DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in Japan on 15 August 2025. It is noted, however, that applicant has not filed a certified copy of the JP2024-135553 application as required by 37 CFR 1.55.
Claim Objections
Claims 10-11 and 17 are objected to because of the following informalities: minor grammatical error. The claims should be amended as such:
10. […] upon determining the calculated length increases over time, calculate a current inclination direction of the ultrasound probe moved by the user as the target operation direction […].
11. […] upon determining the calculated length increases over time, calculate a current inclination direction of the ultrasound probe moved by the user as the target operation direction; and upon determining the calculated length decreases over time, calculate an opposite direction to the current inclination direction of the ultrasound probe moved by the user as the target operation direction.
17. […] upon determining that the calculated similarity decreases over time, calculate an opposite direction to the current rotation direction of the ultrasound probe moved by the user as the target operation direction.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 3-7, 14, and 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Li et al. (US 20240173007).
Regarding Claim 1, Li teaches an ultrasound diagnostic apparatus, ([0031] “system 200, arranged to perform ultrasound imaging”), comprising:
a) an ultrasound probe ([0031] “probe 210”); and
b) a processor, ([0033] “host 220 includes on or more processors, illustratively shown as processor 222”), configured to:
i) acquire a plurality of ultrasound images in which a measurement target organ of a subject is imaged by transmitting and receiving an ultrasound beam using the ultrasound probe ([0031] “The system 200 includes a probe 210 which transmits ultrasound into a subject (e.g., a patient's anatomy) and receives ultrasound echoes from which signals are generated and provided to the main processing portion (also referred to as scanner base or host) 220 for generating ultrasound images.”);
ii) calculate a feature value of the measurement target organ in each of the plurality of ultrasound images by performing image analysis on the plurality of ultrasound images (Claim 17 “selecting at least one image frame from subsequent series of images for obtaining the selected measurement; and automatically obtaining the selected measurement from the at least one image frame.”);
iii) calculate a target operation direction of the ultrasound probe to image an optimal measurement cross section suitable for measuring the measurement target organ based on a time series change in a plurality of feature values calculated in the plurality of ultrasound images (Fig. 6, [0036] “For example, if the selected measurement is VCW, the target view is parasternal long-axis (PLAX) view. Thus, when the system is progressing through the sub-workflow for obtaining the VCW measurement, the system is processing the live images to determine if they represent a PLAX view. If the selected measurement is RVol or RF, the target view is apical 4-chamber (A4C) view, and thus if the system is executing the sub-workflow for obtaining the RVol or RF measurements, the system is processing the live images to determine if they represent a A4C view. […] the system optionally provides guidance to the user for positioning the probe on the subject's body for acquiring the target view” and [0037] “the system (e.g., scanner 200) may additionally provide user guidance for probe adjustments in the target view to ensure the relevant feature(s) of mitral valve regurgitation is properly visualized. For example, when the selected measurement is VCW, the system may process the live images that capture a PLAX view to determine whether the MR jet is fully visualized in the images. If the MR jet is not fully visualized, the system may provide guidance, such as on the display, for fine-tuning positional adjustments (e.g., translation and/or angulation of the probe) while maintaining the probe in the acoustic window for capturing a PLAX view. […] the system (e.g., scanner 200) may either provide guidance to the user for manually tuning the acquisition settings to settings estimated by the processor as suitable or optimal for the selected measurement”); and
iv) notify a user of the target operation direction ([0031] “the user interface 230 includes a primary display which may be used to display images and/or user guidance.”).
Regarding Claim 3, Li teaches all limitations of Claim 1, as discussed above. Furthermore, Li teaches wherein the processor is configured to
a) select one feature value among the plurality of calculated feature values as an optimal feature value corresponding to the optimal measurement cross section, (Claim 1 “wherein the GUI is configured to enable a user to make a selection of […] a measurement from a plurality of predetermined measurements consisting of vena contracta width (VCW), regurgitant volume (RVol), regurgitant fraction (RF) and effective regurgitant orifice area (EROA)”), and
b) notify the user of the selected optimal feature value ([0060] “for the VCW measurement, the processor selects the frame from the systolic phase sequence that shows the largest VCW. Image segmentation can be used, as previously discussed to identify the components of the jet and thus identify the vena contracta in each frame. The processor then comparatively evaluates the size of the vena contracta from each frame to find the frame with the largest VCW” and [0069] “The processor 1100 may include a controller 1114, which may control input to the processor 1100 from other processors and/or components included in a system (e.g., control panel 252 and scan converter 230 shown in FIG. 2) and/or outputs from the processor 1100 to other processors and/or components included in the system (e.g., display 238”).
Regarding Claim 4, Li teaches all limitations of Claim 3, as discussed above. Furthermore, Li teaches wherein the processor is configured to notify the user to acquire the plurality of ultrasound images during the acquisition of the plurality of ultrasound images while moving the ultrasound probe ([0036] “the system optionally provides guidance to the user for positioning the probe on the subject's body for acquiring the target view. For example, the system may display a body marker or other suitable graphic showing simplified illustration of the body and showing the placement of the probe in relation to the human body. […]the system may additionally or alternatively process the live images to determine navigation instructions for guiding the user's placement of the probe. Any suitable technique for optionally providing guidance to a user to properly position the probe on the subject's body to acquiring the target view may be used without departing from the scope of the present disclosure.”).
Regarding Claim 5, Li teaches all limitations of Claim 3, as discussed above. Furthermore, Li teaches a feature value memory configured to store the optimal feature value linked to a specific identifier associated with the subject ([0045] “Local memory 542 may store data generated by the system 500 including ultrasound images, executable instructions, imaging parameters, training data sets, or any other information necessary for the operation of the system 500.”).
Regarding Claim 6, Li teaches all limitations of Claim 3, as discussed above. Furthermore, Li teaches wherein the measurement target organ to be analyzed is a heart ([0001] “The present disclosure relates generally to ultrasound imaging and, in particular, to a method and system that provides user guidance and automated imaging setting selection for improved mitral regurgitation evaluation.”).
Regarding Claim 7, Li teaches all limitations of Claim 4, as discussed above. Furthermore, Li teaches wherein the measurement target organ is a heart ([0001] “The present disclosure relates generally to ultrasound imaging and, in particular, to a method and system that provides user guidance and automated imaging setting selection for improved mitral regurgitation evaluation.”).
Regarding Claim 8, Li teaches all limitations of Claim 5, as discussed above. Furthermore, Li teaches wherein the measurement target organ is a heart ([0001] “The present disclosure relates generally to ultrasound imaging and, in particular, to a method and system that provides user guidance and automated imaging setting selection for improved mitral regurgitation evaluation.”).
Regarding Claim 14, Li teaches all limitations of Claim 6, as discussed above. Furthermore, Li teaches wherein the plurality of feature values vary over time due to pulsation of the heart to have a plurality of maximum values and a plurality of minimum values, ([0028] “The largest VC can occur at different points in the cardiac cycle depending on the underlying etiology of MR.”), and the processor is configured to calculate the target operation direction based on a timeseries change in the plurality of maximum values or the plurality of minimum values (Fig. 3 and [0037] “the system (e.g., scanner 200) may either provide guidance to the user for manually tuning the acquisition settings to settings estimated by the processor as suitable or optimal for the selected measurement, or the system may automatically apply the processor-estimated optimal settings. The processor-estimated optimal settings may be different for each MR quantification measurement, and they may be also referred to, for simplicity, as MR-specific settings.”).
Regarding Claim 18, Li teaches all limitations of Claim 1, as discussed above. Furthermore, Li teaches
a) a position and posture sensor configured to detect a position and an inclination angle of the ultrasound probe, ([0039] “the probe 512 may include one or more sensors 570 associated with a position or motion tracking system. In some examples, the sensor 570 is provided by an IMU which may include an accelerometer, a gyroscope, a magnetometer, and/or a combination thereof. The IMU may provide data relating to the velocity, acceleration, rotation, angular rate, and/or orientation of the probe 512. In some embodiments the sensor 570 includes an EM sensor which is associated with an EM tracking system that tracks the position of the sensor 570 on the probe. In some embodiments the one or more sensors 570 may be a combination of motion and position tracking sensor(s). Any data provided by or responsive to sensor 570 may be referred to collectively as probe position or motion data depending on the type of sensor used.”),
b) wherein the processor is configured to calculate the target operation direction incorporating the position and the inclination angle of the ultrasound probe detected by the position and posture sensor (Figs. 3 and 5 and [0039] “System 200 and process 300 may be implemented by an ultrasound imaging system having components as shown and further described with reference to FIG. 5.”).
Regarding Claim 19, Li teaches all limitations of Claim 1, as discussed above. Furthermore, Li teaches a monitor, wherein the processor is configured to notify the user of the target operation direction by visually presenting the target operation direction on the monitor ([0031] “The system 200 also includes a user interface 230, which includes one or more displays for displaying the ultrasound images and/or one or more user controls and/or instructions (e.g., GUI elements) associated with performing an MR exam.”).
Regarding Claim 20, Li teaches a control method for an ultrasound diagnostic apparatus, the control method comprising:
a) acquiring a plurality of frames of ultrasound images in which a measurement target organ of a subject is imaged by transmitting and receiving an ultrasound beam using an ultrasound probe ([0031] “The system 200 includes a probe 210 which transmits ultrasound into a subject (e.g., a patient's anatomy) and receives ultrasound echoes from which signals are generated and provided to the main processing portion (also referred to as scanner base or host) 220 for generating ultrasound images.”);
b) calculating feature values of the measurement target organ from each of the plurality of frames of ultrasound images through image analysis (Claim 17 “selecting at least one image frame from subsequent series of images for obtaining the selected measurement; and automatically obtaining the selected measurement from the at least one image frame.”);
c) calculating a target operation direction of the ultrasound probe to capture an optimal measurement cross section suitable for measuring the measurement target organ based on time- series variations in the calculated feature values (Fig. 6, [0036] “For example, if the selected measurement is VCW, the target view is parasternal long-axis (PLAX) view. Thus, when the system is progressing through the sub-workflow for obtaining the VCW measurement, the system is processing the live images to determine if they represent a PLAX view. If the selected measurement is RVol or RF, the target view is apical 4-chamber (A4C) view, and thus if the system is executing the sub-workflow for obtaining the RVol or RF measurements, the system is processing the live images to determine if they represent a A4C view. […] the system optionally provides guidance to the user for positioning the probe on the subject's body for acquiring the target view” and [0037] “the system (e.g., scanner 200) may additionally provide user guidance for probe adjustments in the target view to ensure the relevant feature(s) of mitral valve regurgitation is properly visualized. For example, when the selected measurement is VCW, the system may process the live images that capture a PLAX view to determine whether the MR jet is fully visualized in the images. If the MR jet is not fully visualized, the system may provide guidance, such as on the display, for fine-tuning positional adjustments (e.g., translation and/or angulation of the probe) while maintaining the probe in the acoustic window for capturing a PLAX view. […] the system (e.g., scanner 200) may either provide guidance to the user for manually tuning the acquisition settings to settings estimated by the processor as suitable or optimal for the selected measurement”); and
d) notifying a user of the calculated target operation direction ([0031] “the user interface 230 includes a primary display which may be used to display images and/or user guidance.”).
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 2 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (US 20240173007) in view of Hong et al. (US 20240156430).
Regarding Claim 2, Li teaches all limitations of Claim 1, as discussed above. However, Li does not explicitly teach wherein the processor is configured to initiate calculating the target operation direction with a trigger of an elapse of a predetermined time after starting the acquisition of the ultrasound image.
In an analogous heart rhythm determination using machine learning field of endeavor, Hong teaches an ultrasound diagnostic apparatus, (Claim 1 “system for ultrasound imaging”), wherein the processor, ([0097] “at least one processor 210”), is configured to initiate calculating the target operation direction with a trigger of an elapse of a predetermined time after starting the acquisition of the ultrasound image ([0124] “use a threshold to select a single movement most likely to overcome an image quality deficiency, require that such a movement meet a threshold amount or value to be passed to the user, not provide other movement possibilities to the user simultaneously, and apply a time filter (e.g., a minimum time duration) or number filter (e.g., a minimum number of images)” and Fig. 2A).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify the processor with the function of Hong because the modification allows for providing user feedback that is smooth, logical, and not distracting or confusing, and ensures a defined movement of a target organ has been identified and is persisting, as taught by Hong in [0124].
Regarding Claim 17, Li teaches all limitations of Claim 6, as discussed above. Furthermore, Hong teaches wherein the processor is configured to:
a) calculate a similarity between the plurality of ultrasound images and a reference image corresponding to the optimal measurement cross section as each of the plurality of feature values, ([0126] “This method may arrive at this single instruction by using an image processing or machine learning model that compares the current image to a desired image.”), and
b) upon determining that the calculated similarity increases over time, calculate a current rotation direction of the ultrasound probe moved by the user as the target operation direction (Figs. 2A-2B and [0125] “The probe movement instruction that has been determined to best most appropriate to improve the image is that the user should rotate the probe counter clockwise slowly.”); and
c) upon determining that the calculated similarity decreases over time, calculate an opposite direction to the current rotation direction of the ultrasound probe by the user as the target operation direction (Figs. 2A-2B and [0125] “The probe movement instruction that has been determined to best most appropriate to improve the image is that the user should rotate the probe counter clockwise slowly.”).
Claims 9-13 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (US 20240173007) in view of Bharat et al. (US 20230066948) and Miyaki et al. (US 20220330921).
Regarding Claim 9, Li teaches all limitations of Claim 1, as discussed above. However, Li does not explicitly teach wherein the processor is configured to: calculate a depth of an upper end part of a cardiac cavity in the plurality of ultrasound images as each of the plurality of feature values; upon determining that the calculated depth decreases over time, calculate a current movement direction of the ultrasound probe moved by the user along a body surface of the subject as the target operation direction; and upon determining that the calculated depth increases over time, calculate an opposite direction to the current movement direction of the ultrasound probe moved by the user along the body surface of the subject as the target operation direction.
In an analogous ultrasound guidance method field of endeavor, Bharat teaches an ultrasound diagnostic apparatus, ([0001] “system for assisting a user in positioning an ultrasound probe of an ultrasound imaging system.”), wherein the processor, ([0065] “Examples in accordance with a further aspect of the invention provide a computer program product comprising code means configured, when run on a processor, to cause the processor to perform the method in accordance with any of the embodiments or examples outlined above or described herein, or in accordance with any claim of the present application.”), is configured to:
a) calculate a current movement direction of the ultrasound probe moved by the user along a body surface of the subject as the target operation direction ([0134] “Based on the feedback, the user is able to ascertain whether their current movement path for the probe is improving quality results (and so taking them closer to an optimum imaging position), or is deteriorating results (and so taking them further from an optimum position). Based on this, the user can adjust or adapt the movement of the probe to try to improve the quality results, and move toward an optimum position” and [0155] “the assessment procedure is configured to generate feedback guidance 18 based on the assessment of the series of images, the feedback guidance indicative of a suggested or proposed movement of the probe for improving the quality rating score of ultrasound data, i.e. for moving to a new location with a more optimum imaging view.”); and
b) calculate an opposite direction to the current movement direction of the ultrasound probe moved by the user along the body surface of the subject as the target operation direction ([0134] “Based on the feedback, the user is able to ascertain whether their current movement path for the probe is improving quality results (and so taking them closer to an optimum imaging position), or is deteriorating results (and so taking them further from an optimum position). Based on this, the user can adjust or adapt the movement of the probe to try to improve the quality results, and move toward an optimum position” and [0155] “the assessment procedure is configured to generate feedback guidance 18 based on the assessment of the series of images, the feedback guidance indicative of a suggested or proposed movement of the probe for improving the quality rating score of ultrasound data, i.e. for moving to a new location with a more optimum imaging view.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify the processor with the function of Bharat because the improves the quality of the acquired images, as taught by Bharat in Abstract.
However, Li modified by Bharat does not explicitly teach wherein the processor is configured to: calculate a depth of an upper end part of a cardiac cavity in the plurality of ultrasound images as each of the plurality of feature values; determining that the calculated depth decreases over time; and determining that the calculated depth increases over time.
In an analogous medical imaging field of endeavor, Miyaki teaches an ultrasound diagnostic apparatus, wherein the processor is configured to:
a) calculate a depth of an upper end part of a cardiac cavity in the plurality of ultrasound images as each of the plurality of feature values ([0064] “the calculating function 107b is configured to measure […] a left atrial appendage depth 312 indicated in the cross-section A image 310.”);
b) determining that the calculated depth decreases over time (Fig. 4, where the measurement value display region 38 indicates a change in the calculated measurement over time (frame numbers) and [0060] “the shape estimation model 240 is also updated in a real-time manner in conjunction with the update.”); and
c) determining that the calculated depth increases over time (Fig. 4, where the measurement value display region 38 indicates a change in the calculated measurement over time (frame numbers) and [0060] “the shape estimation model 240 is also updated in a real-time manner in conjunction with the update.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify the processor with the function of Miyaki because the modification allows for accurate measurements of target anatomy prior or during a procedure.
Regarding Claim 10, the modified apparatus of Li teaches all limitations of Claim 9, as discussed above. Furthermore, Bharat teaches wherein the processor is configured to:
a) calculate a current inclination direction of the ultrasound probe as the target operation direction ([0134] “Based on the feedback, the user is able to ascertain whether their current movement path for the probe is improving quality results (and so taking them closer to an optimum imaging position), or is deteriorating results (and so taking them further from an optimum position). Based on this, the user can adjust or adapt the movement of the probe to try to improve the quality results, and move toward an optimum position” and [0155] “the assessment procedure is configured to generate feedback guidance 18 based on the assessment of the series of images, the feedback guidance indicative of a suggested or proposed movement of the probe for improving the quality rating score of ultrasound data, i.e. for moving to a new location with a more optimum imaging view.”); and
b) calculate an opposite direction to the current inclination direction of the ultrasound probe moved by the user as the target operation direction ([0134] “Based on the feedback, the user is able to ascertain whether their current movement path for the probe is improving quality results (and so taking them closer to an optimum imaging position), or is deteriorating results (and so taking them further from an optimum position). Based on this, the user can adjust or adapt the movement of the probe to try to improve the quality results, and move toward an optimum position” and [0155] “the assessment procedure is configured to generate feedback guidance 18 based on the assessment of the series of images, the feedback guidance indicative of a suggested or proposed movement of the probe for improving the quality rating score of ultrasound data, i.e. for moving to a new location with a more optimum imaging view.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify the processor with the function of Bharat because the improves the quality of the acquired images, as taught by Bharat in Abstract.
Furthermore, Miyaki teaches wherein the processor is configured to:
a) calculate a length of a major axis of a cardiac cavity as each of the plurality of feature values ([0064] “the calculating function 107b is configured to measure a left atrial appendage distance 311 […] indicated in the cross-section A image 310.”);
b) determining the calculated length increases over time (Fig. 4, where the measurement value display region 38 indicates a change in the calculated measurement over time (frame numbers) and [0060] “the shape estimation model 240 is also updated in a real-time manner in conjunction with the update.”); and
c) determining the calculated length decreases over time (Fig. 4, where the measurement value display region 38 indicates a change in the calculated measurement over time (frame numbers) and [0060] “the shape estimation model 240 is also updated in a real-time manner in conjunction with the update.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify the processor with the function of Miyaki because the modification allows for accurate measurements of target anatomy prior or during a procedure.
Regarding Claim 11, the modified apparatus of Li teaches all limitations of Claim 9, as discussed above. Furthermore, Bharat teaches wherein the processor is configured to:
a) calculate a current inclination direction of the ultrasound probe by the user as the target operation direction ([0134] “Based on the feedback, the user is able to ascertain whether their current movement path for the probe is improving quality results (and so taking them closer to an optimum imaging position), or is deteriorating results (and so taking them further from an optimum position). Based on this, the user can adjust or adapt the movement of the probe to try to improve the quality results, and move toward an optimum position” and [0155] “the assessment procedure is configured to generate feedback guidance 18 based on the assessment of the series of images, the feedback guidance indicative of a suggested or proposed movement of the probe for improving the quality rating score of ultrasound data, i.e. for moving to a new location with a more optimum imaging view.”); and
b) calculate an opposite direction to the current inclination direction of the ultrasound probe moved by the user as the target operation direction ([0134] “Based on the feedback, the user is able to ascertain whether their current movement path for the probe is improving quality results (and so taking them closer to an optimum imaging position), or is deteriorating results (and so taking them further from an optimum position). Based on this, the user can adjust or adapt the movement of the probe to try to improve the quality results, and move toward an optimum position” and [0155] “the assessment procedure is configured to generate feedback guidance 18 based on the assessment of the series of images, the feedback guidance indicative of a suggested or proposed movement of the probe for improving the quality rating score of ultrasound data, i.e. for moving to a new location with a more optimum imaging view.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify the processor with the function of Bharat because the improves the quality of the acquired images, as taught by Bharat in Abstract.
Furthermore, Miyaki teaches wherein the processor is configured to:
a) calculate a length of a major axis of a cardiac cavity as each of the plurality of feature values ([0064] “the calculating function 107b is configured to measure a left atrial appendage distance 311 […] indicated in the cross-section A image 310.”);
b) determining the calculated length increases over time (Fig. 4, where the measurement value display region 38 indicates a change in the calculated measurement over time (frame numbers) and [0060] “the shape estimation model 240 is also updated in a real-time manner in conjunction with the update.”); and
c) determining the calculated length decreases over time (Fig. 4, where the measurement value display region 38 indicates a change in the calculated measurement over time (frame numbers) and [0060] “the shape estimation model 240 is also updated in a real-time manner in conjunction with the update.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify the processor with the function of Miyaki because the modification allows for accurate measurements of target anatomy prior or during a procedure.
Regarding Claim 12, Li teaches all limitations of Claim 6, as discussed above. Furthermore, Bharat teaches wherein the processor is configured to:
a) calculate a current inclination direction of the ultrasound probe moved by the user as the target operation direction ([0134] “Based on the feedback, the user is able to ascertain whether their current movement path for the probe is improving quality results (and so taking them closer to an optimum imaging position), or is deteriorating results (and so taking them further from an optimum position). Based on this, the user can adjust or adapt the movement of the probe to try to improve the quality results, and move toward an optimum position” and [0155] “the assessment procedure is configured to generate feedback guidance 18 based on the assessment of the series of images, the feedback guidance indicative of a suggested or proposed movement of the probe for improving the quality rating score of ultrasound data, i.e. for moving to a new location with a more optimum imaging view.”); and
b) calculate an opposite direction to the current inclination direction of the ultrasound probe moved by the user as the target operation direction ([0134] “Based on the feedback, the user is able to ascertain whether their current movement path for the probe is improving quality results (and so taking them closer to an optimum imaging position), or is deteriorating results (and so taking them further from an optimum position). Based on this, the user can adjust or adapt the movement of the probe to try to improve the quality results, and move toward an optimum position” and [0155] “the assessment procedure is configured to generate feedback guidance 18 based on the assessment of the series of images, the feedback guidance indicative of a suggested or proposed movement of the probe for improving the quality rating score of ultrasound data, i.e. for moving to a new location with a more optimum imaging view.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify the processor with the function of Bharat because the improves the quality of the acquired images, as taught by Bharat in Abstract.
Furthermore, Miyaki teaches wherein the processor is configured to:
a) calculate an area of a cardiac cavity as each of the plurality of feature values ([0064] “the calculating function 107b is configured to measure […] the area of the left atrial appendage entrance part indicated in the cross-section C image 330.”);
b) determining the calculated area increases over time (Fig. 4, where the measurement value display region 38 indicates a change in the calculated measurement over time (frame numbers) and [0060] “the shape estimation model 240 is also updated in a real-time manner in conjunction with the update.”); and
c) determining the calculated area decreases over time (Fig. 4, where the measurement value display region 38 indicates a change in the calculated measurement over time (frame numbers) and [0060] “the shape estimation model 240 is also updated in a real-time manner in conjunction with the update.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify the processor with the function of Miyaki because the modification allows for accurate measurements of target anatomy prior or during a procedure.
Regarding Claim 13, the modified apparatus of Li teaches all limitations of Claim 9, as discussed above. Furthermore, Bharat teaches wherein the processor is configured to:
a) calculate a current inclination direction of the ultrasound probe moved by the user as the target operation direction ([0134] “Based on the feedback, the user is able to ascertain whether their current movement path for the probe is improving quality results (and so taking them closer to an optimum imaging position), or is deteriorating results (and so taking them further from an optimum position). Based on this, the user can adjust or adapt the movement of the probe to try to improve the quality results, and move toward an optimum position” and [0155] “the assessment procedure is configured to generate feedback guidance 18 based on the assessment of the series of images, the feedback guidance indicative of a suggested or proposed movement of the probe for improving the quality rating score of ultrasound data, i.e. for moving to a new location with a more optimum imaging view.”); and
b) calculate an opposite direction to the current inclination direction of the ultrasound probe moved by the user as the target operation direction ([0134] “Based on the feedback, the user is able to ascertain whether their current movement path for the probe is improving quality results (and so taking them closer to an optimum imaging position), or is deteriorating results (and so taking them further from an optimum position). Based on this, the user can adjust or adapt the movement of the probe to try to improve the quality results, and move toward an optimum position” and [0155] “the assessment procedure is configured to generate feedback guidance 18 based on the assessment of the series of images, the feedback guidance indicative of a suggested or proposed movement of the probe for improving the quality rating score of ultrasound data, i.e. for moving to a new location with a more optimum imaging view.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify the processor with the function of Bharat because the improves the quality of the acquired images, as taught by Bharat in Abstract.
Furthermore, Miyaki teaches wherein the processor is configured to:
a) calculate an area of a cardiac cavity as each of the plurality of feature values ([0064] “the calculating function 107b is configured to measure […] the area of the left atrial appendage entrance part indicated in the cross-section C image 330.”);
b) determining the calculated area increases over time (Fig. 4, where the measurement value display region 38 indicates a change in the calculated measurement over time (frame numbers) and [0060] “the shape estimation model 240 is also updated in a real-time manner in conjunction with the update.”); and
c) determining the calculated area decreases over time (Fig. 4, where the measurement value display region 38 indicates a change in the calculated measurement over time (frame numbers) and [0060] “the shape estimation model 240 is also updated in a real-time manner in conjunction with the update.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify the processor with the function of Miyaki because the modification allows for accurate measurements of target anatomy prior or during a procedure.
Regarding Claim 15, the modified apparatus of Li teaches all limitations of Claim 9, as discussed above. Furthermore, Li teaches wherein the plurality of feature values vary over time due to pulsation of the heart to have a plurality of maximum values and a plurality of minimum values, ([0028] “The largest VC can occur at different points in the cardiac cycle depending on the underlying etiology of MR.”), and the processor is configured to calculate the target operation direction based on a timeseries change in the plurality of maximum values or the plurality of minimum values (Fig. 3 and [0037] “the system (e.g., scanner 200) may either provide guidance to the user for manually tuning the acquisition settings to settings estimated by the processor as suitable or optimal for the selected measurement, or the system may automatically apply the processor-estimated optimal settings. The processor-estimated optimal settings may be different for each MR quantification measurement, and they may be also referred to, for simplicity, as MR-specific settings.”).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (US 20240173007) in view of Hong et al. (US 20240156430) and Miyaki et al. (US 20220330921).
Regarding Claim 16, Li teaches all limitations of Claim 6, as discussed above. Furthermore, Hong teaches wherein the processor is configured to: acquire the plurality of ultrasound images sequentially for an apical four-chamber cross section and an apical two-chamber cross section of the heart ([0118] “the anatomical views can include […] apical four-chamber, […] apical two-chamber”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify the processor with the function of Hong because the modification ensures that the image quality is sufficient during the imaging procedure to properly image the region of interest.
Furthermore, Miyaki teaches
b) calculate feature values for a first cross section, corresponding to either the apical four- chamber cross section or the apical two-chamber cross section, (as taught by Hong above), which is imaged first (Fig. 3, Claim 1 “on a basis of information about a size of the target site obtained by using the three-dimensional model,” and [0058] “cross-sections 27a, 27b, and 27c indicate the positions of, and the positional relationships among, the cross-section A image 210, the cross-section B image 220, and the cross-section C image 230 in the volume data.”);
c) select the optimal feature value from the calculated feature values for the first cross section ([0093] “the calculating function 107b included in the ultrasound diagnosis apparatus 100 according to the present embodiment is configured to calculate the information about the size including at least one selected from among the maximum diameter, the minimum diameter, the mean diameter, the perimeter length, and the area of the left atrial appendage entrance part in the shape estimation model”); and
d) notify the user of the selected optimal feature value for the first cross section while acquiring ultrasound images for a second cross section, which is different from the first cross section (Fig. 3 and [0057] “cross-section navigation information display region 27, a measurement value display region 28”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify the processor with the function of Miyaki because the modification allows for accurate measurements of target anatomy prior or during a procedure.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIA CHRISTINA TALTY whose telephone number is (571)272-8022. The examiner can normally be reached M-Th 8:30-5:30 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mike Carey can be reached at (571) 270-7235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MARIA CHRISTINA TALTY/Examiner, Art Unit 3797
/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795
Prosecution Insights