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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/14/2025 has been entered.
Response to Amendment
Applicant’s amendments and remarks, filed 11/14/2025, are acknowledged. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Status of Claims
Claims 1-7, 10-12, 14-16, 18-21 and 23-25 are currently under examination. Claims 8, 13 and 22 are cancelled, Claims 23-25 are new claims.
Priority
The instant application is a national stage entry under §371 of the international application PCT/US2023/015744 which was filed on 03/21/2023.
Applicant’s claim for the benefit of priority under 35 U.S.C. 119(e) to provisional application 63/322,173, filed 03/21/2022, are acknowledged.
Response to Arguments
Applicant’s responses and arguments filed 11/14/2025 regarding claim rejections under 35 USC 103 have been fully considered and found not persuasive for the following reasons.
Regarding the claim rejections under 35 USC 103, Applicant has amended the independent claims for clarifying the scope of the invention with the introduction of subject matter not previously prosecuted therefore necessitating new grounds of rejection.
Applicant argues that the references of record do not teach the amended limitations.
In response, the examiner is considering the arguments as moot since they are directed to subject matter not previously prosecuted and changing the scope of the claims and therefore directed to new grounds of rejection. The examiner is considering new references for addressing the amended limitations.
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.
Claims 1-7, 10-12, 14-16, 18-21, 23-25 are rejected under 35 U.S.C. 103 as being unpatentable over Beck (USPN 20160259022 A1; Pub.Date 09/08/2016; Fil.Date 03/04/2016) in view of DeYoe et al. (USPN 20060058619 A1; Pub.Date 03/16/2006; Fil.Date 08/15/2005) in view of Parrish et al. (USPN 20140180060 A1; Pub.Date 06/26/2014; Fil.Date 12/11/2013).
Regarding claim 1, Beck teaches a medical imaging system (title, abstract and Fig.1, with a fMRI imaging device [0008] for imaging the brain of a patient (abstract)) comprising:
a sound detection device configured to detect an acoustic feature generated by operation of an imaging device ([0047]-[0050] with the fMRI device producing a “pseudo acoustic stimulation for the patient “by switching a gradient coil unit, to create acoustic signals” perceived by the patient and recorded “via a microphone as input parameters” ([0050]));
an interface configured to present a visual stimulus to a patient ([0011]-[0012] stimulating the patient’s brain via various interfaces for visual, haptic, acoustic, mechanic stimuli, an exemplified in [0057]-[0060]); and
at least one processor executing instructions stored on memory to ([0047], [0069] processing unit and memory for executable program storage):
[…record feedback from the patient in response to the presented visual stimulus, the feedback comprising the patient activating an input portion…],
receive imagery of the patient from the imaging device (Fig. 1 receive fMRI imaging of the brain activity [0082]-[0084]);
[…identify, from the recorded feedback, feedback provided by the patient coinciding with the detection of the acoustic feature generated by the operation of the imaging device…];
Identify, from the received imagery, imagery of the patient coinciding with the detection of the acoustic feature generated by the operation of the imaging device ([0092]-[0093] with the corresponding acoustic signals as recognized as a stimulation signals therefore directed to the location of regions activated in the brain for the corresponding activity with the stimulation corresponding to the gradient switching ([0047]-[0055]); and
supply the identified feedback and identified imagery to an operator (output/display [0084] control information and reconstructed images “may be displayed on a display unit” wherein the identified feedback can be interpreted as a control information).
Beck does not specifically teach to record feedback from the patient in response to the presented visual stimulus, the feedback comprising the patient activating an input portion, identify, from the recorded feedback, feedback provided by the patient coinciding with the detection of the acoustic feature generated by the operation of the imaging device as in claim 1.
However, DeYoe teaches within the same field of endeavor of monitoring the brain activity and response to stimuli (Title and abstract) recording feedback from physiological responses to stimuli ([0032]) and from the subject using a feedback device (Fig.6 [0065], [0074] feedback device 238 by pressing buttons in response to stimuli including visual stimuli presented via a display when the subject is within an MRI for functional imaging of the brain) with identifying the brain region responsive to the stimuli ([0043]-0045]) therefore teaching to record feedback from the patient in response to the presented visual stimulus, the feedback comprising the patient activating an input portion .
Therefore it would have been obvious for a person of ordinary skill in the art before the effective filling date of the invention to have modified the device of Beck such that the device further comprises: record feedback from the patient in response to the presented visual stimulus, the feedback comprising the patient activating an input portion, since one of ordinary skill in the art would recognize that using feedback device for voluntary responses for visual and non-visual stimuli with recording the feedback was known in the art as taught by DeYoe. One of ordinary skill in the art would have expected that this modification could have been made with predictable results since Beck and DeYoe both teach performing fMRI imaging of a patient in response to stimulation. The motivation would have been to provide an accurate analysis of the fMRI images with functional analysis to identify regional activity directed to specific stimulation, as suggested by DeYoe ([0043]-0045]).
Beck and DeYoe do not specifically teach to identify, from the recorded feedback, feedback provided by the patient coinciding with the detection of the acoustic feature generated by the operation of the imaging device as in claim 1.
While one could broadly interpret the acoustic signal recorded by the microphone from the gradient switching being a stimuli and therefore the microphone signal as the feedback signal from the patient as related to the gradient switching acoustic stimulatory event, Parrish additionally teaches within the same field of endeavor of analyzing the functional cerebral response to external stimuli using imaging system and sensors (Title, abstract and Fig.1) the use of a “stimulation response measurement equipment” (Fig.1 element 110 and [0015], using also microphone Fig.1 element 109, [0033] to present the recorded response measurement to operators including measurement from the response measurement and auditory equipments, with synchronization with the imaging device [0036], [0058] and claims 11, 15 including devices/sensors for voluntary or unvoluntary response of the patient to the different stimuli including EEG ([0060]) or ECG ([0013] in response to controlled stimuli including sensory or cognitive auditory based stimuli ([0011])) therefore teaching identify, from the recorded feedback, feedback provided by the patient coinciding with the detection of the acoustic feature generated by the operation of the imaging device as claimed in claim 1.
Therefore it would have been obvious for a person of ordinary skill in the art before the effective filling date of the invention to have modified the device of Beck as modified by DeYoe such that the device further comprises: identify, from the recorded feedback, feedback provided by the patient coinciding with the detection of the acoustic feature generated by the operation of the imaging device and identified imagery are supplied to an operator, since one of ordinary skill in the art would recognize that using voluntary and unvoluntary response measurement device to sense and record the physical response of a patient to external stimuli was known in the art as taught by Parrish in order to synchronize the functional cerebral response imagery with the recorded feedback from the patient. One of ordinary skill in the art would have expected that this modification could have been made with predictable results since Beck and Parrish both teach performing fMRI imaging of a patient in response to stimulation. The motivation would have been to provide a more accurate analysis of the fMRI as related to the external stimuli provided to the patient with synchronization with the feedback from the patient, as suggested by Parrish (abstract).
Regarding the dependent claims 2-7, 20, 23, all the elements of these claims are instantly disclosed or fully envisioned by the combination of Beck, DeYoe and Parrish.
Regarding claim 2, as discussed above, Beck teaches the recording device with the microphone recording the acoustic signal of the gradient switching of the fMRI system as providing a loud sudden sound to the patient therefore teaching the acoustic feature associated with the operation of the imaging device relates to electromagnetic modulation of the imaging device as claimed.
Regarding claim 3, as discussed above, Beck teaches a recording device with the microphone recording the acoustic signal of the gradient switching of the fMRI system therefore teaching an acoustic feedback signal while Parrish teaches the use of the stimuli response measurement device for recording the voluntary or unvoluntary response of the patient to the stimuli provided to the patient therefore both teaching a response recorder device accessible by the patient during operation of the imaging device, the response recorder device configured to record feedback provided by the patient.
Regarding claim 4 as dependent from claim 3, as discussed in claim 3, Beck teaches the response recorder device further includes the sound detection device.
Regarding claim 5 as dependent of claim 3, as discussed in claim 3 and claim 1, Parrish teaches the stimulus response measurement and the microphone as response device for recording the feedback from the patient and to be presented to an operator which present the response to a computer for control and analysis of the imagery device (Fig. 1 MRI scanner control computer electrodermal technique device providing a response from the patient to fMRI processor for processing the fMRI signal [0036]-[0037] and [0045]) therefore teaching the response recorder device is configured to provide the feedback from the patient to the at least one processor after the imagery is gathered by the imaging device.
Regarding claim 6 as dependent from claim 3, as discussed above, Beck and Parrish teach both microphone and sensoring/recording technique device for sensing a feedback signal and providing feedback signals including related to the gradient switching acoustic signal to correct the fMRI imaging signal therefore teaching the imaging device is a magnetic resonance imaging device, and the response recorder device includes a sensor to detect a change in a gradient magnetic field based on an acoustic feature indicating gradient switching as claimed.
Regarding claim 7, as discussed for claim 1, Beck teaches the fMRI processing unit using as input the signal from the microphone recording the acoustic signal corresponding to the gradient switching event while Parrish, as discussed above, teaches the voluntary and unvoluntary sensing of the patient response to different stimuli therefore recording the physiological response of the patient to presented stimuli including the gradient switching event of the fMRI system as described by Beck, as used for coinciding feedback responses therefore teaching the at least one processor is further configured to identify coinciding feedback and imagery using the detected change in the gradient magnetic field.
Regarding claim 20, as discussed above, Parrish teaches the use of EEG or ECG sensoring technique to assess some responses from the patient ([0060], [0013]) for recording the physiological response of the patient to stimuli which can include the sound of the switching gradient event of the fMRI system therefore Parish teaches the imaging device comprises at least one of a positron emission tomography device, a near infrared spectroscopy device, an electro- encephalography imaging device, or a magneto-encephalography imaging device, wherein the imaging device is configured to incorporate the acoustic feature as claimed.
Regarding claim 23, as discussed above, DeYoe teaches the display for providing visual stimuli to the patient (Fig.6 [0065], [0074] feedback device 238 by pressing buttons in response to stimuli including visual stimuli presented via a display when the subject is within an MRI for functional imaging of the brain) therefore teaching the visual stimulus is presented on a presentation panel in the same room as the sound detection device and the imaging device.
Regarding independent claim 10, claim 10 is directed to a device presenting the same structural parts claimed in the fMRI imaging system of independent claim 1 above including a generic storage module for data storage attached to processing system (Beck [0070]) and related an interface for communication between the fMRI and the microphone for Beck with the gradient switching acoustic signal as stimuli for being recorded and analyzed for the corresponding activated brain regions, wherein DeYoe teaches also the visual stimulation via a display and the handheld feedback device with buttons to press to communicate the patient’s feedback with the system and for the recording technique sensors/acoustic for Parrish as discussed above as connected to the imaging device control processor system therefore as part of the processing system attached to the fMRI in order to process the response from the patient and the imagery from the imaging device for synchronizing the imaging with the patient response as being both recorded with the same time clock (Parrish [0014]-[0015] for synchronization of data) teaching generated by the operation of the imaging device and imagery of the patient coinciding with the detection of the acoustic feature generated by the operation of the imaging device as claimed in claim 10. The independent claim 10 is therefore made obvious by the teachings of Beck, DeYoe and Parrish discussed above mutandis mutatis.
Regarding the dependent claims 11-12, 21, 24 all the elements of these claims are instantly disclosed or fully envisioned by the combination of Beck, DeYoe and Parrish.
Regarding claim 11, as discussed for claim 1, Beck teaches the fMRI processing unit using as input the signal from the microphone recording the acoustic signal corresponding to the gradient switching event while Parrish teaches the synchronization between the voluntary and unvoluntary response of the patient and with the imaging such as with EEG or ECG for direct physiological response from the patient as coincidental with the stimuli therefore teaching the feedback coincides with the detection of the acoustic feature.
Regarding claim 12, as discussed above for claims 1 and 10, Beck and Parrish teaches the processing system attached to the fMRI for processing the feedback signals and presenting the control information and resulting images to be displayed, with Beck teaching the recording of the fMRI signals and Parrish, as discussed above, teaching the stimulus response measurement and the microphone as response device for recording the feedback from the patient as presented to a computer/processor for control and analysis of the imagery device (Fig. 1 MRI scanner control computer electrodermal technique device providing a response from the patient to fMRI processor for processing the fMRI signal [0036]-[0037] and [0045] with synchronization using the same clock [0054]) therefore teaching at least one processor executing instructions stored on memory to process the data associated with the acoustic feature and the recorded feedback prior to the interface communicating the acoustic feature and the recorded feedback to the external system.
Regarding claim 21, as discussed above, Parrish teaches a common clock for the imaging device and the receiving data from the stimulus response measurement device (Fig.1 and synchronization of the response and imagery using the same clock [0014], [0054] which are recorded and then exported for synchronization and analysis) with both Beck and Parish teaching the recording of the fMRI imaging signals which is therefore understood that both image data and stimulus responses are recorded/stored with the same clock tagging for synchronization for later analysis as taught by Parrish ([0036]) therefore teaching stored data associated with the acoustic feature and the recorded feedback is communicated to the external system in real- time while the stored data is gathered as claimed.
Regarding claim 24, as discussed above, DeYoe teaches the display for providing visual stimuli to the patient (Fig.6 [0065], [0074] feedback device 238 by pressing buttons in response to stimuli including visual stimuli presented via a display when the subject is within an MRI for functional imaging of the brain) therefore teaching the visual stimulus is presented on a presentation panel in the same room as the sound detection device and the imaging device.
Regarding independent claim 14, Beck teaches a method of operating a medical imaging system (Title, abstract and Fig.1, [0002] to use a medical imaging system of Fig. 1 with a fMRI imaging device [0008] for imaging the brain of a patient (abstract)) the method comprising:
gathering imagery of a patient using an imaging device ([0002] to use a medical imaging system of Fig. 1 with a fMRI imaging device [0008] for imaging the brain of a patient (abstract));
detecting an acoustic feature generated by operation of the imaging device ([0047]-[0050] with the fMRI device producing a “pseudo acoustic stimulation for the patient “by switching a gradient coil unit, to create acoustic signals” perceived by the patient and recorded “via a microphone as input parameters” ([0050]); and
triggering, in response to the detected acoustic feature, generated by the operation of the imaging device, presentation of a stimulus to a patient using an interface ([0011]-[0012] stimulating the patient’s brain via various interfaces for visual, haptic, acoustic, mechanic stimuli, an exemplified in [0057]-[0060] including the switching of the gradient coil unit creating acoustic signals via the imaging device as acoustic interface with the patient wherein the acoustic signals are interpreted as the stimulus presented to the patient); and
[…recording a patient feedback to the stimulus presented visual stimulus, the patient feedback comprising the patient activating an input portion…]
Beck does not specifically teach recording a patient feedback to the stimulus presented visual stimulus, the patient feedback comprising the patient activating an input portion as in claim 14.
However, DeYoe teaches within the same field of endeavor of monitoring the brain activity and response to stimuli (Title and abstract) recording feedback from physiological responses to stimuli ([0032]) and from the subject using a feedback device (Fig.6 [0065], [0074] feedback device 238 by pressing buttons in response to stimuli including visual stimuli presented via a display when the subject is within an MRI for functional imaging of the brain) with identifying the brain region responsive to the stimuli ([0043]-0045]) therefore teaching to recording a patient feedback to the stimulus presented visual stimulus, the patient feedback comprising the patient activating an input portion.
Therefore it would have been obvious for a person of ordinary skill in the art before the effective filling date of the invention to have modified the device of Beck such that the device further comprises: recording a patient feedback to the stimulus presented visual stimulus, the patient feedback comprising the patient activating an input portion, since one of ordinary skill in the art would recognize that using feedback device for voluntary responses for visual and non-visual stimuli with recording the feedback was known in the art as taught by DeYoe. One of ordinary skill in the art would have expected that this modification could have been made with predictable results since Beck and DeYoe both teach performing fMRI imaging of a patient in response to stimulation. The motivation would have been to provide an accurate analysis of the fMRI images with functional analysis to identify regional activity directed to specific stimulation, as suggested by DeYoe ([0043]-0045]).
Parrish additionally teaches within the same field of endeavor of analyzing the functional cerebral response to external stimuli using imaging system and sensors (Title, abstract and Fig.1) the use of a “stimulation response measurement equipment” (Fig.1 element 110 and [0015], using also microphone Fig.1 element 109, [0033] to present the recorded response measurement to operators including measurement from the response measurement and auditory equipments, with synchronization with the imaging device [0036], [0058] and claims 11, 15 including devices/sensors for voluntary or unvoluntary response of the patient to the different stimuli including EEG ([0060]) or ECG ([0013] in response to controlled stimuli including sensory or cognitive auditory based stimuli ([0011])) therefore teaching recording a patient feedback to the stimulus as claimed in claim 14.
Therefore it would have been obvious for a person of ordinary skill in the art before the effective filling date of the invention to have modified the device of Beck such that the device further comprises: recording a patient feedback to the stimulus, since one of ordinary skill in the art would recognize that using voluntary and unvoluntary response measurement device to sense and record the physical response of a patient to external acoustic stimuli was known in the art as taught by Parrish in order to synchronize the functional cerebral response imagery with the recorded feedback from the patient. One of ordinary skill in the art would have expected that this modification could have been made with predictable results since Beck and Parrish both teach performing fMRI imaging of a patient in response to stimulation. The motivation would have been to provide a more accurate analysis of the fMRI as related to the external stimuli provided to the patient with synchronization with the feedback from the patient, as suggested by Parrish (abstract).
Regarding the dependent claims 15-16, 18-19, 25 all the elements of these claims are instantly disclosed or fully envisioned by the combination of Beck, DeYoe and Parrish.
Regarding claim 15, as discussed above for claims 1 and 2, Beck teaches the recording device with the microphone recording the acoustic signal of the gradient switching of the fMRI system therefore teaching the acoustic feature associated with the operation of the imaging device relates to electromagnetic modulation of the imaging device as claimed.
Regarding claim 16, as discussed above for claims 1, 8, and 13, as discussed above, Parrish teaches the use of EEG or ECG sensoring technique to assess some responses from the patient ([0060], [0013]) for recording the physiological response of the patient to stimuli which can include the sound of the switching gradient event of the fMRI system as taught by Beck therefore teaching the recorded feedback from the patient is a galvanic skin response, an electrophysiological measurement of the patient, or a patient activation of an input component therefore teaching the recorded feedback from the patient is a galvanic skin response, an electrophysiological measurement of the patient, or a patient activation of an input component.
Regarding claim 18, as discussed above for claim 1, Parrish teaches the use of EEG or ECG device/system ([0013], [0047], [0060]) for recording a physical response of the patient to a stimuli such as acoustic stimulus as for switching of the gradient coil unit as taught by Beck, wherein the EEG or ECG are known to be electrophysiological sensing device with electrodes placed directly on the surface of the patient therefore teaching ab electrodermal technique sensor which includes a skin sensor therefore placed closed to the fMRI system since the patient is monitored by both the imaging fMRI and the sensing EEG or ECG therefore teaching the patient's response is recorded by a response recorder device operational in proximity to a magnetic field produced by a magnetic resonance imaging device as claimed.
Regarding claim 19, as discussed above for claim 1, Beck teaches the identified recording of the acoustic signal using the microphone and Parrish teaches the communication of the voluntary or unvoluntary feedback responses to the imaging device control processor (Fig. 1 and [0045] with clock synchronization [0054]) therefore teaching communicating the identified feedback and imagery coinciding with the gathered acoustic feature as claimed.
Regarding claim 25, as discussed above, DeYoe teaches the display for providing visual stimuli to the patient (Fig.6 [0065], [0074] feedback device 238 by pressing buttons in response to stimuli including visual stimuli presented via a display when the subject is within an MRI for functional imaging of the brain) therefore teaching the visual stimulus is presented on a presentation panel in the same room as the sound detection device and the imaging device.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PATRICK M MEHL whose telephone number is (571)272-0572. The examiner can normally be reached Monday-Friday 9AM-6PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, KEITH M RAYMOND can be reached at (571) 270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PATRICK M MEHL/ Examiner, Art Unit 3798
/KEITH M RAYMOND/ Supervisory Patent Examiner, Art Unit 3798