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 .
Response to Arguments
Applicant's arguments filed 01/22/2026 have been fully considered but they are not persuasive.
1) While does Lang teaches a head-mounted display for a virtual-reality guided experience view, the claim limitation in question, namely that the boundary is specifically a surface of the bone relative to surrounding soft tissue, is clearly taught by way of Lang’s Figures. The visualization of Lang would be readily integrated into the tracked bone saw of May. The Examiner respectfully disagrees with the Applicant’s mis-characterization of what has been cited in Lang as being divergent from the goals of the claimed invention. It is the Examiner’s view that in combination, the claimed invention is rendered obvious by the cited references.
2) The Examiner respectfully disagrees with the Applicant’s claim that the motivation to combine Johnson, May, and Lang is improper due to how Johnson and May already provide robust tracking and visualization. Lang offers a clear teaching that both bone and tissue may be visualized clearly would offer an enhanced visualization to the system of Johnson and May. The fact that both Johnson and May are directed to augmented/mixed reality does not preclude the combination of an additional reference that is also directed to the same subject matter.
3) Concerning the teaching of Kang, the claim limitation in question is whether or not it would have been obvious to cut the power of a surgical tool when the position of the surgical tool reaches a certain location. Kang offers three non-exhaustive examples. One of those examples involves a tool crossing a particular boundary, to which the Applicant attempts to argue that this somehow, weakens the finding of obviousness. It does not. The reason why the third fault was highlighted in the Office Action is because it is specifically tied to shutting off power. Kang teaches that power may be turned off when the detected position of the haptic arm reaches a certain threshold location, or a fault. Setting a boundary beyond or before certain spatial coordinates is an idea that would have been obvious to one of ordinary skill in the art of spatial-based fault detection.
Allowable Subject Matter
Claim 21 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening 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 and 4-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Johnson (US 20190254754, of record) in view of May (US 2018/0256256, of record) in view of Lang (US 11553969, of record).
Regarding claims 1 and 20, Johnson discloses a system for tracking a surgical tool relative to a bone in computer-assisted surgery ([0021]: “orthopedic surgical procedure”; [0124], [0125]: “position tracking system 810” tracks tools; Figs. 10, 11: “computer subsystem 820”), comprising: a processing unit; and a non-transitory computer-readable memory communicatively coupled to the processing unit and comprising computer-readable program instructions executable by the processing unit for: tracking the surgical tool relative to the bone ([0054]: “tracking”; [0124], [0125]: “position tracking system 810”; Fig. 10: “surgical site 804”); merging virtual models of the surgical tool and the bone to the surgical tool and the bone in the tracking ([0006]: patient anatomy and robotic surgery system are registered in patient space; [0008]…[0010]: anatomical models and tool augmentation graphics are registered to the patient space and are thus merged); calculating a location of a working end of the surgical tool relative to the bone using the tracking, in a concealed condition of the working end of the surgical tool relative to the bone; and outputting the location of the working end of the surgical tool relative to the bone ([0053]: pointer tool may be surgical instrument; [0153]: “a surgeon can accurately visual the hidden portion of the pointer tool while positioning and/or orienting it”). Johnson does not explicitly disclose that the surgical tool is configured for altering bone and that there is an indication of a proximity of the working end with a bone while the bone is being altered by the working end. However, May teaches tracking the location of a bone saw as it is being used to cut bone, wherein the bone saw is not within line of sight ([0053]…[0055]). 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 bone saw of May to the system of Johnson, as to provide conventional tracking within an augmented reality environment. Neither Johnson nor May explicitly disclose that the boundary is specifically a surface of the bone relative to surrounding soft tissue. However, Lang teaches visualizing a surface of a bone, the tissue surrounding said bone, and the working end of an instrument used to alter said bone, are all visualized concurrently wherein the proximity of the instrument may be elucidated (Figs. 24BCDE; 248:62-67…249:1-28). 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 a surface of a bone relative to surrounding tissue as taught by Lang to the procedure of Johnson and May, so as to provide robust tracking and visualization of objects in a surgical field of view.
Regarding claim 4, Johnson discloses imaging and displaying the concealed working end of the surgical tool relative to the bone ([0153]: “a surgeon can accurately visual the hidden portion of the pointer tool while positioning and/or orienting it”).
Regarding claim 5, Johnson discloses imaging and displaying the concealed working end of the surgical tool relative to the bone in mixed reality on a face shield worn by an operator ([0153]: “a surgeon can accurately visual the hidden portion of the pointer tool while positioning and/or orienting it”; Fig. 10; [0067]: “rendered super-imposed at a visually aligned location on the patient’s body”, [0082]: a head mounted display is worn by operator).
Regarding claim 6, while Johnson does not explicitly disclose that the computer-readable program instructions are executable by the processing unit are for calibrating the surgical tool by obtaining video images of the surgical tool and its working end and processing same to size the model of the surgical tool, Johnson does teach the use of a calibration module ([0132]: “calibration module 912”). Calibrating surgical robots is conventional and well-known in the art and one of ordinary skill with Johnson in view would have found that calibrating the movement of Johnson’s surgical robot to be obvious and not novel. 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 calibration to the surgical tool’s working end, as to provide robust tracking and patient safety.
Regarding claim 7, Johnson does not explicitly disclose obtaining and processing the video images of the surgical tool and its working end includes imaging an amplitude of movement of the working end and size the amplitude of movement of the concealed working end. However, May teaches tracking the working end of a tool as it moves ([0027], [0029], [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 tracking of May to the system of Johnson, as to provide robust tracking of a tool’s movement.
Regarding claim 8, Johnson discloses obtaining the virtual model of the bone from pre-operative imaging ([0030], [0042], [0067], [0090]).
Regarding claim 9, Johnson does not explicitly disclose obtaining the virtual model of the surgical tool from a manufacturer file. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention that the manufacturer of the Johnson’s surgical navigation system would provide the models for the compatible surgical tools used in the surgical navigation system, as to provide compatible models.
Regarding claim 10, Johnson discloses that the computer-readable program instructions are executable by the processing unit for controlling a robot arm as a function of a position and orientation of the surgical tool ([0035], [0040], [0050], [0053]).
Regarding claim 11, Johnson discloses that continuously outputting the location of the surgical tool includes continuously outputting the location of the robot arm ([0131]: “tracks…robotic surgical system 908”; [0157]: “track positions of a robotic arm”).
Regarding claim 12, Johnson discloses that tracking the surgical tool relative to the bone includes tracking the surgical tool relative to the bone from an image capture device at a point of view of an operator ([0095]: “see-through display device” is an image capture device; [0125]: “perspective view of a wearer of HMD 100”).
Regarding claim 13, Johnson does not explicitly disclose obtaining a feed of tracking from a stationary image capture device in addition to the tracking from the image capture device at the point of view of the operator. However, Johnson does teach using a plurality of stationary cameras for navigational tracking (Fig. 11, [0131]). 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 a second feed of tracking, as to provide robust tracking.
Regarding claim 14, Johnson does not explicitly disclose obtaining the video images from two different image capture devices includes prioritizing the video images from one of the image capture devices over the other of the image capture devices. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply a prioritization of images from a plurality of image capture devices, as to provide focus on critical information provided by that one image capture device during a surgical procedure.
Regarding claim 15, Johnson does not explicitly disclose tracking the surgical tool relative to the bone includes obtaining video images of the surgical tool relative to the bone, and wherein merging virtual models of the surgical tool and the bone to the surgical tool and the bone in the tracking includes processing the video images. However, Johnson teaches acquiring video image data to track critical objects in a surgical patient space and integrating the image data with models for an augmented reality presentation to a surgeon ([0099], [0114]). 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 integration of video image data to objects within the surgical space, as to provide robust tracking and presentation using video images.
Regarding claim 16, Johnson does not explicitly disclose calculating the location of the working end of the surgical tool relative to the bone includes using the video images processed. However, Johnson teaches that the working end of a hidden portion of a surgical tool is elucidated using tracking data ([0035]) and that imaging data may be used for tracking ([0099], [0114]). 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 integration of video image data to objects within the surgical space, as to provide robust tracking and presentation using video images.
Regarding claim 17, while Johnson does not explicitly disclose obtaining video images includes obtaining the video images in a lower frequency capture mode when the tool is distal to the bone, and in a higher frequency capture mode when the tool is proximal to the bone, it would have been obvious to one with ordinary skill in the art before the effective filing date of the present invention to use a higher frequency capture when the tool is proximal to the bone so as to provide finer visual details to the surgeon as the tool is engaged with the bone, as opposed to when the tool is not engaged with the bone, then critical observation is not relatively as important.
Regarding claim 18, Johnson discloses a head-mounted device with at least one camera for obtaining video images ([0099], [0114]).
Regarding claim 19, Johnson discloses that the head-mounted device has a display for outputting data associated with the position and orientation of the at least one object, the data being output in mixed reality ([0093]…[0096]).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Johnson (US 20190254754, of record) in view of May (US 2018/0256256, of record) in view of Lang (US 11553969, of record), as applied to claim 1 above, in view of Kang (US 2007/0270685, of record).
Regarding claim 3, neither Johnson, May, nor Lang, explicitly disclose that the computer-readable program instructions are executable by the processing unit for stopping a powering of the surgical tool when the working end is at the boundary of the bone. However, Kang teaches shutting off the power to a surgical tool in response to a haptic response fault ([0111]). 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 powering off of Kang to the instrument of Johnson, as to provide robust safety measures associated with a haptic boundary.
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 extension fee 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jason Ip whose telephone number is (571)270-5387. The examiner can normally be reached Monday - Friday 9a-5p PST.
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/JASON M IP/
Primary Examiner, Art Unit 3793