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 .
Response to Amendment
In response to the amendment filed 2/13/2026; Claims 1,4-5,7-14,16-20, 22-24 and 29 are pending; claims 2-3,6,15,21 and 25-28 have been cancelled.
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.
Claims 1, 11 – 14, 16 – 17, 24 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Cotin et al. (US 2008/0020362 A1) in view of Higgins et al. (US 2008/0183073 A1) and Duindam et al. (US 2020/0054399 A1).
Re claim 1:
1. Cotin teaches a system (Cotin, Abstract) comprising:
a user control system including at least one input control device for controlling motion of a virtual medical instrument through a virtual passageway (Cotin, [0074]; [0050]);
a display for displaying a graphical user interface and a plurality of training exercises, the graphical user interface including a representation of the virtual medical instrument and a representation of the virtual passageway (Cotin, [0027]; fig. 16; [0109]; [0116]; [0135]); and
a non-transitory, computer-readable storage medium that stores a plurality of instructions executable by one or more computer processors (Cotin, [0047] – [0048]), the instructions for performing operations comprising:
navigating the virtual medical instrument through the virtual passageway based on commands received from the user control system (Cotin, [0152]; fig. 16; [0040]; [0050]); and
evaluating one or more performance metrics for tracking the navigation of the virtual medical instrument through the virtual passageway (Cotin, [0075], “real-time performance”; [0103], “Visual feedback”; [0152], “set of performance assessment metrics can be developed that track specific physical parameters in a simulation system----deviation of a device from its optimal path of motion, for example, or force exerted on a structure”).
Cotin does not explicitly disclose wherein the virtual passageway includes a plurality of sequentially-aligned virtual targets, and wherein the plurality of sequentially-aligned virtual targets indicate a traversal path through the virtual passageway relative to a longitudinal axis of the virtual passageway, wherein the traversal path is to be traversed by the virtual medical instrument as the virtual medical instrument traverses the virtual passageway, and wherein a position of each of the sequentially-aligned virtual targets relative to the longitudinal axis of the virtual passageway is determined based on a shape of the virtual passageway.
Higgins et al. (US 2008/0183073 A1) teaches methods and apparatus assist in planning routes through hollow, branching organs in patients to optimize subsequent endoscopic procedures (Higgins, Abstract).
Higgins teaches wherein the virtual passageway includes a plurality of sequentially-aligned virtual targets, and wherein the plurality of sequentially-aligned virtual targets indicate a traversal path through the virtual passageway relative to a longitudinal axis of the virtual passageway, wherein the traversal path is to be traversed by the virtual medical instrument as the virtual medical instrument traverses the virtual passageway, and wherein a position of each of the sequentially-aligned virtual targets relative to the longitudinal axis of the virtual passageway is determined based on a shape of the virtual passageway (Higgins, fig. 2; [0061], “Each route consists of a sequence of view sites within the 3D medical data”; view sites are sequentially-aligned virtual target; [0011], “the complex branching organs of interest contain many unique paths”; [0018], “approach, segmentation and centerline analysis” Higgins uses so called “centerline-analysis methods” determine the axial structure of the airway tree (Higgins, [0008]). The path with a plurality of view sites is placed in the center of the observed organ (Higgins, [0045], “Invention resides in automated techniques for 3D route planning that: (1) locate the closest paths to a target ROI and (2) extend an incomplete path, if necessary, so that it reaches the ROI. Given a 3D medical image, our methods take as input: (1) precisely defined ROIs; (2) a segmentation of the branching organ through with the endoscopic device will navigate; (3) centerlines (paths) through the segmented organ; and (4) parametric description of the endoscopic device”; [0053], “the tree could be the central axes of the lung airways. Each view site in the tree can optionally be augmented with anatomical labels”);
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Therefore, in view of Higgins, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the system described in Cotin, by providing the plurality of view sites on the path as taught by Higgins, since it was known in the art to provide a plurality of waypoints to form a path. Higgins further suggests that assist in planning routes through hollow, branching organs in patients to optimize subsequent endoscopic procedures (Higgins, Abstract).
Cotin does not explicitly disclose displaying, on the graphical user interface, one or more user instructions to guide a user in navigating the virtual medical instrument through the virtual passageway to complete a first training exercise of the plurality of training exercises, wherein the user instructions are adjustable based on a current progress of the first training exercise.
Duindam et al. (US 2020/0054399 A1) teaches A system and method of monitoring a procedure includes a medical device (Duindam, abstract). Duindam teaches displaying, on the graphical user interface, one or more user instructions to guide a user in navigating the virtual medical instrument through the virtual passageway to complete a first training exercise of the plurality of training exercises, wherein the user instructions are adjustable based on a current progress of the first training exercise (Duindam, [0006], “the method where dynamically displaying the real-time position information includes displaying one or more indicators when an anomaly is detected; the method where when the anomaly includes steering the instrument down an incorrect passageway, the one or more indicators includes a wrong turn indicator; the method where when the anomaly includes driving the instrument beyond an end of the route, the one or more indicators includes a reverse indicator; the method where when the anomaly includes a tight bend radius of the instrument, the one or more indicators includes an excessive bend indicator”; [0069], “The clinician can then proceed with driving the catheter through anatomy while monitoring navigation progress on the graphical user interface”; [0073], “graphical user interface 400 may include various views, controls, indicators, and/or the like, in addition to those depicted in FIG. 4. For example, graphical user interface 400 may include a header, footer, one or more sidebars, message bars, popup windows, backgrounds, overlays, and/or the like”; [0097], “the target indicator/s could be overlaid on the segment, and/or the location of the target may be indicated by altering the color, weight, hue, and/or transparency of the corresponding segment”; [0112], “catheter 1130 may be overlaid on simplified route path 1110 in a contrasting color or shade, such as green. Various indicators and/or alerts may be displayed when anomalies are detected. For example, when catheter 1130 makes a wrong turn, a wrong turn indicator 1142 may appear”; Duindam includes a plurality of indicators that response to real time positions of the probe operated by a user; wherein the indicators are instructions such as wrong turn, reverse, excessive bend, … figs. 5A – 5D further shows instructions that depends on completion of one or more previous steps). Therefore, in view of Duindam, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the system described in Higgins, by providing the navigation progress indicator(s) as taught by Duindam, in order to provide supplemental guidance information that includes one or more direction indicators (a circle with an arrow) in various forms to help navigate branches (Duindam, [0116]; [0119]) and displays an elongated representation of the planned route to the target location, with various features along the route, including the target location, shown in a simplified format (Duindam, [0084]).
Re claims 11 – 12, 16:
Higgins teaches 11. The system of claim 1, wherein the plurality of sequentially-aligned virtual targets is within a lumen of the virtual passageway. 12. The system of claim 11, wherein the traversal path is different than the longitudinal axis of the virtual passageway. 16. The system of claim 13, wherein the traversal path is the optimal traversal path (Higgins, fig. 2; [0061], “Each route consists of a sequence of view sites within the 3D medical data”; view sites are sequentially-aligned virtual target; [0011], “the complex branching organs of interest contain many unique paths”; [0018], “approach, segmentation and centerline analysis”; [0083], “the set of paths in the input tree may not yield routes that adequately reach the ROI”; [0104], “its neighbors on the same path will likely determine unacceptable routes as well”).
Re claim 17:
17. The system of claim 11, wherein the performance metric tracks a number of virtual targets of the plurality of sequentially-aligned virtual targets contacted by the virtual medical instrument, and wherein the instructions for performing operations further comprise: displaying, on the graphical user interface, the performance metric as the virtual medical instrument navigates through the virtual passageway (Duindam, [0130], “a timer 1570 may be displayed to indicate the amount of elapsed time since the clinician started the time. Timer 1570 may, for example, be used to track the duration of a breath hold, or the duration of the procedure, or otherwise. Timer 1570 may be started and/or stopped manually by the physician and/or automatically when certain events are measured by the system, such as detection of the start and stop of a breath hold. Timer 1570 may change appearance (e.g., color, font, size, texture, etc.) to alert the clinician to hazardous conditions, such as the elapsed time exceeding a predetermined threshold ( e.g., one minute)”; [0007], “the medical device where the one or more indicators includes one or more of a wrong turn indicator, a reverse indicator, and an excessive bend indicator”; [0099], “Drive force indicator 800 displays a visual and/or an alphanumeric representation of the axial drive force … other plotting techniques may be used, such as a one-sided bar plot, a line plot, a scatter plot, and/or the like.”; wrong turn / reverse / excessive bend indicator, time / duration or visual / alphanumerical representation are examples of performance metric associated with the virtual instrument).
Re claim 13:
13. The system of claim 1, wherein the instructions for performing operations further comprise determining an optimal traversal path of the virtual passageway (Cotin, [0152], “set of performance assessment metrics can be developed that track specific physical parameters in a simulation system----deviation of a device from its optimal path of motion, for example, or force exerted on a structure”).
Re claim 14:
14. The system of claim 13, wherein the optimal traversal path includes a final target and an optimal position of the virtual medical instrument at the final target (Cotin, [0152], “set of performance assessment metrics can be developed that track specific physical parameters in a simulation system----deviation of a device from its optimal path of motion, for example, or force exerted on a structure”).
Re claim 24:
24. The system of claim 1, wherein the display includes a first display device and a second display device, wherein the first display device displays the graphical user interface and the second display device displays the plurality of training exericses (Cotin, [0038]; fig. 17).
Re claim 29:
29. The system of claim 1, wherein when the virtual medical instrument contacts a virtual target of the plurality of sequentially-aligned virtual targets, an effect is presented to a user (Cotin, [0057], “With such a representation, efficient collision detection and/or collision response algorithms can be developed; stable vessel deformation and real-time flow simulation can be performed, as well as multi-scale anatomical visualization”; [0118], “the motion of any device navigating within the anatomy will respond to the deformation thanks to the collision detection and collision response algorithms”).
Claims 4 – 5, 7 – 8 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Cotin, Higgins and Duindam as applied to claim 1 above, and further in view of Van Dinther (US 2013/0046523 A1).
Re claims 4 - 5:
Cotin teaches 4. The system of claim 1, wherein the performance metric tracks contact occurs between the virtual medical instrument and a wall of the virtual passageway (Cotin, [0026]). Cotin does not explicitly number of contacts (collisions).
Van Dinther teaches a method of determining a position of an object in a virtual environment and for assessing a performance in the movement of said object (Van Dinther, Abstract). Van Dinther teaches 4. The system of claim 1, wherein the performance metric tracks a number of times contact occurs between the virtual medical instrument and a wall of the virtual passageway. 5. The system of claim 4, wherein the performance metric further tracks for each of the number of times contact occurs, a length of time the virtual medical instrument makes contact with the wall of the virtual passageway (Van Dinther, [0141], “other parameters which may be recorded include tip collisions … counting collisions, a measure of the force of impact and the angle of incidence may also be recorded so as to identify occasions where there may have been a danger/discomfort to a patient in a real-life scenario”; [0018], “determining a direction of motion of a said segment following the impact by combining data representing each wall being impacted”; [0055]; [0154], “containing information on the position and orientation of each segment of the simulated bronchoscope … the time since the simulation started… a record is made of what "happened" i.e., movement of tube segments is recorded”). Therefore, in view of Van Dinther, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the system described in Van Dinther, by tracking number of collisions as taught by Van Dither, since counting collisions, a measure of the force of impact and the angle of incidence may also be recorded so as to identify occasions where there may have been a danger/discomfort to a patient in a real-life scenario (Van Dinther, [0141]).
Re claim 7:
7. The system of claim 4, wherein the performance metric further tracks deformation of the virtual medical instrument during the contact (Cotin, [0057], “With such a representation, efficient collision detection and/or collision response algorithms can be developed; stable vessel deformation and real-time flow simulation can be performed, as well as multi-scale anatomical visualization”; [0118], “the motion of any device navigating within the anatomy will respond to the deformation thanks to the collision detection and collision response algorithms”).
Re claim 8:
8. The system of claim 4, wherein contact is determined by a collision force exerted on the wall of the virtual passageway by the virtual medical instrument exceeding a threshold collision force (Cotin, [0074]; [0093]; [0095]).
Re claim 10:
10. The system of claim 4, wherein the graphical user interface further includes a representation of the contact on the representation of the virtual passageway (Cotin, [0057], “With such a representation, efficient collision detection and/or collision response algorithms can be developed; stable vessel deformation and real-time flow simulation can be performed, as well as multi-scale anatomical visualization”; [0118], “the motion of any device navigating within the anatomy will respond to the deformation thanks to the collision detection and collision response algorithms”).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Cotin, Higgins, Duindam and Van Dinther as applied to claim 8 above, and further in view of Cotin et al. (US 6,714,901 B1, Cotin’901).
Re claim 9:
Cotin does not explicitly disclose the amount of deforms corresponds to the collision force. Cotin’901 teaches an electronic device for processing image data. Cotin’901 further teaches the limitation: 9. The system of claim 8, wherein the collision force is based on a distance the virtual medical instrument travels beyond the wall of the virtual passageway (Cotin’901, col. 5, lines 41 – 47, “the collision detection module is capable of modifying the contents of the multiplets between two determinations of presence of points of the tool inside the volume blocks, in the event of detection of a deformation of the mesh by the internal forces module”; col. 2, lines 51 – 56, “calculating the internal forces and the deformation of the volume mesh cell of the object permits continuous simulation of an action exerted on a virtual tool”). Therefore, in view of Cotin’901, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the system described in Cotin, by providing the deformable volume as taught by Cotin’901, in order to calculate the internal forces and the deformation of the volume mesh cell of the object permits continuous simulation of an action exerted on a virtual tool (Cotin’901, col. 2, lines 51 - 56).
Claims 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Cotin, Higgins and Duindam as applied to claim 1 above, and further in view of Rodrigues et al. (US 2021/0007774 A1).
Re claims 18 - 19:
Cotin does not explicitly disclose a number of times the virtual medical instrument is retracted after insertion past a missed target. Rodrigues teaches 18. The system of claim 1, wherein the performance metric tracks a number of virtual targets of the plurality of sequentially-aligned virtual targets missed by the virtual medical instrument. 19. The system of claim 18, wherein the performance metric tracks a number of times the virtual medical instrument is retracted after insertion past a missed target. 20. The system of claim 13, wherein the performance metric tracks a number of times the virtual medical instrument deviates from the optimal traversal path or a length of time the virtual medical instrument deviates from the optimal traversal path (Rodrigues, [0133] – [0136], “Number of attempts: number of tries to reach the puncture site”; [0142]; [0146], “The disclosure preferably demands endoscopic imaging for real-time monitoring of the puncture target and two EMT sensors”). Therefore, in view of Rodrigues, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the system described in Cotin, by providing the number of attempts as taught by Rodrigues, in order to assess the skill level of the surgeon based on the number of attempts (number of errors made).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Cotin, Higgins and Duindam as applied to claim 13 above, and further in view of in view of Rodrigues et al. (US 2021/0007774 A1).
Re claim 20,
Cotin does not explicitly disclose a number of times the virtual medical instrument is retracted after insertion past a missed target. Rodrigues teaches 20. The system of claim 13, wherein the performance metric tracks a number of times the virtual medical instrument deviates from the optimal traversal path or a length of time the virtual medical instrument deviates from the optimal traversal path (Rodrigues, [0133] – [0136], “Number of attempts: number of tries to reach the puncture site”; [0142]; [0146], “The disclosure preferably demands endoscopic imaging for real-time monitoring of the puncture target and two EMT sensors”). Therefore, in view of Rodrigues, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the system described in Cotin, by providing the number of attempts as taught by Rodrigues, in order to assess the skill level of the surgeon based on the number of attempts (number of errors made).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Cotin, Higgins and Duindam as applied to claim 1 above, and further in view of Bell et al. (US 20100120006 A1).
Re claim 22:
22. The system of claim 1, wherein the at least one input control device includes a first input device and a second input device (Cotin, Abstract, “physical environment of an operating room by simulating or tracking, such as C-arm control panel, foot pedals, monitors, real catheters and guidewires, etc”)
Cotin does not explicitly disclose wherein the performance metric tracks an amount of time the first input device and the second input device are simultaneously actuated. Bell teaches an invention contemplates a device and method related to training medical personnel (Bell, Abstract). Bell teaches the missing limitation (Bell, [0092]; [0191]; [0193]). Therefore, in view of Rodrigues, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the system described in Cotin, by tracking the task completion time as taught by Bell, since the task completion time is an indication of efficiency of the surgeon.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Cotin, Higgins and Duindam as applied to claim 8 above, and further in view of Velasco et al. (US 20180233067 A1)
Re claim 23:
Cotin does not explicitly disclose 23. The system of claim 1, wherein the performance metric tracks a number of times the at least one input control device rotates past a threshold angular velocity.
Velasco teaches the missing limitation (Velasco, [0119]; [0121]; [0129]). Therefore, in view of Velasco, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the system described in Cotin, by measuring the angular velocity as taught Velasco, in order to measure the motion smoothness, economy of motion and path length (Velasco, [0119]).
Response to Arguments
Applicant's arguments filed 2/13/2026 have been fully considered but they are not persuasive.
Applicant argues:
Cotin does not disclose or suggest "displaying, on the graphical user interface, one or more user instructions to guide a user in navigating the virtual medical instrument through the virtual passageway to complete a first training exercise of the plurality of training exercises, wherein the user instructions are adjustable based on a current progress of the first training exercise," as recited by amended claim 1. (Emphasis added.)
Cotin, Higgins, and Duindam, alone or in combination, do not disclose or suggest at least "displaying, on the graphical user interface, one or more user instructions to guide a user in navigating the virtual medical instrument through the virtual passageway to complete a first training exercise of the plurality of training exercises, wherein the user instructions are adjustable based on a current progress of the first training exercise," as recited by amended claim 1.
The Office submits that Duindam teaches the new limitation added in the amendment filed on 2/13/2026. Specifically, in claim 1, Duindam teaches displaying, on the graphical user interface, one or more user instructions to guide a user in navigating the virtual medical instrument through the virtual passageway to complete a first training exercise of the plurality of training exercises, wherein the user instructions are adjustable based on a current progress of the first training exercise (Duindam, [0006], “the method where dynamically displaying the real-time position information includes displaying one or more indicators when an anomaly is detected; the method where when the anomaly includes steering the instrument down an incorrect passageway, the one or more indicators includes a wrong turn indicator; the method where when the anomaly includes driving the instrument beyond an end of the route, the one or more indicators includes a reverse indicator; the method where when the anomaly includes a tight bend radius of the instrument, the one or more indicators includes an excessive bend indicator”; [0069], “The clinician can then proceed with driving the catheter through anatomy while monitoring navigation progress on the graphical user interface”; [0073], “graphical user interface 400 may include various views, controls, indicators, and/or the like, in addition to those depicted in FIG. 4. For example, graphical user interface 400 may include a header, footer, one or more sidebars, message bars, popup windows, backgrounds, overlays, and/or the like”; [0097], “the target indicator/s could be overlaid on the segment, and/or the location of the target may be indicated by altering the color, weight, hue, and/or transparency of the corresponding segment”; figs. 5A – 5D; [0112], “catheter 1130 may be overlaid on simplified route path 1110 in a contrasting color or shade, such as green. Various indicators and/or alerts may be displayed when anomalies are detected. For example, when catheter 1130 makes a wrong turn, a wrong turn indicator 1142 may appear”; Duindam includes a plurality of indicators (instructions) that response to the positions of the probe operated by a user wherein the indicators are instructions such as wrong turn, reverse indicator, excessive bend, … figs. 5A – 5D further shows instructions that depends on completion of one or more previous steps).
Re claim 17, Duindam teaches wherein the instructions for performing operations further comprise: displaying, on the graphical user interface, the performance metric as the virtual medical instrument navigates through the virtual passageway (Duindam, [0130], “a timer 1570 may be displayed to indicate the amount of elapsed time since the clinician started the time. Timer 1570 may, for example, be used to track the duration of a breath hold, or the duration of the procedure, or otherwise. Timer 1570 may be started and/or stopped manually by the physician and/or automatically when certain events are measured by the system, such as detection of the start and stop of a breath hold. Timer 1570 may change appearance (e.g., color, font, size, texture, etc.) to alert the clinician to hazardous conditions, such as the elapsed time exceeding a predetermined threshold ( e.g., one minute)”; [0007], “the medical device where the one or more indicators includes one or more of a wrong turn indicator, a reverse indicator, and an excessive bend indicator”; [0099], “Drive force indicator 800 displays a visual and/or an alphanumeric representation of the axial drive force … other plotting techniques may be used, such as a one-sided bar plot, a line plot, a scatter plot, and/or the like.”; a wrong turn / reverse / excessive bend indicator, time / duration or visual / alphanumerical representation are examples of performance metric associated with the operation of a virtual instrument).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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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/JACK YIP/Primary Examiner, Art Unit 3715
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