DETAILED ACTION
Applicant' s arguments, filed 05/27/2026 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 11/13/2025, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claim 1 is the current claim 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 Objections
Claim 1 is objected to because of the following informalities:
Claim 1 line 14 it appears that “the value of a parameter” should read “the values of the parameter”
Appropriate correction is required.
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.
Claim 1 is 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. Claim 1 is directed to a method of processing EEG signals using a computational algorithm, which is an abstract idea. Claim 1 does 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:
[B1] analyzing the EEG data including a plurality of epochs, each epoch corresponding to one of the responses, to identify, in one or more of the epochs, a set of one or more peaks
[C1] determining, for each epoch in the plurality of epochs, values of a parameter, wherein the parameter represents a characteristic of peaks in the set of peaks, wherein the parameter is determined based on a comparison of a number of peaks of a given type between at least a first electrode site of the plurality of electrode sites and a second electrode site of the plurality of electrode sites
[D1] generating a visual representation of the EEG data of the subject, the visual representation including (i) an illustration of the set of peaks associated with a representative epoch or (ii) a heatmap compiled from the plurality of epochs, wherein the visual representation further includes a graphical indication of the values of the parameter associated with the representative epoch, and wherein the graphical indication is presented as evidence of whether the subject is cognitively impaired
These elements [A1]-[D1] 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] accessing electroencephalography (EEG) data of a subject from a plurality of electrode sites, the EEG data including responses of the subject to an activation procedure of an electroencephalography technique, wherein a response of the subject to an activation procedure comprises a measured output of electric activity in the human brain of the subject produced over a predetermined period of time in reaction to an auditory tone
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 adding insignificant extra-solution activity to the judicial exception, i.e., mere data gathering at a higher 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 “the EEG data including responses of the subject to an activation procedure of an electroencephalography technique, wherein a response of the subject to an activation procedure comprises a measured output of electric activity in the human brain of the subject produced over a predetermined period of time in reaction to an auditory tone” does not qualify as significantly more because this limitation merely describes the nature of the received EEG data and does not incorporate the activation procedure of auditory stimulation as part of the claimed invention. Also, the recitation “accessing electroencephalography (EEG) data of a subject from a plurality of electrode sites” is merely insignificant extrasolution activity to the judicial exception, e.g., mere data gathering in conjunction with the abstract idea that uses conventional, routine, and well known elements or simply displaying the results of the algorithm that uses conventional, routine, and well known elements. In particular, the data acquirer is nothing more than a conventional EEG electrode recording EEG signals from sites on the head. Such sensors are routine and conventional as evidenced by:
U.S. Patent Application Publication No. US 2006/0173510 A1 (Besio) discloses that EEG electrodes are conventional (paragraph 0013 of Besio);
U.S. Patent No. US 3993046 A (Fernandez) discloses that EEG signals are conventionally derived from electrodes (Col 1 lines 31-56 of Fernandez);
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.
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.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Ford US Patent Application Publication Number US 2017/0281071 A1 hereinafter Ford in view of Kruglikov US Patent Application Publication Number US 2009/0062676 A1 hereinafter Kruglikov and evidenced by Nakar US Patent Application Publication Number US 20180042510 A1 hereinafter Nakar.
Regarding claim 1, Ford discloses a computer-implemented method (Abstract; Paragraph 0063), comprising:
accessing magnetoencephalography (MEG) data of a subject, the MEG data including responses of the subject to an activation procedure of a magnetoencephalography technique wherein a response of the subject to an activation procedure comprises a measured output of electric activity in the human brain of the subject produced over a predetermined period of time in reaction to an auditory tone (Paragraphs 0059, 0075, and 0175: the sensors detect signals from the user’s brain in response to auditory stimuli; the output from the MEG sensors may be electrical activity);
analyzing the MEG data including a plurality of epochs, each epoch corresponding to one of the responses to identify in one or more epochs, a set of one or more peaks (Paragraphs 0073-0075; Fig. 2B: the identified three peak pattern in the epochs);
determining for each epoch of the plurality of epochs, values of a parameter, wherein the parameter represents a characteristic of peaks in the set of peaks (Paragraph 0084: the plurality of candidate parameters for the three peaks are calculated for each epoch), wherein the value of a parameter is indicative of a likelihood of cognitive impairment (Paragraph 0159: the parameter is displayed and may indicate cognitive impairment); and
generating a visual representation of the MEG data of the subject, the visual representation including (i) an illustration of the set of peaks associated with a representative epoch or (ii) a heatmap compiled from the plurality of epochs, wherein the visual representation further includes a graphical indication of the values of the parameter associated with the representative epoch, and wherein the graphical indication is presented as evidence of whether the subject is cognitively impaired (Paragraph 0078; Figs. 3A-D: the visual representation may be a heat map of the plurality of epochs; Paragraphs 0132-0133; Figs 4B-C: the visual representation may be an illustration of the peaks for a representative epoch; Paragraph 0159; Fig. 5: both types of displays may be presented to a doctor to help them determine if the patient is cognitively impaired, or has Alzheimer’s Disease. The values of parameters are also displayed).
Ford further teaches the determination of a number of epochs that have a number of peaks of a given type between the plurality of epochs (Paragraphs 0077-0081), but fails to disclose the determination of parameters by comparing different channels of MEG data within an epoch.
Ford fails to disclose the method utilizing electroencephalography (EEG) data, and wherein the parameter is determined based on a comparison of a number of peaks of a given type between at least a first electrode site of the plurality of electrode sites and a second electrode site of the plurality of electrode sites.
An obvious variation of Ford would be to determine the various parameters contemplated by Ford in paragraphs 0084, 0094-0096, and 0099-0102 by comparing the various input channels within each epoch in addition to comparing the different epochs to each other such that the inter-epoch channel comparison generates parameters such that the parameter is determined based on a comparison of a number of peaks of a given type between at least a first sensor input of the plurality of sensor inputs and a second sensor input of the plurality of sensor inputs.
Such a variation is considered obvious to try. In particular, Ford already contemplates the evaluation of data from multiple sensors rather than just a single sensor or sensor average in paragraph 0073. Thus Ford contemplates performing the epoch comparisons of paragraphs 0084, 0094-0096, and 0099-0102 using the values of multiple different SQUID or MEG sensors. Furthermore, it is known in the signal processing arts that parameters may be determined by comparing the input of individual channels to a threshold or particular morphology to generate parameters based on the number of channels that satisfy the comparison, see for example Nakar US Patent Application Publication Number US 20180042510 A1 hereinafter Nakar which teaches the evaluation ECG signals (Abstract) and is thus relevant to signal processing algorithms. Nakar teaches that the input channels may each be compared to a morphology pattern to determine if they match. The number of matching channels can then be used to determine a correlation score (Paragraphs 0038-0046). Thus Nakar teaches that parameters may be generated based on the number of input channels that satisfy certain thresholds or criteria. Thus, an obvious variation of Ford would be to determine parameters based on comparisons between different sensor inputs within an epoch because Ford contemplates the analysis of input from multiple sensors (Paragraph 0073) and it would be obvious to try generating parameters based on inter-sensor comparisons because there are a finite number of identifiable and predictable ways to generate parameters related to the peaks detected by Ford such as the number or percentage sensors which detect a particular peak or combination of peaks in a single epoch, the number or percentage of sensors that detect a particular peak or combination of peaks with respect to a detection timeframe in a single epoch, and other inter-sensors comparisons. Additionally, one of ordinary skill in the art would have a reasonable expectation of success in generating and using these parameters for the cognitive analysis of Ford because the generation of these types of parameters are generally known in the signal processing arts as evidenced by Nakar and the generated parameters relate to the peaks detected by Ford which Ford indicates are indicative of cognitive function.
The obvious variation of Ford fails to teach the method utilizing electroencephalography (EEG) data, and the sensor inputs being from electrode sites.
Kruglikov teaches methods and devices for performing electroencephalographic (EEG) phase dependent brain imaging using evoked and event related potentials (EP, ERP) or other forms of brain imaging including functional magnetic resonance imaging (fMRI) and magnetic encephalography (MEG). The methods and devices can be used for a variety of purposes, including for the study of normal and pathological cognitive function (Abstract). Thus, Kruglikov falls within the same field of endeavor as Applicant’s invention.
Kruglikov teaches that EEG recordings may be used to identify peaks such as the P30 and P50 peaks. Kruglikov further teaches that EEG signals may be filtered to remove artifacts (Paragraphs 0064-0065). Kruglikov teaches that EEG recordings are made at various electrode sites, or locations based on the montage, or positional arrangement of electrodes, selected (Paragraph 0015).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to alter the method of Ford to use EEG signals such as is described in Kruglikov because EEG and MEG signals both measure electrical activity in the brain and thus such a change would be a simple substitution of one known element (MEG measurement) for another known element (EEG measurement) with no surprising technical effect. Furthermore, Ford recites that EEG is sensitive to event within the required time period (Ford: Paragraph 0007). While Ford does state that EEG measurement suffer from “unpredictable signal attenuation by the tissues that surround the brain [which] cause both near and far signals to be comingled” Ford does not elaborate on how or why such comingling would affect the recited method. Ford does not elaborate on how such signal attenuation would make the method non-functional. Thus, Ford is not considered to teach away from the use of EEG. One of ordinary skill in the art would have a reasonable expectation of success when using the method of Ford on EEG signals because both measurement modalities record the same type of information and are frequently used interchangeably as evidenced by Kruglikov (Paragraphs 0008, 0021 and 0042) and further evidenced by at least:
Musha US Patent Application Publication Number US 2004/0171960 A1 hereinafter Musha: paragraphs 0070 and 0083 EEG or MEG sensor may be used.
Chen US Patent Application Publication Number US 2017/0224241 A1 hereinafter Chen: paragraphs 0013 EEG or MEG sensors may be used.
D’arcy US Patent Application Publication Number US 2013/0245422 A1 hereinafter D’arcy: paragraphs 0075 EEG or MEG sensors may be used; paragraph 0130 both EEG and MEG sensor may detect evoked responses.
Response to Arguments
Applicant's arguments filed 05/27/2026 have been fully considered but they are not persuasive.
In particular, Applicant’s amendments are considered sufficient to overcome the previously presented grounds of rejection under 35 USC 112.
In regards to Applicant’s arguments directed towards the rejections issued under 35 USC 101:
Applicant argues that the recites processing and generation of display steps are not capable of being reasonably performed in the human mind.
Applicant’s arguments are not found to be persuasive because they are not considered commensurate in scope with the claim language. In particular, the claim language requires the identification of peaks in an EEG signal which is simple pattern matching readily performed in the human mind. Next the claim requires the determination of some form of parameter related to the identified peaks and wherein the parameter is determined based on comparing a number of peaks of a given type between at least two different input channels. Such a generation is readily performed in the human mind by, for example, determining what percentage of the input channels contain a certain type of peak. The claim then requires the generation of a visual display such as a representative epoch which is readily performed by drawing an average of the received inputs for a given epoch, or the generation of a heatmap compiled from the plurality of epochs, the user can draw a heatmap based on data from a plurality of epochs, and wherein the visual representation includes a graphical indication of the values of the parameter which indicates if the user is cognitively impaired, which may simply be drawing a graph of the percentage of channels that include a given peak over time such that the y axis is the percentage of channels that include the peak and the x axis is the epoch. Additionally the recitation of accessing EEG data is addressed as mere data gathering to provide data to perform the abstract idea upon.
Thus each of the recited steps are considered to be practically performed in the human mind and drawn towards an abstract idea.
In regards to Applicant’s arguments directed towards the rejections issued under 35 USC 103:
Applicant argues that Ford does not disclose the determination of parameters based on the identified peaks between electrode sites or channel inputs within a given epoch.
Examiner agrees that Ford is generally directed towards the generation of parameters between epochs rather than between input channels within a given epoch. However Ford does teach the analysis of multiple channels of input (Paragraph 0073) and thus the generation of parameters by comparing different input channels within an epoch rather than comparing the same input channel between different epochs is considered to be an obvious variation of Ford as described in the updated rejection above. Thus the different between the claimed feature generation and the feature generation of Ford is not considered to be a patentable difference because the generated parameters are used for the same purpose, generated based on the same detected features (the peaks in electrical response) and the generation of parameters by comparing channels of input within a single epoch is generally known is the field of signal processing as evidenced by Nakar.
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
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