DETAILED ACTION
The amendment filed on 12/29/25 has been received and considered. By this amendment, claims 1, 4, 5, 21-22, and 25 are amended. Claims 2-3 are cancelled and no claims are added.
Response to Arguments
Applicant’s arguments, see pages 6-8, filed 12/29/25, with respect to the rejection(s) of claim(s) 1-4, 10-11, 16, and 21 under 35 USC 102(a)(1) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Schiff et al. (PG Pub. 2015/0367133).
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) 1, 4-5, 10-11, 16, and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Xia et al. (PG Pub. 2016/0220817) in view of Schiff et al. (PG Pub. 2015/0367133).
Regarding Claims 1 and 21, Xia discloses a method of generating stimulation signals for modulating the arousal and/or wakefulness of a patient (see par. 4), the method comprising: monitoring bioelectrical activity of the nervous system of the patient (see par. 7); detecting characteristics of the monitored bioelectrical activity associated with a state of reduced arousal and/or wakefulness (see drowsiness; par. 18); in response to detecting said characteristics of the monitored bioelectrical activity associated with a state of reduced arousal and/or wakefulness, generating stimulation signals for supply to stimulation transducers (see electrodes 19) arranged to apply electromagnetic stimulation to a neural network of a patient associated with arousal (see Claim 2 and par. 18), the stimulation signals being selected to arouse the patient when the stimulation is applied (see par. 16). Xia discloses measuring bioelectrical signals from the scalp (see EEG; par. 17), but does not disclose monitoring EEG from transducers implanted in a neural network of a patient associated with arousal. Schiff discloses a similar arousal modulating method (see par. 9) comprising implanted monitoring transducers (see sensors 26; par. 75) in the neural network associated with arousal (see par. 162). It would have been obvious to one of ordinary skill in the art at the time of the invention to use implanted sensors instead of, or in addition to, surface sensors because Schiff teaches the bioelectrical activity that indicates arousal can be acquired by both implanted and surface sensors (see par. 84) and the implementation of implanted sensors is a matter of design choice (see par. 75).
Regarding Claim 4, Xia discloses the transducers comprise electrodes (see electrodes 19 and 24) and the electromagnetic stimulation is electrical stimulation (see Claim 2). Schiff discloses the transducers comprise implanted deep brain electrodes (see electrodes 15 or 105; par. 68, 73 and Fig. 1A-1B). It would have been obvious to one of ordinary skill in the art at the time of the invention to implement deep brain electrodes for better access to the thalamus (see par. 83).
Regarding Claim 5, Schiff further discloses the monitoring transducers are integrated with or the same as the stimulation transducers (see par. 55 and 75). It would have been obvious to one of ordinary skill in the art at the time of the invention to integrate the sensors and stimulator because Schiff teaches it as a matter of design choice (see par. 75).
Regarding Claims 10-11, Xia discloses wherein the detected characteristics are features of sleep fragility in the patient, and optionally the stimulation signals are synchronized with the indication of sleep fragility which comprises detecting at least one of: a microarousal, a K-complex, and a sleep-spindle (see par. 17).
Regarding Claim 16, Xia discloses wherein the neural network of the patient associated with arousal is a part of the ascending arousal system, wherein optionally the part of the ascending arousal system is the pedunculopontine nucleus or laterodorsal tegmentum (see par. 4).
Claim(s) 6-9, 12-15, 17-20, and 22-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Xia et al. (PG Pub. 2016/0220817) in view of Schiff et al. (PG Pub. 2015/0367133) as applied to claims 1 and 21 above, and further in view of Youngblood et al. (PG Pub. 2018/0110960).
Regarding Claims 6 and 23, Xia does not explicitly disclose indicating a sleep stage. Youngblood discloses indicating a stage of sleep from the characteristics of the monitored bioelectric activity (see par. 12). It would have been obvious to one of ordinary skill in the art at the time of the invention to indicate the sleep stage because Youngblood teaches it helps determine what stimulus is needed to affect the sleep stages (see par. 12) and when to potentially awaken the user (see par. 14).
Regarding Claim 7, Youngblood further discloses wherein the detected characteristics comprise slow wave activity (see par. 314). It would have been obvious to one of ordinary skill in the art at the time of the invention to identify slow wave activity (or N3 sleep) because that is deep sleep (see par. 214) and might require a more aggressive arousal stimulation.
Regarding Claim 8, Youngblood further discloses wherein the detected characteristics comprise features of non-rapid eye movement Sleep Stage 2 (see N2 par. 213), wherein optionally the features comprise microarousals and/or the features comprise k-complexes and/or the features comprise sleep spindles (see par. 314). It would have been obvious to one of ordinary skill in the art at the time of the invention to monitor for non-REM in order to arouse while the patient is moving in and out of the N2 stage (see par. 214).
Regarding Claim 9, Youngblood further discloses wherein the detected characteristics comprise features of the rapid eye movement sleep stage (see par. 215). It would have been obvious to one of ordinary skill in the art at the time of the invention to identify REM to awaken the user at an optimal point within the sleep cycle to prevent sleep inertia (see par. 219).
Regarding Claim 12, Xia dose not elaborate on machine learning. Youngblood discloses wherein detecting an indication of sleep fragility comprises applying a machine learning algorithm trained to identify signals indicative of sleep fragility (see par. 313-314 and 366). It would have been obvious to one of ordinary skill in the art at the time of the invention to use machine learning to identify sleep fragility indicators because Youngblood teaches it helps improve health outcomes and wellness standards by processing and manipulating the collected data (see par. 38 and 288).
Regarding Claims 13 and 25, Youngblood further discloses monitoring peripheral activity of the patient; and detecting characteristics of the monitored peripheral activity associated with a reduced state of wakefulness and/or arousal (see par. 120), wherein the stimulation signal is generated in response to detecting the characteristics of the monitored bioelectrical activity and the characteristics of the monitored peripheral activity (see Fig. 2). Youngblood discloses the monitoring transducers and interface associated with monitoring the peripheral activity (see EMG sensor 717 and control interface 764; par. 130). It would have been obvious to one of ordinary skill in the art at the time of the invention to use the bioelectric activity and the peripheral activity to generate the stimulation signal because Youngblood teaches they help indicate the sleep stage (see par. 301) which in turn is used for determining appropriate stimulation parameters (see par. 302).
Regarding Claim 14, Youngblood discloses wherein the peripheral activity comprises at least one of: cardiovascular activity, musculoskeletal activity, and or physical activity (see EMG, par. 114 and 120). It would have been obvious to one of ordinary skill in the art at the time of the invention to use musculoskeletal activity because Youngblood teaches it helps determine the state of sleep of the user (see par. 311).
Regarding Claim 15, Youngblood further discloses wherein the detected characteristics are patient-specific (see par. 297). It would have been obvious to one of ordinary skill in the art at the time of the invention to use patient specific characteristics so the program can be customized to their preferences (see par. 303).
Regarding Claim 17, Youngblood discloses the stimulation signals have a stimulation frequency of at least 10 Hz and/or at most 150 Hz (see par. 227). It would have been obvious to one of ordinary skill in the art at the time of the invention to stimulate in this frequency range because Youngblood teaches it ensures the user wakes up (see par. 234).
Regarding Claim 18, Youngblood discloses wherein the stimulation signal comprises at least one stimulation pulse repeating in a cycle, optionally comprising a pair of stimulation pulses of opposite polarity (see par. 105).
Regarding Claim 19, Youngblood discloses the stimulation signals comprise one or more features representative of an endogenous activity pattern associated with arousal and/or wakefulness (see par. 307). It would have been obvious to one of ordinary skill in the art at the time of the invention to include endogenous activity because Youngblood teaches it helps predict realistic values when customizing the program for sleep optimization (see par. 307 and 308).
Regarding Claim 20, Youngblood discloses wherein the stimulation signals comprise one or more features representative of one of: alpha, low gamma, or high gamma activity (see par. 227). It would have been obvious to one of ordinary skill in the art to emulate alpha frequencies to promote sleep (see par. 227).
Regarding Claim 22, see rejection of similarly worded Claim 1 above. Xia further discloses a detection unit and a stimulation generator as one singular unit (see board 20/25; par. 17 and 19). Youngblood discloses a separate detection unit (see Brainwave sensor 718 and par. 163) and stimulation generator (see PEMF device 784 and par. 230). It would have been obvious to one of ordinary skill in the art at the time of the invention to have separately dedicated components as opposed to an integrated component because Youngblood teaches it is a matter of design choice (see par. 357).
Regarding Claim 24, see rejections of similarly worded Claim 10 above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/N.P/ Examiner, Art Unit 3792
/UNSU JUNG/ Supervisory Patent Examiner, Art Unit 3792