DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claims 16 and 32 objected to because of the following informalities: The claims have the limitation “the surgical too”. This should most likely be corrected to the “surgical tool”. Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 16-35 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schers et al (US20210068845A1); hereinafter Schers.
Regarding claim 16, Schers teaches a robotic surgical system (figure 2), comprising:
a surgical tool (figure 2, [130]) having an operative axis (tool's axis);
a robotic device (figure 2, part 100 [131]) operatively attached to the surgical tool for constraining movement of the operative axis of the surgical tool inside a single plane ([182]), the robotic device comprising an end effector (figures 3A,3b, part 2, [130]-[131]) coupled to the surgical tool (2) and a planar articulation mechanism (fig. 3a, part 24, [182]) coupling the end effector to an actuation unit (fig. 3A, part 4, [131]) comprising at least three motorized degrees of freedom ([165]); and
a control unit (fig. 2, part 300, [132]) configured to:
receive a planned trajectory defined by a target axis ([336]-[339] target line) for applying the surgical tool to an anatomical structure of a patient;
determine a position and orientation of the operative axis ([336]) relative to a plane containing the target axis based on localization data from a localization device (fig. 2, tracking unit 200, [134]);
control the actuation unit to constrain the operative axis ([337]) inside the plane containing the target axis while a user moves the end effector closer to the target axis; and
generate and display on a user interface (fig. 2, part 400, [149]), an indication related to the position and orientation of the operative axis relative to the target axis ([336] an interface showing the saw position and orientation relative to the bone and to the target plane is displayed to assist the surgeon).
Regarding claim 17, Schers teaches the robotic surgical system of claim 16, wherein the control unit is further configured to determine an orientation of the planar articulation mechanism relative to the target axis ([0231] tracking unit 200 configured to determine in real time the pose of the saw with respect to the anatomical structure to be cut).
Regarding claim 18, Schers teaches the robotic surgical system of claim 17, wherein the control unit is further configured to control the actuation unit to constrain the plane of the planar articulation mechanism to be perpendicular to the target axis ([0336] target position and orientation (which is a line when considered in the plane orthogonal to the target plane)).
Regarding claim 19, Schers teaches the robotic surgical system of claim 16, wherein the control unit is further configured to control the actuation unit to constrain the operative axis to be parallel to the target axis ([0039] bring the cutting plane into alignment with the target plane).
Regarding claim 20, Schers teaches the robotic surgical system of claim 16, wherein the control unit is further configured to determine a position of a distal tip of the surgical tool ([0297] the user can visualize the position of the tip of the saw blade relative to the bone - in order for visualization to be possible on the screen, the control unit must be determining the position).
Regarding claim 21, Schers teaches the robotic surgical system of claim 20, wherein the received planned trajectory is further defined by a target point or area, and wherein the control unit is further configured to:
compare the position of the distal tip of the surgical tool to the target point or area; and
generate and display on the user interface, an indication related to the position of the distal tip relative to the target point or area ([0298] During the use of the device the control system checks in real time if the saw can be aligned with a target plane, information provided to the user may change, e.g. the color of the arrow is changed).
Regarding claim 22, Schers teaches the robotic surgical system of claim 21, wherein the control unit is further configured to switch off the surgical tool when the distal tip of the surgical tool reaches the target point ([0194] when the robotic device is close to the target position, the holding arm is braked and the user may receive a force-feedback information).
Regarding claim 23, Schers teaches the robotic surgical system of claim 21, wherein the target point defines an end of the trajectory of the surgical tool ([0337] lock or constrain the saw blade to remain inside the target line once it has been reached).
Regarding claim 24, Schers teaches the robotic surgical system of claim 16, wherein the control unit is further configured to determine that the operative axis is aligned with the target axis ([0033] determine the pose of the cutting plane with respect to the target plane and to control the actuation unit so as to bring the cutting plane into alignment with the target plane).
Regarding claim 25, Schers teaches the robotic surgical system of claim 24, wherein the control unit is further configured to determine that the operative axis is aligned with the target when an angle between the operative axis and the target axis is less than 10 ([0055] By “alignment” of the cutting plane with a target plane, is meant in the present text that said cutting plane deviates from the target plane by a distance of less than 1 mm and an angle of less than 1°).
Regarding claim 26, Schers teaches the robotic surgical system of claim 24, wherein the control unit is further configured to prevent actuation of the surgical tool unless the operative axis is aligned with the target axis ([0341] the actuation unit may move only if the saw position and orientation is maintained within a predefined range (e.g. 2 mm and 2 degrees) relatively to the target line).
Regarding claim 27, Schers teaches the robotic surgical system of claim 16, wherein the localization device comprises a first tracker rigidly attached to the end effector or to the surgical tool and a second tracker rigidly attached to the anatomical structure (claim 1 - the tracking unit comprising a tracker configured to be rigidly attached to the actuation unit and a tracker configured to be rigidly attached to the end effector, [0237] In addition, at least one tracker is rigidly attached to the patient's anatomical structure).
Regarding claim 28, Schers teaches the robotic surgical system of claim 16, wherein the actuation unit is supported by a lockable holding arm attached to an operating table ([0049] By “holding arm” is meant an articulated arm made of at least two segments and that can be locked in a given position…attached to a stable structure of the operating room, such as an operating table).
Regarding claim 29, Schers teaches the robotic surgical system of claim 16, wherein the surgical tool comprises an impactor, a drill, a reamer, a burr, a screw, a K-wire, or a pin ([0240] any type of cutting tool.. But also, other surgical tools such as a drill guide…).
Regarding claim 30, Schers teaches the robotic surgical system of claim 16, wherein the end effector comprises a guide tube adapted to guide the surgical tool ([0240] drill guide, cutting guide).
Regarding claim 31, Schers teaches the robotic surgical system of claim 16, wherein the planar articulation mechanism comprises at least two segments connected at a rotational axis orthogonal to the segments ([0170] the rotation of two adjacent segments is parallel to each other and the first axis is orthogonal to the third axis).
Regarding claim 32, Schers teaches a robotic surgical system (figure 2), comprising:
a surgical tool (figure 2, [130]) having a rotational axis ([0184] rotation axis);
a robotic device (figure 2, part 100 [131]) operatively attached to the surgical tool for constraining movement of the rotational axis of the surgical tool inside a single plane ([182]), the robotic device comprising an end effector (figures 3A,3b, part 2, [130]-[131]) coupled to the surgical tool (2) and a planar articulation mechanism (fig. 3a, part 24, [182]) coupling the end effector to an actuation unit (fig. 3A, part 4, [131]) comprising at least three motorized degrees of freedom ([165]); and
a control unit (fig. 2, part 300, [132]) configured to:
receive a planned trajectory defined by a target axis ([336]-[339] target line) for applying the surgical tool to an anatomical structure of a patient;
determine a position and orientation of the rotational axis ([336]) relative to a plane containing the target axis based on localization data from a localization device (fig. 2, tracking unit 200, [134]);
control the actuation unit to constrain the rotational axis ([337]) inside the plane containing the target axis while a user moves the end effector closer to the target axis; and
generate and display on a user interface (fig. 2, part 400, [149]), an indication related to the position and orientation of the rotational axis relative to the target axis ([336] an interface showing the saw position and orientation relative to the bone and to the target plane is displayed to assist the surgeon).
Regarding claim 33, Schers teaches the robotic surgical system of claim 32, wherein the control unit is further configured to prevent actuation of the surgical tool control unless the tool rotational axis is within the planned trajectory ([0341] to prevent wrong cuts, the actuation unit may move only if the saw position and orientation is maintained within a predefined range (e.g. 2 mm and 2 degrees) relatively to the target line.).
Regarding claim 34, Schers teaches the robotic surgical system of claim 32, wherein the indication comprises a distance from a distal tip of the surgical tool to an entry point of the anatomical structure and a difference between the tool rotational axis and the target axis ([0194] a variable flash frequency and/or intensity of a light signal may indicate the distance between the robotic device and its target position).
Regarding claim 35, Schers teaches the robotic surgical system of claim 32, wherein the indication further comprises a cutting depth ([0162] According to an embodiment (not illustrated), the cutting tool is a laser with a system to control the depth of penetration of the laser to avoid damaging soft tissues behind the bone).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Dhrasti SNEHAL Dalal whose telephone number is (571)272-0780. The examiner can normally be reached Monday - Thursday 8:30 am - 6:00 pm, Alternate Friday off, 8:30 am - 5:00 pm.
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/D.S.D./Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796
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