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 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.
Claim(s) 1, 6-13, 16-18 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zucker et al. (US Pub 2019/0231435) in view of Mosnier et al. (US Pub 2020/0315708).
With respect to claim 1, Zucker discloses a robotic system (see figures 1, 2 and 3A below) for inserting a rod (Fig 3A, 32) comprising: a robotic arm (fig 3A, 37) comprising: a proximal end (see fig 3A below); and a distal end (See fig 3A below) movable relative to the proximal end, the distal end configured to position a rod; at least one processor; and a memory storing instructions for execution by the at least one processor that, when executed (paragraph 95, programmed robotic procedure), cause the at least one processor to: track at least one tower to identify a tower (fig 1, 18) movement (paragraph 98), the tower extending from a head of a corresponding implanted pedicle screw (fig 1, 13); calculate an insertion point and a path from the insertion point to the at least one tower (fig 2, 24, 25); cause the robotic arm to insert the rod at the insertion point and along the path (fig 2, 30); and cause the robotic arm to adjust the path during insertion of the rod based on the tower movement (paragraph 98) wherein adjusting the path during insertion of the rod based on the tower movement includes adjusting the insertion point, adjusting an entirety of the path or adjusting a portion of the path (paragraph 52 adjustment of the trajectory occurs in real time based on the position and orientation of the pedicle screw heads) . With respect to claim 6, Zucker discloses wherein tracking the at least one tower uses at least one of a navigation system, a marker, or a sensor (fig 4, 44). With respect to claim 7, Zucker discloses wherein causing the robotic arm to adjust the path includes adjusting at least one of an orientation of the rod or a position of the rod (paragraph 98 and 99) at a number of points along the path (paragraph 52 correction in real time). With respect to claim 8, Zucker discloses wherein the memory stores additional instructions for execution by the at least one processor that, when executed, further cause the at least one processor to: verify placement of the rod in the at least one tower (paragraph 102, tracking system on rod). With respect to claim 9, Zucker discloses wherein verifying placement of the rod in the at least one tower uses at least one of a laser pointer and reflector, a navigation system, a sensor, or a marker (fig 4 and paragraph 102).
With respect to claim 10, Zucker discloses a robotic system (see figs 1, 2 and 3A below) for inserting a rod (fig 3A, 32) comprising: a first robotic arm (fig 3A, 37) and a second robotic arm (paragraph 99, robotic movements for each step of the process including insertion of the screws (fig 4 and fig 2)), each robotic arm comprising: a proximal end (See fig 3A below); and a distal end (See fig 3A below) movable relative to the proximal end, wherein the distal end of the first robotic arm is configured to position a rod (fig 1 and 3A) and the distal end of the second robotic arm is configured to hold at least one tower in a known position (fig 1, tower 18 and paragraph 99), the at least one tower extending from a head of a corresponding pedicle screw implanted in a vertebra of a plurality of vertebrae (fig 1); at least one processor; and a memory storing instructions for execution by the at least one processor that, when executed, cause the at least one processor to: receive position information about a current position of the at least one tower (paragraph 98); calculate an insertion point and a path from the insertion point to the at least one tower based on the current position (fig 2, 24-25); and cause the first robotic arm to insert the rod at the insertion point and along the calculated path (fig 2, 30) wherein adjusting the path during insertion of the rod based on the tower movement includes adjusting the insertion point, adjusting an entirety of the path or adjusting a portion of the path (paragraph 52 adjustment of the trajectory occurs in real time based on the position and orientation of the pedicle screw heads). With respect to claim 11, Zucker discloses wherein the position information is received from at least one sensor (Fig 4, 44) of the second robotic arm. With respect to claim 12, Zucker discloses further comprising: a tracking marker (fig 4, 44) positioned on the second robotic arm; and a navigation system (paragraph 98) configured to generate the position information based on detected movement of the tracking marker. With respect to claim 13, Zucker discloses further comprising at least one sensor, and wherein the memory stores additional instructions for execution by the at least one processor that, when executed, further cause the at least one processor to: verify, by the at least one sensor (fig 4, 44), placement of the rod in the at least one tower (paragraph 98). With respect to claim 16, Zucker discloses wherein the current position is different than the known position, and the memory stores additional instructions for execution by the at least one processor that, when executed, further cause the at least one processor to: cause the first robotic arm to adjust the path during insertion of the rod when a difference between the current position and the known position meets a predetermined threshold (paragraph 88 and 98). With respect to claim 17, Zucker discloses wherein the current position is different than the known position, and the memory stores additional instructions for execution by the at least one processor that, when executed, further cause the at least one processor to (fig 2 and paragraph 43): cause the second robotic arm to adjust a position of the at least one tower based on a difference between the current position and the known position meeting a predetermined threshold (paragraph 18, iterative adjustments of the screw positions.)
With respect to claim 18, Zucker discloses a robotic system (see figures 1, 2 and 3A below) for inserting a rod (Fig 3A, 32) comprising: a robotic arm (fig 3A, 37) comprising: a proximal end (See fig 3A below); and a distal end (fig 3A, 35) movable relative to the proximal end, the distal end configured to hold at least one tower in a known position (Fig 1, 18, (paragraph 99, robotic movements for each step of the process including insertion of the screws (fig 4 and fig 2)); at least one processor; and a memory storing instructions for execution by the at least one processor that (robotic process, fig 2), when executed, cause the at least one processor to: calculate an insertion point and a path from the insertion point to the at least one tower (fig. 2, 24); generate instructions for inserting a rod along the path (fig 2, 30); and update the path during insertion of the rod based on information about a position of the rod or movement of the tower (paragraph 98 and fig 4) wherein adjusting the path during insertion of the rod based on the tower movement includes adjusting the insertion point, adjusting an entirety of the path or adjusting a portion of the path (paragraph 52 adjustment of the trajectory occurs in real time based on the position and orientation of the pedicle screw heads). With respect to claim 20, Zucker discloses wherein the memory stores additional instructions for execution by the at least one processor that, when executed, further cause the at least one processor to: cause the robotic arm to move the tower from the known position to an updated position based at least one of a force exerted (paragraph 32) on the robotic arm or information about a position of the rod (paragraph 99, robotic movements for each step of the process including insertion of the screws (fig 4 and fig 2)).
With respect to claims 1, 10 and 18, Zucker discloses the claimed invention except for trigger an alert to notify a user that the tower movement was detected.
Mosnier discloses trigger an alert to notify a user that the tower movement was detected (paragraph 178) to guide the surgeon during surgery (paragraph 178).
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 Zucker to include a trigger an alert to notify a user that the tower movement was detected in view of Mosnier in order to guide the surgeon during surgery. With respect to claims 1, 10 and 18 Zucker in view of Mosnier discloses a system wherein the movement is detected (Mosnier discloses when movement of the screws occurs paragraph 178) and the calculated path has been adjusted and prompt the user to accept the adjusted path prior to the robotic arm moving the rod along the adjusted path (Zucker discloses a system where the path is adjusted and confirmed by the surgeon finishing performing the procedure, paragraph 42 discloses path planning algorithms that are used in result from changing the tower and screw positions and paragraph 96 discloses that the system aids the surgeon with trajectories as the procedure is progressing).
PNG
media_image1.png
789
813
media_image1.png
Greyscale
Claim(s) 2, 3 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zucker in view of Mosnier as applied to claims 1, and 18 above, and further in view of Crawford et al. (US 10,646,280).
With respect to claims 2, 3 and 19, Zucker in view of Mosnier discloses monitoring for a force threshold (paragraph 32) but does not specifically disclose at least one sensor, wherein the memory stores additional instructions for execution by the at least one processor that, when executed, further cause the at least one processor to: monitor a magnitude of a force received by the robotic arm using the at least one sensor wherein the memory stores additional instructions for execution by the at least one processor that, when executed, further cause the at least one processor to: cause the robotic arm to pause movement of the rod or tower when the magnitude of the force meets a threshold.
Crawford discloses at least one sensor (claim 1, force sensor), wherein the memory stores additional instructions for execution by the at least one processor that, when executed, further cause the at least one processor to (Fig 2, 110): monitor a magnitude of a force received by the robotic arm using the at least one sensor wherein the memory stores additional instructions for execution by the at least one processor that(col. 2, ll. 12-15), when executed, further cause the at least one processor to: cause the robotic arm to pause movement of the rod when the magnitude of the force meets a threshold (col. 2, ll. 18-21) to prevent undesirable conditions from occurring (col. 16, ll. 1-6).
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 Zucker in view of Mosnier to include at least one sensor, wherein the memory stores additional instructions for execution by the at least one processor that, when executed, further cause the at least one processor to: monitor a magnitude of a force received by the robotic arm using the at least one sensor wherein the memory stores additional instructions for execution by the at least one processor that, when executed, further cause the at least one processor to: cause the robotic arm to pause movement of the rod or tower when the magnitude of the force meets a threshold.
Claim(s) 4 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zucker in view of Mosnier as applied to claims 1, and 10 above, and further in view of Bootwala (US Pub 2016/0374735).
With respect to claims 4 and 14, Zucker in view of Mosnier discloses the claimed invention except for wherein the memory stores additional instructions for execution by the at least one processor that, when executed, further cause the at least one processor to: cause the robotic arm to tighten a set screw of the corresponding pedicle screw.
Bootwala discloses wherein the memory stores additional instructions for execution by the at least one processor that, when executed (paragraph 52, robot-assisted procedure), further cause the at least one processor to: cause the robotic arm to tighten a set screw of the corresponding pedicle screw (paragraph 52, set screw positioned and rotatably driven) to lock the rod into the receiver (paragraph 52).
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 Zucker in view of Mosnier to include wherein the memory stores additional instructions for execution by the at least one processor that, when executed, further cause the at least one processor to: cause the robotic arm to tighten a set screw of the corresponding pedicle screw in view of Bootwala in order to lock the rod into the receiver.
Claim(s) 5 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zucker in view of Mosnier as applied to claims 1, and 10 above, and further in view of Goyette et al. (US Pub 2021/0177526)
With respect to claim 5, Zucker in view of Mosnier discloses the claimed invention with towers being removed (fig 1) but does not specifically disclose wherein the memory stores additional instructions for execution by the at least one processor that, when executed, further cause the at least one processor to: cause the robotic arm to remove the at least one tower from the head of the corresponding pedicle screw.
Goyette discloses wherein the memory stores additional instructions for execution by the at least one processor that, when executed, further cause the at least one processor to (fig 2, 210): cause the robotic arm (fig 2, 240) to remove the at least one tower from the head of the corresponding pedicle screw (paragraph 37) to allow the tower to be used to interconnect addition vertebra and screws (paragraph 37).
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 Zucker in view of Mosnier to include wherein the memory stores additional instructions for execution by the at least one processor that, when executed, further cause the at least one processor to: cause the robotic arm to remove the at least one tower from the head of the corresponding pedicle screw in view of Goyette in order to allow the tower to be used to interconnect addition vertebra and screws (paragraph 37).
Response to Arguments
Applicant's arguments filed 11/13/2025 have been fully considered but they are not persuasive. The applicant argues that Zucker does not disclose the amended claim limitation wherein adjusting the path during insertion of the rod based on the tower movement includes adjusting the insertion point, adjusting an entirety of the path or adjusting a portion of the path. The examiner respectfully disagrees. Paragraph 52 adjustment of the trajectory occurs in real time based on the position and orientation of the pedicle screw heads and paragraph 98 discloses the system tracking the position and orientation of the screws and towers. Such that Zucker teaches adjustment of the path (trajectory) of the rod during the procedure as a result of movement of the tower.
The rejections are deemed proper.
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 STEVEN J COTRONEO whose telephone number is (571)270-7388. The examiner can normally be reached Monday-Friday 9am-5pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eduardo Robert can be reached at (571) 272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/S.J.C/Examiner, Art Unit 3773 /EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773
Prosecution Insights