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 .
According to the Amendment filed on 11/9/25, Claims 1, 11 are amended, and claims 7-10, 17-20 are canceled, claims 21-28 are added.
Claim Rejections - 35 USC § 102
(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.
Claim(s) 1-2, 5-6, 11-13, 21, 26 is/are rejected under 35 U.S.C. 102a1 as being anticipated by DUGGAL et al. (US 20230301646 A1).
DUGGAL discloses a bone anchor 600, fig. 4 comprising: a shaft comprising a distal end 409; a distal toggle element 500 rotatably coupled to the distal end such that the distal toggle element is rotatable between: a stowed orientation fig. 4b in which the distal toggle element is insertable into a bone through an aperture formed in a cortex of the bone; and a deployed orientation fig. 16 in which the distal toggle element is positioned to abut an interior surface of the cortex around the aperture; and a flange 402 comprising a shoulder that is moveable distally toward the distal toggle element to abut an exterior surface of the cortexi fig. 34 wherein the distal toggle element 500 is configured to rotate about a rotation pin 405, fig. 4c comprising an axis that is perpendicular to a longitudinal axis of the shaft, wherein the flange 402 is configured to threadably receive the shaft fig. 4b, wherein the distal toggle element comprises a disengagement feature 2001, fig. 5 configured to be actuated to rotate the distal toggle element from the deployed orientation to the stowed orientation, wherein the flange 700 further comprises a drive feature 404 configured to receive torque from a drive instrument to move the shoulder toward the distal toggle element.
a bone anchor configured to receive an implant device (a construct portion as for claims 21, 26) 700 to secure the implant device to a bone figs 55-56, a first actuator 2002, fig. 21 configured to rotate the distal toggle element from the stowed orientation to the deployed orientation; and a second actuator 2202, 2201, fig 22a configured to rotate the distal toggle element from the deployed orientation to the stowed orientation, wherein the second actuator fig. 22a comprises a suture 2202, 2201 configured to pass through the disengagement aperture such that tension on the suture urges the distal toggle element to rotate from the deployed orientation to the stowed orientation.
Claim Rejections - 35 USC § 103
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.
4. Claim(s) 3, 22-25, 27-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over DUGGAL in view of Errico et al. (US 11918262 B2).
DUGGAL fails to teach a construct portion of a poly-axial tulip configured to be polyaxially adjustably coupled to a proximal end of the shaft and configured to receive a rod configured to be coupled to a second bone anchor, wherein the poly-axial tulip is further configured to receive a fastener configured to secure the rod within the poly-axial tulip.
Errico teaches a construct portion of a poly-axial tulip 20, fig. 6 configured to be polyaxially adjustably coupled to a proximal end of the shaft and configured to receive a rod (col. 12, lines 10-14) configured to be coupled to a second bone anchor (col. 1, lines 29-34), wherein the poly-axial tulip is further configured to receive a fastener configured to secure the rod within the poly-axial tulip (col. 12, lines 10-14).
It would have been obvious to a person of ordinary skill in the art at the time of the invention was made to use a poly-axial tulip of Errico with the shaft of DUGGAL in order to facilitating attachment of other surgical devices thereto such as a rod and other bone screw to effectively immobilize the spinal column.
4. Claim(s) 4, 14-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over DUGGAL in view of Ciccone et al. (US 20050222575 A1).
DUGGAL fails to teach the shaft comprises a non-circular cannulation, wherein the first actuator is configured to be slidably received within the non-circular cannulation, wherein the first actuator comprises a counter-torque feature of an inserter.
Ciccone teaches shaft comprises a non-circular cannulation 162, (para. 62), wherein the actuator 343 is configured to be slidably received within the non-circular cannulation 162, wherein the actuator comprises a counter-torque feature (external hex 344) of an inserter.
It would have been obvious to a person of ordinary skill in the art at the time of the invention was made to modify the cannulation and the first actuator of DUGGAL with a hex shape (counter-torque feature as claimed) so the cannulation of screw may wedge against the hex portion causing an interference between the surfaces that may provisionally axially lock them together.
Allowable Subject Matter
The objection to claim 3 is withdrawn.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and 11 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.
Applicant’s arguments, with respect to the rejection(s) of claim(s) 1-6 and 11-16 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of DUGGAL.
Conclusion
Applicant's submission of an information disclosure statement under 37 CFR 1.97(c) with the timing fee set forth in 37 CFR 1.17(p) on 11/9/25 prompted the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 609.04(b). 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 SAMEH RAAFAT BOLES whose telephone number is (571)270-5537. The examiner can normally be reached 9-5 pm.
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/SAMEH R BOLES/Primary Examiner, Art Unit 3775