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 .
Status of Claims
This communication is a first office action, non-final rejection on the merits. Claims 1-20 as filed, are currently pending and have been considered below.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation “to perform actions on the bone” in line 13. There is insufficient antecedent basis for this limitation in the claim
Dependent claims 2-20 are also rejected under 112(b) as depending from claim 1.
Examiner suggests changing to, and will further evaluate the claims in light of the art if as written as, “to perform actions on a patient’s bone.”
Claim Rejections - 35 USC § 103
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.
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 1-7 and 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over Satoh (US PGPUB 20230089195 A1 hereinafter “Satoh”) in view of Maillet et all (US PGPUB 20230346484 A1 hereinafter “Maillet”).
Regarding Claim 1, Satoh discloses in figure 1 and claim 11
A system (10) for tracking an instrument in a robotized computer-assisted , comprising:
a processing unit (13); and
a non-transitory computer-readable memory communicatively coupled to the processing unit and comprising computer-readable program instructions executable by the processing unit for:
Satoh pertains to a computerized system for tracking and calibrating a robotic arm, specifying “Any mechanism (end effector) can be attached to the robot hand according to an execution task” (0074) and “Thus, the robot 12 can perform tasks in a calibrated environment” (0076) but is silent on the specific use of an instrument for use in surgery. However, Maillet teaches “In accordance with a first aspect of the present disclosure, there is provided a system for tracking an end effector of a robot in computer-assisted surgery, comprising: a processing unit; and a non-transitory computer-readable memory communicatively coupled to the processing unit and comprising computer-readable program instructions executable by the processing unit” (0005). Therefore, it would have been known to one of ordinary skill in the art of robotic control to use the system of Satoh to track and calibrate the robot specifically for surgical tasks, as taught by Maillet.
Satoh further discloses in figures 1 and 5 tracking the instrument optically (11) as maneuvered by a robot arm (12) in a calibration sequence (S11-S14) detailing, “The position of the robot 12 can be extracted, for example, by matching the robot 12 included in the observation information (for example, an image) with the representation model data of the robot 12” (0090). Satoh further discloses in step S12 of figure 5 obtaining robot arm maneuvering data during the calibration sequence detailing, “The position calculation unit 18 calculates the actual position of the robot 12 using forward kinematics based on the control information acquired from the robot 12 by the control information acquisition unit 17 and the mechanism model data of the target model accumulation unit 15, and acquires the calculated position (step S12)” (0106). Satoh further discloses in step S105 of figure 10 comparing optical tracking values from the calibration sequence with the robot arm maneuvering data detailing “Next, the robot system 20 inputs the calculated position and the extracted position of the robot 12 to the comparison unit 102, and causes the comparison unit 102 to compare the calculated position with the extracted position. The robot system 20 causes the comparison unit 102 to output the quantified difference as the comparison result (step S105)”(0185). Satoh further discloses in step S107 of figure 10 calibrating the instrument from the comparing for subsequent use of the instrument to perform actions on the ; and. Satoh refers to the calibration of the robot system in terms of a corrected transformation matrix, detailing “On the other hand, when the difference is equal to or more than the threshold value (step S106/N0), the robot system 20 inputs the output of the comparison unit 102 to the correction unit 103. In the correction unit 103, a new parameter θ that is a correction value is calculated, and the correction value is applied to the transformation matrix of the coordinate transformation unit 101 (step S107). The correction value of the transformation matrix is calculated in such a way that the difference becomes small. Then, the robot system 20 repeats step S106”(0186). Satoh is silent on the details of the robotic end effector performing action on bone. However, Maillet teaches the robotic end effector performing action on bone by disclosing “The system 10 could be used for any body parts, including non-exhaustively hip joint, spine, and shoulder bones” (0034). Therefore, it would have been known to one of ordinary skill in the art of robotic control to use the system of Satoh to track and calibrate the robot specifically for surgical tasks on bone, as taught by Maillet.
Satoh further discloses tracking the instrument optically after the calibrating. The system of Satoh tracks and calibrates the robot (including end effector) over time, specifying “In addition, the calculated position xt and the extracted position yt may be vectors having a plurality of elements. The calculated position xt can also be expressed as xi,t, where a suffix for identifying each part of the robot 12, the above-described feature point or feature amount is i (i is an integer of 1 or more and equal to or less than n, where n is the number of parts or feature points). Similarly, a region (each part) extracted from an image captured at time t can be expressed as yi,t. yi,t may be a vector having the plurality of elements” (0113).
Regarding Claim 2, Satoh in view of Maillet discloses all the limitations of claim 1, and Satoh further discloses in figure 10 steps S101-S107 wherein the calibration sequence is preprogrammed.
Regarding Claim 3, Satoh in view of Maillet discloses all the limitations of claim 1, and Satoh further discloses wherein tracking the instrument optically after the calibrating is performed as the instrument is maneuvered by the robot arm by detailing the tracking of robotic segments after calibration as “In addition, the calculated position xt and the extracted position yt may be vectors having a plurality of elements. … Similarly, a region (each part) extracted from an image captured at time t can be expressed as yi,t. yi,t may be a vector having the plurality of elements” (0113).
Regarding Claim 4, Satoh in view of Maillet discloses all the limitations of claim 1. Satoh pertains to a robotic tracking and calibration system that can operate without markers, stating “According to the position extraction unit 16 according to the present example embodiment, it is not essential to attach a sign (marker) to the target robot 12 to be used for motion capture or the like” (0092) and thus lacks details on the geometry of the optical tracker. However, Maillet use markers and discloses wherein calibrating the instrument from the comparing includes recording a geometrical relation between an optical tracker and a working end of the instrument by detailing the use and placement of markers as “The optical trackers 30 are positioned on the robot 20, on patient tissue (e.g., bones B), and/or on the tool(s) T and surgical instruments, and provide tracking data for the robot 20, the patient and/or tools” (0037) and teaching the geometric relationship as “Step 902 may include observing the robot 20 and its trackers 30, and record the geometry of the trackers 30 on the robot 20” (0082). Therefore, if one were to use markers in the tracking and calibration system of Satoh, it would have been known to one of ordinary skill in the art of robotic control to use the marker and geometrical relation of Maillet.
Regarding Claim 5, Satoh in view of Maillet discloses all the limitations of claim 4, and Maillet discloses in figure 3 including the optical tracker (30).
Regarding Claim 6, Satoh in view of Maillet discloses all the limitations of claim 1. As with claim 4 above, the system of Satoh can operate without markers, while the system of Maillet provides the details of the geometric relations if one were to use markers. Maillet further discloses wherein calibrating the instrument from the comparing includes correcting a geometrical relation between an optical tracker and a working end of the instrument and teaches the correcting of a geometrical relation between a tracker and a tool by detailing “Also, the tracking of the tool using the tracking module 60 may be used to detect any discrepancy between a calculated position and orientation of the surgical tool T through the sensors on the robot arm 20A and inertial sensor unit(s) 30, and the actual position and orientation of the surgical tool. For example, an improper mount of the tool T into the chuck of the robot arm 20A could be detected from the output of the tracking module 60, when verified by comparing the position and orientation from the CAS controller 50 (e.g., obtained from the encoders on the robot arm 20A) with the optical tracking on the end effector 23” (0057). Therefore, if one were to use markers in the tracking and calibration system of Satoh, it would have been known to one of ordinary skill in the art of robotic control to use and correct the marker and geometrical relation of Maillet.
Regarding Claim 7, Satoh in view of Maillet discloses all the limitations of claim 6, and Maillet discloses in figure 3 including the optical tracker (30).
Regarding Claim 15, Satoh in view of Maillet discloses all the limitations of claim 1, and Satoh further discloses in figure 5 step S12 wherein obtaining robot arm maneuvering data during the calibration sequence includes obtaining the robot arm maneuvering data from a robot controller detailing “The control information acquisition unit 17 acquires control information output from a controller (actuator, etc., but not illustrated) that controls the operation of the robot 12” (0093).
Regarding Claim 16, Satoh in view of Maillet discloses all the limitations of claim 1, and Satoh further discloses in figure 5 step S12 wherein obtaining robot arm maneuvering data during the calibration sequence includes obtaining the robot arm maneuvering data from a robot controller detailing “Details, formats, acquisition frequencies, and the like of the control information are not particularly limited. Control information similar to a displacement (rotation, angle, or the like) of the controller configuring each articulated (multi-axis/multi-link) may be sequentially obtained” (0093).
Regarding Claim 17, Satoh in view of Maillet discloses all the limitations of claim 1, and Satoh further discloses wherein obtaining robot arm maneuvering data during the calibration sequence includes obtaining the robot arm maneuvering data from a calibration sequence file. Satoh refers to the calibration sequence file as an operation for calibration and details “The operation result accumulation unit 200 accumulates an operation strategy (action policy) that defines a current operation (calibration operation) for obtaining a relationship between the robot coordinate system and the camera coordinate system of the robot 12 and comparison information (difference) that is an output of the comparison unit 102. As described above, the operation here refers to not a task given to the robot but an operation for calibration” (0210).
Regarding Claim 18, Satoh in view of Maillet discloses all the limitations of claim 1, and Satoh further discloses further including tracking the instrument using the robot arm maneuvering data when tracking the instrument optically is disrupted. The system of Satoh will continue to track the instrument using the robot arm data even if the optical data is disrupted. Satoh details this by stating “the motion of the robot in the control plan can be extracted by further using the control information of the robot 12 acquired by the control information acquisition unit 17 in addition to the observation information….According to this method, the position of the robot 12 can be extracted even in a case where an object other than the robot 12 is included in the observation information, and it is difficult to separate the robot 12 from another region or the robot 12 is shielded” (0091).
Regarding Claim 19, Satoh in view of Maillet discloses all the limitations of claim 1, and Satoh further discloses in figure 14 steps S201-S204 further including repeating the calibration sequence and calibrating at least a second time. The system of Satoh will repeat the calibration sequence a predetermined number of times, specifically “When the difference is less than the threshold value, a set of the action policy and the difference at this time is stored in the operation result accumulation unit 200 (step S202). Next, it is determined whether the action policy is updated a predetermined specified number of times (step S203). Here, if the number of updates reaches the predetermined number, the processing is ended, and if not reached, the action policy is updated in such a way that the difference becomes small (step S204).” (0225).
Regarding Claim 20, Satoh in view of Maillet discloses all the limitations of claim 1, and Satoh further discloses in figure 1 further including an optical tracking device (11).
Claims 8-14 are rejected under 35 U.S.C. 103 as being unpatentable over Satoh in view of Maillet, further in view of Jutras et all (US PGPUB 20070100325 A1 hereinafter “Jutras”).
Regarding Claim 8, Satoh in view of Maillet discloses all the limitations of claim 1, but Satoh and Maillet fail to teach a multifaceted tracker. The tracking system of Satoh omits details of the trackers, and the trackers of Maillet are hemispherical but not truly multifaceted. Additionally, Maillet states “Other trackers may be used, such as those described in U.S. Pat. No. 8,386,022 [Jutras]”(0049) (Note that U.S. Pat. No. 8,386,022 is the patent of U.S. PGPUB 2007100325). However, Jutras teaches wherein the instrument has a multifaceted tracker thereon. Jutras pertains to a tracker device associated with surgical instruments and discloses the multifaceted markers in figure 1 and the use of a surgical instrument by detailing “Accordingly, as seen in FIG. 4, a tracker device 10', generally similar to the tracker device 10 of FIGS. 1 to 3, may be connected to the support A of a surgical tool” (0028). Therefore, if one were to use markers in the tracking and calibration system of Satoh, it would have been known to one of ordinary skill in the art of robotic control to use the multifaceted tracker of Jutras as suggested by Maillet.
Regarding Claim 9, Satoh in view of Maillet further in view of Jutras discloses all the limitations of claim 8, and Jutras further discloses wherein calibrating the instrument from the comparing includes recording a geometrical relation between at least two sets of optical elements in the multifaceted tracker. The geometric relation between the optical elements of Jutras is recorded in a database which is referenced when calibrating the instrument. Jutras specifies “A database 106 is provided so as to store the geometrical pattern data. More specifically, the various patterns of the tracker device 10 are stored in the database 106. Similarly, the relation between the instrument and the tracker device is stored in the database 106. The instrument/tracker device relation may result from a calibration performed in the first steps of use of the computer-assisted surgery system” (0054).
Regarding Claim 10, Satoh in view of Maillet further in view of Jutras discloses all the limitations of claim 9, and Jutras further discloses in figure 1 including the multifaceted tracker (10), the multifaceted tracker having at least two sets (14) of three optical elements (44A, 44B, 44C).
Regarding Claim 11, Satoh in view of Maillet further in view of Jutras discloses all the limitations of claim 9, and Jutras further discloses wherein tracking the instrument optically after the calibrating includes tracking the instrument using a first of the at least two sets of optical elements, and switching to tracking the instrument using a second of the at least two sets of optical elements when a line of sight between the first of the at least two sets of optical element and a tracking device is disrupted. Jutras refers to line of sight in terms of range of visibility and addresses possible disruptions by detailing “The sets of elements 44 are strategically positioned with respect to one another so as to optimize a range of visibility of the tracker device 10. More specifically, the sets are positioned such that once the optical sensor apparatus of the CAS system loses sight of one of the sets, another set is visible. This ensures the continuous tracking of the tracking device 10 within a given range of field of view” (0035).
Regarding Claim 12, Satoh in view of Maillet further in view of Jutras discloses all the limitations of claim 8, and Maillet further discloses wherein calibrating the instrument from the comparing includes correcting a geometrical relation value between at least two sets of optical elements in the multifaceted tracker. Maillet suggests incorporating the multifaceted tracker of Jutras into the surgical tracking system, and further details the correcting of the geometric relations by stating “Also, the tracking of the tool using the tracking module 60 may be used to detect any discrepancy between a calculated position and orientation of the surgical tool T through the sensors on the robot arm 20A and inertial sensor unit(s) 30, and the actual position and orientation of the surgical tool. For example, an improper mount of the tool T into the chuck of the robot arm 20A could be detected from the output of the tracking module 60, when verified by comparing the position and orientation from the CAS controller 50 (e.g., obtained from the encoders on the robot arm 20A) with the optical tracking on the end effector 23” (0057).
Claim 13 is rejected in a similar manner to claim 10 above.
Claim 14 is rejected in a similar manner to claim 11 above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nathan Daniel Neckel whose telephone number is (571)272-9537. The examiner can normally be reached M-F, 7-3.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wade Miles can be reached at 571-270-7777. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NATHAN DANIEL NECKEL/Examiner, Art Unit 3656
/WADE MILES/Supervisory Patent Examiner, Art Unit 3656
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