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 Objections
Claim 1 is objected to because of the following informalities: the limitation recites “first side of a bone” in line 3 which is believed should recite “first side of the bone” (emphasis added). Appropriate correction is required.
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) 1, 3-5, and 15-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Medoff et al (US Patent Pub. 20150112343A1) in view of Wagenknecht (US Patent 4978350).
Medoff recites a method of inserting a bone fastener through a bone. Specifically in regards to claim 1, Medoff recites positioning a first bone plate (100, Fig. 24) having a first hole (hole for 118 shown in Fig. 14) on a first side of a bone (12, Fig. 15); drilling a channel (Fig. 25) through the bone (12) from the first side of the bone to a second side of the bone using a drilling guidewire (150), wherein the first end of the first portion (tapered end that allow wire 150 to drill into bone as shown in Fig. 25, see Fig. below) is positioned in the first hole (hole for 118) of the first bone plate (100) prior to drilling the channel through the bone so that the drilling guidewire (150) is fed through the first hole in the first bone plate (100); placing at least a part of the second portion (see Fig. below}of the drilling guidewire within the bone (12); sliding a bone fastener (144, Fig. 26) over the second portion of the drilling guidewire (150), wherein the bone fastener comprises a cannulation configured to receive the second portion of the drilling guidewire (150); and driving the bone fastener (144) through the first hole of the first bone plate (100) and the channel in the bone (100) (Fig. 24-27; and Para. [0122]-[0137]). However, the reference is silent as to the guidewire having two differing diameters.
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Figure 1: Medoff demonstrating portions of the guidewire.
Wagenknecht in regards to claim 1, discloses a drilling guidewire ( 2) wherein the drilling guidewire (2) comprises a first portion (6,16,17) having a drill unit (17) and a second portion (3), the first portion (6,16,17) comprising a first end (17) and a second end (tapered end of 6 connected to 3), the second portion (3) extending from the second end of the first portion (6,16,17), and wherein a diameter of the first portion (6,17,16) is greater than a diameter of the second portion (3) (Fig. 2,4; and Col. 4 lines 6-41). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the drilling guidewire (150) of Medoff to have differing diameters as taught in Wagenknecht so as to simultaneously drill and tap into a bone hole (abstract).
In regards to claim 3, Medoff recites wherein the bone fastener (144) comprises a bone screw (Fig. 26).
In regards to claim 4, Medoff recites positioning a second bone plate (120) with a second hole on the second side of the bone (12, Fig. 24-27).
In regards to claim 5, Medoff recites wherein at least a part of the first portion of the drilling guidewire (150) passes through the channel of the bone (12) and through the second hole of the second bone plate (Fig. 26).
In regards to claim 15, Medoff recites wherein the bone fastener (144) comprises a shaft and a head, wherein a diameter of the head is greater than a diameter of the shaft (Fig. 26).
In regards to claim 16, Medoff recites wherein the diameter of the head is greater than the diameter of the first hole in the first bone plate so the head of the bone fastener secures the first bone plate (100) to the bone (12) (Fig. 26).
In regards to claim 17, Medoff recites wherein the bone comprises a humerus (12) (Fig. 24-27, Para. [0004], 90122]).
In regards to claim 18-19, Medoff in view of Wagenknecht a method of inserting a bone fastener through a bone. Wagenknecht further recites wherein the first portion (6) of the drilling guidewire (2) is in a range of about 1.2 mm to about 6.5 mm (Wagenknecht recites central threaded portion has diameters ranging from 3 to 6 mm.) or, wherein the diameter of the second portion (6) of the drilling guidewire (2) is in a range of about 0.5 mm to about 4.5 mm (Wagenknecht recites that it has a diameter equal to or less than the inner diameter of the thread in the threaded portion 6 it may have a 2, 3, 4 and 5 mm. diameter, respectively.) (Col. 4 lines 54-63). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the drilling guidewire (150) of Medoff to have differing diameters as taught in Wagenknecht so as to simultaneously drill and tap into a bone hole (abstract).
In regards to claim 20, Medoff wherein the diameter of the first portion of the drilling guidewire (150) is greater than a diameter of the cannulation of the bone fastener (144) (IF the guidewire 150 of Medoff were to be modified to have the threaded portion 6 of pin 2 of Wagenknecht then it would be larger than the cannulation of the screw 144 of Medoff.) (Fig. 26 of Medoff and Fig. 2 of Wagenknecht).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Medoff in view of Wagenknecht as applied to claim 1, and further in view of Schoutens (US Patent Pub. 20130274750A1).
Medoff in view of Wagenknecht recite a method of inserting a bone fastener through a bone comprising first and second bone plates, a drilling guidewire having first and second portions that creates a channel from a hole in a first plate and through a bone, and then the pin is used to insert a screw therethrough. However, the references are silent as to the diameter of the wire being substantially equal to the diameter of the screw.
Schoutens recites in regards to claim 2, wherein a minor diameter of the bone fastener (16) is substantially equal to a diameter of the first portion (fluted portion of 12) of the drilling guidewire (Fig. 1; and Para. [0019]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the drilling guidewire (150) of Medoff to have a diameter that is equal to the fastener as taught in Schoutens so as to allow the screw to securely affix the load carrier to the anatomical structure (Para. [0019]).
Claim(s) 7-8 and 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Medoff in view of Wagenknecht as applied to claim 1, and further in view of Bernstein et al (US Patent Pub. 20130090695 A1).
Medoff in view of Wagenknecht recite a method of inserting a bone fastener through a bone comprising first and second bone plates, a drilling guidewire having first and second portions that creates a channel from a hole in a first plate and through a bone, and then the pin is used to insert a screw therethrough. In regards to claim 7, Medoff recites positioning a clamp (148) around the bone (12), wherein the clamp (148) comprises a first guide channel (channel close to 100), wherein positioning the clamp (148) around the bone (12) comprises positioning the first guide channel in line with the first hole in the first bone plate (100) in the first bone plate (100) disposed on the first side of the bone (12) (Fig. 29-30; and Para. [0136]). However, the references are silent as the clamp having two guide channels.
Bernstein recite a method of inserting a bone fastener through a bone. Specifically in regards to claim 7, Bernstein recites positioning a clamp around the bone, wherein the clamp (250) comprises a first and second guide channels (channels for passage of 314), wherein positioning the clamp (250) around the bone comprises: positioning the first guide channel in line with the first hole in the first bone plate disposed on the first side of the bone; and positioning the second guide channel in line with the second hole (144) in the second bone plate disposed on the second side of the bone (Fig. 15-17; and Para. [0084]-[0100]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the clamp (148) of Medoff to have two guide channels as taught in Bernstein so as to ensure that the two plates are properly aligned for the fastener to pass therethrough.
In regards to claim 8, Medoff recites wherein at least a part of the first portion of the drilling guidewire (150) passes through the first guide channel of the clamp (148, Fig. 30-31), the first hole in the first bone plate (100), the channel of the bone (12), the second hole in the second bone plate (120), and the second guide channel of the clamp (IF the clamp 148 were to be modified to have a second channel as disclosed in Bernstein then the wire would pass through the channel and the plate as taught therein.)(Fig. 30-31).
In regards to claim 13, Medoff recites removing the clamp (148); and driving the bone fastener (158) through the first hole in the first plate (100), the channel in the bone, and the second hole in the second bone plate (120) (Fig. 31-34).
In regards to claim 14, Medoff recites wherein at least a portion of the bone fastener (158) comprises an external thread and wherein at least one of the first hole of the first bone plate (100) and the second hole of the second bone plate (120) comprises an internal thread configured to mate with the external thread of the bone fastener (Fig. 34).
Allowable Subject Matter
Claims 6 and 9-12 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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