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 .
Election/Restrictions
Applicant's election with traverse of Invention I in the reply filed on May 6, 2026 is acknowledged. The traversal is on the grounds that Bozung et al. (US 2013/0060278) does not teach or suggest “a control system configured to at least determine a motor status and control the motor based on an error threshold that is based on the motor status”. The arguments were persuasive based off of the amendments. The restriction requirement is withdrawn under the assumption that “corresponding to the motor status” and “based on the motor status” are the same. Additionally, the restriction requirement is withdrawn under the assumption that “guide constraint error threshold” and “error threshold” are the same. The restriction requirement is withdrawn and claims 153, 154, 156-161, and 169-180 are pending under examination.
Specification
The disclosure is objected to because of the following informalities:
[0307]: “error range may be from -0.5 to 0.5… -5 to 5… -0.3 to 0.5” is missing units.
Appropriate correction is required.
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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 161 and 173 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.
In re claim 161, the limitation “wherein the control system is configured to maintain the motor status of the tool drive motor in a permissive state when a position of one or more plurality of actuators is coincident with a joint for that actuator” is unclear. Specifically, it is unclear what “a joint for that actuator” means. The specification states “plurality of actuators in coincident with a joint limit for that actuator” [0312]. For examination purposes, as best understood, the limitation “a joint for that actuator” will be interpreted to mean one or more plurality of actuators is coincident with a joint limit for that actuator; however, under broadest reasonable interpretation, the requirements of a joint limit could be any limit associated with the joint.
In re claim 173, the limitation “wherein the error range is asymmetrical, such as asymmetrical about a median value of zero” is unclear. It is unclear how the error range is asymmetrical, as the error range depends on the range of movement of the tool along a degree of freedom, such as the range of translation or orientation, and the overall range of numbers cannot be asymmetrical. Additionally, it is unclear what median means in regards to the invention and the ranges the tool is able to move in a given degree of freedom. For examination purposes, as best understood, the limitation “wherein the error range is asymmetrical” will be interpreted to mean that in regards to any degree of freedom, the tool may move further up than down, or further left than right in any given range that the tool is able to move. Additionally, the limitation “such as asymmetrical about a median value of zero” will be interpreted to mean that the median refers to the position where the tool starts in the overall range that the tool is able to move in any degree of freedom, so if the tool starts at “zero” and does not have to move equally along each axis, then it is asymmetrical.
Additionally, In re claim 173, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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.
Claims 153-154, 156-161, and 169-180 are rejected under 35 U.S.C. 103 as being unpatentable over Bozung et al. (US 2013/0060278) in view of Sides et al. (US 2019/0247236).
In re claim 153, Bozung discloses a hand-held medical robotic system for use with a surgical tool [0002], the system comprising:
an instrument [0008] comprising;
a hand-held portion to be held by a user [0008];
a tool support coupled to the hand-held portion ([0008]: “working portion”), the tool support comprising
a tool drive motor to drive motion of the surgical tool [0015];
an actuator assembly [0015] operatively interconnecting the tool support and the hand- held portion to move the tool support to move the surgical tool in a plurality of controlled degrees of freedom relative to the hand-held portion [0015] to place the surgical tool at a desired pose [0020],
the actuator assembly being incapable of repositioning the surgical tool in at least one uncontrolled degree of freedom ([0355]): the actuators move the drive mechanism and the drive motor, which can be “fixed along the axis Z”),
the actuator assembly including a plurality of actuators [0015];
a localizer ([0018]: “navigation system”); and
a control system [0021] coupled to the plurality of actuators and the localizer [0022], the control system configured to:
determine, in a known coordinate system [0011, 0262], a state of the surgical tool and a target pose of the surgical tool [0262];
control the plurality of actuators to position the surgical tool in the plurality of controlled degrees of freedom [0025] based on the state of the surgical tool and the target pose of the surgical tool [0275, 0276]; and
determine a motor status of the tool drive motor ([0029]; [0274]: in passive mode, the system is permitted to run as long as it is within the working boundary, once it approaches or intersects the boundary, the motor stops or slows down);
select a guide constraint error threshold ([0155]: “constraint boundary 111”) based on the motor status; and
control the tool drive motor based on the guide constraint error threshold ([0274]: “bur head approaches or intersects this boundary system deflects the position of the cutting accessory”; [0261]; [0284]: “calculated deflection of the bur head is above a threshold percentage of the maximum deflection, controller starts to attenuate motor speed”).
Bozung lacks:
select a guide constraint error threshold based on the motor status.
However, hysteresis control (upper and lower limits for a given threshold) is a known control technique to prevent cycling. For example, Sides teaches a negative wound pressure therapy system that uses circuitry with hysteresis control [0150] by using upper and lower thresholds to prevent the system from turning on and off as often [0191]. Sides teaches where the system is on until the upper threshold is crossed and then will not turn back on until the lower threshold is crossed [0191].
It would be obvious to one of ordinary skill in the art at the time the instant invention was filed to modify the system of Bozung with the use of hysteresis control as is known and evidenced by Sides, as using upper and lower limits would prevent cycling. Such a modification would yield selecting a guide constraint error threshold based on the motor status since the selected threshold depends from the direction of approach which is associated with a given motor status (i.e. above or below the threshold that results in adjustments to motor control).
Additionally, the proposed combination yields selecting a guide constraint error threshold where the motor is able to run until the upper threshold, or maximum deflection of the tool is crossed, and then restricting the motor from running until the lower threshold, or until the tool returns closer to the home position, is crossed.
In re claim 154, see above (In re claim 153) and with respect to the following limitations:
determine an error value between the state of the surgical tool and the target pose of the surgical tool in at least one degree of freedom ([0282] “control system tracks deviation of the working portion from the home position”);
based on the motor status, select an error threshold for the at least one degree of freedom [0261]; and
control the tool drive motor based on the selected error threshold and the error value [0284].
In re claim 156, the proposed combination yields (all mapping directed to Bozung)
wherein the error threshold is an error range ([0261]: the maximum displacement or error range the tool is able to move), and
wherein the control system is configured to control the tool drive motor based on the selected error range and based on the error value ([0282]: “the control system attenuates the cutting speed of the working portion when the working position deviates from the home position”; [0284]: “deflection of the bur head is above a threshold percentage of the maximum deflection, controller starts to attenuate motor speed”).
In re claim 157, the proposed combination teaches (all mapping directed to Bozung, unless otherwise directed) wherein the motor status is selected from a permissive state ([0274]: passive mode, in boundary) and a restricted state ([0274]: passive mode, out of boundary),
wherein in the permissive state, the tool drive motor is permitted to run ([0284]: first sentence) and
in the restricted state, the tool drive motor is restricted from running ([0284]: “controller instructions console to turn off the motor”), and
wherein the error threshold is further characterized as a first error range (Sides, [0150]: the range between the upper and lower hysteresis thresholds), and
wherein the control system is configured to select from the first error range (Sides, [0150]) and a second error range (Sides, [0191]: the threshold range in which the tool required to go to reset itself), and
wherein the control system is configured to select the second error range when the tool drive motor is in the restricted state (Sides, [0191]: the threshold range in which the tool required to go to reset itself), and
wherein the control system is configured to select the first error range when the tool drive motor is in a permissive state (Sides, [0191]: the system is able to run until the upper threshold range is crossed).
In re claim 158, the proposed combination (all mapping directed to Bozung) yields
wherein the at least one degree of freedom is an elevation degree of freedom ([0261]: “displacement of bur head 204 in each of the X- (pitch), Y- (yaw) and Z-axes”).
In re claim 159, see above (In re claim 157) and the following limitations (all mapping directed to Bozung):
wherein the at least one degree of freedom is a first degree of freedom [0169] and the error value is a first error value [0283],
the control system is configured to determine a second error value in a second degree of freedom [0283] based on the target pose of the surgical tool and the pose of the surgical tool, hand-held portion or the tool support ([0283]: “the maximum possible diversion is the distance from the home position to the outer range of the total possible deflection of the cutting accessory”),
wherein the second degree of freedom is different from the first degree of freedom ([0283]: “along any one of the individual X-, Y-, and Z-axes”)
In re claim 160, see above (In re claim 154) and the following limitation (all mapping directed to Bozung)
a control system coupled to the plurality of actuators, the localizer, and the tool drive motor [0015]
In re claim 161, see above (112b) as this limitation is inherently satisfied.
wherein the control system is configured to maintain the motor status of the tool drive motor in a permissive state when a position of one or more plurality of actuators is coincident with a joint for that actuator.
In re claim 169, the proposed combination (all mapping directed to Bozung) yields
wherein the actuator assembly is configured to move the tool support in a plurality of controlled degrees of freedom [0015] relative to the hand-held portion to place the surgical tool at a desired pose [0020]; and
the control system is further configured to control the plurality of actuators to position the surgical tool in the plurality of controlled degrees of freedom [0025] based on the state of the surgical tool and the target pose of the surgical tool [0275, 0276].
In re claim 170, the proposed combination (all mapping directed to Bozung) yields
wherein the control system is configured to utilize a different guide constraint error threshold for each of the plurality of controlled degrees of freedom [0333], including
a first guide constraint error threshold for an elevation degree of freedom [0333, 0283] and
a second guide constraint error threshold for a pitch or roll degree of freedom [0333, 0283].
In re claim 171, the proposed combination (all mapping directed to Bozung) yields
wherein the control system is configured to change a parameter of the motor when the guide constraint error threshold exceeds the threshold or range for any of the plurality of controlled degrees of freedom [0284].
In re claim 172, the proposed combination (all mapping directed to Bozung) yields
wherein the guide constraint error threshold is a guide constraint error range expressed as a range of values ([0261]: the maximum displacement or error range the tool is able to move).
In re claim 173, the proposed combination (all mapping directed to Bozung) yields
wherein the error range is asymmetrical, such as asymmetrical about a median value of zero ([0283]: last two sentences; Note: an asymmetrical range about a median value can be changed based on the chosen “median” value, including if the median is 0, so the tool not being able to move as far along one axis compared to the maximum distance it could be moved, may be asymmetrical about the chosen median).
In re claim 174, the proposed combination (all mapping directed to Sides) yields wherein the control system is configured
to select a first guide constraint error range when the motor has a permissive state ([0150]: “therapeutic range with an upper threshold… and lower threshold”; Note: the motor is able to run between the upper and lower threshold range until the upper threshold limit is crossed) and
to select a second guide constraint error range when the motor is in a restricted state ([150]: “therapeutic range with… lower threshold”; [0191]: “the pump will rest until the… level gradually falls… to the point of the lower threshold”),
such that the first guide constraint error range differs from the second guide constraint error range [0150].
In re claim 175, see above (In re claim 157).
In re claim 176, the proposed combination (all mapping directed to Bozung) yields wherein the control system is further configured to
determine an error value between the pose of the surgical tool and the target pose of the surgical tool in at least one degree of freedom ([0282] “control system tracks deviation of the working portion from the home position”) and
control the tool drive motor based on the error value ([0282]: “working portion is capable of operating at the maximum cutting speed when the working position is in the home position and the control system attenuates the cutting speed of the working portion when the working position deviates from the home position”).
In re claim 177, the proposed combination (all mapping directed to Bozung) yields
wherein the control system is configured to slow or stop the tool drive motor based on the guide constraint error threshold and the error value exceeding a threshold or a range of any one of the at least one degrees of freedom [0284].
In re claim 178, the proposed combination (all mapping directed to Bozung) yields
wherein the control system is configured to determine the error value for each of the plurality of degrees of freedom based on the target pose of the surgical tool and the state of the surgical tool [0276, 0283].
In re claim 179, the proposed combination (all mapping directed to Bozung) yields
wherein the control system is configured to receive a planned pose of an implant in the known coordinate system [0004, 0026] and
wherein the target pose of the surgical tool is based on the planned pose of the implant [0026].
In re claim 180, see above (In re claim 159) and the following limitations:
wherein the control system is configured to
control the tool drive motor based on the first error value [0283] and a first error threshold (see above In re claim 157) and
control the tool drive motor based on the second error value [0283] and a second error threshold (see above In re claim 157).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Wu (US 2014/0088410) teaches a navigation system that can be used to control movement of surgical instruments [0008] by using trackers on the anatomy of the patient and on the surgical tool to ensure that cutting of the anatomy only occurs within a predefined boundary [0016]. The control system of the robot can also control or constrain movement of the cutting tool in multiple degrees of freedom [0016].
Leimbach et al. (US 2018/0132850) teaches a surgical instrument that uses multiple sensors to determine the condition and communicate instructions to the surgical instrument (abstract). A processor is used to take the signals from the sensors and use a reference value for them, then it determines whether the reference value is an on or off value [0412]. On and off values can be determined from correlating the reference values with two or three different ranges and then determining which range the value belongs in [0412].
Contact
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HALEY N. PRUITT whose telephone number is (571)272-1955. The examiner can normally be reached M-T, 7:30 AM -5 PM. F, 7:30-4.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571)270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HALEY N PRUITT/Examiner, Art Unit 3796
/DAVID HAMAOUI/SPE, Art Unit 3796
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