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.
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) 1-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sarli et al. (WO 2022/144639) in view of Yates et al. (US 2022/0387031).
Claim 1
A surgical system having adaptive control, comprising…
E.G. Sarli et al. discloses a robotically-enabled medical system configured to detect interactions and provide responsive control actions during a surgical procedure, [0167]-[0169].
…a surgical cutting device including a cutting tool…a motor configured to drive movement of the tool…
E.G. Yates et al. discloses a surgical tool 2300 including surgical end effector 2312 having a cutting instrument 2332, wherein said end effector drive shaft 2336 causes axial travel of cutting operations [0281]. Yates further discloses motor 65 driving the cutting/stapling operation [0187].
…at least one sensor configured to produce sensor data indicative of at least one property of the cutting tool during use…
Sarli et al. does not expressly teach sensor data indicative of property of a cutting tool during tissue cutting. Yates et al. discloses sensors disposed in the end effector and/or staple cartridge during tissue severing operations, E.G. [0281]. Yates et al. further discloses sensor 110 detecting movement and generating an electrical signal indicative of the voltage of power supplied to motor 65, which controls the cutting operations, [0187]. Under the broadest reasonable interpretation, voltage, power, motor rotation, movement, position and operational state constitute properties of the cutting tool.
…a controller configured to receive the sensor data and determine a performance condition…based on the sensor data…
Sarli et al. does not expressly teach determining a performance condition of the cutting tool itself.
Yates et al. discloses controller 1001 determining whether the cutting instrument has reached an end position and/or a starting position by means of sensors [0263]. Yates further discloses that the sensor output determines the amount of voltage supplied to the motor 65 and the resulting motor rotation, [0187].
Under the broadest reasonable interpretation, the operational state, motor rotation, position,and movement of the cutting instrument constitutes performance conditions of the cutting tool because the represent the operating status of the cutting instrument during the cutting operation.
…where the determined performance condition is an adverse performance condition…”
Sarli et al. discloses detecting undersirable interactions including inadvertent contact, collsions, and force and/or torque conditions outside safe limits requiring responsive action, E.G. [0167]-[0169].
Under the broadest reasonable interpretation, an undersirable operational state of the cutting instrument, including improper position, insufficient motor rotation, incomplete deployment, or undesirable interactions during operation, constitutes an adverse performance condition.
…to…adjust settings of the surgical cutting device or recommend a change relating to use of the surgical cutting device…
Sarli et al. discloses modifying robotic operation in response to detected conditions, including changing movement characteristics, enabling null-space movement, and providing haptic feedback to facilitate safe operation, E.G. [0168]-[0169]. Such responsive actions constitute adjusting settings of the surgical cutting device and/or recommending changes relating to use of the surgical cutting device.
It would have been obvious to one of ordinary skill in the art to incorporate Yates’ sensor-based monitoring of a surgical cutting instrument into Sarli’s adaptive robotic surgical system so that the system could determine operational conditions of the cutting instrument during tissue cutting and automatically respond to underisable operation conditions, thereby improving surgical safety, reliability, and control of the cutting instrument during a surgical procedure.
The proposed modification merely applies known sensor-based monitoring techniques to a known adaptive robotic surgical system for their predictable purpose of improving instrument control and surgical safety and would have yielded no more than predictable results. KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398, 417 (2007). Note that the examiner interprets the recited ‘performance condition’ under the broadest reasonable interpretation to encompass an operational state, position, movement, voltage, power, and/or motor rotation of the cutting instrument as determined from sensor data, absent an explicit definition in the specification limiting the term to tool wear, degradation, or malfunction.
Claim 2.
…wherein the controller…configured to receive other data…determine the performance condition based at least on the sensor data and the other data.
Sarli et al. discloses a controller receiving various information relating to the robotic procedure, including interactions, procedural information, etc. for controlling operation of the robotic system, E.G. [0167]-[0169].
Yates discloses controller 1001 receiving sensor information and operating information associated with the surgical instrument, E.G. via the disclosed controller passages regarding end-position determinations, [0187].
Claim 3.
…wherein the other data includes at least one of: identifying data, patient data, procedure data, robotic system data or navigation data.
Sarli et al. discloses use of surgical plan information, procedural information, et. for controlling surgical operations, E.G. [0167]-[0169].
Claim 4.
…the determined performance condition includes at least one or a stability condition or an efficiency condition.
Sarli et al. discloses determining whether instrument interactions exceed safe contact limits and providing responsive control to maintain safe and efficient operation, E.G. [0167]-[0169].
Under the broadest reasonable interpretation, maintaining safe contact limits and controlling instrument interactions constitute determination of stability and efficiency conditions.
Claim 5.
…the determined performance condition is a binary determination…
Yates et al. disclosed determining whether the cutting instrument has reached an end position or a starting position, which constitutes a yes/no determination, E.G. controller passages, [0187].
Under the broadest reasonable interpretation, such determination constitute binary determinations.
Claim 6.
…the determined performance condition is a scaled determination…”
Yates discloses sensor 110 generating signals proportional to trigger movement and motor rotation, wherein the amount of voltage and motor rotation varies proportionally to trigger displacement, E.G. [0187].
Under broadest reasonable interpretation, proportional sensor outputs constitute scaled determinations.
Claim 7
…the determined performance condition is an adverse performance condition, to adjust settings of the surgical cutting device by adjusting…a speed of the motor; a torque of the motor; or a performance impacting component of the surgical cutting device.
Yates et al. discloses varying the voltage supplied to motor 65, thereby varying the rotational speed of the motor, E.G. [0187].
Sarli et al. discloses modifying operational parameters of the robotic system in response to detected conditions, E.G. [0167]-[0169].
Claim 8.
…the controller is configured, wherein the determined performance condition is an adverse performance condition, to recommend a change relating to use of the surgical cutting device by recommending a manual change in a performance impacting component of the surgical cutting device…
Sarli et a. discloses providing haptic feedback to the surgeon and permitting manual intervention in response to detected conditions, E.G. [0167]-[0169].
Under the broadest reasonable interpretation, providing feedback to facilitate operator actions constitutes recommending a manual change.
Claim 9.
…the at least one sensor includes at least one of: vibration sensor, an audio sensor, a force sensor, a torque sensor, a temperature sensor, and optical sensor, or a motor electrical property sensor.
Yates et al. discloses sensor 110 producing electrical signals indicative of motor operation and power supplied to motor 65, [0187].
Sarli et al. discloses sensors for detecting interactions, forces, and contact conditions, E.G. [0167]-[0169].
Claim 10
…further includes a handle housing the motor therein and a shaft assembly coupled to the handle…an outer sleeve…the cutting tool extends through the outer sleeve
Yates et al. disclose handle 6, motor 65, distal drive shaft 120, and end effector 12 extending distally from the handle through the shaft assembly, E.G. [0187]-[0189].
Claim 11
…the at least one sensor is disposed on or within at least one of: the handle, the outer sleeve or the cutting tool.
Yates et al. discloses sensor 110 disposed in handle 6 and sensors disposed within the end effector and staple cartridge, E.G. [0187], [0271], [0281].
Claim 12
…in real time, to determine the performance condition and, where the determined performance condition is an adverse performance condition…adjust the settings of the surgical cutting device or recommend the change relating to use of the surgical cutting device.
Sarli et al. discloses real-time monitoring of interactions and responsive control actions during performance of a surgical procedure, E.G. [0167]-[0169].
Claim 13.
…further comprising a console configured to supply power and control signals to the surgical cutting device…the controller is disposed within the console.
Sarli et al. discloses robotic system 10/36 having controllers that provide control of the robotic arms and surgical instruments, E.G. [0108], [0122].
Claim 15
Claim 15 is rejected on the same grounds as claim 1 because the method limitations merely recite the functional operation of the system of claim 1 and are taught by the combination of Sarli et al. and Yates et al.
Claim 16.
Claim 16 is rejected on the same grounds as claim 2.
Claim 17.
Claim 17 is rejected on the same grounds as claim 4.
Claim 18.
Claim 18 is rejected on the same grounds as claim 7.
Claim 19.
Claim 19 is rejected on the same grounds as claim 8.
Claim 20.
…wherein the sensor data includes at least one of: vibration data, audio data, torque data, optical data, force data, temperature data, or motor electrical property data.
Yates et al. discloses sensor 110 generating signals indicative of voltage and power supplied to motor 65 [0187].
Sarli et al. discloses sensing force and contact conditions, E.G. [0167]-[0169].
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter: The prior art of record, including Sarli et al. and Yates et al., fails to teach or suggest a controller configured to implement at least one machine learning algorithm to determine the performance condition, as recited in claim 14.
The references disclose controllers that process sensor information and control operation of surgical instruments; however, the references do not disclose or suggest determining a performance condition through implementation of a machine learning algorithm, nor has the examiner identified evidence that such functionality was well-understood, routine, or conventional in the context of the cited surgical systems.
Accordingly, the limitation of claim 14 directed to implementing at least one machine learning algorithm to determine the performance condition is considered to constitute allowable subject matter.
Response to Arguments
Applicant's arguments filed April 28, 2026 have been fully considered but they are not persuasive. The applicant argues the following points in which the examiner provide a reason(s) as to why the arguments are not persuasive:
The applicant argues that the primary reference, Sarli et al., fails to disclose:
“at least one sensor configured to produce sensor data indicative of at least one property of a cutting tool during use of the cutting tool,” and
“a controller configured to receive the sensor data and determine a performance condition of the cutting tool based at least on the sensor data.”
The examiner agrees that Sarli et al. primarily discloses detecting interactions, forces, and collisions associated with operation of the robotic arm and does not expressly disclose monitoring properties of the cutting tool itself or determining a performance condition of the cutting tool based upon sensor data indicative of a property of the cutting tool.
However, the rejection is based upon the combined teaching of Sarli et al. in view of Yates et al.
Yates et al. teaches surgical cutting and fastening instruments that include sensors configured to monitor operational characteristics of the cutting instrument and generate sensor data indicative of properties of the cutting tool and its operation. See, for example, Yates et al. [0187], E.G. sensor detecting movement and rotation of the motor and providing signals indicative of motor operation, [0271], E.G. sensor disposed in the end effector and communicating information associated with cutting instrument, and [0281], E.G. sensor integrated with the surgical tool and configured to monitor operation of the cutting instruments.
Furthermore, Yates et al. teaches that the controller utilizes the sensor information to determine operational conditions of the surgical instrument and to control operation of the instrument based upon the sensed conditions, E.G. [0187]
Under the broadest reasonable interpretation, information indicative of motor operation, rotation, movement, force, torque, and other operational characteristics of the cutting instrument constitutes sensor data indicative of at least one property of the cutting tool. Likewise, determining an operational state or condition of the instrument based on such sensor data reasonably constitutes determining a “performance condition” of the cutting tool, as the claims do not define the term “performance condition” in a narrower manner.
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the robotic surgical system of Sarli et al. to incorporate the sensor monitoring techniques taught by Yates et al. in order to improve monitoring of the cutting instrument, provide additional information regarding the operational state of the instrument, and enable responsive control based upon detected operating conditions. The combination merely applies known sensor monitoring techniques to a known robotic surgical system to achieve the predictable result of improved instrument performance assessment and control. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007).
Accordingly, the applicant’s arguments regarding the deficiencies of Sarli et al. alone are persuasive only with respect to Sarli et al. individually, but are not persuasive as to the teachings of the reference in combination. Therefore, the rejection under 35 U.S.C. §103 is maintained.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLE F JOHNSON whose telephone number is (571)270-5040. The examiner can normally be reached Monday-Friday 8:00am-5:00pm EST.
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/NICOLE F JOHNSON/Primary Examiner, Art Unit 3796
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