DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Specification
The abstract of the disclosure is objected to because of undue length. The abstract should be limited to 150 words and the abstract is currently 329 words. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
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) 1-14 is/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, the electrical brain activity signals to determine values for one or more features of the electrical brain activity signals ([0097] The classifiers may perform computation and/or statistical analysis to detect and/or classify a particular state);
• determining, with a stimulation control system and based on the values for the one or more features of the electrical brain activity signals, one or more parameters for the brain stimulation therapy related to the cognitive process of the patient; 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 - obvious that the applied stimulation would be related to cognitive process because 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 one or more features of the electrical brain activity signals comprise at least one of a power ([0180] the biomarker may, for example, be an amplitude or power level of a signal in a frequency band or a ratio of amplitude or power of signals in different frequency bands) or a coherence of theta-band electrical activity in the right portion of the ANT region and the right portion of the hippocampal region ([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 comprises memory encoding ([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 the one or more features of the electrical brain activity signals comprise at least one of a power ([0180] the biomarker may, for example, be an amplitude or power level of a signal in a frequency band or a ratio of amplitude or power of signals in different frequency bands) or a coherence of theta-band electrical activity in the left portion of the ANT region and the left portion of the hippocampal region ([0180] ratio of amplitude or power of signals in different frequency bands, such as beta, gamma, and/or theta).
Regarding claim 5, Linde teaches the method of claim 4, wherein the cognitive process comprises memory recall ([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 one or more features of the electrical brain activity signals, and determining the one or more parameters for the brain stimulation therapy comprises comparing the values for the one or more features of the electrical brain activity signals determined from the electrical brain activity signals to the target values for the one or more features ([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).
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.).
Claim(s) 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nelson et al (US20140081347A1); hereinafter Nelson.
Nelson teaches a method of adjusting a brain stimulation therapy, comprising:
obtaining results of one or more non-invasive cognitive performance assessments administered to the patient ([0053] One or more scores may be generated based on the results of the patient's performance on the one or more cognitive tests),
wherein the results are indicative of at least one of a memory encoding ability or a memory recall ability of the patient ([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);
based on the results of the one or more non-invasive cognitive performance assessments, determining one or more parameters for the brain stimulation therapy (figure 5 step 530);
and applying the brain stimulation therapy to the patient in accordance with the one or more parameters (figure 5 step 540).
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(s) 14-19 is/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 values for one or more features of the electrical brain activity signals ([0097] The classifiers may perform computation and/or statistical analysis to detect and/or classify a particular state).
Linde fails to teach a cognitive score. Nelson teaches determining, with a stimulation control system and based on the values for the one or more features of the electrical brain activity signals, 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).
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 with Nelson because there is some teaching, suggestion, or motivation to do so. Nelson teaches that “statistical routines can be run on the cognitive performance test results” ([0056]). Therefore, attributing a cognitive score would be obvious because the motivation to do is provided in Nelson in that it would allow for statistical analysis on the data.
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 one or more features of the electrical brain activity signals comprise at least one of a power ([0180] the biomarker may, for example, be an amplitude or power level of a signal in a frequency band or a ratio of amplitude or power of signals in different frequency bands)or a coherence of theta-band electrical activity in the right portion of the ANT region and the right portion of the hippocampal region ([0180] ratio of amplitude or power of signals in different frequency bands, such as beta, gamma, and/or theta).
Regarding claim 16, the combination of Linde and Nelson teaches the method of claim 15. Linde further teaches the cognitive process comprises memory encoding ([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 one or more features of the electrical brain activity signals comprise at least one of a power ([0180] the biomarker may, for example, be an amplitude or power level of a signal in a frequency band or a ratio of amplitude or power of signals in different frequency bands)or a coherence of theta-band electrical activity in the left portion of the ANT region and the left portion of the hippocampal region ([0180] ratio of amplitude or power of signals in different frequency bands, such as beta, gamma, and/or theta).
Regarding claim 18, the combination of Linde and Nelson teaches the method of claim 17. Linde further teaches the cognitive process comprises memory recall ([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), or transmitting data indicative of the cognitive score over a communications network.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Dhrasti SNEHAL Dalal whose telephone number is (571)272-0780. The examiner can normally be reached Monday - Thursday 8:30 am - 6:00 pm, Alternate Friday off, 8:30 am - 5:00 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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/D.S.D./Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796