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 .
Status of Claims
Claims 1, 3-6, 8, 10-13, 15, 17, and 19 are pending in this application. Claims 2, 7, 9, 14, 16, and 18 are cancelled. Claims 1, 3-6, 8, 10-13, 15, 17, and 19 have been examined on the merits.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 3-4, 8, 10, 11, 15, 17 and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Crawford (US20220110701A1).
Regarding Claim 1,
Crawford teaches a method for navigating an operation performed by a surgical system (corresponding disclosure in at least [0144], “user input 170 can be used to plan the trajectory for a desired navigation”), the surgical system comprising a mechanical arm with a plurality of arm joints, the method comprising (corresponding disclosure in at least [0137], where there are a plurality of joints mentioned (series of joints) “Some embodiments include a robot 15 that moves on a Cartesian positioning system; that is, movements in different axes can occur relatively independently of one another instead of at the end of a series of joints.”):
obtaining a medical image, the medical image comprising a plurality of markers on the surgical system (corresponding disclosure in at least [0444], where there are markers shown in the medical image “ this calibration can be done by the technician scrolling through image slices and marking them using the software, or by an algorithm that automatically checks each slice of the medical image, finds the markers 730, verifying that they are the markers 730 of interest based on their physical spacing”);
determining, based on a first output of a plurality of encoders corresponding to the plurality of arm joints, a plurality of mechanism parameters of the mechanical arm, and forward kinematics, a plurality of first positions of the plurality of markers with respect to a first coordinate system (corresponding disclosure in at least [0160], where the position of the markers is known based on where the arm joints are, the mechanism parameters of the arm (tracked location) “ the robotic surgical system 1 can comprise a plurality of conventional tracking markers 720 configured to track the movement of the robot arm 23, the end-effectuator 30, and/or the surgical instrument 35 in three dimensions… three dimensional positional information from tracking markers 720 can be used in conjunction with the one dimensional linear positional information from absolute or relative conventional linear encoders on each axis of the robot 15 to maintain a high degree of accuracy… the plurality of tracking markers 720 can be configured to track the movement of the robot 15 arm, the end-effectuator 30, and/or the surgical instrument 3” further in [0160] “, the computer 100 can utilize the tracking information to calculate the orientation and coordinates of the distal tip 30 a of the surgical instrument 35 based on encoder counts along the x-axis 66, y-axis 68, z-axis 70, the Z-tube axis 64, and the roll 62 and pitch 60 axes.”, further in [0170], where forward kinematics are further used (precise movements of the arm, which is shown using a cartesian coordinate system with the exact movements being recorded “ the marker 720 positions from these moves can be used to establish a Cartesian coordinate system for the robot 15 in which the origin (0,0,0) is through the center of the end-effectuator 30 and is at the location along the end-effectuator 30 closest to where pitch 60 occurs. Additionally or alternatively, in some embodiments, this coordinate system can be rotated to an alignment in which y-axis 68 movement of the robot 15 can occur exactly or substantially along the coordinate system's y-axis 68, while x-axis 66 movement of the robot 15 occurs substantially perpendicular to the y-axis 68, but by construction of the coordinate system, without resulting in any change in the z-axis 70 coordinate." And further in [0264] “the data may be redundant of position data calculated from RF transmitters 120 located on the surgical instrument 35. Therefore, in some embodiments, position data from the position encoders may be used to double-check the position being read from the LPS”);
determining, based on the medical image, a plurality of second positions of the plurality of markers with respect to a second coordinate system (corresponding disclosure in at least [0444], where there are markers shown in the medical image “ this calibration can be done by the technician scrolling through image slices and marking them using the software, or by an algorithm that automatically checks each slice of the medical image, finds the markers 730, verifying that they are the markers 730 of interest based on their physical spacing”, further in [0009], where the location is dynamically updated, meaning the second position, etc. is determined “RF signals can be sent by the RF transmitter on an iterative basis and then analyzed in an iterative process to allow the surgical robot to automatically move the effectuator element and/or surgical instrument to a desired location within a patient's body. The location of the effectuator element and/or surgical instrument can be dynamically updated and, optionally, can be displayed to a user in real-time”);
determining a transformation relationship between the first coordinate system and the second coordinate system based on the plurality of first positions and the plurality of second positions (corresponding disclosure in at least [0183], where an arbitrary coordinate system is used to determine the transformation relationship when there is a change in the markers “at the time the calibration of the fixture 690 occurred, this positional relationship can be retained in a computer memory (e.g., system memory 3412) for later access on real-time or substantially on real-time in a set of four arbitrary reference Cartesian coordinate systems that can be readily reachable through transformations at any later frame of data. In some embodiments, each reference coordinate system can utilize an unambiguous positioning of three of the active markers 720”);
determining, during the operation, based on a second output of the plurality of encoders, the plurality of mechanism parameters of the mechanical arm, and the forward kinematics, a third position of an instrument used for the operation with respect to the first coordinate system (corresponding disclosure in at least [0160], where the position of the markers is known based on where the arm joints are, the mechanism parameters of the arm (tracked location) “ the robotic surgical system 1 can comprise a plurality of conventional tracking markers 720 configured to track the movement of the robot arm 23, the end-effectuator 30, and/or the surgical instrument 35 in three dimensions… three dimensional positional information from tracking markers 720 can be used in conjunction with the one dimensional linear positional information from absolute or relative conventional linear encoders on each axis of the robot 15 to maintain a high degree of accuracy… the plurality of tracking markers 720 can be configured to track the movement of the robot 15 arm, the end-effectuator 30, and/or the surgical instrument 3” further in [0160] “, the computer 100 can utilize the tracking information to calculate the orientation and coordinates of the distal tip 30 a of the surgical instrument 35 based on encoder counts along the x-axis 66, y-axis 68, z-axis 70, the Z-tube axis 64, and the roll 62 and pitch 60 axes.”, further in [0170], where forward kinematics are further used (precise movements of the arm, which is shown using a cartesian coordinate system with the exact movements being recorded “ the marker 720 positions from these moves can be used to establish a Cartesian coordinate system for the robot 15 in which the origin (0,0,0) is through the center of the end-effectuator 30 and is at the location along the end-effectuator 30 closest to where pitch 60 occurs. Additionally or alternatively, in some embodiments, this coordinate system can be rotated to an alignment in which y-axis 68 movement of the robot 15 can occur exactly or substantially along the coordinate system's y-axis 68, while x-axis 66 movement of the robot 15 occurs substantially perpendicular to the y-axis 68, but by construction of the coordinate system, without resulting in any change in the z-axis 70 coordinate." And further in [0264] where the system is being dynamically updated, which provides the third position, or any additional positions the instrument is located “the data may be redundant of position data calculated from RF transmitters 120 located on the surgical instrument 35. Therefore, in some embodiments, position data from the position encoders may be used to double-check the position being read from the LPS”);
determining, based on the third position and the transformation relationship, a fourth position of the instrument with respect to the second coordinate system (corresponding disclosure in at least [0175], where a third position (the position is constantly being updated based on the calculated coordinate system based on the medical image [second coordinate system)” during tracking, the desired trajectory can be first calculated in the medical image coordinate system, then transformed to the robot 15 coordinate system based at least on known relative locations of active markers” and Fig 24 and [0177] further outlining how the calibrated coordinate system using the medical image is incorporated into determining the position of an instrument “FIG. 24 is a flowchart of a method 2400 for positioning and advancing through soft tissue” ); and
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Figure 24 of Crawford
displaying at least one part of the instrument in a navigation image based on the fourth position, wherein the navigation image comprises a superposition of the medical image and the at least one part of the instrument (corresponding disclosure in at least [0266], where the instrument (surgical device) is superimposed onto the medical image (3D anatomical image) “ the computer 100 superimposes a representation of the location calculated in step 270 of the surgical device on the 3D anatomical image of the patient”).
Regarding Claim 3, 10, and 17,
Crawford further teaches wherein a number of the plurality of markers is greater than or equal to 4 (corresponding disclosure in at least Figure 20A and [0182], where there are visibly over 4 markers “ if a targeting fixture 690 has four radio-opaque markers 730, there are six known spacings, with each marker 730 having a quantifiable spacing relative to three other markers 730: the inter-marker spacings for markers 1-2, 1-3, 1-4, 2-3, 2-4, and 3-4. On the 3D medical image of the targeting fixture 690, in some embodiments, if five potential markers 730 are found on the medical image, their inter-marker spacings can be calculated”).
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Figure 20A of Crawford
Regarding Claim 4 and 11,
Crawford further teaches wherein the surgical system further comprises a calibration device arranged at an end of the plurality of arm joints, and the calibration device comprises the plurality of markers (corresponding disclosure in at least [0319], where there is a calibration device (fixture) with a plurality of markers (shown in Figure 20A) “the surgical robot system 1 can comprise a targeting fixture 690 for use with a guidance system. In some embodiments, one targeting fixture 690 comprises a calibration frame” and further in Figure 20D, where the plurality of arm joints (robotic arm) are lowered towards the calibration device, thus the calibration device is arranged at the end of the joints).
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Figure 20D of Crawford
Regarding Claim 8,
Crawford teaches a surgical system comprising: a mechanical arm, comprising a plurality of arm joints and a plurality of encoders corresponding to the plurality of arm joints (corresponding disclosure in at least [0144], “user input 170 can be used to plan the trajectory for a desired navigation” and [0137], where there are a plurality of joints mentioned (series of joints) “Some embodiments include a robot 15 that moves on a Cartesian positioning system; that is, movements in different axes can occur relatively independently of one another instead of at the end of a series of joints.” And further in [0160], where there are a plurality of encoders on the mechanical arm (robot) “ It should be appreciated that three dimensional positional information from tracking markers 720 can be used in conjunction with the one dimensional linear positional information from absolute or relative conventional linear encoders on each axis of the robot 15 to maintain a high degree of accuracy”);
an output device (corresponding disclosure in at least [0219], where there is an output device “any step and/or result of the methods can be output in any form to an output device”); and a processor coupled to the plurality of encoders and the output device (corresponding disclosure in at least [0263], where there are a plurality of encoders, which requires a processor “the surgical robot 15 can also include a plurality of attached conventional position encoders that help determine the position of the surgical instrument 35. In some embodiments, the position encoders can be devices used to generate an electronic signal that indicates a position or movement relative to a reference position”, and further in [0208], where the processor for the robot is mentioned “robotic guidance software 3406 can configure the computing device 3401, or a processor thereof, to perform the automated control of position of the local robot 3416 (for example, surgical robot 15) in accordance with aspects of the invention”), the processor configured to:
obtain a medical image, the medical image comprising a plurality of markers on the surgical system, and the medical image being captured by a medical imaging system (corresponding disclosure in at least [0444], where there are markers shown in the medical image “ this calibration can be done by the technician scrolling through image slices and marking them using the software, or by an algorithm that automatically checks each slice of the medical image, finds the markers 730, verifying that they are the markers 730 of interest based on their physical spacing”);
determine, based on a first output of the plurality of encoders, a plurality of mechanism parameters of the mechanical arm, and forward kinematics, a plurality of first positions of the plurality of markers with respect to a first coordinate system (corresponding disclosure in at least [0160], where the position of the markers is known based on where the arm joints are, the mechanism parameters of the arm (tracked location) “ the robotic surgical system 1 can comprise a plurality of conventional tracking markers 720 configured to track the movement of the robot arm 23, the end-effectuator 30, and/or the surgical instrument 35 in three dimensions… three dimensional positional information from tracking markers 720 can be used in conjunction with the one dimensional linear positional information from absolute or relative conventional linear encoders on each axis of the robot 15 to maintain a high degree of accuracy… the plurality of tracking markers 720 can be configured to track the movement of the robot 15 arm, the end-effectuator 30, and/or the surgical instrument 3” further in [0160] “, the computer 100 can utilize the tracking information to calculate the orientation and coordinates of the distal tip 30 a of the surgical instrument 35 based on encoder counts along the x-axis 66, y-axis 68, z-axis 70, the Z-tube axis 64, and the roll 62 and pitch 60 axes.”, further in [0170], where forward kinematics are further used (precise movements of the arm, which is shown using a cartesian coordinate system with the exact movements being recorded “ the marker 720 positions from these moves can be used to establish a Cartesian coordinate system for the robot 15 in which the origin (0,0,0) is through the center of the end-effectuator 30 and is at the location along the end-effectuator 30 closest to where pitch 60 occurs. Additionally or alternatively, in some embodiments, this coordinate system can be rotated to an alignment in which y-axis 68 movement of the robot 15 can occur exactly or substantially along the coordinate system's y-axis 68, while x-axis 66 movement of the robot 15 occurs substantially perpendicular to the y-axis 68, but by construction of the coordinate system, without resulting in any change in the z-axis 70 coordinate." And further in [0264] “the data may be redundant of position data calculated from RF transmitters 120 located on the surgical instrument 35. Therefore, in some embodiments, position data from the position encoders may be used to double-check the position being read from the LPS”); determine, based on the medical image, a plurality of second positions of the plurality of markers with respect to a second coordinate system (corresponding disclosure in at least [0444], where there are markers shown in the medical image “ this calibration can be done by the technician scrolling through image slices and marking them using the software, or by an algorithm that automatically checks each slice of the medical image, finds the markers 730, verifying that they are the markers 730 of interest based on their physical spacing”, further in [0009], where the location is dynamically updated, meaning the second position, etc. is determined “RF signals can be sent by the RF transmitter on an iterative basis and then analyzed in an iterative process to allow the surgical robot to automatically move the effectuator element and/or surgical instrument to a desired location within a patient's body. The location of the effectuator element and/or surgical instrument can be dynamically updated and, optionally, can be displayed to a user in real-time”);
determine a transformation relationship between the first coordinate system and the second coordinate system based on the plurality of first positions and the plurality of second positions (corresponding disclosure in at least [0183], where an arbitrary coordinate system is used to determine the transformation relationship when there is a change in the markers “at the time the calibration of the fixture 690 occurred, this positional relationship can be retained in a computer memory (e.g., system memory 3412) for later access on real-time or substantially on real-time in a set of four arbitrary reference Cartesian coordinate systems that can be readily reachable through transformations at any later frame of data. In some embodiments, each reference coordinate system can utilize an unambiguous positioning of three of the active markers 720”);
determine, during an operation of the surgical system, based on a second output of the plurality of encoders, the plurality of mechanism parameters of the mechanical arm, and the forward kinematics, a third position of an instrument used for the operation with respect to the first coordinate system (corresponding disclosure in at least [0160], where the position of the markers is known based on where the arm joints are, the mechanism parameters of the arm (tracked location) “ the robotic surgical system 1 can comprise a plurality of conventional tracking markers 720 configured to track the movement of the robot arm 23, the end-effectuator 30, and/or the surgical instrument 35 in three dimensions… three dimensional positional information from tracking markers 720 can be used in conjunction with the one dimensional linear positional information from absolute or relative conventional linear encoders on each axis of the robot 15 to maintain a high degree of accuracy… the plurality of tracking markers 720 can be configured to track the movement of the robot 15 arm, the end-effectuator 30, and/or the surgical instrument 3” further in [0160] “, the computer 100 can utilize the tracking information to calculate the orientation and coordinates of the distal tip 30 a of the surgical instrument 35 based on encoder counts along the x-axis 66, y-axis 68, z-axis 70, the Z-tube axis 64, and the roll 62 and pitch 60 axes.”, further in [0170], where forward kinematics are further used (precise movements of the arm, which is shown using a cartesian coordinate system with the exact movements being recorded “ the marker 720 positions from these moves can be used to establish a Cartesian coordinate system for the robot 15 in which the origin (0,0,0) is through the center of the end-effectuator 30 and is at the location along the end-effectuator 30 closest to where pitch 60 occurs. Additionally or alternatively, in some embodiments, this coordinate system can be rotated to an alignment in which y-axis 68 movement of the robot 15 can occur exactly or substantially along the coordinate system's y-axis 68, while x-axis 66 movement of the robot 15 occurs substantially perpendicular to the y-axis 68, but by construction of the coordinate system, without resulting in any change in the z-axis 70 coordinate." And further in [0264] where the system is being dynamically updated, which provides the third position, or any additional positions the instrument is located “the data may be redundant of position data calculated from RF transmitters 120 located on the surgical instrument 35. Therefore, in some embodiments, position data from the position encoders may be used to double-check the position being read from the LPS”);
determine, based on the third position and the transformation relationship, a fourth position of the instrument with respect to the second coordinate system (corresponding disclosure in at least [0175], where a third position (the position is constantly being updated based on the calculated coordinate system based on the medical image [second coordinate system)” during tracking, the desired trajectory can be first calculated in the medical image coordinate system, then transformed to the robot 15 coordinate system based at least on known relative locations of active markers” and Fig 24 and [0177] further outlining how the calibrated coordinate system using the medical image is incorporated into determining the position of an instrument “FIG. 24 is a flowchart of a method 2400 for positioning and advancing through soft tissue” ); and
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Figure 24 of Crawford
Display, using the output device, at least one part of the instrument in a navigation image based on the fourth position, wherein the navigation image comprises a superposition of the medical image and the at least one part of the instrument (corresponding disclosure in at least [0266], where the instrument (surgical device) is superimposed onto the medical image (3D anatomical image) “ the computer 100 superimposes a representation of the location calculated in step 270 of the surgical device on the 3D anatomical image of the patient”).
Regarding 15,
Crawford teaches a navigation system for navigating an operation performed by a surgical system (corresponding disclosure in at least [0144], “user input 170 can be used to plan the trajectory for a desired navigation”), the surgical system comprising a mechanical arm with a plurality of arm joints and a plurality of encoders corresponding to the plurality of arm joints (corresponding disclosure in at least [0137], where there are a plurality of joints mentioned (series of joints) “Some embodiments include a robot 15 that moves on a Cartesian positioning system; that is, movements in different axes can occur relatively independently of one another instead of at the end of a series of joints.”), the navigation system comprising:
an output device; and a processor coupled to the output device and the plurality of encoders (corresponding disclosure in at least [0219], where there is an output device “any step and/or result of the methods can be output in any form to an output device” and further in [0263], where there are a plurality of encoders, which requires a processor “the surgical robot 15 can also include a plurality of attached conventional position encoders that help determine the position of the surgical instrument 35. In some embodiments, the position encoders can be devices used to generate an electronic signal that indicates a position or movement relative to a reference position”, and further in [0208], where the processor for the robot is mentioned “robotic guidance software 3406 can configure the computing device 3401, or a processor thereof, to perform the automated control of position of the local robot 3416 (for example, surgical robot 15) in accordance with aspects of the invention”), the processor configured to:
obtain a medical image, the medical image comprising a feature on the surgical system, and the medical image being captured by a medical imaging system (corresponding disclosure in at least [0444], where there are markers shown in the medical image “ this calibration can be done by the technician scrolling through image slices and marking them using the software, or by an algorithm that automatically checks each slice of the medical image, finds the markers 730, verifying that they are the markers 730 of interest based on their physical spacing”);
determine, based on a first output of the plurality of encoders, a plurality of mechanism parameters of the mechanical arm, and forward kinematics, a plurality of first positions of the plurality of markers with respect to a first coordinate system (corresponding disclosure in at least [0160], where the position of the markers is known based on where the arm joints are, the mechanism parameters of the arm (tracked location) “ the robotic surgical system 1 can comprise a plurality of conventional tracking markers 720 configured to track the movement of the robot arm 23, the end-effectuator 30, and/or the surgical instrument 35 in three dimensions… three dimensional positional information from tracking markers 720 can be used in conjunction with the one dimensional linear positional information from absolute or relative conventional linear encoders on each axis of the robot 15 to maintain a high degree of accuracy… the plurality of tracking markers 720 can be configured to track the movement of the robot 15 arm, the end-effectuator 30, and/or the surgical instrument 3” further in [0160] “, the computer 100 can utilize the tracking information to calculate the orientation and coordinates of the distal tip 30 a of the surgical instrument 35 based on encoder counts along the x-axis 66, y-axis 68, z-axis 70, the Z-tube axis 64, and the roll 62 and pitch 60 axes.”, further in [0170], where forward kinematics are further used (precise movements of the arm, which is shown using a cartesian coordinate system with the exact movements being recorded “ the marker 720 positions from these moves can be used to establish a Cartesian coordinate system for the robot 15 in which the origin (0,0,0) is through the center of the end-effectuator 30 and is at the location along the end-effectuator 30 closest to where pitch 60 occurs. Additionally or alternatively, in some embodiments, this coordinate system can be rotated to an alignment in which y-axis 68 movement of the robot 15 can occur exactly or substantially along the coordinate system's y-axis 68, while x-axis 66 movement of the robot 15 occurs substantially perpendicular to the y-axis 68, but by construction of the coordinate system, without resulting in any change in the z-axis 70 coordinate." And further in [0264] “the data may be redundant of position data calculated from RF transmitters 120 located on the surgical instrument 35. Therefore, in some embodiments, position data from the position encoders may be used to double-check the position being read from the LPS”);
determine, based on the medical image, a plurality of second positions of the plurality of markers with respect to a second coordinate system (corresponding disclosure in at least [0444], where there are markers shown in the medical image “ this calibration can be done by the technician scrolling through image slices and marking them using the software, or by an algorithm that automatically checks each slice of the medical image, finds the markers 730, verifying that they are the markers 730 of interest based on their physical spacing”, further in [0009], where the location is dynamically updated, meaning the second position, etc. is determined “RF signals can be sent by the RF transmitter on an iterative basis and then analyzed in an iterative process to allow the surgical robot to automatically move the effectuator element and/or surgical instrument to a desired location within a patient's body. The location of the effectuator element and/or surgical instrument can be dynamically updated and, optionally, can be displayed to a user in real-time”);
determine a transformation relationship between the first coordinate system and the second coordinate system based on the plurality of first positions and the plurality of second positions (corresponding disclosure in at least [0183], where an arbitrary coordinate system is used to determine the transformation relationship when there is a change in the markers “at the time the calibration of the fixture 690 occurred, this positional relationship can be retained in a computer memory (e.g., system memory 3412) for later access on real-time or substantially on real-time in a set of four arbitrary reference Cartesian coordinate systems that can be readily reachable through transformations at any later frame of data. In some embodiments, each reference coordinate system can utilize an unambiguous positioning of three of the active markers 720”);
determine, during an operation of the surgical system, based on a second output of the plurality of encoders, a third position of an instrument used for the operation with respect to the first coordinate system (corresponding disclosure in at least [0160], where the position of the markers is known based on where the arm joints are, the mechanism parameters of the arm (tracked location) “ the robotic surgical system 1 can comprise a plurality of conventional tracking markers 720 configured to track the movement of the robot arm 23, the end-effectuator 30, and/or the surgical instrument 35 in three dimensions… three dimensional positional information from tracking markers 720 can be used in conjunction with the one dimensional linear positional information from absolute or relative conventional linear encoders on each axis of the robot 15 to maintain a high degree of accuracy… the plurality of tracking markers 720 can be configured to track the movement of the robot 15 arm, the end-effectuator 30, and/or the surgical instrument 3” further in [0160] “, the computer 100 can utilize the tracking information to calculate the orientation and coordinates of the distal tip 30 a of the surgical instrument 35 based on encoder counts along the x-axis 66, y-axis 68, z-axis 70, the Z-tube axis 64, and the roll 62 and pitch 60 axes.”, further in [0170], where forward kinematics are further used (precise movements of the arm, which is shown using a cartesian coordinate system with the exact movements being recorded “ the marker 720 positions from these moves can be used to establish a Cartesian coordinate system for the robot 15 in which the origin (0,0,0) is through the center of the end-effectuator 30 and is at the location along the end-effectuator 30 closest to where pitch 60 occurs. Additionally or alternatively, in some embodiments, this coordinate system can be rotated to an alignment in which y-axis 68 movement of the robot 15 can occur exactly or substantially along the coordinate system's y-axis 68, while x-axis 66 movement of the robot 15 occurs substantially perpendicular to the y-axis 68, but by construction of the coordinate system, without resulting in any change in the z-axis 70 coordinate." And further in [0264] where the system is being dynamically updated, which provides the third position, or any additional positions the instrument is located “the data may be redundant of position data calculated from RF transmitters 120 located on the surgical instrument 35. Therefore, in some embodiments, position data from the position encoders may be used to double-check the position being read from the LPS”);
determine, based on the third position and the transformation relationship, a fourth position of the instrument with respect to the second coordinate system (corresponding disclosure in at least [0175], where a third position (the position is constantly being updated based on the calculated coordinate system based on the medical image [second coordinate system)” during tracking, the desired trajectory can be first calculated in the medical image coordinate system, then transformed to the robot 15 coordinate system based at least on known relative locations of active markers” and Fig 24 and [0177] further outlining how the calibrated coordinate system using the medical image is incorporated into determining the position of an instrument “FIG. 24 is a flowchart of a method 2400 for positioning and advancing through soft tissue” ); and
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Figure 24 of Crawford
displaying at least one part of the instrument in a navigation image based on the fourth position, wherein the navigation image comprises a superposition of the medical image and the at least one part of the instrument (corresponding disclosure in at least [0266], where the instrument (surgical device) is superimposed onto the medical image (3D anatomical image) “ the computer 100 superimposes a representation of the location calculated in step 270 of the surgical device on the 3D anatomical image of the patient”).
Regarding Claim 19,
Crawford teaches a non-transitory computer-readable medium storing at least one instruction that (corresponding disclosure in at least [0169], where there is a medium for instructions “It should be further appreciated that the methods disclosed in the various embodiments described throughout the subject specification can be stored on an article of manufacture, or computer-readable medium, to facilitate transporting and transferring such methods to a computing device”), when executed by a processor of an electronic device, causes the electronic device to perform a method for navigating an operation performed by a surgical system (corresponding disclosure in at least [0144], “user input 170 can be used to plan the trajectory for a desired navigation”),
the surgical system comprising a mechanical arm with a plurality of arm joints (corresponding disclosure in at least [0137], where there are a plurality of joints mentioned (series of joints) “Some embodiments include a robot 15 that moves on a Cartesian positioning system; that is, movements in different axes can occur relatively independently of one another instead of at the end of a series of joints.”), the method comprising:
obtaining a medical image, the medical image comprising a plurality of markers on the surgical system (corresponding disclosure in at least [0444], where there are markers shown in the medical image “ this calibration can be done by the technician scrolling through image slices and marking them using the software, or by an algorithm that automatically checks each slice of the medical image, finds the markers 730, verifying that they are the markers 730 of interest based on their physical spacing”);
determining, based on a first output of a plurality of encoders corresponding to the plurality of arm joints, a plurality of mechanism parameters of the mechanical arm, and forward kinematics, a plurality of first positions of the plurality of markers with respect to a first coordinate system (corresponding disclosure in at least [0160], where the position of the markers is known based on where the arm joints are, the mechanism parameters of the arm (tracked location) “ the robotic surgical system 1 can comprise a plurality of conventional tracking markers 720 configured to track the movement of the robot arm 23, the end-effectuator 30, and/or the surgical instrument 35 in three dimensions… three dimensional positional information from tracking markers 720 can be used in conjunction with the one dimensional linear positional information from absolute or relative conventional linear encoders on each axis of the robot 15 to maintain a high degree of accuracy… the plurality of tracking markers 720 can be configured to track the movement of the robot 15 arm, the end-effectuator 30, and/or the surgical instrument 3” further in [0160] “, the computer 100 can utilize the tracking information to calculate the orientation and coordinates of the distal tip 30 a of the surgical instrument 35 based on encoder counts along the x-axis 66, y-axis 68, z-axis 70, the Z-tube axis 64, and the roll 62 and pitch 60 axes.”, further in [0170], where forward kinematics are further used (precise movements of the arm, which is shown using a cartesian coordinate system with the exact movements being recorded “ the marker 720 positions from these moves can be used to establish a Cartesian coordinate system for the robot 15 in which the origin (0,0,0) is through the center of the end-effectuator 30 and is at the location along the end-effectuator 30 closest to where pitch 60 occurs. Additionally or alternatively, in some embodiments, this coordinate system can be rotated to an alignment in which y-axis 68 movement of the robot 15 can occur exactly or substantially along the coordinate system's y-axis 68, while x-axis 66 movement of the robot 15 occurs substantially perpendicular to the y-axis 68, but by construction of the coordinate system, without resulting in any change in the z-axis 70 coordinate." And further in [0264] “the data may be redundant of position data calculated from RF transmitters 120 located on the surgical instrument 35. Therefore, in some embodiments, position data from the position encoders may be used to double-check the position being read from the LPS”);
determining, based on the medical image, a plurality of second positions of the plurality of markers with respect to a second coordinate system (corresponding disclosure in at least [0444], where there are markers shown in the medical image “ this calibration can be done by the technician scrolling through image slices and marking them using the software, or by an algorithm that automatically checks each slice of the medical image, finds the markers 730, verifying that they are the markers 730 of interest based on their physical spacing”, further in [0009], where the location is dynamically updated, meaning the second position, etc. is determined “RF signals can be sent by the RF transmitter on an iterative basis and then analyzed in an iterative process to allow the surgical robot to automatically move the effectuator element and/or surgical instrument to a desired location within a patient's body. The location of the effectuator element and/or surgical instrument can be dynamically updated and, optionally, can be displayed to a user in real-time”);
determining a transformation relationship between the first coordinate system and the second coordinate system based on the plurality of first positions and the plurality of second positions (corresponding disclosure in at least [0183], where an arbitrary coordinate system is used to determine the transformation relationship when there is a change in the markers “at the time the calibration of the fixture 690 occurred, this positional relationship can be retained in a computer memory (e.g., system memory 3412) for later access on real-time or substantially on real-time in a set of four arbitrary reference Cartesian coordinate systems that can be readily reachable through transformations at any later frame of data. In some embodiments, each reference coordinate system can utilize an unambiguous positioning of three of the active markers 720”);
determining, during the operation, based on a second output of the plurality of encoders, the plurality of mechanism parameters of the mechanical arm, and the forward kinematics, a third position of an instrument used for the operation with respect to the first coordinate system (corresponding disclosure in at least [0160], where the position of the markers is known based on where the arm joints are, the mechanism parameters of the arm (tracked location) “ the robotic surgical system 1 can comprise a plurality of conventional tracking markers 720 configured to track the movement of the robot arm 23, the end-effectuator 30, and/or the surgical instrument 35 in three dimensions… three dimensional positional information from tracking markers 720 can be used in conjunction with the one dimensional linear positional information from absolute or relative conventional linear encoders on each axis of the robot 15 to maintain a high degree of accuracy… the plurality of tracking markers 720 can be configured to track the movement of the robot 15 arm, the end-effectuator 30, and/or the surgical instrument 3” further in [0160] “, the computer 100 can utilize the tracking information to calculate the orientation and coordinates of the distal tip 30 a of the surgical instrument 35 based on encoder counts along the x-axis 66, y-axis 68, z-axis 70, the Z-tube axis 64, and the roll 62 and pitch 60 axes.”, further in [0170], where forward kinematics are further used (precise movements of the arm, which is shown using a cartesian coordinate system with the exact movements being recorded “ the marker 720 positions from these moves can be used to establish a Cartesian coordinate system for the robot 15 in which the origin (0,0,0) is through the center of the end-effectuator 30 and is at the location along the end-effectuator 30 closest to where pitch 60 occurs. Additionally or alternatively, in some embodiments, this coordinate system can be rotated to an alignment in which y-axis 68 movement of the robot 15 can occur exactly or substantially along the coordinate system's y-axis 68, while x-axis 66 movement of the robot 15 occurs substantially perpendicular to the y-axis 68, but by construction of the coordinate system, without resulting in any change in the z-axis 70 coordinate." And further in [0264] where the system is being dynamically updated, which provides the third position, or any additional positions the instrument is located “the data may be redundant of position data calculated from RF transmitters 120 located on the surgical instrument 35. Therefore, in some embodiments, position data from the position encoders may be used to double-check the position being read from the LPS”);
determining, based on the third position and the transformation relationship, a fourth position of the instrument with respect to the second coordinate system (corresponding disclosure in at least [0175], where a third position (the position is constantly being updated based on the calculated coordinate system based on the medical image [second coordinate system)” during tracking, the desired trajectory can be first calculated in the medical image coordinate system, then transformed to the robot 15 coordinate system based at least on known relative locations of active markers” and Fig 24 and [0177] further outlining how the calibrated coordinate system using the medical image is incorporated into determining the position of an instrument “FIG. 24 is a flowchart of a method 2400 for positioning and advancing through soft tissue” ); and
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Figure 24 of Crawford
displaying at least one part of the instrument in a navigation image based on the fourth position, wherein the navigation image comprises a superposition of the medical image and the at least one part of the instrument (corresponding disclosure in at least [0266], where the instrument (surgical device) is superimposed onto the medical image (3D anatomical image) “ the computer 100 superimposes a representation of the location calculated in step 270 of the surgical device on the 3D anatomical image of the patient”).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 5 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Crawford (US20220110701A1) in view of Drexl (US20210236208A1).
Regarding Claims 5 and 12, Crawford teaches the limitations of Claim 4 and wherein the surgical system further comprises an end effector module (corresponding disclosure in at least [0188], where there is an end effector module “the current position of the robot's end effectuator 30, or by an extrapolation of the end effectuator guide tube 50 if an instrument 35 were to extend from it along the same vector”), but does not teach where the end effector module is configured to couple the calibration device and the instrument.
Drexl, in a similar field of endeavor, teaches a similar concept (tracking surgical systems) of where the end effector module is configured to couple the calibration device and the instrument (corresponding disclosure in at least Figure 1, where there’s a calibration device which is coupled to the instrument, and further in [0186], where the calibration device is at the end, right before the instrument tip (“the instrument tip 11 is calibrated by using the calibration device 20 before the instrument 10 is used for tracking”).
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Figure 1 of Drexl
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated where the end effector module is configured to couple the calibration device and the instrument as taught by Drexl. One of the ordinary skill in the art would have been motivated to incorporate this because adding the calibration device at the end would calibrate the arm joints, which require the precise position and orientation information for the user to accurately navigate through the patient.
Claims 6 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Crawford (US20220110701A1) and Drexl (US20210236208A1) as applied in Claim 5, and in further view of Crawford (US20170252114A1).
Regarding claim 6 and 13, Crawford and Drexl teach the limitations of Claims 5 and 12 and further teaches the calibration device and the instrument are coupled to the end effector module (corresponding disclosure in at least [0186] of Drexl) and the medical image (corresponding disclosure in at least [0444] of Crawford), but does not teach the at least one part of the instrument is surrounded by the plurality of markers of the calibration device in the first image.
Crawford, in a similar field of endeavor, teaches a similar concept (medical instrument positioning and navigation) wherein the at least one part of the instrument is surrounded by the plurality of markers of the calibration device (corresponding disclosure in at least [0080] and Figure 13, where there are markers, which are for calibration, that surround a part of the instrument (the shaft) “three reflective lenses 725 a are used around the outer surface of the shaft 38 of the instrument 35. Although three lenses 725 a are exemplified, it is possible that more or less lenses 725 a may be used. It is also possible that more lenses 725 a or other markers may be provided at other locations on or extending from the instrument 35”).
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Figure 13 of Crawford
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the plurality of markers surrounding a part of the instrument into the teachings of the combined references. One of the ordinary skill in the art would have been motivated to incorporate this because surrounding the instrument would allow the markers to be captured in the image in any orientation or angle without having to reposition the camera to view the marker.
Response to Arguments
Applicant's arguments filed 10/29/25 regarding the Claim objections have been fully considered and are withdrawn.
Applicant's arguments filed 10/29/25 regarding the 35 U.S.C. 101 rejection have been fully considered and are withdrawn in light of the amendments.
Applicant’s arguments regarding the 35 U.S.C. 103 rejections with respect to claims 1, 3-6, 8, 10-13, 15, 17, and 19 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument (see rejection in office action above under 35 U.S.C. 102 (a)(1) and 35 U.S.C. 103).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/K.E.K./Examiner, Art Unit 3797
/SERKAN AKAR/Primary Examiner, Art Unit 3797