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
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.
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) 1-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Crawford et al. (US Pub 2017/0258535) in view of Taylor (US Pub 2015/0088030) and in view of Kim (US Pub 2005/0215866).
With respect to claim 1, Crawford discloses a surgical robotic system, comprising: a motion tracking system to track the position and orientation of one or more objects within a coordinate system (paragraph 98); an imaging device (fig 12B) comprising an o-shaped gantry to obtain image data of a patient positioned therein (fig 12B); a robotic arm (fig 13A, 104) defining an end (Fig 13, 112) movable relative to a support structure (fig 13A, 106) arranged adjacent to the o-shaped gantry of the imaging device, with the robotic arm configured to maintain alignment of the end relative to a target position of a patient's body defined within the coordinate system (paragraph 98); and a retractor apparatus (fig 15B< 608 and paragraph 92, tool can be a retractor) attached to the robotic arm,
Crawford discloses the tool in the robot arm can be a retractor (paragraph 92 and fig 15B, 608) a connecting member (fig 13B, 112) that connects the frame to the end of the robotic arm for concurrent movement relative to the support structure and a marker device (fig 15B, 612) fixed to the frame (body of the tool) that enables the retractor apparatus to be tracked using the motion tracking system to track the position and orientation of the retractor apparatus within the coordinate system (paragraph 98) but does not specifically disclose the retractor apparatus comprising: a frame attached to the robotic arm, the frame defining a central open region; a plurality of retractor blades with at least one retractor blade configurable to provide intraoperative neurophysiological monitoring (IONM), with the at least one retractor blade comprising at least one electrode on at least one retractor blade and a conductive path extending within the at least one retractor blade for electrically coupling the electrode to a power source and a circuit for generating IONM stimulation signals; a plurality of coupling mechanisms for attaching the plurality of retractor blades within the central open region of the frame such that the plurality of retractor blades define a working channel interior of the plurality of retractor blades; a plurality of actuators extending between the frame and each of the coupling mechanisms and configured to move the retractor blades with respect to the frame to vary a dimension of the working channel.
Taylor discloses a retractor apparatus (see fig 3, 18 and 19 below) comprising: a frame (fig 3, 16 and 28) attached to the robotic arm, the frame defining a central open region (apace between the arms;; a plurality of retractor blades (fig 3, 12, 16 and 18) with at least one retractor blade configurable to provide intraoperative neurophysiological monitoring (IONM) (fig 19 and abstract), with the at least one retractor blade comprising at least one electrode (fig 18, 70) on at least one retractor blade and a conductive path (See figs 18and 19 below) extending within the at least one retractor blade (fig 18) for electrically coupling the electrode to a power source (See fig 19 below) and a circuit for generating IONM stimulation signals (see fig 19 below); a plurality of coupling mechanisms (fig 10 shows the blades are coupled to the frame) for attaching the plurality of retractor blades within the central open region of the frame such that the plurality of retractor blades define a working channel (fig 3 15) interior of the plurality of retractor blades; a plurality of actuators (fig 3, 36) extending between the frame and each of the coupling mechanisms and configured to move the retractor blades with respect to the frame to vary a dimension of the working channel to monitor the health and status of the motor neural pathways of the lower extremities during the portions of a surgical procedure in which a tissue retraction assembly is used to maintain an operative corridor (abstract). With respect to claim 2, Taylor discloses wherein the at least one retractor blade comprising the electrode comprises one or more channels (see fig 3 below channel for 66) extending through the at least one retractor blade and the electrode is disposed within at least one of the channels. With respect to claim 3, Taylor discloses wherein the at least one retractor blade comprising the electrode (fig 18, 70) comprises a conductive lead (fig 18, 74) located within at least one of the channels for providing the conductive path to transmit the IONM stimulation signals between the electrode, power source, and circuitry (fig 19). With respect to claim 4, Taylor discloses wherein the electrode is on the at least one retractor facing towards the working channel interior of the plurality of retractor blades (fig 18 shown on the inner surface). With respect to claim 5, Taylor discloses wherein at least one of the coupling mechanism and the at least one retractor blade includes a port (see fig 19 and 18, 78 below) for electrically connecting the electrode on the at least one retractor blade to a separate IONM probe device (fig 19 shows separate probe devices). With respect to claim 6, Taylor discloses wherein at least one of the power source and the circuit for generating IONM stimulation signals is located on the frame of the retractor apparatus (connected to the frame by the wires). With respect to claim 8, Taylor discloses wherein the electrode is configured to electrically stimulate surrounding tissue in response generation of the IONM stimulation signals to detect at least one of presence and proximity of a neural structure (paragraph 45). With respect to claim 9, Taylor discloses further comprising a nerve detection component (fig 19, 177 and paragraph 45) operatively coupled to the electrode and the circuit, the nerve detection component configured to process data associated with the electrode and circuit. With respect to claim 10, Taylor discloses wherein the nerve detection component is configured to control characteristics of the IONM stimulation signals (fig 19, 172 and paragraphs 57 and 58) . With respect to claim 11, Taylor discloses wherein the nerve detection component is configured to measure a tissue response to the stimulation by the electrode (paragraph 58) and determine proximity of a neural structure (paragraph 59 presence and distance and direction of nerves) relative to at least one of the plurality of retractor blades based on the tissue response. With respect to claim 12, Taylor discloses wherein varying the dimension of the working channel is at least partially based on the determination of proximity of a neural structure relative to at least one of the plurality of retractor blades (paragraph 60 provides instructions to surgeon if the retractor blades can be advanced are stopped). With respect to claim 13, Taylor discloses wherein at least one of electrical power and signals are transmitted from the nerve detection component to the retractor apparatus (electrodes are powered). With respect to claim 14 Taylor discloses wherein based on the determination of proximity of a neural structure relative to the plurality of retractor blades, the nerve detection component is configured to control movement of the plurality of retractor blades (paragraph 60 gives commands to advance or hold position). With respect to claim 15, Taylor discloses wherein movement of the retractor blades are stopped (paragraph 60, hold) in response to the determination of proximity of a neural structure via the nerve detection component. With respect to claim 16, Taylor discloses wherein at least one of the retractor blades is moved away from a detected nerve in response to the determination of proximity of a neural structure via the nerve detection component (paragraph 65 avoid problems). With respect to claim 17, Taylor discloses wherein the nerve detection component is configured to a user feedback device to provide at least one of audio and visual feedback based on the determination of proximity of a neural structure relative to at least one of the plurality of retractor blades (paragraph 65). With respect to claim 18, Taylor discloses wherein the at least one retractor blade comprises a plurality of electrodes on the at least one retractor blade, the plurality of electrodes located along the at least one retractor blade for simulating different portions of surrounding tissue (paragraph 45 discloses a plurality of electrodes can be provided to the blade). With respect to claim 19, Taylor discloses wherein the plurality of actuators are configured to move each retractor blade independently of movement of other retractor blades (fig 1 shows independent movement of the blades).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Crawford to include the retractor apparatus comprising: a frame attached to the robotic arm, the frame defining a central open region; a plurality of retractor blades with at least one retractor blade configurable to provide intraoperative neurophysiological monitoring (IONM), with the at least one retractor blade comprising at least one electrode on at least one retractor blade and a conductive path extending within the at least one retractor blade for electrically coupling the electrode to a power source and a circuit for generating IONM stimulation signals; a plurality of coupling mechanisms for attaching the plurality of retractor blades within the central open region of the frame such that the plurality of retractor blades define a working channel interior of the plurality of retractor blades; a plurality of actuators extending between the frame and each of the coupling mechanisms and configured to move the retractor blades with respect to the frame to vary a dimension of the working channel in view of Taylor in order to monitor the health and status of the motor neural pathways of the lower extremities during the portions of a surgical procedure in which a tissue retraction assembly is used to maintain an operative corridor. With respect to claim 7, Crawford in view of Taylor discloses at least one of electrical power and signals are transmitted from the robotic arm to the retractor apparatus (Crawford discloses a robotic arm while Taylor teaches electrical power and signals are provided to the retractor).
Crawford in view of Taylor discloses the actuators are driven manually (paragraph 11 of Taylor) but does not disclose the actuators being driven by one or more motors attached to the frame to drive the retractor blades (paragraph 11).
Kim discloses actuators (paragraph 43, gearing systems) being driven either manually (paragraph 43, manual positioning means) or with one or more motors (stepper motors) attached to the frame to drive the retractor blades (paragraph 43).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to substitute the manual actuators of Crawford in view of Taylor with the actuator being driven by one or more motors in view of Kim because manual actuators and the actuator being driven by one or more motors are mere functional equivalents, and because such a substitution of one for the other would have achieved the same predicable result of driving the retractor blades.
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Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Crawford et al. in view of Taylor and in view of Kim as applied to claim 1 above, and further in view of Gregerson et al. (US Pub 2016/0302871).
With respect to claim 20, Crawford in view of Taylor and in view of Kim discloses the claimed invention except for wherein the support structure includes a curved rail operatively attached to the o-shaped gantry of the imaging device and with the robotic arm defining a second end operatively attached to the curved rail, with a position of the second end of the robotic arm being adjustable along the curved rail.
Gregerson discloses wherein the support structure includes a curved rail (fig 13A, 1300) operatively attached to the o-shaped gantry of the imaging device (Fig 13A, 40) and with the robotic arm (fig 12A, 101) defining a second end (fig 13A, 1301) operatively attached to the curved rail, with a position of the second end of the robotic arm being adjustable along the curved rail (paragraph 73) to allow for additional clearance to tilt the gantry (paragraph 72).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Crawford in view of Taylor and in view of Kim to include wherein the support structure includes a curved rail operatively attached to the o-shaped gantry of the imaging device and with the robotic arm defining a second end operatively attached to the curved rail, with a position of the second end of the robotic arm being adjustable along the curved rail in view of Gregerson in order to allow for additional clearance to tilt the gantry.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/S.J.C/Examiner, Art Unit 3773 /EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773