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
The Amendments under 37 CFR 1.132 filed 06/11/2026 is sufficient to overcome the rejection of claim 1 based upon the current rejection failing to teach all aspects of the amended claim.
Claims 1-6 are currently pending in this application.
Response to Arguments
Applicant’s arguments, see Remarks, filed 06/11/2026, with respect to the rejection(s) of claim(s) 1 under 35 U.S.C. 103 as being unpatentable over Worrell (US 20200022724 A1) in view of Nott (US 20190274716 A1), further in view of Yates (US 20120116379 A1) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Lightcap (US 20190000553 A1).
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.
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) 1-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Worrell (US 20200022724 A1) in view of Nott (US 20190274716 A1), in view of Yates (US 20120116379 A1), further in view of Lightcap (US 20190000553 A1).
Regarding claim 1, Worrell teaches a robotic surgical system, comprising: an electrosurgical instrument including an instrument housing; a shaft extending distally from the instrument housing (Fig 24; shaft 554); an end effector assembly disposed at a distal end of the shaft (Fig 24; end effector 548), the end effector assembly configured to articulate relative to the shaft in at least one direction to an articulated position, the end effector assembly ([0225] FIG. 64, rotation of the handheld surgical user interface 1406 about a pivot point 1430 results in an articulating movement of end effector 528) and including first and second jaw members, at least one of the first or second jaw members movable relative to the other between an open position wherein the first and second jaw members are spaced relative to one another and a closed position wherein the first and second jaw members cooperate to grasp tissue (Fig 24; jaws 551A and 551B); an input (Fig 27; driven elements 564 and rotatable bodies 576) disposed on the instrument housing and configured to be rotated by an external driver from an exterior of the instrument housing ([0167] the driven elements 564 may be aligned with the drive elements 592 of the instrument holder 588 such that rotational motion of the drive elements 592 causes corresponding rotational motion of the driven elements 564. The rotation of the drive elements 592 and driven elements 564 may be electronically controlled, for example, via the robotic arm 612, in response to instructions received from the clinician 502 via a controller 508. The instrument mounting portion 558 may translate rotation of the driven elements 564 into motion of the surgical instrument 522, 523), the input operably coupled to a drive mechanism disposed within the instrument housing (FIGS. 32-34 show one example embodiment of the instrument mounting portion 558 showing components for translating motion of the driven elements 564 into motion of the surgical instrument 522, 523) and operably coupled to the end effector assembly such that the rotation of the input moves the at least one of the first or second jaw members between the open and closed positions ([0169] Each of the rotatable bodies 612 is coupled to a gear train or gear mechanism to provide shaft articulation and rotation and clamp jaw open/close and knife actuation); and at least one handle (Fig 48-60) remotely disposed relative to the instrument housing, the at least one handle including: a housing having a lever operably coupled thereto (Fig 61; shepherd's hook trigger 1320), the housing including a cavity containing one or more components configured to operably connect to the external driver such that movement of the lever relative to the housing correlates to movement of the at least one of the first or second jaw members between the open and closed positions ([0212] The shepherd's hook trigger 1320 may be configured to control, for example, a clamping motion of an end effector attached to the surgical instrument. By pulling the shepherd's hook trigger 1320 towards the handle 1322, a user may cause the jaws of an end effector to pivot into a clamped position, such as, for example, the first and second jaws 551A,B of the end effector 548. Releasing the shepherd's hook trigger 1320 may, in one example embodiment, cause the jaws of the end effector to return to a non-clamped or open position), the one or more components configured to operably regulate the resistance of the lever based on the feedback from the torque sensor ([0209] The one or more sensors attached to the robotic surgical system 500 may be a suitable sensor for providing a feedback signal, such as, for example, a linear position sensor, a rotational position sensor, a force sensor, a thermal sensor, or any other sensor type. The one or more sensors may be combined integrally with the surgical instrument 522, 523 attached to the robotic surgical system or may an additional module connected to the surgical instrument 522, 523 to generate the necessary feedback signal) and an articulated position of the end effector assembly relative to the shaft ([0221] one or more force feedback devices may be located within the surgical device handle 1422. In the illustrated embodiment, two trigger feedback devices 1432a,b are connected to the shepherd's hook trigger 1320. The trigger feedback devices 1432a,b provide haptic feedback in the form of a resistive force when pulling or releasing the shepherd's hook trigger 1320. In one example embodiment, the trigger feedback devices 1432a,b provide a resistive force to the movement of the shepherd's hook trigger 1320 that is proportional to a force encountered by the jaws of an end effector connected to the surgical instrument, such as, for example, the jaws 551A,B of electrosurgical end effector 548).
Worrell fails to fully teach the end effector assembly configured to articulate relative to the shaft in at least one direction; a torque sensor configured to measure a torque applied to the input during the rotation thereof by the external driver to move the at least one of the first or second jaw members between the open and closed positions, the torque sensor configured to provide torque feedback regarding the measured torque applied to the input; a controller configured to attenuate the torque feedback from the torque sensor to account for torque attributed to articulation of the end effector assembly relative to the shaft; and the one or more components configured to operably regulate the resistance of the lever based on the attenuated torque feedback from the torque sensor, and an offset that accounts for torque attributed to the articulated position of the end effector assembly relative to the shaft.
However, Nott teaches a torque sensor ([0339] The output shaft of the motor 704a is coupled to a torque sensor 744a. The torque sensor 744a is coupled to a transmission 706a which is coupled to the closure member 714) ([0341] The torque sensor 744c provides a rotation force feedback signal to the control circuit 710) ([0342] The torque sensor 744d provides an articulation force feedback signal to the control circuit 710. The articulation force feedback signal represents the articulation force applied to the end effector 702) configured to measure the torque applied to the input during the rotation thereof by the external driver to move the at least one of the first or second jaw members between the open and closed positions ([0324] Each of the motors 602, 603, 606a, 606b may comprise a torque sensor to measure the output torque on the shaft of the motor. The force on an end effector may be sensed in any conventional manner, such as by force sensors on the outer sides of the jaws or by a torque sensor for the motor actuating the jaws) ([0350] The control circuit 710 can be configured to simulate the response of the actual system of the instrument in the software of the controller. A displacement member can be actuated to move the closure member 714 in the end effector 702 at or near a target velocity. The robotic surgical instrument 700 can include a feedback controller, which can be one of any feedback controllers, including, but not limited to a PID, a state feedback, a linear-quadratic (LQR), and/or an adaptive controller, for example. The robotic surgical instrument 700 can include a power source to convert the signal from the feedback controller into a physical input such as case voltage, PWM voltage, frequency modulated voltage, current, torque, and/or force, for example), the torque sensor configured to provide torque feedback regarding the measured torque applied to the input ([0342] The torque sensor 744d provides an articulation force feedback signal to the control circuit 710. The articulation force feedback signal represents the articulation force applied to the end effector 702); and the one or more components configured to operably regulate the resistance of the lever in response to the feedback from the torque sensor ([0324] Each of the motors 602, 603, 606a, 606b may comprise a torque sensor to measure the output torque on the shaft of the motor. The force on an end effector may be sensed in any conventional manner, such as by force sensors on the outer sides of the jaws or by a torque sensor for the motor actuating the jaws), and an offset that accounts for torque attributed to the articulated position of the end effector assembly relative to the shaft ([0341] The torque sensor 744c provides a rotation force feedback signal to the control circuit 710. The rotation force feedback signal represents the rotation force applied to the shaft 740. The position sensor 734 may be configured to provide the position of the closure member as a feedback signal to the control circuit 710. Additional sensors 738 such as a shaft encoder may provide the rotational position of the shaft 740 to the control circuit 710); articulation of the end effector assembly relative to the shaft ([0342] The torque sensor 744d provides an articulation force feedback signal to the control circuit 710. The articulation force feedback signal represents the articulation force applied to the end effector 702). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Worrell to include the end effector assembly configured to articulate relative to the shaft in at least one direction; a torque sensor configured to measure the torque applied to the input during the rotation thereof by the external driver; and an offset that accounts for torque attributed to the articulated position of the end effector assembly relative to the shaft. Doing so would measure the torque during articulation of the end effector to operate within safe levels.
Furthermore, the combination of Worrell and Nott fails to fully teach and the one or more components configured to operably regulate the resistance of the lever based on the attenuated feedback from the torque sensor. However, Yates teaches and the one or more components configured to operably regulate the resistance of the lever based on the feedback ([0066]; [0077]; [0082] as the user squeezes trigger (624) toward grip (622) and control module (640) senses that the jaws are encountering thick or dense tissue, control module (640) may activate trigger clutch (612) to arrest movement of trigger (624) or provide some other form of tactile feedback through trigger (624), to alert the user that elongate member (670) will not be translating distally until the tissue is sufficiently heated/sealed by the electrodes in the end effector, etc. As another merely illustrative example, trigger clutch (612) may provide resistance to movement of trigger (624); [0086] Brake (710) is also coupled with projection (726), and is operable to selectively clamp down on projection (726) with pads (not shown) in order to selectively provide frictional resistance to movement of trigger (724)). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Worrell to include teachings of Nott and Yates where one or more components configured to operably regulate the resistance of the lever in response to the feedback from the torque sensor and articulation of the end effector. Doing so would determine a feedback response of the lever for working within predetermined values and allowing the advantage of allowing a user to “feel” the toughness or thickness of tissue (Yates [0082]).
Further, Lightcap teaches a controller configured to attenuate the feedback from the sensor to account for force attributed to a distal end ([0058] processor 231 may reduce an amount of force feedback gain being applied to robotic arm 204 as distal end 211 moves closer to spinal cord 103 so that the impedance of robotic arm 204 increases as distal end 211 moves closer to spinal cord 103). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Worrell to include teachings of Nott, Yates, and Lightcap where a controller is configured to attenuate the torque feedback from the torque sensor to account for torque attributed to articulation of the end effector assembly relative to the shaft. Doing so allows for torque feedback from the torque sensor taught by Nott to be attenuated as taught by Lightcap to account for the torque at the articulated end as taught by Nott and Yates. Further, the combination would allow for resisting the movement to be proportional to the degree of articulation that is sensed.
Regarding claim 2, Worrell teaches the robotic surgical system according to claim 1, wherein the one or more components are configured to operably regulate the resistance of the lever relative to a baseline torque measurement of the input measured during manufacturing ([0232] The feedback signal may be generated by other suitable means, such as, for example, a potentiometer, a rheostat, a position sensor, a linear displacement sensor, a capacitive sensor, an electrical resistance sensor, or any other suitable sensor for generating a feedback signal for the one or more feedback devices).
Regarding claim 3, Worrell teaches the robotic surgical system according to claim 1, wherein the one or more components are configured to operably regulate the resistance of the lever relative to a torque curve of the input ([0206] [0221] one or more force feedback devices may be located within the surgical device handle 1422. In the illustrated embodiment, two trigger feedback devices 1432a,b are connected to the shepherd's hook trigger 1320. The trigger feedback devices 1432a,b provide haptic feedback in the form of a resistive force when pulling or releasing the shepherd's hook trigger 1320).
Regarding claim 4, Worrell teaches The robotic surgical system according to claim 1, wherein the correlation of the resistance of the lever to the torque of the input is linear ([0221] In one example embodiment, the trigger feedback devices 1432a,b provide a resistive force to the movement of the shepherd's hook trigger 1320 that is proportional to a force encountered by the jaws of an end effector connected to the surgical instrument, such as, for example, the jaws 551A,B of electrosurgical end effector 548).
Claim(s) 5 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Worrell in view of Nott (US 20190274716 A1) and Yates (US 20120116379 A1), further in view of Verner (US 20190015169 A1).
Regarding claim 5, Worrell and the combination above teaches the robotic surgical system according to claim 1, but fails to teach wherein the correlation of the resistance of the lever to the torque of the input is non-linear. However, Verner teaches wherein the correlation of the resistance of the lever to the torque of the input is non-linear ([0017] The transformation applied to the desired haptic feedback profile to generate the haptic feedback at the input device can be anything from direct replication of the haptic feedback profile, to scaling of the haptic feedback profile, to applying a non-linear modification of the haptic feedback profile, or any other transformation (e.g., force scaling that varies depending on one or more other factors such as instrument state/speed, viewing magnification, etc.). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Worrell to have the correlation of the resistance of the lever to the torque of the input be non-linear by having a non-linear ratio of 1:2. Doing so may lessen the overall lever force required to generate the appropriate closure pressure at the jaw members.
Regarding claim 6, Worrell and the combination above teaches the robotic surgical system according to claim 1, but fails to teach wherein the combination of components disposed in the cavity include at least one of: one or more levers, one or more gears, one or more linkages, or one or more springs. However, Verner teaches wherein the combination of components disposed in the cavity include at least one of: one or more levers, one or more gears, one or more linkages, or one or more springs (Fig 1; [0017] a surgical system that allows a user (e.g., surgeon) to control a surgical instrument (and/or other elements of the surgical system, such as a robotic arm, set up structure, or positioning element such as a boom or cart) via an input device(s) (e.g., lever(s), gripper(s), joystick(s), or any other structure capable of receiving user input)). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Worrell to include at least one of: one or more levers, one or more gears, one or more linkages, or one or more springs disposed in the cavity. Doing so allows for complex maneuvering and proper sealing for surgical applications.
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 ASHLEIGH LAUREN KERN whose telephone number is (703)756-4577. The examiner can normally be reached 7:30 am - 4:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached on 571-272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ASHLEIGH LAUREN KERN/Examiner, Art Unit 3794
/ADAM Z MINCHELLA/Primary Examiner, Art Unit 3794
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