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 § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(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) 1-4, 6-7, 12-14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Prien et al (US Patent Pub. 20080132900A1).
Prien a method of targeting a variable angled opening formed in a periprosthetic bone plate. Specifically in regards to claim 1, Prien recites positioning the periprosthetic bone plate (110) adjacent a patient’s bone (Fig. 1 and Para. [0025],[0041]). Coupling an alignment guide (120) to the periprosthetic bone plate (110), the alignment guide (120) including a plurality of combo-slots (122) formed therein, each combo-slot (122) including an enlarged central portion and an elongated slot extending from the enlarged central portion (Fig. 3A); and inserting a plug (140) into the enlarged central portion of the combo-slot (122) formed in the alignment guide (120), the plug (140) preventing access to the enlarged central portion, the plug (140) defining opening encompassing the elongated slot and a portion of the plug (140), the opening having a defined trajectory to the variable angled opening formed in the periprosthetic bone plate (110) (Fig. 1-3a; and Para. [0025]-[0028]).
In regards to claim 2-3, Prien recites inserting a surgical instrument (160) within the opening defined by the plug (140) and the combo-slot (122) of the alignment guide (120), and inserting the surgical instrument (160) within the opening until a distal end of the surgical instrument (160) contacts and engages the variable angled opening formed in the periprosthetic bone plate (110) in use (Fig. 1, Para. [0025],[0027],[0031]-[0034]).
In regards to claim 4, Prien recites removing the plug (140) from the opening to enable additional freedom in positioning the surgical instrument relative to the variable angled opening formed in the periprosthetic bone plate (110) (Para. [0035]).
In regards to claim 6, Prien recites wherein positioning the plug (140) within the enlarged central portion of the combo-slot (122) transforms the combo-slot (122) into a circular opening aligned with one of the plurality of variable angled openings formed in the periprosthetic bone plate (110) (Fig. 4a/4b, Para. [0038]-[0041]).
In regards to claim 7, Prien recites wherein coupling an alignment guide (120) to the periprosthetic bone plate (110) comprises: coupling a distal end of a targeter handle (handle on end opposite 140c, Fig. 1) to the periprosthetic bone plate (110) and a proximal end of the targeter handle to the alignment guide (120) (Fig. 1).
In regards to claim 12-13, Prien recites wherein inserting the plug (140) within the enlarged central portion of one of the plurality of combo-slots formed in the alignment guide (120) comprises: inserting a circular projection formed on a distal end of the plug (140) within the enlarged central portion of the combo-slot (122) formed in the alignment guide (120); and wherein the circular projection includes a notch corresponding with a radius of the elongated slotted portion of the combo-slot, the notch partially defining the opening (Fig. 1 and 4a/4b).
In regards to claim 14, Prien recites wherein the periprosthetic bone plate (110) includes a central longitudinal axis, an outer periphery surface, a plurality of threaded locking screw openings (122) to receive a plurality of locking screws, respectively, and a plurality of variable angled openings to receive a plurality of variable angled screws, respectively, the plurality of variable angled openings being positioned along the outer periphery surface of the bone plate (110), the plurality of locking screw openings being positioned closer to the central longitudinal axis of the bone plate (110) (Fig. 1; and Para. [0025]-[0026],[0036]-[0039],[0041]).
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.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Prien in view of Muerner et al (US Patent Pub. 20120089144A1).
Prien recites a method of targeting a variable angled opening formed in a periprosthetic bone plate comprising positioning a plate, coupling an alignment arm with a plurality of combo-slots and a plug meant to be inserted into one of the combo-slots, and inserting a surgical instrument that can be inserted into the opening defined by the plug and combo-slot. However, the reference is silent as to surgical instrument having a particular distal end.
Muerner recites a targeting device. Specifically in regards to claim 5, Muerner recites wherein the distal end (330) of the surgical instrument (310) includes a distal tip arranged and configured to be received within the variable angled opening formed in the periprosthetic bone plate, the distal tip including a cylindrical section (section directly above 336) and a tapered section (section adjacent 311), the tapered section being positioned between the cylindrical section and an intermediate body portion (311) of the surgical instrument (Fig. 7; and Para. [0051]). It would have been obvious to one having an ordinary skill in the art at the time the invention was filed to modify the surgical instrument (160) of Prien to have a particular shaped distal end as taught in Muerner in order to have a means to lock the device into place and allow movement of the device over a screw head after placement (Para. [0026]).
Claim(s) 7-9 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Prien in view of Wack et al (US Patent Pub. 20050049594A1).
Prien recites a method of targeting a variable angled opening formed in a periprosthetic bone plate comprising positioning a plate, coupling an alignment arm with a plurality of combo-slots and a plug meant to be inserted into one of the combo-slots, and inserting a surgical instrument that can be inserted into the opening defined by the plug and combo-slot. However, the reference is silent as to the details of the handle of the alignment guide.
Wack recites a method of using a targeting system arranged and configured to target a variable angled opening in a periprosthetic bone plate to facilitate insertion of a bone fastener into the variable angled opening. Specifically, Wack recites an alignment guide (1434) having openings (1450/1452) and a plug (1514, Fig. 42) (Fig. 39 and 42). In regards to claim 7, Wack recites coupling an alignment guide (1434) to the bone plate (814) comprises coupling a distal end of a targeter handle (1446) to the periprosthetic bone plate (814), the targeter handle (1446) including a distal end arranged and configured to couple to the periprosthetic bone plate (814) and a proximal end to the alignment guide (1446) (Fig. 39, and Para. [0234]). In regards to claim 8, Wack recites wherein the distal end of the targeter handle (1446) includes a projection (projection of 1440) arranged and configured to be positioned within an opening (opening aligned with dotted line Fig. 39) formed in the periprosthetic bone plate (814) (Fig. 39; and [0258]-[0259],[0234]). In regards to claim 9, Wack recites wherein the distal end of the targeter handle (1446) includes an elongated plate-like end portion including a distal surface arranged and configured to contact the top surface of the periprosthetic bone plate (814), the projection (end of 1440 projecting therethrough) extending from the distal surface (Fig. 39; and Para. [0259]). In regards to claim 11, Wack recites wherein the proximal end of the targeter handle (1446) includes a bearing surface , the alignment guide (1446) being seared on the being surface (Fig. 39; and Para. [0258]-[0259]). It would have been obvious to one having an ordinary skill in the art at the time the invention was filed to modify the targeter handle of Prien to have a distal and proximal projection to connect to openings in the plate and guide as taught in Wack in order to have a means to connect the handle to a guide and allow for disassemble an cleaning.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Prien in view of Wack as applied to claim 9 above, and further in view of Lueth (US Patent Pub. 20180289402A1).
Prien and Wack recites a method of targeting a variable angled opening formed in a periprosthetic bone plate comprising positioning a plate, coupling an alignment arm with a plurality of combo-slots and a plug meant to be inserted into one of the combo-slots, and inserting a surgical instrument that can be inserted into the opening defined by the plug and combo-slot. However, the references are silent as to the distal plate end of the alignment guide having drill guide openings.
Lueth recites an alignment guide (210) having openings (262) and a plug (238) (Fig. 14). In regards to claim 10, Lueth recites wherein the elongated plate-like end portion of the handle (230) includes one or more openings (244) aligned with one or more locking screw openings formed in the periprosthetic bone plate (10), and one or more contours formed along a periphery of the elongated plate-like end portion to facilitate access to the variable angled openings formed in the periprosthetic bone plate (10) (Fig. 17-18; and Para. [0122]-[0126]). It would have been obvious to one having an ordinary skill in the art at the time the invention was filed to modify the combination by modifying the distal end of the targeter handle of Prien to have screw hole openings as taught in Lueth in order to have a means to allow passage of a screw that prevents rotation of the guide and provide additional rigidity to the guide (Para. [0124]).
Claim(s) 15-20 is/are rejected under 35 U.S.C. 103 as being anticipated by Prien et al (US Patent Pub. 20080132900A1) in view of Mebarak et al (US Patent Pub. 20140243901A1).
Prien a method of percutaneously locating a fastener opening formed in a periprosthetic bone plate. Specifically in regards to claim 15 and 18, Prien recites positioning the periprosthetic bone plate (110) adjacent to a patient’s bone (Fig. 1 and Para. [0025],[0041]). Coupling an alignment guide (120) to the periprosthetic bone plate (110), the alignment guide (120) including a plurality of combo-slots (122) formed therein (Fig. 3A); and inserting a plug (140) into one of the plurality of combo-slots (122) formed in the alignment guide (120), the plug (140) transforming the combo-slot into a hole with a predefined trajectory aligned with one of a plurality of variable angled openings formed in a periphery of the periprosthetic bone plate (110) (Fig. 1-3a; and Para. [0025]-[0028]). Inserting a surgical instrument (160) through the hole defined by the combo-slot and the plug (140) (Fig. 1, Para. [0025],[0027],[0031]-[0034]). However, the reference is silent as to the plate being positioned adjacent to a bone fracture in a bone that includes a previous surgically implanted implant.
Mebarak a method of percutaneously locating a fastener opening formed in a periprosthetic bone plate. Specifically in regards to claim 15, Mebarak recites positioning the periprosthetic bone plate (1010a) adjacent to a patient’s fractured bone, the patient’s bone including a previous surgically implanted orthopedic implant, coupling an alignment guide (1100) to the plate (1010a), and inserting a surgical instrument (1300) through a hole (1110) in the guide (Fig. 40-41 and Para. [0009],[0067],[0106]-[0113]). In regards to claim 18, Mebarak recites the alignment guide (1100) is coupled to the bone plate (1010a) via a targeter handle (1104) having a distal end (end with 1122) coupled to the bone plate (1010a) and a proximal end (1120) extending through an opening formed in the alignment guide (1100) (A locking guide 1130 is then inserted through the jig hole 1110a at the first end 1111 of the arm, through the throughbore 1128, and into an underlying threaded screw hole 1016 of the plate 1010a.) (Fig. 40-41; and Para. [0106]-[0108]). 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 Prien to position the plate adjacent a bone fracture in a bone that includes a previous surgically implanted implant as taught in Mebarak in order to treat most unstable periprosthetic implant fractures and restore functions (Para. [0006]).
In regards to claim 16, Prien recites wherein the surgical instrument (160) is inserted until a distal end thereof engages the variable angled opening formed in the periprosthetic bone plate (110) (Fig. 1, Para. [0025],[0027],[0031]-[0034]).
In regards to claim 17, Prien recites removing the plug (140) from the combo-slot in the alignment guide (120) to allow the surgical instrument relative to freely move (Para. [0035]).
In regards to claim 19, Prien in view of Mebarak recites a method of percutaneously locating a fastener opening formed in a periprosthetic bone plate. Mebarak further recites wherein the alignment guide (1100) is coupled to the periprosthetic bone plate (1010a) prior to positioning the periprosthetic bone plate (1010a) adjacent to the patients fractured bone (Mebarak recites the jig 1100 is coupled to the plate 1010a in a manner that facilitates minimally invasive insertion of the plate through an incision using the jig 1100 as a handle.) (Fig. 40-41; and Para. [0106],[0109]). 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 Prien to position the plate adjacent a bone fracture in a bone that includes a previous surgically implanted implant as taught in Mebarak in order to treat most unstable periprosthetic implant fractures and restore functions (Para. [0006]).
In regards to claim 20, Prien in view of Mebarak recites a method of percutaneously locating a fastener opening formed in a periprosthetic bone plate. Prien further recites wherein the alignment guide (140) is coupled to the periprosthetic bone plate (110) after positioning the periprosthetic bone plate (110) adjacent to the patients fractured bone (Para. [0041]).
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.
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/MARCELA I. SHIRSAT/ Primary Examiner, Art Unit 3775
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