DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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.
Claim Status
This action is in response to applicant’s filing on 6/2/2025. Claims 1-20 are pending and considered below.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 5 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 5 includes the limitation “… present, on the display device, a message identifying a reason advancement of the surgical instrument along the cutting path in the semi-autonomous mode was terminated”. This limitation is not disclosed in applicant’s specification.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-2, 4, 11-13, 15-16 and 18 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Kang et al. (US-2013/0096574-A1, hereinafter Kang) in view of Weitzner et al. (U.S. Patent Number 7,766,894, hereinafter Weitzner).
Regarding claim 1, Kang discloses:
A surgical system comprising: (paragraph [0026]; and FIG.1E, manipulator-2, controller-14, tool-28, bone-64, display-68, elongate members- 94,96,98,108,110,112, and joints-100,102,104,106,114,116,118,120);
a robotic manipulator comprising a plurality of links and a plurality of actuators configured to move the plurality of links (paragraph [0026]);
an end effector configured to couple to the robotic manipulator and the end effector supporting a surgical instrument (paragraph [0026]);
a sensor coupled to the robotic manipulator and configured to sense forces/torques applied to the surgical instrument (paragraph [0026]);
at least one controller configured to: (paragraph [0026]);
operate the robotic manipulator in a semi-autonomous mode, and in the semi-autonomous mode, the robotic manipulator is controlled to advance the surgical instrument along a cutting path to remove material from a target site (paragraph [0045]); and
during advancement of the surgical instrument along the cutting path in the semi-autonomous mode (paragraph [0045]).
Kang does not disclose evaluating forces and torques sensed by a sensor to detect an obstruction to a surgical instrument. However, Weitzner discloses a robotic medical system, including the following features:
evaluate forces/torques sensed by the sensor to detect an obstruction to the surgical instrument (col. 7, line 64 - col. 8, line 6); and
in response to detection of the obstruction, perform an action to address the obstruction (col. 7, line 64 - col. 8, line 6).
Weitzner teaches that, if the distal end of a catheter detects an obstruction or blockage that provides a force feedback signal to a controller, the controller may interrupt the operation and the catheter may be displayed on a display device (col. 7, line 64 - col. 8, line 6). It would have been obvious for a person of ordinary skill in the art at the time of the effective filing date of the claimed invention to incorporate the controller which responds to detection of an obstruction by interrupting an operation and displaying the position of the obstruction of Weitzner into the bone cutting tool which moves autonomously toward voxels of bone that have been targeted for removal, but which have not yet been in the bone cutting tool path of Kang. A person of ordinary skill would have been motivated to do so, with a reasonable expectation of success, for the purpose of preventing injury to the patient and damage to the robotic surgery system caused by contact with the obstruction.
Regarding claim 2, Kang does not disclose evaluating forces and torques sensed by a sensor to detect an obstruction to a surgical instrument. However, Weitzner further discloses:
wherein the at least one controller addresses the obstruction by being configured to deactivate the surgical instrument (col. 7, line 64 - col. 8, line 6).
Weitzner teaches that, if the distal end of a catheter detects an obstruction or blockage that provides a force feedback signal to a controller, the controller may interrupt the operation and the catheter may be displayed on a display device (col. 7, line 64 - col. 8, line 6). It would have been obvious for a person of ordinary skill in the art at the time of the effective filing date of the claimed invention to incorporate the controller which responds to detection of an obstruction by interrupting an operation and displaying the position of the obstruction of Weitzner into the bone cutting tool which moves autonomously toward voxels of bone that have been targeted for removal, but which have not yet been in the bone cutting tool path of Kang. A person of ordinary skill would have been motivated to do so, with a reasonable expectation of success, for the purpose of preventing injury to the patient and damage to the robotic surgery system caused by contact with the obstruction.
Regarding claim 4, Kang does not disclose evaluating forces and torques sensed by a sensor to detect an obstruction to a surgical instrument. However, Weitzner further discloses:
wherein the at least one controller addresses the obstruction by being configured to terminate advancement of the surgical instrument along the cutting path in the semi-autonomous mode (col. 7, line 64 - col. 8, line 6; and col. 12, lines 1-12).
Weitzner teaches that, if the distal end of a catheter detects an obstruction or blockage that provides a force feedback signal to a controller, the controller may interrupt the operation and the catheter may be displayed on a display device (col. 7, line 64 - col. 8, line 6). Weitzner further teaches that a robotic medical system should include a tracking system which enables a surgeon, through an input device, to select a particular anatomic body site and direct a catheter directly and automatically to that site (col. 12, lines 1-12). It would have been obvious for a person of ordinary skill in the art at the time of the effective filing date of the claimed invention to incorporate the controller which responds to detection of an obstruction by interrupting an operation and displaying the position of the obstruction of Weitzner into the bone cutting tool which moves autonomously toward voxels of bone that have been targeted for removal, but which have not yet been in the bone cutting tool path of Kang. A person of ordinary skill would have been motivated to do so, with a reasonable expectation of success, for the purpose of preventing injury to the patient and damage to the robotic surgery system caused by contact with the obstruction.
Regarding claim 11, Kang does not disclose evaluating forces and torques sensed by a sensor to detect an obstruction to a surgical instrument. However, Weitzner further discloses:
wherein the at least one controller detects the obstruction as an obstruction to the cutting path (col. 7, line 64 - col. 8, line 6).
Weitzner teaches that, if the distal end of a catheter detects an obstruction or blockage that provides a force feedback signal to a controller, the controller may interrupt the operation and the catheter may be displayed on a display device (col. 7, line 64 - col. 8, line 6). It would have been obvious for a person of ordinary skill in the art at the time of the effective filing date of the claimed invention to incorporate the controller which responds to detection of an obstruction by interrupting an operation and displaying the position of the obstruction of Weitzner into the bone cutting tool which moves autonomously toward voxels of bone that have been targeted for removal, but which have not yet been in the bone cutting tool path of Kang. A person of ordinary skill would have been motivated to do so, with a reasonable expectation of success, for the purpose of preventing injury to the patient and damage to the robotic surgery system caused by contact with the obstruction.
Regarding claim 12, Kang does not disclose evaluating forces and torques sensed by a sensor to detect an obstruction to a surgical instrument. However, Weitzner further discloses:
wherein the at least one controller detects the obstruction as an obstruction located above the cutting path (col. 7, line 64 - col. 8, line 6).
Weitzner teaches that, if the distal end of a catheter detects an obstruction or blockage that provides a force feedback signal to a controller, the controller may interrupt the operation and the catheter may be displayed on a display device (col. 7, line 64 - col. 8, line 6). It would have been obvious for a person of ordinary skill in the art at the time of the effective filing date of the claimed invention to incorporate the controller which responds to detection of an obstruction by interrupting an operation and displaying the position of the obstruction of Weitzner into the bone cutting tool which moves autonomously toward voxels of bone that have been targeted for removal, but which have not yet been in the bone cutting tool path of Kang. A person of ordinary skill would have been motivated to do so, with a reasonable expectation of success, for the purpose of preventing injury to the patient and damage to the robotic surgery system caused by contact with the obstruction.
Regarding claim 13, Kang does not disclose evaluating forces and torques sensed by a sensor to detect an obstruction to a surgical instrument. However, Weitzner further discloses:
wherein the obstruction is tissue located above the target site (col. 7, line 64 - col. 8, line 6).
Weitzner teaches that, if the distal end of a catheter detects an obstruction or blockage that provides a force feedback signal to a controller, the controller may interrupt the operation and the catheter may be displayed on a display device (col. 7, line 64 - col. 8, line 6). It would have been obvious for a person of ordinary skill in the art at the time of the effective filing date of the claimed invention to incorporate the controller which responds to detection of an obstruction by interrupting an operation and displaying the position of the obstruction of Weitzner into the bone cutting tool which moves autonomously toward voxels of bone that have been targeted for removal, but which have not yet been in the bone cutting tool path of Kang. A person of ordinary skill would have been motivated to do so, with a reasonable expectation of success, for the purpose of preventing injury to the patient and damage to the robotic surgery system caused by contact with the obstruction.
Regarding claim 15, Kang further discloses:
A method of operating a surgical system, the surgical system including (paragraph [0026]; and FIG.1E, manipulator-2, controller-14, tool-28, bone-64, display-68, elongate members- 94,96,98,108,110,112, and joints-100,102,104,106,114,116,118,120);
a robotic manipulator comprising a plurality of links and a plurality of actuators configured to move the plurality of links (paragraph [0026]);
an end effector configured to couple to the robotic manipulator and the end effector supporting a surgical instrument (paragraph [0026]);
a sensor coupled to the robotic manipulator and configured to sense forces/torques applied to the surgical instrument (paragraph [0026]);
at least one controller, the method comprising the at least one controller performing the following steps: (paragraph [0026]);
operating the robotic manipulator in a semi-autonomous mode, and in the semi-autonomous mode, the robotic manipulator is controlled to advance the surgical instrument along a cutting path for removing material from a target site (paragraph [0045]); and
during advancement of the surgical instrument along the cutting path in the semi-autonomous mode (paragraph [0045]).
Kang does not disclose evaluating forces and torques sensed by a sensor to detect an obstruction to a surgical instrument. However, Weitzner further discloses:
evaluating forces/torques sensed by the sensor for detecting an obstruction to the surgical instrument (col. 7, line 64 - col. 8, line 6); and
in response to detecting the obstruction, performing an action for addressing the obstruction (col. 7, line 64 - col. 8, line 6).
Weitzner teaches that, if the distal end of a catheter detects an obstruction or blockage that provides a force feedback signal to a controller, the controller may interrupt the operation and the catheter may be displayed on a display device (col. 7, line 64 - col. 8, line 6). It would have been obvious for a person of ordinary skill in the art at the time of the effective filing date of the claimed invention to incorporate the controller which responds to detection of an obstruction by interrupting an operation and displaying the position of the obstruction of Weitzner into the bone cutting tool which moves autonomously toward voxels of bone that have been targeted for removal, but which have not yet been in the bone cutting tool path of Kang. A person of ordinary skill would have been motivated to do so, with a reasonable expectation of success, for the purpose of preventing injury to the patient and damage to the robotic surgery system caused by contact with the obstruction.
Regarding claim 16, Kang does not disclose evaluating forces and torques sensed by a sensor to detect an obstruction to a surgical instrument. However, Weitzner further discloses:
comprising the at least one controller addressing the obstruction by deactivating the surgical instrument (col. 7, line 64 - col. 8, line 6).
Weitzner teaches that, if the distal end of a catheter detects an obstruction or blockage that provides a force feedback signal to a controller, the controller may interrupt the operation and the catheter may be displayed on a display device (col. 7, line 64 - col. 8, line 6). It would have been obvious for a person of ordinary skill in the art at the time of the effective filing date of the claimed invention to incorporate the controller which responds to detection of an obstruction by interrupting an operation and displaying the position of the obstruction of Weitzner into the bone cutting tool which moves autonomously toward voxels of bone that have been targeted for removal, but which have not yet been in the bone cutting tool path of Kang. A person of ordinary skill would have been motivated to do so, with a reasonable expectation of success, for the purpose of preventing injury to the patient and damage to the robotic surgery system caused by contact with the obstruction.
Regarding claim 18, Kang does not disclose evaluating forces and torques sensed by a sensor to detect an obstruction to a surgical instrument. However, Weitzner further discloses:
comprising the at least one controller addressing the obstruction by terminating advancement of the surgical instrument along the cutting path in the semi-autonomous mode (col. 7, line 64 - col. 8, line 6; and col. 12, lines 1-12).
Weitzner teaches that, if the distal end of a catheter detects an obstruction or blockage that provides a force feedback signal to a controller, the controller may interrupt the operation and the catheter may be displayed on a display device (col. 7, line 64 - col. 8, line 6). Weitzner further teaches that a robotic medical system should include a tracking system which enables a surgeon, through an input device, to select a particular anatomic body site and direct a catheter directly and automatically to that site (col. 12, lines 1-12). It would have been obvious for a person of ordinary skill in the art at the time of the effective filing date of the claimed invention to incorporate the controller which responds to detection of an obstruction by interrupting an operation and displaying the position of the obstruction of Weitzner into the bone cutting tool which moves autonomously toward voxels of bone that have been targeted for removal, but which have not yet been in the bone cutting tool path of Kang. A person of ordinary skill would have been motivated to do so, with a reasonable expectation of success, for the purpose of preventing injury to the patient and damage to the robotic surgery system caused by contact with the obstruction.
Claims 10 and 14 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Kang in view of Weitzner, as applied to claim 1 above, and further in view of Manzo et al. (US-2008/0046122-A1, hereinafter Manzo).
Regarding claim 10, Kang in view of Weitzner does not disclose a six degrees of freedom force/torque sensor mounted to a coupler. However, Manzo discloses a robotic surgical system, including the following features:
wherein: the robotic manipulator comprises a coupler to which the end effector mounts (paragraphs [0223-0224] and [0260]);
the sensor is mounted to the coupler (paragraphs [0223-0224] and [0260]); and
the sensor is a six degrees of freedom force/torque sensor (paragraph [0229]).
Manzo teaches that sensors are operatively connected to pivotal joints on the robotic arm and at the motors driving the robotic surgical tool (paragraph [0223]). Manzo teaches that sensors will detect movement if the robotic arm is accidentally knocked or knocks into another robotic arm or an endoscope arm (paragraph [0224]). Manzo further teaches that torque or force sensors at the motors or the end effectors enable measurement and control of the force applied to patient tissue (paragraph [0260]). It would have been obvious for a person of ordinary skill in the art at the time of the effective filing date of the claimed invention to incorporate the torque or force sensors located at the motors or the end effectors of Manzo into the bone cutting tool which moves autonomously toward voxels of bone that have been targeted for removal, but which have not yet been in the bone cutting tool path of Kang in view of Weitzner. A person of ordinary skill would have been motivated to do so, with a reasonable expectation of success, for the purpose of accurately measuring forces and torques; and preventing injury to the patient and damage to the robotic surgery system caused by contact with another robotic arm or an endoscope arm.
Regarding claim 14, Kang in view of Weitzner does not disclose that the obstruction is another surgical instrument located at the target site. However, Manzo further discloses:
wherein the obstruction is another surgical instrument located at the target site (paragraph [0224]).
Manzo teaches that sensors will detect movement if the robotic arm is accidentally knocked or knocks into another robotic arm or an endoscope arm (paragraph [0224]). It would have been obvious for a person of ordinary skill in the art at the time of the effective filing date of the claimed invention to incorporate the system for detecting contact with another robotic arm or an endoscope arm of Manzo into the bone cutting tool which moves autonomously toward voxels of bone that have been targeted for removal, but which have not yet been in the bone cutting tool path of Kang in view of Weitzner. A person of ordinary skill would have been motivated to do so, with a reasonable expectation of success, for the purpose of preventing injury to the patient and damage to the robotic surgery system caused by contact between the surgical instrument and other medical equipment.
Allowable Subject Matter
Claims 3, 6-9, 17 and 19-20 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAMARA L WEBER whose telephone number is (303)297-4249. The examiner can normally be reached 8:30-5:00 MTN.
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TAMARA L. WEBER
Examiner
Art Unit 3667
/TAMARA L WEBER/ Examiner, Art Unit 3667
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