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 Arguments
Applicant's arguments filed 3/2/2026 have been fully considered but they are not persuasive.
Applicant argues on page 8 under the Remarks, “To the contrary, Figure 5 of Chappuis (see below) shows the ‘camera tracking system 6’ and the ‘robotic arm 20’ as being separate. Hence, nothing in Chappuis suggests that registration data is generated based on signals the "sensors (encoders)" of Chappuis.” However, the Examiner notes Chappius discloses that the navigation markers are not only positionable on the patient but can also be on the end effector/surgical instrumentation of the robotic arm(par. [0032]) and further discloses this can be monitored with other localization systems (par. [0032]), one example of which is found in encoders on the robotic arm(par. [0060]).
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.
Claims 1, 2, 4-6, 8, 9, 11-13, 15 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Chappuis et al. (EP 3797714 A1) in view of Nikou et al. (WO 2020/163316 A1), further in view of D’Alessio et al. (2008/0015599).
Regarding Claims 1, 8, 15 and 17, Chappuis discloses a surgical assistance system comprising a memory (916) configured to store registration data; and processing circuitry (914) configured to obtain position data (see par. [0067] and Step 4 of par. [0126]) while bones of a joint are at a plurality of positions. Chappuis further discloses an MR visualization device (AR head-mounted display worn by a user, see par. [0068]). Additionally, Chappuis discloses the processing circuitry is further configured to determine, based on position data, positions of the bones of the joint (see Step 4, par. [0126]: “tracking relative movement of femur and tibia”); generate joint tension data based on the positions of the bones of the joint (see par. [0126]: step 4: “Soft-tissue balance information); generate the registration data, wherein the registration data registers markers with a coordinate, wherein the markers are attached to one or more of the bones of the joint (step 4, par. [0126]: “the surgeon attaches navigation markers to the patient’s bone(s), e.g. tibia and femur. The bones are registered with the camera tracking system 6”) having robot 8 and arms 40, 42, 44 attached thereto and/or with markers on the robotic arm/surgical instrument (par. [0032]); and based on the registration data, control operation of the robotic arm, particular arm 44, during removal of bone tissue from the areas of the target bone (the arm can reposition the camera 46 if the registration data indicates the markers are blocked from view, see par. [0043])). Additionally, Chappius discloses that the navigation markers are not only positionable on the patient but can be on the end effector/surgical instrumentation (par. [0032]) and further discloses this can be monitored with other localization systems (par. [0032]), one example of which is found in encoders (par. [0060]). The bones are registered with the camera tracking system 6; and based on the registration data, control operation of a robotic arm of a robot during removal of bone tissue from the areas of the target bone (see step 7, par. [0126]: "the surgical robot 4 automatically moves the robot arm 22 to reposition the passive end effector so the cutting plane of the saw blade becomes aligned with the target plane", this being the first part of the removal operation. One can consider that in view of par. [0092], the holding of the position is also a control of the operation of the robotic arm, see "When the surgical robot 4 achieve a planned position, it holds the position (either on brakes or active motor control) and does not move during the particular bone cut").
Chappuis is silent regarding obtaining or generating the position data from one or more sensors of a mixed-reality (MR) visualization device and is silent regarding determining, based on the joint tension data, areas of a target bone to remove.
However, Nikou discloses utilizing MR head-mounted displays rather than traditional camera systems to generate position data for the purpose of reducing the amount of hardware and also reducing overall system cost (par. [0250-0252]). Therefore 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 device in the Chappuis reference to include utilizing MR head-mounted displays rather than traditional camera systems to generate position data, as taught and suggested by Nikou, for the purpose of reducing the amount of hardware and also reducing overall system cost.
Additionally, D’Alessio discloses utilizing balance information to determine areas/amounts of bone to remove for the purpose of minimizing the amount of bone that needs to be removed during the procedure (see [par. [0113-0116]). Therefore 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 device in the Chappuis and Nikou combination to include utilizing balance information to determine the amount of bone removal, as taught and suggested by D’Alessio, for the purpose of minimizing the amount of bone that needs to be removed during the procedure.
In regard to Claims 2 and 9, Chappuis in view of Nikou and D’Alessio disclose utilizing multiple MR devices that can provide overlays for each person in the operating theater (see Nikkou, par. [0250-0252]).
In regard to Claims 4 and 11, Chappuis discloses the positional data is 3D positional data (par. [0021, 0060]). Chappuis further notes using AR which is 3D and thus overcomes prior 2D representation limitations (par. [0068]).
With regard to Claims 5, 6, 12 and 13, the combination of Chappui, Nikou and D’Alessio would involve determining distances between bones, specifically during flexion and extension (flexion and extension gaps, see Nikou, par. [0113]).
Claims 7 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Chappuis et al. (EP 3797714 A1) in view of Nikou et al. (WO 2020/163316 A1), further in view of D’Alessio et al. (2008/0015599) and Kang et al. (2020/0323540). Chappuis, Nikou and D’Alessio disclose all of the claimed invention except for causing the robotic arm to respond to an attempt by the user to remove bone tissue in other areas of the target bone. However, Kang, in the same field of endeavor of robotic surgery systems, discloses including automatic controls that respond to a user’s attempt to cut/remove bone in other areas of the target location, wherein such controls include stopping operation of the cutting tool when a cutting boundary is reached for the purpose of ensuring accurate cuts and promoting patient safety during the procedure (pat. [0088]). Therefore 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 device in the Chappuis, Nikou and D’Alessio combination to include causing the robotic arm to respond to an attempt by the user to remove bone tissue in other areas of the target bone, as taught and suggested by Kang, for the purpose of ensuring accurate cuts and promoting patient safety during the procedure.
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.Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALLEN PORTER whose telephone number is (571)270-5419. The examiner can normally be reached Mon - Fri 9:00-6:00 EST.
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/ALLEN PORTER/Primary Examiner, Art Unit 3796
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