DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claim 1 is objected to because of the following informalities:
In Line 1, the word “useful” should be replaced with the word --configured--.
In Lines 19-20, the limitation “of the plurality of fastener apertures” should be deleted as there is no antecedent basis for this specific terminology. Appropriate correction is required.
Claim 2 is objected to because of the following informalities:
In Lines 1-2, the limitation “of the plurality of fastener apertures” should be deleted.
In Line 3, the limitation “of the plurality of fastener apertures” should be deleted.
In Line 7, the limitation “of the plurality of fastener apertures” should be deleted.
In Line 10, the word --material-- should be added after the word “polymer”.
In Line 11, the word --induced-- should be added before the word “multi-curved”.
Appropriate correction is required.
Claims 3, 4 & 5 are objected to because of the following informalities: In Line 1, a comma should be added immediately following the number 2. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: In Line 2, the word --a-- should be added before the word “lateral”. Appropriate correction is required.
Claim 11 is objected to because of the following informalities: In Line 1, a comma should be added immediately following the number “1”, and the word --polymeric-- should be added before the word “bone”. Appropriate correction is required.
Claim 12 is objected to because of the following informalities: In Line 1, a comma should be added immediately following the number “1”, and the word --polymeric-- should be added before the word “bone”. In Line 2, the word --of-- should be added before the word “curvature”. Appropriate correction is required.
Claim 13 is objected to because of the following informalities: In Line 1, a comma should be added immediately following the number “1”. Appropriate correction is required.
Claim 14 is objected to because of the following informalities: In Line 1, the word --polymeric-- should be added before the word “bone”. Appropriate correction is required.
Claim 15 is objected to because of the following informalities: In Line 1, the word --polymeric-- should be added before the word “bone”. In Line 3, the word --the-- should be added before the word “fastener”. Appropriate correction is required.
Claim 16 is objected to because of the following informalities: In Line 1, the word “of” should be replaced with the words --according to-- to keep claim terminology consistent throughout. Furthermore, the words --of the plurality of beam sections-- should be added after the word “section”. Appropriate correction is required.
Claim 17 is objected to because of the following informalities: In Line 1, the word --polymeric-- should be added before the word “bone”. In Line 3, the words “plurality of” should be deleted, and the words --of the plurality of beam sections-- should be added after the word “section”. In Line 4, the words --at least one-- should be added before the word “beam”. Appropriate correction is required.
Claim 18 is objected to because of the following informalities: In Line 1, the word --polymeric-- should be added before the word “bone”. In Line 3, the words “plurality of” should be deleted, and the words --of the plurality of beam sections-- should be added after the word “section”. Appropriate correction is required.
Claim 19 is objected to because of the following informalities: In Line 2, the word --diagonal-- should be added before the word “scallop”. Appropriate correction is required.
Claim 20 is objected to because of the following informalities: In Line 2, the word --diagonal-- should be added before the word “scallop”. Appropriate correction is required.
Claim 22 is objected to because of the following informalities: In Line 1, the word --polymeric-- should be added before the word “bone”. In Line 3, the words “plurality of” should be deleted, and the words --of the plurality of beam sections-- should be added after the word “section”. Appropriate correction is required.
Claim 23 is objected to because of the following informalities:
In Line 1, the word “useful” should be replaced with the word --configured--.
In Line 3, the letter “d)” should be replaced with the letter --a)--.
In Line 8, the letter “e)” should be replaced with the letter --b)--.
In Line 13, the limitation “of the plurality of fastener apertures” should be deleted as there is no antecedent basis for this specific terminology.
In Lines 14-15, the limitation “of the plurality of fastener apertures” should be deleted.
In Line 16, the letter “f)” should be replaced with the letter --c)--.
In Lines 20-21, the words “plurality of” should be deleted.
In Line 22, the words “plurality of” should be deleted.
In Line 25, the number “4)” should be replaced with the number --1)--.
In Line 26, the number “5)” should be replaced with the number --2)--.
In Line 28, the number “6)” should be replaced with the number --3)--.
Appropriate correction is required.
Claim 24 is objected to because of the following informalities:
In Line 1, the word “useful” should be replaced with the word --configured--.
In Line 13, the word “oversize” should be replaced with the word –oversized--.
In Line 14, the words “plurality of” should be deleted.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2-7, 11, & 15-23 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 2 recites “wherein each fastener of the plurality of fasteners and the corresponding aperture have a volumetric displacement, and wherein at least one fastener and a corresponding fastener aperture of the plurality of fastener apertures has at least one volume displacement characteristic” which renders the claim indefinite as it is unclear what is meant by each fastener and corresponding aperture have a volumetric displacement, and at least one of the fasteners and corresponding aperture having at least one volume displacement characteristic. Is this a clarifying structural limitation of each separately, or functional during insertion of each fasteners into one of the apertures, or something different? It is suggested that the claim be amended to further describe how/when/where the volumetric displacement occurs in order to better clarify. Appropriate correction is required.
Claim 2 at Line 8 recites the term “the threaded and tapered head of the at least one fastener”. There is insufficient antecedent basis for this limitation. For purposes of examination, the limitation is being interpreted as “a threaded and tapered head of the at least one fastener”. Appropriate correction is required.
Claim 11 at Line 2 recites “and wherein volumetric displacement increases monotonically from the posterior surface to the anterior surface.” Which renders the claim indefinite as it is unclear what volumetric displacement is being referred to. Is this a clarifying structural limitation of the bone plate, or something else? It is suggested that the claim be amended to further describe what volumetric displacement is being recited in order to better clarify. Appropriate correction is required.
Claim 15 at Lines 2-3 recites the limitation “wherein at least a portion of the plurality of fastener apertures are formed in the pads” which renders the claim indefinite as it is unclear if the claim is reciting that at least a portion structurally of each aperture is formed in the pad, or at least some of the apertures are formed in the pads, or something else? Appropriate correction is required.
Claim 17 at Lines 2-3 recites the limitation “wherein at least a portion of the plurality of fastener apertures are formed in the pads” which renders the claim indefinite as it is unclear if the claim is reciting that at least a portion structurally of each aperture is formed in the pad, or at least some of the apertures are formed in the pads, or something else? Appropriate correction is required.
Claim 18 at Lines 2-3 recites the limitation “wherein at least a portion of the plurality of fastener apertures are formed in the pads” which renders the claim indefinite as it is unclear if the claim is reciting that at least a portion structurally of each aperture is formed in the pad, or at least some of the apertures are formed in the pads, or something else? Appropriate correction is required.
Claim 22 at Lines 2-3 recites the limitation “wherein at least a portion of the plurality of fastener apertures are formed in the pads” which renders the claim indefinite as it is unclear if the claim is reciting that at least a portion structurally of each aperture is formed in the pad, or at least some of the apertures are formed in the pads, or something else? Appropriate correction is required.
Claim 23 recites “wherein each fastener of the plurality of fasteners and a corresponding aperture of the plurality of fastener apertures have a volumetric displacement relationship that is selected from one or more ratios in the group consisting of:” which renders the claim indefinite as it is unclear what is meant by each fastener and corresponding aperture have a volumetric displacement relationship. Is this a clarifying structural limitation, or functional during insertion of each fastener into one of the apertures, or something different? It is suggested that the claim be amended to further describe how/when/where the volumetric displacement relationship occurs in order to better clarify. Appropriate correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1, 8-10, 12-22 & 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Greenhalgh et al. (US PG Pub No. 2010/0145386) in view of Yuan et al. (US PG Pub. No. 2022/0054176).
Regarding Claims 1 & 8, Greenhalgh et al. discloses a surgical bone plate system (plate 1 and bone screws 188, Figs. 15-18, 53-55, 97-101 & 105-115, Paragraphs [0094, 0141, 0188-0189, 0192-0202]) capable of helping to fixate at least first and second underlying bone portions such as first and second rib bone portions (The system can be used as an aid in vertebral or other bone fusion and stabilization of the spine or other bones.”, Paragraph [0011]), comprising: a) a polymeric bone plate (plate 1, Fig. 15, Paragraph [0156]) comprising at least one biocompatible polymer material (PEEK, Paragraph [0156]), wherein the polymeric bone plate comprises a native configuration (pre-deformed configuration, Fig. 105-106, Paragraph [0081]) and an induced multi-curved configuration (custom deformed configuration, Figs. 107-109, Paragraphs [0015, 0072]), and wherein the induced multi-curved configuration includes increased curvature comprising at least two of increased bending curvature, increased twisting curvature, and/or increased lateral curvature relative to the native configuration (“The plate 1 can be deformed or otherwise transformed by stretching, expanding or compressing. The plate 1 can be resiliently or deformably transformed, for example by lengthening, shortening, curving or twisting. The plate 1 can be transformed, for example, by a tool that can engage the plate and compress, expand, torque, or otherwise twist the plate, or combinations thereof. The plate 1 can be deformed or otherwise transformed before, during, or after the plate 1 is delivered to the target site, or combinations thereof. The plate 1 can be transformed in situ. For example, the plate 1 can be expanded or lengthened to create a higher distraction force between adjacent vertebrae. The plate 1 can have a curved configuration, for example, to match the anatomy of the patient. The plate 1 can be deformed or otherwise transformed to adjust the mounting hole positions to match the desired attachment sites on the vertebra.”, Paragraphs [0015, 0072]); b) a 1 x n aperture array of fastener apertures (attachment holes 12, Fig. 17, Paragraph [0094]) formed in the at least one biocompatible polymer material of the polymeric bone plate and extending along a length of the polymeric bone plate in a direction from a first bone plate end (left end when viewing Fig. 17) to a second bone plate end (right end when viewing Fig. 17), wherein the 1 x n aperture array comprises n fastener apertures formed in the at least one biocompatible polymer material, and wherein n is 6 or more (“The plate 1 can have a number of attachment or screw holes 2, or sockets therethrough. …from about two screw holes to about 15 screw holes”, Paragraph [0078]); and c) a plurality of fasteners (bone screws 188, Figs. 97-98) that are configured to be installed in the fastener apertures and into the at least first and second underlying bone portions in a manner effective to couple the polymeric bone plate to the at least first and second underlying bone portions (Paragraphs [0118, 0141, 0188-0189]); and wherein the fasteners comprises a fastener material (“Any or all elements of the plate 1 and/or other devices or apparatuses described herein can be made from, for example, a single or multiple stainless steel alloys, nickel titanium alloys (e.g., Nitinol), cobalt-chrome alloys…”) that is harder than the at least one biocompatible polymer material (PEEK) in which the fastener apertures are formed (Paragraph [0156])(The bone plate system is fully and structurally capable of being used to fixate first and second bone portions such as rib bone portions as recited in the functional language above).
Greenhalgh et al. does not disclose wherein the fastener apertures are undersized relative to the fasteners, wherein inserting the fasteners into the fastener apertures volumetrically displaces the at least one biocompatible polymer of the polymeric bone plate in a manner to induce the polymeric bone plate to transition from the native configuration to the multi-curved configuration. Greenhalgh et al. does disclose in Paragraph [0074] that “[0074] The plate 1 can be configured to mate to any polyaxial screw systems. The plate can be deformed once, twice, or more times.”
Yuan et al. discloses a bone fixation system (1000, Figs. 9-13, Paragraph [0053]) comprising an adjustable PEEK bone plate (100, Paragraph [0058]) and a plurality of bone screws (200, Paragraph [0058]) configured to be inserted through unthreaded screw holes (130, Figs. 1-5) formed through the bone plate (Paragraph [0053]), wherein each unthreaded screw hole comprises inner walls (135) having circumferentially arranged interference portions (137, Figs. 2-3, 6, 8, Paragraph [0054]) defining the width of the opening through an upper surface (110) of the bone plate, wherein the width of each opening through the upper surface of the bone plate is slightly smaller than an upper region (212) of the head (210) of the bone screw (Figs. 8A, 8, 20-22, Paragraph [0054]), wherein “The slight difference between d1 and the width of the opening 130A results in interference between the upper region 212 of the screw head 210 of the bone screw 200 and the interference portions 137 of the inner walls 135 to lock the head 210 of the bone screw 200 within the passage 130 upon insertion of the bone screw 200 into the passage 130 at a variable angle of rotation relative to a longitudinal axis of the passage that is substantially perpendicular to the upper surface of the bone plate the head of the bone screw 200,” (Paragraph [0055]), and wherein “Through extensive trials and experiments, the inventor has found that the provision of the deformable interference portions 137 in the configuration as previously described, allows the locking arrangement provided by the interference portions 137 to be re-used for locking the screw head 210 at a slightly different angle of orientation without significantly damaging the locking arrangement provided by the interference portions. Without being bound by theory, it is hypothesized that on first instance, when the upper rim region 212 engages one or more of the interference portions 137, both the upper rim region 212 and the contacting interference portions 137 undergo some level of deformation which may be elastic deformation. When the bone screw 200 is pulled out by applying rotational torque in the reverse direction, the interference portion 137 and the upper rim region 212 are no longer under engagement which may result in the interference portion 137 and the upper rim region 212 of the bone screw 200 fully returning to its original dimensions (under elastic deformation). In other instances, the interference portions 137 and the upper rim region 212 of the screw head 210, upon interference may undergo plastic deformation and after removal of the bone screw 200, the interference portion 137 and the upper rim region 212 of the screw 210 may only partially return to their original dimensions. It is theorised that providing a locking mechanism for the screw head 210 that relies on interference and elastic deformation of the interference portions 137 and the upper rim region 212 of the screw head 210 allows the screw hole 130 in the bone plate 100 to be used repeatedly for engaging the screw head 210 of a bone screw 200 at a variety of angles. The deformation mode of locking the screw head 210 provided by the bone fixing plate 100 allows the screw holes 130 to be utilised repeatedly. Of course, it would also be appreciated by a skilled person that many materials particularly metals cannot undergo elastic deformation infinite number of times. At least in some instances particularly when the bone fixing plate 100 and the bone screw 200 are formed from metallic materials, after been subjected to repeated stresses, the interference portions 137 and/or the upper rim region 212 of the screw head 212 may undergo metal fatigue and as a result may not completely recover to their original dimensions. FIG. 22 shows a top view of a plate hole 130 that has undergone deformation after repeated use. The outline denoted by lines Q across each interference portion illustrates the structural configuration of the interference portions 137 before undergoing deformation and the shaded regions for the interference portions 137 denote deformed parts of the interference portions 137. In comparison, many of the locking mechanisms known for variable angle locking plates are often limited to one-time use because the threads provided on the screw head and inner walls for plate holes of such prior art systems get damaged after being used in the first instance.” (Paragraph [0063]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to substitute each bone screw and attachment hole of Greenhalgh et al. with the polyaxial bone screws and screw holes which have openings defined through the upper surface of the plate slightly smaller than the head of each bone screw and include interference portions along inner walls thereof as taught by Yuan et al. in order to provide the bone plate with a built-in locking mechanism for the screw head that allows the holes to be used repeatedly for engaging the screw head at a variety of angles.
Regarding Claim 9, the combination of Greenhalgh et al. and Yuan et al. discloses the claimed invention as stated above in claim 1, and Greenhalgh et al. further discloses wherein the increased curvature comprises increased bending curvature and increased twisting curvature (“The plate 1 can be resiliently or deformably transformed, for example by lengthening, shortening, curving or twisting. The plate 1 can be transformed, for example, by a tool that can engage the plate and compress, expand, torque, or otherwise twist the plate, or combinations thereof.”, Figs. 67 & 109, Paragraph [0072]).
Regarding Claim 10, the combination of Greenhalgh et al. and Yuan et al. discloses the claimed invention as stated above in claim 1, and Greenhalgh et al. further discloses wherein the polymeric bone plate comprises a lateral curvature in the native configuration (the opposing lateral sides of 1 are curved therealong as seen in Figs. 15 & 17, Paragraph [0097]).
Regarding Claim 12, the combination of Greenhalgh et al. and Yuan et al. discloses the claimed invention as stated above in claim 1, and Greenhalgh et al. further discloses wherein the polymeric bone plate has an in-plane radius of curvature. (“The plate can have a plate radius of curvature 26. The plate radius of curvature 26 can approximate the radius of curvature of the spine length where the plate 1 is deployed, for example the cervical, lumbar or thoracic spine curvature, or combinations thereof. The plate radius of curvature 26 can be with respect to an axis offset and parallel to the transverse axis of the plate 1, as shown, and/or to an axis offset and parallel to the longitudinal axis”, Fig. 16, Paragraph [0097]).
Greenhalgh et al. does not disclose the radius of curvature is in a range from 2 m-1 to 20 m-1 in its native configuration. Paragraph [0141] further discloses that the plate 1 can have a curved profile 114 with a radius of curvature 116 along the longitudinal axis 68 as seen in Figs. 53-55, wherein the “The radius of curvature 116 can be from about 10 mm (0.4 in.) to about an infinite radius (i.e., for a flat profile 112), more narrowly from about 250 cm (100 in.), for example about 50 cm (20 in.). The plate can have a flat or curved profile regardless of thickness or thinness, for example, the curved plate can have a thickness of about half the length of the bone screw 188.” Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the radius of curvature of the bone plate of the combination to be in a range from 2 m-1 to 20 m-1 in its native configuration since it has been held that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 105 USPQ 233.
Regarding Claim 13, the combination of Greenhalgh et al. and Yuan et al. discloses the claimed invention as stated above in claim 1, and Greenhalgh et al. further discloses wherein n is in the range from 8 to 25 (“The plate 1 can have a number of attachment or screw holes 2, or sockets therethrough. …from about two screw holes to about 15 screw holes”, Paragraph [0078]).
Regarding Claim 14, the combination of Greenhalgh et al. and Yuan et al. discloses the claimed invention as stated above in claim 1, and Greenhalgh et al. further discloses wherein the polymeric bone plate comprises PEEK and at least one of the plurality of fasteners comprises titanium (Paragraph [0156]).
Regarding Claim 15 as best understood, the combination of Greenhalgh et al. and Yuan et al. discloses the claimed invention as stated above in claim 1, and Greenhalgh et al. further discloses wherein the polymeric bone plate comprises a plurality of pads (rings surrounding attachment openings 12, Figs. 15 & 17) and a plurality of beam sections (struts 6, Figs. 15 & 17, Paragraph [0094]) that diagonally interconnect the pads, and wherein the fastener apertures are formed in the pads (each opening 12 is formed within a pad/ring as seen in Fig. 17).
Regarding Claim 16, the combination of Greenhalgh et al. and Yuan et al. discloses the claimed invention as stated above in claim 15, and Greenhalgh et al. further discloses wherein at least one beam section of the plurality of beam sections includes an elongate window (windows defined between struts 6, Fig. 17).
Regarding Claim 17 as best understood, the combination of Greenhalgh et al. and Yuan et al. discloses the claimed invention as stated above in claim 1, and Greenhalgh et al. further discloses wherein the polymeric bone plate comprises a plurality of pads (rings surrounding attachment openings 12, Figs. 15 & 17) and a plurality of beam sections (struts 6, Figs. 15 & 17, Paragraph [0094]) that interconnect the pads, wherein the fastener apertures are formed in the pads (each opening 12 is formed within a pad/ring as seen in Fig. 17), and wherein at least one beam section includes dimples (stops 24, Fig. 17) formed on a posterior side thereof (top surface of 1, Fig. 15).
Regarding Claim 18 as best understood, the combination of Greenhalgh et al. and Yuan et al. discloses the claimed invention as stated above in claim 1, and Greenhalgh et al. further discloses wherein the polymeric bone plate comprises a plurality of pads (rings surrounding attachment openings 12, Figs. 15 & 17) and a plurality of beam sections (struts 6, Figs. 15 & 17, Paragraph [0094]) that interconnect the pads, wherein the fastener apertures are formed in the pads (each opening 12 is formed within a pad/ring as seen in Fig. 17), and wherein at least one beam section includes a diagonal scallop (See examiner annotated Fig. 15 below).
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Regarding Claim 19, the combination of Greenhalgh et al. and Yuan et al. discloses the claimed invention as stated above in claim 18, and Greenhalgh et al. further discloses wherein the at least one beam section including the diagonal scallop has an anterior side (bottom, bone-facing side of plate 1) and a posterior side (top side of plate 1), and wherein the scallop is formed on the anterior side (See examiner annotated Fig. 15 above where the scallop is incorporated on and extends from top to bottom surfaces of the plate).
Regarding Claim 20, the combination of Greenhalgh et al. and Yuan et al. discloses the claimed invention as stated above in claim 18, and Greenhalgh et al. further discloses wherein the at least one beam section including the diagonal scallop has an anterior side (bottom, bone-facing side of plate 1) and a posterior side (top side of plate 1), and wherein the scallop is formed on the posterior side (See examiner annotated Fig. 15 above where the scallop is incorporated on and extends from top to bottom surfaces of the plate).
Regarding Claim 21, the combination of Greenhalgh et al. and Yuan et al. discloses the claimed invention as stated above in claim 18, and Greenhalgh et al. further discloses wherein the at least one beam section including the diagonal scallop has an anterior side (bottom, bone-facing side of plate 1) and a posterior side (top side of plate 1), wherein the diagonal scallop is formed on the posterior side (See examiner annotated Fig. 15 above where the scallop is incorporated on and extends from top to bottom surfaces of the plate), and wherein the at least one beam section including the diagonal scallop further comprises an additional scallop on the anterior side (See examiner annotated Fig. 15 above).
Regarding Claim 22 as best understood, the combination of Greenhalgh et al. and Yuan et al. discloses the claimed invention as stated above in claim 1, and Greenhalgh et al. further discloses wherein the polymeric bone plate comprises a plurality of pads (rings surrounding attachment openings 12, Figs. 15 & 17) and a plurality of beam sections (struts 6, Figs. 15 & 17, Paragraph [0094]) that interconnect the pads, wherein the fastener apertures are formed in the pads (each opening 12 is formed within a pad/ring as seen in Fig. 17), and wherein at least one beam section includes a diagonal rib (See examiner annotated Fig. 15 below) projecting from an anterior surface of the at least one beam section.
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Regarding Claim 24, Greenhalgh et al. discloses a bone plate system (plate 1 and bone screws 188, Figs. 15-18, 53-55, 97-101 & 105-115, Paragraphs [0094, 0141, 0188-0189, 0192-0202]) capable of helping to fixate at least first and second underlying bone portions (The system can be used as an aid in vertebral or other bone fusion and stabilization of the spine or other bones.”, Paragraph [0011]), comprising: a) a polymeric bone plate (plate 1, Fig. 15, Paragraph [0156]) comprising at least one biocompatible polymer material (PEEK, Paragraph [0156]), wherein the polymeric bone plate comprises lateral curvature in a native configuration (the opposing lateral sides of 1 are curved therealong as seen in Figs. 15 & 17, Paragraph [0097]); b) a 1 x n aperture array of fastener apertures (attachment holes 12, Fig. 17, Paragraph [0094]) formed in the at least one biocompatible polymer material of the polymeric bone plate and extending along a length of the polymeric bone plate in a direction from a first bone plate end (left end when viewing Fig. 17) to a second bone plate end (right end when viewing Fig. 17), wherein the 1 x n aperture array comprises n fastener apertures formed in the at least one biocompatible polymer material, and wherein n is 6 or more (“The plate 1 can have a number of attachment or screw holes 2, or sockets therethrough. …from about two screw holes to about 15 screw holes”, Paragraph [0078]); and c) a plurality of metal fasteners (bone screws 188, Figs. 97-98) (“Any or all elements of the plate 1 and/or other devices or apparatuses described herein can be made from, for example, a single or multiple stainless steel alloys, nickel titanium alloys (e.g., Nitinol), cobalt-chrome alloys…”) that are capable of being installed in the fastener apertures and into the at least first and second underlying bone portions in a manner effective to couple the polymeric bone plate to the at least first and second underlying bone portions (Paragraphs [0118, 0141, 0188-0189]).
Greenhalgh et al. does not disclose wherein each metal fastener is oversized relative to a corresponding one of the fastener apertures. Greenhalgh et al. does disclose in Paragraph [0074] that “[0074] The plate 1 can be configured to mate to any polyaxial screw systems. The plate can be deformed once, twice, or more times.”
Yuan et al. discloses a bone fixation system (1000, Figs. 9-13, Paragraph [0053]) comprising an adjustable PEEK bone plate (100, Paragraph [0058]) and a plurality of bone screws (200, Paragraph [0058]) configured to be inserted through unthreaded screw holes (130, Figs. 1-5) formed through the bone plate (Paragraph [0053]), wherein each unthreaded screw hole comprises inner walls (135) having circumferentially arranged interference portions (137, Figs. 2-3, 6, 8, Paragraph [0054]) defining the width of the opening through an upper surface (110) of the bone plate, wherein the width of each opening through the upper surface of the bone plate is slightly smaller than an upper region (212) of the head (210) of the bone screw (Figs. 8A, 8, 20-22, Paragraph [0054]), wherein “The slight difference between d1 and the width of the opening 130A results in interference between the upper region 212 of the screw head 210 of the bone screw 200 and the interference portions 137 of the inner walls 135 to lock the head 210 of the bone screw 200 within the passage 130 upon insertion of the bone screw 200 into the passage 130 at a variable angle of rotation relative to a longitudinal axis of the passage that is substantially perpendicular to the upper surface of the bone plate the head of the bone screw 200,” (Paragraph [0055]), and wherein “Through extensive trials and experiments, the inventor has found that the provision of the deformable interference portions 137 in the configuration as previously described, allows the locking arrangement provided by the interference portions 137 to be re-used for locking the screw head 210 at a slightly different angle of orientation without significantly damaging the locking arrangement provided by the interference portions. Without being bound by theory, it is hypothesized that on first instance, when the upper rim region 212 engages one or more of the interference portions 137, both the upper rim region 212 and the contacting interference portions 137 undergo some level of deformation which may be elastic deformation. When the bone screw 200 is pulled out by applying rotational torque in the reverse direction, the interference portion 137 and the upper rim region 212 are no longer under engagement which may result in the interference portion 137 and the upper rim region 212 of the bone screw 200 fully returning to its original dimensions (under elastic deformation). In other instances, the interference portions 137 and the upper rim region 212 of the screw head 210, upon interference may undergo plastic deformation and after removal of the bone screw 200, the interference portion 137 and the upper rim region 212 of the screw 210 may only partially return to their original dimensions. It is theorised that providing a locking mechanism for the screw head 210 that relies on interference and elastic deformation of the interference portions 137 and the upper rim region 212 of the screw head 210 allows the screw hole 130 in the bone plate 100 to be used repeatedly for engaging the screw head 210 of a bone screw 200 at a variety of angles. The deformation mode of locking the screw head 210 provided by the bone fixing plate 100 allows the screw holes 130 to be utilised repeatedly. Of course, it would also be appreciated by a skilled person that many materials particularly metals cannot undergo elastic deformation infinite number of times. At least in some instances particularly when the bone fixing plate 100 and the bone screw 200 are formed from metallic materials, after been subjected to repeated stresses, the interference portions 137 and/or the upper rim region 212 of the screw head 212 may undergo metal fatigue and as a result may not completely recover to their original dimensions. FIG. 22 shows a top view of a plate hole 130 that has undergone deformation after repeated use. The outline denoted by lines Q across each interference portion illustrates the structural configuration of the interference portions 137 before undergoing deformation and the shaded regions for the interference portions 137 denote deformed parts of the interference portions 137. In comparison, many of the locking mechanisms known for variable angle locking plates are often limited to one-time use because the threads provided on the screw head and inner walls for plate holes of such prior art systems get damaged after being used in the first instance.” (Paragraph [0063]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to substitute each bone screw and attachment hole of Greenhalgh et al. with the polyaxial bone screws and screw holes which have openings defined through the upper surface of the plate slightly smaller than the head of each bone screw and include interference portions along inner walls thereof as taught by Yuan et al. in order to provide the bone plate with a built-in locking mechanism for the screw head that allows the holes to be used repeatedly for engaging the screw head at a variety of angles.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
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/JESSICA WEISS/Primary Examiner, Art Unit 3775
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