DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
The previous objection of claim 2-7, 9-14 and 16-18 due to minor informalities has been withdrawn in light of applicant’s amendments made 4/03/2026.
The previous rejection of claim(s) 1-18 over 35 U.S.C. 112(b) as being indefinite has been overcome in light of the amendments made to claim(s) 1, 5-8 and 12-18 on 4/03/2026.
The rejection of claims 1-3 and 5 under 35 U.S.C. 103 as being obvious over Harris et al. (US 2020/0178971) has been withdrawn in light of applicant’s amendment made 4/03/2026. Specifically, Harris does not teach determining, by a controller, a running torque average of the sensed torque.
Applicant’s arguments with respect to claims 1, 3-8 and 10-18 have been considered but are moot because the new ground of rejection does not rely on any reference in the prior art rejection of record for any teaching or matter specifically challenged in the argument. However, as discussed below, the newly added reference Perdue et al. (US 2019/0274769 A1) teaches said limitation.
Claim Objections
Claims 12 and 16 are objected to because of the following informalities: Claims 12 and 16 recite “determining a distal throw” in lines 4, respectively, which should read “determining the distal throw” for consistency purposes. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 15-18 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 15 recites the limitation "the maximum distal throw" in line 23. There is insufficient antecedent basis for this limitation in the claim.
Claims 16-18 are rejected based on their dependency to rejected claim 15 above.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 3 and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harris et al. (US 2020/0178971 A1) in view of Perdue et al. (US 2019/0274769 A1).
Regarding claim 1, Harris discloses a method of determining a distal throw of a knife blade of a robotic surgical instrument (as the control system determines force thresholds based on a length of travel of a firing bar [of a knife blade] compared to a measured torsional force of one or more motors; [0531]), comprising: selectively engaging an end effector (end effector 150300; Fig. 25) onto a housing (housing 150012; Fig. 25) of the robotic surgical instrument (wherein the term “housing” may encompass a housing or similar portion of a robotic system that houses or otherwise operably supports at least one drive system used to actuate an interchangeable shaft assembly; [0051]), the end effector (150300) comprising the knife blade (cutting edge 150182 at the distal end of firing bar 150172/E-beam; Fig. 28) disposed between opposing jaw members (anvil 150306 and elongated channel 150302; Figs. 28, 28); coupling the end effector (150300) to a jaw drive input (at least one drive system; [0551]); initiating a homing algorithm (as the control system senses and detects the position of the E-beam which the knife blade is attached; [0534]-[0535]) to determine a fully retracted position of the knife blade (the most proximal position 20908 of the knife blade can be sensed by the control system associating the position of the E-beam as being in a home position; [0535]; Fig. 23); and initiating an end stop detection algorithm (as the control system monitors the sensed motor torsional force during travel of the E-beam; [0533]-[0534]) comprising: actuating a knife drive coupler (firing bar, E-beam and motor driving the firing bar/E-beam) to advance the knife blade distally through a knife channel (channel shown through staple cartridge 150304 of Fig. 25) defined within the end effector (Fig. 25); sensing a torque (torque of the motor controlling travel of the firing bar) exerted on the knife drive coupler during advancement of the knife blade (as the motor torsional force is “sensed” during travel of the E-beam; [0534]); determining a torque of the sensed torque (as the control system senses torsion forces on the motor controlling travel of the firing bar as can be seen as 20808 breaks into 20810 in Fig. 23; [0533]; [0536]); determining a spike (knife travel force peak 20806) in the sensed torque above a predetermined threshold (the motor threshold 20808); determining a position of the knife blade associated with the spike as a maximum distal throw of the knife blade (detected knife travel force peak 20806; [0535]; Fig. 23); retracting the knife blade (as the firing bar is retracted in a most proximal position 20908; [0535]) to determine an offset position (at approximately 12 mm in length i.e. at 11 seconds in section B of Fig. 23) from the maximum distal throw of the knife blade ([0535]; Fig. 23); and storing the offset position of the knife blade for subsequent usage (via recalibration; [0535]; Fig. 23).
Harris fails to explicitly disclose identifying the end effector and associated operational data therewith, the operational data comprising at least operating parameters and characteristics of the end effector and communicating the operational data back to a controller having a processor and a memory.
However, Harris teaches another embodiment (Figs. 73-74) comprising an end effector (end effector 152400) with a staple cartridge (152406) that can include a suitable sensor (152408) that can be read and communicated to a microcontroller in a surgical device (150010) to communicate information about the stable cartridge to the operator of the instrument ([0660]). Harris further teaches modular devices are connected to a controller (computer system 210) comprising a processor (processor 244) and memory (memory 249; Fig. 8; [0412]; [0427]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the end effector of Harris to include a suitable sensor as taught by the additional embodiment of Harris for communicating with the end effector to recognize the end effector and associated operating parameters and characteristics therewith and communicating operational data back to a controller in order to inform the operator of the instrument whether the end effector is appropriate for the give application and/or if a function of the instrument is inappropriate.
Harris modified determines the sensed torque throughout a firing stroke and a spike (20806) in the sensed torque above the sensed torque by a predetermined threshold (20808; Fig. 23). Based on the dashed line between peaks 20802 and 20806 in section A of Fig. 23, it appears that a running torque average is calculated, but Harris fails to explicitly disclose determining, by the controller, a running torque average of the sensed torque and determining a spike in the sensed torque above the running torque average by a predetermined threshold.
However, Perdue teaches an end effector assembly that includes a torque sensor operably coupled with at least one motor and a control system configured to determine running averages based on the sensed data ([0007]). The control system i.e., controller (system 100) determines running average values in order to filter out noise to reduce a predetermined threshold (required threshold) to positively identify an impending break. The threshold can be measured and altered in real time based on feedback from the controller and/or preferences of the user or can be a fixed value set beforehand by a user ([0049]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of modified Harris so that the controller determines a running torque average of the sensed torque and determines a spike in the sensed torque above the running torque average by a predetermined threshold in light of the teachings of Perdue in order to filter out noise to ensure that higher order derivatives of the target positions are continuous and to positively identify an impending break.
Regarding claim 3, Harris modified discloses the invention as claimed above, and Harris further discloses a predetermined threshold of the spike (the motor threshold 20808; [0534]; Fig. 23), but fails to explicitly disclose wherein the predetermined threshold of the spike is about 20 Nmm above the running torque average.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the predetermined threshold of the spike of modified Harris to be about 20 Nmm above the running torque average since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Smith et al. would not operate differently with the claimed predetermined threshold of the spike and since the spike is within the predetermined threshold, the device would function as appropriately having the claimed value. Further, it appears that applicant places no criticality on the range claimed, indicating simply that the threshold is “about” the claimed range ([0009]).
Regarding claim 5, modified Harris fails to explicitly disclose disengaging the end effector from the housing of the robotic surgical instrument and repeating the method for finding the initiating the end stop detection algorithm to determine a fully retracted position and a distal throw for a new knife blade of a new end effector.
However, Harris teaches it may be useful to replace at least the staple cartridge (which may be considered the end effector; [0790]), along with how to recalibrate the knife ([0535]), and the knife blade moves through the channel within the staple cartridge (Fig. 25).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of modified Harris to disengage the end effector from the housing of the robotic surgical instrument and repeat the initiating the end stop detection algorithm to determine a fully retracted position and a distal throw for a new knife blade of a new end effector in light of the teachings of Harris in order to have efficient knife blade advancement throughout various staple cartridges.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harris et al. (US 2020/0178971 A1) in view of Perdue et al. (US 2019/0274769 A1), as applied to claim 1 above, and further in view of Hart (US 2021/0298751 A1).
Regarding claim 4, Harris modified fails to disclose utilizing a low pass filter to determine the running torque average.
However, Hart teaches techniques for controlling an end effector (end effector of instrument 130; Fig. 1; abstract) in which the values of the force or torque of actuation of a robotic surgical instrument (computer-assisted system 100; Fig. 1) may be low pass filtered for the purpose of reducing the effects of noise, vibrations, and/or the like ([0055]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of modified Harris to utilize a low pass filter to determine the running torque average in light of the teachings of Hart in order to further reduce the effects of noise, vibrations, and/or the like.
Claim(s) 6-8, 10 and 12-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harris et al. (US 2020/0178971 A1) in view of Perdue et al. (US 2019/0274769 A1) in view of Shelton, IV et al. (US 2019/0059889 A1).
Regarding claim 6, Harris modified fails to disclose wherein the position of the knife blade is determined by a number of rotations of the knife drive coupler.
However, Shelton teaches a surgical stapler (100; Fig. 1), similar to that of Harris, wherein a distance traveled by the firing shaft (150, equivalent to firing bar/E-beam of Harris) is determined by one or more sensors and/or encoders associated with the firing motor (143) that determine an expected distance traveled by the firing shaft based on a number of rotations of the firing motor ([0091]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of modified Harris such that the position of the knife blade is determined by the number of rotations of the knife drive coupler as taught by Shelton. All the claimed elements were known in the prior art and one skilled in the art could have combine the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded the predictable result of determining the position of the knife blade.
Regarding claim 7, Harris modified fails to disclose wherein the position of the knife blade is determined by a number of degrees of rotation of the knife drive coupler.
However, Shelton teaches a surgical stapler (100; Fig. 1), similar to that of Harris, wherein a distance traveled by the firing shaft (150, equivalent to firing bar/E-beam of Harris) is determined by one or more sensors and/or encoders associated with the firing motor (143) that determine an expected distance traveled by the firing shaft based on a number of rotations of the firing motor ([0091]) and one rotation is equal to 180 degrees; therefore, determined in degrees of rotation.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of modified Harris such that the position of the knife blade is determined by a number of degrees of rotation of the knife drive coupler as taught by Shelton. All the claimed elements were known in the prior art and one skilled in the art could have combine the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded the predictable result of determining the position of the knife blade.
Regarding claim 8, Harris discloses a method of determining a distal throw of a knife blade of a robotic surgical instrument (as the control system determines force thresholds based on a length of travel of a firing bar [of a knife blade] compared to a measured torsional force of one or more motors; [0531]), comprising: selectively engaging an end effector (end effector 150300; Fig. 25) onto a housing (housing 150012; Fig. 25) of the robotic surgical instrument (wherein the term “housing” may encompass a housing or similar portion of a robotic system that houses or otherwise operably supports at least one drive system used to actuate an interchangeable shaft assembly; [0051]), the end effector (150300) comprising the knife blade (cutting edge 150182 at the distal end of firing bar 150172/E-beam; Fig. 28) disposed between opposing jaw members (anvil 150306 and elongated channel 150302; Figs. 28, 28); coupling the end effector (150300) to a jaw drive input (at least one drive system; [0551]); initiating a homing algorithm (as the control system senses and detects the position of the E-beam which the knife blade is attached; [0534]-[0535]) to determine a fully retracted position of the knife blade (the most proximal position 20908 of the knife blade can be sensed by the control system associating the position of the E-beam as being in a home position; [0535]; Fig. 23); and determining the distal throw of a knife blade including: actuating a knife drive coupler (firing bar, E-beam and motor driving the firing bar/E-beam) to advance the knife blade distally through a knife channel (channel shown through staple cartridge 150304 of Fig. 25) defined within the end effector (Fig. 25); sensing a torque (torque of the motor controlling travel of the firing bar) exerted on the knife drive coupler during advancement of the knife blade (as the motor torsional force is “sensed” during travel of the E-beam; [0534]); determining a torque of the sensed torque (as the control system senses torsion forces on the motor controlling travel of the firing bar as can be seen as 20808 breaks into 20810 in Fig. 23; [0533]; [0536]); determining a spike (knife travel force peak 20806) in the sensed torque that exceeds a predetermined threshold (the motor threshold 20808); determining a position of the knife blade associated with the spike as a maximum distal throw of the knife blade (detected knife travel force peak 20806; [0535]; Fig. 23); stopping the knife drive coupler (at 11 seconds in section B of Fig 23; [0535]); and storing maximum distal throw (at 20806) of the knife blade in the memory for subsequent usage (via recalibration; [0535]; Fig. 23).
Harris fails to explicitly disclose identifying the end effector and associated operational data therewith, the operational data comprising at least operating parameters and characteristics of the end effector and communicating the operational data back to a controller having a processor and a memory.
However, Harris teaches another embodiment (Figs. 73-74) comprising an end effector (end effector 152400) with a staple cartridge (152406) that can include a suitable sensor (152408) that can be read and communicated to a microcontroller in a surgical device (150010) to communicate information about the stable cartridge to the operator of the instrument ([0660]). Harris further teaches modular devices are connected to a controller (computer system 210) comprising a processor (processor 244) and memory (memory 249; Fig. 8; [0412]; [0427]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the end effector of Harris to include a suitable sensor as taught by the additional embodiment of Harris for communicating with the end effector to recognize the end effector and associated operating parameters and characteristics therewith and communicating operational data back to a controller in order to inform the operator of the instrument whether the end effector is appropriate for the give application and/or if a function of the instrument is inappropriate.
Harris modified determines the sensed torque throughout a firing stroke and a spike (20806) in the sensed torque above the sensed torque by a predetermined threshold (20808; Fig. 23). Based on the dashed line between peaks 20802 and 20806 in section A of Fig. 23, it appears that a running torque average is calculated, but Harris fails to explicitly disclose determining, by the controller, a running torque average of the sensed torque and determining a spike in the sensed torque that exceeds the running torque average by a predetermined threshold.
However, Perdue teaches an end effector assembly that includes a torque sensor operably coupled with at least one motor and a control system configured to determine running averages based on the sensed data ([0007]). The control system i.e., controller (system 100) determines running average values in order to filter out noise to reduce a predetermined threshold (required threshold) to positively identify an impending break. The threshold can be measured and altered in real time based on feedback from the controller and/or preferences of the user or can be a fixed value set beforehand by a user ([0049]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of modified Harris so that the controller determines a running torque average of the sensed torque and determines a spike in the sensed torque above the running torque average by a predetermined threshold in light of the teachings of Perdue in order to filter out noise to ensure that higher order derivatives of the target positions are continuous and to positively identify an impending break.
Modified Harris fails to disclose wherein the step of determining a spike above a running torque average within a predetermined threshold is done after a predetermined number of rotations of the knife drive coupler.
However, Shelton teaches a surgical stapler (100; Fig. 1), similar to that of Harris, wherein a distance traveled by the firing shaft (150, equivalent to firing bar/E-beam of Harris) is determined by one or more sensors and/or encoders associated with the firing motor (143, equivalent to the motor of the knife drive coupler of Harris) that determine an expected distance traveled by the firing shaft based on a number of rotations of the firing motor ([0091]). Thus, by using the number of rotations of the firing motor, an equivalent maximum stroke detection method can be realized for a surgical stapler with a rotational knife drive.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of modified Harris such that the predetermined threshold is calculated via a predetermined number of rotations of the knife drive coupler (motor) in light of the teachings of Shelton. All the claimed elements were known in the prior art and one skilled in the art could have combine the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded the predictable result of determining the position of the knife blade.
Regarding claim 10, Harris modified discloses the invention as claimed above, and Harris further discloses a predetermined threshold of the spike (the motor threshold 20808; [0534]; Fig. 23), but fails to explicitly disclose wherein the predetermined threshold of the spike is about 20 Nmm above the running torque average.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the predetermined threshold of the spike of modified Harris to be about 20 Nmm above the running torque average since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Smith et al. would not operate differently with the claimed predetermined threshold of the spike and since the spike is within the predetermined threshold, the device would function as appropriately having the claimed value. Further, it appears that applicant places no criticality on the range claimed, indicating simply that the threshold is “about” the claimed range ([0009]).
Regarding claim 12, modified Harris fails to explicitly disclose disengaging the end effector from the housing of the robotic surgical instrument and repeating the determining a distal throw for a new knife blade of a new end effector.
However, Harris teaches it may be useful to replace at least the staple cartridge (which may be considered the end effector; [0790]), along with how to recalibrate the knife ([0535]), and the knife blade moves through the channel within the staple cartridge (Fig. 25).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of modified Harris to disengage the end effector from the housing of the robotic surgical instrument and repeat the determining a distal throw for a new knife blade of a new end effector in light of the teachings of Harris in order to have efficient knife blade advancement throughout various staple cartridges.
Regarding claim 13, Harris modified fails to disclose wherein the position of the knife blade is determined by a number of rotations of the knife drive coupler.
However, Shelton teaches a surgical stapler (100; Fig. 1), similar to that of Harris, wherein a distance traveled by the firing shaft (150, equivalent to firing bar/E-beam of Harris) is determined by one or more sensors and/or encoders associated with the firing motor (143) that determine an expected distance traveled by the firing shaft based on a number of rotations of the firing motor ([0091]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of modified Harris such that the position of the knife blade is determined by a number of rotations of the knife drive coupler as taught by Shelton. All the claimed elements were known in the prior art and one skilled in the art could have combine the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded the predictable result of determining the position of the knife blade.
Regarding claim 14, Harris modified fails to disclose wherein the position of the knife blade is determined by a number of degrees of rotation of the knife drive coupler.
However, Shelton teaches a surgical stapler (100; Fig. 1), similar to that of Harris, wherein a distance traveled by the firing shaft (150, equivalent to firing bar/E-beam of Harris) is determined by one or more sensors and/or encoders associated with the firing motor (143) that determine an expected distance traveled by the firing shaft based on a number of rotations of the firing motor ([0091]) and one rotation is equal to 180 degrees; therefore, determined in degrees of rotation.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of modified Harris such that the position of the knife blade is determined by a number of degrees of rotation of the knife drive coupler as taught by Shelton. All the claimed elements were known in the prior art and one skilled in the art could have combine the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded the predictable result of determining the position of the knife blade.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harris et al. (US 2020/0178971 A1) in view of Perdue et al. (US 2019/0274769 A1) in view of Shelton, IV et al. (US 2019/0059889 A1), as applied to claim 8 above, and further in view of Hart (US 2021/0298751 A1).
Regarding claim 11, Harris modified fails to disclose utilizing a low pass filter to determine the running torque average.
However, Hart teaches techniques for controlling an end effector (end effector of instrument 130; Fig. 1; abstract) in which the values of the force or torque of actuation of a robotic surgical instrument (computer-assisted system 100; Fig. 1) may be low pass filtered for the purpose of reducing the effects of noise, vibrations, and/or the like ([0055]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of modified Harris to utilize a low pass filter to determine the running torque average in light of the teachings of Hart in order to further reduce the effects of noise, vibrations, and/or the like.
3. Claim(s) 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harris et al. (US 2020/0178971 A1) in view of Perdue et al. (US 2019/0274769 A1) in view of Kopp (US 2018/0263717 A1).
Regarding claim 15, Harris discloses a method of determining a distal throw of a knife blade of a robotic surgical instrument (as the control system determines force thresholds based on a length of travel of a firing bar [of a knife blade] compared to a measured torsional force of one or more motors; [0531]), comprising: selectively engaging an end effector (end effector 150300; Fig. 25) onto a housing (housing 150012; Fig. 25) of the robotic surgical instrument (wherein the term “housing” may encompass a housing or similar portion of a robotic system that houses or otherwise operably supports at least one drive system used to actuate an interchangeable shaft assembly; [0051]), the end effector (150300) comprising the knife blade (cutting edge 150182 at the distal end of firing bar 150172/E-beam; Fig. 28) disposed between opposing jaw members (anvil 150306 and elongated channel 150302; Figs. 28, 28); coupling the end effector (150300) to a knife drive coupler (firing bar, E-beam and motor driving the firing bar/E-beam); sensing a torque (torque of the motor controlling travel of the firing bar) on the knife drive coupler while advancing the knife blade from a retracted position to an extended position (as the motor torsional force is “sensed” during travel of the E-beam; [0534]); determining, by a controller (for example 210 of control system) having a processor (244) and a memory (249), a torque of the sensed torque (as the control system senses torsion forces on the motor controlling travel of the firing bar as can be seen as 20808 breaks into 20810 in Fig. 23; [0533]; [0536]); wherein the sensed torque (knife travel force peak 20806) exceeds a predetermined threshold (the motor threshold 20808); determining the distal throw of the knife blade by using a measuring device to determine a travel (length of travel of the knife blade) of the knife blade from the retracted position (as the control system is configured to monitor the sensed motor torsional force during at least the last part of distal travel of the E-beam to detect the knife travel force peak 20806 exceeding the knife travel threshold 20810; [0534]-[0535]; Fig. 23); determining at least one of basis information or adjusting information (detected knife travel force peak 20806; [0535]; Fig. 23) for the end effector based on a maximum distal throw; and storing the at least one basis information or the adjusting information (detected knife travel force peak 20806; [0535]; Fig. 23) in the memory (data storage or memory of the control system; [0535]).
Harris determines the sensed torque throughout a firing stroke and a spike (20806) in the sensed torque above the sensed torque by a predetermined threshold (20808; Fig. 23). Based on the dashed line between peaks 20802 and 20806 in section A of Fig. 23, it appears that a running torque average is calculated, but Harris fails to explicitly disclose determining, by the controller, a running torque average of the sensed torque and determining when the sensed torque exceeds the running torque average by a predetermined threshold.
However, Perdue teaches an end effector assembly that includes a torque sensor operably coupled with at least one motor and a control system configured to determine running averages based on the sensed data ([0007]). The control system i.e., controller (system 100) determines running average values in order to filter out noise to reduce a predetermined threshold (required threshold) to positively identify an impending break. The threshold can be measured and altered in real time based on feedback from the controller and/or preferences of the user or can be a fixed value set beforehand by a user ([0049]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of modified Harris so that the controller determines a running torque average of the sensed torque and determines a spike in the sensed torque above the running torque average by a predetermined threshold in light of the teachings of Perdue in order to filter out noise to ensure that higher order derivatives of the target positions are continuous and to positively identify an impending break.
Harris fails to explicitly disclose the method is performed during manufacturing.
However, Kopp teaches calibrating a knife blade (218) i.e. determining the distal throw of the knife blade by calibration of a knife bar (132; [0056]), which is equivalent to the firing bar/E-beam of Harris, of a surgical instrument (10; Figs. 1, 3) prior to usage ([0056]), which is equivalent to calibration during manufacturing.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of modified Harris to be performed during manufacturing in light of the teachings of Kopp in order to ensure that the knife blade is calibrated and ready for use at the start of an operation.
Regarding claim 16, modified Harris fails to explicitly disclose disengaging the end effector from the housing of the robotic surgical instrument and repeating the determining a distal throw for a knife blade of a new end effector.
However, Harris teaches it may be useful to replace at least the staple cartridge (which may be considered the end effector; [0790]), along with how to recalibrate the knife ([0535]), and the knife blade moves through the channel within the staple cartridge (Fig. 25).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of modified Harris to disengage the end effector from the housing of the robotic surgical instrument and repeat the determining a distal throw for a knife blade of a new end effector in light of the teachings of Harris in order to have efficient knife blade advancement throughout various staple cartridges.
3. Claim(s) 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harris et al. (US 2020/0178971 A1) in view of Perdue et al. (US 2019/0274769 A1) in view of Kopp (US 2018/0263717 A1), as applied to claim 15, and further in view of Shelton, IV et al. (US 2019/0059889 A1).
Regarding claim 17, Harris modified fails to disclose wherein the travel of the knife blade is determined by a number of rotations of the knife drive coupler.
However, Shelton teaches a surgical stapler (100; Fig. 1), similar to that of Harris, wherein a distance traveled by the firing shaft (150, equivalent to firing bar/E-beam of Harris) is determined by one or more sensors and/or encoders associated with the firing motor (143) that determine an expected distance traveled by the firing shaft based on a number of rotations of the firing motor ([0091]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of modified Harris such that the travel of the knife blade is determined by a number of rotations of the knife drive coupler as taught by Shelton. All the claimed elements were known in the prior art and one skilled in the art could have combine the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded the predictable result of determining the position of the knife blade.
Regarding claim 18, Harris modified fails to disclose wherein the travel of the knife blade is determined by a number of degrees of rotation of the knife drive coupler.
However, Shelton teaches a surgical stapler (100; Fig. 1), similar to that of Harris, wherein a distance traveled by the firing shaft (150, equivalent to firing bar/E-beam of Harris) is determined by one or more sensors and/or encoders associated with the firing motor (143) that determine an expected distance traveled by the firing shaft based on a number of rotations of the firing motor ([0091]) and one rotation is equal to 180 degrees; therefore, determined in degrees of rotation.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of modified Harris such that the travel of the knife blade is determined by a number of degrees of rotation of the knife drive coupler as taught by Shelton. All the claimed elements were known in the prior art and one skilled in the art could have combine the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded the predictable result of determining the position of the knife blade.
Conclusion
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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/SARAH A LONG/Primary Examiner, Art Unit 3771
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