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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. EP 23158090.3, filed on 02/23/2023.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08/18/2025 was filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description:
FIG. 1: Although the specification states: Fig. 1 illustrates an example of a medical instrument 100. The medical instrument 100 is shown as comprising a magnetic resonance imaging system 102 as well as a computer […] A split cylindrical magnet is similar to a standard cylindrical magnet, except that the cryostat has been split into two sections to allow access to the iso-plane of the magnet, such magnets may for instance be used to provide for freer motion of a subject such as when moving the complementary limb 129” [Page 15, Lines 6-14], this figure does not include the label 129.
FIG. 3: Although the specification states “There is additionally a memory 310 which is storing local machine-executable instructions 312 and the audio file 168” [Page 18, Line 23-24]. However, this figure does not include the label 312.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description:
FIG. 3: Although this figure includes the label 318, this label is not found in the specification.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
[Page 8, Lines 33-34]: As written it reads “For example, the VGG family of neural networks such as VGG-11, VGG-13, or VGG-16 would be suitable”. However, this is the first instance of the term “VGG”, therefore, the term should be spelled out to provide clarity.
[Page 11, Lines 26-31 and 35]: As written it reads : Examples of computer-readable storage media include, but are not limited to: a floppy disk, a magnetic hard disk drive, a solid state hard disk, flash memory, a USB thumb drive, Random Access Memory (RAM), Read Only Memory (ROM), an optical disk, a magneto-optical disk, and the register file of the computational system, Examples of optical disks include Compact Disks (CD) and Digital Versatile Disks (DVD), for example CD-ROM, CD-RM, CD-R, DVD-ROM, DVD-RW, or DVD-R disks […] including but not limited to wireless, wire line, optical fiber cable, RF, etc.”. However, this is the first instance of the terms “USB”, “CD-RM”, “CD-R”, “DVD-RW”, “DVD-R” and “RF”, therefore the terms should be spelled out to provide clarity.
[Page 14, Lines 6-9]: As written it reads “a hardware interface include, but are not limited to: a universal serial bus, IEEE 1394 port, parallel port, IEEE 1284 port, serial port, RS-232 port, IEEE-488 port, Bluetooth connection, Wireless local area network connection, TCP/IP connection, Ethernet connection, control voltage interface, MIDI interface, analog input interface, and digital input interface”. However, this is the first indication of the terms “IEEE”, “RS”, “TCP/IP” and “MIDI”, therefore, the terms should be spelled out to provide clarity.
[Page 16, Line 31]: As written it reads “The scout image 144 may not necessarily necessary in all examples”. However to be grammatically correct, the examiner would recommend amending the sentence to read “The scout image 144 may not necessarily be necessary in all examples” or “The scout image 144 may not be necessary in all examples”.
Appropriate correction is required.
Claim Objections
Claims 5 and 7 are objected to because of the following informalities:
Regarding claim 5, as written it reads “receive the signal from the subject interface while controlling the sensory stimulus system with one of a predetermined set of sensory stimulus control commands”. However, the examiner believes “a” should be “the” since the phrase “predetermined set of sensory stimulus control commands” was previously defined in claim 1 on which this claim depends.
Regarding claim 7, as written it reads “The medical system of claim 1, wherein the medical system further comprises a physiological sensor configured to acqure physiological data descriptive of the subject”. However, to correct the typo “acqure” should be “acquire”.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception in the form of an abstract idea, specifically a mental process, without significantly more.
Regarding claims 1, 14 and 15, the examiner notes that the claim is directed to: 1) a medical system; 2) a method of operating a medical system; and 3) a computer program comprising machine executable instructions stored on a non-transitory computer readable medium for execution by a computational system configured to control a medical system. Therefore, the claims fall within the statutory categories of invention.
With reference to Step 2A, Prong One, the claims recite “identify(ing) at least one abnormal stimulus region within the tonotopic mapping” (Claims 1, 14 and 15 and “assign(ing) a numerical score to the one of a/the predetermined set of sensory stimulus control commands by detecting a change in neural activity in the at least one abnormal stimulus region between the baseline functional magnetic resonance image and the reference functional magnetic resonance image, the score being representative of a decrease or an increase in neural activity in the at least one abnormal stimulus region” (Claims 1, 14 and 15).
The limitations, under broadest reasonable interpretation, cover performance of the limitation in the mind and/or read on viewing a tonotopic map to distinguish at least one abnormal stimulus region and designating a numerical score for said region based on an increase or decrease in neural activity, represent actions which can be practically performed in the human mind by a user viewing a tonotopic map, identifying a region located within and assigning that region a score. If a claim limitation under its broadest reasonable interpretation covers performance of the limitation in the mind but for the recitation of generic computer components (i.e. a processor), then it falls within the “mental processes” grouping of abstract ideas.
Following step 2A, Prong Two of the two-prong analysis, the claim recites the following additional elements: “receive(ing) a tonotopic mapping of an audio cortex mapping of the subject, wherein the tonotopic mapping comprises a spatial mapping descriptive of auditory frequency sensitive responses for the subject” (Claims 1, 14 and 15); “acquire(ing) baseline-k-space data by controlling the magnetic resonance imaging system with the pulse sequence commands” (Claims 1, 14 and 15); “reconstruct(ing) a baseline functional magnetic resonance image from the baseline k-space data” (Claims 1, 14 and 15); “acquire(ing) reference k-space data by controlling the magnetic resonance imaging system with the pulse sequence commands” (Claims 1, 14 and 15); “control(ling) the sensory stimulus system with one of a predetermined set of sensory stimulus control commands during acquisition of the reference k-space data, wherein each of the predetermined set of sensory stimulus control commands are configured to control the sensory stimulus system to present a predetermined audio stimulation to the subject” (Claims 1, 14 and 15); “reconstruct(ing) a reference functional magnetic resonance image from the reference k-space data” (Claims 1, 14 and 15).
These additional elements do not integrate the judicial exception into a practical application because the claim as written does not include elements to 1) improve the functioning of a computer (See MPEP 2106.05(a)); 2) effect a particular treatment or prophylaxis (See MPEP 2106.04(d)(2)); 3) use a particular machine (See MPEP 2106.05(b)); 4) use the judicial exceptions in a meaningful way beyond generally linking the use to a particular technological environment (See MPEP 2106.05(h)). Furthermore, these receiving steps do not integrate the judicial exception into a practical application because they add insignificant extra-solution activity to the judicial exception using a well-known device (i.e. sensor coils) (See MPEP 2106.05(g)).
Following step 2B, the additional element(s) (See above) do not amount to significantly more than the judicial exception because these limitations represent data gathering steps which utilize conventional tools (i.e. magnetic resonance imaging system/processor) to perform well understood, routine and conventional activity (i.e. acquiring a tonotopic mapping and reconstructing magnetic resonance images, see Flaeschner et al. US 2020/0170534 A1 “Flaeschner”: [0092]; [0097]; and [0098]; and Petkov et al.: “Optimizing the imaging of the monkey auditory cortex: sparse vs. continuous fMRI”, Magnetic Resonance Imaging, Elsevier Science, Tarrytown NY, US, vol. 27, no. 8, 1 October 2009 (2009-10-01) pages 1065-1072 “Petkov”: FIG. 3 and [Page 1070: Results, Para. 1, Lines 1-3 and Para. 5, Lines 17-25]) in the field, to perform the abstract idea.
Regarding claims 2-12, the claims add additional limitations that append the judgement of claim 1 and/or do not include additional elements that are sufficient to amount to significantly more than the judicial exception, nor a practical application of the judicial exception because they disclose:
steps that can be practically performed within the mind (i.e. adjust the numerical score using the signal”, see claim 5; “wherein the assigning the numerical score to the one of the predetermined set of sensory stimulus control commands further comprises increasing the score if the physiological data is outside of a predetermined value range”, see claim 7; “wherein execution of the machine executable instructions further causes the computational system to identify the at least one abnormal stimulus region within the tonotopic mapping by detecting a deviation beyond a predetermined threshold in comparison to a tonotopic anatomical atlas”, see claim 10; );
provide additional information about the sensory stimulus control commands (i.e. “wherein execution of the machine executable instructions further causes the computational system to render (220) the at least one subject specific sensory stimulus control commands as an audio file”, see claim 2; “wherein the each one of the predetermined set of sensory stimulus control commands is configured to control the sensory stimulus system configured to provide a sequence of audio tones of predetermined duration, volume, timber, and pitch”, see claim 4.);
provide additional information about the components of the medical system used to perform the abstract idea (i.e. “wherein the medical system further comprises a noise cancellation system configured to reduce magnetic field gradient noise while controlling the sensory stimulus system with the one of the predetermined set of sensory stimulus control commands.”, see claim 3; “wherein the medical system further comprises a subject interface configured to receive a signal from the subject descriptive of the sensation of tinnitus experienced by the subject”, see claim 5; “wherein execution of the machine executable instructions are configured to cause the sensory stimulus system to repeat the one of the predetermined set of sensor stimulus commands while the magnetic resonance imaging system is disabled, wherein the signal is received when the magnetic resonance imaging system is disabled”, see claim 6; “wherein the medical system further comprises a physiological sensor configured to acquire physiological data descriptive of the subject”, see claim 7; “wherein the sensory stimulus system further comprises a visual stimulus system configured to provide visual stimulus to the subject, wherein each of the predetermined set of sensory stimulus control commands are configured to control the sensory stimulus system to present a predetermined visual stimulus to the subject”, see claim 8; “wherein the sensory stimulus system further comprises a tactile stimulus system configured to provide tactile stimulus to the subject, wherein each of the predetermined set of sensory stimulus control commands are configured to control the sensory stimulus system to present a predetermined tactile stimulus to the subject”, see claim 9; “control the sensory stimulus system with one of the predetermined set of tonotopic map commands during acquisition of the tonotopic map k-space data, wherein each of the predetermined set of tonotopic map commands are configured to control the sensory stimulus system to present a predetermined audio frequency to the subject”, see claim 11; “wherein the memory further contains an artificial intelligence module configured to output a progress score in response to receiving the control functional magnetic resonance image sequence as input, wherein the progress score is descriptive of a change in neural activity in the abnormal stimulus region, wherein execution of the machine executable instructions further causes the computational system to receive the progress score in response to inputting the control functional magnetic resonance image sequence into the artificial intelligence module”, see claim 13);
and/or constitute insignificant extra-solution activity (i.e. data gathering) (i.e. “wherein execution of the machine executable instructions further causes the computational system to: receive the signal from the subject interface while controlling the sensory stimulus system with one of a predetermined set of sensory stimulus control commands”, see claim 5; “wherein execution of the machine executable instructions further causes the computational system to acquire the physiological data while controlling the sensory stimulus system with the one of the predetermined set of the sensory stimulus control commands”, see claim 7; “acquire initial k-space data by controlling the magnetic resonance imaging system with the pulse sequence commands; reconstruct an initial functional magnetic resonance image from the initial k-space data; […] acquire tonotopic map k-space data by controlling the magnetic resonance imaging system with the pulse sequence commands while the sensory stimulus system is controlled with the one of a predetermined set of tonotopic map commands […] reconstruct an audio frequency specific functional magnetic resonance image from the tonotopic map k-space data; “wherein execution of the machine executable instructions further causes the computational system to construct the tonotopic map using a difference between the audio frequency specific functional magnetic resonance image for each of the set of tonotopic map commands and the initial functional magnetic resonance image”, see claim 11; “acquire calibration k-space data by controlling the magnetic resonance imaging system with the pulse sequence commands; reconstruct a calibration functional magnetic resonance image from the baseline k-space data; acquire control k-space data by controlling the magnetic resonance imaging system with the pulse sequence commands; control the sensory stimulus system the subject specific sensory stimulus control commands during acquisition of the control k-space data, reconstruct a control functional magnetic resonance image from the control k-space data and the calibration k-space data; and repeat the machine executable instructions at time interval greater than two weeks to obtain the control functional magnetic resonance image as a function of time to form a control functional magnetic resonance image sequence”, see claim 12).
Allowable Subject Matter
Claims 1-15, as best understood by the examiner, would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 101 set forth in this Office action.
During the examiner’s search the following prior art references were found: Flaeschner et al. US 2020/0170534 A1 “Flaeschner” and Petkov et al.: “Optimizing the imaging of the monkey auditory cortex: sparse vs. continuous fMRI”, Magnetic Resonance Imaging, Elsevier Science, Tarrytown NY, US, vol. 27, no. 8, 1 October 2009 (2009-10-01) pages 1065-1072 “Petkov”.
Regarding claims 1, 14 and 15, Flaeschner teaches “A medical system comprising:” (Claim 1) (“FIG. 6 illustrates a further example of a medical instrument 600. In this example the activity measurement system 106 comprises an EEG system 402 and a magnetic resonance imaging system 602” [0092]. Therefore, Flaeschner discloses a medical system.);
“A method of operating a medical system, wherein the medical system comprises a magnetic resonance imaging system configured to acquire k-space data of a brain of a subject” (Claim 14) (“FIG. 2 shows a flowchart which illustrates a method of operating the medical instrument 100 of FIG. 1. First in step 200 the stimulus presentation system 108 is controlled with the set of entries 136 from the stimulus reinforcer database 134 to repeatedly provide sensory stimulus to the subject 102. Next in step 202 the activity measurement system 106 is controlled to acquire the brain activity data 138 during each sensor stimulus which is caused by each of the set of entries. Next in step 204 a chosen entry 140 is selected from the set of entries 136 using the brain activity data 138. Finally, in step 206 the chosen entry 140 is stored in the memory 130 for further use” [0084]; “FIG. 1 illustrates an example of a medical instrument 100. […] The medical instrument 100 is further shown as comprising an activity measurement system 106 that is configured for measuring brain activity data from the subject 102 […] Several examples of this may be a magnetic resonance imaging system, an EEG system, and a MEG system. In some instances, the magnetic resonance imaging system and the EEG system could both be combined” [0077]. Therefore, FIG. 2 depicts a method of operating a medical system, wherein the medical system comprises a magnetic resonance imaging system configured to acquire k-space data of a brain of a subject (i.e. brain activity data).);
“A computer program comprising machine executable instructions stored on a non-transitory computer readable medium for execution by a computational system configured to control a medical system” (Claim 15) (“The medical instrument 100 is further shown as comprising a computer 118. The computer comprises a processor 120. The processor 120 is intended to represent one or more processors that may be within the same computing device or may even be distributed amongst various locations or different computing devices. The processor 120 is in communication with a hardware interface 122 that enables the processor 120 to control the other components of the medical instrument 100. […] The processor 120 is further in communication with a memory 130. The memory 130 may be any memory which is accessible to the processor 120. It may for example be volatile or non-volatile memory and may also represent a storage medium such as a hard drive or optical disc” [0080]; “Execution of the machine-executable instructions 132 by the processor 120 enable it to control the operation and function of the medical instrument 100” [0081]. Therefore, Flaeschner discloses a computer program comprising machine executable instructions stored on a non-transitory computer readable medium for execution by a computational system configured to control a medical system.);
“a magnetic resonance imaging system configured for acquiring k-space data of a brain of a subject” (Claim 1); “wherein the medical system comprises a magnetic resonance imaging system configured to acquire k-space data of a brain of a subject” (Claim 15) (See FIG. 6, [0092], and [0077] above. Therefore, the medical system includes a magnetic resonance imaging system configured for acquiring k-space data of a brain of a subject.);
“a sensory stimulus system configured to provide audio stimulation to the subject” (Claim 1); “wherein the medical system further comprises a sensory stimulus system configured for providing to provide audio stimulation to the subject, wherein the method comprises:” (Claim 14); “wherein the medical system further comprises a sensory stimulus system configured for providing to provide audio stimulation to the subject, wherein execution of the machine executable instructions causes the computational system to:” (Claim 15) (“The stimulus presentation system may comprise elements which are able to present various stimuli to one or more senses of the subject 102. […] The subject 102 is also shown as wearing headphones 112. The headphones may be used to present an audio stimulus to the subject 114” [0078]. As shown in FIG. 6, the patient 102 is wearing the headphones 112 (i.e. in addition to the virtual reality goggles 110 and the tactile feedback system 116). Therefore, the medical system comprises a sensory stimulus system configured to provide audio stimulation to the subject.);
“a memory configured to store machine executable instructions and pulse sequence commands, wherein the pulse sequence commands are configured to control the magnetic resonance imaging system to acquire the k-space data according to a functional magnetic resonance imaging protocol configured to measure brain activity in an audio cortex of the subject” (Claim 1) (See [0081] above and “The memory 130 is further shown as containing pulse sequence commands 620. The pulse sequence commands enable the processor 120 to acquire magnetic resonance data 622 according to a magnetic resonance imaging protocol. The magnetic resonance imaging protocol may be selected so that it is able to measure brain activity of the subject 102 directly” [0097]; “For example, the magnetic resonance imaging protocol could be selected so that the so-called BOLD response is measured in real time using functional magnetic resonance imaging. The memory 130 is shown as containing magnetic resonance data 622 that was acquired by executing the pulse sequence commands 620. The memory 130 is further shown as containing a magnetic resonance image 624 that was reconstructed from the magnetic resonance data 622. The magnetic resonance image 624 could for example show the brain activity of the subject 102 at different periods of time” [0098]. As shown in FIG. 6, the medical instrument 600 includes memory 130 which stores machine executable instructions (i.e. 132) and pulse sequence commands (i.e. 620), wherein the pulse sequence commands are configured to control the magnetic resonance imaging system (i.e. 602) to acquire the k-space data (i.e. brain activity data/magnetic resonance data) according to a functional magnetic resonance imaging protocol configured to measure brain activity in an audio cortex of the subject (i.e. caused by the audio stimulus provided by the headphones 112, see [0078]).);
“a computational system to control the medical system, wherein execution of the machine executable instructions causes the computational system to:” (Claim 1) (See [0080] above. Therefore, the processor 120 controls other components of the medical instrument, the processor 120 represents a computational system to control the medical system, wherein execution of the machine executable instructions (i.e. 132, see [0081]) causes the computational system to perform specific functions.); […]
“acquire(ing) baseline k-space data by controlling the magnetic resonance imaging system with the pulse sequence commands” (Claims 1, 14 and 15) (See [0097] above. Therefore, since the pulse sequence commands enable the processor 120 to acquire magnetic resonance data 622, the method carried out by the medical system involves acquiring baseline k-space data by controlling the magnetic resonance imaging system with the pulse sequence commands.);
“reconstruct(ing) a baseline functional magnetic resonance image from the baseline k-space data” (See [0098] above. In order for the memory to store the magnetic resonance image 624 within the memory 130, the method carried out by the medical system involves reconstructing a baseline functional magnetic resonance image from the baseline k-space data.);
“wherein execution of the machine executable instructions causes the computational system to repeatedly:” (Claims 1 and 15); “wherein the method further comprises repeatedly:” (Claim 14) (See [0081] as discussed above and “The medical instrument further comprises a processor for controlling the medical instrument. Execution of the machine-executable instructions causes the processor to control the stimulus presentation system with a set of entries from the stimulus reinforcer database to repeatedly provide sensory stimulus to the subject” [0009]. Therefore, execution of the machine executable instructions causes the computational system (i.e. processor) to repeatedly provide sensory stimulus to the subject.);
“acquire(ing) reference k-space data by controlling the magnetic resonance imaging system with the pulse sequence commands” (Claims 1, 14 and 15) “wherein the pulse sequence commands are configured to control the magnetic resonance imaging system to acquire the k-space data according to a functional magnetic resonance imaging protocol for measuring brain activity in an audio cortex of the subject” (Claim 14) (See [0097] ad [0098] above and “In the example of FIG. 7, a variety of different stimuli is presented one after another to the patient (e.g., using a screen and headphones for auditory, visual and multisensory (audio+video) stimuli). After each stimulus presentation, a real-time fMRI measurement reveals the BOLD response at the amygdala, which reflects the emotional state associated with the stimulus signal” [0126]. Therefore, the method carried out by the medical system involves acquiring reference k-space data by controlling the magnetic resonance imaging system with the pulse sequence commands, wherein the pulse sequence commands are configured to control the magnetic resonance imaging system to acquire the k-space data according to a functional magnetic resonance imaging (i.e. real-time fMRI measurements) protocol for measuring brain activity in an audio cortex of the subject.);
“control(ling) the sensory stimulus system with one of a predetermined set of sensory stimulus control commands during acquisition of the reference k-space data, wherein each of the predetermined set of sensory stimulus control commands are configured to control the sensory stimulus system to present a predetermined audio stimulation to the subject” (Claims 1, 14 and 15) (See [0097], and [0126] above. Therefore, since multiple different stimuli (i.e. auditory via the headphones) are presented to the patient one after another, the method carried out by the medical system involves controlling the sensory stimulus system (i.e. headphones 112) with one of a predetermined set of sensory stimulus control commands during acquisition of the reference k-space data, wherein each of the predetermined set of sensory stimulus control commands are configured to control the sensory stimulus system (i.e. headphones 112) to present a predetermined audio stimulation to the subject.);
“reconstruct(ing) a reference functional magnetic resonance image from the reference k-space data” (Claims 1, 14 and 15) (See [0098] above. Therefore, since the memory contains magnetic resonance images reconstructed from magnetic resonance data and multiple different stimuli are provided (See [0126]), the method carried out by the medical system involves reconstructing a reference functional magnetic resonance image from the reference k-space data.).
Although Flaeschner discloses “The magnetic resonance image 624 could for example show the brain activity of the subject 102 at different periods of time, Flaeschner does not teach “receive(ing) a tonotopic mapping of an audio cortex mapping of the subject, wherein the tonotopic mapping comprises a spatial mapping descriptive of auditory frequency sensitive responses for the subject” (Claims 1, 14 and 15); “identify(ing) at least one abnormal stimulus region within the tonotopic mapping” (Claims 1, 14 and 15); “assign(ing) a numerical score to the one of a/the predetermined set of sensory stimulus control commands by detecting a change in neural activity in the at least one abnormal stimulus region between the baseline functional magnetic resonance image and the reference functional magnetic resonance image, the score being representative of a decrease or an increase in neural activity in the at least one abnormal stimulus region” (Claims 1, 14 and 15); and “wherein execution of the machine executable instructions further causes the computational system to construct at least one subject specific sensory stimulus control command by selecting sensory stimulus control commands from the predetermined set of sensory stimulus control commands that maximize a change in neural activity in the at least one abnormal stimulus region using the numerical score for each repetition of the predetermined set of sensory stimulus control commands” (Claims 1 and 15); “wherein the method further comprises constructing at least one subject specific sensory stimulus control command by selecting sensory stimulus control commands from the predetermined set of sensory stimulus control commands that maximize a change in neural activity in the at least one abnormal stimulus region using the numerical score for each repetition of the predetermined set of sensory stimulus control commands” (Claim 14).
Petkov is within the same field of endeavor as the claimed invention because it involves noninvasive imaging of a monkey auditory system with functional magnetic resonance imaging to generate a tonotopic map (see [Abstract] and FIG. 3).
Petkov teaches “receive(ing) a tonotopic mapping of an audio cortex mapping of the subject, wherein the tonotopic mapping comprises a spatial mapping descriptive of auditory frequency sensitive responses for the subject” (Claims 1, 14 and 15) (“Acoustical stimulation during sparse imaging elicited stronger responses from auditory cortex than the standard continuous-imaging paradigm. […] FIG. 3A shows a typical sparse-imaging experiment with tonotopic mapping (see reference [5] for further examples). In FIG. 3B and C, we show the best examples of tonotopy that we were able to obtain with continuous imaging. Even these maps, by comparison with those from the typical sparse imaging results, contain a much more limited pattern, both anterior to posterior and medial to lateral on the superior temporal plane (compare FIG. 3A with B and C)” [Page 1070: Results, Para. 1, Lines 1-3 and Para. 5, Lines 17-25]. Therefore, the method carried out by the medical system involves receiving a tonotopic mapping of an audio cortex mapping of the subject, wherein the tonotopic mapping comprises a spatial mapping descriptive of auditory frequency sensitive responses for the subject.).
However, the combination of Flaeschner and Petkov does not teach “identify(ing) at least one abnormal stimulus region within the tonotopic mapping” (Claims 1, 14 and 15); “assign(ing) a numerical score to the one of a/the predetermined set of sensory stimulus control commands by detecting a change in neural activity in the at least one abnormal stimulus region between the baseline functional magnetic resonance image and the reference functional magnetic resonance image, the score being representative of a decrease or an increase in neural activity in the at least one abnormal stimulus region” (Claims 1, 14 and 15); and “wherein execution of the machine executable instructions further causes the computational system to construct at least one subject specific sensory stimulus control command by selecting sensory stimulus control commands from the predetermined set of sensory stimulus control commands that maximize a change in neural activity in the at least one abnormal stimulus region using the numerical score for each repetition of the predetermined set of sensory stimulus control commands” (Claims 1 and 15); “wherein the method further comprises constructing at least one subject specific sensory stimulus control command by selecting sensory stimulus control commands from the predetermined set of sensory stimulus control commands that maximize a change in neural activity in the at least one abnormal stimulus region using the numerical score for each repetition of the predetermined set of sensory stimulus control commands” (Claim 14).
Additionally, no prior art references were found to teach the above limitations.
Therefore, as best understood by the examiner, these claims would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 101 set forth in this Office action.
Regarding claim 2, due to its dependence on claim 1, this claim is subject to the reasoning provided therein. Furthermore, the examiner acknowledges that Flaeschner and Petkov, both alone or in combination, do not teach “wherein execution of the machine executable instructions further causes the computational system to render the at least one subject specific sensory stimulus control commands as an audio file”.
Therefore, as best understood by the examiner, these claims would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 101 set forth in this Office action.
Regarding claim 3, Flaeschner teaches “wherein the medical system further comprises a noise cancellation system configured to reduce magnetic field gradient noise while controlling the sensory stimulus system with the one of the predetermined set of sensory stimulus control commands” (“In another embodiment the stimulus presentation system comprises active noise cancelling headphones configured for providing audio stimulus to the subject. This for example may be useful in a magnetic resonance imaging system because during the generation of magnetic gradient pulses large knocking noises may be generated. The use of the active noise cancelling headphones may be used to both provide the audio stimulus and also reduce distracting audio stimulus at the same time” [0037].).
However, due to its dependence on claim 1, this claim is subject to the reasoning provided therein. Therefore, as best understood by the examiner, this claim would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 101 set forth in this Office action.
Regarding claim 4, although Flaeschner discloses “The headphones may be used to present an audio stimulus to the subject 114” [0078] and “The memory 130 is further shown as containing pulse sequence commands 620. The pulse sequence commands enable the processor 120 to acquire magnetic resonance data 622 according to a magnetic resonance imaging protocol. The magnetic resonance imaging protocol may be selected so that it is able to measure brain activity of the subject 102 directly” [0097], Flaeschner and Petkov, both alone or in combination, do not teach “wherein the each one of the predetermined set of sensory stimulus control commands is configured to control the sensory stimulus system configured to provide a sequence of audio tones of predetermined duration, volume, timber, and pitch”.
Furthermore, due to its dependence on claim 1, this claim is subject to the reasoning provided therein. Therefore, as best understood by the examiner, this claim would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 101 set forth in this Office action.
Regarding claim 5, Flaeschner and Petkov, both alone or in combination, do not teach “wherein the medical system further comprises a subject interface configured to receive a signal from the subject descriptive of the sensation of tinnitus experienced by the subject, wherein execution of the machine executable instructions further causes the computational system to: receive the signal from the subject interface while controlling the sensory stimulus system with one of a predetermined set of sensory stimulus control commands; and adjust the numerical score using the signal”.
Furthermore, due to its dependence on claim 1, this claim is subject to the reasoning provided therein. Therefore, as best understood by the examiner, this claim would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 101 set forth in this Office action.
Regarding claim 6, Flaeschner and Petkov, both alone or in combination, do not teach “wherein execution of the machine executable instructions are configured to cause the sensory stimulus system to repeat the one of the predetermined set of sensor stimulus commands while the magnetic resonance imaging system is disabled, wherein the signal is received when the magnetic resonance imaging system is disabled”.
Furthermore, due to its dependence on claims 1 and 5, this claim is subject to the reasoning provided therein. Therefore, as best understood by the examiner, this claim would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 101 set forth in this Office action.
Regarding claim 7, Flaeschner and Petkov, both alone or in combination, do not teach “wherein the medical system further comprises a physiological sensor configured to acquire physiological data descriptive of the subject, wherein execution of the machine executable instructions further causes the computational system to acquire the physiological data while controlling the sensory stimulus system with the one of the predetermined set of the sensory stimulus control commands, wherein the assigning the numerical score to the one of the predetermined set of sensory stimulus control commands further comprises increasing the score if the physiological data is outside of a predetermined value range”.
Furthermore, due to its dependence on claim 1, this claim is subject to the reasoning provided therein. Therefore, as best understood by the examiner, this claim would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 101 set forth in this Office action.
Regarding claim 8, Flaeschner teaches “wherein the sensory stimulus system further comprises a visual stimulus system configured to provide visual stimulus to the subject, wherein each of the predetermined set of sensory stimulus control commands are configured to control the sensory stimulus system to present a predetermined visual stimulus to the subject” (“The stimulus presentation system may comprise elements which are able to present various stimuli to one or more senses of the subject 102. […] The subject 102 is shown as wearing a pair of virtual reality goggles 110. As an alternative to virtual reality goggles there may be a screen or display which is visible to the subject 102” [0078]; “In one example, visual and auditory stimuli are provided to the patient using a screen and headphones” [0106].).
However, due to its dependence on claim 1, this claim is subject to the reasoning provided therein. Therefore, as best understood by the examiner, this claim would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 101 set forth in this Office action.
Regarding claim 9, Flaeschner teaches “wherein the sensory stimulus system further comprises a tactile stimulus system configured to provide tactile stimulus to the subject, wherein each of the predetermined set of sensory stimulus control commands are configured to control the sensory stimulus system to present a predetermined tactile stimulus to the subject” (“The stimulus presentation system 108 is further shown as containing a tactile feedback system 116. This for example may be used for providing a tactile stimulus to the subject 102. As an alternative to a tactile feedback system 116 there may be a display which displays instructions to a helper which manually provides tactile feedback to the subject 102” [0079]).
However, due to its dependence on claim 1, this claim is subject to the reasoning provided therein. Therefore, as best understood by the examiner, this claim would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 101 set forth in this Office action.
Regarding claim 10, Flaeschner and Petkov, both alone or in combination, do not teach “wherein execution of the machine executable instructions further causes the computational system to identify the at least one abnormal stimulus region within the tonotopic mapping by detecting a deviation beyond a predetermined threshold in comparison to a tonotopic anatomical atlas”.
However, due to its dependence on claim 1, this claim is subject to the reasoning provided therein. Therefore, as best understood by the examiner, this claim would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 101 set forth in this Office action.
Regarding claim 11, Flaeschner teaches “wherein execution of the machine executable instructions further causes the computational system to: acquire initial k-space data by controlling the magnetic resonance imaging system with the pulse sequence commands” (See [0097] above. Therefore, since the pulse sequence commands enable the processor 120 to acquire magnetic resonance data 622, the method carried out by the medical system involves acquiring initial k-space data by controlling the magnetic resonance imaging system with the pulse sequence commands.);
“reconstruct an initial functional magnetic resonance image from the initial k-space data” (See [0098] above. In order for the memory to store the magnetic resonance image 624 within the memory 130, the method carried out by the medical system involves reconstructing an initial functional magnetic resonance image from the baseline k-space data.);
“wherein execution of the machine executable instructions causes the computational system to repeatedly:” (See [0081] and [0009] as discussed above. Therefore, execution of the machine executable instructions causes the computational system (i.e. processor) to repeatedly provide sensory stimulus to the subject.);
Petkov teaches “acquire tonotopic map k-space data by controlling the magnetic resonance imaging system with the pulse sequence commands while the sensory stimulus system is controlled with the one of a predetermined set of tonotopic map commands” (See Page 1070: Results, Para. 1, Lines 1-3 and Para. 5, Lines 17-25] above).
However, Flaeschner and Petkov, both alone or in combination, do not teach “control the sensory stimulus system with one of the predetermined set of tonotopic map commands during acquisition of the tonotopic map k-space data, wherein each of the predetermined set of tonotopic map commands are configured to control the sensory stimulus system to present a predetermined audio frequency to the subject”; and “reconstruct an audio frequency specific functional magnetic resonance image from the tonotopic map k-space data”; “wherein execution of the machine executable instructions further causes the computational system to construct the tonotopic map using a difference between the audio frequency specific functional magnetic resonance image for each of the set of tonotopic map commands and the initial functional magnetic resonance image”.
Furthermore, due to its dependence on claim 1, this claim is subject to the reasoning provided therein. Therefore, as best understood by the examiner, this claim would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 101 set forth in this Office action.
Regarding claim 12, Flaeschner teaches “wherein execution of the machine executable instructions further causes the computational system to:” (See [0081] above.);
“acquire calibration k-space data by controlling the magnetic resonance imaging system with the pulse sequence commands” (See [0097] above. Therefore, since the pulse sequence commands enable the processor 120 to acquire magnetic resonance data 622, the method carried out by the medical system involves acquiring calibration k-space data by controlling the magnetic resonance imaging system with the pulse sequence commands.);
“reconstruct a calibration functional magnetic resonance image from the baseline k-space data” (See [0098] above. In order for the memory to store the magnetic resonance image 624 within the memory 130, the method carried out by the medical system involves reconstructing a calibration functional magnetic resonance image from the baseline k-space data.;
“acquire control k-space data by controlling the magnetic resonance imaging system with the pulse sequence commands” (See [0097] above. Therefore, since the pulse sequence commands enable the processor 120 to acquire magnetic resonance data 622, the method carried out by the medical system involves acquiring control k-space data by controlling the magnetic resonance imaging system with the pulse sequence commands.);
“control the sensory stimulus system the subject specific sensory stimulus control commands during acquisition of the control k-space data” (See [0097], and [0126] above. Therefore, since multiple different stimuli (i.e. auditory via the headphones) are presented to the patient one after another, the method carried out by the medical system involves controlling the sensory stimulus system (i.e. headphones 112) the subject specific sensory stimulus control commands during acquisition of the control k-space data.); and
“reconstruct a control functional magnetic resonance image from the control k-space data and the calibration k-space data” (See [0098] above. Therefore, since the memory contains magnetic resonance images reconstructed from magnetic resonance data and multiple different stimuli are provided (See [0126]), the method carried out by the medical system involves reconstructing a control functional magnetic resonance image from the control k-space data and the calibration k-space data.);
However, Flaeschner and Petkov does not teach “repeat the machine executable instructions at time interval greater than two weeks to obtain the control functional magnetic resonance image as a function of time to form a control functional magnetic resonance image sequence”.
Furthermore, due to its dependence on claim 1, this claim is subject to the reasoning provided therein. Therefore, as best understood by the examiner, this claim would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 101 set forth in this Office action.
Regarding claim 13, Flaeschner and Petkov does not teach “wherein the memory further contains an artificial intelligence module configured to output a progress score in response to receiving the control functional magnetic resonance image sequence as input, wherein the progress score is descriptive of a change in neural activity in the abnormal stimulus region, wherein execution of the machine executable instructions further causes the computational system to receive the progress score in response to inputting the control functional magnetic resonance image sequence into the artificial intelligence module”.
Furthermore, due to its dependence on claim 1, this claim is subject to the reasoning provided therein. Therefore, as best understood by the examiner, this claim would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 101 set forth in this Office action.
Conclusion
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/KAITLYN E SEBASTIAN/Examiner, Art Unit 3797
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