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 .
Election/Restrictions
Claims 12-26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II and III, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/05/2026.
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) 1-3 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Andrews et al. (US 2015/0265365).
Regarding claim 1, Andrews et al. discloses a stereotactic system (500) for attachment to a skull of a patient (502, [0087], FIG 5A), the stereotactic system comprising: a mounting device comprising: a mounting base (504, FIG 5B) configured to be attached to the skull of the patient (via screws 508 and 510, [0087-0088]), the mounting base having a first base end (Bottom side which contacts skull) with a flange (at least one of the projections that receive 508a-c is interpreted as a flange), a second base end opposite the first base end (Flat, circular top surface of 504), a base opening extending through the first and second base ends (See opening in FIGs 5A-5B), and a base axis aligned with the base opening (Vertical axis through the opening); a sheath (540, FIGs 5G-5F, [0107-0116]) having a first sheath end (Bottom half of 540 as viewed in FIG 5F) attached to the base opening at the first base end of the mounting base (When inserted as shown in FIG 5G, the required elements are attached because 540 is in direct mechanical contact with and constrained to 506 and therefore 504), a second sheath end opposite the first sheath end (Top half of 540 as viewed in FIG 5F), a sheath opening extending through the first and second sheath ends (Lumen of the sheath, [0115]), and a sheath axis aligned with the sheath opening (Longitudinal axis of at least one of the lumens/openings); a guide frame comprising: a frame body (See annotated FIG 5A below) having a first body end (Bottom surface of the ring shaped structure) attached to the first base end of the mounting base, a second body end (Top surface of the ring shaped structure) opposite the first body end, a body opening extending through the first and second body ends that is aligned with the base opening of the mounting base (FIG 5A shows an opening that 518 is seated into), and a body axis that is aligned with the body opening (FIG 5C best shown the alignment of the axis); a plurality of arms extending outwardly from the frame body (See annotated FIG 5A below); and a guide member (506) removably received within the body opening at the second body end ([0096] discloses 518 of 506 can be clamped into position using a locking mechanism, therefore it is understood to also be removable), the guide member having a first guide end (end having ball joint 518) configured to be insertable into the body opening (FIG 5F-5G) and to engage the first base end of the mounting base (Through mechanical constraint thereto), a second guide end opposite the first guide end (Top end in FIG 5F), and a guide opening extending through the first and second guide ends (Lumen of 506) that is aligned with the base opening of the mounting base (The lumen aligns with the base opening because it allows sheath 540 to pass into the base opening as shown in FIG 5G), wherein the first sheath end is received within the guide opening (FIG 5G) such that the sheath extends through the body opening to the mounting base (FIG 5G), wherein the guide member is configured to removably secure the first sheath end of the sheath to the mounting base (Because 506 can be removed from 504). Andrews further discloses the use of a plurality of fiducials ([0090, 0100, 0103]) positioned on 504, 506, and or/520, but is silent regarding the fiducials specifically being positioned on the plurality of arms.
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However, it would have been an obvious matter of design choice to place a fiducial on each of the plurality of arms, since the arms are a part of elements 504/520, and are positioned in a manner that they would provide positioning information regarding at least an angle of trajectory of the removable guide stem 506 or 520 or identify the x,y offset of the removable guide stem 506 or 520 relative to the low profile anchoring device 504 ([0100]).
Regarding claim 2, Andrews et al. discloses the invention substantially as claimed, as set forth above for claim 1. Andrews further discloses the guide frame is configured such that the plurality of fiducials are non-coplanar (FIGs 5A and 5C show that each of the arms angle slightly downward from the middle at 506 towards the ring 504. Therefore, the fiducials positioned on the arms are non-coplanar due to the angle) and non-collinear relative to each other (the positioning on the arms creates a triangular alignment, but not collinear).
Regarding claim 3, Andrews et al. discloses the invention substantially as claimed, as set forth above for claim 1. Andrews further discloses when the first guide end of the guide member is attached to the mounting base, the second guide end is disposed vertically above each fiducial of the plurality of fiducials (FIG 5C shows the second guide end is vertically above each of the arms and therefore is above the fiducials).
Regarding claim 7, Andrews et al. discloses the invention substantially as claimed, as set forth above for claim 1. Andrews further discloses the mounting device further includes: a fixation plate (one of 514) removably attachable to the mounting base ([0093] 514 is a screw or locking pin an therefore is removable from 504), the fixation plate being configured to constrain movement, relative to the mounting base, of an electrode wire that extends within the sheath opening and through the base opening (Examiner notes the “electrode wire that extends within the sheath opening and through the base opening” is not a positively recited element of the claim. Therefore, the fixation pate need only be capable of performing the intended function. Because 514 is a screw, it is interpreted as being able to constrain movement of a wire if the wire were wrapped around or penetrated by the screw, therefore fixing its movement relative to the mounting base).
Claim(s) 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Andrews et al. (US 2015/0265365) in view of Felenc (US 2020/0197113).
Regarding claims 9-11, Andrews discloses the invention substantially as claimed, as set forth above for claim 1. Andrews further discloses a computer (1100, FIG 11, [0158]) in communication with the plurality of fiducials ([0152]) configured to produce visualization of the skull of the patient based on intraoperative images (step 402, FIG 4A), determine target trajectory (402, [0071]), determine a present trajectory of the stylus relative to the mounting base based on signals received from the fiducials (412, [0075-0076]); and compare the present trajectory with the target trajectory (Performing the self-test function and 422- verify probe placement [0077-0078]), and if the present trajectory is not in alignment with the target trajectory: determine an adjusted trajectory that corresponds to adjustment of the present trajectory to guide the first stylus end to the target area; and provide navigational indications to a user that corresponds to the adjusted trajectory ([0070] describes the process of ensuring the probe matches the intended trajectory and adjusting the positioning until it is confirmed by the user to be correct).
Andrews is silent regarding a stylus having a first stylus end and a second stylus end opposite the first stylus end, an optical sensor arranged on the second stylus end; and a computer in communication with the plurality of fiducials of the guide frame and the optical sensor, the computer being configured to: produce a 3D-visualization of the skull of the patient based on intraoperative images; receive user inputs corresponding to a target area within the 3D-visualization; and determine a target trajectory of the stylus based on the target area that corresponds to the sheath axis and the second stylus end, wherein the intraoperative images are provided by a computerized tomography (CT) imaging device in communication with the computer.
However, Felenc discloses a stylus (202, FIG 2-3) having a first stylus end (216, [0033]) and a second stylus end opposite the first stylus end (proximal end opposite the probe tip 216), an optical sensor arranged on the second stylus end (markers 208a and 212, and LED 213 [0032-0033], FIG 2-3); and a computer (304, FIG 5) in communication with the plurality of fiducials of the guide frame (208c and b, FIG 4) and the optical sensor (208a), the computer being configured to: produce a 3D-visualization of the skull of the patient based on intraoperative images ([0043]); receive user inputs corresponding to a target area within the 3D-visualization ([0030 and 0043-0047]); and determine a target trajectory of the stylus based on the target area that corresponds to the sheath axis and the second stylus end ([0043-045]; the computer is used to guide the user to the target trajectory), wherein the intraoperative images are provided by a computerized tomography (CT) imaging device in communication with the computer ([0030]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the trajectory system of Andrews to further comprise a stylus having a first stylus end and a second stylus end opposite the first stylus end, an optical sensor arranged on the second stylus end; and a computer in communication with the plurality of fiducials of the guide frame and the optical sensor, the computer being configured to: produce a 3D-visualization of the skull of the patient based on intraoperative images; receive user inputs corresponding to a target area within the 3D-visualization; and determine a target trajectory of the stylus based on the target area that corresponds to the sheath axis and the second stylus end, wherein the intraoperative images are provided by a computerized tomography (CT) imaging device in communication with the computer, as taught by Felenc, for the purpose of utilizing a system commonly known int eh art for achieving the predictable result of presenting visualization of the trajectory to the user and confirming or adjusting the instrument trajectory prior to initiation of the surgical procedure.
Allowable Subject Matter
Claims 4-6 and 8 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BROOKE N LABRANCHE whose telephone number is (571)272-9775. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 5712727134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BROOKE LABRANCHE/Primary Examiner, Art Unit 3771
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