Detailed Action
This is the final office action for US application number 19/067,949. Claims are evaluated as filed on June 5, 2026.
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 .
Response to Arguments
Applicant's arguments filed June 5, 2026 have been fully considered but they are not persuasive. The rejections in this office action have been amended to address the amended claims. Examiner asserts that Chapman, Cordaro, and Campbell teach all the newly-amended limitations and are capable of performing the functions as claimed. Examiner directs Applicant to the rejection below for a more in-depth description of the limitations.
With regards to Applicant’s argument that claims 1, 8, and 21 have been amended to differentiate from Chapman (Remarks p. 11-13), Examiner notes that Cordaro has been provided in the below rejections with regards to the threaded major diameter being larger than the slot width and corresponding function. With regards to claim 21, a fastener is shown in Chapman Fig. 14 to be capable of pivoting in a single plane and such is capable of moving along the slot when the plate slid while the fasteners are at least partially secured in bone, which reads on the current claim language. Examiner notes that on page 12 Applicant has asserted that the disclosure of paragraph 297 that the fastener 150 is prevented from rotating relative to the plate supports the limitation that that fastener is able to pivot in a single plane; however, it is unclear how 150 being prevented from rotating supports the ability to pivot or if Applicant is intending for something unclaimed to be included in the claim.
With regards to Applicant’s argument that claims 8, 14, 21, and 25 have been amended to differentiate from Fell with the fasteners capable of being captive in the slots and pivotable (Remarks p. 13-15), Examiner notes that Campbell addresses these limitations in the below rejections.
Claim Objections
Claim(s) 8, 14, 21,and 25 is/are objected to because of the following informalities:
Claim 8 lines 1-5 should read “fracture plating system configured to stabilize a first fracture and a second fracture of a bone of a patient, wherein the first fracture and the second fracture define a flail segment of the bone, the bone comprising an interior surface facing toward an interior body cavity of the patient[[,]] and an exterior surface facing away from the interior body cavity, the fracture plating system comprising:”.
Claim 14 lines 1-5 should read “A fracture plating system configured to stabilize a multiple fractures of a bone of a patient, wherein the multiple fractures define one or more flail segments, the bone comprising an interior surface facing toward an interior body cavity of the patient[[,]] and an exterior surface facing away from the interior body cavity, the fracture plating system comprising:”.
Claim 21 lines 1-4 should read “A fracture plating system configured to stabilize a first fracture and a second fracture of a bone of a patient, the bone comprising an interior surface facing toward an interior body cavity of the patient[[,]] and an exterior surface facing away from the interior body cavity, the fracture plating system comprising:”.
Claim 25 lines 1-5 should read “A fracture plating system configured to stabilize a multiple fractures of a bone of a patient, wherein the multiple fractures define one or more flail segments, the bone comprising an interior surface facing toward an interior body cavity of the patient[[,]] and an exterior surface facing away from the interior body cavity, the fracture plating system comprising:”.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 21 and 24 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chapman et al. (US 5,364,398, hereinafter “Chapman”).
As to claim 21, Chapman discloses a fracture plating system (69, 101, 103, col. 15 lines 46-56) capable of stabilizing a first fracture and a second fracture of a bone of a patient (when positioned appropriately, col. 15 lines 46-56 discloses use for fracture treatment with 1-2 screws in each aperture/slot, col. 16 line 64 – col. 17 line 4 discloses that the substantial allowed angulation of screws within the plate enhances capabilities for fixation of oblique and complex fractures and increases the number of bone fragments that can be direction gripped by a screw), the bone comprising an interior surface facing toward an interior body cavity of the patient (if one so chooses to position the system on such a bone) and an exterior surface facing away from the interior body cavity (if one so chooses to position the system on such a bone), the fracture plating system comprising: a plate (69) capable of being placed on the interior surface (if one so chooses to position the system on such a bone, Figs. 9, 10, and 14, col. 15 lines 46-56 discloses that 69 can be used by itself as a conventional bone plate), the plate comprising one or more slots (79, 80, 85, Figs. 9 and 14, col. 14 lines 58-59) and capable of spanning the first fracture and the second fracture (when positioned appropriately, col. 15 lines 46-56 discloses use for fracture treatment with 1-2 screws in each aperture/slot, col. 16 line 64 – col. 17 line 4 discloses that the substantial allowed angulation of screws within the plate enhances capabilities for fixation of oblique and complex fractures and increases the number of bone fragments that can be direction gripped by a screw); and four fasteners (101s, 103s, Figs. 12A-14, col. 15 lines 46-56 discloses use for fracture treatment with the 6 apertures elongated to be able to receive 1-2 screws in each aperture/slot) each capable of being received in the bone and in one of the one or more slots (Figs. 12A-14, col. 15 lines 46-56, col. 15 lines 5-14) capable of securing the plate to the interior surface of the bone (Figs. 12A-14); wherein: the four fasteners are capable of being received in the bone on opposite sides of each of the first fracture and the second fracture (when positioned appropriately, col. 15 lines 46-56 discloses use for fracture treatment with 1-2 screws in each aperture/slot, col. 16 line 64 – col. 17 line 4 discloses that the substantial allowed angulation of screws within the plate enhances capabilities for fixation of oblique and complex fractures and increases the number of bone fragments that can be direction gripped by a screw); each of the four fasteners comprises a head portion (93) and a first threaded portion (lower portion, i.e. adjacent the free end of the shank, as show in Figs. 12A and 12B, Figs. 12A and 12B, col. 16 lines 10-11) extending from the head portion (Figs. 12A and 12B ); each of the one or more slots is capable of receiving the first threaded portion (Figs. 9, 12A, 12B, and 14) so that the four fasteners are capable of being captive within the one or more slots (at least when the screws are threaded into bone); and while captive in one of the one or more slots, each of the four fasteners is capable of moving along the one of the one or more slots and pivoting in a single plane relative to the one of the one or more slots (when the plate is slid relative to the bone while the fasteners are threaded into the bone, i.e. until the fasteners contact the end of a corresponding slot due to the structure shown in Figs. 9, 10, 12A, and 12B).
As to claim 24, Chapman discloses that each of the one or more slots is capable of receiving at least two of the four fasteners (col. 15 lines 46-56 discloses 6 apertures elongated to be able to receive 1-2 screws in each aperture/slot).
Claim(s) 14-20 and 29 is/are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Campbell et al. (US 2014/0277175, hereinafter “Campbell”).
As to claim 14, Campbell discloses a fracture plating system (1, Figs. 1-16, ¶100) capable of stabilizing a multiple fractures of a bone of a patient (Figs. 1-5 show the system structure capable of such use, Figs. 1-5, 35, 41-44, and 50A-50C, ¶99 discloses use in rib fracture repair), wherein the multiple fractures that the fracture plating system is capable of stabilizing define one or more flail segments (Figs. 1-5 show the system structure capable of such use, Figs. 1-5, 35, 41-44, and 50A-50C, ¶99 discloses use in rib fracture repair), the bone comprising an interior surface (Figs. 1, 2, 4, and 50A-50C) facing toward an interior body cavity of the patient (as defined) and an exterior surface (1-5, 35, 41-44, and 50A-50C) facing away from the interior body cavity (as defined), the fracture plating system comprising: a plate (4, Figs. 1 and 4-8) comprising one or more slots (11, 12) and capable of spanning the multiple fractures (if so positioned, Figs. 1-5 show the system structure capable of such use, Figs. 1-5, 35, 41-44, and 50A-50C); and a plurality of fasteners (8s/20s, ¶100 discloses that fastener 8 is a pivoting locking post, ¶104 discloses that that 20 is a pivoting locking post) each capable of being received in the bone and in the one or more slots (Figs. 1, 4, and 50A-50C) capable of securing the plate to the interior surface of the bone (Figs. 1, 4, and 50A-50C); and one or more tethers (130) capable of being received in the plurality of fasteners (Figs. 41, 45, 46, and 50A-50C) and guiding the plurality of fasteners to the interior surface of the bone (Fig. 41); wherein each of the plurality of fasteners is capable of being to be captive within one of the one or more slots (Figs. 1, 4-8, 46, and 50A-50C, ¶s 122 and 123); with the plurality of fasteners captive within the one or more slots, each of the fasteners is capable of pivoting toward the plate into a lower profile configuration (Fig. 45, ¶122) capable of facilitating introduction of the fracture plating system into an intra-thoracic space (Fig. 45, ¶122); the plate comprises a first side (Figs. 6 and7) and a second side opposite the first side (as defined, Figs. 4 and 5); the first side is capable of contacting the interior surface of the bone (Fig. 1); and each of the plurality of fasteners comprises a head portion (26) capable of contacting only the second side (Figs. 1 and 4).
As to claim 15, Campbell discloses that one of the one or more tethers is further capable of passing through one of the one or more slots of the plate (Figs. 46 and 50A-5C) to guide the plate to the interior surface of the bone (Figs. 41-48).
As to claim 16, Campbell discloses that each of the one or more slots is capable of spanning at least one of the multiple fractures (if so positioned, Figs. 1, 4, and 48).
As to claim 17, Campbell discloses that the plurality of fasteners is capable of being received in the bone on opposite sides of the multiple fractures (if so positioned, Figs. 1, 4, and 50A-50C) capable of securing the plate to the interior surface of the bone (Figs. 1, 4, and 50C).
As to claim 18, Campbell discloses that one of the one or more tethers is further capable of drawing the plate and two of the plurality of fasteners through a portal (108, Fig. 31, ¶115) to the interior surface of the bone (Figs. 41-47).
As to claim 19, Campbell discloses a plurality of locking nuts (9s/30s, ¶100 discloses that fastener 9 is a locking cap, ¶105 discloses that that 30 is a locking cap) capable of receiving one of the plurality of fasteners and cooperating with one of the plurality of fasteners (Fig. 1 and 50A-50C) capable of securing the plate to the interior surface of the bone (Figs. 1, 4, and 50C).
As to claim 20, Campbell discloses that each of the one or more slots is capable of receiving at least two of the plurality of fasteners (due to the structural features shown in Figs. 1 and 4, Figs. 1 and 4).
As to claim 29, Campbell discloses that each of the plurality of fasteners comprises a longitudinal axis (Fig. 9) extending along a longest extent of each of the plurality of fasteners (as defined, Fig. 9); and with the plurality of fasteners captive within the one or more slots, each of the fasteners is capable of pivoting such that the longitudinal axis is constrained to move within a single plane (Figs. 45 and 46, ¶s 122 and 123).
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 of this title, 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) 1, 5, 6, 8, 12, and 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chapman et al. (US 5,364,398, hereinafter “Chapman”) in view of Cordaro (US 2004/006319).
As to claim 1, Chapman discloses a fracture plating system (69, 101, 103, col. 15 lines 46-56) capable of stabilizing a first fracture and a second fracture of a bone of a patient (when positioned appropriately, col. 15 lines 46-56 discloses use for fracture treatment with 1-2 screws in each aperture/slot, col. 16 line 64 – col. 17 line 4 discloses that the substantial allowed angulation of screws within the plate enhances capabilities for fixation of oblique and complex fractures and increases the number of bone fragments that can be direction gripped by a screw), the bone comprising an interior surface facing toward an interior body cavity of the patient (if one so chooses to position the system on such a bone) and an exterior surface facing away from the interior body cavity (if one so chooses to position the system on such a bone), the fracture plating system comprising: a plate (69) capable of being placed on the interior surface (if one so chooses to position the system on such a bone, Figs. 9, 10, and 14, col. 15 lines 46-56 discloses that 69 can be used by itself as a conventional bone plate), the plate comprising one or more slots (79, 80, 85, Figs. 9 and 14, col. 14 lines 58-59) and capable of spanning the first fracture and the second fracture (when positioned appropriately, col. 15 lines 46-56 discloses use for fracture treatment with 1-2 screws in each aperture/slot, col. 16 line 64 – col. 17 line 4 discloses that the substantial allowed angulation of screws within the plate enhances capabilities for fixation of oblique and complex fractures and increases the number of bone fragments that can be direction gripped by a screw); and four fasteners (101s, 103s, Figs. 12A-14, col. 15 lines 46-56 discloses use for fracture treatment with the 6 apertures elongated to be able to receive 1-2 screws in each aperture/slot) each capable of being received in the bone and in one of the one or more slots (Figs. 12A-14, col. 15 lines 46-56, col. 15 lines 5-14) capable of securing the plate to the interior surface of the bone (Figs. 12A-14); wherein: the four fasteners are capable of being received in the bone on opposite sides of each of the first fracture and the second fracture (when positioned appropriately, col. 15 lines 46-56 discloses use for fracture treatment with 1-2 screws in each aperture/slot, col. 16 line 64 – col. 17 line 4 discloses that the substantial allowed angulation of screws within the plate enhances capabilities for fixation of oblique and complex fractures and increases the number of bone fragments that can be direction gripped by a screw); each of the four fasteners comprises a head portion (93) and a first threaded portion (lower portion, i.e. adjacent the free end of the shank, as shown in Figs. 12A and 12B, Figs. 12A and 12B, col. 16 lines 10-11) extending from the head portion (Figs. 12A and 12B); the first threaded portion comprises a first major diameter (Figs. 12A and 12B); each of the one or more slots comprises a slot width (Figs. 9 and 10) that is smaller than the head portion (Figs. 9 and 10); and each of the one or more slots is capable of receiving the four fasteners so that the four fasteners are captive within the one or more slots (at least when the screws are threaded into bone); and with the plate secured to the interior surface of the bone, the first threaded portion is spaced apart from the plate (Figs. 9, 12A, 12B, and 14). As to claim 5, Chapman discloses that each of the one or more slots is capable of spanning at least one of the first fracture and the second fracture (when positioned appropriately, col. 15 lines 46-56 discloses use for fracture treatment with 1-2 screws in each aperture/slot, col. 16 line 64 – col. 17 line 4 discloses that the substantial allowed angulation of screws within the plate enhances capabilities for fixation of oblique and complex fractures and increases the number of bone fragments that can be direction gripped by a screw). As to claim 6, Chapman discloses that each of the one or more slots is capable of receiving at least two of the four fasteners (col. 15 lines 46-56 discloses 6 apertures elongated to be able to receive 1-2 screws in each aperture/slot).
Chapman is silent to the slot width is smaller than the first major diameter.
Cordaro teaches a similar plating system (10, 40, Figs. 1, 2, 10, 11, and 14) capable of stabilizing a first fracture and a second fracture of a bone of a patient (when positioned appropriately due to the shown structure, Figs. 1, 2, 10, 11, and 14, ¶2 discloses use for fusing or stabilizing bone segments), the bone comprising an interior surface facing toward an interior body cavity of the patient (if one so chooses to position the system on such a bone) and an exterior surface facing away from the interior body cavity (if one so chooses to position the system on such a bone), the fracture plating system comprising: a plate (10) comprising one or more slots (14); and a fastener (40/46, Figs. 10, 11, and 14, ¶38) capable of being received in the bone and in one of the one or more slots to secure the plate to the interior surface of the bone (Figs. 1, 2, 10, 11, and 14); wherein: the fastener comprises a head portion (40a, Figs. 10, 11, and 14) and a first threaded portion (40c, Figs. 10, 11, and 14) extending from the head portion (Figs. 10, 11, and 14); the first threaded portion comprises a first major diameter (“outside diameter d3” of ¶33, Figs. 10, 11, and 14, ¶33); the one or more slots comprises a slot width (Figs. 1, 2, 11, and 14) that is smaller than each of the head portion and the first major diameter (Fig. 11, ¶24 discloses that the slot is wider than a neck of the fastener but smaller than the threaded portion); the one or more slots is capable of receiving the fastener so that the fastener is captive within the one or more slots (Fig. 11), wherein each end of the one or more slots comprise a helical track (Figs. 1, 2, and 14, ¶24) each capable of receiving a fastener (¶24).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the slot as disclosed by Chapman to be sized to be wider than a neck of the fastener but smaller than the threaded portion and adding the helical track at each end as taught by Cordaro in order to allow the fastener to travel along the slot and allow the bone segments to settle during fusion (Cordaro ¶24).
As to claim 8, Chapman discloses a fracture plating system (69, 101, 103, col. 15 lines 46-56) capable of stabilizing a first fracture and a second fracture of a bone of a patient (when positioned appropriately, col. 15 lines 46-56 discloses use for fracture treatment with 1-2 screws in each aperture/slot, col. 16 line 64 – col. 17 line 4 discloses that the substantial allowed angulation of screws within the plate enhances capabilities for fixation of oblique and complex fractures and increases the number of bone fragments that can be direction gripped by a screw), wherein the first fracture and the second fracture define a flail segment of the bone (if one so chooses to position the system on such a bone), the bone comprising an interior surface facing toward an interior body cavity of the patient (if one so chooses to position the system on such a bone) and an exterior surface facing away from the interior body cavity (if one so chooses to position the system on such a bone), the fracture plating system comprising: a plate (69) comprising one or more slots (79, 80, 85, Figs. 9 and 14, col. 14 lines 58-59) extending along a first longitudinal axis of the plate (Fig. 9) and capable of spanning the first fracture and the second fracture (when positioned appropriately, col. 15 lines 46-56 discloses use for fracture treatment with 1-2 screws in each aperture/slot, col. 16 line 64 – col. 17 line 4 discloses that the substantial allowed angulation of screws within the plate enhances capabilities for fixation of oblique and complex fractures and increases the number of bone fragments that can be direction gripped by a screw); and at least three fasteners (101s, 103s, Figs. 12A-14, col. 15 lines 46-56 discloses use for fracture treatment with the 6 apertures elongated to be able to receive 1-2 screws in each aperture/slot) capable of being captively received in the one or more slots (at least when the screws are threaded into bone); wherein: a first fastener of the at least three fasteners (101s, 103s, Figs. 12A-14, col. 15 lines 46-56 discloses use for fracture treatment with the 6 apertures elongated to be able to receive 1-2 screws in each aperture/slot) and a second fastener of the at least three fasteners (101s, 103s, Figs. 12A-14, col. 15 lines 46-56 discloses use for fracture treatment with the 6 apertures elongated to be able to receive 1-2 screws in each aperture/slot) are capable of being received in the bone on opposite sides of the first fracture and the second fracture (when positioned appropriately, col. 15 lines 46-56 discloses use for fracture treatment with 1-2 screws in each aperture/slot, col. 16 line 64 – col. 17 line 4 discloses that the substantial allowed angulation of screws within the plate enhances capabilities for fixation of oblique and complex fractures and increases the number of bone fragments that can be direction gripped by a screw) capable of securing the plate to the interior surface of the bone (Figs. 12A-14); a third fastener of the at least three fasteners (101s, 103s, Figs. 12A-14, col. 15 lines 46-56 discloses use for fracture treatment with the 6 apertures elongated to be able to receive 1-2 screws in each aperture/slot) is capable of being received in the flail segment (if one so chooses to position the system on such a bone) capable of securing the plate to the flail segment (if one so chooses to position the system on such a bone); each of the at least three fasteners comprises a second longitudinal axis (vertical in each of Figs. 12A and 12B, Figs. 12A and 12B) extending along a longest extent of each of the at least three fasteners (as defined, Figs. 12A and 12B), and a head portion (93) that is generally symmetrical across two orthogonal planes each passing through the second longitudinal axis (Figs. 12A-13, col. 4 lines 17-18, col. 15 lines 53-55, and col. 16 lines 30-32 disclose that a plate-engaging surface portion of the head is spherically rounded); and a first threaded portion (lower portion, i.e. adjacent the free end of the shank, as shown in Figs. 12A and 12B, Figs. 12A and 12B, col. 16 lines 10-11) that comprises a first major diameter (Figs. 12A and 12B); each of the one or more slots comprises a slot width (Figs. 9 and 10) that is smaller than the head portion (Figs. 9 and 10); and each of the one or more slots is capable of receiving the fasteners so that the fasteners are captive within the one or more slots (at least when the screws are threaded into bone); and with the plate secured to the interior surface of the bone, the first threaded portion is spaced apart from the plate (Figs. 9, 12A, 12B, and 14). As to claim 12, Chapman discloses that each of the one or more slots is capable of spanning at least one of the first fracture and the second fracture (when positioned appropriately, col. 15 lines 46-56 discloses use for fracture treatment with 1-2 screws in each aperture/slot, col. 16 line 64 – col. 17 line 4 discloses that the substantial allowed angulation of screws within the plate enhances capabilities for fixation of oblique and complex fractures and increases the number of bone fragments that can be direction gripped by a screw).
Chapman is silent to the first fastener and the second fastener are configured to be captive within the one or more slots prior to the fasteners being received in the bone.
Cordaro teaches a similar plating system (10, 40, Figs. 1, 2, 10, 11, and 14) capable of stabilizing a first fracture and a second fracture of a bone of a patient (when positioned appropriately due to the shown structure, Figs. 1, 2, 10, 11, and 14, ¶2 discloses use for fusing or stabilizing bone segments), the bone comprising an interior surface facing toward an interior body cavity of the patient (if one so chooses to position the system on such a bone) and an exterior surface facing away from the interior body cavity (if one so chooses to position the system on such a bone), the fracture plating system comprising: a plate (10) comprising one or more slots (14); and a fastener (40/46, Figs. 10, 11, and 14, ¶38) capable of being captively received in the one or more slots (Figs. 1, 2, 10, 11, and 14); wherein: the fastener comprises a second longitudinal axis (Fig. 10) extending along a longest extent of the fastener (as defined, Fig. 10), a head portion (40a, Figs. 10, 11, and 14) that is generally symmetrical across two orthogonal planes each passing through the second longitudinal axis (Figs. 10, 11, and 14), and a first threaded portion (40c, Figs. 10, 11, and 14) extending from the head portion (Figs. 10, 11, and 14); the first threaded portion comprises a first major diameter (“outside diameter d3” of ¶33, Figs. 10, 11, and 14, ¶33); and the first fastener and the second fastener are capable of being captive within the one or more slots prior to the fasteners being received in the bone (due to the relative sizing of the fastener and the slot, Figs. 10, 11, and 14, ¶24), where the one or more slots comprises a slot width (Figs. 1, 2, 11, and 14) that is smaller than each of the head portion and the first major diameter (Fig. 11, ¶24 discloses that the slot is wider than a neck of the fastener but smaller than the threaded portion); wherein each end of the one or more slots comprise a helical track (Figs. 1, 2, and 14, ¶24) each capable of receiving a fastener (¶24).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the slot as disclosed by Chapman to be sized to be wider than a neck of the fastener but smaller than the threaded portion and adding the helical track at each end as taught by Cordaro in order to allow the fastener to travel along the slot and allow the bone segments to settle during fusion (Cordaro ¶24).
As to claim 30, Chapman discloses the invention of claim 21 as well as the first threaded portion comprises a first major diameter (Figs. 12A and 12B); each of the one or more slots comprises a slot width (Figs. 9 and 10) that is smaller than the head portion (Figs. 9 and 10); and each of the one or more slots is capable of receiving the four fasteners so that the four fasteners are captive within the one or more slots (at least when the screws are threaded into bone); and with the plate secured to the interior surface of the bone, the first threaded portion is spaced apart from the plate (Figs. 9, 12A, 12B, and 14).
Chapman is silent to the slot width is smaller than the first major diameter.
Cordaro teaches a similar plating system (10, 40, Figs. 1, 2, 10, 11, and 14) capable of stabilizing a first fracture and a second fracture of a bone of a patient (when positioned appropriately due to the shown structure, Figs. 1, 2, 10, 11, and 14, ¶2 discloses use for fusing or stabilizing bone segments), the bone comprising an interior surface facing toward an interior body cavity of the patient (if one so chooses to position the system on such a bone) and an exterior surface facing away from the interior body cavity (if one so chooses to position the system on such a bone), the fracture plating system comprising: a plate (10) comprising one or more slots (14); and a fastener (40/46, Figs. 10, 11, and 14, ¶38) capable of being received in the bone and in one of the one or more slots to secure the plate to the interior surface of the bone (Figs. 1, 2, 10, 11, and 14); wherein: the fastener comprises a head portion (40a, Figs. 10, 11, and 14) and a first threaded portion (40c, Figs. 10, 11, and 14) extending from the head portion (Figs. 10, 11, and 14); each of the one or more slots is capable of receiving the first threaded portion (Figs. 10, 11, and 14, ¶s 24 and 33) so that the fastener is capable of being captive within the one or more slots (Fig. 11); and while captive in one of the one or more slots, the fasteners is capable of moving along the one of the one or more slots (¶24); wherein the first threaded portion comprises a first major diameter (“outside diameter d3” of ¶33, Figs. 10, 11, and 14, ¶33); the one or more slots comprises a slot width (Figs. 1, 2, 11, and 14) that is smaller than each of the head portion and the first major diameter (Fig. 11, ¶24 discloses that the slot is wider than a neck of the fastener but smaller than the threaded portion); wherein each end of the one or more slots comprise a helical track (Figs. 1, 2, and 14, ¶24) each capable of receiving a fastener (¶24).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the slot as disclosed by Chapman to be sized to be wider than a neck of the fastener but smaller than the threaded portion and adding the helical track at each end as taught by Cordaro in order to allow the fastener to travel along the slot and allow the bone segments to settle during fusion (Cordaro ¶24).
Claim(s) 1-13 and 21-24 are rejected under 35 U.S.C. 103 as being unpatentable over Campbell et al. (US 2014/0277175, hereinafter “Campbell”) in view of Cordaro and Chapman.
As to claims 1-7, Campbell discloses a fracture plating system (1, Figs. 1-16, ¶100) capable of stabilizing a first fracture and a second fracture of a bone of a patient (Figs. 1-5 show the system structure capable of such use, Figs. 1-5, 35, 41-44, and 50A-50C, ¶99 discloses use in rib fracture repair), the bone comprising an interior surface (Figs. 1, 2, 4, and 50A-50C) facing toward an interior body cavity of the patient (as defined) and an exterior surface (1-5, 35, 41-44, and 50A-50C) facing away from the interior body cavity (as defined), the fracture plating system comprising: a plate (4, Figs. 1 and 4-8) capable of being placed on the interior surface (Figs. 1, 2, 4, and 50A-50C), the plate comprising one or more slots (11, 12) and capable of spanning the first fracture and the second fracture (if so positioned, Figs. 1-5 show the system structure capable of such use, Figs. 1-5, 35, 41-44, and 50A-50C); and at least two fasteners (8s/20s, ¶100 discloses that fastener 8 is a pivoting locking post, ¶104 discloses that that 20 is a pivoting locking post) each capable of being received in the bone and in one of the one or more slots (Figs. 1, 4, and 50A-50C) capable of securing the plate to the interior surface of the bone (Figs. 1, 4, and 50A-50C); wherein the at least two fasteners are capable of being received in the bone on opposite sides of each of the first fracture and the second fracture (if so positioned, Figs. 1, 4, and 50A-50C), each of the at least two fasteners comprises a head portion (26) and a first threaded portion (portion shown above 22 in Fig. 9, Fig. 9) extending from the head portion (as defined); the first threaded portion comprises a first major diameter (Figs. 9, 10, 12, 45, and 46); each of the one or more slots comprises a slot width (Figs. 4-8) that is smaller than the head portion (Figs. 4, 5, 45, and 46); and each of the one or more slots is capable of receiving the at least two fasteners so that the at least two fasteners are captive within the one or more slots (Figs. 45 and 46, ¶122); and with the plate secured to the interior surface of the bone, the first threaded portion is spaced apart from the plate (by 22, Figs. 9 and 12); wherein each of the one or more slots comprises an insertion slot (14s) and rounded ends (Fig. 4); the insertion slots capable of receiving an engaging neck portion (22) so that the at least two fasteners are captive within the one or more slots (¶122). As to claim 2, Campbell discloses a first tether (130) capable of being received in a first two fastener (Figs. 41, 45, 46, and 50A-50C) and guiding the first two fasteners to the interior surface of the bone (Fig. 41); and a second tether (130) capable of being received in a second two fasteners (Figs. 41, 45, 46, and 50A-50C) and guiding second two fasteners to the interior surface of the bone (Fig. 41). As to claim 3, Campbell discloses that the first tether is further capable of drawing the plate and a first two fasteners through a portal (108, Fig. 31, ¶115) to the interior surface of the bone (Figs. 41-47); and the second tether is further capable of drawing a second two fasteners through the portal to the interior surface of the bone (Figs. 41-47). As to claim 4, Campbell that the first tether is further capable of drawing a first one of the fasteners through a first hole in a first portion of the bone proximate a first side of one of the first fracture and the second fracture, and drawing a second one of the fasteners through a second hole in a second portion of the bone proximate a second side of one of the first fracture and the second fracture (Figs. 41-47). As to claim 5, Campbell discloses that each of the one or more slots is capable of spanning at least one of the first fracture and the second fracture (if so positioned, Figs. 1, 4, and 48). As to claim 6, Campbell discloses that each of the one or more slots is capable of receiving at least two of four fasteners (due to the structural features shown in Figs. 1 and 4, Figs. 1 and 4). As to claim 7, Campbell discloses at least two locking nuts (9s/30s, ¶100 discloses that fastener 9 is a locking cap, ¶105 discloses that that 30 is a locking cap) each capable of receiving one of the fasteners and cooperating with one of the fasteners (Fig. 1 and 50A-50C) capable of securing the plate to the interior surface of the bone (Figs. 1, 4, and 50C).
Campbell is silent to the at least two fasteners being four fasteners and the slot width is smaller than the first major diameter. As to claim 7, Campbell is silent to the at least two locking nuts being four locking nuts.
Cordaro teaches a similar plating system (10, 40, Figs. 1, 2, 10, 11, and 14) capable of stabilizing a first fracture and a second fracture of a bone of a patient (when positioned appropriately due to the shown structure, Figs. 1, 2, 10, 11, and 14, ¶2 discloses use for fusing or stabilizing bone segments), the bone comprising an interior surface facing toward an interior body cavity of the patient (if one so chooses to position the system on such a bone) and an exterior surface facing away from the interior body cavity (if one so chooses to position the system on such a bone), the fracture plating system comprising: a plate (10) comprising one or more slots (14); and a fastener (40/46, Figs. 10, 11, and 14, ¶38) capable of being received in the bone and in one of the one or more slots to secure the plate to the interior surface of the bone (Figs. 1, 2, 10, 11, and 14); wherein: the fastener comprises a head portion (40a, Figs. 10, 11, and 14) and a first threaded portion (40c, Figs. 10, 11, and 14) extending from the head portion (Figs. 10, 11, and 14); the first threaded portion comprises a first major diameter (“outside diameter d3” of ¶33, Figs. 10, 11, and 14, ¶33); the one or more slots comprises a slot width (Figs. 1, 2, 11, and 14) that is smaller than each of the head portion and the first major diameter (Fig. 11, ¶24 discloses that the slot is wider than a neck of the fastener but smaller than the threaded portion); the one or more slots is capable of receiving the fastener so that the fastener is captive within the one or more slots (Fig. 11), wherein each end of the one or more slots comprise a helical track (Figs. 1, 2, and 14, ¶24) each capable of receiving a fastener (¶24), wherein the fastener comprises an unthreaded neck (40b, Figs. 10 and 11, ¶33).
Chapman teaches as similar plating system (69, 101, 103, col. 15 lines 46-56) capable of stabilizing a first fracture and a second fracture of a bone of a patient (when positioned appropriately, col. 15 lines 46-56 discloses use for fracture treatment with 1-2 screws in each aperture/slot, col. 16 line 64 – col. 17 line 4 discloses that the substantial allowed angulation of screws within the plate enhances capabilities for fixation of oblique and complex fractures and increases the number of bone fragments that can be direction gripped by a screw), the bone comprising an interior surface facing toward an interior body cavity of the patient (if one so chooses to position the system on such a bone) and an exterior surface facing away from the interior body cavity (if one so chooses to position the system on such a bone), the fracture plating system comprising: a plate (69) comprising one or more slots (79, 80, 85, Figs. 9 and 14, col. 14 lines 58-59); and four fasteners (101s, 103s, Figs. 12A-14, col. 15 lines 46-56 discloses use for fracture treatment with the 6 apertures elongated to be able to receive 1-2 screws in each aperture/slot) each capable of being received in the bone and in one of the one or more slots (Figs. 12A-14, col. 15 lines 46-56, col. 15 lines 5-14) capable of securing the plate to the interior surface of the bone (Figs. 12A-14); wherein: the four fasteners are capable of being received in the bone on opposite sides of each of the first fracture and the second fracture (when positioned appropriately, col. 15 lines 46-56 discloses use for fracture treatment with 1-2 screws in each aperture/slot, col. 16 line 64 – col. 17 line 4 discloses that the substantial allowed angulation of screws within the plate enhances capabilities for fixation of oblique and complex fractures and increases the number of bone fragments that can be direction gripped by a screw); each of the four fasteners comprises a head portion (93) and a first threaded portion (lower portion, i.e. adjacent the free end of the shank, as show in Figs. 12A and 12B, Figs. 12A and 12B, col. 16 lines 10-11) extending from the head portion (Figs. 12A and 12B ); and each of the one or more slots is capable of threadably receiving the first threaded portions (Figs. 9, 12A, 12B, and 14) so that the four fasteners are capable of being captive within the one or more slots (at least when the screws are threaded into bone); and with the plate secured to the interior surface of the bone, the first threaded portion is spaced apart from the plate (Figs. 9, 12A, 12B, and 14).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the fasteners and the slots as disclosed by Campbell such that the fasteners comprise a neck and head shape and the slots are sized to be wider than the neck of the fastener but smaller than the threaded portion and adding the helical track at each end as taught by Cordaro in order to allow the fastener to travel along the slot and allow the bone segments to settle during fusion (Cordaro ¶24) to effectively fix the fasteners to the plate (Campbell ¶122), i.e. to provide a known alternate engagement of the fasteners with the slot. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the at least two fasteners as disclosed by Campbell to be four fasteners as taught by Chapman in order to aid in fracture treatment with the slots able to receive two screws in each slot (Chapman col. 15 lines 46-56). In forming the combination and as to claim 7, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention was made to modify the plating system comprising at least two locking nuts that mate with the at least two fasteners as disclosed by Campbell to include four locking nuts to mate with the four fasteners of the combination, since mere duplication of the essential working parts of a device involves only routine skill in the art and one would be motivated to do so in order to additionally secure the bone segments (Figs. 1 and 4, abstract, ¶60) and to provide a nut for each fastener.
As to claims 8-13, Campbell discloses a fracture plating system (1, Figs. 1-16, ¶100) capable of stabilizing a first fracture and a second fracture of a bone of a patient (Figs. 1-5 show the system structure capable of such use, Figs. 1-5, 35, 41-44, and 50A-50C, ¶99 discloses use in rib fracture repair), wherein the first fracture and the second fracture that the fracture plating system is capable of stabilizing define a flail segment of the bone (Figs. 1-5 show the system structure capable of such use, Figs. 1-5, 35, 41-44, and 50A-50C, ¶99 discloses use in rib fracture repair), the bone comprising an interior surface (Figs. 1, 2, 4, and 50A-50C) facing toward an interior body cavity of the patient (as defined) and an exterior surface (1-5, 35, 41-44, and 50A-50C) facing away from the interior body cavity (as defined), the fracture plating system comprising: a plate (4, Figs. 1 and 4-8) comprising one or more slots (11, 12) extending along a first longitudinal axis of the plate (horizontal as shown in Figs. 1 and 46, Figs.1, 4-8, 46, and 50A-50C) and capable of spanning the first fracture and the second fracture (if so positioned, Figs. 1-5 show the system structure capable of such use, Figs. 1-5, 35, 41-44, and 50A-50C), each of the one or more slots comprises an insertion slot (14s); and at least two fasteners (8s/20s, ¶100 discloses that fastener 8 is a pivoting locking post, ¶104 discloses that that 20 is a pivoting locking post) capable of being captively received in the one or more slots (Figs. 1, 4, and 50A-50C); wherein first and second fasteners of the at least two fasteners are capable of being received in the bone on opposite sides of each of the first fracture and the second fracture (if so positioned, Figs. 1, 4, and 50A-50C) capable of securing the plate to the interior surface of the bone (Figs. 1, 4, and 50A-50C); and the first and second fasteners of the at least two fasteners are capable of being received in the flail segment (due to the structure shown in Figs. 1-3 and 9-16, Figs. 1, 4, and 50A-50C) capable of securing the plate to the flail segment (if one so chooses to insert them therein, Figs. 1, 4, and 50A-50C), each of the at least two fasteners comprises a second longitudinal axis (vertical as shown in Figs. 1, 46, and 50A-50C, Figs. 1, 4-8, 46, and 50A-50C) extending along a longest extent of each of the fasteners (as defined); and a head portion (26) that is generally symmetrical across a plane passing through the second longitudinal axis (Fig. 5); and the first fastener and the second fastener are capable of being captive within the one or more slots prior to the fasteners being received in the bone (Figs. 1, 4-8, 46, and 50A-50C, ¶122), wherein each of the two fasteners is capable of moving along the first longitudinal axis in more than one direction (left or right as shown in Figs. 1 and 5, e.g. to align the fasteners 20 for insertion into the bone holes 118 of ¶123, Figs. 1, 4-8, 46, and 50A-50C, ¶123), each of the at least two fasteners comprises a first threaded portion (portion shown above 22 in Fig. 9, Fig. 9) comprising a first major diameter (Figs. 9, 10, 12, 45, and 46); each of the one or more slots comprises a slot width (Figs. 4-8) that is smaller than the head portion (Figs. 4, 5, 45, and 46); wherein each of the one or more slots comprises an insertion slot (14s) and rounded ends (Fig. 4); the insertion slots capable of receiving an engaging neck portion (22) so that the at least two fasteners are captive within the one or more slots (¶122). As to claim 9, Campbell discloses a tether (130) capable of being received in a two of the fasteners (Figs. 41, 45, 46, and 50A-50C) and guiding two of the fasteners to the interior surface of the bone (Fig. 41). As to claim 10, Campbell discloses that the tether is further capable of passing through one of the one or more slots of the plate (Figs. 46 and 50A-5C) to guide the plate to the interior surface of the bone (Figs. 41-48). As to claim 11, Campbell the tether is further capable of drawing the plate and two of the fasteners through a portal (108, Fig. 31, ¶115) to the interior surface of the bone (Figs. 41-47). As to claim 12, Campbell discloses that each of the one or more slots is capable of spanning at least one of the first fracture and the second fracture (if so positioned, Figs. 1, 4, and 48). As to claim 13, Campbell discloses at least two locking nuts (9s/30s, ¶100 discloses that fastener 9 is a locking cap, ¶105 discloses that that 30 is a locking cap) capable of receiving one of the fasteners and cooperating with one of the fasteners (Fig. 1 and 50A-50C) capable of securing the plate to the interior surface of the bone (Figs. 1, 4, and 50C).
Campbell is silent to the at least two fasteners being at least three fasteners and the head portion being generally symmetrical across two orthogonal planes each passing through the second longitudinal axis. As to claim 13, Campbell is silent to the at least two locking nuts being at least three locking nuts.
Cordaro teaches a similar plating system (10, 40, Figs. 1, 2, 10, 11, and 14) capable of stabilizing a first fracture and a second fracture of a bone of a patient (when positioned appropriately due to the shown structure, Figs. 1, 2, 10, 11, and 14, ¶2 discloses use for fusing or stabilizing bone segments), the bone comprising an interior surface facing toward an interior body cavity of the patient (if one so chooses to position the system on such a bone) and an exterior surface facing away from the interior body cavity (if one so chooses to position the system on such a bone), the fracture plating system comprising: a plate (10) comprising one or more slots (14); and a fastener (40/46, Figs. 10, 11, and 14, ¶38) capable of being captively received in the one or more slots (Figs. 1, 2, 10, 11, and 14); wherein: the fastener comprises a second longitudinal axis (Fig. 10) extending along a longest extent of the fastener (as defined, Fig. 10), a head portion (40a, Figs. 10, 11, and 14) that is generally symmetrical across two orthogonal planes each passing through the second longitudinal axis (Figs. 10, 11, and 14), and a first threaded portion (40c, Figs. 10, 11, and 14) extending from the head portion (Figs. 10, 11, and 14); the first threaded portion comprises a first major diameter (“outside diameter d3” of ¶33, Figs. 10, 11, and 14, ¶33); and the first fastener and the second fastener are capable of being captive within the one or more slots prior to the fasteners being received in the bone (due to the relative sizing of the fastener and the slot, Figs. 10, 11, and 14, ¶24), where the one or more slots comprises a slot width (Figs. 1, 2, 11, and 14) that is smaller than each of the head portion and the first major diameter (Fig. 11, ¶24 discloses that the slot is wider than a neck of the fastener but smaller than the threaded portion); wherein each end of the one or more slots comprise a helical track (Figs. 1, 2, and 14, ¶24) each capable of receiving a fastener (¶24).
Chapman teaches as similar plating system (69, 101, 103, col. 15 lines 46-56) capable of stabilizing a first fracture and a second fracture of a bone of a patient (when positioned appropriately, col. 15 lines 46-56 discloses use for fracture treatment with 1-2 screws in each aperture/slot, col. 16 line 64 – col. 17 line 4 discloses that the substantial allowed angulation of screws within the plate enhances capabilities for fixation of oblique and complex fractures and increases the number of bone fragments that can be direction gripped by a screw), the bone comprising an interior surface facing toward an interior body cavity of the patient (if one so chooses to position the system on such a bone) and an exterior surface facing away from the interior body cavity (if one so chooses to position the system on such a bone), the fracture plating system comprising: a plate (69) comprising one or more slots (79, 80, 85, Figs. 9 and 14, col. 14 lines 58-59); and four fasteners (101s, 103s, Figs. 12A-14, col. 15 lines 46-56 discloses use for fracture treatment with the 6 apertures elongated to be able to receive 1-2 screws in each aperture/slot) each capable of being received in the bone and in one of the one or more slots (Figs. 12A-14, col. 15 lines 46-56, col. 15 lines 5-14) capable of securing the plate to the interior surface of the bone (Figs. 12A-14); wherein: the four fasteners are capable of being received in the bone on opposite sides of each of the first fracture and the second fracture (when positioned appropriately, col. 15 lines 46-56 discloses use for fracture treatment with 1-2 screws in each aperture/slot, col. 16 line 64 – col. 17 line 4 discloses that the substantial allowed angulation of screws within the plate enhances capabilities for fixation of oblique and complex fractures and increases the number of bone fragments that can be direction gripped by a screw); each of the four fasteners comprises a head portion (93) and a first threaded portion (lower portion, i.e. adjacent the free end of the shank, as show in Figs. 12A and 12B, Figs. 12A and 12B, col. 16 lines 10-11) extending from the head portion (Figs. 12A and 12B ); and each of the one or more slots is capable of threadably receiving the first threaded portions (Figs. 9, 12A, 12B, and 14) so that the four fasteners are capable of being captive within the one or more slots (at least when the screws are threaded into bone); and with the plate secured to the interior surface of the bone, the first threaded portion is spaced apart from the plate (Figs. 9, 12A, 12B, and 14).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the fasteners and the slots as disclosed by Campbell such that the fasteners comprise a neck and head shape and the slots are sized to be wider than the neck of the fastener but smaller than the threaded portion and adding the helical track at each end as taught by Cordaro in order to allow the fastener to travel along the slot and allow the bone segments to settle during fusion (Cordaro ¶24) to effectively fix the fasteners to the plate (Campbell ¶122), i.e. to provide a known alternate engagement of the fasteners with the slot. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the at least two fasteners as disclosed by Campbell to be four fasteners as taught by Chapman in order to aid in fracture treatment with the slots able to receive two screws in each slot (Chapman col. 15 lines 46-56). In forming the combination and as to claim 13, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention was made to modify the plating system comprising at least two locking nuts that mate with the at least two fasteners as disclosed by Campbell to include four locking nuts to mate with the four fasteners of the combination, since mere duplication of the essential working parts of a device involves only routine skill in the art and one would be motivated to do so in order to additionally secure the bone segments (Figs. 1 and 4, abstract, ¶60) and to provide a nut for each fastener.
As to claims 21-24, Campbell discloses a fracture plating system (1, Figs. 1-16, ¶100) capable of stabilizing a first fracture and a second fracture of a bone of a patient (Figs. 1-5 show the system structure capable of such use, Figs. 1-5, 35, 41-44, and 50A-50C, ¶99 discloses use in rib fracture repair), the bone comprising an interior surface (Figs. 1, 2, 4, and 50A-50C) facing toward an interior body cavity of the patient (as defined) and an exterior surface (1-5, 35, 41-44, and 50A-50C) facing away from the interior body cavity (as defined), the fracture plating system comprising: a plate (4, Figs. 1 and 4-8) capable of being placed on the interior surface (Figs. 1, 2, 4, and 50A-50C), the plate comprising one or more slots (11, 12) and capable of spanning the first fracture and the second fracture (if so positioned, Figs. 1-5 show the system structure capable of such use, Figs. 1-5, 35, 41-44, and 50A-50C); and at least two fasteners (8s/20s, ¶100 discloses that fastener 8 is a pivoting locking post, ¶104 discloses that that 20 is a pivoting locking post) each capable of being received in the bone and in one of the one or more slots (Figs. 1, 4, and 50A-50C) capable of securing the plate to the interior surface of the bone (Figs. 1, 4, and 50A-50C); wherein the at least two fasteners are capable of being received in the bone on opposite sides of each of the first fracture and the second fracture (if so positioned, Figs. 1, 4, and 50A-50C), each of the at least two fasteners comprises a head portion (26) and a first threaded portion (portion shown above 22 in Fig. 9, Fig. 9) extending from the head portion (as defined); each of the one or more slots is capable of receiving the first threaded portion so that the at least two fasteners are capable of being captive within the one or more slots (Figs. 45 and 46, ¶122); the first threaded portion comprises a first major diameter (Figs. 9, 10, 12, 45, and 46); while captive in one of the one or more slots, each of the fasteners is capable of moving along the one of the one or more slots (Figs. 45 and 46, ¶122) and pivoting in a single plane relative to the one of the one or more slots (Figs. 45 and 46, ¶122); wherein each of the one or more slots comprises a slot width (Figs. 4-8) that is smaller than the head portion (Figs. 4, 5, 45, and 46); and with the plate secured to the interior surface of the bone, the first threaded portion is spaced apart from the plate (by 22, Figs. 9 and 12); wherein each of the one or more slots comprises an insertion slot (14s) and rounded ends (Fig. 4); the insertion slots capable of receiving an engaging neck portion (22) so that the at least two fasteners are captive within the one or more slots (¶122). As to claim 22, Campbell discloses a first tether (130) capable of being received in a first two fastener (Figs. 41, 45, 46, and 50A-50C) and guiding the first two fasteners to the interior surface of the bone (Fig. 41); and a second tether (130) capable of being received in a second two fasteners (Figs. 41, 45, 46, and 50A-50C) and guiding second two fasteners to the interior surface of the bone (Fig. 41). As to claim 23, Campbell discloses that the first tether is further capable of drawing the plate and a first two fasteners through a portal (108, Fig. 31, ¶115) to the interior surface of the bone (Figs. 41-47); and the second tether is further capable of drawing a second two fasteners through the portal to the interior surface of the bone (Figs. 41-47). As to claim 24, Campbell discloses that each of the one or more slots is capable of receiving at least two of four fasteners (due to the structural features shown in Figs. 1 and 4, Figs. 1 and 4).
Campbell is silent to the at least two fasteners being four fasteners and the slot width is smaller than the first major diameter.
Cordaro teaches a similar plating system (10, 40, Figs. 1, 2, 10, 11, and 14) capable of stabilizing a first fracture and a second fracture of a bone of a patient (when positioned appropriately due to the shown structure, Figs. 1, 2, 10, 11, and 14, ¶2 discloses use for fusing or stabilizing bone segments), the bone comprising an interior surface facing toward an interior body cavity of the patient (if one so chooses to position the system on such a bone) and an exterior surface facing away from the interior body cavity (if one so chooses to position the system on such a bone), the fracture plating system comprising: a plate (10) comprising one or more slots (14); and a fastener (40/46, Figs. 10, 11, and 14, ¶38) capable of being received in the bone and in one of the one or more slots to secure the plate to the interior surface of the bone (Figs. 1, 2, 10, 11, and 14); wherein: the fastener comprises a head portion (40a, Figs. 10, 11, and 14) and a first threaded portion (40c, Figs. 10, 11, and 14) extending from the head portion (Figs. 10, 11, and 14); the first threaded portion comprises a first major diameter (“outside diameter d3” of ¶33, Figs. 10, 11, and 14, ¶33); the one or more slots comprises a slot width (Figs. 1, 2, 11, and 14) that is smaller than each of the head portion and the first major diameter (Fig. 11, ¶24 discloses that the slot is wider than a neck of the fastener but smaller than the threaded portion); the one or more slots is capable of receiving the fastener so that the fastener is captive within the one or more slots (Fig. 11), wherein each end of the one or more slots comprise a helical track (Figs. 1, 2, and 14, ¶24) each capable of receiving a fastener (¶24), wherein the fastener comprises an unthreaded neck (40b, Figs. 10 and 11, ¶33).
Chapman teaches as similar plating system (69, 101, 103, col. 15 lines 46-56) capable of stabilizing a first fracture and a second fracture of a bone of a patient (when positioned appropriately, col. 15 lines 46-56 discloses use for fracture treatment with 1-2 screws in each aperture/slot, col. 16 line 64 – col. 17 line 4 discloses that the substantial allowed angulation of screws within the plate enhances capabilities for fixation of oblique and complex fractures and increases the number of bone fragments that can be direction gripped by a screw), the bone comprising an interior surface facing toward an interior body cavity of the patient (if one so chooses to position the system on such a bone) and an exterior surface facing away from the interior body cavity (if one so chooses to position the system on such a bone), the fracture plating system comprising: a plate (69) comprising one or more slots (79, 80, 85, Figs. 9 and 14, col. 14 lines 58-59); and four fasteners (101s, 103s, Figs. 12A-14, col. 15 lines 46-56 discloses use for fracture treatment with the 6 apertures elongated to be able to receive 1-2 screws in each aperture/slot) each capable of being received in the bone and in one of the one or more slots (Figs. 12A-14, col. 15 lines 46-56, col. 15 lines 5-14) capable of securing the plate to the interior surface of the bone (Figs. 12A-14); wherein: the four fasteners are capable of being received in the bone on opposite sides of each of the first fracture and the second fracture (when positioned appropriately, col. 15 lines 46-56 discloses use for fracture treatment with 1-2 screws in each aperture/slot, col. 16 line 64 – col. 17 line 4 discloses that the substantial allowed angulation of screws within the plate enhances capabilities for fixation of oblique and complex fractures and increases the number of bone fragments that can be direction gripped by a screw); each of the four fasteners comprises a head portion (93) and a first threaded portion (lower portion, i.e. adjacent the free end of the shank, as show in Figs. 12A and 12B, Figs. 12A and 12B, col. 16 lines 10-11) extending from the head portion (Figs. 12A and 12B); each of the one or more slots is capable of receiving the first threaded portion (Figs. 9, 12A, 12B, and 14) so that the four fasteners are capable of being captive within the one or more slots (at least when the screws are threaded into bone); and while captive in one of the one or more slots, each of the four fasteners is capable of moving along the one of the one or more slots and pivoting in a single plane relative to the one of the one or more slots (when the plate is slid relative to the bone while the fasteners are threaded into the bone, i.e. until the fasteners contact the end of a corresponding slot due to the structure shown in Figs. 9, 10, 12A, and 12B), and each of the one or more slots is capable of threadably receiving the first threaded portions (Figs. 9, 12A, 12B, and 14) so that the four fasteners are capable of being captive within the one or more slots (at least when the screws are threaded into bone); and with the plate secured to the interior surface of the bone, the first threaded portion is spaced apart from the plate (Figs. 9, 12A, 12B, and 14). As to claim 24, Chapman teaches that each of the one or more slots is capable of receiving at least two of the four fasteners (col. 15 lines 46-56 discloses 6 apertures elongated to be able to receive 1-2 screws in each aperture/slot).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the fasteners and the slots as disclosed by Campbell such that the fasteners comprise a neck and head shape and the slots are sized to be wider than the neck of the fastener but smaller than the threaded portion and adding the helical track at each end as taught by Cordaro in order to allow the fastener to travel along the slot and allow the bone segments to settle during fusion (Cordaro ¶24) to effectively fix the fasteners to the plate (Campbell ¶122), i.e. to provide a known alternate engagement of the fasteners with the slot. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the at least two fasteners as disclosed by Campbell to be four fasteners as taught by Chapman in order to aid in fracture treatment with the slots able to receive two screws in each slot (Chapman col. 15 lines 46-56). In forming the combination, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention was made to modify the plating system comprising at least two locking nuts that mate with the at least two fasteners as disclosed by Campbell to include four locking nuts to mate with the four fasteners of the combination, since mere duplication of the essential working parts of a device involves only routine skill in the art and one would be motivated to do so in order to additionally secure the bone segments (Figs. 1 and 4, abstract, ¶60) and to provide a nut for each fastener.
Claim(s) 25-28 are rejected under 35 U.S.C. 103 as being unpatentable over Campbell in view of Cordaro.
As to claims 25-28, Campbell discloses a fracture plating system (1, Figs. 1-16, ¶100) capable of stabilizing a multiple fractures of a bone of a patient (Figs. 1-5 show the system structure capable of such use, Figs. 1-5, 35, 41-44, and 50A-50C, ¶99 discloses use in rib fracture repair), wherein the multiple fractures that the fracture plating system is capable of stabilizing define one or more flail segments (Figs. 1-5 show the system structure capable of such use, Figs. 1-5, 35, 41-44, and 50A-50C, ¶99 discloses use in rib fracture repair), the bone comprising an interior surface (Figs. 1, 2, 4, and 50A-50C) facing toward an interior body cavity of the patient (as defined) and an exterior surface (1-5, 35, 41-44, and 50A-50C) facing away from the interior body cavity (as defined), the fracture plating system comprising: a plate (4, Figs. 1 and 4-8) comprising one or more slots (11, 12) and capable of spanning the multiple fractures (if so positioned, Figs. 1-5 show the system structure capable of such use, Figs. 1-5, 35, 41-44, and 50A-50C); a plurality of fasteners (8s/20s, ¶100 discloses that fastener 8 is a pivoting locking post, ¶104 discloses that that 20 is a pivoting locking post) each capable of being received in the bone and in the one or more slots (Figs. 1, 4, and 50A-50C) capable of securing the plate to the interior surface of the bone (Figs. 1, 4, and 50A-50C); and one or more tethers (130) capable of being received in the plurality of fasteners (Figs. 41, 45, 46, and 50A-50C) and guiding the plurality of fasteners to the interior surface of the bone (Fig. 41); wherein each of the plurality of fasteners is capable of being captive within one of the one or more slots (Figs. 1, 4-8, 46, and 50A-50C, ¶s 122 and 123); with the plurality of fasteners captive within the one or more slots, each of the fasteners is capable of pivoting toward the plate into a lower profile configuration (Fig. 45, ¶122) capable of facilitating introduction of the fracture plating system into an intra-thoracic space (Fig. 45, ¶122); wherein each of the fasteners comprises a head portion (26) and a first threaded portion (portion shown above 22 in Fig. 9, Fig. 9) comprising a first major diameter (Figs. 9, 10, 12, 45, and 46); while captive in one of the one or more slots, each of the fasteners is capable of moving along the one of the one or more slots (Figs. 45 and 46, ¶122) and pivoting in a single plane relative to the one of the one or more slots (Figs. 45 and 46, ¶122); wherein each of the one or more slots comprises a slot width (Figs. 4-8) that is smaller than the head portion (Figs. 4, 5, 45, and 46); and with the plate secured to the interior surface of the bone, the first threaded portion is spaced apart from the plate (by 22, Figs. 9 and 12); wherein each of the one or more slots comprises an insertion slot (14s) and rounded ends (Fig. 4); the insertion slots capable of receiving an engaging neck portion (22) so that the at least two fasteners are captive within the one or more slots (¶122). As to claim 26, Campbell discloses that one of the one or more tethers is further capable of passing through one of the one or more slots of the plate (Figs. 46 and 50A-5C) to guide the plate to the interior surface of the bone (Figs. 41-48). As to claim 27, Campbell discloses that one of the one or more tethers is further capable of drawing the plate and two of the plurality of fasteners through a portal (108, Fig. 31, ¶115) to the interior surface of the bone (Figs. 41-47). As to claim 20, Campbell discloses that each of the one or more slots is capable of receiving at least two of the plurality of fasteners (due to the structural features shown in Figs. 1 and 4, Figs. 1 and 4).
Campbell is silent to each of the plurality of fasteners is configured to be captive within one of the one or more slots independently of engagement of any protruding feature of each of the plurality of fasteners with the slot.
Cordaro teaches a similar plating system (10, 40, Figs. 1, 2, 10, 11, and 14) capable of stabilizing a first fracture and a second fracture of a bone of a patient (when positioned appropriately due to the shown structure, Figs. 1, 2, 10, 11, and 14, ¶2 discloses use for fusing or stabilizing bone segments), the bone comprising an interior surface facing toward an interior body cavity of the patient (if one so chooses to position the system on such a bone) and an exterior surface facing away from the interior body cavity (if one so chooses to position the system on such a bone), the fracture plating system comprising: a plate (10) comprising one or more slots (14); and a fastener (40/46, Figs. 10, 11, and 14, ¶38) capable of being captively received in the one or more slots (Figs. 1, 2, 10, 11, and 14); wherein: each of the plurality of fasteners is capable of being captive within one of the one or more slots independently of engagement of any protruding feature of each of the plurality of fasteners with the slot (Figs. 10, 11, and 14, ¶38); the fastener comprises a head portion (40a, Figs. 10, 11, and 14) that is generally symmetrical across two orthogonal planes each passing through a second longitudinal axis (Figs. 10, 11, and 14) and a first threaded portion (40c, Figs. 10, 11, and 14) comprising a first major diameter (“outside diameter d3” of ¶33, Figs. 10, 11, and 14, ¶33); and the first fastener and the second fastener are capable of being captive within the one or more slots prior to the fasteners being received in the bone (due to the relative sizing of the fastener and the slot, Figs. 10, 11, and 14, ¶24), where the one or more slots comprises a slot width (Figs. 1, 2, 11, and 14) that is smaller than each of the head portion and the first major diameter (Fig. 11, ¶24 discloses that the slot is wider than a neck of the fastener but smaller than the threaded portion); wherein each end of the one or more slots comprise a helical track (Figs. 1, 2, and 14, ¶24) each capable of receiving a fastener (¶24).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the fasteners and the slots as disclosed by Campbell such that the fasteners comprise a neck and head shape and the slots are sized to be wider than the neck of the fastener but smaller than the threaded portion and adding the helical track at each end as taught by Cordaro in order to allow the fastener to travel along the slot and allow the bone segments to settle during fusion (Cordaro ¶24) to effectively fix the fasteners to the plate (Campbell ¶122), i.e. to provide a known alternate engagement of the fasteners with the slot.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY SIPP whose telephone number is (313)446-6553. The examiner can normally be reached on Monday through Thursday, 6:30am-4pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong can be reached on 571-272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/AMY R SIPP/Primary Examiner, Art Unit 3775
Prosecution Insights