Target Freq") lists the main target frequency according the particular brain entrainment set. Similarly, the third, fourth and fifth columns identify the secondary target frequencies, the auxiliary frequencies and the binding frequencies (if any) of the particular brain entrainment sets, para 0051).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify Lizarazu to include a fourth waveform with a fourth frequency and a fifth waveform with a fifth frequency as taught in Chang for the purpose of obtaining the required brain entrainment sets (see Chang, para 0051).
Regarding Claim 22, modified Lizarazu discloses the method of claim 20, wherein the first, second, third waveforms are selected from the group consisting of delta waves, theta waves, alpha waves, beta waves and gamma waves (Furthermore, we measured the maximum MI value (MImax) and the phase (fphase) and amplitude (famp) frequency values of Mlmax for the MI cluster (theta-beta/gamma), for each condition and ROI (Table 2), page 146, para 1).
Lizarazu fails to explicitly disclose a fourth and fifth waveform
Chang discloses a fourth and fifth waveform (Table 2 below provides some other examples of brain entrainment modulation sets. The first column ("Target Task") lists the type of brain entrainment desired. The second column ("Main Target Freq") lists the main target frequency according the particular brain entrainment set. Similarly, the third, fourth and fifth columns identify the secondary target frequencies, the auxiliary frequencies and the binding frequencies (if any) of the particular brain entrainment sets, para 0051).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify Lizarazu to include a fourth and fifth waveform as taught in Chang for the purpose of obtaining the required brain entrainment sets (see Chang, para 0051).
Regarding Claim 27, Lizarazu fails to disclose the method of claim 23, wherein the second wave is a harmonic of the first wave.
Chang discloses wherein the second wave is a harmonic of the first wave ('Harmonic relationships' among the entrainment frequencies are maximized to enhance global harmony and to amplify entrainment in the brain. An example is an entrainment with target frequencies 13 and 20, auxiliary frequencies 10, 7.83 and 4, and a binding frequency 40. These have the following harmonic relations: 4×2.5=10, 4×5=20, 4×10=40; 7.83×5 It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify Lizarazu to include the higher harmonic of a waveform as taught in Chang for the purpose of enhancing global harmony and amplifying brain entrainment (see Chang, para 0032).
Conclusion
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/JOANNE M RODDEN/ Supervisory Patent Examiner, Art Unit 3794