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 and 3-4 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Torre (US Patent 4944739).
Torre recites a surgical tool configured to be used in wrist fusion, or intercarpal fusion, or four corner fusion. Specifically in regards to claim 1, Torre recites wherein the tool (10) comprises first and second clamping arms (11/13) that are each offset relative to a transverse plane (plane that bisects the tool into top and bottom sections) defined by a main body (body of 10) of the tool (10), the first clamping arm (11) having a first portion terminating at a connected end (end joined at 15) and a second portion terminating at a free end (35), the second clamping arm (13) having a first portion terminating at a connected end (end joined at 15) and a second portion terminating at a free end (37), the connected ends of the first and second clamping arms (13/13) rotatably coupled (coupled at 15), the transverse plane extending through the first portions of the first and second clamping arms (11/13), wherein the second portions of the first and second clamping arms (11/13) extend away from the transverse plane such that the free ends (35/37) of the first and second clamping arms (11/13) are located on opposite sides of the transverse plane, the free ends (35/37) of the first and second clamping arms (11/13) includes a first/second inner surface (surface of 23/21), the first and second inner surfaces face each other, the free ends (35/37) of the first and second clamping arms (11/13) further comprising a first and second protrusions (serrations) extending from the first and second inner surfaces, wherein the first and second protrusions (serrations) are configured to grip bone (The Torre reference recites that the finger portions 21, 23 are spaced apart a predetermined distance and offset both vertically and horizontally from each other.) (Fig. 1-2 and 4-5, Col. 2 lines 35-68). Torre also recites wherein a locking mechanism (25) for locking relative positions of the first and second clamping arms (11/13) once a desired alignment of bones at a wrist joint is achieved (The recitation in the preamble of the tool used in a wrist fusion procedure is being examined as intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.) (Fig. 1-2 and 4-5; and Col. 3 line 15-36).
In regards to claim 3-4, Torre recites wherein the first and second clamping arms (11/13) are offset relative to the transverse plane such that the tool (10) is configured to be for use by a left-handed user or a right-handed user (The tool 10 is fully capable of being used in either the user’s right or left hand since the handles have no directionality.) (Fig. 1-2).
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 Torre in view of Rosenwasser et al (US Patent Pub. 20140214095A1).
Torre discloses a reduction tool comprising first and second clamping arms having first portions terminating in connected ends and second portions terminating at free ends that have projections that can grip bones, and a locking mechanism that can lock the arms in place. However, the reference is silent as to the locking mechanism being a screw.
Rosenwasser recites a surgical tool configured to be used in wrist fusion, or intercarpal fusion, or four corner fusion. Specifically in regards to claim 5, Rosenwasser recites a reduction tool (200) comprising first and second clamping arms (220) having first portions terminating in connected ends and second portions terminating at free ends (ends with 230) and a locking mechanism (210), wherein the locking mechanism comprises a screw (210) (Fig. 14; and Para. [00710]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the reduction tool locking mechanism of Torre to be a screw as taught in Rosenwasser in order to allow for smaller and more precise locking positions (Para. [0070]).
Claim(s) 6-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Torre in view of Huebner et al (US Patent Pub. 20040127901A1).
Torre discloses a tool capable of being used in a surgical method for use performing wrist fusion on a patient. Specifically in regards to claim 6, Torre recites a reduction tool (10) comprising first and second clamping arms (11/13) offset relative to a transverse plane (plane that bisects the tool into top and bottom sections) defined by a main body (body of 10) of the tool (10), the first clamping arm (11) having a first portion terminating at a connected end (end joined at 15) and a second portion terminating at a free end (35), the second clamping arm (13) having a first portion terminating at a connected end (end joined at 15) and a second portion terminating at a free end (37), the connected ends of the first and second clamping arms (13/13) rotatably coupled (coupled at 15), the transverse plane extending through the first portions of the first and second clamping arms (11/13), wherein the second portions of the first and second clamping arms (11/13) extend away from the transverse plane such that the free ends (35/37) of the first and second clamping arms (11/13) are located on opposite sides of the transverse plane, the free ends (35/37) of the first and second clamping arms (11/13) includes a first/second inner surface (surface of 23/21), the first and second inner surfaces face each other, the free ends (35/37) of the first and second clamping arms (11/13) further comprising a first and second protrusions (serrations) extending from the first and second inner surfaces, wherein the first and second protrusions (serrations) are configured to grip bone (The Torre reference recites that the finger portions 21, 23 are spaced apart a predetermined distance and offset both vertically and horizontally from each other.) (Fig. 1-2 and 4-5, Col. 2 lines 35-68). Torre also recites using the reduction tool (10) to reduce the bones (Fig. 4) by engaging the first and second protrusions (serrations) of the offset clamping arms (11/13) with bones of the surgical site and rotating the offset clamping arms (11/13) to push the bones (Fig.4-5; and Col. 3 line 44 to Col. 4 line 6). However, the reference is silent as to the use of plate on the wrist bones.
Huebner recites a surgical method for use performing wrist fusion on a patient. Specifically in regards to claim 6, Huebner recites using a plate (10) having a curvature (surface 46) configured to substantially follow the natural anatomy of the wrist (Huebner recites wherein the surface 46 substantially match and contact a first portion (or all) of recessed bone surfaces formed in bones at an inter-bone junction or movable joint.) (Fig. 1-6b; and Para. [0028]-[0030]). Huebner recites attaching the plate (10) to the bones at the wrist joint of the patient using at least one screw (16/32); and inserting a remainder of a plurality of screws (16) into the bones at the wrist joint, wherein, when fully implanted, the plurality of screws are coupled to the plate (10) and inserted into the bones at the wrist joint in different directions (Fig. 1-6b; and Para. [0028]-[0030],[0053]-[0054]). 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 Torre to include a wrist plate on wrist bones as taught in Huebner in order to a bone that matches the wrist joint and allows for the insertion of screws into poor quality bone (Para. [0005]).
In regards to claim 7, Torre recites wherein using the reduction tool (10) is performed before attaching the plate to the bone(s) using at least one screws. (Torre recites utilizing tool 10 prior to use of other implants.) (Fig. 4-5).
In regards to claim 8, Torre in view of Huebner recites wherein using the reduction tool (10) is performed after attaching the plate to the bone(s) using at least one screws . (Torre recites utilizing tool 10 prior to use of other implants.) (Fig. 4-5).
In regards to claim 10-11, Torre recites wherein the first and second clamping arms (11/13) of the reduction tool are offset relative to the transverse plane such that the tool is configured to be for use by a left-handed/right-handed user (The tool 10 is fully capable of being used in either the user’s right or left hand since the handles have no directionality.) (Fig. 1-2).
In regards to claim 12, Torre recites locking relative positions of the first and second clamping arms (11/13) once a desired alignment of bones is achieved using a locking mechanism (25) (Fig. 1-2 and 4-5; and Col. 3 line 15-36).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Torre in view Huebner as applied to claim 12 as applied above, and further in view of Rosenwasser et al (US Patent Pub. 20140214095A1).
Torre in view of Huebner discloses a method of utilizing a reduction tool comprising first and second clamping arms having first portions terminating in connected ends and second portions terminating at free ends that have projections that can grip bones, and a locking mechanism that can lock the arms in place to fuse two bone in a wrist utilizing a plate. However, the reference is silent as to the locking mechanism being a screw.
Rosenwasser recites a surgical tool configured to be used in wrist fusion, or intercarpal fusion, or four corner fusion. Specifically in regards to claim 5, Rosenwasser recites a reduction tool (200) comprising first and second clamping arms (220) having first portions terminating in connected ends and second portions terminating at free ends (ends with 230) and a locking mechanism (210), wherein the locking mechanism comprises a screw (210) (Fig. 14; and Para. [00710]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the combination by modifying the reduction tool locking mechanism of Torre to be a screw as taught in Rosenwasser in order to allow for smaller and more precise locking positions (Para. [0070]).
Claim(s) 14-16 is/are rejected under 35 U.S.C. 103 as being anticipated by Huebner in view of Torre.
Huebner recites a system for fusing at least two bones in a wrist, or intercarpal fusion, or four corner fusion. Specifically in regards to claim 14, Huebner recites the system comprising: a plate (10) having a curvature (surface 46) configured to substantially follow the natural anatomy of the wrist; and a plurality of screws (16/32) configured to point in different directions when coupled to the plate (10) (Huebner recites wherein the surface 46 substantially match and contact a first portion (or all) of recessed bone surfaces formed in bones at an inter-bone junction or movable joint.) (Fig. 1-6b; and Para. [0028]-[0030],[0053]-[0054]). However, the reference is silent as to a clamping tool.
Torre recites a system for fusing at least two bones. Specifically in regards to claim 14, Torre recites a reduction tool (10) comprising first and second clamping arms (11/13) offset relative to a transverse plane (plane that bisects the tool into top and bottom sections) defined by a main body (body of 10) of the tool (10), the first clamping arm (11) having a first portion terminating at a connected end (end joined at 15) and a second portion terminating at a free end (35), the second clamping arm (13) having a first portion terminating at a connected end (end joined at 15) and a second portion terminating at a free end (37), the connected ends of the first and second clamping arms (13/13) rotatably coupled (coupled at 15), the transverse plane extending through the first portions of the first and second clamping arms (11/13), wherein the second portions of the first and second clamping arms (11/13) extend away from the transverse plane such that the free ends (35/37) of the first and second clamping arms (11/13) are located on opposite sides of the transverse plane, the free ends (35/37) of the first and second clamping arms (11/13) includes a first/second inner surface (surface of 23/21), the first and second inner surfaces face each other, the free ends (35/37) of the first and second clamping arms (11/13) further comprising a first and second protrusions (serrations) extending from the first and second inner surfaces, wherein the first and second protrusions (serrations) are configured to grip bone (The Torre reference recites that the finger portions 21, 23 are spaced apart a predetermined distance and offset both vertically and horizontally from each other.) (Fig. 1-2 and 4-5, Col. 2 lines 35-68). Torre also recites using the reduction tool (10) to reduce the bones (Fig. 4) by engaging the first and second protrusions (serrations) of the offset clamping arms (11/13) with bones of the surgical site and rotating the offset clamping arms (11/13) to push the bones (Fig.4-5; and Col. 3 line 44 to Col. 4 line 6). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the system of Huebner by adding a clamping tool in view of Torre in order to allow for manual compression control of a bone discontinuity for improved repair of fractures, fusions, and other bone discontinuities.
In regards to claim 15, Huebner recites wherein the plurality of screws (32) comprise locking screws (Fig. 6a-6b).
In regards to claim 16, Huebner recites wherein the plurality of screws (16) comprise non-locking screws (Fig. 6a-6b).
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