DETAILED ACTION
Amendment received 3 September 2025 is acknowledged. Claims 1-21 are pending and have been considered as follows.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2, 7, 11-13, and 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over Verard (US Pub. No. 2004/0097805) in view of Viswanathan (US Pub. No. 2006/0074297), further in view of Sakaguchi (US Pub. No. 2010/0104167).
As per Claim 1, Verard a medical image processing apparatus (10) (Fig. 1; ¶56-57), comprising:
processing circuitry (34) (Fig. 1; ¶56-63) configured to
extract three-dimensional blood vessel data (as per “pre-operative or real-time images of a patent 14” in ¶57; as per “The work station 34 provides facilities for displaying on the display 36, saving, digitally manipulating, or printing a hard copy of the received images” in ¶59; as per “Images of the navigated organ, such as the heart 222, are acquired at block 222 during the procedure 220. Each of the images acquired at block 224 is registered to the patient at block 236” in ¶119; and “A virtual 3-dimensional curve can then be built to represent an actual cavity or vessel” in ¶122) of an object (14) from three-dimensional image data (as per “generate two-dimensional images that can be converted to three-dimensional volumetric images” in ¶63) of the object (14) (Figs. 1, 3, 13; ¶56-63, 83-87, 118-122),
detect a tip position (as per “the location of the catheter tip 120 can be determined” in ¶94) of a medical device (52) moving in a blood vessel (as per “superior vena cava” in ¶105) in real time (as per “real-time images” in ¶57) from a fluoroscopic image (as per “fluro-scopic x-ray imaging device” in ¶57) of the object (14) inputted during an operation (as per “during the procedure 220” in ¶119), the medical device (52) being a catheter (as per “electromagnetic catheter 52” in ¶69) configured to place a stent (as per “this process can be applied to any type of cardiac therapy as discussed herein, such as … stenting” in ¶92) (Figs. 1, 3, 4A, 7-8, 13; ¶56-73, 83-88, 92, 94, 105-107, 118-122), and
calculate a recommended route (as per “providing various guide points within the template that identify on the display 36 where the catheter 52 should be navigated” in ¶112) that continuously extends (as per production of images 156, 164 in Figs. 7-8 and as per determination of guide points as per ¶112) from a current tip position (as per end of icon 157 nearest reference numeral 158) of the catheter (52) in a blood vessel (as per “through the superior vena cava” in ¶105) to a target position (158), by using (1) the extracted 3D blood vessel data (as per “Once the anterior/posterior anatomic image is acquired in block 194 and the lateral anatomic image is acquired in block 200, the procedure 184 proceeds to block 204 where the acquired images are activated” in ¶112; as per “A virtual 3-dimensional curve can then be built to represent an actual cavity or vessel” in ¶122), (2) route data (as per “As the catheter 52 reaches a particular guide point, the system 10 can then prompt the surgeon to then go to the next guide point, thereby providing a roadmap to the surgeon” in ¶112) of the catheter (52), and (3) the detected tip position (as per “the location of the catheter tip 120 can be determined” in ¶94) of the catheter (52) (Figs. 1, 3, 4A, 7-8, 11, 13; ¶56-73, 83-88, 93-94, 105-107, 110-112, 118-122); and
a terminal (34, 36) including a display (36) (Figs. 1, 7-8, 11; ¶59, 105, 107, 110-112) and configured to
display a three-dimensional blood vessel image (as per “superior vena cava” in ¶105) of the object (14) generated from the 3D blood vessel data (as per “Once the anterior/posterior anatomic image is acquired in block 194 and the lateral anatomic image is acquired in block 200, the procedure 184 proceeds to block 204 where the acquired images are activated” in ¶112; as per “A virtual 3-dimensional curve can then be built to represent an actual cavity or vessel” in ¶122) (Figs. 7-11; ¶105-112), and
wherein the processing circuitry (34) is further configured to
calculate a position (as per “target site” in ¶97) for releasing the stent (as per “this process can be applied to any type of cardiac therapy as discussed herein, such as … stenting” in ¶92, as per “deliver a lead to the desired cardiac location” in ¶93) when a tip (120) of the catheter (52) approaches a placement site designated be a user (as per “The user or physician would then manually manipulate or steer the catheter tip 120 to the identified location” in ¶99) (Figs. 6-11; ¶92-112).
Verard does not expressly disclose:
wherein the route data includes a rough route;
wherein the terminal is configured to receive a designation of the rough route of the catheter on the 3D blood vessel image, wherein the rough route is designated by tracing, through a user operation, a desired route on the 3D blood vessel image displayed on the terminal; and
wherein the processing circuitry is further configured to display a simulated image of the stent at a position corresponding to the calculated position.
Viswanathan discloses a navigation system for a medical device (Figs. 1-3; ¶6, 15, 40-41). A user viewing a set of images of a patient’s vasculature sketches a rough path on the image by clicking or dragging with a mouse or pen-table or other suitable input-output device (Fig. 1; ¶36-39). Based on the rough path sketched by the user, an image processing system reconstructs an accurate path in three dimensions (¶39). Once the desired path has been marked or defined, the device can be steered in an automated manner (¶46). Like Verard, Viswanathan is concerned with medical control systems.
Sakaguchi discloses a display unit (23) for use with a diagnosis apparatus (100) (Fig. 1; ¶45-46). The display unit (3) includes a monitor that displays a graphical user interface for receiving a command from the operator and displays other images (¶59). The displayed images include an enlarged image of a stent (Figs. 7A-B; ¶64, 92-94). In this way, the system facilitates the user’s recognition of the state of the stent (¶174). Like Verard, Sakaguchi is concerned with medical control systems.
Therefore, from these teachings of Verard, Viswanathan, and Sakaguchi, one of ordinary skill in the art before the effective filing date would have found it obvious to apply the teachings of Viswanathan and Sakaguchi to the system of Verard since doing so would enhance the system by: automatically steering the device in accordance with a user defined path; and facilitating the user’s recognition of the state of the stent. Applying the teachings of Viswanathan and Sakaguchi to the system of Verard would result in a system that operates:
“wherein the route data includes a rough route” in that the system of Verard would be adapted to provide guide points informed by data including user inputs of a rough path as per Viswanathan;
“wherein the terminal is configured to receive a designation of the rough route of the catheter on the 3D blood vessel image, wherein the rough route is designated by tracing, through a user operation, a desired route on the 3D blood vessel image displayed on the terminal” in that the system of Verard would be adapted to provide guide points informed by data including a rough path input by a user through clicking or dragging over an image of the patient as per Viswanathan; and
“wherein the processing circuitry is further configured to display a simulated image of the stent at a position corresponding to the calculated position” in that the system of Verard would be adapted in to provide an enlarged image of the stent at specified positions during the procedure as per Sakaguchi.
As per Claim 2, the combination of Verard, Viswanathan, and Sakaguchi teaches or suggests all limitations of Claim 1. Verard further discloses wherein the processing circuitry (34) is further configured to generate a display image (Figs. 7-11) in which the recommended route (as per “providing various guide points within the template that identify on the display 36 where the catheter 52 should be navigated” in ¶112) is superimposed (as per “Templates may also be superimposed” in ¶112) on at least one of the fluoroscopic image (as per “fluro-scopic x-ray imaging device” in ¶57) and a combined image (as per “superimposed over the images” in ¶112) and output the display image (Figs. 7-11) to an external device (34, 36), the combined image (as per “superimposed over the images” in ¶112) being an image combining the 3D blood vessel image (as per “superior vena cava” in ¶105) and the fluoroscopic image (as per “fluro-scopic x-ray imaging device” in ¶57) (Figs. 7-11; ¶105-112).
As per Claim 7, the combination of Verard, Viswanathan, and Sakaguchi teaches or suggests all limitations of Claim 1. Verard further discloses wherein:
the processing circuitry (34) is further configured to detect a first blood vessel position (as per “detect both the position of the patient’s anatomy” in ¶79; as per “the navigation system 10 continuously tracks the position of the patent 14 during registration and navigation” in ¶82) of the object (14) during the operation from a fluoroscopic image (as per “fluro-scopic x-ray imaging device” in ¶57) of a blood vessel in which a contrast agent (as per “Once in the coronary sinus, a contrast agent may be administered” in ¶133) is administered by a user using injector (as per “a contrast agent may be administered through the navigation catheter 52” in ¶133), and
when a second blood vessel position (as per “any movement of the patient 14 is detected as relative motion” in ¶74) in the 3D blood vessel data (as per “pre-operative or real-time images of a patent 14” in ¶57; as per “The work station 34 provides facilities for displaying on the display 36, saving, digitally manipulating, or printing a hard copy of the received images” in ¶59; as per “Images of the navigated organ, such as the heart 222, are acquired at block 222 during the procedure 220. Each of the images acquired at block 224 is registered to the patient at block 236” in ¶119; and “A virtual 3-dimensional curve can then be built to represent an actual cavity or vessel” in ¶122) differs from the detected (as per “detect both the position of the patient’s anatomy” in ¶79; as per “the navigation system 10 continuously tracks the position of the patent 14 during registration and navigation” in ¶82) first blood vessel position detected during the operation by predetermined amount or more (as per “any movement of the patient 14” in ¶74), the processing circuitry (34) is further configured to update the second blood vessel position (as per “any movement of the patient 14 is detected as relative motion” in ¶74) to match the first blood vessel position (as per “detect both the position of the patient’s anatomy” in ¶79; as per “the navigation system 10 continuously tracks the position of the patent 14 during registration and navigation” in ¶82), and use the 3D blood vessel data (as per “pre-operative or real-time images of a patent 14” in ¶57; as per “The work station 34 provides facilities for displaying on the display 36, saving, digitally manipulating, or printing a hard copy of the received images” in ¶59; as per “Images of the navigated organ, such as the heart 222, are acquired at block 222 during the procedure 220. Each of the images acquired at block 224 is registered to the patient at block 236” in ¶119; and “A virtual 3-dimensional curve can then be built to represent an actual cavity or vessel” in ¶122) where an updated second blood vessel position (as per “any movement of the patient 14 is detected as relative motion” in ¶74) is reflected for calculating the recommended route (as per “providing various guide points within the template that identify on the display 36 where the catheter 52 should be navigated” in ¶112) of the catheter (52).
As per Claim 11, the combination of Verard, Viswanathan, and Sakaguchi teaches or suggests all limitations of Claim 1. Verard further discloses wherein:
the fluoroscopic image (as per “fluro-scopic x-ray imaging device” in ¶57) is an image generated by an imaging apparatus (12) with a single-plane arm (16) (Fig. 1; ¶57); and
the processing circuitry (28, 34) is further configured to
rotate (as per “the C-arm controller 28 may also control the rotation of the C-arm” in ¶57) the single-plane arm 16) to acquire fluoroscopic images (as per “fluro-scopic x-ray imaging device” in ¶57) of the object (14) from a plurality of directions (as per “allowing anterior or lateral views of the patient 14 to be imaged” in ¶57), when the tip (120) of the catheter (52) is determined to be at a vascular branch position (as per 270, 272 in Fig. 13) by determination based on the extracted 3D blood vessel data (as per “pre-operative or real-time images of a patent 14” in ¶57; as per “The work station 34 provides facilities for displaying on the display 36, saving, digitally manipulating, or printing a hard copy of the received images” in ¶59; as per “Images of the navigated organ, such as the heart 222, are acquired at block 222 during the procedure 220. Each of the images acquired at block 224 is registered to the patient at block 236” in ¶119; and “A virtual 3-dimensional curve can then be built to represent an actual cavity or vessel” in ¶122) and information on the tip position (120) of the catheter (52), or {when the tip of the catheter is determined to be at a curve portion having a curvature equal to or larger than a predetermined value}, and
three-dimensionally detect the tip position (120) of the catheter (52) based on the fluoroscopic images (as per “fluro-scopic x-ray imaging device” in ¶57) from the plurality of directions (as per “allowing anterior or lateral views of the patient 14 to be imaged” in ¶57) acquired by rotation (as per “the C-arm controller 28 may also control the rotation of the C-arm” in ¶57) of the single-plane arm (16) (Fig. 1; ¶57).
As per Claim 12, the combination of Verard, Viswanathan, and Sakaguchi teaches or suggests all limitations of Claim 1. Verard further discloses wherein:
a sensor (as per “localization sensor 58” in ¶72) configured to detect three-dimension positional information (as per “The electromagnetic tracking system 44 continuously compares the relative position of the dynamic reference frame 54 and the catheter 52 during localization” in ¶80) is provided at a tip portion (120) of the (52); and
the processing circuitry (34) is further configured to three-dimensionally (as per “The electromagnetic tracking system 44 continuously compares the relative position of the dynamic reference frame 54 and the catheter 52 during localization” in ¶80) detect (as per “Taken with the electrode sensors 58 information, the location of the catheter tip 120 can be determined” in ¶94) the tip position of the catheter (52) based on the 3D positional information (as per “The electromagnetic tracking system 44 continuously compares the relative position of the dynamic reference frame 54 and the catheter 52 during localization” in ¶80) outputted from the sensor (58).
As per Claim 13, the combination of Verard, Viswanathan, and Sakaguchi teaches or suggests all limitations of Claim 2. Verard further discloses wherein the processing circuitry (34) is further configured to {control a position and an orientation of a bed on which the object is placed,} and/or control an operation of an arm (16) supporting an X-ray irradiator (18) and an X-ray detector (20) for imaging the object (14), such that the tip (120) of the catheter (52) displayed by the external device (34, 36) is positioned at a center of a screen (Figs. 7-11) of the external device (36) (Figs. 1, 4A; 7-11; ¶57-59, 88, 105, 107, 110-112).
As per Claim 19, the combination of Verard, Viswanathan, and Sakaguchi teaches or suggests all limitations of Claim 1. The combination of Verard, Viswanathan, and Sakaguchi further teaches or suggests an X-ray diagnostic apparatus (per “diagnostic or pre-acquired images” in ¶81 of Verard as modified in view of Viswanathan and Sakaguchi) comprising the medical image processing apparatus (as per system 10 of Verard as modified in view of Viswanathan and Sakaguchi) according to claim 1 (see rejection of Claim 1)
As per Claim 20, Verard discloses a non-transitory computer-readable storage medium storing a program (as per “Programs executed by the control system” in ¶22) enabling a computer (34) to execute processing comprising:
extracting three-dimensional blood vessel data (as per “pre-operative or real-time images of a patent 14” in ¶57; as per “The work station 34 provides facilities for displaying on the display 36, saving, digitally manipulating, or printing a hard copy of the received images” in ¶59; as per “Images of the navigated organ, such as the heart 222, are acquired at block 222 during the procedure 220. Each of the images acquired at block 224 is registered to the patient at block 236” in ¶119; and “A virtual 3-dimensional curve can then be built to represent an actual cavity or vessel” in ¶122) of an object (14) from three-dimensional image data (as per “generate two-dimensional images that can be converted to three-dimensional volumetric images” in ¶63) of the object (14) (Figs. 1, 3, 13; ¶56-63, 83-87, 118-122);
causing a terminal (34, 36) including a display (36) to display a three-dimensional blood vessel image (as per “superior vena cava” in ¶105) of the object (14) generated from the extracted 3D blood vessel data (as per “Once the anterior/posterior anatomic image is acquired in block 194 and the lateral anatomic image is acquired in block 200, the procedure 184 proceeds to block 204 where the acquired images are activated” in ¶112; as per “A virtual 3-dimensional curve can then be built to represent an actual cavity or vessel” in ¶122) (Figs. 7-11; ¶105-112);
acquiring route data (as per “As the catheter 52 reaches a particular guide point, the system 10 can then prompt the surgeon to then go to the next guide point, thereby providing a roadmap to the surgeon” in ¶112) of a medical device (52) moving in a blood vessel (as per “through the superior vena cava” in ¶105), the medical device (52) being a catheter (as per “electromagnetic catheter 52” in ¶69) configured to place a stent (as per “this process can be applied to any type of cardiac therapy as discussed herein, such as … stenting” in ¶92) (Figs. 1, 3, 4A, 7-8, 13; ¶56-73, 83-88, 92, 94, 105-107, 118-122);
detecting a tip position (as per “the location of the catheter tip 120 can be determined” in ¶94) of the catheter (52) in real time (as per “real-time images” in ¶57) from a fluoroscopic image (as per “fluro-scopic x-ray imaging device” in ¶57) of the object (14) inputted during an operation (as per “during the procedure 220” in ¶119) (Figs. 1, 3, 4A, 7-8, 13; ¶56-73, 83-88, 94, 105-107, 118-122);
calculating a recommended route (as per “providing various guide points within the template that identify on the display 36 where the catheter 52 should be navigated” in ¶112) that continuously extends (as per production of images 156, 164 in Figs. 7-8 and as per determination of guide points as per ¶112) from a current tip position (as per end of icon 157 nearest reference numeral 158) of the catheter (52) in a blood vessel (as per “through the superior vena cava” in ¶105) to a target position (158) by using (1) the extracted 3D blood vessel data (as per “Once the anterior/posterior anatomic image is acquired in block 194 and the lateral anatomic image is acquired in block 200, the procedure 184 proceeds to block 204 where the acquired images are activated” in ¶112; as per “A virtual 3-dimensional curve can then be built to represent an actual cavity or vessel” in ¶122), (2) the route data (as per “As the catheter 52 reaches a particular guide point, the system 10 can then prompt the surgeon to then go to the next guide point, thereby providing a roadmap to the surgeon” in ¶112) of the catheter (52), and (3) the tip position (as per “the location of the catheter tip 120 can be determined” in ¶94) of the catheter (52) (Figs. 1, 3, 4A, 7-8, 11, 13; ¶56-73, 83-88, 93-94, 105-107, 110-112, 118-122);
calculating a position (as per “target site” in ¶97) for releasing the stent (as per “this process can be applied to any type of cardiac therapy as discussed herein, such as … stenting” in ¶92, as per “deliver a lead to the desired cardiac location” in ¶93) when a tip (120) of the catheter (52) approaches a placement site designated by a user (as per “The user or physician would then manually manipulate or steer the catheter tip 120 to the identified location” in ¶99) (Figs. 6-11; ¶92-112).
Verard does not expressly disclose:
wherein the route data includes a rough route, the rough route being designated on the 3D blood vessel image displayed on the terminal;
wherein the rough route is designated by tracing, through a user operation, a desired route on the 3D blood vessel image displayed on the terminal; and
displaying a simulated image of the stent at a position corresponding to the calculated position.
Viswanathan discloses a navigation system for a medical device (Figs. 1-3; ¶6, 15, 40-41). A user viewing a set of images of a patient’s vasculature sketches a rough path on the image by clicking or dragging with a mouse or pen-table or other suitable input-output device (Fig. 1; ¶36-39). Based on the rough path sketched by the user, an image processing system reconstructs an accurate path in three dimensions (¶39). Once the desired path has been marked or defined, the device can be steered in an automated manner (¶46). Like Verard, Viswanathan is concerned with medical control systems.
Sakaguchi discloses a display unit (23) for use with a diagnosis apparatus (100) (Fig. 1; ¶45-46). The display unit (3) includes a monitor that displays a graphical user interface for receiving a command from the operator and displays other images (¶59). The displayed images include an enlarged image of a stent (Figs. 7A-B; ¶64, 92-94). In this way, the system facilitates the user’s recognition of the state of the stent (¶174). Like Verard, Sakaguchi is concerned with medical control systems.
Therefore, from these teachings of Verard, Viswanathan, and Sakaguchi, one of ordinary skill in the art before the effective filing date would have found it obvious to apply the teachings of Viswanathan and Sakaguchi to the system of Verard since doing so would enhance the system by: automatically steering the device in accordance with a user defined path; and facilitating the user’s recognition of the state of the stent. Applying the teachings of Viswanathan and Sakaguchi to the system of Verard would result in a system that operates:
“wherein the route data includes a rough route, the rough route being designated on the 3D blood vessel image displayed on the terminal” in that the system of Verard would be adapted to provide guide points informed by data including user inputs of a rough path as per Viswanathan;
“wherein the rough route is designated by tracing, through a user operation, a desired route on the 3D blood vessel image displayed on the terminal” in that the system of Verard would be adapted to provide guide points informed by data including a rough path input by a user through clicking or dragging over an image of the patient as per Viswanathan; and
“displaying a simulated image of the stent at a position corresponding to the calculated position” in that the system of Verard would be adapted in to provide an enlarged image of the stent at specified positions during the procedure as per Sakaguchi.
As per Claim 21, the combination of Verard, Viswanathan, and Sakaguchi teaches or suggests all limitations of Claim 1. Verard does not expressly disclose wherein the rough route is designated by tracing along the blood vessel depicted in the 3D blood vessel image displayed on the terminal.
See rejection of Claim 1 for discussion of teachings of Viswanathan.
Therefore, from these teachings of Verard, Viswanathan, and Sakaguchi, one of ordinary skill in the art before the effective filing date would have found it obvious to apply the teachings of Viswanathan and Sakaguchi to the system of Verard since doing so would enhance the system by: automatically steering the device in accordance with a user defined path; and facilitating the user’s recognition of the state of the stent. Applying the teachings of Viswanathan and Sakaguchi to the system of Verard would result in a system that operates: “wherein the rough route is designated by tracing along the blood vessel depicted in the 3D blood vessel image displayed on the terminal” in that the system of Verard would be adapted to provide guide points informed by data including a rough path input by a user through clicking or dragging over an image of the patient as per Viswanathan.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Verard (US Pub. No. 2004/0097805) in view of Viswanathan (US Pub. No. 2006/0074297), further in view of Sakaguchi (US Pub. No. 2010/0104167), further in view of Zarkh (US Pub. No. 2010/0312100).
As per Claim 3, the combination of Verard, Viswanathan, and Sakaguchi teaches or suggests all limitations of Claim 1. Verard does not expressly disclose wherein the processing circuitry is further configured to:
calculate at least one of a blood vessel centerline and a blood vessel contour from the 3D blood vessel data;
calculate a curvature of the blood vessel from at least one of the blood vessel centerline and the blood vessel contour; and
calculate the recommended route of the catheter based on the curvature of the blood vessel.
See rejection of Claim 1 for discussion of teachings of Viswanathan and Sakaguchi.
Zarkh discloses a system (100) for positioning a catheter (200) within an artery (210) in which an X-ray camera (105) provides images (108) to a display (120) (Figs. 1-2; ¶33-34). In operation, the system (100) performs calculation of vessel centerlines, boundaries, diameters as well as determination of branching points and curvature (Fig. 3; ¶35). In one embodiment (700), the display (as per 120) includes centerline (716) of the vessel as well as location of vessel walls (724) (Fig. 7; ¶57). In this way, the system improves patient safety by enabling a physician to drill through an occlusion area (702) without perforating the vessel (¶57). Like Verard, Zarkh is concerned with surgical control systems.
Therefore, from these teachings of Verard, Viswanathan, Sakaguchi, and Zarkh one of ordinary skill in the art before the effective filing date would have found it obvious to apply the teachings of Viswanathan, Sakaguchi, Zarkh and to the system of Verard since doing so would enhance the system by: automatically steering the device in accordance with a user defined path; facilitating the user’s recognition of the state of the stent; and improving patient safety. Applying the teachings of Viswanathan, Sakaguchi, and Zarkh to the system of Verard would result in a system configured to:
“calculate at least one of a blood vessel centerline and a blood vessel contour from the 3D blood vessel data” in that data gathered as per Verard would be processed to produce images including data as per Zarkh;
“calculate a curvature of the blood vessel from at least one of the blood vessel centerline and the blood vessel contour” in that data gathered as per Verard would be processed to produce images including data as per Zarkh;
“calculate the recommended route of the catheter based on the curvature of the blood vessel” in that in guidance routes produced as per Verard as informed by Viswanathan and Sakaguchi would be further informed by the teachings of Zarkh.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Verard (US Pub. No. 2004/0097805) in view of Viswanathan (US Pub. No. 2006/0074297), further in view of Sakaguchi (US Pub. No. 2010/0104167), further in view of Zarkh (US Pub. No. 2010/0312100), further in view of Tsusaka (US Pub. No. 2015/0057575).
As per Claim 4, the combination of Verard, Viswanathan, Sakaguchi, and Zarkh teaches or suggests all limitations of Claim 3. Verard does not expressly disclose wherein the processing circuitry is further configured to:
calculate a route along the blood vessel centerline as the recommended route, in a region where the calculated curvature is smaller than a predetermined value; and
calculate a route in which the tip of the catheter moves while contacting a wall of the blood vessel as the recommended route, in a region where the calculated curvature is equal to or larger than the predetermined value.
See rejection of Claim 1 for discussion of teachings of Viswanathan and Sakaguchi.
Zarkh discloses a system (100) for positioning a catheter (200) within an artery (210) in which an X-ray camera (105) provides images (108) to a display (120) (Figs. 1-2; ¶33-34). In operation, the system (100) performs calculation of vessel centerlines, boundaries, diameters as well as determination of branching points, curvature, and a complexity index comprising local curvatures and tortuosity (Fig. 3; ¶35). In one embodiment (700), the display (as per 120) includes centerline (716) of the vessel as well as location of vessel walls (724) (Fig. 7; ¶57). In this way, the system improves patient safety by enabling a physician to drill through an occlusion area (702) without perforating the vessel (¶57). Like Verard, Zarkh is concerned with surgical control systems.
Tsusaka discloses a catheterization system (Fig. 1) in which an operator (6) inserts a guide wire (2) into the blood vessel (3) of a patient (4) with the aid of monitor (8a) that outputs images of the guide wire (2) within the blood vessel (3) (Fig. 1; ¶112-115). A force measurement apparatus (1) associated with the guide wire (2) includes: a force detector (13) that measures a force acting on the guide wire (2); and a force deciding unit (12) that determines that a load is applied to the blood vessel (3) (Figs. 1-2; ¶114, 116-119, 145-148). In operation, when the force deciding unit (12) determines that the force exceeds a threshold value (YES at S11 in Fig. 6), the monitor (8a) outputs (S12 in Fig. 6) a warning (Fig. 6; ¶149-167). As such, Tsusaka discloses that contact force below the specified threshold value (S11) may be acceptable. In this way, the system of Tsusaka operates to prevent damage to ducts (¶3). Like Verard, Tsusaka is concerned with surgical control systems.
Therefore, from these teachings of Verard, Viswanathan, Sakaguchi, Zarkh, and Tsusaka one of ordinary skill in the art before the effective filing date would have found it obvious to apply the teachings of Viswanathan, Sakaguchi, Zarkh, and Tsusaka to the system of Verard since doing so would enhance the system by: automatically steering the device in accordance with a user defined path; facilitating the user’s recognition of the state of the stent; improving patient safety; and preventing damage to ducts. Applying the teachings of Viswanathan, Sakaguchi, Zarkh, and Tsusaka to the system of Verard would result in a system that operates wherein the processing circuitry is further configured to:
“calculate a route along the blood vessel centerline as the recommended route in a region where the calculated curvature is smaller than a predetermined value” in that route generation as per Verard would be informed by determinations of centerline and curvature as per Zarkh; and
“calculate a route in which the tip of the catheter moves while contacting a wail of the blood vessel as the recommended route, in a region where the calculated curvature is equal to or larger than the predetermined value” in that route generation as per Verard as informed by Viswanathan and Sakaguchi would be further informed by determinations of centerline and curvature as per Zarkh as well determinations of acceptable contact as per Tsusaka.
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Verard (US Pub. No. 2004/0097805) in view of Viswanathan (US Pub. No. 2006/0074297), further in view of Sakaguchi (US Pub. No. 2010/0104167), further in view of Zarkh (US Pub. No. 2010/0312100), further in view of Tsusaka (US Pub. No. 2015/0057575), further in view of Germain (US Pub. No. 2017/0360508).
As per Claim 5, the combination of Verard, Viswanathan, Sakaguchi, and Zarkh teaches or suggests all limitations of Claim 3. Verard does not expressly disclose wherein the processing circuitry is further configured to:
calculate a pressing force by which the catheter presses against a wall of the blood vessel when the catheter passes through a curse portion of the blood vessel using rigidity information on the catheter and a deformation amount of the catheter when the catheter passes through the curve portion of the blood vessel having the calculated curvature; and
determine whether or not the catheter can be moved along the designated rough route, by determining whether or not a strength of the blood vessel can withstand the pressing force.
See rejection of Claim 1 for discussion of teachings of Viswanathan and Sakaguchi.
Zarkh discloses a system (100) for positioning a catheter (200) within an artery (210) in which an X-ray camera (105) provides images (108) to a display (120) (Figs. 1-2; ¶33-34). In operation, the system (100) performs calculation of vessel centerlines, boundaries, diameters as well as determination of branching points, curvature, and a complexity index comprising local curvatures and tortuosity (Fig. 3; ¶35). In one embodiment (700), the display (as per 120) includes centerline (716) of the vessel as well as location of vessel walls (724) (Fig. 7; ¶57). In this way, the system improves patient safety by enabling a physician to drill through an occlusion area (702) without perforating the vessel (¶57). Like Verard, Zarkh is concerned with surgical control systems.
Tsusaka discloses a catheterization system (Fig. 1) in which an operator (6) inserts a guide wire (2) into the blood vessel (3) of a patient (4) with the aid of monitor (8a) that outputs images of the guide wire (2) within the blood vessel (3) (Fig. 1; ¶112-115). A force measurement apparatus (1) associated with the guide wire (2) includes: a force detector (13) that measures a force acting on the guide wire (2); and a force deciding unit (12) that determines that a load is applied to the blood vessel (3) (Figs. 1-2; ¶114, 116-119, 145-148). In operation, when the force deciding unit (12) determines that the force exceeds a threshold value (YES at S11 in Fig. 6), the monitor (8a) outputs (S12 in Fig. 6) a warning (Fig. 6; ¶149-167). As such, Tsusaka discloses that contact force below the specified threshold value (S11) may be acceptable. In this way, the system of Tsusaka operates to prevent damage to ducts (¶3). Like Verard, Tsusaka is concerned with surgical control systems.
Germain discloses a system (100) for determining an insertion path for a medical device in which a path analysis component (102) includes: a path assessment component (104) generates a set of implantation paths; and a path recommendation component (106) ranks the paths (Fig. 1; ¶21-29). Ranking of the paths by the recommendation component (106) involves: determinations of properties of the medical device including rigidity; and determinations of properties of the vessel into which the device is to be inserted including curvature (¶29-30). In one embodiment, the vessel (902) includes a curvature and the path analysis component (102) determines that an implantation path (904) is not suitable for a medical device (906) (Fig. 9; ¶55). In response to the determination, the path analysis component (102) may select a different implantation path and/or a different medical device for the path (904) (¶55). In this way, efficiency of path planning may be improved (¶1). Like Verard, Germain is concerned with surgical control systems.
Therefore, from these teachings of Verard, Viswanathan, Sakaguchi, Zarkh, Tsusaka, and Germain one of ordinary skill in the art before the effective filing date would have found it obvious to apply the teachings of Viswanathan, Sakaguchi, Zarkh, Tsusaka, and Germain to the system of Verard since doing so would enhance the system by: automatically steering the device in accordance with a user defined path; facilitating the user’s recognition of the state of the stent; improving patient safety; preventing damage to ducts; and improving efficiency of path planning. Applying the teachings of Viswanathan, Sakaguchi, Zarkh, Tsusaka, and Germain to the system of Verard would result in a system that operates wherein the processing circuitry is configured to:
“calculate a pressing force by which the catheter presses against a wall of the blood vessel when the catheter passes through a curse portion of the blood vessel using rigidity information on the catheter and a deformation amount of the catheter when the catheter passes through the curve portion of the blood vessel having the calculated curvature” in that route generation as per Verard would be informed by teachings of Viswanathan and Sakaguchi, determinations of centerline and curvature as per Zarkh, determinations of force as per Tsusaka, and determinations involving rigidity information of a medical device through a specified curve as per Germain; and
“determine whether or not the catheter can be moved along the designated rough route, by determining whether or not a strength of the blood vessel can withstand the pressing force” in that route generation as per Verard would be informed by teachings of Viswanathan and Sakaguchi, determinations of centerline and curvature as per Zarkh, determinations of acceptable contact as per Tsusaka, and determinations involving rigidity information of a medical device through a specified curve as per Germain.
As per Claim 6, the combination of Verard, Viswanathan, Sakaguchi, Zarkh, Tsusaka, and Germain teaches or suggests all limitations of Claim 5. Verard does not expressly disclose wherein, when the processing circuitry determines that the catheter cannot be moved along the designated rough route, the processing circuitry is further configured to notify a user of such information.
See rejection of Claim 1 for discussion of teachings of Viswanathan and Sakaguchi.
See rejection of Claim 5 for discussion of teachings of Verard, Zarkh, and Germain.
Therefore, from these teachings of Verard, Viswanathan, Sakaguchi, Zarkh, Tsusaka, and Germain one of ordinary skill in the art before the effective filing date would have found it obvious to apply the teachings of Viswanathan, Sakaguchi, Zarkh, Tsusaka, and Germain to the system of Verard since doing so would enhance the system by: automatically steering the device in accordance with a user defined path; facilitating the user’s recognition of the state of the stent; improving patient safety; preventing damage to ducts; and improving efficiency of path planning. Applying the teachings of Viswanathan, Sakaguchi, Zarkh, Tsusaka, and Germain to the system of Verard would result in a system that operates “wherein, when the processing circuitry determines that the catheter cannot be moved along the designated rough route, the processing circuitry is further configured to notify a user of such information” in that route generation as per Verard would be informed by the teachings of Viswanathan, Sakaguchi, Zarkh, Tsusaka, and Germain to generate a warning as per Tsusaka in the event that event that the system determines that a proposed route involves excessive force.
Claims 8 and 15-18 are Verard (US Pub. No. 2004/0097805) in view of Viswanathan (US Pub. No. 2006/0074297), further in view of Sakaguchi (US Pub. No. 2010/0104167), further in view of Tsusaka (US Pub. No. 2015/0057575).
As per Claim 8, the combination of Verard, Viswanathan, and Sakaguchi teaches or suggests all limitations of Claim 1. Verard further discloses wherein the processing circuitry is further configured to:
detect a vascular branch portion (as per 270, 272 in Fig. 13) from 3D vascular data (as per “pre-operative or real-time images of a patent 14” in ¶57; as per “The work station 34 provides facilities for displaying on the display 36, saving, digitally manipulating, or printing a hard copy of the received images” in ¶59; as per “Images of the navigated organ, such as the heart 222, are acquired at block 222 during the procedure 220. Each of the images acquired at block 224 is registered to the patient at block 236” in ¶119; and “A virtual 3-dimensional curve can then be built to represent an actual cavity or vessel” in ¶122) (Figs. 1, 3, 13; ¶56-63, 83-87, 118-122).
Verard does not expressly disclose wherein the processing circuitry is further configured to: calculate a route in which the tip of the catheter moves while contacting a vascular wall opposite to a branching blood vessel, as the recommended route.
See rejection of Claim 1 for discussion of teachings of Viswanathan and Sakaguchi.
Tsusaka discloses a catheterization system (Fig. 1) in which an operator (6) inserts a guide wire (2) into the blood vessel (3) of a patient (4) with the aid of monitor (8a) that outputs images of the guide wire (2) within the blood vessel (3) (Fig. 1; ¶112-115). A force measurement apparatus (1) associated with the guide wire (2) includes: a force detector (13) that measures a force acting on the guide wire (2); and a force deciding unit (12) that determines that a load is applied to the blood vessel (3) (Figs. 1-2; ¶114, 116-119, 145-148). In operation, when the force deciding unit (12) determines that the force exceeds a threshold value (YES at S11 in Fig. 6), the monitor (8a) outputs (S12 in Fig. 6) a warning (Fig. 6; ¶149-167). As such, Tsusaka discloses that contact force below the specified threshold value (S11) may be acceptable. In this way, the system of Tsusaka operates to prevent damage to ducts (¶3). Like Verard, Tsusaka is concerned with surgical control systems.
Therefore, from these teachings of Verard, Viswanathan, Sakaguchi, and Tsusaka one of ordinary skill in the art before the effective filing date would have found it obvious to apply the teachings of Viswanathan, Sakaguchi, and Tsusaka to the system of Verard since doing so would enhance the system by: automatically steering the device in accordance with a user defined path; facilitating the user’s recognition of the state of the stent; and preventing damage to ducts. Applying the teachings of Viswanathan, Sakaguchi, and Tsusaka to the system of Verard would result in a system that operates “wherein the processing circuitry is further configured to: calculate a route in which the tip of the catheter moves while contacting a vascular wall opposite to a branching blood vessel, as the recommended route” in that in that route generation as per Verard would be informed by the teachings of Viswanathan and Sakaguchi as well as determinations of acceptable contact as per Tsusaka.
As per Claim 15, the combination of Verard, Viswanathan, and Sakaguchi teaches or suggests all limitations of Claim 1. Verard does not expressly disclose wherein the processing circuitry is further configured to:
exchange control data with an Interventional Radiology (IVR) support robot that controls a procedure using the catheter from a remote location, or performs a fully automated or semi-automated procedure using the catheter; and
control a movement of the IVR support robot by converting the recommended route of the catheter into the control data and outputting the control data to the IVR support robot such that the catheter moves based on the recommended route.
See rejection of Claim 1 for discussion of teachings of Viswanathan and Sakaguchi.
Tsusaka discloses a catheterization system (Fig. 1) in which an operator (6) inserts a guide wire (2) into the blood vessel (3) of a patient (4) with the aid of monitor (8a) that outputs images of the guide wire (2) within the blood vessel (3) (Fig. 1; ¶112-115). In one embodiment, the guide wire (2) is inserted by the operator (6) (Fig. 1; ¶112-113). In an alternative embodiment, the guide wire (2) is inserted by a robotic system (18, 19) (Fig. 19; ¶230-233). Accordingly, Tsusaka discloses that manual insertion and robotic insertion of a medical instrument are matters of design choice. Like Verard, Tsusaka is concerned with surgical control systems.
Therefore, from these teachings of Verard, Viswanathan, Sakaguchi, and Tsusaka one of ordinary skill in the art before the effective filing date would have found it obvious to apply the teachings of Viswanathan, Sakaguchi, and Tsusaka to the system of Verard since doing so would: enhance the system by automatically steering the device in accordance with a user defined path; facilitating the user’s recognition of the state of the stent; and be, according to Tsusaka, a matter of design choice. Applying the teachings of Viswanathan, Sakaguchi, and Tsusaka to the system of Verard would result in a system that operates wherein the processing circuitry is configured to:
“exchange control data with an Interventional Radiology (IVR) support robot that controls a procedure using the catheter from a remote location, or performs a fully automated or semi-automated procedure using the catheter” in that the system of Verard as informed by teachings of Viswanathan and Sakaguchi would be adapted to perform robotic control as per Tsusaka
“control a movement of the IVR support robot by converting the recommended route of the catheter into the control data and outputting the control data to the IVR support robot such that the catheter moves based on the recommended route” in that movement of the medical instrument of Verard as informed by teachings of Viswanathan and Sakaguchi would be performed by the robotic control system as per Tsusaka.
As per Claim 16, the combination of Verard, Viswanathan, and Sakaguchi teaches or suggests all limitations of Claim 1. Verard further discloses wherein the processing circuitry (34) is further configured to: determine a moving speed (as per 262 in Fig. 13) of the catheter (52) suitable for a tissue (as per 222) or an organ of the object (14) at which the tip (120) of the catheter (52) is positioned (Figs. 1, 3, 4A, 7-8, 11, 13; ¶56-73, 83-88, 105-107, 110-112, 118-122).
Verard does not expressly disclose wherein the processing circuitry is further configured to:
exchange control data with an IVR support robot that controls a procedure using the catheter from a remote location, or performs a fully automated or semi-automated procedure using the catheter; and
control a movement of the IVR support robot such that the catheter moves based on the determined moving speed.
See rejection of Claim 1 for discussion of teachings of Viswanathan, and Sakaguchi.
See rejection of Claim 15 for discussion of teachings of Tsusaka.
Therefore, from these teachings of Verard, Viswanathan, Sakaguchi, and Tsusaka one of ordinary skill in the art before the effective filing date would have found it obvious to apply the teachings of Viswanathan, Sakaguchi, and Tsusaka to the system of Verard since doing so would: enhance the system by automatically steering the device in accordance with a user defined path; facilitating the user’s recognition of the state of the stent; and be, according to Tsusaka, a matter of design choice. Applying the teachings of Viswanathan, Sakaguchi, and Tsusaka to the system of Verard would result in a system that operates wherein the processing circuitry is configured to:
“exchange control data with an IVR support robot that controls a procedure using the catheter from a remote location, or performs a fully automated o