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 08/29/2025 is insufficient to overcome the previous rejection of claim 1 based upon Harris teaching all aspects of the amended claim as set forth in the last Office action because: The cited portions of Harris (US 20190200981 A1) in the pervious Action were not sufficient in teaching the amended claim 1, however newly cited portions in Harris teach the amended claim 1 portions.
The Amendments under 37 CFR 1.132 filed 08/29/2025 is insufficient to overcome the previous rejection of claims 12 and 17 based upon Harris teaching all aspects of the amended claim as set forth in the last Office action.
Response to Arguments
Applicant's arguments filed 08/29/2025 have been fully considered but they are not persuasive.
Regarding claim 1, Harris teaches a first drive system ([0463] closure motor 603); and a second drive system ([0462] firing motor 602) different from the first drive system ([0462] closure motor 603 and firing motor 602).
Regarding claim 12, Harris teaches detect a current through the closure motor ([0502] A current sensor 786 can be employed to measure the current drawn by the motor 754. The force required to advance the I-beam 764 corresponds to the current drawn by the motor 754. The force is converted to a digital signal and provided to the control circuit 760); set a firing parameter of the motor-powered firing system based on the detected current ([0502] The force required to advance the I-beam 764 corresponds to the current drawn by the motor 754) ([0494] In one aspect, a current sensor 736 can be employed to measure the current drawn by each of the motors 704a-704e. The force required to advance any of the movable mechanical elements such as the I-beam 714 corresponds to the current drawn by one of the motors 704a-704e. The force is converted to a digital signal and provided to the control circuit 710. 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 an I-beam 714 in the end effector 702 at or near a target velocity).
Regarding claim 17, Harris teaches determine a rate of change of the load applied by the end effector to the tissue ([0490] the control circuit 710 can sense (1) the closure load experienced by the distal closure tube and its position) ([0096] FIG. 84 is a graph of a control system configured to provide progressive closure of a closure member during a firing stroke when the firing member advances distally and couples into a clamp arm to lower the closure force load on the closure member at a desired rate); determine a tissue type of the tissue based on the determined rate of change ([0479] The control circuit 710 may be programmed to sense tissue conditions, such as thickness, either directly or indirectly, as described herein. The control circuit 710 may be programmed to select a firing control program or closure control program based on tissue conditions. A firing control program may describe the distal motion of the displacement member. Different firing control programs may be selected to better treat different tissue conditions. For example, when thicker tissue is present, the control circuit 710 may be programmed to translate the displacement member at a lower velocity and/or with lower power. When thinner tissue is present, the control circuit 710 may be programmed to translate the displacement member at a higher velocity and/or with higher power); set a firing parameter of the motor-powered firing system based on the determined type of tissue ([0479] The control circuit 710 may be programmed to select a firing control program or closure control program based on tissue conditions. A firing control program may describe the distal motion of the displacement member. Different firing control programs may be selected to better treat different tissue conditions).
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Harris (US 20190200981 A1).
Regarding claim 1, Harris teaches a surgical system, comprising: a surgical instrument, comprising: an end effector (FIG. 28 is an exploded view of an end effector of the surgical instrument of FIG. 25, in accordance with at least one aspect of this disclosure); a first drive system ([0463] closure motor 603); and a second drive system ([0462] firing motor 602) different from the first drive system ([0462] closure motor 603 and firing motor 602); and a control system ([0467] common control module 610), configured to: detect the actuation of the first drive system of the surgical instrument ([0467] the common control module 610 can be selectively switched between operable engagement with the articulation motors 606a, 606b and operable engagement with either the firing motor 602 or the closure motor 603) ([0468] [0468] Each of the motors 602, 603, 606a, 606b may comprise a torque sensor to measure the output torque on the shaft of the motor) ([0469] FIG. 16, the common control module 610 may comprise a motor driver 626 which may comprise one or more H-Bridge FETs); drive a first function of the end effector using the first drive system ([0483] The control circuit 710 provides a motor set point to a motor control 708a, which provides a drive signal to the motor 704a); monitor a first parameter associated with a first function ([0490] the control circuit 710 may be in communication with one or more sensors 738. The sensors 738 may be positioned on the end effector 702 and adapted to operate with the robotic surgical instrument 700 to measure the various derived parameters such as the gap distance versus time, tissue compression versus time, and anvil strain versus time) driven by the first drive system ([0501] The sensors 788 may be is configured to measure forces exerted on the anvil 766 by a closure drive system. For example, one or more sensors 788 can be at an interaction point between a closure tube and the anvil 766 to detect the closure forces applied by a closure tube to the anvil 766); set a second parameter associated with a second function of the end effector based on the monitored first parameter ([0494] The force required to advance any of the movable mechanical elements such as the I-beam 714 corresponds to the current drawn by one of the motors 704a-704e); and drive the second function of the end effector using the second drive system ([0494] The force required to advance any of the movable mechanical elements such as the I-beam 714 corresponds to the current drawn by one of the motors 704a-704e. The force is converted to a digital signal and provided to the control circuit 710. 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 an I-beam 714 in the end effector 702 at or near a target velocity).
Regarding claim 2, Harris teaches the surgical system of Claim 1, wherein: the end effector comprises a jaw movable between an open position and a clamped position ([0015] the end effector comprises a first jaw and a second jaw; establishing a communication pathway between the surgical instrument and a surgical hub; grasping tissue between the first jaw and the second jaw); the first function comprises transitioning the jaw of the end effector toward the clamped position ([0463] the surgical instrument or tool may include a closure motor 603. The closure motor 603 may be operably coupled to a closure motor drive assembly 605 which can be configured to transmit closure motions, generated by the motor 603 to the end effector) ([0463] The closure motions may cause the end effector to transition from an open configuration to an approximated configuration to capture tissue); and the first parameter comprises a load applied by the jaw to tissue positioned within the end effector ([0479] The control circuit 710 may be programmed to sense tissue conditions, such as thickness, either directly or indirectly, as described herein. A closure control program may control the closure force applied to the tissue by the anvil 716) ([0490] Accordingly, the control circuit 710 can sense (1) the closure load experienced by the distal closure tube and its position, (2) the firing member at the rack and its position, (3) what portion of the staple cartridge 718 has tissue on it, and (4) the load and position on both articulation rods).
Regarding claim 3, Harris teaches the surgical system of Claim 2, wherein: the end effector comprises a staple cartridge comprising staples removably stored therein (Fig 17; a removable staple cartridge 718); the surgical instrument further comprises a firing member movable from an unfired position toward a fired position ([0505] When ready to use the instrument 750, the clinician may provide a firing signal, for example by depressing a trigger of the instrument 750. In response to the firing signal, the motor 754 may drive the displacement member distally along the longitudinal axis of the end effector 752 from a proximal stroke begin position to a stroke end position distal of the stroke begin position); the staples are deployable from the staple cartridge based on the firing member moving toward the fired position ([0462] The firing motor 602 may be operably coupled to a firing motor drive assembly 604 which can be configured to transmit firing motions, generated by the motor 602 to the end effector, in particular to displace the I-beam element. In certain instances, the firing motions generated by the motor 602 may cause the staples to be deployed from the staple cartridge into tissue captured by the end effector and/or the cutting edge of the I-beam element to be advanced to cut the captured tissue, for example); the second function comprises driving the firing member toward the fired position ([0462]); and the second parameter comprises a speed of the firing member ([0506] A firing control program may describe the distal motion of the displacement member. Different firing control programs may be selected to better treat different tissue conditions. For example, when thicker tissue is present, the control circuit 760 may be programmed to translate the displacement member at a lower velocity and/or with lower power. When thinner tissue is present, the control circuit 760 may be programmed to translate the displacement member at a higher velocity and/or with higher power).
Regarding claim 4, Harris teaches the surgical system of Claim 1, wherein: the end effector comprises an energy delivery component ([0751] the staple cartridge may comprise an active electrode to deliver electrosurgical energy (e.g., RF energy) to the grasped tissue and at least a portion of the anvil may act as a return electrode); the first function comprises applying energy to tissue positioned within the end effector with the energy delivery component ([0751] the staple cartridge may comprise an active electrode to deliver electrosurgical energy (e.g., RF energy) to the grasped tissue and at least a portion of the anvil may act as a return electrode); and the first parameter comprises an amount of time that energy has been applied to the tissue ([0611] if the end effector 151340 includes electrodes coupled to an RF energy source, the electrical impedance of the tissue increases as energy is delivered through the tissue between the anvil 151306 and the staple cartridge 151304 of the end effector 151340) ([0611] The sensors may be adapted and configured to measure tissue impedance “Z” over time “t” as represented graphically in FIG. 48) ([0752] a generator producing the electrosurgical energy and/or a sensor, e.g., 23134, integrated in the surgical instrument may be configured to detect when impedance between the electrodes falls below a threshold value for a threshold time period (i.e., impedance drop indicative of a short)).
Regarding claim 5, Harris teaches the surgical system of Claim 4, wherein the energy delivery component comprises an electrode ([0751] the staple cartridge may comprise an active electrode to deliver electrosurgical energy (e.g., RF energy) to the grasped tissue and at least a portion of the anvil may act as a return electrode).
Regarding claim 6, Harris teaches the surgical system of Claim 4, wherein the energy delivery component comprises an ultrasonic blade ([0791] the disclosed aspects similarly apply to other surgical instruments including energy devices (e.g. RF and/or ultrasonic surgical instruments)) ([0720] It should be noted that surgeons regularly switch back and forth between surgical stapling/cutting instruments and surgical energy (i.e., RF or ultrasonic) instruments depending upon the particular step in the procedure because different instruments are better adapted for particular tasks).
Regarding claim 7, Harris teaches the surgical system of Claim 4, wherein: the end effector comprises a jaw movable between an open position and a clamped position ([0463] the surgical instrument or tool may include a closure motor 603. The closure motor 603 may be operably coupled to a closure motor drive assembly 605 which can be configured to transmit closure motions, generated by the motor 603 to the end effector) ([0463] The closure motions may cause the end effector to transition from an open configuration to an approximated configuration to capture tissue); the second function comprises transitioning the jaw toward the clamped position ([0463]); and the second parameter comprises a load applied by the jaw to the tissue positioned within the end effector ([0479] The control circuit 710 may be programmed to sense tissue conditions, such as thickness, either directly or indirectly, as described herein. A closure control program may control the closure force applied to the tissue by the anvil 716) ([0490] Accordingly, the control circuit 710 can sense (1) the closure load experienced by the distal closure tube and its position, (2) the firing member at the rack and its position, (3) what portion of the staple cartridge 718 has tissue on it, and (4) the load and position on both articulation rods).
Regarding claim 8, Harris teaches the surgical system of Claim 1, wherein: the end effector comprises an energy delivery component ([0751] the staple cartridge may comprise an active electrode to deliver electrosurgical energy (e.g., RF energy) to the grasped tissue and at least a portion of the anvil may act as a return electrode); the first function comprises applying energy to tissue positioned within the end effector with the energy delivery component ([0751] the staple cartridge may comprise an active electrode to deliver electrosurgical energy (e.g., RF energy) to the grasped tissue and at least a portion of the anvil may act as a return electrode); and the first parameter comprises a change in impedance of the tissue over time (FIG. 48 is an illustrative graph of impedance over time).
Regarding claim 9, Harris teaches the surgical system of Claim 8, wherein the energy delivery component comprises an electrode ([0751] the staple cartridge may comprise an active electrode to deliver electrosurgical energy (e.g., RF energy) to the grasped tissue and at least a portion of the anvil may act as a return electrode).
Regarding claim 10, Harris teaches the surgical system of Claim 8, wherein the energy delivery component comprises an ultrasonic blade ([0791] the disclosed aspects similarly apply to other surgical instruments including energy devices (e.g. RF and/or ultrasonic surgical instruments)) ([0720] It should be noted that surgeons regularly switch back and forth between surgical stapling/cutting instruments and surgical energy (i.e., RF or ultrasonic) instruments depending upon the particular step in the procedure because different instruments are better adapted for particular tasks).
Regarding claim 11, Harris teaches the surgical system of Claim 8, wherein: the end effector comprises a jaw movable between an open position and a clamped position ([0463] the surgical instrument or tool may include a closure motor 603. The closure motor 603 may be operably coupled to a closure motor drive assembly 605 which can be configured to transmit closure motions, generated by the motor 603 to the end effector) ([0463] The closure motions may cause the end effector to transition from an open configuration to an approximated configuration to capture tissue); the second function comprises transitioning the jaw toward the clamped position ([0463]); and the second parameter comprises a load applied to the tissue positioned within the end effector ([0479] The control circuit 710 may be programmed to sense tissue conditions, such as thickness, either directly or indirectly, as described herein. A closure control program may control the closure force applied to the tissue by the anvil 716) ([0490] Accordingly, the control circuit 710 can sense (1) the closure load experienced by the distal closure tube and its position, (2) the firing member at the rack and its position, (3) what portion of the staple cartridge 718 has tissue on it, and (4) the load and position on both articulation rods).
Regarding claim 12, Harris teaches a surgical instrument, comprising: an end effector configurable between an open state and a clamped state ([0463] the surgical instrument or tool may include a closure motor 603. The closure motor 603 may be operably coupled to a closure motor drive assembly 605 which can be configured to transmit closure motions, generated by the motor 603 to the end effector) ([0463] The closure motions may cause the end effector to transition from an open configuration to an approximated configuration to capture tissue); a motor-powered firing system ([0462] firing motor drive assembly 604), comprising: a firing member movable from an unfired position toward a fired position during a firing stroke ([0505] When ready to use the instrument 750, the clinician may provide a firing signal, for example by depressing a trigger of the instrument 750. In response to the firing signal, the motor 754 may drive the displacement member distally along the longitudinal axis of the end effector 752 from a proximal stroke begin position to a stroke end position distal of the stroke begin position); a firing motor configured to drive the firing member through the firing stroke ([0462] The firing motor 602 may be operably coupled to a firing motor drive assembly 604 which can be configured to transmit firing motions, generated by the motor 602 to the end effector, in particular to displace the I-beam element. In certain instances, the firing motions generated by the motor 602 may cause the staples to be deployed from the staple cartridge into tissue captured by the end effector and/or the cutting edge of the I-beam element to be advanced to cut the captured tissue, for example); a motor-powered closure system comprising a closure motor ([0444] motor driver 492); and a control system ([0517] control circuit 760), configured to: drive the motor-powered closure system to transition the end effector toward the clamped state ([0517] The control circuit 760 receives real-time sample measurements to provide and analyze time-based information and assess, in real time, closure forces applied to the anvil 766) ([0467] the common control module 610 can be selectively switched between operable engagement with the articulation motors 606a, 606b and operable engagement with either the firing motor 602 or the closure motor 603) ([0469] FIG. 16, the common control module 610 may comprise a motor driver 626 which may comprise one or more H-Bridge FETs); detect a current through the closure motor ([0502] A current sensor 786 can be employed to measure the current drawn by the motor 754); set a firing parameter of the motor-powered firing system based on the detected current ([0502] The force required to advance the I-beam 764 corresponds to the current drawn by the motor 754); and drive the firing member through the firing stroke with the motor-powered firing system using the firing parameter ([0503] The control circuit 760 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 an I-beam 764 in the end effector 752 at or near a target velocity) ([0501] The control circuit 760 receives real-time sample measurements to provide and analyze time-based information and assess, in real time, closure forces applied to the anvil 766).
Regarding claim 13, Harris teaches the surgical instrument of Claim 12, wherein the control system is further configured to dynamically adjust the firing parameter during the firing stroke ([0506] the surgical instrument 750 may comprise a control circuit 760 programmed to control the distal translation of the displacement member, such as the I-beam 764, for example, based on one or more tissue conditions. The control circuit 760 may be programmed to sense tissue conditions, such as thickness, either directly or indirectly, as described herein. The control circuit 760 may be programmed to select a firing control program based on tissue conditions. A firing control program may describe the distal motion of the displacement member).
Regarding claim 14, Harris teaches the surgical instrument of Claim 12, wherein the end effector comprises a staple cartridge comprising staples removably stored therein (Fig 17; a removable staple cartridge 718), and wherein the staples are deployable from the staple cartridge based on the firing member moving toward the fired position ([0462] The firing motor 602 may be operably coupled to a firing motor drive assembly 604 which can be configured to transmit firing motions, generated by the motor 602 to the end effector, in particular to displace the I-beam element. In certain instances, the firing motions generated by the motor 602 may cause the staples to be deployed from the staple cartridge into tissue captured by the end effector and/or the cutting edge of the I-beam element to be advanced to cut the captured tissue, for example).
Regarding claim 15, Harris teaches the surgical instrument of Claim 12, wherein the firing parameter comprises a speed of the firing member ([0506] A firing control program may describe the distal motion of the displacement member. Different firing control programs may be selected to better treat different tissue conditions. For example, when thicker tissue is present, the control circuit 760 may be programmed to translate the displacement member at a lower velocity and/or with lower power. When thinner tissue is present, the control circuit 760 may be programmed to translate the displacement member at a higher velocity and/or with higher power).
Regarding claim 16, Harris teaches the surgical instrument of Claim 12, wherein the firing parameter comprises a duty cycle of the firing motor ([0445] An internal charge pump for the high-side drive allows DC (100% duty cycle) operation).
Regarding claim 17, Harris teaches a surgical instrument, comprising: an end effector configurable from an open state to a clamped state to capture tissue within the end effector ([0015] the end effector comprises a first jaw and a second jaw; establishing a communication pathway between the surgical instrument and a surgical hub; grasping tissue between the first jaw and the second jaw); a motor-powered firing system ([0462] firing motor drive assembly 604), comprising: a firing member movable from an unfired position toward a fired position during a firing stroke ([0678] FIG. 82 is a section view of an end effector 153502 showing an I-beam 153514 firing stroke relative to tissue 153526 grasped within the end effector 153502, in accordance with at least one aspect of this disclosure. A firing bar 153520 is translatable distally and proximally along a longitudinal axis 153515 of the end effector 153502. When the end effector 153502 is not articulated, the end effector 153502 is in line with the shaft of the instrument. An I-beam 153514 comprising a cutting edge 153509 is illustrated at a distal portion of the firing bar 153520); a firing motor configured to drive the firing member through the firing stroke ([0505] a motor 754 may drive a displacement member distally and proximally along a longitudinal axis of the end effector 752); a motor-powered closure system comprising a closure motor ([0484] the control circuit 710 is configured to drive a closure member such as the anvil 716 portion of the end effector 702. The control circuit 710 provides a motor set point to a motor control 708b, which provides a drive signal to the motor 704b); and a control system ([0484] control circuit 710), configured to: drive the motor-powered closure system to transition the end effector toward the clamped state ([0463] The closure motor 603 may be operably coupled to a closure motor drive assembly 605 which can be configured to transmit closure motions, generated by the motor 603 to the end effector, in particular to displace a closure tube to close the anvil and compress tissue between the anvil and the staple cartridge); detect a load applied by the end effector to the tissue ([0479] The control circuit 710 may be programmed to sense tissue conditions, such as thickness, either directly or indirectly, as described herein. A closure control program may control the closure force applied to the tissue by the anvil 716) ([0490] Accordingly, the control circuit 710 can sense (1) the closure load experienced by the distal closure tube and its position, (2) the firing member at the rack and its position, (3) what portion of the staple cartridge 718 has tissue on it, and (4) the load and position on both articulation rods); determine a rate of change of the load applied by the end effector to the tissue ([0490] the control circuit 710 can sense (1) the closure load experienced by the distal closure tube and its position) ([0096] FIG. 84 is a graph of a control system configured to provide progressive closure of a closure member during a firing stroke when the firing member advances distally and couples into a clamp arm to lower the closure force load on the closure member at a desired rate); determine a tissue type of the tissue based on the determined rate of change ([0479] The control circuit 710 may be programmed to sense tissue conditions, such as thickness, either directly or indirectly, as described herein. The control circuit 710 may be programmed to select a firing control program or closure control program based on tissue conditions. A firing control program may describe the distal motion of the displacement member. Different firing control programs may be selected to better treat different tissue conditions. For example, when thicker tissue is present, the control circuit 710 may be programmed to translate the displacement member at a lower velocity and/or with lower power. When thinner tissue is present, the control circuit 710 may be programmed to translate the displacement member at a higher velocity and/or with higher power); set a firing parameter of the motor-powered firing system based on the determined type of tissue ([0479] The control circuit 710 may be programmed to select a firing control program or closure control program based on tissue conditions. A firing control program may describe the distal motion of the displacement member. Different firing control programs may be selected to better treat different tissue conditions); and drive the firing member through the firing stroke with the motor-powered firing system using the firing parameter ([0479]).
Regarding claim 18, Harris teaches the surgical instrument of Claim 17, wherein the control system is further configured to dynamically adjust the firing parameter during the firing stroke ([0479] Different firing control programs may be selected to better treat different tissue conditions. For example, when thicker tissue is present, the control circuit 710 may be programmed to translate the displacement member at a lower velocity and/or with lower power. When thinner tissue is present, the control circuit 710 may be programmed to translate the displacement member at a higher velocity and/or with higher power).
Regarding claim 19, Harris teaches the surgical instrument of Claim 17, wherein the end effector comprises a staple cartridge comprising staples removably stored therein (Fig 17; a removable staple cartridge 718), and wherein the staples are deployable from the staple cartridge based on the firing member moving toward the fired position ([0462] The firing motor 602 may be operably coupled to a firing motor drive assembly 604 which can be configured to transmit firing motions, generated by the motor 602 to the end effector, in particular to displace the I-beam element. In certain instances, the firing motions generated by the motor 602 may cause the staples to be deployed from the staple cartridge into tissue captured by the end effector and/or the cutting edge of the I-beam element to be advanced to cut the captured tissue, for example).
Regarding claim 20, Harris teaches the surgical instrument of Claim 17, wherein the firing parameter comprises a speed of the firing member ([0479] Different firing control programs may be selected to better treat different tissue conditions. For example, when thicker tissue is present, the control circuit 710 may be programmed to translate the displacement member at a lower velocity and/or with lower power. When thinner tissue is present, the control circuit 710 may be programmed to translate the displacement member at a higher velocity and/or with higher power).
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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/ASHLEIGH LAUREN KERN/Examiner, Art Unit 3794
/ADAM Z MINCHELLA/Primary Examiner, Art Unit 3794
Prosecution Insights