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 .
Allowable Subject Matter
Claims 7 and 14 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1, 3, 6, 8, 10, 15-17, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Shuai (“Design and Evaluation of Personalized Percutaneous Coronary Intervention Surgery Simulation System”, copy provided, see PTO-892) in view of Braido et al. (U.S.P.G. Pub. No. 2021/0369394).
Regarding claim 1, Shuai (“Design and Evaluation of Personalized Percutaneous Coronary
Intervention Surgery Simulation System”, copy provided, see PTO-892) discloses:
A computer-implemented method for creating a training scenario to perform a percutaneous coronary intervention using an elongated instrument and a patient simulator (see, e.g., Figures 4 and 5, page 4154), the computer-implemented method comprising:
receiving a desired position for a lesion (page 4156, the VR tasks include lesions – for example, the proximal left coronary artery);
receiving a desired value for at least one property of the lesion (page 4156, various properties, such as size of lesion, are implicitly disclosed by virtue of representation of the lesion in virtual reality; further, the simulation includes training tasks from VIST G5, which includes lesion scenarios of different sizes);
configuring a haptic feedback to be applied on the elongated instrument (page 4154-55, haptic feedback is applied to the manipulated instrument) when received in the patient simulator based on the desired location for the lesion and the desired value for the properties of the lesion (page 4156, VR tasks are based on lesions as described); and
outputting the haptic feedback, the desired position and the desired value for the properties (pages 4154-4156, the VR simulator outputs the user a visualization of the lesion with its position/properties and associated haptic feedback)
Even assuming arguendo that Shuai does not explicitly disclose:
receiving a desired value for at least one property of the lesion;
Braido et al. (U.S.P.G. Pub. No. 2021/0369394) discloses:
receiving a desired position for a lesion (Figure 12W, paragraphs [0409]-[0410], the system receives a position of a lesion in the XR system for display);
receiving a desired value for at least one property of the lesion (Figure 12W, paragraphs [0409]-[0410], the system receives characteristics such as growth over time and vessel occlusion for use in the XR system)
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to combine the system of Braido with the system of Shuai such that the system would have been configured to include desired values for properties of the lesions as described. The suggestion/motivation would have been in order to implement a system capable of providing “more robust and scalable solutions for implementing medical assistance technologies” (paragraph [0007] of the Braido reference).
Regarding claim 3, the combination of the combination of Shuai and Braido discloses the method of the parent claim (claim 1).
Shuai additionally discloses:
wherein the at least one property of the lesion comprises at least one of a length of the lesion, an occlusion percentage, a Thrombolysis In Myocardial Infarction (TIMI) flow grade and an eccentricity of the lesion (page 4156, various properties, such as length of lesion, are implicitly disclosed by virtue of representation of the lesion in virtual reality; further, the simulation includes training tasks from VIST G5, which includes lesion scenarios of different lengths)
Even assuming arguendo that Shuai does not explicitly disclose:
wherein the at least one property of the lesion comprises at least one of a length of the lesion, an occlusion percentage, a Thrombolysis In Myocardial Infarction (TIMI) flow grade and an eccentricity of the lesion
Braido additionally discloses:
wherein the at least one property of the lesion comprises at least one of a length of the lesion, an occlusion percentage, a Thrombolysis In Myocardial Infarction (TIMI) flow grade and an eccentricity of the lesion (Figure 12W, paragraphs [0409]-[0410], the system receives characteristics such as vessel occlusion for use in the XR system; further, the representation of the lesion in the XR system implies the use of a length of the lesion)
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to combine the system of Braido with the system of Shuai such that the system would have been configured to include at least one property of the lesion comprising at least one of a length of the lesion, an occlusion percentage, a Thrombolysis In Myocardial Infarction (TIMI) flow grade and an eccentricity of the lesion as described in Braido. The suggestion/motivation would have been in order to implement a system capable of providing “more robust and scalable solutions for implementing medical assistance technologies” (paragraph [0007] of the Braido reference).
Regarding claim 6, Shuai additionally discloses:
generating an electrocardiogram (ECG) graph and outputting the ECG graph (page 4151, ECG data is generated and outputted to the model)
Regarding claim 8, Shuai discloses:
A system for training a healthcare professional to perform a percutaneous coronary intervention, the system comprising:
a patient simulator configured for receiving a portion of an elongated instrument therein (see, e.g., Figures 4 and 5, page 4154) and applying a haptic feedback on the received portion of the elongated instrument (page 4154, haptic feedback is applied associated with the simulation); and
a processing unit coupled to a memory, the processing unit being configured for:
allowing a trainer to define a position of a lesion and at least one property of the lesion (page 4156, the VR tasks include lesions – for example, the proximal left coronary artery); and
configuring the haptic feedback based on the position and properties of the lesion (pages 4154-4156, the VR simulator outputs the user a visualization of the lesion with its position/properties and associated haptic feedback)
Even assuming arguendo that Shuai does not explicitly disclose:
Defining at least one property of the lesion
Braido et al. (U.S.P.G. Pub. No. 2021/0369394) discloses:
allowing a trainer to define a position of a lesion (Figure 12W, paragraphs [0409]-[0410], the system receives a position of a lesion in the XR system for display); and at least one property of the lesion (Figure 12W, paragraphs [0409]-[0410], the system receives characteristics such as growth over time and vessel occlusion for use in the XR system)
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to combine the system of Braido with the system of Shuai such that the system would have been configured to include desired values for properties of the lesions as described. The suggestion/motivation would have been in order to implement a system capable of providing “more robust and scalable solutions for implementing medical assistance technologies” (paragraph [0007] of the Braido reference).
Regarding claim 10, the combination of the combination of Shuai and Braido discloses the method of the parent claim (claim 8).
Shuai additionally discloses:
wherein the at least one property of the lesion comprises at least one of a length of the lesion, an occlusion percentage, a Thrombolysis In Myocardial Infarction (TIMI) flow grade and an eccentricity of the lesion (page 4156, various properties, such as length of lesion, are implicitly disclosed by virtue of representation of the lesion in virtual reality; further, the simulation includes training tasks from VIST G5, which includes lesion scenarios of different lengths)
Even assuming arguendo that Shuai does not explicitly disclose:
wherein the at least one property of the lesion comprises at least one of a length of the lesion, an occlusion percentage, a Thrombolysis In Myocardial Infarction (TIMI) flow grade and an eccentricity of the lesion
Braido additionally discloses:
wherein the at least one property of the lesion comprises at least one of a length of the lesion, an occlusion percentage, a Thrombolysis In Myocardial Infarction (TIMI) flow grade and an eccentricity of the lesion (Figure 12W, paragraphs [0409]-[0410], the system receives characteristics such as vessel occlusion for use in the XR system; further, the representation of the lesion in the XR system implies the use of a length of the lesion)
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to combine the system of Braido with the system of Shuai such that the system would have been configured to include at least one property of the lesion comprising at least one of a length of the lesion, an occlusion percentage, a Thrombolysis In Myocardial Infarction (TIMI) flow grade and an eccentricity of the lesion as described in Braido. The suggestion/motivation would have been in order to implement a system capable of providing “more robust and scalable solutions for implementing medical assistance technologies” (paragraph [0007] of the Braido reference).
Regarding claim 15, Shuai discloses:
A computer-implemented method for training a healthcare professional to perform a percutaneous coronary intervention using an elongated instrument and a patient simulator (see, e.g., Figures 4 and 5, page 4154), the computer-implemented method comprising:
independently receiving:
a selection of a position (page 4156, the VR tasks include lesions – for example, the proximal left coronary artery) and a physical attribute for a first lesion (page 4156, various properties, such as size of lesion, are implicitly disclosed by virtue of representation of the lesion in virtual reality; further, the simulation includes training tasks from VIST G5, which includes lesion scenarios of different sizes); and
a selection of a position (page 4156, the VR tasks include lesions – for example, bifurcation lesions) and a physical attribute for a second lesion (page 4156, various properties, such as size of lesion, are implicitly disclosed by virtue of representation of the lesion in virtual reality; further, the simulation includes training tasks from VIST G5, which includes lesion scenarios of different sizes); and
processing a detected position and motion of the elongated instrument (page 4154-55, haptic feedback is applied to the manipulated instrument) within the patient simulator and the selected position and physical attribute of each of the first and second lesion, to determine properties of a haptic feedback (page 4156, VR tasks are based on lesions as described); and
providing control signals causing the patient simulator to mechanically impart to the elongated instrument the haptic feedback having the determined properties (pages 4154-4156, the VR simulator outputs the user a visualization of the lesion with its position/properties and associated haptic feedback)
Even assuming arguendo that Shuai does not explicitly disclose:
Selection of a physical attribute for a lesion;
Braido et al. (U.S.P.G. Pub. No. 2021/0369394) discloses:
a selection of a position (Figure 12W, paragraphs [0409]-[0410], the system receives a position of a lesion in the XR system for display) and a physical attribute for a lesion (Figure 12W, paragraphs [0409]-[0410], the system receives characteristics such as growth over time and vessel occlusion for use in the XR system); and
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to combine the system of Braido with the system of Shuai such that the system would have been configured to include desired values for properties of the lesions as described. The suggestion/motivation would have been in order to implement a system capable of providing “more robust and scalable solutions for implementing medical assistance technologies” (paragraph [0007] of the Braido reference).
Regarding claim 16, the combination of the combination of Shuai and Braido discloses the method of the parent claim (claim 15).
Shuai additionally discloses:
wherein the physical attribute of the lesion comprises at least one of a length of the lesion, an occlusion percentage, a Thrombolysis In Myocardial Infarction (TIMI) flow grade and an eccentricity of the lesion (page 4156, various properties, such as length of lesion, are implicitly disclosed by virtue of representation of the lesion in virtual reality; further, the simulation includes training tasks from VIST G5, which includes lesion scenarios of different lengths)
Even assuming arguendo that Shuai does not explicitly disclose:
wherein the physical attribute of the lesion comprises at least one of a length of the lesion, an occlusion percentage, a Thrombolysis In Myocardial Infarction (TIMI) flow grade and an eccentricity of the lesion
Braido additionally discloses:
wherein the physical attribute of the lesion comprises at least one of a length of the lesion, an occlusion percentage, a Thrombolysis In Myocardial Infarction (TIMI) flow grade and an eccentricity of the lesion (Figure 12W, paragraphs [0409]-[0410], the system receives characteristics such as vessel occlusion for use in the XR system; further, the representation of the lesion in the XR system implies the use of a length of the lesion)
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to combine the system of Braido with the system of Shuai such that the system would have been configured to include at least one property of the lesion comprising at least one of a length of the lesion, an occlusion percentage, a Thrombolysis In Myocardial Infarction (TIMI) flow grade and an eccentricity of the lesion as described in Braido. The suggestion/motivation would have been in order to implement a system capable of providing “more robust and scalable solutions for implementing medical assistance technologies” (paragraph [0007] of the Braido reference).
Regarding claim 17, Shuai additionally discloses:
wherein the haptic feedback comprises at least one of a pulling force, a pushing force and a rotation (page 4154, see, for example, Figures 4 and 5)
Regarding claim 18, arguments analogous to claim 15 are applicable. The computerized system disclosed in Shuai (see, for example, pages 4152-4153) performing the functions described above in the rejection of claim 15 constitutes the system of claim 18.
Regarding claim 19, arguments analogous to claim 16 are applicable. The computerized system disclosed in Shuai (see, for example, pages 4152-4153) performing the functions described above in the rejection of claim 16 constitutes the system of claim 19.
Regarding claim 20, arguments analogous to claim 17 are applicable. The computerized system disclosed in Shuai (see, for example, pages 4152-4153) performing the functions described above in the rejection of claim 20 constitutes the system of claim 17.
Claim(s) 2, 4, 5, 9, 11, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Shuai in view of Braido in further view of VIST Carotid Intervention Procedural Training Module (hereinafter, “VIST”, copy provided, see PTO-892)
Regarding claim 2, the combination of Shuai and Braido discloses the method of the parent claim (claim 1).
The combination of Shuai and Braido does not explicitly disclose:
wherein said receiving the desired position comprises receiving a selection of the desired position amongst a predefined number of possible lesion positions
VIST discloses:
wherein said receiving the desired position comprises receiving a selection of the desired position amongst a predefined number of possible lesion positions (page 1, a variety of lesion placements are included in different scenarios)
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to combine the system of VIST with the combination of Shuai and Braido such that the system would have been configured to receive a selection of the desired position amongst a predefined number of possible lesion positions as described in VIST. The suggestion/motivation would have been in order to implement a system capable of “allow[ing] the learner to gain a thorough hands-on understanding of this high-risk procedure, without any risk to the patient (page 1 of the VIST reference).
Regarding claim 4, the combination of the combination of Shuai and Braido discloses the method of the parent claim (claim 1).
Shuai additionally discloses:
further comprising generating a patient description based on the desired position for the lesion and the desired value for the at least one property of the lesion and outputting the patient description (page 4156, the training tasks have associated descriptions describing the scenario)
Even assuming arguendo Shuai does not explicitly disclose:
further comprising generating a patient description based on the desired position for the lesion and the desired value for the at least one property of the lesion and outputting the patient description.
VIST discloses:
further comprising generating a patient description based on the desired position for the lesion and the desired value for the at least one property of the lesion and outputting the patient description (pages 1-2, a variety of lesion placements are included in different scenarios; the scenarios are all named- e.g., “endovascular aortic repair”)
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to combine the system of VIST with the combination of Shuai and Braido such that the system would have been configured to generate a patient description based on the desired position for the lesion and the desired value for the at least one property of the lesion and outputting the patient description as described in VIST. The suggestion/motivation would have been in order to implement a system capable of “allow[ing] the learner to gain a thorough hands-on understanding of this high-risk procedure, without any risk to the patient (page 1 of the VIST reference).’
Regarding claim 5, the combination of the combination of Shuai, Braido, and VIST discloses the method of the parent claim (claim 4).
The combination of Shuai and Braido does not explicitly disclose:
wherein said generating the patient description comprises accessing a database comprising a plurality of predefined patient descriptions each having associated thereto a respective lesion position and at least one respective property value and selecting the patient description amongst the plurality of predefined patient descriptions based on the desired position and the desired value.
VIST discloses:
wherein said generating the patient description comprises accessing a database comprising a plurality of predefined patient descriptions each having associated thereto a respective lesion position and at least one respective property value and selecting the patient description amongst the plurality of predefined patient descriptions based on the desired position and the desired value (pages 1-2, a variety of lesion placements are included in different scenarios; the scenarios are all named- e.g., “endovascular aortic repair”)
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to combine the system of VIST with the combination of Shuai and Braido such that the system would have been configured to generate the patient description comprising accessing a database comprising a plurality of predefined patient descriptions each having associated thereto a respective lesion position and at least one respective property value and selecting the patient description amongst the plurality of predefined patient descriptions based on the desired position and the desired value as described in VIST. The suggestion/motivation would have been in order to implement a system capable of “allow[ing] the learner to gain a thorough hands-on understanding of this high-risk procedure, without any risk to the patient (page 1 of the VIST reference).
Regarding claim 9, the combination of Shuai and Braido discloses the method of the parent claim (claim 8).
The combination of Shuai and Braido does not explicitly disclose:
wherein the processing unit being configured for allowing the trainer to select the position of the lesion amongst a predefined number of possible lesion positions.
VIST discloses:
wherein the processing unit being configured for allowing the trainer to select the position of the lesion amongst a predefined number of possible lesion positions (page 1, a variety of lesion placements are included in different scenarios)
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to combine the system of VIST with the combination of Shuai and Braido such that the system would have been configured to receive a selection of the desired position amongst a predefined number of possible lesion positions as described in VIST. The suggestion/motivation would have been in order to implement a system capable of “allow[ing] the learner to gain a thorough hands-on understanding of this high-risk procedure, without any risk to the patient (page 1 of the VIST reference).
Regarding claim 11, the combination of the combination of Shuai and Braido discloses the method of the parent claim (claim 8).
Shuai additionally discloses:
further comprising generating a patient description based on the desired position for the lesion and the desired value for the at least one property of the lesion and outputting the patient description (page 4156, the training tasks have associated descriptions describing the scenario)
Even assuming arguendo Shuai does not explicitly disclose:
further comprising generating a patient description based on the desired position for the lesion and the desired value for the at least one property of the lesion and outputting the patient description.
VIST discloses:
further comprising generating a patient description based on the desired position for the lesion and the desired value for the at least one property of the lesion and outputting the patient description (pages 1-2, a variety of lesion placements are included in different scenarios; the scenarios are all named- e.g., “endovascular aortic repair”)
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to combine the system of VIST with the combination of Shuai and Braido such that the system would have been configured to generate a patient description based on the desired position for the lesion and the desired value for the at least one property of the lesion and outputting the patient description as described in VIST. The suggestion/motivation would have been in order to implement a system capable of “allow[ing] the learner to gain a thorough hands-on understanding of this high-risk procedure, without any risk to the patient (page 1 of the VIST reference).’
Regarding claim 12, the combination of the combination of Shuai and Braido discloses the method of the parent claim (claim 11).
The combination of Shuai and Braido does not explicitly disclose:
wherein said generating the patient description comprises accessing a database comprising a plurality of predefined patient descriptions each having associated thereto a respective lesion position and at least one respective property value and selecting the patient description amongst the plurality of predefined patient descriptions based on the desired position and the desired value.
VIST discloses:
wherein said generating the patient description comprises accessing a database comprising a plurality of predefined patient descriptions each having associated thereto a respective lesion position and at least one respective property value and selecting the patient description amongst the plurality of predefined patient descriptions based on the desired position and the desired value (pages 1-2, a variety of lesion placements are included in different scenarios; the scenarios are all named- e.g., “endovascular aortic repair”)
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to combine the system of VIST with the combination of Shuai and Braido such that the system would have been configured to generate the patient description comprising accessing a database comprising a plurality of predefined patient descriptions each having associated thereto a respective lesion position and at least one respective property value and selecting the patient description amongst the plurality of predefined patient descriptions based on the desired position and the desired value as described in VIST. The suggestion/motivation would have been in order to implement a system capable of “allow[ing] the learner to gain a thorough hands-on understanding of this high-risk procedure, without any risk to the patient (page 1 of the VIST reference).
Claim(s) 13 is rejected under 35 U.S.C. 103 as being unpatentable over Shuai in view of Braido in further view of Ramphal et al. (U.S.P.G. Pub. No. 2004/0033477).
Regarding claim 13, the combination of the combination of Shuai and Braido discloses the method of the parent claim (claim 8).
Shuai additionally discloses wherein the processing unit is further configured for generating an electrocardiogram (ECG) graph and providing the ECG graph for display (see Figure 2, pages 4151, 4153, ECG data is generated and outputted to the model)
Even assuming arguendo that Shuai does not explicitly disclose:
providing the ECG graph for display
Ramphal et al. (U.S.P.G. Pub. No. 2004/0033477) discloses:
providing the ECG graph for display (paragraph [0050], the ECG is output on the simulator display)
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to combine the system of Ramphal with the combination of Shuai and Braido such that the system would have provided the ECG graph for display as described in Ramphal. The suggestion/motivation would have been in order to implement a system capable of “provid[ing] a more realistic environment for surgical training” (paragraph [0010] of the Ramphal reference).
Conclusion
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/JOHN R WALLACE/ Primary Examiner, Art Unit 2682