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 § 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 6 is 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 claim 6, “the motor” lacks antecedent basis.
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) 1-3, 10-11, 14-17, and 21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Anderson (US 2005/0107687).
Anderson shows an electromagnetic localization system and method of use ([0026]) comprising at least one locating unit and one processing unit, the locating unit comprising at least two locating transducers wherein at least one locating transducer is a transmitter adapted to emit at least one magnetic field and at least one locating transducer is a receiver adapted to receive and measure the magnetic field emitted by the transmitter ([0032]), wherein at least one first locating transducer is adapted to be locked in a fixed position with respect to a first object and at least one second locating transducer is adapted to be locked in a fixed position with respect to a second object (determining relative position from transmitter to receiver fixed/attached on moveable instrument; [0032]), the processing unit being configured to: a determine a pose of the first locating transducer with respect to the second locating transducer based on the measurement of the magnetic field emitted by the transmitter of the locating unit ([0032]-[0033]), b. calculate an indicator related to the accuracy of the measurement of the magnetic field (analyze residual errors; [0037]), c. compare the calculated indicator with a predefined threshold ([0037]), d. determine the pose of the first object with respect to the second object, based on the determined pose of the transducers when the calculated indicator is below the predefined threshold ([0037]), and e. generate an instruction to displace at least one of the locating transducers when the calculated indicator exceeds the predefined threshold, such instruction being executable manually by a user of the system or automatically by an actuator (if residual errors are not reliably below a certain threshold, then the instrument or tracker is further adjusted to reduce residual errors, [0037]; test various receiver configurations and/or placements with the instrument to minimize distortion in the EM tracker; [0033], [0038]).
Anderson also shows at least one alert device and wherein the processing unit is adapted to send the instruction to displace one of the locating transducers to the alert device, the execution of such instruction resulting in that the alert device provides an information to the user according to which one of the locating transducers must be displaced (generates distortion model and field map; [0033]); wherein the second locating transducer is movably attached to the second object (various receiver configurations/placement with instrument, [0033]); wherein the processing unit is further configured to: a. determine a distance between the first locating transducer and the second locating transducer of at least one locating unit b. compare the determined distance measured between the first locating transducer and the second locating transducer of the locating unit with a predetermined threshold, c. generate an instruction to displace at least one of the locating transducers when the determined distance exceeds the predetermined threshold, such instruction being executable manually by a user of the system or automatically by an actuator ([0075]-[0076]); wherein the processing unit is configured to calculate the indicator by combining at least two elementary indicators based on at least two different detection modalities (tracking unit measures parameters such as field, position and orientation data which may be considered elementary indicators, as the instrument is simulated/moved, [0033]; [0037]); wherein the processing unit is adapted to monitor a pose of a plurality of transducers arranged according to a known geometry and to calculate as an elementary indicator a deviation between a geometry computed from the magnetic field of said plurality of transducers and the known geometry (measure orientation and utilize distortion model/field map to minimize distortion according to various configurations and placements with the instrument, [0033]); wherein the second object is held by a robotic arm and the processing unit is configured to receive from the robotic arm an indication that operation of the robotic arm has failed (robotic system to map distortion, where errors may correspond with failure of the robotic arm; [0040]-[0041], [0048], [0066]); wherein the processing unit is adapted to monitor an electrical current flowing in each transmitting coil and to calculate as an elementary indicator a difference between said electrical current and an input electrical current (determine magnetic field per coil current; [0063]-[0065]); wherein the processing unit is adapted to monitor a phase of the magnetic field received and measured by the receiver of a locating unit and to calculate as an elementary indicator a variation of said phase (determine magnetic field per coil current, [0063]-[0065]; [0072]).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 4-6 and 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Anderson (US 2005/0107687) in view of DiMaio et al. (US 2019/0216555; hereinafter DiMaio).
Anderson shows the invention substantially as described in the 102 rejection above.
Anderson fails to show wherein the second locating transducer is mounted on a guide fixedly attached to the second object, and wherein the system comprises at least one locking device adapted to lock the pose of the second locating transducer with respect to the second object; wherein the second locating transducer is mounted on a guide fixedly attached to the second object, the guide comprising an indexing device adapted to lock the pose of the second locating transducer in one of a number of determined poses with respect to the second object; wherein the second locating transducer is motor-driven, the processing unit being adapted to send the instruction to displace one of the locating transducers to the motor driving the second locating transducer, the execution of the instruction resulting in a displacement of the second locating transducer; wherein the processing unit is configured to assign a respective weight to each elementary indicator; a computer-assisted surgery system comprising at least one robotic arm with at least one motor-driven joint formed between two adjacent segments, the robotic arm extending between a base and an end-effector, such end-effector being adapted to hold at least one of a surgical guide and/or a surgical instrument, the computer-assisted surgery system comprising at least one electromagnetic localization system according to claim 1, wherein the first object is an anatomical structure and wherein the end-effector forms the second object; wherein the processing unit is adapted to send an instruction to displace the second locating transducer to the motor-driven joint of the robotic arm.
DiMaio discloses a robotically controllable arm for positioning and tracking a surgical tool. DiMaio teaches wherein the second locating transducer is mounted on a guide fixedly attached to the second object, and wherein the system comprises at least one locking device adapted to lock the pose of the second locating transducer with respect to the second object ([0192]-[0194]); wherein the second locating transducer is mounted on a guide fixedly attached to the second object, the guide comprising an indexing device adapted to lock the pose of the second locating transducer in one of a number of determined poses with respect to the second object ([0192]-[0194]); wherein the second locating transducer is motor-driven, the processing unit being adapted to send the instruction to displace one of the locating transducers to the motor driving the second locating transducer, the execution of the instruction resulting in a displacement of the second locating transducer (actuation of degrees of freedom of the surgical instrument driven by motors; [0219]); wherein the processing unit is configured to assign a respective weight to each elementary indicator (determine optimum pose utilizing indices with assigned weights; [0141]-[0142]); a computer-assisted surgery system comprising at least one robotic arm with at least one motor-driven joint formed between two adjacent segments, the robotic arm extending between a base and an end-effector, such end-effector being adapted to hold at least one of a surgical guide and/or a surgical instrument, the computer-assisted surgery system comprising at least one electromagnetic localization system according to claim 1, wherein the first object is an anatomical structure and wherein the end-effector forms the second object (Figs. 1-2); wherein the processing unit is adapted to send an instruction to displace the second locating transducer to the motor-driven joint of the robotic arm (Figs. 1-2).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Anderson to utilize a guide and locking device as taught by DiMaio, in order to more accurately maintain the position of the medical instrument/robotic arm thereby producing a more accurate measurement. Furthermore, it would be obvious to utilize the electromagnetic distortion tracking system described by Anderson in a computer assisted surgery system as taught by DiMaio, in order to provide a more accurate surgical procedure by reducing operator errors.
Claim(s) 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Anderson (US 2005/0107687) in view of Frame et al. (US 2017/0239013; hereinafter Frame).
Anderson shows the invention substantially as described in the 102 rejection above.
Anderson fails to show wherein the processing unit is configured to monitor the pose of the receiver relative to an additional transducer arranged at a known or determinable distance from said receiver, and to calculate as an elementary indicator a variation of said relative pose; wherein the processing unit is configured to monitor a working status of each transducer and to calculate as an elementary indicator a signal intensity of each transducer.
Frame discloses a patient reference assembly for a surgical navigation system. Frame teaches wherein the processing unit is configured to monitor the pose of the receiver relative to an additional transducer arranged at a known or determinable distance from said receiver, and to calculate as an elementary indicator a variation of said relative pose (patient reference sensor, [0057]); wherein the processing unit is configured to monitor a working status of each transducer and to calculate as an elementary indicator a signal intensity of each transducer (adjusted to regulate intensity of sensor; computing system may monitor current, voltage, power; [0057]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Anderson to utilize a reference sensor and monitoring of signal intensity as taught by Frame, as the use of an additional reference sensor will provide supplementary position/orientation measurement data, and where monitoring of signal intensity will provide feedback to allow for the sensor to be arranged as desired, thereby improving the accuracy of the measurement.
Allowable Subject Matter
Claims 7-9 are 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 prior art of record fails to teach at least two locating units, each locating unit comprising at least two locating transducers wherein at least one locating transducer is a transmitter adapted to emit at least one magnetic field and at least one locating transducer is a receiver adapted to receive and measure the magnetic field emitted by the transmitter, wherein the two locating units comprise at least one shared locating transducer adapted to be locked in a fixed position with respect to both objects and wherein the processing unit is adapted to a. determine a pose of the locating transducers of each locating unit with respect to one another based on the measurement of the magnetic field emitted by the transmitter of the concerned locating unit, b. calculate one indicator related to the accuracy of the measurements of the magnetic field for each measurement, c. compare each of the calculated indicators with a predefined threshold, d. determine the pose of the first object with respect to the second object, based on the determined pose of the transducers when the calculated indicators are both below the predefined threshold, and e. generate an instruction to displace at least one of the locating transducers when at least one of the calculated indicators exceed the predefined threshold, such instruction being executable manually by a user of the system or automatically by an actuator; wherein the processing unit is adapted to generate an instruction to displace the shared locating transducer when both calculated indicators exceed the predefined threshold; wherein the locating unit comprises at least two second locating transducers adapted to be locked in position with respect to the second object, the two second locating transducers being either transmitters adapted to emit the electromagnetic field then received and measured by the first locating transducer or receivers adapted to receive and measure the electromagnetic field emitted by the first locating transducer, the processing unit being adapted to: a. determine the pose of the first locating transducer with respect to each of the second locating transducers, b. calculate at least one indicator related to the accuracy of the measurements of the magnetic fields for each determined pose, c. compare each calculated indicator to the predefined threshold d. determine the pose of the first object with respect to the second object when at least one of the calculated indicators is below the predefined threshold, based on the determined pose of the first locating transducer with respect to the one of the second locating transducers for which the calculated indicator related to the accuracy of the measurement of the magnetic field is the lowest e. generate an instruction to displace at least one of the locating transducers when all the calculated indicators exceed the predefined threshold, such instruction being executable manually or automatically.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
DiMaio (US 2019/0231460) discloses a positioning indicator system for a remotely controllable arm (abstract).
Frame (US 2017/0238996) discloses a medical tracking sensor assembly (abstract).
Hartmann (US 2008/0200927) discloses automated identification of tracked surgical devices using an electromagnetic localization system (abstract).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN CWERN whose telephone number is (571)270-1560. The examiner can normally be reached Monday - Friday, 8:00 am - 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher Koharski can be reached at (571) 272-7230. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JONATHAN CWERN/Primary Examiner, Art Unit 3797
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