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 .
Allowable Subject Matter
Claims 1-20 are allowable over the prior art.
The following is a statement of reasons for the indication of allowable subject matter:
Most pertinent prior art, including U.S. Patent No. 11,065,069 to Kang et al., U.S. Patent No. 11,058,494 to Bueno et al., and U.S. Patent No. 7,725,162 to Malackowski et al. disclose a surgical instrument having an actuator and a tool tip. The instrument includes a controller for providing power to the surgical instrument, the controller operable to monitor an actuator operation of the instrument during a medical procedure. The system includes a navigation system including a localizer having a localizer coordinate system, the localizer operable to register a patient tracker coupled to a tissue. The system includes registering the patient tracker in the localizer coordinate system, defining a location of the tissue relative to the localizer coordinate system, and to register the instrument tracker in the localizer coordinate system, defining a location of an instrument tool tip relative to the localizer coordinate system. The navigation system is operable to monitor a position of the instrument tool tip relative to the tissue to determine when the instrument tool tip is in contact with the tissue in the localizer coordinate system.
The prior art fails to teach or disclose, however, wherein the system is configured to determine an error condition when the monitored position of the instrument tool tip is in contact with the tissue in the common coordinate system and the monitored actuator operation equals a defined actuator operation for the surgical instrument corresponding to operation of the surgical instrument when the instrument tool tip is not in contact with the tissue, and trigger an action when an error condition is determined.
The prior art fails to teach or disclose, however, wherein the system is configured to determine a contact time between the instrument tool tip and the tissue when the monitored actuator operation deviates from a defined actuator operation for the surgical instrument corresponding to operation of the surgical instrument when the instrument tool tip is not in contact with the tissue, and determine a tool-to-bone offset as a distance between the instrument tool tip and a surface of the tissue in the common coordinate system.
The prior art fails to teach or disclose, however, wherein the system is configured to determine the tool tip does not depart the predefined proximity by more than a predefined magnitude over a predefined duration, determine an offset distance based on the tracked position of the surgical instrument and the patient anatomy in the common coordinate system, compare the offset distance to a predefined threshold, and trigger an action when the offset distance is greater than the predefined threshold.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,343,092. Although the claims at issue are not identical, they are not patentably distinct from each other because both the present application and granted patent disclose a surgical system. The surgical system comprises a navigation system operable to register a patient tracker in a coordinate system, defining a location of the tissue relative to the coordinate system, and to register the instrument tracker in the localizer coordinate system, monitor a position of the instrument tool tip relative to the tissue to determine when the instrument tool tip is in contact with the tissue in the localizer coordinate system, define an actuator operation for the instrument when the instrument tool tip is not in contact with the tissue, determine an error condition when the monitored position of the instrument tool tip is in contact with the tissue in the coordinate system and the monitored actuator operation equals the defined actuator operation for the instrument when the instrument tool tip is not in contact with the tissue, and trigger an action when an error condition is determined.
Both the present application and granted patent disclose a surgical system. The surgical system comprises a navigation system having a coordinate system, defining a location of the tissue relative to the coordinate system, and to register the instrument tracker in the localizer coordinate system, wherein the navigation system is configured to monitor a position of the instrument tool tip relative to the tissue in the coordinate system, define a first actuator operation of the surgical instrument operating while not in contact with the tissue, compare the monitored actuator operation to the defined actuator operation, determine a contact time between the instrument tool tip and the tissue when the monitored actuator operation deviates from the defined first actuator operation, and determine a tool-to-bone offset as a distance between the instrument tool tip and a surface of the tissue in the localizer coordinate system.
Both the present application and granted patent disclose a surgical navigation system. The system is configured to verify a tracking registration during a surgical operation, the surgical system comprising an instrument tracker coupled to a surgical instrument, the surgical instrument including a tool tip, a patient tracker to be coupled to a patient's anatomy, and a navigation system in communication with data representing the surgical instrument and data representing the patient's anatomy. The navigation system is configured to track the surgical instrument and the anatomy and storing first data representing the tracked surgical instrument and second data representing the tracked anatomy in a common coordinate system, determine the tool tip is within a predefined proximity to the tracked anatomy based on the first data representing the tracked surgical instrument and second data representing the tracked anatomy, determine the tool tip does not depart the predefined proximity by more than a predefined magnitude over a predefined duration, determine an offset distance based on the first data representing the tracked surgical instrument and the second data representing the tracked anatomy, compare the offset distance to a predefined threshold, and trigger an action when the offset distance is greater than the predefined threshold.
Conclusion
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/CHRISTOPHER J BECCIA/Primary Examiner, Art Unit 3775
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