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 § 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) 1-9, 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Quaid et al. (U.S. Publication No. 2006/0142657).
Quaid et al. discloses a robotic surgery system (30) for preparing a humerus to receive a shoulder implant (paragraph 89, the shoulder is listed as an applicable joint), the robotic surgery system comprising: a robotic manipulator (35); a first cutting tool and a second cutting tool configured to be interchangeably coupled to the robotic manipulator (Paragraph 118, “The tool 50 may be, for example, a surgical tool (such as a burr, drill, probe, saw, etc.), medical device, microscope, laser range finder, camera, light, endoscope, ultrasound probe, irrigation device, suction device, radiotherapy device, and/or any other component useful for surgery, surgical planning, and/or surgical navigation. The end effector 35 is preferably configured to removably engage the tool 50 so that the user can install the appropriate tool 50 for a particular procedure and interchange tools as necessary.”); and a controller (37) coupled to the robotic manipulator and being configured to: control the robotic manipulator and the first cutting tool to resect a head of the humerus along a resection plane to define a resection surface for supporting the shoulder implant; and control the robotic manipulator and the second cutting tool to form at least one bore below the resection surface to receive at least one attachment feature of the shoulder implant. Note: A claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987.)
Regarding claim 2, a localizer (49) configured to track movement of the first cutting tool and the humerus, and wherein the localizer is configured to register a virtual cutting boundary for constraining the first cutting tool to the resection plane (paragraph 133). It is noted that the device is configured and capable of use with the humerus as stated above.
Regarding claim 3, the robotic manipulator is operable in an autonomous mode in which the controller operates the robotic manipulator to control movement of the first cutting tool autonomously to resect the head of the humerus along the resection plane (Paragraph 8). Although the device of Quaid does not include autonomous mode, it is included by Quaid as what is known in the state of the art, and thus it is considered that Quaid anticipates autonomous mode since the Description of the related art can be used as evidence of anticipation.
Regarding claim 4, the robotic manipulator is operable in a haptic mode in which a user manually manipulates the first cutting tool relative to the virtual cutting boundary and the robotic manipulator generates a haptic feedback based on a position of the first cutting tool relative to the virtual cutting boundary (paragraph 108).
Regarding claim 5, comprising a localizer is configured to track movement of the second cutting tool and the humerus, and wherein the localizer is configured to register a virtual object for constraining the second cutting tool to form the at least one bore (paragraph 133) It is noted that since the localizer is configured to track movement of the first cutting tool it is also configured to track movement of the second cutting tool.
Regarding claim 6, the robotic manipulator is operable in an autonomous mode in which the controller operates the robotic manipulator to control movement of the second cutting tool autonomously to form at least one bore (see claim 3 above).
Regarding claim 7, the robotic manipulator is operable in a haptic mode in which a user manually manipulates the second cutting tool relative to the virtual object and the robotic manipulator generates a haptic feedback based on a position of the second cutting tool relative to the virtual object (paragraph 108). It is noted that what is stated for the first cutting tool is also true for the second cutting tool since such are only functional statements.
Regarding claim 8, the virtual object is configured to extend below an anatomical neck of the humerus and terminate above a diaphysis of the humerus (paragraph 115, “parameter relative to the anatomy”). The virtual object is only functionally claimed, thus it is considered that the can be configured or is capable of being placed anywhere relative to the anatomy.
Regarding claim 9, the first cutting tool is a saw blade and the second cutting tool is a rotary cutting tool (paragraph 118, the tool can be a burr, drill probe saw, etc.).
Regarding claim 18, Quaid et al discloses A robotic surgery system (30) for preparing a humerus to receive a shoulder implant (capable of, paragraph 89), the robotic surgery system comprising: a robotic manipulator (35), and a controller (37) coupled to the robotic manipulator and being configured to (paragraph 120): control the robotic manipulator with a saw blade to resect a head of the humerus along a resection plane to define a resection surface for supporting the shoulder implant; and control the robotic manipulator with a rotary cutting tool to form at least one bore below the resection surface to receive at least one attachment feature of the shoulder implant (paragraph 118 teaches discloses a saw and drill that are interchangeable). Note: A claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987.)
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.
Claim(s) 10, 11, 13, 14, 16, 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Winslow et al. (U.S. Publication No. 2006/0009852) in view of Quaid et al. (U.S. Publication No. 2006/0142657).
Winslow et al. discloses a method of preparing a humerus to receive a should implant (Figure 24-26A), the method comprising a system with a first cutting tool (paragraph 60, “resected using a saw”) and a second cutting tool (96). The first cutting tool resects the head of the humerus along a resection plane for defining a resection surface for supporting the shoulder implant (paragraph 60). The second cutting tool is for forming at least one bore below the resection surface for receiving at least one attachment feature of the shoulder implant (Paragraphs 61-63). Winslow fails to that the method is done with a robotic surgery system where the first and second cutting tools are interchangeably coupled to the robotic manipulator and a controller for controlling the robotic manipulator.
Quaid et al. teaches a robotic surgery system (30) for preparing a humerus to receive a shoulder implant (paragraph 89, the shoulder is listed as an applicable joint), the robotic surgery system comprising: a robotic manipulator (35); a first cutting tool and a second cutting tool configured to be interchangeably coupled to the robotic manipulator (Paragraph 118, “The tool 50 may be, for example, a surgical tool (such as a burr, drill, probe, saw, etc.), medical device, microscope, laser range finder, camera, light, endoscope, ultrasound probe, irrigation device, suction device, radiotherapy device, and/or any other component useful for surgery, surgical planning, and/or surgical navigation. The end effector 35 is preferably configured to removably engage the tool 50 so that the user can install the appropriate tool 50 for a particular procedure and interchange tools as necessary.”); and a controller (37) coupled to the robotic manipulator and being configured to: control the robotic manipulator (paragraph 120). The system allows for the surgery to spare healthy bone in orthopedic joint replacement applications, enable intraoperative adaptability and surgical planning, and produce operative results that are sufficiently predictable, repeatable, and/or accurate regardless of surgical skill level (Paragraph 10).
It would have been obvious to one skilled in the art to perform the method of Winslow et al. with the robotic system of Quaid et al. to allow the surgery to spare healthy bone and produce results that are repeatable and accurate.
The following claims are obvious as established by Winslow in view of Quaid et al. however only Quaid is being referenced for parts of the robotic system unless otherwise stated
Regarding claim 11, Quaid et al. teaches: tracking movement of the first cutting tool (using tracker 47, para 133) and the humerus with a localizer (anatomy 43); and registering, with the localizer, a virtual cutting boundary for constraining the first cutting tool to the resection plane (108). It is noted that the combination can be applied to the humerus since the shoulder is listed as an appropriate joint for the system.
Regarding claim 13, Quaid et al. teaches the method comprises controlling, with the controller, the robotic manipulator in a haptic mode in which a user manually manipulates the first cutting tool relative to the virtual cutting boundary and the robotic manipulator generates a haptic feedback based on a position of the first cutting tool relative to the virtual cutting boundary (paragraph 108).
Regarding claim 14, Quaid fails to specifically disclose tracking movement of the second cutting tool and the humerus with a localizer; and registering, with the localizer, a virtual object for constraining the second cutting tool to form the at least one bore. However, since Quaid teaches interchanging tools during a surgery (paragraph 118) it can be construed that all the tracking disclosed in paragraph 133 and the virtual object in paragraph 108 is applied to the second cutting tool.
Regarding claim 16, Quaid teaches controlling, with the controller, the robotic manipulator in a haptic mode in which a user manually manipulates the second cutting tool relative to the virtual object and the robotic manipulator generates a haptic feedback based on a position of the second cutting tool relative to the virtual object (paragraph 108).
Regarding claim 17, Winslow and Quaid fail to disclose with the controller, the virtual object to extend below an anatomical neck of the humerus and to terminate above a diaphysis of the humerus. Quaid however, does teach creating virtual boundaries and objects based on the patient’s anatomy to prevent the tool to contacting critical tissue. Furthermore, as seen in figure 27, 28 it can be seen that the neck of the humerus and the diaphysis are the critical tissue. Thus it would have been obvious to create the virtual object from the anatomical neck to the diaphysis of the humerus as such would protect the critical tissue in the method of Winslow in view of Quaid.
Claim(s) 10, 11, 12, 14, 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Winslow et al. (U.S. Publication No. 2006/0009852) in view of Quaid et al. (U.S. Publication No. 2004/0106916) and further in view of Quaid et al. (U.S. Publication No. 2006/0142657).
Winslow et al. discloses a method of preparing a humerus to receive a should implant (Figure 24-26A), the method comprising a system with a first cutting tool (paragraph 60, “resected using a saw”) and a second cutting tool (96). The first cutting tool resects the head of the humerus along a resection plane for defining a resection surface for supporting the shoulder implant (paragraph 60). The second cutting tool is for forming at least one bore below the resection surface for receiving at least one attachment feature of the shoulder implant (Paragraphs 61-63). Winslow fails disclose that the method is done with a robotic surgery system.
Quaid et al. ‘916 teaches a robotic surgery system (Figure 1) comprising: a robotic manipulator (113); and a controller (10) coupled to the robotic manipulator and being configured to: control the robotic manipulator (paragraph 36). The system allows for the surgery to avoid features such as blood vessels, tendons, nerves and critical areas (paragraph 49).
It would have been obvious to one skilled in the art to perform the method of Winslow et al. with the robotic system of Quaid et al. ‘916 to allow the surgery to spare critical areas.
Regarding claim 11, Quaid et al. ‘916 teaches: tracking movement of the first cutting tool and the humerus with a localizer; and registering, with the localizer, a virtual cutting boundary for constraining the first cutting tool to the resection plane (paragraph 40). It is noted the combination makes obvious to track the humerus.
Regarding claim 12, Quaid ‘916 teaches controlling, with the controller, the robotic manipulator in an autonomous mode for controlling movement of the first cutting tool autonomously for resecting the head of the humerus along the resection plane (paragraph 120).
Regarding claim 14, Quaid ‘916 fails to specifically disclose tracking movement of the second cutting tool and the humerus with a localizer; and registering, with the localizer, a virtual object for constraining the second cutting tool to form the at least one bore. However, the combination makes obvious to track the second tool.
Regarding claim 15, controlling, with the controller, the robotic manipulator in an autonomous mode for controlling movement of the second cutting tool autonomously for forming at least one bore (paragraph 120, the combination makes obvious to track the second tool).
Winslow and Quaid ‘916 fails to disclose that the first and second cutting tools are interchangeable connected to the robotic manipulator. Quaid ‘657 teaches a robotic manipulator (35); a first cutting tool and a second cutting tool configured to be interchangeably coupled to the robotic manipulator (Paragraph 118, “The tool 50 may be, for example, a surgical tool (such as a burr, drill, probe, saw, etc.), medical device, microscope, laser range finder, camera, light, endoscope, ultrasound probe, irrigation device, suction device, radiotherapy device, and/or any other component useful for surgery, surgical planning, and/or surgical navigation. The end effector 35 is preferably configured to removably engage the tool 50 so that the user can install the appropriate tool 50 for a particular procedure and interchange tools as necessary.”) It would have been obvious to construct the device of Winslow et al. and Quaid ‘916 and further in view of Quaid ‘657 so that the user could interchange tools as necessary.
Conclusion
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/ANDREW YANG/Primary Examiner, Art Unit 3775