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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/05/2026 has been entered.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-4, 6-18, & 20 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.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-4, & 6-20 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitations “in a tracking coordinate system” in Lines 3 and Line 7. It is unclear whether the 2 coordinate systems are intended to be the same or unique.
Claim 1 also recites the limitation “the determined third pose of the virtual 6-DOF tracker” which has a lack of antecedent basis. Earlier in the claim the virtual tracker is cited as “a third pose of the virtual tracker in six DOF”.
Claim 18 recites the limitations “in a tracking coordinate system” in Lines 3 and Line 7. It is unclear whether the 2 coordinate systems are intended to be the same or unique.
Claim 18 also recites the limitation “the determined third pose of the virtual 6-DOF tracker” which has a lack of antecedent basis. Earlier in the claim the virtual tracker is cited as “a third pose of the virtual tracker in six DOF”.
Claim 20 recites the limitations “in a tracking coordinate system” in Lines 3 and Line 7. It is unclear whether the 2 coordinate systems are intended to be the same or unique.
Claim 20 also recites the limitation “the determined third pose of the virtual 6-DOF tracker” which has a lack of antecedent basis. Earlier in the claim the virtual tracker is cited as “a third pose of the virtual tracker in six DOF”.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-4, 6-18, & 20 is rejected under 35 U.S.C. 103 as being unpatentable over Corpa (WO2021076560A1; hereinafter referred to as Corpa) in view of Crawford et al (US20230009846A1; hereinafter referred to as Crawford) and further in view of Traxel et al (US20010010004A1; hereinafter referred to as Traxel).
Regarding Claim 1, Corpa discloses a method for use in surgical navigation, the method being performed by a computing system and comprising ("The present disclosure relates generally to methods, systems, and apparatuses related to a computer-assisted surgical system that includes various hardware and software components that work together to enhance surgical workflows." [0002]):
obtaining first tracking data for a first tracker in a tracking coordinate system, wherein the first tracker is associated with an anatomical object ("Accordingly, as described and illustrated herein, in some examples this technology includes a surgical tracking method that includes tracking, by a surgical computer 150, a first position of an external tracker 801 attached externally to a patient based on a tracking array 810 rigidly attached to the external tracker 801" [0182], " an internal tracker 802 may be affixed to the patient’s anatomy 804 (e.g., a patient’ s bone)." [0152]);
determining, based on the first tracking data, a first pose of the first tracker in five degrees of freedom, DOF ("FIG. 2, is limited to detecting five (5) total degrees-of-freedom (DOF). For example, sensor 200 may be able to track/determine movement in the X, Y, or Z direction, as well as rotation around the Y-axis 202 or Z-axis 201." [0039] “Referring now to FIG. 3C, in some embodiments, two 5DOF EM sensors (e.g., 301C and 302C) may be inserted into the patient (e.g., in a patient bone) at different locations and with different angular orientations (e.g., angle 303C is non-zero)” [0042];
obtaining second tracking data for a second tracker in a tracking coordinate system, wherein the second tracker is associated with the anatomical object (“and as shown in FIGS. 8-9, an internal tracker 802 may be affixed to the patient’s anatomy 804 (e.g., a patient’ s bone” [0152], "A second position of the internal tracker 802 is subsequently generated, by the surgical computer 150, from the field data." [0182]);
determining, based on the second tracking data, a second pose of the second tracker in five DOFs (“FIG. 2, is limited to detecting five (5) total degrees-of-freedom (DOF). For example, sensor 200 may be able to track/determine movement in the X, Y, or Z direction, as well as rotation around the Y-axis 202 or Z-axis 201.” [0039], “Referring now to FIG. 3C, in some embodiments, two 5DOF EM sensors (e.g., 301C and 302C) may be inserted into the patient (e.g., in a patient bone) at different locations and with different angular orientations (e.g., angle 303C is non-zero)” [0042]);
and combining the first and second tracking data ,wherein combining the first and second tracking data comprises determining, based on the first pose and the second pose, a third pose of in six DOF, the third pose having a fixed spatial relationship relative to the anatomical object in the six DOF of the third pose ("An EM field generated by one or more EM transmitting coils 808 of the external tracker is then received by one or more EM receiving coils 807 of an internal tracker 802 attached to anatomy 804 of the patient… A third position of the internal tracker 802 is then determined by the surgical computer 150 based on the first position and the second position." [0182], “The third position is within a global tracking system 1201 associated with an operating environment 1200 in these examples.” [0183], “In some EM based tracking devices, two coils may be affixed to each other, such as is shown in FIG. 3B. Because the two coils 301B and 302B are rigidly affixed to each other, not perfectly parallel, and have locations that are known relative to each other, it is possible to determine the sixth degree of freedom 303B with this arrangement.” [0040], Corpa states that the coil arrangement within the sensors can be used to determine 6 DOFs, the trackers noted above include the same electromagnetic coils and can thus be arranged to achieve the same outcome of the sensors stated earlier).
and triggering display, on a display, representations of tracked surgical instruments based on the determined third pose of the 6-DOF tracker (“The Surgical Computer 150 provides the Display 125 with any visualization that is needed by the Surgeon 111 during surgery. For monitors, the Surgical Computer 150 may provide instructions for displaying images, GUIs, etc. using techniques known in the art. The display 125 can include various features of the workflow of a surgical plan. During the registration process, for example, the display 125 can show a preoperatively constructed 3D bone model and depict the locations of the point probe 114 as the surgeon uses the probe to collect locations of anatomical landmarks on the patient. The display 125 can include information about the surgical target area. For example, in connection with a TKA, the display 125 can depict the mechanical and anatomical axes of the femur and tibia. The display 125 can depict varus and valgus angles for the knee joint based on a surgical plan, and the CASS 100 can depict how such angles will be affected if contemplated revisions to the surgical plan are made. Accordingly, the display 125 is an interactive interface that can dynamically update and display how changes to the surgical plan would impact the procedure and the final position and orientation of implants installed on bone.” [0090], “The display 125 can provide the surgeon 111 with a variety of data and information about the patient, the planned surgical intervention, and the implants. Various patient-specific information can be displayed, including real-time data concerning the patient’s health such as heart rate, blood pressure, etc. The display 125 can also include information about the anatomy of the surgical target region including the location of landmarks, the current state of the anatomy (e.g., whether any resections have been made, the depth and angles of planned and executed bone cuts), and future states of the anatomy as the surgical plan progresses.“ [0092])
Corpa does not specifically disclose that a first pose of the first tracker is in exactly four degrees of freedom, DOF, that a second pose of the second tracker is in exactly four DOF, wherein the four DOF of at least one of the first pose and the second pose consists of two translational DOF and two rotational DOF, combining the first and second tracking data for determining a single virtual tracker, the single virtual tracker being different from the first tracker and different from the second tracker, wherein combining the first and second tracking data comprises determining, based on the first pose and the second pose, a third pose of the virtual tracker in six DOF, the virtual tracker having a fixed spatial relationship relative to the anatomical object in the six DOF of the third pose.
However, in a similar field of endeavor, Crawford teaches position recognition systems and more particularly to end-effector and instrument tracking and manipulation during robot assisted surgical procedures [0001].
Crawford also teaches a first pose of the first tracker is in exactly four degrees of freedom, DOF, that a second pose of the second tracker is in exactly four DOF, wherein the four DOF of at least one of the first pose and the second pose consists of two translational DOF and two rotational DOF (“As shown in FIG. 15B, when a snugly fitting instrument 608 is placed within the guide tube 1014, the instrument 608 becomes mechanically constrained in 4 of 6 degrees of freedom. That is, the instrument 608 cannot be rotated in any direction except about the longitudinal axis 1016 of the guide tube 1014 and the instrument 608 cannot be translated in any direction except along the longitudinal axis 1016 of the guide tube 1014. In other words, the instrument 608 can only be translated along and rotated about the centerline of the guide tube 1014.” [0127], “Logistically, the surgeon 120 or user could place the instrument 608 within the guide tube 1014 and slightly rotate it or slide it down into the guide tube 1014 and the system 100, 300, 600 would be able to detect that the instrument 608 is within the guide tube 1014 from tracking of the five markers (four markers 804 on instrument 608 plus single marker 1018 on guide tube 1014). Knowing that the instrument 608 is within the guide tube 1014, all 6 degrees of freedom may be calculated that define the position and orientation of the end-effector 1012 in space” [0131]).
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Corpa as outlined above with a first pose of the first tracker is in exactly four degrees of freedom, DOF, that a second pose of the second tracker is in exactly four DOF, wherein the four DOF of at least one of the first pose and the second pose consists of two translational DOF and two rotational DOF as taught by Crawford, because it can be performed relatively quickly and accurately [0005].
Corpa in view of Crawford does not specifically teach combining the first and second tracking data for determining a single virtual tracker, the single virtual tracker being different from the first tracker and different from the second tracker, wherein combining the first and second tracking data comprises determining, based on the first pose and the second pose, a third pose of the virtual tracker in six DOF, the virtual tracker having a fixed spatial relationship relative to the anatomical object in the six DOF of the third pose.
However, in a similar field of endeavor, Traxel teaches a device and method for referencing reference points of a fiducial implant [Abstract].
Traxel also teaches combining the first and second tracking data for determining a single virtual tracker, the single virtual tracker being different from the first tracker and different from the second tracker (“The invention allows a spatial relationship to be determined between reference points associated with the physical body's system of coordinates and the corresponding positions of the reference points in a coordinate system of an image of the body. Preferably, the body comprises at least a portion of a patient, such as a bone. The reference points associated with the body's system of coordinates are preferably reference points of at least one fiducial implant, such as a fiducial screw for insertion in a bone. “ [0022], “To reference the reference points, a pointer fitted with markers is positioned in a precisely defined spatial relationship relative a fiducial implant having fixed reference points. One reference point of the implant preferably corresponds to the tip of the implant and the other reference point preferably corresponds to the head of the implant.” [0023], “As an alternative to using a pointer configured with LED's emitting electromagnetic radiation, pointer 3 may be configured with markers to detect electromagnetic radiation or with acoustic transducers to emit or detect acoustic waves. In each of the alternative cases a position finder cooperates with the markers or acoustic transducers to allow the position of the pointer in three-dimensional space to be determined.” [0036]),
wherein combining the first and second tracking data comprises determining, based on the first pose and the second pose, a third pose of the virtual tracker in six DOF, the virtual tracker having a fixed spatial relationship relative to the anatomical object in the six DOF of the third pose (“Upon associating the positions of the reference points in the image with the positions of the reference points in the coordinate system of the body, any point in the image can be related by a coordinate transformation to the corresponding point in the physical body, and vice-versa. Fiduciary matching or registration thus relates to the determination of the spatial relationship of reference points in the coordinate system of the image to the reference point positions in the coordinate system of the physical body. Because the fiducial implant of the invention comprises at least two reference points, two fiducial implants inserted in the body provide a sufficient number of reference points to allow the registration or matching of the systems of the two coordinate systems. Thus, only the portion of the body receiving the implant need be exposed allowing for a minimally invasive registration of the coordinate systems.” [0027], “If the positions of the reference points of at least two implanted fiducial implants are matched with the corresponding positions of the reference points in an image of the body showing the implants, a coordinate transformation can be determined to allow the positions of points of the body and the corresponding positions of the body points in the image to be related to one another.” [0035]).
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Corpa in view of Crawford as outlined above with combining the first and second tracking data for determining a single virtual tracker, the single virtual tracker being different from the first tracker and different from the second tracker, wherein combining the first and second tracking data comprises determining, based on the first pose and the second pose, a third pose of the virtual tracker in six DOF, the virtual tracker having a fixed spatial relationship relative to the anatomical object in the six DOF of the third pose as taught by Traxel, because it can be performed relatively quickly and accurately [0005].
Regarding Claim 2, Corpa in view of Crawford discloses all limitations noted above except further comprising determining or obtaining a transformation between (i) a fourth pose of the anatomical object in six DOF in an image coordinate system of image data of the anatomical object and (ii) the third pose.
However, in a similar field of endeavor, Traxel teaches further comprising determining or obtaining a transformation between (i) a fourth pose of the anatomical object in six DOF in an image coordinate system of image data of the anatomical object and (ii) the third pose (“The steps of mating and position determining can be repeated for each of the fiducial implants to be referenced. Subsequently, the positions of the reference points can be registered or matched with the corresponding coordinates of the reference points in an image showing the reference points. Suitable images can be recorded prior to the position determining and include, for example, 3-dimensional images formed by computer tomography. If the positions of the reference points of at least two implanted fiducial implants are matched with the corresponding positions of the reference points in an image of the body showing the implants, a coordinate transformation can be determined to allow the positions of points of the body and the corresponding positions of the body points in the image to be related to one another.” [0035])
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Corpa in view of Crawford as outlined above with further comprising determining or obtaining a transformation between (i) a fourth pose of the anatomical object in six DOF in an image coordinate system of image data of the anatomical object and (ii) the third pose as taught by Traxel, because it can be performed relatively quickly and accurately [0005].
Regarding Claim 3, Corpa in view of Crawford discloses all limitations noted above except further comprising determining a fifth pose of the anatomical object in six DOF based on the third pose and the transformation.
However, in a similar field of endeavor, Traxel teaches further comprising determining a fifth pose of the anatomical object in six DOF based on the third pose and the transformation (“The steps of mating and position determining can be repeated for each of the fiducial implants to be referenced. Subsequently, the positions of the reference points can be registered or matched with the corresponding coordinates of the reference points in an image showing the reference points. Suitable images can be recorded prior to the position determining and include, for example, 3-dimensional images formed by computer tomography. If the positions of the reference points of at least two implanted fiducial implants are matched with the corresponding positions of the reference points in an image of the body showing the implants, a coordinate transformation can be determined to allow the positions of points of the body and the corresponding positions of the body points in the image to be related to one another.” [0035])
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Corpa in view of Crawford as outlined above with further comprising determining a fifth pose of the anatomical object in six DOF based on the third pose and the transformation as taught by Traxel, because it can be performed relatively quickly and accurately [0005].
Regarding Claim 4, Corpa discloses all limitations noted above except the determined first pose defines a fixed spatial relationship of the first tracker relative to the anatomical object in only the four DOF of the first pose, and wherein the determined second pose defines a fixed spatial relationship of the second tracker relative to the anatomical object in only the four DOF of the second pose.
However, in a similar field of endeavor, Crawford teaches the determined first pose defines a fixed spatial relationship of the first tracker relative to the anatomical object in only the four DOF of the first pose, and wherein the determined second pose defines a fixed spatial relationship of the second tracker relative to the anatomical object in only the four DOF of the second pose (“As shown in FIG. 15B, when a snugly fitting instrument 608 is placed within the guide tube 1014, the instrument 608 becomes mechanically constrained in 4 of 6 degrees of freedom. That is, the instrument 608 cannot be rotated in any direction except about the longitudinal axis 1016 of the guide tube 1014 and the instrument 608 cannot be translated in any direction except along the longitudinal axis 1016 of the guide tube 1014. In other words, the instrument 608 can only be translated along and rotated about the centerline of the guide tube 1014.” [0127]).
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Corpa as outlined above with a first pose of the first tracker is in exactly four degrees of freedom, DOF, that a second pose of the second tracker is in exactly four DOF, wherein the four DOF of at least one of the first pose and the second pose consists of two translational DOF and two rotational DOF as taught by Crawford, because it can be performed relatively quickly and accurately [0005].
Regarding Claim 6, Corpa discloses all limitations noted above except a first of the two translational DOF and a first of the two rotational DOF are associated with a first trajectory, and wherein a second of the two translational DOF and a second of the two rotational DOF are associated with a second trajectory different from the first trajectory.
However, in a similar field of endeavor, Crawford teaches the determined first pose defines a fixed spatial relationship of the first tracker relative to the anatomical object in only the four DOF of the first pose, and wherein the determined second pose defines a fixed spatial relationship of the second tracker relative to the anatomical object in only the four DOF of the second pose (“As shown in FIG. 15B, when a snugly fitting instrument 608 is placed within the guide tube 1014, the instrument 608 becomes mechanically constrained in 4 of 6 degrees of freedom. That is, the instrument 608 cannot be rotated in any direction except about the longitudinal axis 1016 of the guide tube 1014 and the instrument 608 cannot be translated in any direction except along the longitudinal axis 1016 of the guide tube 1014. In other words, the instrument 608 can only be translated along and rotated about the centerline of the guide tube 1014.” [0127], “With emphasis on FIG. 15E, the presence of the single marker 1018 being tracked as well as the four markers 804 on the instrument 608, it is possible to construct the centerline vector C′ of the guide tube 1014 and instrument 608 and the normal vector through the single marker 1018 and through the centerline vector C′ . This normal vector has an orientation that is in a known orientation relative to the forearm of the robot distal to the wrist (in this example, oriented parallel to that segment) and intersects the centerline vector C′ at a specific fixed position. For convenience, three mutually orthogonal vectors k′, j′, i′ can be constructed, as shown in FIG. 15E, defining rigid body position and orientation of the guide tube 1014. One of the three mutually orthogonal vectors k′ is constructed from the centerline vector C′ , the second vector j′ is constructed from the normal vector through the single marker 1018, and the third vector i′ is the vector cross product of the first and second vectors k′, j’. The robot’s joint positions relative to these vectors k′, j′, i′ are known and fixed when all joints are at zero, and therefore rigid body calculations can be used to determine the pose of any section of the robot relative to these vectors k′, j′, i′ when the robot is at a home position. During robot movement, if the positions of the instrument markers 804 (while the instrument 608 is in the guide tube 1014) and the position of the single marker 1018 are detected from the tracking system, and angles/linear positions of each joint are known from encoders, then position and orientation of any section of the robot can be determined.” [0132]).
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Corpa as outlined above with the determined first pose defines a fixed spatial relationship of the first tracker relative to the anatomical object in only the four DOF of the first pose, and wherein the determined second pose defines a fixed spatial relationship of the second tracker relative to the anatomical object in only the four DOF of the second pose as taught by Crawford, because it can be performed relatively quickly and accurately [0005].
Regarding Claim 7, Corpa discloses all limitations noted above except the step of determining the third pose of the virtual tracker further comprises: determining, based on one of the first pose and the second pose, a third trajectory defined by the first or second tracker associated with the one of the first pose and the second pose, the third trajectory being different from the first trajectory and the second trajectory; and determining the third pose of the virtual tracker further based on the third trajectory.
However, in a similar field of endeavor, Crawford teaches the step of determining the third pose of the virtual tracker further comprises: determining, based on one of the first pose and the second pose, a third trajectory defined by the first or second tracker associated with the one of the first pose and the second pose, the third trajectory being different from the first trajectory and the second trajectory (“As shown in FIG. 15B, when a snugly fitting instrument 608 is placed within the guide tube 1014, the instrument 608 becomes mechanically constrained in 4 of 6 degrees of freedom. That is, the instrument 608 cannot be rotated in any direction except about the longitudinal axis 1016 of the guide tube 1014 and the instrument 608 cannot be translated in any direction except along the longitudinal axis 1016 of the guide tube 1014. In other words, the instrument 608 can only be translated along and rotated about the centerline of the guide tube 1014.” [0127], “Logistically, the surgeon 120 or user could place the instrument 608 within the guide tube 1014 and slightly rotate it or slide it down into the guide tube 1014 and the system 100, 300, 600 would be able to detect that the instrument 608 is within the guide tube 1014 from tracking of the five markers (four markers 804 on instrument 608 plus single marker 1018 on guide tube 1014). Knowing that the instrument 608 is within the guide tube 1014, all 6 degrees of freedom may be calculated that define the position and orientation of the end-effector 1012 in space. Without the single marker 1018, even if it is known with certainty that the instrument 608 is within the guide tube 1014, it is unknown where the guide tube 1014 is located along the instrument’s centerline vector C′ and how the guide tube 1014 is rotated relative to the centerline vector C′.” [0131]).
and determining the third pose of the virtual tracker further based on the third trajectory (“With emphasis on FIG. 15E, the presence of the single marker 1018 being tracked as well as the four markers 804 on the instrument 608, it is possible to construct the centerline vector C′ of the guide tube 1014 and instrument 608 and the normal vector through the single marker 1018 and through the centerline vector C′ . This normal vector has an orientation that is in a known orientation relative to the forearm of the robot distal to the wrist (in this example, oriented parallel to that segment) and intersects the centerline vector C′ at a specific fixed position. For convenience, three mutually orthogonal vectors k′, j′, i′ can be constructed, as shown in FIG. 15E, defining rigid body position and orientation of the guide tube 1014. One of the three mutually orthogonal vectors k′ is constructed from the centerline vector C′ , the second vector j′ is constructed from the normal vector through the single marker 1018, and the third vector i′ is the vector cross product of the first and second vectors k′, j’. The robot’s joint positions relative to these vectors k′, j′, i′ are known and fixed when all joints are at zero, and therefore rigid body calculations can be used to determine the pose of any section of the robot relative to these vectors k′, j′, i′ when the robot is at a home position. During robot movement, if the positions of the instrument markers 804 (while the instrument 608 is in the guide tube 1014) and the position of the single marker 1018 are detected from the tracking system, and angles/linear positions of each joint are known from encoders, then position and orientation of any section of the robot can be determined.” [0132])
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Corpa as outlined above with the step of determining the third pose of the virtual tracker further comprises: determining, based on one of the first pose and the second pose, a third trajectory defined by the first or second tracker associated with the one of the first pose and the second pose, the third trajectory being different from the first trajectory and the second trajectory; and determining the third pose of the virtual tracker further based on the third trajectory as taught by Crawford, because it can be performed relatively quickly and accurately [0005].
Regarding Claim 8, Corpa discloses the step of determining the third pose of the virtual tracker further comprises: determining, based on the first pose, a first instance of the third trajectory; determining, based on the second pose, a second instance of the third trajectory, wherein the second instance of the third trajectory is non-parallel relative to the first instance of the third trajectory; and determining, based on the first instance of the third trajectory and the second instance of the third trajectory, a virtual coordinate system, the virtual coordinate system having a predefined spatial relationship relative to the third pose of the virtual tracker.
However, in a similar field of endeavor, Crawford teaches the step of determining the third pose of the virtual tracker further comprises: determining, based on the first pose, a first instance of the third trajectory; determining, based on the second pose, a second instance of the third trajectory, wherein the second instance of the third trajectory is non-parallel relative to the first instance of the third trajectory; and determining, based on the first instance of the third trajectory and the second instance of the third trajectory, a virtual coordinate system, the virtual coordinate system having a predefined spatial relationship relative to the third pose of the virtual tracker (“With emphasis on FIG. 15E, the presence of the single marker 1018 being tracked as well as the four markers 804 on the instrument 608, it is possible to construct the centerline vector C′ of the guide tube 1014 and instrument 608 and the normal vector through the single marker 1018 and through the centerline vector C′ . This normal vector has an orientation that is in a known orientation relative to the forearm of the robot distal to the wrist (in this example, oriented parallel to that segment) and intersects the centerline vector C′ at a specific fixed position. For convenience, three mutually orthogonal vectors k′, j′, i′ can be constructed, as shown in FIG. 15E, defining rigid body position and orientation of the guide tube 1014. One of the three mutually orthogonal vectors k′ is constructed from the centerline vector C′ , the second vector j′ is constructed from the normal vector through the single marker 1018, and the third vector i′ is the vector cross product of the first and second vectors k′, j’. The robot’s joint positions relative to these vectors k′, j′, i′ are known and fixed when all joints are at zero, and therefore rigid body calculations can be used to determine the pose of any section of the robot relative to these vectors k′, j′, i′ when the robot is at a home position. During robot movement, if the positions of the instrument markers 804 (while the instrument 608 is in the guide tube 1014) and the position of the single marker 1018 are detected from the tracking system, and angles/linear positions of each joint are known from encoders, then position and orientation of any section of the robot can be determined.” [0132])
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Corpa as outlined above with the step of determining the virtual coordinate system further comprises determining a first directional vector of the first instance of the third trajectory, determining a second directional vector of the second instance of the third trajectory, and defining a coordinate axis) of the virtual coordinate system to lie within a plane spanned by the first directional vector and the second directional vector as taught by Crawford, because it can be performed relatively quickly and accurately [0005].
Regarding Claim 9, Corpa discloses all limitations noted above except the step of determining the virtual coordinate system further comprises determining a first directional vector of the first instance of the third trajectory, determining a second directional vector of the second instance of the third trajectory, and defining a coordinate axis) of the virtual coordinate system to lie within a plane spanned by the first directional vector and the second directional vector.
However, in a similar field of endeavor, Crawford teaches the step of determining the virtual coordinate system further comprises determining a first directional vector of the first instance of the third trajectory, determining a second directional vector of the second instance of the third trajectory, and defining a coordinate axis) of the virtual coordinate system to lie within a plane spanned by the first directional vector and the second directional vector (“With emphasis on FIG. 15E, the presence of the single marker 1018 being tracked as well as the four markers 804 on the instrument 608, it is possible to construct the centerline vector C′ of the guide tube 1014 and instrument 608 and the normal vector through the single marker 1018 and through the centerline vector C′ . This normal vector has an orientation that is in a known orientation relative to the forearm of the robot distal to the wrist (in this example, oriented parallel to that segment) and intersects the centerline vector C′ at a specific fixed position. For convenience, three mutually orthogonal vectors k′, j′, i′ can be constructed, as shown in FIG. 15E, defining rigid body position and orientation of the guide tube 1014. One of the three mutually orthogonal vectors k′ is constructed from the centerline vector C′ , the second vector j′ is constructed from the normal vector through the single marker 1018, and the third vector i′ is the vector cross product of the first and second vectors k′, j’. The robot’s joint positions relative to these vectors k′, j′, i′ are known and fixed when all joints are at zero, and therefore rigid body calculations can be used to determine the pose of any section of the robot relative to these vectors k′, j′, i′ when the robot is at a home position. During robot movement, if the positions of the instrument markers 804 (while the instrument 608 is in the guide tube 1014) and the position of the single marker 1018 are detected from the tracking system, and angles/linear positions of each joint are known from encoders, then position and orientation of any section of the robot can be determined.” [0132])
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Corpa as outlined above with the step of determining the virtual coordinate system further comprises determining a first directional vector of the first instance of the third trajectory, determining a second directional vector of the second instance of the third trajectory, and defining a coordinate axis) of the virtual coordinate system to lie within a plane spanned by the first directional vector and the second directional vector as taught by Crawford, because it can be performed relatively quickly and accurately [0005].
Regarding Claim 10, Corpa discloses all limitations noted above except the step of determining the virtual coordinate system further comprises defining a coordinate axis of the virtual coordinate system to coincide with one of the first instance of the third trajectory and the second instance of the third trajectory.
However, in a similar field of endeavor, Crawford teaches the step of determining the virtual coordinate system further comprises defining a coordinate axis of the virtual coordinate system to coincide with one of the first instance of the third trajectory and the second instance of the third trajectory (“With emphasis on FIG. 15E, the presence of the single marker 1018 being tracked as well as the four markers 804 on the instrument 608, it is possible to construct the centerline vector C′ of the guide tube 1014 and instrument 608 and the normal vector through the single marker 1018 and through the centerline vector C′ . This normal vector has an orientation that is in a known orientation relative to the forearm of the robot distal to the wrist (in this example, oriented parallel to that segment) and intersects the centerline vector C′ at a specific fixed position. For convenience, three mutually orthogonal vectors k′, j′, i′ can be constructed, as shown in FIG. 15E, defining rigid body position and orientation of the guide tube 1014. One of the three mutually orthogonal vectors k′ is constructed from the centerline vector C′ , the second vector j′ is constructed from the normal vector through the single marker 1018, and the third vector i′ is the vector cross product of the first and second vectors k′, j’. The robot’s joint positions relative to these vectors k′, j′, i′ are known and fixed when all joints are at zero, and therefore rigid body calculations can be used to determine the pose of any section of the robot relative to these vectors k′, j′, i′ when the robot is at a home position. During robot movement, if the positions of the instrument markers 804 (while the instrument 608 is in the guide tube 1014) and the position of the single marker 1018 are detected from the tracking system, and angles/linear positions of each joint are known from encoders, then position and orientation of any section of the robot can be determined.” [0132])
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Corpa as outlined above with the step of determining the virtual coordinate system further comprises defining a coordinate axis of the virtual coordinate system to coincide with one of the first instance of the third trajectory and the second instance of the third trajectory as taught by Crawford, because it can be performed relatively quickly and accurately [0005].
Regarding Claim 11, Corpa discloses all limitations noted above except the step of determining the virtual coordinate system further comprises determining a direction of a smallest distance between the first instance of the third trajectory and the second instance of the third trajectory, and defining a coordinate axis of the virtual coordinate system to coincide with the direction.
However, in a similar field of endeavor, Crawford teaches the step of determining the virtual coordinate system further comprises determining a direction of a smallest distance between the first instance of the third trajectory and the second instance of the third trajectory, and defining a coordinate axis of the virtual coordinate system to coincide with the direction (“With emphasis on FIG. 15E, the presence of the single marker 1018 being tracked as well as the four markers 804 on the instrument 608, it is possible to construct the centerline vector C′ of the guide tube 1014 and instrument 608 and the normal vector through the single marker 1018 and through the centerline vector C′ . This normal vector has an orientation that is in a known orientation relative to the forearm of the robot distal to the wrist (in this example, oriented parallel to that segment) and intersects the centerline vector C′ at a specific fixed position. For convenience, three mutually orthogonal vectors k′, j′, i′ can be constructed, as shown in FIG. 15E, defining rigid body position and orientation of the guide tube 1014. One of the three mutually orthogonal vectors k′ is constructed from the centerline vector C′ , the second vector j′ is constructed from the normal vector through the single marker 1018, and the third vector i′ is the vector cross product of the first and second vectors k′, j’. The robot’s joint positions relative to these vectors k′, j′, i′ are known and fixed when all joints are at zero, and therefore rigid body calculations can be used to determine the pose of any section of the robot relative to these vectors k′, j′, i′ when the robot is at a home position. During robot movement, if the positions of the instrument markers 804 (while the instrument 608 is in the guide tube 1014) and the position of the single marker 1018 are detected from the tracking system, and angles/linear positions of each joint are known from encoders, then position and orientation of any section of the robot can be determined.” [0132])
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Corpa as outlined above with the step of determining the virtual coordinate system further comprises determining a direction of a smallest distance between the first instance of the third trajectory and the second instance of the third trajectory, and defining a coordinate axis of the virtual coordinate system to coincide with the direction as taught by Crawford, because it can be performed relatively quickly and accurately [0005].
Regarding Claim 12, Corpa discloses all limitations noted above except the step of determining the transformation further comprises: detecting an alignment trajectory in the image data, the alignment trajectory having a known spatial relationship relative to at least one of the first tracker and the second tracker; and matching the detected alignment trajectory to the pose of the at least one of the first tracker and the second tracker, using the known spatial relationship.
However, in a similar field of endeavor, Crawford teaches the step of determining the transformation further comprises: detecting an alignment trajectory in the image data, the alignment trajectory having a known spatial relationship relative to at least one of the first tracker and the second tracker; and matching the detected alignment trajectory to the pose of the at least one of the first tracker and the second tracker, using the known spatial relationship (“With emphasis on FIG. 15E, the presence of the single marker 1018 being tracked as well as the four markers 804 on the instrument 608, it is possible to construct the centerline vector C′ of the guide tube 1014 and instrument 608 and the normal vector through the single marker 1018 and through the centerline vector C′ . This normal vector has an orientation that is in a known orientation relative to the forearm of the robot distal to the wrist (in this example, oriented parallel to that segment) and intersects the centerline vector C′ at a specific fixed position. For convenience, three mutually orthogonal vectors k′, j′, i′ can be constructed, as shown in FIG. 15E, defining rigid body position and orientation of the guide tube 1014. One of the three mutually orthogonal vectors k′ is constructed from the centerline vector C′ , the second vector j′ is constructed from the normal vector through the single marker 1018, and the third vector i′ is the vector cross product of the first and second vectors k′, j’. The robot’s joint positions relative to these vectors k′, j′, i′ are known and fixed when all joints are at zero, and therefore rigid body calculations can be used to determine the pose of any section of the robot relative to these vectors k′, j′, i′ when the robot is at a home position. During robot movement, if the positions of the instrument markers 804 (while the instrument 608 is in the guide tube 1014) and the position of the single marker 1018 are detected from the tracking system, and angles/linear positions of each joint are known from encoders, then position and orientation of any section of the robot can be determined.” [0132])
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Corpa as outlined above with the step of determining the transformation further comprises: detecting an alignment trajectory in the image data, the alignment trajectory having a known spatial relationship relative to at least one of the first tracker and the second tracker; and matching the detected alignment trajectory to the pose of the at least one of the first tracker and the second tracker, using the known spatial relationship as taught by Crawford, because it can be performed relatively quickly and accurately [0005].
Regarding Claim 14, Corpa discloses all limitations noted above except the at least one of the first tracker and the second tracker is mechanically coupled to one or more elements chosen from: (i) a linear member arranged in a fixed spatial relationship relative to the anatomical object, wherein the alignment trajectory corresponds to or is parallel to a longitudinal axis of the linear member; (ii) a cannulated implant, the cannulated implant arranged in a fixed spatial relationship relative to the anatomical object, wherein the alignment trajectory corresponds to or is parallel to a longitudinal axis of a cannulation within the cannulated implant; (iii) a surgical instrument, the surgical instrument arranged in a fixed spatial relationship relative to the anatomical object, wherein the alignment trajectory corresponds to or is parallel to a longitudinal axis of a cannulation or tracker receptacle within the surgical instrument; and (iv) a linear hole in the anatomical object, wherein the alignment trajectory corresponds to or is parallel to a longitudinal axis of the linear hole.
However, in a similar field of endeavor, Crawford teaches the at least one of the first tracker and the second tracker is mechanically coupled to one or more elements chosen from: (i) a linear member arranged in a fixed spatial relationship relative to the anatomical object, wherein the alignment trajectory corresponds to or is parallel to a longitudinal axis of the linear member; (ii) a cannulated implant, the cannulated implant arranged in a fixed spatial relationship relative to the anatomical object, wherein the alignment trajectory corresponds to or is parallel to a longitudinal axis of a cannulation within the cannulated implant; (iii) a surgical instrument, the surgical instrument arranged in a fixed spatial relationship relative to the anatomical object, wherein the alignment trajectory corresponds to or is parallel to a longitudinal axis of a cannulation or tracker receptacle within the surgical instrument; and (iv) a linear hole in the anatomical object, wherein the alignment trajectory corresponds to or is parallel to a longitudinal axis of the linear hole (“With emphasis on FIG. 15E, the presence of the single marker 1018 being tracked as well as the four markers 804 on the instrument 608, it is possible to construct the centerline vector C′ of the guide tube 1014 and instrument 608 and the normal vector through the single marker 1018 and through the centerline vector C′ . This normal vector has an orientation that is in a known orientation relative to the forearm of the robot distal to the wrist (in this example, oriented parallel to that segment) and intersects the centerline vector C′ at a specific fixed position. For convenience, three mutually orthogonal vectors k′, j′, i′ can be constructed, as shown in FIG. 15E, defining rigid body position and orientation of the guide tube 1014. One of the three mutually orthogonal vectors k′ is constructed from the centerline vector C′ , the second vector j′ is constructed from the normal vector through the single marker 1018, and the third vector i′ is the vector cross product of the first and second vectors k′, j’. The robot’s joint positions relative to these vectors k′, j′, i′ are known and fixed when all joints are at zero, and therefore rigid body calculations can be used to determine the pose of any section of the robot relative to these vectors k′, j′, i′ when the robot is at a home position. During robot movement, if the positions of the instrument markers 804 (while the instrument 608 is in the guide tube 1014) and the position of the single marker 1018 are detected from the tracking system, and angles/linear positions of each joint are known from encoders, then position and orientation of any section of the robot can be determined.” [0132])
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Corpa as outlined above with the at least one of the first tracker and the second tracker is mechanically coupled to one or more elements chosen from: (i) a linear member arranged in a fixed spatial relationship relative to the anatomical object, wherein the alignment trajectory corresponds to or is parallel to a longitudinal axis of the linear member; (ii) a cannulated implant, the cannulated implant arranged in a fixed spatial relationship relative to the anatomical object, wherein the alignment trajectory corresponds to or is parallel to a longitudinal axis of a cannulation within the cannulated implant; (iii) a surgical instrument, the surgical instrument arranged in a fixed spatial relationship relative to the anatomical object, wherein the alignment trajectory corresponds to or is parallel to a longitudinal axis of a cannulation or tracker receptacle within the surgical instrument; and (iv) a linear hole in the anatomical object, wherein the alignment trajectory corresponds to or is parallel to a longitudinal axis of the linear hole as taught by Crawford, because it can be performed relatively quickly and accurately [0005].
Regarding Claim 15, Corpa discloses all limitations noted above except at least one of: the first tracking data is indicative of a tracked pose of the first tracker in five or six DOF, and wherein determining the first pose comprises selectively disregarding one or two of the DOF of the tracked pose of the first tracker to obtain the first pose in the exactly four DOF; and the second tracking data is indicative of a tracked pose of the second tracker in five or six DOF, and wherein determining the second pose comprises selectively disregarding one or two of the DOF of the tracked pose of the second tracker to obtain the second pose in the exactly four DOF.
However, in a similar field of endeavor, Crawford teaches at least one of: the first tracking data is indicative of a tracked pose of the first tracker in five or six DOF, and wherein determining the first pose comprises selectively disregarding one or two of the DOF of the tracked pose of the first tracker to obtain the first pose in the exactly four DOF; and the second tracking data is indicative of a tracked pose of the second tracker in five or six DOF, and wherein determining the second pose comprises selectively disregarding one or two of the DOF of the tracked pose of the second tracker to obtain the second pose in the exactly four DOF (“As shown in FIG. 15B, when a snugly fitting instrument 608 is placed within the guide tube 1014, the instrument 608 becomes mechanically constrained in 4 of 6 degrees of freedom. That is, the instrument 608 cannot be rotated in any direction except about the longitudinal axis 1016 of the guide tube 1014 and the instrument 608 cannot be translated in any direction except along the longitudinal axis 1016 of the guide tube 1014. In other words, the instrument 608 can only be translated along and rotated about the centerline of the guide tube 1014.” [0127], “it may be useful to fix the orientation of the instrument 608 relative to the guide tube 1014. For example, the end-effector guide tube 1014 may be oriented in a particular position about its axis 1016 to allow machining or implant positioning. Although the orientation of anything attached to the instrument 608 inserted into the guide tube 1014 is known from the tracked markers 804 on the instrument 608, the rotational orientation of the guide tube 1014 itself in the camera coordinate system is unknown without the additional tracking marker 1018 (or multiple tracking markers in other embodiments) on the guide tube 1014. This marker 1018 provides essentially a “clock position” from -180° to +180° based on the orientation of the marker 1018 relative to the centerline vector C′. Thus, the single marker 1018 can provide additional degrees of freedom to allow full rigid body tracking and/or can act as a surveillance marker to ensure that assumptions about the robot and camera positioning are valid.” [0133])
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Corpa as outlined above with at least one of: the first tracking data is indicative of a tracked pose of the first tracker in five or six DOF, and wherein determining the first pose comprises selectively disregarding one or two of the DOF of the tracked pose of the first tracker to obtain the first pose in the exactly four DOF; and the second tracking data is indicative of a tracked pose of the second tracker in five or six DOF, and wherein determining the second pose comprises selectively disregarding one or two of the DOF of the tracked pose of the second tracker to obtain the second pose in the exactly four DOF as taught by Crawford, because it can be performed relatively quickly and accurately [0005].
Regarding Claim 16, Corpa discloses (i) at least one of the first tracker and the second tracker is a 3-DOF, 4-DOF or 5-DOF tracker comprising a coil, wherein the coil is configured to be tracked by an electromagnetic tracking system, or (ii) at least one of the first tracker and the second tracker is a 3-DOF, 4-DOF or 5-DOF tracker comprising one, two or more optical tracking markers defining a line in space, wherein the markers are configured to be tracked by an optical tracking system, and wherein, in case of the first tracker being a 3-DOF tracker, different positions of the tracker tracked at different points in time are used to determine a tracked pose of the tracker in more than 3 DOF (“ Generally, EM based tracking devices include one or more wire coils and a reference field generator. The one or more wire coils may be energized (e.g., via a wired or wireless power supply). Once energized, the coil creates an electromagnetic field that can be detected and measured (e.g., by the reference field generator or an additional device) in a manner that allows for the location and orientation of the one or more wire coils to be determined. As should be understood by someone of ordinary skill in the art, a single coil, such as is shown in FIG. 2, is limited to detecting five (5) total degrees-of-freedom (DOF). For example, sensor 200 may be able to track/determine movement in the X, Y, or Z direction, as well as rotation around the Y-axis 202 or Z-axis 201.” [0039]).
Regarding Claim 17, Corpa discloses the anatomical object is a vertebra of a spine of a human patient (“The present disclosure relates generally to methods, systems, and apparatuses related to a computer-assisted surgical system that includes various hardware and software components that work together to enhance surgical workflows. The disclosed techniques may be applied to, for example, shoulder, hip, and knee arthroplasties, as well as other surgical interventions such as arthroscopic procedures, spinal procedures, maxillofacial procedures, rotator cuff procedures, ligament repair and replacement procedures.” [0002]).
Regarding Claim 18, Corpa discloses a computing system comprising a display, at least one processor and at least one memory, the at least one memory storing instructions which, when executed by the at least one processor ("The present disclosure relates generally to methods, systems, and apparatuses related to a computer-assisted surgical system that includes various hardware and software components that work together to enhance surgical workflows." [0002], “a processor may track that tool or bone as it moves through the environment in a three-dimensional model.” [0046], “The Display 125 provides graphical user interfaces (GUIs) that display images collected by the Tissue Navigation System 120 as well other information relevant to the surgery.” [0051]), configure the at least one processor to:
obtain first tracking data for a first tracker in a tracking coordinate system, wherein the first tracker is associated with an anatomical object ("Accordingly, as described and illustrated herein, in some examples this technology includes a surgical tracking method that includes tracking, by a surgical computer 150, a first position of an external tracker 801 attached externally to a patient based on a tracking array 810 rigidly attached to the external tracker 801" [0182], " an internal tracker 802 may be affixed to the patient’s anatomy 804 (e.g., a patient’ s bone)." [0152]);
determine, based on the first tracking data, a first pose of the first tracker in five degrees of freedom, DOF ("FIG. 2, is limited to detecting five (5) total degrees-of-freedom (DOF). For example, sensor 200 may be able to track/determine movement in the X, Y, or Z direction, as well as rotation around the Y-axis 202 or Z-axis 201." [0039] “Referring now to FIG. 3C, in some embodiments, two 5DOF EM sensors (e.g., 301C and 302C) may be inserted into the patient (e.g., in a patient bone) at different locations and with different angular orientations (e.g., angle 303C is non-zero)” [0042];
obtain second tracking data for a second tracker in a tracking coordinate system, wherein the second tracker is associated with the anatomical object (“and as shown in FIGS. 8-9, an internal tracker 802 may be affixed to the patient’s anatomy 804 (e.g., a patient’ s bone” [0152], "A second position of the internal tracker 802 is subsequently generated, by the surgical computer 150, from the field data." [0182]);
determine, based on the second tracking data, a second pose of the second tracker in five DOFs (“FIG. 2, is limited to detecting five (5) total degrees-of-freedom (DOF). For example, sensor 200 may be able to track/determine movement in the X, Y, or Z direction, as well as rotation around the Y-axis 202 or Z-axis 201.” [0039], “Referring now to FIG. 3C, in some embodiments, two 5DOF EM sensors (e.g., 301C and 302C) may be inserted into the patient (e.g., in a patient bone) at different locations and with different angular orientations (e.g., angle 303C is non-zero)” [0042]);
and combine the first and second tracking data ,wherein combining the first and second tracking data comprises determining, based on the first pose and the second pose, a third pose of in six DOF, the third pose having a fixed spatial relationship relative to the anatomical object in the six DOF of the third pose ("An EM field generated by one or more EM transmitting coils 808 of the external tracker is then received by one or more EM receiving coils 807 of an internal tracker 802 attached to anatomy 804 of the patient… A third position of the internal tracker 802 is then determined by the surgical computer 150 based on the first position and the second position." [0182], “The third position is within a global tracking system 1201 associated with an operating environment 1200 in these examples.” [0183], “In some EM based tracking devices, two coils may be affixed to each other, such as is shown in FIG. 3B. Because the two coils 301B and 302B are rigidly affixed to each other, not perfectly parallel, and have locations that are known relative to each other, it is possible to determine the sixth degree of freedom 303B with this arrangement.” [0040], Corpa states that the coil arrangement within the sensors can be used to determine 6 DOFs, the trackers noted above include the same electromagnetic coils and can thus be arranged to achieve the same outcome of the sensors stated earlier).
and triggering display, on a display, representations of tracked surgical instruments based on the determined third pose of the 6-DOF tracker (“The Surgical Computer 150 provides the Display 125 with any visualization that is needed by the Surgeon 111 during surgery. For monitors, the Surgical Computer 150 may provide instructions for displaying images, GUIs, etc. using techniques known in the art. The display 125 can include various features of the workflow of a surgical plan. During the registration process, for example, the display 125 can show a preoperatively constructed 3D bone model and depict the locations of the point probe 114 as the surgeon uses the probe to collect locations of anatomical landmarks on the patient. The display 125 can include information about the surgical target area. For example, in connection with a TKA, the display 125 can depict the mechanical and anatomical axes of the femur and tibia. The display 125 can depict varus and valgus angles for the knee joint based on a surgical plan, and the CASS 100 can depict how such angles will be affected if contemplated revisions to the surgical plan are made. Accordingly, the display 125 is an interactive interface that can dynamically update and display how changes to the surgical plan would impact the procedure and the final position and orientation of implants installed on bone.” [0090], “The display 125 can provide the surgeon 111 with a variety of data and information about the patient, the planned surgical intervention, and the implants. Various patient-specific information can be displayed, including real-time data concerning the patient’s health such as heart rate, blood pressure, etc. The display 125 can also include information about the anatomy of the surgical target region including the location of landmarks, the current state of the anatomy (e.g., whether any resections have been made, the depth and angles of planned and executed bone cuts), and future states of the anatomy as the surgical plan progresses.“ [0092])
Corpa does not specifically disclose that a first pose of the first tracker is in exactly four degrees of freedom, DOF, that a second pose of the second tracker is in exactly four DOF, wherein the four DOF of at least one of the first pose and the second pose consists of two translational DOF and two rotational DOF, combine the first and second tracking data for determining a single virtual tracker, the single virtual tracker being different from the first tracker and different from the second tracker, wherein combining the first and second tracking data comprises determining, based on the first pose and the second pose, a third pose of the virtual tracker in six DOF, the virtual tracker having a fixed spatial relationship relative to the anatomical object in the six DOF of the third pose.
However, in a similar field of endeavor, Crawford teaches position recognition systems and more particularly to end-effector and instrument tracking and manipulation during robot assisted surgical procedures [0001].
Crawford also teaches a first pose of the first tracker is in exactly four degrees of freedom, DOF, that a second pose of the second tracker is in exactly four DOF, wherein the four DOF of at least one of the first pose and the second pose consists of two translational DOF and two rotational DOF (“As shown in FIG. 15B, when a snugly fitting instrument 608 is placed within the guide tube 1014, the instrument 608 becomes mechanically constrained in 4 of 6 degrees of freedom. That is, the instrument 608 cannot be rotated in any direction except about the longitudinal axis 1016 of the guide tube 1014 and the instrument 608 cannot be translated in any direction except along the longitudinal axis 1016 of the guide tube 1014. In other words, the instrument 608 can only be translated along and rotated about the centerline of the guide tube 1014.” [0127], “Logistically, the surgeon 120 or user could place the instrument 608 within the guide tube 1014 and slightly rotate it or slide it down into the guide tube 1014 and the system 100, 300, 600 would be able to detect that the instrument 608 is within the guide tube 1014 from tracking of the five markers (four markers 804 on instrument 608 plus single marker 1018 on guide tube 1014). Knowing that the instrument 608 is within the guide tube 1014, all 6 degrees of freedom may be calculated that define the position and orientation of the end-effector 1012 in space” [0131]).
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Corpa as outlined above with a first pose of the first tracker is in exactly four degrees of freedom, DOF, that a second pose of the second tracker is in exactly four DOF, wherein the four DOF of at least one of the first pose and the second pose consists of two translational DOF and two rotational DOF as taught by Crawford, because it can be performed relatively quickly and accurately [0005].
Corpa in view of Crawford does not specifically teach combining the first and second tracking data for determining a single virtual tracker, the single virtual tracker being different from the first tracker and different from the second tracker, wherein combining the first and second tracking data comprises determining, based on the first pose and the second pose, a third pose of the virtual tracker in six DOF, the virtual tracker having a fixed spatial relationship relative to the anatomical object in the six DOF of the third pose.
However, in a similar field of endeavor, Traxel teaches a device and method for referencing reference points of a fiducial implant [Abstract].
Traxel also teaches combining the first and second tracking data for determining a single virtual tracker, the single virtual tracker being different from the first tracker and different from the second tracker (“The invention allows a spatial relationship to be determined between reference points associated with the physical body's system of coordinates and the corresponding positions of the reference points in a coordinate system of an image of the body. Preferably, the body comprises at least a portion of a patient, such as a bone. The reference points associated with the body's system of coordinates are preferably reference points of at least one fiducial implant, such as a fiducial screw for insertion in a bone. “ [0022], “To reference the reference points, a pointer fitted with markers is positioned in a precisely defined spatial relationship relative a fiducial implant having fixed reference points. One reference point of the implant preferably corresponds to the tip of the implant and the other reference point preferably corresponds to the head of the implant.” [0023], “As an alternative to using a pointer configured with LED's emitting electromagnetic radiation, pointer 3 may be configured with markers to detect electromagnetic radiation or with acoustic transducers to emit or detect acoustic waves. In each of the alternative cases a position finder cooperates with the markers or acoustic transducers to allow the position of the pointer in three-dimensional space to be determined.” [0036]),
wherein combining the first and second tracking data comprises determining, based on the first pose and the second pose, a third pose of the virtual tracker in six DOF, the virtual tracker having a fixed spatial relationship relative to the anatomical object in the six DOF of the third pose (“Upon associating the positions of the reference points in the image with the positions of the reference points in the coordinate system of the body, any point in the image can be related by a coordinate transformation to the corresponding point in the physical body, and vice-versa. Fiduciary matching or registration thus relates to the determination of the spatial relationship of reference points in the coordinate system of the image to the reference point positions in the coordinate system of the physical body. Because the fiducial implant of the invention comprises at least two reference points, two fiducial implants inserted in the body provide a sufficient number of reference points to allow the registration or matching of the systems of the two coordinate systems. Thus, only the portion of the body receiving the implant need be exposed allowing for a minimally invasive registration of the coordinate systems.” [0027], “If the positions of the reference points of at least two implanted fiducial implants are matched with the corresponding positions of the reference points in an image of the body showing the implants, a coordinate transformation can be determined to allow the positions of points of the body and the corresponding positions of the body points in the image to be related to one another.” [0035]).
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Corpa in view of Crawford as outlined above with combining the first and second tracking data for determining a single virtual tracker, the single virtual tracker being different from the first tracker and different from the second tracker, wherein combining the first and second tracking data comprises determining, based on the first pose and the second pose, a third pose of the virtual tracker in six DOF, the virtual tracker having a fixed spatial relationship relative to the anatomical object in the six DOF of the third pose as taught by Traxel, because it can be performed relatively quickly and accurately [0005].
Regarding Claim 20, Corpa discloses A computer program product stored on non-transitory computer-readable medium and comprising instructions which, when executed on at least one processor ("The present disclosure relates generally to methods, systems, and apparatuses related to a computer-assisted surgical system that includes various hardware and software components that work together to enhance surgical workflows." [0002], “a processor may track that tool or bone as it moves through the environment in a three-dimensional model.” [0046], “The Display 125 provides graphical user interfaces (GUIs) that display images collected by the Tissue Navigation System 120 as well other information relevant to the surgery.” [0051]), cause the at least one processor to:
obtain first tracking data for a first tracker in a tracking coordinate system, wherein the first tracker is associated with an anatomical object ("Accordingly, as described and illustrated herein, in some examples this technology includes a surgical tracking method that includes tracking, by a surgical computer 150, a first position of an external tracker 801 attached externally to a patient based on a tracking array 810 rigidly attached to the external tracker 801" [0182], " an internal tracker 802 may be affixed to the patient’s anatomy 804 (e.g., a patient’ s bone)." [0152]);
determine, based on the first tracking data, a first pose of the first tracker in five degrees of freedom, DOF ("FIG. 2, is limited to detecting five (5) total degrees-of-freedom (DOF). For example, sensor 200 may be able to track/determine movement in the X, Y, or Z direction, as well as rotation around the Y-axis 202 or Z-axis 201." [0039] “Referring now to FIG. 3C, in some embodiments, two 5DOF EM sensors (e.g., 301C and 302C) may be inserted into the patient (e.g., in a patient bone) at different locations and with different angular orientations (e.g., angle 303C is non-zero)” [0042];
obtain second tracking data for a second tracker in a tracking coordinate system, wherein the second tracker is associated with the anatomical object (“and as shown in FIGS. 8-9, an internal tracker 802 may be affixed to the patient’s anatomy 804 (e.g., a patient’ s bone” [0152], "A second position of the internal tracker 802 is subsequently generated, by the surgical computer 150, from the field data." [0182]);
determine, based on the second tracking data, a second pose of the second tracker in five DOFs (“FIG. 2, is limited to detecting five (5) total degrees-of-freedom (DOF). For example, sensor 200 may be able to track/determine movement in the X, Y, or Z direction, as well as rotation around the Y-axis 202 or Z-axis 201.” [0039], “Referring now to FIG. 3C, in some embodiments, two 5DOF EM sensors (e.g., 301C and 302C) may be inserted into the patient (e.g., in a patient bone) at different locations and with different angular orientations (e.g., angle 303C is non-zero)” [0042]);
and combine the first and second tracking data ,wherein combining the first and second tracking data comprises determining, based on the first pose and the second pose, a third pose of in six DOF, the third pose having a fixed spatial relationship relative to the anatomical object in the six DOF of the third pose ("An EM field generated by one or more EM transmitting coils 808 of the external tracker is then received by one or more EM receiving coils 807 of an internal tracker 802 attached to anatomy 804 of the patient… A third position of the internal tracker 802 is then determined by the surgical computer 150 based on the first position and the second position." [0182], “The third position is within a global tracking system 1201 associated with an operating environment 1200 in these examples.” [0183], “In some EM based tracking devices, two coils may be affixed to each other, such as is shown in FIG. 3B. Because the two coils 301B and 302B are rigidly affixed to each other, not perfectly parallel, and have locations that are known relative to each other, it is possible to determine the sixth degree of freedom 303B with this arrangement.” [0040], Corpa states that the coil arrangement within the sensors can be used to determine 6 DOFs, the trackers noted above include the same electromagnetic coils and can thus be arranged to achieve the same outcome of the sensors stated earlier).
and triggering display, on a display, representations of tracked surgical instruments based on the determined third pose of the 6-DOF tracker (“The Surgical Computer 150 provides the Display 125 with any visualization that is needed by the Surgeon 111 during surgery. For monitors, the Surgical Computer 150 may provide instructions for displaying images, GUIs, etc. using techniques known in the art. The display 125 can include various features of the workflow of a surgical plan. During the registration process, for example, the display 125 can show a preoperatively constructed 3D bone model and depict the locations of the point probe 114 as the surgeon uses the probe to collect locations of anatomical landmarks on the patient. The display 125 can include information about the surgical target area. For example, in connection with a TKA, the display 125 can depict the mechanical and anatomical axes of the femur and tibia. The display 125 can depict varus and valgus angles for the knee joint based on a surgical plan, and the CASS 100 can depict how such angles will be affected if contemplated revisions to the surgical plan are made. Accordingly, the display 125 is an interactive interface that can dynamically update and display how changes to the surgical plan would impact the procedure and the final position and orientation of implants installed on bone.” [0090], “The display 125 can provide the surgeon 111 with a variety of data and information about the patient, the planned surgical intervention, and the implants. Various patient-specific information can be displayed, including real-time data concerning the patient’s health such as heart rate, blood pressure, etc. The display 125 can also include information about the anatomy of the surgical target region including the location of landmarks, the current state of the anatomy (e.g., whether any resections have been made, the depth and angles of planned and executed bone cuts), and future states of the anatomy as the surgical plan progresses.“ [0092])
Corpa does not specifically disclose that a first pose of the first tracker is in exactly four degrees of freedom, DOF, that a second pose of the second tracker is in exactly four DOF, wherein the four DOF of at least one of the first pose and the second pose consists of two translational DOF and two rotational DOF, combine the first and second tracking data for determining a single virtual tracker, the single virtual tracker being different from the first tracker and different from the second tracker, wherein combining the first and second tracking data comprises determining, based on the first pose and the second pose, a third pose of the virtual tracker in six DOF, the virtual tracker having a fixed spatial relationship relative to the anatomical object in the six DOF of the third pose.
However, in a similar field of endeavor, Crawford teaches position recognition systems and more particularly to end-effector and instrument tracking and manipulation during robot assisted surgical procedures [0001].
Crawford also teaches a first pose of the first tracker is in exactly four degrees of freedom, DOF, that a second pose of the second tracker is in exactly four DOF, wherein the four DOF of at least one of the first pose and the second pose consists of two translational DOF and two rotational DOF (“As shown in FIG. 15B, when a snugly fitting instrument 608 is placed within the guide tube 1014, the instrument 608 becomes mechanically constrained in 4 of 6 degrees of freedom. That is, the instrument 608 cannot be rotated in any direction except about the longitudinal axis 1016 of the guide tube 1014 and the instrument 608 cannot be translated in any direction except along the longitudinal axis 1016 of the guide tube 1014. In other words, the instrument 608 can only be translated along and rotated about the centerline of the guide tube 1014.” [0127], “Logistically, the surgeon 120 or user could place the instrument 608 within the guide tube 1014 and slightly rotate it or slide it down into the guide tube 1014 and the system 100, 300, 600 would be able to detect that the instrument 608 is within the guide tube 1014 from tracking of the five markers (four markers 804 on instrument 608 plus single marker 1018 on guide tube 1014). Knowing that the instrument 608 is within the guide tube 1014, all 6 degrees of freedom may be calculated that define the position and orientation of the end-effector 1012 in space” [0131]).
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Corpa as outlined above with a first pose of the first tracker is in exactly four degrees of freedom, DOF, that a second pose of the second tracker is in exactly four DOF, wherein the four DOF of at least one of the first pose and the second pose consists of two translational DOF and two rotational DOF as taught by Crawford, because it can be performed relatively quickly and accurately [0005].
Corpa in view of Crawford does not specifically teach combining the first and second tracking data for determining a single virtual tracker, the single virtual tracker being different from the first tracker and different from the second tracker, wherein combining the first and second tracking data comprises determining, based on the first pose and the second pose, a third pose of the virtual tracker in six DOF, the virtual tracker having a fixed spatial relationship relative to the anatomical object in the six DOF of the third pose.
However, in a similar field of endeavor, Traxel teaches a device and method for referencing reference points of a fiducial implant [Abstract].
Traxel also teaches combining the first and second tracking data for determining a single virtual tracker, the single virtual tracker being different from the first tracker and different from the second tracker (“The invention allows a spatial relationship to be determined between reference points associated with the physical body's system of coordinates and the corresponding positions of the reference points in a coordinate system of an image of the body. Preferably, the body comprises at least a portion of a patient, such as a bone. The reference points associated with the body's system of coordinates are preferably reference points of at least one fiducial implant, such as a fiducial screw for insertion in a bone. “ [0022], “To reference the reference points, a pointer fitted with markers is positioned in a precisely defined spatial relationship relative a fiducial implant having fixed reference points. One reference point of the implant preferably corresponds to the tip of the implant and the other reference point preferably corresponds to the head of the implant.” [0023], “As an alternative to using a pointer configured with LED's emitting electromagnetic radiation, pointer 3 may be configured with markers to detect electromagnetic radiation or with acoustic transducers to emit or detect acoustic waves. In each of the alternative cases a position finder cooperates with the markers or acoustic transducers to allow the position of the pointer in three-dimensional space to be determined.” [0036]),
wherein combining the first and second tracking data comprises determining, based on the first pose and the second pose, a third pose of the virtual tracker in six DOF, the virtual tracker having a fixed spatial relationship relative to the anatomical object in the six DOF of the third pose (“Upon associating the positions of the reference points in the image with the positions of the reference points in the coordinate system of the body, any point in the image can be related by a coordinate transformation to the corresponding point in the physical body, and vice-versa. Fiduciary matching or registration thus relates to the determination of the spatial relationship of reference points in the coordinate system of the image to the reference point positions in the coordinate system of the physical body. Because the fiducial implant of the invention comprises at least two reference points, two fiducial implants inserted in the body provide a sufficient number of reference points to allow the registration or matching of the systems of the two coordinate systems. Thus, only the portion of the body receiving the implant need be exposed allowing for a minimally invasive registration of the coordinate systems.” [0027], “If the positions of the reference points of at least two implanted fiducial implants are matched with the corresponding positions of the reference points in an image of the body showing the implants, a coordinate transformation can be determined to allow the positions of points of the body and the corresponding positions of the body points in the image to be related to one another.” [0035]).
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Corpa in view of Crawford as outlined above with combining the first and second tracking data for determining a single virtual tracker, the single virtual tracker being different from the first tracker and different from the second tracker, wherein combining the first and second tracking data comprises determining, based on the first pose and the second pose, a third pose of the virtual tracker in six DOF, the virtual tracker having a fixed spatial relationship relative to the anatomical object in the six DOF of the third pose as taught by Traxel, because it can be performed relatively quickly and accurately [0005].
Claims 13 is rejected under 35 U.S.C. 103 as being unpatentable over Corpa in view of Crawford and further in view of Traxel as applied to Claim 1 above, and further in view of Norman et al (US20220047295A1; hereinafter referred to as Norman).
Regarding Claim 13, Corpa in view of Crawford and further in view of Traxel discloses all limitations noted above except that at least one of the first tracker and the second tracker is movably arranged along an alignment trajectory having a fixed spatial relationship relative to the anatomical object.
However, in a similar field of endeavor, Norman a surgical kit for performing minimally invasive spine surgery [Abstract].
Norman also teaches that at least one of the first tracker and the second tracker is movably arranged along an alignment trajectory having a fixed spatial relationship relative to the anatomical object (“The surgical kit's sensor carrier is configured to be removably arranged in the lumen of a medical instrument of the plurality of medical instruments. The sensor carrier has at least two localizers the position and orientation of which can be determined with the position detection system. The sensor carrier's localizers each are configured for providing a sensor signal representing position and orientation of the respective localizer. A medical instrument being equipped with the sensor carrier can be connected to the position detection system. With the sensor carrier being arranged in a medical instrument's lumen, position and orientation of the sensor carrier's localizers can be determined by the position detection system from provided sensor signals. From determined position and orientation of the sensor carrier's localizers, position and orientation of the medical instrument can be calculated by the position detection system.” [0011], “The at least two localizers arranged in the distal end region of the sensor carrier can be configured to implement and/or can be treated as one sensor or as independent sensors. In case of the sensor carrier being arranged in the medical instrument's lumen, the position of the first localizer and the position of the second localizer along the longitudinal axis of the medical instrument can be used by the position detection system to calculate one virtual longitudinal axis between the two localizers by drawing a virtual line connecting the two central positions of the localizers, for creating a comparatively stable and accurate virtual axis for the sensor carrier and medical instrument. A medical instrument's virtual longitudinal axis, preferably, is the axis that intersects the positions of the at least two localizers of the arranged sensor carrier. The medical instrument's virtual longitudinal axis is defined in the coordinate system of the position detection system based on position and/or orientation of localizers. The physical instrument axis is defined by means of coordinates in real space.” [0028]).
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Corpa in view of Crawford and further in view of Traxel as outlined above with at least one of the first tracker and the second tracker is movably arranged along an alignment trajectory having a fixed spatial relationship relative to the anatomical object as taught by Norman, because it can visually assist a surgeon in navigating the medical instrument [0008].
Conclusion
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/Steven Maldonado/
Patent Examiner, Art Unit 3797
/JOSEPH M SANTOS RODRIGUEZ/Primary Examiner, Art Unit 3797
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