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 Amendment
This Office Action is responsive to the amendment filed on 30 June 2026. As directed by the amendment: claim 1 has been amended, and claim 2 is cancelled. Claims 1 and 3-10 currently stand pending in the application.
Response to Arguments
Applicant’s arguments with respect to the rejections under 35 U.S.C. 103 have been considered but are moot because the new ground of rejection does not rely on any combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
Claims 1 and 3-6 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. US 11,707,284 to Sharifi-Mehr et al. (hereinafter, “Sharifi-Mehr”), in view of U.S. Patent No. US 8,096,202 to Komori, U.S. Patent Application Publication No. US 2022/0338938 to Walen et al. (hereinafter, “Walen”), U.S. Patent Application Publication No. US 2022/0142681 to Jeffords et al. (hereinafter, “Jeffords”), and U.S. Patent No. US 11,419,614 to Weitzman et al. (hereinafter, “Weitzman”).
As to claim 1, Sharifi-Mehr discloses an automatic screw implantation system (4000), FIGS. 42-47, comprising: a screw implantation device including: a power transmission assembly (robotic coupler, transmits torque from the robot to the screwdriver to power the screwdriver) used to implant a hollow pedicle screw (4010) (col. 16 / lines 49-57), FIGS. 43 and 48; a guide pin (4150) passing through and arranged coaxially with the hollow pedicle screw (col. 14 / lines 45-48); wherein the guide pin advances and simultaneously spins at a first rotational speed and a first torque (col. 17 / lines 53-58; rotating the guide pin to advance into bone occurs at a speed and a torque); wherein the power transmission assembly controls the hollow pedicle screw to spin at a second rotational speed and a second torque (col. 17 / lines 58-61; rotating the screw to advance into bone occurs at a speed and a torque).
As to claim 3, Sharifi-Mehr discloses the automatic screw implantation system according to claim 1, wherein the guide pin spins in a first rotational direction (counter-clockwise), the hollow pedicle screw spins in a second rotational direction (clockwise), and the first rotational direction is opposite to the second rotational direction (col. 17 / lines 53-61).
As to claim 4, Sharifi-Mehr discloses the automatic screw implantation system according to claim 1, wherein the guide pin and the hollow pedicle screw are spaced apart from and do not interfere with each other (the guide pin and the screw are radially spaced apart from each other since the screw is sleeved around the guide pin, spaced apart at least enough so that they do not interfere with each other since they can rotate independently).
As to claim 5, Sharifi-Mehr discloses the automatic screw implantation system according to claim 4, wherein, when the guide pin spins, the hollow pedicle screw is sleeved around the guide pin and remains stationary (when the guide pin is being rotated to advance axially into bone, the screw remains relatively stationary).
As to claim 6, Sharifi-Mehr discloses the automatic screw implantation system according to claim 1, wherein, when the power transmission assembly controls the hollow pedicle screw to spin, the guide pin retracts relative to the hollow pedicle screw (col. 17 / lines 58-61).
Although Sharifi-Mehr discloses that the system is robotically operated (col. 16 / lines 42-59, col. 17 / lines 47-61), Sharifi-Mehr is silent as to a motor dynamically coupled to the power transmission assembly and the guide pin; wherein the motor is configured for driving the guide pin and the power transmission assembly to control the hollow pedicle screw.
Komori teaches that robots are driven by electric motors (col. 1 / lines 41-43).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to power the robotic system disclosed in Sharifi-Mehr with a motor, as taught by Komori, so that the surgeon need not expend energy by performing the operations manually. Sharifi-Mehr presents manual and robotic systems as alternatives, and providing a motor powered robot would be an alternative to manual force. Since Sharifi-Mehr discloses that the robotic system facilitates movement of the guide pin and torqueing of the screw, the motor provided, in view of Komori, to power the robotic system, would thus be configured for driving the guide pin to advance and spin (col. 17 / lines 47-61) and controlling the screw to spin (col. 16 / lines 53-55). The robotic coupler that transmits torque to the screwdriver and is interpreted as the power transmission assembly is thus driven by the motor that now drives the robotic system. The motor is therefore dynamically coupled, as part of the whole operating system, to the power transmission assembly and the guide pin.
Sharifi-Mehr is silent as to the second rotational speed is smaller than the first rotational speed, and the second torque is greater than the first torque.
Walen teaches that a drilling process requires a high speed and low torque operating mode, while a driving process requires a low speed and high torque operating mode (par. [0146]), with both modes provided by a variable speed motor that can switch between modes.
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to drive the guide pin at a first, high speed and a first, low torque, since this is a drilling process that drills the guide pin initially into bone and the smaller diameter of the guide pin would require a lower torque, with a high speed preventing catching of the tissues on the pin; and to drive the screw into bone at a second, low speed and a second, high torque, since this is a driving process that threads the screw into the bone which requires a higher torque due to the threads and larger diameter of the screw, and a lower speed so as not to damage the bone or the screw and to prevent misthreading of the screw into the bone. The second rotational speed is thus smaller than the first rotational speed, and the second torque is greater than the first torque. A variable speed motor such as taught by Walen would be provided in the system to achieve switching between the speeds and torques.
Sharifi-Mehr is silent as to wherein the first rotational speed is greater than 10,000 rpm, the first torque is smaller than 0.5 Nm, the second rotational speed is smaller than 300 rpm, and the second torque is greater than 5 Nm.
Jeffords teaches that a pedicle screw is inserted at a decreased speed, about 300 rpm, and increased torque, about 100 inch-pound (about 11 Nm) (par. [0008]), and that a stylet or k-wire is inserted at an increased speed and decreased torque.
Weitzman teaches a wire that transfers torque to cut bone (col. 4 / lines 61-62; col. 6 / lines 59-62; col. 8 / lines 25-27) is rotatable at at least 15,000 RPM with a torque of at least 4 Ncm (0.04 Nm) (col. 7 / lines 9-13).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to insert the pedicle screw at the second rotational speed of about 300 rpm and the second torque of about 11 Nm (which is greater than 5 Nm as claimed), since Jeffords teaches that the relatively decreased speed and increased torque are appropriate for driving a pedicle screw into bone without damaging the bone or screw. It would have been obvious to make the second rotational speed smaller than 300 rpm, since Jeffords teaches “about” 300 rpm, and allowing for minor variability based on tool manufacturing tolerances, the second rotational speed could be slightly less than 300 rpm.
It further would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to advance the guide pin at a first rotational speed of at least 15,000 rpm (greater than 10,000 rpm as claimed) and a first torque of 4 Ncm (4 Ncm is the low goalpost of the disclosed at least 4 Ncm; 4 Ncm equals 0.04 Nm which is smaller than 0.5 Nm as claimed), since Sharifi-Mehr discloses that the guide pin (4150) cuts through bone to form a cannulation for ease of insertion of the screw (col. 14 / lines 55-58; col. 17 / lines 19-21), and thus it would have been obvious to utilize the teaching of Weitzman which teaches that a bone drilling wire is rotatable at such a rotational speed and torque to drill a bone with precision, and such a first rotational speed and first torque would meet the teaching in Jeffords that the pedicle screw is inserted at a relatively decreased second rotational speed (300 rpm is less than 15,000 rpm) and a relatively increased second torque (11 Nm is greater than 0.04 Nm). Such a higher first rotational speed would allow the guide pin to rotate quickly and not allow tissue to catch on it, therefore resulting in quick and clean insertion into the bone, and such a lower first torque would ensure that the guide pin is not inadvertently bent and damaged by excessive torque.
Claims 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Sharifi-Mehr in view of Komori, Walen, Jeffords, and Weitzman (hereinafter, “Sharifi-Mehr/Komori/Walen/Jeffords/Weitzman”), as applied to claims 1 and 3-6 above, and further in view of U.S. Patent No. US 11,065,069 to Kang et al. (hereinafter, “Kang”).
As to claim 7, Sharifi-Mehr/Komori/Walen/Jeffords/Weitzman disclose wherein the automatic screw implantation system further includes a robot device (4200), the robot device is connected to the screw implantation device (col. 16 / lines 50-53), FIG. 48.
As to claim 9, Sharifi-Mehr/Komori/Walen/Jeffords/Weitzman disclose wherein the robot device is configured to move the screw implantation device.
Sharifi-Mehr/Komori/Walen/Jeffords/Weitzman are silent as to a processing device, the processing device is electrically connected to the robot device, and the processing device is used to control operation of the robot device (claim 7); wherein the automatic screw implantation system further includes a surgical navigation module, the surgical navigation module includes a plurality of navigation markers, the plurality of navigation markers are disposed on the robot device, the screw implantation device, and a target site, such that a spatial coordinate system is established, and the processing device plans a predetermined surgical path based on the spatial coordinate system (claim 8); wherein the robot device is configured to move the screw implantation device according to the predetermined surgical path, and the robot device further calibrates a posture of the screw implantation device according to the predetermined surgical path; wherein the posture includes a position and an angle of the screw implantation device (claim 9).
As to claims 1 and 7, Kang teaches an automatic screw implantation system, comprising a screw implantation device (tool 30 comprising driver 44) (col. 8 / lines 24-27), FIG. 6; a motor (col. 8 / lines 28-30); a robot device (20 and 22) (col. 8 / lines 16-21) and a processing device (32) (col. 5 / lines 23-49), the processing device is electrically connected to the robot device, the robot device is connected to the screw implantation device (col. 8 / lines 16-21), and the processing device is used to control operation of the robot device (col. 7 / lines 23-24, col. 8 / lines 47-50).
As to claim 8, Kang teaches the automatic screw implantation system according to claim 7, wherein the automatic screw implantation system further includes a surgical navigation module (36) (col. 5 / lines 23-49), the surgical navigation module includes a plurality of navigation markers (16), the plurality of navigation markers are disposed on the robot device (col. 6 / lines 13-14), the screw implantation device (col. 6 / lines 15-18), and a target site (col. 5 / lines 50-67), such that a spatial coordinate system is established (col. 4 / lines 31-43), and the processing device plans a predetermined surgical path based on the spatial coordinate system (col. 1 / lines 29-41, col. 9 / lines 12-24; the processing device plans the path by having the path inputted into the processing device so that the path can be executed according to the plan, and creating haptic objects to stay on the path).
As to claim 9, Kang teaches the automatic screw implantation system according to claim 8, wherein the robot device is configured to move the screw implantation device according to the predetermined surgical path (col. 7 / lines 4-26, col. 9 / lines 39-51, col. 10 / lines 10-45), and the robot device (as part of the whole system) further calibrates a posture of the screw implantation device (col. 7 / lines 10-13) according to the predetermined surgical path (since the position of the tool is calibrated relative to its desired path, to achieve a desired pose of the screws); wherein the posture includes a position and an angle of the screw implantation device (col. 6 / lines 13-14, col. 7 / lines 36-50, col. 9 / lines 25-51).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include in the system of Sharifi-Mehr/Komori/Walen/Jeffords/Weitzman a processing device and a surgical navigation module, as taught by Kang, so that the robot device of Sharifi-Mehr/Komori/Walen/Jeffords/Weitzman can be controlled by the processing device to stay on a desired trajectory to prevent injury to the patient, and the surgical navigation module can utilize information from navigation markers to ensure that the device stays on the desired trajectory. The navigation markers would be placed on the robot device, the screw implantation device, and the target bone, to establish a coordinate system and track movement and posture of the device in this coordinate system, therefore ensuring the device stays on trajectory throughout the surgery. Automating the system so that it is controlled by the processing device and the navigation module would allow the system to more accurately achieve the surgical goals, using preplanned information and information specific to the patient and the moving tool during the surgery.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Sharifi-Mehr/Komori/Walen/Jeffords/Weitzman in view of Kang (hereinafter, “Sharifi-Mehr/Komori/Walen/Jeffords/Weitzman/Kang”), as applied to claims 7-9 above, and further in view of U.S. Patent No. US 11,337,682 to Van Liere et al. (hereinafter, “Van Liere”).
As to claim 10, Sharifi-Mehr/Komori/Walen/Jeffords/Weitzman/Kang disclose wherein the screw implantation device includes a torque sensor (Kang, col. 13 / lines 40-54) connected to the motor, the torque sensor is used to detect a torque value of the motor, the torque sensor is electrically connected to the processing device, and the processing device is used to read the torque value of the motor, so as to monitor operation of the screw implantation device (Kang, col. 8 / lines 35-50, col. 13 / lines 40-54).
Sharifi-Mehr/Komori/Walen/Jeffords/Weitzman/Kang are silent as to a motor encoder, and the motor encoder is used to detect a rotational speed value of the motor, the motor encoder is electrically connected to the processing device, and the processing device is used to read the rotational speed value.
Van Liere teaches a motor encoder used to detect a rotational speed value of the motor (col. 6 / line 66 – col. 7 / line 10).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include in the system of Sharifi-Mehr/Komori/Walen/Jeffords/Weitzman/Kang a motor encoder used to detect a rotational speed value of the motor, so that the rotational speed of the motor can be monitored and the motor can be stopped immediately if the speed indicates that the device has strayed from the desired trajectory, therefore preventing injury to the patient. As applied to the system of Sharifi-Mehr/Komori/Walen/Jeffords/Weitzman/Kang, the motor encoder, like the torque sensor disclosed in Kang, is electrically connected to the processing device, so that the processing device is used to read and monitor the rotational speed value and stop the motor if necessary, as also disclosed by Kang.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TRACY L KAMIKAWA whose telephone number is (571)270-7276. The examiner can normally be reached M-F 10:00-6:30 PM.
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/TRACY L KAMIKAWA/Examiner, Art Unit 3775
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