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 .
Status of the Claims
This Office Action is responsive to the amendment filed January 20, 2026. As directed by the amendment: Claims 21, 22, 25, and 40 have been amended. Claims 1-20, 38, and 39 have been cancelled. Claims 21-37 and 40 are presently pending in this application.
Examiner’s Note
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.
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) 21-29, 32-37, and 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cowens et al. (US 10,722,269), herein referred to as Cowens, and in view of Langdale et al. (US 2017/0056081), herein referred to as Langdale, and further in view of Gabelberger et al. (US 2022/0117639), herein referred to as Gabelberger.
Regarding claim 21, Cowens discloses a method of using a fracture fixation system (figures 20-24), comprising inserting a bone nail (60) into a canal of a bone (70) (figure 20), inserting a bone plate (30) against a surface of the bone (70) (figures 22-24), locating a first end of the bone plate (30) adjacent to a first end of the bone nail (60) (figures 22-24).
Yet, Cowens lacks inserting an alignment instrument through a first plate hole of the bone plate and through a first nail hole of the bone nail.
However, Langdale teaches an alignment instrument (e.g. one or more k-wires, ¶72) through a first plate hole (224) of a bone plate (210) and through a first nail hole (256) of a bone nail (250) (figure 4C).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide Cowens’ method with the step of inserting an alignment instrument through a first plate hole of the bone plate and through a first nail hole of the bone nail as taught by Langdale, since such a modification would assist with preliminary placement of the plate and intramedullary nail (¶72).
The modified Cowens’ method has drilling (via element 45 of Cowens) a first bore in the bone (70 of Cowens) (col. 18, ll. 62-66 of Cowens) through the first plate hole (516 of Cowens) and through the first nail hole (considered as a first element 822 of Cowens), inserting a first fastener (40 of Cowens) into the first plate hole (516 of Cowens) and the first nail hole (element 822 of Cowens) to couple the bone nail (60 of Cowens) and the bone plate (30 of Cowens). Next, Cowens discloses a slot (defined as “an aperture” by Dictionary.com) (518) in the bone plate (30) and a second nail hole (considered as a second element 822) in the bone nail (60), the slot (518) located between the first plate hole (516) and a third plate hole (another element 518), the second nail hole (considered as another element 822) located between the first nail hole and a third nail hole (elements 822) (figures 20-24). Yet, Cowens lacks drilling a second bore in the bone through a slot in the bone plate and a second nail hole in the bone nail.
However, Langdale teaches drilling a second bore (e.g. pilot holes, ¶73) in a bone (102) through a slot (e.g. fastener opening, 220) in a bone plate (210) and a second nail hole (256) in a bone nail (250) (¶73). Furthermore, a mere duplication of a step involves only routine skill in the art.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the modified Cowens’ method with the step of drilling a second bore in the bone through a slot in the bone plate and a second nail hole in the bone nail as taught by Landale, since such a step would prepare the bone plate and nail to receive the respective fasteners and wherein a mere duplication of a step involves only routine skill in the art.
Thus, the modified Cowens’ method has inserting a second fastener (another element 40 of Cowens) (col. 4, ll. 13-14 of Cowens) into the slot (518 of Cowens) and the second nail hole (considered as a second element 822 of Cowens).
The modified Cowens’ method further lacks a detailed description on wherein the first fastener is inserted into the first plate hole without tightening the first fastener against the bone plate such that further movement of the bone plate with respect to the bone is permitted, wherein the second fastener is inserted into the slot without tightening the second fastener against the bone plate such that further movement of the bone plate with respect to the bone is permitted and after the steps of inserting the first fastener and inserting the second fastener, moving at least a portion of the bone plate with respect to the bone in a direction that is substantially perpendicular to a longitudinal axis of the bone plate.
However, Gabelberger teaches wherein a first fastener (¶92) is inserted into a first plate hole (figure 10) without tightening (¶92) the first fastener against a bone plate (300) such that further movement of the bone plate with respect to the bone is permitted (¶92), wherein a second fastener (¶92) is inserted into a slot (figure 10) without tightening (¶92) the second fastener (¶92) against the bone plate (300) such that further movement of the bone plate with respect to the bone is permitted (¶92) and after the steps of inserting the first fastener (¶92) and inserting the second fastener (¶92), moving at least a portion of the bone plate (300) with respect to the bone (70) in a direction that is substantially perpendicular to a longitudinal axis of the bone plate (300) (¶92).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the modified Cowens’ method with wherein the first fastener is inserted into the first plate hole without tightening the first fastener against the bone plate such that further movement of the bone plate with respect to the bone is permitted, wherein the second fastener is inserted into the slot without tightening the second fastener against the bone plate such that further movement of the bone plate with respect to the bone is permitted and after the steps of inserting the first fastener and inserting the second fastener, moving at least a portion of the bone plate with respect to the bone in a direction that is substantially perpendicular to a longitudinal axis of the bone plate as taught by Gabelberger, since such a modification would allow the surgeon to fit/adjust the plate to the bone before being tightened.
Regarding claims 22, 23, the modified Cowens’ method discloses all the features/elements as claimed but lacks further comprising inserting an alignment instrument through the third plate hole, wherein each of the alignment instruments is a k-wire.
However, Langdale teaches further comprising inserting an alignment instrument (another k-wire, ¶72) through a third plate hole (another element 224), wherein each of the alignment instruments is a k-wire (¶72).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the modified Cowens’ method with further comprising inserting an alignment instrument through the third plate hole, wherein each of the alignment instruments is a k-wire as taught by Langdale, since such a modification would assist with preliminary placement of the plate and intramedullary nail (¶72).
Regarding claim 24, the modified Cowens’ method has wherein the step of inserting the bone nail (60 of Cowens) includes inserting a retrograde femoral nail (figures 20-24 of Cowens) into an entry location at a distal end of a femur (col. 4, ll. 16-18 of Cowens).
Regarding claim 25, the modified Cowens’ method discloses all the features/elements as claimed but lacks further comprising drilling a third bore through the third plate hole and inserting a third fastener into the third plate hole.
However, it is known that a mere duplication of a step involves only routine skill in the art.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the modified Cowens’ method with further comprising drilling a third bore through the third plate hole and inserting a third fastener into the third plate hole, since it is known that a mere duplication of a step involves only routine skill in the art.
Regarding claim 26, the modified Cowens’ method has wherein the step of inserting the first fastener, the step of inserting the second fastener, and/or the step of inserting the third fastener comprises inserting a screw (40 of Cowens) and threading a head of the screw (coll. 14, ll. 20-25 of Cowens) into the first plate hole (516 of Cowens), the slot, and/or the third plate hole, respectively.
Regarding claim 27, the modified Cowens’ method discloses all the features/elements as claimed including wherein the step of inserting the first fastener (40 of Cowens) and the step of inserting the third fastener (another element 40 of Cowens) comprises inserting a screw (col. 14, ll. 20-25 of Cowens) and threading a head of the screw (coll. 14, ll. 20-25 of Cowens) into the first plate hole (516 of Cowens) and the third plate hole (518 of Cowens), respectively. Yet, the modified Cowens’ method lacks the step of inserting the second fastener comprises inserting a non-threaded head of the second fastener into the slot.
However, Langdale teaches a screw (230) having a non-threaded head (¶62).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the modified Cowens’ method having the second fastener with a fastener having a non-threaded head as taught by Langdale, since such a modification would allow for dynamic compression of the bone (¶63).
Regarding claim 28, the modified Cowens’ method has wherein any of the steps of drilling includes using a targeting arm (50 of Cowens) attached to the bone nail (60 of Cowens) (figures 21-23 of Cowens).
Regarding claim 29, the modified Cowens’ method has wherein any of the steps of drilling includes using a drill sleeve (20 of Cowens) (figure 22 of Cowens).
Regarding claims 32, 33, 35, the modified Cowens’ method discloses all the features/elements as claimed including inserting a fourth fastener (65 of Cowens) into the fourth plate hole (another element 518 of Cowens) and avoiding contact/alignment of the fourth fastener (65 of Cowens) with the bone nail (60 of Cowens) (figure 24 of Cowens), inserting a fifth fastener (another element 65 of Cowens) into the fifth plate hole (another element 518 of Cowens) and avoiding contact/alignment of the fifth fastener (another element 65 of Cowens) with the bone nail (60 of Cowens) (figure 24 of Cowens), wherein the steps of inserting the fourth and fifth fasteners (elements 65 of Cowens) comprise inserting the fourth and fifth fasteners substantially parallel to each other (figure 24 of Cowens). Yet, the modified Cowens’ method lacks further comprising drilling a fourth bore in the bone through a fourth plate hole of the bone plate and to avoid alignment with a hole in the bone nail, drilling a fifth bore in the bone through a fifth plate hole of the bone plate and to avoid alignment with a hole in the bone nail.
However, Langdale teaches drilling a fourth bore (via element 170) in the bone (102) through a fourth plate hole of a bone plate (110) (figures 2A and 2B) and drilling a fifth bore (via element 170) in the bone (102) through a fifth plate hole of the bone plate (110) (figures 2A and 2B).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the modified Cowens’ method with the steps of drilling a fourth bore in the bone through a fourth plate hole of the bone plate and drilling a fifth bore in the bone through a fifth plate hole of the bone plate as taught by Langdale, since a drill would create a hole at the trajectory that the fasteners is intended to be inserted (¶53).
Regarding claim 34, the modified Cowens’ method has wherein the step of drilling the fourth bore comprises drilling the fourth bore (via element 170 of Langdale) to a first side of the bone nail (60 of Cowens) (figure 24 of Cowens), and the step of drilling the fifth bore (via element 170 of Langdale) comprises drilling the fifth bore to a second side of the bone nail (60 of Cowens) opposite the first side (figure 24 of Cowens).
Regarding claim 36, the modified Cowens’ method has wherein the step of inserting the bone nail (60 of Cowens) comprises inserting the bone nail into a tibia, a humerus, or a femur (col. 4, ll. 16-19 of Cowens).
Regarding claim 37, the modified Cowens’ method has wherein the first plate hole is a slot (516 of Cowens) (figure 17 of Cowens).
Regarding claim 40, the modified Cowens’ method has further comprising tightening the first fastener (¶92 of Gabelberger) and the second fastener (¶92 of Gabelberger) against the bone plate (30 of Cowens).
Claim(s) 30 and 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cowens and Langdale as applied to claims above, and further in view of Stemniski et al. (US 2012/0271314), herein referred to as Stemniski.
Regarding claims 30, 31, the modified Cowens’ method discloses all the features/elements as claimed but lacks wherein any of the steps of drilling comprises using a drill guide having a guide hole defined by a first conical surface and a second planar surface or wherein any of the steps of drilling comprises using a drill guide having a guide hole defined only by a first conical surface and a second planar surface.
However, Stemniski teaches using a drill guide (200, 202) having a guide hole (206) defined by a first conical surface (figures 16, 19, 20) and a second planar surface (220) or using a drill guide (200, 202) having a guide hole (206) defined only by a first conical surface (figures 16, 19, 20) and a second planar surface (220).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified Cowens’ method having a drill guide with a drill guide having a guide hole defined by a first conical surface and a second planar surface or a drill guide having a guide hole defined only by a first conical surface and a second planar surface as taught by Stemniski, since such a modification would provide an alternative drill guide shape and it appears the drill guide would perform equally well in receiving a drill.
Response to Arguments
Applicant's arguments filed January 20, 2026 have been fully considered but they are not persuasive.
Applicant’s arguments on pages 5-7, under 35 U.S.C. 103, of the Remarks are directed to the amended claim 21 and the combination of references (Cowens, Langdale, Gabelberger). Applicant argues “Gabelberger does not teach or disclose inserting a first fastener into a first plate hole and a second fastener into a slot without tightening the first and second fasteners against the bone plate and moving at least a portion of the bone plate with respect to the bone in a direction that is substantially perpendicular to a longitudinal axis of the bone plate”. However, the Examiner respectfully disagrees because as generally claimed, Gabelberger teaches wherein a first fastener (¶92) is inserted into a first plate hole (figure 10) without tightening (¶92) the first fastener against a bone plate (300) such that further movement of the bone plate with respect to the bone is permitted (¶92), wherein a second fastener (¶92) is inserted into a slot (figure 10) without tightening (¶92) the second fastener (¶92) against the bone plate (300) such that further movement of the bone plate with respect to the bone is permitted (¶92) and after the steps of inserting the first fastener (¶92) and inserting the second fastener (¶92), moving at least a portion of the bone plate (300) with respect to the bone (70) in a direction that is substantially perpendicular to a longitudinal axis of the bone plate (300) (¶92). The Examiner further notes a lateral pressure is considered moving at least a portion of the bone plate in a direction that is substantially perpendicular to a longitudinal axis of the bone plate (considered as a long axis running lengthwise through the plate).
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.
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/SI MING KU/Primary Examiner, Art Unit 3775
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