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 .
Information Disclosure Statement
The information disclosure statements (IDS) were submitted on 3/28/2025 and 4/15/2025. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-6, 9, 11, 13-18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Nair et al. (U.S. Pub. No. 20200129147) hereinafter Nair, in view of Grady et al. (U.S. Pub. No. 20150089337) hereinafter Grady.
Regarding claim 1, primary reference Nair teaches:
An image diagnostic system (abstract) comprising:
a catheter insertable into a blood vessel ([0009], ultrasound imaging catheter; [0036], catheter);
a memory that stores a program ([0043], memory; [0046]; [0086]);
a display ([0009]-[0013], display; [0043]-[0049], display device monitor 108); and
a processor configured to execute the program ([0043]-[0046], processor) to:
control the catheter to acquire a tomographic image of a blood vessel ([0060], tomographic image is generated and displayed on the screen of a blood vessel; [0061]-[0070]; [0071]-[0072], image generation),
determine a first region corresponding to a main trunk of the blood vessel and a second region corresponding to a side branch of the blood vessel in the acquired image, and determine whether the first and second regions are connected to each other ([0060], “Visible in each instance 610a, 610b, and 610c is the vessel lumen 120 and the side branch 515. Where side branches occur in a tomographic image (e.g., an IVUS image), determining the lumen boundary of the vessel becomes difficult, as for any given frame it may be a matter of individual clinical preference whether the side branch is considered part of the main vessel or not.” A user determines in the selection screen whether the regions are connected to another or not for purposes of contour generation; [0061]-[0067], figures 6-7 show the main trunk and side branch of the vessels in an acquired image and determination whether contour is to be selected for both; [0069]-[0083]),
upon determining that the first and second regions are connected to each other, determine a first contour line of the first region in the acquired image ([0060], “Visible in each instance 610a, 610b, and 610c is the vessel lumen 120 and the side branch 515. Where side branches occur in a tomographic image (e.g., an IVUS image), determining the lumen boundary of the vessel becomes difficult, as for any given frame it may be a matter of individual clinical preference whether the side branch is considered part of the main vessel or not.” A user determines in the selection screen whether the regions are connected to another or not for purposes of contour generation, and the system generates a first contour line that encompasses the main trunk of the vessel corresponding to the first contour line as claimed; [0061]-[0067], figures 6-7 show the main trunk and side branch of the vessels in an acquired image and determination whether contour is to be selected for both. The main trunk contour line forms the first contour line of the first region; [0069]-[0083]),
determine a second contour line of the second region in the acquired image based on the first contour line ([0060], “Visible in each instance 610a, 610b, and 610c is the vessel lumen 120 and the side branch 515. Where side branches occur in a tomographic image (e.g., an IVUS image), determining the lumen boundary of the vessel becomes difficult, as for any given frame it may be a matter of individual clinical preference whether the side branch is considered part of the main vessel or not.” A user determines in the selection screen whether the regions are connected to another or not for purposes of contour generation, and the system generates a second contour line that encompasses the side branch of the vessel corresponding to the second contour line as claimed; [0061]-[0067], figures 6-7 show the main trunk and side branch of the vessels in an acquired image and determination whether contour is to be selected for both. The side branch contour line forms the second contour line of the second region; [0069]-[0083]), and
Primary reference Nair fails to teach:
control the display to display the first and second contour lines on the acquired image using different display modes
However, the analogous art of Grady of a system and method for displaying anatomical images to a user (abstract) teaches:
control the display to display the first and second contour lines on the acquired image using different display modes ([0192], “To better separate out distinctions between sections, a selected section may have a different contour indicator from other sections' contours. As discussed previously, lumen task 700 may include different sets of contours for the parent vessel and adjoining branch vessels. Thus, various contours may be displayed on the MPRs 723 in different colors.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the contour line generation and display system of Nair to incorporate the display of first and second lines in different modes as taught by Grady because different display modes enable rapid differentiation between contour boundaries by a user, leading to improved and more efficient visualization of anatomical regions of interest (Grady, [0192]). This leads to improved clinical outcomes.
Regarding claim 2, the combined references of Nair and Grady teach all of the limitations of claim 1. Primary reference Nair further teaches:
wherein the processor executes the program to input the acquired image into a computer model to generate information indicating the first and second regions, the computer model having been trained with a plurality of tomographic images of blood vessels and a plurality of information each specifying a region corresponding to a main trunk of the blood vessel and a region corresponding to a side branch of the blood vessel in a corresponding one of the tomographic images ([0061]-[0065], algorithm including a trained machine learning algorithm is utilized to determine contours including the lumen boundaries with bifurcations and side branches in the observed images; [0073]-[0075]).
Regarding claim 3, the combined references of Nair and Grady teach all of the limitations of claim 1. Primary reference Nair further teaches:
wherein the processor executes the program to, after determining the first contour line and before determining the second contour line:
determine a boundary portion of the second region that is adjacent to the first region, and correct a shape of the boundary portion so that the boundary portion aligns with the first contour line (0060], “Visible in each instance 610a, 610b, and 610c is the vessel lumen 120 and the side branch 515. Where side branches occur in a tomographic image (e.g., an IVUS image), determining the lumen boundary of the vessel becomes difficult, as for any given frame it may be a matter of individual clinical preference whether the side branch is considered part of the main vessel or not.” A user determines in the selection screen whether the regions are connected to another or not for purposes of contour generation, and the system generates a second contour line that encompasses the side branch of the vessel corresponding to the second contour line and forms an alignment of both lines as in figure 6, 610A with the combined contours of main and side branch vessels; [0061]-[0067], figures 6-7 show the main trunk and side branch of the vessels in an acquired image and determination whether contour is to be selected for both. The side branch contour line forms the second contour line of the second region; [0069]-[0083]).
Regarding claim 4, the combined references of Nair and Grady teach all of the limitations of claim 3. Primary reference Nair further teaches:
wherein the processor corrects the shape of the boundary portion by merging a region located between the first and second regions into the boundary portion (0060], “Visible in each instance 610a, 610b, and 610c is the vessel lumen 120 and the side branch 515. Where side branches occur in a tomographic image (e.g., an IVUS image), determining the lumen boundary of the vessel becomes difficult, as for any given frame it may be a matter of individual clinical preference whether the side branch is considered part of the main vessel or not.” A user determines in the selection screen whether the regions are connected to another or not for purposes of contour generation, and the system generates a second contour line that encompasses the side branch of the vessel corresponding to the second contour line and forms an alignment of both lines as in figure 6, 610A with the combined contours of main and side branch vessels merged; [0061]-[0067], figures 6-7 show the main trunk and side branch of the vessels in an acquired image and determination whether contour is to be selected for both. The side branch contour line forms the second contour line of the second region; [0069]-[0083]).
Regarding claim 5, the combined references of Nair and Grady teach all of the limitations of claim 3. Primary reference Nair further teaches:
wherein the processor executes the program to:
determine a plurality of points on a peripheral edge of the second region ([0069] and [0076]-[0077], as depicted in figure 7, plurality of points are selected and connected in the region of the main trunk vessel, and when included in the side branch (not pictured) forms a second line to form the second contour line connected the main trunk and the side branch vessel),
connect one or more of the points located in a portion of the second region other than the boundary portion to form a first line ([0069] and [0076]-[0077], as depicted in figure 7, plurality of points are selected and connected in the region of the main trunk vessel, and when included in the side branch (not pictured) forms a second line to form the second contour line connected the main trunk and the side branch vessel),
connect one or more of the points located in the boundary portion to form a second line, and combine the first and second lines to form the second contour line ([0069] and [0076]-[0077], as depicted in figure 7, plurality of points are selected and connected in the region of the main trunk vessel, and when included in the side branch (not pictured) forms a second line to form the second contour line connected the main trunk and the side branch vessel).
Regarding claim 6, the combined references of Nair and Grady teach all of the limitations of claim 1. Primary reference Nair further teaches:
wherein the acquired image includes a visual field area in which the blood vessel is imaged and a non-visual field area outside the visual field area, the processor executes the program to determine whether a portion of the second region abuts a boundary between the visual field area and the non-visual field area, and the second contour line is determined based on the boundary (0060], “Visible in each instance 610a, 610b, and 610c is the vessel lumen 120 and the side branch 515. Where side branches occur in a tomographic image (e.g., an IVUS image), determining the lumen boundary of the vessel becomes difficult, as for any given frame it may be a matter of individual clinical preference whether the side branch is considered part of the main vessel or not.” As the imaging is a catheter based pullback intravascular image, the non-visual field area forms the regions outside of the vessel regions, wherein the contour lines delineate vessel walls from the non-visual field areas and form a boundary; [0061]-[0067], figures 6-7 show the main trunk and side branch of the vessels in an acquired image and determination whether contour is to be selected for both. The side branch contour line forms the second contour line of the second region; [0069]-[0083]).
Regarding claim 9, the combined references of Nair and Grady teach all of the limitations of claim 1. Primary reference Nair further teaches:
wherein the processor executes the program to calculate an area or a diameter of the first and second regions using the first and second contour lines ([0056], diameter and area; [0057] diameter or lumen cross sectional area; [0061]; [0075]-[0076]; [0080]).
Regarding claim 11, the combined references of Nair and Grady teach all of the limitations of claim 1. Primary reference Nair further fails to teach:
wherein the first and second contour lines are displayed using lines of different styles, widths, or colors
However, the analogous art of Grady of a system and method for displaying anatomical images to a user (abstract) teaches:
wherein the first and second contour lines are displayed using lines of different styles, widths, or colors ([0192], “To better separate out distinctions between sections, a selected section may have a different contour indicator from other sections' contours. As discussed previously, lumen task 700 may include different sets of contours for the parent vessel and adjoining branch vessels. Thus, various contours may be displayed on the MPRs 723 in different colors.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the contour line generation and display system of Nair and Grady to incorporate the display of first and second lines in different colors as taught by Grady because different display modes enable rapid differentiation between contour boundaries by a user, leading to improved and more efficient visualization of anatomical regions of interest (Grady, [0192]). This leads to improved clinical outcomes.
Regarding claim 13, primary reference Nair teaches:
An image diagnostic method (abstract) comprising:
acquiring a tomographic image of a blood vessel ([0060], tomographic image is generated and displayed on the screen of a blood vessel; [0061]-[0070]; [0071]-[0072], image generation);
determining a first region corresponding to a main trunk of the blood vessel and a second region corresponding to a side branch of the blood vessel in the acquired image, and determining whether the first and second regions are connected to each other ([0060], “Visible in each instance 610a, 610b, and 610c is the vessel lumen 120 and the side branch 515. Where side branches occur in a tomographic image (e.g., an IVUS image), determining the lumen boundary of the vessel becomes difficult, as for any given frame it may be a matter of individual clinical preference whether the side branch is considered part of the main vessel or not.” A user determines in the selection screen whether the regions are connected to another or not for purposes of contour generation; [0061]-[0067], figures 6-7 show the main trunk and side branch of the vessels in an acquired image and determination whether contour is to be selected for both; [0069]-[0083]);
upon determining that the first and second regions are connected to each other, determining a first contour line of the first region in the acquired image ([0060], “Visible in each instance 610a, 610b, and 610c is the vessel lumen 120 and the side branch 515. Where side branches occur in a tomographic image (e.g., an IVUS image), determining the lumen boundary of the vessel becomes difficult, as for any given frame it may be a matter of individual clinical preference whether the side branch is considered part of the main vessel or not.” A user determines in the selection screen whether the regions are connected to another or not for purposes of contour generation, and the system generates a first contour line that encompasses the main trunk of the vessel corresponding to the first contour line as claimed; [0061]-[0067], figures 6-7 show the main trunk and side branch of the vessels in an acquired image and determination whether contour is to be selected for both. The main trunk contour line forms the first contour line of the first region; [0069]-[0083]);
determining a second contour line of the second region in the acquired image based on the first contour line ([0060], “Visible in each instance 610a, 610b, and 610c is the vessel lumen 120 and the side branch 515. Where side branches occur in a tomographic image (e.g., an IVUS image), determining the lumen boundary of the vessel becomes difficult, as for any given frame it may be a matter of individual clinical preference whether the side branch is considered part of the main vessel or not.” A user determines in the selection screen whether the regions are connected to another or not for purposes of contour generation, and the system generates a second contour line that encompasses the side branch of the vessel corresponding to the second contour line as claimed; [0061]-[0067], figures 6-7 show the main trunk and side branch of the vessels in an acquired image and determination whether contour is to be selected for both. The side branch contour line forms the second contour line of the second region; [0069]-[0083]); and
Primary reference Nair fails to teach:
displaying the first and second contour lines on the acquired image using different display modes
However, the analogous art of Grady of a system and method for displaying anatomical images to a user (abstract) teaches:
displaying the first and second contour lines on the acquired image using different display modes ([0192], “To better separate out distinctions between sections, a selected section may have a different contour indicator from other sections' contours. As discussed previously, lumen task 700 may include different sets of contours for the parent vessel and adjoining branch vessels. Thus, various contours may be displayed on the MPRs 723 in different colors.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the contour line generation and display system of Nair to incorporate the display of first and second lines in different modes as taught by Grady because different display modes enable rapid differentiation between contour boundaries by a user, leading to improved and more efficient visualization of anatomical regions of interest (Grady, [0192]). This leads to improved clinical outcomes.
Regarding claim 14, the combined references of Nair and Grady teach all of the limitations of claim 13. Primary reference Nair further teaches:
wherein said determining the first region and the second region includes inputting the acquired image into a computer model to generate information indicating the first and second regions, the computer model having been trained with a plurality of tomographic images of blood vessels and a plurality of information each specifying a region corresponding to a main trunk of the blood vessel and a region corresponding to a side branch of the blood vessel in a corresponding one of the tomographic images ([0061]-[0065], algorithm including a trained machine learning algorithm is utilized to determine contours including the lumen boundaries with bifurcations and side branches in the observed images; [0073]-[0075]).
Regarding claim 15, the combined references of Nair and Grady teach all of the limitations of claim 13. Primary reference Nair further teaches:
wherein said determining the second contour line includes: determining a boundary portion of the second region that is adjacent to the first region, and correcting a shape of the boundary portion so that the boundary portion aligns with the first contour line (0060], “Visible in each instance 610a, 610b, and 610c is the vessel lumen 120 and the side branch 515. Where side branches occur in a tomographic image (e.g., an IVUS image), determining the lumen boundary of the vessel becomes difficult, as for any given frame it may be a matter of individual clinical preference whether the side branch is considered part of the main vessel or not.” A user determines in the selection screen whether the regions are connected to another or not for purposes of contour generation, and the system generates a second contour line that encompasses the side branch of the vessel corresponding to the second contour line and forms an alignment of both lines as in figure 6, 610A with the combined contours of main and side branch vessels; [0061]-[0067], figures 6-7 show the main trunk and side branch of the vessels in an acquired image and determination whether contour is to be selected for both. The side branch contour line forms the second contour line of the second region; [0069]-[0083]).
Regarding claim 16, the combined references of Nair and Grady teach all of the limitations of claim 15. Primary reference Nair further teaches:
wherein said correcting includes merging a region located between the first and second regions into the boundary portion (0060], “Visible in each instance 610a, 610b, and 610c is the vessel lumen 120 and the side branch 515. Where side branches occur in a tomographic image (e.g., an IVUS image), determining the lumen boundary of the vessel becomes difficult, as for any given frame it may be a matter of individual clinical preference whether the side branch is considered part of the main vessel or not.” A user determines in the selection screen whether the regions are connected to another or not for purposes of contour generation, and the system generates a second contour line that encompasses the side branch of the vessel corresponding to the second contour line and forms an alignment of both lines as in figure 6, 610A with the combined contours of main and side branch vessels merged; [0061]-[0067], figures 6-7 show the main trunk and side branch of the vessels in an acquired image and determination whether contour is to be selected for both. The side branch contour line forms the second contour line of the second region; [0069]-[0083]).
Regarding claim 17, the combined references of Nair and Grady teach all of the limitations of claim 15. Primary reference Nair further teaches:
wherein said determining the second contour line includes:
determining a plurality of points on a peripheral edge of the second region ([0069] and [0076]-[0077], as depicted in figure 7, plurality of points are selected and connected in the region of the main trunk vessel, and when included in the side branch (not pictured) forms a second line to form the second contour line connected the main trunk and the side branch vessel),
connecting one or more of the points located in a portion of the second region other than the boundary portion to form a first line ([0069] and [0076]-[0077], as depicted in figure 7, plurality of points are selected and connected in the region of the main trunk vessel, and when included in the side branch (not pictured) forms a second line to form the second contour line connected the main trunk and the side branch vessel),
connecting one or more of the points located in the boundary portion to form a second line ([0069] and [0076]-[0077], as depicted in figure 7, plurality of points are selected and connected in the region of the main trunk vessel, and when included in the side branch (not pictured) forms a second line to form the second contour line connected the main trunk and the side branch vessel), and
combining the first and second lines to form the second contour line ([0069] and [0076]-[0077], as depicted in figure 7, plurality of points are selected and connected in the region of the main trunk vessel, and when included in the side branch (not pictured) forms a second line to form the second contour line connected the main trunk and the side branch vessel).
Regarding claim 18, the combined references of Nair and Grady teach all of the limitations of claim 13. Primary reference Nair further teaches:
wherein the acquired image includes a visual field area in which the blood vessel is imaged and a non-visual field area outside the visual field area, said determining the second contour line includes determining whether a portion of the second region abuts a boundary between the visual field area and the non-visual field area, and the second contour line is determined based on the boundary (0060], “Visible in each instance 610a, 610b, and 610c is the vessel lumen 120 and the side branch 515. Where side branches occur in a tomographic image (e.g., an IVUS image), determining the lumen boundary of the vessel becomes difficult, as for any given frame it may be a matter of individual clinical preference whether the side branch is considered part of the main vessel or not.” As the imaging is a catheter based pullback intravascular image, the non-visual field area forms the regions outside of the vessel regions, wherein the contour lines delineate vessel walls from the non-visual field areas and form a boundary; [0061]-[0067], figures 6-7 show the main trunk and side branch of the vessels in an acquired image and determination whether contour is to be selected for both. The side branch contour line forms the second contour line of the second region; [0069]-[0083]).
Regarding claim 20, primary reference Nair teaches:
A non-transitory computer readable storage medium storing a program causing a computer to execute an image diagnostic method (abstract) comprising:
acquiring a tomographic image of a blood vessel ([0060], tomographic image is generated and displayed on the screen of a blood vessel; [0061]-[0070]; [0071]-[0072], image generation);
determining a first region corresponding to a main trunk of the blood vessel and a second region corresponding to a side branch of the blood vessel in the acquired image, and determining whether the first and second regions are connected to each other ([0060], “Visible in each instance 610a, 610b, and 610c is the vessel lumen 120 and the side branch 515. Where side branches occur in a tomographic image (e.g., an IVUS image), determining the lumen boundary of the vessel becomes difficult, as for any given frame it may be a matter of individual clinical preference whether the side branch is considered part of the main vessel or not.” A user determines in the selection screen whether the regions are connected to another or not for purposes of contour generation; [0061]-[0067], figures 6-7 show the main trunk and side branch of the vessels in an acquired image and determination whether contour is to be selected for both; [0069]-[0083]);
upon determining that the first and second regions are connected to each other, determining a first contour line of the first region in the acquired image ([0060], “Visible in each instance 610a, 610b, and 610c is the vessel lumen 120 and the side branch 515. Where side branches occur in a tomographic image (e.g., an IVUS image), determining the lumen boundary of the vessel becomes difficult, as for any given frame it may be a matter of individual clinical preference whether the side branch is considered part of the main vessel or not.” A user determines in the selection screen whether the regions are connected to another or not for purposes of contour generation, and the system generates a first contour line that encompasses the main trunk of the vessel corresponding to the first contour line as claimed; [0061]-[0067], figures 6-7 show the main trunk and side branch of the vessels in an acquired image and determination whether contour is to be selected for both. The main trunk contour line forms the first contour line of the first region; [0069]-[0083]);
determining a second contour line of the second region in the acquired image based on the first contour line ([0060], “Visible in each instance 610a, 610b, and 610c is the vessel lumen 120 and the side branch 515. Where side branches occur in a tomographic image (e.g., an IVUS image), determining the lumen boundary of the vessel becomes difficult, as for any given frame it may be a matter of individual clinical preference whether the side branch is considered part of the main vessel or not.” A user determines in the selection screen whether the regions are connected to another or not for purposes of contour generation, and the system generates a second contour line that encompasses the side branch of the vessel corresponding to the second contour line as claimed; [0061]-[0067], figures 6-7 show the main trunk and side branch of the vessels in an acquired image and determination whether contour is to be selected for both. The side branch contour line forms the second contour line of the second region; [0069]-[0083]); and
Primary reference Nair fails to teach:
displaying the first and second contour lines on the acquired image using different display modes
However, the analogous art of Grady of a system and method for displaying anatomical images to a user (abstract) teaches:
displaying the first and second contour lines on the acquired image using different display modes ([0192], “To better separate out distinctions between sections, a selected section may have a different contour indicator from other sections' contours. As discussed previously, lumen task 700 may include different sets of contours for the parent vessel and adjoining branch vessels. Thus, various contours may be displayed on the MPRs 723 in different colors.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the contour line generation and display system of Nair to incorporate the display of first and second lines in different modes as taught by Grady because different display modes enable rapid differentiation between contour boundaries by a user, leading to improved and more efficient visualization of anatomical regions of interest (Grady, [0192]). This leads to improved clinical outcomes.
Claims 7 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Nair, in view of Grady as applied to claims 6 or 18 above, and further in view of Rosselet et al. (U.S. Pub. No. 20160196661) hereinafter Rosselet.
Regarding claim 7, the combined references of Nair and Grady teach all of the limitations of claim 6. Primary reference Nair further fails to teach:
wherein the processor executes the program to: determine a first plurality of points on a peripheral edge of the second region, remove one or more of the points located along the boundary, and connect the points from which said one or more of the points have been removed to form a contour line of the second region inside the visual field area
However, the analogous art of Rosselet of a drawing tool for image segmentation (abstract) teaches:
wherein the processor executes the program to: determine a first plurality of points on a peripheral edge of the second region, remove one or more of the points located along the boundary, and connect the points from which said one or more of the points have been removed to form a contour line of the second region inside the visual field area ([0044], delete contour points 351 and the tool reinitializes with manually selected points after removing one or more points from the segmentation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the contour line generation and display system of Nair and Grady to incorporate the contour point deletion tool as taught by Rosselet because it enables quick realignment when a user has erroneously traced a portion of an incorrect visible edge or when semiautomatic drawing tool has selected poorly positioned contour points (Rosselet, [0044]).
Regarding claim 19, the combined references of Nair and Grady teach all of the limitations of claim 18. Primary reference Nair further fails to teach:
wherein said determining the second contour line includes: determining a first plurality of points on a peripheral edge of the second region, removing one or more of the points located along the boundary, and connecting the points from which said one or more of the points have been removed to form a contour line of the second region inside the visual field area
However, the analogous art of Rosselet of a drawing tool for image segmentation (abstract) teaches:
wherein said determining the second contour line includes: determining a first plurality of points on a peripheral edge of the second region, removing one or more of the points located along the boundary, and connecting the points from which said one or more of the points have been removed to form a contour line of the second region inside the visual field area ([0044], delete contour points 351 and the tool reinitializes with manually selected points after removing one or more points from the segmentation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the contour line generation and display system of Nair and Grady to incorporate the contour point deletion tool as taught by Rosselet because it enables quick realignment when a user has erroneously traced a portion of an incorrect visible edge or when semiautomatic drawing tool has selected poorly positioned contour points (Rosselet, [0044]).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Nair, in view of Grady, in further view of Rosselet as applied to claim 7 above, and further in view of Kono et al. (U.S. Pub. No. 20170112357) hereinafter Kono.
Regarding claim 8, the combined references of Nair, Grady, and Rosselet teach all of the limitations of claim 7. Primary reference Nair further fails to teach:
wherein the processor executes the program to: determine a virtual contour line of the second region outside the visual field area based on the contour line of the second region inside the visual field area, and control the display to display the virtual contour line together with the contour line of the second region inside the visual field area
However, the analogous art of Kono of a blood vessel sharpness image creation unit for determining vessel diagnostics (abstract) teaches:
wherein the processor executes the program to: determine a virtual contour line of the second region outside the visual field area based on the contour line of the second region inside the visual field area, and control the display to display the virtual contour line together with the contour line of the second region inside the visual field area ([0058]-[0059], “The extension information on the blood vessel region is information indicating a state how the blood vessel region extends around the candidate region. In the first embodiment, the number of blood vessel regions intersecting at an intersection angle having a predetermined range with respect to the contour of the candidate region is used as the extension information on the blood vessel region.”; [0066]-[0073], as depicted in figures 12A-12B, the neighborhood outside region m3 forms a virtual contour line outside the visual field area of the contour line m2 of the intravascularly imaged vessel of interest. As depicted in figure 12A this forms an external virtual contour line in addition to the contour line of the second region in the combined prior art invention; [0072], displaying abnormal region; [0087]-[0095]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the contour line generation and display system of Nair, Grady, and Rosselet to incorporate the external virtual vessel contour line as taught by Kono because abnormality of vessels can be determined based on a state in which a blood vessel extends (Kono, [0005]). This leads to additional clinical insights beyond the measured initial contour line, and improved patient outcomes.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Nair, in view of Grady as applied to claim 1 above, and further in view of Siemionow et al. (U.S. Pub. No. 20210290076) hereinafter Siemionow.
Regarding claim 10, the combined references of Nair and Grady teach all of the limitations of claim 1. Primary reference Nair further fails to teach:
wherein the processor executes the program to: generate a three-dimensional image of the blood vessel based on the first and second contour lines, and control the display to display the three-dimensional image
However, the analogous art of Siemionow of a method for determining blood vessel diagnostics (abstract) teaches:
wherein the processor executes the program to: generate a three-dimensional image of the blood vessel based on the first and second contour lines, and control the display to display the three-dimensional image ([0020], “providing an image segmenter configured to process input image data and to output a 3D segmented model containing description of blood vessels arrangement within the imaged volume, including at least the location and dimensions of the vessels by use of at least one of the following half-automated or fully-automated methods: region growing from seed, active shapes and active contours,”; see also [0038]-[0060]; [0051]; claim 8).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the contour line generation and display system of Nair and Grady to incorporate the 3D segmentation output including active contour method as taught by Siemionow because 3D segmentation provides additional visualization of vessel health to a clinician, leading to enhanced diagnostics and better medical interventions for diseased vessels (Siemionow, [0020]).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Nair, in view of Grady as applied to clam 1 above, and further in view of Keshwani (U.S. Pub. No. 20220148286) hereinafter Keshwani.
Regarding claim 12, the combined references of Nair and Grady teach all of the limitations of claim 1. Primary reference Nair further fails to teach:
wherein the processor controls the display to display the first and second regions on the acquired image using different hatching patterns
However, the analogous art of Keshwani of a target image learning unit and display control system (abstract) teaches:
wherein the processor controls the display to display the first and second regions on the acquired image using different hatching patterns ([0067], hatching labeling of regions).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the contour line generation and display system of Nair and Grady to incorporate the different hatching patterns as taught by Keshwani because it provides clear distinct visualization of regions and boundaries to a user of the system (Keshwani, [0067]). This leads to more efficient procedures.
Conclusion
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/SEAN A FRITH/Primary Examiner, Art Unit 3798
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