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 .
Status of Claims and Rejections
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
Claims 3, 11, 12, 14, and 15 have been amended.
Claims 1-18 are currently pending.
In light of the claim amendments, the Section 112(b) rejection of claim 11 has been withdrawn.
In light of Applicant’s arguments, the Section 101 rejection of claims 1-18 have been withdrawn.
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 1-5, 7-10, 13, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Appl. Publ. No. 2016/0183841 A1 (hereinafter “DUINDAM”) and U.S. Patent Appl. Publ. No. 2019/0362552 A1 (hereinafter “AVERBUCH”) and U.S. Patent Appl. Publ. No. 2012/0176365 A1 (hereinafter “HANSEGARD”).
DUINDAM teaches “systems and methods for navigating a patient anatomy to conduct a minimally invasive procedure, and more particularly to apparatus and methods for using a graphical user interface to assist interventional instrument guidance.” ([0001]).
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With respect to claim 1, DUINDAM teaches a navigation system ([0001]: “systems and methods for navigating a patient anatomy to conduct a minimally invasive procedure, and more particularly to apparatus and methods for using a graphical user interface to assist interventional instrument guidance”) comprising a display device (“display system 110” see Figure 1 and graphical user interface (GUI) 300 in Figure 3); and a controller configured to display on the display device ([0029]: control system 112 having memory and at least one processor for “effecting control” of the display system 110.).
The controller is configured to display an image of a biological lumen imaged from the distal end of a bendable medical device that is in the biological lumen (Figure 3 and [0048]: “an endoscopic camera image 302 generated by an endoscopic camera within the patient anatomy”); and a representation of an airway structure (Id.: “a virtual overview pathway image 306 providing an overview of the anatomical passageway system); wherein the representation of the airway structure further comprises: a navigation path through at least a portion of the airway structure ([0049]: “the GUI 300 additionally contains guidance information in the form of a virtual roadmap 310”).
However, DUINDAM does not explicitly teach that the representation of the airway structure further comprises a guidance reference plane oriented perpendicular to the navigation path and located at an insertion depth of the distal end of the bendable medical device in the biological lumen.
In the same field of endeavor, AVERBUCH teaches systems and methods that “uses a system of planned waypoints along a planned route through the bronchial tree in order to incrementally advance the image presented to the physician.” ([0008]). “Thus, a physician using the system and method of the present invention will see an image of the bronchial tree and an image of the sensor being advanced through the airways to a subsequent waypoint.” ([0009]).
Like DUINDAM, AVERBUCH teaches showing an overview while also showing an interior view from within the airway. “During navigation to the target lesion 102, an virtual interior view of the airway will be displayed along with the overview 100. This interior view may be realistic, constructed from CT scans, for example, or may be very basic (schematic)” ([0023]). The overview includes “a path 104” that is “determined in a pre-operative planning stage, either manually or automatically, or a combination thereof (semi-automatically, for example).” ([0022]). The overview also shows an indicator that represents the position of the probe. More specifically, AVERBUCH shows an “arrowhead 108, or some other indication” as the probe advances along the path. ([0024] and [0025]). Compare Figures 4, 6, 8, and 10 to see
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how the arrowhead 108 continues to advance through the airway.
It would have been obvious to one having ordinary skill in the art to illustrate an overview that shows an indicator that is located at an insertion depth of the distal end of the bendable medical device in the biological lumen as the indicator. One would be motivated to show the indicator at the depth of the distal tip as it more clearly indicates the distal tip relative to the airway structure and where the distal tip is located along the path. There would have been a reasonable expectation of success as DUINDAM teaches a similar overview with the airway structure and the indicator is graphical addition.
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Neither DUINDAM or AVERBUCH teach that the indicator is a guidance reference plane oriented perpendicular to the navigation path.
However, it is well-known GUI feature to identify a location within a patient’s anatomy (represented by 3D medical imaging data) using a reference plane. For example, HANSEGARD teaches a system “for displaying a three-dimensional (3D) ultrasound dataset” and “a user interface for translating a slice plane through the 3D ultrasound dataset.” (Abstract). In HANSEGARD, an operator is able to manually position a slice plane with respect to a ROI. (see, e.g., Figure 5 and [0033]). The purpose of the slice plane, as opposed to other indicators, is that the plane provides not just a location or position along one or two dimensions but an orientation within three dimensions.
It would have been obvious to one having ordinary skill in the art to replace the arrowhead of AVERBUCH with a reference plane as taught in HANSEGARD. Both DUINDAM and AVERBUCH concern navigating through 3D models and AVERBUCH suggests than another indicator (other than an arrowhead) may be used. One would be motivated to replace the arrowhead with a plane because, as demonstrated by HANSEGARD, a reference plane can indicate orientation within three dimensions. The plane would be oriented perpendicular to the navigation path because that orientation would provide the perspective for viewing downstream from the current position (i.e., where the distal tip is heading). There would have been a reasonable expectation of success as DUINDAM is concerned with 3D image data and graphics and one skilled in the art could replace the arrowhead with a plane.
With respect to claim 2, DUINDAM teaches wherein the representation of the airway structure comprises: a centerline, a target site, or both the centerline and the target site are shown on the representation of the airway structure. (see Figure 3 and [0049]: “Such target locations 312 may also be incorporated into (e.g., overlaid, superimposed, otherwise combined with) any of the images in the GUI as demonstrated in images 306 and 308.”).
With respect to claim 3, DUINDAM teaches that the controller is further configured to display a guidance virtual endoscope view having an image center at the centerline on the guidance reference plane and a view orientation of the distal direction along the orientation of the guidance reference plane. (see Figure 3 and [0048]: “a virtual endoscopic image 304 generated from pre-operative or intra-operative imaging processed by the virtual visualization system”: NOTE: The image center is at the center of the path and the view is downstream (i.e., distal direction). See also Figure 6A of Applicant’s disclosure in which the view of the “guidance virtual endoscope view 426” is similar to the view in DUINDAM’s virtual endoscopic image 304).
With respect to claim 4 (depending from claim 3), DUINDAM teaches that the controller is further configured to display a second virtual endoscope view having an image center at the distal end of the bendable medical device. (see Figures 3 and 4 and [0051]: “The navigation aid image 314 provides an adaptive targeting system that provides information about distance and direction for use by a surgeon when guiding the tip portion 218 of an interventional instrument to a target location. The image 314 is updated as the tip portion 218 is moved within the patient anatomy to provide the surgeon with current information about the position and orientation of the tip portion relative to the target location.”).
With respect to claim 5, DUINDAM teaches that the controller is further configured to display on the display device navigation information comprising at least one of: a navigation modality, a distance from the bendable medical device to target site; an insertion depth of the bendable medical device; an information as to the position of a marker displayed on the airway structure; and a warning(s) that the bendable medical device is reaching a threshold limit of force or bending angle. (see Figure 3 and [0049]: “a distance display 316.” NOTE: Figure 3 also shows a “navigation modality” in upper right corner as “park” or “passive” or “manual”).
With respect to claim 7, the combination of DUINDAM, AVERBUCH, and HANSEGARD teach that wherein the controller is configured to update the display of the guidance reference plane as the bendable medical device is moved through the airway structure. (Figure 3 shows graphical representation of instrument 313 which is updated during the procedure. “Additionally, the other images in the GUI 300, such as the virtual overview pathway image 306 and the pre-operative image 312 rotate appropriately to reflect the orientation of the tip portion.” ([0062])).
It would have been obvious to one having ordinary skill in the art to update the display of the guidance reference plane as the bendable medical device is moved through the airway structure. One would have been motivated to update the display as the medical device is moved as the purpose of the navigation system is to inform the surgeon of the current location and orientation of the medical device. There would have been a reasonable expectation of success as DUINDAM and AVERBUCH already teach updating the location of the device and indicator.
With respect to claim 8, the combination of DUINDAM, AVERBUCH, and HANSEGARD teach that wherein the guidance reference plane is displayed as having a three-dimensional perspective. DUINDAM teaches that the “virtual overview pathway image 306 [provides] an overview of the anatomical passageway system and [is] generated from pre-operative or intra-operative imaging processed by the virtual visualization system.” ([0048]). DUINDAM also teaches that “[t]he presented preoperative or intra-operative images may include two-dimensional, three-dimensional, or four-dimensional (including e.g., time based or velocity based information) images and models.” ([0026]).
As discussed above with respect to claim 1, the purpose of the slice plane, as opposed to other indicators, is that the plane provides not just a location or position along one or two dimensions but an orientation within three dimensions.
It would have been obvious to one having ordinary skill in the art to display the guidance reference plane as having a three-dimensional perspective. One would have been motivated to use the three-dimensional perspective quality of the plane as the purpose of the 3D navigation system is to inform the surgeon of the current location and orientation of the medical device. There would have been a reasonable expectation of success as HANSEGARD teaches that a reference plane can be oriented within 3D space.
With respect to claim 9, DUINDAM teaches that the representation of the airway structure is a model of a patient airway based on one or more computerized tomography (CT) scanner data and/or magnetic resonance imaging (MRI) scanner data. DUINDAM teaches that the “virtual overview pathway image 306 [provides] an overview of the anatomical passageway system and [is] generated from pre-operative or intra-operative imaging processed by the virtual visualization system.” ([0048]). “More specifically, the virtual visualization system processes images of the surgical site recorded and/or modeled using imaging technology such as computerized tomography (CT), magnetic resonance imaging (MRI)….” ([0031]).
With respect to claim 10, DUINDAM teaches that wherein the representation of the airway structure further includes one or more markers indicating one or more bifurcation points of the airway structure. (see Figure 3 and [0049]: “The virtual roadmap 310 may be used by the surgeon to guide insertion of the interventional instrument 200 in order to reach target locations 312 which are identified before or during surgery. Such target locations 312 may also be incorporated into (e.g., overlaid, superimposed, otherwise combined with) any of the images in the GUI as demonstrated in images 306 and 308. A target location may include, for example, a tumor which the surgeon intends to remove or biopsy, a part of the anatomy which the surgeon intends to image or analyze with equipment in the interventional instrument system 200, a bifurcation in an anatomical passageway,….”).
With respect to claim 13, DUINDAM teaches a medical system comprising: a bendable medical device; an actuator system for actuating the bendable medical device and the navigation system of claim 1. (see “flexible catheter body 206” in Figure 2. With respect to the “actuator system” see [0045]: “The flexible catheter body 216 may also house cables, linkages, or other steering controls (not shown) that extend between the instrument body 204 and the distal end 218 to controllably bend or turn the distal end 218 as shown for example by the dotted line versions of the distal end. In embodiments in which the instrument system 200 is actuated by a robotic assembly, the instrument body 204 may include drive inputs that couple to motorized drive elements of the robotic assembly” and see [0023]: “The robotic assembly 102 includes plurality of actuators (e.g., motors) that drive inputs on the interventional instrument 104. These motors actively move in response to commands from the control system (e.g., control system 112).”).
With respect to claim 14 (depending from claim 13), DUINDAM teaches wherein the controller is further configured to display a guidance virtual endoscope view having an image center at the centerline on the guidance reference plane and a view orientation of the distal direction along the orientation of the guidance reference plane. (see Figure 3 and [0048]: “a virtual endoscopic image 304 generated from pre-operative or intra-operative imaging processed by the virtual visualization system”: NOTE: The image center is at the center of the path and the view is downstream (i.e., distal direction). See also Figure 6A of Applicant’s disclosure in which the view of the “guidance virtual endoscope view 426” is similar to the view in DUINDAM’s virtual endoscopic image 304).
Claims 15-18 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Appl. Publ. No. 2016/0183841 A1 (hereinafter “DUINDAM”), U.S. Patent Appl. Publ. No. 2009/0227861 A1 (hereinafter “GANATRA”), U.S. Patent Appl. Publ. No. 2019/0362552 A1 (hereinafter “AVERBUCH”), and U.S. Patent Appl. Publ. No. 2012/0176365 A1 (hereinafter “HANSEGARD”).
With respect to claim 15, DUINDAM teaches a method for controlling a display. DUINDAM teaches “systems and methods for navigating a patient anatomy to conduct a minimally invasive procedure, and more particularly to apparatus and methods for using a graphical user interface to assist interventional instrument guidance.” ([0001]). DUINDAM also teaches a control system having memory and at least one processor for “effecting control” of the display system. ([0029]). The method includes:
acquiring an image of a biological lumen from the distal end of the bendable medical device (Figure 3 and [0048]: “an endoscopic camera image 302 generated by an endoscopic camera within the patient anatomy”);
obtaining a representation of an airway structure (Id.: “a virtual overview pathway image 306 providing an overview of the anatomical passageway system);
obtaining a target site ([0049]: “The virtual roadmap 310 may be used by the surgeon to guide insertion of the interventional instrument 200 in order to reach target locations 312 which are identified before or during surgery.”);
generating a navigation path through at least a portion of the airway structure to the target site ([0049]: “the GUI 300 additionally contains guidance information in the form of a virtual roadmap 310”);
displaying, on a display device, the representation of an airway structure (see “virtual overview pathway image 306” in Figure 3 showing airway structure), wherein the a representation of an airway structure further comprises: a navigation path through at least
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a portion of the airway structure; and wherein the representation of the airway structure further comprises: a navigation path through at least a portion of the airway structure.
However, DUINDAM does not explicitly teach the method including generating a centerline of at least a portion of the airway structures;
In the same field of endeavor, GANATRA teaches generating a centerline of an airway structure using 3D data. “FIG. 1 is an over-all view, alongside a close-up view, of a model of a bronchial tree structure generated from a volumetric data set of images collected via CT scanning of an exemplary patient. FIG. 1 illustrates the model including a surface outline of the tree and a pathway (bolder lines) along branches of the tree, which is defined by predetermined points from the data set, for example, centerline points of the branches of the tree. A subset of the predetermined points defining the pathway, which will be called designated points, include a reference point within a coordinate system of the model and other points, each located at an unique Euclidean distance (i.e. straight line distance) from the reference point, for a given branch of the tree.” ([0017]).
It would have been obvious to one having ordinary skill in the art to generate a centerline of at least a portion of an airway structure. One would have been motivated to generate the centerlines because the centerline is used to generate bronchial tree as well as the navigation path as taught in GANATRA. There would have been a reasonable expectation of success as GANATRA teaches 3D models can be generated to make bronchial trees based on the centerlines.
However, DUINDAM and GANATRA do not explicitly teach that the representation of the airway structure further comprising a guidance reference plane oriented perpendicular to the navigation path and located at an insertion depth of the distal end of the bendable medical device in the biological lumen.
In the same field of endeavor, AVERBUCH teaches systems and methods that “uses a system of planned waypoints along a planned route through the bronchial tree in order to incrementally advance the image presented to the physician.” ([0008]). “Thus, a physician using the system and method of the present invention will see an image of the bronchial tree and an image of the sensor being advanced through the airways to a subsequent waypoint.” ([0009]).
Like DUINDAM, AVERBUCH teaches showing an overview while also showing an interior view from within the airway. “During navigation to the target lesion 102, an virtual interior view of the airway will be displayed along with the overview 100. This interior view may be realistic, constructed from CT scans, for example, or may be very basic (schematic)” ([0023]). The overview includes “a path 104” that is “determined in a pre-operative planning stage, either manually or automatically, or a combination thereof (semi-automatically, for example).” ([0022]). The overview also shows an indicator that represents the position of the probe. More specifically, AVERBUCH shows an “arrowhead 108, or some other indication” as the probe advances along the path. ([0024] and [0025]). Compare Figures 4, 6, 8, and 10 to see
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how the arrowhead 108 continues to advance through the airway.
It would have been obvious to one having ordinary skill in the art to illustrate an overview that shows an indicator that is located at an insertion depth of the distal end of the bendable medical device in the biological lumen as the indicator. One would be motivated to show the indicator at the depth of the distal tip as it more clearly indicates the distal tip relative to the airway structure and where the distal tip is located along the path. There would have been a reasonable expectation of success as DUINDAM teaches a similar overview with the airway structure and the indicator is graphical addition.
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None DUINDAM, GANATRA, or AVERBUCH teaches that the indicator is a guidance reference plane oriented perpendicular to the navigation path.
However, it is well-known GUI feature to identify a location within a patient’s anatomy (represented by 3D medical imaging data) using a reference plane. For example, HANSEGARD teaches a system “for displaying a three-dimensional (3D) ultrasound dataset” and “a user interface for translating a slice plane through the 3D ultrasound dataset.” (Abstract). In HANSEGARD, an operator is able to manually position a slice plane with respect to a ROI. (see, e.g., Figure 5 and [0033]). The purpose of the slice plane, as opposed to other indicators, is that the plane provides not just a location or position along one or two dimensions but an orientation within three dimensions.
It would have been obvious to one having ordinary skill in the art to replace the arrowhead of AVERBUCH with a reference plane as taught in HANSEGARD. Both DUINDAM and AVERBUCH concern navigating through 3D models and AVERBUCH suggests than another indicator (other than an arrowhead) may be used. One would be motivated to replace the arrowhead with a plane because, as demonstrated by HANSEGARD, a reference plane can indicate orientation within three dimensions. The plane would be oriented perpendicular to the navigation path because that orientation would provide the perspective for viewing downstream from the current position (i.e., where the distal tip is heading). There would have been a reasonable expectation of success as DUINDAM is concerned with 3D image data and graphics and one skilled in the art could replace the arrowhead with a plane.
With respect to claim 16, DUINDAM teaches further comprising displaying, on the display device, the image of a biological lumen. (Figure 3 and [0048]: “an endoscopic camera image 302 generated by an endoscopic camera within the patient anatomy”).
With respect to claim 17, DUINDAM teaches wherein the representation of an airway structure is obtained from a pre-operative CT image. DUINDAM teaches that the “virtual overview pathway image 306 [provides] an overview of the anatomical passageway system and [is] generated from pre-operative or intra-operative imaging processed by the virtual visualization system.” ([0048]). “More specifically, the virtual visualization system processes images of the surgical site recorded and/or modeled using imaging technology such as computerized tomography (CT), magnetic resonance imaging (MRI)….” ([0031]).
With respect to claim 18, DUINDAM teaches wherein the target site is obtained from a user. ([0049]: “The virtual roadmap 310 may be used by the surgeon to guide insertion of the interventional instrument 200 in order to reach target locations 312 which are identified before or during surgery. Such target locations 312 may also be incorporated into (e.g., overlaid, superimposed, otherwise combined with) any of the images in the GUI as demonstrated in images 306 and 308. A target location may include, for example, a tumor which the surgeon intends to remove or biopsy, a part of the anatomy which the surgeon intends to image or analyze.” (emphasis added)).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Appl. Publ. No. 2016/0183841 A1 (hereinafter “DUINDAM”) and U.S. Patent Appl. Publ. No. 2019/0362552 A1 (hereinafter “AVERBUCH”) and U.S. Patent Appl. Publ. No. 2012/0176365 A1 (hereinafter “HANSEGARD”) as applied to claim 1 above, and further in view of U.S. Patent Appl. Publ. No. 2019/0246882 A1 (hereinafter “GRAETZEL”).
With respect to claim 6, none of the cited art teach wherein the controller is configured to initiate a corrective action when the bendable medical device is reaching a threshold limit of force or bending angle. ([0030]: “control system 112 may include one or more servo controllers to provide force and torque feedback from the interventional instrument system 104 to one or more corresponding servomotors for the operator input system 106.”).
GRAETZEL is concerned with “systems and techniques for driving a medical instrument….” (Abstract). GRAETZEL is particularly concerned with bronchoscopy. (see, e.g., [0003], [0047]). GRAETZEL monitors tension of the medical instrument to avoid damage to the instrument or injury to the patient. (
“FIG. 30 illustrates an embodiment of tension monitoring for a medical instrument in accordance with aspects of this disclosure. In particular, FIG. 30 illustrates a number of articulation actions 1300 which may be taken by the system based on a comparison of the tension measured in one or more of the tendons of a one of the outer and inner bodies to four threshold tension values.” ([0177]). “When the measured tension is greater than the third threshold value, but less than a fourth threshold value, the system may automatically relax the inner body 1320. After the articulation is capped, the tension in the tendon may increase in certain situations, such as when retracting the inner body into a portion of the lumen, or the lumen changing shape and applying a force to the tendon. The system may normally adjust the force applied to the tendons in response to external forces applied to the tendon, and thereby, increase the force to the tendon in order to maintain the current amount of articulation. By providing an auto-relax function 1320 when the tension is greater than third threshold value, the system may prevent the forces applied by the inner body to the lumen from reaching a level that may cause injury to the patient.” ([0179]).
It would have been obvious to one having ordinary skill in the art to incorporate the injury-avoidance feature of GRAETZEL. One would be motivated to incorporate this feature in order to reduce injury to the patient during bronchoscopic procedures. There would be a reasonable expectation of success as GRAETZEL teaches that the feature can be incorporated into systems for bronchoscopy.
Claims 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Appl. Publ. No. 2016/0183841 A1 (hereinafter “DUINDAM”) and U.S. Patent Appl. Publ. No. 2019/0362552 A1 (hereinafter “AVERBUCH”) and U.S. Patent Appl. Publ. No. 2012/0176365 A1 (hereinafter “HANSEGARD”) as applied to claim 1 above, and further in view of U.S. Patent Appl. Publ. No. 2016/0371883 A1 (hereinafter “MERKINE”).
With respect to claim 11 (and in light of the Section 112 rejection) and claim 12 (which depends from claim 11), the cited art does not teach wherein, in response to a user input selecting a bifurcation point, the guidance reference plane is movable to the bifurcation point of the airway structure to preview the navigation path (claim 11) and does not teach wherein the user input comprises selecting a markers indicating one or more bifurcation points of the airway structure located on the representation of the airway structure (claim 12).
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MERKINE teaches “systems and methods for dynamically displaying medical images during forward and backward movement in a virtual bronchoscopy during pathway planning based on a position and a direction of a virtual camera being navigated through airways of the lungs.” (emphasis added) ([0003]). MERKINE teaches selecting a series of locations and directions associated with the locations along a planned path. (see, e.g., [0006]).
“Once a pathway plan is generated, a virtual bronchoscopy view (illustrated in FIGS. 6A-6C) may be displayed, which allows a clinician to navigate within the virtual airways of the patient based on the pathway plan.” ([0031]). Figures 6A-6C illustrated the planned path. With the planned path, a user can select different locations (i.e., points) along the planned path and then view the image associated with that location. “In FIG. 6A, a user is able to see, in virtual bronchoscopy window 600, pathway 660 containing locations 510, 520, and 530 along with the forking branches of airway passage 501. As the virtual camera approaches location 520 (FIG. 6B), the view shown in virtual bronchoscopy window 600 is approaching the forking branches. Once the virtual camera has reached location 530 (FIG. 6C), an airway passage is displayed at location 530. During forward motion, a user moves the pointer or cursor with an input device such as a mouse, keyboard, or touchpad, and selects locations forward along pathway 660, such as locations 510, 520, and 530.” (emphasis added) ([0056]).
Each of the locations 520 and 530 is represented by a marker shown in Figures 6A-6C. As discussed above, the markers are selectable by the user. Notably, the location 520 corresponds to an overview guidance reference plane. “During forward motion, a user moves the pointer or cursor with an input device such as a mouse, keyboard, or touchpad, and selects locations forward along pathway 660, such as locations 510, 520, and 530. Thus, as a user notices forking branches, a user is able to select locations along pathway 660 which enter the forking branches, such as location 530. As each location is selected during forward motion, the virtual camera centers the view at that location.” ([0056]).
Accordingly, MERKINE teaches a “virtual bronchoscopy window” having a virtual image that is similar to the virtual endoscopic image of DUINDAM. The selectable locations in MERKINE change the virtual image to the virtual image associated with that location. Notably, Figure 5 of MERKINE shows a “3D map window” that includes a 3D model of a bronchial tree similar to the overview pathway image of DUINDAM. The locations 510, 520, and 530 of MERKINE are shown in the 3D model. Thus, the indicator (i.e., guidance reference plane) would move to the location within the 3D model that is associated with the selected location.
With respect to claim 11, it would have been obvious to one having ordinary skill in the art to incorporate the pathway planning feature of MERKINE that allows one to select locations, including those associated with a bifurcation, that would move the guidance reference plane to the location associated with the bifurcation. One would be motivated to include this feature because viewing virtual images along the pathway help the physician better understand the overall procedure. There would have been a reasonable expectation of success as both DUINDAM and MERKINE concern viewing virtual pathways for bronchoscopic procedures.
With respect to claim 12, It would have also been obvious to one having ordinary skill in the art to allow a user to preview the planned pathway location-by-location by selecting (i.e., by user input) markers that represent the locations along the planned pathway as taught by MERKINE. The locations would include those associated with bifurcations. One would be motivated to include this feature because viewing virtual images along the pathway help the physician better understand the overall procedure and selecting the locations allows the physician to view the more relevant points along the pathway (e.g., the bifurcation points). There would have been a reasonable expectation of success as both DUINDAM and MERKINE concern viewing virtual pathways for bronchoscopic procedures.
RESPONSE TO APPLICANT’S ARGUMENTS
The Office Action relies upon AVERBUCH and HANSEGARD for teaching a guidance reference plane oriented perpendicular to the navigation path and located at an insertion depth of the distal end of the bendable medical device in the biological lumen. AVERBUCH is relied upon for teaching an indicator being located at an insertion depth of the distal end of the bendable medical device in the biological lumen. HANSEGARD is relied upon for teaching that the “indicator” is a reference plane that is oriented perpendicular to the navigation path.
As an initial matter, Applicant argues that claim 1 recites “a guidance reference plane that is ‘at an insertion depth’ of the bendable medical device. This is dynamically updated as the bendable medical device moves through the biological lumen.” (p.7 of the Response). The claims do not recite the guidance reference plane being dynamically updated. Claim 7 recites that the controller is configured to update the display of the guidance reference plane as the bendable medical device is moved through the airway structure. However, claim 1 does not require that the guidance reference plane being dynamically or continuously updated. This interpretation is consistent with Applicant’s disclosure. “The guidance reference plane is optionally updated as the bendable medical device is moved through the airway structure.” (emphasis added) ([0010]). The disclosure also suggests the guidance reference plane is movable away from the medical device by the user. ([0012]).
Applicant argues against the references individually. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
With respect to AVERBUCH, Applicant argues that the reference does not teach an arrowhead (or other indication) moving with the tip of the locatable guide as the locatable guide is moved. (p.7 of the Response). Instead, Applicant appears to allege that the arrowhead only appears at waypoints or its position is somehow determined by waypoints.
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[AltContent: arrow][AltContent: arrow]Examiner disagrees. The arrowhead provides a depiction of the location of the tip of the locatable guide as it moves through the lumen. “Also, as seen in FIG. 6, the arrowhead 108 continues to advance along the path. It is envisioned that the arrowhead 108 may always be depicted along the desired path, thereby providing only an indication of how far along the path the locatable guide has been advance, or more preferably, the arrowhead may float independent of the path, thereby providing indication of the location of the locatable guide in the event that the physician has advanced the tip of the probe down an incorrect airway.” ([0025]).
Applicant alleges that “[t]he Action also argues that the waypoint is ‘an indicator that represents the position of the probe.’ (Action page 10).” This statement is not correct. The Office Action states that “[t]he overview also shows an indicator that represents the position of the probe.” The overview refers to a realistic display of the bronchial tree. ([0021]). Furthermore, this portion of the Office Action also specifically refers to the arrowhead as indicating the position of the probe.
Figures 4, 6, and 8 of AVERBUCH are shown above here and include the overview 100. The figures indicate the movement of the arrowhead 108 and the positions of waypoints 106a, 106b. As shown, the arrowhead 108 is capable of moving to locations between the waypoints. For example, in Figures 6 and 8, the arrowhead 108 is located between waypoints 106a and 106b. By comparing Figures 6 and 8, the arrowhead 108 only moves a small distance away from the waypoint 106a and toward the waypoint 106b. To be clear, the position of the arrowhead in AVERBUCH is not determined by the waypoints.
With respect to HANSEGARD, Applicant focuses on HANSEGARD’s purpose in moving the reference plane (i.e., to measure parameters of the anatomical structure). The Office Action does not rely upon these teachings. AVERBUCH already suggests that another indicator can be used. HANSEGARD is that other indicator. As explained above, one would be motivated to replace the arrowhead with a plane because, as demonstrated by HANSEGARD, a reference plane can indicate orientation within three dimensions. The plane would be oriented perpendicular to the navigation path because that orientation would provide the perspective for viewing downstream from the current position (i.e., where the distal tip is heading).
Prior Art Made of Record
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US-20200078103-A1 teaches a “field of view indicator.” (Figure 6). “I n some examples, field of view indicator 625 may be displayed as a prism and/or conical shape. In some examples, a miniature version of camera view window 410 and/or virtual endoscopic view window 420 may be projected onto the flat face of field of view indicator 625 to further reinforce the correspondence between each of the various windows.” ([0082]).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/JASON P GROSS/ Examiner, Art Unit 3797
/SERKAN AKAR/ Primary Examiner, Art Unit 3797
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