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 .
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 4-8, 13, 16, 17, 21, 27 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.
Regarding claim 4, the phrase “a subject” in line 3 renders the claim indefinite. It is unclear if the phrase is referring to the subject of claim 1, or to a different subject. For the purpose of examination, the phrase in claim 4 is being interpreted as “the subject”. The phrase “the plurality of sensory stimuli” in line 4 of claim 4 lacks proper antecedent basis, as does “the same sensory stimulus of the plurality of sensory stimuli”. For the purpose of examination, claim 4 is being interpreted such that each session comprises acquiring brain activity measurements of the subject responsive to multiple repeated presentations of the same sensory stimulus.
Regarding claim 6, it is unclear how a measurement, which is measured, would be “estimated” as a function. Clarification is requested.
Regarding claim 7, it is unclear if the acquired brain activity measurements recited in the claim are the same as or different than the brain activity measurements of claim 1. For the purpose of examination, claim 7 is being interpreted such that the brain activity measurements of claim 1 are frequency band limited.
Regarding claim 8, the phrase “wherein 1 serial assessment of Pxj(τ)(xj; τ) for the subject provides an indication of brain function over the plurality of sessions” is unclear. It is believed that the term “1” should be deleted from the limitation”. Further regarding claim 8, the phrase “the plurality of sessions” lacks proper antecedent basis. For the purpose of examination, claim 8 is being interpreted such that serial assessment of Pxj(τ)(xj; τ) provides an indication of brain function over a plurality of sessions.
Regarding claim 13, it is unclear how multiple changes would be defined between one differential entropy value and a baseline reference value. Clarification is requested.
Regarding claim 16, the phrase “a subject” in line 4 renders the claim indefinite. It is unclear if the phrase is referring to the subject of claim 1. It is also unclear if the “a sensory stimulus” in line 5 of the claim is referring to the sensory stimulus of claim 1. For the purpose of examination, “a subject” is being interpreted as “the subject”, and the repeated sensory stimulus is being interpreted as the repeated sensory stimulus recited in claim 1. The same indefiniteness issue and interpretation apply to claim 21 and 27.
With further regard to claim 21, it is noted that the phrase “responsive to responsive to” in line 5 should be amended to read “responsive to”.
Claims not explicitly rejected above are rejected due to their dependence 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, 4-9, 11-13, 16-19, 21, 24, 27, 29, and 30 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 1 follows.
Regarding claim 1, the claim recites a series of steps or acts, including acquiring a plurality of brain activity measurements of a subject over a plurality of predetermined time periods, evaluating variability in the acquired brain activity measurements to a plurality of repeated sensory stimuli according to a probability density function, and generating a report of changes in brain responsiveness states from the variability in said brain activity measurements over the plurality of predetermined time periods. Thus, the claim is directed to a process, which is one of the statutory categories of invention.
The claim is then analyzed to determine whether it is directed to any judicial exception. The step of evaluating variability in the acquired brain activity measurements to a plurality of repeated sensory stimuli according to a probability density function sets forth a judicial exception. This step describes a concept performed in the human mind (including an observation, evaluation, judgment, opinion) based on use of a Mathematical Concept. Thus, the claim is drawn to both a Mental Process and a Mathematical Concept, which is an Abstract Idea.
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. Claim 1 recites generating a report of changes in brain responsiveness states from the variability in said brain activity measurements, which is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)). The generation of the report does not provide an improvement to the technological field, the method does not effect a particular treatment or effect a particular change based on the generated report, nor does the method use a particular machine to perform the Abstract Idea.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, the claim recites the additional step of acquiring a plurality of brain activity measurements responsive to repeated presentations of a sensory stimulus, each measurement being acquired before and after the presentation of the sensory stimulus. The acquiring step is recited at a high level of generality such that it amounts to insignificant presolution activity, e.g., mere data gathering step necessary to perform the Abstract Idea. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes it from well-understood, routine, and conventional data gathering activity engaged in by medical professionals prior to Applicant's invention. Furthermore, it is well established that the mere physical or tangible nature of additional elements such as the obtaining and evaluating steps do not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)).
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
Regarding claim 24, the system recited in the claim is a generic system comprising processors (computers) configured to perform the presolution activity, the Abstract Idea, and the extra-solution activity. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application.
The same rationale applies to claim 30.
The dependent claims also fail to add something more to the abstract independent claims as they generally recite method steps pertaining to data gathering and the use of mathematical formulas (the use of mathematical formulas is itself drawn to an Abstract Idea). The acquiring, evaluating, and generating steps recited in the independent claims maintain a high level of generality even when considered in combination with the dependent claims.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 4, 5, 7-9, 11, 12, 16, 18, 19, 21, 24, 27, 29 and 30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zheng et al. (Investigating Critical Frequency Bands… – previously cited).
Regarding claim 1, Zheng et al. discloses a computer-implemented method for reconstructing a representation of changes in the state of responsiveness of a mammalian subject’s brain to sensory stimuli, the method including: acquiring a plurality of brain activity measurements of a subject responsive to repeated presentations of a sensory stimulus, wherein each of said measurements are acquired over a time window which starts at a time preceding the presentation of the sensory stimulus and finished after a time following the presentation of the sensory stimulus (see III. METHODS A. Preprocessing on page 165, and IV. EXPERIMENTS C. Protocol on page 167); using a processor to evaluate a variability in the plurality of acquired brain activity measurements (see III. METHODS B. Feature Extraction on page 165; IV. EXPERIMENTS C. Protocol on page 167; and V. EXPERIMENTAL RESULTS A. Neural Patterns starting on page 167); and generating a report of changes in brain responsiveness state from the variability in said plurality of brain activity measurements, (see Figure 6 and description thereof). The variability in said plurality of brain activity measurements is evaluated by the processor according to a probability density function Pxj(τ)(xj; τ) for brain activity measurements corresponding to the random variable xj(τ), recorded at a plurality of physical brain locations, each indexed by the integer j, at a time τ, with respect to the presentation of stimuli at time τ = 0 (see III. METHODS B. Feature Extraction on page 165; IV. EXPERIMENTS C. Protocol on page 167; and V. EXPERIMENTAL RESULTS A. Neural Patterns starting on page 167).
Regarding claim 4, Pxj(τ)(xj; τ) is serially estimated in time from a plurality of sessions for the subject, wherein each session comprises acquiring brain activity measurements of the subject responsive to multiple repeated presentations of the same sensory stimulus of the plurality of sensory stimuli and the sessions are spaced apart at intervals selected from a plurality of hours, plurality of days, plurality of months or a plurality of years (see the Abstract on page 162: “Each subject performs the experiments twice at the interval of a few days.” and first paragraph of V. EXPERIMENTAL RESULTS B. Classifier Training on page 168: “In the emotion experiments, we collect the EEG data from fifteen subjects and each subject has done the experiments twice at intervals of about one week.”; III. METHODS B. Feature Extraction on page 165; and IV. EXPERIMENTS C. Protocol on page 167; and see Figure 5).
Regarding claim 5, the serial estimation of Pxj(τ)(xj; τ) for the specified subject provides an indication of changes in brain function between sessions (this is inherent).
Regarding claim 7, Pxj(τ)(xj; τ) is empirically estimated on acquired brain activity measurements which are frequency band limited (see III. METHODS A. Preprocessing on page 165).
Regarding claim 8, a serial assessment of Pxj(τ)(xj; τ) for the specified subject provides an indication of brain function over the plurality of sessions (this is inherent).
Regarding claim 9, the brain activity measurements are acquired with an EEG modality (see III. METHODS A. Preprocessing on page 165; and IV. EXPERIMENTS C. Protocol on page 167).
Regarding claim 11, the measurements are acquired from a plurality of brain locations during a predetermined time period (see III. METHODS B. Feature Extraction on page 165; IV. EXPERIMENTS C. Protocol on page 167; and see Figures 4 and 5, with Figure 5 showing a plurality of predetermined time periods).
Regarding claim 12, one brain responsiveness state is differential entropy determined according to the recited equation, wherein hj(τ) is the differential entropy at a time τ after the presentation of a stimulus, for a physical brain location specified by the index j (see equation (1) on page 165).
Regarding claim 16, hj(τ) is longitudinally estimated from a plurality of sessions for the specified subject wherein each session comprises acquiring brain activity measurements of the subject responsive to repeated presentations of a sensory stimulus, wherein each of said measurements are acquired over a time window which starts at a time preceding the presentation of the sensory stimulus and finished after a time following the presentation of the sensory stimulus, and the sessions are spaced apart at intervals selected from a plurality of hours, plurality of days, plurality of months or a plurality of years (see the Abstract on page 162: “Each subject performs the experiments twice at the interval of a few days.”; IV. EXPERIMENTS C. Protocol on page 167; and see Figure 5).
Regarding claims 18 and 19, the variability of said brain activity is used to derive one or more quantitative information theoretic measures representative of brain responsiveness state (the differential entropy measures are quantitative information theoretic measures representative of brain responsiveness state).
Regarding claim 21, the one or more quantitative information theoretic measures representative of brain function are longitudinally estimated from a plurality of sessions for the specified subject, wherein each session comprises acquiring brain activity measurements of the subject responsive to repeated presentations of a sensory stimulus, wherein ach of said measurements are acquired over a time window which starts at a time preceding the presentation of the sensory stimulus and finishes after a time following the presentation of the sensory stimulus, and the sessions are spaced apart at intervals selected from a plurality of hours, a plurality of days, a plurality of months or a plurality of years (see the Abstract on page 162: “Each subject performs the experiments twice at the interval of a few days.”; IV. EXPERIMENTS C. Protocol on page 167; and see Figure 5).
Regarding claims 24, 27, and 29, the sections of Zheng et al. cited above disclose a system comprising at least one processor (i.e., the claimed acquiring module, evaluating module, and determining module) configured to perform the functions recited in the claims (see III. METHODS A. Preprocessing on page 165: “All signal processing was performed in the Matlab software.”; and IV. EXPERIMENTS C. Protocol on page 167).
Regarding claim 30, the system of Zheng et al. inherently comprises a non-transitory computer readable medium comprising program instructions that, when executed by its one or more processors, implements the method recited in the claim (see III. METHODS A. Preprocessing on page 165: “All signal processing was performed in the Matlab software.”).
Claim Rejections - 35 USC § 103
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.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Zheng et al., as applied to claim 16, in view of Kutepov et al. (Visualization of EEG signal entropy… – previously cited).
Zheng et al. discloses all of the elements of the current invention, as discussed in paragraph 7 above, except for the longitudinal estimates of hj(τ) (differential entropy) being plotted topographically with respect to physical brain location. Kutepov et al. teaches that plotting entropy values topographically with respect to physical brain location is useful in diagnosing subjects of EEG examination (see 7. Conclusion, and entropy topographic images shown in Figure 3). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Zheng et al. such that it plots the longitudinal estimates of differential entropy with respect to physical brain location, as Kutepov et al. teaches that the visualization of entropy with respect to physical brain location is useful for diagnosing subjects of EEG examination.
Examiner’s Note
The following is a statement of the reason for the lack of a prior art rejection for claim 13:
None of the prior art discloses or suggests, either alone or in combination, a method comprising empirically estimating a differential entropy from a finite number of samples, and defining changes in differential entropy with respect to a baseline reference value, in combination with the other claimed steps.
Response to Arguments
Applicant's arguments filed 29 June 2026 have been fully considered.
Regarding the previous rejections of claims under 35 U.S.C. 112(b), while Applicant’s amendments have overcome some of the rejections, as noted in paragraph 3 above, indefiniteness issues remain.
Regarding the rejections of the claims in view of the previously cited prior art, Applicant’s arguments are not persuasive. Applicant appears to be arguing that Zheng does not teach acquiring a plurality of brain activity measurements of a subject responsive to repeated presentations of the same sensory stimulus. This argument is not persuasive as none of claims 1, 24, or 30 recite repeating presentations of the same sensory stimulus. Figure 5 of Zheng clearly shows providing repeated presentations of a sensory stimulus (each session acquires brain activity measurements of a subject responsive to a presentation of a sensory stimulus), wherein brain activity measurements responsive to each presentation of a sensory stimulus are acquired.
Applicant next argues that any “variability” in Zheng is reflective of a measure of the complexity or “uncertainty” of a signal within a 1-second epoch, and that this “is completely different from the claimed techniques of evaluating trial-by-trial variability to the presentation of repeated (same) stimulus”. This argument is not persuasive as the claims, as currently written, do not require evaluating trial-by-trial variability to the presentation of a repeated same stimulus. Figure 6 of Zheng shows determining variability/differential entropy (DE) across an over 3000 second timespan, the approximately 3000 second timespan encompassing the time window in which the plurality of brain activity measurements of the subject are acquired. As the Applicant’s specification (paragraph [0020] of the published specification) and claim 12 specifically define DE as a brain responsiveness state, the output of Figure 6 of Zheng is considered the generation of a report of changes in brain responsiveness states from the variability in said plurality of brain activity measurements.
Regarding Applicant’s argument that emotional states differ from brain responsiveness states, as noted above, Applicant’s specification and claim 12 define DE as a brain responsiveness state. As Zheng calculates DE, each DE calculation is indicative of a brain responsiveness state. As Figure 6 shows changes in DE over time, the report shown in Figure 6 shows changes in brain responsiveness states (DE) from the variability in said plurality of brain activity measurements.
Applicant’s arguments that Zheng does not teach or suggest “using a PDF to evaluate the distribution of brain activity measurements xj(τ) across repeated stimulus presentations at specific latencies to determine a brain responsiveness state” are not persuasive as the claims do not require “using a PDF to evaluate the distribution of brain activity measurements xj(τ) across repeated stimulus presentations at specific latencies to determine a brain responsiveness state”.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Mammone et al. (Clustering of entropy topography… – previously cited) teaches outputting topographic images of various types of EEG-based entropy calculations. Keshmiri (Entropy and the Brain:… – previously cited) provides an overview of using entropy calculations during EEG signal analysis to determine brain states. Hwang et al. (Learning CNN features from DE features… – previously cited) teaches using EEG-based differential entropy calculations to train neural networks that are configured to determine changes in the state of responsiveness of a mammalian subject’s brain to a plurality of repeated sensory stimuli. Li et al. (Hierarchical Convolution Neural Networks… – previously cited) teaches using EEG-based differential entropy calculations to train neural networks configured to determine changes in the state of responsiveness of a subject’s brain to a plurality of repeated sensory stimuli. Li et al. (Emotion Recognition of Subjects… – previously cited) teaches a method for constructing a representation of changes in the state of responsiveness of a mammalian subject’s brain to a plurality of repeated sensory stimuli, the method comprising the steps set forth in claim 1, as well as a step of outputting a topographic image of differential entropy. Duan et al. (Differential Entropy Feature… – previously cited) teaches using differential entropy features determined from EEG signals to classify a state of responsiveness of a mammalian subject.
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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