DETAILED ACTION
Notice of 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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claim(s) 4, 5, 8, and 13-15 is/are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Regarding claims 4, 5, 8, and 13-15, the recited “threshold” is not positively defined in the claims.
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 may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claim(s) 1-3, 6, 7, 9-12, 18, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chopra (US 2012/0289843) in view of Higgins (US 2008/018073).
Regarding claims 1, 11, and 18, Chopra discloses a system and method of navigating an instrument comprising: an instrument comprising a body configured to be driven through a lumen in the outer body ([0035], [0036]: “medical device 110 has a flexible body 114”); one or more instrument manipulators configured to control movement of the body ([0035]: “Control cables”); and one or more computer devices configured to: generate and store data representing a model of at least a portion of a luminal network ([0041], [0044], [0045], [0047]: “3-D model”), and a position of a target with respect to the luminal network ([0043]…[0045]: “one or more targets are identified in the anatomical structure”). Chopra does not explicitly disclose determining a path to the target; identifying a portion of the luminal network along the path having a shape matching a park assistance signature; and causing an output to be provided indicating an outer body parking position corresponding to the identified portion of the luminal network. However, Higgins teaches determining and visually displaying a path to a target and identifying a portion of a luminal network having a shape matching a “park assistance signature” ([0130], [0131]: “route-planning implementation”, Figs. 7, 8ABCD, 9ABC, 10). The outlined path serves as a “park assistance signature” because the shape of the path is clearly elucidated as where an instrument would be parked. Chopra does not explicitly disclose that the body comprises an inner and an outer body. However, Higgins teaches an endoscope with an inner body containing a tool and an outer body which carries said tool ([0081]). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the path planning and endoscope structure of Higgins to the endoscopic system of Chopra, as to provide robust deployment and navigation of an endoscope.
Regarding claims 2, 3, 12, and 19, Chopra does not explicitly disclose displaying a visual indicator on a representation of the virtual anatomical model on a display indicating the parking position. However, Higgins teaches determining and visually displaying a path to a target and identifying a portion of a luminal network having a shape matching a “park assistance signature” ([0130], [0131]: “route-planning implementation”, Figs. 7, 8ABCD, 9ABC, 10). The outlined path serves as a “park assistance signature” because the shape of the path is clearly elucidated as where an instrument would be parked. Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the path planning and endoscope structure of Higgins to the endoscopic system of Chopra, as to provide robust navigation of an endoscope.
Regarding claim 6, while Chopra does not explicitly disclose that the park assistance signature is based on previously performed medical procedures, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply consideration of prior medical procedures, which may affect the present anatomy that’s relied upon to generate the model being used.
Regarding claim 7, Chopra does not explicitly disclose user input of a selection identifying the portion of the luminal network as corresponding to the outer body parking position. However, Higgins teaches that a user may manually input regions of interest which would influence the calculation of the “parking position” ([0055]: “ROI may be defined manually”; [0061]: “closest routes to the ROI”). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the manual selection of Higgins to the system of Chopra, as to provide robust user-input.
Regarding claim 9, while Chopra does not explicitly disclose detecting that the instrument is prolapsing and rendering an indication of this to be displayed, Chopra does teach real-time tracking and visualizing the spatial position of an inserted medical device ([0047], Fig. 7), which would reveal the presence of a prolapse. Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the visualization of Chopra in the detection of detecting instrument prolapse, as to provide robust tracking of an inserted instrument.
Regarding claim 10, Chopra does not explicitly disclose receiving, via one or more user input device, an inner body advancement instruction to advance the inner body; causing the one or more instrument manipulators to advance the inner body; and determining that the instrument is prolapsing based on a determination that a position of a distal end of the inner body is inconsistent with the inner body advancement instruction. However, Chopra does teach real-time tracking and visualizing the spatial position of a medical device that is advanced into the body ([0047], Fig. 7), which would reveal the presence of a prolapse. Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the visualization of Chopra in the detection of detecting instrument prolapse, as to provide robust tracking of an inserted instrument.
Claim(s) 4, 5, 13, 14, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chopra (US 2012/0289843) in view of Higgins (US 2008/018073), as applied to claims 3 and 18 above, in view of Rios (US 2017/0252108).
Regarding claim 4, 13, and 20, neither Chopra nor Higgins explicitly disclose determining that a distance from the identified portion of the luminal network to the target is less than a threshold insertion distance associated with the inner body; and in response to determining that the distance from the identified portion to the target is less than the threshold insertion distance associated with the inner body, cause the rendering of the outer body parking position. However, Rios teaches that a proximity measurement determines an object rendering in a virtual environment ([0054]). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the rendering of Rios to the modeling of Chopra, as to provide robust visualization.
Regarding claim 5 and 14, neither Chopra nor Higgins explicitly disclose receiving, via one or more user input devices, an outer body park instruction to park the outer body at a current location; determining that a distance from the current location to the target is more than a threshold insertion distance associated with the inner body; and in response to determining that the distance from the current location to the target is more than the threshold insertion distance associated with the inner body, causing a rendering to be displayed that indicates that the target is not reachable by the inner body with the outer body parked at the current location. However, Rios teaches that a proximity measurement determines an object rendering in a virtual environment ([0054]). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the rendering of Rios to the modeling of Chopra, as to provide robust visualization.
Claim(s) 8, 15, and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chopra (US 2012/0289843) in view of Higgins (US 2008/018073), as applied to claims 1 and 11 above, in view of Romo (US 2016/0184032, of record).
Regarding claims 8 and 15, neither Chopra nor Higgins explicitly disclose identifying a location along the path at which a diameter of a lumen in the luminal network is within a threshold range of a diameter of the outer body; and identifying the portion of the luminal network based on the identified location along the path. However, Romo teaches that the diameter of a luminal model may be known ([0245]). In combination with the taught model generation of Higgins as described in the rejection of parent claim 1, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the luminal diameter of Romo to the system of Chopra and Higgins, as to provide a measurement of lumen diameter for robust anatomical modeling.
Regarding claim 16, neither Chopra nor Higgins explicitly disclose robotically advancing the sheath and the endoscope in a paired driving mode prior to parking of the sheath; and after parking of the sheath, robotically advancing the endoscope from the sheath in an unpaired driving mode. However, Romo teaches a sheath and endoscope system wherein both may be independently or dependently controlled by robotic arms ([0008]). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the separate robot control of Romo to the endoscopic system of Chopra and Higgins, as to provide robust robotic control.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chopra (US 2012/0289843) in view of Higgins (US 2008/018073), as applied to claim 11 above, in view of Wang (US 2019/0350659).
Regarding claim 17, neither Chopra nor Higgins explicitly disclose identifying a location along the path at which a radius of curvature of an anatomical lumen of the anatomy is less than a threshold value; and identifying the portion of the anatomy based on the identified location along the path. However, Wang teaches identifying the curvature of a bronchial passageway model ([0068]). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the consideration of curvature as taught by Wang to the system of Chopra, as to provide generation of a robust model properly incorporating anatomical curvature.
Conclusion
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/JASON M IP/Primary Examiner, Art Unit 3793