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 .
Response to Arguments
Applicant’s argument on Pages 12-13 regarding the objection to the drawings has been fully considered. While some of the objections are addressed, not all objections were addressed. Therefore, the objection to the drawings is maintained.
Applicant’s argument on Page 13 regarding the objection to the specification has been fully considered. The objection to the specification is withdrawn in view of the amendments.
Applicant does not explicitly address the objections to Claims 24, 34, and 36. However, the objections to Claims 24, 34, and 36 are withdrawn in view of the amendments.
Applicant’s argument on Page 13 regarding the rejections of Claims 22-24 and 32-34 under 35 U.S.C. 112(b) has been fully considered. The rejections of Claims 22-24 and 32-34 under 35 U.S.C. 112(b) are withdrawn in view of the amendments.
Applicant’s acknowledgement on Page 13 of the double patenting rejection is noted.
Applicant’s argument on Pages 20-26 regarding the rejection of Claims 21-40 under 35 U.S.C. 101 has been fully considered but is not persuasive. The amendments to the claims do not overcome the rejection. The amendment recites “vendor-specific scanner controls of the selected third-party vendor” and “stored anatomic models and vendor-specific imaging parameters,” which are merely software and/or programmed components of a computer, and do not, as applicant argues on Page 21, transform the abstract idea into a practical application. A step to integrate the abstract idea into a practical application follows the last step of the method may be beneficial in order to overcome the rejection under 35 U.S.C. 101. Additionally, applicant argues on Pages 21-22 that the amended claims cannot be performed using a general-purpose computer. However, with the amended claims, the limitations may still be performed using processing components of a general-purpose computer to present the virtual MRI interface. The interface merely requires selection, a display function (which any displace-interface will do), and simulation, all of which may be performed by processing components of a general-purpose computer. Furthermore, applicant argues on Page 22 that the claims are not “merely using a computer as a tool, but rather a specific implementation that improves MRI training technology by replicating the technical complexities of actual MRI scanners,” however, the claim limitations are not embodied in such a way as to overcome issues under 35 U.S.C. 101.
Applicant’s arguments on Pages 22-26 regarding the depending claims and how they had significantly more have been fully considered but are not persuasive. The dependent claims continue to add to the list of software and/or programmed components that the computer may carry out, and do not add significantly more nor integrate the abstract idea into a practical application.
Applicant’s argument on Pages 15-17 regarding the rejection of Claims 21 and 31 under 35 U.S.C. 103 over Nesichi in view of Long has been fully considered but is not persuasive under new grounds of rejection as below.
Applicant’s argument on Page 18 regarding the rejections of Claims 22-24 and 32-34 under 35 U.S.C. 103 over Nesichi in view of Long further in view of Wolf has been fully considered but is not persuasive. Applicant argues that “Wolf’s generic case-specific information input does not disclose or suggest one or more critical questions relating to the user selected MRI examination procedure to be simulated.” However, as discussed in the new grounds of rejection as below, “questions” and “responses” may merely be filling in input blocks.
Applicant’s argument on Pages 18-19 regarding the rejection of Claims 25-26 and 35-36 under 35 U.S.C. 103 over Nesichi in view of Long further in view of Kuang has been fully considered but is not persuasive under new grounds of rejection as below.
Applicant’s argument on Page 19 regarding the rejection of Claims 27 and 37 under 35 U.S.C. 103 over Nesichi in view of Long further in view of Giap has been fully considered but is not persuasive. Applicant argues that “Giaps’s system is directed to patient treatment and monitoring, not MRI simulation training.” However, one of ordinary skill in the art would understand that under the basis of Nesichi and Sakuragi, any non-virtual MRI limitations are transferable to the virtual environment, in order to make the simulation as realistic as possible. Furthermore, as discussed in the new grounds of rejection as below, “questions” and “responses” may merely be filling in input, where the responses in [0068] relate to evaluation of position and biometric data for compliance and safety.
Applicant’s argument on Pages 19-20 regarding the rejection of Claims 30 and 40 under 35 U.S.C. 103 over Nesichi in view of Long further in view of Volkar has been fully considered but is not persuasive. Applicant argues that Volkar’s post-study quality assessment of actual medical imaging does not disclose or suggest the claimed real-time deviation analysis during MRI simulation training. However, one of ordinary skill in the art would understand that under the basis of Nesichi and Sakuragi, any non-virtual MRI limitations are transferable to the virtual environment, in order to make the simulation as realistic as possible.
Regarding the rejection of all remaining corresponding claims, applicant’s argument submitted on Page 14 relies on the supposed deficiencies with respect to the rejection of parent Claims 21 and 31. Applicant’s argument is moot for the same reasons detailed above.
Drawings
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: 656 (Fig. 5H). 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.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 21-40 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding Claims 21 and 31, the claims recite the limitation “vendor-specific scanner controls of the selected third-party vendor” which is not taught by the specification. For purposes of applying prior art, the limitation is interpreted as options of pre-installed imaging parameters for a user to choose from for the simulation.
Claims not explicitly addressed above are rejected as depending from a rejected claim and failing to cure deficiencies of the parent claim.
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 21-40 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite an abstract idea as discussed below. This judicial exception is not integrated into a practical application for the reasons discussed below. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the reasons discussed below.
Step 1 requires the examiner to determine if the claims are to one of the statutory categories of invention. Applied to the present application, the claims belong to one of the statutory classes of a process or product as a computer implemented method or a computer system/product.
Step 2A is divided into two prongs. Prong 1 requires to determine if the claims recite an abstract idea, and further requires that the abstract idea belong to one of three enumerated groupings: mathematical concepts, mental processes, and certain methods of organizing human activity.
Regarding Claims 21 and 31, the independent claims are directed to a computer implemented method for simulation of a Magnetic Resonance Imaging (MRI) medical procedure. The examiner notes that claim limitation “visually displaying, at the user terminal for user selection, one or more criteria for initiating simulation of the MRI procedure in accordance with the settings of the selected third-party vendor; visually displaying, at the user terminal for user selection, one or more MRI examination procedures to be simulated based upon the user selected criteria for simulation of the MRI procedure; visually displaying, at the user terminal, a virtual MRI interface that replicates vendor-specific scanner controls of the selected third-party vendor for accepting user input for configuring imaging to be initiated for the user selected MRI examination procedure to be simulated based upon the user selected criteria for simulation of the MRI procedure; simulating, by the processor, the user selected MRI examination procedure based upon the user selected criteria for simulation of the MRI procedure to generate resulting MRI images using stored anatomic models and vendor-specific imaging parameters associated with the selected third-party vendor; and visually displaying, at the user terminal, the generated resulting MRI images” are directed to an abstract idea because the claims invention can be performed using a general purpose computer which has a graphic user interface as discussed in more detail below.
Using the general purpose computer with the graphic user interface, a user can input any image data that includes MRI image using an inputting device such as a keyboard mouse, storing MRI image data in the computer using a spread sheet application such as Excel or another data processing software program, which can store anatomic models and imaging parameters, simulating the MRI image data carried out, for example, by generating a graph using Excel that represents the MRI image data, utilizing the controls and parameters set by the software, and visually analyzing the graphic data derived from the simulation results on the computer screen.
Furthermore, the additional claim limitations “simulating and visually displaying” described above are not sufficient to amount to significantly more than the abstract idea because generating an output is directed to an extra solution activity/displaying the results of the abstract idea.
Moreover, the additional element of a generic computer component (“processor”) to execute the abstract ideas does not add significantly more than the abstract idea because since the processor is merely a generic computer component and the computer is being used as a tool for performing the recited functions.
Regarding Claim 31, the claim has similar limitations of Claim 21, thus the rejection applied to Claim 21 is also applied to Claim 31.
In consideration of each of the relevant factors and the claim elements both individually and in combination, Claims 21 and 31 are directed to abstract ideas without sufficient integration into a practical application and without significantly more. Accordingly, Claims 21 and 31 are directed to non-eligible patent subject matter and is therefore rejected.
Regarding Claims 22 and 32, the claims are directed to a computer implemented method for simulation and a computer system, and the limitation “visually displaying, at the user terminal, one or more questions relating to the user selected MRI examination procedure to be simulated based upon the user selected criteria for simulation of the MRI procedure, wherein a user provides one or more responses to the one or more questions” does not integrate the judicial exception into a practical application or amount significantly more than the judicial exception. The additional elements of the user terminal is recited at a high level of generality. As disclosed in Fig. 2 and [0013] of the published specification, the user terminal is a virtual MRI interface for accepting user input for configuring imaging to be initiated for a user selected MRI examination procedure to be simulated based upon the user selected criteria for simulation of a MRI procedure. User-terminals are well-understood and routine devices within the art. The user terminal is recited at a high level of generality within the specification and does not recite improvements to these technologies. Using the user terminal to collect data does not integrate the judicial exception into a practical application. The additional elements, taken either individually or as a whole, do not amount to significantly more than the judicial exception. Accordingly, Claims 22 and 32 are directed to non-eligible patent subject matter and are therefore rejected.
Regarding Claims 23 and 33, the claims are directed to a computer implemented method for simulation and a computer system, and the limitation “wherein the one or more questions includes at least one question selected from one or more of the categories relating to: Safety; Pathology Recognition; Anatomy; Clinical Procedures; Parameters and Trade-Offs; and Artifacts” does not recite additional elements that integrate the judicial exception into a practical application and does not amount to significantly more than the judicial exception. Accordingly, Claims 23 and 33 are directed to non-eligible patent subject matter and are therefore rejected.
Regarding Claims 24 and 34, the claims are directed to a computer implemented method for simulation and a computer system, and the limitation “wherein the one or more questions includes at least one question relating to angiography contrast exam timing” does not recite additional elements that integrate the judicial exception into a practical application and does not amount to significantly more than the judicial exception. Accordingly, Claims 24 and 34 are directed to non-eligible patent subject matter and are therefore rejected.
Regarding Claims 25 and 35, the claims are directed to a computer implemented method for simulation and a computer system, and the limitation “wherein the one or more criteria includes selecting a type of virtual MRI scanner from a plurality of virtual MRI scanner types stored in the storage medium” does not integrate the judicial exception into a practical application or amount significantly more than the judicial exception. The additional elements of the virtual MRI scanner and storage medium are recited at a high level of generality. As disclosed in Fig. 2 and [0030] of the published specification, a computer-readable storage medium is an electronic, magnetic, optical, electromagnetic, infrared, or semiconductor system, apparatus, or device, cloud service or any suitable combination. A virtual MRI scanner and the storage medium are well-understood and routine devices within the art. The virtual MRI scanner and the storage medium are both recited at high levels of generality within the specification and do not recite improvements to these technologies. Using the virtual MRI scanner and the storage medium to collect data does not integrate the judicial exception into a practical application. The additional elements, taken either individually or as a whole, do not amount to significantly more than the judicial exception. Accordingly, Claims 25 and 35 are directed to non-eligible patent subject matter and are therefore rejected.
Regarding Claims 26 and 36, the claims are directed to a computer implemented method for simulation and a computer system, and the limitation “wherein the one or more MRI examination procedures includes selecting a virtual anatomic model of a patient body component from a plurality of anatomic models stored in the storage medium” does not integrate the judicial exception into a practical application or amount significantly more than the judicial exception. The additional element of storing a virtual anatomic model in the storage medium is recited at a high level of generality. As disclosed in Fig. 2 and [0030] of the published specification, a computer-readable storage medium is an electronic, magnetic, optical, electromagnetic, infrared, or semiconductor system, apparatus, or device, cloud service or any suitable combination. The storage of a virtual anatomic model in the storage medium is well-understood and a routine device within the art. The storing a virtual anatomic model in the storage medium is recited at high levels of generality within the specification and does not recite improvements to this technology. Using the storage of a virtual anatomic model in the storage medium to collect data does not integrate the judicial exception into a practical application. The additional elements, taken either individually or as a whole, do not amount to significantly more than the judicial exception. Accordingly, Claims 26 and 36 are directed to non-eligible patent subject matter and are therefore rejected.
Regarding Claims 27 and 37, the claims are directed to a computer implemented method for simulation and a computer system, and the limitation “visually displaying, at the user terminal, one or more safety questions relating to the user selected MRI examination procedure to be simulated based upon the user selected criteria for simulation of the MRI procedure, wherein the user provides one or more responses to the one or more safety questions” does not integrate the judicial exception into a practical application or amount significantly more than the judicial exception. The additional element of the user terminal is recited at a high level of generality. As disclosed in Fig. 2 and [0013] of the published specification, the user terminal is a virtual MRI interface for accepting user input for configuring imaging to be initiated for a user selected MRI examination procedure to be simulated based upon the user selected criteria for simulation of a MRI procedure. User-terminals are well-understood and routine devices within the art. The user terminal is recited at a high level of generality within the specification and does not recite improvements to these technologies. Using the user terminal to collect data does not integrate the judicial exception into a practical application. The additional elements, taken either individually or as a whole, do not amount to significantly more than the judicial exception. Accordingly, Claims 27 and 37 are directed to non-eligible patent subject matter and are therefore rejected.
Regarding Claims 28 and 38, the claims are directed to a computer implemented method for simulation and a computer system, and the limitation “visually displaying, at the user terminal, the virtual MRI interface includes accepting user input for configuring one or more of: MRI slice positions; MRI pulse sequences, one or more entry points into patient tissue, one or more target locations to be treated, and a first target location to be approached first” does not integrate the judicial exception into a practical application or amount significantly more than the judicial exception. The additional element of the user terminal and virtual MRI interface are recited at a high level of generality. As disclosed in Fig. 2 and [0013] of the published specification, the user terminal is a virtual MRI interface for accepting user input for configuring imaging to be initiated for a user selected MRI examination procedure to be simulated based upon the user selected criteria for simulation of a MRI procedure. User-terminals are well-understood and routine devices within the art. The user terminal and virtual MRI interface are recited at a high level of generality within the specification and do not recite improvements to these technologies. Using the user terminal to collect data does not integrate the judicial exception into a practical application. The additional elements, taken either individually or as a whole, do not amount to significantly more than the judicial exception. Accordingly, Claims 28 and 38 are directed to non-eligible patent subject matter and are therefore rejected.
Regarding Claims 29 and 39, the claims are directed to a computer implemented method for simulation and a computer system, the limitation “wherein the virtual MRI interface provides a same interface as associated with an actual MRI scanner of the selected third-party vendor” does not integrate the judicial exception into a practical application or amount to significantly more than the judicial exception. The additional elements of an interface associated with the MRI interface is recited at high levels of generality. As described in Fig. 3 and [0047] of the published specification, the web application server 320 is a Contrast Lab Application Program Interface 330 and Resolution Lab Application program interface 332 preferably providing a complex dataset of MRI imaging maps. The additional element of the interface as associated with MRI scanner is recited at a high level of generality. As described in Fig. 5G and [0052] of the published specification, the interface is associated with the actual MRI scanner is well-understood and routine within the art and do not recite improvements to these technologies. Using the interface as associated with the MRI scanner to collect data does not integrate the judicial exception into a practical application. The additional elements, taken either individually or as a whole, do not amount to significantly more than the judicial exception. Accordingly, Claims 29 and 39 are directed to non-eligible patent subject matter and are therefore rejected.
Regarding Claims 30 and 40, the claims are directed to a computer implemented method for simulation and a computer system, the limitation “determining, by the processor, a deviation value from which the generated resulting MRI images deviate from acceptable MRI images relating to the user selected MRI examination procedure; and determining, by the processor, a score value for the user's simulated MRI examination procedure based upon the determined deviation value” does not integrate the judicial exception into a practical application or amount to significantly more than the judicial exception. The additional element of a processor is recited at high levels of generality. Using the general purpose computer with the graphic user interface, a user can input any image data that includes MRI image using an inputting device such as a keyboard mouse, storing MRI image data in the computer using a spread sheet application such as Excel, simulating the MRI image data carried out, for example, by generating a graph using Excel that represents the MRI image data, and visually analyzing the graphic data derived from the simulation results on the computer screen. Moreover, the additional element of a generic computer component (“processor”) to execute the abstract ideas does not add significantly more than the abstract idea because since the processor is merely a generic computer component and the computer is being used as a tool for performing the recited functions. Accordingly, Claims 30 and 40 are directed to non-eligible patent subject matter and are therefore rejected.
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 21-23, 28-29, 31-33, and 38-39 are rejected under 35 U.S.C. 103 as being unpatentable over Nesichi et al. (US 20180098813) in view of Sakuragi et al. (US 20200271742) and Siemens (“MRI Acronyms”).
Regarding Claim 21, Nesichi teaches a computer-implemented method, (Abstract “methods for rendering medical procedures in a virtual reality operating room for a training a trainee are provided.”), for simulation of a Magnetic Resonance Imaging (MRI) medical procedure, ([0076] “The simulation information can include […] magnetic resonance imaging information”), the computer implemented method executed within a computer system comprising a computer processor connected to a storage medium, ([0080] “The above-described methods can be implemented in digital electronic circuitry, in computer hardware, firmware, and/or software. The implementation can be as a computer program product (e.g., a computer program tangibly embodied in an information carrier). The implementation can, for example, be in a machine-readable storage device for execution by, or to control the operation of, data processing apparatus. The implementation can, for example, be a programmable processor, a computer, and/or multiple computers.”), and a user interface having a user terminal, ([0065] “The method can also involve rendering a user interface overlay (Step 275). The user interface can be the user interface in the virtual reality operating room. The user interface can include indicators for selected tool types, selected energy mode, camera angle and/or pedal.”), the method comprising the steps of:
a) visually displaying, at the user terminal for user selection, one or more MRI examination procedures to be simulated based upon the user selected criteria for simulation of the MRI procedure (Figs. 5a-5f, [0072] “rendering a simulation of the selected medical procedure, via a haptics medical simulation system” and [0085] “The interaction with a user can be, for example, a display of information to the user and a keyboard and a pointing device (e.g., a mouse or a trackball) by which the user can provide input to the computer (e.g., interact with a user interface element). Other kinds of devices can be used to provide for interaction with a user. Other devices can be, for example, feedback provided to the user in any form of sensory feedback (e.g., visual feedback, auditory feedback, or tactile feedback). Input from the user can be, for example, received in any form, including acoustic, speech, and/or tactile input.”);
b) visually displaying, at the user terminal, a virtual MRI interface that replicates vendor-specific scanner controls of the selected third-party vendor for accepting user input for configuring imaging to be initiated for the user selected MRI examination procedure to be simulated based upon the user selected criteria for simulation of the MRI procedure (Figs. 5a-5f and Claim 9 “rendering, via a virtual reality simulation system coupled to the medical procedure simulation system, i) a virtual reality operating room scene that corresponds to the type of medical procedure to simulate, and ii) the simulation of the selected medical procedure into a virtual reality scene; providing simulation information, via a surface sharing module, from the medical simulation system to the virtual reality simulation system that allows the virtual reality simulation system to render the virtual reality operating room scene that corresponds to the haptics medical simulation; and displaying, via a virtual reality headset, the virtual reality scene.”); and
c) simulating, by the processor, the user selected MRI examination procedure based upon the user selected criteria for simulation of the MRI procedure to generate resulting MRI images using stored anatomic models and vendor-specific imaging parameters associated with the selected third-party vendor; and visually displaying, at the user terminal, the generated resulting MRI images ([0076] “The method can also involve providing simulation information, via a surface sharing module (e.g., the surface sharing module 122, as shown above in FIG. 1) from the haptics medical simulation system to the virtual reality simulation system to render the virtual reality operating room scene that corresponds to the haptics medical procedure simulation (Step 460). The simulation information can include […] magnetic resonance imaging information”).
However, Nesichi does not explicitly teach selecting, for user interaction on the user terminal, MRI settings associated with a third-party MRI vendor selected from a listing of certain third-party vendors; visually displaying, at the user terminal for user selection, one or more criteria for initiating simulation of the MRI procedure in accordance with the settings of the selected third-party vendor.
In an analogous MRI imaging control program field of endeavor, Sakuragi teaches a computer-implemented method of a Magnetic Resonance Imaging (MRI) medical procedure, the computer implemented method executed within a computer system comprising a computer processor connected to a storage medium, (Claim 7 “A control program for a magnetic resonance imaging apparatus including a computation unit that performs action control of the entire apparatus and computation” and [0026] “computation unit 20 includes a storage unit 21”), and a user interface having a user terminal, ([0025] “The GUI 10 is a unit which receives various input instructions issued by the user”), the method comprising the steps of:
a) selecting, for user interaction on the user terminal, MRI settings associated with a third-party MRI vendor selected from a listing of certain third-party vendors ([0048] “user is allowed to set specific contents or conditions of processing for every processing. With regard to imaging processing, the user presets, via the GUI 10, for example, a scan time of “Scanogram” and specific contents of “Scan”, for example, a scan condition (imaging parameter), such as a pulse sequence and an imaging cross-section, or a scan time. These contents or conditions are stored as imaging processing data in the storage unit 21.”); and
b) visually displaying, at the user terminal for user selection, one or more criteria for initiating simulation of the MRI procedure in accordance with the settings of the selected third-party vendor ([0048] “the user presets, via the GUI 10” and see Siemens NPL, which lists the various vendor provided codes for difference imaging sequences, which may appear on the GUI for the user to choose the imaging and processing conditions.).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify the teachings of Nesichi with Sakuragi because it reduces user burden in setting each and every parameter associated with the intended scanning sequence or procedure, as taught by Sakuragi in [0008]. If the user is simply provided with a list of procedures to choose from that contain all settings regarding the procedure, there is minimal setting or selection required by the user, thus reducing burden.
Regarding Claim 22, the modified computer-implemented method of Nesichi teaches all limitations of Claim 21, as discussed above. Furthermore, Sakuragi teaches visually displaying, at the user terminal, one or more questions relating to the user selected MRI examination procedure to be simulated based upon the user selected criteria for simulation of the MRI procedure, wherein a user provides one or more responses to the one or more questions ([0048] “Additionally, with regard to processing, the user is allowed to set specific contents or conditions of processing for every processing. With regard to imaging processing, the user presets, via the GUI 10, for example, a scan time of “Scanogram” and specific contents of “Scan”, for example, a scan condition (imaging parameter), such as a pulse sequence and an imaging cross-section, or a scan time. These contents or conditions are stored as imaging processing data in the storage unit 21. With regard to post processing too, the user is also allowed to set a rule of processing. For example, in the case of performing processing of a 3D image, the user is allowed to previously determine, for example, a sequence name or a field of view (FOV) region required for 3D processing.” Where it would be obvious to one of ordinary skill in the art that “questions” and “responses” may merely be filling in input blocks 201, 202 (i.e., Fig. 2, “EXAMINATION REGION: brain”), which is met by the user presetting via the GUI 10 in Sakuragi.).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify the teachings of Nesichi with Sakuragi because it reduces user burden in setting each and every parameter associated with the intended scanning sequence or procedure, as taught by Sakuragi in [0008]. For example, setting the examination region to the brain may automatically set specific conditions for the method.
Regarding Claim 23, the modified computer-implemented method of Nesichi teaches all limitations of Claim 22, as discussed above. Furthermore, Sakuragi teaches wherein the one or more critical questions includes at least one question selected from one or more of the categories relating to: Safety; Pathology Recognition; Anatomy (Fig. 2, “EXAMINATION REGION: brain,” “AGE,” and “BODY WEIGHT”); Clinical Procedures (Fig. 2 “DATA OF EXAMINATION FLOW”); Parameters and Trade-Offs ([0048] “Additionally, with regard to processing, the user is allowed to set specific contents or conditions of processing for every processing. With regard to imaging processing, the user presets, via the GUI 10, for example, a scan time of “Scanogram” and specific contents of “Scan”, for example, a scan condition (imaging parameter), such as a pulse sequence and an imaging cross-section, or a scan time.”); and Artifacts.
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of Sakuragi for the same reasons as Claim 22 as discussed above.
Regarding Claim 28, the modified computer-implemented method of Nesichi teaches all limitations of Claim 21, as discussed above. Furthermore, Nesichi teaches wherein the step of visually displaying, at the user terminal, the virtual MRI interface includes accepting user input for configuring one or more of: MRI slice positions; MRI pulse sequences, one or more entry points into patient tissue, one or more target locations to be treated, ([0070] “receiving (e.g., via the input device 105 as described above in FIG. 1) a type of medical procedure to simulate (Step 410). The type of medical procedure can be specified by a trainee, a person who wants to monitor the trainee (e.g., teacher) or any other user. The type of medical procedure can be a surgery, diagnostic procedure using ultrasound and/or other imaging modalities, anesthesia, cardiovascular interventions, and/or emergency room treatments.” Where the type of medical procedure would include the one or more target locations to be treated.), and a first target location to be approached first.
Regarding Claim 29, the modified computer-implemented method of Nesichi teaches all limitations of Claim 21, as discussed above. Furthermore, Sakuragi teaches wherein the virtual MRI interface provides a same interface as associated with an actual MRI scanner of the selected third-party vendor (Figs. 5-10 and [0025] “The GUI 10 is a unit which receives various input instructions issued by the user, including, for example, a scan condition and setting for executing examinations, outputs the input instructions to the computation unit 20, and displays, to the user, for example, results of imaging and input screens needed for instructions, and includes, for example, a display device and an input device”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify the teachings of Nesichi with Sakuragi because the modification ensures that the user may correctly infer diagnosis, surgical or treatment planning, or recovery from the displayed MRI images.
Regarding Claim 31, Nesichi teaches a computer system for simulation of a Magnetic Resonance Imaging (MRI) medical procedure, comprising:
a) a memory configured to store instructions ([0080] “The above-described methods can be implemented in digital electronic circuitry, in computer hardware, firmware, and/or software. The implementation can be as a computer program product (e.g., a computer program tangibly embodied in an information carrier). The implementation can, for example, be in a machine-readable storage device for execution by, or to control the operation of, data processing apparatus. The implementation can, for example, be a programmable processor, a computer, and/or multiple computers.”);
b) a processor disposed in communication with said memory, ([0080] “The above-described methods can be implemented in digital electronic circuitry, in computer hardware, firmware, and/or software. The implementation can be as a computer program product (e.g., a computer program tangibly embodied in an information carrier). The implementation can, for example, be in a machine-readable storage device for execution by, or to control the operation of, data processing apparatus. The implementation can, for example, be a programmable processor, a computer, and/or multiple computers.”), wherein said processor upon execution of the instructions is configured to:
i) visually display, at the user terminal for user selection, one or more criteria for initiating simulation of the MRI procedure in accordance with the settings of the selected third- party vendor ([0070] “receiving (e.g., via the input device 105 […]) a type of medical procedure to simulate (Step 410). The type of medical procedure can be specified by a trainee, a person who wants to monitor the trainee (e.g., teacher) or any other user” and [0084] “Data transmission and instructions can also occur over a communications network. Information carriers suitable for embodying computer program instructions and data include all forms of non-volatile memory, including by way of example semiconductor memory devices. The information carriers can, for example, be EPROM, EEPROM, flash memory devices, magnetic disks, internal hard disks, removable disks, magneto-optical disks, CD-ROM, and/or DVD-ROM disks. The processor and the memory can be supplemented by, and/or incorporated in special purpose logic circuitry.” Where data transmission over a network is interpreted as receiving the settings via a third-party vendor.);
ii) visually display, at the user terminal for user selection, one or more MRI examination procedures to be simulated based upon the user selected criteria for simulation of the MRI procedure (Figs. 5a-5f and ([0072] “rendering a simulation of the selected medical procedure, via a haptics medical simulation system”);
iii) simulate, by the processor, the user selected MRI examination procedure based upon the user selected criteria for simulation of the MRI procedure to generate resulting MRI images using stored anatomic models and vendor-specific imaging parameters associated with the selected third party vendor (Figs. 5a-5f and Claim 9 “rendering, via a virtual reality simulation system coupled to the medical procedure simulation system, i) a virtual reality operating room scene that corresponds to the type of medical procedure to simulate, and ii) the simulation of the selected medical procedure into a virtual reality scene; providing simulation information, via a surface sharing module, from the medical simulation system to the virtual reality simulation system that allows the virtual reality simulation system to render the virtual reality operating room scene that corresponds to the haptics medical simulation; and displaying, via a virtual reality headset, the virtual reality scene.”); and
iv) visually display, at the user terminal, the generated resulting MRI images ([0076] “The method can also involve providing simulation information, via a surface sharing module (e.g., the surface sharing module 122, as shown above in FIG. 1) from the haptics medical simulation system to the virtual reality simulation system to render the virtual reality operating room scene that corresponds to the haptics medical procedure simulation (Step 460). The simulation information can include […] magnetic resonance imaging information”).
However, Nesichi does not explicitly teach wherein said processor upon execution of the instructions is configured to: select, for user interaction on a user terminal, MRI settings associated with a third-party MRI vendor selected from a listing of certain third-party vendors; and visually display, at the user terminal, a virtual MRI interface that replicates vendor-specific scanner controls of the selected third-party vendor for accepting user input for configuring imaging to be initiated for the user selected MRI examination procedure to be simulated based upon the user selected criteria for simulation of the MRI procedure.
In an analogous MRI imaging control program field of endeavor, Sakuragi teaches a computer-system for a Magnetic Resonance Imaging (MRI) medical procedure, comprising: a processor disposed in communication with said memory, (Claim 7 “A control program for a magnetic resonance imaging apparatus including a computation unit that performs action control of the entire apparatus and computation” and [0026] “computation unit 20 includes a storage unit 21”), wherein said processor upon execution of the instructions is configured to:
a) select, for user interaction on a user terminal, ([0025] “The GUI 10 is a unit which receives various input instructions issued by the user”), MRI settings associated with a third-party MRI vendor selected from a listing of certain third-party vendors ([0048] “user is allowed to set specific contents or conditions of processing for every processing. With regard to imaging processing, the user presets, via the GUI 10, for example, a scan time of “Scanogram” and specific contents of “Scan”, for example, a scan condition (imaging parameter), such as a pulse sequence and an imaging cross-section, or a scan time. These contents or conditions are stored as imaging processing data in the storage unit 21.”); and
b) visually display, at the user terminal, a virtual MRI interface that replicates vendor-specific scanner controls of the selected third-party vendor for accepting user input for configuring imaging to be initiated for the user selected MRI examination procedure to be simulated based upon the user selected criteria for simulation of the MRI procedure ([0048] “the user presets, via the GUI 10” and see Siemens NPL, which lists the various vendor provided codes for difference imaging sequences, which may appear on the GUI for the user to choose the imaging and processing conditions.).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify the teachings of Nesichi with Sakuragi because it reduces user burden in setting each and every parameter associated with the intended scanning sequence or procedure, as taught by Sakuragi in [0008]. If the user is simply provided with a list of procedures to choose from that contain all settings regarding the procedure, there is minimal setting or selection required by the user, thus reducing burden.
Regarding Claim 32, the modified computer system of Nesichi teaches all limitations of Claim 31, as discussed above. Furthermore, Sakuragi teaches wherein the processor is configured to, visually display, at the user terminal, one or more questions relating to the user selected MRI examination procedure to be simulated based upon the user selected criteria for simulation of the MRI procedure, wherein a user provides one or more responses to the one or more questions ([0048] “Additionally, with regard to processing, the user is allowed to set specific contents or conditions of processing for every processing. With regard to imaging processing, the user presets, via the GUI 10, for example, a scan time of “Scanogram” and specific contents of “Scan”, for example, a scan condition (imaging parameter), such as a pulse sequence and an imaging cross-section, or a scan time. These contents or conditions are stored as imaging processing data in the storage unit 21. With regard to post processing too, the user is also allowed to set a rule of processing. For example, in the case of performing processing of a 3D image, the user is allowed to previously determine, for example, a sequence name or a field of view (FOV) region required for 3D processing.” Where it would be obvious to one of ordinary skill in the art that “questions” and “responses” may merely be filling in input blocks 201, 202 (i.e., Fig. 2, “EXAMINATION REGION: brain”), which is met by the user presetting via the GUI 10 in Sakuragi.).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify the teachings of Nesichi with Sakuragi because it reduces user burden in setting each and every parameter associated with the intended scanning sequence or procedure, as taught by Sakuragi in [0008]. For example, setting the examination region to the brain may automatically set specific conditions for the method.
Regarding Claim 33, the modified computer system of Nesichi teaches all limitations of Claim 32, as discussed above. Furthermore, Sakuragi teaches wherein the one or more critical questions includes at least one question selected from one or more of the categories relating to: Safety; Pathology Recognition; Anatomy (Fig. 2, “EXAMINATION REGION: brain,” “AGE,” and “BODY WEIGHT”); Clinical Procedures (Fig. 2 “DATA OF EXAMINATION FLOW”); Parameters and Trade-Offs ([0048] “Additionally, with regard to processing, the user is allowed to set specific contents or conditions of processing for every processing. With regard to imaging processing, the user presets, via the GUI 10, for example, a scan time of “Scanogram” and specific contents of “Scan”, for example, a scan condition (imaging parameter), such as a pulse sequence and an imaging cross-section, or a scan time.”); and Artifacts.
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of Sakuragi for the same reasons as Claim 22 as discussed above.
Regarding Claim 38, the modified computer system of Nesichi teaches all limitations of Claim 21, as discussed above. Furthermore, Nesichi teaches wherein the step of visually displaying, at the user terminal, the virtual MRI interface includes accepting user input for configuring one or more of: MRI slice positions; MRI pulse sequences, one or more entry points into patient tissue, one or more target locations to be treated, ([0070] “receiving (e.g., via the input device 105 as described above in FIG. 1) a type of medical procedure to simulate (Step 410). The type of medical procedure can be specified by a trainee, a person who wants to monitor the trainee (e.g., teacher) or any other user. The type of medical procedure can be a surgery, diagnostic procedure using ultrasound and/or other imaging modalities, anesthesia, cardiovascular interventions, and/or emergency room treatments.” Where the type of medical procedure would include the one or more target locations to be treated.), and a first target location to be approached first.
Regarding Claim 39, the modified computer system of Nesichi teaches all limitations of Claim 31, as discussed above. Furthermore, Sakuragi teaches wherein the virtual MRI interface provides a same interface as associated with an actual MRI scanner of the selected third-party vendor (Figs. 5-10 and [0025] “The GUI 10 is a unit which receives various input instructions issued by the user, including, for example, a scan condition and setting for executing examinations, outputs the input instructions to the computation unit 20, and displays, to the user, for example, results of imaging and input screens needed for instructions, and includes, for example, a display device and an input device”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify the teachings of Nesichi with Sakuragi because the modification ensures that the user may correctly infer diagnosis, surgical or treatment planning, or recovery from the displayed MRI images.
Claims 24 and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Nesichi et al. (US 20180098813) in view of Sakuragi et al. (US 20200271742) and Siemens (“MRI Acronyms”), as applied to Claims 23 and 33, further in view of Wolf et al. (US 20200273581).
Regarding Claim 24, the modified computer-implemented method of Nesichi teaches all limitations of Claim 23, as discussed above. However, the modified computer-implemented method of Nesichi does not explicitly teach wherein the one or more questions includes at least one question relating to angiography contrast exam timing.
In an analogous analysis of videos of surgical procedures field of endeavor, Wolf teaches a computer-implemented method for simulation of a Magnetic Resonance Imaging (MRI) medical procedure, ([0007] “Consistent with disclosed embodiments, systems, methods, and computer readable media related to reviewing surgical video are disclosed” and [0248] “the presentation may include a display of a simulated surgical procedure based on the identified group of intraoperative events likely to be encountered and/or the identified specific frames in specific sets of the plurality of sets of surgical video footage corresponding to the identified group of intraoperative events.”), wherein the one or more critical questions includes at least one question relating to angiography contrast exam timing ([0183] “Some non-limiting examples of such patient characteristics may include […] characteristics of past medical test performed on the patient (such as type of test, time of test […]), characteristics of past medical treatments performed on the patient (such as type of treatment, time of treatment, […]), and so forth. Some non-limiting examples of such medical tests may include […] medical imaging (such as […] angiography”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of Wolf because the timing of contrast is highly important in angiographic imaging in order to ensure the highest quality images of the patient are obtained, in that the contrast is not washed out.
Regarding Claim 34, the modified computer system of Nesichi teaches all limitations of Claim 33, as discussed above. However, the modified computer system of Nesichi does not explicitly teach wherein the one or more questions includes at least one question relating to angiography contrast exam timing.
In an analogous analysis of videos of surgical procedures field of endeavor, Wolf teaches a computer system for simulation of a Magnetic Resonance Imaging (MRI) medical procedure, ([0007] “Consistent with disclosed embodiments, systems, methods, and computer readable media related to reviewing surgical video are disclosed” and [0248] “the presentation may include a display of a simulated surgical procedure based on the identified group of intraoperative events likely to be encountered and/or the identified specific frames in specific sets of the plurality of sets of surgical video footage corresponding to the identified group of intraoperative events.”), wherein the one or more critical questions includes at least one question relating to angiography contrast exam timing ([0183] “Some non-limiting examples of such patient characteristics may include […] characteristics of past medical test performed on the patient (such as type of test, time of test […]), characteristics of past medical treatments performed on the patient (such as type of treatment, time of treatment, […]), and so forth. Some non-limiting examples of such medical tests may include […] medical imaging (such as […] angiography”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of Wolf because the timing of contrast is highly important in angiographic imaging in order to ensure the highest quality images of the patient are obtained, in that the contrast is not washed out.
Claims 25 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Nesichi et al. (US 20180098813) in view of Sakuragi et al. (US 20200271742) and Siemens (“MRI Acronyms”), as applied to Claim 21 and 31, further in view of Baily (“Simulating Medical Imaging: MRI Simulators […]”).
Regarding Claim 25, the modified computer-implemented method of Nesichi teaches all limitations of Claim 21, as discussed above. However, the modified computer-implemented method of Nesichi does not explicitly teach wherein the one or more criteria includes selecting a type of virtual MRI scanner from a plurality of virtual MRI scanner types stored in the storage medium.
In an analogous simulation field of endeavor, Baily teaches wherein the one or more criteria includes selecting a type of virtual MRI scanner from a plurality of virtual MRI scanner types stored in the storage medium (Corsmed “Corsmed’s MRI simulator lets both new and experienced users practice and improve their skills in a safe setting. Practitioners can select a preferred scanner system and patient type”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of Baily because the modification ensures efficiency of the MRI method in order to carry out the procedure as appropriate.
Regarding Claim 35, the modified computer system of Nesichi teaches all limitations of Claim 31, as discussed above. However, the modified computer system of Nesichi does not explicitly teach wherein the one or more criteria includes selecting a type of virtual MRI scanner from a plurality of virtual MRI scanner types stored in the storage medium.
In an analogous simulation field of endeavor, Baily teaches wherein the one or more criteria includes selecting a type of virtual MRI scanner from a plurality of virtual MRI scanner types stored in the storage medium (Corsmed “Corsmed’s MRI simulator lets both new and experienced users practice and improve their skills in a safe setting. Practitioners can select a preferred scanner system and patient type”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of Baily because the modification ensures efficiency of the MRI method in order to carry out the procedure as appropriate.
Claims 26 and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Nesichi et al. (US 20180098813) in view of Sakuragi et al. (US 20200271742) and Siemens (“MRI Acronyms”), as applied to Claim 21 and 31, further in view of Xanthis et al. (“coreMRI: a high-performance, publicly available MR simulation platform on the cloud”).
Regarding Claim 26, the modified computer-implemented method of Nesichi teaches all limitations of Claim 21, as discussed above. However, the modified computer-implemented method of Nesichi does not explicitly teach wherein the one or more MRI examination procedures includes selecting a virtual anatomic model of a patient body component from a plurality of anatomic models stored in the storage medium.
In an analogous MR simulation platform field of endeavor, Xanthis teaches wherein the one or more MRI examination procedures includes selecting a virtual anatomic model of a patient body component from a plurality of anatomic models stored in the storage medium (2.1.1 Magnetic Resonance (MR) imaging mode “The selection of the anatomical model is performed through the tab “Anatomical Models” from the left-side menu (Fig 2A). In this page, the user is allowed to 1) upload anatomical models in a .mat file format, 2) view/download the uploaded anatomical models, 3) share anatomical models with the coreMRI community, 4) view the anatomical models that other users have uploaded and shared (through the Public Repository).”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of Kuang because the modification increases the speed at which the MR model is established and thereby improves user experience.
Regarding Claim 36, the modified computer system of Nesichi teaches all limitations of Claim 31, as discussed above. However, the modified computer system of Nesichi does not explicitly teach wherein the one or more MRI examination procedures includes selecting a virtual anatomic model of a patient body component from a plurality of anatomic models stored in the storage medium.
In an analogous MR simulation platform field of endeavor, Xanthis teaches wherein the one or more MRI examination procedures includes selecting a virtual anatomic model of a patient body component from a plurality of anatomic models stored in the storage medium (2.1.1 Magnetic Resonance (MR) imaging mode “The selection of the anatomical model is performed through the tab “Anatomical Models” from the left-side menu (Fig 2A). In this page, the user is allowed to 1) upload anatomical models in a .mat file format, 2) view/download the uploaded anatomical models, 3) share anatomical models with the coreMRI community, 4) view the anatomical models that other users have uploaded and shared (through the Public Repository).”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of Kuang because the modification increases the speed at which the MR model is established and thereby improves user experience.
Claims 27 and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Nesichi et al. (US 20180098813) in view of Sakuragi et al. (US 20200271742) and Siemens (“MRI Acronyms”), as applied to Claims 21 and 31, further in view of Giap et al. (US 20150306340).
Regarding Claim 27, the modified computer-implemented method of Nesichi teaches all limitations of Claim 21, as discussed above. However, the modified computer-implemented method of Nesichi does not explicitly teach including the step, visually displaying, at the user terminal, one or more safety questions relating to the user selected MRI examination procedure to be simulated based upon the user selected criteria for simulation of the MRI procedure, wherein the user provides one or more responses to the one or more safety questions.
In an analogous virtual reality medical application field of endeavor, Giap teaches a computer-implemented method for simulation of Magnetic Resonance Imaging (MRI) medical procedure, ([0020] “The Virtual Reality Medical Application System of the present, in a preferred embodiment, […] may be used to cover patients undergoing […] Magnetic Resonance Imaging (MRI)” and [0088] “A VR Medical Application controller 108 includes a treatment selection database 152, a patient biometric database 154 and a patient physical database 156, and may include a computer console 150 for the technician to operate and interface with the Reality Medical Application System of the present invention.”), including the step, visually displaying, at the user terminal, one or more safety questions relating to the user selected MRI examination procedure to be simulated based upon the user selected criteria for simulation of the MRI procedure, wherein the user provides one or more responses to the one or more safety questions (Fig. 10, [0068] “FIG. 10 is a flow chart representing the beginning of treatment of FIG. 6 using patient controller input, and includes the verification of patient identity, the activation of the medical treatment apparatus, and the subsequent monitoring and evaluation of position and biometric data for compliance and safety, providing a patient with biometric and positional feedback to assist with correction, receipt of patient input data, and modification of the virtual reality program to facilitate such patient correction,” [0089] “Data may be exchanged between console 106 and user controller 108. For instance, control inputs 160 including historical data and patient data, alerts 162 including interrupts, biometric data and physical data, and bidirectional channel 164 including audio and video signals. These data channels provide a technician seated apart from the patient the ability to fully monitor the patient 102, and the patient's interaction with the Virtual Reality Medical Application System and the treatment apparatus 104” and [0144] “If it is determined in step 714 that the patient biometric data is not within the preset tolerances, it is determined in step 738 whether the biometric data is outside the safety range. If safe, the technician is alerted in step 740 of the biometric error, and treatment is adjusted in step 742”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of Giap because the modification ensures high levels of patient safety, as taught by Giap in [0106], as the modification allows real-time correction, minimizing harm to the patient, as further taught by Giap in [0012].
Regarding Claim 37, the modified computer system of Nesichi teaches all limitations of Claim 31, as discussed above. However, the computer system of Nesichi does not explicitly teach wherein the processor is further configured to, visually display, at the user terminal, one or more safety questions relating to the user selected MRI examination procedure to be simulated based upon the user selected criteria for simulation of the MRI procedure, wherein the user provides one or more responses to the one or more safety questions.
In an analogous virtual reality medical application field of endeavor, Giap teaches a computer system for simulation of Magnetic Resonance Imaging (MRI) medical procedure, ([0020] “The Virtual Reality Medical Application System of the present, in a preferred embodiment, […] may be used to cover patients undergoing […] Magnetic Resonance Imaging (MRI)” and [0088] “A VR Medical Application controller 108 includes a treatment selection database 152, a patient biometric database 154 and a patient physical database 156, and may include a computer console 150 for the technician to operate and interface with the Reality Medical Application System of the present invention.”), wherein the processor is further configured to, visually display, at the user terminal, one or more safety questions relating to the user selected MRI examination procedure to be simulated based upon the user selected criteria for simulation of the MRI procedure, wherein the user provides one or more responses to the one or more safety questions (Fig. 9, [0067] “FIG. 9 is a flow chart representing the beginning of treatment of FIG. 6 without using patient controller input, and includes the verification of patient identity, the activation of the medical treatment apparatus, and the subsequent monitoring and evaluation of position and biometric data for compliance and safety, and providing a patient with biometric and positional feedback to assist with correction, and modification of the virtual reality program to facilitate such patient correction,” [0089] “Data may be exchanged between console 106 and user controller 108. For instance, control inputs 160 including historical data and patient data, alerts 162 including interrupts, biometric data and physical data, and bidirectional channel 164 including audio and video signals. These data channels provide a technician seated apart from the patient the ability to fully monitor the patient 102, and the patient's interaction with the Virtual Reality Medical Application System and the treatment apparatus 104” and [0144] “If it is determined in step 714 that the patient biometric data is not within the preset tolerances, it is determined in step 738 whether the biometric data is outside the safety range. If safe, the technician is alerted in step 740 of the biometric error, and treatment is adjusted in step 742”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of Giap because the modification ensures high levels of patient safety, as taught by Giap in [0106], as the modification allows real-time correction, minimizing harm to the patient, as further taught by Giap in [0012].
Claims 30 and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Nesichi et al. (US 20180098813) in view of Sakuragi et al. (US 20200271742) and Siemens (“MRI Acronyms”), as applied to Claims 21 and 31, further in view of Volkar et al. (US 20190214149)
Regarding Claim 30, the modified computer-implemented method of Nesichi teaches all limitations of Claim 21, as discussed above. However, the modified computer-implemented method of Nesichi does not explicitly teach further including the steps: determining, by the processor, a deviation value from which the generated resulting MRI images deviate from acceptable MRI images relating to the user selected MRI examination procedure; and determining, by the processor, a score value for the user's simulated MRI examination procedure based upon the determined deviation value.
In an analogous scoring quality of radiology examinations field of endeavor, Volkar teaches a computer-implemented method for simulation of Magnetic Resonance Imaging (MRI) medical procedure, ([0054] “At Step D, a host of data related to the study is captured. This data can include data generated before, during, and after the study is performed. For example, this data can include data entered into the radiology information system (RIS) when the study is ordered, the set of images that were acquired by the scanner including the DICOM headers […]. […] Step D can also involve communicating data from the study to existing systems, such as RIS, the picture archiving and communication system (PACS), the hospital information system (HIS), the electronic medical record (EMR), etc” and [0074] “Each of the protocol units 20a-d, scoring unit 40, and reviewing units 60a-d can be in the form of a terminal, such as a server or other computer comprised of hardware and software, having an associated processor (or series of processors) and non-transitory, computer readable storage medium that is in operable communication with the processor such that the processor can execute programming instructions stored in the storage medium so as to perform the functions associated with each unit.” Where the generated data is interpreted as simulation of the MRI procedure.), further including the steps: determining, by the processor, a deviation value from which the generated resulting MRI images deviate from acceptable MRI images relating to the user selected MRI examination procedure; and determining, by the processor, a score value for the user's simulated MRI examination procedure based upon the determined deviation value ([0055] “At Step E, the study metrics can be used to assess the quality of the study and generate a new entry in the score repository. In this step, a metrics assessment algorithm can be used to apply the study metrics against data generated from the study, such as text, image data, reconstructed images, as well as other data concerning the study, such as data that may be electronically stored in, for example, the RIS, PACS, or EMR, to assess how the data matches up with the metrics.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of Volkar because the modification ensures a proper and accurate exam is fulfilled by the user, as taught by Volkar in [0007].
Regarding Claim 40, the modified computer system of Nesichi teaches all limitations of Claim 31, as discussed above. However, the modified computer system of Nesichi does not explicitly teach wherein the processor is further configured to: determine a deviation value from which the generated resulting MRI images deviate from acceptable MRI images relating to the user selected MRI examination procedure; and determine a score value for the user's simulated MRI examination procedure based upon the determined deviation value.
In an analogous scoring quality of radiology examinations field of endeavor, Volkar teaches a computer system for simulation of Magnetic Resonance Imaging (MRI) medical procedure, ([0054] “At Step D, a host of data related to the study is captured. This data can include data generated before, during, and after the study is performed. For example, this data can include data entered into the radiology information system (RIS) when the study is ordered, the set of images that were acquired by the scanner including the DICOM headers […]. […] Step D can also involve communicating data from the study to existing systems, such as RIS, the picture archiving and communication system (PACS), the hospital information system (HIS), the electronic medical record (EMR), etc” and [0074] “Each of the protocol units 20a-d, scoring unit 40, and reviewing units 60a-d can be in the form of a terminal, such as a server or other computer comprised of hardware and software, having an associated processor (or series of processors) and non-transitory, computer readable storage medium that is in operable communication with the processor such that the processor can execute programming instructions stored in the storage medium so as to perform the functions associated with each unit.” Where the generated data is interpreted as simulation of the MRI procedure.), wherein the processor is further configured to: determine a deviation value from which the generated resulting MRI images deviate from acceptable MRI images relating to the user selected MRI examination procedure; and determine a score value for the user's simulated MRI examination procedure based upon the determined deviation value ([0055] “At Step E, the study metrics can be used to assess the quality of the study and generate a new entry in the score repository. In this step, a metrics assessment algorithm can be used to apply the study metrics against data generated from the study, such as text, image data, reconstructed images, as well as other data concerning the study, such as data that may be electronically stored in, for example, the RIS, PACS, or EMR, to assess how the data matches up with the metrics.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of Volkar because the modification ensures a proper and accurate exam is fulfilled by the user, as taught by Volkar in [0007].
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/MARIA CHRISTINA TALTY/ Examiner, Art Unit 3797
/MICHAEL J CAREY/ Supervisory Patent Examiner, Art Unit 3795
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