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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description:
-Fig. 2 references 203 which is not found within the description.
-Fig. 2 references 203d which is not found within the description. It’s possible “103d” in [0050] should read –203d—
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to because Fig. 3 contains improper shading and blurry text. All reference labels and text appear to be duplicated and written over. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claims 1, 2, 5, 6, 10, 11 are objected to because of the following informalities:
-Claim 1 recites “the subject” in lines 5 and 11. Examiner recommends amending to –the adolescent subject—
-Claim 2 recites “each of the brain networks” in line 2. Examiner recommends amending to –each of the at least two brain networks—
-Claim 5 recites “one of the brain networks” in line 2. Examiner recommends amending to –at least one of the brain networks—
-Claim 6 recites “one of the brain networks” in line 2. Examiner recommends amending to –at least one of the brain networks—
-Claim 10 recites “the subject” in line 1. Examiner recommends amending to –the adolescent subject—
-Claim 11 recites “the subject” in lines 9, 15 and 16. Examiner recommends amending to –the adolescent subject—
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
-Claim 11 recites “a sensor” which is a generic placeholder. There is no sufficient structure for this limitation provided in the claims. The function of this limitation is to cause the system to:…activity in the subject. Based on the specification, there is no disclosure provided to disclose the corresponding structure.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 5, 6, 11-20 is 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 limitation “sensor” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. Although the description provides reference to the sensor including one or many sensors, no further information is provided as to the structure of this element. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
-Claim 5 recites “activity level” in line 2. It is unclear whether this is the same or different from the activity level referenced in claim 1, line 9. Further clarification should be provided.
-Claim 6 recites “activity level” in line 2. It is unclear whether this is the same or different from the activity level referenced in claim 1, line 9. Further clarification should be provided.
-Claim 11 recites “the at least one brain networks” in line 7. There is insufficient antecedent basis for this limitation in the claim.
-Claim 13 recites “the scalp of the user” in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
-Claim 14 recites “using frequency specific components of the electroencephalography signals” in lines 1-2. It is unclear whether these are the same or different from the frequency specific components of electroencephalography signals originally referenced in claim 12, lines 1-2.
-Claim 15 recites “activity level” in line 2. It is unclear whether this is the same or different from the activity level referenced in claim 11, line 13. Further clarification should be provided.
-Claim 16 recites “activity level” in line 2. It is unclear whether this is the same or different from the activity level referenced in claim 11, line 13. Further clarification should be provided.
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.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 13 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
-Claim 13 recites “signals are recorded on the scalp of the user wearing the system.” This claim is directed to or encompassing a human organism and is ineligible.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s) a series of mental processes that can occur in the human mind. These mental processes include:
- functionally locating at least two brain networks which could include a practitioner analyzing data related to brain networks,
- recording signals which could also include observations made by the practitioner during the resting/meditation state of the patient,
- determining an activity metric which equates to decision-making performed by the practitioner, and
-providing neurofeedback which, as recited, appears to be displaying data for the patient to view.
This judicial exception is not integrated into a practical application because the processor is recited as performing the generic computer function of functionally locating, recording, determining and providing data to the user. Further, mere instructions or commands to apply a judicial exception using a generic processor does not impose meaningful limits on practicing the abstract idea. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the locating, recording and determining steps merely define the data acquisition that can be presented to the mind and can be performed by hand (an individual manually locating brain network data, writing down analysis based on this data and showing the patient that data) based on the individual's analysis and decisions regarding the data (the mental process). The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements recited in claims 2-10 and 12-20 do not apply or use the judicial exception to affect a particular treatment or prophylaxis for a disease or medical condition. The recitation of neurofeedback is generically described as presenting data to a patient and does not necessarily embody a specific treatment for the treatment of a medical condition and does not present an actual neurofeedback, neuromodulation, brain stimulation method as presented.
An analysis of the claims is shown below:
Step 1: Claims 1-10 are directed towards a neurofeedback method, which is a statutory category of invention.
Claims 11-20 are directed towards a system or apparatus, which is a statutory category of invention.
Step 2A, prong 1: Claims 1-20 recite limitations that are directed to an abstract idea. These claims recite acquiring brain network information, recording signals, and determining data values. These limitations, under their broadest reasonable interpretation, fall within the mental processes grouping of abstract ideas. It would be practically performable in a human’s mind, or with pen and paper, to analyze brain network data as well to make decisions whether the data changes over time. Analyzing information and making a determination based on information is akin to an observation, evaluation or judgement that defines the mental process grouping. Thus Claims 1-20 are directed to a judicial exception, an abstract idea.
Step 2A, prong 2: Claims 1-20 do not recite additional elements that integrate the judicial exception into a practical application. Claims 1-20 recite the following additional elements:
-functional magnetic resonance imaging (claims 2, 12)
-real-time functional magnetic resonance imaging (claim 3)
-electroencephalography (claims 4, 12, 14)
-processor (claim 11)
-sensor (claim 11)
-memory (claim 11)
-screen (claim 20)
The fMRI, rt-MRI, EEG, processor, sensor and memory, and screen components are generically recited at a high level of generality. Further mere instructions or commands to apply judicial exception using a generic processor independently does not impose meaningful limits on practicing the abstract idea.
Most notably, none of the additional elements recited in these claims apply or use the judicial exception to affect a particular treatment or prophylaxis for a disease or
medical condition. While the bodies of these claims discuss neurofeedback and modulating brain activity, there is no claim limitation that recites a particular treatment method as presentation of data to a patient would not inherently include neuromodulation techniques.
Thus claims 1-20 do not integrate the abstract idea into a practical application.
Step 2B: When considered individually and in combination, the claims do not recite additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to the integration of the abstract idea into a practical application, the additional elements of claims 2, 8, 12, and 18 further limit type of data used, claims 3, 4, 13, and 14 further define types of signals recorded, claims 5-7, 9, 15-17, and 19 further limit parameters of the activity performed, claim 10 further limits the medical condition, and claim 20 further defines a means for presentation of data to the patient and are also generically recited at a high level of generality. Mere command to apply a judicial exception using a generic processor does not impose meaningful limits on practicing the abstract idea. Furthermore, the processes and steps can be considered nonfunctional descriptive material because there are no elements that show how the processor interacts with other components or fulfills the function of neurofeedback or modulating brain activity to deliver a change within the system or treatment to a patient.
In reconsidering the additional elements of the method, the additional elements were determined to be well-understood, routine and conventional based on the following evidence:
-Poltorak (U.S. 20210041953) discloses functional magnetic resonance imaging [0858; “fMRI”], real-time functional magnetic resonance imaging [0912; “real-time BOLD fMRI”], electroencephalography [0919; EEG input”], processor [0789; “computer cluster”], sensor [0798; “sensors”], memory [0784; “physical memory”], and screen [0950; “computer screen”] in reference to an imaging system collecting data while a user is in a particular state including a meditative state [0864].
Therefore, these elements are demonstrated to be generic, well understood components that are commonly recited in the art.
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.
Claim(s) 1, 2, 4-6, 8-16 and 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ogawa (U.S. 20230293036) in view of Barthelemy (U.S. 20170311832).
Regarding Claim 1, Ogawa teaches a neurofeedback method for modulating brain activity [0029], the method comprising: functionally locating at least two brain networks in an adolescent subject during a resting state [0071; “a signal source belonging to a single brain region or coordination of signal sources belonging to a plurality of spatially distant brain regions.”] and [0072]—which defines the types of networks and subnetworks associated with resting state networks, recording signals from each of the brain networks while the subject is performing a meditation task [0071; “The brain network is also referred to as a resting state network (RSN), and it is a generic denotation of a characteristic brain activity pattern originating from a signal source belonging to a single brain region or coordination of signal sources belonging to a plurality of spatially distant brain regions. The brain network is defined mainly by fMRI in the resting state.”] and [0233]—describing the subject using their brain for meditation during training; determining an activity metric based on a difference derived from the recorded signals [0124; “ Referring to FIG. 11, processing apparatus 100 selects an ROI of interest of calculation of a BOLD signal (step S1121) and extracts each amount of activity from an image feature value in a region corresponding to the ROI selected from fMRI measurement data 30 (step S1122).”], wherein changes in the activity metric over time are indicative of changes in relative activity level of the brain networks [0194; “ By deconvolution of change over time in extracted amount of activity with HRF, a time waveform of the BOLD signal is calculated (step S1123) and the time waveform is stored in association with the selected ROI (step S1124).”]; and providing neurofeedback by delivering a representation of the activity metric to the subject during the recording [0031; “The brain activity training method includes calculating, in the neurofeedback training, disorder-likelihood of the subject with the estimation model based on the brain wave measurement data and outputting a signal for representation corresponding to the disorder-likelihood to a presentation apparatus.”] and [0125; “Then, time correlation of BOLD signal …the amounts of activity in two ROIs of interest.”], thereby modulating brain activity in the subject [0263; “Representation control module …the estimated disorder-likelihood of the subject.”] and [0029].
Ogawa is silent on at least one of the brain networks being associated with affective disorder symptoms during adolescence. Barthelemy teaches at least one of the brain networks being associated with affective disorder symptoms during adolescence [0268].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the described method for adolescents as taught by Barthelemy to provide treatment for affective disorders as suggested by Ogawa, as Ogawa discusses the treatment of depression and schizophrenia as the disorders of interest [0271] with Barthelemy because Barthelemy teaches treatment of childhood ADHD with neurofeedback protocols [0268].
Regarding Claim 2, Ogawa further teaches wherein the functionally locating comprises using functional magnetic resonance imaging to generate a network map for each of the brain networks [0067]—reference to use of fMRI.
Regarding Claim 4, Ogawa teaches wherein the signals are electrical signals recorded using fMRI compatible simultaneous electroencephalography [0222]—reference to EEG/fMRI simultaneous measurement data obtained.
Regarding Claim 5, Ogawa teaches wherein modulating the brain activity comprises downregulating or decreasing activity level in one of the brain networks [0108]—reference to down sampling in regards to frequency of EEG measurement.
Regarding Claim 6, Ogawa is silent on wherein modulating the brain activity comprises upregulating or increasing activity level in one of the brain networks. Barthelemy teaches wherein modulating the brain activity comprises upregulating or increasing activity level in one of the brain networks [Example 2 and 0263; “Increase baseline concentration” “Increase movement precision”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to cause increases in activity level during/after treatment as taught by Barthelemy to provide cognitive improvement via training as suggested by Ogawa, as Ogawa discusses the treatment showing improvement in cognitive function [0271] with Barthelemy because Barthelemy teaches the improvement via modulation for specific cerebral activity [0230].
Regarding Claim 8, Ogawa teaches wherein the brain networks include, a default mode network (DMN), a central executive network (CEN), or a frontoparietal control network (FPCN) [0072] and [0074].
Regarding Claim 9, Ogawa teaches further comprising determining a first resting state activity before the performing of the meditation task [Fig. 20A-C, element “Pre”], determining a second resting state activity after the performing of the meditation task [Fig. 23A-C, element “Post”] [0315]—describes score estimations (activity) before and after training, where training can include meditation according to [0233], and assessing a change in functional connectivity of at least one of the brain networks based on a comparison between the first and second resting state activities [Fig. 23A-C, elements “WLS”. “BDI”, “PRS” and “PRS: brooding”] and [0304]—showing pre and post scores related to rumination and brooding.
Regarding Claim 10, Ogawa teaches wherein the subject is suffering from a major depressive disorder [0304]—reference to training in connection with major depressive disorder (MDD).
Regarding Claim 11, Ogawa teaches a neurofeedback system for modulating brain activity [0029], the system comprising: a processor [Fig. 3, element 100]; a sensor [Fig. 3, element 220] and [0082]; and a memory with computer code instructions stored thereon [Fig. 4, element 104] and [0097], the processor, the sensor, and the memory, being configured to cause the system to: functionally locate at least two brain networks in an adolescent subject during a resting state [0071]-[0072], record signals from each of the brain networks while the subject is performing a meditation task [0071] and [0233]; determine an activity metric based on a difference derived from the recorded signals [0124], wherein changes in the activity metric over time are indicative of changes in relative activity level of the brain networks [0194]; and provide neurofeedback to the subject by delivering a representation of the activity metric to the subject during the recording [0031], [0125], thereby modulating brain activity in the subject [0263] and [0029].
Ogawa is silent on the at least one brain networks being associated with affective disorder symptoms during adolescence. Barthelemy teaches at least one of the brain networks being associated with affective disorder symptoms during adolescence [0268].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the described method for adolescents as taught by Barthelemy to provide treatment for affective disorders as suggested by Ogawa, as Ogawa discusses the treatment of depression and schizophrenia as the disorders of interest [0271] with Barthelemy because Barthelemy teaches treatment of childhood ADHD with neurofeedback protocols [0268].
Regarding Claim 12, Ogawa teaches wherein the functionally locating comprises using frequency specific components of electroencephalography signals as correlates of functional magnetic resonance imaging to generate a network map for each of the brain networks [0067]—reference to use of fMRI, [0229]—referencing generating data gathered from simultaneous EEG and fMRI and [0150-0152]—referencing the correlating the brain network data collected, the functional connectivity of said brain network and correlation between ROI and fMRI data alongside using time waveforms from EEG to create estimations.
Regarding Claim 13, Ogawa teaches wherein the electroencephalography signals are recorded on the scalp of the user wearing the system [0014].
Regarding Claim 14, Ogawa teaches wherein using frequency specific components of the electroencephalography signals as correlates of functional magnetic resonance imaging further includes using user specific electroencephalography signals processed with user specific functional magnetic resonance imaging data to generate central executive network (CEN) dynamics, default mode network (DMN) dynamics, or both [0072] and [0074] and [0275]—which describes an optimal feature value condition for each subject.
Regarding Claim 15, Ogawa teaches wherein the modulating comprises downregulating or decreasing activity level in one of the brain networks [0108]—reference to down sampling in regards to frequency of EEG measurement.
Regarding Claim 16, Ogawa is silent on wherein modulating the brain activity comprises upregulating or increasing activity level in one of the brain networks. Barthelemy teaches wherein modulating the brain activity comprises upregulating or increasing activity level in one of the brain networks [Example 2 and 0263; “Increase baseline concentration” “Increase movement precision”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to cause increases in activity level during/after treatment as taught by Barthelemy to provide improvement via training as suggested by Ogawa, as Ogawa discusses the treatment showing improvement in cognitive function [0271] with Barthelemy because Barthelemy teaches the improvement via modulation for specific cerebral activity [0230].
Regarding Claim 18, Ogawa teaches wherein the brain networks include a default mode network (DMN), a central executive network (CEN), or a frontoparietal control network (FPCN) [0072] and [0074].
Regarding Claim 19, Ogawa teaches wherein the system is further configured to determine a first resting state activity level before the performing of the meditation task Fig. 20A-C, element “Pre”], determine a second resting state activity level after the performing of the meditation task [Fig. 23A-C, element “Post”] [0315]—describes score estimations (activity) before and after training, and assess a change in functional connectivity of at least one of the brain networks based on a comparison between the first and second resting state activity levels [Fig. 23A-C, elements “WLS”. “BDI”, “PRS” and “PRS:brooding”] and [0304]—showing pre and post scores related to rumination and brooding.
Regarding Claim 20, Ogawa teaches wherein the neurofeedback provided to the subject is visually provided on a screen [0095].
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ogawa (U.S. 20230293036) in view of Barthelemy (U.S. 20170311832) and in further view of Hendler (U.S. 20210259615).
Regarding Claim 3, Ogawa further teaches wherein the signals are blood-oxygen-level-dependent (BOLD) signals [0124]. Ogawa and Barthelemy are silent on recorded using real-time functional magnetic resonance imaging (rt-fMRI). Hendler teaches recorded using real-time functional magnetic resonance imaging (rt-fMRI) [0363]—reference to overcoming limitations of rt-fMRI through the use of simultaneous EEG and fMRI.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the use of rt-fMRI as taught by Hendler with the methods for neuromodulation and neurofeedback as suggested by Ogawa, and Barthelemy, as Ogawa discusses using time compensation methods to deconvolute the BOLD and EEG data [0186] and Barthelemy which discusses concerns with speed and delays during processing [0022] with Hendler because Hendler teaches the combination of fMRI with EEG to overcome limited applicability of this method [0363].
Claim(s) 7, 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ogawa (U.S. 20230293036) in view of Barthelemy (U.S. 20170311832) and in further view of Bach (U.S. 20200008725).
Regarding Claim 7, Ogawa and Barthelemy are silent on wherein the meditation task comprises mindfulness meditation. Bach teaches wherein the meditation task comprises mindfulness meditation [0199]—reference to the training task including meditation/mindfulness.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use mindfulness meditation as the training task as taught by Bach to collect data relating to this training task by use of simultaneous EEG and fMRI as suggested by Ogawa, and Barthelemy, as Ogawa discusses using time the activity and training tasks including rumination [0304] and Barthelemy which discusses the disclosed methods and systems used for meditating [0112] with Bach because Bach teaches using simultaneous fMRI and EEG data to create a database that requires less input of EEG sensors and more accurate data collection [0126].
Regarding Claim 17, Ogawa and Barthelemy are silent on wherein the meditation task comprises mindfulness meditation. Bach teaches wherein the meditation task comprises mindfulness meditation [0199]—reference to the training task including meditation/mindfulness.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use mindfulness meditation as the training task as taught by Bach to collect data relating to this training task by use of simultaneous EEG and fMRI as suggested by Ogawa, and Barthelemy, as Ogawa discusses using time the activity and training tasks including rumination [0304] and Barthelemy which discusses the disclosed methods and systems used for meditating [0112] with Bach because Bach teaches using simultaneous fMRI and EEG data to create a database that requires less input of EEG sensors and more accurate data collection [0126].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
-Zagorchev (WO 2018162307)—references the use of EEG with MRI to quantify three dimensional signals relative to brain regions
-Bower (U.S. 20190216392)—discusses cognitive platforms that include increasing difficulty levels to indicate cognitive abilities of the user.
-Laufs et al. Electroencephalographic signatures of attentional and cognitive default modes in spontaneous brain activity fluctuations at rest, PNAS, 100, 19, 11053-11058, 2003—reference to collection of EEG and fMRI data simultaneously while the individual is at rest
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/B.N.K./ Examiner, Art Unit 3791
/CHRISTINE H MATTHEWS/ Primary Examiner, Art Unit 3791
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