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 without traverse of Invention I/Species A (Cl. 1-6,8-15) in the reply filed on 4/10/26 is acknowledged.
Claims 7, 16-20 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention/species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 4/10/26. Dependent claim 7 was included in the withdrawn claims since it recites an undercut to the ulnar lobe which is discussed in relation to Fig.10a of applicants specification as originally filed which is Species B.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 11-12 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
In claim 11 at line 2-3 the limitation recites “first opening with a trajectory targeted at a radial styloid”.
In claim 12 at line 3-4 the limitation recites “openings are aligned so that nominal trajectories of the fasteners follow articular surfaces of a radiocarpal joint and a distal radio-ulnar joint”.
These limitations cannot be satisfied without the inclusion of the human organism, or the sternum, therefore, applicant is claiming the sternum as part of the invention. Instead, applicant should use “adapted to” or “configured to” language to overcome the 101 rejection.
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.
Claim 9-15 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 9 is rejected as indefinite for the recitation of “the ulnar-side lobe is longer than the radial side lobe” in lines 7-8. However, this is considered indefinite since the specification as originally filed does not recite how the length of each lobe is measured. For example is the height measured between the peeks of each lobe, at the start of each lobe adjacent the groove, or at their edges abutting the side edges of the plate. Since the claim does not state how or where the measurements are taken from examiner in the interest in compact prosecution will measure the lobes in the same manner as shown in Fig. 4 of Applicant’s specification which appears to be from the peek of one lobe to what appears to be the distal most edge of the other lobe closest to the plate edge.
Claims 10-15 are rejected as indefinite for depending upon an indefinite claim.
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) 1-6, 8-9, 12, 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hirata et al (US Patent Pub. 20170231673A1).
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).
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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), and 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.) (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]).
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 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 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) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hirata in view of Chan et al (US Patent Pub. 20080140130A1).
Hirata 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 Davison et al (US Patent Pub. 20180049787A1).
Hirata 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 targeted 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]).
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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