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 .
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-16, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ziaei et al (US Patent Pub. 20110082587A1) in view of Nikou et al (US Patent Pub. 20220211454A1).
Ziaei recites a system for performing robot-assisted surgery. Specifically in regards to claim 1, Ziaei recites a surgical robot having a robotic arm (30, Fig. 3a-3b and Para, [0052]-[0056]); an end effector (40, Fig. 3b and Para. [0057]) coupled to the robotic arm (30), wherein the end effector is adapted to receive, translate, and orient a navigated surgical instrument (100/200/300/400, Fig. 4a,6a,7a,9a); and a camera tracking system (8, Fig. 3a Para. [0052],[0055]) adapted to intra-operatively track a pose of the navigated surgical instrument relative to a defined coordinate system; and a computer platform (7, Fig. 3a and Para, [0055]) including a processor and a memory, the computer platform being operative to: display (9, Fig. 3a and Para. [0056],[0079]) to a user an image of a target location on a patient, and the pose of the navigated surgical instrument; and selectively control translation and orientation of the navigated surgical instrument (100/200/300/400, Fig. 4a,6a,7a,9a) based on a defined operational mode, to perform a surgical process under user control, wherein the navigated surgical instrument (100/200/300/400, Fig. 4a,6a,7a,9a) is configured for reaming an acetabulum (Para. [0077]-[0090]) of the patient to a planned center of an acetabular prosthesis, and the robotic arm (30) is configured for positioning the acetabular prosthesis in the reamed acetabulum (Para. [0092]-[0093]). The navigated surgical instrument (100) includes a handle (112) disposed on a proximal side of the end effector (40) and a reamer (112) that is disposed on a distal side of the end effector (40) (Fig. 4a; and Para. [0059]-[0060]). However, the reference is silent as to a marker positioned between the handle and the reamer.
Nikou recites a system for performing robot-assisted surgery. Specifically in regards to claim 1, Nikou recites a navigated surgical instrument (740) includes a handle (710) disposed on a proximal side and a navigation array (760) disposed in between the handle (710) and a tool end (740) that is disposed on a distal side (Fig. 4a; and Para. [0059]-[0060]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the navigated surgical instrument (100) of Ziaei to add a tracking array as taught in Nikou since Ziaei recites that the tracking device which tracks the pose of the surgical tool and the patient anatomy for the navigation system can be optical (Ziaei: Para. [0055]).
In regards to claim 2, Ziaei recites wherein the navigated surgical instrument (100/200/300/400, Fig. 4a,6a,7a,9a) comprises the reamer (100/200 Fig. 4a/6a), configured for reaming the acetabulum of the patient to the planned center of the acetabular prosthesis (Fig. 11-13b and 14d; and Para. [0077]-[0090]).
In regards to claim 3, Ziaei recites wherein the navigated surgical instrument is configured for insertion of the reamer (100/200) into the acetabulum (22), and wherein the defined operational mode comprises a force control mode, in which: translation of the reamer (100/200) along the X-, Y-, and Z-axes is permitted, pitch, yaw, and roll of the reamer are permitted, and translation and orientation of the reamer (100/200) are controlled by application of a force and/or a torque by a user (Fig. 13a, Para. [0054],[0056],[0083]-[0090]).
In regards to claim 4, Ziaei recites wherein the reamer (100/200) is configured to align with a defined ream trajectory, and wherein the defined operational mode comprises a rotate control mode, in which: rotation of the reamer is permitted about a fixed point located at a center of the reamer or about a trajectory defined by a rotational axis of the reamer, and within a workspace of the robotic arm, translation of the reamer along the X-, Y-, and Z-axes is constrained, and rotation of the reamer is controlled by the user (Fig. 13b; and Para. [0086]-[0090]).
In regards to claim 5, Ziaei recites wherein the computer platform (7) is further operative to determine and display the defined ream trajectory on a user interface (Fig. 13a-14e).
In regards to claim 6, Ziaei recites wherein the reamer (100/200) is configured to be aligned along the defined ream trajectory (Fig. 13a-13b) such that the fixed point (“P”) located at the center of the reamer is colocalized with a native center of the acetabulum, and wherein the defined operational control mode comprises a translate control mode, in which: translation of the reamer along the X-, Y-, and Z-axes is permitted, and pitch, yaw, and roll of the reamer are constrained, and the computer platform is operative to provide, during the translating, navigational guidance to the user based at least in part on the image of the target location, the pose of the navigated surgical instrument, and a defined surgical plan (Fig. 13a-13b; and [0085]-[0086]).
In regards to claim 7, Ziaei recites wherein the surgical navigated instrument is configured for, following the translating, reaming the acetabulum from the native center of the acetabulum to the planned center of the acetabular prosthesis (28, Fig. 2a), and wherein the defined operational control mode comprises a translate/rotate control mode, in which: the reamer (100/200) is permitted to rotate about the fixed point (“P”) at the center of the reamer (100/200), the fixed point at the center of the reamer is permitted to translate along the defined ream trajectory (Fig. 13a/13b), and the computer platform (7) is operative to provide, during the reaming, navigational guidance to the user based at least in part on the image of the target location, the pose of the navigated surgical instrument, and the defined surgical plan (Fig. 14a-14f; and Para. [0056],[0082],[0089]).
In regards to claim 8, Ziaei recites wherein following the reaming, the computer platform (7) is operative to selectively control translation and orientation of the reamer (100/200) based one or more of the rotation control mode or the force control mode and the reamer being configured to be removed from the patient (Fig. 14a-14f; and [00899]-[0092]).
In regards to claim 9, Ziaei recites wherein the surgical instrument tool is configured for one or more of the inserting, the aligning, the translating, or the reaming being performed iteratively (Fig. 11).
In regards to claim 10, Ziaei recites wherein the navigated surgical instrument (100/200/300/400 Fig. 4a,6a,7a,9a) comprises an inserter (300/400 Fig. 7a,9a) configured for positioning the acetabular prosthesis in the acetabulum, wherein the acetabulum has been prepared prior to the positioning (Fig. 14f; Para. [0092]-[0093]).
In regards to claim 11, Ziaei recites wherein the inserter (300/400) is configured for positioning into the acetabulum, and wherein the defined operational mode comprises a force control mode, in which: translation of the inserter along the X-, Y-, and Z-axes is permitted, pitch, yaw, and roll of the inserter are permitted, and translation and orientation of the inserter are controlled by application of a force and/or a torque by a user (Fig. 13a, Para. [0092]-[0093],[0054],[0056],[0083]-[0090]).
In regards to claim 12, Ziaei recites wherein the inserter is configured for aligning with a defined insertion trajectory, and wherein the defined operational mode comprises a rotate control mode, in which: translation of the inserter along the X-, Y-, and Z-axes is constrained, pitch, yaw, and roll of the inserter are permitted; and rotation of the inserter is controlled by the user (Fig. 13b; and Para. [0092]-[0093],[0086]-[0090]).
In regards to claim 13, Ziaei recites wherein the computer platform is further operative to: determine and display the defined insertion trajectory on a user interface; and to display planned screw locations such that when the prosthesis is rotated, screw holes on the prostheses can be aligned with the displayed screw locations (Fig. 14d-14f, and Para. [0088]-[0093]).
In regards to claim 14, Ziaei recites wherein the inserter is configured to, following the aligning, translating along the defined insertion trajectory such that an axis of the inserter is colocalized with a planned axis of the acetabular prosthesis, and wherein the defined operational mode comprises a translate control mode, in which: translation of the inserter along the X-, Y-, and Z-axes is permitted, pitch, yaw, and roll of the inserter are constrained, and the computer platform (7) is operative to provide, during the translating, navigational guidance to the user based at least in part on the image of the target location, the pose of the navigated surgical instrument, and a defined surgical plan (Fig. 14a-14f and 13a-13b; and [0092]-[0093],[0085]-[0086]).
In regards to claim 15, Ziaei recites wherein the computer platform 97) is further operative to: adjust a position of the acetabular prosthesis (28) in the defined surgical plan based on intra-operative input from the user (Fig. 11).
In regards to claim 16, Ziaei recites wherein the positioning further comprises: following the translating, impacting the acetabular prosthesis (28), wherein the computer platform (7) is operative to confirm seating of the acetabular prosthesis (28) prior to removing the acetabular prosthesis from the inserter (300/400); wherein the inserter (300/400) is configured for removal from the acetabulum (22), wherein the computer platform (7) is operative to selectively control translation and orientation using the force control mode during the removing of the inserter (300/400) from the acetabulum (22) (Fig. 11 and 14a-14f; and Para. [0092]-[0093]).
In regards to claim 19, Ziaei recites an imaging device (Para. [0079]) in communication with the computer platform (7), and capable of capturing at least one image of the target location of the patient, wherein the computer platform (7) is operative to: receive the at least one image from the imaging device, and provide navigational guidance to the user based at least in part on the at least one image of the patient and a defined surgical plan (Para. [0079]).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ziaei in view of Nikou as applied to claim 10 above, and further in view of Jaramaz et al (US Patent Pub. 20250302490A1).
Ziaei and Nikou recites a system for performing robot-assisted surgery comprising a surgical robot with a robotic arm having an end effector coupled thereto adapted to receive, translate, and orient a surgical instrument; a camera tracking system to track the instrument; and a computer platform operative to: display to a user an image of a target location on a patient, and the pose of the navigated surgical instrument; and selectively control translation and orientation of the navigated surgical instrument based on a defined operational mode, to perform a surgical process under user control that comprises one or more of: reaming an acetabulum of the patient to a planned center of an acetabular prosthesis, or positioning the acetabular prosthesis in the reamed acetabulum. However, the reference is silent as to the platform being operative to control the positioning and assessing a trial prosthesis.
Jaramaz in regards to claim 17 recites a system for performing robot-assisted surgery (100) comprising a surgical robot with a robotic arm (105a) having an end effector (105b) and a computer platform (150) wherein the computer platform is further operative to: selectively control translation and orientation of the inserter based on the defined operational mode, to perform a process comprising: providing a trial acetabular prosthesis configured for positioning in the prepared acetabulum, assessing a fit of the trial acetabular prosthesis therein, and wherein the trial acetabular prosthesis is configured for removal from the prepared acetabulum (Fig. 1-8b; and Para. [0067]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the combination by modifying the system of Ziaei to add to the platform the operation of assessing and positioning a trial prosthesis as taught in Jaramaz in order to provide the surgeon with the option of re-planning and re-doing the reaming and implant impaction by preparing a new surgical plan if the surgeon is not satisfied with the original implant position and orientation (Para. [0067]).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ziaei in view of Nikou as applied to claim 1 above, and further in view of McKinnon et al (US Patent Pub. 20200275976A1).
Ziaei in view of Nikou recites a system for performing robot-assisted surgery comprising a surgical robot with a robotic arm having an end effector coupled thereto adapted to receive, translate, and orient a surgical instrument; a camera tracking system to track the instrument; and a computer platform operative to: display to a user an image of a target location on a patient, and the pose of the navigated surgical instrument; and selectively control translation and orientation of the navigated surgical instrument based on a defined operational mode, to perform a surgical process under user control that comprises one or more of: reaming an acetabulum of the patient to a planned center of an acetabular prosthesis, or positioning the acetabular prosthesis in the reamed acetabulum. However, the reference is silent as to the use of an extended reality headset.
McKinnon in regards to claim 18 recites a system for performing robot-assisted surgery (100) comprising a surgical robot with a robotic arm (105a) having an end effector (105b) (Fig. 1 and Para. [0097]-[0098]) and further comprising an extended reality (XR) headset adapted to display to the user the image of the target location on the patient, and the pose of the navigated surgical instrument, and information relating to a defined surgical plan (Para. [0258]-[0259]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the combination by modifying the system of Ziaei to add to the use of an extended reality headset as taught in McKinnon in order to allow for the information to be projected onto the surgical environment (Para. [0259]).
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because the arguments do not apply to the new combination of references being used in the current rejection.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCELA I SHIRSAT whose telephone number is (571)270-5269. The examiner can normally be reached M-F 9:00am-5:30pm MST.
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/MARCELA I. SHIRSAT/ Primary Examiner, Art Unit 3775
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