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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on August 3, 2026 has been entered.
Claim Objections
Claims 1, 28, 30, 31, 33-34 and 37-41 are objected to because of the following informalities:
In claim 1, in the 4th to last line, --- the --- should be inserted before “dominant”.
In claim 28, in line 2, “a sleep stage” should be replaced with --- the sleep stage --.
In claim 30, in the 3rd to last line, --- the --- should be inserted before “slow wave power”. Claim 41 is similarly objected to (see lines 7-8).
In claim 31, in line 22, “ultrasound pulses have” should be replaced with ---at least one ultrasound pulse has ---.
In claims 33-34 and 37-40, in line 1, --- neuromodulation --- should be inserted before “system”.
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 30 and 41 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 30 recites the limitation "the comparison of slow wave power…" in the third to last line. There is insufficient antecedent basis for this limitation in the claim.
Claim 41 recites the limitation "the comparison of slow wave power…" in lines 7-8. There is insufficient antecedent basis for this limitation in the claim.
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 16-18, 20-29 and 31-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 5-15 of U.S. Patent No. 11,730,960 in view of Onarheim et al. and Grossman et al..
With regards to claims 16-18, 20, 25-26, 31-32 and 35, claims 1 and 12-13 of the Patent meet most of the limitations of the claims (i.e. a neuromodulation device including a wearable device and ultrasound-emitting elements and one or more EEG electrodes, a stimulation control computing environment/at least one processor configured to use brain image data to identify the target brain area, perform one or more acoustic simulations, detect a phase of at least one slow wave, and control the ultrasound emissions/waveform parameters such that the ultrasound emissions constructively interference, process real-time data acquired by the one or more EEG electrodes to detect a phase of at least one slow wave, etc. and wherein the stimulation circuit optimizes one or more parameters of the ultrasound emissions based on a current slow wave amplitude reading relative to a baseline slow wave amplitude reading [Patent claim 12]).
However, with regards to claims 16 and 31, though claim 1 of the Patent does disclose identifying the target brain area based on brain image data (see claim 1, referring to “use brain image data to identify the centromedian thalamus [i.e. target brain area]), the Patent does not specifically disclose that identification of the target brain area is further based on at least one biometric feature of a user. Further, claim 1 of the Patent does not specifically disclose transforming the acquired real-time data into a frequency domain and using the frequency domain, determine a dominant frequency within a slow-wave frequency band of the acquired real-time data.
Onarheim et al. disclose an a stimulation device for achieving various cognitive effects, wherein a ’10-20 system’ is a method that is used to describe and apply the location of scalp electrodes (i.e. stimulation emitting elements) (Abstract; paragraphs [0001], [0292]). The method was developed to ensure standardized reproducibility so that a subject’s studies could be compared over time and subjects could be compared to each other, wherein the system is based on the relationship between the location of an electrode and the underlying area of cerebral cortex (paragraph [0292]). The “10” and “20” refer to the fact that the actual distances between adjacent electrodes are either 10% or 20% of the total front-back or right-left distance of the skull (i.e. biometric distance) (paragraph [0292], Figures 9-10). Earlobes, nasopharyngeal and frontal polar sites are identified and two anatomical landmarks are used for the essential positioning of the EEG electrode: first, the nasion, which is the distinctly depressed area between the eyes; second, the inion, which is the lowest part of the skull from the back of the head and is normally indicated by a prominent bump; further, the purpose of the electrode placement is to target certain predefined brain area inside the skull, wherein the use of the 10-20 system coordinates is a way of seeking to achieve the correct placement on the outside of the skull to target the desired brain areas (paragraphs [0292], [0296], note that a target brain area (i.e. targeted “certain predefined brain area inside the skull”) is thus identified based on at least one biometric feature (i.e distance from anatomical landmarks (i.e. nasion, inion); Figures 9-10).
At the time of the invention, it would have been obvious to one of ordinary skill in the art to have the identification of the target brain area of the Patent be further based on at least one biometric feature of a user, as taught by Onarheim et al., in order to achieve the correct placement on the outside of the skull to target the desired brain areas and ensure standardized reproducibility so that a subject’s studies could be compared over time and subjects could be compared to each other (paragraphs [0292], [0296]).
However, with regards to claims 16 and 31, the Patent does not specifically disclose transforming the acquired real-time data into a frequency domain and using the frequency domain, determine a dominant frequency within a slow-wave frequency band of the acquired real-time data and that the detected phase is associated with the determined dominant frequency and that the detected phase is associated with the determined dominant frequency and further that the ultrasound emissions are adaptively modulated in one or more of timing, amplitude, duration, and spatial focus in response to changes in the detected phase or dominant frequency.
Grossman et al. disclose a neuromodulator which may output stimuli that causes a user to fall asleep faster than the user would in the absence of the stimuli or may modify a sleep state or behavior associated with a sleep state, wherein the neuromodulator may take EEG measurements and the stimuli/neuromodulation signal may comprise an ultrasound signal (Abstract; paragraphs [0271], [0284], referring to an ultrasound transducer (1505) delivering ultrasound stimulation to the brain of a user; paragraph [0058], referring to the measurement of endogenous electrical activity of the brain via EEG electrodes; Figures 1, 15B). A method for accelerating sleep onset comprises of using an EEG sensor to take EEG measurements of the endogenous neural signal, wherein the endogenous neural signal may be the dominant (highest amplitude) neural signal in a frequency band, such as in the delta band (paragraphs
[0083],[0013],[0014]). A neuromodulator may, based on the EEG measurements, calculate instantaneous phase and instantaneous amplitude of the endogenous neural signal by a calculation that involves use of an endpoint-corrected Hilbert Transform (ECHT) (Step 102), wherein the ECHT algorithm can comprise a “frequency domain” version of ECHT which comprises performing a Fast Fourier transform (FFT) on the EEG signal (paragraphs [0083], [0086], note that the real-time EEG data is thus transformed into a frequency domain; Figure 1A). A neuromodulator may, based on the detected instantaneous phase (e.g., instantaneous phase estimated based on the EEG measurements) calculate stimulation that is phase-locked with the endogenous neural signal, such as the dominant neural signal (i.e. dominant frequency) in a delta frequency band (i.e. a slow-wave frequency band), and then physically output this stimulation in a manner perceptible to the human subject (Step 103) (paragraphs [0013]-[0014], [0083], [0173], [0176], note that a dominant/peak frequency within a slow-wave frequency band (i.e. delta band; see paragraph [0013] which refers to the “slow wave (delta) activity”) and a phase of the slow wave (i.e. delta band) with the determined dominant/peak frequency of the acquired real time data is determined and used to control the stimulation to be phase-locked with the dominant neural signal of the slow wave (i.e. delta band); Figure 1A). The neuromodulator may dynamically compute parameters that specify a pulse’s start phase, end phase, minimum duration and maximum duration, as well as dynamically compute other parameters, such as the type(s) of stimulation, location(s) of stimulation, maximum and minimum amplitude of stimulation and duration of stimulation session, such as dynamically computing the start phase as corresponding to the phase of an endogenous neural signal when the pulse ends (paragraphs [0142]-[0143], [0147], note that the “dynamic computation”/dynamic adjustment in real time of parameters that specify a pulses start/end phases/duration and amplitude corresponds to the stimulation (i.e. ultrasound emissions in the above combined references) being adaptively modulated in one or more of timing, amplitude, duration, etc., in response to changes in the detected phase/dominant frequency). The method may be performed iteratively to calculate, in each iteration, the instantaneous phase and instantaneous amplitude for the most recent sample in the sample window and to control stimulation based on the instantaneous phase and instantaneous amplitude (paragraph [0132]; Figure 1A, wherein steps 101, 102, 103, 100 are iteratively/continuously performed).
At the time of the invention, it would have been obvious to one of ordinary skill in the art to have the invention of the Patent further comprise transforming the acquired real-time data into a frequency domain and using the frequency domain, determine a dominant frequency within a slow-wave frequency band of the acquired real-time data and that the detected phase is associated with the determined dominant frequency and further that the ultrasound emissions are adaptively modulated in one or more of timing, amplitude, duration, and spatial focus in response to changes in the detected phase or dominant frequency, as taught by Grossman et al., in order to cause a user to fall asleep faster or modify a sleep state or behavior associated with a sleep state or hinder a transition from a waking state to a sleep state or from a sleep state to another sleep state (Abstract; paragraphs [0014]-[0015]).
With regards to instant claim 21, claim 5 of the Patent sets forth the same limitations.
With regards to instant claim 22, claim 6 of the Patent sets forth the same limitations.
With regards to instant claim 23, claim 7 of the Patent sets forth the same limitations.
With regards to instant claim 24, claim 8 of the Patent sets forth the same limitations.
With regards to instant claim 27, claim 9 of the Patent sets forth the same limitations.
With regards to instant claim 28, claim 10 of the Patent sets forth the same limitations.
With regards to instant claim 29, claim 11 of the Patent sets forth the same limitations.
With regards to instant claim 33, claim 14 of the Patent sets forth the same limitations.
With regards to instant claim 34, claim 15 of the Patent sets forth the same limitations.
With regards to claim 37, Onarheim et al. disclose that the at least one biometric feature of the user is selected from one or more eyes of the user, one or more ears of the user, an eyebrow ridge of the user, a nose of the user, a mouth of the user, a jawline of the user, and combinations thereof (paragraph [0292], referring to the 10-20 coordinate system relying upon identification of the earlobes (i.e. ears), nasopharyngeal (i.e. nose) sites and nasion [which is associated with the eyes and nose (i.e. area between eyes, just above the bridge of the nose)]; Figures 9-10).
With regards to claim 38, Onarheim et al. meet the limitations (see double patenting rejection above of claim 16 under Onarheim et al.).
With regards to claim 39, Grossman et al. meet the limitations (see double patenting rejection above of claims 16 and 31).
With regards to claim 40, Grossman et al. meet the limitations (see double patenting rejection above of claims 16 and 31).
Allowable Subject Matter
Claims 16-18, 20-24, 27-34 and 37-41 contain allowable subject matter.
The following is a statement of reasons for the indication of allowable subject matter: The prior art does not teach or suggest that the stimulation control unit optimizes one or more parameters of the ultrasound emissions [from the one or more ultrasound-emitting elements] based on a current slow wave amplitude reading relative to a baseline slow wave amplitude reading, in combination with the other claimed elements.
Response to Arguments
Applicant’s arguments, see pgs. 8-9, filed August 3, 2026, with respect to the prior art rejections have been fully considered and are persuasive. The prior art rejections of claims 16-18, 20-24, 27-34 and 37-41 has been withdrawn.
The Double Patenting rejecting remains, as well as objectionable issues and a 35 USC 112(b) rejection for amended claim 30 and new claim 41.
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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 KATHERINE L FERNANDEZ whose telephone number is (571)272-1957. The examiner can normally be reached Monday-Friday 9:00 AM - 5:30 PM (ET).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Pascal Bui-Pho can be reached at (571) 272-2714. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KATHERINE L FERNANDEZ/Primary Examiner, Art Unit 3798
Prosecution Insights