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 .
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.
Joint Inventors
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2 September 2025 has been entered.
Response to Amendment
Claims 1, 8, and 11 have been amended. No claims have been added or cancelled.
Response to Arguments
Applicant's arguments filed 08/05/2025 have been fully considered but they are not persuasive.
Applicants arguments regarding the previous prior art rejection is considered moot with regards to the newly presented rejection below.
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 1-8 and 10-18 are rejected under 35 U.S.C. 103 as being unpatentable over Keller et al. (US20200016758, referred to as Keller) in view of Mitra et al. (US20210322148, referred to as Mitra).
Regarding claim 1: Keller discloses: A method for operating a computer assisted surgery device, the method comprising: acquiring an x-ray image of a bony structure together with at least one of (1) an implant targeting [sleeve] having an implanting trajectory and a reference geometry, and (2) an implant having an implanting trajectory and a reference geometry, the bony structure having an implanting area with a predetermined implanting axis; ([0035] Markers mounted on the manipulator and/or end effector or designed integrally with them have the advantage that they can be designed to be captured reliably by the medical imaging device. If the medical imaging device is an x-ray-based medical imaging device, for example, such as a C arm or a computer tomograph (CT), then the markers may be x-ray markers, which can be clearly identified in the image capture. In particular, the markers may be of a type, such that they produce the fewest possible artifacts in the image created to enable an accurate capture of the markers and to be able to carry out an accurate calibration. In the case of magnetic resonance-based imaging systems, the markers may be fluid-filled objects, in which the fluid is water and/or an alcohol, for example. [0066] The markers 32, 30, 34 are designed to be captured by the medical imaging device 50. The medical imaging device 50 may be any medical imaging device, which is used in the medical field. In the example shown here, it is designed as a C arm. The C arm has an x-ray source 52 and an x-ray recording unit 54. The x-ray recording unit 54 captures the x-rays emitted by the x-ray source 52 to capture an image.) acquiring a deviation of the implanting trajectory of at least one of (1) the implant targeting [sleeve] and (2) the implant from the predetermined implanting axis of the implanting area based on the acquired x- ray image; ([0015] In particular, this object is achieved by a method for calibrating a manipulator of a diagnostic and/or therapeutic manipulator system, wherein the manipulator system comprises at least one medical imaging device, and wherein the method comprises at least the following steps: a) Approaching at least one target pose by means of the manipulator (10); b) Capturing at least one image of at least one part of the manipulator and/or at least one part of an end effector of the manipulator by means of the medical imaging device when the manipulator has approached the target pose; c) Determining the actual pose of the manipulator by means of the captured image; d) Determining the deviation between the target pose and the actual pose of the manipulator;) determining a measure of a required motion of the at least one of (1) the implant targeting [sleeve] and (2) the implant to be executed, based on the deviation, for bringing the implanting trajectory of the at least one of (1) the implant targeting [sleeve] and (2) the implant from a deviated state of the implanting trajectory of the at least one of (1) the implant targeting [sleeve] and (2) the implant into alignment with the predetermined implanting axis of the implanting area; and ([0015] In particular, this object is achieved by a method for calibrating a manipulator of a diagnostic and/or therapeutic manipulator system, wherein the manipulator system comprises at least one medical imaging device, and wherein the method comprises at least the following steps: a) Approaching at least one target pose by means of the manipulator (10); b) Capturing at least one image of at least one part of the manipulator and/or at least one part of an end effector of the manipulator by means of the medical imaging device when the manipulator has approached the target pose; c) Determining the actual pose of the manipulator by means of the captured image; d) Determining the deviation between the target pose and the actual pose of the manipulator; e) Calculating at least one calibration parameter based on the deviation determined;) controlling a motion of at least one of (1) the implant targeting [sleeve] and (2) the implant based on the determined measure of required motion ([0015] In particular, this object is achieved by a method for calibrating a manipulator of a diagnostic and/or therapeutic manipulator system, wherein the manipulator system comprises at least one medical imaging device, and wherein the method comprises at least the following steps: a) Approaching at least one target pose by means of the manipulator (10); b) Capturing at least one image of at least one part of the manipulator and/or at least one part of an end effector of the manipulator by means of the medical imaging device when the manipulator has approached the target pose; c) Determining the actual pose of the manipulator by means of the captured image; d) Determining the deviation between the target pose and the actual pose of the manipulator; e) Calculating at least one calibration parameter based on the deviation determined; and f) Calibrating the manipulator.) [wherein the method occurs in real time to display a real-time position of the at least one of the implant targeting sleeve and the implant].
Keller does not explicitly disclose: [sleeve] [wherein the method occurs in real time to display a real-time position of the at least one of the implant targeting sleeve and the implant]
Keller does not explicitly disclose the following limitations, however, Mitra teaches: sleeve ([0086] The robotic arm 205A may also be used for resurfacing applications. For example, the robotic arm 205A may stabilize the surgeon while using traditional instrumentation and provide certain restrictions or limitations to allow for proper placement of implant components (e.g., guide wire placement, chamfer cutter, sleeve cutter, plan cutter, etc.). Where only a burr is employed, the robotic arm 205A may stabilize the surgeon's handpiece and may impose restrictions on the handpiece to prevent the surgeon from removing unintended bone in contravention of the surgical plan.) wherein the method occurs in real time to display a real-time position of the at least one of the implant targeting sleeve and the implant ([0043] the term “real-time” is used to refer to calculations or operations performed on-the-fly as events occur or input is received by the operable system. However, the use of the term “real-time” is not intended to preclude operations that cause some latency between input and response, so long as the latency is an unintended consequence induced by the performance characteristics of the machine. [0051] The Tracking System 215 uses one or more sensors to collect real-time position data that locates the patient's anatomy and surgical instruments. For example, for TKA procedures, the Tracking System may provide a location and orientation of the End Effector 205B during the procedure.)
Keller and Mitra are analogous art to the claimed invention since they are from the similar field of surgical end effector control. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the end effector trajectory generating system of Keller with the implant sleeve end effector and real time data collection/presentation taught in Mitra.
The motivation for modification would have been to utilize the trajectory updating system disclosed in Keller with a common surgical end effector and end effector tracking method as taught in Mitra.
Regarding claim 2: The combination of Keller and Mitra teaches: The method according to claim 1,
Keller further discloses: wherein the computer assisted surgery device has a segmented robot arm with a plurality of segments and a plurality of joints, wherein two adjacent segments of the plurality of segments are coupled with a joint of the plurality of joints, ([0056] The control device may control at least one manipulator and/or one mobile manipulator according to the method described above. It is also possible to control a plurality of manipulators by means of one control device. For example, a plurality of manipulators, which are jointed arm manipulators, can be controlled by a control device and calibrated according to the method. [0067] A marker 36 may be associated with the manipulator 10 at its manipulator base. The manipulator system 1, which can be seen in FIG. 1, preferably comprises a stationary manipulator 10 and a stationary imaging device 50, i.e., these are secured in space relative to one another.) the segmented robot arm capable of being transitioned from a fixed state to a released state and vice versa, wherein a first end of the segmented robot arm is connected to a fix point and wherein a second end of the segmented robot arm is connected to the implant targeting [sleeve], wherein the method further comprises: before acquiring the x-ray image, transitioning the plurality of joints of the segmented robot arm to the fixed state, after determining a measure of required motion, transitioning at least one of the plurality of joints to the released state, controlling a motion of at least one of the segments of the plurality of segments adjacent to the released joints in order to move the at least one of the implant targeting [sleeve] and the implant according to the determined measure of required motion, and transitioning the released joints from the released state to the fixed state. ([0069] The manipulator additionally comprises the markers 30, 32, 34, 36 described above. The manipulator system additionally comprises an imaging device 50 (C arm), which has an x-ray source 52 and an x-ray recording unit 54. In addition, a patient bed 40 having markers 42, 44 may be associated with the manipulator system 2. The mobile manipulator 10' comprises coupling means 18, which can couple in a form-fitting manner with the complementary coupling means 58 and/or 48 of the imaging device 50 and/or of the patient bed 40, for example. The manipulator can therefore be secured in relation to the patient bed 40 and/or the imaging device 50, so that the calibration of the manipulator 10 is simplified.)
Keller does not explicitly disclose: [sleeve]
Mitra further teaches: sleeve ([0086] The robotic arm 205A may also be used for resurfacing applications. For example, the robotic arm 205A may stabilize the surgeon while using traditional instrumentation and provide certain restrictions or limitations to allow for proper placement of implant components (e.g., guide wire placement, chamfer cutter, sleeve cutter, plan cutter, etc.). Where only a burr is employed, the robotic arm 205A may stabilize the surgeon's handpiece and may impose restrictions on the handpiece to prevent the surgeon from removing unintended bone in contravention of the surgical plan.)
As previously stated, Keller and Mitra are analogous art to the claimed invention since they are from the similar field of surgical end effector control. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the end effector trajectory generating system of Keller with the implant sleeve end effector taught in Mitra.
The motivation for modification would have been to utilize the trajectory updating system disclosed in Keller with a common surgical end effector as taught in Mitra.
Regarding claim 3: The combination of Keller and Mitra teaches: The method according to claim 2,
Keller further discloses: wherein the segmented robot arm has a plurality of actuators each adapted to controllably actuate a motion of two adjacent segments of the plurality of segments with respect to each other along their connecting joint, ([0056] The control device may control at least one manipulator and/or one mobile manipulator according to the method described above. It is also possible to control a plurality of manipulators by means of one control device. For example, a plurality of manipulators, which are jointed arm manipulators, can be controlled by a control device and calibrated according to the method.) wherein the method further comprises: before acquiring the x-ray image, controlling the plurality of actuators to transition the plurality of joints of the segmented arm to the fixed state, after determining a measure of required motion, controlling the plurality of actuators to transition the plurality of joints to the released state and move at least a part of the segments of the plurality of segments to move the at least one of the implant targeting [sleeve] and the implant according to the determined measure of required motion, and controlling the plurality of actuators to transition the plurality of joints of the segmented arm to the fixed state. ([0053] The mobile manipulator may comprise at least one coupling means, wherein the mobile manipulator can be secured in a stationary position by using the coupling means. To be able to accurately position and orient the mobile manipulator in relation to the imaging device in order to perform an accurate calibration, the manipulator may comprise coupling means, with which it can be secured in a stationary position. For example, the coupling means may be a mechanical coupling means, with which the manipulator can be secured on a stationary object. The coupling means may then be designed, for example, as a projection and a complementary stationary coupling means may be designed as a corresponding setback, for example, with a conical shape, such that the cone fits into a mating cone in a form-fitting manner. Other geometric shapes are also possible. In particular, the coupling means may be locked to one another. This locking may be accomplished by means of a form-fitting and/or force-locking connection. For example, the coupling means may be equipped with magnets, so that they snap together when the coupling means are coupled. Other coupling means comprising locking levers, snaps or the like are also conceivable. [0054] The imaging device may comprise a complementary coupling means, which can be coupled to the coupling means of the mobile manipulator in order to secure the mobile manipulator in relation to the imaging device. If the imaging device is equipped with a complementary coupling means, then there may be a direct coupling of the mobile manipulator and the imaging device, so that the accuracy in calibration can be further increased because the imaging device and the manipulator are aligned accurately with one another. In particular, it should be pointed out that the coupling means can be releasably connected to one another and are preferably quick coupling means, i.e., they can be coupled to one another and/or uncoupled from one another without the use of tools. [0069] The manipulator additionally comprises the markers 30, 32, 34, 36 described above. The manipulator system additionally comprises an imaging device 50 (C arm), which has an x-ray source 52 and an x-ray recording unit 54. In addition, a patient bed 40 having markers 42, 44 may be associated with the manipulator system 2. The mobile manipulator 10' comprises coupling means 18, which can couple in a form-fitting manner with the complementary coupling means 58 and/or 48 of the imaging device 50 and/or of the patient bed 40, for example. The manipulator can therefore be secured in relation to the patient bed 40 and/or the imaging device 50, so that the calibration of the manipulator 10 is simplified.)
Keller does not explicitly disclose: [sleeve]
Mitra further teaches: sleeve ([0086] The robotic arm 205A may also be used for resurfacing applications. For example, the robotic arm 205A may stabilize the surgeon while using traditional instrumentation and provide certain restrictions or limitations to allow for proper placement of implant components (e.g., guide wire placement, chamfer cutter, sleeve cutter, plan cutter, etc.). Where only a burr is employed, the robotic arm 205A may stabilize the surgeon's handpiece and may impose restrictions on the handpiece to prevent the surgeon from removing unintended bone in contravention of the surgical plan.)
As previously stated, Keller and Mitra are analogous art to the claimed invention since they are from the similar field of surgical end effector control. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the end effector trajectory generating system of Keller with the implant sleeve end effector taught in Mitra.
The motivation for modification would have been to utilize the trajectory updating system disclosed in Keller with a common surgical end effector as taught in Mitra.
Regarding claim 4: The combination of Keller and Mitra teaches: The method according to claim 1,
Keller further discloses: wherein acquiring the x-ray image of the bony structure together with at least one of the implant targeting [sleeve] and the implant comprises: acquiring a first at least bi-planar image from a first view point onto the bony structure together with the at least one of the implant targeting [sleeve] and the implant, and a second at least bi-planar image from a second view point onto the bony structure together with the at least one of the implant targeting [sleeve] and the implant, correlating the first at least bi-planar image and the second at least bi-planar image; and generating a three dimensional image of the bony structure based on the first at least bi-planar image, the second at least bi-planar image, and a correlation of the first at least bi-planar image and the second at least bi-planar image. ([0032] Furthermore, the medical imaging device may be equipped to create two-dimensional and/or three-dimensional images. [0033] If two-dimensional images are created by the medical imaging device or if the device is equipped to do so , then it may be necessary to capture multiple images in order to be able to unambiguously determine the actual pose of the manipulator [0045] In particular steps a ) through f ) can be carried out for at least two different target positions . If steps a ) through f ) of the method are carried out for different target positions , then the manipulator can be calibrated in the entire working range of the manipulator, and a high absolute accuracy can be achieved throughout the entire working range. Various poses that are distributed over the entire working range of the manipulator are typically used as target poses.)
Keller does not explicitly disclose: [sleeve]
Mitra further teaches: sleeve ([0086] The robotic arm 205A may also be used for resurfacing applications. For example, the robotic arm 205A may stabilize the surgeon while using traditional instrumentation and provide certain restrictions or limitations to allow for proper placement of implant components (e.g., guide wire placement, chamfer cutter, sleeve cutter, plan cutter, etc.). Where only a burr is employed, the robotic arm 205A may stabilize the surgeon's handpiece and may impose restrictions on the handpiece to prevent the surgeon from removing unintended bone in contravention of the surgical plan.)
As previously stated, Keller and Mitra are analogous art to the claimed invention since they are from the similar field of surgical end effector control. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the end effector trajectory generating system of Keller with the implant sleeve end effector taught in Mitra.
The motivation for modification would have been to utilize the trajectory updating system disclosed in Keller with a common surgical end effector as taught in Mitra.
Regarding claim 5: The combination of Keller and Mitra teaches: The method according to claim 1,
Keller further discloses: further comprising determining the implanting area and the predetermined implanting axis based on the acquired x-ray image of the bony structure and ([0034] The manipulator and/or the end effector may comprise at least one marker , which is equipped to be captured by the imaging device, and wherein the marker is also captured in capturing the image. [0035] Markers mounted on the manipulator and/or end effector or designed integrally with them have the advantage that they can be designed to be captured reliably by the medical imaging device. If the medical imaging device is an X-ray-based medical imaging device, for example, such as a C arm or a computer tomograph (CT), then the markers may be X-ray markers, which can be clearly identified in the image capture.) a bone data base having stored therein a plurality of data of bony structures, optimized implanting areas thereon and/or therein, and predetermined implanting axes, as well as correlations thereof. ([0005] Other known applications relate to the placement of implants, in particular the placement of surgical screws. [0022] The actual pose of the manipulator is determined on the basis of the captured image, and a deviation between the target pose and the actual pose is determined. The deviation is a measure of the absolute accuracy. If the repeat accuracy is to be improved , then the target pose may be a pose approached previously and need not be determined by exact coordinates in space. [0023] Calibration parameters are then calculated on the basis of the deviations determined, and are in turn used to calibrate the manipulator. This is typically achieved by adapting a model of the manipulator in a control device of the manipulator, so that commanded control commands result in the exact/accurate approach to the target pose. [0029] Repeating the preceding steps a ) through f ) increases the accuracy of the calibration because errors that occur can be averaged. In particular, it is possible to approach the target pose from various directions in order to achieve a higher accuracy . Then the method can be terminated when the result falls below a predefined quality parameter , i.e. , the desired accuracy has been reached . The accuracy may relate to the repeat accuracy or the absolute accuracy of the manipulator , for example . It is also possible to use other definitions of accuracy to determine the quality parameter or to combine different accuracy values . For example , the quality parameter can be obtained proportion ally from a first factor , which determines the absolute accuracy , and from a second factor , which determines the repeat accuracy . [0030] The medical imaging device may preferably be an X - ray imaging device , an ultrasonic imaging device and / or a magnetic resonance imaging device.)
Regarding claim 6: The combination of Keller and Mitra teaches: The method according to claim 1,
Keller further discloses: wherein the implanting area of the bony structure represents an area which is defined by a geometry of an implant to be implanted on and/or in the bony structure. ([0005] Other known applications relate to the placement of implants, in particular the placement of surgical screws. [0043] The marker may also be releasably connected to the manipulator and/or the end effector, in which case the method may comprise the following step : arranging and/or releasing at least one marker on the manipulator and/or the end effector, with the mounting being accomplished in particular by means of a releasable connection. [0044] If the markers are releasably connected to the manipulator , then it is possible to remove them after calibration to prevent the markers from interfering with carrying out the diagnostic/therapeutic procedure. In this case, the method for calibration may comprise the method steps: disposing at least one marker on the manipulator and / or end effector, so that the marker is preferably also moved together when the manipulator is moved ; and detaching the marker from the manipulator and/or end effector after the calibration has been performed.)
Regarding claim 7: The combination of Keller and Mitra teaches: The method according to claim 1,
Keller further discloses: wherein the method comprises: after controlling a motion of the at least one of the implant targeting [sleeve] and the implant, ([0005] Other known applications relate to the placement of implants, in particular the placement of surgical screws. [0027] Determining a quality parameter indicating the accuracy of the manipulator in approach to the target pose, wherein the quality parameter indicates in particular the absolute accuracy and/or the repeat accuracy of the manipulator; and [0028] Repeating steps a) through f) until the quality parameter has fallen below a predefined quality limit.) acquiring a further at least bi-planar image from a first view point onto the bony structure together with the at least one of the implant targeting [sleeve] and the implant, and a further at least bi-planar image from a second view point onto the bony structure together with the at least one of the implant targeting [sleeve] and the implant, ([0032] Furthermore, the medical imaging device may be equipped to create two-dimensional and/or three-dimensional images. [0033] If two-dimensional images are created by the medical imaging device or if the device is equipped to do so , then it may be necessary to capture multiple images in order to be able to unambiguously determine the actual pose of the manipulator [0045] In particular steps a ) through f ) can be carried out for at least two different target positions . If steps a ) through f ) of the method are carried out for different target positions , then the manipulator can be calibrated in the entire working range of the manipulator, and a high absolute accuracy can be achieved throughout the entire working range. Various poses that are distributed over the entire working range of the manipulator are typically used as target poses.) determining a deviation of the implanting trajectory of the ate least one of the implant targeting [sleeve] and the implant from the predetermined implanting axis of the implanting area of the bony structure. ([0015] In particular, this object is achieved by a method for calibrating a manipulator of a diagnostic and/or therapeutic manipulator system, wherein the manipulator system comprises at least one medical imaging device, and wherein the method comprises at least the following steps: a) Approaching at least one target pose by means of the manipulator (10); b) Capturing at least one image of at least one part of the manipulator and/or at least one part of an end effector of the manipulator by means of the medical imaging device when the manipulator has approached the target pose; c) Determining the actual pose of the manipulator by means of the captured image; d) Determining the deviation between the target pose and the actual pose of the manipulator; e) Calculating at least one calibration parameter based on the deviation determined;)
Regarding claim 8: Keller discloses: A device for computer assisted surgery, the device comprising: an image acquiring unit adapted for acquiring an x-ray image of a bony structure together with at least one of an implant targeting [sleeve] and an implant having an implanting trajectory and a reference geometry; ([0035] Markers mounted on the manipulator and/or end effector or designed integrally with them have the advantage that they can be designed to be captured reliably by the medical imaging device. If the medical imaging device is an x-ray-based medical imaging device, for example, such as a C arm or a computer tomograph (CT), then the markers may be x-ray markers, which can be clearly identified in the image capture. In particular, the markers may be of a type, such that they produce the fewest possible artifacts in the image created to enable an accurate capture of the markers and to be able to carry out an accurate calibration. In the case of magnetic resonance-based imaging systems, the markers may be fluid-filled objects, in which the fluid is water and/or an alcohol, for example. [0066] The markers 32, 30, 34 are designed to be captured by the medical imaging device 50. The medical imaging device 50 may be any medical imaging device, which is used in the medical field. In the example shown here, it is designed as a C arm. The C arm has an x-ray source 52 and an x-ray recording unit 54. The x-ray recording unit 54 captures the x-rays emitted by the x-ray source 52 to capture an image.) a deviation acquiring unit adapted for acquiring a deviation of the implanting trajectory of the at least one of the implant targeting [sleeve] and the implant from a predetermined implanting axis of an implanting area of the bony structure based on the acquired x-ray image; ([0015] In particular, this object is achieved by a method for calibrating a manipulator of a diagnostic and/or therapeutic manipulator system, wherein the manipulator system comprises at least one medical imaging device, and wherein the method comprises at least the following steps: a) Approaching at least one target pose by means of the manipulator (10); b) Capturing at least one image of at least one part of the manipulator and/or at least one part of an end effector of the manipulator by means of the medical imaging device when the manipulator has approached the target pose; c) Determining the actual pose of the manipulator by means of the captured image; d) Determining the deviation between the target pose and the actual pose of the manipulator;) a motion determining unit adapted for determining a measure of a required motion of the at least one of the implant targeting [sleeve] and the implant to be executed, based on the deviation, for bringing the implanting trajectory of the at least one of the implant targeting [sleeve] and the implant from the acquired deviation of the implanting trajectory of the at least one of the implant targeting [sleeve] and the implant into alignment with the predetermined implanting axis of the implanting area; and ([0015] In particular, this object is achieved by a method for calibrating a manipulator of a diagnostic and/or therapeutic manipulator system, wherein the manipulator system comprises at least one medical imaging device, and wherein the method comprises at least the following steps: a) Approaching at least one target pose by means of the manipulator (10); b) Capturing at least one image of at least one part of the manipulator and/or at least one part of an end effector of the manipulator by means of the medical imaging device when the manipulator has approached the target pose; c) Determining the actual pose of the manipulator by means of the captured image; d) Determining the deviation between the target pose and the actual pose of the manipulator; e) Calculating at least one calibration parameter based on the deviation determined;) a motion controlling unit adapted for controlling a motion of the at least one of the implant targeting [sleeve] and the implant based on the measure of required motion determined by the motion determining unit. ([0015] In particular, this object is achieved by a method for calibrating a manipulator of a diagnostic and/or therapeutic manipulator system, wherein the manipulator system comprises at least one medical imaging device, and wherein the method comprises at least the following steps: a) Approaching at least one target pose by means of the manipulator (10); b) Capturing at least one image of at least one part of the manipulator and/or at least one part of an end effector of the manipulator by means of the medical imaging device when the manipulator has approached the target pose; c) Determining the actual pose of the manipulator by means of the captured image; d) Determining the deviation between the target pose and the actual pose of the manipulator; e) Calculating at least one calibration parameter based on the deviation determined; and f) Calibrating the manipulator.) [wherein the processor is configured to perform steps in real time to display a real-time position of the at least one of the implant targeting sleeve and the implant].
Keller does not explicitly disclose: [sleeve] [wherein the processor is configured to perform steps in real time to display a real-time position of the at least one of the implant targeting sleeve and the implant]
Keller does not explicitly disclose the following limitations, however, Mitra teaches: sleeve ([0086] The robotic arm 205A may also be used for resurfacing applications. For example, the robotic arm 205A may stabilize the surgeon while using traditional instrumentation and provide certain restrictions or limitations to allow for proper placement of implant components (e.g., guide wire placement, chamfer cutter, sleeve cutter, plan cutter, etc.). Where only a burr is employed, the robotic arm 205A may stabilize the surgeon's handpiece and may impose restrictions on the handpiece to prevent the surgeon from removing unintended bone in contravention of the surgical plan.) wherein the processor is configured to perform steps in real time to display a real-time position of the at least one of the implant targeting sleeve and the implant ([0043] the term “real-time” is used to refer to calculations or operations performed on-the-fly as events occur or input is received by the operable system. However, the use of the term “real-time” is not intended to preclude operations that cause some latency between input and response, so long as the latency is an unintended consequence induced by the performance characteristics of the machine. [0051] The Tracking System 215 uses one or more sensors to collect real-time position data that locates the patient's anatomy and surgical instruments. For example, for TKA procedures, the Tracking System may provide a location and orientation of the End Effector 205B during the procedure.)
Keller and Mitra are analogous art to the claimed invention since they are from the similar field of surgical end effector control. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the end effector trajectory generating system of Keller with the implant sleeve end effector and real time data collection/presentation taught in Mitra.
The motivation for modification would have been to utilize the trajectory updating system disclosed in Keller with a common surgical end effector and end effector tracking method as taught in Mitra.
Regarding claim 10: The combination of Keller and Mitra teaches: The device according to claim 8,
Keller further discloses: further comprising: a segmented arm with a plurality of segments, wherein at least two adjacent segments of the plurality of segments are coupled with a joint ([0056] The control device may control at least one manipulator and/or one mobile manipulator according to the method described above. It is also possible to control a plurality of manipulators by means of one control device. For example, a plurality of manipulators, which are jointed arm manipulators, can be controlled by a control device and calibrated according to the method. [0067] A marker 36 may be associated with the manipulator 10 at its manipulator base. The manipulator system 1, which can be seen in FIG. 1, preferably comprises a stationary manipulator 10 and a stationary imaging device 50, i.e., these are secured in space relative to one another.) being capable of being transitioned from a fixed state to a released state and vice versa, wherein a first end of the segmented arm is connected to a fix point and a second end of the segmented arm is connectable to at least one of (1) the implant targeting [sleeve] and (2) the implant, wherein the image acquiring unit is adapted to acquire the x-ray image in the fixed state of the segmented arm; and wherein the motion controlling unit is adapted for transitioning the segmented arm from the fixed state to the released state for controlling the motion of the segmented arm based on the measure of the required motion determined by the motion determining unit, and for transitioning the segmented arm from the released state to the fixed state. ([0069] The manipulator additionally comprises the markers 30, 32, 34, 36 described above. The manipulator system additionally comprises an imaging device 50 (C arm), which has an x-ray source 52 and an x-ray recording unit 54. In addition, a patient bed 40 having markers 42, 44 may be associated with the manipulator system 2. The mobile manipulator 10' comprises coupling means 18, which can couple in a form-fitting manner with the complementary coupling means 58 and/or 48 of the imaging device 50 and/or of the patient bed 40, for example. The manipulator can therefore be secured in relation to the patient bed 40 and/or the imaging device 50, so that the calibration of the manipulator 10 is simplified.)
Keller does not explicitly disclose: [sleeve]
Keller does not explicitly disclose the following limitations, however, Mitra teaches: sleeve ([0086] The robotic arm 205A may also be used for resurfacing applications. For example, the robotic arm 205A may stabilize the surgeon while using traditional instrumentation and provide certain restrictions or limitations to allow for proper placement of implant components (e.g., guide wire placement, chamfer cutter, sleeve cutter, plan cutter, etc.). Where only a burr is employed, the robotic arm 205A may stabilize the surgeon's handpiece and may impose restrictions on the handpiece to prevent the surgeon from removing unintended bone in contravention of the surgical plan.)
Keller and Mitra are analogous art to the claimed invention since they are from the similar field of surgical end effector control. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the end effector trajectory generating system of Keller with the implant sleeve end effector taught in Mitra.
The motivation for modification would have been to utilize the trajectory updating system disclosed in Keller with a common surgical end effector as taught in Mitra.
Regarding claim 11: Keller discloses: A device for computer assisted surgery, the device comprising: a first segmented robot arm having a plurality of segments and a plurality of actuators each being adapted to controllably actuate a motion of two adjacent segments with respect to each other about a connecting joint of the two adjacent segments, ([0056] The control device may control at least one manipulator and/or one mobile manipulator according to the method described above. It is also possible to control a plurality of manipulators by means of one control device. For example, a plurality of manipulators, which are jointed arm manipulators, can be controlled by a control device and calibrated according to the method.) wherein the connecting joint is capable of being transitioned from a fixed state to a released state and vice versa, wherein a first end of the the first segmented robot arm is connected to a fix point and a second end of the first segmented robot arm is connectable to at least one of (1) an implant targeting [sleeve] having an implanting trajectory and a reference geometry, and (2) an implant having an implanting trajectory and a reference geometry, an image acquiring unit adapted for acquiring an x-ray image of a bony structure together with the at least one of the implant targeting [sleeve] and the implant at a fixed state of the first segmented robot arm; ([0053] The mobile manipulator may comprise at least one coupling means, wherein the mobile manipulator can be secured in a stationary position by using the coupling means. To be able to accurately position and orient the mobile manipulator in relation to the imaging device in order to perform an accurate calibration, the manipulator may comprise coupling means, with which it can be secured in a stationary position. For example, the coupling means may be a mechanical coupling means, with which the manipulator can be secured on a stationary object. The coupling means may then be designed, for example, as a projection and a complementary stationary coupling means may be designed as a corresponding setback, for example, with a conical shape, such that the cone fits into a mating cone in a form-fitting manner. Other geometric shapes are also possible. In particular, the coupling means may be locked to one another. This locking may be accomplished by means of a form-fitting and/or force-locking connection. For example, the coupling means may be equipped with magnets, so that they snap together when the coupling means are coupled. Other coupling means comprising locking levers, snaps or the like are also conceivable. [0054] The imaging device may comprise a complementary coupling means, which can be coupled to the coupling means of the mobile manipulator in order to secure the mobile manipulator in relation to the imaging device. If the imaging device is equipped with a complementary coupling means, then there may be a direct coupling of the mobile manipulator and the imaging device, so that the accuracy in calibration can be further increased because the imaging device and the manipulator are aligned accurately with one another. In particular, it should be pointed out that the coupling means can be releasably connected to one another and are preferably quick coupling means, i.e., they can be coupled to one another and/or uncoupled from one another without the use of tools. [0069] The manipulator additionally comprises the markers 30, 32, 34, 36 described above. The manipulator system additionally comprises an imaging device 50 (C arm), which has an x-ray source 52 and an x-ray recording unit 54. In addition, a patient bed 40 having markers 42, 44 may be associated with the manipulator system 2. The mobile manipulator 10' comprises coupling means 18, which can couple in a form-fitting manner with the complementary coupling means 58 and/or 48 of the imaging device 50 and/or of the patient bed 40, for example. The manipulator can therefore be secured in relation to the patient bed 40 and/or the imaging device 50, so that the calibration of the manipulator 10 is simplified.) a deviation acquiring unit adapted for acquiring a deviation of the implanting trajectory of the at least one of the implant targeting [sleeve] and the implant from a predetermined implanting axis of an implanting area of the bony structure based on the acquired x-ray image; ([0015] In particular, this object is achieved by a method for calibrating a manipulator of a diagnostic and/or therapeutic manipulator system, wherein the manipulator system comprises at least one medical imaging device, and wherein the method comprises at least the following steps: a) Approaching at least one target pose by means of the manipulator (10); b) Capturing at least one image of at least one part of the manipulator and/or at least one part of an end effector of the manipulator by means of the medical imaging device when the manipulator has approached the target pose; c) Determining the actual pose of the manipulator by means of the captured image; d) Determining the deviation between the target pose and the actual pose of the manipulator;) a motion determining unit adapted for determining a measure of a required motion of the ate least one of the implant targeting [sleeve] and the implant to be executed, based on the deviation, for bringing the implanting trajectory of the at least one of the implant targeting [sleeve] and the implant from the acquired deviation of the implanting trajectory of the at least one of the implant targeting [sleeve] and the implant into alignment with the predetermined implanting axis of the implanting area; and ([0015] In particular, this object is achieved by a method for calibrating a manipulator of a diagnostic and/or therapeutic manipulator system, wherein the manipulator system comprises at least one medical imaging device, and wherein the method comprises at least the following steps: a) Approaching at least one target pose by means of the manipulator (10); b) Capturing at least one image of at least one part of the manipulator and/or at least one part of an end effector of the manipulator by means of the medical imaging device when the manipulator has approached the target pose; c) Determining the actual pose of the manipulator by means of the captured image; d) Determining the deviation between the target pose and the actual pose of the manipulator; e) Calculating at least one calibration parameter based on the deviation determined;) a motion controlling unit adapted for transitioning connecting joints of the first segmented robot arm from the fixed state to the released state, for controlling the motion of the plurality of actuators of the first segmented robot arm based on the measure of required motion determined by the motion determining unit, and for transitioning the connecting joints of the first segmented robot arm from the released state to the fixed state ([0015] In particular, this object is achieved by a method for calibrating a manipulator of a diagnostic and/or therapeutic manipulator system, wherein the manipulator system comprises at least one medical imaging device, and wherein the method comprises at least the following steps: a) Approaching at least one target pose by means of the manipulator (10); b) Capturing at least one image of at least one part of the manipulator and/or at least one part of an end effector of the manipulator by means of the medical imaging device when the manipulator has approached the target pose; c) Determining the actual pose of the manipulator by means of the captured image; d) Determining the deviation between the target pose and the actual pose of the manipulator; e) Calculating at least one calibration parameter based on the deviation determined; and f) Calibrating the manipulator.) [wherein the processor is configured to operate in real time to display a real-time position of the at least one of the implant targeting sleeve and the implant].
Keller does not explicitly disclose: [sleeve] [wherein the processor is configured to operate in real time to display a real-time position of the at least one of the implant targeting sleeve and the implant]
Keller does not explicitly disclose the following limitations, however, Mitra teaches: sleeve ([0086] The robotic arm 205A may also be used for resurfacing applications. For example, the robotic arm 205A may stabilize the surgeon while using traditional instrumentation and provide certain restrictions or limitations to allow for proper placement of implant components (e.g., guide wire placement, chamfer cutter, sleeve cutter, plan cutter, etc.). Where only a burr is employed, the robotic arm 205A may stabilize the surgeon's handpiece and may impose restrictions on the handpiece to prevent the surgeon from removing unintended bone in contravention of the surgical plan.) wherein the processor is configured to operate in real time to display a real-time position of the at least one of the implant targeting sleeve and the implant ([0043] the term “real-time” is used to refer to calculations or operations performed on-the-fly as events occur or input is received by the operable system. However, the use of the term “real-time” is not intended to preclude operations that cause some latency between input and response, so long as the latency is an unintended consequence induced by the performance characteristics of the machine. [0051] The Tracking System 215 uses one or more sensors to collect real-time position data that locates the patient's anatomy and surgical instruments. For example, for TKA procedures, the Tracking System may provide a location and orientation of the End Effector 205B during the procedure.)
Keller and Mitra are analogous art to the claimed invention since they are from the similar field of surgical end effector control. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the end effector trajectory generating system of Keller with the implant sleeve end effector and real time data collection/presentation taught in Mitra.
The motivation for modification would have been to utilize the trajectory updating system disclosed in Keller with a common surgical end effector and end effector tracking method as taught in Mitra.
Regarding claim 12: The combination of Keller and Mitra teaches: The device according to claim 8,
Keller further discloses: wherein the image acquiring unit is adapted for acquiring a first at least bi-planar image from a first view point onto the bony structure together with at least one of an implant targeting [sleeve] and an implant, and a second at least bi-planar image from a second view point onto the bony structure together with the at least one of the implant targeting [sleeve] and the implant, and for composing an x-ray image out of the first at least bi-planar image and the second at least bi-planar image. ([0005] Other known applications relate to the placement of implants, in particular the placement of surgical screws. [0032] Furthermore, the medical imaging device may be equipped to create two-dimensional and/or three-dimensional images. [0033] If two-dimensional images are created by the medical imaging device or if the device is equipped to do so , then it may be necessary to capture multiple images in order to be able to unambiguously determine the actual pose of the manipulator [0045] In particular steps a ) through f ) can be carried out for at least two different target positions . If steps a ) through f ) of the method are carried out for different target positions , then the manipulator can be calibrated in the entire working range of the manipulator, and a high absolute accuracy can be achieved throughout the entire working range. Various poses that are distributed over the entire working range of the manipulator are typically used as target poses.)
Keller does not explicitly disclose: [sleeve]
Mitra further teaches: sleeve ([0086] The robotic arm 205A may also be used for resurfacing applications. For example, the robotic arm 205A may stabilize the surgeon while using traditional instrumentation and provide certain restrictions or limitations to allow for proper placement of implant components (e.g., guide wire placement, chamfer cutter, sleeve cutter, plan cutter, etc.). Where only a burr is employed, the robotic arm 205A may stabilize the surgeon's handpiece and may impose restrictions on the handpiece to prevent the surgeon from removing unintended bone in contravention of the surgical plan.)
As previously stated, Keller and Mitra are analogous art to the claimed invention since they are from the similar field of surgical end effector control. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the end effector trajectory generating system of Keller with the implant sleeve end effector taught in Mitra.
The motivation for modification would have been to utilize the trajectory updating system disclosed in Keller with a common surgical end effector as taught in Mitra.
Regarding claim 13: The combination of Keller and Mitra teaches: The device according to claim 11,
Keller further discloses: wherein the image acquiring unit comprises a correlation unit adapted for correlating the first at least bi-planar image and the second at least bi-planar image and generating a three dimensional image of the bony structure based on the first at least bi-planar image, the second at least bi-planar image, and the correlation of the first at least bi-planar image and the second at least bi-planar image. ([0032] Furthermore, the medical imaging device may be equipped to create two-dimensional and/or three-dimensional images. [0033] If two-dimensional images are created by the medical imaging device or if the device is equipped to do so , then it may be necessary to capture multiple images in order to be able to unambiguously determine the actual pose of the manipulator [0045] In particular steps a ) through f ) can be carried out for at least two different target positions . If steps a ) through f ) of the method are carried out for different target positions , then the manipulator can be calibrated in the entire working range of the manipulator, and a high absolute accuracy can be achieved throughout the entire working range. Various poses that are distributed over the entire working range of the manipulator are typically used as target poses.)
Regarding claim 14: The combination of Keller and Mitra teaches: The device according to claim 8,
Keller further discloses: further comprising an implanting area determining unit being adapted for determining the implanting area and the predetermined implanting axis ([0034] The manipulator and/or the end effector may comprise at least one marker, which is equipped to be captured by the imaging device, and wherein the marker is also captured in capturing the image. [0035] Markers mounted on the manipulator and/or end effector or designed integrally with them have the advantage that they can be designed to be captured reliably by the medical imaging device. If the medical imaging device is an X-ray-based medical imaging device, for example, such as a C arm or a computer tomograph (CT), then the markers may be X-ray markers, which can be clearly identified in the image capture.) based on the acquired bony structure and a bone data base having stored therein a plurality of data of bony structures, optimized implanting areas thereon and/or therein, and predetermined implanting axes, as well as a correlation thereof. ([0005] Other known applications relate to the placement of implants, in particular the placement of surgical screws. [0022] The actual pose of the manipulator is determined on the basis of the captured image, and a deviation between the target pose and the actual pose is determined. The deviation is a measure of the absolute accuracy. If the repeat accuracy is to be improved , then the target pose may be a pose approached previously and need not be determined by exact coordinates in space. [0023] Calibration parameters are then calculated on the basis of the deviations determined, and are in turn used to calibrate the manipulator. This is typically achieved by adapting a model of the manipulator in a control device of the manipulator, so that commanded control commands result in the exact/accurate approach to the target pose. [0029] Repeating the preceding steps a ) through f ) increases the accuracy of the calibration because errors that occur can be averaged. In particular, it is possible to approach the target pose from various directions in order to achieve a higher accuracy . Then the method can be terminated when the result falls below a predefined quality parameter , i.e. , the desired accuracy has been reached . The accuracy may relate to the repeat accuracy or the absolute accuracy of the manipulator , for example . It is also possible to use other definitions of accuracy to determine the quality parameter or to combine different accuracy values . For example , the quality parameter can be obtained proportion ally from a first factor , which determines the absolute accuracy , and from a second factor , which determines the repeat accuracy . [0030] The medical imaging device may preferably be an X - ray imaging device , an ultrasonic imaging device and / or a magnetic resonance imaging device.)
Regarding claim 15: The combination of Keller and Mitra teaches: The device according to claim 8,
Keller further discloses: further comprising as part of a system a reference geometry, wherein the reference geometry is a reference body which is attachable to at least one of the implant targeting [sleeve] and the implant, representing a unique position and orientation of the at least one of the implant targeting [sleeve] and the implant. ([0005] Other known applications relate to the placement of implants, in particular the placement of surgical screws. [0043] The marker may also be releasably connected to the manipulator and/or the end effector, in which case the method may comprise the following step : arranging and/or releasing at least one marker on the manipulator and/or the end effector, with the mounting being accomplished in particular by means of a releasable connection. [0044] If the markers are releasably connected to the manipulator , then it is possible to remove them after calibration to prevent the markers from interfering with carrying out the diagnostic/therapeutic procedure. In this case, the method for calibration may comprise the method steps: disposing at least one marker on the manipulator and / or end effector, so that the marker is preferably also moved together when the manipulator is moved ; and detaching the marker from the manipulator and/or end effector after the calibration has been performed.)
Keller does not explicitly disclose: [sleeve]
Mitra further teaches: sleeve ([0086] The robotic arm 205A may also be used for resurfacing applications. For example, the robotic arm 205A may stabilize the surgeon while using traditional instrumentation and provide certain restrictions or limitations to allow for proper placement of implant components (e.g., guide wire placement, chamfer cutter, sleeve cutter, plan cutter, etc.). Where only a burr is employed, the robotic arm 205A may stabilize the surgeon's handpiece and may impose restrictions on the handpiece to prevent the surgeon from removing unintended bone in contravention of the surgical plan.)
As previously stated, Keller and Mitra are analogous art to the claimed invention since they are from the similar field of surgical end effector control. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the end effector trajectory generating system of Keller with the implant sleeve end effector taught in Mitra.
The motivation for modification would have been to utilize the trajectory updating system disclosed in Keller with a common surgical end effector as taught in Mitra.
Keller does not explicitly disclose: [sleeve]
Mitra further teaches: sleeve ([0086] The robotic arm 205A may also be used for resurfacing applications. For example, the robotic arm 205A may stabilize the surgeon while using traditional instrumentation and provide certain restrictions or limitations to allow for proper placement of implant components (e.g., guide wire placement, chamfer cutter, sleeve cutter, plan cutter, etc.). Where only a burr is employed, the robotic arm 205A may stabilize the surgeon's handpiece and may impose restrictions on the handpiece to prevent the surgeon from removing unintended bone in contravention of the surgical plan.)
As previously stated, Keller and Mitra are analogous art to the claimed invention since they are from the similar field of surgical end effector control. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the end effector trajectory generating system of Keller with the implant sleeve end effector taught in Mitra.
The motivation for modification would have been to utilize the trajectory updating system disclosed in Keller with a common surgical end effector as taught in Mitra.
Regarding claim 16: The combination of Keller and Mitra teaches: The device according to claim 8,
Keller further discloses: further comprising as part of a system an implant targeting [sleeve], wherein the reference geometry is an integral portion of the implant targeting [sleeve], ([0035] Markers mounted on the manipulator and/or end effector or designed integrally with them have the advantage that they can be designed to be captured reliably by the medical imaging device. If the medical imaging device is an x-ray-based medical imaging device, for example, such as a C arm or a computer tomograph (CT), then the markers may be x-ray markers, which can be clearly identified in the image capture. In particular, the markers may be of a type, such that they produce the fewest possible artifacts in the image created to enable an accurate capture of the markers and to be able to carry out an accurate calibration. In the case of magnetic resonance-based imaging systems, the markers may be fluid-filled objects, in which the fluid is water and/or an alcohol, for example. [0036] The marker may also have a defined geometric shape, which simplifies the determination of the position and/or orientation of the marker on the basis of the captured image. [0037] If the marker has geometrically defined shapes, then the actual pose of the manipulator can be determined quickly and easily. The marker is preferably designed, so that the position and orientation of the marker in space can be determined unambiguously when an image, in particular exactly one image, is compiled.) wherein the integral portion has a geometry having a unique projection pattern for each projection direction. ([0053] The mobile manipulator may comprise at least one coupling means, wherein the mobile manipulator can be secured in a stationary position by using the coupling means. To be able to accurately position and orient the mobile manipulator in relation to the imaging device in order to perform an accurate calibration, the manipulator may comprise coupling means, with which it can be secured in a stationary position. For example, the coupling means may be a mechanical coupling means, with which the manipulator can be secured on a stationary object. The coupling means may then be designed, for example, as a projection and a complementary stationary coupling means may be designed as a corresponding setback, for example, with a conical shape, such that the cone fits into a mating cone in a form-fitting manner. Other geometric shapes are also possible.)
Keller does not explicitly disclose: [sleeve]
Mitra further teaches: sleeve ([0086] The robotic arm 205A may also be used for resurfacing applications. For example, the robotic arm 205A may stabilize the surgeon while using traditional instrumentation and provide certain restrictions or limitations to allow for proper placement of implant components (e.g., guide wire placement, chamfer cutter, sleeve cutter, plan cutter, etc.). Where only a burr is employed, the robotic arm 205A may stabilize the surgeon's handpiece and may impose restrictions on the handpiece to prevent the surgeon from removing unintended bone in contravention of the surgical plan.)
As previously stated, Keller and Mitra are analogous art to the claimed invention since they are from the similar field of surgical end effector control. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the end effector trajectory generating system of Keller with the implant sleeve end effector taught in Mitra.
The motivation for modification would have been to utilize the trajectory updating system disclosed in Keller with a common surgical end effector as taught in Mitra.
Regarding claim 17: The combination of Keller and Mitra teaches: The device according to claim 8,
Keller further discloses: further comprising as part of a system an implant, wherein the reference geometry is an integral portion of the implant, ([0035] Markers mounted on the manipulator and/or end effector or designed integrally with them have the advantage that they can be designed to be captured reliably by the medical imaging device. If the medical imaging device is an x-ray-based medical imaging device, for example, such as a C arm or a computer tomograph (CT), then the markers may be x-ray markers, which can be clearly identified in the image capture. In particular, the markers may be of a type, such that they produce the fewest possible artifacts in the image created to enable an accurate capture of the markers and to be able to carry out an accurate calibration. In the case of magnetic resonance-based imaging systems, the markers may be fluid-filled objects, in which the fluid is water and/or an alcohol, for example. [0036] The marker may also have a defined geometric shape, which simplifies the determination of the position and/or orientation of the marker on the basis of the captured image. [0037] If the marker has geometrically defined shapes, then the actual pose of the manipulator can be determined quickly and easily. The marker is preferably designed, so that the position and orientation of the marker in space can be determined unambiguously when an image, in particular exactly one image, is compiled.) wherein the integral portion has a geometry having a unique projection pattern for each projection direction. ([0053] The mobile manipulator may comprise at least one coupling means, wherein the mobile manipulator can be secured in a stationary position by using the coupling means. To be able to accurately position and orient the mobile manipulator in relation to the imaging device in order to perform an accurate calibration, the manipulator may comprise coupling means, with which it can be secured in a stationary position. For example, the coupling means may be a mechanical coupling means, with which the manipulator can be secured on a stationary object. The coupling means may then be designed, for example, as a projection and a complementary stationary coupling means may be designed as a corresponding setback, for example, with a conical shape, such that the cone fits into a mating cone in a form-fitting manner. Other geometric shapes are also possible.)
Regarding claim 18: The combination of Keller and Mitra teaches: The device according to claim 8,
Keller further discloses: wherein the reference geometry has a plurality of fiducial markers, wherein the fiducial markers have a spatial arrangement having a unique projection pattern for each projection direction. ([0053] The mobile manipulator may comprise at least one coupling means, wherein the mobile manipulator can be secured in a stationary position by using the coupling means. To be able to accurately position and orient the mobile manipulator in relation to the imaging device in order to perform an accurate calibration, the manipulator may comprise coupling means, with which it can be secured in a stationary position. For example, the coupling means may be a mechanical coupling means, with which the manipulator can be secured on a stationary object. The coupling means may then be designed, for example, as a projection and a complementary stationary coupling means may be designed as a corresponding setback, for example, with a conical shape, such that the cone fits into a mating cone in a form-fitting manner. Other geometric shapes are also possible [0055] the manipulator system may also comprise at least one stationary marker, which is equipped to be captured by the imaging device, such that the marker is also captured when the image is captured. Stationary markers, such as the markers described above, which are arranged on the manipulator, make it possible to establish a spatial reference (position and/or orientation) between the end effector and/or the manipulator and the stationary coordinate system.)
Conclusion
The prior art made of record, and not relied upon, considered pertinent to applicant' s disclosure or directed to the state of art is listed on the enclosed PTO-892.
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/ATTICUS A CAMERON/ /JASON HOLLOWAY/ Primary Examiner, Art Unit 3658 Examiner, Art Unit 3658A