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 § 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.
Claims 5, 7 and 20 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 5 is rejected as indefinite for the recitation of “a bone fixation implant is a cannulated bone fixation implant” in lines 1-2. However, as shown in Fig. 5a-5e the implant 510 is shown as being cannulated and claim 1 from which claim 5 directly depends only discloses a single bone implant therefore, it is unclear as to what this new implant is meant to be without a further structural description provided in the limitation. In the interest in compact prosecution the claim will be interpreted as further clarifying the implant from claim 1.
Claim 7 is rejected as indefinite for depending upon an indefinite claim.
Claim 20 is rejected as indefinite for the recitation of “a second dynamic compression screw is received in the second tunnel” in lines 4-5. The claim recites that a second screw is inserted into the tunnel in lines 4-5 prior to the discussion of the second dynamic compression screw therefore it is unclear how a second screw can fit within the same tunnel.
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, 15-23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Palmer et al (US Patent Pub. 20130325076A1).
Palmer recites a bone implant for supporting a damaged bone or for fixing a bone fracture. Specifically in regards to claim 1, Palmer recites a shaft (16) having a proximal end (12) and a distal end (14) and a longitudinal axis (X-X) (Fig. 1; and Para. [0071]); the shaft (16) having a threaded shaft portion (20b) extending in a proximal to distal direction and located proximate the distal end (14) (Fig. 2; and Para. [0072]-[0073]); the shaft (16) having an unthreaded shaft portion (portion between 20a and 20b) located between a proximal end (12) of the shaft (16) and the threaded shaft portion (20b) (Fig. 1-3); an archway (18c) extending from the distal end (14) of the threaded shaft portion (20b), the archway (18c) forming a tunnel that is configured to receive a bone fixing screw in a direction that is inclined to the longitudinal axis (X-X) (Fig. 2 and 9-10; and Para. [0076],[0097]-[0098]); and the proximal end (40/42 in 12) of the shaft (16) configured to allow a user to drive the shaft (16) into bone (Fig. 8-10; and Para. [0082],[0103],[0169]).
In regards to claim 2, Palmer recites a connector (40/42) at the proximal end (12) of the shaft (16) configured for coupling to a driving tool to drive or twist the bone implant (10) into bone (Fig. 8-10; and Para. [0082],[0103]).
In regards to claim 3, Palmer recites wherein the direction is perpendicular to the longitudinal axis (X-X) (Palmer recites that the direction of the aperture 18c in relation to the longitudinal axis can be 90 degrees.) (Para. [0098]).
In regards to claim 4, Palmer recites wherein the shaft (16) comprises a second tunnel (18b) extending across one of the threaded or the unthreaded shaft portion in a second direction that is inclined to the longitudinal axis (X-X) (Fig. 1-8).
In regards to claim 6, Palmer recites wherein the unthreaded shaft portion (portion between 20a and 20b) comprises a proximal part (part with 18a) and a distal part (part with 18b) (Fig. 1-8).
In regards to claim 12, Palmer recites wherein the second tunnel (18b) is configured to receive a second screw (50b) in a direction inclined relative the longitudinal axis (X-X) and to a transverse direction of a first screw (50c), wherein the second screw (50b) if is configured to provide a dynamic compression (Fig. 17-18; and Para. [0122],[0127]).
In regards to claim 15, Palmer recites a kit for bone fracture or orthopaedic repair surgery. Specifically, Palmer recites the bone implant of claim 1 (Fig. 1-10). Palmer also recites a jig (200) configured for use with the bone implant (10) to align surgical drills (drills to pass through 265) with the bone implant (10), the jig (200) comprising: an L-shaped component configured to be coupled to the bone implant (10) by means of a coupler (282) (Fig. 21-22; and Para. [0141]-[0142],[0145]-[0146],[0169]); one or more tunnels configured to align a hole formed device or to hold an aligning component such as a drill sleeve (265a-265c) at a required position and alignment relative to the bone implant (10) (Fig. 21-22; and Para. [0141]-[0142],[0151]-[0154]).
In regards to claim 16, Palmer recites a method of using a bone implant of claim 1 in an orthopaedic procedure to provide a compression and suspension system for fixation of a fracture. Specifically, Palmer recites forming a first hole at the fracture site (Fig. 17-18); inserting the bone implant (10) into the hole, wherein the bone implant (10) is threaded (20b) to engage a bone as driven inwardly, wherein a proximal end (12) of the bone implant (10) has a head which is configured to engage a surface of the bone, and a distal end (14) of the bone implant (10) is configured to be located distally in the hole, the distal end (14) comprising an archway (18c) defining a first tunnel (18c) for receiving a first bone fixing screw (50c) (Fig. 17-18); determining a rotational orientation of the bone implant (10) about a longitudinal axis (X-X) thereof, wherein the head is not symmetrical (non-symmetry shown in Fig. 3-4) and wherein determining the rotational orientation of the head of the bone implant (10) allows determination of the rotational orientation of the bone implant (10) and a location and orientation of the archway (18c) and the first tunnel (As can be seen in Fig. 1-6, the positioning of the tip surfaces 22/24 or lack thereof can be used to tell where the aperture 18c is located.) (Fig. 1-6); drilling a hole to receive a first bone fixing screw (50c), the hole being drilled to align with the bone implant (10) such that the hole is formed to receive the screw and to locate it in the first tunnel (18c) (Fig. 21-24; and Para. [0041],[0158]-[0160]); locating the first bone fixing screw (50c) in the first tunnel (18c), such that the interaction of the bone fixing screw with the bone implant (10) at the archway defines a suspension of the bone implant (10) in the bone through the application of forces including by the bone fixing screw located in the first tunnel (18c) at the distal end (14) of the bone implant (10) and substantially transverse to the bone implant (10), and wherein the head at the proximal end (12) engages the bone at the proximal end (12) (Fig. 17-18 and 21-24).
In regards to claim 17, Palmer recites wherein the first bone fixing screw (50c) when arranged in interlocking engagement with the archway (18c) defines a suspension screw, based on the forces acting at the bone implant, bone, and screw (Fig. 17-18).
In regards to claim 18, Palmer recites a second tunnel (18b) extending through the bone implant (10) and configured to receive a second screw (50b), the second tunnel located between the distal end (14) and the proximal end (12) of the bone implant (10) and arranged at an angle to the longitudinal axis (X-X) of the bone implant (10), the method further comprising: drilling a second hole to receive the second screw (50b), wherein the second screw (50b) defines a dynamic compression screw, the hole being drilled to align with the bone implant (10) such that the hole is formed to receive the second screw (50b) and to locate it in the second tunnel (18b) (Fig. 17-18; and Para. [0041],[0158]-[0160]).
In regards to claim 19, Palmer recites a inserting the bone implant (10) into the bone in a direction generally transverse to the fracture such that a threaded portion (20b) of the bone implant (10) engages the bone distally and proximally of the fracture; locating the first tunnel (18c) distally of the fracture; and inserting the first bone engaging screw (50c) in a direction substantially transverse to the longitudinal axis (X-X) of the bone implant (10) (Palmer recites that the direction of the aperture 18c in relation to the longitudinal axis can be 90 degrees.) (Fig. 17-18; and Para. [0098]).
In regards to claim 20, Palmer recites the second tunnel (18b) being located distally of the fracture; inserting the second screw (50b), defining a dynamic compression screw to locate it in the second tunnel (18b), wherein the bone implant (10) is configured such that when the second dynamic compression screw is received in the second tunnel it is inclined relative to the longitudinal axis (X-X) of the bone implant (10) and engages the bone to apply a dynamic compression force (Fig. 17-18).
In regards to claim 21, Palmer recites coupling a jig (200) to the bone implant, wherein the jig (200) is an L-shaped piece and is configured with a series of jig tunnels (265a-c), each jig tunnel (265a-c) configured to align a hole forming device to provide a guide such that the one or more holes are located as required at the bone implant (10) (Fig. 21-22).
In regards to claim 22, Palmer recites a suspension and compression system for fixation of a fracture in a bone in an orthopaedic procedure, the system comprising: a bone implant as claimed in claims 1 (Fig. 17-18); at least one bone engaging screw (50a-50c) configured for interlocking with the bone implant (10) at a direction inclined relative to a longitudinal axis (X-X) of the bone implant (10) when located in the bone (Fig. 17-18).
In regards to claim 23, Palmer recites a jig (200), wherein the jig (200) is configured for: coupling to the bone implant (10), and providing alignment of surgical drills with the bone implant (10); wherein the jig (200) comprises: an L-shaped component configured to be coupled to the bone implant (10) by means of a coupler (40/42 and 282, Para. [0169]); one or more tunnels (268a-c) configured to align a hole formed device or to hold an aligning component such as a drill sleeve (265a-c) at a required position and alignment relative to the bone implant (10) to allow engagement of one or more screws (50a-c) with the bone implant (10) (Fig. 17-18 and 21-24).
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, 7, 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Palmer in view of Patel (US Patent Pub. 20210022873A1).
Palmer recites a bone implant having proximal and distal ends, a shaft with a threaded and unthreaded portions, an archway with a tunnel at the distal end. However, the reference is silent as to the implant being cannulated or wherein the proximal end has a keyed socket.
Patel recites a bone implant for supporting a damaged bone or for fixing a bone fracture. Specifically in regards to claim 5, Palmer recites a bone implant (108) having proximal and distal ends (150/130) and a shaft (120) wherein the bone implant (108) us a cannulated bone fixation implant and comprises a lumen (134) in the longitudinal direction for coupling to a guidewire (Fig. 4-9; and Para. [0009],[0021],[0071]-[0072]). In regards to claim 10, Patel recites wherein the proximal end of the unthreaded shaft portion (146) comprises a keyed socket (152, Fig. 3) for engaging and rotationally locking with a corresponding key (Fig. 3 and 10-11; and Para. [0070],[0075]). It would have been obvious to one hving ordinary skill in the art at the time the invention was filed to modify the shaft (16) and socket (40) of the implant (10) of Palmer to be keyed and cannulated as taught in Patel in order to allow for the implant to be guided into proper place by a guidewire and to allow for a driver to be inserted to and to grip the implant in a better manner.
In regards to claim 7, Palmer recites wherein a second tunnel (18b) is disposed in a distal part (Fig. 1-4).
In regards to claim 11, Palmer recites a threaded lumen (42) concentrically disposed with the keyed socket (40) for engaging with a threaded coupler (282) to lock the key into the keyed socket (Fig. 8, 21-22; and Para. [0169]).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Palmer in view of Koay et al (US Patent Pub. 20160143676A1).
Palmer recites a bone implant having proximal and distal ends, a shaft with a threaded and unthreaded portions, an archway with a tunnel at the distal end. In regards to claim 13, Palmer recites an unthreaded end-piece (portion between 20a-20b) (Fig. 1-5). However, the reference is silent as to the implant being comprised of Grade 5 Titanium.
Koay recites a bone implant for supporting a damaged bone or for fixing a bone fracture. Specifically in regards to claim 13, Koay recites a bone implant (100) having proximal and distal ends (102/108) and a shaft (106), and comprises Grade 5 Titanium (Claim 37 and Para. [0019]). It would have been obvious to one hving ordinary skill in the art at the time the invention was filed to modify the implant (10) of Palmer to be composed of Grade 5 Titanium as taught in Koay in order to formed of a material selected to have a greater hardness that a material of a bone, and also prevents burring of the threads of the bone screw as they are inserted into the bone fixation device while also increasing a holding strength of the bone fixation system (Para. [0019]).
Allowable Subject Matter
Claims 8-9 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