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.
Claims 1-17, 21, and 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Christian et al (US Pub 2016/0135903 -cited by applicant).
Re claim 1: Christian discloses a surgical navigation method comprising:
inserting an implant into a patient's body in a desired pose using a placement instrument comprising a two-dimensional optical tracking pattern, the implant comprising a through-hole (figure 5, 0017-0019, 0043, 0107; see the implant 14 with holes 15 fixed to a bone using a placement instrument 11 with optical markers 22 forming a pattern, wherein the marker is a marker sphere which has a 2D pattern); and
navigating a surgical instrument relative to the inserted implant, the surgical instrument having an imaging unit attached thereto, the navigating being performed using a displayed indication of a spatial relationship between the surgical instrument and the through-hole that is at least based on a localization of the optical tracking pattern in the image data acquired by the imaging unit, the image data being representative of at least a part of the optical tracking pattern, wherein the pattern does not encode information about the implant [0017-0019, 0037, 0040, 0111-0112; see surgical instrument 19 having an imager 16 attached thereto wherein the imaging displays a relationship between the instrument 19 and the hole 15 and also localizes (or finds) the QR-code pattern to subsequently navigate the instrument 19, wherein the localizing is a QR-code graphical pattern that is encoded or alternatively is spatial relationship between active or passive marker spheres].
Re claim 2: Navigating further comprises using a simultaneously displayed indication of a plurality of predefined spatial relationships between the surgical instrument and the through-hole [0111, 0112; see the display of plural predetermined relationships between the instrument 19 and holes 15 wherein the FOV comprises simultaneous indications as they are displayed together].
Re claim 3: Navigating further comprises changing a pose of the surgical instrument relative to the implant such that the pose of the surgical instrument matches one or more of the predefined spatial relationships [0112; see the positioning of the instrument 19 which is a change of its pose to view the holes for navigation].
Re claims 4-6, 11: The predefined spatial relationships is defined by a border with respect to the through-hole, the border separating a first region in space from a second region in space, wherein the border is defined such that, when the surgical instrument is in any one of the plurality of predefined spatial relationships, it is located in the first region and, when it is in another spatial relationship not corresponding to one of the plurality of predefined spatial relationships, it is located in the second region, wherein a geometry of the first region depends on at least one of the following parameters: a type of the implant; geometrical properties of the implant; a type of the through-hole; a type of the surgical instrument; anatomical properties of the patient's body, and wherein the first region is rotationally symmetric around a center axis of the through-hole (figure 5; see the holes 15 along with the border/edge of the particular type of implant 14, thereby defining a separate first and second region, wherein the instrument 19 is in the first region including a rotationally symmetric area of the hole when it overlaps the implant 14 and is in a second region when it does not overlap)). wherein the first region is rotationally symmetric around a center axis of the through-hole.
Re claims 7, 8: The simultaneously displayed indication of the plurality of predefined spatial relationships comprises a visualization of at least a part of the border and a displayed visualization representing a view along an axis of the surgical instrument (figures 4, 5; see that the FOV provides a visualization of the border/edge of the implant 14 via an axis of the instrument 19 on which the imager 16 is attached).
Re claim 9: Navigating comprises using a displayed visualization representing a view along a center axis of the through-hole, the visualization further visualizing the at least a part of the border (figure 4; see the visualization of the FOV of the imager that includes the border/edge of the implant 14 wherein guiding the instrument 19 inlcudes visualization of a view of the hole axis).
Re claim 10: The simultaneously displayed indication of the plurality of predefined spatial relationships comprises a different visualization of at least a part of the first region compared to the second region or a different visualization of at least a part of the second region compared to the first region [0111; as the instrument 19 is guided, different visualization relative to the first and second regions of the implant 14 and region outside of the implant are provided and displayed].
Re claim 12, 13: The displayed indication of the spatial relationship between the surgical instrument and the through-hole comprises a visualization of a pose of an axis of the surgical instrument relative to a center axis of the through-hole and of an offset of a tip of the surgical instrument from a center or center axis of the through-hole (figure 4; see the visualization provided by the FOV of the imager 16 which views the pose of the instrument 19 to which it is attached and of an amount of offset of the tip to the hole 15).
Re claim 14: The implant comprises a plurality of through-holes, the method further comprising selecting one of the plurality of through-holes as said through-hole (figure 4; see the plurality of holes 15).
Re claims 15, 16: The method comprising inserting a screw through the through-hole using the surgical instrument to screw into a bone of the patient's body to fix the implant onto the bone [0107, 0108; see the screws for fastening the implant to the anatomy (i.e. bone)].
Re claim 17: The method comprising pre-operatively defining the plurality of spatial relationships (figure 4; see the arrangement of the holes 15 on implant 14 which is determined preoperatively).
Re claim 21: The method comprising obtaining, before any image is acquired by the imaging unit, implant data, from a memory or a database, wherein the implant data is representative of a spatial relationship between the optical tracking pattern and the through-hole extending through the implant [0018, 0037; see that the relationship of the active/passive marker arrangement is predetermined and stored in a database to subsequently be compared to the image data].
Re claim 22: The imaging unit is a camera [0083; see the camera].
Response to Arguments
Applicant's arguments filed 12/15/25 have been fully considered but they are not persuasive. Applicant argues that Christian fails to disclose that a discloses an optical pattern that corresponds to marker spheres. In particular, Christian discloses that the implant attachment unit information is described by the graphical pattern defined by the two-dimensional appearance of the marker array in an image of the marker array [0019]. Therefore, the rejection is maintained.
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL T ROZANSKI whose telephone number is (571)272-1648. The examiner can normally be reached Mon - Fri 8:00-4:00.
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/MICHAEL T ROZANSKI/Primary Examiner, Art Unit 3797