DETAILED ACTION
Applicant' s arguments, filed 08/22/2025 have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 04/02/2025, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1-3, 6-8, and 11 are the current claims hereby under examination.
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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-3, 6-8, and 11 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “converting an ESI for a patient into a plurality of ESI waveforms, wherein the ESI is a combination of a model of a brain with a plurality of scalp signals from an EEG that estimates a source and intensity of a signal within the patient's brain, and is measured in micro-volts as a time series in parallel to the actual scalp EEG” but it is unclear what is measured “in parallel to the actual scalp EEG” It would seem that the ESI includes actual EEG signals so it is unclear if the EEG is recorded in parallel with itself or if some other parameter is recorded in parallel with the EEG. For the purposes of this examination, the limitation will be interpreted as the EEG signals are real signals recorded from the scalp. This rejection is further applied to the similar recitations in claims 6 and 11.
Claim 1 lines 7-8 recites “the actual scalp EEG” but it is unclear if this limitation is the same as, related to, or different from “a plurality of scalp signals from an EEG” of claim 1 lines 4-5. For the purposes of this examination, the limitations will be interpreted as referring to the same signals. This rejection is further applied to the similar recitations in claims 6 and 11.
Claims 2-3 are rejected by virtue of their dependence on claim 1.
Claims 7-8 are rejected by virtue of their dependence on claim 6.
Claim Rejections - 35 USC § 101
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 1-3, 6-8, and 11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claims 1-3, 6-8, and 11 are directed to a method of processing ESI signals using a computational algorithm, which is an abstract idea. Claims 1-3, 6-8, and 11 do not include additional elements that integrate the exception into a practical application or that are sufficient to amount to significantly more than the judicial exception for the reasons provided below which are in line with the 2014 Interim Guidance on Patent Subject Matter Eligibility (Federal Register, Vol. 79, No. 241, p 74618, December 16, 2014), the July 2015 Update on Subject Matter Eligibility (Federal Register, Vol. 80, No. 146, p. 45429, July 30, 2015), the May 2016 Subject Matter Eligibility Update (Federal Register, Vol. 81, No. 88, p. 27381, May 6, 2016), and the 2019 Revised Patent Subject Matter Eligibility Guidance (Federal Register, Vol. 84, No. 4, page 50, January 7, 2019).
The analysis of claim 1 is as follows:
Step 1: Claim 1 is drawn to a process.
Step 2A – Prong One: Claim 1 recites an abstract idea. In particular, claim 1 recites the following limitations:
[A1] converting an ESI for a patient into a plurality of ESI waveforms wherein the ESI is a combination of a model of a brain with a plurality of scalp signals from an EEG that estimates a source and intensity of a signal within the patient's brain, and is measured in micro-volts as a time series in parallel to the actual scalp EEG
[B1] placing a virtual electrode at a three-dimensional (3D) location of a representation of the patient's brain or on a surface of the scalp along with a circumference representing an area to be sampled
[C1] receiving a direct measurement of the virtual electrode at the 3D location utilizing the plurality of ESI waveforms
These elements [A1]-[C1] of claim 1 are drawn to an abstract idea since (1) they involve mathematical concepts in the form of mathematical relationships, mathematical formulas or equations, and/or mathematical calculations.
Step 2A – Prong Two: Claim 1 recites the following additional limitations that are beyond the judicial exception.
[A2] a processor
This element [A2] of claim 1 does not integrate the exception into a practical application of the exception. In particular, the element [A2] is merely an instruction to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.04(d) and MPEP 2106.05(f).
Step 2B: Claim 1 does not recite additional elements that amount to significantly more than the judicial exception itself. In particular, the recitation “wherein the ESI is a combination of a model of a brain with a plurality of scalp signals from an EEG that estimates a source and intensity of a signal within the patient's brain, represented by a set of three dimensional voxels with each voxel having an estimated value at a point in time based on the plurality of scalp signals, and is measured in micro-volts as a time series” does not qualify as significantly more because this limitation merely describes the nature of the ESI data and does not incorporate the plurality of scalp electrodes as part of the claimed invention.
Further, the element [A2] does not qualify as significantly more because this limitation is simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014)) and/or a claim to an abstract idea requiring no more than being stored on a computer readable medium which is a well-understood, routine and conventional activity previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taking individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Claims 2-3 depend from claim 1, and recite the same abstract idea as claim 1. Furthermore, these claims only contain recitations that further limit the abstract idea (that is, the claims only recite limitations that further limit the algorithm).
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations of each claim as an ordered combination in conjunction with the claims from which they depend (that is, as a whole) adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
The analysis of claim 6 is done in light of the above analysis of claim 1 and may be abridged where elements are similar.
The analysis of claim 6 is as follows:
Step 1: Claim 6 is drawn to a machine.
Step 2A – Prong One: Claim 6 recites an abstract idea. In particular, claim 6 recites the following limitations:
[A1] converting an ESI for a patient into a plurality of ESI waveforms wherein the ESI is a combination of a model of a brain with a plurality of scalp signals from an EEG that estimates a source and intensity of a signal within the patient's brain, and is measured in micro-volts as a time series in parallel to the actual scalp EEG
[B1] placing a virtual electrode at a three-dimensional (3D) location of a representation of the patient's brain or on a surface of the scalp along with a circumference representing an area to be sampled
[C1] receiving a direct measurement of the virtual electrode at the 3D location utilizing the plurality of ESI waveforms
These elements [A1]-[C1] of claim 6 are drawn to an abstract idea since (1) they involve mathematical concepts in the form of mathematical relationships, mathematical formulas or equations, and/or mathematical calculations.
Step 2A – Prong Two: Claim 6 recites the following limitations that are beyond the judicial exception:
[A2] a non-transitory computer-readable medium
[B2] a processor
These elements [A2]-[B2] of claim 6 does not integrate the exception into a practical application of the exception. In particular, the elements [A2]-[B2] are merely an instruction to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.04(d) and MPEP 2106.05(f).
Step 2B: Claim 6 does not recite additional elements that amount to significantly more than the judicial exception itself. In particular, the recitation “wherein the ESI is a combination of a model of a brain with a plurality of scalp signals from an EEG that estimates a source and intensity of a signal within the patient's brain, represented by a set of three dimensional voxels with each voxel having an estimated value at a point in time based on the plurality of scalp signals, and is measured in micro-volts as a time series” does not qualify as significantly more because this limitation merely describes the nature of the ESI data and does not incorporate the plurality of scalp electrodes as part of the claimed invention.
Further, the elements [A2]-[B2] do not qualify as significantly more because this limitation is simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014)) and/or a claim to an abstract idea requiring no more than being stored on a computer readable medium which is a well-understood, routine and conventional activity previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taking individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Claims 7-8 depend from claim 6, and recite the same abstract idea as claim 6. Furthermore, these claims only contain recitations that further limit the abstract idea (that is, the claims only recite limitations that further limit the algorithm).
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations of each claim as an ordered combination in conjunction with the claims from which they depend (that is, as a whole) adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
The analysis of claim 11 is done in light of the above analysis of claims 1 and 6 and may be abridged where elements are similar.
The analysis of claim 11 is as follows:
Step 1: Claim 11 is drawn to a process.
Step 2A – Prong One: Claim 1 recites an abstract idea. In particular, claim 1 recites the following limitations:
[A1] converting an ESI for a patient into a plurality of ESI waveforms wherein the ESI is a combination of a model of a brain with a plurality of scalp signals from an EEG that estimates a source and intensity of a signal within the patient's brain, and is measured in micro-volts as a time series in parallel to the actual scalp EEG
[B1] placing a virtual electrode at a three-dimensional (3D) location of a representation of the patient's brain or on a surface of the scalp along with a circumference representing an area to be sampled
[C1] receiving a direct measurement of the virtual electrode at the 3D location utilizing the plurality of ESI waveforms
[D1] generating a virtual SEEG probe based on the measurement from the virtual electrode
These elements [A1]-[D1] of claim 11 are drawn to an abstract idea since (1) they involve mathematical concepts in the form of mathematical relationships, mathematical formulas or equations, and/or mathematical calculations.
Step 2A – Prong Two: Claim 1 recites the following additional limitations that are beyond the judicial exception.
[A2] a processor
This element [A2] of claim 1 does not integrate the exception into a practical application of the exception. In particular, the element [A2] is merely an instruction to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.04(d) and MPEP 2106.05(f).
Step 2B: Claim 1 does not recite additional elements that amount to significantly more than the judicial exception itself. In particular, the recitation “wherein the ESI is a combination of a model of a brain with a plurality of scalp signals from an EEG that estimates a source and intensity of a signal within the patient's brain, represented by a set of three dimensional voxels with each voxel having an estimated value at a point in time based on the plurality of scalp signals, and is measured in micro-volts as a time series” does not qualify as significantly more because this limitation merely describes the nature of the ESI data and does not incorporate the plurality of scalp electrodes as part of the claimed invention.
Further, the element [A2] does not qualify as significantly more because this limitation is simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014)) and/or a claim to an abstract idea requiring no more than being stored on a computer readable medium which is a well-understood, routine and conventional activity previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taking individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-3, 6-8, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over He US Patent Application Publication Number US 2013/0096408 A1 hereinafter He in view of Wu US Patent Application Publication Number US 2016/0120457 A1 hereinafter Wu further in view of Ramanathan US Patent Application publication Number US 2014/0005563 A1 hereinafter Ramanathan.
Regarding claim 1, He discloses a computer-implemented method for visualizing data from electrical source imaging (ESI) for long term events (Abstract), the method comprising:
Converting, at a processor, (Paragraph 0063: the algorithm is implemented on a processor) an ESI for a patient into a plurality of ESI waveforms, wherein the ESI is a combination of a model of a brain with a plurality of scalp signals from an EEG that estimates a source and intensity of a signal within the patient's brain (Paragraphs 0015 and 0029-0032: the 3-D distributed source model generated from MRI images and scalp EEG recordings), and is measured as a time series in parallel to the actual scalp EEG (Paragraphs 0032-0034 and 0048-0050: the scalp EEGs are used to determine the seizure onset zone using time-varying source power and are used in the model. Thus they are recorded in parallel; Figs. 1 and 2A-B the waveform in the time domain.);
He fails to explicitly disclose the method wherein the EEG is measured in micro-volts; and placing a virtual electrode at a three-dimensional (3D) location of a representation of the patient's brain or on a surface of the scalp along with a circumference representing an area to be sampled; and receiving, at a processor, a direct measurement of the virtual electrode at the 3D location utilizing the plurality of ESI waveforms.
Wu teaches methods, systems, and computer readable media for visualization of a resection target during epilepsy surgery and for real time spatiotemporal visualization of neurophysiologic biomarkers. One exemplary method includes a real time neurophysiologic biomarker visualization system implemented by at least one computer, receiving, as input, a pre-electrode-implantation MRI of an epilepsy patient's brain (Abstract). Thus, Wu falls within the same field of endeavor as Applicant’s invention.
Wu teaches an EEG measured in micro-volts as a time series (Fig. 3a: The scale at the bottom left depicts that the Y axis is measured in micro-volts and the X axis is measured in milliseconds; Paragraph 0029-0031); generating a virtual electrode from the plurality of ES| waveforms (Paragraph 0067); placing the virtual electrode at a three-dimensional (3D) location of a representation of the patient's brain or on a surface of the scalp along with a circumference representing an area to be sampled (Paragraph 0067; Fig. 2(c) and (d) the circles around each of the electrode numbers appear to be an area that the electrode is sampling from. It would seem that the virtual electrode would be represented similarly).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to incorporate the scale of EEG measurement, virtual electrode functionality, and definition of an area being sampled by an electrode as taught by Wu into the method of He because the EEG scale used by Wu is typical for EEG measurement and would allow the system to more easily communicate with and share data to other programs using this typical scale. Furthermore, He discloses the creating of a 3-D map which illustrates electrical activity (He: Paragraphs 0029-0030), Wu utilizes a similar map (Wu: Paragraph 0067: cortical surface model) and teaches that using the model for virtual electrode modeling can reduce the burden of manually transposing the electrode locations (Wu: Paragraph 0067). Finally, incorporating the definition of an area being sampled by each electrode such as illustrated by Wu would provide the user a direct method of visualizing what electrodes are most directly sampling the area of interest which may allow for the reduction in overall number of electrodes and thus reduced computational intensity.
He in view of Wu fails to teach the method comprising: receiving, at the processor, a direct measurement of the virtual electrode at the 3D location utilizing the plurality of ESI waveforms.
Ramanathan teaches a system for visualizing electrophysiology information comprising receiving and storing electroanatomic data over time which is representative of electrical activity on the region of interest within the patient’s body. The system then provides a visual representation of physiological information by applying at least one analysis method to the stored data (Abstract). Thus, Ramanathan falls within the same field of endeavor as the applicant’s invention.
Ramanathan teaches a system comprising an electrode array to gather electrophysiological data from the region of interest. The gathered data is combined with patient geometry information to reconstruct the electrical activity for a desired surface region of an organ (Paragraph 0037). The geometry information may come from a variety of imaging techniques including MRI (Paragraph 0041). The created model can then be utilized for the placement and analysis of virtual electrodes which provide electrograms or plots of other physiological information at the location they are placed (Paragraph 0045). The virtual electrodes may produce data at a single point, at multiple points, and/or from a multiple dimension space (Paragraph 0067).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to include the receiving of data from the placed virtual electrode as taught by Ramanathan into the method of He in view of Wu because configuring the method to receive a direct measurement from the virtual electrode allows for better experimentation of electrode placement to find the optimal measurement position virtually.
Regarding claim 2, He in view of Wu further in view of Ramanathan teaches the method according to claim 1. He further discloses the method wherein the ESI comprises MRI imaging (Paragraph 0029).
Regarding claim 3, He in view of Wu further in view of Ramanathan teaches the method according to claim 1. He further discloses the method wherein the model of the brain is created prior to an operation (Paragraph 0029: the model is constructed of pre-operative MRI images), but fails to explicitly disclose the method wherein the model of the brain is created prior to an acquisition of the EEG.
Ramanathan teaches a method wherein the MRI model of the brain may be created separately from the EEG capture and may be created prior to or after the EEG capture (Paragraph 0041)
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to create the model prior to the EEG capture as taught by Ramanathan into the method of He in view of Wu further in view of Ramanathan because creating the model prior to the EEG capture may allow for further refinement of the model to better relate the actual structures and properties of the patient prior to adding the EEG data.
Regarding claim 6, He discloses a non-transitory computer-readable medium that stores a program that causes a processor to perform functions to visual data from electrical source imaging (ESI) for long term events by executing the following steps (Abstract; Paragraph 0122):
Converting, at the processor, (Paragraph 0063: the algorithm is implemented on a processor) an ESI for a patient into a plurality of ESI waveforms, wherein the ESI is a combination of a model of a brain with a plurality of scalp signals from an EEG that estimates a source and intensity of a signal within the patient's brain, (Paragraphs 0015 and 0029-0032: the 3-D distributed source model generated from MRI images and scalp EEG recordings) and is measured as a time series in parallel to the actual scalp EEG (Paragraphs 0032-0034 and 0048-0050: the scalp EEGs are used to determine the seizure onset zone using time-varying source power and are used in the model. Thus they are recorded in parallel; Figs. 1 and 2A-B the waveform in the time domain.);
He fails to explicitly disclose the system wherein the EEG is measured in micro-volts; and placing a virtual electrode at a three-dimensional (3D) location of a representation of the patient's brain along with a circumference representing an area to be sampled; and receiving, at the processor, a direct measurement of the virtual electrode at the 3D location utilizing the plurality of ESI waveforms.
Wu teaches an EEG measured in micro-volts as a time series (Fig. 3a: The scale at the bottom left depicts that the Y axis is measured in micro-volts and the X axis is measured in milliseconds; Paragraph 0029-0031); generating a virtual electrode from the plurality of ES| waveforms (Paragraph 0067); placing the virtual electrode at a three-dimensional (3D) location of a representation of the patient's brain or on a surface of the scalp along with a circumference representing an area to be sampled (Paragraph 0067; Fig. 2(c) and (d) the circles around each of the electrode numbers appear to be an area that the electrode is sampling from. It would seem that the virtual electrode would be represented similarly).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to incorporate the scale of EEG measurement, virtual electrode functionality, and definition of an area being sampled by an electrode as taught by Wu into the system of He because the EEG scale used by Wu is typical for EEG measurement and would allow the system to more easily communicate with and share data to other programs using this typical scale. Furthermore, He discloses the creating of a 3-D map which illustrates electrical activity (He: Paragraphs 0029-0030), Wu utilizes a similar map (Wu: Paragraph 0067: cortical surface model) and teaches that using the model for virtual electrode modeling can reduce the burden of manually transposing the electrode locations (Wu: Paragraph 0067). Finally, incorporating the definition of an area being sampled by each electrode such as illustrated by Wu would provide the user a direct method of visualizing what electrodes are most directly sampling the area of interest which may allow for the reduction in overall number of electrodes and thus reduced computational intensity.
He in view of Wu fails to teach the system comprising: receiving, at the processor, a direct measurement of the virtual electrode at the 3D location utilizing the plurality of ESI waveforms.
Ramanathan teaches a system comprising an electrode array to gather electrophysiological data from the region of interest. The gathered data is combined with patient geometry information to reconstruct the electrical activity for a desired surface region of an organ (Paragraph 0037). The geometry information may come from a variety of imaging techniques including MRI (Paragraph 0041). The created model can then be utilized for the placement and analysis of virtual electrodes which provide electrograms or plots of other physiological information at the location they are placed (Paragraph 0045). The virtual electrodes may produce data at a single point, at multiple points, and/or from a multiple dimension space (Paragraph 0067).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to include the receiving of data from the placed virtual electrode as taught by Ramanathan into the system of He in view of Wu because configuring the method to receive a direct measurement from the virtual electrode allows for better experimentation of electrode placement to find the optimal measurement position virtually.
Regarding claim 7, He in view of Wu further in view of Ramanathan teaches the non-transitory computer readable medium according to claim 6. He further discloses the system wherein the ESI comprises MRI imaging (Paragraph 0029).
Regarding claim 8, He in view of Wu further in view of Ramanathan teaches the non-transitory computer readable medium according to claim 6. He further discloses the system wherein the model of the brain is created prior to an operation (Paragraph 0029: the model is constructed of pre-operative MRI images), but fails to explicitly disclose the processor executes the further step of creating the model of the brain prior to generating the EEG..
Ramanathan teaches a method wherein the MRI model of the brain may be created separately from the EEG capture and may be created prior to or after the EEG capture (Paragraph 0041)
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to create the model prior to the EEG capture as taught by Ramanathan into the system of He in view of Wu further in view of Ramanathan because creating the model prior to the EEG capture may allow for further refinement of the model to better relate the actual structures and properties of the patient prior to adding the EEG data.
Regarding claim 11, He discloses a computer-implemented method for visualizing data from electrical source imaging (ESI) for stereo EEG (SEEG) (Abstract), the method comprising:
Converting, at a processor, (Paragraph 0063: the algorithm is implemented by a processor) an ESI for a patient into a plurality of ESI waveforms, wherein the ESI is a combination of a model of a brain with a plurality of scalp signals from an EEG that estimates a source and intensity of a signal within the patient's brain (Paragraphs 0015 and 0029-0032: the 3-D distributed source model generated from MRI images and scalp EEG recordings), and is measured as a time series in parallel to the actual scalp EEG (Paragraphs 0032-0034 and 0048-0050: the scalp EEGs are used to determine the seizure onset zone using time-varying source power and are used in the model. Thus they are recorded in parallel; Figs. 1 and 2A-B the waveform in the time domain.);
He fails to explicitly disclose the method wherein the EEG is measured in micro-volts; and placing a virtual electrode at a three-dimensional (3D) location of a representation of the patient's brain along with a circumference representing an area to be sampled; receiving, at the processor, a direct measurement of the virtual electrode at the 3D location utilizing the plurality of ESI waveforms; generating, at the processor, a virtual SEEG probe based on the measurement from the virtual electrode.
Wu teaches an EEG measured in micro-volts as a time series (Fig. 3a: The scale at the bottom left depicts that the Y axis is measured in micro-volts and the X axis is measured in milliseconds; Paragraph 0029-0031); generating a virtual electrode from the plurality of ESI waveforms (Paragraph 0067); placing the virtual electrode at a three-dimensional (3D) location of a representation of the patient's brain or on a surface of the scalp along with a circumference representing an area to be sampled (Paragraph 0067; Fig. 2(c) and (d) the circles around each of the electrode numbers appear to be an area that the electrode is sampling from. It would seem that the virtual electrode would be represented similarly); and generating a virtual SEEG probe based on the measurement from the virtual electrode (It is noted that an SEEG probe is merely an implantable type of EEG probe which is utilized by Wu see Fig. 2 and Paragraph 0016 thus the virtual probe of Paragraph 0067 would also seem to be an implantable or SEEG probe)
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to incorporate the scale of EEG measurement, virtual electrode functionality, and definition of an area being sampled by an electrode as taught by Wu into the method of He because the EEG scale used by Wu is typical for EEG measurement and would allow the system to more easily communicate with and share data to other programs using this typical scale. Furthermore, He discloses the creating of a 3-D map which illustrates electrical activity (He: Paragraphs 0029-0030), Wu utilizes a similar map (Wu: Paragraph 0067: cortical surface model) and teaches that using the model for virtual electrode modeling can reduce the burden of manually transposing the electrode locations (Wu: Paragraph 0067). Finally, incorporating the definition of an area being sampled by each electrode such as illustrated by Wu would provide the user a direct method of visualizing what electrodes are most directly sampling the area of interest which may allow for the reduction in overall number of electrodes and thus reduced computational intensity.
He in view of Wu fails to teach the method comprising: receiving, at the processor, a direct measurement of the virtual electrode at the 3D location utilizing the plurality of ESI waveforms.
Ramanathan teaches a system comprising an electrode array to gather electrophysiological data from the region of interest. The gathered data is combined with patient geometry information to reconstruct the electrical activity for a desired surface region of an organ (Paragraph 0037). The geometry information may come from a variety of imaging techniques including MRI (Paragraph 0041). The created model can then be utilized for the placement and analysis of virtual electrodes which provide electrograms or plots of other physiological information at the location they are placed (Paragraph 0045). The virtual electrodes may produce data at a single point, at multiple points, and/or from a multiple dimension space (Paragraph 0067).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to include the receiving of data from the placed virtual electrode as taught by Ramanathan into the method of He in view of Wu because configuring the method to receive a direct measurement from the virtual electrode allows for better experimentation of electrode placement to find the optimal measurement position virtually.
Response to Arguments
Applicant's arguments filed 085/22/2025 have been fully considered but they are not persuasive.
In particular, Applicant’s amendments have overcome the previously presented grounds of rejection under 35 USC 113 but necessitated new grounds of rejection.
In particular, the incorporation of a processor into the methods of claims 1 and 11 are insufficient to implement the methods into a practical application because the computer is merely a tool to implement the method. The method does not improve the functioning of the computer itself and is thus not considered an improvement to the computer.
In particular, Applicant argues that it would not be obvious to combine He, Wu, and Ramanathan and that the prior art fails to disclose the intensity of a signal is measured in micro-volts as a time series in parallel to the actual scalp EEG.
These arguments are not found to be persuasive because Applicant does not provide any rationale as to why the references are not obvious to combine and He is considered to teach the intensity signals being acquired in parallel to the actual scalp signals as best understood in light of the above presented 35 USC 112 rejections.
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.
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/MATTHEW ERIC OGLES/Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791