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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 6-8 and 10-19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 6, the claim recites the limitation “wherein control system”. There is unclear antecedent basis for the limitation “control system”. It is unclear how this control system relates to the control system previously set forth. Clarification is required. For examination purposes, this limitation will be interpreted as reciting “wherein the control system”.
Regarding claim 16, the claim recites the limitation “the spherical virtual boundary” in line 2. No spherical virtual boundary has previously been set forth. Did the Applicant intend to have claim 16 depend on claim 14 or 15? Clarification is required.
Regarding claim 19, the claim recites the limitation “an end effector of the instrument”. There is unclear antecedent basis for this limitation in the claim. It is unclear how this end effector relates to the previously set forth an end effect of the instrument. Clarification is required. For examination purposes, this limitation will be interpreted as referring to the previously set forth end effector.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2 and 65-66 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Walen et al. (WO2021062373A2, hereafter Walen).
Regarding claims 1 and 65-66, Walen discloses a hand-held surgical system, a navigation system, and a method for navigating a surgical instrument comprising:
an instrument (surgical instrument 220, 320, 420) configured to be held in a hand of a user (Figure 1A, showing handheld instruments) (Walen, Para 49; “Accordingly, Figures 1A and IB illustrate an exemplary surgical system 10 that may comprise a surgical navigation system 100 for tracking one or more surgical instrument assemblies 200, 300, 400 including a surgical instrument 220, 320, 420 to assist the medical professional, such as a surgeon, in executing a medical procedure.”), the instrument including a drive motor (motor 245, 345, 445 ) (Walen, Para 120; “For example, the surgical navigation system 100 may be configured to decelerate the motor 245, 345, 445”);
a tracking device (instrument tracking device 230, 330, 430) coupled to the instrument (Walen, Para 182; “The method may also comprise tracking the position of the surgical instrument 220, 320, 420 using the position and orientation of the instrument tracking device 230, 330, 430 relative to the patient 20 and/or the surgical site 30. This may be accomplished using the surgical navigation system 100. The instrument tracking device 230, 330, 430 of the surgical instrument 220, 320, 420 may be registered to the surgical navigation system 100”) (Walen, Figure 1A; showing that they are coupled);
a tracking unit (tracking unit 110) configured to cooperate with the tracking device to generate tracking data indicative of a pose of the instrument in a known coordinate system (Walen, Para 182; “The surgical navigation system 100, using the tracking unit 110, may then track the position, orientation, and/or pose of the surgical instrument 220, 320, 420 during execution of the medical procedure.”);
an alert module (alert device 255, 355, 455) for indicating a position of the instrument relative to a region of interest in a surgical procedure (Walen, Para 77; “It is also contemplated that the first alert device 255 may include a combination of audible, tactile, and/or visually perceptible devices. […] alert may be based on the end-effector 240 reaching the target location.”) (Walen, Para 91; “the second alert device 355 may produce a tactile alert, such as vibrating the switch 350, to notify the surgeon that the end-effector 340 has reached the target location/zone, such as a preferred depth or position relative to a critical anatomical boundary.”) (Walen, Para 103; “The end-effector 440 may then contact the next zone closest to the critical anatomical structure, triggering the alert device 455 to produce a second alert. The first and second alerts configured to notify the surgeon of the occurrence of the end-effector 440 entering the respective zones assigned to the first and second alerts.”); and
a control system (navigation processor 140) in communication with the tracking unit, the alert module, and the instrument (Walen, Para 57; “The surgical navigation system 100 may further comprise a navigation processor 140.”) (Walen, Figure 1B; showing this), the control system configured to:
track the pose of the instrument in the known coordinate system based on the tracking data, determine a boundary (boundary 1, 2, 3, 4) in the known coordinate system, the boundary being associated with the region of interest, control the alert module based on the boundary and the tracked pose of the instrument in the known coordinate system (Walen, Para 118; “As described above, the surgical navigation system 100 may be configured to track the position and/or orientation of the surgical instrument 220, 320, 420 relative to the various virtual boundaries (Boundary 1, 2, 3, 4) and/or alert zones (Zones 1, 2, 3, 4) and communicate a signal or instruction to the instrument processor 215, 315, 415 to activate the alert device 255, 355, 455 to notify the surgeon when the end-effector 240, 340, 440 approaches and/or enters one of the various virtual boundaries (Boundary 1, 2, 3, 4) and/or alert zones (Zones 1, 2, 3, 4)”),
determine that an occlusion event has occurred for the tracking device, and disable the drive motor based on the occlusion event, the boundary, and the tracked pose of the instrument (Walen, Para 122; “It is further contemplated that the navigation system 100 may be configured to disable or stop the motor 245, 345, 445 to prevent operation of the end-effector 240, 340, 440 if the tracking device of the surgical instrument 220, 320, 420 is out of view of the navigation system 100 for a defined period of time in order to prevent operation of the surgical instrument 220, 320, 420 when its position is unknown within the patient space”).
Regarding claim 2, Walen discloses all of the limitations of claim 1 as discussed above.
Walen further discloses wherein the control system is further configured to: determine a duration of the occlusion event, and disable the drive motor based on the duration of the occlusion event, the boundary, and the tracked pose of the instrument (Walen, Para 122; “It is further contemplated that the navigation system 100 may be configured to disable or stop the motor 245, 345, 445 to prevent operation of the end-effector 240, 340, 440 if the tracking device of the surgical instrument 220, 320, 420 is out of view of the navigation system 100 for a defined period of time in order to prevent operation of the surgical instrument 220, 320, 420 when its position is unknown within the patient space”) (Walen, Para 178-179; “Para 178-179; "As described above, it is also contemplated that manipulation of the snooze button may temporarily deactivate the triggered alert [...] Below is an exemplary operation of said snooze function: [...] The end-effector has been adjacent and/or distal to and proximal to virtual boundary, or in and out of the alert zone for less than a defined period of time"”).
Allowable Subject Matter
Claims 3-5 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.
Claims 6-8 and 10-19 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
The prior art does not disclose nor reasonably suggest the limitations set forth in claim 3. Specifically, the prior art does not disclose a hand-held surgical system comprising: an instrument configured to be held in a hand of a user, the instrument including a drive motor; a tracking device coupled to the instrument; a tracking unit configured to cooperate with the tracking device to generate tracking data indicative of a pose of the instrument in a known coordinate system; an alert module for indicating a position of the instrument relative to a region of interest in a surgical procedure; and a control system in communication with the tracking unit, the alert module, and the instrument, the control system configured to: track the pose of the instrument in the known coordinate system based on the tracking data, determine a boundary in the known coordinate system, the boundary being associated with the region of interest, control the alert module based on the boundary and the tracked pose of the instrument in the known coordinate system, determine that an occlusion event has occurred for the tracking device, and disable the drive motor based on the occlusion event, the boundary, and the tracked pose of the instrument, wherein the control system is further configured to: determine a duration of the occlusion event, and disable the drive motor based on the duration of the occlusion event, the boundary, and the tracked pose of the instrument, and wherein the control system is further configured to: determine a duration threshold based on the boundary and the tracked pose of the instrument; and disable the drive motor based on the duration of the occlusion event and the duration threshold. Although the prior art does disclose disabling the drive motor based for a duration based on the tracked pose of the instrument and the duration of the occlusion event, it does not disclose determining a duration of the threshold based on the boundary. It only discloses determining that a pause should occur based on the proximity to a boundary, not the duration. For example, in Walen one condition for an alert is whether “the end-effector has been adjacent and/or distal to and proximal to virtual boundary, or in and out of the alert zone for less than a defined period of time “ but the actual defined period of time is not adjusted based on the boundary. Additionally, although the prior art discloses setting the duration threshold based on things such as user settings, the occlusion event, and snooze functions, it does not appear to change the set period of time based on the proximity to the boundary at least within the context of the rest of the claim limitations. Accordingly, claim 3 is indicated as allowable.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US-20160242858A1 - Discloses a method of tracking surgical instruments while they are hidden from view to prevent collisions
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/JOHN D LI/Primary Examiner, Art Unit 3798
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