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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on June 24, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings filed on March 05, 2024 are accepted.
Claim Objections
Claims 2-20 are objected to because of the following informalities: claims 2-20 should recite a comma after “claim _”). Claim 4 appears to have a typographical error and is intended to recite, “The method of claim 3, further comprising:…”.
Appropriate correction is required.
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.
Claims 1-20 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 the limitation “each EEG electrode”. There is insufficient antecedent basis for this limitation in the claim. There are no EEG electrodes previously recited.
Claim 1 recites the limitation “a time series of binary images” it is unclear if “binary images” are the same as “a binary image”. There is insufficient antecedent basis for this limitation in the claim.
Dependent claims are rejected as depending on a rejected base claim.
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 1-20 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.
Step 1 of the subject matter eligibility test (see MPEP 2106.03).
Claim 1 is directed to “a method” which describes one of the four statutory categories of patentable subject matter, i.e. a process.
Each of Claims 1-20 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A of the subject matter eligibility test (see MPEP 2106.04).
Prong One:
Claim 1 recites (“sets forth” or “describes”) the abstract idea of “mathematical concepts” (MPEP 2106.04(a)(2).I.), substantially as follows: “determining a power envelope of the EEG data for each EEG electrode; detecting depressions in the power envelope of each EEG electrode; projecting the detected depressions from each EEG electrode on a 2D plane; obtaining a binary image from the projection of the detected depressions; estimating movement of wavefronts in a time series of binary images; determining a dominant direction of propagation of the wavefronts; scoring each wavefront based on a consistency of speed and propagation; and selecting candidate frames based on the score for each wavefront; and stitching together selected frames using a sliding time window to obtain a final temporal detection indicating presence of a spreading depolarization (SD) wavefront.”
The above recited steps are mathematical concepts, which is defined as mathematical relationships, mathematical formulas or equations, and mathematical calculations. The Specification teaches that EEG data may be used to convert to a binary image and estimate the wavefronts movement direction and speed and propagation and stitch together frames to detect a spreading depolarization SD wavefront.. Spec. pages 9-26. Computing these encompasses the use of mathematical equations, which has been recognized as an abstract idea (i.e., a mathematical concept). Patent Eligibility Guidance, 84 Fed. Reg. at 52. In sum, we determine that Prong 1 recites a judicial exception, and proceed to Step 2A, Prong 2.
Therefore, each of the above steps are grouped as mathematical concepts, hence an abstract idea.
Claim 1 recites (“sets forth” or “describes”) the abstract idea of “a mental process” (MPEP 2106.04(a)(2).III.), substantially as follows: “determining a power envelope of the EEG data for each EEG electrode; detecting depressions in the power envelope of each EEG electrode; projecting the detected depressions from each EEG electrode on a 2D plane; obtaining a binary image from the projection of the detected depressions; estimating movement of wavefronts in a time series of binary images; determining a dominant direction of propagation of the wavefronts; scoring each wavefront based on a consistency of speed and propagation; and selecting candidate frames based on the score for each wavefront; and stitching together selected frames using a sliding time window to obtain a final temporal detection indicating presence of a spreading depolarization (SD) wavefront.”
The above recited steps can be practically performed in the human mind, with the aid of a pen and paper or with a generic computer, in a computer environment, or merely using the generic computer as a tool to perform the steps. If a person were to visually examine, i.e., perform an observation, the EEG data, either in a printout or an electronic format, he/she would be able to perform the calculations to the binary images via pen and paper. He/she would further be able to select binary images, stitch them together and determine spreading depolarization (SD) wavefronts via visual examination. There is nothing recited in the claim to suggest an undue level of complexity in how the wavefronts are to be identified. Therefore, a person would be able to perform the identification of peaks mentally or with a generic computer.
Prong Two: Claim 1 does not include additional elements that integrate the mental process into a practical application.
This judicial exception is not integrated into a practical application. In particular, the claims recites (1) “receiving EEG data”
The steps in (1) represent merely data gathering or pre-solution activities that are necessary for use of the recited judicial exception and are recited at a high level of generality with conventionally used tools (see below Step IIB for further details).
The step in (2) represents merely notification outputting by a processor as a post-solution activity and is recited at a high level of generality.
The steps in (3) merely recite generic computer components used to implement the abstract idea on, as tools.
As a whole, the additional elements merely serve to gather and feed information to the abstract idea and to output a notification based on the abstract idea, while generically implementing it on conventionally used tools. There is no practical application because the abstract idea is not applied, relied on, or used in a meaningful way. No improvement to the technology is evident, and the estimated bio-information is not outputted in any way such that a practical benefit is realized. Therefore, the additional elements, alone or in combination, do not integrate the abstract idea into a practical application.
Step 2B of the subject matter eligibility test (see MPEP 2106.05).
Claim 1 does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above, the claims recite additional steps of “receive EEG data”.
These steps represents mere data gathering, data outputting or pre/post/extra-solution activities that are necessary for use of the recited judicial exception and are recited at a high level of generality.
The EEG data is obtained from scalp EEG. These additional limitations merely represent insignificant, conventional pre-solution activities well-understood in the industry of EEGs, as the sensors recited are well understood, routine and conventional, as evidenced by that it is so well-known that it need not be described in detail in the patent specification. See [0006], [0019] and [0065] describing the EEG sensors as generic, reciting, “using standard scalp EEG…standard locations…”.
Accordingly, these additional steps and tools for measuring an EEG signal, and outputting a notification amount to no more than insignificant conventional extra-solution activity. Mere insignificant conventional extra-solution activity cannot provide an inventive concept.
The recited processors and computer-readable storage medium are generic computer elements (i.d. para. [0065] describing generic computers).
Therefore, none of claim 1 amounts to significantly more than the abstract idea itself.
Accordingly, claim 1 is not patent eligible and rejected under 35 U.S.C. 101 as being directed to abstract ideas implemented on a generic computer in view of the Supreme Court Decision in Alice Corporation Pty. Ltd. v. CLS Bank International, et al. and 2019 PEG.
Dependent Claims
The following dependent claims merely further define the abstract idea and are, therefore, directed to an abstract idea for similar reasons:
Claims 2-20 recitations further limits the abstract idea above, detecting falling edges, cross-correlating, spatial interpolation, the thresholding, etc. all merely further defines the mental process or mathematical equations discussed above. “wherein detecting depressions in the power envelope for each EEG electrode comprises: detecting falling edges of the power envelope; cross-correlating the power envelope for each EEG electrode with a first-derivative kernel such that the falling edges of the power envelope appear as peaks in a cross-correlation curve; rectifying the cross-correlation curve for each EEG electrode to isolate the peaks; wherein the detected depressions are projected on a 2D plane using cylindrical projection of locations of the EEG electrodes; performing spatial interpolation on the projected depressions to produce a smooth 2D image; thresholding the smooth 2D image to obtain the binary image; wherein the thresholding comprises: setting a pixel value to 0 in the smooth 2D image when the value of the pixel is below a first threshold; and setting the pixel value to 1 in the smooth 2D image when the pixel value is above the first threshold to create the binary image; wherein pixels representing a location of each EEG electrode are present in the binary image; wherein estimating movement of SD wavefronts in the time series of binary images comprises: spatially subsampling each binary image in the time series to reduce inter-electrode distances in each binary image; and applying an optical flow calculation to the time series of binary images to determine a magnitude of speed and direction of propagation of the SD wavefront; wherein determining a dominant direction of movement of the wavefronts comprises: assigning bounding boxes to connected components in the time series of binary images; calculating an orientation histogram for each bounding box; quantizing the orientation of the optical flows based on the quantization; and extracting a dominant direction of propagation for each bounding box based on the orientations; removing non-propagating bounding boxes; calculating an effective propagation measure for each bounding box; and removing bounding boxes having an effective propagation measure below a second threshold; removing all bounding boxes having a magnitude of speed outside of a predetermined range; finding spatial and temporal neighbor frames for each remaining bounding box; wherein a frame is a temporal neighbor of another frame in the bounding box if its temporal distance is within a temporal range is given by a third threshold; determining a spatiotemporal score for each remaining bounding box based on the number of matching bounding boxes; determining a temporal score for each remaining bounding box; wherein the temporal score is based on a ratio of the remaining frames of the bounding box having a non-zero temporal score to the total number of frames of the bounding box; removing the bounding box if the total number of frames having a temporal neighbor is less than a fourth threshold; stitching together remaining frames using a sliding time window to obtain a final determination of the existence of an SD wavefront; wherein the first, second, third and fourth thresholds are learned parameters; wherein the learned parameters are selected based on performance on a validation dataset after being optimized on a training dataset.” All merely further defines the mental process or mathematical equations discussed above.
Taken alone and in combination, the additional elements do not integrate the judicial exception into a practical application at least because the abstract idea is not applied, relied on, or used in a meaningful way. They also do not add anything significantly more than the abstract idea. Their collective functions merely provide computer/electronic implementation and processing, and no additional elements beyond those of the abstract idea. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. There is no indication that the combination of elements improves the functioning of a computer, output device, improves technology other than the technical field of the claimed invention, etc. Therefore, the claims are rejected as being directed to non-statutory subject matter.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Hartings et al. (US-20180085047-A1) and (US-20170135594-A1) both describe similar methods for detecting a spreading depolarization (SD) wavefront.
Ellison (US-20190378621-A1) discloses a binary image method for interpreting EEG data.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH A TOMBERS whose telephone number is (571)272-6851. The examiner can normally be reached on M-TH 7:00-16:00, F 7:00-11:00(Eastern).
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/JOSEPH A TOMBERS/Examiner, Art Unit 3791
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