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 . 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 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.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. The current application is a 371 national stage of PCT/US2023/021912 (with an effective filing date of 05/11/2023), and also claims benefit to provisional 63/340,573. Examiner has checked and verified that the subject matter of the instant application is supported by the earlier filed provisional. As such, the earlier filed date of 05/11/2022 is granted.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 11/14/2024 and 12/02/2024, were filed before the mailing of a First Office Action on the Merits. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Status of Claims
This action is in response to Applicant’s filing on 11/11/2024. Claims 1-19 and 33 are pending and examined below.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 5-6, 9-12, 16-19, and 33 are rejected under both 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Panescu et al., US 20170181808 A1, herein referred to as Panescu.
Regarding claim 1,
Panescu discloses the following:
a manipulator arm configured to support an instrument (Fig. 6, Paragraph 0060)
the surgical system may include multiple robotic arms, each of which may hold a surgical instrument 101
an input device configured to accept user commands to move the instrument (Paragraph 0139)
a haptic user interface may be utilized to accept user commands for controlling the surgical instrument(s)
an actuator system coupled to the input device (Paragraphs 0134, 0139, 0141)
actuators may be coupled to each pin in the haptic user interface (input device) to provide haptic feedback
a controller comprising at least one processor (Paragraphs 0013, 0056)
the system may include processors and can utilize a computer to perform the various functions (controller; also contains processors)
determine a component of a change in force at the instrument, the component correlating with a direction of motion of the input device (Paragraphs 0128, 0134-0136, 0140)
force and displacement changes for a patient’s tissue can be determined
these force and displacement changes correspond to the haptic user interface engaging with the patient’s tissue in a given direction
the haptic user interface may approximate the 3D model structure of the associated tissue
in response to a determination that an environmental stiffness experienced by the instrument exceeds a threshold stiffness, determine a feedback force based at least in part on the environmental stiffness and the component of the change in force (Paragraphs 0128, 0142, 0150)
each pin may have a default stiffness before the tooling engages tissue
when the tooling engages the tissue, the stiffness exceeds this threshold due to the changes in force and displacement
the pins may push back against the user to perform haptic feedback (this generates a feedback force)
the stiffness of a given tissue may be mapped to the haptic user interface; this allows for various stiffness to be presented for various parts of the tissue
this mapped stiffness may be considered the environmental stiffness
cause the actuator system to drive the input device to apply the feedback force (Paragraphs 0128, 0141, 0150)
the actuators for each pin may be driven towards a user’s finger to provide force feedback that corresponds to the tissue stiffness
Regarding claim 2,
Panescu discloses all the limitations of claim 1. Panescu further discloses the following:
wherein the instrument comprises a distal portion (Fig. 6, 28B, Paragraph 0141)
each surgical instrument may have a distal portion that interacts with the tissue
wherein the change in force comprises a change in distal force at the distal portion of the instrument (Fig. 28B, Paragraph 0141)
changes in force may be due to the distal portion of the surgical instruments interacting with the tissue
Regarding claim 5,
Panescu discloses all the limitations of claim 1. Panescu further discloses the following:
wherein the controller is configured to determine the feedback force by: determining the feedback force as opposing the direction of motion of the input device (Paragraphs 0128, 0142, 0150)
haptic feedback (force) may be applied to counteract a user pressing on a pin
this means that the feedback force is opposed to the direction of the user input
Regarding claim 6,
Panescu discloses all the limitations of claim 1. Panescu further discloses the following:
determine the feedback force based at least in part on the environmental stiffness and the threshold stiffness by: using a comparison of the environmental stiffness and the threshold stiffness (Paragraphs 0128, 0142, 0150)
haptic feedback (force) may be determined based on the stiffness mapping of the tissue (environmental stiffness) and the default stiffness of the pins (threshold stiffness)
the haptic feedback may be present when the instrument contacts a tissue with given stiffness (environmental stiffness (felt) is greater than the pin default stiffness), and is effectively a comparison of the two stiffnesses
Regarding claim 9,
Panescu discloses all the limitations of claim 1. Panescu further discloses the following:
determine a saturation limit based on the environmental stiffness and the threshold stiffness (Paragraph 0174)
a force safety limit may be imposed regardless of what the stiffness map of the tissue is
the applied force may not exceed this limit and the maximum stiffness limited by this force limit can be considered a saturation limit
apply the saturation limit to the component of the change in force to produce a resultant change in force, wherein the controller is configured to determine the feedback force by accumulating the resultant change in force (Paragraphs 0128, 0142, 0150, 0174)
because there is a force safety limit, the stiffness map will always be limited through a ceiling value
this can be considered an application of the saturation limit to the stiffness map (changes in force and displacement), and the feedback itself is based on the stiffness and this overall force limit
for instance, the stiffness will always have a ceiling as the force changes have an upper bound
Regarding claim 10,
Panescu discloses all the limitations of claim 1. Panescu further discloses the following:
the controller is configured to determine the feedback force by: limiting the feedback force to a force limit determined based on a force at the instrument (Paragraphs 0128, 0142, 0150, 0174)
the feedback force experienced by the user may be limited by a force safety limit
the force limit may be based on forces exerted on the tissue by the instrument
Regarding claim 11,
Panescu discloses all the limitations of claim 1. Panescu further discloses the following:
determine the force limit in at least two degrees of freedom of the input device, the at least two degrees of freedom of the input device correlating with at least two degrees of freedom of the instrument (Paragraphs 0136, 0174)
a force limit may be established based on a sensed force of the instrument on a tissue
the force sensed at the instrument may be a force vector which indicates forces in multiple degrees of freedom
Regarding claim 12,
Panescu discloses all the limitations of claim 1. Panescu further discloses the following:
determine the feedback force by: using only the component of the change in force correlating with the direction of motion of the input device and not any other components of the change in force, or disregarding any components of the change in force not correlating with the direction of motion of the input device to determine the feedback force (Paragraphs 0128, 0142, 0150)
the feedback force is exerted onto the user’s fingers through the pins
the pins may displace in a given direction through feedback actuation
this feedback force occurs in the axis that the user input is applied
Regarding claim 16,
Panescu discloses all the limitations of claim 1. Panescu further discloses the following:
the actuator system is a first actuator system (Paragraphs 0134, 0139, 0141)
the actuators for providing feedback forces for the haptic user interface can be considered the first actuator system
a second actuator system coupled to the manipulator arm, the second actuator system configured to drive motion of the instrument (Figs. 28A-28C, Paragraphs 0128, 0141-0142, 0150)
the haptic user interface may allow for a user to press on a pin to actuate the surgical instrument to contact the tissue
this can be considered the second actuator system
determine the environmental stiffness based on an amount of force or torque associated with the second actuator system when driving the motion of the instrument, or determine the environmental stiffness based on a resulting motion of the instrument when driving the motion of the instrument with the second actuator system (Paragraphs 0128, 0141-0142, 0150)
the stiffness map of the tissue may be based on stiffness values established when the surgical instrument is contacting the tissue
this means that the environment stiffness is based on a resulting motion of the second actuator system (instrument is engaged with tissue)
Regarding claim 17, a portion of the claim limitations are similar to those in claim 16 and are rejected using the same rationale as seen above in claim 16. Additionally, Panescu discloses determine the environmental stiffness based on a motion of a point when the second actuator system is driving the motion of the instrument, wherein the point is fixed relative to the instrument (Paragraphs 0128, 0141-0142, 0150; the stiffness map of the tissue may be based on stiffness values established when the surgical instrument is contacting the tissue; this means that the environment stiffness is based on a resulting motion of the tip of the instrument contacting the tissue; this point/tip of the instrument is fixed relative to the instrument).
Regarding claim 18, the claim limitations are similar to those in claim 1 and are rejected using the same rational as seen above in claim 1.
Regarding claim 19, the claim limitations are similar to those in claim 2 and are rejected using the same rationale as seen above in claim 2.
Regarding claim 33, the claim limitations are similar to those in claim 1 and are rejected using the same rational as seen above in claim 1.
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 3-4 and 7-8 are rejected under 35 U.S.C. 103 as being obvious over Panescu and in view of Verner et al., US 20190015169 A1, herein referred to as Verner.
Regarding claim 3, Panescu discloses all the limitations of claim 1. Panescu further discloses one or more sensors coupled to the instrument (Paragraphs 0128, 0138, 0142, 0150; a force sensor may be attached to the instruments for detecting instrument forces), the one or more sensors configured to sense forces applied to the instrument, wherein the controller is configured to determine the change in force based on the forces applied to the instrument (Paragraphs 0128, 0138, 0142, 0150; a force sensor may be attached to the instruments for detecting instrument forces; force changes detected by the force sensor may be used for stiffness mapping), but fails to disclose one or more sensors coupled to the manipulator arm, the one or more sensors configured to sense forces applied to the manipulator arm, wherein the controller is configured to determine the change in force based on the forces applied to the manipulator arm. However, Verner, in an analogous field of endeavor, teaches one or more sensors coupled to the manipulator arm, the one or more sensors configured to sense forces applied to the manipulator arm, wherein the controller is configured to determine the change in force based on the forces applied to the manipulator arm (Paragraphs 0031-0032; sensing may occur on the shaft of a robotic arm). Therefore, from the teaching of Verner, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified, with a reasonable expectation for success, the robotic system of Panescu to include one or more sensors coupled to the manipulator arm, the one or more sensors configured to sense forces applied to the manipulator arm, wherein the controller is configured to determine the change in force based on the forces applied to the manipulator arm, as taught/suggested by Verner. The motivation to do so would be to determine forces at a variety of locations on the robotic system. This can lead to better robotic control as the applied forces to the robotic system are more accurately accounted for.
Regarding claim 4, Panescu discloses all the limitations of claim 1. Panescu further discloses the direction of motion of the input device is determined in at least one degree of freedom (Paragraphs 0128, 0142, 0150; user input may be provided by pushing down on the pins which have a single degree of freedom (axis) for motion), and wherein the direction of motion of the input device is a direction of a velocity of the input device (Paragraphs 0128, 0142, 0150; a user providing input to the haptic user interface pins will press the pins with a given velocity; the pin displacement will be the same direction as the velocity), but fails to disclose the direction of motion of the input device is determined in at least two degrees of freedom. However, Verner teaches the direction of motion of the input device is determined in at least two degrees of freedom (Paragraph 0018; multiple degrees of freedom may be used for user input). Therefore, from the teaching of Verner, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified, with a reasonable expectation for success, the robotic system of Panescu to include the direction of motion of the input device is determined in at least two degrees of freedom, as taught/suggested by Verner. The motivation to do so would be to increase the adaptability and accuracy of the system by including more degrees of freedom for the input device. This can lead to the surgeon being able to perform more accurate control as they can better express certain movements with multiple degrees of freedom.
Regarding claim 7, Panescu discloses all the limitations of claim 1. Panescu further discloses determine the feedback force based at least in part on the environmental stiffness and the threshold stiffness (Paragraphs 0128, 0142, 0150; each pin may have a default stiffness before the tooling engages tissue; when the tooling engages the tissue, the stiffness exceeds this threshold due to the changes in force and displacement; the pins may push back against the user to perform haptic feedback (this generates a feedback force); the stiffness of a given tissue may be mapped to the haptic user interface; this allows for various stiffness to be presented for various parts of the tissue; this mapped stiffness may be considered the environmental stiffness), but fails to disclose determining a gain factor based at least in part on the threshold stiffness and environmental stiffness, and applying the gain factor to the component of the change in force. However, Verner teaches determining a gain factor based at least in part on the threshold stiffness and environmental stiffness and applying the gain factor to the component of the change in force (Paragraphs 0025-0027; output limits may be used to generate scaling factors for a given force application; this can be considered as a gain factor). Therefore, from the teaching of Verner, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified, with a reasonable expectation for success, the robotic system of Panescu to include determining a gain factor based at least in part on the threshold stiffness and environmental stiffness, and applying the gain factor to the component of the change in force, as taught/suggested by Verner. The motivation to do so would be to modify the stiffness values with a gain factor to better approximate certain procedures or tissues.
Regarding claim 8, Panescu in view of Verner renders obvious all the limitations of claim 7. Panescu further discloses a difference between the threshold stiffness and the environmental stiffness (Paragraphs 0128, 0142, 0150; default stiffness (threshold stiffness) may be used in conjunction with a tissue stiffness mapping (environmental stiffness) for determining force feedback; this can be considered as determining a difference between the two), but fails to disclose determining the gain factor comprises using a difference between the threshold stiffness and the environmental stiffness. However, Verner teaches determining the gain factor comprises using a difference between the threshold stiffness and the environmental stiffness (Paragraphs 0025-0027; a scaling factor may be determined for various force applications and is based on various force limits). Therefore, from the teaching of Verner, it would have been obvious to one of ordinary skill in the art before the effective filing date to have further modified, with a reasonable expectation for success, the robotic system of Panescu and Verner to include determining the gain factor comprises using a difference between the threshold stiffness and the environmental stiffness, as taught/suggested by Verner. The motivation to do so would be to ensure that the gain factor is appropriately defined based on various stiffness data. This can ensure that control of the robotic system is accurately tuned to the correct tissue being operated on.
Allowable Subject Matter
Claims 13-15 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.
Regarding claim 13, the examiner has performed a thorough search and has not found a piece of prior art, either alone or in combination with other prior art, that discloses, teaches, suggests, or renders obvious the claim limitations. The closest piece of prior art, US 20170181808 A1 by Panescu, discloses causing the actuator system to drive the input device to apply a restoring force (Paragraphs 0128, 0142, 0150; each pin of the haptic user interface may actuate towards a user’s finger to illicit a feedback), but fails to disclose cause the actuator system to drive the input device to apply a restoring force superimposed on the feedback force, the restoring force being in a direction perpendicular to the direction of motion of the input device. These features are novel in that they allow for a unique method of feedback that can create new haptic sensations that may better allow for accuracy. This can reduce potential errors caused by drift or other minute variances that can build up over time.
Regarding claim 14, the claim depends form claim 13 and contains the same object to subject matter as claim 13. As such, claim 14 is also objected to for containing allowable subject matter.
Regarding claim 15, the examiner has performed a thorough search and has not found a piece of prior art, either alone or in combination with other prior art, that discloses, teaches, suggests, or renders obvious the claim limitations. The closest piece of prior art combination, US 20170181808 A1 by Panescu and US 20110202068 A1 by Diolaiti, teaches all the limitations of claim 1 (see Panescu and claim 1 rationale), and an error in force feedback and a change in force that has an opposite component correlating with an opposite direction of the direction of motion of the input device (Diolaiti, 0075; a user may feel an opposing force while moving the input in a given direction; the system may recognize the opposing force as an error), but fails to disclose in response to a determination that the change in force plus an error in the feedback force is greater than a previous change in force at the instrument and in response to determining that the change in force has the opposite component, determine the feedback force further based in the opposite component plus the error. These features are novel in that it allows for the system to track errors and compare them with past changes in force (variances in stiffness). This can lead to reduction of errors over time as they are consistently accounted for. Additionally, this ensures that the opposing force components are compensated for, further increasing accuracy.
Conclusion
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/CHRISTOPHER A BUKSA/Examiner, Art Unit 3658