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
This office action is in response to amendments filed 04/02/2026. Claims 1-3, 5-19, 21-22 are pending.
Applicant's arguments with respect to rejections of Claims 1-19 under 35 USC 103 have been fully considered but they are not persuasive.
With respect to applicant’s arguments that Seamann and Junio fail to teach different force thresholds for lateral and axial directions with respect to the length of the robot arm, examiner respectfully finds the arguments unpersuasive.
Seamann teaches an X, Y, Z coordinate system that alights with the claimed lateral and axial directions with respect to the robot (see par. 0072, Fig. 2A)
Junio clearly teaches in par. 0093 having different force thresholds for alerting the user for each X, Y, Z axes.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system taught by Seamann to incorporate the teachings of Junio wherein the force sensor is a 6 DOF force/torque sensor and there are different force and torque thresholds for each of the three axes, in order to arrive at having different force thresholds for different robot-aligned axes. Junio also discloses that the benefit of incorporating this logic would be to improve positioning accuracy and increasing patient safety (see par. 0058).
Claim Rejections - 35 USC § 103
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.
Claim(s) 1-3, 5-7, 9-14, 16-19, 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Seemann et al (US 20230133689, hereinafter Seemann) in view of Junio et al (US 20220192701, hereinafter Junio).
Regarding Claim 1, Seemann teaches:
a system (see at least "Turning first to FIG. 1, a block diagram of a system 100 according to at least one embodiment of the present disclosure is shown. The system 100 may be used to facilitate the performance of a surgery or surgical procedure; to detect deflections or bends in one or more components thereof during the surgery or surgical procedure; to verify the accuracy of one or more sensors; to detect excessive forces on one or more components thereof; and/or carry out one or more other aspects of one or more of the methods disclosed herein." in par. 0051) , comprising:
a robotic arm that includes a distal end interface (see at least "The cantilever 224E may comprise or be mechanically coupled with an end effector 230. The end effector 230 may be capable of gripping, holding, accepting, or otherwise mechanically couple with a surgical tool, such that the surgical tool is held in a stable position during use thereof." in par. 0080) ;
a force transducer comprising a first end with a first surface that is couplable to the distal end interface to contact a first surface of the distal end interface and a second end opposite the first end, wherein the first transducer and that measures forces exerted on the force transducer (see at least "In some embodiments, the inertial sensors 236 may be disposed on each of the distal ends 244A-244C and may measure the force 240 and provide readings indicative of the magnitude and direction of the force 240." in par. 0086 and Fig. 2A) ; and
an end effector with a first end configured to be in force-transmitting, surface-to-surface contact with a second surface of the second end of the force transducer (see at least "As shown in FIG. 2A, the inertial sensors 236 may be disposed on the surgical bed 204, the attachment mechanism 206, the base 208, the shoulder 216, one or more of the cantilevers 224A-224E, and/or the end effector 230." in par. 0082 and Fig. 2A).
a processor; and a memory coupled to the processor and storing data thereon that, when executed by the processor, enable the processor to (see at least " A processor other than any processor described herein may also be used to execute the method 300. The at least one processor may perform the method 300 by executing instructions stored in a memory such as the memory 106." in par. 0088):
determine, based on a measurement from the force transducer, a direction of a force on a surgical tool connected to the end effector (see at least "In some embodiments, the inertial sensors 236 may be disposed on each of the distal ends 244A-244C and may measure the force 240 and provide readings indicative of the magnitude and direction of the force 240. The navigation system 118 may use the readings to determine a change in pose of the cantilevers. In some embodiments, the navigation system 118 may use the readings to determine the second pose of each of the cantilevers (e.g., the pose after the force 240 has been applied to the cantilever 224D). For instance, the system 100 may use or implement a transformation 124 that transforms the measurements from the inertial sensors 236 to determine a pose of the cantilevers 224A-224C" in par. 0086, note while this example talks of measuring deflection on a cantilever, Seamann makes clear in par. 0091 that the tracked object could be the end effector or surgical tool as well); and
determine an event of the surgical tool has occurred based on an amplitude of the force meeting or exceeding a threshold value (see at least "The method 500 also comprises generating, when the measured force exceeds a first threshold value, a first alert (step 512). The measured force may be directly measured (e.g., by a force sensor) or determined (e.g., using positional data generated by the plurality of inertial sensors in content stored in the memory 106) and compared with the first threshold value. In some embodiments, the first threshold value may be a predetermined quantitative indicator (e.g., a percent value, an integer, etc.) related to the safety or stability of or required by the system 100 (or components thereof such as the navigation system 118); for instance, the first threshold value may be 1 Newton (N), which may indicate that any force generated on the cantilever that exceeds 1 N is deemed unsafe or unacceptable by, for example, the navigation system 118 (e.g., a force of greater than 1 N may risk moving the robotic arm 116 enough to change the angle of drilling of a surgical tool attached thereto)." in par. 0115),
determining when the direction of the force is lateral with respect to a length of the robotic arm, and determining when the direction of the force is axial with respect to the length of the robotic arm. (see at least " The inertial sensor 236 may generate measurements (e.g., force measurements, pose changes, etc.) and provide such measurements to the system 100 and/or components thereof (e.g., the computing device 102, the processor 104, the database 130, etc.). The measurements may be used the by navigation system 118 to, for example, determine the poses of one or more components of the system 100 (e.g., the robotic arm 116 or components thereof, the shoulder 216, etc.) relative to one another or relative to a reference coordinate system (e.g., a patient coordinate system), as well as any change in pose of the one or more components of the system 100." in par. 0082)
Seamann does not appear to explicitly teach all of the following, but Junio does teach:
a force transducer couplable to the distal end interface and that measures forces exerted on the force transducer in up to six degrees of freedom (see at least "The force may be detected with a sensor such as a sensor 144. The detected force may be or comprise a linear force, rotational force (e.g., torque), and/or any other type of force. The sensor may be positioned on the robotic arm or elsewhere. The sensor may be configured to detect motion of the robotic arm and to calculate a force based on information about a stiffness of the robotic arm as well as the detected motion. Alternatively, the sensor may be configured to measure force directly. Any type of sensor capable of direct measurement of force, or of calculation of force based on some other measurement, may be used to detect the force for purposes of the step 216. In some embodiments, the detected force may comprise one or more individual force components (e.g., a force component in each of an X-axis, a Y-axis, and a Z-axis, and/or a torque component around an X-axis, a Y-axis, and a Z-axis)." in par. 0089)
wherein the threshold value is a first value when the direction of the force is lateral with respect to a length of the robotic arm, and wherein the threshold value is a second value when the direction of the force is axial with respect to the length of the robotic arm. (see at least "Additionally, in some embodiments, the predetermined threshold may comprise a threshold magnitude that depends on a direction of the detected force vector. Thus, for example, the predetermined threshold may comprise a first threshold magnitude for a force exerted in a first direction, and a second threshold magnitude different than the first threshold magnitude for a force exerted in a second direction different than the first direction. The different threshold magnitudes may be based, for example, on an ability of the robotic arm to generate a counteractive force in each direction (which may be different for different directions). Also, as referenced above, the predetermined threshold may comprise individual components (e.g., in the X-axis, Y-axis, and Z-axis directions, and/or around the X-axis, the Y-axis, and the Z-axis) or may simply comprise an overall threshold magnitude and direction. In still other embodiments, the predetermined threshold may comprise only a threshold magnitude.” In par. 0093)
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system taught by Seamann to incorporate the teachings of Junio wherein the force sensor is a 6 DOF force/torque sensor and there are different force and torque thresholds for each of the three axes, in order to arrive at having different force thresholds for different robot-aligned axes. The motivation to incorporate the teachings of Junio would be to improve positioning accuracy and increasing patient safety (see par. 0058).
Regarding Claim 2, Seemann as modified by Junio (references to Seamann) teaches:
the system of claim 1,
wherein determining the direction of the force on the surgical tool is based at least in part on a reading from a pose sensor disposed on the end effector, and wherein the event comprises a deflection of the surgical tool (see at least " The system 100 may comprise one or more inertial sensors 236 (or, more generally, one or more inertial measurement units 138) disposed in one or more locations of the robotic arm 116. In some embodiments, the inertial sensors 236 may be similar to or the same as the inertial sensors 142. As shown in FIG. 2A, the inertial sensors 236 may be disposed on the surgical bed 204, the attachment mechanism 206, the base 208, the shoulder 216, one or more of the cantilevers 224A-224E, and/or the end effector 230. The inertial sensor 236 may generate measurements (e.g., force measurements, pose changes, etc.) and provide such measurements to the system 100 and/or components thereof (e.g., the computing device 102, the processor 104, the database 130, etc.)." in par. 0082 and “As depicted in FIG. 2B, the force 240 may displace the distal end 244C of the cantilever 224C, such that the cantilever 224C bends, deflects, or otherwise moves from a first position (where the cantilever 224C is aligned with the axis of rotation 228D) to a second position—where cantilever 224C is no longer aligned with the axis of rotation 228D. While FIG. 2B depicts the force 240 being applied to the cantilever 224C, the force 240 may additionally or alternatively be applied to the end effector 230 and/or the surgical tools attached thereto (e.g., a drill, a saw, a reamer, etc.).” in par. 0084) .
Regarding Claim 3, Seemann as modified by Junio (references to Seamann) teaches:
the system of claim 1, further comprising:
wherein the data further enable the processor to:
determine an orientation of the end effector relative to sensing axes of the force transducer when the force is detected by the force transducer (see at least "In some embodiments, the inertial sensors 236 may be disposed on each of the distal ends 244A-244C and may measure the force 240 and provide readings indicative of the magnitude and direction of the force 240. The navigation system 118 may use the readings to determine a change in pose of the cantilevers. In some embodiments, the navigation system 118 may use the readings to determine the second pose of each of the cantilevers (e.g., the pose after the force 240 has been applied to the cantilever 224D). For instance, the system 100 may use or implement a transformation 124 that transforms the measurements from the inertial sensors 236 to determine a pose of the cantilevers 224A-224C" in par. 0086, note while this example talks of measuring deflection on a cantilever, Seamann makes clear in par. 0091 that the tracked object could be the end effector or surgical tool as well) ; and
determine an orientation of a surgical tool relative to the sensing axes of the force transducer when the force is detected by the force transducer. (see at least "The method 300 comprises receiving, from a first sensor coupled with a tracked object, a first sensor reading (step 304). The tracked object may be a robotic arm 116, portions of the surgical bed 204, an attachment mechanism 206, a base 208, a height adjustment device 212, a shoulder 216, cantilevers 224A-224E, an end effector 230 (and/or a surgical tool gripped by or otherwise coupled with the end effector 230), combinations thereof, and/or the like." in par. 0089 and “The second sensor may be or comprise an inertial measurement unit 138 and/or an inertial sensor 236 that is coupled with the tracked object (e.g., disposed on the tracked object, disposed proximate the tracked object, disposed a first distance from the tracked object, etc.) and capable of measuring the change in pose of the tracked object…another example, the inertial measurement unit 138 may include a force sensor that measures a force 240 on the tracked object, and provides information related to the magnitude and direction of the force in the second sensor reading. In some embodiments, the movement of the tracked object reflected in the second sensor reading may be caused, for example, by the operation of a surgical tool, such as a surgical tool held by the robotic arm 116 and operated autonomously or semi-autonomously by a navigation system 118 and/or a user (e.g., a surgeon).” In par. 0091, note while this example talks of measuring deflection on a cantilever, Seamann makes clear in par. 0091 that the tracked object could be the end effector or surgical tool as well).
Regarding Claim 5, Seemann as modified by Junio (references to Seamann) teaches:
the system of claim 1, wherein the data further enable the processor to:
generate, when the force meets or exceeds at least one of the threshold value, an alert indicating the surgical tool has experienced a deflection (see at least “Similarly, and due to the mechanical coupling of the end effector 230 with the robotic arm 116, the force 240 may also propagate through the cantilevers 224A-224E connected to the end effector 230. As the force 240 is propagated through the cantilevers 224A-224E and the end effector 230, each of the cantilevers 224A-224E and/or the end effector 230 may experience a deflection, bending, or other displacement due to the force. In some embodiments, the force 240 may be generated due to gravity or any other force not directly related to the surgery or surgical procedure.” In par. 0114 and "The method 500 also comprises generating, when the measured force exceeds a first threshold value, a first alert (step 512). The measured force may be directly measured (e.g., by a force sensor) or determined (e.g., using positional data generated by the plurality of inertial sensors in content stored in the memory 106) and compared with the first threshold value. In some embodiments, the first threshold value may be a predetermined quantitative indicator (e.g., a percent value, an integer, etc.) related to the safety or stability of or required by the system 100 (or components thereof such as the navigation system 118); for instance, the first threshold value may be 1 Newton (N), which may indicate that any force generated on the cantilever that exceeds 1 N is deemed unsafe or unacceptable by, for example, the navigation system 118 (e.g., a force of greater than 1 N may risk moving the robotic arm 116 enough to change the angle of drilling of a surgical tool attached thereto)." in par. 0115).
Regarding Claim 6, Seemann as modified by Junio (references to Seamann) teaches:
The system of claim 5, wherein the data further enable the processor to:
automatically disable, when the alert is generated, the surgical tool (see at least " Additionally or alternatively, the navigation system 118 may cause the surgery or surgical procedure to pause or stop when the first threshold value is exceeded. The exceeding of the first threshold value may indicate that the force experienced by the surgical robot (or components thereof) is too high, which may indicate that the current operation of the surgical robot is dangerous or undesired. In some embodiments, the navigation system 118 may deactivate an operation of the surgical tool (e.g., turning off a drill attached to the end effector 230) until the first threshold value is no longer exceeded." in par. 0117) .
Regarding Claim 7, Seemann as modified by Junio (references to Seamann) teaches:
the system of claim 3, wherein the data further enable the processor to:
determine, based on the measurement from the force transducer and the orientation of the end effector relative to the sensing axes, a second direction of the force on the end effector (see at least "In some embodiments, the inertial sensors 236 may be disposed on each of the distal ends 244A-244C and may measure the force 240 and provide readings indicative of the magnitude and direction of the force 240. The navigation system 118 may use the readings to determine a change in pose of the cantilevers. In some embodiments, the navigation system 118 may use the readings to determine the second pose of each of the cantilevers (e.g., the pose after the force 240 has been applied to the cantilever 224D). For instance, the system 100 may use or implement a transformation 124 that transforms the measurements from the inertial sensors 236 to determine a pose of the cantilevers 224A-224C" in par. 0086) ;.
Regarding Claim 9, Seemann as modified by Junio (references to Seemann) also teaches:
An apparatus (see Fig. 2A) comprising the components of the system of Claim 1 (see Claim 1 analysis for rejection of the system)
Regarding Claim 10, Seemann as modified by Junio also teaches:
An apparatus comprising the components of the system of Claim 3 (see Claim 3 analysis for rejection of the system)
Regarding Claim 11, Seemann as modified by Junio also teaches:
An apparatus comprising the components of the system of Claim 4 (see Claim 4 analysis for rejection of the system)
Regarding Claim 12, Seemann as modified by Junio also teaches:
An apparatus comprising the components of the system of Claim 5 (see Claim 5 analysis for rejection of the system)
Regarding Claim 13, Seemann as modified by Junio also teaches:
An apparatus comprising the components of the system of Claim 6 (see Claim 6 analysis for rejection of the system)
Regarding Claim 14, Seemann as modified by Junio also teaches:
An apparatus comprising the components of the system of Claim 7 (see Claim 7 analysis for rejection of the system)
Regarding Claim 16, Seemann teaches:
A surgical system (see at least "Turning first to FIG. 1, a block diagram of a system 100 according to at least one embodiment of the present disclosure is shown. The system 100 may be used to facilitate the performance of a surgery or surgical procedure; to detect deflections or bends in one or more components thereof during the surgery or surgical procedure; to verify the accuracy of one or more sensors; to detect excessive forces on one or more components thereof; and/or carry out one or more other aspects of one or more of the methods disclosed herein." in par. 0051), comprising:
a robotic arm that includes a distal end interface (see at least "Turning first to FIG. 1, a block diagram of a system 100 according to at least one embodiment of the present disclosure is shown. The system 100 may be used to facilitate the performance of a surgery or surgical procedure; to detect deflections or bends in one or more components thereof during the surgery or surgical procedure; to verify the accuracy of one or more sensors; to detect excessive forces on one or more components thereof; and/or carry out one or more other aspects of one or more of the methods disclosed herein." in par. 0051);
a force transducer extending from a first end couplable to the distal end interface to a second end opposite the first end, wherein the first and that measures forces exerted on the force transducer (see at least "Turning first to FIG. 1, a block diagram of a system 100 according to at least one embodiment of the present disclosure is shown. The system 100 may be used to facilitate the performance of a surgery or surgical procedure; to detect deflections or bends in one or more components thereof during the surgery or surgical procedure; to verify the accuracy of one or more sensors; to detect excessive forces on one or more components thereof; and/or carry out one or more other aspects of one or more of the methods disclosed herein." in par. 0051 and Fig. 2A);
an end effector with a first end configured to be in force-transmitting contact with the second end of the force transducer and a second end opposite the first end that is couplable to a surgical tool (see at least The end effector 230 may be capable of gripping, holding, accepting, or otherwise mechanically couple with a surgical tool, such that the surgical tool is held in a stable position during use thereof. " in par. 0080 and "As shown in FIG. 2A, the inertial sensors 236 may be disposed on the surgical bed 204, the attachment mechanism 206, the base 208, the shoulder 216, one or more of the cantilevers 224A-224E, and/or the end effector 230." in par. 0082 and Fig. 2A).;
a processor; and memory coupled to the processor and storing data thereon that enable the processor to (see at least " A processor other than any processor described herein may also be used to execute the method 300. The at least one processor may perform the method 300 by executing instructions stored in a memory such as the memory 106." in par. 0088) ::
determine an orientation of the surgical tool relative to sensing axes of the force transducer (see at least "The method 300 comprises receiving, from a first sensor coupled with a tracked object, a first sensor reading (step 304). The tracked object may be a robotic arm 116, portions of the surgical bed 204, an attachment mechanism 206, a base 208, a height adjustment device 212, a shoulder 216, cantilevers 224A-224E, an end effector 230 (and/or a surgical tool gripped by or otherwise coupled with the end effector 230), combinations thereof, and/or the like." in par. 0089 and “The second sensor may be or comprise an inertial measurement unit 138 and/or an inertial sensor 236 that is coupled with the tracked object (e.g., disposed on the tracked object, disposed proximate the tracked object, disposed a first distance from the tracked object, etc.) and capable of measuring the change in pose of the tracked object…another example, the inertial measurement unit 138 may include a force sensor that measures a force 240 on the tracked object, and provides information related to the magnitude and direction of the force in the second sensor reading. In some embodiments, the movement of the tracked object reflected in the second sensor reading may be caused, for example, by the operation of a surgical tool, such as a surgical tool held by the robotic arm 116 and operated autonomously or semi-autonomously by a navigation system 118 and/or a user (e.g., a surgeon).” In par. 0091, note while this example talks of measuring deflection on a cantilever, Seamann makes clear in par. 0091 that the tracked object could be the end effector or surgical tool as well); and
determine an orientation of the end effector relative to the sensing axes of the force transducer (see at least "In some embodiments, the inertial sensors 236 may be disposed on each of the distal ends 244A-244C and may measure the force 240 and provide readings indicative of the magnitude and direction of the force 240. The navigation system 118 may use the readings to determine a change in pose of the cantilevers. In some embodiments, the navigation system 118 may use the readings to determine the second pose of each of the cantilevers (e.g., the pose after the force 240 has been applied to the cantilever 224D). For instance, the system 100 may use or implement a transformation 124 that transforms the measurements from the inertial sensors 236 to determine a pose of the cantilevers 224A-224C" in par. 0086, note while this example talks of measuring deflection on a cantilever, Seamann makes clear in par. 0091 that the tracked object could be the end effector or surgical tool as well) .
Seamann does not appear to explicitly teach all of the following, but Junio does teach:
a force transducer couplable to the distal end interface and that measures forces exerted on the force transducer in up to six degrees of freedom (see at least " The force may be detected with a sensor such as a sensor 144. The detected force may be or comprise a linear force, rotational force (e.g., torque), and/or any other type of force. The sensor may be positioned on the robotic arm or elsewhere. The sensor may be configured to detect motion of the robotic arm and to calculate a force based on information about a stiffness of the robotic arm as well as the detected motion. Alternatively, the sensor may be configured to measure force directly. Any type of sensor capable of direct measurement of force, or of calculation of force based on some other measurement, may be used to detect the force for purposes of the step 216. In some embodiments, the detected force may comprise one or more individual force components (e.g., a force component in each of an X-axis, a Y-axis, and a Z-axis, and/or a torque component around an X-axis, a Y-axis, and a Z-axis)." in par. 0089)
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system taught by Seamann to incorporate the teachings of Junio wherein the force sensor is a 6 DOF force/torque sensor. The motivation to incorporate the teachings of Junio would be to improve positioning accuracy and increasing patient safety (see par. 0058).
Regarding Claim 17, Seemann as modified by Junio (references to Seamann) teaches:
The surgical system of claim 16,
wherein the data further enable the processor to:
determine, when the force transducer measures a first force in a first direction and based on at least one of the orientation of the surgical tool relative to the sensing axes and the orientation of the end effector relative to the sensing axes, a direction and an amplitude of a resulting force on at least one of the surgical tool and the end effector (see at least " The second sensor reading may be or comprise information related to the force 240 that acts on the tracked object. For instance, the force 240 may be a force generated by a surgical tool drilling into a vertebra of a patient, with the force 240 causing movement of the cantilever 224E (which may be or comprise the tracked object) that is mechanically coupled with the surgical tool through the end effector 230. In such embodiments, the second sensor may be disposed proximate to, on, or a predetermined distance from the cantilever 224E, and may detect the force 240 and/or the movement of the cantilever 224E and produce the second sensor reading comprising information related thereto." in par. 0092 and “The method 300 also comprises determining, based on the second sensor reading, a second pose of the tracked object (step 316). The step 316 may use or implement content stored in the memory 106 that performs one or more transformations 124 that transform the second sensor reading and the first pose information to determine the second pose. In some embodiments, the transformation 124 may receive the first pose information and may use the second sensor reading to determine a change in pose of the first pose from the first pose to the second pose. In some embodiments, the second sensor reading may be related to a force on the tracked object (e.g., the force 240 on the cantilever 224E), with the second sensor reading providing information indicative of the location of the force and the magnitude and direction of the force on the tracked object; the transformation 124 may use this information, along with the first pose information, to determine new coordinates describing the second pose of the tracked object.” In par. 00093, note while this example talks of measuring deflection on a cantilever, Seamann makes clear in par. 0091 that the tracked object could be the end effector or surgical tool as well).
Regarding Claim 18, Seemann as modified by Junio (references to Seamann) teaches:
The surgical system of claim 17, wherein the data further enable the processor to:
compare the resulting force to a first threshold value when the direction of the resulting force is in a second direction (see at least " The method 500 also comprises generating, when the measured force exceeds a first threshold value, a first alert (step 512). The measured force may be directly measured (e.g., by a force sensor) or determined (e.g., using positional data generated by the plurality of inertial sensors in content stored in the memory 106) and compared with the first threshold value. In some embodiments, the first threshold value may be a predetermined quantitative indicator (e.g., a percent value, an integer, etc.) related to the safety or stability of or required by the system 100 (or components thereof such as the navigation system 118); for instance, the first threshold value may be 1 Newton (N), which may indicate that any force generated on the cantilever that exceeds 1 N is deemed unsafe or unacceptable by, for example, the navigation system 118 (e.g., a force of greater than 1 N may risk moving the robotic arm 116 enough to change the angle of drilling of a surgical tool attached thereto)." in par. 0115) ;;
generate, when the resulting force exceeds at least one of the first threshold value and the second threshold value, an alert indicating at least one of the surgical tool and the end effector has experienced deflection (see at least “Similarly, and due to the mechanical coupling of the end effector 230 with the robotic arm 116, the force 240 may also propagate through the cantilevers 224A-224E connected to the end effector 230. As the force 240 is propagated through the cantilevers 224A-224E and the end effector 230, each of the cantilevers 224A-224E and/or the end effector 230 may experience a deflection, bending, or other displacement due to the force. In some embodiments, the force 240 may be generated due to gravity or any other force not directly related to the surgery or surgical procedure.” In par. 0114 and "The method 500 also comprises generating, when the measured force exceeds a first threshold value, a first alert (step 512). The measured force may be directly measured (e.g., by a force sensor) or determined (e.g., using positional data generated by the plurality of inertial sensors in content stored in the memory 106) and compared with the first threshold value. In some embodiments, the first threshold value may be a predetermined quantitative indicator (e.g., a percent value, an integer, etc.) related to the safety or stability of or required by the system 100 (or components thereof such as the navigation system 118); for instance, the first threshold value may be 1 Newton (N), which may indicate that any force generated on the cantilever that exceeds 1 N is deemed unsafe or unacceptable by, for example, the navigation system 118 (e.g., a force of greater than 1 N may risk moving the robotic arm 116 enough to change the angle of drilling of a surgical tool attached thereto)." in par. 0115).
Seamann does not appear to explicitly teach all of the following, but Junio does teach:
compare the resulting force to a second threshold value when the direction of the resulting force on the surgical tool is in a third direction (see at least "Additionally, in some embodiments, the predetermined threshold may comprise a threshold magnitude that depends on a direction of the detected force vector. Thus, for example, the predetermined threshold may comprise a first threshold magnitude for a force exerted in a first direction, and a second threshold magnitude different than the first threshold magnitude for a force exerted in a second direction different than the first direction. The different threshold magnitudes may be based, for example, on an ability of the robotic arm to generate a counteractive force in each direction (which may be different for different directions). Also, as referenced above, the predetermined threshold may comprise individual components (e.g., in the X-axis, Y-axis, and Z-axis directions, and/or around the X-axis, the Y-axis, and the Z-axis) or may simply comprise an overall threshold magnitude and direction. In still other embodiments, the predetermined threshold may comprise only a threshold magnitude.” In par. 0093);
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system taught by Seamann to incorporate the teachings of Junio wherein direction-dependent force thresholds are set that trigger a user alert . The motivation to incorporate the teachings of Junio would be to avoid damage to the robot or the patient (see par. 0091)
Regarding Claim 19, Seemann as modified by Junio (references to Seamann) teaches:
The surgical system of claim 18,
wherein the data further enable the processor to:
automatically disable, when the alert is generated, the surgical tool (see at least " Additionally or alternatively, the navigation system 118 may cause the surgery or surgical procedure to pause or stop when the first threshold value is exceeded. The exceeding of the first threshold value may indicate that the force experienced by the surgical robot (or components thereof) is too high, which may indicate that the current operation of the surgical robot is dangerous or undesired. In some embodiments, the navigation system 118 may deactivate an operation of the surgical tool (e.g., turning off a drill attached to the end effector 230) until the first threshold value is no longer exceeded." in par. 0117).
Regarding Claim 21, Seamann as modified by Junio (references to Seamann teaches:
the system of claim 2,
wherein the first end of the end effector remains fixed relative to the force transducer (see at least "As shown in FIG. 2A, the inertial sensors 236 may be disposed on the surgical bed 204, the attachment mechanism 206, the base 208, the shoulder 216, one or more of the cantilevers 224A-224E, and/or the end effector 230. " in par. 0082 and Fig. 2A)
and wherein the surgical tool is movable relative to the force transducer. (see at least “ The surgical tool may be held by the end effector 230 during the course of a surgery or surgical procedure. The surgical tool may be a drill, reamer, saw, shaver, scalpel, tap, burr, combinations thereof, and/or the like. " in par. 0080)
Claim(s) 8, 15, 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Seemann et al (US 20230133689, hereinafter Seemann) in view of Junio et al (US 20220192701, hereinafter Junio) and Matsuo et al (US 20200122336, hereinafter Matsuo)
Regarding Claim 8, Seemann as modified by Junio (references to Seamann) teaches:
The system of claim 7, wherein the data further enable the processor to:
Seamann and Junio do not appear to explicitly teach all of the following, but Matsuo does teach:
compare a second amplitude of the force on the end effector to a second threshold value, wherein the second threshold value is a third value when the direction of the force is lateral with respect to the length of the robotic arm, and wherein the second threshold value is a fourth value when the direction of the force is axial with respect to the length of the robotic arm (see at least "To perform a threshold-based operation for each of the force in the advancing direction F of the tool T, the force in the tool radial direction D perpendicular to the advancing direction F of the tool T, and the force in the direction of the tool axis AX, the first threshold and the second threshold are to be set for each of the force in the advancing direction F of the tool T, the force in the tool radial direction D) perpendicular to the advancing direction F of the tool T, and the force in the direction of the tool axis AX.” in par. 0108)
generate, when the second amplitude of the force meets or exceeds the second threshold value, a second alert indicating the end effector has experienced deflection. (see at least " As described above, if the force applied to the arm 4 in the advancing direction F of the tool T is excessively large, the tool T may vibrate, leading to a possibility of deterioration in the machining quality. Hence, before the arm 4 is stopped, warning information can be outputted. Of course, from the viewpoint of avoiding a situation such as interference with the tool T and the copying guide 8 due to errors in the setting of the work W and the copying mold J1, warning information may also be outputted before the arm 4 is stopped if the force in the tool radial direction D perpendicular to the advancing direction F of the tool T and the force in the direction of the tool axis AX are greater than or equal to respective thresholds or exceed the thresholds.” In par. 0106);
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system taught by Seamann as modified by Junio to incorporate the teachings of Matsuo wherein each direction has first and second threshold force levels that when triggered cause warning and then warning and stopping of the robot.The motivation to incorporate the teachings of Matsuo would be to avoid reduction in quality of the machining operation (see par. 0106)
Regarding Claim 15, Seemann as modified by Junio and Matsuo also teaches:
An apparatus comprising the components of the system of Claim 8 (see Claim 8 analysis for rejection of the system)
Regarding Claim 22, Seemann as modified by Junio (references to Seamann) teaches:
the system of claim 1,
wherein the first surface of the force transducer and the second surface of the force transducer have the same surface area (see at least cylindrical sensors 236 in Fig. 2A ), and
Seamann and Junio do not appear to explicitly teach all of the following, but Matsuo does teach:
wherein the surface area of the first surface of the force transducer is greater than the surface area of the first surface of the distal end interface. (see at least " In the example illustrated in FIG. 1, the attaching jig 5 is attached to the arm 4 with a stepped disc-shaped force sensor 9 interposed therebetween." in par. 0051 and force sensor 9 first surface area shown to be greater than the first surface of the distal end of the arm that it is attached to in Fig. 1)
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system taught by Seamann as modified by Junio to incorporate the teachings of Matsuo wherein the force sensor surface area is larger than that of the distal end of the arm that it attaches to. The motivation to incorporate the teachings of Matsuo would be to form a stronger structural connection that keeps the force sensor axis and arm axis in alignment.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DYLAN M KATZ whose telephone number is (571)272-2776. The examiner can normally be reached Mon-Thurs. 8:00-6:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Abby Lin can be reached on (571) 270-3976. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DYLAN M KATZ/Examiner, Art Unit 3657
Prosecution Insights