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) 16-33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Whitman et al. (US 20110166587), cited previously, in view of Fegert (US 20050288576), cited in IDS.
Regarding claim 16, Whitman discloses a medical system for determining a position of an active surgical instrument 1000 in an work region 402 comprising a patient 400 (Fig. 14A-B), the system comprising an active surgical instrument 1000 comprising a detachably held instrument tip 1120, an instrument control unit 1375 configured to supply power to the active surgical instrument (section 0092, The displacement of the sensing tip 1350 causes the state of the switch 1375 to change from ON to OFF or vice versa depending on whether switch 1375 is configured as a normally-closed or normally-open switch. The change of state of the switch 1375 signals the control system of the electro-mechanical driver device 1 that the trocar device 1000 is in position against the surface 402 of the tissue), a navigation unit 1370 to determine the position of the active surgical instrument or an instrument tip relative to the patient by means of a first sensor 1350 connected to the navigation unit 1370 and configured to be arranged at a known location in the work region 402 (Fig. 13, 14A-B, sections 0085, 0092, The sensing tip is slidably disposed within a bore of the tapered distal end of the blade housing portion and arranged, e.g., substantially parallel to a longitudinal axis 1360 of the rotating cutter trocar device. The sensing tip is caused to be displaced in the direction of the arrow and toward spring element by the pressing of the trocar device against the surface of the tissue. The displacement of the sensing tip causes the state of the switch to change from ON to OFF or vice versa depending on whether switch is configured as a normally-closed or normally-open switch), the navigation unit 1370 further configured to connect to the instrument control unit 1375 of the active surgical instrument, wherein a signal is sent by the navigation unit to the instrument control unit when the instrument tip is at one or more predefined positions in the work region (Fig. 14B, section 0092, The sensing tip is caused to be displaced in the direction of the arrow and toward spring element by the pressing of the trocar device against the surface of the tissue. The displacement of the sensing tip causes the state of the switch to change from ON to OFF or vice versa depending on whether switch is configured as a normally-closed or normally-open switch. The change of state of the switch signals the control system of the electro-mechanical driver device that the trocar device is in position against the surface of the tissue).
However, Whitman does not disclose the navigation unit comprising a location detection unit and a position detection unit. Fegert discloses the navigation unit comprising a location detection unit and a position detection unit (section 0002, 0022-0024). This allow for precise measurement points of the system at an accurate time. Therefore, it would have been obvious to one of ordinary skill in the art, at the time of the invention, to modify the device of Whitman by adding the navigation unit comprising a location detection unit and a position detection unit as taught by Fegert in order to facilitate precise measurement points of the system at an accurate time.
Regarding claim 17, Whitman discloses the signal sent by the navigation unit to the instrument control unit ceases to supply power to the active surgical instrument when the instrument tip is a minimum distance from an object or patient anatomical location in the work region (Fig. 14B, section 0092, The displacement of the sensing tip causes the state of the switch to change from ON to OFF or vice versa depending on whether switch is configured as a normally-closed or normally-open switch. The change of state of the switch signals the control system of the electro-mechanical driver device that the trocar device is in position against the surface of the tissue).
Regarding claim 19, Whitman discloses power to the active surgical instrument is throttled down (turned off) if the position of the instrument tip is a minimum distance from an object or patient anatomical location in the work region (Section 0092, The displacement of the sensing tip causes the state of the switch to change from ON to OFF or vice versa depending on whether switch is configured as a normally-closed or normally-open switch. The change of state of the switch signals the control system of the electro-mechanical driver device that the trocar device is in position against the surface of the tissue).
Regarding claim 23, Whitman discloses the one or more predefined positions are specified as being a minimum distance from an object or patient anatomical location in the work region (Fig. 14A-B, section 0092, The sensing tip 1350 is caused to be displaced in the direction of the arrow 1395 and toward spring element 1370 by the pressing of the trocar device 1000 against the surface 402 of the tissue 400. The displacement of the sensing tip 1350 causes the state of the switch 1375 to change from ON to OFF or vice versa depending on whether switch 1375 is configured as a normally-closed or normally-open switch).
Regarding claim 24, Whitman discloses the work region is an interior of the patient (Section 0074, A surgical cannula is also provided for insertion into tissue).
Regarding claim 27, Whitman discloses a medical system for determining a position of an active surgical instrument 100 in an work region 402 comprising a patient 400, the system comprising an active surgical instrument comprising a detachably held instrument tip (Fig. 14A-B), an instrument control unit 1375 configured to supply power to the active surgical instrument (Fig. 14A-B, section 0092, The displacement of the sensing tip 1350 causes the state of the switch 1375 to change from ON to OFF or vice versa depending on whether switch 1375 is configured as a normally-closed or normally-open switch. The change of state of the switch 1375 signals the control system of the electro-mechanical driver device 1 that the trocar device 1000 is in position against the surface 402 of the tissue), a navigation unit 1370 to determine the position of the active surgical instrument or an instrument tip relative to the patient by means of a first sensor 1350 configured to be arranged at a known location in the work region and connected to the navigation unit 1370 (Fig. 13, 14B, sections 0085, 0092, The sensing tip is slidably disposed within a bore of the tapered distal end of the blade housing portion and arranged, e.g., substantially parallel to a longitudinal axis 1360 of the rotating cutter trocar device. The sensing tip is caused to be displaced in the direction of the arrow and toward spring element by the pressing of the trocar device against the surface of the tissue. The displacement of the sensing tip causes the state of the switch to change from ON to OFF or vice versa depending on whether switch is configured as a normally-closed or normally-open switch), the navigation unit 1370 further configured to connect to the instrument control unit 1375 of the active surgical instrument, wherein the navigation unit transmits a control signal to the instrument control unit to (a) throttle power of the active surgical instrument or (b) send an output signal to a user of the active surgical instrument if the navigation unit determines that the active surgical instrument or the instrument tip is below a first minimum distance from an object in the work region (Fig. 14B, section 0092, The sensing tip is caused to be displaced in the direction of the arrow and toward spring element by the pressing of the trocar device against the surface of the tissue. The displacement of the sensing tip causes the state of the switch to change from ON to OFF or vice versa depending on whether switch is configured as a normally-closed or normally-open switch. The change of state of the switch signals the control system of the electro-mechanical driver device that the trocar device is in position against the surface of the tissue).
However, Whitman does not disclose the navigation unit comprising a location detection unit and a position detection unit. Fegert discloses the navigation unit comprising a location detection unit and a position detection unit (section 0002, 0022-0024). This allow for precise measurement points of the system at an accurate time. Therefore, it would have been obvious to one of ordinary skill in the art, at the time of the invention, to modify the device of Whitman by adding the navigation unit comprising a location detection unit and a position detection unit as taught by Fegert in order to facilitate precise measurement points of the system at an accurate time.
Regarding claim 28, Whitman discloses the object 402 is a sensitive structure of the patient (section 0047, surface of tissue).
Regarding claim 29, Whitman discloses the user is a surgeon (section 0086).
Regarding claim 30, Whitman discloses the output signal is selected from the group consisting of a haptic indication, audible indication, and visible indication (section 0077, the controller stores in the memory device, an indication that the trocar device has been utilized. If an attempt is made to use the trocar device again, the controller reads the information in the memory device, determines that the trocar device has already been used, and displays an error message to the operator).
Regarding claim 33, Whitman discloses the active surgical instrument or instrument tip 1120 is connected to an instrument control unit 1375 by way of an instrument cable 1110, 1115, said instrument control unity supplying power to the active surgical instrument (Section 0092-0093, the change of state of the switch 1375 signals the control system of the electro-mechanical driver device 1 that the trocar device 1000 is in position against the surface 402 of the tissue 400. Until the control system determines that the trocar device 1000 is in position against the surface 402 of tissue 400, in accordance with the state of switch 1375, the control system prevents the operation of the first driving element 1110 and the second driving element).
Response to Arguments
Applicant’s arguments with respect to claim(s) 16-32 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
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JON ERIC C MORALES whose telephone number is (571)272-3107. The examiner can normally be reached Monday-Friday 830AM-530PM CST.
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/JON ERIC C MORALES/Primary Examiner, Art Unit 3796
/J.C.M/Primary Examiner, Art Unit 3796
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