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 § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 2-21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Independent claims 2, 9, and 15 recite
There is no recitation of any “layers” of material within the specification.
[0013] of the specification reads: In some implementations, at least the elongated member and the fastening member may be made of different materials. As an example, the elongated member may be made from a material that exhibits a certain flexibility so that the elongated member can be wound around the bone parts. On the other hand, the fastening member may be made from a rigid material that will not, or not easily, deform upon an engagement with the bone fastener. As such, the rigidity of the fastening member material may generally be higher than the rigidity of the engagement member material.
[0030] describes: In all the implant aspects, the fastening member may be made from a metallic material (e.g., stainless steel, titanium or a titanium alloy). In addition, or as an alternative, at least one of the elongated member and the engagement member may be made from a polymeric material (e.g., polyetheretherketone, PEEK). In certain variants, the engagement member and the fastening member may at least partially be realized as a one-piece structure. As such, the engagement member may at least partially be made from the same material than the fastening member.
[0060] describes: As will be appreciated, using a polymeric material for the elongated member 12 and the engagement member 14 facilitates injection molding of those two members 12, 14 to the fastening member 16. However, the present disclosure in relation to the visual indicator 22 is not limited to manufacturing the implant 10 using one or more injection molding processes. Moreover, the visual indicator 22 could also be realized in connection with an implant 10 that is realized as a one-piece structure (e.g., from a polymeric material and, optionally, in a single injection molding process).
[0067] describes: Further, each tapering portion 34 ends in a circumferential lip 36 of reduced material thickness around the respective hole 20. The lip 36 constitutes a locking feature configured to lock a bone fastener to the fastening member 16 as generally illustrated in FIG. 6 (for a different cross-sectional configuration of the fastening member 16).
Examiner contends that these most relevant portions of the specification do not provide support for first and second reinforcing regions, first and second layers protruding into first and second openings, a first inner wall of the elongated member defining the first opening including an inner portion embedded in between a first outer portion and a second outer portion such that the inner portion is remote from ends of the first opening, or the fixation member being partially embedded within the elongated member such that the first surface is covered by the elongated member and the second surface is covered by the elongated member.
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 2-18 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Pu. No. 2011/0060366 to Heim et al. in view of U.S. Patent Pub. No. 2002/0165545 to Happonen et al.
As to Claim 2, Heim discloses an implant for bone fixation (10g, Figs. 36-37, [0161]). The implant comprises an elongated member (12) defining a first opening (first opening 632) and a second opening (opening 632, Fig. 39, [0163]) spaced apart from the first opening (Fig. 39). The embodiment of Figs. 36-37 does not explicitly disclose a second opening. The implant of Fig. 5 can include multiple load-bearing reinforced holes 32, described in [0134]. The elongated member is reinforced such that a first inner reinforcing region (at 636, [0161]) disposed between a first outer layer (644) of the elongated member and a second outer layer (opposing side 644) of the elongated member protrudes into the first opening (seen in Fig. 36, [0161]). A second inner reinforcing region (second region at 636, analogous to second hole 32, [0134, 0161]) is disposed between the first outer layer (644) and the second outer layer (opposing side 644) protrudes into the second opening (seen in Fig. 36, [0161]), the first and second outer layers (644) being made of a first material (mesh 644, [0161, 0163]) and the first and second inner reinforcing regions (636) being made of a second material different from the first material (densely embroidered region 636, [0163]).
As to Claim 3, Heim discloses an implant for bone fixation wherein the first and second inner reinforcing regions (at 636, [0161]) are embedded in between the first outer layer (644) and the second outer layer (opposing side 644) internal to peripheral ends of the respective first and second openings (seen in Figs. 36-37).
As to Claim 4, Heim discloses an implant for bone fixation wherein the first and second outer layers are injection molded over the first and second inner reinforcing regions (injection molding described in [0129-0130]).
As to Claim 5, Heim discloses an implant for bone fixation wherein the first and second inner reinforcing regions (at 636, [0161]) have a tapering thickness toward an inner enclosed edge ([0161, 0163], seen in Figs. 36-37).
As to Claim 6, Heim discloses an implant for bone fixation wherein a minimum diameter of the first opening (632) is defined by the first inner reinforcing region ([0161, 0163], seen in Figs. 36-37).
As to Claim 7, Heim discloses an implant for bone fixation wherein the first material is polymeric and the second material is metallic (materials described in [0129-0130]).
As to Claim 9, Heim discloses an implant for bone fixation (10g, Figs. 36-37, [0161]). The implant comprises an elongated member (12) defining a first opening (first opening 632) and a second opening (opening 632, Fig. 39, [0163]) spaced apart from the first opening (Fig. 39). The embodiment of Figs. 36-37 does not explicitly disclose a second opening. The implant of Fig. 5 can include multiple load-bearing reinforced holes 32, described in [0134]. Each of the first opening (632) and the second opening (632) being configured to receive a bone fastener (630, [0161]). A first inner wall of the elongated member (at 636, [0161]) defining the first opening (Figs. 36 and 37) including an inner portion embedded in between a first outer portion (644) and a second outer portion (opposing side 644) such that the inner portion is remote from ends of the first opening (seen in Figs. 36-37), the inner portion (mesh 644, [0161, 0163]) being made of a different material than the first and second outer portions (densely embroidered region 636, [0163]).
As to Claim 12, Heim discloses an implant for bone fixation wherein the first material is polymeric and the second material is metallic (materials described in [0129-0130]).
As to Claim 14, Heim discloses an implant for bone fixation wherein a portion of an outer periphery of the inner portion (at 636, [0161]) is embedded within a peripheral portion of the elongated member (644), the peripheral portion being made of the same material as the first outer portion and the second outer portion (materials described in [0129-0130]).
As to Claim 15, Heim discloses an implant for bone fixation (10g, Figs. 36-37, [0161]). The implant comprises an elongated member (12) made of a first material (materials described in [0129-0130]), and a fixation member (636) made of a second material different from the first material (e.g. (mesh 644, [0161, 0163]), the fixation member having a first surface (644) and a second surface opposite the first surface (opposing surface 644), the fixation member being partially embedded within the elongated member such that the first surface is covered by the elongated member and the second surface is covered by the elongated member ([0161, 0163, Figs. 36-37), wherein the elongated member (12) and the fixation member (636) define an opening (632), a portion of the opening being defined by the fixation member extending from the first surface to the second surface ([0161, 0163, Figs. 36-37).
As to Claim 16, Heim discloses an implant for bone fixation wherein the portion of the opening defined by the fixation member has a varying diameter (seen in Figs. 36-37, from 632 to 632).
As to Claim 17, Heim discloses an implant for bone fixation wherein a minimum diameter of the opening is defined by the fixation member (at 636, Figs. 36-37).
As to Claim 19, Heim discloses an implant for bone fixation wherein a portion of the fixation member has a uniform thickness from the first surface to the second surface ([0164], Figs. 36-37).
As to Claim 20, Heim discloses an implant for bone fixation wherein the elongated member is injection molded over the fixation member (injection molding described in [0129-0130]).
As to Claim 21, Heim discloses an implant for bone fixation wherein the first material is polymeric and the second material is metallic (materials described in [0129-0130]).
As to Claims 2-8, Heim discloses the claimed invention except for wherein the elongated member has a first width at the first opening and the second opening and a second width in between the first opening and second opening, the second width being less than the first width, wherein a first diameter of the first opening at the inner portion is less than a second diameter of the first opening at an outer edge of the first opening at one of the first and second outer portions, wherein the first opening tapers from the outer edge to the inner portion such that a minimum diameter of the first opening is defined by the inner portion, wherein a width of the elongated member orthogonal to an elongate dimension of the elongated member varies along the elongate dimension such that the elongated member has a first width at a center of the first opening and a second width between the first opening and the second opening, the first width being greater than the second width.
Happonen discloses an implant for bone fixation (1, [0002, 0004]) wherein an elongated member (2) has a first width at a first opening (width at opening 3, Fig. 1) and a second opening (width at opening 3, Fig. 1) and a second width in between the first opening and second opening (at 8, Fig. 1), the second width being less than the first width (second width of 8 being less than that of 2 at openings 3, seen in Fig. 2). A first diameter of the first opening (width at opening 5, Fig. 1) at the inner portion is less than a second diameter of the first opening at an outer edge of the first opening (at 4, Fig. 1) at one of the first and second outer portions (Figs. 1-2). The first opening (3) tapers from the outer edge (at 4) to the inner portion (at 5) such that a minimum diameter of the first opening is defined by the inner portion (Fig. 1, [0027]). A width of the elongated member (2) orthogonal to an elongate dimension of the elongated member varies along the elongate dimension such that the elongated member has a first width at a center of the first opening (width at opening 3, Fig. 1) and a second width between the first opening and the second opening (at 8, Fig. 1), the first width being greater than the second width (second width of 8 being less than that of 2 at openings 3, seen in Fig. 2) in order to more easily allow the implant to be shaped to the surface of the bone where it is implanted [0028].
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the implant for bone fixation of Heim with the dimension modification of Happonen in order to more easily allow the implant to be shaped to the surface of the bone where it is implanted.
Conclusion
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/CHRISTOPHER J BECCIA/ Primary Examiner, Art Unit 3775
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