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
Claims 23 and 33 are objected to because of the following informalities:
in claim 23, line 18: “of the periodic biometric activity” should be deleted; and
in claim 33, line 2: “extends” should be “extend”.
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.
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 24, 37-38, and 40 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.
Claim 24 recites “controlling the auditory-stimulation-generation circuitry to deliver the auditory stimulation to the user based on the one or more auditory stimulation parameters” in lines 3-5; however, it is not clear the relationship between this recitation and the recitation “one or more parameters of the auditory stimulation to be delivered by the auditory-stimulation- generation circuitry” in claim 23, lines 13-15. The similar phraseology and the definite article “the” suggest that they are the same, but the context of the claim suggests that they are different. In this case, the one or more parameters appear to be determined and used in the subsequent delivery of the audio stimulation in claim 23, so it is not clear what additional parameters are utilized in claim 24. This inconsistency renders claim 24 indefinite. Appropriate correction is required.
Claim 37 recites “generate the auditory stimulation based on the one or more SO parameters” in line 3; however, the auditory stimulation has already been claimed to have been generated based on the one or more parameters (see claim 23, lines 13-15; and see claim 36, lines 5-6). It is not clear which set of parameters, or both, is utilized to generate the auditory stimulation. This inconsistency renders claim 37 indefinite. Appropriate clarification is required.
Claim 38 is rejected by virtue of its dependence from claim 37.
Claim 38 recites “a typical SO” in lines 6-7, but it is not clear if this recitation is the same as, related to, or different from the recitation “a typical SO” in line 4. The similar phraseology suggests that they are the same, but the indefinite article “a” suggests that they are different. If the recitations are the same, the present recitation should be “the typical SO”. If the recitations are different, the relationship between these recitations should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements). For the purposes of examination, the examiner is interpreting that the recitations are the same. Appropriate correction is required.
The term “typical” in claim 38 is a relative term which renders the claim indefinite. The term “typical” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The specification describes that “some waves can exhibit morphology consistent with 'typical' or 'normal' brain activity while some waves can exhibit morphology that is not consistent with 'typical' or 'normal' brain activity. These waves are sometimes referred to as "well-behaved" and "poorly-behaved". As such, waves can be tagged with an inclusion/exclusion tag to designate if the wave should be used or excluded from model training and/or model deployment (e.g., preventing stimulation when such a SO wave is observed” (see ¶[0233]-[0234]), but does not describe/define what a typical or normal SO wave actually is. Therefore, the scope of the claim is not clear. Typical is not being given patentable weight for the purposes of examination. Appropriate correction is required.
Claim 40 is rejected by virtue of its dependence from claim 38.
Claim 40 recites “one or more features” in line 2. A claim, although clear on its face, may also be indefinite when a conflict or inconsistency between the claimed subject matter and the specification disclosure renders the scope of the claim uncertain as inconsistency with the specification disclosure or prior art teachings may make an otherwise definite claim take on an unreasonable degree of uncertainty. See MPEP § 2173.03. In this case, the specification details that SO features are extracted from the SO (see specification ¶[0014]-[0015]), including SO morphological features (see specification ¶[0094]). This detail is reflected in the claim with the extracted SO parameters (which is not recited in the specification itself). Therefore, it is not clear what relation the “one or more features” of claim 40, line 2 has with the SO parameters; because, based on the specification, they appear to be the same thing. The confusion between the two terms renders claim 40 indefinite. Appropriate correction is required.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 23-28 and 34-42 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 5-6, 9, 11-13, and 21-22 of copending Application No. 19/069,825 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant invention claims are broader than the copending claims and thus the copending species claims are anticipated by the pending claims. Due to the fact that the species or sub-genus claimed in the conflicting application anticipates the claimed genus in the application, a patent to the genus would improperly extend the right to exclude granted by a patent to the species or sub-genus should the genus issue as a patent after the species or sub-genus.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding Claims 23-28 and 34-42, all elements of application claims 23-28 and 34-42 are present in and correspond to copending claims 1-2, 5-6, 9, 11-13, and 21-22.
Claims 29-32 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 5-6, 9, 11-13, and 21-22 of copending Application No. 19/069,825 in view of Crow et al. (US Patent Application Publication 2019/0099582 – cited by Applicant), hereinafter Crow. This is a provisional nonstatutory double patenting rejection.
Regarding Claims 29-32, all elements of application claims 23-28 and 34-42 are present in and correspond to copending claims 1-2, 5-6, 9, 11-13, and 21-22, except the headband structure.
Crow teaches about sleep performance systems and methods involving recommendations based on sleep metrics measured via EEG electrodes during the user’s sleep (see abstract), in which the system may utilize audio stimulation, provided via bone conduction by transmitting sound signals through bone to a user's inner ear, such as via piezoelectric actuator (see ¶[0104]), in which the device may be utilized with the subject’s head via a unitary band or three bands 15a, 15b, and 15c (see ¶[0102] and Fig. 1B), in which the first headband 15a fits a front portion of the head, the second headband 15b fits an upper back portion of the head, and the third headband 15c fits a lower back portion of the head (see Fig. 1B).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the three band headband or unitary headband of Crow for as the headband in the copending claims 1-2, 5-6, 9, 11-13, and 21-22 because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results; and/or (2) the copending claims 1-2, 5-6, 9, 11-13, and 21-22 require a headband and Crow teaches such headbands; and/or (3) the addition of the third headband 15c helps to prevent any potential slippage/movement of the headband (see Crow ¶[0102]).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 23-26, 28-30, 33-39, and 41-42 are rejected under 35 U.S.C. 103 as being unpatentable over Garcia Molina (US Patent Application 2021/0138185 – cited by Applicant), hereinafter Molina ‘185, and in view of Garcia Molina et al. (US Patent Application 2019/0344042 – cited by Applicant), hereinafter Molina ‘042.
Regarding Claims 23 and 41-42, Molina ‘185 teaches a prediction of a user’s slow wave response to stimulation and updating the stimulation based on the determination (see abstract and Figs. 1-4). Molina ‘185 teaches a system/method for providing stimulation to a user (see abstract and Fig. 4), the system comprising:
a device (¶[0028] the headset 201; Figs. 1-2) comprising:
one or more sensors configured to collect physiological data from the user (¶[0026] and ¶[0028] the sensor 14 comprising sensing electrodes for generation of the EEG signals; Figs. 1-2); and
auditory-stimulation-generation circuitry configured to deliver auditory stimulation to a targeted area of the user (abstract and ¶[0028]-[0030] the stimulator 16 to deliver audio stimulation (such as via a speaker), electric and/or, visual stimulation; Figs. 1-2);
one or more processors (¶[0028] processor 20; Figs. 1-2); and
a memory storing instructions that, when executed by the one or more processors (¶[0028] and ¶[0066] electronic storage 22; Figs. 1-2), cause the one or more processors to:
extract, from the physiological data, one or more parameters indicating periodic biometric activity of the user (¶[0026]-[0028] and ¶[0036]-[0038] the EEG signal output from the sensor 14, including sensing electrodes, ¶[0009]-[0010] stimulated and unstimulated slow wave brain activity is detected, ¶[0038] brain activity parameters are determined from the EEG signal, including slow wave parameters of amplitude, frequency, timing, ¶[0056]-[0058] the stimulation is delivered during a period after a zero-crossing, or second zero-crossing of a slow wave, calculate average and/or running average of data; Figs. 3-4);
determine, based on the one or more parameters (¶[0041] the output signals from the sensors, the EEG data, is input into the neural network model; Fig. 3), one or more predicted physiological values, wherein the one or more predicted physiological values correspond to a prediction of the periodic biometric activity over a future period of time (¶[0041] and ¶[0051]-[0053] the output of the neural network model are values that are used to indicate the predicted sleep stage of the user based on the stimulation, ¶[0037] the predicted sleep stage relates to slow wave deep sleep); and
determine, based on the one or more predicted physiological values, one or more parameters of the auditory stimulation to be delivered by the auditory-stimulation-generation circuitry (¶[0042]-[0050] and ¶[0054]-[0055] the stimulation parameters are made and modulated based on the output from the neural network model, the stimulation is updated based on the neural network output and sensor output; Figs. 2-4);
control the auditory-stimulation-generation circuitry to deliver the auditory stimulation to the targeted area of the user (abstract and ¶[0028]-[0030] stimulator 16 to deliver audio stimulation (such as via a speaker); Figs. 1-2).
Molina ‘185 does not specifically teach that the auditory stimulation causes the periodic biometric activity to approach a target morphology of the periodic biometric activity.
Molina ‘042 teaches a system and method for delivery sensory stimulation to a user during a sleep session based on sensor data, including EEG data from EEG electrodes (see abstract and ¶[0024]-[0025]; Fig. 2) in which a neural network uses brain activity parameters determined from the sensor data to predict sleep stages that will occur at future times during the sleep session of the user, so that stimulation may be applied during the appropriate sleep stage via the control component (see abstract and ¶[0037]-[0044]; Figs. 2-3), in which the deep sleep is related to slow wave activity of the user (see ¶[0034]-[0035]; see also ¶[0052] and Fig. 6, the output of the neural network may include frequency morphology output, including of the slow wave oscillations).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the future time and morphological neural network prediction of Molina ‘042 for the neural network prediction in Molina ‘185 because (1) it is the application of a known technique to a known device/method ready for improvement to yield predictable results; and/or (2) predicting sleep stages at a future time point would give better understanding to how the user would react to the given stimulation; and/or (3) the output morphological features would better indicate how what type of sleep activity the user is experiencing, including a desired deeper sleep, slow wave oscillation period.
Regarding Claim 24, Molina ‘185 in view of Molina ‘042 teaches the system of claim 23 as stated above. Molina ‘185 further teaches the auditory-stimulation-generation circuitry comprises one or more sound wave generators; and wherein controlling the auditory-stimulation-generation circuitry comprises controlling the auditory-stimulation-generation circuitry to deliver the auditory stimulation to the user based on the one or more auditory stimulation parameter (abstract and ¶[0028]-[0030] the stimulator 16 to deliver audio stimulation (such as via a speaker), ¶[0030]-[0031], ¶[0049]-[0050], and ¶[0054] the audio stimulation may be modulated based on the output from the neural network; Figs. 1-2).
Regarding Claim 25, Molina ‘185 in view of Molina ‘042 teaches the system of claim 24 as stated above. Molina ‘185 further teaches a number of the one or more sound wave generators is within a range from one to four (abstract and ¶[0028]-[0030] the stimulator 16 to deliver audio stimulation, which may comprise one or more audio speakers).
Regarding Claim 26, Molina ‘185 in view of Molina ‘042 teaches the system of claim 24 as stated above. Molina ‘185 further teaches the one or more sound wave generators are configured to deliver the auditory stimulation to an inner ear of the user (abstract and ¶[0028]-[0030] stimulator 16 to deliver audio stimulation, such as via a speaker, which would necessarily passthrough the ear canal to the inner ear, such as contemplated by the present application, see specification ¶[0202]; Figs. 1-2).
Regarding Claim 28, Molina ‘185 in view of Molina ‘042 teaches the system of claim 24 as stated above. Molina ‘185 further teaches the one or more sound wave generators are configured to deliver the auditory stimulation to the inner ear of the user by emitting the auditory stimulation into an ear canal of the user so that the auditory stimulation reaches the inner ear through the ear canal (abstract and ¶[0028]-[0030] stimulator 16 to deliver audio stimulation, such as via a speaker, which would necessarily passthrough the ear canal to the inner ear, such as contemplated by the present application, see specification ¶[0202]; Figs. 1-2).
Regarding Claim 29, Molina ‘185 in view of Molina ‘042 teaches the system of claim 23 as stated above. Molina ‘185 further teaches a device comprising the one or more sensors, the auditory-stimulation-generation circuitry, and a device body including one or more bands sized to fit around a surface of a head of the user, wherein each sensor of the one or more sensors is attached to the one or more bands so that the sensor is proximate the surface of the head of the user when the device is worn by the user, and wherein the auditory-stimulation-generation circuitry is attached to the one or more bands so that the auditory-stimulation-generation circuitry is proximate the surface of the head of the user when the device is worn by the user (¶[0027]-[0030] the sensor 14, the sensory stimulator 16, the processor 20, and the electronic storage 22 may be grouped into a singular device, such as a headband worn by the user, the EEG sensors would necessarily be located on the head to sense EEG signals, the speakers may be located in and/or near the ears of the subject; Fig. 2).
Regarding Claim 30, Molina ‘185 in view of Molina ‘042 teaches the system of claim 29 as stated above. Molina ‘185 further teaches the auditory-stimulation-generation circuitry comprises one or more sound wave generators, wherein each sound wave generator of the one or more sound wave generators comprises a speaker that is attached to the one or more bands at a location proximate to an ear of the user so that the speaker delivers the auditory stimulation into an ear canal of the user so that the auditory stimulation reaches an inner ear of the user (¶[0027]-[0030] the sensor 14, the sensory stimulator 16, the processor 20, and the electronic storage 22 may be grouped into a singular device, such as a headband worn by the user, the speakers may be located in and/or near the ears of the subject, abstract and ¶[0028]-[0030] stimulator 16 to deliver audio stimulation, such as via a speaker, which would necessarily passthrough the ear canal to the inner ear, such as contemplated by the present application, see specification ¶[0202]; Figs. 1-2).
Regarding Claim 33, Molina ‘185 in view of Molina ‘042 teaches the system of claim 29 as stated above. Molina ‘185 further teaches the one or more bands comprise a single band sized to extends around a circumference of the head of the user (see ¶[0027] and Fig. 2, there would necessarily be at least one band, Figure 2 shows a singular band going around the head of the user).
Regarding Claim 34, Molina ‘185 in view of Molina ‘042 teaches the system of claim 23 as stated above. Molina ‘185 further teaches the physiological data comprises any one or combination of electroencephalography (EEG) data, electrooculography (EOG) data, electromyography (EMG) data, electrocardiography (ECG) data, pulse oximetry data, temperature data, and pressure data (¶[0026] and ¶[0028] the sensor 14 comprising sensing electrodes for generation of the EEG signals; Figs. 1-2).
Regarding Claim 35, Molina ‘185 in view of Molina ‘042 teaches the system of claim 23 as stated above. Molina ‘185 further teaches the physiological data comprises EEG data (¶[0026] and ¶[0028] the sensor 14 comprising sensing electrodes for generation of the EEG signals; Figs. 1-2).
Regarding Claim 36, Molina ‘185 in view of Molina ‘042 teaches the system of claim 23 as stated above. The modified Molina ‘185 further teaches to extract the one or more parameters indicating periodic biometric activity of the user, the one or more processors are configured to extract one or more slow oscillation (SO) parameters corresponding to an SO of the periodic biometric activity (see Molina ‘185 ¶[0041] and ¶[0051]-[0053], the output of the neural network model are values that are used to indicate the predicted sleep stage of the user based on the stimulation, ¶[0037] the predicted sleep stage relates to slow wave deep sleep; see Molina ‘042 abstract and ¶[0037]-[0044], a neural network uses brain activity parameters determined from the sensor data to predict sleep stages that will occur at future times during the sleep session of the user, so that stimulation may be applied during the appropriate sleep stage via the control component, Figs. 2-3, see ¶[0034]-[0035], in which the deep sleep is related to slow wave activity of the user, see also ¶[0052] and Fig. 6, the output of the neural network may include frequency morphology output, including of the slow wave oscillations), and
wherein the one or more processors are configured to determine the one or more parameters of the auditory stimulation based on the one or more SO parameters corresponding to the SO of the periodic biometric activity (see Molina ‘185 ¶[0042]-[0050] and ¶[0054]-[0055] the stimulation parameters are made and modulated based on the output from the neural network model, the stimulation is updated based on the neural network output and sensor output; Figs. 2-4).
Regarding Claim 37, Molina ‘185 in view of Molina ‘042 teaches the system of claim 36 as stated above. The modified Molina ‘185 further teaches the auditory-stimulation-generation circuitry is configured to: generate the auditory stimulation based on the one or more SO parameters (see Molina ‘185 ¶[0042]-[0050] and ¶[0054]-[0055] the stimulation parameters are made and modulated based on the output from the neural network model, the stimulation is updated based on the neural network output and sensor output; Figs. 2-4); and
deliver the auditory stimulation so that the user receives the auditory stimulation while the periodic biometric activity of the user indicates the SO (see Molina ‘185 ¶[0048]-[0050] and ¶[0054]-[0056] the stimulation is provided to the subject during deep sleep, ¶[0037] the predicted sleep stage deep sleep relates to slow wave deep sleep, Fig. 4; see Molina ‘042 abstract and ¶[0039]-[0044] the neural network uses brain activity parameters determined from the sensor data to predict sleep stages that will occur at future times during the sleep session of the user, so that stimulation may be applied during the appropriate sleep stage, the deep sleep, Figs. 2-3, ¶[0034]-[0035] in which the deep sleep is related to slow wave activity of the user, see also ¶[0052] and Fig. 6, the output of the neural network may include frequency morphology output, including of the slow wave oscillations).
Regarding Claim 38, Molina ‘185 in view of Molina ‘042 teaches the system of claim 37 as stated above. Molina ‘185 further teaches the one or more processors are further configured to: compare, based on the one or more SO parameters, the SO with a target SO morphology; determine, based on the comparison, whether the SO is a typical SO; and send, to the auditory-stimulation-generation circuitry, a message to the auditory- stimulation-generation circuitry to generate the stimulation based on determining that the SO is a typical SO (¶[0009]-[0012] and ¶[0058]-[0062] based on the comparison of the stimulated slow wave activity to unstimulated slow wave activity, the stimulation parameters are updated; Figs. 4 and 7).
Regarding Claim 39, Molina ‘185 in view of Molina ‘042 teaches the system of claim 36 as stated above. Molina ‘185 further teaches the physiological data comprises an EEG signal (¶[0026] and ¶[0028] the sensor 14 comprising sensing electrodes for generation of the EEG signals; Figs. 1-2), and
wherein to extract the one or more SO parameters, the one or more processors are configured to determine, based on the SO of the periodic biometric activity, any one or more of:
a positive-to-negative zero-crossing of the EEG signal corresponding to the SO; a negative-to-positive zero-crossing of the EEG signal corresponding to the SO (¶[0038] brain activity parameters are determined from the EEG signal, including slow wave parameters of amplitude, frequency, timing, ¶[0056]-[0058] the stimulation is delivered during a period after a zero-crossing, or second zero-crossing of a slow wave, calculate average and/or running average of data, the zero-crossing detections would necessarily include both positive-to-negative and negative-to-positive; Figs. 3-4);
a point after the positive-to-negative zero-crossing at which a slope of the EEG signal corresponding to the SO falls under a negative slope threshold;
a negative peak of the EEG signal corresponding to the SO;
a point before the negative-to-positive zero-crossing at which a slope of the EEG signal corresponding to the SO falls under a positive slope threshold; and
a positive peak of the EEG signal corresponding to the SO.
Claims 27 and 31-32 are rejected under 35 U.S.C. 103 as being unpatentable over Molina ‘185 in view of Molina ‘042 as applied to claims 26 and 29 above, respectively, and in view of Crow et al. (US Patent Application Publication 2019/0099582 – cited by Applicant), hereinafter Crow.
Regarding Claim 27, Molina ‘185 in view of Molina ‘042 teaches the system of claim 27 as stated above. The modified Molina ‘185 is silent regarding the one or more sound wave generators are configured to deliver the auditory stimulation to the inner ear of the user by causing one or more bones of a head of the user to vibrate in a way that delivers the auditory stimulation to the inner ear.
Crow teaches about sleep performance systems and methods involving recommendations based on sleep metrics measured via EEG electrodes during the user’s sleep (see abstract), in which the system may utilize audio stimulation, provided via bone conduction by transmitting sound signals through bone to a user's inner ear, such as via piezoelectric actuator (see ¶[0104]), in which the device may be utilized with the subject’s head via three bands 15a, 15b, and 15c (see ¶[0102] and Fig. 1B).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the bone conduction audio stimulation of Crow for as the speaker audio stimulation in the modified Molina ‘185 because (1) it is the application of a known technique to a known device/method ready for improvement to yield predictable results; and/or (2) the modified Molina ‘185 requires a sound delivery device and Crow teaches one such device; and/or (3) providing the audio stimulation through the bone conduction would limit excess noise into the environment, such as to avoid disturbing anyone else sleeping adjacent to the user, such as a partner or child.
Regarding Claim 31, Molina ‘185 in view of Molina ‘042 teaches the system of claim 29 as stated above. The modified Molina ‘185 is silent regarding that the auditory-stimulation-generation circuitry comprises one or more actuator assemblies, wherein each actuator assembly of the one or more actuator assemblies comprises a bone-conduction device comprising a piezoelectric transducer that is attached to the one or more bands proximate to one or more bones of the head of the user so that the piezoelectric transducer delivers the auditory stimulation to cause the one or more bones to vibrate so that the auditory stimulation reaches an inner ear of the user.
Crow teaches about sleep performance systems and methods involving recommendations based on sleep metrics measured via EEG electrodes during the user’s sleep (see abstract), in which the system may utilize audio stimulation, provided via bone conduction by transmitting sound signals through bone to a user's inner ear, such as via piezoelectric actuator (see ¶[0104]), in which the device may be utilized with the subject’s head via three bands 15a, 15b, and 15c (see ¶[0102] and Fig. 1B).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the bone conduction audio stimulation of Crow for as the speaker audio stimulation on the bands in the modified Molina ‘185 because (1) it is the application of a known technique to a known device/method ready for improvement to yield predictable results; and/or (2) the modified Molina ‘185 requires a sound delivery device and Crow teaches one such device; and/or (3) providing the audio stimulation through the bone conduction would limit excess noise into the environment, such as to avoid disturbing anyone else sleeping adjacent to the user, such as a partner or child.
Regarding Claim 32, Molina ‘185 in view of Molina ‘042 teaches the system of claim 29 as stated above. Molina ‘185 teaches the usage of a headband singular device (see ¶[0027]-[0028]; Fig. 2); however, the modified Molina ‘185 does not teach the specific of such a headband including that the one or more bands comprise: a first band sized to fit a front portion of the head of the user; a second band sized to fit a first back portion of the head of the user; and a third band sized to fit a second back portion of the head of the user, wherein the second back portion is below the first back portion when the head of the user occupies an upright position, wherein the first band, the second band, and the third band are connected to form a headband sized to extends around a circumference of the head of the user.
Crow teaches about sleep performance systems and methods involving recommendations based on sleep metrics measured via EEG electrodes during the user’s sleep (see abstract), in which the system may utilize audio stimulation, provided via bone conduction by transmitting sound signals through bone to a user's inner ear, such as via piezoelectric actuator (see ¶[0104]), in which the device may be utilized with the subject’s head via three bands 15a, 15b, and 15c (see ¶[0102] and Fig. 1B), in which the first headband 15a fits a front portion of the head, the second headband 15b fits an upper back portion of the head, and the third headband 15c fits a lower back portion of the head (see Fig. 1B).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the three band headband of Crow for as the headband in the modified Molina ‘185 because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results; and/or (2) the modified Molina ‘185 requires a headband and Crow teaches one such headband; and/or (3) the addition of the third headband 15c helps to prevent any potential slippage/movement of the headband (see Crow ¶[0102]).
Claim 40 is rejected under 35 U.S.C. 103 as being unpatentable over Molina ‘185 in view of Molina ‘042 as applied to claim 38 above, and in view of Qin et al. (Chinese Patent Document CN113288176A – cited to translation from Espacenet.com, cited by Applicant), hereinafter Qin.
Regarding Claim 40, Molina ‘185 in view of Molina ‘042 teaches the system of claim 38 as stated above. The modified Molina ‘185 further teaches the one or more processors are configured to determine, based on the one or more SO parameters, one or more features that define a morphology of the SO of the ongoing brain activity including one or more interval values (see Molina ‘042 abstract and ¶[0039]-[0044] the neural network uses brain activity parameters determined from the sensor data to predict sleep stages that will occur at future times during the sleep session of the user, so that stimulation may be applied during the appropriate sleep stage, the deep sleep, Figs. 2-3, ¶[0034]-[0035] in which the deep sleep is related to slow wave activity of the user, see also ¶[0052] and Fig. 6, the output of the neural network may include frequency morphology output, including of the slow wave oscillations).
The modified Molina ‘185 is silent regarding one or more slope values.
Qin teaches a system for distinguishing between different slow wave types via EEG signals obtained via an EEG acquisition module (see abstract), in which the slope of the slow wave may be utilized as a parameter for further analysis once the slow wave is detected (see ¶[0013]-[0017] and ¶[0039]-[0041]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the slow wave slope parameter of Qin as a slow wave slope parameter in the modified Molina ‘185 because (1) it is the application of a known technique to a known device/method ready for improvement to yield predictable results; and/or (2) the modified Molina ‘185 requires a parameter of the slow wave and Qin teaches one such parameter; and/or (3) the slope can provide an accurate way to determine phase of the slow wave (see Qin ¶[0039]-[0041]).
Conclusion
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/J.D.M./ Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791
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