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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 8/13/26 has been entered.
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 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Choi (US Patent Pub. 20040006371A1).
Choi recites a surgical tool capable of being configured to be used in wrist fusion, or intercarpal fusion, or four corner fusion. Specifically in regards to claim 1, Choi discloses a surgical tool (forceps, Fig. 4-5) comprising first and second clamping arms (20,30) each having a first portion (21,31) extending from first/second gripping portion (thumb holes adjacent 22/32) to a first/second pivot point (23) and a second portion (24,34) extending from the pivot points (23) to a first/second free end (26/36) including a first/second inner surface and a first/second protrusions (37/27) extending from the inner surfaces (Fig. 4; and Para. [0022]-[0025]); a transverse plane (plane that extends at a perpendicular angle along the longitudinal axis that passes from 23 to 37/27) extending through the first portion (21/31) of the first and second clamping arms (20/30) (Fig. 4); and a locking mechanism (22/32) configured to lock relative positions of the first and second clamping arms (20/30) once a desired alignment of bones at a wrist joint is achieved (The limitation of the tool being used on a wrist bone is being interpreted as an intended use limitation. 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. 5; and Para, [0025]). The second portion (24) of the first clamping arm (20) extends away from the transverse plane (plane that extends at a perpendicular angle along the longitudinal axis that passes from 23 to 37/27) in a first direction and the second portion (34) of the second clamping arm (30) extends away from the transverse plane (plane that extends at a perpendicular angle along the longitudinal axis that passes from 23 to 37/27) in a second direction different than the first direction such that the first free end (27) of the first clamping arm and the second free (37) end of the second clamping arm are located on opposite sides of the transverse plane (The tips 27/37 face one another by means of the inner surfaces each facing in opposite directions.) (Fig. 4). The first and second inner surfaces face each other, and the first and second protrusions (27/37) are configured to grip bone (Fig. 4-5).
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) 3-4 is/are rejected under 35 U.S.C. 103 as being obvious over Choi in view of Torre (US Patent 4944739).
Choi recites a surgical tool comprising first and second clamping arms each having a first and second portion wherein the second portion has a free end with a protrusion configured to grip bone. However, the reference is silent as to the clamping arms being offset relative to the transverse plane.
Torre recites a surgical tool configured to be used in wrist fusion, or intercarpal fusion, or four corner fusion. Specifically, Torre recites wherein the tool (10) comprises first and second clamping arms (11/13), 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) (Fig. 1-2 and 4-5, Col. 2 lines 35-68). 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). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the clamping arms of Choi to have an offset portion as taught in Torre in order to allow for one portion gripping a bone segment above a diagonal cut and the other portion gripping the other bone segment on the opposing side and below the cut with the portions being clear of the osteotomy site (Col. 1 line 64 to Col. 2 line 2).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Choi in view of Rosenwasser et al (US Patent Pub. 20140214095A1).
Choi recites a surgical tool comprising first and second clamping arms each having a first and second portion wherein the second portion has a free end with a protrusion configured to grip bone, 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 Choi to be a screw as taught in Rosenwasser in order to allow for smaller and more precise locking positions (Para. [0070]).
Claim(s) 6-8 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Choi in view of Huebner et al (US Patent Pub. 20040127901A1).
Choi recites a surgical tool capable of being configured to be used in wrist fusion, or intercarpal fusion, or four corner fusion. Specifically in regards to claim 6, Choi discloses a reduction tool (forceps, Fig. 4-5) comprising first and second clamping arms (20,30) each having a first portion (21,31) extending from first/second gripping portions (thumb holes adjacent 22/32) to a first/second pivot points (23) wherein the second pivot point is rotatably coupled to the first pivot point and a second portion (24,34) extending from the pivot points (23) to a first/second free ends (26/36) each including a first/second inner surfaces and a first/second protrusions (37/27) extending from the inner surfaces (Fig. 4; and Para. [0022]-[0025]); a transverse plane (plane that extends at a perpendicular angle along the longitudinal axis that passes from 23 to 37/27) extending through the first portions (21/31) of the first and second clamping arms (20/30), wherein the second portions (24,34) of each of the first and second clamping arms (20.30) extend away from the transverse plane (plane that extends at a perpendicular angle along the longitudinal axis that passes from 23 to 37/27) in first and second directions which are different from each other such that the first and second free ends (26,36) of the first and second clamping arms (20,30) are located on opposite sides of the transverse plane (The limitation of the tool being used on a wrist bone is being interpreted as an intended use limitation. 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. The tips 27/37 face one another by means of the inner surfaces each facing in opposite directions.) (Fig. 5; and Para, [0025]). Choi also recites using the reduction tool (forceps, Fig. 4-5) to reduce the bones (Fig. 2-3 and 5) by engaging the first and second protrusions (37/27) of the offset clamping arms (10/20) with bones of the surgical site and rotating the offset clamping arms (10/20) to push the bones (Fig.4-5; and Para. [0022] and [0030]-[0032]). 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 Choi to include the tool being used to place 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, Choi recites wherein using the reduction tool (Fig. 4) is performed before attaching the plate to the bone(s) using at least one screws. (Choi recites utilizing forceps prior to use of other implants.) (Fig. 4-5).
In regards to claim 8, Choi in view of Huebner recites wherein using the reduction tool (forceps) is performed after attaching the plate to the bone(s) using at least one screws . (Choi recites utilizing forceps prior to use of other implants.) (Fig. 4-5).
In regards to claim 12, Choi recites locking relative positions of the first and second clamping arms (20/30) once a desired alignment of bones is achieved using a locking mechanism (22/32) (Fig. 4-5; and Para. [0025]).
Claim(s) 10-11 is/are rejected under 35 U.S.C. 103 as being obvious over Choi in view of Huebner as applied to claim 6 above and further in view of Torre.
Choi 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 clamping arms being offset relative to the transverse plane.
Torre recites a surgical tool configured to be used in wrist fusion, or intercarpal fusion, or four corner fusion. Specifically, Torre recites wherein the tool (10) comprises first and second clamping arms (11/13), 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) (Fig. 1-2 and 4-5, Col. 2 lines 35-68). In regards to claim 10-11, 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). 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 clamping arms of Choi to have an offset portion as taught in Torre in order to allow for one portion gripping a bone segment above a diagonal cut and the other portion gripping the other bone segment on the opposing side and below the cut with the portions being clear of the osteotomy site (Col. 1 line 64 to Col. 2 line 2).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Choi in view Huebner and Torre as applied to claim 12 as applied above, and further in view of Rosenwasser et al (US Patent Pub. 20140214095A1).
Choi in view of Huebner and Torre 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 13, 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 Choi 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 Choi.
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 surgical clamping tool.
Choi recites a surgical tool capable of being configured to be used in wrist fusion, or intercarpal fusion, or four corner fusion. Specifically in regards to claim 14, Choi discloses a surgical tool (forceps, Fig. 4-5) comprising first and second clamping arms (20,30) each having a first portion (21,31) extending from first/second gripping portions (thumb holes adjacent 22/32) to a first/second pivot points (23) wherein the second pivot point is rotatably coupled to the first pivot point and a second portion (24,34) extending from the pivot points (23) to a first/second free ends (26/36) each including a first/second inner surfaces and a first/second protrusions (37/27) extending from the inner surfaces (Fig. 4; and Para. [0022]-[0025]); a transverse plane (plane that extends at a perpendicular angle along the longitudinal axis that passes from 23 to 37/27) extending through the first portions (21/31) of the first and second clamping arms (20/30), wherein the second portions (24,34) of each of the first and second clamping arms (20.30) extend away from the transverse plane (plane that extends at a perpendicular angle along the longitudinal axis that passes from 23 to 37/27) in first and second directions which are different from each other such that the first and second free ends (26,36) of the first and second clamping arms (20,30) are located on opposite sides of the transverse plane (The limitation of the tool being used on a wrist bone is being interpreted as an intended use limitation. 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. The tips 27/37 face one another by means of the inner surfaces each facing in opposite directions.) (Fig. 5; and Para, [0025]). 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 as taught in Choi 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
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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