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 § 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) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hartdegen et al (US Patent Pub. 20170281157A1) in view of Stamp et al (US Patent Pub. 20210052289A1) and Brown et al (US Patent 6514258B1).
Hartdegen recites a method of implanting a surgical staple in a bone-fracture-repair procedure. Specifically in regards to claim 4, Hartdegen recites the method comprising: determining an implantation location for the staple (7200) relative to the bone fracture; selecting a staple leg configuration for the determined implantation location from a plurality of different, staple leg configurations (Hartdegen recites a surgical method for stabilizing first and second bone fragments may include any or all of the following steps in any order, and choosing an implant from a group of implants of various sizes.) (Para. [0253]). Hartdegen also recites positioning the surgical staple (7200) on an inserter (7300), the inserter having prongs (7520,7620) that are configured to be disposed underneath a bridge (7206) of the surgical staple (7200), the inserter (7300) further including a dial (7900) having an axis of rotation in line with a longitudinal axis of the inserter (7300) to move the prongs (7520,7620) to distract the staple legs 7204,7202) of the staple (Fig. 97-116; and Para. [0229],[0233],[0236],[0248],[0253]). Advancing a drill bit to form pilot holes corresponding to the staple (7200) to be implanted (Para. [0253]). However, the reference is silent as to the guide being pinned with k-wires in lateral wire holes and the drill having depth markers.
Stamp recites a method of implanting a surgical staple in a bone-fracture-repair procedure. Specifically in regards to claim 4, Stamp recites positioning a set of drill guide holes of a drill guide corresponding to the staple leg configuration in operative proximity to the implantation location across a fracture or osteotomy which is held in place by means of pinning the drill guide holes relative to the implantation location by fixing k-wires (openings 77 for k-wires) between the bone and the drill guide (50) (Fig. 1; and Para. [0013],[0016], and claim 1). In regards to claim 5, Stamp recites wherein the step of pinning the drill guide holes relative to the implantation location comprises advancing a set of the k-wires at respective locations spaced from the drill guide holes (84) through a corresponding set of k-wire holes (77) of the drill guide (50) (Fig. 1). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the method of Hartdegen to have a guide and that guide to have k-wire holes as taught in Stamp in order for the guide to be to position or apply compression to the bone or bone segments, either before or after the drill guide is used to drill pilot holes for the legs of the associated bone staple (Stamp: Para. [0013]).
However, the combination is still silent as to the drill having depth markers.
Brown recites a tool capable of being used in a method of implanting a surgical staple in a bone-fracture-repair procedure. Specifically in regards to claim 4-5, Brown recites detecting a mark (26a-d/30) on the drill bit (10) corresponding to the limit depth of the pilot hole and to the implant to be used; and ceasing to advance the drill bit (10) into the bone in response to the detection of the mark (30/26a-d) at a predetermined position corresponding to the limit depth (Fig. 4-8a; and Col. 1 lines 32-42 and 58-64, Col. 3 line 3 to Col. 4 line 48). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the drill (1200) of Coleman to have several depth markers that work with a depth stop as taught in Brown in order to detect the depth limit and ensure the proper depth is reached and have a single drill that can achieve various depths as needed (Brown: Col. 1 lines 32-42 and 58-64).
In regards to claim 9-10, Hartdegen in view of Stamp and Brown recite a method of implanting a surgical staple in a bone-fracture-repair procedure. Hartdegen discloses a bone fracture (Para. [0016]). Stamp further recites wherein the step of advancing the drill bit through the drill guide holes (84) comprises forming the pilot holes along a first lateral axis (axis through 84) on either side of the bone fracture, wherein the step of fixing the k-wires (wires through 77) comprises fixing the k-wires in spaced relation to each other along a second lateral axis (axis through 77) parallel to the first lateral axis, the distance between the two lateral axes defining an offset (Fig. 1). Stamp also recites a step aligning the staple to be implanted with the pilot holes by reference to the offset (The staple to be inserted is aligned to be inserted with openings 84 which are offset from wire openings 77.) (Fig. 1 and Para. [0013]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the modify the method of Hartdegen to have a guide and that guide to have k-wire holes as taught in Stamp in order for the guide to be to position or apply compression to the bone or bone segments, either before or after the drill guide is used to drill pilot holes for the legs of the associated bone staple (Stamp: Para. [0013]).
Claim(s) 6-8 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hartdegen in view of Brown and Stamp as applied to claim 4 above, and further in view of Gaston et al (US Patent Pub. 20200000464A1).
Hartdegen in view of Brown and Stamp recite a method of implanting a surgical staple in a bone-fracture-repair procedure comprising the steps determining an implant location, selecting a staple configuration, positioning the staple on an inserter, positioning a set of drill guide holes, pinning the guide holes, advancing a drill bit through the guide holes wherein the drill bit has a mark that corresponds to a depth limit and ceasing to advance the drill bit into the bone in response to the detection of the mark. However, the references are silent as to fixing k-wires between the bone and the drill guide by advancing the k-wires through first and second of the drill guide holes, and selecting a drill guide head that matches the staple leg configuration.
. Specifically, Gaston recites the method comprising: determining an implantation location for the staple (6) relative to the bone fracture (120) (Fig. 14); selecting a staple leg configuration (Fig. 14) for the determined implantation location from a plurality of different, staple leg configurations (Fig. 14); positioning a set of drill guide holes (40) of a drill guide (27) corresponding to the staple leg configuration in operative proximity to the implantation location (120) (Fig. 15); pinning the drill guide holes (41, Fig. 6) relative to the implantation location by fixing k-wires (30) between the bone and the drill guide (27); advancing a drill bit (31) through the drill guide holes (41) to form pilot holes corresponding to the staple (6) to be implanted (Fig. 17-18) (Fig. 5-23; and Para. [0046]-[0052],[0057]-[0072]). However, the reference is silent as to the guide being pinned with k-wires and the drill having depth markers. In regards to claim 6, Gaston recites wherein the pinning step comprises fixing a first one of the k-wires (30) between the bone (115/110) and the drill guide (27) by advancing the k-wire (30) through a first one of the drill guide holes (41) (Fig. 16; and Para. [0059]-0060]). In regards to claim 7, Gaston recites wherein the pinning step comprises fixing a second one of the k-wires (30 between the bone (115/110) and the drill guide (27) by advancing the second one of the k-wires (30) through a second one of the drill guide holes (41) (Fig. 16; and Para. [0059]-0060]). In regards to claim 8, Gaston recites wherein the pinning step comprises advancing at least one of the k-wires (30) through at least one pilot hole formed at the implantation location (Fig. 16; and Para. [0059]-0060]). In regards to claim 14, Gaston recites wherein the step of selecting the staple leg configuration comprises selecting a corresponding drill guide head (27, Fig. 5) from a plurality of drill guide heads of different drill guide hole configurations (Fig. 5; and Para. [0046]-[0048]).It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the combinations by modifying the method of Hartdegen to fix k-wires between the bone and the drill guide by advancing the k-wires through first and second of the drill guide holes, and selecting a drill guide head that matches the staple leg configuration as taught in Gaston in order to holding the first and second bones in their retained anatomical position thereby providing the surgeon with an ability to verify whether the retained anatomical position and thus the conforming anatomical position correspond with the predetermined anatomical position prior to an actual drilling of drilled holes (Para. [0060]) and to allow for permits the drilling of three or more holes (Para. [0048]).
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because the arguments do not apply to the new combination of references being used in the current rejection.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 MARCELA I SHIRSAT whose telephone number is (571)270-5269. The examiner can normally be reached M-F 9:00am-5:30pm MST.
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/MARCELA I. SHIRSAT/ Primary Examiner, Art Unit 3775
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