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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/07/2026 has been entered.
Claims 1-3, 6-8, and 11 are hereby the present claims under consideration.
Examiner’s Note: All references to Applicant’s specification are made using the paragraph numbers assigned in the US publication of the present application US 20210369181 A1.
Claim Objections
Claims, 1-2, 6-7 and 11 are objected to because of the following informalities:
Claim 1 line 6 it appears that “EEG” should read “electroencephalogram (EEG)”
Claim 2 line 2 it appears that “MRI” should read “magnetic resonance imaging (MRI)”
Claim 6 line 6 it appears that “EEG” should read “electroencephalogram (EEG)”
Claim 7 line 2 it appears that “MRI” should read “magnetic resonance imaging (MRI)”
Claim 11 line 2 it appears that “stereo EEG” should read “stereo electroencephalogram (SEEG)”
Claim 11 line 5 it appears that “EEG” should read “electroencephalogram (EEG)”
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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” but it is unclear what “ESI waveforms” are meant to refer to. In particular, the claim appears to refer to ESI waveforms as separate and distinct from EEG signals in the limitation “a scalp EEG that estimates a source and intensity of a signal within the patient's brain, and the ESI is measured in micro-volts as a time series in parallel to the scalp EEG” which sets forth that the scalp EEG is measured in parallel with, but is not the same as, the ESI which is converted into a plurality of ESI waveforms. It is unclear what the ESI waveforms entail and how the ESI is converted into such waveforms since it would seem that an ESI comprises a model of the brain that has been associated with measured EEG signals to identify sources of the measured EEG signals. Thus the only “waveforms” seemingly associated with the ESI are the measured EEG waveforms themselves. The locations of the sources of the signals which are derived from the measured EEG to generate the ESI are not considered to be waveforms. The relationship between the EEG signals, the ESI waveforms, and how the ESI waveforms are converted from the ESI is unclear. For the purposes of this examination, the ESI waveforms are interpreted as simulated EEG signals generated using the brain model and source estimates. This rejection and interpretation are similarly applied to the similar limitations of claims 6 and 11.
Claim 1 recites “the ESI is measured in micro-volts as a time series in parallel to the scalp EEG” but it would seem that the ESI waveforms are generated from the ESI which has been derived from the measured scalp EEG signals. Thus it is unclear how the ESI waveforms are considered to be measured “in parallel” to the scalp EEG signals from which they are derived. For the purposes of this examination, the simulated waveforms generated from ESI are considered to inherently be generated in parallel with the scalp EEG signals from which they are derived since the simulated waveforms are intrinsically linked to the scalp EEG recordings from which they are derived. This rejection and interpretation are similarly applied to the similar limitations of claims 6 and 11.
Claim 1 recites “a representation of the patient’s brain” in line 9 but it is unclear if this representation is the same as, related to, or different from “an ESI for a patient” which includes a model of the patient’s brain. For the purposes of this examination the representation of the patient’s brain will be interpreted as the ESI model or a graphical representation thereof. This rejection and interpretation are similarly applied to the similar limitations of claims 6 and 11.
Claim 1 recites “placing, at a processor, a plurality of virtual electrodes at three-dimensional (3D) locations in a representation of the patient's brain or on a surface of the scalp along with a circumference representing an area to be sampled to construct an array that matches an array of implants in intracranial EEG monitoring” but it is unclear how virtually placing electrodes on the scalp is considered to “construct an array that matches an array of implants in intracranial EEG monitoring” since it would seem the virtual scalp electrodes are not intracranial. For the purposes of this examination, the placement of virtual scalp electrodes will be considered as constructing an array of implants in intracranial EEG monitoring.
Claim 1 recites “displaying the array on an EEG page to appear as a page produce by actual invasive recordings” but it is unclear if this limitation is meant to convey that the “array” of electrodes (i.e. the plurality of virtually placed electrodes) is being displayed, or if the “direct measurements” therefrom are being displayed or if both the measurements and the placements are being displayed. The recitation of displaying the array appears to indicate that the placements are displayed while the recitation of “appear as a page produces by actual invasive recordings” seems to indicate that the “direct measurements” are displayed. For the purposes of this examination, the limitation will be interpreted as requiring both the virtual placement locations and the associated recording as being displayed.
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 11 recites “generating, at the processor, a virtual SEEG probe based on the measurement from the virtual electrode” but it is unclear how this generation differs from or is related to the placement of the virtual electrode and receipt of data from the virtual electrode. It is unclear if the virtual electrode itself is considered to be the SEEG probe after the receipt of data or if the received data is further processed in some manner to generate data from an SEEG probe, or if some other form of generating a SEEG probe is occurring. For the purposes of this examination, the limitation will be interpreted as requiring the virtual electrode to be placed within the brain such that the virtual electrode is a SEEG probe.
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), and the 2024 Update on Subject Matter Eligibility (Federal Register, Vol 89, No. 137, page 58128, July 17, 2024).
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
[B1] placing a plurality of virtual electrodes at three-dimensional (3D) locations in a representation of the patient's brain or on a surface of the scalp along with a circumference representing an area to be sampled to construct an array that matches an array of implants in intracranial EEG monitoring
These elements [A1]-[B1] of claim 1 are drawn to an abstract idea since they involve a mental process that can be practically performed in the human mind including observation, evaluation, judgment, and opinion and using pen and paper.
Step 2A – Prong Two: Claim 1 recites the following additional limitations that are beyond the judicial exception.
[A2] a processor
[B2] receiving direct measurements of the virtual electrodes at the 3D locations utilizing the plurality of ESI waveforms
[C2] displaying the array on an EEG page to appear as a page produce by actual invasive recordings
These elements [A2]-[C2] of claim 1 do 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). Also, the element [B2] merely adds the words “apply it” (or an equivalent) with the judicial exception – see MPEP 2106.05(f). Additionally, the element [C2] is merely adding insignificant extra-solution activity to the judicial exception, i.e., mere data gathering at a higher level of generality or displaying of results recited at a high level of generality - see MPEP 2106.04(d) and MPEP 2106.05(g)
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 a scalp EEG that estimates a source and intensity of a signal within the patient's brain, and the ESI is measured in micro-volts as a time series in parallel to the scalp EEG” 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.
Additionally, the element [C2] is merely insufficient extra-solution activity involving the display of the output of the algorithm and uses well-known, routine, and conventional computing elements of a computer such as a display. The step of displaying the output is recited at a high level of generality and is thus not considered to amount to the generation of a particular display.
The element [B2] merely adds the words “apply it” or the equivalent to the judicial exception because the element [B2] is drawn towards receiving signals from the virtually placed electrodes which is merely an instruction to implement the abstract idea on a computer and carry out the abstract idea. See MPEP 2106.05(f).
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
[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
These elements [A1]-[B1] of claim 6 are drawn to an abstract idea since they involve a mental process that can be practically performed in the human mind including observation, evaluation, judgment, and opinion and using pen and paper.
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
[C2] receiving a direct measurement of the virtual electrode at the 3D location utilizing the plurality of ESI waveforms
These elements [A2]-[C2] 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). Also, the element [C2] merely adds the words “apply it” (or an equivalent) with the judicial exception – see 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 a scalp EEG that estimates a source and intensity of a signal within the patient's brain, and the ESI is measured in micro-volts as a time series in parallel to the scalp EEG” 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.
Furthermore the elements [B2] and [C2] do not amount to significantly more than the abstract idea for the same reasons presented in regards to the similar limitations of claim 1.
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 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 11 recites an abstract idea. In particular, claim 11 recites the following limitations:
[A1] converting an ESI for a patient into a plurality of ESI waveforms
[B1] 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
These elements [A1]-[B1] of claim 11 are drawn to an abstract idea since they involve a mental process that can be practically performed in the human mind including observation, evaluation, judgment, and opinion and using pen and paper.
Step 2A – Prong Two: Claim 11 recites the following additional limitations that are beyond the judicial exception.
[A2] a processor
[B2] receiving a direct measurement of the virtual electrode at the 3D location utilizing the plurality of ESI waveforms
[C2] generating a virtual SEEG probe based on the measurement from the virtual electrode
This element [A2] of claim 11 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). Also, the elements [B2] and [C2] merely adds the words “apply it” (or an equivalent) with the judicial exception – see MPEP 2106.05(f)
Step 2B: Claim 11 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 a scalp EEG that estimates a source and intensity of a signal within the patient's brain, and the ESI is measured in micro-volts as a time series in parallel to the scalp EEG” 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.
Furthermore the elements [A2] and [B2] do not amount to significantly more than the abstract idea for the same reasons presented above with respect to the similar elements of claims 1 and 6.
The element [C2] merely adds the words “apply it” or the equivalent to the judicial exception because the element [C2] is drawn towards the generation of a virtual probe based the received signals which is merely an instruction to implement the abstract idea on a computer and carry out the abstract idea by receiving virtual signals and associating said signals with a virtual probe. See MPEP 2106.05(f). The step of generating is recited with a high degree of generality and the particular metes and bounds of the generating step are unclear as described in the above presented rejection under 35 USC 112(b) and thus the generation of the SEEG probe is considered to amount to nothing more than a recitation to apply the abstract idea on a computer.
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 1-2 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 Leon “The Virtual Brain: a simulator of primate brain network dynamics” published by Frontiers in Neuroinformatics on June 10th 2013 pages 1-23 hereinafter Leon, in view of Hosseini “Electromagnetic source imaging using simultaneous scalp EEG and intracranial EEG: An emerging tool for interacting with pathological brain networks” published by Science Direct in January 2018, pages 1-20 hereinafter Hosseini, in view of Cavuoto US Patent Application Publication Number US 20150366497 A1 hereinafter Cavuoto further in view of Wu US Patent Application Publication Number US 2016/0120457 A1 hereinafter Wu.
Regarding claim 1, He discloses a computer-implemented method for visualizing data from electrical source imaging (ESI) for long term events (Abstract), the computer implemented 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 a scalp EEG that estimates a source and intensity of a signal within the patient's brain (Paragraphs 0015 and 0029-0032: the scalp signals and brain model (BEM) are used to localize a plurality of sources ,the ESI is the combination of the scalp signals and brain model to localize the sources. The ESI is used to generate a spatio-temporal representation of the whole brain neural activity based on the plurality of sources, the conversion of the ESI into ESI waveforms; Paragraph 0049: source waveforms can be achieved in each voxel of interest), and the ESI is measured as a time series in parallel to the actual scalp EEG (Paragraphs 0032-0035 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 the generated spatio-temporal representation of the whole brain using the localized sources in considered to be in parallel with the scalp EEG measurements; Paragraph 0049: source waveforms can be achieved in each voxel of interest);
He discloses the measurement of source waveforms at any voxel of interest in the brain (Paragraphs 0034-0035 and 0049). However He fails to explicitly disclose the method wherein the EEG is measured in micro-volts; and placing, at a processor, a plurality of virtual electrodes at three-dimensional (3D) locations in a representation of the patient's brain or on a surface of the scalp along with a circumference representing an area to be sampled to construct an array that matches an array of implants in intracranial EEG monitoring; and receiving, at the processor, direct measurements of the virtual electrodes at the 3D locations utilizing the plurality of ESI waveforms; and displaying the array on an EEG page to appear as a page produced by actual invasive recordings.
Leon teaches a brain simulation method (Abstract). Thus, Leon falls within the same field of endeavor as Applicant’s invention.
Leon teaches a method including placing, at a processor, a plurality of virtual electrodes on a surface of the scalp to construct an array that matches an array of implants in intracranial EEG monitoring; and receiving, at the processor, direct measurements of the virtual electrodes at the 3D locations utilizing the plurality of ESI waveforms (Page 10: section 2.3.5 Monitors: the model may include a plurality of monitors which provide physically realistic measurement processes of the simulation including generating EEG data); and displaying the array on an EEG page to appear as a page produced by actual invasive recordings (Pages 12-14 Section 2.4 Analyzers and visualizers: the visualizers includes displays of interactive time series plots generated from the monitors and display of the sensor locations; Fig. 6C and Fig. 6 description)
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 virtual electrode placement and visualization taught by Leon into the method of He because HE already contemplates the ability to record waveforms from any voxel of the brain model (He: Paragraph 0049) and the virtual electrode placement and display taught by Leon would provide the system with an intuitive user interface for selecting areas of interest and displaying the resultant simulated waveforms. While Leon only illustrates electrode placement along the surface of the brain. He does contemplate the determination of waveforms at any voxel including those internal to the brain.
He in view of Leon fails to further teach the method wherein the EEG is measured in micro-volts, wherein the virtual electrodes are placed at three-dimensional (3D) locations in a representation of the patient's brain and wherein the virtual electrodes are displayed along with a circumference representing an area to be sampled.
Hosseini teaches an electrical source imaging model (Abstract). Thus Hosseini falls within the same field of endeavor as Applicant’s invention.
Hosseini teaches a model wherein virtual electrodes are placed at three-dimensional (3D) locations in a representation of the patient's brain (Pages 3-4 and Figs. 1-2: The model simulates electrical activity measurements taken at simulated locations for given source activity inputs. The simulated electrodes may be sEEG electrodes placed in a desired location with a particular number of contacts. The electrode placement may be visualized as in Fig. 2).
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 three dimensional electrode placement in the modelled brain as taught by Hosseini because He already contemplates the determination of a waveform for any given voxel in the model (Paragraph 0049) and including the capability of placing virtual electrodes inside the brain rather than just on the surface would improve the usefulness of the model by allowing a wider range of simulation possibilities.
He in view of Leon further in view of Hosseini fails to further teach the method wherein the EEG is measured in micro-volts, and wherein the virtual electrodes are displayed along with a circumference representing an area to be sampled.
Cavuoto teaches a system for analyzing neurological signals to generate modified neurological signals corresponding to a particular electrode placement (Abstract). Thus, Cavuoto falls within the same field of endeavor as Applicant’s invention.
Cavuoto teaches that electrodes have a radius to their ability to sense electrical impulses and that knowing this radius helps in the interpolation of determining what a sensor at a different location may record (Paragraphs 0052-0053).
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 radius of sensing capability of an electrode as taught by Cavuoto into the virtual electrode placement of He in view of Leon further in view of Hosseini such that the virtual electrodes are portrayed with some manner of indication of their sensing radius because Cavuoto teaches that knowing such a radius may help in interpolating additional virtual electrode data. Additionally displaying such a radius may allow a user to more easily identify the sensing area for each electrode in the simulation and allow them to adjust the positioning and/or number of electrodes such that a desired sensing area is covered.
He in view of Leon in view of Hosseini further in view of Cavuoto fails to further teach the method wherein the EEG is measured in micro-volts.
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).
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 as taught by Wu into the method of He in view of Leon in view of Hosseini further in view of Cavuoto 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. Additionally the particular scale of measurement is a matter of routine optimalization and experimentation to optimize the display and/or output for the method to suit a desired use case or readability.
Regarding claim 2, He in view of Leon in view of Hosseini in view of Cavuoto, further in view of Wu teaches the computer implemented method according to claim 1. Modified He further discloses the method wherein the ESI comprises MRI imaging (Paragraph 0029: the model is constructed from MRI images).
Regarding claim 11, He discloses a computer-implemented method for visualizing data from electrical source imaging (ESI) (Abstract) for stereo EEG (SEEG), 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 a scalp EEG that estimates a source and intensity of a signal within the patient's brain (Paragraphs 0015 and 0029-0032: the scalp signals and brain model (BEM) are used to localize a plurality of sources ,the ESI is the combination of the scalp signals and brain model to localize the sources. The ESI is used to generate a spatio-temporal representation of the whole brain neural activity based on the plurality of sources, the conversion of the ESI into ESI waveforms; Paragraph 0049: source waveforms can be achieved in each voxel of interest), and the ESI is measured as a time series in parallel to the actual scalp EEG (Paragraphs 0032-0035 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 the generated spatio-temporal representation of the whole brain using the localized sources in considered to be in parallel with the scalp EEG measurements; Paragraph 0049: source waveforms can be achieved in each voxel of interest.);
He discloses the measurement of source waveforms at any voxel of interest in the brain (Paragraphs 0034-0035 and 0049). However He fails to explicitly disclose the method being for stereo EEG (sEEG), wherein the EEG is measured in micro-volts; and placing, at the processor, 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.
Leon teaches a method including placing, at the processor, a virtual electrode at a three-dimensional (3D) location of a representation of the patient's brain; and receiving, at the processor, direct measurements of the virtual electrodes at the 3D locations utilizing the plurality of ESI waveforms (Page 10: section 2.3.5 Monitors: the model may include a plurality of monitors which provide physically realistic measurement processes of the simulation including generating EEG data).
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 virtual electrode placement and visualization taught by Leon into the method of He because HE already contemplates the ability to record waveforms from any voxel of the brain model (He: Paragraph 0049) and the virtual electrode placement and display taught by Leon would provide the system with an intuitive user interface for selecting areas of interest and displaying the resultant simulated waveforms. While Leon only illustrates electrode placement along the surface of the brain. He does contemplate the determination of waveforms at any voxel including those internal to the brain.
He in view of Leon fails to further teach the method being for stereo EEG (sEEG), wherein the EEG is measured in micro-volts; and placed along with a circumference representing an area to be sampled; generating, at the processor, a virtual SEEG probe based on the measurement from the virtual electrode.
Hosseini teaches a model for sEEG wherein virtual electrodes are placed at three-dimensional (3D) locations in a representation of the patient's brain, and generating, at the processor, a virtual SEEG probe based on the measurement from the virtual electrode. (Pages 3-4 and Figs. 1-2: The model simulates electrical activity measurements taken at simulated locations for given source activity inputs. The simulated electrodes may be sEEG electrodes placed in a desired location with a particular number of contacts. The electrode placement may be visualized as in Fig. 2).
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 three dimensional electrode placement in the modelled brain as taught by Hosseini because He already contemplates the determination of a waveform for any given voxel in the model (Paragraph 0049) and including the capability of placing virtual electrodes inside the brain rather than just on the surface would improve the usefulness of the model by allowing a wider range of simulation possibilities.
He in view of Leon further in view of Hosseini fails to further teach the method wherein the EEG is measured in micro-volts, and wherein the virtual electrodes are displayed along with a circumference representing an area to be sampled.
Cavuoto teaches that electrodes have a radius to their ability to sense electrical impulses and that knowing this radius helps in the interpolation of determining what a sensor at a different location may record (Paragraphs 0052-0053).
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 radius of sensing capability of an electrode as taught by Cavuoto into the virtual electrode placement of He in view of Leon further in view of Hosseini such that the virtual electrodes are portrayed with some manner of indication of their sensing radius because Cavuoto teaches that knowing such a radius may help in interpolating additional virtual electrode data. Additionally displaying such a radius may allow a user to more easily identify the sensing area for each electrode in the simulation and allow them to adjust the positioning and/or number of electrodes such that a desired sensing area is covered.
He in view of Leon in view of Hosseini further in view of Cavuoto fails to further teach the method wherein the EEG is measured in micro-volts.
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).
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 as taught by Wu into the method of He in view of Leon in view of Hosseini further in view of Cavuoto 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. Additionally the particular scale of measurement is a matter of routine optimalization and experimentation to optimize the display and/or output for the method to suit a desired use case or readability.
Claim 3 is 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 Leon “The Virtual Brain: a simulator of primate brain network dynamics” published by Frontiers in Neuroinformatics on June 10th 2013 pages 1-23 hereinafter Leon, in view of Hosseini “Electromagnetic source imaging using simultaneous scalp EEG and intracranial EEG: An emerging tool for interacting with pathological brain networks” published by Science Direct in January 2018, pages 1-20 hereinafter Hosseini, in view of Cavuoto US Patent Application Publication Number US 20150366497 A1 hereinafter Cavuoto in view of Wu US Patent Application Publication Number US 2016/0120457 A1 hereinafter Wu as applied to claim 1 above and further in view of Ramanathan US Patent Application Publication Number US 20140005563 A1 hereinafter Ramanathan.
Regarding claim 3, He in view of Leon in view of Hosseini in view of Cavuoto, further in view of Wu teaches the computer implemented method according to claim 1. Modified 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 of visualizing electrophysiological information (Abstract). Thus Ramanathan is reasonably pertinent to the problem at hand.
Ramanathan teaches a method wherein an 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: the patient geometry data may be determined from MRI data; such imaging can be performed before, at the same time as, or after the recording of patient electrical activity)
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 model creating prior to the EEG capture as taught by Ramanathan into the method of modified He 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.
Claims 6-7 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 Leon “The Virtual Brain: a simulator of primate brain network dynamics” published by Frontiers in Neuroinformatics on June 10th 2013 pages 1-23 hereinafter Leon, in view of Cavuoto US Patent Application Publication Number US 20150366497 A1 hereinafter Cavuoto further in view of Wu US Patent Application Publication Number US 2016/0120457 A1 hereinafter Wu.
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 a scalp EEG that estimates a source and intensity of a signal within the patient's brain, (Paragraphs 0015 and 0029-0032: the scalp signals and brain model (BEM) are used to localize a plurality of sources ,the ESI is the combination of the scalp signals and brain model to localize the sources. The ESI is used to generate a spatio-temporal representation of the whole brain neural activity based on the plurality of sources, the conversion of the ESI into ESI waveforms; Paragraph 0049: source waveforms can be achieved in each voxel of interest) and the ESI is measured as a time series in parallel to the scalp EEG (Paragraphs 0032-0035 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 the generated spatio-temporal representation of the whole brain using the localized sources in considered to be in parallel with the scalp EEG measurements; Paragraph 0049: source waveforms can be achieved in each voxel of interest.);
He discloses the measurement of source waveforms at any voxel of interest in the brain (Paragraphs 0034-0035 and 0049). However He fails to explicitly disclose the system wherein the EEG is measured in micro-volts; and placing, at the processor, 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.
Leon teaches a method including placing, at the processor, a virtual electrode at a three-dimensional (3D) location of a representation of the patient's brain; and receiving, at the processor, a direct measurement of the virtual electrode at the 3D location utilizing the plurality of ESI waveforms. (Page 10: section 2.3.5 Monitors: the model may include a plurality of monitors which provide physically realistic measurement processes of the simulation including generating EEG data).
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 virtual electrode placement and visualization taught by Leon into the method of He because HE already contemplates the ability to record waveforms from any voxel of the brain model (He: Paragraph 0049) and the virtual electrode placement and display taught by Leon would provide the system with an intuitive user interface for selecting areas of interest and displaying the resultant simulated waveforms. While Leon only illustrates electrode placement along the surface of the brain. He does contemplate the determination of waveforms at any voxel including those internal to the brain.
He in view of Leon fails to further teach the method wherein the EEG is measured in micro-volts, and wherein the virtual electrodes are displayed along with a circumference representing an area to be sampled.
Cavuoto teaches that electrodes have a radius to their ability to sense electrical impulses and that knowing this radius helps in the interpolation of determining what a sensor at a different location may record (Paragraphs 0052-0053).
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 radius of sensing capability of an electrode as taught by Cavuoto into the virtual electrode placement of He in view of Leon such that the virtual electrodes are portrayed with some manner of indication of their sensing radius because Cavuoto teaches that knowing such a radius may help in interpolating additional virtual electrode data. Additionally displaying such a radius may allow a user to more easily identify the sensing area for each electrode in the simulation and allow them to adjust the positioning and/or number of electrodes such that a desired sensing area is covered.
He in view of Leon further in view of Cavuoto fails to further discos the method wherein the EEG is measured in micro-volts.
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).
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 as taught by Wu into the method of He in view of Leon further in view of Cavuoto 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. Additionally the particular scale of measurement is a matter of routine optimalization and experimentation to optimize the display and/or output for the method to suit a desired use case or readability.
Regarding claim 7, He in view of Leon in view of Cavuoto, further in view of Wu teaches the non-transitory computer readable medium according to claim 6. Modified He further discloses the system wherein the ESI comprises MRI imaging (Paragraph 0029: the model is constructed from MRI images).
Claim 8 is 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 Leon “The Virtual Brain: a simulator of primate brain network dynamics” published by Frontiers in Neuroinformatics on June 10th 2013 pages 1-23 hereinafter Leon, in view of Cavuoto US Patent Application Publication Number US 20150366497 A1 hereinafter Cavuoto in view of Wu US Patent Application Publication Number US 2016/0120457 A1 hereinafter Wu as applied to claim 6 above and further in view of Ramanathan US Patent Application Publication Number US 20140005563 A1 hereinafter Ramanathan.
Regarding claim 8, He in view of Leon in view of Cavuoto, further in view of Wu 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 an 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: the patient geometry data may be determined from MRI data; such imaging can be performed before, at the same time as, or after the recording of patient electrical activity)
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 model creating prior to the EEG capture as taught by Ramanathan into the method of modified He 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.
Response to Arguments
Applicant's arguments filed 04/07/2026 have been fully considered but they are not persuasive.
In particular, Applicant’s arguments directed towards the rejection issued under 35 USC 103 are considered moot in light of the new grounds of rejection.
Applicant’s arguments that the recitation of performing the method on a processor render the claim eligible under 35 USC 101 is not found to be persuasive because the recitation of the processor is merely a recitation to implement the abstract idea onto a generic computer to use the computer as the tool for carrying out the abstract idea. Thus the processor is not considered to amount to significantly more than the abstract idea itself.
Conclusion
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/MATTHEW ERIC OGLES/Examiner, Art Unit 3791
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