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 .
The amendment filed on February 5, 2026 has been received and considered. By this amendment, claims 1, 13, and 14 are amended, claims 16-25, 27-29, and 31 are cancelled, claims 32-34 are added, and claims 1-15, 26, 30, and 32-34 are now pending in the application.
Drawings
The Applicant is reminded to carefully review the drawing figures and the accompanying specification to ensure that all reference numerals present in the drawing figures are defined within the specification.
Claim Objections
Claim 1 is objected to because of the following informalities: line 7 ends with a period, however because the claim continues after the period, it is believed this should be a semicolon and be followed by the word “and” (i.e. “; and”). 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.
Claim 9 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.
Claim 9 recites the limitation "the detection algorithm is validated for specificity, sensitivity and reliability in detecting the impulsive state by utilizing both the electrophysiological signal at the scalp and the physiological signal at a location other than the scalp" in lines 1-4. The metes and bounds of the claim are unclear, as it is unknown if it is intending to require a step of validating the detection algorithm or if it is attempting to limit the detection algorithm to one that has previously been validated for specificity, sensitivity, and reliability. Clarification is requested.
Claim 9 recites the limitation "the impulsive state" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
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 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 1-5, 7-15, 26, 30, and 32 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Widge et al. (U.S. 2017/0042474), herein Widge. Regarding claim 1, Widge disclseos a system, comprising: a first sensor configured to be worn on a user, the first sensor being a non-invasive sensor configured to detect an electrophysiology signal at the scalp of the user and to output a first sensor signal corresponding to the detected electrophysiology signal (“The non-invasive system may be combined with EEG, for example, to produce a closed-loop system. The non-invasive system may include a plurality of scalp or non-contact electrodes and/or neuro-stimulation coils in communication with a software-controlled helmet, cap, or set of electrodes that can stimulate areas of the brain.”, paragraph [0070]); a second sensor 58 (see Fgiure 2) configured to be worn on the user, the second sensor being a non-invasive sensor configured to detect a physiological signal at a body location other than the scalp and to output a second sensor signal corresponding to the detected physiological signal (“This closed-loop control may not be limited to brain electrical signals. For example, fear may be related to a number of autonomic signals that are detectable non-invasively, including heart rate variability, skin conductance, and pupil diameter. These autonomic signals may be measured by a non-invasive device, such as the sensors 58 shown in FIG. 2”, paragraph [0123]); and a computing device 20 in operable communication with the first sensor and second sensor (“The head mounted interface 20 may be a wearable processing unit that communicates, configures, and can control the implanted system 10.”, paragraph [0052]), the computing device configured to receive the first sensor signal and second sensor signal, the computing device having a software application which programs the computing device to process the first and second sensor signals and utilize a detection algorithm which utilizes both the first sensor signal and the second sensor signal to detect an impulsivity state of the user (“Once activity from the brain and body are recorded at process block 204, optionally, the system 10 may identify the patient's deviation in functional domains, such as the functional domains shown in the table of FIG. 7, that the transdiagnostic assessment showed as compared to healthy controls or population norms at process block 206. Transdiagnostic assessments of population norms may be acquired from a database of patients without evident psychiatric impairment who have performed the various transdiagnostic tasks. The patient's performance on the battery of transdiagnostic tasks may be compared to healthy controls by the system 10”, paragraph [0108]).
Regarding claim 2, Widge discloses that the electrophysiology signal is a correlate of a nucleus accumbens (NAc) signal (it is respectfully submitted that the EEG of Widge is a “correlate” of a nucleus accumbens (NAc) signal because the measurement of brain waves via the EEG would likewise be a measurement of signal emanating from the different brain regions, including the nucleus accumbens (NAc)).
Regarding claim 3, Widge discloses that the first sensor is a scalp sensor comprising an array of scalp sensors which detects a dorsal-lateral prefrontal cortex (dlPFC) theta (4-8Hz) signal (“some of the electrodes 16 may be recording electrodes that consist of cortical ECoG arrays recording from the dorsolateral prefrontal cortex (dIPFC)“, paragraph [0053], and “it may be known that theta-frequency (4-8 Hz) coupling between the vmPFC brain region and the amygdala brain region plays a role in the encoding and extinction of fear memories. For the example PTSD patient, the emotional decoding algorithm may “decode” the patient's current capacity for fear extinction, either from relative theta power in the vmPFC and dACC brain regions, or more likely from theta-band coherence between the dACC, vmPFC, and amygdala brain regions”, paragraph [0121]).
Regarding claim 4, Widge discloses that the physiological signal is a correlate of a nucleus accumbens (NAc) signal (it is respectfully submitted that the “heart rate, eye movements and blinks, eye pupil diameter, skin conductance/galvanic skin response (i.e., measure of autonomic arousal), respiratory rate, recorded speech (e.g., quantitatively analyzed for tone, amount, and prosody), and electromyography” of Widge is a “correlate” of a nucleus accumbens (NAc) signal because the measurement of these signals is the measurement of the body’s response to signals sent from the nucleus accumbens (NAc), which is known to play a role in processing reward and reinforcement stimuli).
Regarding claim 5, Widge discloses that the second sensor is a heart rate sensor configured to detect at least one of heart rate and heart rate variability (“the biomarkers may include, but are not limited to, heart rate”, paragraph [0107]).
Regarding claim 7, it is respectfully submitted that the EEG of Widge is a “correlate” of the delta band of a nucleus accumbens (NAc) signal because the measurement of brain waves via the EEG would likewise be a measurement of signal emanating from the different brain regions, including the nucleus accumbens (NAc).
Regarding claim 8, Widge discloses that the correlate of the delta band of NAc signal is a dorsal-lateral prefrontal cortex (dlPFC) theta (4-8Hz) signal (“some of the electrodes 16 may be recording electrodes that consist of cortical ECoG arrays recording from the dorsolateral prefrontal cortex (dIPFC)“, paragraph [0053], and “it may be known that theta-frequency (4-8 Hz) coupling between the vmPFC brain region and the amygdala brain region plays a role in the encoding and extinction of fear memories. For the example PTSD patient, the emotional decoding algorithm may “decode” the patient's current capacity for fear extinction, either from relative theta power in the vmPFC and dACC brain regions, or more likely from theta-band coherence between the dACC, vmPFC, and amygdala brain regions”, paragraph [0121]).
Regarding claim 9, it is respectfully submitted that because Widge uses both the electrophysiological signal at the scalp and the physiological signal at a location other than the scalp, as set out in claim 1, then Widge necessarily discloses that the detection algorithm is validated for specificity, sensitivity and reliability in detecting the impulsive state by utilizing both the electrophysiological signal at the scalp and the physiological signal at a location other than the scalp based on the language of the claim.
Regarding claim 10, Widge discloses that the computing device is configured to communicate with the first sensor and second sensor via a wireless communication protocol (“Either part may also exist outside the body and communicate wirelessly to the electrodes 16. The hub 12, or implanted module, may be implanted under the scalp of a patient and can wirelessly communicate… monitoring heart rate wirelessly”, paragraph [0052], and “These autonomic signals may be measured by a non-invasive device, such as the sensors 58 shown in FIG. 2, and transmitted to the controller hub 12 via a communication protocol.”, paragraph [0123]).
Regarding claim 11, Widge discloses that the wireless communication protocol is one of Bluetooth, WiFi (“Either part may also exist outside the body and communicate wirelessly to the electrodes 16. The hub 12, or implanted module, may be implanted under the scalp of a patient and can wirelessly communicate… monitoring heart rate wirelessly”, paragraph [0052], and “These autonomic signals may be measured by a non-invasive device, such as the sensors 58 shown in FIG. 2, and transmitted to the controller hub 12 via a communication protocol.”, paragraph [0123], which are descriptions of local area network, or wi-fi, communications), and wireless USB.
Regarding claim 12, Widge discloses an electrical stimulation system configured to deliver electrical stimulation directly to the user in response to the impulsivity state (“The implantable system 10 may be designed to record and stimulate brain circuits.”, paragraph [0053]); and wherein the software application is configured to utilize a control program to control the electrical stimulation system to deliver a controlled, closed-loop electrical stimulation to the user based on the impulsivity state (“Algorithms stored on the hub 12 may enable the system 10 to merge spike and field-potential data to estimate the patient's psychiatric state and deliver therapeutic stimulation. The frequency of stimulation delivery may depend upon how frequently neural signatures that trigger stimulation occur.”, paragraph [0054], and “closed-loop algorithms for adaptive neuromodulation therapy”, paragraph [0063]).
Regarding claim 13, Widge discloses that the impulsivity state is a loss of control eating behavior (the “Reward Motivation”, “Emotion Regulation”, “Decision Making/Impulsivity”, and “Attention/Perseveration” domains shown in Figure 7 are all considered “loss of control eating behavior” under the broadest reasonable interpretation because each of these domains is a known behavior associated with loss of control eating), and the electrical stimulation system is configured to deliver electrical stimulation to the nucleus accumbens (NAc) of the user configured to attenuate the loss of control eating behavior (“Stimulation may be performed with subcortical DBS leads placed in the nucleus accumbens (NAcc)”, paragraph [0053]).
Regarding claim 14, Widge discloses that the electrical stimulation system is a closed-loop stimulation system (“closed-loop algorithms for adaptive neuromodulation therapy”, paragraph [0063]).
Regarding claim 15, Widge discloses a method of determining an impulsivity state of a user, comprising: obtaining a first sensor signal corresponding to a detected electrophysiology signal from a first sensor worn on the scalp of the user (“The non-invasive system may be combined with EEG, for example, to produce a closed-loop system. The non-invasive system may include a plurality of scalp or non-contact electrodes and/or neuro-stimulation coils in communication with a software-controlled helmet, cap, or set of electrodes that can stimulate areas of the brain.”, paragraph [0070]); obtaining a second sensor signal corresponding to a detected physiological signal from a second sensor positioned at a body location of the user other than the scalp (“This closed-loop control may not be limited to brain electrical signals. For example, fear may be related to a number of autonomic signals that are detectable non-invasively, including heart rate variability, skin conductance, and pupil diameter. These autonomic signals may be measured by a non-invasive device, such as the sensors 58 shown in FIG. 2”, paragraph [0123]); a computing device 20 receiving the first sensor signal and the second sensor signal (“The head mounted interface 20 may be a wearable processing unit that communicates, configures, and can control the implanted system 10.”, paragraph [0052]); the computing device processing the first sensor signal and the second sensor signal and detecting an impulsivity state of the user utilizing a detection algorithm which utilizes both the first sensor signal and the second sensor signal (“Once activity from the brain and body are recorded at process block 204, optionally, the system 10 may identify the patient's deviation in functional domains, such as the functional domains shown in the table of FIG. 7, that the transdiagnostic assessment showed as compared to healthy controls or population norms at process block 206. Transdiagnostic assessments of population norms may be acquired from a database of patients without evident psychiatric impairment who have performed the various transdiagnostic tasks. The patient's performance on the battery of transdiagnostic tasks may be compared to healthy controls by the system 10”, paragraph [0108]).
Regarding claim 26, Widge discloses a software application utilizing a control program to control an electrical stimulation system to deliver a controlled, closed-loop electrical stimulation to the user based on the impulsivity state; and the electrical stimulation system delivering the controlled, closed-loop electrical stimulation directly to the user in response to the impulsivity state (“The implantable system 10 may be designed to record and stimulate brain circuits.”, paragraph [0053], “Algorithms stored on the hub 12 may enable the system 10 to merge spike and field-potential data to estimate the patient's psychiatric state and deliver therapeutic stimulation. The frequency of stimulation delivery may depend upon how frequently neural signatures that trigger stimulation occur.”, paragraph [0054], and “closed-loop algorithms for adaptive neuromodulation therapy”, paragraph [0063]).
Regarding claim 30, Widge discloses a computer executable method stored on a storage device, comprising:receiving as input a first sensor signal or information indicative of the first second signal, the first sensor signal corresponding to a detected electrophysiology signal from a first sensor worn on the scalp of the user (“The non-invasive system may be combined with EEG, for example, to produce a closed-loop system. The non-invasive system may include a plurality of scalp or non-contact electrodes and/or neuro-stimulation coils in communication with a software-controlled helmet, cap, or set of electrodes that can stimulate areas of the brain.”, paragraph [0070]);receiving as input a second sensor signal or information indicative of the second signal, the second sensor signal corresponding to a detected physiological signal from a second sensor positioned at a body location of the user other than the scalp (“This closed-loop control may not be limited to brain electrical signals. For example, fear may be related to a number of autonomic signals that are detectable non-invasively, including heart rate variability, skin conductance, and pupil diameter. These autonomic signals may be measured by a non-invasive device, such as the sensors 58 shown in FIG. 2”, paragraph [0123]); anddetermining an impulsivity state of the user utilizing the first sensor signal and the second sensor signal, or the information indicative of the first and second sensor signals (“Once activity from the brain and body are recorded at process block 204, optionally, the system 10 may identify the patient's deviation in functional domains, such as the functional domains shown in the table of FIG. 7, that the transdiagnostic assessment showed as compared to healthy controls or population norms at process block 206. Transdiagnostic assessments of population norms may be acquired from a database of patients without evident psychiatric impairment who have performed the various transdiagnostic tasks. The patient's performance on the battery of transdiagnostic tasks may be compared to healthy controls by the system 10”, paragraph [0108]).
Regarding claim 32, Widge discloses that the software application of the computing device is conifugred to detect when the physiological signal and the electrophysiological signal togetheter exceed an amplitude threshold (“Once activity from the brain and body are recorded at process block 204, optionally, the system 10 may identify the patient's deviation in functional domains, such as the functional domains shown in the table of FIG. 7, that the transdiagnostic assessment showed as compared to healthy controls or population norms at process block 206.”, paragraph [0108], where the comparison to healthy controls or population norms is considered the claimed “amplitude threshold”).
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.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Widge (U.S. 2017/0042474). Widge discloses the invention substantially as claimed, including detecting at least one of heart rate (“the biomarkers may include, but are not limited to, heart rate”, paragraph [0107]) and heart rate variability (“a number of autonomic signals that are detectable non-invasively, including heart rate variability”, paragraph [0123]), but fails to disclose that the second sensor comprises one or more electrodes configured to be placed above the user's wrist to detect at least one of heart rate and heart rate variability. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the inventon of Widge such that the second sensor comprises one or more electrodes configured to be placed above the user's wrist, since it was known in the art that measuring heart rate and heart rate variability using one or more electrodes configured to be placed above a user’s wrist provides an accurate measurement for these variables.
Allowable Subject Matter
Claims 33 and 34 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See attached PTO-892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAMMIE K MARLEN whose telephone number is (571)272-1986. The examiner can normally be reached Monday through Friday from 8 am until 4 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Carl Layno can be reached at 571-272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TAMMIE K MARLEN/Primary Examiner, Art Unit 3796