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 .
Formal Matters
Applicants Arguments and Amendments filed 25 March 2026 are acknowledged. Claims 5, 7, 8, 18, and 20 are cancelled. Claims 1, 6, 9, 10, 11, 13, and 15 are currently amended. New claims 21-23 are added. Claims 1-4, 6, 9-17, 19, and 21-23 are pending and under examination.
Objections/Rejections Withdrawn
The rejection of claims 5, 7, 8, 18, and 20 under 35 U.S.C. 103 as being unpatentable over Overmyer et al., US 20170079642 (23 March 2017), in view of Shelton et al., US 20190201146 (4 July 2019) (hereinafter Shelton ‘146), are withdrawn in light of Applicant’s cancellation of the claims. However, insofar as the subject matter of the cancelled claims has been amended into other claims, the rejection of record may still apply, as set forth below.
Response to Arguments
Applicant argues that the Shelton ‘458 reference “at best” proposes a transmission of device identifiers (serial numbers) from modular components to a hub for device recognition and routine, not a procedure-independent manner monitored by a sensor based on which a default motor-control algorithm is adjusted (Remarks, numbered p. 7). Applicant argues that Shelton uses data via lookup tables, which are procedure-related parameters rather than sensor-monitored parameters as required by the claims (Remarks, p. 7). Applicant argues that Harris ‘981 sensor-detected parameters in ¶734 are inherently tied to the ongoing surgical procedures rather than constituting a sensor-monitored parameter independent of the procedure that is used to pre-adjust a default control algorithm before performing the treatment as recited in the claims (Remarks, pp. 7 to 8). Applicant argues that independent claims 1, 15, and 19 are amended to clarify the “independent parameter” and the “one or more default parameters” and clarifies that the default parameter(s) are adjusted based on the independent parameter.
Applicant’s arguments have been fully considered, but they are not persuasive. Applicant’s arguments overlook the sensors taught by Overmyer as mapped to the claims of record. Shelton ‘146 provides more specific guidance on feedback controllers and their integration in control circuits that are configured to receive input and adjust the one or more default parameters.
Applicant’s amendments include the incorporation of subject matter from now cancelled claims 5, 7, 8, 18, and 20, which were previously rejected of record. The mere recombination of subject matter does not overcome the prior art of record where the prior art teaches the claimed subject matter. Insofar as the amendment provides clarification or additional alternatives which were discussed during the Interview held on 12 March 2026, both Shelton ‘146 and Harris et al., US 20190200981 (4 July 2019) are applicable as set forth in the modified rejections below, necessitated by Amendment.
New and Modified Claim Objections/Rejections – Necessitated by Amendment
Claim Objections
Claim 10 is objected to because of the following informalities: the claim, as amended, is awkwardly written. It is suggested that the words “based on” in line 2 are deleted. Appropriate correction is required.
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.
Claims 1-4, 6, 9, 11, 13, 15-17, 19, and 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Overmyer et al., US 20170079642 (23 March 2017), in view of Shelton et al., US 20190201146 (4 July 2019) (hereinafter Shelton ‘146), and further in view of Harris et al., US 20190200981 (4 July 2019).
Regarding currently amended independent claim 1, Overmyer teaches a surgical instrument (surgical stapler, ¶149) for treating tissue in a surgical procedure (¶149) the surgical instrument comprising:
an end effector (end effector comprising a first and second jaw, ¶149), comprising:
an anvil (anvil, ¶150); and
a staple cartridge (staple cartridge, ¶¶149-150);
a drive train (¶¶199, 206) operably coupled to the end effector (¶204);
a motor (motor 2048, ¶206) configured to motivate the drive train (FIGs 21A-B, ¶¶ 199, 206) based on a default control algorithm (FIGs 21A-B, ¶204),
the default control algorithm (FIGs 21A-B; ¶¶204, 217) indicating one or more default parameters (¶218) for motivating the drive train (FIG 21B, ¶205, “segmented circuit 2000 comprises a position encoder segment 2002f (segment 6) which comprises one or more magnetic rotary position encoders 2040a-2040b, configured to identify the rotational position of a motor 2048”),
to affect a tissue treatment motion of the end effector (¶204);
a sensor (FIGs 21A-B, motor position sensors 2040a, 2040b; ¶213), configured to monitor an independent parameter of the surgical procedure (FIGs 21A-B, ¶¶213-215), before motivating the drive train to affect the tissue treatment motion of the end effector (activation signal, ¶214),
wherein the independent parameter is independent of the motion of the end effector (¶213) and comprises at least one of an articulation angle of the end effector (¶213), a presence of a buttress on a staple cartridge, a configuration of the staple cartridge, a shelf life of the staple cartridge (usage cycle counter after a predetermined period of time, ¶226), a tissue thickness, or staple cartridge age (usage cycle, ¶222; use indicator 2106 configured to monitor the firings of the surgical instrument corresponding to the deployment of the staple cartridge or measuring the number of firings, ¶224); and
a control circuit (FIG 21A/B, segmented circuit 2000 comprising primary processor 2006, safety processor 2004; ¶¶199, 213-217) coupled to the motor (FIG 21B, motor 2048, ¶213; FIG 21B, motor controller 2043, ¶213) and the sensor (FIGs 21A-B; motor sensors 2040a 2040b “e.g. magnetic rotary position encoders”, ¶212),
wherein the control circuit (FIGs 21A-B; ¶¶199, 217) is configured to:
receive an input from the sensor (¶212) indicative of the independent parameter (FIGs 21A-B; ¶217) and
adjust the default control algorithm based on the independent parameter (FIGs 21A-B; ¶216), wherein the one or more default parameters (¶217) comprise at least one of a default speed of the motor (¶212), a rate-of-change of velocity of the motor, a stroke, a default current of the motor (¶206), a default maximum load of the drive train (¶253), a default travel distance of the drive train (¶161), or delay time of the default control algorithm; and
control the motor to motivate the drive train based on the adjusted default control algorithm to affect the tissue treatment motion of the end effector (¶216).
Overmyer teaches general default control and safety mechanisms related to fault detection and teaches that safety processor 2004 may open the motor power switch 2020 to cut power to the motor circuit segment 2002g when a fault is detected (¶216).
Overmyer does not expressly teach that the control circuit is configured to receive input and adjust the one or more default parameters, using the same language as the claims, but does provide examples of actions meeting those requirements. Shelton ‘146 provides more specific guidance on feedback controllers and their integration in control circuits that are configured to receive input and adjust the one or more default parameters.
Shelton ‘146 teaches surgical instrumentation for treating tissue in a surgical procedure comprising a drive train control circuit (Abstract; FIG 19; ¶¶288, 296), as well as an anvil and stapling head assembly (¶303). Motor (482) driven by motor driver (492) is taught at ¶288. The control circuit comprising a microcontroller (461) comprising processor 462 and one or more sensors is taught at ¶288 (FIG 12). “Microcontroller 461 may be programmed to provide precise control over the speed and position of displacement members and articulation systems and may be configured to compute a response in the software of the microcontroller 461” (¶292). The computed response is compared to a measured response of the actual system to obtain an “observed” response, which is used for actual feedback decisions (¶292). Shelton ‘146 also teaches tracking system 480 comprising an absolute positioning system may comprise and/or be programmed to implement a feedback controller, such as a PID, state feedback, and adaptive controller (¶301). A power source converts the signal from the feedback controller into a physical input to the system (voltage). Other examples include a pulse width modulation (PWM) of the voltage, current, and force. Other sensor(s) may be provided to measure physical parameters of the physical system in addition to the position measured by the position sensor 472. The absolute positioning system provides an absolute position of the displacement member upon power-up of the instrument, without retracting or advancing the displacement member to a reset (zero or home) position as may be required with conventional rotary encoders that merely count the number of steps forwards or backwards that the motor 482 has taken to infer the position of a device actuator, drive bar, knife, or the like (¶302).
Harris teaches wherein the independent parameter is independent of the motion of the end effector and comprises at least one of a configuration of the staple cartridge, a shelf life of the staple cartridge, a tissue thickness, or staple cartridge age (historical data, ¶734). Specifically, Harris teaches an end effector assembly 23130 configured to receive data from an external database comprising staple cartridge data (¶734). Based on the received data (sensor data, internal and/or external data, the end effector control circuit 23132 may be configured to continually derive inferences (e.g. contextual information) about an ongoing surgical procedure (¶734). Harris also teaches that other surgical instrument component control circuit (e.g., 23112 and/or 23122) may be similarly configured to perform the various aspects of the end effector control circuit 23132 (¶734). Harris teaches that the “situationally aware” surgical instrument 23102 may be configured to prevent a surgical function based on a discrepancy including that a detected parameter exceeds a preferred/ideal parameter associated with sized or types of staples or expected tissues and or tissue types (¶734).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Overmyer, Shelton ‘146, and Harris, given that the prior art included each element claimed, although not necessarily in a single reference.
Overmyer, Shelton ‘146, and Harris teach in the same field of endeavor, surgical instruments comprising surgical staplers.
Although, Overmyer discloses the claimed base surgical instrument and components, it does not teach the control circuit receipt of input and adjustment of parameters other than motor parameters, end effector articulation angles, and end effector use indicators. The default algorithm as a baseline control circuit, encoders, algorithms and signals are taught by Overmyer.
Overmyer does not expressly teach that the control circuit is configured to receive input and adjust the one or more default parameters, using the same language as the claims, but does provide examples of actions meeting those requirements. However, Overmyer teaches general default control and safety mechanisms related to fault detection and teaches that safety processor 2004 may open the motor power switch 2020 to cut power to the motor circuit segment 2002g when a fault is detected (¶216).
Shelton ‘146 provides more specific guidance on feedback controllers, PID, state feedback, and adaptive controls, and their integration in control circuits that are configured to receive input and adjust the one or more default parameters.
Harris specifically addresses a “situationally aware” surgical control system able to provide controlled adjustment based on sensor data, data received from internal or external sources, about staple cartridge data and tissue data as default parameters and make comparisons to situational configurations (¶734).
Because Overmyer includes algorithms related to moving the drive train to affect a tissue treatment motion of the end effector, such as articulation, as well as algorithms, signals, generic feedback, and outcomes of parameter adjustments that are independent of the motion of the end effector, including stopping the motor when a fault is detected, one of ordinary skill in the art seeking specific feedback (e.g. input and adjustment) mechanisms would reasonably consult Shelton ‘146’s feedback control solutions. The feedback control can be integrated into hardware sensors, or in the form of software either through a microcontroller or EEPROM. The feedback controllers of Shelton ‘146 can be incorporated alongside the control circuits and microprocessors of Overmyer using known assembly and programming methods without redesigning Overmyer’s core circuit configuration. Further, the “situationally aware” surgical control system of Harris utilizes database as well as sensor data and is configured to continually derive inferences (contextual data) from all of those sources of data in order to prevent a surgical function based on a discrepancy (¶734).
Because both references address the same engineering problem (controlling components of minimally invasive robotic surgical systems) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding feedback control into an existing control circuits to provide contextual awareness of the surgical instrumentation and the configurations to which the surgical instruments are adapted), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
The “motion of the end effector” is interpreted in its broadest reasonable interpretation in light of the disclosure. At ¶104 of the Specification, the “motion of the end effector” encompasses grasping of tissue by jaws and closure motion of the jaws to grasp tissue. Paragraph 105 of the Specification defines “motion of the end effector” to encompass “closing speed, firing speed” and also states that independent parameters include” “staple cartridge configuration, tissue thickness, articulation angle, and etc.”.
The default control algorithm is broadly interpreted as a control feedback system. The interpretation is supported by the Specification at ¶106 (referring to FIG 15; a flow chart) providing that “the control circuit determines a default control algorithm to affect the tissue treatment motion of the end effector. For example, a default control algorithm could be chosen based on the surgical procedure that is being performed. In another instance, the default control algorithm could be chosen based on a tissue type to be treated by the end effector.
The default control algorithm can have default values, or profiles, set for a default speed of the motor, a default current of the motor, a default maximum load of the drive train, and a default travel distance of the drive train, among other possible parameters of the tissue treatment motion.” See also, at least paragraphs ¶108-119. Accordingly, the control circuit controls the default control algorithm and the independent parameters which affect the control are based on feedback to the control circuit (¶¶ 112, 118; independent parameters of threshold force and articulation angle). Paragraph 123 (FIG 19; a flow chart) also expressly discloses that the control circuit determined a default control algorithm to affect the tissue treatment motion of the end effector.
Regarding claim 2, Overmyer modified by Shelton ‘146 and Harris teaches the surgical instrument of claim 1, as set forth above, for the reasons set forth above.
Overmyer teaches wherein the independent parameter comprises a first independent parameter (FIGs 21A-B; ¶212, motor position sensor 2040a),
wherein the surgical instrument further comprises a second sensor configured to monitor a second independent parameter of the surgical procedure (¶212, motor position sensor 2040b),
wherein the second independent parameter is different than the first independent parameter (¶213), and
wherein the control circuit (¶199, segmented circuit 2000; ¶214, safety processor 2004, primary processor 2006) is further configured to:
receive an input from the second sensor indicative of the second independent parameter (¶214); and
adjust the default control algorithm based on the first independent parameter and the second independent parameter (¶214, prevent operation of motor segment 2002g).
Regarding claim 3, Overmyer modified by Shelton ‘146 and Harris teaches the surgical instrument of Claim 1, as set forth above, for the reasons set forth above.
Overmyer teaches wherein the motion is a closure motion of the end effector to grasp tissue between the anvil and the staple cartridge (¶158, shaft assembly 200, microcontroller 1500 can determine whether the closure trigger 32 is in the open configuration of the end effector; ¶167, shaft assembly 200, end effector 300, anvil 306, staple cartridge 304).
Regarding claim 4, Overmyer modified by Shelton ‘146 and Harris teaches the surgical instrument of Claim 1, as set forth above, for the reasons set forth above.
Overmyer teaches wherein the motion is a firing motion of the end effector to deploy staples into the tissue (¶165).
Regarding currently amended claim 6, Overmyer modified by Shelton ‘146 and Harris teaches the surgical instrument of Claim 1, as set forth above, for the reasons set forth above.
Overmyer teaches the instrument further comprising:
a shaft (200); and
an articulation joint (270) extending between the shaft and the end effector, wherein the end effector is articulatable relative to the shaft about the articulation joint (¶149), wherein the independent parameter is the articulation angle of the end effector relative to the shaft (¶213).
Regarding currently amended claim 9, Overmyer modified by Shelton ‘146 and Harris teaches the surgical instrument of Claim 6, as set forth above, for the reasons set forth above.
Overmyer teaches wherein the control circuit reduces the motor speed as the articulation angle increases (¶212).
Regarding currently amended claim 11, Overmyer modified by Shelton ‘146 and Harris teaches the surgical instrument of Claim 1, as set forth above, for the reasons set forth above.
Overmyer teaches wherein the independent parameter comprises a staple cartridge type (¶154).
Harris also teaches wherein the independent parameter comprises a staple cartridge type (¶734).
Regarding currently amended claim 13, Overmyer modified by Shelton ‘146 and Harris teaches the surgical instrument of claim 1, as set forth above, for the reasons set forth above.
Overmyer teaches a usage cycle (¶222) for determining the age of a staple cartridge (“use indicator 2106 configured to monitor the firings of the surgical instrument corresponding to the deployment of the staple cartridge or measuring the number of firings”, ¶224). Overmyer teaches wherein the control circuit is further configured to set a maximum speed for the motor (“motor sensor 2040a is coupled to safety processor 2004, which monitors motor sensor 2040a and compares the value to a maximum speed and/or position value and prevents operation of the motor 2048 above the predetermined values”, ¶212). Overmyer also teaches fault procedures when the safety processor 2004 takes at least one action (¶216). Additionally, Overmyer teaches “the power assembly 2100 comprises a usage cycle circuit 2102 having a continuous power draw to maintain one or more components of the usage cycle circuit 2102, such as, the use indicator 2106 and/or a counter 2108, in an active state” (¶220).
Overmyer does not expressly teach wherein the control circuit reduces the motor speed based on the staple cartridge age.
However, Overmyer specifically teaches that motor sensor 2040a provides motor speed and position information to the safety processor 2004. The safety processor 2004 monitors the motor sensor2040a and compares the value to a maximum speed and/or position value and prevents operation of the motor 2048 above the predetermined values (¶212). Overmyer teaches that the predetermined values are calculated based on real-time speed and/or position of the motor 2048 calculated from values supplied by a second motor sensor 2040b (magnetic rotary position encoder) in communication with the primary processor and/or provided to the safety processor 2004 from a memory module coupled to the safety processor (¶212). Further, Overmyer teaches that a power assembly 2100 is disabled when the usage cycle amount exceeds a predetermined usage limit (¶221).
Harris teaches wherein the independent parameter is independent of the motion of the end effector and comprises staple cartridge age (historical data, ¶734). Specifically, Harris teaches end effector assembly 23130 configured to receive data from an external database comprising staple cartridge data (¶734). Based on the received data (sensor data, internal and/or external data, the end effector control circuit 23132 may be configured to continually derive inferences (e.g. contextual information) about an ongoing surgical procedure (¶734). Harris also teaches that other surgical instrument component control circuit (e.g., 23112 and/or 23122) may be similarly configured to perform the various aspects of the end effector control circuit 23132 (¶734). Harris teaches that the “situationally aware” surgical instrument 23102 may be configured to prevent a surgical function based on a discrepancy including that a detected parameter exceeds a preferred/ideal parameter associated with sized or types of staples or expected tissues and or tissue types (¶734).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Overmyer, Shelton ‘146, and Harris, given that the prior art included each element claimed, although not necessarily in a single reference.
Overmyer, Shelton ‘146, and Harris teach in the same field of endeavor, surgical instruments comprising surgical staplers.
Although, Overmyer discloses the claimed base surgical instrument and components, it does not expressly teach wherein the control circuit reduces the motor speed based on the staple cartridge age.
Shelton ‘146 provides more specific guidance on feedback controllers, PID, state feedback, and adaptive controls, and their integration in control circuits that are configured to receive input and adjust the one or more default parameters.
Harris specifically addresses a “situationally aware” surgical control system able to provide controlled adjustment based on sensor data, data received from internal or external sources, about staple cartridge data and tissue data as default parameters and make comparisons to situational configurations, including historical data (broadly interpreted as encompassing age) (¶734).
Because Overmyer includes algorithms related to moving the drive train to affect a tissue treatment motion of the end effector, such as articulation, as well as algorithms, signals, generic feedback, and outcomes of parameter adjustments that are independent of the motion of the end effector, including stopping the motor when a fault is detected, one of ordinary skill in the art seeking specific to motivate a motor based on historical data including age from a staple cartridge would reasonably consult Harris’ situationally aware control solutions. The controller-data solution of Harris can be incorporated alongside the control circuits and sensors of Overmyer using known assembly and programming methods without redesigning Overmyer’s core circuit configuration, as many of Overmyer’s control circuit configurations and functions overlap those of Harris. Further, the “situationally aware” surgical control system of Harris utilizes database as well as sensor data and is configured to continually derive inferences (contextual data) from all of those sources of data in order to prevent a surgical function based on a discrepancy (¶734).
Because both references address the same engineering problem (controlling components of minimally invasive robotic surgical systems) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding feedback control into an existing control circuits to provide contextual awareness of the surgical instrumentation and the configurations to which the surgical instruments are adapted), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Regarding currently amended independent claim 15, Overmyer teaches a surgical instrument (surgical stapler, ¶149) for treating tissue in a surgical procedure (¶149), the surgical instrument comprising:
an end effector (end effector, jaw members, ¶149), comprising:
an anvil (anvil, ¶150); and
a staple cartridge (staple cartridge, ¶¶149-150);
a drive train assembly (¶¶199, 206) operably coupled to the end effector (¶204);
a motor assembly (motor 2048, ¶206) configured to motivate the drive train assembly (FIGs 21A-B, ¶¶199, 206) based on a default control instructions (FIGs 21A-B, ¶204, 217),
the default control instructions (FIGs 21A-B; ¶¶204, 217) indicating one or more default parameters (¶218 primary processor 2006 may indicate to the safety processor 2004 that the primary processor 2006 is executing code and operating normally) for motivating the drive train (FIG 21B, ¶205), to affect a tissue treatment motion of the end effector (articulation, ¶204);
a control circuit (FIG 21A-B, segmented circuit 2000 comprising primary processor 2006, safety processor 2004; ¶¶199, 213-217) coupled to the motor (FIG 21B, motor 2048, ¶213; FIG 21B, motor controller 2043, ¶213),
wherein the control circuit (FIGs 21A-B; ¶¶199, 217) is configured to:
receive, before motivating the drive train to affect the tissue treatment motion of the end effector (activation signal, ¶214), an input indicative of a situational parameter (¶217) associated with the surgical procedure, wherein the situational parameter is unrelated to the drive train (¶219), and wherein the situational parameter is unrelated to the motor (¶222) and wherein the situational parameter comprises at least one of an articulation angle of the end effector (¶213), a presence of a buttress on a staple cartridge, a configuration of the staple cartridge (use indicator 2106 configured to monitor the firings of the surgical instrument corresponding to the deployment of the staple cartridge or measuring the number of firings, ¶224), a shelf life of the staple cartridge (usage cycle counter after a predetermined period of time, ¶226), a tissue thickness, or staple cartridge age (usage cycle, ¶222); and
adjust the one or more default parameters indicated by the default control instructions based on the situational parameter (FIGs 21A-B; ¶216), wherein the one or more default parameters (¶217) comprise at least one of a default speed of the motor (¶212), a rate-of-change of velocity of the motor, a stroke, a default current of the motor (¶206), a default maximum load of the drive train (¶253), a default travel distance of the drive train (¶161), or delay time of the default control algorithm; and
control the motor to motivate the drive train based on the adjusted default control algorithm to affect the tissue treatment motion of the end effector (¶216).
Overmyer teaches general default control and safety mechanisms related to fault detection and teaches that safety processor 2004 may open the motor power switch 2020 to cut power to the motor circuit segment 2002g when a fault is detected (¶216).
Overmyer does not expressly teach that the control circuit is configured to receive input and adjust the one or more default parameters, using the same language as the claims, but does provide examples of actions meeting those requirements. Shelton ‘146 provides more specific guidance on feedback controllers and their integration in control circuits that are configured to receive input and adjust the one or more default parameters. Shelton ‘146 teaches surgical instrumentation for treating tissue in a surgical procedure comprising a drive train control circuit (Abstract; FIG 19; ¶¶288, 296), as well as an anvil and stapling head assembly (¶303). Motor (482) driven by motor driver (492) is taught at ¶288. The control circuit comprising a microcontroller (461) comprising processor 462 and one or more sensors is taught at ¶288 (FIG 12). “Microcontroller 461 may be programmed to provide precise control over the speed and position of displacement members and articulation systems and may be configured to compute a response in the software of the microcontroller 461” (¶292). The computed response is compared to a measured response of the actual system to obtain an “observed” response, which is used for actual feedback decisions (¶292). Shelton ‘146 also teaches tracking system 480 comprising an absolute positioning system may comprise and/or be programmed to implement a feedback controller, such as a PID, state feedback, and adaptive controller (¶301). A power source converts the signal from the feedback controller into a physical input to the system (voltage). Other examples include a pulse width modulation (PWM) of the voltage, current, and force. Other sensor(s) may be provided to measure physical parameters of the physical system in addition to the position measured by the position sensor 472. The absolute positioning system provides an absolute position of the displacement member upon power-up of the instrument, without retracting or advancing the displacement member to a reset (zero or home) position as may be required with conventional rotary encoders that merely count the number of steps forwards or backwards that the motor 482 has taken to infer the position of a device actuator, drive bar, knife, or the like (¶302).
Harris teaches wherein the independent parameter is independent of the motion of the end effector and comprises at least one of a configuration of the staple cartridge, a shelf life of the staple cartridge, a tissue thickness, or staple cartridge age (¶734). Specifically, Harris teaches an end effector assembly 23130 configured to receive data from an external database comprising staple cartridge data (¶734). Based on the received data (sensor data, internal and/or external data, the end effector control circuit 23132 may be configured to continually derive inferences (e.g. contextual information) about an ongoing surgical procedure (¶734). Harris also teaches that other surgical instrument component control circuit (e.g., 23112 and/or 23122) may be similarly configured to perform the various aspects of the end effector control circuit 23132 (¶734). Harris teaches that the “situationally aware” surgical instrument 23102 may be configured to prevent a surgical function based on a discrepancy including that a detected parameter exceeds a preferred/ideal parameter associated with sized or types of staples or expected tissues and or tissue types (¶734).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Overmyer, Shelton ‘146, and Harris, given that the prior art included each element claimed, although not necessarily in a single reference.
Overmyer, Shelton ‘146, and Harris teach in the same field of endeavor, surgical instruments comprising surgical staplers.
Although, Overmyer discloses the claimed base surgical instrument and components, it does not teach the control circuit receipt of input and adjustment of parameters other than motor parameters, end effector articulation angles, and end effector use indicators. The default algorithm as a baseline control circuit, encoders, algorithms and signals are taught by Overmyer.
Overmyer does not expressly teach that the control circuit is configured to receive input and adjust the one or more default parameters, using the same language as the claims, but does provide examples of actions meeting those requirements. However, Overmyer teaches general default control and safety mechanisms related to fault detection and teaches that safety processor 2004 may open the motor power switch 2020 to cut power to the motor circuit segment 2002g when a fault is detected (¶216).
Shelton ‘146 provides more specific guidance on feedback controllers, PID, state feedback, and adaptive controls, and their integration in control circuits that are configured to receive input and adjust the one or more default parameters.
Harris specifically addresses a “situationally aware” surgical control system able to provide controlled adjustment based on sensor data, data received from internal or external sources, about staple cartridge data and tissue data as default parameters and make comparisons to situational configurations (¶734).
Because Overmyer includes algorithms related to moving the drive train to affect a tissue treatment motion of the end effector, such as articulation, as well as algorithms, signals, generic feedback, and outcomes of parameter adjustments that are independent of the motion of the end effector, including stopping the motor when a fault is detected, one of ordinary skill in the art seeking specific feedback (e.g. input and adjustment) mechanisms would reasonably consult Shelton ‘146’s feedback control solutions. The feedback control can be integrated into hardware sensors, or in the form of software either through a microcontroller or EEPROM. The feedback controllers of Shelton ‘146 can be incorporated alongside the control circuits and microprocessors of Overmyer using known assembly and programming methods without redesigning Overmyer’s core circuit configuration.
Because the references address the same engineering problem (controlling components of minimally invasive robotic surgical systems) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding a specific feedback controller into an existing control circuit), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
The “motion of the end effector” is interpreted in its broadest reasonable interpretation in light of the disclosure. At ¶104 of the Specification, the “motion of the end effector” encompasses grasping of tissue by jaws and closure motion of the jaws to grasp tissue. Paragraph 105 of the Specification defines “motion of the end effector” to encompass “closing speed, firing speed” and also states that independent parameters include” “staple cartridge configuration, tissue thickness, articulation angle, and etc.”.
The default control algorithm is broadly interpreted as a control feedback system. The interpretation is supported by the Specification at ¶106 (referring to FIG 15; a flow chart) providing that “the control circuit determines a default control algorithm to affect the tissue treatment motion of the end effector. For example, a default control algorithm could be chosen based on the surgical procedure that is being performed. In another instance, the default control algorithm could be chosen based on a tissue type to be treated by the end effector. The default control algorithm can have default values, or profiles, set for a default speed of the motor, a default current of the motor, a default maximum load of the drive train, and a default travel distance of the drive train, among other possible parameters of the tissue treatment motion.” See also, at least paragraphs ¶108-119. Accordingly, the control circuit controls the default control algorithm and the independent parameters which affect the control are based on feedback to the control circuit (¶¶ 112, 118; independent parameters of threshold force and articulation angle). Paragraph 123 (FIG 19; a flow chart) also expressly discloses that the control circuit determined a default control algorithm to affect the tissue treatment motion of the end effector.
Regarding claim 16, Overmyer modified by Shelton ‘146 and Harris, teaches the surgical instrument of Claim 15, as set forth above, for the reasons set forth above.
Harris teaches wherein the input is received from a user (user interface, ¶731).
Regarding claim 17, Overmyer modified by Shelton ‘146 and Harris teaches the surgical instrument of Claim 15, as set forth above, for the reasons set forth above.
Harris teaches wherein the input is the result of an image processing analysis (¶716).
Regarding currently amended independent claim 19, Overmyer teaches a surgical instrument (surgical stapler, ¶149) for treating tissue in a surgical procedure (¶149), the surgical instrument comprising:
an end effector (end effector, ¶149), comprising:
a first jaw (¶149); and
a second jaw (¶149) movable (pivotable, ¶149) relative to the first jaw to grasp the tissue between the first jaw and the second jaw (¶158);
a drive train assembly (¶¶199, 206) coupled to the end effector (¶204);
a motor assembly (¶206, motor 2048) configured to motivate the drive train assembly (FIGs 21A-B, ¶¶199, 206) based on a default control instructions (FIGs 21A-B, ¶204, 217),
the default control instructions (FIGs 21A-B; ¶¶204, 217) indicating one or more default parameters (¶218 primary processor 2006 may indicate to the safety processor 2004 that the primary processor 2006 is executing code and operating normally) for motivating the drive train (FIG 21B, ¶205), to affect a tissue treatment motion of the end effector (articulation, ¶204);
a control circuit (FIG 21A-B, segmented circuit 2000 comprising primary processor 2006, safety processor 2004; ¶¶199, 213-217) coupled to the motor (FIG 21B, motor 2048, ¶213; FIG 21B, motor controller 2043, ¶213),
wherein the control circuit (FIGs 21A-B; ¶¶199, 217) is configured to:
receive, before motivating the drive train to affect the tissue treatment motion of the end effector (activation signal, ¶214), an input indicative of a parameter (¶217) associated with the surgical procedure, wherein the parameter is unrelated to the drive train assembly (¶219), wherein the parameter is unrelated to the motor assembly (¶222) and wherein the parameter comprises at least one of an articulation angle of the end effector (¶213), a presence of a buttress on a staple cartridge, a configuration of the staple cartridge (use indicator 2106 configured to monitor the firings of the surgical instrument corresponding to the deployment of the staple cartridge or measuring the number of firings, ¶224), a shelf life of the staple cartridge (usage cycle counter after a predetermined period of time, ¶226), a tissue thickness, or staple cartridge age (usage cycle, ¶222); and
adjust the one or more default parameters indicated by the default control instructions based on the parameter (FIGs 21A-B; ¶216), wherein the one or more default parameters (¶217) comprise at least one of a default speed of the motor (¶212), a rate-of-change of velocity of the motor, a stroke, a default current of the motor (¶206), a default maximum load of the drive train (¶253), a default travel distance of the drive train (¶161), or delay time of the default control algorithm; and control the motor to motivate the drive train based on the adjusted default control algorithm to affect the tissue treatment motion of the end effector (¶216)
Overmyer teaches general default control and safety mechanisms related to fault detection and teaches that safety processor 2004 may open the motor power switch 2020 to cut power to the motor circuit segment 2002g when a fault is detected (¶216).
Overmyer does not expressly teach that the control circuit is configured to receive input and adjust the one or more default parameters, using the same language as the claims, but does provide examples of actions meeting those requirements. Shelton ‘146 provides more specific guidance on feedback controllers and their integration in control circuits that are configured to receive input and adjust the one or more default parameters. Shelton ‘146 teaches surgical instrumentation for treating tissue in a surgical procedure comprising a drive train control circuit (Abstract; FIG 19; ¶¶288, 296), as well as an anvil and stapling head assembly (¶303). Motor (482) driven by motor driver (492) is taught at ¶288. The control circuit comprising a microcontroller (461) comprising processor 462 and one or more sensors is taught at ¶288 (FIG 12). “Microcontroller 461 may be programmed to provide precise control over the speed and position of displacement members and articulation systems and may be configured to compute a response in the software of the microcontroller 461” (¶292). The computed response is compared to a measured response of the actual system to obtain an “observed” response, which is used for actual feedback decisions (¶292). Shelton ‘146 also teaches tracking system 480 comprising an absolute positioning system may comprise and/or be programmed to implement a feedback controller, such as a PID, state feedback, and adaptive controller (¶301). A power source converts the signal from the feedback controller into a physical input to the system (voltage). Other examples include a pulse width modulation (PWM) of the voltage, current, and force. Other sensor(s) may be provided to measure physical parameters of the physical system in addition to the position measured by the position sensor 472. The absolute positioning system provides an absolute position of the displacement member upon power-up of the instrument, without retracting or advancing the displacement member to a reset (zero or home) position as may be required with conventional rotary encoders that merely count the number of steps forwards or backwards that the motor 482 has taken to infer the position of a device actuator, drive bar, knife, or the like (¶302).
Harris teaches wherein the parameter is independent of the motion of the end effector and comprises at least one of a configuration of the staple cartridge, a shelf life of the staple cartridge, a tissue thickness, or staple cartridge age (¶734). Specifically, Harris teaches an end effector assembly 23130 configured to receive data from an external database comprising staple cartridge data (¶734). Based on the received data (sensor data, internal and/or external data, the end effector control circuit 23132 may be configured to continually derive inferences (e.g. contextual information) about an ongoing surgical procedure (¶734). Harris also teaches that other surgical instrument component control circuit (e.g., 23112 and/or 23122) may be similarly configured to perform the various aspects of the end effector control circuit 23132 (¶734). Harris teaches that the “situationally aware” surgical instrument 23102 may be configured to prevent a surgical function based on a discrepancy including that a detected parameter exceeds a preferred/ideal parameter associated with sized or types of staples or expected tissues and or tissue types (¶734).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Overmyer, Shelton ‘146, and Harris, given that the prior art included each element claimed, although not necessarily in a single reference.
Overmyer, Shelton ‘146, and Harris teach in the same field of endeavor, surgical instruments comprising surgical staplers.
Although, Overmyer discloses the claimed base surgical instrument and components, it does not teach the control circuit receipt of input and adjustment of parameters other than motor parameters, end effector articulation angles, and end effector use indicators. The default algorithm as a baseline control circuit, encoders, algorithms and signals are taught by Overmyer.
Overmyer does not expressly teach that the control circuit is configured to receive input and adjust the one or more default parameters, using the same language as the claims, but does provide examples of actions meeting those requirements. However, Overmyer teaches general default control and safety mechanisms related to fault detection and teaches that safety processor 2004 may open the motor power switch 2020 to cut power to the motor circuit segment 2002g when a fault is detected (¶216).
Shelton ‘146 provides more specific guidance on feedback controllers, PID, state feedback, and adaptive controls, and their integration in control circuits that are configured to receive input and adjust the one or more default parameters.
Harris specifically addresses a “situationally aware” surgical control system able to provide controlled adjustment based on sensor data, data received from internal or external sources, about staple cartridge data and tissue data as default parameters and make comparisons to situational configurations (¶734).
Because Overmyer includes algorithms related to moving the drive train to affect a tissue treatment motion of the end effector, such as articulation, as well as algorithms, signals, generic feedback, and outcomes of parameter adjustments that are independent of the motion of the end effector, including stopping the motor when a fault is detected, one of ordinary skill in the art seeking specific feedback (e.g. input and adjustment) mechanisms would reasonably consult Shelton ‘146’s feedback control solutions. The feedback control can be integrated into hardware sensors, or in the form of software either through a microcontroller or EEPROM. The feedback controllers of Shelton ‘146 can be incorporated alongside the control circuits and microprocessors of Overmyer using known assembly and programming methods without redesigning Overmyer’s core circuit configuration.
Because the references address the same engineering problem (controlling components of minimally invasive robotic surgical systems) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding a specific feedback controller into an existing control circuit), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
The “motion of the end effector” is interpreted in its broadest reasonable interpretation in light of the disclosure. At ¶104 of the Specification, the “motion of the end effector” encompasses grasping of tissue by jaws and closure motion of the jaws to grasp tissue. Paragraph 105 of the Specification defines “motion of the end effector” to encompass “closing speed, firing speed” and also states that parameters include” “staple cartridge configuration, tissue thickness, articulation angle, and etc.”.
The default control algorithm is broadly interpreted as a control feedback system. The interpretation is supported by the Specification at ¶106 (referring to FIG 15; a flow chart) providing that “the control circuit determines a default control algorithm to affect the tissue treatment motion of the end effector. For example, a default control algorithm could be chosen based on the surgical procedure that is being performed. In another instance, the default control algorithm could be chosen based on a tissue type to be treated by the end effector. The default control algorithm can have default values, or profiles, set for a default speed of the motor, a default current of the motor, a default maximum load of the drive train, and a default travel distance of the drive train, among other possible parameters of the tissue treatment motion.” See also, at least paragraphs ¶108-119. Accordingly, the control circuit controls the default control algorithm and the parameters which affect the control are based on feedback to the control circuit (¶¶ 112, 118; parameters of threshold force and articulation angle). Paragraph 123 (FIG 19; a flow chart) also expressly discloses that the control circuit determined a default control algorithm to affect the tissue treatment motion of the end effector.
Regarding new claim 21, Overmyer modified by Shelton ‘146 and Harris teach the surgical instrument of Claim 1, as set forth above, for the reason set forth above.
Harris teaches wherein the control circuit is further configured to choose the default control algorithm based on the surgical procedure (FIG 90, ¶¶732-734).
Regarding new claim 22, Overmyer modified by Shelton ‘146 and Harris teach the surgical instrument of Claim 15, as set forth above, for the reason set forth above.
Harris teaches wherein the control circuit is further configured to choose the default control algorithm based on the surgical procedure (FIG 90, ¶¶732-734).
Regarding new claim 23, Overmyer modified by Shelton ‘146 and Harris teach the surgical instrument of Claim 19, as set forth above, for the reason set forth above.
Harris teaches wherein the control circuit is further configured to choose the default control algorithm based on the surgical procedure (FIG 90, ¶¶732-734).
Claims 10 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Overmyer et al., US 20170079642 (23 March 2017), in view of Shelton et al., US 20190201146 (4 July 2019) (herein after Shelton ‘146), and Harris et al., US 20190200981 (4 July 2019) and further in view of Shelton et al., US 20190200986 (4 July 2019) (hereinafter Shelton ‘986), and Huitema et al., US 20150297225 (22 October 2015).
Regarding currently amended claim 10, Overmyer modified by Shelton ‘146 and Harris teaches the surgical instrument of claim 1, as set forth above, for the reasons set forth above.
Overmeyer modified by Shelton ‘146 and Harris does not expressly teach wherein the independent parameter comprises [sic] based on the presence of the buttress on the staple cartridge, wherein the control circuit is further configured to determine a compression of the buttress in response to detecting the presence of the buttress.
However, Overmyer teaches actuated and unactuated positions of the end effector wherein a closure motion of the end effector comprises grasping tissue between the anvil and the staple cartridge (¶158). Overmyer teaches that “magnetic field sensor 65 can be in signal communication with microcontroller 1500 and can determine whether the closure trigger 32 is in the open or closed configuration of the end effector” (FIG 19, ¶158).
Shelton ‘986 teaches “control circuit coupled to a sensor capable of detecting the data-representative feature can thus determine the cartridge type according to the degree or level of the maximum force to close (FTC), the characteristics of the FTC response and other such characteristics of the FTC detected over time” (¶580).
Huitema teaches anvils comprising an adjunct material at ¶382. “An adjunct material can comprise at least one layer of material which is positioned over the tissue-engaging surface of the anvil and is implanted into the patient by staples deployed from a staple cartridge, for example. In various instances, the at least one layer of material can comprise buttress material and/or a tissue thickness compensator (¶382). Huitema teaches staple cartridges comprising an adjunct material at ¶367. “An adjunct material can comprise at least one layer of material which is positioned over the deck of the staple cartridge and is implanted into the patient by staples deployed from the staple cartridge, for example. In various instances, the at least one layer of material can comprise buttress material and/or a tissue thickness compensator” (¶367). Huitema describes many different kinds of buttress material at ¶458-461. Huitema describes the buttress material as comprising “at least one layer” (¶¶367, 382).
Overmyer incorporates Hall et al, U.S. Patent Application Publication 20140263552 by reference at ¶312.
Hall teaches staple cartridge tissue thickness sensor systems and a tissue thickness sensing module located adjacent to the distal end of the staple cartridge (¶6). “The tissue thickness sensing module comprises a sensor and a controller. The sensor is configured to generate a tissue thickness signal indicative of a thickness of the tissue located between the anvil and the staple cartridge. The controller is in signal communication with the sensor. The controller comprises means for identifying the staple cartridge type of the staple cartridge. The staple cartridge type and the thickness of the tissue are used to determine if the thickness of the tissue located between the anvil and the staple cartridge is within the optimal tissue thickness range of the staple cartridge” (¶6).
Accordingly, the presence of the buttress material on either the staple cartridge or the anvil, as taught by Huitema, comprising at least one layer, will innately impact the type of or size of the staple cartridges within the shaft assemblies taught by Overmyer merely because the layer exists in three-dimensional space. The additional at least one layer (broadly read as encompassing a buttress presence) may be sensed by the thickness sensor taught by Hall, as incorporated by reference in Overmyer.
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Overmyer, Shelton ‘146, Harris, Huitema, and Hall given that the prior art included each element claimed, although not necessarily in a single reference. Overmyer, Shelton ‘146, Harris, Huitema, and Hall all teach in the same field of endeavor, surgical instruments comprising surgical staplers.
Although, Overmyer modified by Shelton ‘146 and Haris discloses the claimed base surgical instrument, they do not expressly teach wherein the independent parameter comprises [sic] based on the presence of the buttress on the staple cartridge, wherein the control circuit is further configured to determine a compression of the buttress in response to detecting the presence of the buttress.
Overmyer teaches actuated and unactuated positions of the end effector wherein a closure motion of the end effector comprises grasping tissue between the anvil and the staple cartridge (¶158) and Overmyer teaches that magnetic field sensor 65 can be in signal communication with microcontroller 1500 and can determine whether the closure trigger 32 is in the open or closed configuration of the end effector (FIG 19, ¶158). Shelton ‘986 provides a disclosure of a control circuit coupled to a sensor capable of detecting data-representative features and can determined the cartridge type based on the degree or level of maximum force to close. Huitema teaches anvils comprising an adjunct material (¶382) where at least one layer of material can comprise buttress material and/or a tissue thickness compensator (¶382). Hall teaches staple cartridge tissue thickness sensor systems and a tissue thickness sensing module located adjacent to the distal end of the staple cartridge (¶6). “The sensor is configured to generate a tissue thickness signal indicative of a thickness of the tissue located between the anvil and the staple cartridge. The controller is in signal communication with the sensor. The controller comprises means for identifying the staple cartridge and type of the staple cartridge. The staple cartridge type and the thickness of the tissue are used to determine if the thickness of the tissue located between the anvil and the staple cartridge is within the optimal tissue thickness range of the staple cartridge” (¶6). The combination of Overmyer, Shelton ‘986, Huitema, and Hall demonstrate art-recognized controller-sensor signal communications that provide a teaching, suggestion, and motivation for one of ordinary skill in the art to configure a control circuit, as taught by Overmyer, Huitema, and Hall) to determine compression (force to close of Shelton ‘986) of the buttress in response to detecting the presence of the buttress. A person of ordinary skill in the art, seeking to detect and control compression of a buttress material between the jaws of a surgical stapler using Overmyer’s architecture would reasonably consult controller-sensor signal communications solution of Overmyer, Shelton ‘986, Huitema, and Hall, which provide a teaching, suggestion, and motivation for one of ordinary skill in the art to configure a control circuit to use sensors determine the presence of a buttress and the compression (force-to-close of the buttress. The sensors and signal communications can be incorporated alongside Overmyer’s surgical stapler (same general location and interaction with the controller circuits)0 using known assembly methods without redesigning Overmyer’s core device. A person of ordinary skill in the art attempting to render Overmyer’s surgical stapler compatible with buttress material in particular use-cases would look for established controller/sensor designs to avoid creating a novel interface. The controller/sensor designs of Overmyer, Shelton ‘986, Huitema, and Hall are modular and can be adapted to the control circuitry of the surgical stapler of Overmyer to buttress detection and compression (force to close) in response to detecting the presence of the buttress.
Because the references address the same engineering problem (controller and sensor components of minimally invasive robotic surgical systems) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding an art-recognized controller/sensors for buttress detection and force-to-close (compression) responses), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Regarding claim 12, Overmyer modified by Shelton ‘146 and Harris teaches the surgical instrument of claim 11, as set forth above, for the reasons set forth above.
Overmyer teaches that the staple cartridge type provides a staple material composition (use indicator, ¶223). Overmyer also teaches wherein the control circuit is further configured to set a maximum speed for the motor (¶212).
Overmyer does not expressly teach that the basis for the control circuit configuration is based on the staple material composition.
Shelton ‘986 teaches surgical instrument cartridge sensor assemblies (Abstract). Shelton ‘986 teaches data elements associated with the staple cartridge (FIG 92; ¶587). Shelton
‘986 teaches “that the cartridge body material and/or thickness can be different for the various cartridge types in order to create keyed resistance ranges for each cartridge type, which can then be detected by a sensor” (FIG 93; ¶579). Shelton ‘986 teaches “the material and/or geometry of the data-representative feature(s) disposed on the cartridge deck can be customized for each of the various cartridge types to yield different detectable responses in the force to close (FTC) the anvil. A control circuit coupled to a sensor capable of detecting the data-representative feature can thus determine the cartridge type according to the degree or level of the maximum FTC and other such characteristics of the FTC detected over time” (¶580).
Huitema teaches “a staple cartridge body 185 can be comprised of plastic materials, metallic materials, and/or ceramic materials” (¶302). Huitema also teaches that surgical staples can be comprised of metals, metal oxides, and coatings (¶310).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Overmyer, Shelton ‘146, Harris, Huitema, and Hall given that the prior art included each element claimed, although not necessarily in a single reference. Overmyer, Shelton ‘146, Harris, Huitema, and Hall all teach in the same field of endeavor, surgical instruments comprising surgical staplers.
Although, Overmyer discloses the claimed base surgical stapler assembly and teaches that the staple cartridge type provides a staple material composition (use indicator, ¶223) in addition to teaching wherein the control circuit is further configured to set a maximum speed for the motor (¶212), Overmyer does not expressly disclose that the basis for the control circuit configuration is based on the staple material composition.
Shelton ‘986 specifically addresses data elements associated with staple cartridges which can be detected by sensors and communicated to controllers. Because Overmyer’s surgical stapler includes a controller-sensor system in signal communication, a person of ordinary skill in the art, seeking to enhance controlled features through sensors would reasonably consult Shelton ‘986’s controller-sensor system for determining the cartridge body material and a staple’s material composition based on the cartridge type using known controller/sensor methods without redesigning Overmyer’s core surgical stapler device.
Huitema discloses compositions of staple cartridge bodies and staple materials. A person of ordinary skill in the art attempting to render Overmyer’s surgical stapler assembly more situationally aware (Shelton ‘146) would look for established designs in order to avoid creating novel controller-sensor subsystems.
Because the references address the same engineering problem (controller and sensor components of minimally invasive robotic surgical systems) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding an art-recognized controller/sensor subsystem), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Overmyer et al., US 20170079642 (23 March 2017) in view of Shelton et al., et al., US 20190201146 (4 July 2019) (hereinafter Shelton ‘146), and Harris et al., US 20190200981 (4 July 2019) and further in view of Shelton et al., US 20160256071 (4 February 2020) (hereinafter Shelton ‘071).
Regarding claim 14, Overmyer modified by Shelton ‘146 and Harris teaches the surgical instrument of claim 1, as set forth above, for the reasons set forth above.
Overmyer generally teaches interchangeable shaft assemblies including assemblies that are configured to apply radio frequency (RF) energy adapted for use in connection with various surgical applications and procedures (¶154).
Overmyer does not expressly teach wherein the sensor comprises a radio frequency scanner. However, Overmyer expressly incorporates by reference U.S. Patent Application serial number 14/640,935, which published at US 20160256071 on 8 September 2016 and issued as US 10,548,504 on 4 February 2020, and cited herein as Shelton ‘071 (Overmyer, ¶56).
Shelton ‘071 teaches stapling instruments 10 configured to use RF sensor scanners to sense tissue compression and to sense internal tissue parameters as an adjunct to the stapling operation at ¶274-277.
Shelton ‘146 generally teaches surgical instrumentation for treating tissue in a surgical procedure comprising a control circuit (Abstract; FIGs 30,32; ¶¶36,38, and 202-206), as well as an anvil and stapling head assembly (FIGs 2, 4, 7-14 and 17; ¶¶8, 10, 13-20, and 23). More specifically, Shelton ‘146 teaches FIG 20 (¶29) which encompasses a stroke length graph as an example of a control system modifying the length of a clamping assembly based on the articulation angle. FIG 21 (¶30) teaches a closure tube assembly positioning graph showing an example of a control system modifying a longitudinal position of the closure tube assembly based on the articulation angle. Shelton ‘146 also teaches that “the housing 150012 may be employed with a variety of interchangeable shaft assemblies, including assemblies configured to apply other motions and forms of energy such as radio frequency (RF) energy …” (FIG 25; ¶399; see also FIG 44 and ¶454).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Overmyer, Shelton ‘146, Harris, and Shelton ‘071, given that the prior art included each element claimed, although not necessarily in a single reference. Overmyer, Shelton ‘146, Harris, and Shelton ‘071 teach in the same field of endeavor of surgical staplers.
Although Overmyer discloses the base device comprising interchangeable shaft assemblies including assemblies that are configured to apply radio frequency (RF) energy adapted for use in connection with various surgical applications and procedures, Overmyer does not expressly teach wherein the sensor comprises a radio frequency scanner.
Overmyer acknowledges the teachings of Shelton ‘071 by incorporating it by reference. Shelton ‘071 specifically addresses teaches stapling instruments configured to use RF sensor scanners to sense tissue compression and to sense internal tissue parameters as an adjunct to the stapling operation (¶¶274-277). The teachings of Overmyer are also supported by Shelton ‘146, which discloses that “the housing 150012 may be employed with a variety of interchangeable shaft assemblies, including assemblies configured to apply other motions and forms of energy such as radio frequency (RF) energy …” (FIG 25; ¶399).
Because Overmyer includes the base device comprising interchangeable shaft assemblies including assemblies that are configured to apply radio frequency (RF) energy sensors adapted for use in connection with various surgical applications and procedures, a person of ordinary skill in the art, seeking to control the specific types of RF energy sensors applied would reasonably consult Shelton ‘071’s RF scanner solution. Shelton’s RF scanner can be incorporated alongside Overmyer’s assemblies for the application of RF energy using known assembly methods without redesigning Overmyer’s base device. A person of ordinary skill in the art attempting to select applied RF energy assemblies would look for established devices and designs to avoid creating a novel interface.
Because the references address the same engineering problem (applying RF energy sensors to surgical stapler assemblies) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding an RF scanner as an RF sensor), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Conclusion
No claim is allowed.
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.
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/CHERIE M POLAND/Examiner, Art Unit 3771
/SHAUN L DAVID/Primary Examiner, Art Unit 3771
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