DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 4-9, & 11have 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.
Claim 11 recites the limitation "the at least three positions" in Line 10. There is insufficient antecedent basis for this limitation in the claim.
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, 4-9,& 11 are rejected under 35 U.S.C. 103 as being unpatentable over Xu et al (US20200197099A1; hereinafter referred to as Xu) in view of Link et al (US20080039868A1; hereinafter referred to as Link)
Regarding Claim 1, Xu discloses a system for monitoring an orientation of a medical device (‘An instrument tracking system includes an instrument tracker as described above with a wireless communication module and a display device. The tracker controller is operatively connected to the wireless communication module for communicating at least one of angular orientation and insertion depth to the display device.” [0013]),
comprising the medical device, a measuring device, and an external device that communicates with the measuring device (“Display device 26 includes a display device controller 28, a memory 30, a user interface 32, a processor 34, and an interface 36. Processor 34 is disposed in communication with memory 30. Memory 30 includes a non-transitory machine readable medium having a plurality of program modules 38 recorded on memory 30. Program modules 38 include instructions that, when read by processor 34 cause processor 34 to undertake certain actions, e.g., a method 200 (shown in FIG. 21) of tracking position of an instrument.” [0043], “instrument tracking system 200 is shown. Instrument tracking system includes instrument tracker 100 (shown in FIG. 4) and display device 26 (shown in FIG. 3). Instrument tracker 100 includes a wireless communication module 108 (shown in FIG. 12) for wireless communication with display device 26 and controller 106 (shown in FIG. 12) operatively connected to wireless communication module 108 for communicating at least one of position information 46 (shown in FIG. 4) and angular orientation information 48 (shown in FIG. 4) of instrument tracker 100 to display device. Position information 46 and angular orientation information 48 are generated using position information controller 106 receives from IMU 104 (shown in FIG. 12), which can include magnetometer 134 (shown in FIG. 12). Controller 106 fuses the position information 46 and angular information 48 with image data 24 (shown in FIG. 2) of subject 10 (shown in FIG. 1) for display on display device 26.” [0050],
wherein the external device contains a communication module, a control unit, a power source and a display (“Display device 26 includes a display device controller 28, a memory 30, a user interface 32, a processor 34, and an interface 36. Processor 34 is disposed in communication with memory 30. Memory 30 includes a non-transitory machine readable medium having a plurality of program modules 38 recorded on memory 30. Program modules 38 include instructions that, when read by processor 34 cause processor 34 to undertake certain actions, e.g., a method 200 (shown in FIG. 21) of tracking position of an instrument.” [0043]),
wherein the measuring device is connected to the medical device, the measuring device contains a sensing system, which includes a gyroscope and an accelerometer, a measuring device power source, a measuring device communication module and a measuring device control unit (“An instrument tracker includes a case having an interior and exterior with a plurality of instrument seats, an inertial measurement unit (IMU) arranged within the interior of the case, and a controller. The controller is arranged within the interior of the case, is disposed in communication with the IMU, and is responsive to instructions recorded on a non-transitory machine readable medium to receive position information from the IMU and determine at least one of position and orientation of an instrument fixed relative to the case by the plurality of instrument seats using the position information received from the IMU.” [0008], “the IMU can include one or more of a magnetometer, an accelerometer, and a gyroscope. The one or more of a magnetometer, an accelerometer, and a gyroscope can be disposed in communication with the controller. A battery can be battery arranged within the interior of the case end. The battery can be electrically connected to the IMU and the controller. A wired charging circuit can be electrically connected to the battery for direct-connect charging of the battery. A wireless charging circuit can be electrically connected to the battery for wirelessly charging of the battery. The instrument tracker can include a wireless communication module for communication with a display device. The controller can be operatively connected to the wireless communication module.” [0010]),
and the device has a position adapted for calibrating the medical device, wherein the position of the device is adapted for calibrating the medical device in a horizontal plane relative to a computed tomography (CT} table (“calibration of instrument tracker 100 is shown. In a further aspect one-touch calibration can be used for off-axial-plane needle insertion. In this respect, for tumor targets at different locations requiring off-plane targeting, a calibration procedure of the instrument tracker can be done in a fast and simple one-touch step. Calibration can be accomplished by placing instrument tracker 100 at any two perpendicular edges of the CT table that aligns the tracker to the X and Z-axes of the CT table, as shown in FIG. 19B. The calibration can be takes approximately a few seconds to generate the calibration matrices and can be performed prior to instrument insertion.” [0073].
wherein the measuring device does not include a magnetometer (“IMU 104 is an electronic device that measures and reports a body's specific force, angular rate, and sometimes the magnetic field surrounding the body, using a combination of accelerometers, gyroscopes, and/or magnetometers.” [0065], Xu teaches embodiments which do not require magnetometers).
Xu does not specifically disclose a calibrating device that has at least three positions adapted for calibrating the medical device, wherein a second position of the at least three positions of the calibrating device is adapted for determining a direction of the medical device relative to the CT table, wherein a third position of the at least three positions of the calibrating device is adapted for calibrating the medical device in a vertical plane relative to the CT table; wherein the calibrating device is operable to secure the medical device in each of the at least three positions to determine a reference frame for the measuring device in a world frame, wherein the reference frame is based on: the calibrating the medical device in a horizontal plane, the determined direction of the medical device relative to the CT table, and the calibrating the medical device in a vertical plane relative to the CT table; and wherein the measuring device is operable to communicate orientation data to the external deice, wherein the external device is operable to calculate geometric transformations within the world frame.
However, in a similar field of endeavor, Link teaches a method for calibrating a spatial position and/or orientation of at least one surgical referencing unit of a surgical navigation system fitted with at least one inertial sensor in relation to a spatial coordinate system [0002].
Link also teaches a calibrating device that has at least three positions adapted for calibrating the medical device (“An appropriate referencing is necessary, depending on whether positions and/or orientations in the coordinate system are to be determined with the referencing units 14 or 18. For this the referencing units 14 and 18 can be fitted, for example, with so-called calibration gauges, which are matched geometrically to a part or section of the calibration unit 36 in order to define a unique orientation, a unique position or a unique position including orientation. This also applies analogously to the above-described origin calibration, and therefore the calibration gauges described below could also serve, in principle, as origin calibration gauges. It should also be noted that the calibration gauges, as described below by way of example, can also be arranged on the calibration unit 36 and brought into engagement with corresponding sections or parts of the referencing units 14 or 18.” [0127], “To predefine an axis, a calibration gauge 100 can be used, for example, which is substantially cuboidal in shape and has a wedge-shaped groove 102 extending parallel to the side edges. A cylindrical section of the calibration unit can be placed against the groove 102 and thus define an axis 104. The calibration gauge 100 is shown schematically in FIGS. 8 and 9.” [0128], “The calibration gauges shown in FIGS. 8 to 20 are only meant as examples to perform one-dimensional referencing, i.e. direction referencing, two-dimensional referencing, e.g. plane referencing, and three-dimensional referencing, in particular point-direction referencing. Naturally, the precise dimensions of the calibration gauges and their fittings can be previously determined prior to use in association with a navigation system 22 for a high-precision navigation operation.” [0136])),
wherein a second position of the at least three positions of the calibrating device is adapted for determining a direction of the medical device relative to the operating table (“The origin calibration gauge 42, which optionally can also be fastened to a circumferentially arranged rail on the operating table in the operating theatre or on an instrument table, thus defines a so-called absolute or global coordinate system 60.” [0111], “. For this the referencing units 14 and 18 can be fitted, for example, with so-called calibration gauges, which are matched geometrically to a part or section of the calibration unit 36 in order to define a unique orientation, a unique position or a unique position including orientation” [0127], “The calibration gauges shown in FIGS. 8 to 20 are only meant as examples to perform one-dimensional referencing, i.e. direction referencing, two-dimensional referencing, e.g. plane referencing, and three-dimensional referencing, in particular point-direction referencing. Naturally, the precise dimensions of the calibration gauges and their fittings can be previously determined prior to use in association with a navigation system 22 for a high-precision navigation operation.” [0136]),
wherein a third position of the at least three positions of the calibrating device is adapted for calibrating the medical device in a vertical plane relative to the operating table (“To predefine an axis, a calibration gauge 100 can be used, for example, which is substantially cuboidal in shape and has a wedge-shaped groove 102 extending parallel to the side edges. A cylindrical section of the calibration unit can be placed against the groove 102 and thus define an axis 104. The calibration gauge 100 is shown schematically in FIGS. 8 and 9.” [0128], “The calibration gauges shown in FIGS. 8 to 20 are only meant as examples to perform one-dimensional referencing, i.e. direction referencing, two-dimensional referencing, e.g. plane referencing, and three-dimensional referencing, in particular point-direction referencing. Naturally, the precise dimensions of the calibration gauges and their fittings can be previously determined prior to use in association with a navigation system 22 for a high-precision navigation operation.” [0136]);
wherein the calibrating device is operable to secure the medical device in each of the at least three positions to determine a reference frame for the measuring device in a world frame (“A surgical calibration device according to the invention, given the overall reference 10, comprising a calibration unit 36 serves to calibrate the referencing units 14 or 18. The calibration unit can be configured in particular in the form of a feeler or probing instrument” [0108], “A calibration of the referencing units 14 and 18 can be performed, for example, in a fixed spatial coordinate system 60, e.g. an operating theatre. In particular, an origin can be defined by means of an origin calibration gauge 42. This is a spatially fixed device arranged, for example, on a table top 44 or an operating table 46, which can have a receiving means 48, into which a part of the calibration unit 36 can be inserted, i.e. preferably in a positive and one-to-one arrangement. In this case, one-to-one means that there is precisely only one possibility of inserting the calibration unit 36 into the receiving means 48.” [0109], “The calibration gauges shown in FIGS. 8 to 20 are only meant as examples to perform one-dimensional referencing, i.e. direction referencing, two-dimensional referencing, e.g. plane referencing, and three-dimensional referencing, in particular point-direction referencing. Naturally, the precise dimensions of the calibration gauges and their fittings can be previously determined prior to use in association with a navigation system 22 for a high-precision navigation operation. Thus, for example, a relative position between the probe tip 50 and the calibration gauge arranged on the calibration unit 36 can be determined with high precision.” [0136])
wherein the reference frame is based on: the calibrating the medical device in a horizontal plane, the determined direction of the medical device relative to the operating table, and the calibrating the medical device in a vertical plane relative to the operating table (“A calibration of the referencing units 14 and 18 can be performed, for example, in a fixed spatial coordinate system 60, e.g. an operating theatre. In particular, an origin can be defined by means of an origin calibration gauge 42. This is a spatially fixed device arranged, for example, on a table top 44 or an operating table 46, which can have a receiving means 48, into which a part of the calibration unit 36 can be inserted, i.e. preferably in a positive and one-to-one arrangement. In this case, one-to-one means that there is precisely only one possibility of inserting the calibration unit 36 into the receiving means 48.” [0109], “The calibration gauges shown in FIGS. 8 to 20 are only meant as examples to perform one-dimensional referencing, i.e. direction referencing, two-dimensional referencing, e.g. plane referencing, and three-dimensional referencing, in particular point-direction referencing. Naturally, the precise dimensions of the calibration gauges and their fittings can be previously determined prior to use in association with a navigation system 22 for a high-precision navigation operation. Thus, for example, a relative position between the probe tip 50 and the calibration gauge arranged on the calibration unit 36 can be determined with high precision.” [0136]; and
wherein the measuring device is operable to communicate orientation data to the external deice, wherein the external device is operable to calculate geometric transformations within the world frame (“a navigation system with a data processing unit, wherein the navigation system and the data processing unit are configured and programmed in such a manner that position and/or orientation data of the referencing unit are determinable in relation to the coordinate system;” [0043], “An appropriate referencing is necessary, depending on whether positions and/or orientations in the coordinate system are to be determined with the referencing units 14 or 18. For this the referencing units 14 and 18 can be fitted, for example, with so-called calibration gauges, which are matched geometrically to a part or section of the calibration unit 36 in order to define a unique orientation, a unique position or a unique position including orientation. This also applies analogously to the above-described origin calibration, and therefore the calibration gauges described below could also serve, in principle, as origin calibration gauges. It should also be noted that the calibration gauges, as described below by way of example, can also be arranged on the calibration unit 36 and brought into engagement with corresponding sections or parts of the referencing units 14 or 18.” [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 Xu as outlined above with a calibrating device that has at least three positions adapted for calibrating the medical device, wherein a second position of the at least three positions of the calibrating device is adapted for determining a direction of the medical device relative to the CT table, wherein a third position of the at least three positions of the calibrating device is adapted for calibrating the medical device in a vertical plane relative to the CT table; wherein the calibrating device is operable to secure the medical device in each of the at least three positions to determine a reference frame for the measuring device in a world frame, wherein the reference frame is based on: the calibrating the medical device in a horizontal plane, the determined direction of the medical device relative to the CT table, and the calibrating the medical device in a vertical plane relative to the CT table; and wherein the measuring device is operable to communicate orientation data to the external deice, wherein the external device is operable to calculate geometric transformations within the world frame as taught by Link, because it allows for calibration or referencing errors to be minimised or often even completely excluded [0019].
Regarding Claim 4, Xu discloses that the calibrating device uses at least one rotation matrix (“Calibration can be accomplished by placing instrument tracker 100 at any two perpendicular edges of the CT table that aligns the tracker to the X and Z-axes of the CT table, as shown in FIG. 19B. The calibration can be takes approximately a few seconds to generate the calibration matrices and can be performed prior to instrument insertion.” [0073], "The computer device may send, receive, and/or manipulate data regarding the location, position, orientation, or coordinate(s) of a position indicating element (e.g., sensor coils or other position indicating elements), or one or more other elements, received by tracking device. " [0085], “In addition to providing rotational information, magnetometer 134 can provide information for detecting the relative orientation of instrument tracker 100 relative to the Earth's magnetic north.” [0067], if the data is placed in a common coordinate system then a rotation matrix is inherently used).
Regarding Claim 5, Xu discloses that the system further comprises an imaging apparatus for monitoring the position of the medical device in the body ("Display device 26 receives image data 24 from imaging device 22 (shown in FIG. 2) and reconstructs an image 40 including subject 10. Further, using image data 24 and/or in conjunction with user input received at user interface 32, display device 26 generates an insertion path 42." [0044])
Regarding Claim 6, Xu teaches that the medical device is a biopsy needle ("instrument tracking system 200 may include one or more surgical devices or device assemblies, the position and orientation of which may be tracked by tracking device. Examples of surgical devices may include therapeutic devices such as needles, ablation needles, " [0083] “Control application may additionally generate and display (e.g., on display device) a point at which a needle or other instrument placed in a hole of the tracker will intersect a target lesion if the projected path of the needle or instrument intersects the determined path of the target lesion, as well as an indicator of the closest approach from a needle or other instrument passing through a hole in the tracker to the target lesion if the projected path of the needle or instrument does not intersect tissue not intended to be treated or biopsied.” [0089]).
Regarding Claim 7, Xu teaches that the medical device is an ablation needle ("instrument tracking system 200 may include one or more surgical devices or device assemblies, the position and orientation of which may be tracked by tracking device. Examples of surgical devices may include therapeutic devices such as needles, ablation needles, " [0083]).
Regarding Claim 8, Xu discloses that the medical device is a needle ("instrument tracking system 200 may include one or more surgical devices or device assemblies, the position and orientation of which may be tracked by tracking device. Examples of surgical devices may include therapeutic devices such as needles, ablation needles, " [0083] “Control application may additionally generate and display (e.g., on display device) a point at which a needle or other instrument placed in a hole of the tracker will intersect a target lesion if the projected path of the needle or instrument intersects the determined path of the target lesion, as well as an indicator of the closest approach from a needle or other instrument passing through a hole in the tracker to the target lesion if the projected path of the needle or instrument does not intersect tissue not intended to be treated or biopsied.” [0089]).
Xu does not specifically disclose the medical device is a drainage needle.
However, 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 Xu as outlined above with the medical device is a drainage needle, because it would be simple substitution of one known needle element for another to obtain predictable results of tracking a needle.
Regarding Claim 9, Xu discloses that the medical device also has a connection element (“FIG. 18A showing the instrument tracker as a clip added on different medical devices and/or needle instruments, FIG. 18B showing an instrument removably fixed to the instrument tracker inserted in a subject” [0032], "To visualize the relative position of instrument 20 relative to predetermined insertion path 42 instrument tracker 100 is removably fixed to instrument 20. Instrument tracker 100 is configured and adapted to transmit at least one of position information 46 and angular orientation information 48 of instrument 20 to display device 26. " [0045]).
Regarding Claim 11, Xu discloses a system for monitoring an orientation of a medical device (‘An instrument tracking system includes an instrument tracker as described above with a wireless communication module and a display device. The tracker controller is operatively connected to the wireless communication module for communicating at least one of angular orientation and insertion depth to the display device.” [0013]),
comprising the medical device, a measuring device, and an external device that communicates with the measuring device (“Display device 26 includes a display device controller 28, a memory 30, a user interface 32, a processor 34, and an interface 36. Processor 34 is disposed in communication with memory 30. Memory 30 includes a non-transitory machine readable medium having a plurality of program modules 38 recorded on memory 30. Program modules 38 include instructions that, when read by processor 34 cause processor 34 to undertake certain actions, e.g., a method 200 (shown in FIG. 21) of tracking position of an instrument.” [0043], “instrument tracking system 200 is shown. Instrument tracking system includes instrument tracker 100 (shown in FIG. 4) and display device 26 (shown in FIG. 3). Instrument tracker 100 includes a wireless communication module 108 (shown in FIG. 12) for wireless communication with display device 26 and controller 106 (shown in FIG. 12) operatively connected to wireless communication module 108 for communicating at least one of position information 46 (shown in FIG. 4) and angular orientation information 48 (shown in FIG. 4) of instrument tracker 100 to display device. Position information 46 and angular orientation information 48 are generated using position information controller 106 receives from IMU 104 (shown in FIG. 12), which can include magnetometer 134 (shown in FIG. 12). Controller 106 fuses the position information 46 and angular information 48 with image data 24 (shown in FIG. 2) of subject 10 (shown in FIG. 1) for display on display device 26.” [0050],
wherein the external device contains a communication module, a control unit, a power source and a display (“Display device 26 includes a display device controller 28, a memory 30, a user interface 32, a processor 34, and an interface 36. Processor 34 is disposed in communication with memory 30. Memory 30 includes a non-transitory machine readable medium having a plurality of program modules 38 recorded on memory 30. Program modules 38 include instructions that, when read by processor 34 cause processor 34 to undertake certain actions, e.g., a method 200 (shown in FIG. 21) of tracking position of an instrument.” [0043]),
wherein the measuring device is connected to the medical device, the measuring device contains a sensing system, which includes a gyroscope and an accelerometer, a connection element, a measuring device power source, a measuring device communication module and a measuring device control unit (“An instrument tracker includes a case having an interior and exterior with a plurality of instrument seats, an inertial measurement unit (IMU) arranged within the interior of the case, and a controller. The controller is arranged within the interior of the case, is disposed in communication with the IMU, and is responsive to instructions recorded on a non-transitory machine readable medium to receive position information from the IMU and determine at least one of position and orientation of an instrument fixed relative to the case by the plurality of instrument seats using the position information received from the IMU.” [0008], “the IMU can include one or more of a magnetometer, an accelerometer, and a gyroscope. The one or more of a magnetometer, an accelerometer, and a gyroscope can be disposed in communication with the controller. A battery can be battery arranged within the interior of the case end. The battery can be electrically connected to the IMU and the controller. A wired charging circuit can be electrically connected to the battery for direct-connect charging of the battery. A wireless charging circuit can be electrically connected to the battery for wirelessly charging of the battery. The instrument tracker can include a wireless communication module for communication with a display device. The controller can be operatively connected to the wireless communication module.” [0010], “FIG. 18A showing the instrument tracker as a clip added on different medical devices and/or needle instruments, FIG. 18B showing an instrument removably fixed to the instrument tracker inserted in a subject” [0032], "To visualize the relative position of instrument 20 relative to predetermined insertion path 42 instrument tracker 100 is removably fixed to instrument 20. Instrument tracker 100 is configured and adapted to transmit at least one of position information 46 and angular orientation information 48 of instrument 20 to display device 26. " [0045]),
and the device has a position adapted for calibrating the medical device, wherein the position of the device is adapted for calibrating the medical device in a horizontal plane relative to a computed tomography (CT} table (“calibration of instrument tracker 100 is shown. In a further aspect one-touch calibration can be used for off-axial-plane needle insertion. In this respect, for tumor targets at different locations requiring off-plane targeting, a calibration procedure of the instrument tracker can be done in a fast and simple one-touch step. Calibration can be accomplished by placing instrument tracker 100 at any two perpendicular edges of the CT table that aligns the tracker to the X and Z-axes of the CT table, as shown in FIG. 19B. The calibration can be takes approximately a few seconds to generate the calibration matrices and can be performed prior to instrument insertion.” [0073].
wherein the external device is operable to display the at least three positions, a target position, and a direction and a magnitude of correction to reach the target position (“the control application may facilitate mapping of a target lesion (e.g., a cancerous region) or other portion of a patient's anatomy, or other operations related to a map of the target lesion or portion of the patient's anatomy. For example, control application may generate and display (e.g., on display device) the position of a tracker relative to a location in a target lesion, a projected path (of the target paths of the tracker) including a path a needle or other instrument inserted into a hole (or a needle guide or a channel) of the tracking device will follow if the needle or instrument is extended past a distal end portion of the tracker. Control application may additionally generate and display (e.g., on display device) a point at which a needle or other instrument placed in a hole of the tracker will intersect a target lesion if the projected path of the needle or instrument intersects the determined path of the target lesion, as well as an indicator of the closest approach from a needle or other instrument passing through a hole in the tracker to the target lesion if the projected path of the needle or instrument does not intersect tissue not intended to be treated or biopsied. Additional displays may be presented. The foregoing system architecture is exemplary only, and should not be viewed as limiting.” [0089])
wherein the measuring device is connected to the medical device through the connection element, wherein the measuring device is attached at a terminal end of the medical device (“FIG. 18A showing the instrument tracker as a clip added on different medical devices and/or needle instruments, FIG. 18B showing an instrument removably fixed to the instrument tracker inserted in a subject” [0032], "To visualize the relative position of instrument 20 relative to predetermined insertion path 42 instrument tracker 100 is removably fixed to instrument 20. Instrument tracker 100 is configured and adapted to transmit at least one of position information 46 and angular orientation information 48 of instrument 20 to display device 26. " [0045])
Xu does not specifically disclose a calibrating device that has at least three positions adapted for calibrating the medical device, wherein a second position of the at least three positions of the calibrating device is adapted for determining a direction of the medical device relative to the CT table, wherein a third position of the at least three positions of the calibrating device is adapted for calibrating the medical device in a vertical plane relative to the CT table; wherein the calibrating device is operable to secure the medical device in each of the at least three positions to determine a reference frame for the measuring device in a world frame, wherein the reference frame is based on: the calibrating the medical device in a horizontal plane, the determined direction of the medical device relative to the CT table, and the calibrating the medical device in a vertical plane relative to the CT table; and wherein the measuring device is operable to communicate orientation data to the external deice, wherein the external device is operable to calculate geometric transformations within the world frame.
However, in a similar field of endeavor, Link teaches a method for calibrating a spatial position and/or orientation of at least one surgical referencing unit of a surgical navigation system fitted with at least one inertial sensor in relation to a spatial coordinate system [0002].
Link also teaches a calibrating device that has at least three positions adapted for calibrating the medical device (“An appropriate referencing is necessary, depending on whether positions and/or orientations in the coordinate system are to be determined with the referencing units 14 or 18. For this the referencing units 14 and 18 can be fitted, for example, with so-called calibration gauges, which are matched geometrically to a part or section of the calibration unit 36 in order to define a unique orientation, a unique position or a unique position including orientation. This also applies analogously to the above-described origin calibration, and therefore the calibration gauges described below could also serve, in principle, as origin calibration gauges. It should also be noted that the calibration gauges, as described below by way of example, can also be arranged on the calibration unit 36 and brought into engagement with corresponding sections or parts of the referencing units 14 or 18.” [0127], “To predefine an axis, a calibration gauge 100 can be used, for example, which is substantially cuboidal in shape and has a wedge-shaped groove 102 extending parallel to the side edges. A cylindrical section of the calibration unit can be placed against the groove 102 and thus define an axis 104. The calibration gauge 100 is shown schematically in FIGS. 8 and 9.” [0128], “The calibration gauges shown in FIGS. 8 to 20 are only meant as examples to perform one-dimensional referencing, i.e. direction referencing, two-dimensional referencing, e.g. plane referencing, and three-dimensional referencing, in particular point-direction referencing. Naturally, the precise dimensions of the calibration gauges and their fittings can be previously determined prior to use in association with a navigation system 22 for a high-precision navigation operation.” [0136])),
wherein a second position of the at least three positions of the calibrating device is adapted for determining a direction of the medical device relative to the operating table (“The origin calibration gauge 42, which optionally can also be fastened to a circumferentially arranged rail on the operating table in the operating theatre or on an instrument table, thus defines a so-called absolute or global coordinate system 60.” [0111], “. For this the referencing units 14 and 18 can be fitted, for example, with so-called calibration gauges, which are matched geometrically to a part or section of the calibration unit 36 in order to define a unique orientation, a unique position or a unique position including orientation” [0127], “The calibration gauges shown in FIGS. 8 to 20 are only meant as examples to perform one-dimensional referencing, i.e. direction referencing, two-dimensional referencing, e.g. plane referencing, and three-dimensional referencing, in particular point-direction referencing. Naturally, the precise dimensions of the calibration gauges and their fittings can be previously determined prior to use in association with a navigation system 22 for a high-precision navigation operation.” [0136]),
wherein a third position of the at least three positions of the calibrating device is adapted for calibrating the medical device in a vertical plane relative to the operating table (“To predefine an axis, a calibration gauge 100 can be used, for example, which is substantially cuboidal in shape and has a wedge-shaped groove 102 extending parallel to the side edges. A cylindrical section of the calibration unit can be placed against the groove 102 and thus define an axis 104. The calibration gauge 100 is shown schematically in FIGS. 8 and 9.” [0128], “The calibration gauges shown in FIGS. 8 to 20 are only meant as examples to perform one-dimensional referencing, i.e. direction referencing, two-dimensional referencing, e.g. plane referencing, and three-dimensional referencing, in particular point-direction referencing. Naturally, the precise dimensions of the calibration gauges and their fittings can be previously determined prior to use in association with a navigation system 22 for a high-precision navigation operation.” [0136]);
wherein the calibrating device is operable to secure the medical device in each of the at least three positions to determine a reference frame for the measuring device in a world frame (“A surgical calibration device according to the invention, given the overall reference 10, comprising a calibration unit 36 serves to calibrate the referencing units 14 or 18. The calibration unit can be configured in particular in the form of a feeler or probing instrument” [0108], “A calibration of the referencing units 14 and 18 can be performed, for example, in a fixed spatial coordinate system 60, e.g. an operating theatre. In particular, an origin can be defined by means of an origin calibration gauge 42. This is a spatially fixed device arranged, for example, on a table top 44 or an operating table 46, which can have a receiving means 48, into which a part of the calibration unit 36 can be inserted, i.e. preferably in a positive and one-to-one arrangement. In this case, one-to-one means that there is precisely only one possibility of inserting the calibration unit 36 into the receiving means 48.” [0109], “The calibration gauges shown in FIGS. 8 to 20 are only meant as examples to perform one-dimensional referencing, i.e. direction referencing, two-dimensional referencing, e.g. plane referencing, and three-dimensional referencing, in particular point-direction referencing. Naturally, the precise dimensions of the calibration gauges and their fittings can be previously determined prior to use in association with a navigation system 22 for a high-precision navigation operation. Thus, for example, a relative position between the probe tip 50 and the calibration gauge arranged on the calibration unit 36 can be determined with high precision.” [0136])
wherein the reference frame is based on: the calibrating the medical device in a horizontal plane, the determined direction of the medical device relative to the operating table, and the calibrating the medical device in a vertical plane relative to the operating table (“A calibration of the referencing units 14 and 18 can be performed, for example, in a fixed spatial coordinate system 60, e.g. an operating theatre. In particular, an origin can be defined by means of an origin calibration gauge 42. This is a spatially fixed device arranged, for example, on a table top 44 or an operating table 46, which can have a receiving means 48, into which a part of the calibration unit 36 can be inserted, i.e. preferably in a positive and one-to-one arrangement. In this case, one-to-one means that there is precisely only one possibility of inserting the calibration unit 36 into the receiving means 48.” [0109], “The calibration gauges shown in FIGS. 8 to 20 are only meant as examples to perform one-dimensional referencing, i.e. direction referencing, two-dimensional referencing, e.g. plane referencing, and three-dimensional referencing, in particular point-direction referencing. Naturally, the precise dimensions of the calibration gauges and their fittings can be previously determined prior to use in association with a navigation system 22 for a high-precision navigation operation. Thus, for example, a relative position between the probe tip 50 and the calibration gauge arranged on the calibration unit 36 can be determined with high precision.” [0136]; and
wherein the measuring device is operable to communicate orientation data to the external deice, wherein the external device is operable to calculate geometric transformations within the world frame (“a navigation system with a data processing unit, wherein the navigation system and the data processing unit are configured and programmed in such a manner that position and/or orientation data of the referencing unit are determinable in relation to the coordinate system;” [0043], “An appropriate referencing is necessary, depending on whether positions and/or orientations in the coordinate system are to be determined with the referencing units 14 or 18. For this the referencing units 14 and 18 can be fitted, for example, with so-called calibration gauges, which are matched geometrically to a part or section of the calibration unit 36 in order to define a unique orientation, a unique position or a unique position including orientation. This also applies analogously to the above-described origin calibration, and therefore the calibration gauges described below could also serve, in principle, as origin calibration gauges. It should also be noted that the calibration gauges, as described below by way of example, can also be arranged on the calibration unit 36 and brought into engagement with corresponding sections or parts of the referencing units 14 or 18.” [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 Xu as outlined above with a calibrating device that has at least three positions adapted for calibrating the medical device, wherein a second position of the at least three positions of the calibrating device is adapted for determining a direction of the medical device relative to the CT table, wherein a third position of the at least three positions of the calibrating device is adapted for calibrating the medical device in a vertical plane relative to the CT table; wherein the calibrating device is operable to secure the medical device in each of the at least three positions to determine a reference frame for the measuring device in a world frame, wherein the reference frame is based on: the calibrating the medical device in a horizontal plane, the determined direction of the medical device relative to the CT table, and the calibrating the medical device in a vertical plane relative to the CT table; and wherein the measuring device is operable to communicate orientation data to the external deice, wherein the external device is operable to calculate geometric transformations within the world frame as taught by Link, because it allows for calibration or referencing errors to be minimised or often even completely excluded [0019].
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEVEN MALDONADO whose telephone number is 703-756-1421. The examiner can normally be reached 8:00 am-4:00 pm PST M-Th Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at
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/Steven Maldonado/
Patent Examiner, Art Unit 3797
/CHRISTOPHER KOHARSKI/Supervisory Patent Examiner, Art Unit 3797