DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 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.
Claim(s) 1, 3-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Azizian et al (US 20190069963, hereinafter Azizian) in view of Oleynik et al (US 20220118618, hereinafter Oleynik).
Regarding Claim 1, Azizian teaches:
a computer implemented medical method of calibrating a motorized medical support structure with respect to a medical device (see at least "methods of representation" in par. 0011) , the method comprising:
acquiring presence data that describes a presence of the support structure and of the medical device within predefined spatial surroundings within a treatment room (see at least "In one aspect, the system may be configured such that a user inputs the location of the table to which the registration device is attached as well as which manipulator is coupled with the registration device (for example, by use of a dialog box prompt shown in FIG. 18). In another aspect, the system may automatically detect, such as by use of a mechanical means, RFID, sonar or optical sensing means, at which location of the table the registration device 310 is attached as well as which manipulator is coupled with the registration device 310." in par. 0073) ;
determining pre-positioning data based on the presence data, wherein the pre-positioning data describes a spatial position of the medical device with respect to the support structure in which the medical device is within a working range of the support structure (see at least "For example, as shown in FIG. 18, if there are four possible locations on the table at which the registration device 310 can be attached, then the position and/or orientation of the table can be accurately determined, typically within less than one centimeter or less, using a known geometry of the surgical table and the joint state sensor data from the manipulator attached to the registration device 310 mounted to the table at known location." in par. 0073) ;
determining calibration target data based on the pre-positioning data, wherein the calibration target data describes an expected spatial position of a calibration target of the medical device with respect to the support structure (see at least " While various methods may be used to avoid such collisions, it is particularly useful if the position of the surgical table relative to the manipulators of the Patient Side Cart is determined so that movements of the manipulators can be calculated to account for the position of the surgical table and/or to compensate for movement and/or repositioning of the surgical table during a procedure." in par. 0064) ;
determining reaching data based on the calibration target data, wherein the reaching data describes whether a calibration section of the support structure has reached the calibration target by being moved to the expected spatial position of the calibration target (see at least "In one aspect, methods of registration include a pre-docking registration. Prior to docking the surgical manipulators to a patient on the patient support surface of the surgical table, a manipulator arm is docked to a table-side mounted registration device 310 (such as in FIG. 15A or FIG. 16A). By reading encoder values of the Patient Side Manipulator (PSM) and Set-up Joints (SUJs) (q.sub.robot) and solving and a rigid body kinematic problem, the position and orientation of the surgical robot (i.e., Patient Side Cart) can be resolved with respect to the registration device 310. As detailed above, the registration device 310 is configured such that it can only be attached to the table in a unique way, that is at one or more particular locations of the table at a particular alignment/orientation relative to the table (e.g. such as at one of four locations where the side rails connect to the table top). Therefore the pose of the gadget with respect to the table can readily be determined, such as from CAD models of the table geometry or from a calibration of the table top using one or more sensors or an external tracker." in par. 0087); and
determining calibration data that describes a spatial relative position between the support structure and the medical device with the calibration section having reached the calibration target. (see at least " In another aspect, contact with the surgical table may include contacting a single location with a location component and determining a position and/or orientation along one or more degrees of freedom of the surgical table by constraining movement of the location component along corresponding degrees of freedom. For example, as shown in FIG. 14, the registration feature 300 is a table-mounted registration device 310 to which a distal portion of a manipulator 82 can be releasably coupled. When coupled with the registration device 310, movement of the manipulator 82 is constrained along multiple degrees of freedom such that the position and/or orientation of the surgical table in corresponding degrees of freedom of the surgical table can be determined from joint sensors of the manipulator." in par. 0070)
Azizian does not appear to explicitly teach all of the following, but Oleynik does teach:
acquiring guidance data based on the calibration section of the support structure not reaching the calibration target, wherein the guidance data describes a necessary positional correction of the calibration section to reach the calibration target (see at least "In one or more embodiments, the transformation data set is generated by a contact based calibration or adaption process. The contact based calibration or adaption process moves at least one element of the robotic apparatus from a start configuration until the at least one element of the robotic apparatus is in contact with or touches a predetermined surface of an object. The method records a location value and/or an orientation value of the surface of the object based on or when detecting the contact with the surface of the object. The method compares the recorded location value and/or the recorded orientation value with an expected location value and/or with an expected orientation value to determine a positional and/or orientational/rotational deviation. The method stores the determined positional and/or orientational/rotational deviation in the transformation data set." in par. 0047 and “In one or more embodiments, the robotic apparatus is or is part of a robotic kitchen, is a telerobot in a hospital environment, or is a robotic apparatus in a laboratory environment.” In par. 0063)
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method taught by Azizian to incorporate the teachings of Oleynik wherein a contact calibration is performed to determine a transformation data set between expected and actual positions of equipment in the workspace. The motivation to incorporate the teachings of Oleynik would be to minimize the deviation between the robot’s model of the environment and the physical environment around the robot (see par. 0285), which improves accuracy.
Regarding Claim 3, Azizian as modified by Oleynik teaches:
the method according to claim 1,
Azizian further teaches: wherein the presence data describes the spatial position of at least one of the support structure and the medical device (see at least “In one aspect, the system may be configured such that a user inputs the location of the table to which the registration device is attached as well as which manipulator is coupled with the registration device (for example, by use of a dialog box prompt shown in FIG. 18). In another aspect, the system may automatically detect, such as by use of a mechanical means, RFID, sonar or optical sensing means, at which location of the table the registration device 310 is attached as well as which manipulator is coupled with the registration device 310." in par. 0073) , and/or wherein the presence data is acquired via at least one of:
an optical camera system assigned to the medical device and adapted to recognize the support structure;
an optical camera system assigned to the support structure and adapted to recognize the medical device; (see at least “In one aspect, the system may be configured such that a user inputs the location of the table to which the registration device is attached as well as which manipulator is coupled with the registration device (for example, by use of a dialog box prompt shown in FIG. 18). In another aspect, the system may automatically detect, such as by use of a mechanical means, RFID, sonar or optical sensing means, at which location of the table the registration device 310 is attached as well as which manipulator is coupled with the registration device 310." in par. 0073);
an optical camera system assigned to a predefined spatial volume comprising a treatment room or operating theatre, and adapted to recognize the medical device and/or the support structure;
a portable optical camera system assigned to a wearable device and adapted to recognize the medical device and/or the support structure;
a predefined treatment plan describing utilization of the medical device and/or the support structure (see at least “In one aspect, the system may be configured such that a user inputs the location of the table to which the registration device is attached as well as which manipulator is coupled with the registration device (for example, by use of a dialog box prompt shown in FIG. 18). In another aspect, the system may automatically detect, such as by use of a mechanical means, RFID, sonar or optical sensing means, at which location of the table the registration device 310 is attached as well as which manipulator is coupled with the registration device 310." in par. 0073); and/or
a network based localization functionality describing the location of the medical device and/or the support structure within a hospital (see at least “In one aspect, the system may be configured such that a user inputs the location of the table to which the registration device is attached as well as which manipulator is coupled with the registration device (for example, by use of a dialog box prompt shown in FIG. 18). In another aspect, the system may automatically detect, such as by use of a mechanical means, RFID, sonar or optical sensing means, at which location of the table the registration device 310 is attached as well as which manipulator is coupled with the registration device 310." in par. 0073).
Regarding Claim 4, Azizian as modified by Oleynik teaches:
the method according to claim 1,
Azizian further teaches: wherein the determining the pre-positioning data comprises outputting control data for moving at least one of the support structure and the medical device with respect to each other to position the medical device at the spatial position within the working range of the support structure. (see at least “In one aspect, the system may be configured such that a user inputs the location of the table to which the registration device is attached as well as which manipulator is coupled with the registration device (for example, by use of a dialog box prompt shown in FIG. 18). In another aspect, the system may automatically detect, such as by use of a mechanical means, RFID, sonar or optical sensing means, at which location of the table the registration device 310 is attached as well as which manipulator is coupled with the registration device 310." in par. 0073).
Regarding Claim 5, Azizian as modified by Oleynik teaches:
the method according to claim 1,
Azizian further teaches: wherein the determining the calibration target data comprises outputting control data for moving the calibration section of the support structure to the expected spatial position of a calibration target of the medical device. (see at least " In one approach, registration is performed by facilitated contact between the Patient Side Cart and the surgical table. Methods of registration may include contacting the surgical table at one or more locations with a component of the Patient Side Cart and determining a position and/or orientation of the surgical table relative the Patient Side Cart. This may be accomplished by determining the position and/or orientation of the surgical table relative to a frame of reference of the Patient Side Cart or a common frame of reference having a known or determinable relationship to both the Patient Side Cart and the surgical table." in par. 0068)
Regarding Claim 6, Azizian as modified by Oleynik teaches:
the method according to claim 4,
Azizian further teaches: wherein the control data is output via a user interface for instructing medical personnel to move at least one of the medical device and the support structure with respect to each other to position the medical device at the spatial position within the working range of the support structure (see at least "In one aspect, the system may be configured such that a user inputs the location of the table to which the registration device is attached as well as which manipulator is coupled with the registration device (for example, by use of a dialog box prompt shown in FIG. 18)." in par. 0073) ,
wherein at least one of the medical device and the support structure is moved manually or via at least one manually controlled motor. (see at least "The servomechanism used for telesurgery will often accept input from two master controllers (one for each of the surgeon's hands) and may include two or more tele-surgical arms on each of which a surgical instrument is mounted. Operative communication between master controllers and associated manipulator arm and instrument assemblies is typically achieved through a control system. The control system typically includes at least one processor that relays input commands from the master controllers to the associated manipulator arm and instrument assemblies and back from the instrument and arm assemblies to the associated master controllers in the case of, for example, force feedback or the like." in par. 0005)
Regarding Claim 7, Azizian as modified by Oleynik teaches:
the method according to claim 6,
Azizian further teaches: wherein the control data is output to at least one motor control unit for automatically moving at least one of the medical device and the support structure with respect to each other to position the medical device at the spatial position within the working range of the support structure (see at least " In one aspect, the system may be configured such that a user inputs the location of the table to which the registration device is attached as well as which manipulator is coupled with the registration device (for example, by use of a dialog box prompt shown in FIG. 18). In another aspect, the system may automatically detect, such as by use of a mechanical means, RFID, sonar or optical sensing means, at which location of the table the registration device 310 is attached as well as which manipulator is coupled with the registration device 310." in par. 0073) ; and/or
to position the calibration section of the support structure in the expected spatial position of the calibration target. (see at least " In one aspect, the system may be configured such that a user inputs the location of the table to which the registration device is attached as well as which manipulator is coupled with the registration device (for example, by use of a dialog box prompt shown in FIG. 18). In another aspect, the system may automatically detect, such as by use of a mechanical means, RFID, sonar or optical sensing means, at which location of the table the registration device 310 is attached as well as which manipulator is coupled with the registration device 310." in par. 0073)
Regarding Claim 8, Azizian as modified by Oleynik teaches:
the method according to claim 1,
Azizian further teaches: wherein the reaching data and/or the guidance data is acquired via at least one of:
at least one force sensitive sensor assigned to the support structure and adapted to sense a force acting on the support structure via the calibration section;
at least one force sensitive sensor assigned to the medical device and adapted to sense a force acting on the medical device via the calibration target and/or via a surface section of the medical device surrounding the calibration target;
an optical camera system comprising a camera system of a medical tracking system and/or an optical camera system adapted to recognize the calibration section and the calibration target (see at least "In another approach, various other non-contact means may be used by which to determine a position and/or orientation of the surgical table relative the Patient Side Cart. Such means may include any of optical or radiation sensing means, sonar, laser range sensors, or any other suitable means. In one aspect, such sensing means can be attached to the Patient Side Cart and configured to sense one or more points on the surgical table (e.g. RFID tags, identifiable optical or laser markers) such that the position and/or orientation of the table relative the Patient Side Cart can be determined before and/or during the procedure." in par. 0083); and/or
at least one light sensitive sensor assigned to one of the medical device and the support structure and adapted to sense a laser-beam emitted via a laser-emitter assigned to the other one of the medical device and the support structure.
Regarding Claim 9, Azizian as modified by Oleynik teaches:
the method according to claim 1,
Azizian further teaches: wherein the acquiring the guidance data comprises scanning, via the at least one sensor or the at least one camera system a surface section of the medical device surrounding the calibration target and providing information as to the spatial position of the calibration target. (see at least "In another aspect, the system may automatically detect, such as by use of a mechanical means, RFID, sonar or optical sensing means, at which location of the table the registration device 310 is attached as well as which manipulator is coupled with the registration device 310." in par. 0073).
Regarding Claim 10, Azizian as modified by Oleynik (references to Azizian) also teaches:
a computer program comprising logic instructions stored on a non-transient storage medium that when the program is executed by a processor of a computer cause the computer to carry out a method of calibrating a motorized medical support structure with respect to a medical device (see at least "Processor 58 will typically include a combination of hardware and software, with the software comprising tangible media embodying computer readable code instructions for performing the method steps of the control functionally described herein. " in par. 0042) , the method comprising:
the method of Claim 1 (see Claim 1 analysis for rejection of the method)
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Azizian et al (US 20190069963, hereinafter Azizian) in view of Oleynik et al (US 20220118618, hereinafter Oleynik) and Cameron et al (US 11571265, hereinafter Cameron)
Regarding Claim 2, Azizian as modified by Oleynik teaches:
the method according to claim 1,
Azizian and Oleynik does not appear to explicitly teach all of the following, but Cameron does teach:
wherein the medical device is selected from the group consisting of:
a robotic support arm; and
a medical imaging device, wherein the support structure is calibrated with respect to an image space defined by the imaging device, and with respect to at least one 2D- or 3D-image dataset acquired via the imaging device. (see at least " An intraoperative scanner 852, such as an X-ray machine or other scanning device, may have a tracking array 854 with tracking markers 855, mounted thereon for registration. Based on the fixed, known position of the tracking array 854 on the scanning device, the system may be calibrated to directly map (register) the tracking space to the image space of any scan acquired by the system. Once registration is achieved, the registration, which is initially based on the tracking markers 855 (e.g. gantry markers) of the scanner's array 854, is related or transferred to the tracking markers 842 of a DRB 840, which may be fixed to a clamping fixture 830 holding the patient's head 828 by a mounting arm 841 or other rigid means.” In col. 13 lines 21-32 and Figs. 8A-8B)
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method taught by Azizian as modified by Oleynik to incorporate the teachings of Cameron wherein a scanning device has a tracking array fixed to it at a known position for calibration. The motivation to incorporate the teachings of Cameron would be to avoid the need for fiducials or other image markers to be in the image space (see col. 13 lines 35-38).
Claim(s) 11-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Azizian et al (US 20190069963, hereinafter Azizian) in view of Cameron et al (US 11571265, hereinafter Cameron)
Regarding Claim 11, Azizian teaches:
a medical system (see at least "Minimally Invasive Tele-surgical (MIRS) system 10" in par. 0037) comprising:
a computer comprising a processor, a non-transient memory device, and logic instructions stored on the non-transient memory device (see at least " Processor 58 will typically include a combination of hardware and software, with the software comprising tangible media embodying computer readable code instructions for performing the method steps of the control functionally described herein. " in par. 0042);
a motorized medical support structure (see at least "Each of the manipulators 82 is operable to selectively articulate a surgical instrument mounted to the manipulator 82 and insertable into a patient along an insertion axis." in par. 0046) ; and
wherein the computer is operably coupled to at least the support structure and the medical device (see at least "The control system typically includes at least one processor that relays input commands from the master controllers to the associated manipulator arm and instrument assemblies and back from the instrument and arm assemblies to the associated master controllers in the case of, for example, force feedback or the like." in par. 0005) , for outputting control data to cause:
at least one of the support structure and/or the medical device to move with respect to each other to position the medical device at a spatial position within a working range of the support structure (see at least "The one or more joints may be adjusted by a patient side-assistant or anesthesiologist, as needed, or may be configured to be adjusted by a more remote user, such as a physician from the Surgeon Console, or by the system according to an autonomous algorithm or according to one or more calculated movements, such as a compensating movement for physiological movements, such as patient breathing and the like." in par. 0062 and “While various methods may be used to avoid such collisions, it is particularly useful if the position of the surgical table relative to the manipulators of the Patient Side Cart is determined so that movements of the manipulators can be calculated to account for the position of the surgical table and/or to compensate for movement and/or repositioning of the surgical table during a procedure.” In par. 0064); and/or
the calibration section of the support structure to move to the expected spatial position of a calibration target of the medical device. (see at least "In one aspect, methods of registration include a pre-docking registration. Prior to docking the surgical manipulators to a patient on the patient support surface of the surgical table, a manipulator arm is docked to a table-side mounted registration device 310 (such as in FIG. 15A or FIG. 16A). By reading encoder values of the Patient Side Manipulator (PSM) and Set-up Joints (SUJs) (q.sub.robot) and solving and a rigid body kinematic problem, the position and orientation of the surgical robot (i.e., Patient Side Cart) can be resolved with respect to the registration device 310. As detailed above, the registration device 310 is configured such that it can only be attached to the table in a unique way, that is at one or more particular locations of the table at a particular alignment/orientation relative to the table (e.g. such as at one of four locations where the side rails connect to the table top). Therefore the pose of the gadget with respect to the table can readily be determined, such as from CAD models of the table geometry or from a calibration of the table top using one or more sensors or an external tracker." in par. 0087)
Azizian does not appear to explicitly teach all of the following, but Cameron does teach:
a medical device comprising a medical imaging device (see at least " An intraoperative scanner 852, such as an X-ray machine or other scanning device, may have a tracking array 854 with tracking markers 855, mounted thereon for registration. Based on the fixed, known position of the tracking array 854 on the scanning device, the system may be calibrated to directly map (register) the tracking space to the image space of any scan acquired by the system. Once registration is achieved, the registration, which is initially based on the tracking markers 855 (e.g. gantry markers) of the scanner's array 854, is related or transferred to the tracking markers 842 of a DRB 840, which may be fixed to a clamping fixture 830 holding the patient's head 828 by a mounting arm 841 or other rigid means.” In col. 13 lines 21-32 and Figs. 8A-8B)
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method taught by Azizian to incorporate the teachings of Cameron wherein a scanning device has a tracking array fixed to it at a known position for calibration. The motivation to incorporate the teachings of Cameron would be to avoid the need for fiducials or other image markers to be in the image space (see col. 13 lines 35-38).
Regarding Claim 12, Azizian as modified by Cameron teaches:
the system according to claim 11,
Azizian further teaches: wherein the support structure (1) is transportable, particularly portable, specifically as an entire unit, and/or wherein the medical device (2) is transportable, particularly as an entire unit, specifically via a wheeled undercarriage (18). (see at least " In many embodiments, the mounting base 72 is movable and floor supported, thereby enabling selective repositioning of the overall surgery system 70, for example, within an operating room. The mounting base 72 can include a steerable wheel assembly and/or any other suitable support features that provide for both selective repositioning as well as selectively preventing movement of the mounting base 72 from a selected position." in par. 0047)
Regarding Claim 13, Azizian as modified by Cameron teaches:
the medical system according to claim 11,
Azizian further teaches: wherein the support structure comprises a calibration section and the medical device comprises a corresponding calibration target adapted to receive the calibration section at a predefined position. (see at least "In another aspect, contact with the surgical table may include contacting a single location with a location component and determining a position and/or orientation along one or more degrees of freedom of the surgical table by constraining movement of the location component along corresponding degrees of freedom. For example, as shown in FIG. 14, the registration feature 300 is a table-mounted registration device 310 to which a distal portion of a manipulator 82 can be releasably coupled. When coupled with the registration device 310, movement of the manipulator 82 is constrained along multiple degrees of freedom such that the position and/or orientation of the surgical table in corresponding degrees of freedom of the surgical table can be determined from joint sensors of the manipulator." in par. 0070)
Regarding Claim 14, Azizian as modified by Cameron teaches:
the medical system according to claim 11,
Azizian further teaches: wherein a surface section of the medical device surrounding the calibration target is adapted to provide information as to the spatial position of the calibration target, wherein the surface section comprises at least one detectable marker indicating the spatial position of the calibration target with respect to the marker (see at least "other non-contact means may be used by which to determine a position and/or orientation of the surgical table relative the Patient Side Cart. Such means may include any of optical or radiation sensing means, sonar, laser range sensors, or any other suitable means. In one aspect, such sensing means can be attached to the Patient Side Cart and configured to sense one or more points on the surgical table (e.g. RFID tags, identifiable optical or laser markers) such that the position and/or orientation of the table relative the Patient Side Cart can be determined before and/or during the procedure." in par. 0083) , wherein the at least one marker comprises:
an optically detectable marker (see at least "other non-contact means may be used by which to determine a position and/or orientation of the surgical table relative the Patient Side Cart. Such means may include any of optical or radiation sensing means, sonar, laser range sensors, or any other suitable means. In one aspect, such sensing means can be attached to the Patient Side Cart and configured to sense one or more points on the surgical table (e.g. RFID tags, identifiable optical or laser markers) such that the position and/or orientation of the table relative the Patient Side Cart can be determined before and/or during the procedure." in par. 0083) ; and/or
a haptically detectable marker. (see at least " In certain aspects, by attaching the table-mounted device 310 to the table at a known location, the position and/or orientation of the table can be more accurately determined using a known or estimated geometry of the table. For example, as shown in FIG. 18, if there are four possible locations on the table at which the registration device 310 can be attached, then the position and/or orientation of the table can be accurately determined, typically within less than one centimeter or less, using a known geometry of the surgical table and the joint state sensor data from the manipulator attached to the registration device 310 mounted to the table at known location." in par. 0073)
Allowable Subject Matter
Claim 15 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The closest prior art comes from Azizian, Oleynik, and Cameron but the prior art does not appear to teach “wherein the calibration target comprises an array of sensors adapted to detect the spatial position of a contact or an encounter with the calibration section of the support structure, wherein the plurality of sensors comprises:
at least one force sensitive sensor; and/or
at least one optically sensitive sensor.” in combination with all of the other limitations in the claim.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DYLAN M KATZ whose telephone number is (571)272-2776. The examiner can normally be reached Mon-Thurs. 8:00-6:00.
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/DYLAN M KATZ/Primary Examiner, Art Unit 3657