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 .
Election/Restriction
Applicant’s election without traverse of group I, claims 1-16 in the reply filed on 23 January 2026 is acknowledged.
Claims 17-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 23 January 2026.
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-8, 10, 11 and 13-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bowling et al., U.S. PG-Pub 2014/0039681 in view of Shalayev et al., WO 2017/200785.
Regarding claim 1, Bowling et al. discloses a surgical system, comprising: a manipulator (50) including a robotic arm (68, 70) formed of a plurality of links and joints, wherein the robotic arm supports an end effector (110) configured to receive an instrument (Figs. 1 and 4-5); a navigation system (210) comprising a localizer (216) configured to track a pose of bone (via 212) and a pose of the end effector (via 214) (Fig. 1 and paragraphs [0108], [0111]); and a controller (124) coupled to the manipulator and the navigation system, the controller configured to obtain a surgical plan defining a planned relationship between the instrument and the bone; acquire, from the navigation system, the tracked poses of the bone and the end effector; and based on the tracked poses and the surgical plan, control the manipulator to enable movement of the end effector and the instrument to facilitate placement of the instrument relative to the bone (Figs. 1, 11 and paragraphs [0063], [0111]).
Bowling et al. does not explicitly disclose the end effector comprising a stem insertion tool configured to detachably receive a neck portion of a stem implant or the controller defining the planned relationship between the stem implant and the bone and controlling the manipulator to enable movement of end effector while the neck portion of the stem implant is received by the stem insertion tool to facilitate insertion of the stem implant. However, Bowling et al. does disclose the system removing tissue so the patient can be fitted with an implant and maps a shape of an orthopedic implant to be fitted to the bone of the patient and that manipulator (50) assists in the fitting of the orthopedic implant to define where over the tissue should be position (paragraphs [0122]-[0123]). Therefore, it is heavily implied that the system of Bowling et al. could be used to insert an implant.
Shalayev et al. discloses a system to facilitate insertion of an implant having a robotic arm (60) with an end effector (64) that can receive a tool (66), wherein the tool can be any device to contact, perform work or install an implant on a subject’s anatomy, wherein the tool is controlled by commands from a controller (54) and a navigation system (56) (Fig. 4 and paragraph [0048]), wherein such control is based on having bone and pre-operative plan registration to successfully align and insert the components (paragraph [0072]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Bowling et al. such that the end effector comprises a stem insertion tool configured to detachably receive a neck of a stem implant and the controller defines the planned relationship between the stem implant and the bone and controls the manipulator to enable movement of end effector while the neck portion of the stem implant is received by the stem insertion tool to facilitate insertion of the stem implant in view of Shalayev et al. to permit the system be usable to accurately align and insert the implant under the same parameters as those used to control placement of its resection/cavity creation device.
Regarding claims 2 and 3, Bowling et al. discloses wherein the surgical plan comprises a preprogrammed/predetermined path for the tool (160) attached to the end effector (110) (Fig. 1 and paragraph [0063]); wherein the controller (124) is configured to control the manipulator (50) to enable movement of the tool attached to the end effector along the preprogrammed/predetermined path (paragraph [0086]); wherein the surgical plan comprises a final position of the tool attached to the end effector; and wherein the controller is configured to control the manipulator to enable movement of the tool attached to the end effector to the final position (paragraph [0173]). Therefore, the combination of Bowling et al. as modified in view of Shalayev et al. discloses wherein the surgical plan comprises an insertion path for inserting the stem implant into the cavity and a final implant position of the stem implant relative to the cavity, and wherein the controller is configured to control movement of the implant along the insertion path to the final implant position.
Regarding claim 4, Bowling et al. discloses wherein a cavity creation tool (160) is used to penetrate the bone to form the cavity, and wherein the navigation system (210) is configured to: determine a final position of the cavity creation tool after penetration of the bone to form the cavity; and determine the final implant position based on the final position of the cavity creation tool (Figs. 8-10 and paragraphs [0122]-[0123]).
Regarding claims 5 and 6, Bowling et al. discloses wherein the controller (124) controls the manipulator (50) to enable movement of the tool (160) attached to the end effector (110) being configured to operate in a semi-automated mode whereby the manipulator is configured to autonomously direct movement (paragraphs [0056]-[0058]); and wherein the surgical plan comprises a preprogrammed/predetermined path for the tool (160) attached to the end effector (110) (Fig. 1 and paragraph [0063]); wherein the controller (124) is configured to control the manipulator (50) in the semi-automated mode to autonomously direct movement of the tool attached to the end effector along the preprogrammed/predetermined path (paragraphs [0056]-[0058] and [0086]). Therefore, the combination of Bowling et al. as modified in view of Shalayev et al. discloses wherein the surgical plan comprises an insertion path for inserting the stem implant into the cavity and a final implant position of the stem implant relative to the cavity, and wherein the controller is configured to control movement of the implant along the insertion path to the final implant position.
Regarding claims 7 and 8, Bowling et al. discloses wherein the controller (124) controls the manipulator (50) to enable movement of the tool (160) attached to the end effector (110) by being configured to operate in a manual mode whereby the manipulator facilitates movement of the tool in response to manual manipulation of the end effector by a user to direct to tool; wherein the surgical plan comprises a path for the tool attached to the end effector and the controller controls the manipulator in the manual mode to facilitate directed movement along the path (Fig. 1 and paragraphs [0053]-[0055]). Therefore, the combination of Bowling et al. as modified in view of Shalayev et al. discloses wherein the surgical plan comprises an insertion path for inserting the stem implant into the cavity and the controller facilitates directed movement of the stem implant along the path.
Regarding claim 10, Bowling et al. discloses wherein the controller (124) is configured to: associate a virtual constraint boundary with the path; and control the manipulator (50) in the manual mode to prevent user-directed movement of the end effector (110) beyond the virtual constraint boundary associated with the path (Fig. 1 and paragraph [0062]).
Regarding claims 11 and 13, Bowling et al. discloses wherein the surgical plan comprises a final position of the tool attached to the end effector; and wherein the controller controls the manipulator in the manual mode to facilitate user-directed movement of the tool attached to the end effector to the final position (paragraphs [0053]-[0055] and [0173]); and wherein the controller (124) is configured to: associate a virtual constraint boundary with the final position; and control the manipulator (50) in the manual mode to prevent user-directed movement of the end effector (110) beyond the virtual constraint boundary associated with the path (Fig. 1 and paragraph [0062]). Therefore, the combination of Bowling et al. as modified in view of Shalayev et al. discloses wherein the surgical plan comprises a final implant position of the stem implant relative to the cavity and the controller controls movement of the implant along the insertion path to the final implant position.
Regarding claims 14-16, Bowling et al. discloses wherein the controller (124) is configured to detect movement of the bone based on the tracked pose of the bone (via 212) and control the manipulator (50) to account for movement of the bone; wherein the controller is configured to obtain the surgical plan based on intra-operative planning input (paragraphs [0063], [0108], [0111]); and wherein the combination of Bowling et al. as modified in view of Shalayev et al. discloses the system being configured to facilitate insertion of the stem implant into the cavity of the bone for total joint replacement surgery.
Claim(s) 9 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bowling et al., U.S. PG-Pub 2014/0039681 in view of Shalayev et al., WO 2017/200785 as applied above, and further in view of Nikou et al., U.S. PG-Pub 2014/0135791.
Regarding claims 9 and 12, Bowling et al. in view of Shalayev et al. discloses the controller (124) being configured to detect a deviation of the end effector (110) from the path; and detect final position has been reached (paragraphs [0062] and [0235]-[0236] of Bowling et al.).
Bowling et al. does not disclose providing a haptic feedback through the end effector in response to detection of the deviation or having reached the final position.
Nikou et al. discloses a system providing haptic feedback through a device (130) to indicate a particularly bad alignment of the device relative to a pre-operative plan or to indicate successful placement of the implant (i.e. final position) (paragraph [0079]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Bowling et al. to include providing haptic feedback through the end effector in response to detection of the deviation or having reached the final position further in view of Nikou et al. to permit indicating a particularly bad alignment of the end effector relative to the surgical plan or to indicate successful placement of an implant.
Allowable Subject Matter
Claim 24 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.
Response to Arguments
Applicant's arguments filed 23 January 2026 have been fully considered but they are not persuasive. Applicant contends Shalayev fails to teach the interaction of the stem implant and end effector and lacks any disclosure of an insertion tool supported by the robotic arm.
In response to applicant's argument that Shalayev fails to teach the interaction of the stem implant and end effector, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
In the instant case, Shalayev discloses a system to facilitate insertion of an implant having a robotic arm (60) with an end effector (64) that can receive a tool (66), wherein the tool can be any device to contact, perform work or install an implant on a subject’s anatomy (Fig. 4 and paragraph [0048]), wherein one having ordinary skill in the art would understand utilizing such concept as being fully capable of interacting with a stem implant.
In response to applicant’s argument that Shalayev lacks any disclosure of an insertion tool supported by the robotic arm, Shalayev discloses a system to facilitate insertion of an implant having a robotic arm (60) with an end effector (64) that can receive a tool (66), wherein the tool can be any device to contact, perform work or install an implant on a subject’s anatomy (Fig. 4 and paragraph [0048]), wherein it is understood that a tool used to install an implant is inserting the implant within a patient, thus the tool is an “insertion” tool.
For such reason, claim 1 remains rejected under 35 U.S.C. 103 to Bowling et al., U.S. PG-Pub 2014/0039681 as modified in view of Shalayev et al., WO 2017/200785.
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 Eric Gibson whose telephone number is (571)270-5274. The examiner can normally be reached Monday-Thursday ~6:00 A.M. to 4:00 P.M. (CST).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Kevin Truong, at (571) 272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERIC S GIBSON/ Primary Examiner, Art Unit 3775