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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 19 November 2025 has been entered.
Response to Amendment
This Office Action is responsive to the amendment filed on 19 November 2025. As directed by the amendment: claims 1, 4, 9, 12, 17, and 20 have been amended and claims 8 and 16 are cancelled. Claims 1-7, 9-15, and 17-21 currently stand pending in the application.
The amendments to the claims are sufficient to overcome the claim objections listed in the previous action, which are correspondingly withdrawn.
Response to Arguments
Applicant’s arguments with respect to the rejections under 35 U.S.C. 102(a)(1)/(2) as anticipated by Pappalardo et al. (US 2011/0264149) have been considered but are moot because the new ground of rejection does not rely on any combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Any deficiencies in Pappalardo are resolved by Dahners (US 6,955,677).
Applicant’s arguments with respect to the rejections under 35 U.S.C. 102(a)(1)/(2) as anticipated by Pfefferle et al. (US 6,730,091) have been fully considered but they are not persuasive. Applicant contends that Pfefferle discloses partial threads, and therefore the threads (referenced in the rejection as inwardly extending tabs) are inclined relative to and not parallel to a top surface of the bone plate. Examiner respectfully submits that Pfefferle discloses that the inwardly extending tabs 81 lie at the same height on both sides of the longitudinal axis of the plate (col. 10 / lines 28-30), and are therefore not partial threads but are non-threaded protruding tabs. As seen in FIG. 7B, the tabs are parallel at least at their bottom surfaces/in their direction of extension to a top surface of the bone plate.
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.
Claims 1-4, 7, 9-12, 15, and 17-20 are rejected under 35 U.S.C. 102(a)(1)/(2) as anticipated by U.S. Patent No. US 6,730,091 to Pfefferle et al. (hereinafter, “Pfefferle”).
As to claim 1, Pfefferle discloses a method of fixing a bone fracture in a patient’s bone, FIGS. 10A-10C, the method comprising: positioning a bone plate to the patient’s bone and across at least a portion of the bone fracture so that a first end of the bone plate extends along the patient’s bone on a first side of the bone fracture and a second end of the bone plate extends along the patient’s bone on a second side of the bone fracture opposite the first side, FIG. 10A, the bone plate extending axially between the first and second ends along a central longitudinal axis of the bone plate and including a plurality of screw holes (4) including a first screw hole and a second screw hole (embodiment of the holes 4 shown in FIG. 7A), FIG. 2A; inserting, at least partially, a first bone screw in the first screw hole to couple the bone plate to the first side of the bone fracture, FIG. 10B; and inserting, at least partially, a second bone screw in the second screw hole to couple the bone plate to the second side of the bone fracture, FIG. 10B; wherein the second screw hole comprises an elongated variable angle hole extending between a first end and a second end (either end along its length) (col. 8 / line 66 – col. 9 / line 3), FIGS. 4B and 7A, defining a length extending a first distance (length of negative space between 82s, i.e. the open gap between opposite 82s in FIG. 7A) as measured along the central longitudinal axis, FIGS. 2A and 7A, and a width having a second distance (width of negative space between distal-most 81s, i.e. the open gap between opposite 81s in FIG. 7A) as measured perpendicular to the central longitudinal axis, FIGS. 2A and 7A, the first distance being greater than the second distance, FIG. 7A, the elongated variable angle hole further including: a plurality of inwardly extending tabs (81) on each side of the central longitudinal axis extending and spaced circumferentially about the elongated variable angle hole, FIGS. 7A-7B, the plurality of inwardly extending tabs separated by recesses (at runout areas 82, or above and below the tabs), FIG. 7A, the tabs and recesses providing a series of non-threaded protruding tabs (each protruding tab 81 is non-threaded because each tab does not have threads thereon) separated by concave recesses, FIG. 7A, the plurality of inwardly extending tabs being arranged and configured to engage threads formed on a head portion (including larger diameter threaded portion of screw) of the second bone screw for securing a position of the second bone screw relative to the bone plate, FIG. 10C; first and second axial offset recesses (each longitudinal end portion/half of hole; both recesses are axially offset from a central point or axis of the elongated variable angle hole) positioned at the first and second ends of the elongated variable angle hole, respectively, FIG. 7A, each of the first and second axial offset recesses being configured to receive insertion of the second bone screw at a location in the elongated variable angle hole at which a central axis of the second bone screw is axially offset by an offset distance from a central axis of the elongated variable angle hole, FIG. 10B; a wedge wall (7) operatively associated with and extending around, or up to, the first and second axial offset recesses at the first and second ends of the elongated variable angle hole (the angled or tapered surface 7 is operatively associated with the axial offset recesses as part of the recess as a whole, and extends around, or up to, the axial offset recesses which are located at the first and second ends/end portions of the elongated variable angle hole), the wedge wall having a shape and size configured to be contacted by the second bone screw during insertion to axially displace the second bone screw relative to the bone plate (col. 10 / line 62 – col. 11 / line 3), FIG. 10C; and wherein the plurality of inwardly extending tabs are parallel to a top surface of the bone plate (the tabs 81 lie at the same height on both sides of the longitudinal axis of the plate, col. 10 / lines 28-30, and are parallel at least at their bottom surfaces/in their direction of extension to a top surface of the bone plate, FIG. 7B).
As to claim 2, Pfefferle discloses the method of claim 1, wherein the wedge wall axially displaces the second bone screw relative to the bone plate in opposite directions that decreases the offset distance between the central axis of the second bone screw and the central axis of the elongated variable angle hole (col. 10 / line 62 – col. 11 / line 3), FIGS. 10B-10C.
As to claim 3, Pfefferle discloses the method of claim 1, wherein the wedge wall axially displaces the second bone screw relative to the bone plate to compress the patient’s bone to reduce the bone fracture (col. 10 / line 52 – col. 11 / line 3), FIGS. 10B-10C.
As to claim 4, Pfefferle discloses the method of claim 1, wherein the plurality of inwardly extending tabs include first and second layers of tabs (top and bottom 81s), FIG. 7B, the first layer of tabs being positioned in closer proximity to the top surface of the bone plate than the second layer of tabs, each tab in the first layer of tabs being circumferentially separated from adjacent tabs in the first layer of tabs by a respective one of the recesses (at portion of runout area 82), each tab in the second layer of tabs being circumferentially separated from adjacent tabs in the second layer of tabs by a respective one of the recesses (at portion of runout area 82).
As to claim 7, Pfefferle discloses the method of claim 1, wherein the first and second axial offset recesses extend in opposite directions along the central longitudinal axis of the bone plate, FIG. 7A.
As to claim 9, Pfefferle discloses a method of fixing a bone fracture in a patient’s bone, FIGS. 10A-10C, the method comprising: positioning a bone plate to the patient’s bone and across at least a portion of the bone fracture so that a first end of the bone plate extends along a first portion of the patient’s bone on a first side of the bone fracture and a second end of the bone plate extends along a second portion of the patient’s bone on a second side of the bone fracture opposite the first side, FIG. 10A, the bone plate extending axially between the first and second ends along a central longitudinal axis of the bone plate, the bone plate including a plurality of screw holes (4) including a first screw hole and a second screw hole (embodiment of the holes 4 shown in FIG. 7A), FIG. 2A, the second screw hole including an elongated variable angle hole extending between a first end and a second end (either end along its length) (col. 8 / line 66 – col. 9 / line 3), FIGS. 4B and 7A, defining a length extending a first distance (length of negative space between 82s, i.e. the open gap between opposite 82s in FIG. 7A) as measured along the central longitudinal axis, FIGS. 2A and 7A, and a width having a second distance (width of negative space between distal-most 81s, i.e. the open gap between opposite 81s in FIG. 7A) as measured perpendicular to the central longitudinal axis, FIGS. 2A and 7A, the first distance being greater than the second distance, FIG. 7A, the elongated variable angle hole further including: a plurality of inwardly extending tabs (81) on each side of the central longitudinal axis extending and spaced circumferentially about the elongated variable angle hole, FIGS. 7A-7B, the plurality of inwardly extending tabs separated by recesses (at runout areas 82, or above and below the tabs), FIG. 7A, the tabs and recesses providing a series of non-threaded protruding tabs (each protruding tab 81 is non-threaded because each tab does not have threads thereon) separated by concave recesses, FIG. 7A, the plurality of inwardly extending tabs being arranged and configured to engage threads formed on a head portion (including larger diameter threaded portion of screw) of a second bone screw inserted therein for securing a position of the second bone screw relative to the bone plate, FIG. 10C; first and second axial offset recesses (each longitudinal end portion/half of hole; both recesses are axially offset from a central point or axis of the elongated variable angle hole) positioned at the first and second ends of the elongated variable angle hole, respectively, FIG. 7A, each of the first and second axial offset recesses being configured to receive the second bone screw at a location in the elongated variable angle hole at which a central axis of the second bone screw is axially offset by an offset distance from a central axis of the elongated variable angle hole, FIG. 10B; a wedge wall (7) operatively associated with and extending around, or up to, the first and second axial offset recesses at the first and second ends of the elongated variable angle hole (the angled or tapered surface 7 is operatively associated with the axial offset recesses as part of the recess as a whole, and extends around, or up to, the axial offset recesses which are located at the first and second ends/end portions of the elongated variable angle hole), the wedge wall having a shape and size configured to be contacted by the second bone screw during insertion (col. 10 / line 62 – col. 11 / line 3), FIG. 10C; and wherein the plurality of inwardly extending tabs are parallel to a top surface of the bone plate (the tabs 81 lie at the same height on both sides of the longitudinal axis of the plate, col. 10 / lines 28-30, and are parallel at least at their bottom surfaces/in their direction of extension to a top surface of the bone plate, FIG. 7B); inserting, at least partially, a first bone screw in the first screw hole to couple the bone plate to the first portion of the patient’s bone, FIG. 10B; and inserting, at least partially, the second bone screw in the second screw hole to couple the bone plate to the second portion of the patient’s bone, FIG. 10B, wherein the inserting of the second bone screw causes the second bone screw to contact the wedge wall to axially displace the second bone screw relative to the bone plate (col. 10 / line 62 – col. 11 / line 3), FIG. 10C.
As to claim 10, Pfefferle discloses the method of claim 9, wherein the wedge wall axially displaces the second bone screw relative to the bone plate in opposite directions that decreases the offset distance between the central axis of the second bone screw and the central axis of the elongated variable angle hole (col. 10 / line 62 – col. 11 / line 3), FIGS. 10B-10C.
As to claim 11, Pfefferle discloses the method of claim 9, wherein the wedge wall axially displaces the second bone screw relative to the bone plate to compress the patient’s bone to reduce the bone fracture (col. 10 / line 52 – col. 11 / line 3), FIGS. 10B-10C.
As to claim 12, Pfefferle discloses the method of claim 9, wherein the plurality of inwardly extending tabs include first and second layers of tabs (top and bottom 81s), FIG. 7B, the first layer of tabs being positioned in closer proximity to the top surface of the bone plate than the second layer of tabs, each tab in the first layer of tabs being circumferentially separated from adjacent tabs in the first layer of tabs by a respective one of the recesses (at portion of runout area 82), each tab in the second layer of tabs being circumferentially separated from adjacent tabs in the second layer of tabs by a respective one of the recesses (at portion of runout area 82).
As to claim 15, Pfefferle discloses the method of claim 9, wherein the first and second axial offset recesses extend in opposite directions along the central longitudinal axis of the bone plate, FIG. 7A.
As to claim 17, Pfefferle discloses a method of fixing a bone fracture in a patient’s bone, FIGS. 10A-10C, the method comprising: positioning a bone plate to the patient’s bone and across at least a portion of the bone fracture so that a first end of the bone plate extends along the patient’s bone on a first side of the bone fracture and a second end of the bone plate extends along the patient’s bone on a second side of the bone fracture opposite the first side, FIG. 10A, the bone plate extending axially between the first and second ends along a central longitudinal axis of the bone plate and including a plurality of openings (4) including a first opening and a second opening (embodiment of the holes 4 shown in FIG. 7A), FIG. 2A; inserting, at least partially, a first fixation element in the first opening to couple the bone plate to the first side of the bone fracture, FIG. 10B; and inserting, at least partially, a bone screw in the second opening to couple the bone plate to the second side of the bone fracture, FIG. 10B; wherein the second opening comprises an elongated variable angle hole extending between a first end and a second end (either end along its length) (col. 8 / line 66 – col. 9 / line 3), FIGS. 4B and 7A, defining a length extending a first distance (length of negative space between 82s, i.e. the open gap between opposite 82s in FIG. 7A) as measured along the central longitudinal axis, FIGS. 2A and 7A, and a width having a second distance (width of negative space between distal-most 81s, i.e. the open gap between opposite 81s in FIG. 7A) as measured perpendicular to the central longitudinal axis, FIGS. 2A and 7A, the first distance being greater than the second distance, FIG. 7A, the elongated variable angle hole further including: a plurality of inwardly extending tabs (81) on each side of the central longitudinal axis extending and spaced circumferentially about the elongated variable angle hole, FIGS. 7A-7B, the plurality of inwardly extending tabs separated by recesses (at runout areas 82, or above and below the tabs), FIG. 7A, the tabs and recesses providing a series of non-threaded protruding tabs (each protruding tab 81 is non-threaded because each tab does not have threads thereon) separated by concave recesses, FIG. 7A, the plurality of inwardly extending tabs being arranged and configured to engage threads formed on a head portion (including larger diameter threaded portion of screw) of the bone screw inserted therein for securing a position of the bone screw relative to the bone plate, FIG. 10C; first and second axial offset recesses (each longitudinal end portion/half of hole; both recesses are axially offset from a central point or axis of the elongated variable angle hole) positioned at the first and second ends of the elongated variable angle hole, respectively, FIG. 7A, each of the first and second axial offset recesses being configured to receive the bone screw at a location in the elongated variable angle hole at which a central axis of the bone screw is axially offset by an offset distance from a central axis of the elongated variable angle hole, FIG. 10B; a wedge wall (7) operatively associated with and extending around, or up to, the first and second axial offset recesses at the first and second ends of the elongated variable angle hole (the angled or tapered surface 7 is operatively associated with the axial offset recesses as part of the recess as a whole, and extends around, or up to, the axial offset recesses which are located at the first and second ends/end portions of the elongated variable angle hole), the wedge wall having a shape and size configured to be contacted by the bone screw during insertion to axially displace the bone screw relative to the bone plate (col. 10 / line 62 – col. 11 / line 3), FIG. 10C; and wherein the plurality of inwardly extending tabs are parallel to a top surface of the bone plate (the tabs 81 lie at the same height on both sides of the longitudinal axis of the plate, col. 10 / lines 28-30, and are parallel at least at their bottom surfaces/in their direction of extension to a top surface of the bone plate, FIG. 7B).
As to claim 18, Pfefferle discloses the method of claim 17, wherein the wedge wall axially displaces the bone screw relative to the bone plate in opposite directions that decreases the offset distance between the central axis of the bone screw and the central axis of the elongate variable angle hole (col. 10 / line 62 – col. 11 / line 3), FIGS. 10B-10C.
As to claim 19, Pfefferle discloses the method of claim 17, wherein the wedge wall axially displaces the bone screw relative to the bone plate to compress the patient’s bone to reduce the bone fracture (col. 10 / line 52 – col. 11 / line 3), FIGS. 10B-10C.
As to claim 20, Pfefferle discloses the method of claim 17, wherein the plurality of inwardly extending tabs including first and second layers of tabs (top and bottom 81s), FIG. 7B, the first layer of tabs being positioned in closer proximity to the top surface of the bone plate than the second layer of tabs, each tab in the first layer of tabs being circumferentially separated from adjacent tabs in the first layer of tabs by a respective one of the recesses (at portion of runout area 82), each tab in the second layer of tabs being circumferentially separated from adjacent tabs in the second layer of tabs by a respective one of the recesses (at portion of runout area 82).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-6, 9-14, and 17-21 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. US 2011/0264149 to Pappalardo et al. (hereinafter, “Pappalardo”) in view of U.S. Patent No. US 6,955,677 to Dahners.
As to claim 1, Pappalardo discloses a method of fixing a bone fracture in a patient’s bone, the method comprising: positioning a bone plate (22) to the patient’s bone and across at least a portion of the bone fracture (28) so that a first end of the bone plate extends along the patient’s bone on a first side of the bone fracture and a second end of the bone plate extends along the patient’s bone on a second side of the bone fracture opposite the first side, FIG. 1A, the bone plate extending axially between the first and second ends along a central longitudinal axis of the bone plate and including a plurality of screw holes including a first screw hole (52 in bone plate head portion 46) and a second screw hole (57) (par. [0073]), FIG. 2A; inserting, at least partially, a first bone screw in the first screw hole to couple the bone plate to the first side of the bone fracture (par. [0070]); and inserting, at least partially, a second bone screw in the second screw hole to couple the bone plate to the second side of the bone fracture (par. [0075]-[0077]); wherein the second screw hole comprises an elongated variable angle hole (57) extending between a first end and a second end (either end along its length) defining a length extending a first distance as measured along the central longitudinal axis and a width having a second distance as measured perpendicular to the central longitudinal axis, FIG. 2D, the first distance being greater than the second distance, the elongated variable angle hole further including: a plurality of inwardly extending tabs (thread sections 58 in portion 52 of second screw hole 57) on each side of the central longitudinal axis extending and spaced circumferentially about the elongated variable angle hole, FIG. 2A, the plurality of inwardly extending tabs separated by recesses (concavities between the columns 56), shown labeled for exemplary purposes in FIG. 2B, the tabs and recesses providing a series of non-threaded protruding tabs (each protruding tab 58 is non-threaded because each tab does not have threads thereon) separated by concave recesses, FIG. 2D, the plurality of inwardly extending tabs being arranged and configured to engage threads formed on a head portion of the second bone screw for securing a position of the second bone screw relative to the bone plate (par. [0075]-[0076]); first and second axial offset recesses (one axial offset recess is 54 on one end of the hole, and the other axial offset recess is 52 on the other end of the hole; both recesses are axially offset from a central point or axis of the elongated variable angle hole) positioned at the first and second ends of the elongated variable angle hole, respectively, each of the first and second axial offset recesses being configured to receive insertion of the second bone screw at a location (on one side of the recess 54, or in portion 52) in the elongated variable angle hole at which a central axis of the second bone screw is axially offset by an offset distance from a central axis (axis entering the elongated variable angle hole at its longitudinal center, i.e. approximately between portions 54 and 52) of the elongated variable angle hole (par. [0077]); and a wedge wall (chamfered tapered top surface of 57) operatively associated with (as parts of the functional whole) and extending around, or up to, the first and second axial offset recesses (the wedge wall extends around one axial offset recess 54 and up to the other axial offset recess 52; alternatively, the wedge wall extends around both axial offset recesses as there is a chamfered tapered top surface also seen around 52) at the first and second ends of the elongated variable angle hole, the wedge wall having a shape and size configured to be contacted by the second bone screw during insertion (into 54) to axially displace the second bone screw relative to the bone plate (par. [0077]).
As to claim 2, Pappalardo discloses the method of claim 1, wherein the wedge wall, FIG. 2D, axially displaces the second bone screw relative to the bone plate in opposite directions that decreases the offset distance between the central axis of the second bone screw and the central axis of the elongated variable angle hole (par. [0077]).
As to claim 3, Pappalardo discloses the method of claim 1, wherein the wedge wall axially displaces the second bone screw relative to the bone plate to compress the patient’s bone to reduce the bone fracture (par. [0077]).
As to claim 4, Pappalardo discloses the method of claim 1, wherein the plurality of inwardly extending tabs include first and second layers of tabs (one revolution of the thread comprises one layer of tabs across the columns), the first layer of tabs being positioned in closer proximity to a top surface of the bone plate than the second layer of tabs, each tab in the first layer of tabs being circumferentially separated from adjacent tabs in the first layer of tabs by a respective one of the recesses (portion of 60 between the adjacent tabs), each tab in the second layer of tabs being circumferentially separated from adjacent tabs in the second layer of tabs by a respective one of the recesses.
Pappalardo discloses the claimed invention except for wherein the plurality of inwardly extending tabs are parallel to a top surface of the bone plate (claim 1); wherein all of the tabs in the first layer of tabs are circumferentially offset relative to all of the tabs in the second layer of tabs (claim 5); and wherein the first layer of tabs includes a greater number of tabs than the second layer of tabs (claim 6).
Dahners teaches a method of fixing a bone fracture in a patient’s bone, the method comprising: positioning a bone plate (60) to the patient’s bone and across at least a portion of the bone fracture so that a first end of the bone plate extends along the patient’s bone on a first side of the bone fracture and a second end of the bone plate extends along the patient’s bone on a second side of the bone fracture opposite the first side, FIG. 3, the bone plate extending axially between the first and second ends along a central longitudinal axis of the bone plate and including a plurality of screw holes including a first screw hole and a second screw hole; inserting, at least partially, a first bone screw in at least one of the first and second screw holes (col. 9 / lines 15-49), FIG. 3; wherein the second screw hole comprises a variable angle hole; at least one of the first and second bone screw holes include a plurality of inwardly extending tabs (87) (col. 9 / lines 50-60) on each side of the central longitudinal axis extending and spaced circumferentially about the screw hole, FIGS. 2A-2B, the plurality of inwardly extending tabs separated by recesses (89), the tabs and recesses providing a series of non-threaded protruding tabs separated by concave recesses (since the recesses are along a concave surface of the hole), the plurality of inwardly extending tabs being arranged and configured to engage threads (51) formed on a head portion of the respective bone screw, FIG. 1, for securing a position of the bone screw relative to the bone plate (col. 9 / lines 50-60); wherein the plurality of inwardly extending tabs are parallel to a top surface of the bone plate, FIG. 2B.
As to claim 4, Dahners teaches the method of claim 1, wherein the plurality of inwardly extending tabs include first and second layers of tabs, FIG. 2B, the first layer of tabs (horizontal layer of tabs at the widest part of the hole) being positioned in closer proximity to the top surface of the bone plate than the second layer of tabs (lower-most horizontal layer of tabs), each tab in the first layer of tabs being circumferentially separated from adjacent tabs in the first layer of tabs by a respective one of the recesses (89), FIGS. 2A-2B, each tab in the second layer of tabs being circumferentially separated from adjacent tabs in the second layer of tabs by a respective one of the recesses (89).
As to claim 5, Dahners teaches wherein all of the tabs in the first layer of tabs are circumferentially offset relative to all of the tabs in the second layer of tabs, FIG. 2B.
As to claim 6, Dahners teaches wherein the first layer of tabs includes a greater number of tabs than the second layer of tabs (since the tabs are evenly sized and spaced and the first layer has a greater circumference and therefore can fit more tabs in the first layer of tabs than the second layer of tabs).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Pappalardo such that the variable angle portion (52) of the second screw hole/opening in Pappalardo has tappable regions comprising layers of circumferentially offset tabs as taught in Dahners, so that the bone plate variable angle hole is able to receive and affix the screw inserted therein at any desired angle in relation to the aperture, therefore providing significant flexibility in practice (Dahners, col. 2 / lines 26-29), so that regions of stronger bone can be targeted by the screw depending on the patient’s bone morphology. As applied to the variable angle portion in Pappalardo, the thread segments would be replaced with the layers of tabs as taught by Dahners, with each adjacent layer having circumferentially offset tabs, and the plurality of inwardly extending tabs being parallel to a top surface of the bone plate. Since the variable angle portion of the hole/opening in Pappalardo is distally tapered (see e.g. FIGS. 2D and 3A), the tabs would take a similar number as taught in Dahners which also teaches a tapered hole; the layer of tabs at the widest part of the hole (which is also closer to the top surface of the bone plate) would include a greater number of tabs than the layer of tabs at the distal end of the hole, since the distal end of the hole has a smaller circumference and would thus accommodate a smaller number of the equally sized and spaced tabs.
As to claim 9, Pappalardo discloses a method of fixing a bone fracture in a patient’s bone, the method comprising: positioning a bone plate (22) to the patient’s bone and across at least a portion of the bone fracture (28) so that a first end of the bone plate extends along a first portion of the patient’s bone on a first side of the bone fracture and a second end of the bone plate extends along a second portion of the patient’s bone on a second side of the bone fracture opposite the first side, FIG. 1A, the bone plate extending axially between the first and second ends along a central longitudinal axis of the bone plate, the bone plate including a plurality of screw holes including a first screw hole (52 in bone plate head portion 46) and a second screw hole (57) (par. [0073]), FIG. 2A, the second screw hole including an elongated variable angle hole (57) extending between a first end and a second end (either end along its length) defining a length extending a first distance as measured along the central longitudinal axis and a width having a second distance as measured perpendicular to the central longitudinal axis, FIG. 2D, the first distance being greater than the second distance, the elongated variable angle hole further including: a plurality of inwardly extending tabs (thread sections 58 in portion 52 of second screw hole 57) on each side of the central longitudinal axis extending and spaced circumferentially about the elongated variable angle hole, FIG. 2A, the plurality of inwardly extending tabs separated by recesses (concavities between the columns 56), shown labeled for exemplary purposes in FIG. 2B, the tabs and recesses providing a series of non-threaded protruding tabs (each protruding tab 58 is non-threaded because each tab does not have threads thereon) separated by concave recesses, FIG. 2D, the plurality of inwardly extending tabs being arranged and configured to engage threads formed on a head portion of a second bone screw inserted therein for securing a position of the second bone screw relative to the bone plate (par. [0075]-[0076]); first and second axial offset recesses (one axial offset recess is 54 on one end of the hole, and the other axial offset recess is 52 on the other end of the hole; both recesses are axially offset from a central point or axis of the elongated variable angle hole) positioned at the first and second ends of the elongated variable angle hole, respectively, each of the first and second axial offset recesses being configured to receive the second bone screw at a location (on one side of the recess 54, or in portion 52) in the elongated variable angle hole at which a central axis of the second bone screw is axially offset by an offset distance from a central axis (axis entering the elongated variable angle hole at its longitudinal center, i.e. approximately between portions 54 and 52) of the elongated variable angle hole (par. [0077]); and a wedge wall (chamfered tapered top surface of 57) operatively associated with (as parts of the functional whole) and extending around, or up to, the first and second axial offset recesses (the wedge wall extends around one axial offset recess 54 and up to the other axial offset recess 52; alternatively, the wedge wall extends around both axial offset recesses as there is a chamfered tapered top surface also seen around 52) at the first and second ends of the elongated variable angle hole, the wedge wall having a shape and size configured to be contacted by the second bone screw during insertion (par. [0077]); inserting, at least partially, a first bone screw in the first screw hole to couple the bone plate to the first portion of the patient’s bone (par. [0070]); and inserting, at least partially, the second bone screw in the second screw hole to couple the bone plate to the second portion of the patient’s bone (par. [0075]-[0077]), wherein the inserting of the second bone screw causes the second bone screw to contact the wedge wall (around 54) to axially displace the second bone screw relative to the bone plate (par. [0077]).
As to claim 10, Pappalardo discloses the method of claim 9, wherein the wedge wall, FIG. 2D, axially displaces the second bone screw relative to the bone plate in opposite directions that decreases the offset distance between the central axis of the second bone screw and the central axis of the elongated variable angle hole (par. [0077]).
As to claim 11, Pappalardo discloses the method of claim 9, wherein the wedge wall axially displaces the second bone screw relative to the bone plate to compress the patient’s bone to reduce the bone fracture (par. [0077]).
As to claim 12, Pappalardo discloses the method of claim 9, wherein the plurality of inwardly extending tabs include first and second layers of tabs (one revolution of the thread comprises one layer of tabs across the columns), the first layer of tabs being positioned in closer proximity to a top surface of the bone plate than the second layer of tabs, each tab in the first layer of tabs being circumferentially separated from adjacent tabs in the first layer of tabs by a respective one of the recesses (portion of 60 between the adjacent tabs), each tab in the second layer of tabs being circumferentially separated from adjacent tabs in the second layer of tabs by a respective one of the recesses (portion of 60 between the adjacent tabs).
Pappalardo discloses the claimed invention except for wherein the plurality of inwardly extending tabs are parallel to a top surface of the bone plate (claim 9); wherein all of the tabs in the first layer of tabs are circumferentially offset relative to all of the tabs in the second layer of tabs (claim 13); and wherein the first layer of tabs includes a greater number of tabs than the second layer of tabs (claim 14).
As to claim 9, Dahners teaches a method of fixing a bone fracture in a patient’s bone, the method comprising: positioning a bone plate (60) to the patient’s bone and across at least a portion of the bone fracture so that a first end of the bone plate extends along the patient’s bone on a first side of the bone fracture and a second end of the bone plate extends along the patient’s bone on a second side of the bone fracture opposite the first side, FIG. 3, the bone plate extending axially between the first and second ends along a central longitudinal axis of the bone plate and including a plurality of screw holes including a first screw hole and a second screw hole; the second screw hole including a variable angle hole; at least one of the first and second bone screw holes include a plurality of inwardly extending tabs (87) (col. 9 / lines 50-60) on each side of the central longitudinal axis extending and spaced circumferentially about the screw hole, FIGS. 2A-2B, the plurality of inwardly extending tabs separated by recesses (89), the tabs and recesses providing a series of non-threaded protruding tabs separated by concave recesses (since the recesses are along a concave surface of the hole), the plurality of inwardly extending tabs being arranged and configured to engage threads (51) formed on a head portion of the respective bone screw, FIG. 1, for securing a position of the bone screw relative to the bone plate (col. 9 / lines 50-60); wherein the plurality of inwardly extending tabs are parallel to a top surface of the bone plate, FIG. 2B; inserting, at least partially, a first bone screw in at least one of the first and second screw holes (col. 9 / lines 15-49), FIG. 3.
As to claim 12, Dahners teaches the method of claim 1, wherein the plurality of inwardly extending tabs include first and second layers of tabs, FIG. 2B, the first layer of tabs (horizontal layer of tabs at the widest part of the hole) being positioned in closer proximity to the top surface of the bone plate than the second layer of tabs (lower-most horizontal layer of tabs), each tab in the first layer of tabs being circumferentially separated from adjacent tabs in the first layer of tabs by a respective one of the recesses (89), FIGS. 2A-2B, each tab in the second layer of tabs being circumferentially separated from adjacent tabs in the second layer of tabs by a respective one of the recesses (89).
As to claim 13, Dahners teaches wherein all of the tabs in the first layer of tabs are circumferentially offset relative to all of the tabs in the second layer of tabs, FIG. 2B.
As to claim 14, Dahners teaches wherein the first layer of tabs includes a greater number of tabs than the second layer of tabs (since the tabs are evenly sized and spaced and the first layer has a greater circumference and therefore can fit more tabs in the first layer of tabs than the second layer of tabs).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Pappalardo such that the variable angle portion (52) of the second screw hole/opening in Pappalardo has tappable regions comprising layers of circumferentially offset tabs as taught in Dahners, so that the bone plate variable angle hole is able to receive and affix the screw inserted therein at any desired angle in relation to the aperture, therefore providing significant flexibility in practice (Dahners, col. 2 / lines 26-29), so that regions of stronger bone can be targeted by the screw depending on the patient’s bone morphology. As applied to the variable angle portion in Pappalardo, the thread segments would be replaced with the layers of tabs as taught by Dahners, with each adjacent layer having circumferentially offset tabs, and the plurality of inwardly extending tabs being parallel to a top surface of the bone plate. Since the variable angle portion of the hole/opening in Pappalardo is distally tapered (see e.g. FIGS. 2D and 3A), the tabs would take a similar number as taught in Dahners which also teaches a tapered hole; the layer of tabs at the widest part of the hole (which is also closer to the top surface of the bone plate) would include a greater number of tabs than the layer of tabs at the distal end of the hole, since the distal end of the hole has a smaller circumference and would thus accommodate a smaller number of the equally sized and spaced tabs.
As to claim 17, Pappalardo discloses a method of fixing a bone fracture in a patient’s bone, the method comprising: positioning a bone plate (22) to the patient’s bone and across at least a portion of the bone fracture (28) so that a first end of the bone plate extends along the patient’s bone on a first side of the bone fracture and a second end of the bone plate extends along the patient’s bone on a second side of the bone fracture opposite the first side, FIG. 1A, the bone plate extending axially between the first and second ends along a central longitudinal axis of the bone plate and including a plurality of openings including a first opening (52 in bone plate head portion 46) and a second opening (57) (par. [0073]), FIG. 2A; inserting, at least partially, a first fixation element in the first opening to couple the bone plate to the first side of the bone fracture (par. [0070]); and inserting, at least partially, a bone screw in the second opening to couple the bone plate to the second side of the bone fracture (par. [0075]-[0077]); wherein the second opening comprises an elongated variable angle hole (57) extending between a first end and a second end (either end along its length) defining a length extending a first distance as measured along the central longitudinal axis and a width having a second distance as measured perpendicular to the central longitudinal axis, FIG. 2D, the first distance being greater than the second distance, the elongated variable angle hole further including: a plurality of inwardly extending tabs (thread sections 58 in portion 52 of second screw hole 57) on each side of the central longitudinal axis extending and spaced circumferentially about the elongated variable angle hole, FIG. 2A, the plurality of inwardly extending tabs separated by recesses (concavities between the columns 56), shown labeled for exemplary purposes in FIG. 2B, the tabs and recesses providing a series of non-threaded protruding tabs (each protruding tab 58 is non-threaded because each tab does not have threads thereon) separated by concave recesses, FIG. 2D, the plurality of inwardly extending tabs being arranged and configured to engage threads formed on a head portion of the bone screw inserted therein for securing a position of the bone screw relative to the bone plate (par. [0075]-[0076]); first and second axial offset recesses (one axial offset recess is 54 on one end of the hole, and the other axial offset recess is 52 on the other end of the hole; both recesses are axially offset from a central point or axis of the elongated variable angle hole) positioned at the first and second ends of the elongated variable angle hole, respectively, each of the first and second axial offset recesses being configured to receive the bone screw at a location (on one side of the recess 54, or in portion 52) in the elongated variable angle hole at which a central axis of the bone screw is axially offset by an offset distance from a central axis (axis entering the elongated variable angle hole at its longitudinal center, i.e. approximately between portions 54 and 52) of the elongated variable angle hole (par. [0077]); a wedge wall (chamfered tapered top surface of 57) operatively associated with (as parts of the functional whole) and extending around, or up to, the first and second axial offset recesses (the wedge wall extends around one axial offset recess 54 and up to the other axial offset recess 52; alternatively, the wedge wall extends around both axial offset recesses as there is a chamfered tapered top surface also seen around 52) at the first and second ends of the elongated variable angle hole, the wedge wall having a shape and size configured to be contacted by the bone screw during insertion (into 54) to axially displace the bone screw relative to the bone plate (par. [0077]).
As to claim 18, Pappalardo discloses the method of claim 17, wherein the wedge wall, FIG. 2D, axially displaces the bone screw relative to the bone plate in opposite directions that decreases the offset distance between the central axis of the bone screw and the central axis of the elongated variable angle hole (par. [0077]).
As to claim 19, Pappalardo discloses the method of claim 17, wherein the wedge wall axially displaces the bone screw relative to the bone plate to compress the patient’s bone to reduce the bone fracture (par. [0077]).
As to claim 20, Pappalardo discloses the method of claim 17, wherein the plurality of inwardly extending tabs including first and second layers of tabs (one revolution of the thread comprises one layer of tabs across the columns), the first layer of tabs being positioned in closer proximity to a top surface of the bone plate than the second layer of tabs, each tab in the first layer of tabs being circumferentially separated from adjacent tabs in the first layer of tabs by a respective one of the recesses (portion of 60 between the adjacent tabs), each tab in the second layer of tabs being circumferentially separated from adjacent tabs in the second layer of tabs by a respective one of the recesses (portion of 60 between the adjacent tabs).
As to claim 17, Dahners teaches a method of fixing a bone fracture in a patient’s bone, the method comprising: positioning a bone plate (60) to the patient’s bone and across at least a portion of the bone fracture so that a first end of the bone plate extends along the patient’s bone on a first side of the bone fracture and a second end of the bone plate extends along the patient’s bone on a second side of the bone fracture opposite the first side, FIG. 3, the bone plate extending axially between the first and second ends along a central longitudinal axis of the bone plate and including a plurality of openings including a first opening and a second opening; inserting, at least partially, a first fixation element in at least one of the first and second openings (col. 9 / lines 15-49), FIG. 3; wherein the second opening comprises a variable angle hole; at least one of the first and second openings include a plurality of inwardly extending tabs (87) (col. 9 / lines 50-60) on each side of the central longitudinal axis extending and spaced circumferentially about the opening, FIGS. 2A-2B, the plurality of inwardly extending tabs separated by recesses (89), the tabs and recesses providing a series of non-threaded protruding tabs separated by concave recesses (since the recesses are along a concave surface of the hole), the plurality of inwardly extending tabs being arranged and configured to engage threads (51) formed on a head portion of the respective bone screw, FIG. 1, for securing a position of the bone screw relative to the bone plate (col. 9 / lines 50-60); wherein the plurality of inwardly extending tabs are parallel to a top surface of the bone plate, FIG. 2B.
As to claim 20, Dahners teaches the method of claim 1, wherein the plurality of inwardly extending tabs include first and second layers of tabs, FIG. 2B, the first layer of tabs (horizontal layer of tabs at the widest part of the hole) being positioned in closer proximity to the top surface of the bone plate than the second layer of tabs (lower-most horizontal layer of tabs), each tab in the first layer of tabs being circumferentially separated from adjacent tabs in the first layer of tabs by a respective one of the recesses (89), FIGS. 2A-2B, each tab in the second layer of tabs being circumferentially separated from adjacent tabs in the second layer of tabs by a respective one of the recesses (89).
As to claim 21, Dahners teaches wherein all of the tabs in the first layer of tabs are circumferentially offset relative to all of the tabs in the second layer of tabs, FIG. 2B.
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Pappalardo such that the variable angle portion (52) of the second screw hole/opening in Pappalardo has tappable regions comprising layers of circumferentially offset tabs as taught in Dahners, so that the bone plate variable angle hole is able to receive and affix the screw inserted therein at any desired angle in relation to the aperture, therefore providing significant flexibility in practice (Dahners, col. 2 / lines 26-29), so that regions of stronger bone can be targeted by the screw depending on the patient’s bone morphology. As applied to the variable angle portion in Pappalardo, the thread segments would be replaced with the layers of tabs as taught by Dahners, with each adjacent layer having circumferentially offset tabs, and the plurality of inwardly extending tabs being parallel to a top surface of the bone plate.
Conclusion
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/TRACY L KAMIKAWA/Examiner, Art Unit 3775