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
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.
Claims 1-11 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Peterson et al. (US 2017/0333102).
Regarding claim 1, Peterson et al. disclose a method of attaching a fixation construct to a long bone comprising attaching a guide block (7003, figure 71) to a bone plate (7001, figure 71, ¶1161); placing the bone plate against a surface of the long bone (¶1161-1162); connecting two k-wires to the guide block (7007, 7009, figures 70-71, ¶1162); locating the medial-lateral direction (this is done visually by the user during placement of the bone plate against a surface of the long bone); confirming a positioning of the bone plate with respect to the bone (this is done visually by the user during placement of the bone plate against a surface of the long bone and thereafter to make sure placement is proper); and securing the bone plate to the bone (¶1161-1162). However, the embodiment of figures 70-71 fails to expressly teach or disclose confirming an overlapping alignment of the two k-wires in the medial-lateral direction. The k-wires (7007, 7009), of figures 70-71 do not expressly show overlapping alignment of the wires. Peterson et al. disclose within a second embodiment (figures 72-75) the use of k-wires (7211, 7215, figures 72-74) in an overlapping alignment (figures 72-75) as it is a known configuration for fastening a bone plate (7203) and guide block (7201) to the long bone (figures 72-75).
Accordingly, it would have been obvious to one of ordinary skill in the art at the time of filing to have constructed the method of Peterson et al. to have the k-wires in overlapping alignment in the medial-lateral direction (figures 72-75) as it is a known configuration for fastening a bone plate and guide block to the long bone.
Regarding claim 2, Peterson et al. disclose the step of attaching includes aligning holes in the guide block with holes in the bone plate (¶1161).
Regarding claim 3, Peterson et al disclose the step of attaching further includes securing the guide block to the bone plate by inserting a fixation screw (7023, figure 71) through one of the holes in the guide block and into one of the holes in the bone plate (¶1161).
Regarding claim 4, Peterson et al. disclose the step of attaching includes removably securing a handle (7009, figure 70) to the guide block (¶1162).
Regarding claim 5, Peterson et al. disclose the step of placing the bone plate includes manipulating the handle to place the bone plate on a lateral surface of the long bone (figures 70-71). Regarding claim 6, Peterson et al. disclose the step of placing the bone plate is initially influenced by contours of the surface of the long bone (¶1161-1162 as it resides on the long bone).
Regarding claim 7, Peterson et al. disclose the step of connecting the two k-wires includes inserting an end of each of the k-wires into the guide plate such that the k-wires extend anteriorly from the guide plate (figure 70-71).
Regarding claim 8, Peterson et al. disclose the step of connecting the two k-wires further includes the k-wires being non-parallel (figure 70-71).
Regarding claim 9, Peterson et al. disclose the step of connecting the two k-wires includes the k-wires extending along diverging axes (figure 70-71). Regarding claim 10, Peterson et al. disclose the step of connecting the two k-wires includes the k-wires being disposed within a plane that is substantially parallel to the transverse plane (figure 70-75).
Regarding claim 11, Peterson et al. disclose the step of connecting the two k-wires includes inserting the ends of each of the k-wires at a location on the guide block at a distal end of the bone plate placed against the surface of the long bone (figure 70-75).
Regarding claim 15, Peterson et al. disclose the step of securing the bone plate includes inserting a fastener (7005, figure 70) through a hole of the bone plate and into the long bone (¶1161-1162).
Claims 12 and 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Peterson et al. (US 2017/0333102) in view of Zander et al. (US 2024/0156499). Regarding claim 12, Peterson et al. disclose the claimed invention except for the teach of the step of locating includes aligning condyles of the long bone under fluoroscopy.
Zander et al. disclose the use of fluoroscopy in order to properly place and align the components of system within the bone (¶62). Accordingly, it would have been obvious to one of ordinary skill in the art at the time of filing to have the step of locating aligning condyles of the long bone under fluoroscopy as taught by Zander as it allows for proper placement and alignment of the components of the system.
Regarding claim 16, Peterson et al. disclose the claimed invention except for the step of inserting an intramedullary nail into the medullary canal of the long bone.
Zander discloses a system (100) including a guide block (200), bone plate (10) and k-wires (¶49-50) to stabilize a long bone (figure 11) including an intramedullary nail (70) placed into the medullary canal of the long bone (figures 1, 5, 9-19). Accordingly, it would have been obvious to one of ordinary skill in the art at the time of filing to have constructed the system to include an intramedullary nail placed into the medullary canal of the long bone.
Regarding claim 17, Peterson et al. in view of Zander et al. disclose the step of inserting the intramedullary nail includes aligning a targeting arm (figure 17 of Zander, see figure below) attached to a proximal end of the nail with a portion of the secured bone plate (figure 19).
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Regarding claim 18, Peterson et al. in view of Zander et al. disclose inserting a fastener (52, figure 5 of Zander) through both a hole (14) of the bone plate (10) and a hole (73) in the intramedullary nail (70, ¶50).
Regarding claim 19, Peterson et al. in view of Zander et al. disclose the step of inserting the intramedullary nail includes inserting the intramedullary nail such that a hole axis of the bone plate aligns with a hole axis of the intramedullary nail (axes of plate hole 14 and axis of hole 73 of IM nail, figures 5, 19 of Zander).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Peterson et al. (US 2017/0333102) in view of Zander et al. (US 2024/0156499) in further view of Thakkar (US 2007/0219636).
Regarding claim 14, Peterson et al. disclose the claimed invention except for
inserting a guide wire at an entry point of the distal end of the long bone and into the long bone parallel to a medullary canal thereof, wherein the step of confirming the positioning of the bone plate with respect to the bone includes aligning the bone plate with the guide wire to confirm the positioning of the bone plate along an anterior-posterior axis of the femur.
Thakkar discloses inserting a guide wire (63, figure 22) at an entry point of the distal end of the long bone and into the long bone parallel to a medullary canal thereof (¶90, ¶101), wherein the step of confirming the positioning of the bone plate with respect to the bone includes aligning the bone plate with the guide wire to confirm the positioning of the bone plate along an anterior-posterior axis of the femur (¶90, ¶101) as the guide wire allows for accurate guidance of the IM nail into the target location and allows for passage of reamer(s) to guide the reamer(s) through the IM canal (¶90, ¶101). Accordingly, it would have been obvious to one of ordinary skill in the art at the time of filing to have constructed the method of Peterson et al. in view Zander et al. to include inserting a guide wire at an entry point of the distal end of the long bone and into the long bone parallel to a medullary canal thereof, wherein the step of confirming the positioning of the bone plate with respect to the bone includes aligning the bone plate with the guide wire to confirm the positioning of the bone plate along an anterior-posterior axis of the femur.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW JAMES LAWSON whose telephone number is (571)270-7375. The examiner can normally be reached Mon - Fri 6:30-3:00.
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/MATTHEW J LAWSON/Primary Examiner, Art Unit 3619