DETAILED ACTION
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 1/14/2026 was considered by the examiner.
Response to Amendment
Receipt is acknowledged of the amendment filed 12/16/2025. Claims 1-20 are pending. Claims 1, 3-4, 7-8, and 11-14 were amended. Claims 16-20 were added.
Response to Arguments
Applicant’s arguments, see pages 9-12 of arguments filed 12/16/2025, with respect to the rejection(s) of claim(s) 1-15 under 35 USC 103 have been fully considered but are not persuasive.
The pending rejection of independent claims 1, 13, and 14 are made over US 2011/0263968 (Quattrocki) in view of US 2024/0418814 (Dosenbach).
Applicant’s arguments on pages 9-11 directed toward Quattrocki are moot as the rejection acknowledges Quattrocki fails to teach “wherein the at least one signal comprises an instruction to pause, terminate and/or restart said acquisition.”
The Examiner notes, however, the Applicant concludes at the bottom of page 10:
“Therefore, there is no teaching of generating a signal specifically in response to poor performance or poor compliance, as in claim 1.” (Underline added by the Applicant, with bold/italic added by the Examiner).
The Examiner emphasizes claim 1 recites, “a poor performance of and/or compliance” and does not specify “poor compliance” as suggested by the Applicant’s arguments. In view of a broadest reasonable interpretation, the claim may reasonably be interpreted to including terminating the acquisition once an activity measure indicates compliance, i.e. terminating the acquisition upon determination from the activity that the subject was in compliance with the task.
Regarding arguments on page 11 directed toward Dosenbach are not persuasive.
The Applicant concludes Dosenbach does not teach:
“at least one signal, generated responsive to poor performance and/or non-compliance with a test-task, comprising an instruction to pause, terminate and/or restart the acquisition, as in claim 1.” (Underline added by the Applicant, with bold/italic added by the Examiner).
Similar to above, the Applicant’s argument is not consistent with the limitation as claimed. The Examiner emphasizes claim 1 recites, “a poor performance of and/or compliance” and does not specify “non-compliance” as stated in the argument. Thus, terminating the acquisition once an activity measure indicates compliance would reasonably read on the limitation as claimed.
The Applicant further argues on page 11 that Dosenbach “does not teach the at least one signal comprising an instruction to pause, terminate and/or restart acquisition of a time series of functional magnetic resonance images of the brain of the subject using an MRI system. The at least one signal refers to a signal generated in response to a determined activity measure being indicative of a poor performance of and/or compliance to the predetermined test task.” The Examiner respectfully disagrees.
The Applicant states on page 11:
“For example, para. [0029] of Dosenbach provides: "Scanner operators may be alerted about any sudden or unusual changes in head movement and may be enabled to interrupt such scans to investigate if the subject has started moving more because they have grown uncomfortable and whether a bathroom break, blanket, repositioning or other intervention could make them feel more comfortable." See also para. [0048] ("In one aspect, the method 200 further includes evaluating at least one of a plurality of factors to determine whether the current MRI scan should be terminated at step 210. In various aspects, the scan may be terminated in accordance with at least one of a plurality of termination criteria including, but not limited to, one of more movements of an unacceptably high magnitude, and unacceptably high number of relatively low magnitude movements ....")” (emphasis added by Applicant).
The Examiner notes the Applicant’s argument relies on a piecemeal analysis of [0048] by omitting relevant portions from [0048] of Dosenbach quoted in the rejection of claim 1. For clarity, [0048] states in its entirety:
“In various aspects, the method 200 may further include determining the total movement of the patient at step 208 between the previous data and the current data in response to the sensory feedback display generated at step 206. In one aspect, the method 200 further includes evaluating at least one of a plurality of factors to determine whether the current MRI scan should be terminated at step 210. In various aspects, the scan may be terminated in accordance with at least one of a plurality of termination criteria including, but not limited to, one of more movements of an unacceptably high magnitude, and unacceptably high number of relatively low magnitude movements, a determination that a suitable number of useable data were obtained, a prediction that a suitable number of useable data cannot be obtained in the time remaining in the scan, a prediction that a suitable number of useable data cannot be obtained within a reasonable cumulative scan time, and any combination thereof. If it is determined at step 210 to continue the scan, the method 200 may communicate at least one feedback signal 212 to be used in part to calculate the data quality metric at step 202 to start another iteration of the method 200 for subsequent data.” (Emphasis added by Examiner).
Therefore, Dosenbach teaches wherein the fMRI scan may be stopped due to a number of criteria, including “one of more movements of an unacceptably high magnitude, and unacceptably high number of relatively low magnitude movements, a determination that a suitable number of useable datasets were obtained, a prediction that a suitable number of useable datasets cannot be obtained in the time remaining in the scan, a prediction that a suitable number of useable datasets cannot be obtained within a reasonable cumulative scan time.” The fMRI data collected as task fMRI data would reasonably be interpreted as “at least one activity measure” based on movement and/or suitability of the datasets, wherein acquisition may be terminated based on any of the above conditions.
It is unclear to the Examiner how the passages cited by the Applicant, taken in part or in its entirety, support the conclusion, “Accordingly, there is no teaching of at least one signal, generated responsive to poor performance and/or non-compliance with a test task, comprising an instruction to pause, terminate and/or restart the acquisition, as in claim 1.” The examiner maintains the prior art of record teaches all limitations as claimed, as outlined below.
The Applicant is reminded the claims are interpreted in light of the specification and rejected in view of a broadest reasonable interpretation.
The Examiner is unable to identify a precise definition of “activity measure” nor does the term have a standard definition in the art. Further, the Examiner is unable to identify any specific details, calculations or examples explaining or otherwise limiting how an “activity measure” is “indicative of a poor performance of and/or compliance to the predetermined test task” as recited in the claim. Therefore, these limitations are interpreted in view of a broadest reasonable interpretation of one having ordinary skill in the art. No rejection was made for enablement as, in the opinion of the Examiner, the limitations as claimed would be well-understood by one of ordinary skill in the art in view of a broadest reasonable interpretation.
For example, fMRI data is generally understood in the art to be “indicative of brain activity in at least one predetermined region of interest” as recited in the claim. As stated in Dosenbach, it is known that motion damages the clinical value of the images ([0003], [0023], [0025]), and fMRI data may also be used to calculate the relative motion (see calculations starting at [0035]). Further, Dosenbach teaches wherein an fMRI acquisition may be terminated or data may be re-acquired to address motion. See [0029], [0048]. Therefore, terminating an acquisition in accordance with motion of unacceptably high magnitude as determined from task fMRI data would reasonably be interpreted as equivalent to “at least one determined activity measure being indicative of a poor performance of and/or compliance to the predetermined test task, …., and wherein the at least one signal comprises an instruction to pause, terminate and/or restart said acquisition” in view of a broadest reasonable interpretation. Further support is provided below.
As best understood by the examiner, the rejection over Dosenbach is seemingly consistent with what is disclosed in the specification which repeatedly identifies movement as example of poor performance or non-compliance as discussed below.
The specification filed 7/25/2023 teaches in the paragraph starting at page 2, line 34 (see [0009] of corresponding Pg. Pub. US 2024/0410964) states:
“Regardless of the specific task paradigm and fMRI imaging protocol, the cooperation of the imaged subject in diligently performing the prescribed task is typically required. Even if a specific task were to rely only on a subconscious or autonomous reaction of the brain, the imaged subject would likely still need to cooperate in order to avoid movement artefacts that could prevent the subtle image contrast of interest from being detected. Non-compliance with the prescribed task can manifest in various ways, for example, random responses or even no responses of the test subject to the task-related cues. This could easily be caused by the subject being distracted, or even falling asleep.” (Emphasis provided by Examiner).
The pending specification teaches at page 9, lines 7-12 (see [0052]-[0053] of corresponding Pg. Pub. US 2024/0410964) states:
“A method in accordance with embodiments of the present invention may comprise a further step of detecting a further activity measure indicative of a sleep state and/or of sleep drowsiness during the timeseries acquisition.
A method in accordance with embodiments of the present invention may comprise detecting motion of the subject during the acquisition of the timeseries, and generating the signal or a further signal if the detected motion exceeds a predetermined threshold.” (Emphasis provided by Examiner).
The pending specification teaches at pages 27-29 of the pending specification (see [0126]-[0135] of corresponding Pg. Pub. US 2024/0410964) discuss generating the alert in response to detecting motion, including motion from a slow breathing pattern that could indicate a sleeping state.
For example, the paragraph starting at page 27, line 3 (see [0126] of corresponding Pg. Pub. US 2024/0410964) states:
“Furthermore, optionally, the method may also comprise detecting 15 motion of the subject during the acquisition of the fMRI timeseries, e.g. detecting motion in (near) real-time. This motion detection may be performed by analysis of the acquired fMRI images (e.g. of the images that have been most recently acquired of the timeseries). Methods to estimate motion on the basis of, for example, image registration of two or more images of the timeseries are well-known in the art. …” (Emphasis provided by Examiner).
The pending specification teaches in the paragraph starting at page 27, line 3 (see [0126] of corresponding Pg. Pub. US 2024/0410964) states:
“For example, the method may comprise monitoring movement via a (near) real-time image registration of the fMRI image timeseries, which may be useful information to an operator (and/or automatically correct and/or discard images that were acquired when the subject was moving too much). This movement pattern may be further analyzed to detect a breathing pattern (e.g. by temporal frequency analysis, e.g. Fourier analysis), whereas, for example, a slowing of the breathing could indicate a sleeping state or the onset thereof.” (Emphasis provided by Examiner).
The pending specification teaches in the paragraph starting at page 29, line 19 (see [0135] of corresponding Pg. Pub. US 2024/0410964) states:
“The method 10 further comprises generating 14 a signal, e.g. an alert signal, when the determined activity measure indicates of a poor task performance and/or compliance by the subject. The signal may be generated before completion of the acquisition of the fMRI time series (e.g. at least insofar the activity measure actually indicates a need for the alert), e.g. such that action can be taken by an operator during the further acquisition of the time series. This signal can be considered as an (conditional) output of the method, but is not necessarily an ‘output’ of a system or device executing the method, e.g. the signal may be entirely internal to the system, e.g. activating a subroutine to extend, pause, terminate, and/or restart the fMRI examination. It will also be clear that the signal may comprise a plurality of separate signals, which may be of a similar or different nature (e.g. a value stored in a memory, a message displayed on a screen, an auditory cue, a computer network transmission, etc.). Such plurality of different signals may also disambiguate between different reasons why the (conditional) output is triggered, e.g. detected motion, expected task-related brain activation not detected, unexpected brain activation in non-task-related brain regions, high probability of sleep/sleep onset, etc.” (Emphasis provided by Examiner).
Therefore, Dosenbach teaches fMRI data is collected, including task fMRI where “Task fMRI includes where a subject performs a task or responds to a stimuli while imaging is being performed.” See [0023]. Further, Dosenbach teaches in [0043] wherein “the scan may be terminated in accordance with at least one of a plurality of termination criteria including, but not limited to, one of more movements of an unacceptably high magnitude, and unacceptably high number of relatively low magnitude movements, a determination that a suitable number of useable datasets were obtained, a prediction that a suitable number of useable datasets cannot be obtained in the time remaining in the scan, a prediction that a suitable number of useable datasets cannot be obtained within a reasonable cumulative scan time, and any combination thereof.” Or a scan may be restarted, “If it is determined at step 210 to continue the scan, the method 200 may communicate at least one feedback signal 212 to be used in part to calculate the data quality metric at step 202 to start another iteration of the method 200 for a subsequent dataset.”
Therefore, in light of the specification, the above teaching of Dosenbach would reasonably read on the limitations “generating at least one signal in response to said at least one determined activity measure being indicative of a poor performance of and/or compliance to the predetermined test task,” and “wherein the at least one signal comprises an instruction to pause, terminate and/or restart said acquisition.” As recited in claims 1, 13, and 14. Therefore, the current claims stand rejected as outlined below.
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(s) 1-9 and 12-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2011/0263968 (Quattrocki) in view of US 2024/0418814 (Dosenbach).
Regarding claim 1, Quattrocki teaches a method for monitoring the performance of a predetermined test task executed by a subject during a functional magnetic resonance imaging (MRI) examination (a method for performing fMRI scans while a patient performs a task; see [0035]-[0040], [0082]-[0088]), the method comprising:
- acquiring a time series of functional magnetic resonance images of the brain of the subject using a magnetic resonance imaging system (fMRI images are performed in a region of the brain as a function of time; see Fig. 2; see [0035]-[0040], [0082]-[0088]);
- providing at least one sensory stimulus via a sensory stimulus source to the subject during the acquisition of said time series to prompt the subject to perform the predetermined test task and/or to induce an intended brain activity in accordance with the predetermined test task (a patient is given one or more cognitive tasks and/or is presented with one or more sensory stimuli to activate a given brain region; see [0035]-[0040], [0082]-[0088]);
- determining, after providing the sensory stimulus, at least one activity measure indicative of brain activity in at least one predetermined region of interest in the subject's brain imaged by the time series of images (a patient is given one or more cognitive tasks and/or presented with one or more sensory stimuli, while undergoing rt-fMRI scans and real-time fMRI neurofeedback is provided to the patient based on images from a specific region or circuit of the brain; see [0035]-[0040], [0082]-[0088]); and
- generating at least one signal when said at least one determined activity measure is indicative of a poor performance of and/or compliance to the predetermined test task, wherein said signal is generated during said acquisition of the time series and/or before removing the subject from the magnetic resonance imaging system (neurofeedback is provided to the patient in real time based on images of the brain as it is occurring to increase or decrease regional brain activity; see [0035]-[0040], [0082]-[0088]).
Quattrocki fails to explicitly teach generating at least one signal in response to said at least one determined activity measure being indicative of a poor performance of and/or compliance to the predetermined test task, wherein the at least one signal comprises an instruction to pause, terminate and/or restart said acquisition.
Dosenbach teaches generating at least one signal in response to said at least one determined activity measure being indicative of a poor performance of and/or compliance to the predetermined test task, wherein the at least one signal comprises an instruction to pause, terminate and/or restart said acquisition (“Scanner operators may be alerted about any sudden or unusual changes in head movement and may be enabled to interrupt such scans…a scan could be stopped, the subject could be further instructed or reminded on ways to try remaining still, the scan could be re-acquired, and the like, to address motion.” And “In one aspect, the method 200 further includes evaluating at least one of a plurality of factors to determine whether the current MRI scan should be terminated at step 210. In various aspects, the scan may be terminated in accordance with at least one of a plurality of termination criteria including, but not limited to, one of more movements of an unacceptably high magnitude, and unacceptably high number of relatively low magnitude movements, a determination that a suitable number of useable data were obtained, a prediction that a suitable number of useable data cannot be obtained in the time remaining in the scan, a prediction that a suitable number of useable data cannot be obtained within a reasonable cumulative scan time, and any combination thereof.”; see [0027], [0029], [0048]; see Figs. 2-4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the features of Dosenbach into Quattrocki in order to gain the advantage of determining when if a scan should be interrupted, stopped, re-acquired, terminated due to movement of an unacceptably high magnitude, unacceptably high number of relatively low magnitude movements, a determination that a suitable number of useable data were obtained, a prediction that a suitable number of useable data cannot be obtained in the time remaining in the scan, a prediction that a suitable number of useable data cannot be obtained within a reasonable cumulative scan time.
Regarding claim 13, Quattrocki teaches a non-transitory computer readable medium storing machine executable instructions for execution by a processor of a functional magnetic resonance imaging (fMRI) system comprising an MRI system and a sensory stimulus source (MRI system of Figs. 1A,B includes a computer 116, computer program 128 and computer readable medium 126 for executing an MRI system, wherein the system includes providing stimulus conditions; see [0025], [0076]; see Fig. 1B), wherein execution of the machine executable instructions causes the processor to:
receive a time series of functional magnetic resonance images of the brain of the subject using the MIRI system (fMRI images are performed in a region of the brain as a function of time; see Fig. 2; see [0035]-[0040], [0082]-[0088]);;
provide at least one sensory stimulus via a sensory stimulus source to the subject during acquisition of the time series to prompt the subject to perform the predetermined test task and/or to induce an intended brain activity in accordance with the predetermined test task (a patient is given one or more cognitive tasks and/or is presented with one or more sensory stimuli to activate a given brain region; see [0035]-[0040], [0082]-[0088]);
determine, after providing the sensory stimulus, at least one activity measure indicative of brain activity in at least one predetermined region of interest in the subject's brain imaged by the time series of images (a patient is given one or more cognitive tasks and/or presented with one or more sensory stimuli, while undergoing rt-fMRI scans and real-time fMRI neurofeedback is provided to the patient based on images from a specific region or circuit of the brain; see [0035]-[0040], [0082]-[0088]); and
generate at least one signal in response to the at least one determined activity measure being indicative of a poor performance of and/or compliance to the predetermined test task, wherein the signal is generated during the acquisition of the time series and/or before removing the subject from the MIRI system, and wherein the at least one signal comprises an instruction to pause, terminate and/or restart the acquisition (neurofeedback is provided to the patient in real time based on images of the brain as it is occurring to increase or decrease regional brain activity; see [0035]-[0040], [0082]-[0088]).
Quattrocki fails to explicitly teach generating at least one signal in response to said at least one determined activity measure being indicative of a poor performance of and/or compliance to the predetermined test task, wherein the at least one signal comprises an instruction to pause, terminate and/or restart said acquisition.
Dosenbach teaches generating at least one signal in response to said at least one determined activity measure being indicative of a poor performance of and/or compliance to the predetermined test task, wherein the at least one signal comprises an instruction to pause, terminate and/or restart said acquisition (“Scanner operators may be alerted about any sudden or unusual changes in head movement and may be enabled to interrupt such scans…a scan could be stopped, the subject could be further instructed or reminded on ways to try remaining still, the scan could be re-acquired, and the like, to address motion.” And “In one aspect, the method 200 further includes evaluating at least one of a plurality of factors to determine whether the current MRI scan should be terminated at step 210. In various aspects, the scan may be terminated in accordance with at least one of a plurality of termination criteria including, but not limited to, one of more movements of an unacceptably high magnitude, and unacceptably high number of relatively low magnitude movements, a determination that a suitable number of useable data were obtained, a prediction that a suitable number of useable data cannot be obtained in the time remaining in the scan, a prediction that a suitable number of useable data cannot be obtained within a reasonable cumulative scan time, and any combination thereof.”; see [0027], [0029], [0048]; see Figs. 2-4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the features of Dosenbach into Quattrocki in order to gain the advantage of determining when if a scan should be interrupted, stopped, re-acquired, terminated due to movement of an unacceptably high magnitude, unacceptably high number of relatively low magnitude movements, a determination that a suitable number of useable data were obtained, a prediction that a suitable number of useable data cannot be obtained in the time remaining in the scan, a prediction that a suitable number of useable data cannot be obtained within a reasonable cumulative scan time.
Regarding claim 14, Quattrocki teaches a computer system for monitoring the performance of a predetermined test task executed by a subject during a functional magnetic resonance imaging examination (a computer 116 of Fig. 1B), the computer system comprising:
- an input for receiving, in substantially real-time, a time series of functional magnetic resonance images of the brain of the subject acquired using a magnetic resonance imaging system (computer system 116 comprises an input for receiving signal from signal processing 114 corresponding to (fMRI images, in real-time, which are performed in a region of the brain as a function of time; see Figs. 1A,B, 2; see [0035]-[0040], [0082]-[0088]));
- a first output for providing at least one sensory stimulus via a sensory stimulus source to the subject during the acquisition of said time series to prompt the subject to perform the predetermined test task and/or to induce an intended brain activity in accordance with the predetermined test task (output device outputs a tactile stimulus derived from feedback data during the acquisition; see [0035]-[0040], [0071], [0082]-[0088]);
- a processor for determining, after providing the sensory stimulus, at least one activity measure indicative of brain activity in at least one predetermined region of interest in the subject's brain imaged by the time series of images on the basis of images received by said input and for generating at least one signal when said at least one determined activity measure is indicative of a poor performance of and/or compliance to the predetermined test task (signal processing 114 for processing signals after a patient is given one or more cognitive tasks and/or is presented with one or more sensory stimuli, while undergoing rt-fMRI scans and real-time fMRI neurofeedback is provided to the patient based on images from a specific region or circuit of the brain; see [0035]-[0040], [0082]-[0088]), and
- a second output for outputting said at least one signal (signal processing 114 outputs the signal to computer 116; see Fig. 1B);
wherein said processor is adapted for generating said signal during said acquisition of the time series and/or shortly after completion of said time series acquisition (neurofeedback is provided to the patient in real time, e.g. 3-6 second delay, based on images of the brain as it is occurring to increase or decrease regional brain activity; see [0035]-[0040], [0082]-[0088]).
Quattrocki fails to teach generating at least one signal in response to said at least one determined activity measure being indicative of a poor performance of and/or compliance to the predetermined test task, and wherein said signal comprises an instruction to pause, terminate and/or restart said acquisition.
Dosenbach teaches generating at least one signal in response to said at least one determined activity measure being indicative of a poor performance of and/or compliance to the predetermined test task, and wherein said signal comprises an instruction to pause, terminate and/or restart said acquisition (“Scanner operators may be alerted about any sudden or unusual changes in head movement and may be enabled to interrupt such scans…a scan could be stopped, the subject could be further instructed or reminded on ways to try remaining still, the scan could be re-acquired, and the like, to address motion.” And “In one aspect, the method 200 further includes evaluating at least one of a plurality of factors to determine whether the current MRI scan should be terminated at step 210. In various aspects, the scan may be terminated in accordance with at least one of a plurality of termination criteria including, but not limited to, one of more movements of an unacceptably high magnitude, and unacceptably high number of relatively low magnitude movements, a determination that a suitable number of useable data were obtained, a prediction that a suitable number of useable data cannot be obtained in the time remaining in the scan, a prediction that a suitable number of useable data cannot be obtained within a reasonable cumulative scan time, and any combination thereof.”; see [0027], [0029], [0048]; see Figs. 2-4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the features of Dosenbach into Quattrocki in order to gain the advantage of determining when if a scan should be interrupted, stopped, re-acquired, terminated due to movement of an unacceptably high magnitude, unacceptably high number of relatively low magnitude movements, a determination that a suitable number of useable data were obtained, a prediction that a suitable number of useable data cannot be obtained in the time remaining in the scan, a prediction that a suitable number of useable data cannot be obtained within a reasonable cumulative scan time.
Regarding claims 2, 16, and 20, Quattrocki teaches wherein said at least one signal comprises: - an alert signal to inform an operator of the magnetic resonance imaging system, and/or - an instruction to the magnetic resonance imaging system to extend said acquisition, and/or - a performance feedback signal provided to the subject (output device 123 instructs a user to administer an agent, neurofeedback is provided to the patient in real time based on images of the brain as it is occurring to increase or decrease regional brain activity; see [0035]-[0040], [0071], [0082]-[0088]).
Regarding claims 3, 17, and 18, Quattrocki teaches said at least one signal comprising: - annotation information for storing along with the acquired time series of functional magnetic resonance images, such that an evolution of the determined at least one activity measure over the timespan of said time series can be taken into account when analyzing the time series after said acquisition; and/or- a measure of overall attention or distraction and/or compliance over the entire time series, for use in planning future functional magnetic resonance imaging examinations having a same or similar test task design and/or targeted at a same subject population (Figs. 5A-C show a measure of the percent activation between different runs which would be reasonably interpreted as a measure of compliance over a time series; see Figs. 5A-C; see [0036], [0085]-[0088]).
Regarding claims 4 and 19, Quattrocki teaches wherein a plurality of sensory stimuli is provided to the subject at different times during the acquisition(the activity is measured in a loop of steps 212, 214, 216 which would reasonably include recently determined activity indicative of poor performance or compliance; see Fig. 2; see [0077]).
Regarding claim 5, Quattrocki teaches wherein determining the activity measure comprises comparing at least one first image of the time series acquired while an effect of the stimulus in the brain is presumed to be absent and at least one second image of the time series acquired while a direct or indirect effect of the stimulus in the brain is presumed to be present (comparison was made between activation blocks and deactivation blocks; see [0098]).
Regarding claim 6, Quattrocki teaches wherein providing the sensory stimulus comprises displaying a visual cue, emitting an auditory cue, providing a touch sensation and/or providing another type of perceptual stimulus, wherein the activity measure is determined for at least one region of interest including a sensory brain area, the primary visual cortex, the auditory cortex, the somatosensory cortex, and/or parts thereof and/or combinations thereof, for which neural activation is implicated by the sensory stimulus (the sensory stimulus includes visual, audio, olfactory, tactile or other stimulus for activating corresponding parts of the brain; see [0035], [0038]).
Regarding claim 7, Quattrocki teaches comprising providing instructions and/or a trial or pilot run of the predetermined test task or a related task before acquiring the time series, to train the subject in executing the predetermined test task, to test comprehension and/or performance of the predetermined test task and/or to calibrate an expected magnitude of the activity measure used in determining the activity measure and/or to localize the region or regions of interest used in determining the activity measure (see [0036]).
Regarding claim 8, Quattrocki teaches comprising acquiring additional information via different imaging modalities and/or physiological parameter sensors, during the acquisition of the time series, wherein this additional information is taken into account in determining the activity measure (imaging is performed using at least one of functional magnetic resonance imaging, electroencephalography, magnetoencephalography, positron emission tomography, and single photon emission computed tomography which suggests one or more different acquisitions; see [0006]).
Regarding claim 9, Quattrocki teaches wherein determining the activity measure comprises performing an attentional network activation analysis, and/or detecting activation and/or deactivation in at least one region of interest that is implicated in the predetermined task; and/or detecting activation and/or deactivation in at least one region of interest that has no known association with the predetermined task (comparison was made between activation blocks and deactivation blocks; see [0098]).
Regarding claim 12, Quattrocki fails to teach comprising detecting motion of the subject during the acquisition of the time series, and generating the signal or generating a further signal if the detected motion exceeds a predetermined threshold.
Dosenbach teaches comprising detecting motion of the subject during the acquisition of the time series, and generating the signal or generating a further signal if the detected motion exceeds a predetermined threshold (The fMRI data used in accordance with the present disclosure may include task fMRI data, rs-fMRI data, or a combination thereof, and may also be referred to as Blood Oxygenation Level Dependent (BOLD) data or BOLD activity data. Task fMRI includes where a subject performs a take or responds to a stimuli while imaging is being performed. Resting-state fMRI is where the subject does not perform a task or respond to stimuli while imaging is being performed. Motion may be detected until the desired number of low- or no-movement data sets are collected. See [0021]-[0029]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the features of Dosenbach into Quattrocki in order to gain the advantage of monitoring motion which may result in errors or artifacts until a desired number of low- or no-movement datasets are acquired in real-time.
Regarding claim 15, Quattrocki teaches a magnetic resonance imaging system comprising said computer system of claim 14 (the MRI system of Figs. 1A,B).
Claim(s) 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2011/0263968 (Quattrocki) in view of US 2024/0418814 (Dosenbach), and in further view of US 2014/0206982 (Schmidt).
Regarding claims 10 and 11, Quattrocki fails to teach wherein said at least one region of interest that has no known association with the predetermined task comprises the anterior cingulate cortex, the basal ganglia, the ventro-medial prefrontal cortex and/or another brain region in which brain activity is indicative of cognitive fatigue, and/or wherein said at least one region of interest that has no known association with the predetermined task comprises a disorder-specific and/or pathology-specific brain region, in which region neural activation is indicative of a hallucination or other episode of said disorder or pathology; and wherein said method comprises detecting a further activity measure indicative of a sleep state and/or of sleep drowsiness during the time series acquisition.
Schmidt teaches wherein said at least one region of interest that has no known association with the predetermined task comprises the anterior cingulate cortex, the basal ganglia, the ventro-medial prefrontal cortex and/or another brain region in which brain activity is indicative of cognitive fatigue, and/or wherein said at least one region of interest that has no known association with the predetermined task comprises a disorder-specific and/or pathology-specific brain region, in which region neural activation is indicative of a hallucination or other episode of said disorder or pathology; and wherein said method comprises detecting a further activity measure indicative of a sleep state and/or of sleep drowsiness during the time series acquisition (In fMRI sleep or cognitive fatigue of a patient can be monitored by an activation of brain areas of a default mode network DMN. A DMN is understood in neuroscience generally to mean a group of brain areas which are active when “doing nothing” and are deactivated in the event of a concentrated mental task. The rest activity of these brain areas can be proven for instance with fMRI, EEG, MEG. If an activation of such a brain area is determined, a signal from the group of acoustic, optical or tactile signals can restore the patient into an awake state. See [0047]-[0055], [0073]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the features of Schmidt into Quattrocki in order to gain the advantage of a warning system to prevent a patient from falling asleep during an fMRI study.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEVEN LEE YENINAS whose telephone number is (571)270-0372. The examiner can normally be reached M - F 10 - 6.
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/STEVEN L YENINAS/Primary Examiner, Art Unit 2858