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
Applicant’s election of (Group II Claims 4-14, and Species a,aa,aaa Figs. 1-6b and 24-26) in the reply filed on 12/22/25 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 1-3 and 15-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions and species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/22/25.
In addition. Claims 11-13 are also withdrawn for being geared towards the inserter shown in the Species ee shown in Fig. 30 which was not selected.
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 4-10 and 14 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.
Claim 4 is rejected as indefinite for the recitation of “detecting a mark on the drill bit corresponding to the limit depth of the pilot hole and to the staple to be used” in lines 12-13. It is unclear from the claim what is meant to be doing the detecting of the mark on the drill bit. Therefore in the interest in compact prosecution the detecting will be done by the user.
Claims 5-10 and 14 are rejected as indefinite for depending upon an indefinite claim.
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) 4-5 and 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Coleman et al (US Patent Pub. 20170202552A1) in view of Stamp et al (US Patent Pub. 20210052289A1) and Brown et al (US Patent 6514258B1).
Coleman recites a method of implanting a surgical staple in a bone-fracture-repair procedure. Specifically in regards to claim 4-5, Coleman recites the method comprising: determining an implantation location for the staple (1100) relative to the bone fracture (Coleman recites after exposure of the operative site, the osteotomy or fracture may be reduced and held in place.) (Para. [0033]); selecting a staple leg configuration for the determined implantation location from a plurality of different, staple leg configurations (Coleman recites that the staples included in the kit may include one or more implants 1100 similar to the embodiments described in the reference.) (Fig. 9 and Para. [0033]); positioning a set of drill guide holes of a drill guide (1300) corresponding to the staple leg configuration in operative proximity to the implantation location (The drill guide or reamer guide may be placed across the fusion site with both guide tubes against the bone.) (Fig. 9 and Para. [0033]); and advancing a drill bit (1200) through the drill guide holes (holes in 1300) to form pilot holes corresponding to the staple (1100) to be implanted (Fig. 9-10b; and Para. [0033]-[0034]). 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 the utilization of a drill guide 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 guide (1300) of Coleman 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, Coleman in view of Stamp and Brown recite a method of implanting a surgical staple in a bone-fracture-repair procedure. Coleman discloses a bone fracture (see Fig. 10a-10b). 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 guide (1300) of Coleman 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) 4, 6-8, and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gaston et al (US Patent Pub. 20200000464A1) and Brown et al (US Patent 6514258B1).
Gaston recites a method of implanting a surgical staple in a bone-fracture-repair procedure. Specifically in regards to claim 4, 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. However, the reference is 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, 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 (31) of Gaston 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 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]).
Conclusion
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong can be reached at 571-272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MARCELA I. SHIRSAT/ Primary Examiner, Art Unit 3775