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 .
Status of Claims
In the response dated May 12, 2026, Applicant amended claims 1-5, 7, and 14-18. Claim 20 is canceled. Claims 21 and 22 are newly presented. Claims 1-19 and 21-22 are pending.
Response to Arguments
In response to the argument put forward in the amendment, Examiner will address them in the order they were presented.
Regarding the abstract objection, Applicant's arguments have been considered and are persuasive. The Office’s internal documents correctly depict the proper abstract and Examiner withdraws the abstract objection.
Applicant's amendments dated 5/12/2026 merit new grounds for rejection in view of previously cited references Linde and Nelson.
With respect to claims 1 and 14, Linde further teaches processing, with a signal analysis system, ([0097] “The classifiers may perform computation and/or statistical analysis to detect and/or classify a particular state”) the electrical brain activity signals to determine a first measure of power or coherence of theta-band electrical activity in the hippocampal region of the brain and a second measure of power or coherence of theta-band electrical activity in the ANT region of the brain ([0080] “sensors may detect biomarkers based on, for example, amplitudes or power of the LFP in one or more spectral bands” and [0180] “The biomarker may, for example, be an amplitude or power level of… different frequency bands, such as… theta” and [0210] “the first target area and the second target area may be within a circuit of Papez of the brain. The circuit of Papez includes an anterior nucleus of a thalamus … hippocampus”) ; determining, with a stimulation control system and based on the first measure of power or coherence of the theta-band electrical activity in the hippocampal region of the brain and the second measure of power or coherence of the theta-band electrical activity in the ANT region of the brain, , one or more parameters for the brain stimulation therapy the one or more parameters selected to cause the brain stimulation therapy to affect a change of the theta-band electrical activities in the hippocampal and ANT regions in a manner modeled to improve the cognitive process of the patient (see [0080], [0180], and [0210] above; see also [0081] “Using sensed states… may allow IMD 16 to … control the delivery of therapy”); and applying the brain stimulation therapy to the patient in accordance with the one or more parameters ([0052] another stimulation mode (e.g., delivering stimulation to a second target area different than the first target area and/or according to a second set of parameter settings different than the first set of parameter settings), based on one or more classified states of the patient – includes applying stimulation related to cognitive process as the neurological/cognitive disorders treated by the device are already specified).
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 1-13 and 21-22 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.
The term “modeled to improve the cognitive process” in claim 1 is a relative term which renders the claim indefinite. The term “improve” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Claims 2-13 and 21-22 by dependency are also rejected under 35 U.S.C 112(b). Appropriate correction is required. Examiner will interpret improving the cognitive process to encompass any adjustment in signal detection caused by stimulation parameters.
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.
Claim(s) 1-13 and 21-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Linde et al (US20210121697A1); hereinafter Linde.
Regarding claim 1, Linde teaches a method of adjusting a brain stimulation therapy ([0005] multi-target adaptive neurostimulation therapy control) to affect a cognitive process of a patient ([0058] treat a variety of neurological disorders and diseases), the method comprising: acquiring, with a data acquisition system, electrical brain activity signals sensed by electrodes in a brain of the patient ([0058] local field potential sensors) the electrical brain activity signals comprising at least one signal indicative of electrical activity in a hippocampal region of the brain ([0207] The first and/or second stimulation therapy may be delivered via one or more electrodes in a temporal lobe of the brain. The temporal lobe may, for example, be one of a amygdala, a hippocampus, [0078] these sensors may be included in the IMD (so they sense from the same areas that are stimulated)) and at least one signal indicative of electrical activity in an anterior nucleus of the thalamus (“ANT”) region of the brain ([0210] the first target area and the second target area may be within a circuit of Papez of the brain. The circuit of Papez includes an anterior nucleus of a thalamus) processing, with a signal analysis system, ([0097] “The classifiers may perform computation and/or statistical analysis to detect and/or classify a particular state”) the electrical brain activity signals to determine a first measure of power or coherence of theta-band electrical activity in the hippocampal region of the brain and a second measure of power or coherence of theta-band electrical activity in the ANT region of the brain ([0080] “sensors may detect biomarkers based on, for example, amplitudes or power of the LFP in one or more spectral bands” and [0180] “The biomarker may, for example, be an amplitude or power level of… different frequency bands, such as… theta” and [0210] “the first target area and the second target area may be within a circuit of Papez of the brain. The circuit of Papez includes an anterior nucleus of a thalamus … hippocampus”) ; determining, with a stimulation control system and based on the first measure of power or coherence of the theta-band electrical activity in the hippocampal region of the brain and the second measure of power or coherence of the theta-band electrical activity in the ANT region of the brain, , one or more parameters for the brain stimulation therapy the one or more parameters selected to cause the brain stimulation therapy to affect a change of the theta-band electrical activities in the hippocampal and ANT regions in a manner modeled to improve the cognitive process of the patient (see [0080], [0180], and [0210] above; see also [0081] “Using sensed states… may allow IMD 16 to … control the delivery of therapy”); and applying the brain stimulation therapy to the patient in accordance with the one or more parameters ([0052] another stimulation mode (e.g., delivering stimulation to a second target area different than the first target area and/or according to a second set of parameter settings different than the first set of parameter settings), based on one or more classified states of the patient – includes applying stimulation related to cognitive process as the neurological/cognitive disorders treated by the device are already specified).
Regarding claim 2, Linde further teaches the method of claim 1, wherein:
the electrical brain activity signals comprise a first signal indicative of electrical activity in a right portion of the ANT region ([0062] In the example therapy system 10 of FIG. 1, lead segments 28, 30 are implanted within the right and left hemispheres, respectively, of patient 14 in order to deliver electrical stimulation to one more regions of patient 14.) and a second signal indicative of electrical activity in a right portion of the hippocampal region ([0062] In the example therapy system 10 of FIG. 1, lead segments 28, 30 are implanted within the right and left hemispheres, respectively, of patient 14 in order to deliver electrical stimulation to one more regions of patient 14.); and the first measure of power or coherence is a measure of power or coherence of the theta band electrical activity in the right portion of the hippocampal region and the second measure of power or coherence is a measure of power or coherence of the theta-band electrical activity in the right portion of the ANT region ([0080] “sensors may detect biomarkers based on, for example, amplitudes or power of the LFP in one or more spectral bands” and [0180] “The biomarker may, for example, be an amplitude or power level of… different frequency bands, such as… theta” and [0210] “the first target area and the second target area may be within a circuit of Papez of the brain. The circuit of Papez includes an anterior nucleus of a thalamus … hippocampus”) ([0180] ratio of amplitude or power of signals in different frequency bands, such as beta, gamma, and/or theta).
Regarding claim 3, Linde teaches the method of claim 2, wherein the cognitive process is a memory encoding process ([0058] treat any of a variety of neurological disorders or diseases. Example neurological disorders may include depression, dementia, Alzheimer's disease, and obsessive-compulsive disorder).
Regarding claim 4, Linde teaches the method of claim 1, wherein: the electrical brain activity signals comprise a first signal indicative of electrical activity in a left portion of the ANT region ([0062] In the example therapy system 10 of FIG. 1, lead segments 28, 30 are implanted within the right and left hemispheres, respectively, of patient 14 in order to deliver electrical stimulation to one more regions of patient 14.) and a second signal indicative of electrical activity in a left portion of the hippocampal region ([0062] In the example therapy system 10 of FIG. 1, lead segments 28, 30 are implanted within the right and left hemispheres, respectively, of patient 14 in order to deliver electrical stimulation to one more regions of patient 14.); and first measure of power or coherence is a measure of power or coherence of the theta band electrical activity in the left portion of the hippocampal region and the second measure of power or coherence is a measure of power or coherence of the theta-band electrical activity in the left portion of the ANT region ([0080] “sensors may detect biomarkers based on, for example, amplitudes or power of the LFP in one or more spectral bands” and [0180] “The biomarker may, for example, be an amplitude or power level of… different frequency bands, such as… theta” and [0210] “the first target area and the second target area may be within a circuit of Papez of the brain. The circuit of Papez includes an anterior nucleus of a thalamus … hippocampus”)
Regarding claim 5, Linde teaches the method of claim 4, wherein the cognitive process is a memory recall process ([0058] treat any of a variety of neurological disorders or diseases. Example neurological disorders may include depression, dementia, Alzheimer's disease, and obsessive-compulsive disorder).
Regarding claim 6, Linde teaches the method of claim 1, wherein the one or more parameters for the brain stimulation therapy are determined using a model that relates at least one electrical brain activity signal feature to at least one brain stimulation therapy parameter determined to affect the cognitive process ([0097] Each of the classifiers may be configured to detect and/or classify whether patient 14 is in a given state based on physiological data received from electrical sensing module 38 and/or sensors 40 and generate data indicative of whether the given state has been detected for patient 14, [0104] The state machine and/or the control policy algorithm may generate therapy decisions based on one or more sensed states of patient 14).
Regarding claim 7, Linde teaches the method of claim 6, wherein the model defines target values for the first measure of power or coherence of the theta-band electrical activity in the hippocampal region and the second measure of power or coherence of the theta-band electrical activity in the ANT region, and determining the one or more parameters for the brain stimulation therapy comprises comparing the first measure of power or coherence of the theta-band electrical activity in the hippocampal region and the second measure of power or coherence of the theta-band electrical activity in the ANT region to their respective target values ([0096] each of the binary values may correspond to a respective one of a plurality of physiological states that may be sensed by patient 14. For example, each of the binary values may be indicative of whether a respective one of one or more physiological states has been detected for patient 14 based on the data received from one or more physiological sensors - the binary value of no pathological state detected is the target value and collecting the brain activity data and determining its binary value constitutes comparing the values ([0080] “sensors may detect biomarkers based on, for example, amplitudes or power of the LFP in one or more spectral bands” and [0180] “The biomarker may, for example, be an amplitude or power level of… different frequency bands, such as… theta” and [0210] “the first target area and the second target area may be within a circuit of Papez of the brain. The circuit of Papez includes an anterior nucleus of a thalamus … hippocampus”)).
Regarding claim 8, Linde teaches the method of claim 1, wherein the one or more parameters for the brain stimulation therapy comprise at least one of a stimulation frequency ([0101] frequency), a stimulation start time, a stimulation end time ([0148] threshold amount of time), or a selection of one or more stimulation sites in the brain of the patient ([0092] In some cases, processor 32 may subdivide electrodes 20 into different subsets of electrodes and cause each of the different subsets of electrodes to deliver electrical stimulation to a respective one of a plurality of target tissue sites.).
Regarding claim 9, Linde teaches the method of claim 1, wherein the brain stimulation therapy comprises a deep brain stimulation therapy (“DBS”) ([0058] In some examples, IMD 16 may deliver, as neurostimulation therapy, deep brain stimulation (DBS)).
Regarding claim 10, Linde teaches the method of claim 1, wherein the patient is diagnosed with epilepsy and the brain stimulation therapy is administered at least in part to treat symptoms of epilepsy ([0058] epilepsy).
Regarding claim 11, Linde teaches the method of claim 1, comprising: identifying at least one of a type or a time of an anticipated cognitive process; and determining the one or more parameters for the brain stimulation therapy based on at least one of the type or the time of the anticipated cognitive process ([0058] deep brain stimulation (DBS) or cortical stimulation (CS) therapy to patient 14 via electrodes 20 based on the sensed physiological states of patient 14 to treat any of a variety of neurological disorders or diseases - identifying and treating a neurological disorder or disease involves identifying and treating an anticipated cognitive process).
Regarding claim 12, Linde teaches the method of claim 11, comprising identifying the type of the anticipated cognitive process and determining the one or more parameters for the brain stimulation therapy based on the type of the anticipated cognitive process, wherein the type of the anticipated cognitive process is selected from a group comprising memory encoding and memory recall ([0058] Example neurological disorders may include depression, dementia, Alzheimer's disease, and obsessive-compulsive disorder - these disorders involve memory encoding and memory recall).
Regarding claim 13, Linde teaches the method of claim 1, wherein the electrical brain activity signals comprise local field potentials (“LFPs”) sensed by the electrodes in the brain of the patient ([0078] Bioelectrical sensors may include sensors that sense bioelectrical signals, such as, e.g., local field potential (LFP) signals, electrocardiography (ECG) signals, electromyography (EMG) signals, evoked potentials, etc.).
Regarding claim 20, Linde teaches the method of claim 1. Linde further teaches wherein the first measure is a measure of power of theta band electrical activity in the hippocampal region and the second measure is a measure of power of theta-band electrical activity in the ANT region. ([0080] “sensors may detect biomarkers based on, for example, amplitudes or power of the LFP in one or more spectral bands” and [0180] “The biomarker may, for example, be an amplitude or power level of… different frequency bands, such as… theta” and [0210] “the first target area and the second target area may be within a circuit of Papez of the brain. The circuit of Papez includes an anterior nucleus of a thalamus … hippocampus”)).
Regarding claim 21, Linde teaches the method of claim 1. Linde further teaches wherein the first measure is a measure of coherence of theta-band electrical activity in the hippocampal region and the second measure is a measure of coherence of theta-band electrical activity in the ANT region. ([0098] “signal characteristics that can be compared include … a peak, average or lowest biosignal amplitude within a particular range of time, a characteristic waveform of the biosignal (e.g. “saw-tooth” wave forms from an EEG signal), a pattern in a biosignal amplitude over time, and the like.” Where the timing of amplitudes comprises a coherence of theta-band activities. [0080] “sensors may detect biomarkers based on, for example, amplitudes or power of the LFP in one or more spectral bands” and [0180] “The biomarker may, for example, be an amplitude or power level of… different frequency bands, such as… theta” and [0210] “the first target area and the second target area may be within a circuit of Papez of the brain. The circuit of Papez includes an anterior nucleus of a thalamus … hippocampus”)).
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.
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.
Claim 14-19 are rejected under 35 U.S.C. 103 as being unpatentable over Linde in view of Nelson.
Regarding claim 14, Linde teaches a method of assessing a cognitive process of a patient ([0005] multi-target adaptive neurostimulation therapy control) ([0058] treat a variety of neurological disorders and diseases), comprising: acquiring, with a data acquisition system, electrical brain activity signals sensed by electrodes in a brain of the patient ([0058] local field potential sensors) the electrical brain activity signals comprising at least one signal indicative of electrical activity in a hippocampal region of the brain ([0207] The first and/or second stimulation therapy may be delivered via one or more electrodes in a temporal lobe of the brain. The temporal lobe may, for example, be one of a amygdala, a hippocampus, [0078] these sensors may be included in the IMD (so they sense from the same areas that are stimulated)) and at least one signal indicative of electrical activity in an anterior nucleus of the thalamus (“ANT”) region of the brain ([0210] the first target area and the second target area may be within a circuit of Papez of the brain. The circuit of Papez includes an anterior nucleus of a thalamus); processing, with a signal analysis system, the electrical brain activity signals to determine a first measure of power or coherence of theta-band electrical activity in the hippocampal region of the brain and a second measure of power or coherence of theta-band electrical activity in the ANT region of the brain ([0097] The classifiers may perform computation and/or statistical analysis to detect and/or classify a particular state) and [0080] “sensors may detect biomarkers based on, for example, amplitudes or power of the LFP in one or more spectral bands” and [0180] “The biomarker may, for example, be an amplitude or power level of… different frequency bands, such as… theta” and [0210] “the first target area and the second target area may be within a circuit of Papez of the brain. The circuit of Papez includes an anterior nucleus of a thalamus … hippocampus”).
Linde fails to teach a cognitive score. Nelson teaches determining, first measure of power or coherence of the theta-band electrical activity in the hippocampal region of the brain and the second measure of power or coherence of the theta-band electrical activity in the ANT region of the brain, ([Table 1] “Theta band” is one measured frequency band analyzed and [0133] “A target for sensing and/or stimulation for addressing a neurological condition can be in… the hippocampus… the anterior nucleus” and [0134] “the sense location and target site for stimulation are different areas of the brain that are networked”) , a cognitive score indicative of a predicted level of cognition of the patient with respect to the cognitive process ([0055] a decline in the patient's performance on the cognitive tests over time (e.g., as measured by a standard score for each test) may be correlated with an increase in non-motor epileptiform bioelectrical activity over the same time, each of which may indicate a worsening cognitive disorder); And providing an output based on the cognitive score ([0030] The assessment may be used to track the cognitive disorder and provide an output in some embodiments. Such an output may comprise a report printed out and/or displayed on a screen of a computing device such as a programmer).
Linde and Nelson both are in the same field of invention of treating neurological disorders through sensing and stimulating regions deep in the brain. It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Linde’s system to include a cognitive score indicative of the patient’s cognition, as taught by Nelson, with a reasonable expectation of success. Nelson teaches that “statistical routines can be run on the cognitive performance test results” [0056] and would allow for a more accurate impression of a patient’s cognitive state.
Regarding claim 15, the combination of Linde and Nelson teaches the method of claim 14. Linde further teaches the electrical brain activity signals comprise a first signal indicative of electrical activity in a right portion of the ANT region ([0062] In the example therapy system 10 of FIG. 1, lead segments 28, 30 are implanted within the right and left hemispheres, respectively, of patient 14 in order to deliver electrical stimulation to one more regions of patient 14.) and a second signal indicative of electrical activity in a right portion of the hippocampal region ([0062] In the example therapy system 10 of FIG. 1, lead segments 28, 30 are implanted within the right and left hemispheres, respectively, of patient 14 in order to deliver electrical stimulation to one more regions of patient 14); and the first measure of power or coherence is a measure of power or coherence of the theta band electrical activity in the right portion of the hippocampal region and the second measure of power or coherence is a measure of power or coherence of the theta-band electrical activity in the right portion of the ANT region ([0080] “sensors may detect biomarkers based on, for example, amplitudes or power of the LFP in one or more spectral bands” and [0180] “The biomarker may, for example, be an amplitude or power level of… different frequency bands, such as… theta” and [0210] “the first target area and the second target area may be within a circuit of Papez of the brain. The circuit of Papez includes an anterior nucleus of a thalamus … hippocampus”)).
Regarding claim 16, the combination of Linde and Nelson teaches the method of claim 15. Linde further teaches the cognitive process is a memory encoding process([0058] treat any of a variety of neurological disorders or diseases. Example neurological disorders may include depression, dementia, Alzheimer's disease, and obsessive-compulsive disorder).
Regarding claim 17, the combination of Linde and Nelson teaches the method of claim 14. Linde further teaches the electrical brain activity signals comprise a first signal indicative of electrical activity in a left portion of the ANT region ([0062] In the example therapy system 10 of FIG. 1, lead segments 28, 30 are implanted within the right and left hemispheres, respectively, of patient 14 in order to deliver electrical stimulation to one more regions of patient 14.) and a second signal indicative of electrical activity in a left portion of the hippocampal region ([0062] In the example therapy system 10 of FIG. 1, lead segments 28, 30 are implanted within the right and left hemispheres, respectively, of patient 14 in order to deliver electrical stimulation to one more regions of patient 14.); and the first measure of power or coherence is a measure of power or coherence of the theta band electrical activity in the left portion of the hippocampal region and the second measure of power or coherence is a measure of power or coherence of the theta-band electrical activity in the left portion of the ANT region ([0080] “sensors may detect biomarkers based on, for example, amplitudes or power of the LFP in one or more spectral bands” and [0180] “The biomarker may, for example, be an amplitude or power level of… different frequency bands, such as… theta” and [0210] “the first target area and the second target area may be within a circuit of Papez of the brain. The circuit of Papez includes an anterior nucleus of a thalamus … hippocampus”)).
Regarding claim 18, the combination of Linde and Nelson teaches the method of claim 17. Linde further teaches the cognitive process is a memory recall process ([0058] treat any of a variety of neurological disorders or diseases. Example neurological disorders may include depression, dementia, Alzheimer's disease, and obsessive-compulsive disorder).
Regarding claim 19, the combination of Linde and Nelson teaches the method of claim 14. Nelson further teaches providing the output comprises recording data indicative of the cognitive score in a memory device ([0055] a decline in the patient's performance on the cognitive tests over time (e.g., as measured by a standard score for each test) may be correlated with an increase in non-motor epileptiform bioelectrical activity over the same time, each of which may indicate a worsening cognitive disorder), presenting data indicative of the cognitive score on an electronic display ([0030] The assessment may be used to track the cognitive disorder and provide an output in some embodiments. Such an output may comprise a report printed out and/or displayed on a screen of a computing device such as a programmer)
Additional Considerations
The prior art made of record and not relied upon that is considered pertinent to applicant’s disclosure can be found on PTO-892 of the prior office action.
Marks, Lech, Gregg, et al. (“Chronic modulation of human memory and thalamic-hippocampal theta activities”) details that electrical stimulation in the anterior thalamic nuclei modulates theta frequency activities and improves human verbal memory performance chronically.
Ezzy et al. (“Closed-loop stimulation of temporal cortex rescues functional networks and improves memory”) discloses improving memory outcomes through direct modulation of brain activity with electrical stimulation.
Conclusion
THIS ACTION IS MADE FINAL. 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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/R.A.S/Examiner, Art Unit 3792
/AMANDA L STEINBERG/
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