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 .
Response to Amendment
The Office Action is responsive to the Amendment filed 22 May 2026. Claims 1-20 are now pending. The Examiner acknowledges the amendments to claims 1-20.
Claim Objections
Claims 2 and 11 are objected to because of the following informalities:
Regarding claim 2, in line 2, there should be a comma in between “(REM)” and “sleep”.
Regarding claim 11, in line 11, there should be a comma in between “oscillation episode” and “each”.
Appropriate correction is required.
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.
Claims 1-6 and 8-10 are rejected under 35 U.S.C. 103 as being obvious over Walter et al. (US 20170193831 A1) (hereon referred as Walter) in view of Pless (US 20080319511 A1).
Regarding claim 1, Walter teaches a method for treating sleeping or movement disorder ("may be applied to patients with memory disorders…Parkinson's disease…and other disorders", paragraph [0053]) the method comprising:
Recording a brainwave of a patient with sleeping or movement disorder ("brain wave patterns that are commonly detected during an EEG recording…brainwave patterns that may be seen while a subject is sleeping", paragraph [0040]);
Identifying an onset of a sawtooth wave (STW) oscillation episode from the brainwave ("further, during REM sleep, various bursts of sawtooth waves may be observed…sawtooth waves that may be seen during REM sleep may precede a burst of rapid eye movements", paragraph [0042]);
Wherein the STW oscillation episode is a STW signal having an oscillation frequency in a range of from 2 Hz to about 4 Hz ("sawtooth waves, as seen on an EEG recording oscillate at the theta frequency", paragraph [0042], "subject's brain hippocampal wave frequency is generally about 3-8 hertz (the theta frequency)", paragraph [0043]);
Delivering a first stimulation to the patient when the onset of the STW oscillation episode is identified from the brainwave ("reinforcing cue…provided by a stimulation device to the subject according to one or more patterns during the specific sleep interval based on the subject being in the specific sleep interval", paragraph [0130]);
Adapting the first stimulation according to a measurable feature of the STW oscillation episode ("if the post-sleep recall accuracy determined in step 1304 is below the threshold…the first pattern of the reinforcing cue stimulation should be changed to a different pattern", paragraph [0171])
Walter does not teach the method of delivering a first electrical stimulation to the patient when the onset of the STW oscillation episode is identified from the brainwave, as well as adapting the first electrical stimulation according to a measurable feature of the STW oscillation episode.
However, Pless teaches a method for treating sleeping or movement disorder (“neurostimulator for treating…movement disorders”, abstract) the method comprising:
Recording a brainwave of a patient with sleeping or movement disorder (“recording controller 2402 can be configured to record and store recordings of the patient’s brainwaves”, paragraph [0232]);
Delivering a first electrical stimulation to the patient from the brainwave data (“method of delivering and monitoring electrical stimulation…delivering a first course of electrical stimulation”, paragraph [0018]);
Adapting the first electrical stimulation according to a measurable feature of the brainwave data (“changing the first value to a second value…delivering a second course of electrical stimulation therapy”, paragraph [0018]);
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the method of Walter with the method of Pless and provide electrical stimulation as part of the treatment when the onset of an STW oscillation frequency is identified, as electrical stimulation is effective in supplying stimulation for deeper brain regions and is beneficial to patients with sleep or movement disorders.
Regarding claim 2, Walter in view of Pless teaches the sleeping or movement disorder comprising Parkinson's disease (PD) ("may be applied to patients with…Parkinson's disease", paragraph [0053], Walter).
Furthermore, Pless teaches the first electrical stimulation being delivered to a cerebral region or a cerebellar region of the patient (“electrode…implanted in a desired location in the patient’s brain”, paragraph [0067], Pless).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the method of Walter in view of Pless and direct the first electrical stimulation directly to the brain of the patient in order to treat sleep or movement disorders.
Regarding claim 3, Walter in view of Pless teaches all the limitations of claim 1.
Furthermore, Walter teaches identifying whether the onset of the STW oscillation episode occurs in a REM stage or an awake stage of the patient ("wearable sensor may be used to determine sleep and wakefulness of the subject", paragraph [0076], Walter); and
Delivering the first stimulation to the patient only when (1) the onset of the STW oscillation episode occurs during awake stage of the patient ("providing by a stimulation device a first reinforcing cue to a subject during learning wakefulness", paragraph [0066], Walter) or (2) the onset of the STW oscillation episode occurs during the REM stage of the patient and in excess of a predetermined occurrence frequency ("reinforcing cues…are then re-presented during sleep of the subject", paragraph [0058], Walter).
Walter does not teach providing electrical stimulation.
However, Pless teaches delivering electrical stimulation to the patient during an awake stage of the patient (“providing a first treatment to the patient…prompting means for prompting the patient to provide input about the therapy”, the patient would be awake during the electrical stimulation, paragraph [0019]), as well as during the REM stage of the patient (“detection subsystem...detect head tremor or orientation (e.g., for sleep detection)”, paragraph [0086]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the method of Walter in view of Pless and provide electrical stimulation dependent on the onset of the STW oscillation episode during an awake stage as well as during the REM stage of a patient in order to provide stimulation where STW is abnormally high during REM stage or an awake stage.
Regarding claim 4, Walter in view of Pless teaches all the limitations of claim 1.
Furthermore, Walter teaches the first stimulation being applied during a course of the STW oscillation episode, and the first electrical stimulation being terminated when the STW signal is decayed to a lower threshold ("if the post-sleep recall accuracy determined in step 904 is below the threshold…the first reinforcing cue stimulated should be changed to a different cue", paragraph [0142], Walter). First stimulation will be terminated and adapted when STW signal decays to a lower threshold.
Walter does not teach providing electrical stimulation.
However, Pless teaches the first electrical stimulation being applied, and the first electrical stimulation being terminated when a threshold is reached (“first course of electrical stimulation therapy…automatically changing the first value to a second value of the at least one parameter, delivering a second course of electrical stimulation therapy”, paragraph [0018], Pless).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the method of Walter in view of Pless and terminate the first electrical stimulation after the STW signal decays to a lower threshold, as the first electrical treatment can be reduced for when the STW signals also reduce.
Regarding claim 5, Walter in view of Pless teaches the measurable feature of the STW oscillation episode comprising an oscillation intensity, the oscillation frequency, and an oscillation duration ("patterns of reinforcing cue re-presentation during sleep may vary in frequency, intensity…duration…variables may be dependent on specific brainwave patterns…predicted sleep stage", paragraph [0163], Walter).
Regarding claim 6, Walter in view of Pless teaches the onset of the STW oscillation episode being identified from the brainwave of the patient by monitoring electroencephalography (EEG) ("sawtooth waves, as seen on an EEG recording", paragraph [0042], Walter), electromyography (EMG), and electro- oculography (EOG) recordings ("EOG and/or EMG may also be useful in determining the sleep cycle of a subject…in REM sleep", paragraph [0046], Walter) simultaneously.
Regarding claim 8, Walter in view of Pless teaches recording the measurable feature of the STW oscillation episode before or during delivering the first electrical stimulation (paragraph [0018], Pless) ("during REM sleep, various bursts of sawtooth waves may be observed”, paragraph [0042], “monitoring…onset of sleep of the subject…also includes providing a reinforcing cue”, paragraph [0067], Walter), the measurable feature comprises at least one of an oscillation intensity, the oscillation frequency, and an oscillation duration of the STW oscillation episode ("patterns of reinforcing cue re-presentation during sleep may vary in frequency, intensity…duration…variables may be dependent on specific brainwave patterns…predicted sleep stage", paragraph [0163]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the method of Walter in view of Pless and record a measurable feature of the STW oscillation episode before or during the first electrical stimulation, to receive brainwave data before and after stimulation.
Regarding claim 9, Walter in view of Pless teaches delivering a second stimulation subsequent to terminating the first stimulation when an onset of another STW oscillation episode is identified in the brainwave ("a second reinforcing cue to be delivered to the subject during a second sleep period subsequent to the receiving of the indication is determined by the controller device", paragraph [0141], "indication of accuracy below the threshold…a new, second reinforcing cue to be used", paragraph [0143]), wherein the second stimulation is applied with the stimulation form determined by at least one of the oscillation duration of the STW oscillation episode or the frequency of occurrence of the STW oscillation episode within the predetermined timeframe ("patterns of reinforcing cue…may vary in frequency…duration", paragraph [0163]).
Walter does not teach providing electrical stimulation.
However, Pless teaches delivering a second electrical stimulation subsequent to terminating the first electrical stimulation (paragraph [0018]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the method of Walter in view of Pless and deliver a second electrical stimulation when an onset of another STW oscillation episode is identified in the brainwave, in order to adapt to the changes in STW oscillation in the brainwave.
Regarding claim 10, Walter in view of Pless teaches all the limitations of claim 1.
Furthermore, Pless teaches pausing the first electrical stimulation during the course of the oscillation episode before the first electrical stimulation is terminated (“first course of therapy to the patient, such as an electrostimulation…provide a course of therapy continuously or according to a preprogrammed delivery schedule…or commanded by a clinician using the programmer”, paragraph [0256]). The first electrical stimulation would be paused until termination, in order to prepare for the second electrical stimulation.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the method of Walter in view of Pless and pause the first electrical stimulation before the first electrical stimulation is terminated in order to determine measurable features of the STW signal before termination.
Claim 7 is rejected under 35 U.S.C. 103 as being obvious over Walter in view of Pless and further in view of Poltorak (US 11413425 B2) (provisional filing date of 05/24/2019, also attached in OC set with paragraph numbers).
Regarding claim 7, Walter in view of Pless teaches all the limitations of claim 1, but does not teach the first stimulation comprising multiple intermittent sub-stimulations.
However, Poltorak teaches the first electrical stimulation (“transcranial electrical stimulation”, paragraph [0211]) comprising multiple intermittent sub- stimulations during the STW oscillation episode ("using an intermittent stimulation, in which tones were played in blocks of 15s spaced out by stimulation-free intervals", paragraph [0211]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the method of the Walter in view of Pless with the method of Poltorak and performing multiple intermittent sub-stimulations during the first stimulation in order to reduce the overall dose of stimulation during each STW oscillation episode and minimizing side effects.
Claims 11-17 are rejected under 35 U.S.C. 103 as being obvious over Pless in view of Walter.
Regarding claim 11, Pless teaches a system for treating sleeping or movement disorder (“neurostimulator for treating…movement disorders”, abstract), comprising:
An electrode module (implantable device 110), comprising:
A plurality of electrodes (electrodes 412, 414, 416, 418), configured to obtain pathological activities of a patient with sleeping or movement disorder (“receive EEG signals from the electrodes 412-418…to process those EG signals to identify neurological activity indicative of neurological disorders…movement disorders”, paragraph [0085]); and
A neuromodulation module coupled with the plurality of electrodes (“control module 410…coupled to a plurality of electrodes”, paragraph [0083]; control module 410), configured to record pathological activities and execute an electrical stimulation through the plurality of electrodes simultaneously when the pathological activities are recorded (“control module…for sensing, stimulation, or both”, paragraph [0083]), and
A dock module wirelessly connected to the electrode module, configured to optimize a parameter of the electrical stimulation (“external programmer 312…in communication with the implantable device 110…used to manually control the operation of the device, as well as to transmit information to or receive information from the implantable device”, paragraph [0075]).
Pless does not teach the pathological activities comprise a sawtooth wave (STW).
However, Walter teaches a system for treating sleeping or movement disorders ("may be applied to patients with memory disorders…Parkinson's disease…and other disorders", paragraph [0053]), comprising:
A plurality of electrodes configured to obtain pathological activities of a patient with sleeping or movement disorder (“EEG records the neural activity…by a plurality of electrodes”, paragraph [0039]), and
Wherein the pathological activities comprise a sawtooth wave (STW) demonstrating at least one oscillation episode, each having an oscillation frequency in a range of from about 2 Hz to about 4 Hz ("sawtooth waves, as seen on an EEG recording oscillate at the theta frequency", paragraph [0042], "subject's brain hippocampal wave frequency is generally about 3-8 hertz (the theta frequency)", paragraph [0043]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the system of Pless with the system of Walter and configure the plurality of electrodes to detect sawtooth waves in order to treat patients with sleep or movement disorders who may have an abnormal occurrence of STW in their brainwave data.
Regarding claim 12, Pless in view of Walter teaches all the limitations of claim 11.
Furthermore, Walter teaches the electrode module being a wearable device, and that the dock module is separate from the wearable device (“wearable patches…head of a subject”, paragraph [0086]). The dock would be separate from the wearable device as it is a wireless connection.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the system of Pless in view of Walter and make a wearable device for the electrode module for the convenience of the patient to wear the device while receiving treatment.
Regarding claim 13, Pless in view of Walter teaches the neuromodulation module comprising:
A plurality of stimulation submodules (“therapy subsystem 424 can be configured to apply electrical stimulation”, paragraph [0087]) and a plurality of recording submodules (“detection subsystem 423…receive EEG signals from the electrodes”, paragraph [0085]) configured to control the plurality of electrodes;
A central control submodule configured to control the plurality of stimulation submodules and the plurality of recording submodules (“detection subsystem 423 and the electrode interface 420 is also connected to a therapy subsystem 424”, paragraph [0084]).
Regarding claims 14 and 15, Pless in view of Walter teaches each of the stimulation submodules being electrically isolated from each of the recording submodules, as well as being communicated with each of the recording submodules by a non-electrical manner (“external sensor 421 can be connected to…detection subsystem 423…by wireless communication”, paragraph [0086]).
Regarding claim 16, Pless in view of Walter teaches the plurality of electrodes each further comprising an amplifier module configured to amplify a brainwave of the patient (“electrodes…connected to an electrode interface 420…electrode interface 420 also can provide any other features…amplification”, paragraph [0084]).
Regarding claim 17, Pless in view of Walter teaches the stimulation submodules comprising a first processing unit and the recording submodules comprising a second processing unit (“central processing unit…coupled to the detection subsystem…the therapy subsystem”, paragraph [0090]).
Claims 18 and 19 are rejected under 35 U.S.C. 103 as being obvious over Pless in view of Walter and further in view of Poltorak.
Regarding claims 18 and 19, Pless in view of Walter teaches all the limitations of claim 17, but does not teach a stimulation central of the central control submodule comprising a first AI core or a recording central of the central control submodule comprising a second AI core.
However, Poltorak teaches a stimulation central of the central control submodule comprising a first AI core or a recording central of the central control submodule comprising a second AI core, and the dock module comprising an AI core ("artificial intelligence (AI) and machine learning methods, such as artificial neural networks, deep neural networks, etc., may be implemented to extract the signals", paragraph [0528]). There are multiple processors for Al use.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the system of Pless in view of Walter with the system of Poltorak in order to use AI to learn the optimal parameters for delivering electrical stimulation to the patient.
Claim 20 is rejected under 35 U.S.C. 103 as being obvious over Pless in view of Walter, further in view of Poltorak and furthest in view of George (US 20210326704 A1).
Regarding claim 20, the modified system teaches all the limitations of claim 19, but does not teach the Al core being configured to implement a Kalman filter for detection among different durations or patients.
However, George teaches a system for utilizing an AI model with a plurality of sensors at different positions on a human body (paragraph [0005]) being configured to implement a computationally-intensive Kalman filter for maintaining detection among different durations or patients ("AI regression model includes a modified Kalman filter (MKF)", paragraph [0055]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the modified system with the system of George and utilize the algorithm based on the Kalman filter with the AI core parts of Poltorak to maintain reliable detection of signals received from patients during treatment.
Response to Arguments
Applicant’s arguments, see page 2, filed 22 May 2026, with respect to the 35 U.S.C. 112 rejections have been fully considered and are persuasive in light of the amendments. The rejections have been withdrawn.
Applicant’s arguments with respect to claims 1-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The rejection of all pending claims 1-20 under 35 U.S.C § 102(a)(1) and 35 U.S.C. § 103 have been updated accordingly.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LARA LINH TRAN whose telephone number is (571)272-3598. The examiner can normally be reached 7:30am-5:00pm M-F.
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/L.L.T./Examiner, Art Unit 3791 /ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791
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