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 listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 2, 4-9, 11-13, 16-19, 21, 24, 25, 27, and 29-31 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 1, the phrase “wherein each of said measurements are of the subject’s brain activity preceding and following the presentation of a sensory stimulus” renders the claim indefinite. It is unclear how a single measurement would be taken both before and after (preceding and following) the presentation of a sensory stimulus. Further regarding claim 1, the phrase “using a processor to evaluate variability in the acquired brain activity measurements to a plurality of repeated sensory stimuli” renders the claim indefinite. It is unclear what “to a plurality of repeated sensory stimuli” means in the context of the limitation. Furthermore, it is unclear if the “a plurality of repeated sensory stimuli” is the same as or different than the “the presentation of a sensory stimulus” recited earlier in the claim. For the purpose of examination, the claim is being interpreted such that a plurality of brain activity measurements are acquired responsive to the presentation of a plurality of repeated sensory stimuli, wherein each of said plurality of measurements include the subject’s brain activity preceding and following the presentation of a sensory stimulus of the plurality of repeated sensory stimuli, and wherein a processor is used to evaluate variability in the acquired brain activity measurements. The same indefiniteness issues and interpretation also apply to claims 24 and 30. The phrase “the changes in brain responsiveness states” in claim 1 lacks proper antecedent basis as there is no previous recitation of determining changes in brain responsiveness states. For the purpose of examination, the phrase is being interpreted as “changes in brain responsiveness states”. The same indefiniteness issue and interpretation also apply to claims 24 and 30. Regarding claim 2, the phrase “said brain activity” in line 1 lacks proper antecedent basis. For the purpose of examination, the phrase is being interpreted as “said acquired brain activity measurements”. The same indefiniteness issue and interpretation also apply to claim 25. Regarding claim 4, it is unclear if the “a specified subject” is the same as or different than the “subject” of claim 1. Clarification is requested. For the purpose of examination, the specified subject may be either the same subject recited in claim 1, or a different subject. Further regarding claim 4, it is unclear if the measurements of brain activity and plurality of repeated stimuli are the same brain activity measurements and plurality of stimuli recited in claim 1, or if new brain activity measurements and stimuli are presented to the subject. Clarification is requested. For the purpose of examination, the brain activity measurements and stimuli of claim 4 are being interpreted as the brain activity measurements and stimuli of claim 1. The same indefiniteness issues and interpretations also apply to claim 27. Regarding claim 7, it is unclear if the 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 “the serial assessment of Pxj(τ)(xj; τ)” lacks proper antecedent basis. For the purpose of examination, the phrase is being interpreted as “a serial assessment of Pxj(τ)(xj; τ)”. Further regarding claim 8, it is unclear if the “a specified subject” in the claim is the same subject as the one recited in claim 1. For the purpose of examination, the specified subject of claim 8 is being interpreted as the subject of claim 1. Finally, the phrase “the cumulative sessions” lacks proper antecedent basis as none of claims 1, 2, or 8 previously recite a session or multiple sessions. Regarding claim 11, it is unclear if the “a plurality of predetermined time periods” in the claim is the same as or different than the “a plurality of predetermined time periods” of claim 1. Clarification is requested. For the purpose of examination, the plurality of predetermined time periods of claim 11 are the same plurality of predetermined time periods of claim 1. Regarding claim 13, it is unclear if the differential entropy is determined according to the equation in claim 12, or if the differential entropy is empirically estimated from a finite number of samples as recited in claim 13. Further 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 claim is dependent on a cancelled claim. For the purpose of examination, claim 16 is being interpreted as being dependent on claim 12. It is also unclear if the “a specified subject” in the claim is the same subject as the one recited in claim 1. For the purpose of examination, the specified subject of claim 16 is being interpreted as the subject of claim 1. Further regarding claim 16, it is unclear if the measurements of brain activity and plurality of repeated stimuli are the same brain activity measurements and plurality of stimuli recited in claim 1, or if new brain activity measurements and stimuli are presented to the subject. Clarification is requested. For the purpose of examination, the brain activity measurements and stimuli of claim 16 are being interpreted as the brain activity measurements and stimuli of claim 1. Regarding claim 21, it is unclear if the “a specified subject” in the claim is the same subject as the one recited in claim 1. For the purpose of examination, the specified subject of claim 21 is being interpreted as the subject of claim 1. Further regarding claim 21, it is unclear if the measurements of brain activity and plurality of repeated stimuli are the same brain activity measurements and plurality of stimuli recited in claim 1, or if new brain activity measurements and stimuli are presented to the subject. Clarification is requested. For the purpose of examination, the brain activity measurements and stimuli of claim 21 are being interpreted as the brain activity measurements and stimuli of claim 1. Regarding claim 31, the phrase “hj(τ)” lacks proper antecedent basis. For the purpose of examination, claim 31 is being interpreted as being dependent on claim 12. It is noted that with the interpretations of claims 16 and 31, both claims are identical.
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, 2, 4-9, 11-13, 16-19, 21, 24, 25, 27, and 29-31 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, 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 sets forth a judicial exception. This step describes a concept performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to a Mental Process, 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 over the plurality of predetermined time periods, 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 over a plurality of predetermined time periods, each measurement being acquired before and after the presentation of a 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, 2, 4, 5, 7-9, 11, 12, 16, 18, 19, 21, 24, 25, 27, and 29-31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zheng et al. (Investigating Critical Frequency Bands…).
Regarding claim 1, Zheng et al. discloses a method for reconstructing a representation of changes in the state of responsiveness of a mammalian subject’s brain to a plurality of repeated sensor stimuli, the method including: acquiring a plurality of brain activity measurements of a subject over a plurality of predetermined time periods, wherein each of said measurements are of the subject’s brain activity preceding and following the presentation of a 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 acquired brain activity measurements to a plurality of repeated sensory stimuli (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 the changes in brain responsiveness state from the variability in said brain activity measurements over the plurality of predetermined time periods (see Figure 6 and description thereof).
Regarding claim 2, the variability in said brain activity is evaluated 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 a specified subject, wherein each session comprises measurements of brain activity for a plurality of repeated 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 a 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 frequency band limited brain activity measurements (see III. METHODS A. Preprocessing on page 165).
Regarding claim 8, a serial assessment of Pxj(τ)(xj; τ) for a specified subject provides an indication of brain function over the cumulative 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 for a plurality of predetermined time periods (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 claims 16 and 31, hj(τ) is longitudinally estimated from a plurality of sessions for a specified subject wherein each session comprises measurements of brain activity for a plurality of repeated 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.”; 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 a specified subject, wherein each session comprises measurements of brain activity for a plurality of repeated stimuli 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, 25, 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 performing 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 6 is rejected under 35 U.S.C. 103 as being unpatentable over Zheng et al., as applied to claim 2, in view of Applicant Admitted Prior Art (AAPA).
Zheng et al. discloses all of the elements of the current invention, as discussed in paragraph 8 above, except for the brain activity being time-ensemble estimated stimulus evoked activity. According to Applicant’s specification, it is known in the art to address the variability in an acquired brain activity signal by time ensemble averaging the acquired brain activity signals (section [0005] of the published specification). 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 its brain activity is time-ensemble estimated stimulus evoked activity, as AAPA teaches that time ensemble averaging the acquired brain activity measurements to address the variability in the acquired signals is well known and typically performed.
Regarding the functions (i), (ii), and (iii) recited in claim 6, it is noted that the claim states that the brain activity “can be” estimated as one of the recited functions, indicating that it need not be estimated as one of the recited functions.
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…).
Zheng et al. discloses all of the elements of the current invention, as discussed in paragraph 8 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.
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…) teaches outputting topographic images of various types of EEG-based entropy calculations. Keshmiri (Entropy and the Brain:…) provides an overview of using entropy calculations during EEG signal analysis to determine brain states. Hwang et al. (Learning CNN features from DE features…) 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…) 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…) 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…) teaches using differential entropy features determined from EEG signals to classify a state of responsiveness of a mammalian subject.
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/ETSUB D BERHANU/Primary Examiner, Art Unit 3791