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) 1-6, 8-9, 12, 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hirata et al (US Patent Pub. 20170231673A1) in view of Federspiel et al (US Patent Pub. 20120078312A1).
Hirata recites a distal radius bone plate. Specifically, in regards to claim 1, Hirata recites a body (body of 4) extending along a central longitudinal axis (see Fig. 1 below) from a proximal end (end with single 6) configured to sit on a shaft of a radius to a distal end (end with openings 18) configured to sit on a distal radius (Fig. 1a, and Para. [0021]-[0022],[0152]-[0156],[0177]); a top surface and an opposite, bottom surface (surface with 14, Fig. 2a-d) configured to contact the radius (3); and an elongated proximal shaft (having slot 20) and an enlarged distal head (head with multiple rows of 6) extending therefrom (Fig. 1a-2d), wherein the enlarged distal head defines a tendon groove (see Fig. 1 below) in the distal end configured to accommodate a flexor pollicus longus tendon, the tendon groove includes a concave recess at a distal edge of the plate forming two rounded lobes on either side of the groove, the lobes include an ulnar-side lobe and a radial-side lobe (See Fig. 1 below). However, the reference is silent as to a graft window adjacent the locking holes in the distal part of the plate.
Federspiel recites a distal radius bone plate. Specifically in regards to claim 1, Federspiel recites a body (body of 52) extending along a central longitudinal axis (axis through center of 52) from a proximal end (end with 118) configured to sit on a shaft of a radius to a distal end (end with openings 104/106/108) configured to sit on a distal radius; and wherein the distal end (end with openings 104/106/108) includes locking holes (104/106/108) and a graft window (128) disposed directly below the locking holes (Fig. 4; and Para. [0044]-[0045],[0048]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the plate of Hirata to add locking holes and a graft window as taught in Federspiel in order to have a means to access the underlying bone to facilitate its manipulation (Para. [0048]).
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Figure 1: Hirata demonstrating portions of the plate.
In regards to claim 2, Hirata recites wherein the two rounded lobes are not symmetrical (Fig. 1a and 2a).
In regards to claim 3, Hirata recites wherein the ulnar-side lobe is longer than the radial side lobe (As shown above in Fig. 1, the lobes when measured in a similar manner to applicant’s Fig. 4 appear to have differing lengths.)(Fig. 2a and see Fig. 1 above).
In regards to claim 4, Hirata recites wherein the tendon groove (see Fig. 1 above) is located off-center of the central longitudinal axis of the plate.
In regards to claim 5, Hirata recites wherein the radial-side lobe is thicker than the ulnar-side lobe (Fig. 2a).
In regards to claim 6, Hirata recites wherein the ulnar-side lobe includes a curved ulnar surface on the bottom surface of the plate to promote best fit of the distal head with the distal radius (Fig. 3a).
In regards to claim 8, Hirata recites wherein the ulnar-side lobe includes a variable chamfered surface along its edge to minimize tendon disruption (As can be seen in Fig. 2, the entire distal edge has a chamfered edge.) (Fig. 2a-2d).
In regards to claim 9, Hirata recites a stabilization system for stabilizing a distal radius, the system. Specifically, Hirata recites a plate (4) having a top surface and an opposite, bottom surface (surface with 14, Fig. 2a-d) configured to contact a radius (3), the plate (4) has an elongated proximal shaft (shaft with slot 20) and an enlarged distal head (head having lobes, see Fig. 1 above) extending therefrom, the distal head defines a tendon groove (see Fig. 1 above) configured to receive a flexor pollicus longus tendon, the tendon groove includes a concave recess at a distal edge of the plate (4) forming two rounded lobes on either side of the groove, the lobes include an ulnar-side and a radial-side lobes (see Fig. 1 above) each including fastener openings (6) (As shown above in Fig. 1, the lobes when measured in a similar manner to applicant’s Fig. 4 appear to have differing lengths.) (see Fig. 2a and Fig. 1 above); and a plurality of fasteners (5, Fig. 1a) receivable through the fastener openings (6) and configured to lock the plate (3) to the distal radius (3) (Fig. 1a-2d; and Para. [0021]-[0022],[0152]-[0156],[0177]).
Federspiel recites a distal radius bone plate. Specifically in regards to claim 9, Federspiel recites a body (body of 52) extending along a central longitudinal axis (axis through center of 52) from a proximal end (end with 118) configured to sit on a shaft of a radius to a distal end (end with openings 104/106/108) configured to sit on a distal radius; and wherein the distal end (end with openings 104/106/108) includes locking holes (104/106/108) and a graft window (128) disposed directly below the locking holes (Fig. 4; and Para. [0044]-[0045],[0048]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the plate of Hirata to add locking holes and a graft window as taught in Federspiel in order to have a means to access the underlying bone to facilitate its manipulation (Para. [0048]).
In regards to claim 12, Hirata recites wherein the lobes define a distal-most row of fastener openings (row of 6 closest to edge of plate), and when the fasteners are received therein, screw trajectories of the distal-most row of fastener openings are configured to be aligned so that nominal trajectories of the fasteners follow articular surfaces of a radiocarpal joint and a distal radio-ulnar joint (As shown in Fig. 1 the screws 5 inserted into the distal most row of screws closest to the edge would follow the surface shape of the bone.) (Fig. 1a).
In regards to claim 15, Hirata recites wherein the proximal shaft (shaft with 20) defines a positioning slot (20) configured to receive a non-locking fastener such that the plate is adjustable in proximal-distal and/or medial-lateral directions during provisional placement of the plate (4) (Fig. 11 and Para. [0178]).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hirata in view of Federspiel as applied to claim 9 above, and further in view of Chan et al (US Patent Pub. 20080140130A1).
Hirata in view of Federspiel recites a system comprising a plate with an elongated proximal shaft and an enlarged distal head comprising ulnar and radial lobes. In regards to claim 10, Hirata recites fastener openings (6) (Fig. 1a-1b). However, the reference is silent as to the fastener openings being polyaxial opening with a cone of angulation of up to 40 degrees.
Chan recites a stabilization system for stabilizing a distal radius, the system. Specifically, in regards to claim 10, Chan recites a plate (1300) having a shaft and an enlarged head (end with openings 1340), wherein the head has a plurality of fastener openings (1340) (Fig. 13, Para. [0072]). The fastener openings (1340) include polyaxial openings having a cone of angulation (1362) up to 40 degrees (Chan recites wherein the range of angles forms a cone having an angle 1362 of about 30 degrees.) (Fig. 13 and Para. [0072]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the openings (6) in the head of the plate (4) of Hirata to be polyaxial openings with a cone of angulation of up to 40 degrees as taught in Chan so that the variable-angle locking screws do not require a bushing, a compression cap, an expandable ring, or an expandable head to lock the angular position of the screw relative to the bone plate (Para. [0017]).
Claim(s) 11-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hirata in view of Federspiel as applied to claim 9 above, and further in view of Davison et al (US Patent Pub. 20180049787A1).
Hirata in view of Federspiel recites a system comprising a plate with an elongated proximal shaft and an enlarged distal head comprising ulnar and radial lobes. In regards to claim 10, Hirata recites fastener openings (6) (Fig. 1a-1b). However, the reference is silent as to the screw trajectories such as a screw trajectory targeted at the radial styloid, or screw trajectories being nominal and following surfaces of the joint.
Davison recites a stabilization system for stabilizing a distal radius, the system. Specifically, Davison recites a plate (110) having a shaft (140) and an enlarged head (142), wherein the head (142) has a plurality of fastener openings (120A) to accommodate fasteners (130A) (Fig. 1D and 1E; and Para. [0053],[0060]-[0062]). In regards to claim 11, Davison recites wherein the radial-side lobe defines a first opening (120B) with a trajectory configured to target at a radial styloid (Fig. 1d/1e, and Para. [0062]). In regards to claim 12, Davison recites wherein the lobes define a distal-most row of fastener openings (row of 120A and 120B), and when the fasteners (130A) are received therein, screw trajectories of the distal-most row of fastener openings are aligned so that nominal trajectories of the fasteners (130A) follow articular surfaces of a radiocarpal joint and a distal radio-ulnar joint (Davison recites that the plurality of holes 120A are aligned so that their nominal trajectories follow the articular surfaces of both the radio-carpal joint and the distal radio ulnar-joint (Fig. 1D; and Para. [0057],[0060]). In regards to claim 13, Davison recites wherein the lobes define a second row of fastener openings (row of three 120A, Fig. 1e), and when the fasteners (130A) are received therein, screw trajectories of the second row of fastener openings have trajectories that fit between the distal-most row of fasteners such that the trajectories converge with the distal-most row screw trajectories (Fig. 1D, Para. [0060]). In regards to claim 14, Davison recites wherein the second row of fastener openings (row of three 120A) include a first opening in the radial-side lobe and a second fastener opening in the ulnar-side lobe, the first opening receives a fastener that extends dorsally and toward the radial styloid screw trajectory and the second opening receives a fastener that extends dorsally and fits between trajectories of the distal-most openings on the ulnar-side lobe (Fig. 1d and 1e, Para. [0060]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the openings (6) in the head of the plate (4) of Hirata to have specified trajectories in relation to the radial styloid, radiocarpal/radio-ulnar joints, and each other as taught in Davison so that the plurality of holes are aligned so that their nominal trajectories follow the articular surfaces of both the radio-carpal joint and the distal radio ulnar-joint to allow the fasteners to buttress and support the articular surfaces during fracture reconstruction (Para. [0017]).
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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