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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 8/21/2025 has been entered.
Response to Amendment
This action is in response to Applicant’s remarks, filed on 8/21/2025. The amendments to claim(s) 1-2, 5-6, 8-10, 13, 17, 19 and 23 have been entered. Claim(s) 20 were cancelled by Applicant and therefore withdrawn from further consideration pursuant to 37 CFR 1.142(b). Accordingly, claim(s) 1-19 and 21-23 remain pending for examination on the merits.
Response to Arguments
Applicant’s arguments, see p.1-2, filed 8/21/2025, with respect to the rejections of claim(s) 1-19 and 21-23 have been fully considered.
After review of the amendments and remarks regarding claim(s) 1-19 and 21-23, Examiner respectfully disagrees with the Applicant and the prior rejections under 35 USC §112(b) have been revised in view of the amendments and are maintained. The Applicant’s arguments pertaining to the rejection under 35 U.S.C. §102 and §103 are not persuasive, and the rejection from the prior office action are maintained. The ground(s) of rejection is/are made in view of the following: new amendments provided by Applicant and attached remarks; updated search and review of relevant prior art; and/or different interpretation of the previously applied references. Regarding the rejection(s) to claim(s) 1-19 and 21-23 under 35 U.S.C. §102 and 35 U.S.C. §103, Applicant argued the following:
35 U.S.C. §102 (Claims 1-12, 14-15, 17-18, and 23) - DeCharms
The Office rejected claims 1-12, 14-15, 17-18, and 23 under 35 U.S.C. §102 as anticipated by US Patent Publ. US2014/0316248 to DeCharms ("DeCharms"). Applicant respectfully disagrees, but amends claim 1 to advance prosecution.
DeCharms appears to teach methods to guide brain activity testing. However, DeCharms does not appear to teach the specific steps recited in amended claim 1 to visualize the pattern of change in the brain of the patient when different stimulus are applied to the patient, and externally stimulating a portion of the patient brain known to be related to the ailment.
Examiner respectfully disagrees with the Applicant. While the Applicant’s reply appears to present a bona fide response to the prior action, the amendments and remarks fail to address the prior rejections and fail to distinguish from a conventional fMRI study. Applicant has provided no evidence to establish an unobvious difference between the claimed product and the prior art, but rather has merely argued such alleged difference. Mere arguments can not take the place of evidence. In re Walters, 168 F.2d 79,80, 77 USPQ 609,610 (CCPA 1948); In re Cole, 326 F.2d. 769,773, 140 USPQ 230,233 (CCPA 1964); In re Schulze, 346 F.2d 600,602, 145 USPQ 716,718 (CCPA 1965); In re Lindner, 457 F.2d 506,508, 173 USPQ 356,358 (CCPA 1972); In re Pearson, 494 F.2d 1399,1405, 181 USPQ 641,646 (CCPA 1974); Meitzner v. Mindick, 549 F.2d 775,782, 193 USPQ 17,22 (CCPA), cert. Denied, 434 U.S. 854 (1977); In re DeBlauwe, 736 F.2d 699,705, 222 USPQ 191,196 (Fed. Cir. 1984).
Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references. Applicant's arguments do not comply with 37 CFR 1.111(c) because they do not clearly point out the patentable novelty which he or she thinks the claims present in view of the state of the art disclosed by the references cited or the objections made. Further, they do not show how the amendments avoid such references or objections.
As discussed in the prior office actions, and in view of the 35 U.S.C. §112 rejections, the Applicant’s assertion that “DeCharms does not appear to teach the specific steps recited in amended claim 1 to visualize the pattern of change in the brain of the patient when different stimulus are applied to the patient, and externally stimulating a portion of the patient brain known to be related to the ailment” is not found persuasive. Indeed, DeCharms clearly teaches the limitations at issue. DeCharms teaches anatomical scanning of the subject using functional magnetic resonance imaging, providing:
“The term “intervention,” as used herein refers to any manipulation of a subject. This includes pharmacological interventions, such as the administration of a pharmacological agent, stimulatory manipulations, such as the application of current to the nervous system using a stimulation device (e.g. deep brain stimulation), non-invasive stimulatory manipulations, such as the application of a stimulus to the nervous system using trans-cutaneous magnetic stimulation or another non-invasive stimulation modality, and behavioral manipulations such as rehabilitative therapy or behavioral therapy.”
DeCharms [0029] (emphasis added)
“Functional magnetic resonance imaging (fMRI) is a particular example of a brain scanning technology that is capable of measuring and monitoring brain activity. fMRI is based upon changes in Blood Oxygen Level Dependent (BOLD) contrast and provides spatially and temporally resolved visualization of the hemodynamic response evoked by neuronal activation. fMRI scanning can be performed according to widely published procedures.”
DeCharms [0242] (emphasis added)
Again, DeCharms clearly teaches the monitoring/visualization of a subject using fMRI while simultaneously applying stimuli to the subject to localize hemodynamic response (i.e., brain activity). DeCharms clearly teaches an intervention – in response to fMRI monitoring – may be non-invasive (e.g., magnetic stimulation).
Examiner respectfully notes that Applicant' s arguments only address independent claim(s) 1, and no remarks regarding the dependent claim(s) 2-19 and 21-23 have been presented. Rejections to dependent claims 2-19 and 21-23are modified to address Applicant' s amendments and the new rejection to independent claim(s) 1 and are sustained. The rejections of claim(s) 1-19 and 21-23 under 35 U.S.C. §102 and 35 U.S.C. §103 are maintained.
Claim Rejections – 35 USC § 112
35 USC § 112(b)
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.
Claim(s) 1-19 and 21-23 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim(s) 2-19 and 21-23 are rejected at least by virtue of dependency upon rejected independent claim 1.
Claim 1 recites the limitations “using the contemporaneously monitored change in the brain from the first and second sets of stimuli to visualize the pattern of change in the brain the patient; and externally stimulating a portion of the brain of the patient brain known to be related to the ailment” which renders the claim indefinite because the amended language is indefinitely broad, and one of ordinary skill in the art would be unable to determine the scope of the limitations. First, the claim fails to distinguish between the use of ‘monitoring’ and ‘visualizing’ – in the art of functional magnetic resonance imaging these may be synonymous, and it is unclear how ‘monitoring’ using fMRI differs from ‘visualizing’ using fMRI. The difference between ‘monitoring’ and ‘visualizing’ is not addressed or explained in the instant specification.
Next, as previously discussed in rejections from the prior office actions, the instant specification fails to provide any “pattern of change in the brain” which are subsequently visualized to arrive at the “ailment”; similarly, the specification is devoid of how the method determines which portion and how to administer ‘external stimulation’ corresponding to the ‘ailment’ that has been visualized from the brain activity. For the purposes of examination, the broadest reasonable interpretation of the claim limitations must be applied. This includes any region or area of the brain is eligible for fMRI imaging, and includes any possible type of brain activity and pattern of change that may occur in the brain which can be monitored using fMRI. Furthermore, this also includes any type of condition or disease which may be assessed in a patient’s brain (e.g., addiction, headaches, tumors, stroke, etc.), and any type of treatment (e.g., invasive, non-invasive, pharmaceutical, psychological intervention, etc.). Appropriate correction is required.
Claims 10, 13 and 19 recite the phrase “empirically shown”, rendering the claims indefinite. Aside from merely reciting “Patients are presented with a slideshow that contains words/concepts that have been empirically shown to generate a response in those with the specific condition”, the instant specification does not define what ‘empirically shown’ is claiming. There is no qualifying research, description of scientific method/study, or even a definition of the ‘empirical’ standard relative to the ‘stimuli’, which indicates what set of ‘stimuli’ qualifies as ‘empirically shown’. For the purposes of examination, the broadest reasonable interpretation of the ‘empirically shown’ is any stimuli that is presented to the patient to induce a response.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-12, 14-15, 17-18 and 23 is/are rejected under 35 U.S.C. 102(a)(2) as being clearly anticipated by DeCharms (US2014/0316248 A1; 2014-10-23), (hereinafter “DeCharms”).
Regarding claim 1, DeCharms teaches a method of visualizing a pattern of change in a brain of a patient (“Computer executable software is provided for guiding brain activity testing” [clm 18]; “any brain measurement methodology may be used in conjunction with the present invention so long as the physiological activity of one or more discretely localized regions of the brain can be effectively monitored […] the brain scanning methodology used is functional magnetic resonance imaging (fMRI).” [0178]; A method is provided for selecting how to test activation of one or more regions of interest of a subject, and monitoring physiological activity in the human brain and nervous system [clm 18], [0002, 0017-0076], [fig. 1-5]), comprising:
applying a first set of stimuli to the patient and contemporaneously using fMRI to monitor change in the brain (“logic for communicating instructions to a subject to perform a first behavior and/or a first stimulus to the subject; logic for taking activity measurements of one or more regions of interest of the subject in response to the first behavior or first stimulus” [clm 18]; “Physiological activity measurement may take one or more of several forms, including fMRI BOLD signals, fMRI EPI signals, […] Examples of measurement apparati that may be used alone or in combination include, but are not limited to functional magnetic resonance imaging (fMRI),” [0241]; “in order to measure the modulation, a stimulus or behavior condition is presented to the subject following a rest or background period to constitute a physiological localization trial. These trials may be repeated one or more times. Measurements are made of the resultant physiological activation patterns in the brain scan volume at multiple time points throughout the localization trials.” [0303]; A selected instruction or stimulus (e.g., visual display, auditory, applying physical force, causing physical sensation, etc.) may be presented to a subject (i.e., first stimulus) and brain activity is measured using fMRI [clm 18], [0073, 0176-0206, 0229-0283, 0299-0383], [fig. 1-5]);
applying a second set of stimuli comprising a stimulus selected to generate a response from the patient related to an ailment and contemporaneously using fMRI to monitor change in the brain, wherein the patient suppresses the response to the stimulus (“selecting a second behavior or a second stimulus for activating the one or more regions of interest based, at least in part, on the measured brain activity; and logic for communicating instructions to the subject to perform the second behavior and/or the second stimulus to the subject; logic for testing the activity measurements” [clm 18]; “The subject may be in an fMRI scanner as described, and physiological measurements may be conducted repeatedly throughout to measure scan volumes. A series of trials may be conducted, each trial consisting of a 30 second rest or background period, followed by a 30 second period of activation by a behavior” [0319]; “This process is repeated for different stimuli or instructions for behavior until all the stimuli or instructions for behavior to be evaluated have been presented, or until stimuli or instructions for behavior have been identified that provide a desired level of activation.” [0320]; “when the target spatial activity pattern is hypothetical, it may be based on a target spatial activity pattern that is hypothesized to be desirable for a given mental, cognitive, emotional, or behavioral state or process.” [0578]; “the therapy may relate to stress or anger management where how effectively stress or anger is being managed is measured during therapy.” [0650]; The subject may be presented a second stimuli (e.g., related to stress or anger management) and instructed to perform a second behavior (e.g., emotional task, sensory perception, motor activities, cognitive processes, etc.) in response to the second stimuli during fMRI monitoring of the subject’s brain [clm 18], [0049-0076, 0176-0206, 0229-0383], [fig. 1-5]),
wherein the sets of stimuli are selected from the group consisting of tactile, auditory, or visual stimuli (“Using some form of display, the subject views instructions of what the subject is to do, and/or other forms of information such as perceptual stimuli.” [0281]; “Auditory stimuli may also be presented to the subject, such as digitized speech, tones, music, or other types of sounds. Auditory stimuli may be presented to the subject via some form of speaker system, optionally worn by the subject. Tactile stimuli may be presented using a tactile stimulation apparatus […] Temperature stimuli may be presented using skin heating or cooling probes. Olfactory stimuli may be communicated using a device […] When the subject receives any of these stimuli, associated changes in the brain of the subject may be observed. These changes may then be measured as has been described.” [0283]; Different types of stimulus may be presented to the subject for the subject to experience (e.g., visual stimulation, auditory, tactile, proprioceptive, odorant, temperature, gustatory, etc.) [0190-0283, 0299-0383], [fig. 1-5]);
using the contemporaneously monitored change in the brain from the first and second sets of stimuli to visualize the pattern of change in the brain of the patient (“logic for testing the activity measurements and performing a diagnosis of the subject or of the efficacy of an applied intervention.” [clm 18]; “evaluating the set of stimuli comprises calculating and comparing activation metrics computed for each stimuli based on measured activities for the different stimuli. In another variation, the activation in the regions of interest is used as an indicator in diagnosis of a condition of the subject.” [0063]; “One criterion used for automated physiological definition of a region of interest is a difference criterion, such as the average difference in % BOLD activation level between the stimulus or behavior condition and background, […] Another criterion used for automated physiological definition of a region of interest is a correlation, such as the correlation of the activation of a voxel with the stimulus or behavior condition across repeated trials.” [0312]; “This process is repeated for different stimuli or instructions for behavior until all the stimuli or instructions for behavior to be evaluated have been presented, or until stimuli or instructions for behavior have been identified that provide a desired level of activation.” [0320]; “a subject may receive a T2*-weighted functional MRI scan, […] These values may be interpreted as indicators of the functional status of corresponding brain regions. These values may be interpreted as indicators of the presence of abnormal function or disease” [0480]; The subject may undergo continuous fMRI monitoring while presented different stimuli overtime to form a pattern of activation (i.e., a 2-D or 3-D pattern of change within a brain region), wherein measurements may include sub-regions of increased activation and sub-regions of neutral or decreased activation [clm 18], [0190-0283, 0299-0383], [fig. 1-5]); and
externally stimulating a portion of the brain of the patient brain known to be related to the ailment (“logic for testing the activity measurements and performing a diagnosis of the subject or of the efficacy of an applied intervention.” [clm 18]; “The term “intervention,” as used herein refers to any manipulation of a subject. This includes pharmacological interventions, such as the administration of a pharmacological agent, stimulatory manipulations, such as the application of current to the nervous system using a stimulation device (e.g. deep brain stimulation), non-invasive stimulatory manipulations, such as the application of a stimulus to the nervous system using trans-cutaneous magnetic stimulation or another non-invasive stimulation modality, and behavioral manipulations such as rehabilitative therapy or behavioral therapy.” [0029]; “Once these stimuli or behaviors have been determined, this serves as a characterization of the function of this brain region of interest. It is possible to perform this characterization to generate new knowledge of the functions of a brain region. […] For example, this new knowledge may be used to design treatments involving the characterized brain region of interest. These treatments may include pharmacological treatments, surgical treatments, electrical stimulation treatments, or other treatments. The knowledge of the characterization of a brain region may be used for diagnostic purposes as well” [0664]; The tissue function may be determined by comparing the value of an activity metric with a reference value based on the measurements from same subject, and interventions (e.g., external stimulation) may be applied to the region of the brain corresponding with the assessed condition [clm 18], [0190-0283, 0299-0383, 0476-0480], [fig. 1-5]).
Regarding claim 2, DeCharms teaches the method of claim 1,
DeCharms further teaching wherein a further response to the first set of stimuli is unsuppressed by the patient (“various types of information that may be communicated to the subject include, but are not limited to, instructions, physiological measurement related information, subject performance related information, and stimulus information that causes the subject to have a perception.” [0027]; “A selected instruction, or stimulus, then may be presented via a display means 180 to a subject 190. […] The instruction may also be to ‘rest’, or not to perform an overt behavior.” [0177]; “if the trials contain a rest period and a task period, a region may be determined which is activated selectively during the task period compared to the rest period” [0305]; “the therapy may relate to stress or anger management where how effectively stress or anger is being managed is measured during therapy.” [0650]; The data analysis control software generates information and selects instructions for the patient to perform a physical/mental action (e.g., instructions to activate a brain region to a designated level) in response to stimuli [0190-0283, 0299-0383, 0476-0480], [fig. 1-5], [see claim 1 rejection]).
Regarding claim 3, DeCharms teaches the method of claim 1,
DeCharms further teaching wherein suppressing the response comprises one of self soothing, self coping, or self encouragement (“The term “instructions,” as used herein, refers to any instruction to perform a physical or mental action that is communicated to a subject or an operator assisting a subject. Examples of instructions include, but are not limited to instructions to a subject to perform a behavior; instructions to a subject to rest;” [0028]; “The term “rest,” as used herein, refers to a period during which a subject is not engaged in a particular overt behavior. This may mean that the subject has received no instructions, that they have just received the instruction to remain still during measurement, that they have received the instruction to perform a ‘background task’ that leads to little brain activation in a measured region” [0037]; “These instructions alert a subject regarding different things that the subject is asked to do including perform a testing exercise, rest and other forms of response that may be asked of the subject. The instructions may be displayed concurrently with other forms of information.” [0492]; The subject may be instructed to rest (e.g., self sooth, self cope, etc.) [0017-0076, 0190-0283, 0299-0383, 0476-0480], [fig. 1-5]).
Regarding claim 4, DeCharms teaches the method of claim 1,
DeCharms further teaching wherein the first set of stimuli is the same as the second set of stimuli, with the exception of an element of the sets of stimuli (“Once the region of interest has been identified, optionally, stimuli or behaviors may be evaluated by monitoring the physiological activity response in the region of interest in order to determine stimuli or behaviors that are effective” [0315]; “certain stimuli or instructions are selected. This selection is typically made by selecting a small number of stimuli or instructions for behavior from the complete set that elicit the largest activation in the region of interest. The more effective stimuli or instructions for behaviors are then used” [0321]; “Once a brain region of interest has been localized and effective stimuli or instructions for behavior have been selected based upon their ability to modulate the brain regions of interest, these stimuli or instructions for behavior may be used to test the subject.” [0323]; The subject may be presented the same sets of stimuli after the set of stimuli has been found to be effective [0299-0383, 0476-0480], [fig. 1-5], [see claim 1 rejection]).
Regarding claim 5, DeCharms teaches the method of claim 1,
DeCharms further teaching wherein the patient rates their emotional state after applying the first set of stimuli and before applying the second set of stimuli (“In another variation, an activity metric is calculated based on the measured activity and the subject estimates the activity metric. It is noted that the subject's estimate of the measured activity can be a qualitative estimate (e.g., higher than a value, lower than a value) or quantitative (e.g., a numerical estimate).” [0122]; “the behavior may optionally be selected from the group consisting of sensory perceptions, detection or discrimination, motor activities, cognitive processes, emotional tasks, and verbal tasks.” [0132]; “In some cases, the subject may provide an overt response to the selected stimuli or instructions as well, as would be the case if the subject were completing a sensory discrimination task.” [0352]; “if a subject is performing a visual stimulus discrimination task designed to activate visual sensory areas during testing, then performance on this task may be computed for each trial. For each trial, the subject provides a response (e.g. a button-press indicating which of two alternative areas contained a visual stimulus). The analysis and control software records these responses and makes computations of the subjects performance level.” [0364]; “The target spatial activity pattern can also be measured for a subject when the subject reports a positive mental state or experience.” [0580]; Subjects may perform emotional tasks and report on mental state or experience [0190-0283, 0299-0383, 0569-0607], [fig. 1-5]).
Regarding claim 6, DeCharms teaches the method of claim 1,
DeCharms further teaching further comprising a training regimen of applying the first and second sets of stimuli to the patient, wherein the training regimen is applied before the steps of applying and monitoring brain change in the brain (“A subject is preferably pre-trained using exercises that closely mimic the exercises that will be performed when the brain activity is being measured.” [0222]; “pre-training is typically preferably designed to generate an experience as close as possible to the real training that the subject will undergo. Therefore, the tasks that the subject is asked to perform, the percent correct achieved, the displays that are provided, stimuli that the subject experiences, and actions that the subject undertakes are all preferably similar to those the subject will observe when actual testing is performed.” [0224]; The subject may be pre-trained prior to performing fMRI monitoring [0190-0383], [fig. 1]).
Regarding claim 7, DeCharms teaches the method of claim 1,
DeCharms further teaching wherein the steps of applying the first stimuli and the second stimuli are separated by 1, 5, 10, 15, or 20 minutes (“in one variation, the subject performs a behavior, has a perception and/or is exposed to a stimulus repeatedly for a period of at least 1, 5, 10, 20, 30, 60 or more minutes.” [0158]; “Testing may comprise performing trials comprised of alternating periods of rest, followed by exercise, or periods of different types of exercise. These trials may be designed to engage the regions of interest of the brain using the selected set of effective stimuli or instructions for behavior. These alternating periods of rest and performing a task are typically formed together into testing blocks that last at least 0.25, 0.5, 1, 5, 10, 20, 30 or more minutes, with physiological scanning beginning at the start of a testing block, and taking place during each testing block.” [0325]; The alternating trial periods may be separated by minute rest periods [0190-0383], [fig. 1-5], [see claim 1 rejection]).
Regarding claim 8, DeCharms teaches the method of claim 1,
DeCharms further teaching wherein the first set of stimuli comprises a stimulus selected to generate a response from the patient related to the ailment and externally stimulating the portion of the brain of the patient comprises application of an extracranial magnet (“non-invasive stimulatory manipulations, such as the application of a stimulus to the nervous system using trans-cutaneous magnetic stimulation or another non-invasive stimulation modality,” [0029]; “This process is repeated for different stimuli or instructions for behavior until all the stimuli or instructions for behavior to be evaluated have been presented, or until stimuli or instructions for behavior have been identified that provide a desired level of activation.” [0320]; “when the target spatial activity pattern is hypothetical, it may be based on a target spatial activity pattern that is hypothesized to be desirable for a given mental, cognitive, emotional, or behavioral state or process.” [0578]; “the therapy may relate to stress or anger management where how effectively stress or anger is being managed is measured during therapy.” [0650]; The stimuli may be selected that provide a desired level of activation and based on a target spatial activity pattern for a given emotional state (e.g., related to stress or anger management), wherein multiple different stimuli are presented to the subject [0190-0383, 0569-0607], [fig. 1-5], [see claim 1 rejection]).
Regarding claim 9, DeCharms teaches the method of claim 5,
DeCharms further teaching further comprising the step of using the first and second set of stimuli, the patient's emotional state rating, and the respective contemporaneously monitored change in the brain to map an emotional response of the patient to the first and second sets of stimuli (“One primary type of display that may be presented include measures of physiological activity such as variance maps, activation maps of the subject's brain activity, activity metrics from localized brain regions.” [0278]; “Adjacent brain sites generally correspond with nearly adjacent regions in perceptual space (e.g. adjacent points in visual space, adjacent points on the body for tactile sensation, adjacent sound frequencies, similar movements, similar conceptual processes, similar emotional states, similar words or ideas). Therefore, it is possible to create representational maps.” [0518]; Activation maps of a subjects brain activity may be generated from fMRI measurements, representing an emotional state based on stimuli response and behaviors performed by the subject [0190-0383, 0569-0607], [fig. 1-5], [see claim 1 rejection]).
Regarding claim 10, DeCharms teaches the method of claim 1,
DeCharms further teaching wherein the ailment is selected from the group consisting of addiction, obsessive compulsive disorder, general anxiety disorder, social anxiety disorder, pain, and tinnitus, and at least one stimulus in the first set of stimulus is empiricallv shown to generate a further response from the patient related to the ailment (“Also according to any of the above embodiments, in one variation, the subject has one or more of the following conditions: Parkinson's disease, Alzheimer's disease, attention & attention deficit disorder, depression, substance abuse & addiction, schizophrenia.” [0174]; “if it has been determined that a brain region of interest is implicated in a condition, such as a disease, then using the stimuli or behaviors determined to engage that brain region may be used as a diagnostic for whether a subject has that condition, and the extent or severity of the condition.” [0664]; [see claim 1 rejection]).
Regarding claim 11, DeCharms teaches the method of claim 1,
DeCharms further teaching wherein the first set of stimuli comprises a first pain stimulus and the second set of stimuli comprises a second pain stimulus different than the first pain stimulus (“Examples of ways of communicating information include, but are not limited to displaying information to the subject, playing audio for the subject, […] and causing a physical sensation for the subject (e.g., cold, hot, pain, electrical charge, etc.).” [0027]; “Tactile stimuli may be presented using a tactile stimulation apparatus […] Temperature stimuli may be presented using skin heating or cooling probes.” [0283]; The subject may be subjected to different pain stimuli during testing [0190-0383, 0569-0607]).
Regarding claim 12, DeCharms teaches the method of claim 11,
DeCharms further teaching wherein the first pain stimulus is associated with a first visual stimulus and the second pain stimulus is associated with a second visual stimulus different than the first visual stimulus (“Examples of ways of communicating information include, but are not limited to displaying information to the subject, playing audio for the subject, […] and causing a physical sensation for the subject (e.g., cold, hot, pain, electrical charge, etc.).” [0027]; “A variety of types of information and display screens can be presented. For example, visual stimuli may be presented to the subject via some form of display. […] Auditory stimuli may also be presented to the subject, such as digitized speech, tones, music, or other types of sounds. Auditory stimuli may be presented to the subject via some form of speaker system, optionally worn by the subject.” [0282-0283]; “The information can relate to instructions, brain measurements, sensory stimuli, and testing performance. Each of these different types of information may be displayed by itself or in combination with other types of information.” [0488]; The subject may be given the different stimuli types (e.g., visual, audio, tactile, etc.) in combination [0190-0383, 0569-0607], [fig. 1-5], [see claim 1 rejection]).
Regarding claim 14, DeCharms teaches the method of claim 1,
DeCharms further teaching wherein the first set of stimuli comprises a first auditory stimulus and the second set of stimuli comprises at least one auditory stimulus different than the first auditory stimulus (“According to any of the above embodiments where information is communicated, in one variation, the information is communicated by a manner selected from the group consisting of providing audio to the subject, providing tactile stimuli to the subject, providing a smell to the subject, displaying an image to the subject.” [0162]; “Auditory stimuli may also be presented to the subject, such as digitized speech, tones, music, or other types of sounds. Auditory stimuli may be presented to the subject via some form of speaker system, optionally worn by the subject.” [0281]; The different stimulus presented to the subject may be auditory stimuli [0190-0383, 0569-0607], [fig. 1-5], [see claim 1 rejection]).
Regarding claim 15, DeCharms teaches the method of claim 14,
DeCharms further teaching wherein the first auditory stimulus is associated with a first visual stimulus and the at least one auditory stimulus is associated with a second visual stimulus different than the first visual stimulus (“A variety of types of information and display screens can be presented. For example, visual stimuli may be presented to the subject via some form of display. […] Auditory stimuli may also be presented to the subject, such as digitized speech, tones, music, or other types of sounds. Auditory stimuli may be presented to the subject via some form of speaker system, optionally worn by the subject.” [0280-0281]; “Determining effective and more effective stimuli or behaviors may be performed by presenting a series of different stimuli or instructions for behavior from a set of exemplars one or more times, determining an activity measure or index for each different stimulus or behavior from one or more brain regions of interest” [0317]; “This process is repeated for different stimuli or instructions for behavior until all the stimuli or instructions for behavior to be evaluated have been presented, or until stimuli or instructions for behavior have been identified that provide a desired level of activation.” [0320]; “For example, the therapy may relate to stress or anger management where how effectively stress or anger is being managed is measured during therapy.” [0650]; Different types of stimuli (e.g., auditory, visual, etc.) may be presented to the subject over different trials/testing periods [0190-0383, 0569-0607], [fig. 1-5], [see claim 1 rejection]).
Regarding claim 17, DeCharms teaches the method of claim 1,
DeCharms further teaching wherein, preceding the step of applying the first set of stimuli to the patient, the steps of:
without fMRI monitoring, applying one of the first set of stimuli to the patient; and without fMRI monitoring, applying one of the second set of stimuli to the patient; (“Optionally, the subject is pre-trained using a device that simulates the experiences that the subject will experience when actual diagnosis is performed. This may include providing the subject with the same or similar visual and auditory experiences that will later be provided.” [0219]; “Therefore, the tasks that the subject is asked to perform, the percent correct achieved, the displays that are provided, stimuli that the subject experiences, and actions that the subject undertakes are all preferably similar to those the subject will observe when actual testing is performed.” [0224]; A subject may be trained before fMRI monitoring using a similar user interface and training schedule and uses the same selected stimuli that a subject would encounter during testing in the scanning apparatus [0218-0228], [see claim 6 rejections]);
wherein the patient does not suppress an emotional response to one of the first set of stimuli (“A selected instruction, or stimulus, then may be presented via a display means 180 to a subject 190. […] The instruction may also be to ‘rest’, or not to perform an overt behavior.” [0177]; [0190-0383], [see claim 1-3 rejections]); and
wherein the patient suppresses an emotional response to one of the second set of stimuli (“This process is repeated for different stimuli or instructions for behavior until all the stimuli or instructions for behavior to be evaluated have been presented, or until stimuli or instructions for behavior have been identified that provide a desired level of activation.” [0320]; “when the target spatial activity pattern is hypothetical, it may be based on a target spatial activity pattern that is hypothesized to be desirable for a given mental, cognitive, emotional, or behavioral state or process.” [0578]; “the therapy may relate to stress or anger management where how effectively stress or anger is being managed is measured during therapy.” [0650]; The subject is instructed and given similar behavioral tasks and stimuli during pretraining prior to brain monitoring using fMRI [0190-0383], [see claim 1 rejection]).
Regarding claim 18, DeCharms teaches he method of claim 17,
DeCharms further teaching wherein one of the first and second sets of stimuli comprise at least one of tactile, auditory, or visual stimuli related to a condition (“Using some form of display, the subject views instructions of what the subject is to do, and/or other forms of information such as perceptual stimuli.” [0281]; “Auditory stimuli may also be presented to the subject, such as digitized speech, tones, music, or other types of sounds. Auditory stimuli may be presented to the subject via some form of speaker system, optionally worn by the subject. Tactile stimuli may be presented using a tactile stimulation apparatus […] Temperature stimuli may be presented using skin heating or cooling probes. Olfactory stimuli may be communicated using a device […] When the subject receives any of these stimuli, associated changes in the brain of the subject may be observed. These changes may then be measured as has been described.” [0283]; [0190-0283, 0299-0383], [fig. 1-5], [see claim 1, 5 rejections]).
Regarding claim 23, DeCharms teaches the method of claim 1,
DeCharms further teaching wherein the stimulus generate the response from the patient related to the ailment comprises a word related to the ailment (“Adjacent brain sites generally correspond with nearly adjacent regions in perceptual space (e.g. adjacent points in visual space, adjacent points on the body for tactile sensation, adjacent sound frequencies, similar movements, similar conceptual processes, similar emotional states, similar words or ideas).” [0518]; “The subject can undergo interchange with a psychological counselor or psychotherapist while undergoing measurement and testing as described in this invention to evaluate the person's response. For example, the therapy may relate to stress or anger management where how effectively stress or anger is being managed is measured during therapy.” [0650]; Word association in therapy may be applied in stress or anger management [0650]).
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.
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(s) 13 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over DeCharms as applied to claim 1 above, in view of Butler et al. (“The neural correlates of attempting to suppress negative versus neutral memories” Cognitive, Affective, & Behavioral Neuroscience. 2010, 10 (2), 182-194; 2010-06) (hereinafter “Butler”), as provided by Applicant.
Regarding claim 13, DeCharms teaches the method of claim 1,
but DeCharms may fail to explicitly teach stimuli comprises sets of words.
However, in the same field of endeavor, Butler teaches a method of visualizing a pattern of change in a brain of a patient (“an event-related fMRI study comparing attempts at suppressing recall of negative versus neutral memories” [abst], [p.184, col 1], [fig. 2]);
Butler further teaching wherein the first set of stimuli comprises sets of words, wherein each word in the sets of words is empirically shown to generate a further response from the patient related to the ailment (“Each of the 40 word pairs consisted of a cue and a target. All 40 cues were neutral (low arousal with intermediate valence). Half of the target words were neutral (low arousal with intermediate valence), and half were negative (high arousal with low valence).” [p.184, col 2]; The word pairs had a neutral word and a target (e.g., inflammatory) word [p.184, col 2]).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the invention to combine the method taught by DeCharms with word stimulus as taught by Butler. It is known in the art that adjacent brain sites generally correspond with nearly adjacent regions in perceptual space (e.g. adjacent points in visual space, adjacent points on the body for tactile sensation, adjacent sound frequencies, similar movements, similar conceptual processes, similar emotional states, similar words or ideas) (DeCharms [0518]). Investigation of the mechanisms underlying the suppression of negative thoughts may help to optimize treatment in the future, and a better understanding of the crucial mechanisms of suppression is now available through the use of new experimental paradigms that can be used in concert with neuroimaging techniques. In particular, the think/no-think (TNT) paradigm allows one to study the effects of suppression on subsequent memory retrieval by using functional MRI to compare neural activity during recall versus suppression (Butler [p.183, col 1-p.184, col 2]).
Regarding claim 19, DeCharms teaches the method of claim 17,
but DeCharms may fail to explicitly teach stimuli comprises sets of words.
However, in the same field of endeavor, Butler teaches wherein one of the first and second sets of stimuli comprise words that are empiricallv shown to generate a further response from the patient related to the ailment (“Each of the 40 word pairs consisted of a cue and a target. All 40 cues were neutral (low arousal with intermediate valence). Half of the target words were neutral (low arousal with intermediate valence), and half were negative (high arousal with low valence).” [p.184, col 2]; Word pairs had a neutral word and a target (i.e., inflammatory) word [p.184, col 2]).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the invention to combine the method taught by DeCharms with word stimulus as taught by Butler. It is known in the art that adjacent brain sites generally correspond with nearly adjacent regions in perceptual space (e.g. adjacent points in visual space, adjacent points on the body for tactile sensation, adjacent sound frequencies, similar movements, similar conceptual processes, similar emotional states, similar words or ideas) (DeCharms [0518]). Investigation of the mechanisms underlying the suppression of negative thoughts may help to optimize treatment in the future, and a better understanding of the crucial mechanisms of suppression is now available through the use of new experimental paradigms that can be used in concert with neuroimaging techniques. In particular, the think/no-think (TNT) paradigm allows one to study the effects of suppression on subsequent memory retrieval by using functional MRI to compare neural activity during recall versus suppression (Butler [p.183, col 1-p.184, col 2]).
Claims 16 and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over DeCharms as applied to claim 1 above, and further in view of Malchano et al. (US2018/0133507 A1; 2018-05-17) (hereinafter “Malchano”).
Regarding claim 16, DeCharms teaches the method of claim 1,
DeCharms further teaching the patient responds to a word with a manual gesture representative of the word (“a stimulus or behavior condition is presented to the subject following a rest or background period to constitute a physiological localization trial. These trials may be repeated one or more times. Measurements are made of the resultant physiological activation patterns in the brain scan volume at multiple time points throughout the localization trials. In order to localize the primary motor cortical representation of the hand, a subject may be asked to alternate between 30 second periods of rest with 30 second periods of moving, or imagining moving, the index finger of the right hand while scanning of the T2* weighted activation level is measured at every voxel within a brain scan volume every second.” [0303]).
but DeCharms may fail to explicitly teach stimuli comprises sets of words.
However, in the same field of endeavor, Malchano teaches systems and methods for treating cognitive dysfunction in a subject [abst];
Malchano further teaching the set of stimuli comprises sets of words (“the audio sequence can include a change in frequency, tone, amplitude, or insert words or music in a predetermined, random, or pseudo-random pattern” [0499]; The system introduces subject to an audio sequence of words (i.e., set of stimuli comprises sets of words) and detects the subject’s brain activity in response thereof [0499]), and
the patient responds to a word from the sets of words with a manual gesture representative of the word (“A wide variety of I/O devices 730 a-730 n can be present in the computing device 700” [0315]; “Some devices 730 a-730 n allow gesture recognition inputs through combining some of the inputs and outputs” [0316]; “While administering the assessment, the CAS can receive input from the subject via a measurement device to measure the assessment result” [0810], [fig. 8]; The subject may use a manual gesture detected by the system in response to the word (i.e., representative of the word) [0316]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to modify the method with first and second stimuli taught by DeCharms with the word sets and gesture detection taught by Malchano. It is known in the art that adjacent brain sites generally correspond with nearly adjacent regions in perceptual space (e.g. adjacent points in visual space, adjacent points on the body for tactile sensation, adjacent sound frequencies, similar movements, similar conceptual processes, similar emotional states, similar words or ideas) (DeCharms [0518]). Modifying the method as claimed enables visual stimulation to provide beneficial effects to one or more cognitive states or cognitive functions of the brain or the immune system, while mitigating or preventing adverse consequences on a cognitive state or cognitive function (e.g., Alzheimer's Disease) (Malchano [0004]).
Regarding claim 21, DeCharms and Malchano teach the method of claim 16,
DeCharms further teaching wherein the patient suppresses an emotion evoked by the word in conjunction with the manual gesture (“selecting a second behavior or a second stimulus for activating the one or more regions of interest based, at least in part, on the measured brain activity; and logic for communicating instructions to the subject to perform the second behavior and/or the second stimulus to the subject;” [clm 18]; “a stimulus or behavior condition is presented to the subject following a rest or background period to constitute a physiological localization trial. These trials may be repeated one or more times. Measurements are made of the resultant physiological activation patterns in the brain scan volume at multiple time points throughout the localization trials. In order to localize the primary motor cortical representation of the hand, a subject may be asked to alternate between 30 second periods of rest with 30 second periods of moving, or imagining moving, the index finger of the right hand while scanning of the T2* weighted activation level is measured at every voxel within a brain scan volume every second.” [0303]; “when the target spatial activity pattern is hypothetical, it may be based on a target spatial activity pattern that is hypothesized to be desirable for a given mental, cognitive, emotional, or behavioral state or process.” [0578]; [0190-0383], [fig. 1-5], [see claim 1 rejection]).
Regarding claim 22, DeCharms and Malchano teach the method of claim 16,
DeCharms further teaches wherein the patient does not suppress an emotion evoked by the word in conjunction with the manual gesture (“various types of information that may be communicated to the subject include, but are not limited to, instructions, physiological measurement related information, subject performance related information, and stimulus information that causes the subject to have a perception.” [0027]; “A selected instruction, or stimulus, then may be presented via a display means 180 to a subject 190. […] The instruction may also be to ‘rest’, or not to perform an overt behavior.” [0177]; “a stimulus or behavior condition is presented to the subject following a rest or background period to constitute a physiological localization trial. These trials may be repeated one or more times. Measurements are made of the resultant physiological activation patterns in the brain scan volume at multiple time points throughout the localization trials. In order to localize the primary motor cortical representation of the hand, a subject may be asked to alternate between 30 second periods of rest with 30 second periods of moving, or imagining moving, the index finger of the right hand while scanning of the T2* weighted activation level is measured at every voxel within a brain scan volume every second.” [0303]; “if the trials contain a rest period and a task period, a region may be determined which is activated selectively during the task period compared to the rest period” [0305]; [0190-0383], [fig. 1-5], [see claim 1 rejection]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Any inquiry concerning this communication or earlier communications from the examiner should be directed to James F. McDonald III whose telephone number is (571)272-7296. The examiner can normally be reached M-F; 8AM-6PM EST.
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JAMES FRANKLIN MCDONALD III
Examiner
Art Unit 3797
/CHRISTOPHER KOHARSKI/Supervisory Patent Examiner, Art Unit 3797
Prosecution Insights