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 .
A Continuation-In-Part (CIP) application has a split priority (effective) filing date (MPEP 2133.01 Rejections of Continuation-In-Part (CIP) Applications). Claims containing only subject matter disclosed in the parent application receive the parent's filing date, while claims supported only by new matter receive the CIP's actual filing date. The CIP’s new matter is only protected from its own filing date, and its total 20-year patent term is typically calculated from the filing date of the original parent application.
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.
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 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over MORGAN et al (US 20250064531).
As per claim 1, Morgan teaches the claimed “surgical system” comprising: “a tracked pointer” (Morgan, [0047] - In conventional surgical navigation systems, the objects to be tracked are initially located and registered using a navigation pointer P. For example, the navigation pointer P may have an integrated tracker PT); “a tracking system for tracking positions of the tracked pointer” (Morgan, [0042] - The navigation computer 26 may present a visual interface to allow the operator to designate which markers define the tracker and allow the operator to designate the object, including in some cases a specified volume in space, to be tracked); and “a display for displaying a selectable input and a selection location for positioning the tracked pointer to select the selectable input” (Morgan, [0029] - The navigation interface includes a first display 28 adapted to be situated outside of the sterile field and a second display 29 adapted to be situated inside the sterile field; [0044] - For instance, images taken by the optical sensors 40, or video camera 41, of the surgical site may be displayed on one or more of the displays 28, 29 (and/or other displays). The operator then, using a mouse, digital pen, or the like, traces objects to be located/tracked on the display 28 and/or 29), “wherein the selection location is defined with respect to anatomy” (Morgan, [0035] - a plurality of tracking devices 44, 46, 48, also referred to herein simply as trackers. In the illustrated example, two trackers 44, 46 are coupled to the tibia T of the patient; [0048] - In some examples the trackers 44, 46 include fiducials that are connected to a tracker controller (not shown) located in a housing (not shown) of the associated tracker 44, 46 that transmits/receives data to/from the navigation computer 26… In some examples, the trackers 44, 46 may also include a gyroscope sensor 60 and accelerometer 70... These additional sensors 60, 70, may provide information to the navigation computer 26 for use by the navigation computer to determine or track the trackers' 44, 46 position or orientation; [0050] - As illustrated in FIG. 2, the camera unit 36 receives optical signals 53 from the fiducials 50 of the trackers 44, 46 and outputs to the processor 52 signals relating to the position of the fiducials 50 of the trackers 44, 46 relative to the localizer 34. Based on the received optical (or non-optical signals, in some examples), navigation processor 52 generates data indicating the relative positions and orientations of the trackers 44, 46, 48 relative to the localizer 34; [0103] - Using the pointer P or other registration process, the defined marker arrangement of step 208 is associated with the object model in the virtual environment of the navigation computer 26. Once registered, the navigation system 20 can provide precise information about the position and orientation of the object by tracking the movement of the tracker). It is noted that Morgan’s trackers 44, 46 coupled to the tibia T of the patient suggests the claimed “selection location is defined with respect to anatomy.” The motivation is to control information related to the patient’s anatomy through the bone trackers.
Claim 2 adds into claim 1 “determine the positions of the tracked pointer relative to the anatomy” (Morgan, [0050] - As illustrated in FIG. 2, the camera unit 36 receives optical signals 53 from the fiducials 50 of the trackers 44, 46 and outputs to the processor 52 signals relating to the position of the fiducials 50 of the trackers 44, 46 relative to the localizer 34. Based on the received optical (or non-optical signals, in some examples), navigation processor 52 generates data indicating the relative positions and orientations of the trackers 44, 46, 48 relative to the localizer 34); and “record the selectable input when the tracked pointer is positioned at a location on the anatomy that corresponds to the selection location” (Morgan, [0060] - During an initial phase of the procedure, the bone trackers 44, 46 are coupled to the bones of the patient. The pose (position and orientation) of coordinate system TBONE must be mapped to coordinate systems BTRK1 and BTRK2, respectively. Given the fixed relationship between the bones and their bone trackers 44, 46, positions and orientations of the tibia T in the tibia coordinate system TBONE must be transformed to the bone tracker coordinate systems BTRK1 and BTRK2 so the camera unit 36 is able to track the tibia T by tracking the bone trackers 44, 46. This pose-describing data are stored in memory integral with both manipulator controller 54 and navigation processor 52; [0103] - Using the pointer P or other registration process, the defined marker arrangement of step 208 is associated with the object model in the virtual environment of the navigation computer 26. Once registered, the navigation system 20 can provide precise information about the position and orientation of the object by tracking the movement of the tracker).
Claim 3 adds into claim 2 “wherein the tracked pointer comprises an input mechanism, wherein the computer records the selectable input in response to a user triggering the input mechanism” (Morgan, [0116] - More specifically, the robotic manipulator 56 can utilize the attached surgical instrument 22 or energy applicator EA to touch the anatomical landmark. The selected anatomical landmark can be registered in different ways. In one example, the navigation system 20 tracks the position of the instrument tracker 48 on the robot 56 and fuses this data with known relationship data between the instrument tracker 48 and the instrument 22 and known relationship data between the instrument 22 and a tool center point of the energy applicator EA).
Claim 4 adds into claim 2 “wherein the computer automatically records the selectable input when the tracked pointer is positioned at the location on the anatomy that corresponds to the selection location” (Morgan, [0103] - Using the pointer P or other registration process, the defined marker arrangement of step 208 is associated with the object model in the virtual environment of the navigation computer 26. Once registered, the navigation system 20 can provide precise information about the position and orientation of the object by tracking the movement of the tracker).
Claim 5 adds into claim 1 “wherein the display displays a first selectable input and a second selectable input, wherein the first selectable input is associated with a first selection location and the second selectable input is associated with a second selection location, wherein the first selection location is defined with respect to a first location on the anatomy and the second selection location is defined with respect to a second location on the anatomy, and wherein the first location is different than the second location” (Morgan, [0069]-[0072] - Each of tracker 44 and 46 includes a tracker support which can be affixed to the object. Each of tracker 44 and 46 includes one or more fiducials or markers mounted on the tracker support... In the tracker 44 and 46 example illustrated in FIGS. 1-3, the tracker support comprises a single bone pin affixed to the patient's tibia which extends integrally into a planar surface at the distal end. As described above, and in alternative examples below, the fiducials or markers may be include active LED markers, or passive reflective markers).
Claim 6 adds into claim 5 “wherein the first location corresponds to a first anatomical landmark and the second location corresponds to a second anatomical landmark” (Morgan, [0069]-[0072] - Each of tracker 44 and 46 includes a tracker support which can be affixed to the object. Each of tracker 44 and 46 includes one or more fiducials or markers mounted on the tracker support... In the tracker 44 and 46 example illustrated in FIGS. 1-3, the tracker support comprises a single bone pin affixed to the patient's tibia which extends integrally into a planar surface at the distal end. As described above, and in alternative examples below, the fiducials or markers may be include active LED markers, or passive reflective markers).
Claim 7 adds into claim 5 “wherein the first location corresponds to a first region on the anatomy and the second location corresponds to a second region on the anatomy” (Morgan, [0069]-[0072] - Each of tracker 44 and 46 includes a tracker support which can be affixed to the object. Each of tracker 44 and 46 includes one or more fiducials or markers mounted on the tracker support... In the tracker 44 and 46 example illustrated in FIGS. 1-3, the tracker support comprises a single bone pin affixed to the patient's tibia which extends integrally into a planar surface at the distal end. As described above, and in alternative examples below, the fiducials or markers may be include active LED markers, or passive reflective markers).
Claim 8 adds into claim 5 “wherein the first location corresponds to a first bone and the second location corresponds to a second bone” (Morgan, [0073] - Continuing with the example workflow described, once the navigation computer accepts the defined marker arrangement forming the tracker, the tracker is registered to the object, in this example, the patient's tibia, T; [0079] - In one example, an “F” form may be provided to designate a tracker attached to a patient's Femur, and a “T” from may designate attachment to a patient's Tibia).
Claim 9 adds into claim 8 “wherein the first bone is a femur and the second bone is a tibia” (Morgan, [0079] - In one example, an “F” form may be provided to designate a tracker attached to a patient's Femur, and a “T” from may designate attachment to a patient's Tibia).
Claim 10 adds into claim 1 “wherein the positioning of the tracked pointer refers to the positioning of a pointer tip of the tracked pointer” (Morgan, [0047] - The navigation computer 26 may store initial data corresponding to a location of the tip of the pointer P relative to the tracker PT such that the navigation system 20 is able to locate and track the tip of the pointer P in the localizer coordinate system LCLZ).
Claim 11 adds into claim 1 “wherein the display further displays a bone model and the selection location with respect to the bone model” (Morgan, [0073] - Continuing with the example workflow described, once the navigation computer accepts the defined marker arrangement forming the tracker, the tracker is registered to the object, in this example, the patient's tibia, T; [0058] - Navigation system 20, through the localizer 34 monitors the positions of the tibia T of the patient by monitoring the position of bone trackers 44, 46 coupled to the bone. The tibia coordinate system is TBONE, which are the coordinate systems of the bone to which the trackers 44, 46 are coupled).
Claim 12 adds into claim 11 “wherein the display further displays the selectable input next to the selection location” (Morgan, [0029] - The navigation interface includes a first display 28 adapted to be situated outside of the sterile field and a second display 29 adapted to be situated inside the sterile field. The displays 28, 29 are adjustably mounted to the computer cart assembly 24. First and second input devices (not shown) such as a keyboard and mouse can be used to input information into the navigation computer 26 or otherwise select/control certain aspects of the navigation computer 26. Other input devices are contemplated including a touch screen 30, gesture control, or voice-activation).
Claim 13 adds into claim 1 “wherein the display further displays an icon indicating the real-time position of the tracked pointer relative to the anatomy” (Morgan, [0044] - For instance, images taken by the optical sensors 40, or video camera 41, of the surgical site may be displayed on one or more of the displays 28, 29 (and/or other displays). The operator then, using a mouse, digital pen, or the like, traces objects to be located/tracked on the display 28 and/or 29. The software stores the pixels associated with the object that was traced into its memory. The operator (or other user) may identify each object by a unique identifier such as naming the object using the software so that the saved group of pixels may be associated with the unique identifier).
Claims 14-20 claim a method based on the system of the claims 1-13; therefore, they are rejected under a similar rationale.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHU K NGUYEN whose telephone number is (571)272-7645. The examiner can normally be reached M-F 8-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Daniel F. Hajnik can be reached at (571) 272-7642. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PHU K NGUYEN/ Primary Examiner, Art Unit 2616
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