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 .
Response to Arguments
In response to the Examiner’s Non-Final Rejection (filed May 29, 2025), the Applicant filed Amendments to the Claims and Remarks on August 29, 2025. These have been carefully considered by the Examiner.
Amendments to the Claims
Per the Applicant, claims 1-5 and 7-21 are pending at the time of this Office Action. Claim 1 has been amended and is said to be supported “by at least para. [0192] and FIG. 25 of the published application”. (Remarks, pg. 6) The Examiner concurs that no new matter is added.
Objection to the Specification
Applicant’s arguments, see Remarks pg. 6, filed August 29, 2025, with respect to the objection to the specification have been fully considered and are persuasive. The objection of the specification has been withdrawn.
Non-Statutory Double Patenting
Claims 1-5 and 7-20 were provisionally rejected on the ground of non-statutory double patenting over claims 1-20 of copending U.S. Pat. App. No. 17/968,739. The Applicant has requested that the Office hold the remaining non-statutory double patenting rejections in abeyance until all claims are indicated as being allowable. (Remarks, pg. 6) The Examiner notes that this double patenting rejection is held in abeyance until prosecution of both cases is completed.
Claim Rejections
Applicant’s arguments, see Remarks pg. 6-10, filed August 29, 2025, with respect to the claim rejections have been fully considered and are persuasive. The 35 U.S.C. § 103 rejections of claims 1-21 have been withdrawn.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-5, 7, 9-11, 13, and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over John (US 2006/0217781) (cited previously) in view of Vierto-Oja et al. (US 2003/0167019, hereinafter referred to as Vierto-Oja).
Regarding independent, amended claim 1, John discloses methods and systems for treatment of brain disorders using neuromodulation that is provided to modulate structures of brain networks. John further discloses a method of providing a neurostimulation therapy to a patient ([0049]: “Neurostimulation may be either excitatory or inhibitory stimulation, and may be at least electrical, magnetic, optical or chemical, or a combination of two or more of these.”), comprising:
applying electrical pulses to a neural target of a patient ([0050]: “As used herein, the term “stimulation subsystem” refers to all components that permit the [brain modulation system] to actively alter (‘modulate’) neural tissue during neuromodulation treatment, and may include at least one pulse generator…”);
obtaining electroencephalogram (EEG) data corresponding to a neurological response of the patient to the electrical pulses ([0081]: “…functional imaging data may used to identify and evaluate the brain networks of a patient before and during treatment.”; [0041]: “…functional neuroimaging can include techniques such as electroencephalography (EEG)…”);
processing the EEG data to form EEG localization data reflecting neural activity at cortical locations of the patient ([0082]: “Rather than occurring within the [brain neuromodulation device (BND)] itself, under the direction of a physician, abnormal activity in dispersed portions of a network may be measured in a number of manners, for example, by superposition of three dimensional source localization of the generators of quantitative EEG (QEEG) measurements.”);
comparing the multi-dimensional representation of a state of the patient to one or more multi-dimensional representations of a state of healthy controls ([0089]: “With respect to evaluating treatment of the brain networks 108, evaluation can occur by comparing sensed data to reference data, which can be normative data, with respect to treatment criteria.”);
adjusting one or more stimulation parameters based on the comparing (“Evaluate treatment” 108 in Fig. 2A; [0078]: “…the effects of the treatment provided by the modulation of the brain network are evaluated 108…”); and
programming an implantable pulse generator ([0050]: “…may include at least one pulse generator…”) of the patient to operate according to the one or more adjusted stimulation parameters (“Modify treatment” 110 in Fig. 2A; [0078]: “…modulation parameters are adjusted 110…”).
John is silent to forming a multi-dimensional representation of a state of the patient by selecting a predetermined number of features corresponding to activity within multiple respective frequency bands at a subset of the cortical locations of the patient; and
comparing the multi-dimensional representation of a state of the patient to one or more multi-dimensional representations of a state of healthy controls ([0089]: “With respect to evaluating treatment of the brain networks 108, evaluation can occur by comparing sensed data to reference data, which can be normative data, with respect to treatment criteria.”).
However, Vierto-Oja teaches a method and apparatus for determining the cerebral state of a patient with fast response. Vierto-Oja further teaches forming, using the EEG localization data ([0009]: “The recorded signals comprise an electroencephalogram or EEG.”), a multi-dimensional representation of a state of the patient ([0119]: “Artifact detector 314 detects artifacts arising from electrocardiac activity, and other sources. The output of artifact detector 314 is connected to computational unit 316 which carries out the steps of the methods described above and shown in FIGS. 6 and 8 and produces an output of the type shown in FIGS. 3, 4, 5, 7, 9, and 10 in display 318. Or, the information may be presented in display 318 in numerical form. Display 318 may also display other physiological data, such as electrocardiographic data, breath rate, pulse, blood pressure, etc., obtained from other monitors.”; [0107]) by selecting a predetermined number of features (Features can be electrocardiac activity, electrocardiographic data, breath rate, pulse, blood pressure, etc. as described in [0119].) corresponding to activity within multiple respective frequency bands (Fig. 1; [0077]-[0079]; multiple frequency bands are mentioned, such as in [0095]) at a subset of the cortical locations of the patient ([0009]: “The biopotential electrical signals are usually obtained by a pair, or plurality of pairs, of electrodes placed on the patient's scalp at locations designated by a recognized protocol and a set, or a plurality of sets or channels, of electrical signals are obtained from the electrodes. These signals are amplified and filtered. The recorded signals comprise an electroencephalogram or EEG.”).
In combination with the comparisons disclosed by John, Vierto-Oja teaches comparing the multi-dimensional representation (Vierto-Oja [0117]; [0107]) of a state of the patient to one or more multi-dimensional representations of a state of healthy controls (John [0089]: “With respect to evaluating treatment of the brain networks 108, evaluation can occur by comparing sensed data to reference data, which can be normative data, with respect to treatment criteria.”).
Vierto-Oja teaches a similar pursuit to that of the instant application and John in teaching detecting the frequency distribution of signals, e.g. detecting delta, theta, alpha, beta, or gamma waves, as well as observing a patient’s physiological responses to electrical stimulation. Therefore, it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the invention of John to include a multi-dimensional representation of a state of the patient in order to monitor a patient’s physiological responses to electrical stimulation. Further, it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to combine the historical comparisons of John with the multi-dimensional representation of a state of the patient taught by John in order to effectively adjust the stimulation parameters applied to a patient.
Regarding claim 2, in view of the John/Vierto-Oja combination, John discloses that the comparing comprises:
calculating a distance metric that measures a multi-dimensional distance between the multi- dimensional representation of the state of the patient to a multi-dimensional representation that is reflective of an average state from a population of health controls ([0089]: “With respect to evaluating treatment of the brain networks 108, evaluation can occur by comparing sensed data to reference data, which can be normative data, with respect to treatment criteria.”; [0091]).
John is silent to the multi- dimensional representation of the state of the patient.
However, Vierto-Oja teaches a multi-dimensional representation of a state of the patient ([0119]: “Artifact detector 314 detects artifacts arising from electrocardiac activity, and other sources. The output of artifact detector 314 is connected to computational unit 316 which carries out the steps of the methods described above and shown in FIGS. 6 and 8 and produces an output of the type shown in FIGS. 3, 4, 5, 7, 9, and 10 in display 318. Or, the information may be presented in display 318 in numerical form. Display 318 may also display other physiological data, such as electrocardiographic data, breath rate, pulse, blood pressure, etc., obtained from other monitors.”; [0107]).
In combination with the comparisons disclosed by John, Vierto-Oja teaches comparing the multi-dimensional representation (Vierto-Oja [0117]; [0107]) of a state of the patient to one or more multi-dimensional representations of a state of healthy controls (John [0089]: “With respect to evaluating treatment of the brain networks 108, evaluation can occur by comparing sensed data to reference data, which can be normative data, with respect to treatment criteria.”).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the invention of John to include a multi-dimensional representation of a state of the patient in order to monitor a patient’s physiological responses to electrical stimulation. Further, it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to combine the historical comparisons of John with the multi-dimensional representation of a state of the patient taught by John in order to effectively adjust the stimulation parameters applied to a patient.
Regarding claim 3, in view of the John/Vierto-Oja combination, John discloses a value of the calculated distance metric ([0089]; [0091]).
John is silent to providing output to a clinician reflecting a value of the calculated distance metric.
However, Vierto-Oja teaches providing output to a clinician ([0119]: “…produces an output of the type shown in FIGS. 3, 4, 5, 7, 9, and 10 in display 318. Or, the information may be presented in display 318 in numerical form. Display 318 may also display other physiological data, such as electrocardiographic data, breath rate, pulse, blood pressure, etc., obtained from other monitors.”; [0107]).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the invention of John to include displaying calculated values to a clinician, as taught by Vierto-Oja, in order to alert the clinician to the state of the patient.
Regarding claim 4, in view of the John/Vierto-Oja combination, John discloses that the distance metric ([0089]; [0091]) is a norm vector calculation ([0089]: “The [Brain State Vector] can be a vector computed as the difference between normative vector and an abnormal vector, or alternatively the BSV can be computed from z-scores and thus can be both statistically-based and normalized.”).
Regarding claim 5, in view of the John/Vierto-Oja combination, John discloses that automatically calculating one or more values for one or more stimulation parameters ([0091]: “The detection of network events can occur due to the evaluation of sensed data using treatment criteria and can occur automatically in the processor of the control subsystem of the [brain neuromodulation device].”) based on the distance metric ([0089]; [0091]).
Regarding claim 7, in view of the John/Vierto-Oja combination, John discloses conducting an analysis to determine a patient systemic response to neurostimulation ([0070]: “The computer subsystem also contains circuitry to perform signal processing and statistics on the sensed data in order to guide therapy. Its components operate to provide sensing from implanted sensors and processing of the sensed data to deliver either electrical or pharmaceutical treatment.”; [0075]) that depends upon the distance metric ([0089]; [0091]).
Regarding claim 9, John discloses that the comparing comprises:
defining a boundary between representations of patients with a same or similar neurological condition as the patient and representations of health controls ([0089]: “With respect to evaluating treatment of the brain networks 108, evaluation can occur by comparing sensed data to reference data, which can be normative data, with respect to treatment criteria.”).
John is silent to multi-dimensional representations of patients.
In combination with the comparisons disclosed by John, Vierto-Oja teaches defining a boundary between multi-dimensional representations of patients ([0117]; [0107]) with a same or similar neurological condition as the patient and multi-dimensional representations of health controls.
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the invention of John to include a multi-dimensional representation of a state of the patient in order to monitor a patient’s physiological responses to electrical stimulation. Further, it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to combine the historical comparisons of John with the multi-dimensional representation of a state of the patient taught by John in order to effectively adjust the stimulation parameters applied to a patient.
Regarding claim 10, in view of the John/Vierto-Oja combination, John discloses representing the multi-dimensional representation of a state of the patient relative to one or more multi-dimensional representations of states of health controls (see claim 9).
John does not disclose providing a user interface display to a clinician.
However, Vierto-Oja teaches providing a user interface display to a clinician (display 318 in Fig. 11; [0119]: “…an output of the type shown in FIGS. 3, 4, 5, 7, 9, and 10 in display 318. Or, the information may be presented in display 318 in numerical form. Display 318 may also display other physiological data, such as electrocardiographic data, breath rate, pulse, blood pressure, etc., obtained from other monitors.”; [0107]).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the controls of John to include a graphical user interface or display screen in order to aid the clinician in neurostimulation parameter adjustment.
Regarding claim 11, in view of the John/Vierto-Oja combination, John discloses a path graphical element representing changes to the state of the patient relative that were measured in response to multiple changes in stimulation parameters relative to one or more representations of states of health controls ([0089]).
John is silent to providing a user interface display to a clinician of a path graphical element representing changes to the multi-dimensional representation of a state of the patient relative that were measured in response to multiple changes in stimulation parameters relative to one or more multi- dimensional representations of states of health controls ([0089]).
However, Vierto-Oja teaches providing a user interface display to a clinician (display 318 in Fig. 11; [0119]; [0107]) of a path graphical element representing changes to the multi-dimensional representation of a state of the patient ([0119]; [0107]).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the controls of John to include a graphical user interface or display screen in order to aid the clinician in neurostimulation parameter adjustment. Additionally, it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the invention of John to include a multi-dimensional representation of a state of the patient in order to monitor a patient’s physiological responses to electrical stimulation. Further, it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to combine the historical comparisons of John with the multi-dimensional representation of a state of the patient taught by John in order to effectively adjust the stimulation parameters applied to a patient.
Regarding claim 13, in view of the John/Vierto-Oja combination, John discloses that the patient is a chronic pain patient ([0060]: “In the treatment of some types of pain, treatment can be provided to block ascending signals so that these do not reach the areas of the brain which are responsible for the subjective sensation of pain...”) and the representation of a state of the patient comprises at least one patient feature corresponding to an insular cortex location ([0124]: “The stimulation can be applied, for example, to a network including one or more of the hippocampus, insula, right middle temporal gyrus, occipital cortex, temporal cortex, hypothalamus, anterior pituitary, posterior pituitary, and right posterior temporal lobe.”; Note that insula is a synonym for the insular cortex.).
John is silent to the multi- dimensional representation of the state of the patient.
However, Vierto-Oja teaches a multi-dimensional representation of a state of the patient ([0119]: “Artifact detector 314 detects artifacts arising from electrocardiac activity, and other sources. The output of artifact detector 314 is connected to computational unit 316 which carries out the steps of the methods described above and shown in FIGS. 6 and 8 and produces an output of the type shown in FIGS. 3, 4, 5, 7, 9, and 10 in display 318. Or, the information may be presented in display 318 in numerical form. Display 318 may also display other physiological data, such as electrocardiographic data, breath rate, pulse, blood pressure, etc., obtained from other monitors.”; [0107]).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the invention of John to include a multi-dimensional representation of a state of the patient in order to monitor a patient’s physiological responses to electrical stimulation.
Regarding claim 16, in view of the John/Vierto-Oja combination, John is silent to that the multi-dimensional representation of a state of the patient comprises respective features corresponding to cortical activity at respective locations with low theta, high theta, alpha, beta, and gamma frequency bands.
However, Vierto-Oja teaches that the multi-dimensional representation of a state of the patient ([0119]: “Artifact detector 314 detects artifacts arising from electrocardiac activity, and other sources. The output of artifact detector 314 is connected to computational unit 316 which carries out the steps of the methods described above and shown in FIGS. 6 and 8 and produces an output of the type shown in FIGS. 3, 4, 5, 7, 9, and 10 in display 318. Or, the information may be presented in display 318 in numerical form. Display 318 may also display other physiological data, such as electrocardiographic data, breath rate, pulse, blood pressure, etc., obtained from other monitors.”; [0107]) comprises respective features corresponding to cortical activity at respective locations ([0009]: “The biopotential electrical signals are usually obtained by a pair, or plurality of pairs, of electrodes placed on the patient's scalp at locations designated by a recognized protocol and a set, or a plurality of sets or channels, of electrical signals are obtained from the electrodes. These signals are amplified and filtered. The recorded signals comprise an electroencephalogram or EEG.”) with low theta, high theta, alpha, beta, and gamma frequency bands (Fig. 1; [0077]-[0079]; multiple frequency bands are mentioned, such as in [0095]).
Vierto-Oja teaches a similar pursuit to that of the instant application and John in teaching detecting the frequency distribution of signals, e.g. detecting delta, theta, alpha, beta, or gamma waves, as well as observing a patient’s physiological responses to electrical stimulation. It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the invention of John to include a multi-dimensional representation of a state of the patient in order to monitor a patient’s physiological responses to electrical stimulation.
Regarding claim 17, in view of the John/Vierto-Oja combination, John discloses establishing a communication connection between a patient device and a clinician device for a remote programming session ([0074]: “It should be noted that in conceivable circumstances, such as a multi-bed intensive care unit or coma ward, there might be a central station that remotely communicates with the processors of multiple BNDs which are treating multiple patients.”) to provide the neurostimulation therapy to the patient ([0142]: “The linked rules and the protocols can be contained within a database of the BND, can be adjusted by the medical personnel or patient using the external patient programmer.”).
Regarding claim 18, in view of the John/Vierto-Oja combination, John discloses establishing a communication connection between a patient device and a clinician device for an in-person programming session to provide the neurostimulation therapy to the patient ([0074]: “It should be noted that in conceivable circumstances, such as a multi-bed intensive care unit or coma ward, there might be a central station that remotely communicates with the processors of multiple BNDs which are treating multiple patients.”; [0142]: “The linked rules and the protocols can be contained within a database of the BND, can be adjusted by the medical personnel or patient using the external patient programmer.”).
Regarding claim 19, in view of the John/Vierto-Oja combination, John discloses conducting an automatic adjustment of stimulation parameters (step 110 “modify treatment in Fig. 2A) across respective parameter ranges for neurostimulation of the patient while repetitively performing the forming the representation of a state of the patient and comparing the of a state of the patient to one or more multi-dimensional representations of a state of healthy controls ([0089]: “With respect to evaluating treatment of the brain networks 108, evaluation can occur by comparing sensed data to reference data, which can be normative data, with respect to treatment criteria.”).
John is silent to the multi- dimensional representation of the state of the patient.
However, Vierto-Oja teaches a multi-dimensional representation of a state of the patient ([0119]: “Artifact detector 314 detects artifacts arising from electrocardiac activity, and other sources. The output of artifact detector 314 is connected to computational unit 316 which carries out the steps of the methods described above and shown in FIGS. 6 and 8 and produces an output of the type shown in FIGS. 3, 4, 5, 7, 9, and 10 in display 318. Or, the information may be presented in display 318 in numerical form. Display 318 may also display other physiological data, such as electrocardiographic data, breath rate, pulse, blood pressure, etc., obtained from other monitors.”; [0107]).
In combination with the comparisons disclosed by John, Vierto-Oja teaches comparing the multi-dimensional representation (Vierto-Oja [0117]; [0107]) of a state of the patient to one or more multi-dimensional representations of a state of healthy controls (John [0089]: “With respect to evaluating treatment of the brain networks 108, evaluation can occur by comparing sensed data to reference data, which can be normative data, with respect to treatment criteria.”).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the invention of John to include a multi-dimensional representation of a state of the patient in order to monitor a patient’s physiological responses to electrical stimulation. Further, it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to combine the historical comparisons of John with the multi-dimensional representation of a state of the patient taught by John in order to effectively adjust the stimulation parameters applied to a patient.
Regarding claim 20, in view of the John/Vierto-Oja combination, John discloses that the automatic adjustment of stimulation parameters comprising adjusting pulse amplitude, pulse width, pulse frequency parameters, and electrode polarity parameters ([0134]: “It is obvious that the linked rules can be applied to any characteristic of the stimulation protocol, including pulse width, pulse frequency, pulse shape, stimulation time, frequency, voltage, current, and any other stimulation characteristic that determines the treatment stimulation.”). While pulse amplitude and electrode polarity parameters are not directly described by John, it would be obvious to one having ordinary skill in the art at the effective filing date of the invention that these parameters would be included in the phrase “…any other stimulation characteristic that determines the treatment stimulation.” ([0134]).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over the John/Vierto-Oja combination further in view of Pappa (NASA Technical Memorandum 109066).
Regarding claim 8, in view of the John/Vierto-Oja combination, John discloses that the analysis to determine a patient systemic response and characterizing an expected patient response to stimulation ([0091]: “The treatment criteria used to evaluate sensed data with respect to network events can utilize simple thresholds, statistical criteria, population or self-norm data, and may rely upon the output of modeling algorithms which compare the results of the modeling of current data to target values for the model, to see if the treatment criteria have been met.”).
The John/Vierto-Oja combination does not disclose an eigenvalue realization algorithm (ERA).
However, Pappa teaches a methodology of using ERA for structural modal identification and minimum-order system realization. Pappa teaches an eigenvalue realization algorithm (pg. 1, Section 1.1: “The Eigensystem Realization Algorithm (ERA) is a multiple-input, multiple-output, time domain technique for structural modal identification and minimum-order system realization. The name Eigensystem Realization Algorithm reflects the combination of modal testing technology involving the identification of structural eigenvalues and eigenvectors (natural frequencies, damping, mode shapes, and modal masses) and system realization theory involving the construction of state-space models [A,B,C,D] for modern control design. ERA was introduced in 1984 by the author and Dr. Jer-Nan Juang as a tool for system identification of future large space structures.”).
The instant application’s Specification states that “the eigenvalue system characterization approach …be employed to select stimulation parameters and/or stimulation pattern”, as well calculating “the A, B, C, D matrix of the state space equation through system identification operations”, so it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to combine the John/Vierto-Oja combination’s analysis to determine a patient systemic response with the eigenvalue realization algorithm of Pappa to characterize an expected patient response to stimulation.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over the John/Vierto-Oja/Pappa combination further in view of Moffitt (US 2011/0093045) (cited previously).
Regarding claim 12, in view of the John/Vierto-Oja/Pappa combination, the John/Vierto-Oja/Pappa combination does not disclose that the neurostimulation therapy is selected from the listing consisting of: spinal cord stimulation, dorsal root ganglion stimulation, peripheral nerve stimulation, cortical stimulation, and deep brain stimulation.
However, Moffitt teaches that the neurostimulation therapy could be selected from the listing consisting of: spinal cord stimulation, peripheral nerve stimulation, and cortical stimulation ([0040]: “…the present invention may be used as part of a spinal cord stimulator, …a stimulator configured to produce coordinated limb movement, a cortical stimulator, peripheral nerve stimulator, …or in any other neural stimulator configured to treat urinary incontinence, sleep apnea, shoulder subluxation, headache, etc.”). Moffitt additionally teaches deep brain stimulation ([0019]: “FIG. 1 is a plan view of an embodiment of a deep brain stimulation (DBS) system.”).
While Moffitt does not explicitly teach dorsal root ganglion stimulation, it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention that this is implied along with Moffitt teaching spinal cord stimulation. Additionally, it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the John/Vierto-Oja/Pappa combination’s modulation of brain networks to further include the neurostimulation therapies taught by Moffitt.
Claims 14-15 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over the John/Vierto-Oja/Pappa/Moffitt combination further in view of De Ridder (US 8682441) (cited previously).
Regarding claim 14, in view of the John/Vierto-Oja/Pappa/Moffitt combination, John discloses that the patient is a chronic pain patient ([0060]: “In the treatment of some types of pain, treatment can be provided to block ascending signals so that these do not reach the areas of the brain which are responsible for the subjective sensation of pain...”) and the representation of a state of the patient comprises at least one patient feature.
John is silent to the multi- dimensional representation of the state of the patient.
However, Vierto-Oja teaches a multi-dimensional representation of a state of the patient ([0119]: “Artifact detector 314 detects artifacts arising from electrocardiac activity, and other sources. The output of artifact detector 314 is connected to computational unit 316 which carries out the steps of the methods described above and shown in FIGS. 6 and 8 and produces an output of the type shown in FIGS. 3, 4, 5, 7, 9, and 10 in display 318. Or, the information may be presented in display 318 in numerical form. Display 318 may also display other physiological data, such as electrocardiographic data, breath rate, pulse, blood pressure, etc., obtained from other monitors.”; [0107]).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the invention of John to include a multi-dimensional representation of a state of the patient in order to monitor a patient’s physiological responses to electrical stimulation.
The John/Vierto-Oja/Pappa/Moffitt combination does not disclose a correspondence to a dorsolateral prefrontal cortex (DLPFC) location.
However, De Ridder teaches a correspondence to a dorsolateral prefrontal cortex (DLPFC) location ([col. 6, li. 10-15]: “…brain tissue also includes cortical targets, for example, auditory cortex, prefrontal cortex, the dorsolateral prefrontal cortex, the ventromedial prefrontal cortex, the cingulate cortex, subcallosal area, anterior cingulate cortex, the subgenual anterior cingulate cortex, the motor cortex and the somatosensory cortex.”). De Ridder further discusses a pain treatment context ([col. 16, li. 42-44]: “…the neuromodulation method described herein is utilized to treat a subject suffering from or suspected of suffering from pain.”)
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the John/Vierto-Oja/Pappa/Moffitt combination to include De Ridder’s utilizing of patient features corresponding to a DLPFC location in order to properly support patient pain management.
Regarding claim 15, in view of the John/Vierto-Oja/Pappa/Moffitt/De Ridder combination, John discloses that the patient is a chronic pain patient ([0060]) and the representation of a state of the patient comprises at least one patient feature.
John is silent to the multi- dimensional representation of the state of the patient.
However, Vierto-Oja teaches a multi-dimensional representation of a state of the patient ([0119]: “Artifact detector 314 detects artifacts arising from electrocardiac activity, and other sources. The output of artifact detector 314 is connected to computational unit 316 which carries out the steps of the methods described above and shown in FIGS. 6 and 8 and produces an output of the type shown in FIGS. 3, 4, 5, 7, 9, and 10 in display 318. Or, the information may be presented in display 318 in numerical form. Display 318 may also display other physiological data, such as electrocardiographic data, breath rate, pulse, blood pressure, etc., obtained from other monitors.”; [0107]).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the invention of John to include a multi-dimensional representation of a state of the patient in order to monitor a patient’s physiological responses to electrical stimulation.
The John/Vierto-Oja/Pappa/Moffitt combination does not disclose a correspondence to a medial prefrontal cortex location.
However, De Ridder teaches a correspondence to a medial prefrontal cortex location ([col. 6, li. 10-15]: “…brain tissue also includes cortical targets, for example, auditory cortex, prefrontal cortex, the dorsolateral prefrontal cortex, the ventromedial prefrontal cortex, the cingulate cortex, subcallosal area, anterior cingulate cortex, the subgenual anterior cingulate cortex, the motor cortex and the somatosensory cortex.”). De Ridder further discusses a pain treatment context ([col. 16, li. 42-44]: “…the neuromodulation method described herein is utilized to treat a subject suffering from or suspected of suffering from pain.”).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the John/Vierto-Oja/Pappa/Moffitt combination to include De Ridder’s utilizing of patient features corresponding to a medial prefrontal cortex location in order to properly support patient pain management.
Regarding claim 21, in view of the John/Vierto-Oja/Pappa/Moffitt/De Ridder combination, the John/Vierto-Oja/Pappa/Moffitt combination does not disclose that the EEG localization data indicates a plurality of data vertices, and wherein the subset of the cortical locations of the patient correspond to, and are selected from among the cortical locations in accordance with, the plurality of data vertices.
However, De Ridder teaches that the EEG localization data indicates a plurality of data vertices, and wherein the subset of the cortical locations of the patient correspond to, and are selected from among the cortical locations in accordance with, the plurality of data vertices ([col. 4, li. 29-36]: “…add an alpha frequency peak to stimulate primary and secondary cortical areas; add a beta frequency peak to stimulate association cortical areas, such as frontal cortex; add a theta frequency peak to stimulate the cingulate, hippocampus, amygdala; add a delta frequency peak to stimulate the brainstem, ventral tegmental area (VTA), nucleus accumbens/ventral medial prefrontal cortex (VMPFC).”; [col. 4, li. 38-44]: “…EEG or MEG measurements or any other measurement to obtain the individual peak frequency or the frequencies can be obtained from a database, for example a database containing a list of given frequencies and spectral structures for a brain structure or brain area.”).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to combine the multi-dimensional representation the John/Vierto-Oja/Pappa/Moffitt combination with the EEG localization data and corresponding cortical locations of De Ridder in order to aid in source localization computations.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Carlson et al. (US 7761146);
Parra et al. (US 2015/0248615); and
Gustavson et al. (US 2017/0128735).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARY G SCHLUETER whose telephone number is (703)756-4601. The examiner can normally be reached M-F 9:00am-5:30pm EST.
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, 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.
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.
/M.G.S./Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796
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