DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Formal Matters
Applicant’s Response and Amendments files 2 July 2026 are acknowledged. Claim 1, the only independent claim, is amended. Claims 1-23 are pending and under examination.
Objections/Rejections Withdrawn
The rejection of claims 1-3, 10, 11, and 18-23 under 35 U.S.C. 103 as being unpatentable over Carlson et al., US 20190175211 (13 June 2019) in view of Rivers et al., US 20150051626 (19 February 2015), as evidenced by Shturman, US 20090318942 (24 December 2009), is withdrawn in light of Applicants arguments and amendments. However, modified rejections, necessitated by amendment, are set forth below.
The rejection of claims 4-7 and 12-17 under 35 U.S.C. 103 as being unpatentable over Carlson et al., US 20190175211 (13 June 2019) in view of Rivers et al., US 20150051626 (19 February 2015), as evidenced by Shturman, US 20090318942 (24 December 2009), and further in view of Benamou et al., US 20170303990 (26 October 2017), is withdrawn in light of Applicants arguments and amendments. However, modified rejections, necessitated by amendment, are set forth below.
The rejection of claims 8 and 9 under 35 U.S.C. 103 as being unpatentable over Carlson et al., US 20190175211 (13 June 2019) in view of Rivers et al., US 20150051626 (19 February 2015), as evidenced by Shturman, US 20090318942 (24 December 2009), and further in view of Culp et al., US 6,329,778 (11 December 2001), is withdrawn in light of Applicants arguments and amendments. However, modified rejections, necessitated by amendment, are set forth below.
Response to Arguments
Applicant argues that the combination of braking and non-braking conditions are discussed within ¶¶46-47 of the Specification (Remarks, p. 6 of 8). Applicant argues that the braking conditions are a control aspect in which the controller intentionally causes the electric motor to oppose the existing rotation of the drive system with the objection to also dissipate kinetic and, more importantly, stored torsional energy in the flexible drive shaft after a stall or obstruction (Remarks, p. 6 of 8). Applicant argues that a non-braking condition is a period during which the controller is not intentionally producing braking torque, but that does not necessarily mean the motor is actively driving (Remarks, p. 6 of 8). Applicant argues that an important distinction is that the controller is not commanding torque that opposes rotation (Remarks, p. 6 of 8). Applicant argues that the invention uses alternating braking and non-braking intervals to release stored torsional energy gradually rather than instantaneously (Remarks, p. 7 of 8). Applicant argues that the cited prior art of Carlson, Rivers, and Shturman lack any similar disclosure and that Benamou and Culp do not overcome the deficiencies of the primary references (Remarks, p. 7 of 8).
Applicant’s arguments have been fully considered and are persuasive. However, Applicant’s amendments to the claims require further search and consideration and in light of the search of the claim amendments, additional relevant prior art has been identified. Accordingly, modified claim rejections are presented below.
Modified Claim Rejections – Necessitated by Amendment
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 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 1-3, 10, 11, and 18-23 are rejected under 35 U.S.C. 103 as being unpatentable over Carlson et al., US 20190175211 (13 June 2019) in view of Rivers et al., US 20150051626 (19 February 2015), as evidenced by Shturman, US 20090318942 (24 December 2009), and further in view of Hansen et al., US 20220304719 (29 September 2022).
Regarding independent claim 1, Carlson teaches a rotational atherectomy system (10, ¶44), comprising:
an elongated flexible drive shaft (18, ¶44);
an atherectomy tool (rotational device 20) disposed at or near a distal end of the drive shaft (¶44);
an electric motor (FIG 2, motor 37) rotationally connected with a proximal end of the drive shaft (FIGs 1, 2, ¶45),
wherein the electric motor is configured to apply torque to, and rotate, the drive shaft and the atherectomy tool in a first rotational direction;
a controller (FIGs 2, 3; 14/52; ¶58) operatively connected with the electric motor (37), the controller (14) comprising a memory (40), a processor (38) comprising preprogrammed executable instructions (reference schedule 48; ¶¶60-62) and in operative connection with the memory (FIG 2);
at least one sensor (FIG 3, sensors 44/46,) operatively coupled with the motor (37) (¶63),
each one of the at least one sensor (44/46) providing a sensed signal corresponding with an operational parameter of the electric motor (input current, ¶64), the sensor (44/46) in operative communication (via motor state estimator 50) with the controller (FIG 3, ¶63),
wherein the controller (52) is configured to use each one of the sensed signals to detect when a stall condition has occurred (¶66),
wherein when a stall condition is detected (FIG 4, ¶68), the controller is configured to stop the electric motor (37) from applying torque to the drive shaft in the first rotational direction (¶65) and to cause the electric motor to execute a dynamic braking (FIG 4, line 60, ¶69, “represented by line 60 brakes the motor (e.g., the motor 37) and effectively throws away a portion of the system's kinetic energy”), comprising one or more braking conditions (¶66, jam or stall) and one or more non-braking conditions, the non-braking conditions comprising applying torque to the drive shaft in a second rotational direction opposite that of the first rotational direction (¶80, “the control signal may reverse the motor torque to decelerate the motor until the motor speed is at or about zero (0)”).
Carlson does not teach that the elongated flexible drive shaft (18, ¶44) comprises coiled wires. Additionally, Carlson does not expressly teach wherein plural braking conditions are intervening with plural non-braking conditions, but suggests it at ¶¶80-81.
Rivers teaches drive shaft 20 is constructed from helically coiled wire (FIG 1, ¶36).
Shturman provides evidence that rotational devices comprising coiled wires are beneficial because “the inner and the outer torque transmitting coils being wound in opposite directions so that, when the drive shaft is rotated, the outer torque transmitting coil prevents unwinding of the inner torque transmitting coil” (¶40).
Hansen teaches that motor rotation is halted (FIG 12) by active or dynamic braking and that dynamic braking occurs by crowbarring the motor to rapidly dissipate the kinetic energy of the motor as heat and electrical energy through a resistive load (¶31). Hansen also expressly discloses that the controller deactivates the motor by dynamic braking and thereby rapidly arrests rotation of the motor to dissipate kinetic energy of the motor as heat and electrical energy through a resistive load (claim 14). Hansen teaches controlling the torque of the drive assembly 48 by reducing the motor voltage, but stored kinetic energy must be dissipated through braking the motor 43 actively (¶38) or dynamically (¶43). Hansen also discloses that controller 50 may measure a change in speed over a period of time and deactivate the motor if the amount of the change exceeds a predetermined threshold (¶43). Speed measurements may be taken at intervals of 25 microseconds and the thresholds may be fixed or proportional (¶43). Stall alerts are taught at ¶44.
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Carlson, Rivers, and Hansen as evidenced by Shturman, given that the prior art included each element claimed, although not necessarily in a single reference. Carlson, Rivers, Hansen, and Shturman teach in the same field of endeavor, surgical atherectomy devices comprising elongated flexible drive shafts with braking solutions.
Although, Carlson discloses the claimed atherectomy device comprising a motor and a control system with active braking, Carlson does not expressly teach that the flexible elongate drive shaft comprises coiled wires. Rivers specifically addresses this in teaching drive shafts 20 of atherectomy devices constructed from helically coiled wire (FIG 1, ¶36) that are capable of braking (¶79). Shturman provides evidence that rotational devices comprising coiled wires are beneficial because “the inner and the outer torque transmitting coils being wound in opposite directions so that, when the drive shaft is rotated, the outer torque transmitting coil prevents unwinding of the inner torque transmitting coil” (¶40). FIGs 10 and 11 of Rivers shows that there unwinding of the drive shaft occurs as the motor is slowing and that the unwinding is a function of time. Shturman provides evidence that the coiled wires are typically wound in opposite directions so that the outer torque transmitting coil prevents unwinding of the inner torque transmitting coil, thus reducing the time of torque kinetic energy off-loading during active (dynamic) braking.
Because Carlson includes an atherectomy device comprising a drive shaft constructed from helically coiled wire that is also capable of braking, a person of ordinary skill in the art, seeking to utilize common structural components known in the art would reasonably consult River’s helical coiled wire construction solution, especially given the kinetic off-loading benefits, as evidenced by Shturman. River’s helically coiled wire shaft can be incorporated alongside Carlson’s controller and braking system solution using known assembly methods without redesigning Carlson’s controlled braking solution delivery pathway. Carlson shows the unique features of the braking design system using three different atherectomy devices in FIG 4 and determines that the resulting differences are based on difference in the controlled torque components rather than other differences of the different atherectomy systems (¶¶67-69).
Additionally, Hansen teaches that motor rotation is halted (FIG 12) “by active or dynamic braking” and that “dynamic braking occurs by crowbarring the motor to rapidly dissipate the kinetic energy of the motor as heat and electrical energy through a resistive load” (¶31). Hansen also expressly discloses that the controller deactivates the motor by dynamic braking and thereby rapidly arrests rotation of the motor to dissipate kinetic energy of the motor as heat and electrical energy through a resistive load (claim 14). Hansen teaches controlling the torque of the drive assembly 48 by reducing the motor voltage, but stored kinetic energy must be dissipated through braking the motor 43 actively (¶38) or dynamically (¶43). Hansen also discloses that controller 50 may measure a change in speed over a period of time and deactivate the motor if the amount of the change exceeds a predetermined threshold (¶43). Speed measurements may be taken at intervals of 25 microseconds and the thresholds may be fixed or proportional (¶43). Stall alerts are taught at ¶44. The dynamical braking and multiple measurements of Hansen, which occur on an ongoing basis while the system is operational (¶43), show that plural braking conditions are intervening with plural non-braking conditions over the course of any given procedure (¶¶5, 46) as determined by the controller.
These multiple measurement-based actions (active and dynamic) of and by the controller are also supported in Carlson’s disclosure that “a control signal may be generated by a controller based on the reference voltage and the real time or instantaneous RMS voltage and the controller may issue a control signal to the motor based on the differences between the reference voltage and the real time or instantaneous RMS voltage to maintain operation and/or make slight modifications (e.g., damping, corrective, and/or other modifications) such that the controller will output a control signal based on the difference between the reference voltage and the real time or instantaneous RMS voltage to brake the motor and mitigate forces applied to a patient as a speed of a motor is reduced” (¶82). Both Carlson and Hansen recognize the problem of changing conditions throughout the operational cycle and both have found controller-based feedback solutions for error correction in real or near-real time (Carlson at ¶82, “reference schedule 75 of FIG. 8 may be followed and the following steps may be repeated over time until a jam or stall condition is identified”). Both Carlson (FIG 5) and Hansen (claim 3) utilize sensors and multiple measurements in rapid succession over time, with Hansen using a logistic curve as input for the calibration process to produce lookup tables that are stored in memory (¶46). Carlson expressly discloses using the control signal to identify 106 a reference motor state and then output 108 a control signal based on the reference motor state or reference motor input (FIG 5, ¶72). Carlson teaches addressing the jam or stall condition at ¶77. Carlson teaches that the atherectomy system 10 may include a plurality of speed settings (e.g., a first setting having a first maximum speed and a second setting having a second maximum speed) and each setting may have a different threshold value associated with two or more of the settings (¶78). Carlson also expressly teaches using the threshold value to detect the jam or stall condition before the jam or the stall actually occur (¶78). Hansen expressly teaches both active braking and dynamic “crowbarring” conditions in order to rapidly dissipate the kinetic energy of the motor as heat and electrical energy through resistive load (¶31).
Because Carlson teaches the base atherectomy device comprising a controller, sensors, and reference schedules (e.g. look up tables) for operational motor measurements during a procedure to predict and address a jam or stall condition and Hansen teaches both active and dynamic braking to remedy a jam or stall condition and not only stop a motor but also to rapidly dissipate the kinetic energy through resistive load using lookup tables (reference schedules) and algorithms, a person of ordinary skill in the art, seeking to utilize common structural hardware and software components known in the art would reasonably consult Carlson and Hansen’s sensor-driven controller feedback system for plural braking and non-braking conditions, as needed by the system in real time as signals are received that are indicative of parameter values of a motor (Carlson, FIG 5, 102) where the system acts upon those signals (Carlson, FIG 5, 104), especially given the kinetic off-loading benefits of dynamic braking, as taught by Hansen and as evidenced by Shturman. Hansen’s dual active and dynamic braking solution can be incorporated alongside Carlson’s controller feedback system and braking system solution using known assembly methods without redesigning Carlson’s controlled braking solution or its delivery pathway. Carlson shows the unique features of the braking design system using three different atherectomy devices in FIG 4 and determines that the resulting differences are based on differences in the controlled torque components rather than other differences of the different atherectomy systems (¶¶67-69).
Because the references address the same engineering problem (atherectomy systems comprising elongated flexible drive shafts in need for sensor-based controlled feedback resolution of adverse conditions with plural braking solutions) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (utilizing an elongated flexible drive shaft comprising coiled wires and utilizing a controller feedback system comprising sensors and a reference schedule to predict and mitigate jams and stalls utilizing plural braking conditions), 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 and suggestions based on the references.
Regarding claim 2, Carlson modified by Rivers, Shturman, and Hansen teaches the rotational atherectomy system of claim 1, as set forth above, for the reasons set forth above.
Carlson teaches wherein the at least one sensor is selected from one or more of the group consisting of: current sensor (¶63), voltage sensor, applied torque sensor, and rotational speed sensor.
Additionally, Carlson also teaches that “although sensors 44, 46 are disclosed as sensing current and motor position, these sensors may be configured to sense additional or alternative other parameters and/or other sensors may be included in the atherectomy system 10 that sense similar or different motor parameters” (¶63). Carlson teaches examples of sensed parameters including drive voltage (¶63), speed of the motor (¶64), and torque of the motor (¶64).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the embodiments and suggestions Carlson that other types of sensors could be added or included in the atherectomy system including sensors that function with the expressly disclosed motor parameters that are expressly taught as being available to be provided to the motor state estimator 50 (¶¶63-66). Because Carlson expressly suggests including these other sensors (¶¶63, 66), a person of ordinary skill in the art, seeking to gain more information about the system that can be regulated through the motor state estimator 50, using common mechanical feedback control variables known in the art and expressly suggested by Carlson, would reasonably consult Carlson’s suggested and exemplified motor parameters to add additional corresponding sensors. The additional sensors can be incorporated alongside Carlson’s controller and motor state estimator, as expressly suggested by Carlson without redesigning Carlson’s controller system and motor state estimator. Because Carlson expressly suggests the addition of other sensors and expressly names the parameters that can be measured and included in the other sensor data provided to the motor state estimator, and the proposed modifications are mechanically compatible and implemented by routine engineering practices (providing sensors for the known and suggested motor state parameters suggested by Carlson), 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 3, Carlson modified by Rivers, Shturman, and Hansen teaches the rotational atherectomy system of claim 2, as set forth above, for the reasons set forth above.
Carlson teaches wherein the sensed signal corresponding with an operational parameter of the electric motor is selected from one or more of the group consisting of: current, rate of change of current (¶63), voltage (¶63), rate of change of voltage (¶79), applied torque (¶64), rate of change of applied torque (¶80), rotational speed (¶63), and rate of change of rotational speed (¶¶81, 82).
Regarding claim 10, Carlson modified by Rivers, Shturman, and Hansen teaches the rotational atherectomy system of claim 3, as set forth above, for the reasons set forth above.
Carlson teaches wherein following execution of at least one braking condition (¶66, jam or stall) and non-braking condition (¶65), the controller is configured to instruct the electric motor to remove all torque applied to the drive shaft (¶72) and to allow the drive shaft to freely rotate (¶68).
Regarding claim 11, Carlson modified by Rivers, Shturman, and Hansen teaches the rotational atherectomy system of claim 10, as set forth above, for the reasons set forth above.
Carlson teaches that at least one sensor monitors whether the drive shaft rotates in the second rotational direction such that the parameter values of a motor may be sensed by one or more sensors and signals indicative of the sensed parameter values may be sent from the sensors to a controller (¶71). Carlson teaches real time or instantaneous back EMF may be calculated and repeated over time until a jam or stall condition is identified (¶82). Carlson teaches that a control signal to decelerate the motor to stop the motor after a jam or stall condition has been detected may result in reversing a direction of torque on the motor or direction of current in response to the jam or stall condition (¶72).
Rivers teaches the electric motor being capable of rotating the drive shaft in a first direction and in a second direction opposite the first direction and control electronics for monitoring and controlling the rotation of the electric motor (¶19). Rivers teaches that when the drive shaft unwinds and converts all of its rotational potential energy into rotational kinetic energy and spinning the free-spinning motor in the opposite direction (FIG 11, “drive shaft unwinding”), the curve will settle to a steady-state at zero, where the drive shaft is essentially unwound and stationary and the motor is essentially stationary and there is no torque applied to the end of the distal end of the drive shaft (¶¶115-116).
These are functions that are capable of being met by the prior art structure taught by Carlson modified by Rivers and Hansen, as evidenced by Shturman, as set forth above. However, the manner of operating the system wherein the at least one sensor monitors whether the drive shaft rotates in the second rotational direction and wherein the controller is configured to determine if the drive shaft is fully unwound or not fully unwound does not differentiate the apparatus claim from the prior art. MPEP 2114.
Regarding claim 18, Carlson modified by Rivers, Shturman, and Hansen teaches the rotational atherectomy system of claim 3, as set forth above, for the reasons set forth above.
Carlson teaches further comprising predetermined threshold limits (reference schedule 48, ¶60) for one or more of the group consisting of: motor current (¶60), rate of change of motor current (¶79), motor voltage (¶60), rate of change of motor voltage (¶79), applied torque by the motor to the drive shaft rate of change of applied torque by the motor to the drive shaft (¶80), motor rotational speed (¶60), and rate of change of motor rotational speed (¶¶81, 82), wherein a stall condition is detected if one or more of the predetermined threshold limits is exceeded (¶80).
Regarding claim 19, Carlson modified by Rivers, Shturman, and Hansen teaches the rotational atherectomy system of claim 3, as set forth above, for the reasons set forth above.
Carlson further comprising a predetermined threshold limit for motor current (¶¶60, 63, 81), wherein a stall condition is detected if the predetermined threshold limit for motor current is exceeded (¶81).
Regarding claim 20, Carlson modified by Rivers, Shturman, and Hansen teaches the rotational atherectomy system of claim 3, as set forth above, for the reasons set forth above.
Carlson further comprising a predetermined threshold limit for motor current rate of change (¶79), wherein a stall condition is detected if the predetermined threshold limit for motor current rate of change is exceeded (¶81).
Regarding claim 21, Carlson modified by Rivers, Shturman, and Hansen teaches the rotational atherectomy system of claim 3, as set forth above, for the reasons set forth above.
Carlson teaches further comprising a predetermined threshold limit for motor current (¶¶60, 63, 81), and a predetermined threshold limit for motor current rate of change (¶79), wherein a stall condition is detected if the predetermined threshold limit for motor current and the predetermined threshold limit for motor current rate of change are both exceeded (¶81).
Regarding claim 22, Carlson modified by Rivers, Shturman, and Hansen teaches the rotational atherectomy system of claim 3, as set forth above, for the reasons set forth above.
Carlson teaches further comprising a predetermined threshold limit for motor current (¶60) and a predetermined threshold limit for motor rotational speed (¶60), wherein a stall condition is detected if the predetermined threshold limit for motor current and the predetermined threshold limit for motor rotational speed are both exceeded (¶66, 81).
Regarding claim 23, Carlson modified by Rivers, Shturman, and Hansen teaches the rotational atherectomy system of claim 3, as set forth above, for the reasons set forth above.
Carlson teaches further comprising a predetermined threshold limit for motor current rate of change (¶79), and a predetermined threshold limit for motor rotational speed (¶60), wherein a stall condition is detected if the predetermined threshold limit for motor current rate of change and the predetermined threshold limit for motor rotational speed are both exceeded (¶66, 81).
Claims 4-7 and 12-17 are rejected under 35 U.S.C. 103 as being unpatentable over Carlson et al., US 20190175211 (13 June 2019) in view of Rivers et al., US 20150051626 (19 February 2015), as evidenced by Shturman, US 20090318942 (24 December 2009), and Hansen et al., US 20220304719 (29 September 2022), and further in view of Benamou et al., US 20170303990 (26 October 2017).
Regarding claim 4, Carlson modified by Rivers and Hansen, as evidenced by Shturman, teaches the rotational atherectomy system of claim 1, as set forth above, for the reasons set forth above.
Carlson modified by Rivers does not expressly teach wherein a first braking condition comprises a time period that is less than the time period of any subsequent braking condition.
However, Carlson teaches timing of a first braking condition (¶69) in three different atherectomy systems (FIG 4).
Hansen teaches that motor rotation is halted (FIG 12) by active or dynamic braking and that dynamic braking occurs by crowbarring the motor to rapidly dissipate the kinetic energy of the motor as heat and electrical energy through a resistive load (¶31). Hansen also expressly discloses that the controller deactivates the motor by dynamic braking and thereby rapidly arrests rotation of the motor to dissipate kinetic energy of the motor as heat and electrical energy through a resistive load (claim 14).
Benamou teaches improving control of motor-drive and other powered components of surgical devices (¶7) with rotational parameters that may comprise rotational speed of the drive coupling based on the rotational positioning over a time interval (¶10). Benamou teaches mechanisms including dynamic braking and algorithms to stop rotations of cutting members (¶51). Benamou expressly teaches that the amount of braking torque that can be applied can be dynamically changed as the load decelerates (¶55) and that this is a property of the function of kinetic energy in the spinning mass: as it declines, so does braking capacity (¶55). Accordingly, the braking capacity of the of the first braking condition will always be greater than any subsequent breaking condition as a fundamental property of physics. FIG 8 of Benamou shows wherein a first braking condition comprises a time period that is less than the time period of any subsequent braking condition.
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Carlson, Rivers, Hansen, and Benamou, as evidenced by Shturman, given that the prior art included each element claimed, although not necessarily in a single reference. Carlson, Rivers, Shturman, Hansen, and Benamou teach in the same field of endeavor, rotational surgical devices comprising elongated flexible drive shafts with braking solutions.
Although, Carlson modified by Rivers and Hansen, as evidenced by Shturman, discloses the claimed atherectomy device comprising a motor, coiled drive shaft, and a control system with active braking and Carlson teaches timing of a first braking condition (¶69) in three different atherectomy systems (FIG 4), Carlson modified by Rivers and Hansen does not expressly teach wherein a first braking condition comprises a time period that is less than the time period of any subsequent braking condition.
Benamou expressly teaches the braking capacity of the of the first braking condition will always be greater than any subsequent breaking condition as a fundamental property of physics (¶55, FIG 8). Because Carlson modified by Rivers includes an atherectomy device comprising a drive shaft constructed from helically coiled wire that is also capable of braking, a person of ordinary skill in the art, seeking to utilize common structural components known in the art would reasonably consult River’s helical coiled wire construction solution. Shturman evidences that rotational devices comprising coiled wires are beneficial because “the inner and the outer torque transmitting coils being wound in opposite directions so that, when the drive shaft is rotated, the outer torque transmitting coil prevents unwinding of the inner torque transmitting coil” (¶40), thus making it faster to off-load torque in an active/dynamic braking system. Because Hansen expressly discloses dynamic braking and Benamou teaches that the physics of the braking capacity of the of the first braking condition will always be greater than any subsequent breaking condition, a person of ordinary skill in the art, seeking to improve the speed, accuracy, and conditions of braking would reasonably consult Hansen’s and Benamou’s stopping methods, mechanism and algorithms, especially given the kinetic off-loading benefits, evidenced by Shturman and disclosed by Hansen. Because the references address the same engineering problem (rotational surgical systems comprising elongated flexible drive shafts in need of controlled resolution of adverse conditions with braking solutions) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (utilizing an elongated flexible drive shaft comprising coiled wires and the known properties of physics such that as kinetic energy in a spinning mass declines, so does its braking capacity), 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 5, Carlson modified by Rivers, Hansen, and Benamou, as evidenced by Shturman, teaches the rotational atherectomy system of claim 4, as set forth above, for the reasons set forth above.
Benamou teaches wherein the time period of the braking conditions increases successively (¶55).
Regarding claim 6, Carlson modified by Rivers, Hansen, and Benamou, as evidenced by Shturman, teaches the rotational atherectomy system of claim 1, as set forth above, for the reasons set forth above.
Benamou teaches wherein a first non-braking condition comprises a time period that is longer than the time period of subsequent non-braking conditions (¶58, FIG 8).
The examiner interprets a “non-braking condition” as disclosed in the Specification at ¶47 as a “motor reversing condition period”.
Additionally, Benamou expressly teaches improving control of motor-drive and other powered components of surgical devices (¶7) with rotational parameters that may comprise rotational speed of the drive coupling based on the rotational positioning over a time interval (¶10). Benamou teaches mechanisms including dynamic braking and algorithms to stop rotations of cutting members (¶51).
Regarding claim 7, Carlson modified by Rivers, Hansen, and Benamou, as evidenced by Shturman, teaches the rotational atherectomy system of claim 6, as set forth above, for the reasons set forth above.
Carlson modified by Rivers, Hansen, and Benamou, as evidenced by Shturman does not expressly teach wherein the time period of each non-braking condition increases successively. This is also a function that is capable of being met by the prior art structure taught by Carlson modified by Rivers, Hansen, and Benamou, as evidenced by Shturman, as set forth above, particularly in light of the reference schedules of Carlson and Hansen’s and Benamou’s control algorithms (Benamou, ¶58).
Regarding claim 12, Carlson modified by Rivers, Hansen, and Benamou, as evidenced by Shturman, teaches the rotational atherectomy system of claim 11, as set forth above, for the reasons set forth above.
Carlson modified by Rivers does not expressly teach wherein if the drive shaft is determined to not be fully unwound, the controller is configured to instruct the electric motor to execute it least one dynamic braking cycle comprising a braking condition followed by a non-braking condition.
However, Carlson teaches timing of a first braking condition (¶69) in three different atherectomy systems (FIG 4). Carlson teaches that the control signal may reverse the motor torque to decelerate the motor until the motor speed is at or about zero (FIG 6, ¶80-83).
Rivers teaches the electric motor being capable of rotating the drive shaft in a first direction and in a second direction opposite the first direction and control electronics for monitoring and controlling the rotation of the electric motor (¶19). Rivers teaches that when the drive shaft unwinds and converts all of its rotational potential energy into rotational kinetic energy and spinning the free-spinning motor in the opposite direction (FIG 11, “drive shaft unwinding”), the curve will settle to a steady-state at zero, where the drive shaft is essentially unwound and stationary and the motor is essentially stationary and there is no torque applied to the end of the distal end of the drive shaft (¶¶115-116).
Benamou teaches improving control of motor-drive and other powered components of surgical devices (¶7) with rotational parameters that may comprise rotational speed of the drive coupling based on the rotational positioning over a time interval (¶10). FIG 8 of Benamou shows wherein a first braking condition followed by a subsequent braking condition. Benamou teaches mechanisms including dynamic braking and algorithms to stop rotations of cutting members (¶51). Benamou expressly teaches that the amount of braking torque that can be applied can be dynamically changed as the load decelerates (¶55) and that this is a property of the function of kinetic energy in the spinning mass: as it declines, so does braking capacity (¶55).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Carlson, Rivers, Hansen, and Benamou, as evidenced by Shturman, given that the prior art included each element claimed, although not necessarily in a single reference. Carlson, Rivers, Shturman, Hansen, and Benamou teach in the same field of endeavor, rotational surgical devices comprising elongated flexible drive shafts with braking solutions.
Although, Carlson modified by Rivers and Hansen, as evidenced by Shturman, discloses the claimed atherectomy device comprising a motor, coiled drive shaft, and a control system with active braking and Carlson teaches timing of a first braking condition (¶69) in three different atherectomy systems (FIG 4), Carlson modified by Rivers and Hansen, as evidenced by Shturman, does not expressly teach wherein if the drive shaft is determined to not be fully unwound, the controller is configured to instruct the electric motor to execute it least one dynamic braking cycle comprising a braking condition followed by a non-braking condition. Hansen teaches that motor rotation is halted (FIG 12) by active or dynamic braking and that dynamic braking occurs by crowbarring the motor to rapidly dissipate the kinetic energy of the motor as heat and electrical energy through a resistive load (¶31). Hansen also expressly discloses that the controller deactivates the motor by dynamic braking and thereby rapidly arrests rotation of the motor to dissipate kinetic energy of the motor as heat and electrical energy through a resistive load (claim 14).
Additionally, Benamou expressly teaches the braking capacity of the of the first braking condition will always be greater than any subsequent breaking condition as a fundamental property of physics (¶55, FIG 8). Because Benamou teaches that the physics of the braking capacity of the of the first braking condition will always be greater than any subsequent breaking condition, a person of ordinary skill in the art, seeking to improve the speed, accuracy, and conditions of braking would reasonably consult Benamou’s stopping method, mechanism and algorithms, especially given the kinetic off-loading benefits, evidenced by Shturman.
Because the references address the same engineering problem (rotational surgical systems comprising elongated flexible drive shafts in need of controlled resolution of adverse conditions with braking solutions) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (utilizing an elongated flexible drive shaft comprising coiled wires and the known properties of physics such that as kinetic energy in a spinning mass declines, so does its braking capacity), 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. Additionally, this is also a function that is capable of being met by the prior art structure taught by Carlson modified by Rivers, Hansen, and Benamou, as evidenced by Shturman, as set forth above, particularly in light of the reference schedules of Carlson and Hansen’s and Benamou’s control algorithms (Benamou, ¶58).
Regarding claim 13, Carlson modified by Rivers, Hansen, and Benamou, as evidenced by Shturman, teaches the rotational atherectomy system of claim 1, as set forth above, for the reasons set forth above.
Carlson modified by Rivers, Hansen, and Benamou, as evidenced by Shturman does not expressly teach wherein the dynamic braking comprises a predetermined number of braking conditions and non-braking conditions.
This is also a function that is capable of being met by the prior art structure taught by Carlson modified by Rivers, Hansen, and Benamou, as evidenced by Shturman, as set forth above, particularly in light of the reference schedules of Carlson and Hansen’s and Benamou’s control algorithms (Benamou, ¶58). Additionally, Carlson teaches that the reference schedule may be predetermined before operation of the atherectomy device and saved in memory or a user may be able to adjust or otherwise modify the reference schedule and save it in memory (¶62).
Regarding claim 14, Carlson modified by Rivers, Hansen, and Benamou, as evidenced by Shturman, teaches the rotational atherectomy system of claim 5, as set forth above, for the reasons set forth above.
Carlson modified by Rivers, Hansen, and Benamou, as evidenced by Shturman does not expressly teach wherein the dynamic braking comprises predetermined time periods for each braking condition.
However, this is a function that is capable of being met by the prior art structure taught by Carlson modified by Rivers, Hansen, and Benamou, as evidenced by Shturman, as set forth above, particularly in light of the reference schedules of Carlson and Hansen’s and Benamou’s control algorithms (Benamou, ¶58). Additionally, Carlson teaches that the reference schedule may be predetermined before operation of the atherectomy device and saved in memory or a user may be able to adjust or otherwise modify the reference schedule and save it in memory (¶62).
Regarding claim 15, Carlson modified by Rivers, Hansen, and Benamou, as evidenced by Shturman, teaches the rotational atherectomy system of claim 7, as set forth above, for the reasons set forth above.
Carlson modified by Rivers, Hansen, and Benamou, as evidenced by Shturman does not expressly teach wherein the dynamic braking comprises predetermined time periods for each non-braking condition.
This is also a function that is capable of being met by the prior art structure taught by Carlson modified by Rivers, Hansen, and Benamou, as evidenced by Shturman, as set forth above, particularly in light of the reference schedules of Carlson and Hansen’s and Benamou’s control algorithms (Benamou, ¶58). Additionally, Carlson teaches that the reference schedule may be predetermined before operation of the atherectomy device and saved in memory or a user may be able to adjust or otherwise modify the reference schedule and save it in memory (¶62).
Regarding claim 16, Carlson modified by Rivers, Hansen, and Benamou, as evidenced by Shturman, teaches the rotational atherectomy system of claim 13, as set forth above, for the reasons set forth above.
Carlson modified by Rivers, Hansen, and Benamou, as evidenced by Shturman does not expressly teach wherein the dynamic braking is customized and predetermined for an individual model of drive shaft.
This is also a function that is capable of being met by the prior art structure taught by Carlson modified by Rivers, Hansen, and Benamou, as evidenced by Shturman, as set forth above, particularly in light of the reference schedules of Carlson and Hansen’s and Benamou’s control algorithms (Benamou, ¶58). Additionally, Carlson teaches that the reference schedule may be predetermined before operation of the atherectomy device and saved in memory or a user may be able to adjust or otherwise modify the reference schedule and save it in memory (¶62).
Regarding claim 17, Carlson modified by Rivers, Hansen, and Benamou, as evidenced by Shturman, teaches the rotational atherectomy system of claim 16, as set forth above, for the reasons set forth above.
Carlson modified by Rivers, Hansen, and Benamou, as evidenced by Shturman does not expressly teach wherein the customized and predetermined dynamic braking for one or more individual models of drive shafts is stored within the memory or processor for instructed execution by the electric motor.
This is also a function that is capable of being met by the prior art structure taught by Carlson modified by Rivers, Hansen, and Benamou, as evidenced by Shturman, as set forth above, particularly in light of the reference schedules of Carlson and Hansen’s and Benamou’s control algorithms (Benamou, ¶58). Additionally, Carlson teaches that the reference schedule may be predetermined before operation of the atherectomy device and saved in memory or a user may be able to adjust or otherwise modify the reference schedule and save it in memory (¶62).
Claims 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Carlson et al., US 20190175211 (13 June 2019) in view of Rivers et al., US 20150051626 (19 February 2015), as evidenced by Shturman, US 20090318942 (24 December 2009), and further in view of and further in view of Hansen et al., US 20220304719 (29 September 2022) and Culp et al., US 6,329,778 (11 December 2001).
Regarding claim 8, Carlson modified by Rivers and Hansen, as evidenced by Shturman, teaches the rotational atherectomy system of claim 1, as set forth above, for the reasons set forth above.
Carlson does not teach wherein the motor comprises a plurality of motor windings in switched communication with low-side switches, wherein when a stall is detected, the controller is configured to actuate all of the low-side switches and to cause a back emf of the motor to resist rotation
However, Carlson does teach a back EMF (a winding) of the motor to resist rotation (¶¶79, 82).
Culp teaches integrated system for powered surgical tools. Motor driver current sense circuit 510 including motor driver chip 728 comprising both high side and low side controls are taught at column 38, lines 44-55 as being commercially available. Additionally, Culp teaches that the field-effect transistors (FET) driver signal employed to cause the application of the motor power signals to the windings or to tie the windings to ground (column 38, lines 50-53). Culp also teaches that each of the low side FET serves as the switch to connect the handpiece winding to ground (column 39, lines 4-13). Culp teaches other windings including inductors (col 39, lines 26-48) and resistors (col 30, lines 8-27).
The detailed workings of standard electrical motors in surgical instruments are old and well-known, as demonstrated by Culp. The key takeaway from Culp is the teaching that driving the windings to the low side switches will tie them to ground. Carlson notes some of these effects at ¶79 and FIGs 6-8, although in not as much detail as provided by Culp. The controller of Carlson is designed as the modulator of motor parameters and Carlson teaches that real time or instantaneous torque on the motor may be based on a measured motor state and a measured motor drive state (¶80). A control signal for the motor may then be generated by a controller based on the reference motor torque and the real time or instantaneous torque (¶80). In this way a back EMF of the motor is signaled to resist rotation (¶¶79, 82).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Carlson, Rivers, Hansen, and Culp, as evidenced by Shturman, given that the prior art included each element claimed, although not necessarily in a single reference. Carlson, Rivers, Shturman, Hansen, and Culp teach in the same field of endeavor, surgical devices comprising electrical motors.
Although, Carlson modified by Rivers, and Hansen, as evidenced by Shturman, discloses the claimed atherectomy device comprising a motor, coiled drive shaft, and a control system with active braking and Carlson teaches teach a back electromotive force (EMF) of the motor to resist rotation (¶¶79, 82), Carlson modified by Rivers and Hansen, as evidenced by Shturman, does not expressly teach wherein the motor comprises a plurality of motor windings in switched communication with low-side switches, wherein when a stall is detected, the controller is configured to actuate all of the low-side switches and to cause a back emf of the motor to resist rotation. Culp expressly teaches multiple electrical motor windings and how power is utilized and offloaded by an integrated surgical tool system.
Because Carlson modified by Rivers and Hansen, as evidenced by Shturman, includes surgical device driven by an electrical motor with a control system, a person of ordinary skill in the art, seeking to utilize common structural electrical motor components known in the art and commercially available would reasonably consult Culp’s electrical motor solutions when considering how to offload power and/or torque during controlled braking in surgical instrument systems. Shturman evidences that rotational devices comprising coiled wires are beneficial because “the inner and the outer torque transmitting coils being wound in opposite directions so that, when the drive shaft is rotated, the outer torque transmitting coil prevents unwinding of the inner torque transmitting coil” (¶40), thus making it faster to off-load torque in an active/dynamic braking system. This resonates with Culp’s teachings of off-loading power to ground by moving all of the windings to low side switches to tie them to ground. It allows the system to shed power almost instantaneously and, as Carlson teaches, effectively throws away a portion of the system’s kinetic energy (¶69), just like Hansen’s disclosure that motor rotation is halted (FIG 12) “by active or dynamic braking” and that “dynamic braking occurs by “crowbarring” the motor to rapidly dissipate the kinetic energy of the motor as heat and electrical energy through a resistive load” (¶31).
Because the references address the same engineering problem (controlling electrical motors in surgical tools in need of controlled resolution of adverse conditions with braking solutions) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (utilizing an elongated flexible drive shaft comprising coiled wires and the known properties of physics such that as kinetic energy in a spinning mass declines, so does its braking capacity and offloading power to ground to shed energy almost instantaneously), 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 9, Carlson modified by Rivers, Hansen, and Culp, as evidenced by Shturman, teaches the rotational atherectomy system of claim 8, as set forth above, for the reasons set forth above.
Culp teaches wherein actuation of the low-side switches results in a braking condition (the low side FETs serves as the switch to tie the winding to ground (column 39, lines 4-13).
Carlson teaches a back electromotive force (EMF) (a winding) of the motor to resist rotation (¶¶79, 82).
These are functions that are capable of being met by the prior art structure taught by Carlson modified by Hansen and Rivers, as evidenced by Shturman, as set forth above, for the reasons set forth above. However, the manner of operating the system wherein the at least one sensor monitors whether the drive shaft rotates in the second rotational direction and wherein the controller is configured to determine if the drive shaft is fully unwound or not fully unwound does not differentiate the apparatus claim from the prior art. MPEP 2114.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/CHERIE M POLAND/Examiner, Art Unit 3771
/SHAUN L DAVID/Primary Examiner, Art Unit 3771
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