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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 13 November 2025 has been entered.
Formal Matters
No claims have been amended. Claims 1-20 are pending and under examination.
Response to Arguments
Applicant argues that the amendments to the claims overcome the rejections of record. Applicant argues that the cited references record do not teach “the default control algorithm indicating one or more default parameters for motivating the drive train or wherein the control circuit is configured to adjust the one or more default parameters indicated by the default control algorithm based on the independent parameter in response to input from the sensor indicative of the independent parameter, where the independent parameter is independent of the motion of the end effector” (Remarks, numbered p. 6). Applicant argues that the portions of Shelton ‘146 relies on are silent on any default parameters and default control algorithm and does not mention whether to adjust such default parameters and how to adjust the default parameters” (Remarks, numbered p. 6).
Applicant argues that the portions cited in Overmyer fail to disclose or suggest the claimed “default control algorithm” as recited in independent claims 1, 15, and 19 and that Overmyer does not disclose or suggest making changes to the algorithms (Remarks, numbered p. 6).
Applicant incorporates previously presented arguments by reference to the Remarks filed 5 June 2025 and argues that the EEPROM in the second shaft related to shaft assemblies or end effectors “generally are not a drive train” and that the EEPROM “are not for motivating the drive train” (Remarks, filed 5 June 2025, numbered pages 7 to 8).
Applicant’s arguments have been fully considered, but they are not persuasive. Overmyer and Shelton are cited for all that they teach. In addition to the prior discussions of record, Overmyer provides a detailed description of various electrical/electronic components of surgical instrument 10, including segmented circuit 2000 comprising a plurality of circuit segments 2002a-2002g at ¶199. Element 2002g is the motor segment (segment 7), which is coupled to microcontroller 2006, also called the primary processor (¶199). See also, FIGs 21A-B. Motor segment 2002g comprises motor 2048 to control one or more movements of the powered surgical instrument 10 (¶206). Segmented circuit 2000 is taught as being implemented by a PCBA within the powered surgical instrument (¶199). Additionally, ¶199 teaches that “safety processor 2004 and/or the primary processor 2006 are configured to interact with one or more additional circuit segments 2002c-2002g to control operation of the powered surgical instrument 10.” Overmyer also teaches that motor 2048 is coupled to the primary processor 2006 through motor controller 2043 (¶206). Primary processor 2006 provides motor reset signal 2082 to the motor controller 2043 through a buffer 2084 (¶206). A motor current sensor 2046 is coupled in series with the motor 2048 to measure the current draw of the motor 2048 (¶206). The motor current sensor 2046 is in signal communication with the primary processor 2006 and/or the safety processor 2004 (¶206). Thus, when Overmyer teaches “safety control processor 2004 is configured to execute an independent control algorithm … and/or override signals from other circuit components”, the drive train is expressly encompassed within this control circuit (¶217).
Overmyer also teaches a separate, but related, specific embodiment of sensor-controlled (¶246) bailout assemblies. At FIG 25 and ¶246, Overmyer teaches segmented circuit 2400 (FIG 25) comprises bailout switch 2456 and safety processor 2402, which are coupled to an AND gate 2419 (¶246). The AND gate 2419 provides an input to an FET switch 2413. When the bailout switch 2456 detects a bailout condition, the bailout switch 2456 provides a bailout shutdown signal to the AND gate 2416. When output of the AND gate 2419 is low, the FET switch 2413 is opened and operation of the motor 2448 is prevented (¶246). The parameters of the bailout assemblies are independent of the motion of the end effector.
Overmyer teaches general default control 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. 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). Accordingly, the rejections are maintained for the reasons of record and the reasons set forth herein. The rejections of record have been modified using the previously cited references to provide more clarity to Applicant. The Office Action is Non-Final.
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 1-9, 11, and 15-20 remain 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), for the reasons of record and the reasons set forth above.
Regarding independent claim 1, Overmyer teaches a surgical instrument (10) for treating tissue in a surgical procedure (¶2, surgical stapler), the surgical instrument comprising:
an end effector (¶2, 300; ¶149, jaw members), comprising:
an anvil (¶2, 306); and
a staple cartridge (¶2, 306);
a drive train (Abstract; ¶¶199, 206) operably coupled to the end effector (¶204, end effector 300);
a motor (¶206, motor 2048) configured to motivate the drive train (Abstract; ¶199, electrical components of surgical system 10 in FIGs 21A-B; ¶206) based on a default control algorithm (¶204; FIGs 21A-B),
the default control algorithm (¶¶204, 217; FIGs 21A-B) 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, “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, articulation by way of an articulation switch);
a sensor (FIGs 21A-B; ¶213, motor position sensors 2040a, 2040b), configured to monitor an independent parameter of the surgical procedure (FIGs 21A-B, segmented circuit 2000, motor segment 2002g (Segment 7), microcontroller 2006), wherein the independent parameter is independent of the motion of the end effector (FIGs 21A-B; ¶213, motor position sensors 2040a, 2040b provide respective signals to the safety processor 2004 and the primary processor 2006 indicative of the position of the motor 2048”); and
a control circuit coupled to the motor and the sensor (Abstract; FIGs 21A-B; ¶199, electrical components of surgical system 10; ¶217, segmented circuit 2000, safety processor 2004)
wherein the control circuit (FIGs 21A-B; ¶¶199, 217) is configured to: receive an input from the sensor indicative of the independent parameter (FIGs 21A-B; ¶217, “safety processor 2004 monitors the segmented circuit 2000 and is configured to control and/or override signals from other circuit components, such as, for example, the primary processor 2006, independently”);
and adjust the default control algorithm based on the independent parameter (FIGs 21A-B; ¶216 “safety processor 2004 may open the motor power switch 2020 to cut power to the motor circuit segment 2002g when a fault is detected”; “when a fault occurs, the safety processor 2004 takes at least one action, such as, for example, preventing operation of at least one of the circuit segments, executing a predetermined operation, and/or resetting the primary processor 2006”).
Overmyer teaches general default control and safety mechanisms related to fault detection.
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).
Overmyer and Shelton ‘146 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 in more than a general manner. 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. 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.
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 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 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 2, Overmyer modified by Shelton ‘146 teaches the surgical instrument of claim 1, as set forth above, wherein the independent parameter comprises a first independent parameter (Overmyer: 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 (Overmyer: ¶212, motor position sensor 2040b),
wherein the second independent parameter is different than the first independent parameter (Overmyer: ¶213), and
wherein the control circuit (Overmyer: ¶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 (Overmyer: ¶214); and adjust the default control algorithm based on the first independent parameter and the second independent parameter (Overmyer: ¶214, prevent operation of motor segment 2002g).
Regarding claim 3, Overmyer modified by Shelton ‘146 teaches the surgical instrument of Claim 1, as set forth above, wherein the motion is a closure motion of the end effector to grasp tissue between the anvil and the staple cartridge (Overmyer: ¶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 teaches the surgical instrument of Claim 1, as set forth above, wherein the motion is a firing motion of the end effector to deploy staples into the tissue (Overmyer: ¶165, with data from the first sensor 803 and/or the second sensor 804, the microcontroller can determine the position of the magnet 802 along a predefined path and, based on that position, the microcontroller can determine whether the firing trigger 130 is in its unfired position, its fully fired position, or a position therebetween”).
Regarding currently amended claim 5, Overmyer modified by Shelton ‘146 teaches the surgical instrument of Claim 1, as set forth above, wherein the default control algorithm (Overmyer: ¶217) comprises at least one of :
a default speed of the motor (Overmyer: ¶212, motor sensor 2040a provides motor speed and position information to the safety processor 2004),
a default current of the motor (Overmyer: ¶206, current draw of motor 2048; ¶207, current sensor 2012),
a default maximum load of the drive train (Overmyer: ¶253, “primary processor 2606 isolates the control section 2602 from heavy swings in the batter voltage to ensure proper operation even during heavy motor loads, and/or allows for real-time operating system (RTOS) to be used by the segmented circuit 2600”), and
a default travel distance of the drive train (Overmyer: ¶161 drive member 120 axially driven in the distal direction or proximal direction; “handle assembly 14 can include a sensor configured to detect the position of the drive member 120 and/or the direction in which the drive member 120 is being moved”).
Regarding claim 6, Overmyer modified by Shelton ‘146 teaches the surgical instrument of Claim 1, as set forth above, further comprising: a shaft (Overmyer: 200); and an articulation joint (Overmyer: 270) extending between the shaft and the end effector, wherein the end effector is articulatable relative to the shaft about the articulation joint (Overmyer: ¶149 “[t]he surgical stapling system further comprises an articulation joint configured to permit the end effector to be rotated, or articulated, relative to the shaft. The end effector is rotatable about an articulation axis extending through the articulation joint”).
Regarding claim 7, Overmyer modified by Shelton ‘146 teaches the surgical instrument of Claim 6, as set forth above, wherein the independent parameter is an articulation angle of the end effector relative to the shaft (Overmyer: ¶213, “[t]he motor position sensors 2040a, 2040b may comprise any suitable motor position sensor, such as, for example, a magnetic angle rotary input comprising a sine and cosine output. The motor position sensors 2040a, 2040b provide respective signals to the safety processor 2004 and the primary processor 2006 indicative of the position of the motor 2048”).
Regarding claim 8, Overmyer modified by Shelton ‘146 teaches the surgical instrument of Claim 7, as set forth above, wherein the control circuit is configured to adjust the default control algorithm based on the articulation angle (Overmyer: ¶213, “[t]he motor position sensors 2040a, 2040b may comprise any suitable motor position sensor, such as, for example, a magnetic angle rotary input comprising a sine and cosine output. The motor position sensors 2040a, 2040b provide respective signals to the safety processor 2004 and the primary processor 2006 indicative of the position of the motor 2048”).
Regarding claim 9, Overmyer modified by Shelton ‘146 teaches the surgical instrument of Claim 8, as set forth above, wherein the control circuit reduces the motor speed as the articulation angle increases (Overmyer: ¶212, motor sensor 2040a provides motor speed and position information to the safety processor 2004. The safety processor 2004 monitors the 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. In some examples, the predetermined values are calculated based on real-time speed and/or position of the motor 2048”).
Regarding claim 11, Overmyer modified by Shelton ‘146 teaches the surgical instrument of Claim 1, wherein the independent parameter is based on a staple cartridge type (Overmyer: ¶154 “interchangeable shaft assemblies that include end effectors that are adapted to support different sizes and types of staple cartridges, have different shaft lengths, sizes, and types, etc.”).
Regarding independent claim 15, Overmyer teaches a surgical instrument (10) for treating tissue in a surgical procedure (¶2, surgical stapler), the surgical instrument comprising:
an end effector (¶2, 300; ¶149, jaw members), comprising:
an anvil (¶2, 306); and
a staple cartridge (¶2, 306);
a drive train assembly (Abstract; ¶¶199, 206) operably coupled to the end effector (¶204, end effector 300);
a motor assembly (¶206, motor 2048) configured to motivate the drive train assembly (Abstract; ¶199, electrical components of surgical system 10 in FIGs 21A-B; ¶206) based on a default control instructions (¶204; FIGs 21A-B),
the default control instructions (¶¶204, 217; FIGs 21A-B) 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, “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, articulation by way of an articulation switch);
a control circuit coupled to the motor (Abstract; FIGs 21A-B; ¶199, electrical components of surgical system 10; ¶217, segmented circuit 2000, safety processor 2004)
wherein the control circuit (FIGs 21A-B; ¶¶199, 217) is configured to:
receive an input indicative of a situational parameter associated with the surgical procedure, wherein the situational parameter is unrelated to the drive train, and wherein the situational parameter is unrelated to the motor (FIGs 21A-B; ¶217, “safety processor 2004 monitors the segmented circuit 2000 and is configured to control and/or override signals from other circuit components, such as, for example, the primary processor 2006, independently”); and
adjust the one or more default parameters indicated by the default control instructions based on the situational parameter (FIGs 21A-B; ¶216 “when a fault occurs, the safety processor 2004 takes at least one action, such as, for example, preventing operation of at least one of the circuit segments, executing a predetermined operation, and/or resetting the primary processor 2006).
Overmyer teaches general default control and safety mechanisms related to fault detection.
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).
Overmyer and Shelton ‘146 teach in the same field of endeavor, surgical instruments comprising surgical staplers. Overmyer teaches general default control and safety mechanisms related to fault detection. 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, 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. 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 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 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 teaches the surgical instrument of Claim 15, as set forth above, wherein the input is received from a user (Overmyer: ¶189, microcontroller 1500 has a received an input indicating that a shaft assembly has been at least partially coupled to the handle assembly 14, and that, as a result, the electrical contacts 1401a-1401f are no longer exposed, the microcontroller 1500 can enter into its normal, or powered-up, operating state; ¶217, “[t]he safety processor 2004 may execute a preprogrammed algorithm and/or may be updated or programmed on the fly during operation based on one or more actions and/or positions of the surgical instrument 10”).
Regarding claim 17, Overmyer modified by Shelton ‘146 teaches the surgical instrument of Claim 15, as set forth above, wherein the input is the result of an image processing analysis (Overmyer: ¶237, the usage cycle circuit 2102 may be coupled to a display formed integrally with the surgical instrument 2110. The usage cycle circuit 2102 displays a message indicating that the predetermined usage limit has been exceeded).
Regarding claim 18, Overmyer modified by Shelton ‘146 teaches the surgical instrument of Claim 15, as set forth above, wherein the default control instructions (Overmyer: ¶217) comprise at least one of:
a default speed of the motor assembly (Overmyer: ¶212, motor sensor 2040a provides motor speed and position information to the safety processor 2004),
a default current of the motor assembly (Overmyer: ¶206, current draw of motor 2048; ¶207, current sensor 2012),
a default maximum load of the drive train assembly (Overmyer: ¶253, “primary processor 2606 isolates the control section 2602 from heavy swings in the batter voltage to ensure proper operation even during heavy motor loads, and/or allows for real-time operating system (RTOS) to be used by the segmented circuit 2600”), and
a default travel distance of the drive train assembly (Overmyer: ¶161 drive member 120 axially driven in the distal direction or proximal direction; ¶161 “the handle assembly 14 can include a sensor configured to detect the position of the drive member 120 and/or the direction in which the drive member 120 is being moved”).
Regarding independent claim 19, Overmyer teaches a surgical instrument (10) for treating tissue in a surgical procedure (¶2, surgical stapler), the surgical instrument comprising:
an end effector (¶2, 300; ¶149, jaw members), comprising:
a first jaw (¶2, staple cartridge 304); and
a second jaw movable (¶149, pivotable) relative to the first jaw to grasp the tissue between the first jaw and the second jaw (¶2, anvil 306);
a drive train assembly (Abstract; ¶¶199, 206) coupled to the end effector (¶204, end effector 300);
a motor assembly (¶206, motor 2048) configured to motivate the drive train assembly (Abstract; ¶199, electrical components of surgical system 10 in FIGs 21A-B; ¶206) based on a default control instructions (FIGs 21A-B; ¶218 primary processor 2006 may indicate to the safety processor 2004 that the primary processor 2006 is executing code and operating normally), to effect a tissue treatment motion of the end effector (¶204, articulation by way of an articulation switch);
a control circuit coupled to the motor assembly is configured to: receive an input indicative of a parameter associated with the surgical procedure (FIGs 21A-B, ¶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”),
wherein the parameter is unrelated to the drive train assembly (¶222, usage cycle) and
adjust the default control instructions based on the parameter (¶222, use cycle count control signal when the usage cycle count exceeds the predetermined usage limit; ¶226 “[a]fter incrementing the usage cycle count, the processor 2104 resets the timing circuit of the use indicator 2106).
Overmyer teaches general default control and safety mechanisms related to fault detection.
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).
Overmyer and Shelton ‘146 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 in more than a general manner. 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. 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.
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 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 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 20, Overmyer modified by Shelton ‘146 teaches the surgical instrument of claim 19, as set forth above, wherein adjust the default control instructions based on the parameter comprises adjusting the default control instructions prior to performing the tissue treatment motion (¶229, “during a sterilization procedure, an inappropriate chemical may be used that leads to degradation of the power assembly 2100. The processor 2104 increments the usage cycle count when the use indicator 2106 detects an inappropriate chemical”).
Claim 10 remains 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 further in view of Huitema et al., US 20150297225 (22 October 2015), as evidenced by or alternatively in further view of Hall et al, US 20140263552 (18 September 2014), incorporated by reference in Overmyer, for the reasons of record and the reasons set forth herein.
Regarding claim 10, Overmyer modified by Shelton ‘146 teaches the surgical instrument of claim 1, as set forth above. Overmyer teaches independent parameters based on a staple cartridge type (¶217, 154 “interchangeable shaft assemblies that include end effectors that are adapted to support different sizes and types of staple cartridges, have different shaft lengths, sizes, and types, etc.”; see also ¶151, cartridge 304 “ housing 12 may be configured for use in connection with interchangeable shaft assemblies that include end effectors that are adapted to support different sizes and types of staple cartridges, have different shaft lengths, sizes, types, etc.”).
Overmyer modified by Shelton ‘146 does not expressly teach wherein the independent parameter is based on a buttress presence.
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 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 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 by reference: Hall et al, U.S. Patent Application Publication 20140263552 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.
Overmyer, Shelton ‘146, Huitema, and Hall all 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 in more than a general manner. 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. 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.
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.
Huitema discloses that the at least one layer of material can comprise buttress material and/or a tissue thickness compensator (¶367). Hall teaches staple cartridge tissue thickness sensor systems and a tissue thickness sensing module where 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). A person of ordinary skill in the art attempting to render Overmyer’s control circuit where the parameter assessing a buttress presence would look for established buttress presence designs to avoid creating a novel interface. Overmyer recognizes Hall’s teachings by specifically incorporating it by reference. Huitema’s sensors and optimization controls are modular and can be adapted to the stapler of Overmyer by routine engineering practices, similar to those taught by Hall. 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.
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 and sensing a buttress presence), 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.
Claims 12 and 13 remain 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), Shelton et al., US 20190200986 (4 July 2019) (hereinafter Shelton ‘986), and further in view of Huitema et al., US 20150297225 (22 October 2015) for the reasons of record and the reasons set forth herein.
Regarding claim 12, Overmyer modified by Shelton ‘146 teaches the surgical instrument of claim 11, as set forth above. Overmyer teaches wherein the control circuit is further configured to set a maximum speed for the motor (¶212, 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). Overmyer also teaches fault procedures when the safety processor 2004 takes at least one action (¶216).
Overmyer does not expressly teach that the basis for this configuration is based on the staple material composition.
Overmyer does not teach wherein the staple cartridge type provides a staple material composition.
Shelton ‘986 teaches surgical instrument cartridge sensor assemblies (Abstract). Shelton ‘986 teaches data elements associated with the staple cartridge (¶587; FIG 92). Shelton
‘986 teaches “that the cartridge body 27205 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 27224 (FIG. 93) associated with the end effector 150300 of the surgical instrument 150302” (¶579). Shelton ‘986 teaches “the material and/or geometry of the data-representative feature(s) 27204 disposed on the cartridge deck 27206 can be customized for each of the various cartridge types to yield different detectable responses in the force to close (FTC) the anvil 150306. A control circuit 27222 coupled to a sensor capable of detecting the data-representative feature 27204 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).
Overmyer, Shelton ‘146, Shelton ‘986, and Huitema teach in the same field of endeavor of surgical staplers. Overmyer teaches the base device upon which the claimed invention is an improvement, that general properties (e.g. a first property and a second property) of surgical instrument components can be monitored by at least one sensor of a primary processor and/or a safety processor, as set forth above in claims 1 and 11.
Shelton ‘986 teaches comparable devices and expands upon the general first and second properties of Overmyer in teaching that surgical instrument components comprise data features that include physical or visually identifiable features or structures associated with or disposed on a staple cartridge, including the material that the cartridge body is constructed from or other physical properties. Shelton ‘986 also teaches the material and/or geometry of the data-representative features can be customized for each of the various cartridge types to yield different detectable responses and that these features and other such characteristics can be detected over time. These more specific properties and features improve upon the general properties to be sensed and monitored by Overmyer’s instrument system. Huitema teaches the material compositions of staple cartridge body materials and the staple material composition. The physical properties and material composition of the various art-recognized staples and staple cartridge bodies taught by Huitema are readily incorporated into the teachings of Shelton ‘986, which expressly encompasses material compositions of the cartridge body and other physical properties. One of ordinary skill in the art would recognize that the material composition of staples would be encompasses in this feature assessment, given the teachings of Huitema, which teaches both staple material composition and staple cartridge material composition.
One of ordinary skill in the art, before the effective filing date of the claimed invention, could have applied the known improvement of Shelton ‘986 in view of Huitema, to further improve the base device of Overmyer modified by Shelton ‘146 by incorporating or otherwise substituting specific physical properties of staple cartridges, staple cartridge material composition, and staple material composition for the general first and second properties of the surgical instrument components taught by Overmyer modified by Shelton ‘146. The proposed modifications would have been reasonably predictable because they are mechanically compatible and implemented by routine engineering practices (adding a specific feedback controller into an existing control circuit and establishing the maximum speed for the motor based on the staple material composition). Accordingly, 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 13, Overmyer modified by Shelton ‘146 teaches the surgical instrument of claim 1, as set forth above. Overmyer teaches wherein the control circuit is further configured to set a maximum speed for the motor (¶212, 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). Overmyer also teaches fault procedures when the safety processor 2004 takes at least one action (¶216). Additionally, Overmyer teaches “usage cycle circuit 2102 is configured to prevent operation of the surgical instrument 2110 after the predetermined usage limit is reached. In some instances, the surgical instrument 2110 comprises a visible indicator to indicate when the predetermined usage limit has been reached and/or exceeded” (¶237).
Overmyer does not expressly teach wherein the independent parameter is based on staple cartridge age.
Overmyer does not expressly teach wherein the control circuit reduces the motor speed based on the staple cartridge age.
Shelton ‘986 teaches surgical instrument cartridge sensor assemblies (Abstract). Shelton ‘986 teaches data elements associated with the staple cartridge (¶587; FIG 92). Shelton
986 teaches “data-representative feature 27204 can include a physically or visually identifiable feature or structure that is associated with or disposed on the cartridge 27200. Data-representative feature 27204 can include the material that the cartridge body 27205 is constructed from and/or the thickness of the cartridge body 27205. The cartridge body 27205 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 27224 (FIG. 93) associated with the end effector 150300 of the surgical instrument 150302” (¶579).
Similarly, Shelton ‘986 teaches “the material and/or geometry of the data-representative feature(s) 27204 disposed on the cartridge deck 27206 can be customized for each of the various cartridge types to yield different detectable responses in the force to close (FTC) the anvil 150306. A control circuit 27222 coupled to a sensor capable of detecting the data-representative feature 27204 can thus determine the cartridge type according to the degree or level of the maximum FTC, the characteristics of the FTC response (e.g., the shape of the FTC curve plotted verse time, as depicted in various graphs described under the heading “Surgical Instrument Hardware,” such as FIG. 83), and other such characteristics of the FTC detected over time” (¶580).
Huitema teaches “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).
Overmyer, Shelton ‘146, Shelton ‘986, and Huitema teach in the same field of endeavor of surgical staplers. Overmyer teaches the base device upon which the claimed invention is an improvement, that general properties (e.g. a first property and a second property) of surgical instrument components can be monitored by at least one sensor of a primary processor and/or a safety processor, as set forth above in claims 1 and 11.
Shelton ‘986 teaches comparable devices and expands upon the general first and second properties of Overmyer in teaching that surgical instrument components comprise data features that include physical or visually identifiable features or structures associated with or disposed on a staple cartridge, including features that can be detected over time. Shelton ‘986 also teaches the material and/or geometry of the data-representative features can be customized for each of the various cartridge types to yield different detectable responses and that these features and other such characteristics can be detected over time. These more specific properties and features including detection over time improve upon the general properties to be sensed and monitored by Overmyer’s instrument system, including usage cycles and predetermined usage limits.
Huitema teaches the material compositions of staple cartridge body materials and the staple material composition. The physical properties and material composition of the various art-recognized staples and staple cartridge bodies taught by Huitema are readily incorporated into the teachings of Shelton ‘986, which expressly encompasses material compositions of the cartridge body and other physical properties. One of ordinary skill in the art would recognize that the material composition of staples and their age would be encompasses in this feature assessment, given the teachings of Huitema, which teaches both staple material composition and staple cartridge material composition.
One of ordinary skill in the art, before the effective filing date of the claimed invention, could have applied the known improvement of Shelton ‘986 in view of Huitema, to further improve the base device of Overmyer modified by Shelton ‘146 by incorporating or otherwise substituting specific physical properties of staple cartridges, staple cartridge material composition, and staple material composition and the age thereof including a predetermined usage limit for the general first and second properties of the surgical instrument components taught by Overmyer modified by Shelton ‘146, and the inclusion would have been reasonably predictable. The proposed modifications are mechanically compatible and implemented by routine engineering practices (adding a specific feedback controller into an existing control circuit and establishing the maximum speed for the motor based on the staple material composition). Compare “use by” dates and failure rate assessments for material components that may indicate that the components should be disposed of (Overmyer: ¶237). Techniques for improving surgical staplers were part of the ordinary capabilities of one skilled in the art, in view of the technique for improvement in other situations. Accordingly, 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 remains 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 further in view of Shelton et al., US 20160256071 (4 February 2020) (hereinafter Shelton ‘071), for the reasons of record and the reasons set forth herein.
Regarding claim 14, Overmyer modified by Shelton ‘146 teaches the surgical instrument of claim 1, as 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).
Overmyer, Shelton ‘146, and Shelton ‘071 teach in the same field of endeavor of surgical staplers. Overmyer teaches 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 (¶154). Overmyer acknowledges the teachings of Shelton ‘071 by incorporating it by reference. Shelton ‘071 teaches stapling instrument 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. 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; see also FIG 44 and ¶454).
Techniques for improving surgical staplers were part of the ordinary capabilities of one skilled in the art, in view of the technique for improvement in other situations. The proposed modifications are mechanically compatible and implemented by routine engineering practices (adding sensor comprises a radio frequency scanner for when interchangeable shaft assemblies are used, such as assemblies configured to apply RF energy). Accordingly, 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHERIE M POLAND whose telephone number is (703)756-1341. The examiner can normally be reached M-W (9am-9pm CST) and R-F (9am-3pm CST).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at 571-272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CHERIE M POLAND/Examiner, Art Unit 3771
/SHAUN L DAVID/Primary Examiner, Art Unit 3771