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 Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
In claim 17, "a first processing unit" and “a second processing unit” → defined as a computer/computer part with broadest reasonable interpretation
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claim 19 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 19, it recites the limitation "third AI core". However, there is no mention of a first or second AI core in claim 11. It is unclear whether or not claim 19 should be dependent on claim 18, or if there needs to be three AI cores or one that is a part of the docket module.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-6 and 8-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Walter et al. (US 20170193831 A1).
Regarding claim 1, Walter et al. 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])
Regarding claim 2, Walter et al. teaches the sleeping or movement disorder comprises Parkinson’s disease (PD) (“may be applied to patients with…Parkinson’s disease”, paragraph [0053]).
Regarding claim 3, Walter et al. teaches the method further comprising:
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])
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]) 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])
Regarding claim 4, Walter et al. teaches the first stimulation being applied during a course of the STW oscillation episode, and the first 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]). First stimulation will be terminated and adapted when STW signal decays to a lower threshold.
Regarding claim 5, Walter et al. 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]). Regarding claim 6, Walter et al. 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]), 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]) simultaneously.
Regarding claim 8, Walter et al. teaches recording the measurable feature of the STW oscillation episode before or during delivering the first stimulation (“sleep stages and sleep cycles may also be determined and/or predicted based on…other measurements of activity used to predict sleep and wakefulness”, paragraph [0179]), 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]).
Regarding claim 9, Walter et al. 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]).
Regarding claim 10, Walter et al. teaches pausing the first stimulation during the course of the oscillation episode before the first stimulation is terminated (“indication of accuracy below the threshold…a new, second reinforcing cue to be used”, paragraph [0143]). It is implied that for the second stimulation to occur, the first stimulation would be paused.
Claims 11-13, 16, and 18 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Poltorak (US 11413425 B2) (provisional filing date of 05/24/2019, also attached in OC set with paragraph numbers).
Regarding claim 11, Poltorak teaches a system for treating sleeping or movement disorder (“improving immune response to antigen challenge by inducing sleep”, paragraph [0002]), comprising:
An electrode module, comprising:
A plurality of electrodes, configured to obtain pathological activities of a patient with sleeping or movement disorder (“electrodes placed on the scalp…EEG signals may be captured”, paragraph [0404])
A neuromodulation module coupled with the plurality of electrodes (“generating a waveform for neuromodulation to improve sleep in a subject”, paragraph [0568]), configured to record pathological activities (“recording brain activity patterns of a first subject”, paragraph [0569]) and execute a stimulation through the plurality of electrodes simultaneously (“a plurality of stimuli may be applied…through different stimulator electrodes”, paragraph [0523])
A dock module wirelessly connected to the electrode module, configured to optimize a parameter of the stimulation (“port 12 can be connected to CPU 0 and can be temporarily attached…to a docking station to transmit information”, paragraph [0627])
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 are seen which are described…waves of 2 to 8 Hz”, paragraph [0226])
Regarding claim 12, Poltorak teaches the electrode module being a wearable device (“wearable EEG headset provides a headset with eight electrode channels”, paragraph [0408]), and the dock module being separated from the wearable device (“port 12 can be connected to CPU 10 and can be temporarily attached, for example, to a docking station”, paragraph [0627]).
Regarding claim 13, Poltorak teaches the neuromodulation module comprising:
A plurality of stimulation submodules and a plurality of recording submodules configured to control the plurality of electrodes and a central control submodule configured to control the plurality of stimulation submodules and the plurality of recording submodules ((“non-transitory readable medium storing instructions for controlling a processor to…select a waveform from a plurality of waveforms derived from brainwaves of at least one sleeping donor”, paragraph [0567]).
Regarding claim 16, Poltorak teaches the plurality of electrodes each further comprising an amplifier module configured to amplify a brainwave of the patient (“the waveform may be modulated on said at least one stimulus by varying at least one of a frequency and an amplitude”, paragraph [0543]).
Regarding claim 18, 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 (“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 AI use.
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 7 is rejected under 35 U.S.C. 103 as being obvious over Walter et al. in view of Poltorak.
Regarding claim 7, Walter et al. teaches all the limitations of claim 1, but does not teach the first stimulation comprising multiple intermittent sub-stimulations.
However, Poltorak teaches the first stimulation 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 Walter et al. with the method of Poltorak and performing multiple intermittent sub-stimulations during the first stimulation in order to enhance dep sleep based on artificial and synthetic stimulation paradigms (paragraph [0211]) and help treat sleep disorders.
Claims 14 and 15 is rejected under 35 U.S.C. 103 as being obvious over Poltorak in view of Litt et al. (US 6658287 B1).
Regarding claim 14, Poltorak teaches all of the limitations of claim 13, but does not teach the stimulation submodules being electrically isolated from each of the following submodules.
However, Litt et al. teaches each of the stimulation submodules being electrically isolated from each of the recording submodules (“the link 114 between the implanted unit 102 and the portable unit 104 is a electrical conductor link, optical link, magnetic link, radio frequency link, sonographic link or other types of wireless links…type of link the implanted unit 102 and the portable unit 104 has the appropriate hardware to achieve communication with each other”, paragraph Col. 6, lines 32-38).
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 stimulation submodules and recording submodules with the system of Litt et al. and have the submodules electrically isolated from each other in order to achieve proper communication between parts.
Regarding claim 15, Poltorak teaches all the limitations of claim 13, but does not teach the stimulation submodules being communicated with each of the recording submodules by a non-electrical manner.
However, Litt et al. teaches a non-electrical communication between modules (“the link 114 between the implanted unit 102 and the portable unit 104 is a…optical link, magnetic link, radio frequency link”, Col. 6, lines 31-33).
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 stimulation submodule and the recording submodule of Poltorak with the non-electrical communication of Litt et al. for the convenience of communication between modules and data transfer.
Claims 17 and 19 are rejected under 35 U.S.C. 103 as being obvious over Poltorak.
Regarding claim 17, Poltorak teaches all the limitations of claim 13, but does not teach the stimulation submodule comprising a first processing unit, and the recording submodules comprising a second processing unit. Poltorak does teach the use of multiple processors (“single instruction, multiple data processors, such as graphics processing units…may be employed for general purpose computing”, paragraph [0428]).
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that each component, stimulation submodules and the recording submodules, have their own processing unit as it is known in the art to use multiple processors and computer parts.
Regarding claim 19, Poltorak teaches all the limitations of claim 11, but does not teach the dock module comprising a third AI core.
However, Poltorak does teach the use of AI (“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]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify an AI core for the dock module and other processing units, if other submodules comprise of an AI core in order to implement AI and machine learning.
Claim 20 is rejected under 35 U.S.C. 103 as being obvious over Poltorak in view of George (US 20210326704 A1).
Regarding claim 20, a modified Poltorak teaches all the limitations of claim 19, but does not teach the third AI 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 system of Poltorak 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 for patients.
Conclusion
Any inquiry concerning this communicationor 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