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 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.
Claim(s) 1-3, 5-8, 10-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Austin et al. (U.S. Publication No. 2008/0300637).
Austin et al. discloses a method for securing a first screw (80) to a bone plate (12), comprising the steps of: inserting a shaft of the first screw through the bone plate from an upper surface of the bone plate to a bone-contacting surface of the bone plate (Figure 1), contacting at least one of a plurality of screw-engaging members (24) in the bone plate with a head of the first screw (84) (Figure 5) , the screw-engaging members (24) defining a converging-diverging profile (Figure 9) and extending between an intermediate surface and the bone-contacting surface (Figure 10, the intermediate surface disposed between the upper surface and the bone-contacting surface (Figure 10); plastically deforming (paragraph 116, “this movement of fins 24 is a permanent deformation, so that the fins cannot flex back and allow the fastener to work its way out”) at least one of the plurality of screw-engaging members with threads of the head to form an interference connection between the first screw and the bone plate (paragraph 116); and advancing the first screw until a portion of the head is positioned between to the upper surface and the bone contacting surface of the bone plate (paragraph 116).
Regarding claim 2, the head (84) of the first screw has a frusto-conical shape (Figure 6).
Regarding claim 3, the inserting step includes inserting the first screw through a hole in the bone plate at an angle within a 30-degree cone with respect to a central axis of the hole (Figure 5, Paragraph 138, “Locking screws can be angled and locked up to 15 degrees in any direction”.)
Regarding claim 5, the inserting step includes inserting the first screw through a first hole of the bone plate and inserting a second screw through a second hole of the bone plate (as seen in Figure 42, there are multiple holes for accepting screws and thus anticipates inserting in a first hole and a second hole).
Regarding claim 6, the first screw is locked at a first angle with respect to an axis of the first hole, and the second screw is locked at a second angle with respect to an axis of the second hole, the first and second angles being different (paragraph 138, “multi-directional locked plating constructs”).
Regarding claim 7, Austin et al. discloses a method for securing a screw (80) to a bone plate (12), comprising the steps of: selecting the screw from a plurality of screws (Figure 12); inserting a shaft (82) of the screw through the bone plate from an upper surface of the bone plate to a bone-contacting surface of the bone plate (Figure 1), contacting at least one of a plurality of screw-engaging members (24) in the bone plate with a head (84) of the screw (Figure 1, 3, 5), the plurality of screw-engaging members (24) being spaced around a circumference of a hole and defining a converging-diverging profile (Figure 9) that extends from an intermediate surface towards the bone-contacting surface (Figure 10), wherein the intermediate surface is spaced apart from the upper surface and is perpendicular to the central axis of the hole (Figure 10); and securing the screw to the bone plate by plastically deforming at least one of the plurality of screw-engaging members with the head of the screw (paragraph 116, “this movement of fins 24 is a permanent deformation, so that the fins cannot flex back and allow the fastener to work its way out”).
Regarding claim 8, the method further comprising advancing the screw until a portion of the head (84) of the screw is disposed between the upper surface and the intermediate surface of the bone plate (Figure 5, it can be seen at least a portion of the head is between the upper surface and the intermediate surface).
Regarding claim 10, the head of the screw includes at least one sharp cutting edge configured to shear into the bone plate (the threads of the screw can be considered a sharp cutting edges and capable of shearing in the bone plate if one so desired, furthermore, it can be considered that driving the screw into elements 24 of the bone plate is the thread shearing into the bone plate to cause the elements 24 to deform).
Regarding claim 11, the bone plate is configured to receive the screw and other screws in polyaxial orientations (paragraph 138, “multi-directional locked plating constructs”).
Regarding claim 12, the contacting step includes applying torque to the screw to engage bone and the bone plate (it can be construed that the threaded screw requires torque to be engage the bone and bone plate).
Regarding claim 13, Austin et al. discloses a method for securing a screw to a bone plate, comprising the steps of: selecting an insertion angle of the screw from a plurality of insertion angles (Paragraph 138); inserting a shaft of the screw through the bone plate from an upper surface of the bone plate to a bone-contacting surface of the bone plate and along the selected insertion angle (Figure 1); contacting at least one of a plurality of screw-engaging members (24) in the bone plate with a head of the screw, the plurality of screw-engaging members being spaced around a circumference of a first hole and defining a converging-diverging profile that extends from an intermediate surface along a central axis of the first hole (Figure 8), wherein the intermediate surface is disposed between the upper surface and the bone-contacting surface (Figure 8); and plastically deforming at least one of the plurality of screw-engaging members with threads defined by the head of the screw (paragraph 116, “this movement of fins 24 is a permanent deformation, so that the fins cannot flex back and allow the fastener to work its way out”).
Regarding claim 14, the first hole has at least eight screw-engaging members evenly spaced apart (Figure 7).
Regarding claim 15, the method further comprising a second hole (18) and a third hole (62), the second hole being identical to the first hole (Figure 12), and the third hole having a different structural configuration than that of the first and the second holes (Figure 12).
Regarding claim 16. The method of claim 13, wherein the insertion angle is within 30 degrees of a central axis of the hole (Figure 5, Paragraph 138, “Locking screws can be angled and locked up to 15 degrees in any direction”).
Regarding claim 17, the plurality of screw-engaging members each include an upper-region, a middle region (See figure below), and a lower region (the side under the upper region).
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Regarding claim 18, the middle region is positioned closer to the central axis of the first hole than the upper and lower regions (see figure above).
Regarding claim 19, the first hole further includes scalloped regions (60) disposed between the plurality of screw-engaging members (Figure 9). It is noted that the embodiment of Figure 9 also anticipates claim 13 and thus can be used for anticipating claim 19).
Regarding claim 20, at least one of the plurality of screw-engaging members defines a surface having either a diamond shape or a rectangular shape (in figure 10, what is analogous to the middle region as indicated above in figure 8 is a rectangular shape).
Claim(s) 1, 4 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Eckhof et al. (U.S. Patent No. 8506607).
Dominik et al. discloses a method for securing a first screw (2) to a bone plate (3), comprising the steps of: inserting a shaft of the first screw through the bone plate from an upper surface of the bone plate to a bone-contacting surface of the bone plate (Figure 4), contacting at least one of a plurality of screw-engaging members (6) in the bone plate with a head of the first screw (Figure 4, 5A) , the screw-engaging members (6) defining a converging-diverging profile (Figure 5B) and extending between an intermediate surface and the bone-contacting surface (Figure 5b, “an intermediate surface is considered any surface between the upper and lower surface of the plate, thus the screw engaging members although extend the length of the bore, at least a portion extends between “an intermediate surface and the bone contacting surface”), the intermediate surface disposed between the upper surface and the bone-contacting surface (See explanation above); plastically deforming at least one of the plurality of screw-engaging members with threads of the head to form an interference connection between the first screw and the bone plate (Column 9, Lines 43-57); and advancing the first screw until a portion of the head is positioned between to the upper surface and the bone contacting surface of the bone plate (Figure 4)
Regarding claim 4, the bone plate is formed of a first material and the first screw is formed of a second material harder than the first material to plastically deform the plurality of screw-engaging members (Column 6, Lines 44-51).
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) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Austin et al. (U.S. Publication No. 2008/0300637) in view of Mocanu et al. (U.S. Patent No. 8906076).
Austin et al. discloses the claimed information except for the ahead of the screw having a double lead thread. Mocanu et al. teaches a locking bone plate system with a double lead thread of a screw whole which provides the advantage of enabling a locking screw to engage the plate in half as many turns than that of a single thread (Column 2, Lines 64-67). Although the thread is taught in the screw aperture, the motivation of the thread can be used in the reverse where the thread is on the screw head since it has been held that a mere reversal of the essential working parts of a device involves only routine skill in the art. In re Einstein, 8 USPQ 167. It would have been obvious to one skilled in the art to construct the screw head of Austin et al. with a double lead thread in view of Mocanu et al. so that the head could lock into plate in half as many turns than that of a single thread.
Conclusion
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/ANDREW YANG/Primary Examiner, Art Unit 3775