CTNF 18/905,413 CTNF 101525 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Claim Objections 07-29-01 AIA Claim 9 , objected to because of the following informalities: sense sensing a local field in line 2 . Appropriate correction is required. Claim Rejections - 35 USC § 101 07-04-01 AIA 07-04 35 U.S.C. 101 reads as follows: Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title. Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter of abstract ideas under the mental processes and mathematical concepts groupings, without significantly more. The framework for establishing a prima facie case of lack of subject matter eligibility requires that the Examiner determine: (1) Does the claim fall within the four categories of patent eligible subject matter; (2a) prong 1: Does the claim recite an abstract idea, law of nature, or natural phenomenon and (2a) prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application; and (2b) Does the claim recite additional elements that amount of significantly more than the judicial exception. Under Step (1): Independent claims 1, 9, and 18 are directed to a system or a method, and thus, the claims all fall under one of the four patent eligible categories. Under Step 2(a) prong 1: Independent claims 1, 9, and 18 recite limitation of “sensing a local field potential signal” and determining a power spectral density of LFP signal, slope of the PSD, and physiological state of patient based on the slope of PSD. These limitations appear to be directed toward abstract ideas under mental processes because sensing and determining concern identification, comparison, and/or evaluation of signal data which can be performed in the mind or with pen and paper. Dependent claims 3, 6, 7, 11, 14-17, 20 recite additional limitations of determining changes in patient states, generating a prompt, sensing signals, and/or determining vagal tone. These limitations appear to be directed toward mental processes because they further specify one or more abstract determinations and/or concern processes such as identification, comparison, and/or evaluation of data which can be performed in the mind or with pen and paper. Under Step 2(a) prong 2: This part of the eligibility analysis evaluates whether the claim as a whole integrates the recited judicial exception into a practical application of the exception. This evaluation is performed by (1) identifying whether there are any additional elements recited in the claim beyond the judicial exception, and (2) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. MPEP 2106.04(d). Claims 1, 9, 18 recite additional elements of “medical device”, “neurostimulation device”, “sensing circuit”, “implantable electrodes”, “signal processing circuitry”, “non-transitory computer readable storage medium”, and “instructions” but appear to link the abstract ideas to a particular technological environment, adds insignificant extra-solution activity, and/or implements abstract ideas using a generic computer and/or components. In addition, “sensing a local field potential signal” is directed to insignificant pre-solution activity. Dependent claims 6, 7, 14-16 also recite sensing LFP signals and directed to insignificant pre-solution activity. Dependent claims 3, 11 recite generating a prompt based on patient state and directed to insignificant post-solution activity. Despite the fact that the abstract ideas claimed are performed on a generic computer, the courts do not distinguish between claims that recite mental processes performed by humans and claims that recite mental processes performed on a computer. As the Federal Circuit has explained, "[c]ourts have examined claims that required the use of a computer and still found that the underlying, patent-ineligible invention could be performed via pen and paper or in a person’s mind." Versata Dev. Group v. SAP Am., Inc., 793 F.3d 1306, 1335, 115 USPQ2d 1681, 1702 (Fed. Cir. 2015). See also Intellectual Ventures I LLC v. Symantec Corp., 838 F.3d 1307, 1318, 120 USPQ2d 1353, 1360 (Fed. Cir. 2016) (‘‘[W]ith the exception of generic computer-implemented steps, there is nothing in the claims themselves that foreclose them from being performed by a human, mentally or with pen and paper.’’); Mortgage Grader, Inc. v. First Choice Loan Servs. Inc., 811 F.3d 1314, 1324, 117 USPQ2d 1693, 1699 (Fed. Cir. 2016) (holding that computer-implemented method for "anonymous loan shopping" was an abstract idea because it could be "performed by humans without a computer"). See MPEP 2106.04(a)(2)(III). Furthermore, generic computer components that perform abstract ideas are still abstract mental processes unless the claim limitation cannot be practically performed in the mind. As such, “medical device”, “sensing circuit”, and “signal processing circuitry” appears to amount to nothing more than a suggestion to “apply it” on a computer; Alice Corp., 573 U.S. at 223, 110 USPQ2d at 1983. See also 573 U.S. at 224, 110 USPQ2d at 1984. For at least these reasons, the judicial exceptions are not considered to be integrated into a practical application. Under Step 2b: The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the judicial exception into a practical application, the additional elements of “medical device”, “neurostimulation device”, “sensing circuit”, “implantable electrodes”, and “signal processing circuitry”, are well-understood, routine, and conventional activities previously known in the fields of neurostimulation as indicated by the following references: US 2007/0112398 A1: See [0209] for medical device, neurostimulation device, implantable electrodes. US 2007/0106144 A1: See [0002] for implantable electrodes, medical device. US 2006/0064143 A1: See [0039] for sensing circuit, signal processing circuitry. US 2003/0204220 A1: See [0023] for sensing circuit, signal processing circuitry, neurostimulation device. Claim Rejections - 35 USC § 103 07-06 AIA 15-10-15 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. 07-20-aia AIA 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. 07-23-aia AIA 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. 07-20-02-aia AIA 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. 07-21-aia AIA Claim (s) 1, 2, 4, 5, 8-10, 12, 13, 17-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Little et al (WO/2025101224 A2) . Regarding claim 1, Little teaches a computer-implemented method of operating a medical device (Medtronic Summit RC+S system, [00210], Fig. 4A), the method comprising: sensing a local field potential (LFP) signal of a patient using the medical device ([00108]; “In certain embodiments, the brain electrical signal data comprises field potential data”); determining, by the medical device, a power spectral density (PSD) of the sensed LFP signal ([00267], Fig. 4); “Power spectral density plots from intracranial electrodes (FIG. 4G and FIG. 12) demonstrated expected classical changes in canonical frequency bands in NREM and REM sleep stages…” Little does not disclose a slope of the PSD of the sensed LFP signal or determining a physiological state of the patient using the slope of the PSD of the sensed LFP signal as claimed. However, Little teaches, at least in the embodiment unconstrained by the embedded implantable device [00258], a method further comprising: a slope of the PSD of the sensed LFP signal ([00258]; “These nonlinear classifiers would utilize a larger feature space, including, but not limited to, entropy or slope of frequency powers…”); and determining a physiological state of the patient using the slope of the PSD of the sensed LFP signal ([00213], [00258], [00262]); on-board and external classifiers detect wakefulness, sleep stages, and physiological states such as movement; nonlinear classifiers utilizing a larger feature space that includes slope of frequency necessitates analysis of slope calculations for physiological state determinations. It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to further modify the method of Little with the slope of the PSD of the sensed LFP signal and determining a physiological state of the patient using the slope of the PSD of the sensed LFP signal as taught by Little. One of ordinary skill in the art would have been motivated to make these modifications to improve symptom treatment by including non-linear classification methods that improve detection accuracy [00258]. Regarding claim 2, Little teaches the method of claim 1, and further teaches, at least in the embodiment unconstrained by the embedded implantable device [00258], a method including: delivering electrical neurostimulation therapy to the patient using the medical device [00107]; “The method includes positioning a first electrode in a basal ganglia region or cortex region of the brain of a subject to deliver electrical stimulation to the brain (i.e., DBS electrode).” detecting a movement state of the patient using the slope of the PSD of the sensed LFP signal, wherein the movement state is indicative of tremor movement of the patient ([00107]; “…positioning a second electrode at a subcortical region or a cortical region of the brain of the subject to detect brain electrical signals from neural activity associated with a sleep feature or sleep stage of interest while the subject is sleeping (i.e., detection electrode)”; sleep features comprise brain signals received during sleep and include movement states), wherein the movement state is indicative of tremor movement of the patient ([0097]; “Tremor, rigidity and dyskinesias associated with a movement disorder such as Parkinson’s disease may occur during nocturnal awakenings and contribute to sleep dysfunction by prolonging awakenings and inability to fall back to sleep”); and changing a neurostimulation therapy parameter based on the detected movement state of the patient ([00107]; “The electrical stimulation may be applied to the basal ganglia using the DBS electrode in a manner effective for treating sleep dysfunction when a brain electrical signal associated with the sleep feature or sleep stage of interest is detected from the subcortical region or cortical region of the brain using the detection electrode”). Little does not disclose detecting a movement state using the slope of the PSD of the sensed LFP signal as claimed. However, Little teaches, at least in the embodiment unconstrained by the embedded implantable device [00258], a method further including: detecting a movement state of the patient using the slope of the PSD of the sensed LFP signal ([00213], [00258], [00262]); on-board and external classifiers detect wakefulness, sleep stages, and physiological states such as movement; nonlinear classifiers utilizing a larger feature space that includes slope of frequency necessitates analysis of slope calculations for physiological state determinations. It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to further modify the method of Little using the slope of the PSD of the sensed LFP signal as taught by Little. One of ordinary skill in the art would have been motivated to make these modifications to improve symptom treatment by including non-linear classification methods that improve detection accuracy [00258]. Regarding claim 4, Little teaches the method of claim 1, including: delivering electrical neurostimulation therapy to the patient using the medical device [00107]; detecting a sleep state of the patient using the sensed LFP signal, wherein the sleep state is indicative of depth of the sleep of the patient [00107]; “The electrical stimulation may be applied to the basal ganglia using the DBS electrode in a manner effective for treating sleep dysfunction when a brain electrical signal associated with the sleep feature or sleep stage of interest is detected from the subcortical region or cortical region of the brain using the detection electrode”; and changing a neurostimulation therapy parameter based on the detected sleep state of the patient [00107]; “The electrical stimulation may be applied to the basal ganglia using the DBS electrode in a manner effective for treating sleep dysfunction when a brain electrical signal associated with the sleep feature or sleep stage of interest is detected from the subcortical region or cortical region of the brain using the detection electrode;” Little does not disclose detecting a sleep state of the patient using the slope of the PSD of the sensed LFP signal. However, Little teaches, at least in the embodiment unconstrained by the embedded implantable device [00258], a system further including: detecting a sleep state of the patient using the slope of the PSD of the sensed LFP signal [00254-00258], wherein the sleep state is indicative of depth of the sleep of the patient ([0041]; spectral power changes compared to average delta, gamma, and beta power indicate pre-awakening or awakening states). It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to further modify the method of Little with the method for detecting a sleep state of the patient using the slope of the PSD of the sensed LFP signal as taught by Little. One of ordinary skill in the art would have been motivated to make these modifications to improve efficacy of sleep dysfunction treatment by optimizing neurostimulation parameters [00107]. Regarding claim 5, Little teaches the method of claim 1, and further teaches a method including: delivering electrical neurostimulation therapy to the patient using the medical device [00107]; detecting a change in impairment state of the patient ([00151]; “Upon detection of electrical activity indicative of sleep dysfunction, the closed loop system may automatically commence a treatment protocol of applying electrical stimulation to the brain to target sleep dysfunction at one or more sleep stages or when one or more sleep features are detected that indicate that sleep is impaired”); and changing a neurostimulation therapy parameter based on the detected change in impairment state of the patient ([00151], [00137], [00250]); under BRI, impairment states may also include physical, cognitive, behavioral, neurological and/or psychiatric impairment. Little does not disclose detecting a change in impairment state of the patient using the slope of the PSD of the sensed LFP signal, as claimed. However, Little teaches, at least in the embodiment unconstrained by the embedded implantable device [00258], a method further including: detecting a change in impairment state of the patient using the slope of the PSD of the sensed LFP signal ([00250], [00213], [00258], [00262]); on-board and external classifiers detect wakefulness, sleep stages, and physiological states such as movement; nonlinear classifiers utilizing a larger feature space that includes slope of frequency necessitates analysis of slope calculations for physiological state determinations. It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to further modify the method of Little with the method of detecting a change in impairment state of the patient using the slope of the PSD of the sensed LFP signal as taught by Little. One of ordinary skill in the art would have been motivated to make these modifications to reduce sleep impairment by maximizing slow wave brain activity [00151]. Regarding claim 8, Little teaches the method of claim 1, and further teaches a method with a gamma electroencephalography frequency band of the sensed LFP signal ([0022], [0028]) but does not disclose wherein the determining the slope of the PSD includes determining the slope of a gamma electroencephalography frequency band of the sensed LFP signal as claimed. However, Little teaches, at least in the embodiment unconstrained by the embedded implantable device [00258], a method further including: wherein the determining the slope of the PSD includes determining the slope of the gamma electroencephalography frequency band ([0022], [0028]) of the sensed LFP signal [00258]. It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to further modify the method of Little with the method of determining the slope of the PSD of a gamma electroencephalography frequency band of the sensed LFP signal as taught by Little. One of ordinary skill in the art would have been motivated to make these modifications to target sleep dysfunction treatment in patients by associating changes in sleep features or states identified from spectral frequency ranges ([0005], [0039]). Regarding claims 9 & 18, Little teaches a neurostimulation device (Medtronic Summit RC+S system, [00210], Fig. 4A) comprising: a sensing circuit configured to sense sensing a local field potential (LFP) signal of a patient when connected to implantable electrodes ([00210], Fig. 4B; “Implanted electrodes were connected to investigational sensing-enabled Summit RC+S (Medtronic) DBS implantable neurostimulators (INS)”; and signal processing circuitry operatively coupled to the sensing circuit ([00210]; “Field potential (FP) time series recordings were analyzed via time frequency decomposition through the Fast Fourier Transform (FFT) embedded within the INS”) and configured to: compute a power spectral density (PSD) of the sensed LFP signal ([00210], Fig. 1E & 4G); well known to one of ordinary skill in the art that PSD is calculated from various FFT normalization and scaling methods. Little does not disclose, as claimed, a system comprising: compute a slope of the PSD of the sensed LFP signal; and determine a physiological state of the patient using the computed slope of the PSD of the sensed LFP signal. However, Little teaches, at least in the embodiment unconstrained by the embedded implantable device [00258], a system further comprising: compute a slope of the PSD of the sensed LFP signal [00258]; and determine a physiological state of the patient using the computed slope of the PSD of the sensed LFP signal ([00213], [00258], [00262]); It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to further modify the system of Little with the slope of the PSD of the sensed LFP signal and determining a physiological state of the patient using the slope of the PSD of the sensed LFP signal as taught by Little. One of ordinary skill in the art would have been motivated to make these modifications to improve symptom treatment by including non-linear classification methods that improve detection accuracy [00258]. Regarding claims 10 & 19, Little teaches the systems of claims 9 & 18 respectively, and further teaches a system including: stimulation circuit configured to deliver electrical neurostimulation therapy to the patient when connected to the implantable electrodes [00107]; and a control circuit operatively coupled to the stimulation circuit and the signal processing circuitry, and configured to control delivery of the neurostimulation therapy to the patient [00210]; wherein the signal processing circuitry is configured to detect a movement state indicative of tremor movement of the patient ([00107]; “…positioning a second electrode at a subcortical region or a cortical region of the brain of the subject to detect brain electrical signals from neural activity associated with a sleep feature or sleep stage of interest while the subject is sleeping (i.e., detection electrode)”), wherein the movement state is indicative of tremor movement of the patient ([0097]; “Tremor, rigidity and dyskinesias associated with a movement disorder such as Parkinson’s disease may occur during nocturnal awakenings and contribute to sleep dysfunction by prolonging awakenings and inability to fall back to sleep”); and wherein the control circuit is configured to change a neurostimulation therapy parameter based on the detected movement state of the patient ([00107]; “The electrical stimulation may be applied to the basal ganglia using the DBS electrode in a manner effective for treating sleep dysfunction when a brain electrical signal associated with the sleep feature or sleep stage of interest is detected from the subcortical region or cortical region of the brain using the detection electrode”). Little does not disclose a movement state indicative of tremor movement of the patient using the slope of the PSD of the sensed LFP signal as claimed. However, Little teaches, at least in the embodiment unconstrained by the embedded implantable device [00258], a system further including: wherein the signal processing circuitry is configured to detect a movement state indicative of tremor movement of the patient using the slope of the PSD of the sensed LFP signal ([00213], [00258], [00262]); on-board and external classifiers detect wakefulness, sleep stages, and physiological states such as movement; nonlinear classifiers utilizing a larger feature space that includes slope of frequency necessitates analysis of slope calculations for physiological state determinations. It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to further modify the system of Little using the slope of the PSD of the sensed LFP signal as taught by Little. One of ordinary skill in the art would have been motivated to make these modifications to improve symptom treatment by including non-linear classification methods that improve detection accuracy [00258]. Regarding claim 12, Little teaches the system of claim 9, and further teaches a system including: a stimulation circuit configured to deliver electrical neurostimulation therapy to the patient when connected to the implantable electrodes [00107]; and a control circuit operatively coupled to the stimulation circuit and the signal processing circuitry, and configured to control delivery of the neurostimulation therapy to the patient [00210]; wherein the signal processing circuitry is configured to detect a sleep state of the patient using the sensed LFP signal ([00107]; “The electrical stimulation may be applied to the basal ganglia using the DBS electrode in a manner effective for treating sleep dysfunction when a brain electrical signal associated with the sleep feature or sleep stage of interest is detected from the subcortical region or cortical region of the brain using the detection electrode”), wherein the sleep state is indicative of depth of the sleep of the patient ([0041]; spectral power changes compared to average delta, gamma, and beta power indicate pre-awakening or awakening states). wherein the control circuit is configured to change a neurostimulation therapy parameter based on the detected sleep state of the patient [00107]; “The electrical stimulation may be applied to the basal ganglia using the DBS electrode in a manner effective for treating sleep dysfunction when a brain electrical signal associated with the sleep feature or sleep stage of interest is detected from the subcortical region or cortical region of the brain using the detection electrode.” Little does not disclose detecting a sleep state of the patient using the slope of the PSD of the sensed LFP signal as claimed. However, Little teaches, at least in the embodiment unconstrained by the embedded implantable device [00258], a system further including: wherein the signal processing circuitry is configured to detect a sleep state of the patient using the slope of the PSD of the sensed LFP signal [00254-00258], wherein the sleep state is indicative of depth of the sleep of the patient ([0041]; It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to further modify the system of Little with the system for detecting a sleep state of the patient using the slope of the PSD of the sensed LFP signal, as taught by Little. One of ordinary skill in the art would have been motivated to make these modifications to improve efficacy of sleep dysfunction treatment by optimizing neurostimulation parameters [00107]. Regarding claim 13, Little teaches the system of claim 9, and teaches, at least in the embodiment unconstrained by the embedded implantable device [00258], a system further including: a stimulation circuit delivering electrical neurostimulation therapy to the patient using the medical device/when connected to implantable electrodes [00107]; a control circuit operatively coupled to the stimulation circuit and the signal processing circuitry, and configured to control delivery of the neurostimulation therapy to the patient [00210]; wherein the signal processing circuitry is configured to detect a change in impairment state of the patient ([00151], [00137], [00250]); under BRI, impairment states may also include physical, cognitive, behavioral, neurological and/or psychiatric impairment.); and wherein the control circuit is configured to change a neurostimulation therapy parameter based on the detected change in impairment state of the patient [00107]; “The electrical stimulation may be applied to the basal ganglia using the DBS electrode in a manner effective for treating sleep dysfunction when a brain electrical signal associated with the sleep feature or sleep stage of interest is detected from the subcortical region or cortical region of the brain using the detection electrode.” Little does not disclose detecting a change in impairment state of the patient using the slope of the PSD of the sensed LFP signal as claimed. However, Little teaches, at least in the embodiment unconstrained by the embedded implantable device [00258], a system further including: wherein the signal processing circuitry is configured to detect a change in impairment state of the patient using the slope of the PSD of the sensed LFP signal ([00250], [00213], [00258], [00262]); on-board and external classifiers detect wakefulness, sleep stages, and physiological states such as movement; nonlinear classifiers utilizing a larger feature space that includes slope of frequency necessitates analysis of slope calculations for physiological state determinations. It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to further modify the system of Little with the system of detecting a change in impairment state of the patient using the slope of the PSD of the sensed LFP signal as taught by Little. One of ordinary skill in the art would have been motivated to make these modifications to reduce sleep impairment by maximizing slow wave brain activity [00151]. Regarding claim 17, Little teaches the system of claim 9, and further teaches a system with a gamma electroencephalography frequency band of the sensed LFP signal ([0022], [0028]). Little does not disclose, as claimed, wherein the signal processing circuitry is configured to: calculate the slope of the PSD of a gamma electroencephalography frequency band of the sensed LFP signal; and determine the physiological state of the patient using the calculated slope of the gamma electroencephalography frequency band of the sensed LFP signal; However, Little teaches, at least in the embodiment unconstrained by the embedded implantable device [00258], a system further including: calculate the slope of the PSD of a gamma electroencephalography frequency band of the sensed LFP signal [00258]; and determine the physiological state of the patient using the calculated slope of the PSD ([00213], [00258], [00262]) of the gamma electroencephalography frequency band of the sensed LFP signal ([0028], [0022]). It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to further modify the system of Little with the system to calculate the slope of the PSD of a gamma electroencephalography frequency band of the sensed LFP signal and to determine the physiological state of the patient using the calculated slope of the PSD of the gamma electroencephalography frequency band of the sensed LFP signal as taught by Little. One of ordinary skill in the art would have been motivated to make these modifications to target sleep dysfunction treatment in patients by associating changes in sleep features or states identified from spectral frequency ranges ([0005], [0039]). Regarding claim 20, Little teaches the non-transitory computer readable storage medium of claim 18, but does not disclose including instructions that cause the medical device to perform acts including determining at least one of a sleep state, movement state, medication state, or disease impairment state of the patient using the slope of the PSD of the sensed LFP signal, as claimed. However, Little teaches, at least in the embodiment unconstrained by the embedded implantable device [00258], a system further including instructions that cause the medical device to perform acts including determining at least one of a sleep state [00107], movement state [0097], medication state ([00203]; (27-28, 30-31, 41-42), [00137]), or disease impairment state [00151] of the patient using the slope of the PSD of the sensed LFP signal [00258]. Examiner notes that sleep state was selected for examination; movement state, medication state, and disease impairment state are optional limitations. It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to further modify the system of Little with the system for detecting a sleep state of the patient using the slope of the PSD of the sensed LFP signal as taught by Little. One of ordinary skill in the art would have been motivated to make these modifications to improve efficacy of sleep dysfunction treatment by optimizing neurostimulation parameters [00107] . 07-21-aia AIA Claim (s) 3, 6, 11, 14-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Little et al (WO/2025101224) , in view of Molnar et al (US Pre Grant Publication 2021/0038897) . Regarding claim 3, Little teaches the method of claim 1, but does not disclose, as including: determining a medication state of the patient using the slope of the PSD of the sensed LFP signal; and generating a prompt related to medication of the patient based on the determined medication state of the patient. However, Little teaches, at least in the embodiment unconstrained by the embedded implantable device [00258], a method further including: determining a medication state of the patient ([00203]; (27-28, 30-31, 41-42), [0137]) using the slope of the PSD of the sensed LFP signal [00258]; Little does not disclose a method for generating a prompt related to medication of the patient based on the determined medication state of the patient. However, Molnar teaches a method including: generating a prompt related to medication of the patient based on the determined medication state of the patient ([0011], [0112]); examiner interprets prompt to comprise indications and/or alerts for a specified medication event; “For example, the sensors may trigger an electrical modulation response or communicate and trigger the flow of drug via an implanted drug pump, or trigger an alert on the patient's device programmer to take their scheduled or PRN (i.e., on an “as needed” basis) oral medications.” It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method of Little with the method to generate a prompt related to medication of the patient based on the determined medication state of the patient as taught by Molnar. One of ordinary skill in the art would have been motivated to make these modifications to improve DBS therapy by targeting specific brain circuits that may require multi-modal and multi-symptom therapy management (Molnar, [0011]). Regarding claim 6, Little teaches the method of claim 1, but does not disclose: wherein the sensing the LFP signal includes sensing a spinal LFP signal from spinal nerve tissue of the patient; wherein the determining the slope of the PSD includes determining the slope of the PSD of the sensed spinal LFP signal; and determining a change in a pain state of the patient using the slope of the PSD of the sensed peripheral LFP signal ([0011-0013], ). However, Molnar teaches a method: wherein the sensing the LFP signal includes sensing a spinal LFP signal from spinal nerve tissue of the patient [0088]; “In certain embodiments, sensors may also be placed in the peripheral nervous system (e.g. electromyography (EMG) electrodes, spinal cord leads, peripheral nerve sensors) to be used instead of, or in addition to, cortical output and to measure DBS cortical controllability for electrode selection.” Molnar does not disclose, as claimed, a method: determining the slope of the PSD includes determining the slope of the PSD of the sensed spinal LFP signal; and determining a change in a pain state of the patient using the slope of the PSD of the sensed peripheral LFP signal. However, Molnar teaches, at least in the exemplary embodiment to treat pain [0064-0065], a method further comprising sensing algorithms to detect and monitor patient states; pain treatment necessitates measurement and/or monitoring of patient pain or determining a change in pain state. It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method of Little with the modified method wherein the sensing the LFP signal includes sensing a spinal LFP signal from spinal nerve tissue of the patient, the determining the slope of the PSD includes determining the slope of the PSD of the sensed spinal LFP signal, and determining a change in a pain state of the patient using the slope of the PSD of the sensed peripheral LFP signal as taught by Molnar. One of ordinary skill in the art would have been motivated to make these modifications to improve DBS therapy by placing electrodes in the peripheral nervous system (Molnar, [0088]). Regarding claim 11, Little teaches the neurostimulation device of claim 9, but does not disclose, as claimed, wherein the signal processing circuitry is configured to: determine a medication state of the patient using the slope of the PSD of the sensed LFP signal; and generate a prompt related to medication of the patient based on the determined medication state of the patient. However, Little teaches, at least in the embodiment unconstrained by the embedded implantable device [00258], a system further configured to: determine a medication state of the patient ([00203]; (27-28, 30-31, 41-42), [0137]) using the slope of the PSD of the sensed LFP signal [00258]; Little does not disclose a system to generate a prompt related to medication of the patient based on the determined medication state of the patient. However, Molnar teaches a system wherein the signal processing circuitry (IPG 12; at least controller (22)) is configured to [0039]: generate a prompt related to medication of the patient based on the determined medication state of the patient ([0011], [0112]); examiner interprets prompt to comprise indications and/or alerts for a specified medication event; “For example, the sensors may trigger an electrical modulation response or communicate and trigger the flow of drug via an implanted drug pump, or trigger an alert on the patient's device programmer to take their scheduled or PRN (i.e., on an “as needed” basis) oral medications.” It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system of Little with the system to generate a prompt related to medication of the patient based on the determined medication state of the patient as taught by Molnar. One of ordinary skill in the art would have been motivated to make these modifications to improve DBS therapy by targeting specific brain circuits that may require multi-modal and multi-symptom therapy management (Molnar, [0011]). Regarding claim 14, Little teaches the neurostimulation device of claim 9, but does not disclose: wherein the sensing circuit is configured to sense a spinal LFP signal from spinal nerve tissue of the patient; and wherein the signal processing circuitry is configured to determine the slope of the PSD of the sensed spinal LFP signal; However, Molnar teaches a system wherein the sensing circuit is configured to sense a spinal LFP signal from spinal nerve tissue of the patient [0088]; “In certain embodiments, sensors may also be placed in the peripheral nervous system (e.g. electromyography (EMG) electrodes, spinal cord leads, peripheral nerve sensors) to be used instead of, or in addition to, cortical output and to measure DBS cortical controllability for electrode selection.” It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system of Little with the system wherein the sensing circuit is configured to sense a spinal LFP signal from spinal nerve tissue of the patient and the signal processing circuitry is configured to determine the slope of the PSD of the sensed spinal LFP signal as taught by Molnar. One of ordinary skill in the art would have been motivated to make these modifications to improve DBS therapy by placing electrodes in the peripheral nervous system (Molnar, [0088]). Regarding claim 15, Little teaches the system of claim 9, but does not disclose: wherein the sensing circuit is configured to sense a peripheral LFP signal from peripheral nerve tissue peripheral to a spine of the patient; and wherein the signal processing circuitry is configured to determine the slope of the PSD of the sensed peripheral LFP signal. However, Molnar teaches a system: wherein the sensing circuit is configured to sense a peripheral LFP signal from peripheral nerve tissue peripheral to a spine of the patient [0088]. It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system of Little with the system wherein the sensing circuit is configured to sense a peripheral LFP signal from peripheral nerve tissue peripheral to a spine of the patient as taught by Molnar. One of ordinary skill in the art would have been motivated to make these modifications to improve DBS therapy by placing electrodes in the peripheral nervous system that allow for additional measurement and stimulation (Molnar, [0088]). Regarding claim 16, Little teaches the system of claim 9, but does not disclose: wherein the sensing circuit is configured to sense a peripheral LFP signal from peripheral nerve tissue peripheral to a brain of the patient; and wherein the signal processing circuitry is configured to determine the slope of the PSD of the sensed peripheral LFP signal. However, Molnar teaches a system: wherein the sensing circuit is configured to sense a peripheral LFP signal from peripheral nerve tissue peripheral to a brain of the patient [0088]; vagus nerve is peripheral nerve tissue once it exits the brain and peripheral to a brain of the patient when closer to the brain than the spine. It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system of Little with the system wherein the sensing circuit is configured to sense a peripheral LFP signal from peripheral nerve tissue peripheral to a brain of the patient as taught by Molnar. One of ordinary skill in the art would have been motivated to make these modifications to improve DBS therapy by placing electrodes in the peripheral nervous system that allow for additional measurement and stimulation (Molnar, [0088]) . 07-21-aia AIA Claim (s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Little et al (WO/2025101224) , in view of Molnar et al (US Pre Grant Publication 2021/0038897) , and in further view of Gerdt et al (US Pre Grant Publication 2025/0040865) . Regarding claim 7, Little teaches the method of claim 1, but does not disclose: wherein the sensing the LFP signal includes sensing a peripheral LFP signal from vagus nerve tissue of the patient; wherein the determining the slope of the PSD includes determining the slope of the PSD of the sensed peripheral LFP signal; and determining vagal tone of the patient using the slope of the PSD of the sensed peripheral LFP signal. Molnar teaches a method for sensing a peripheral LFP signal from peripheral nerve tissue of the patient [0088], but does not disclose, as claimed: sensing a peripheral LFP signal from vagus nerve tissue of the patient; wherein the determining the slope of the PSD includes determining the slope of the PSD of the sensed peripheral LFP signal; and determining vagal tone of the patient using the slope of the PSD of the sensed peripheral LFP signal. However, Gerdt teaches a method: determining vagal tone of the patient using the PSD of the sensed peripheral LFP signal from sensing circuit ([0063-0066]); [0063] detector includes electrical sensors thereby field potentials; [0066] vagal tone determined by power level in PSD. It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method of Little with the methods for sensing a peripheral LFP signal from vagus nerve tissue of the patient, determining the slope of the PSD of the sensed peripheral LFP signal, and determining vagal tone of the patient using the PSD of the sensed peripheral LFP signal as taught by Molnar and Gerdt. One of ordinary skill in the art would have been motivated to make these modifications to improve neuromodulation therapy by analyzing sympathetic and parasympathetic cardio-nervous system data (Gerdt, [0002]). Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to DWANE COLLARD whose telephone number is (571)272-6553. The examiner can normally be reached M-F 9 am-6 pm. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ben Klein can be reached at (571) 270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /DWANE COLLARD/Examiner, Art Unit 3792 /Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792 Application/Control Number: 18/905,413 Page 2 Art Unit: 3792 Application/Control Number: 18/905,413 Page 3 Art Unit: 3792 Application/Control Number: 18/905,413 Page 4 Art Unit: 3792 Application/Control Number: 18/905,413 Page 5 Art Unit: 3792 Application/Control Number: 18/905,413 Page 6 Art Unit: 3792 Application/Control Number: 18/905,413 Page 7 Art Unit: 3792 Application/Control Number: 18/905,413 Page 8 Art Unit: 3792 Application/Control Number: 18/905,413 Page 9 Art Unit: 3792 Application/Control Number: 18/905,413 Page 10 Art Unit: 3792 Application/Control Number: 18/905,413 Page 11 Art Unit: 3792 Application/Control Number: 18/905,413 Page 12 Art Unit: 3792 Application/Control Number: 18/905,413 Page 13 Art Unit: 3792 Application/Control Number: 18/905,413 Page 14 Art Unit: 3792 Application/Control Number: 18/905,413 Page 15 Art Unit: 3792 Application/Control Number: 18/905,413 Page 16 Art Unit: 3792 Application/Control Number: 18/905,413 Page 17 Art Unit: 3792 Application/Control Number: 18/905,413 Page 18 Art Unit: 3792 Application/Control Number: 18/905,413 Page 19 Art Unit: 3792 Application/Control Number: 18/905,413 Page 20 Art Unit: 3792 Application/Control Number: 18/905,413 Page 21 Art Unit: 3792 Application/Control Number: 18/905,413 Page 22 Art Unit: 3792 Application/Control Number: 18/905,413 Page 23 Art Unit: 3792 Application/Control Number: 18/905,413 Page 24 Art Unit: 3792 Application/Control Number: 18/905,413 Page 25 Art Unit: 3792 Application/Control Number: 18/905,413 Page 26 Art Unit: 3792 Application/Control Number: 18/905,413 Page 27 Art Unit: 3792 Application/Control Number: 18/905,413 Page 28 Art Unit: 3792 Application/Control Number: 18/905,413 Page 29 Art Unit: 3792
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