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 .
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 15 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 15 recites the limitation “setting current implant parameters as final implant parameters in response to the first sensor being within the threshold of the second angle”. The specification lacks disclosure of setting current implant parameters as final implant parameters. Paragraph 0096 of the specification disclose “After the navigation computer 26 adjusts the IMU parameters, the method 300 may continue back at 320 where the calibration motion is performed again. At 356, the method 300 sets the current parameters of the IMU 64 as the final parameters of the IMU 64 to register the coordinate system of the IMU to the anatomical coordinate system and the method 300 may end. The final parameters of the IMU 64 may correspond to a combination of the sensor coordinate system and the relationship between the sensor coordinate system and the anatomical coordinate system. As a result, the sensor coordinate system may be registered to the anatomical coordinate system such that sensor readings provided by the IMU 64 (e.g. translation and/or rotation of the sensor) are provided relative to the anatomical coordinate system instead of or in addition to the sensor coordinate system.” Which describes setting the current sensor parameters as the final parameters of the sensor and not of the implant. The implant parameters are defined as the physical dimensions and geometrical profile of the implant which differ from the parameters of the sensors. The examiner questions what are the final implant parameters, the difference between the current implant parameters and the final implant parameters, and how are they being set if the implant is already attached to the patient.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-6, 8-10, and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Roche et al. (US 2022/0202505) in the view of Kim et al. (US 2021/0134011).
Regarding claim 1, Roche teaches a method for registering a sensor coordinate system of a first sensor of an implant to an anatomical coordinate system using a surgical system, the implant including a second sensor, the surgical system including a surgical navigation system, the first sensor having a predetermined spatial relationship relative to the implant, the implant being coupled to a bone of a patient, the method comprising (paras. 0027 and 0036; a prosthetic component configured to rotate after being coupled to a bone; a sensored prosthesis having an articular surface where the sensored prosthesis is configured to couple to a second prosthetic component, the sensored prosthesis has a plurality of load sensors coupled to the articular surface and a position measurement system configured to measure position, slope, rotation, or trajectory. Surgical system 10 comprises a surgical navigation system 30, an implant device 24, and an implant device 26. Tracking device 14 and tracking device 18 respectively relate to tibia 20 and femur 22 through a process of registration. The process of registration links a tracking device to the bone to which it couples. In the example, registration allows the tracking devices to precisely track a position of a first bone relative to a second bone. As an example or a registration process, navigation system 30 links the patient and the area of interest (the knee joint and leg) with a pre-operative scan. The process can include merging the physical space to the image space. For example, they can be paired point to point from a physical location to the location on the image. The computer 12 can then computer a 3D coordinate transformation of the physical and the image. The registration process is completed when the error is less than a predetermined amount. In one embodiment, the registration process further includes identifying the locations of holes 32 and holes 34 relative to tibia 20 and femur 22. The location of holes 32 and holes 34 can be used to support registration of implanted devices 24 and 26 post-operatively. The examiner notes that a prosthetic component comprise a position sensing mechanism configured to measure pose data and a navigation system comprising tibia tracker and femur tracker. The system registers the coordinates of the sensors and the trackers to an anatomical coordinate system based on preoperative image.):
receiving at least one medical image defining the anatomical coordinate system, the at least one medical image including a first body segment and a second body segment forming a joint (para. 0036; an example or a registration process, navigation system 30 links the patient and the area of interest (the knee joint and leg) with a pre-operative scan. In one embodiment, the scan can be a CT scan, MRI scan, or a fluoroscope image.); and
after the implant has been coupled to the first body segment and the second body segment forming the joint, while the first body segment and the second body segment are in a first pose (paras. 0027 and 0037; Surgical system 10 further includes implantable device 24 and implantable device 26. Implantable devices 24 and 26 are configured to be installed after the installation of the one or more prosthetic components. The examiner notes that the implantable devices can be part of the prosthetic components as described in para. 0027):
obtaining motion data from at least one of the first sensor and the second sensor (para. 0037; The measurement data from the IMU of implantable device 24 or device 26 can be used to determine range of motion, joint alignment, and gait mechanics after the prosthetic knee joint is installed. ), and
obtaining navigation data of the first body segment and the second body segment with the surgical navigation system (para. 0036; Surgical navigation system 30 allows precise tracking of the position tracking device 14, tracking device 16, and tracking device 18 thereby tracking tibia 20 and femur 22. Tracking device 14 and tracking device 18 respectively relate to tibia 20 and femur 22 through a process of registration. The process of registration links a tracking device to the bone to which it couples. In the example, registration allows the tracking devices to precisely track a position of a first bone relative to a second bone.).
Although Roche teaches measuring movement of femur relative to tibia , rotation of the knee joint, anterior-posterior movement, a range of motion based on motion data from the sensors and the trackers and registering all coordinates to an anatomical coordinate system defined by a preoperative image. However fails to explicitly teach determining a first angle of the joint based on the motion data; determining a second angle of the joint based on the surgical navigation system; comparing the first angle to the second angle; and selectively adjusting one or more parameters of the first sensor so that the first angle falls within a threshold of the second angle.
Kim, in the same field of endeavor, teaches determining a first angle of the joint based on the motion data (para. 0041; body movement analysis engine 112 can run algorithms that take the raw sensor data and compute human readable motion analysis, for example, taking quaternion sensor data and computing Euler angles relative to the three axis of rotation of bone segments. This can then be converted into joint movement data such as internal/external rotation, abduction/adduction and flexion/extension of a joint (e.g., hip, knee, shoulder, etc.), or bony segment (e.g., femur, tibia/fibula, humerus, radius ulna, vertebra, etc.).); determining a second angle of the joint based on the surgical navigation system (para. 0041; body movement analysis engine 112 can compute the angle of the lines drawn on the x-ray image to determine the initial offset. The algorithm will compute the segment and joint movements frame by frame captured by the sensors and map out the data in graph form.); comparing the first angle to the second angle (para. 0041; At block 525, method 500 determines an offset of the at least one bone or joint relative to a reference frame, wherein the offset represents the actual orientation of the at least one bone or joint in the initial position. Furthermore, the bone and joint movement data can take the x-ray data 145 to make an off-set adjustment of the initial orientation.); and selectively adjusting one or more parameters of the first sensor so that the first angle falls within a threshold of the second angle (paras. 0024, 0027, and 0041-0042; body movement analysis engine 112 receives the 3D motion capture data 144 of the subject user 140 performing the physical activity or physical movement and receives the x-ray data 145 of subject user 140 representing at least a portion of subject user's body while in the initial position. Body movement analysis engine 112 can use x-ray data 145 to refine the motion capture data 344 and improve the readings of motion capture sensors 142. At block 525, method 500 determines an offset of the at least one bone or joint relative to a reference frame, wherein the offset represents the actual orientation of the at least one bone or joint in the initial position. At block 530, to calibrate the initial orientation of the plurality of 3D motion capture sensors 142 to reflect the actual orientation of the at least one bone or joint in the initial position, method 500 replaces first values of tilt and rotation measured by the plurality of 3D motion capture sensors 142 with second values of tilt and rotation determined from the x-ray data 145. The examiner notes that the system calculates the angle of the joint in initial pose based on motion captured data from sensors and from X-ray image and compare the angles to determine an offset between the two measurements. The system further adjust the parameters of the sensors based on the determined offset and calibrate the sensor.).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the registration step of Roche with the registration steps that includes determining and comparing joint angle determined from motion data and navigation system to adjust and calibrate parameters of the motion sensors, as taught by Kim, because such modification would enable accurate registration and representation of the actual amount of joint movement, angles, position and orientation of the joint as disclosed within Kim in paras. 0016 and 0027.
Regarding claim 2, Roche teaches the method of claim 1, the surgical navigation system includes determining a pose of the first body segment and a pose of the second body segment with the surgical navigation system (para. 0036; Surgical navigation system 30 allows precise tracking of the position tracking device 14, tracking device 16, and tracking device 18 thereby tracking tibia 20 and femur 22. Tracking device 16 which supports a bone cut can be precisely placed relative to tibia 20 or femur 22. Tracking device 14 and tracking device 18 respectively relate to tibia 20 and femur 22 through a process of registration. The process of registration links a tracking device to the bone to which it couples. In the example, registration allows the tracking devices to precisely track a position of a first bone relative to a second bone.).
Although Roche teaches determining the pose of the tibia relative to the femur based on navigation data from a surgical navigation system, however, fails to explicitly teach obtaining a joint angle based on determined pose of the two joint segments.
Kim, in the same field of endeavor, teaches obtaining a joint angle based on determined pose of the two joint segments (paras. 0025-0026 and 0041; body movement analysis engine 112 determines an actual orientation of at least one bone or joint from the portion of the subject user's body in the initial position, as represented in x-ray data 145. In one embodiment, body movement analysis engine 112 generates an image (i.e., an x-ray image) from the received x-ray data 145, where the image is of a portion of the body (e.g., the pelvis) of subject user 140. A surgeon, doctor, technician, health professional, or other user, can provide user input data 146 including an indication of at least one bone or joint depicted in the x-ray image. As illustrated in FIG. 3, the user input can include an alignment indicator indicating the at least one bone or joint. In this case, alignment indicator 312 indicates the alignment of the pelvis shown in the x-ray image, and alignment indicator 314 indicates the alignment of the femur shown in the x-ray image. Based on the alignment indicator(s), body movement analysis engine 112 can calculate an offset or offsets of the at least one bone or joint relative to a reference frame. For example, body movement analysis engine 112 can determine that alignment indicator 312 indicates a certain degree of pelvic tilt (e.g., −10 degrees) on a given axis, and that alignment indicator 314 indicates a certain degree of femur flexion (e.g., 1 degree). In one embodiment, body movement analysis engine 112 can compute the angle of the lines drawn on the x-ray image to determine the initial offset.).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the registration step of Roche with the registration steps that includes determining joint angle based on pose of the joint segments, as taught by Kim, because such modification would enable accurate registration and representation of the actual amount of joint movement, angles, position and orientation of the joint by calculating the initial offset between angles determined based on measured motion data and pose of the segments to calibrate motion sensors as disclosed within Kim in paras. 0016 and 0027.
Regarding claim 3, Roche teaches the method of claim 2, where the first body segment is a femur and the second body segment is a tibia (para. 0035; Surgical navigation system 30 is configured to couple to one or more bones in the musculoskeletal system. In the example, surgical system 10 is coupled to a tibia 20 and a femur 22.).
Regarding claim 4, Roche teaches the method of claim 1, however, fails to explicitly teach wherein the first angle and the second angle include at least one of a flexion/extension (F/E) angle, an internal/external (IE) rotation angle and a varus/valgus (V/V) angle.
Kim, in the same field of endeavor, disclose the first angle and the second angle include at least one of a flexion/extension (F/E) angle, an internal/external (IE) rotation angle and a varus/valgus (V/V) angle (para. 0041; body movement analysis engine 112 can run algorithms that take the raw sensor data and compute human readable motion analysis, for example, taking quaternion sensor data and computing Euler angles relative to the three axis of rotation of bone segments. This can then be converted into joint movement data such as internal/external rotation, abduction/adduction and flexion/extension of a joint (e.g., hip, knee, shoulder, etc.), or bony segment (e.g., femur, tibia/fibula, humerus, radius ulna, vertebra, etc.)).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the registration step of Roche with the registration steps that includes determining and comparing joint angle determined from motion data and navigation system to adjust and calibrate parameters of the motion sensors, as taught by Kim, because such modification would enable accurate registration and representation of the actual amount of joint movement, angles, position and orientation of the joint as disclosed within Kim in paras. 0016 and 0027.
Regarding claim 5, Roche teaches the method of claim 1, further comprising coupling a first tracking element to the first body segment and coupling a second tracking element to the body second segment, the surgical navigation system using the first tracking element and the second tracking element in determining a pose of the first body segment and a pose of the second body segment, the pose of the first body segment and the pose of the second body segment being used to calculate the first angle (paras. 0035-0036; Surgical navigation system 30 is configured to couple to one or more bones in the musculoskeletal system. In the example, surgical system 10 is coupled to a tibia 20 and a femur 22. A tracking device 14 is coupled to tibia 22. A tracking device 18 is coupled to femur 20. Surgical navigation system 30 allows precise tracking of the position tracking device 14, tracking device 16, and tracking device 18 thereby tracking tibia 20 and femur 22. Tracking device 16 which supports a bone cut can be precisely placed relative to tibia 20 or femur 22. Tracking device 14 and tracking device 18 respectively relate to tibia 20 and femur 22 through a process of registration. The process of registration links a tracking device to the bone to which it couples. In the example, registration allows the tracking devices to precisely track a position of a first bone relative to a second bone.).
Regarding claim 6, Roche teaches the method of claim 1, however, fails to explicitly teach wherein obtaining the second angle of the joint of the patient with the surgical navigation system includes identifying a center of the joint.
Kim, in the same field of endeavor, teaches wherein obtaining the second angle of the joint of the patient with the surgical navigation system includes identifying a center of the joint (paras. 0040-0041; In one embodiment, the interface 300 includes a number of controls through which the user can provide input data 146 to indicate the bone or joint. For example, the controls can provide the ability to draw a line, such as 312 or 314 indicating the alignment of a certain bone in the x-ray image. body movement analysis engine 112 can compute the angle of the lines drawn on the x-ray image to determine the initial offset.).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the registration step of Roche with the registration steps that includes determining joint angle based on pose of the joint segments, as taught by Kim, because such modification would enable accurate registration and representation of the actual amount of joint movement, angles, position and orientation of the joint by calculating the initial offset between angles determined based on measured motion data and pose of the segments to calibrate motion sensors as disclosed within Kim in paras. 0016 and 0027.
Regarding claim 8, Roche teaches the method of claim 1, wherein the sensor coordinate system includes an x-axis, a y-axis, and a z-axis, and wherein the first sensor is configured to measure a roll about the x-axis of the sensor coordinate system, a pitch about the y- axis of the sensor coordinate system, and a yaw about the z-axis of the sensor coordinate system (para. 0050; IMU 80 is configured to measure 6 degrees of freedom comprising translation movement along the X, Y, and Z axis as well as rotational movement such as yaw, roll, and pitch around each axis. ).
Regarding claim 9, Roche teaches the method of claim 1, however, fails to explicitly teach wherein the sensor coordinate system includes at least one axis and wherein adjusting the one or more parameters includes: determining at least one anatomical axis defined by the anatomical coordinate system based on the motion data in the anatomical coordinate system and the at least one medical image (paras. 0040-0041; For example, the controls can provide the ability to draw a line, such as 312 or 314 indicating the alignment of a certain bone in the x-ray image. A surgeon, radiologist, or other user can use known landmarks visible in the x-ray to position the lines. For example on the pelvis, a trained professional will know to position one end of the line on a specific part of the bone and the other on another specific part of the bone. At block 525, method 500 determines an offset of the at least one bone or joint relative to a reference frame, wherein the offset represents the actual orientation of the at least one bone or joint in the initial position. In one embodiment, body movement analysis engine 112 can run algorithms that take the raw sensor data and compute human readable motion analysis, for example, taking quaternion sensor data and computing Euler angles relative to the three axis of rotation of bone segments. This can then be converted into joint movement data such as internal/external rotation, abduction/adduction and flexion/extension of a joint (e.g., hip, knee, shoulder, etc.), or bony segment (e.g., femur, tibia/fibula, humerus, radius ulna, vertebra, etc.), as well as joint and skeletal contact stresses and joint reaction forces. Furthermore, the bone and joint movement data can take the x-ray data 145 to make an off-set adjustment of the initial orientation. For example, the initial orientation may assume that a certain bone or other body part has zero forward or backward bend. The x-ray data 145 may provide initial forward and backward angle bends for the body parts, which can be an input parameter to provide the actual orientation of the body part from which the relative movement data of the sensors can be offset. In one embodiment, body movement analysis engine 112 can compute the angle of the lines drawn on the x-ray image to determine the initial offset.); and determining a relationship between the at least one anatomical axis and the at least one axis of the sensor coordinate system (paras. 0040-0041; At block 525, method 500 determines an offset of the at least one bone or joint relative to a reference frame, wherein the offset represents the actual orientation of the at least one bone or joint in the initial position. In one embodiment, body movement analysis engine 112 can run algorithms that take the raw sensor data and compute human readable motion analysis, for example, taking quaternion sensor data and computing Euler angles relative to the three axis of rotation of bone segments. This can then be converted into joint movement data such as internal/external rotation, abduction/adduction and flexion/extension of a joint (e.g., hip, knee, shoulder, etc.), or bony segment (e.g., femur, tibia/fibula, humerus, radius ulna, vertebra, etc.), as well as joint and skeletal contact stresses and joint reaction forces. Furthermore, the bone and joint movement data can take the x-ray data 145 to make an off-set adjustment of the initial orientation. For example, the initial orientation may assume that a certain bone or other body part has zero forward or backward bend. The x-ray data 145 may provide initial forward and backward angle bends for the body parts, which can be an input parameter to provide the actual orientation of the body part from which the relative movement data of the sensors can be offset. In one embodiment, body movement analysis engine 112 can compute the angle of the lines drawn on the x-ray image to determine the initial offset.); and adjusting the one or more parameters based on the relationship (paras. 0041-0042; At block 530, to calibrate the initial orientation of the plurality of 3D motion capture sensors 142 to reflect the actual orientation of the at least one bone or joint in the initial position, method 500 replaces first values of tilt and rotation measured by the plurality of 3D motion capture sensors 142 with second values of tilt and rotation determined from the x-ray data 145.).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the registration step of Roche with the registration steps that includes determining and comparing joint angle determined from motion data and navigation system to adjust and calibrate parameters of the motion sensors, as taught by Kim, because such modification would enable accurate registration and representation of the actual amount of joint movement, angles, position and orientation of the joint as disclosed within Kim in paras. 0016 and 0027.
Regarding claim 10, Roche teaches the method of claim 1, further comprising coupling the implant to at least one of the first body segment and the second body segment (para. 0035; receiving a tibial prosthetic component and a femoral prosthetic component.).
Regarding claim 13, Roche teaches the method of claim 1, wherein the first sensor and the second sensor are inertial measurement units, the implant is a knee implant including a femoral component and a tibial component, the first sensor being disposed on the tibial component, the second sensor being disposed on the femoral component (paras. 0027, 0035, and 0037; implantable devices 24 and 26 each have an inertial measurement unit (IMU) for measuring movement, position, and orientation. The position measurement system can also be a GPS chip, an acoustical ranging device, optical devices, inertial devices, magnetometers, inclinometers, or MEMs devices. Implantable devices 24 and 26 are configured to transmit measurement data to a computer or smart device. Examples of monitoring can comprise: a prosthetic component configured to rotate after being coupled to a bone; a sensored prosthesis having an articular surface where the sensored prosthesis is configured to couple to a second prosthetic component, such as a tibial prosthetic component and a femoral prosthetic component, the sensored prosthesis has a plurality of load sensors coupled to the articular surface and a position measurement system configured to measure position, slope, rotation, or trajectory. The examiner notes that the implantable devices can couple to the tibial and femoral component of the prosthesis instead of being coupled to the tibia and the femur segment.).
Regarding claim 13, Roche teaches the method of claim 1, however, fails to explicitly teach correlating motion data obtained in the first pose to navigation data obtained in the first pose.
Kim, in the same field of endeavor, teaches correlating motion data obtained in the first pose to navigation data obtained in the first pose (paras. 0041-0042; method 500 determines an offset of the at least one bone or joint relative to a reference frame, wherein the offset represents the actual orientation of the at least one bone or joint in the initial position. body movement analysis engine 112 can compute the angle of the lines drawn on the x-ray image to determine the initial offset. to calibrate the initial orientation of the plurality of 3D motion capture sensors 142 to reflect the actual orientation of the at least one bone or joint in the initial position, method 500 replaces first values of tilt and rotation measured by the plurality of 3D motion capture sensors 142 with second values of tilt and rotation determined from the x-ray data 145.).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the registration step of Roche with the registration steps that includes determining and comparing joint angle determined from motion data and navigation system to adjust and calibrate parameters of the motion sensors, as taught by Kim, because such modification would enable accurate registration and representation of the actual amount of joint movement, angles, position and orientation of the joint as disclosed within Kim in paras. 0016 and 0027.
Regarding claim 15, Roche teaches the method of claim 1, however, fails to explicitly teach further comprising correlating motion data obtained in the first pose to navigation data obtained in the first pose.
Kim, in the same field of endeavor, teaches fails to explicitly teach further comprising correlating motion data obtained in the first pose to navigation data obtained in the first pose (para. 0042; At block 530, to calibrate the initial orientation of the plurality of 3D motion capture sensors 142 to reflect the actual orientation of the at least one bone or joint in the initial position, method 500 replaces first values of tilt and rotation measured by the plurality of 3D motion capture sensors 142 with second values of tilt and rotation determined from the x-ray data 145. The examiner notes if there is an offset between the actual pose and the measured pose, the system adjusts the parameters of the sensors by replacing the values of the tilt and rotation of the sensor by the values of tilt and rotation determined from x-ray data. If the is no offset present the system keeps the parameters of the sensor without changing them).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the registration step of Roche with the registration steps that includes determining and comparing joint angle determined from motion data and navigation system to adjust and calibrate parameters of the motion sensors, as taught by Kim, because such modification would enable accurate registration and representation of the actual amount of joint movement, angles, position and orientation of the joint as disclosed within Kim in paras. 0016 and 0027.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Roche et al. (US 2022/0202505) in the view of Kim et al. (US 2021/0134011) and in further view of Luck et al. (US 7,257,237).
Regarding claim 7, Roche in the view of Kim teach the method of claim 1, although Roche teaches determining an anatomical coordinate system using a preoperative image and determining the pose of the tibia and femur using tracking device of the surgical navigation system however fails to explicitly teach wherein the surgical navigation system includes a camera configured to autonomously identify coordinates of the joint and at least one of a pose of the first body segment and a pose of the second body segment without a tracking element coupled to either the first body segment or the second body segment.
Luck, in the same field of endeavor, disclose a camera configured to autonomously identify coordinates of the joint and at least one of a pose of the first body segment and a pose of the second body segment without a tracking element coupled to either the first body segment or the second body segment (Col 12, lines 12-25; f the real time markerless motion tracking method using linked kinematic chains (70), comprising the steps of; calibrating cameras and workspace (20), developing a model template (30), acquiring volumetric data (32), initializing the model (40), acquiring volumetric data (50) and aligning the model to the volumetric data (60). In the method, volumetric data (32) is acquired from the first frame or first few frames of viewing the subject in a workspace and is used to initialize a model of the subject. After the model is initialized, volumetric data is collected from subsequent frames (50) and is used in aligning the model within the workspace. The examiner notes that the system uses cameras to identify coordinates of the joint and poses of the segments of the joint without using markers attached to the segments).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the surgical navigation system of Roche in the view of Kim with the camera that can track pose and motion of human anatomy without the use of markers, as taught by Luck, because such modification would reduce the cost of the tracking device, eliminate the need to attach or wear specialized equipment’s to the patient, increase convenient, and reduce constrains as disclosed within Luck in the background of the invention section.
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Roche et al. (US 2022/0202505) in the view of Kim et al. (US 2021/0134011) and in further view of Disilvestro et al. (US 2015/0272447).
Regarding claim 11, Roche teach the method of claim 1, wherein the first body segment is a femur and the second body segment is a tibia, the implant is a knee implant including a femoral component and a tibial component (para. 0035; Surgical navigation system 30 is configured to couple to one or more bones in the musculoskeletal system. In the example, surgical system 10 is coupled to a tibia 20 and a femur 22. A tracking device 14 is coupled to tibia 22. A tracking device 18 is coupled to femur 20. Also shown is a tracking device 16 to support one or more bone cuts that can be aligned by navigation to cut tibia 20 or femur 22 for respectively receiving a tibial prosthetic component and a femoral prosthetic component. Tracking device 14 and tracking device 18 are typically located to allow the surgeon access to the knee joint to install the prosthetic knee joint. ), the tibial component includes the first sensor, the first sensor configured to generate inertial data representative of a pose of the tibia (para. 0037; Surgical system 10 further includes implantable device 24 and implantable device 26. Implantable devices 24 and 26 are configured to be installed after the installation of the one or more prosthetic components and the surgical navigation system is removed.), the motion data including the inertial data, the method further comprising (para. 0037; implantable devices 24 and 26 each have an inertial measurement unit (IMU) for measuring movement, position, and orientation. The position measurement system can also be a GPS chip, an acoustical ranging device, optical devices, inertial devices, magnetometers, inclinometers, or MEMs devices. Implantable devices 24 and 26 are configured to transmit measurement data to a computer or smart device.): determining a pose of the tibia based on the inertial data (para. 0037; implantable devices 24 and 26 each have an inertial measurement unit (IMU) for measuring movement, position, and orientation. The position measurement system can also be a GPS chip, an acoustical ranging device, optical devices, inertial devices, magnetometers, inclinometers, or MEMs devices. Implantable devices 24 and 26 are configured to transmit measurement data to a computer or smart device.); determining a pose of the femur based on the inertial data (para. 0037; implantable devices 24 and 26 each have an inertial measurement unit (IMU) for measuring movement, position, and orientation. The position measurement system can also be a GPS chip, an acoustical ranging device, optical devices, inertial devices, magnetometers, inclinometers, or MEMs devices. Implantable devices 24 and 26 are configured to transmit measurement data to a computer or smart device.).
However, fails to explicitly teach the femoral component includes a plurality of magnets, and the tibial component includes a sensor, the sensor configured to generate a magnetic data representative of a pose of the plurality of magnets relative to the second sensor, the motion data including the magnetic data, determining a pose of the femur based on the magnetic data; and determining the first angle based on a pose of the femur and the pose of the tibia.
Kim, in the same field of endeavor, teaches determining the first angle based on a pose of the femur and the pose of the tibia (paras. 0019 and 0041; In one embodiment, body movement analysis engine 112 can run algorithms that take the raw sensor data and compute human readable motion analysis, for example, taking quaternion sensor data and computing Euler angles relative to the three axis of rotation of bone segments. This can then be converted into joint movement data such as internal/external rotation, abduction/adduction and flexion/extension of a joint (e.g., hip, knee, shoulder, etc.), or bony segment (e.g., femur, tibia/fibula, humerus, radius ulna, vertebra, etc.)).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the registration step of Roche with the registration steps that includes determining and comparing joint angle determined from motion data and navigation system to adjust and calibrate parameters of the motion sensors, as taught by Kim, because such modification would enable accurate registration and representation of the actual amount of joint movement, angles, position and orientation of the joint as disclosed within Kim in paras. 0016 and 0027.
However, Roche in view of Kim fail to explicitly teach femoral component includes a plurality of magnets, and the tibial component includes a sensor, the sensor configured to generate a magnetic data representative of a pose of the plurality of magnets relative to the second sensor, the motion data including the magnetic data, determining a pose of the femur based on the magnetic data.
Disilvestro, in the same field of endeavor, teaches femoral component includes a plurality of magnets, and the tibial component includes a sensor, the sensor configured to generate a magnetic data representative of a pose of the plurality of magnets relative to the second sensor, the motion data including the magnetic data, determining a pose of the femur based on the magnetic data (paras. 0004 and 0024; the implantable sensor may be embodied as a permanent magnet embedded in the first joint prosthesis component and a Hall effect switch embedded in the second joint prosthesis component. The system may further comprising electronics associated with the permanent magnet and the Hall effect switch that are adapted to determine the number of occasions in which the first and second joint prosthesis component are in a predetermined position relative to one another. the joint use measurement device 10 includes an implanted sensor 50. The sensor 50 may be embodied as a single sensor or as an array of sensors. In the exemplary embodiment of FIG. 3, the implanted sensor 50 includes a signal source 52, such as a permanent magnet, that is embedded in the distal femoral component 28, and a sensor 54, such as a Hall effect switch, embedded in the proximal tibial component 22. In other words, the joint use measurement device 10 illustrated in FIG. 3 utilizes an implanted sensor to determine the number of occasions in which the components of the knee endoprosthesis system 14 are in a predetermined relative position with one another (e.g., the number of occasions in which a predetermined flexion angle is attained), thereby determining cycles of use of the system 14.).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the motion tracking sensors of Roche in the view of Kim to add the permanent magnet embedded in the first joint prosthesis component and a Hall effect switch embedded in the second joint prosthesis component, as taught by Disilvestro, because such modification would increase the accuracy of the motion data by measuring inertial data from inertial sensor and measuring the relative position/angle from the hall effect sensor.
Regarding claim 12, Roche in the view of Kim teach the method of claim 11, however fails to explicitly teach wherein the second sensor is a hall effect sensor.
Disilvestro, in the same field of endeavor, teaches second sensor is a hall effect sensor (paras. 0004 and 0024; the implantable sensor may be embodied as a permanent magnet embedded in the first joint prosthesis component and a Hall effect switch embedded in the second joint prosthesis component. The system may further comprising electronics associated with the permanent magnet and the Hall effect switch that are adapted to determine the number of occasions in which the first and second joint prosthesis component are in a predetermined position relative to one another. the joint use measurement device 10 includes an implanted sensor 50. The sensor 50 may be embodied as a single sensor or as an array of sensors. In the exemplary embodiment of FIG. 3, the implanted sensor 50 includes a signal source 52, such as a permanent magnet, that is embedded in the distal femoral component 28, and a sensor 54, such as a Hall effect switch, embedded in the proximal tibial component 22. In other words, the joint use measurement device 10 illustrated in FIG. 3 utilizes an implanted sensor to determine the number of occasions in which the components of the knee endoprosthesis system 14 are in a predetermined relative position with one another (e.g., the number of occasions in which a predetermined flexion angle is attained), thereby determining cycles of use of the system 14.).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the motion tracking sensors of Roche in the view of Kim to add the permanent magnet embedded in the first joint prosthesis component and a Hall effect switch embedded in the second joint prosthesis component, as taught by Disilvestro, because such modification would increase the accuracy of the motion data by measuring inertial data from inertial sensor and measuring the relative position/angle from the hall effect sensor.
Claims 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Roche et al. (US 2022/0202505) in the view of Krebs et al. (US 2021/0353367) and Kim et al. (US 2021/0134011).
Regarding claim 16, Roche teaches a system comprising:
an implant including a sensor defining a sensor coordinate system including at least one sensor axis, the implant configured to be fixed to a first bone of a patient and the sensor having a first fixed spatial relationship relative to the implant, wherein the sensor is configured to output inertial data of the implant (paras. 0027, 0035, and 0037; implantable devices 24 and 26 each have an inertial measurement unit (IMU) for measuring movement, position, and orientation. The position measurement system can also be a GPS chip, an acoustical ranging device, optical devices, inertial devices, magnetometers, inclinometers, or MEMs devices. Implantable devices 24 and 26 are configured to transmit measurement data to a computer or smart device. Examples of monitoring can comprise: a prosthetic component configured to rotate after being coupled to a bone; a sensored prosthesis having an articular surface where the sensored prosthesis is configured to couple to a second prosthetic component, such as a tibial prosthetic component and a femoral prosthetic component, the sensored prosthesis has a plurality of load sensors coupled to the articular surface and a position measurement system configured to measure position, slope, rotation, or trajectory. The examiner notes that the implantable devices can couple to the tibial and femoral component of the prosthesis instead of being coupled to the tibia and the femur segment.);
a patient tracking element configured to couple to the patient (para. 0035; Surgical navigation system 30 is configured to couple to one or more bones in the musculoskeletal system. In the example, surgical system 10 is coupled to a tibia 20 and a femur 22. A tracking device 14 is coupled to tibia 22. A tracking device 18 is coupled to femur 20. );
a navigation system configured to: receive an image of the patient defining an anatomical coordinate system (para. 0036; As an example or a registration process, navigation system 30 links the patient and the area of interest (the knee joint and leg) with a pre-operative scan. In one embodiment, the scan can be a CT scan, MRI scan, or a fluoroscope image. The process can include merging the physical space to the image space. For example, they can be paired point to point from a physical location to the location on the image. The computer 12 can then computer a 3D coordinate transformation of the physical and the image.);
register the patient in a global coordinate system to the anatomical coordinate system (para. 0036; As an example or a registration process, navigation system 30 links the patient and the area of interest (the knee joint and leg) with a pre-operative scan. In one embodiment, the scan can be a CT scan, MRI scan, or a fluoroscope image. The process can include merging the physical space to the image space. For example, they can be paired point to point from a physical location to the location on the image. The computer 12 can then computer a 3D coordinate transformation of the physical and the image.);
determine the pose of the implant in the anatomical coordinate system (para. 0037; implantable devices 24 and 26 each have an inertial measurement unit (IMU) for measuring movement, position, and orientation. The position measurement system can also be a GPS chip, an acoustical ranging device, optical devices, inertial devices, magnetometers, inclinometers, or MEMs devices. Implantable devices 24 and 26 are configured to transmit measurement data to a computer or smart device. The location of the holes on tibia 20 and femur 22 can be provided for use in the registration of implantable devices 24 and 26. Alternatively, a registration process can be performed with the leg performing one or more predetermined movements with implantable devices 24 and 26 enabled to respectively link implantable devices 24 and 26 to tibia 20 and femur 22. ).
However, fails to explicitly teach a surgical instrument configured to couple to the implant, the surgical instrument including an instrument tracking element; and track a pose of the surgical instrument in the global coordinate system, determine a pose of the implant based on the pose of the surgical instrument in the global coordinate system, selectively adjust one or more parameters of the sensor to register the sensor coordinate system to the anatomical coordinate system.
Krebs, in the same field of endeavor, teaches a surgical instrument configured to couple to the implant (paras. 0034 and 0090; robotic system 104 includes a base 105, an articulated arm 106, a force system (not shown), and a controller (not shown). A surgical tool 110 (e.g., an end effector having an operating member, such as a saw, reamer, or burr) may be coupled to the articulated arm 106. The surgeon can manipulate the surgical tool 110 by grasping and manually moving the articulated arm 106 and/or the surgical tool 110. Furthermore, the robotic arm can be used to hold the implant in place relative to the bone while the cement is curing.), the surgical instrument including an instrument tracking element; and track a pose of the surgical instrument in the global coordinate system, determine a pose of the implant based on the pose of the surgical instrument in the global coordinate system (paras. 0034 and 0036; Tracking system 101 is configured to determine a pose (i.e., position and orientation) of one or more objects during a surgical procedure to detect movement of the object(s). For example, the tracking system 101 may include a detection device that obtains a pose of an object with respect to a coordinate frame of reference of the detection device. As the object moves in the coordinate frame of reference, the detection device tracks the pose of the object to detect (or enables the surgical system 100 to determine) movement of the object. As a result, the computing system 102 can capture data in response to movement of the tracked object or objects. Tracked objects may include, for example, tools/instruments, patient anatomy, implants/prosthetic devices, and components of the surgical system 100. Using pose data from the tracking system 101, the surgical system 100 is also able to register (or map or associate) coordinates in one space to those in another to achieve spatial alignment or correspondence (e.g., using a coordinate transformation process as is well known). Objects in physical space may be registered to any suitable coordinate system, such as a coordinate system being used by a process running on a surgical controller and/or the computer device of the robotic system 104. For example, utilizing pose data from the tracking system 101, the surgical system 100 is able to associate the physical anatomy, such as the patient's tibia, with a representation of the anatomy (such as an image displayed on the display device 103). Based on tracked object and registration data, the surgical system 100 may determine, for example, a spatial relationship between the image of the anatomy and the relevant anatomy.).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system of Roche to add a surgical tool with a tracking element for navigating an implant, as taught by Krebs, because such modification would increase the accuracy of positioning the implant in the correct desired position and helps guide the insertion of the implant.
However, Roche in the view of Krebs fail to explicitly teach selectively adjust one or more parameters of the sensor to register the sensor coordinate system to the anatomical coordinate system.
Kim, in the same field of endeavor, teaches selectively adjust one or more parameters of the sensor to register the sensor coordinate system to the anatomical coordinate system (paras. 0024, 0027, and 0041-0042; body movement analysis engine 112 receives the 3D motion capture data 144 of the subject user 140 performing the physical activity or physical movement and receives the x-ray data 145 of subject user 140 representing at least a portion of subject user's body while in the initial position. Body movement analysis engine 112 can use x-ray data 145 to refine the motion capture data 344 and improve the readings of motion capture sensors 142. At block 525, method 500 determines an offset of the at least one bone or joint relative to a reference frame, wherein the offset represents the actual orientation of the at least one bone or joint in the initial position. At block 530, to calibrate the initial orientation of the plurality of 3D motion capture sensors 142 to reflect the actual orientation of the at least one bone or joint in the initial position, method 500 replaces first values of tilt and rotation measured by the plurality of 3D motion capture sensors 142 with second values of tilt and rotation determined from the x-ray data 145. The examiner notes that the system calculates the angle of the joint in initial pose based on motion captured data from sensors and from X-ray image and compare the angles to determine an offset between the two measurements. The system further adjust the parameters of the sensors based on the determined offset and calibrate the sensor.).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the registration step of Roche in the view of Krebs with the registration steps that includes determining and comparing joint angle determined from motion data and navigation system to adjust and calibrate parameters of the motion sensors, as taught by Kim, because such modification would enable accurate registration and representation of the actual amount of joint movement, angles, position and orientation of the joint as disclosed within Kim in paras. 0016 and 0027.
Regarding claim 17, Roche teaches the system of claim 16, however, fails to explicitly teach wherein the navigation system determines the pose of the implant in the global coordinate system based on the pose of the surgical instrument in the global coordinate system and a spatial relationship between the surgical instrument and the implant.
Kerbs, in the same field of endeavor, teaches wherein the navigation system determines the pose of the implant in the global coordinate system based on the pose of the surgical instrument in the global coordinate system and a spatial relationship between the surgical instrument and the implant (paras. 0034 and 0036; Tracking system 101 is configured to determine a pose (i.e., position and orientation) of one or more objects during a surgical procedure to detect movement of the object(s). For example, the tracking system 101 may include a detection device that obtains a pose of an object with respect to a coordinate frame of reference of the detection device. As the object moves in the coordinate frame of reference, the detection device tracks the pose of the object to detect (or enables the surgical system 100 to determine) movement of the object. As a result, the computing system 102 can capture data in response to movement of the tracked object or objects. Tracked objects may include, for example, tools/instruments, patient anatomy, implants/prosthetic devices, and components of the surgical system 100. Using pose data from the tracking system 101, the surgical system 100 is also able to register (or map or associate) coordinates in one space to those in another to achieve spatial alignment or correspondence (e.g., using a coordinate transformation process as is well known). Objects in physical space may be registered to any suitable coordinate system, such as a coordinate system being used by a process running on a surgical controller and/or the computer device of the robotic system 104. For example, utilizing pose data from the tracking system 101, the surgical system 100 is able to associate the physical anatomy, such as the patient's tibia, with a representation of the anatomy (such as an image displayed on the display device 103). Based on tracked object and registration data, the surgical system 100 may determine, for example, a spatial relationship between the image of the anatomy and the relevant anatomy.).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system of Roche to add a surgical tool with a tracking element for navigating an implant, as taught by Krebs, because such modification would increase the accuracy of positioning the implant in the correct desired position and helps guide the insertion of the implant.
Regarding claim 18, Roche teaches the system of claim 16, however, fails to explicitly teach wherein the surgical instrument includes a robotic manipulator configured to guide the implant relative to the patient.
Kerbs, in the same field of endeavor, teaches wherein the navigation system determines the pose of the implant in the global coordinate system based on the pose of the surgical instrument in the global coordinate system and a spatial relationship between the surgical instrument and the implant (paras. 0034, 0036, and 0090; Tracking system 101 is configured to determine a pose (i.e., position and orientation) of one or more objects during a surgical procedure to detect movement of the object(s). For example, the tracking system 101 may include a detection device that obtains a pose of an object with respect to a coordinate frame of reference of the detection device. As the object moves in the coordinate frame of reference, the detection device tracks the pose of the object to detect (or enables the surgical system 100 to determine) movement of the object. As a result, the computing system 102 can capture data in response to movement of the tracked object or objects. Tracked objects may include, for example, tools/instruments, patient anatomy, implants/prosthetic devices, and components of the surgical system 100. Using pose data from the tracking system 101, the surgical system 100 is also able to register (or map or associate) coordinates in one space to those in another to achieve spatial alignment or correspondence (e.g., using a coordinate transformation process as is well known). Objects in physical space may be registered to any suitable coordinate system, such as a coordinate system being used by a process running on a surgical controller and/or the computer device of the robotic system 104. For example, utilizing pose data from the tracking system 101, the surgical system 100 is able to associate the physical anatomy, such as the patient's tibia, with a representation of the anatomy (such as an image displayed on the display device 103). Based on tracked object and registration data, the surgical system 100 may determine, for example, a spatial relationship between the image of the anatomy and the relevant anatomy.).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system of Roche to add a surgical tool with a tracking element for navigating an implant, as taught by Krebs, because such modification would increase the accuracy of positioning the implant in the correct desired position and helps guide the insertion of the implant.
Regarding claim 19, Roche teaches the system of claim 16, wherein the sensor includes an inertial measurement unit configured to output the inertial data which corresponds to the pose of the implant (para. 0037; In one embodiment, implantable devices 24 and 26 each have an inertial measurement unit (IMU) for measuring movement, position, and orientation. The position measurement system can also be a GPS chip, an acoustical ranging device, optical devices, inertial devices, magnetometers, inclinometers, or MEMs devices. Implantable devices 24 and 26 are configured to transmit measurement data to a computer or smart device).
Regarding claim 20, Roche teaches the system of claim 19, wherein the sensor coordinate system includes an x- axis, a y-axis, and a z-axis, and wherein the inertial measurement unit is configured to measure a roll about the x-axis of the sensor coordinate system, a pitch about the y-axis of the sensor coordinate system, and a yaw about the z-axis of the sensor coordinate system (para. 0050; . In one embodiment, IMU 80 comprises a geomagnetic sensor 74, a gyroscope sensor 76, and an accelerometer sensor 78. IMU 80 is configured to measure 6 degrees of freedom comprising translation movement along the X, Y, and Z axis as well as rotational movement such as yaw, roll, and pitch around each axis. ).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZAINAB M ALDARRAJI whose telephone number is (571)272-8726. The examiner can normally be reached Monday-Thursday7AM-5PM EST.
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/ZAINAB MOHAMMED ALDARRAJI/ Patent Examiner, Art Unit 3797
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