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 .
This is the initial Office action for the 19/031,595 application. Claims 1-15 are pending.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-15 are rejected under 35 U.S.C. 101 because in claim 1, applicant positively recites part of a human, i.e. "a bridge component extending from the disc space.” Thus claim 1 includes a human within its scope and is non-statutory.
A claim directed to or including a human within its scope is not considered patentable subject matter under 35 U.S.C. 101. The grant of a limited, but exclusive property right in a human being is prohibited by the Constitution. In re Wakefield, 422 F.2d 897, 164 USPQ 636 (CCPA 1970).
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 1-15 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 1 recites the limitation "the distal end of the bridge component" in line 15. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1-4, 7-10, 13 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carls et al. (U.S. 2008/0300685 A1) in view of Coppes et al. (U.S. 2010/0280617 A1).
Concerning claim 1, Carls et al. disclose a prosthetic system for implantation between upper and lower vertebrae, the system comprising: an upper joint component (see Fig. 8 below) comprising a metallic upper contact surface and a polyethylene upper articulation surface (see par. 0061); a lower joint component (see Fig. 9 below) comprising a first lower contact surface for engaging a cancellous bone surface exposed by resection of one or more endplate surfaces of the lower vertebrae and a metallic lower articulation surface configured to movably engage the polyethylene upper articulation surface to form an articulating joint (see par. 0061), wherein the articulating joint is adapted for implantation within a disc space between the upper and lower vertebrae, allowing the upper and lower vertebrae to move relative to one another; and a bridge component (see Fig. 8 below) extending posteriorly from the lower joint component and configured to extend from the disc space, the bridge component having a second lower contact surface (see Fig. 9 below) configured for engaging a resected bone surface of a pedicle of the lower vertebrae, wherein a distal end of the bridge component comprises a connection component (see Fig. 9 below) adapted to receive a fastener.
[AltContent: arrow][AltContent: textbox (2nd lower contact surface)][AltContent: textbox (1st lower contact surface)][AltContent: connector][AltContent: connector][AltContent: connector][AltContent: connector][AltContent: textbox (Motion Limiter – including a curved surface)][AltContent: arrow][AltContent: textbox (Fastener)][AltContent: connector][AltContent: textbox (Connection Component)][AltContent: connector][AltContent: arrow][AltContent: textbox (Lower Joint Component)][AltContent: connector][AltContent: textbox (Bridge Bone Contacting Surface)][AltContent: connector][AltContent: textbox (Bridge Component)][AltContent: connector][AltContent: textbox (Convex Lower Articulation Surface)][AltContent: connector][AltContent: textbox (Lower Keel)][AltContent: connector][AltContent: textbox (Concave Upper Articulation Surface)][AltContent: textbox (Motion Limiter)][AltContent: connector][AltContent: textbox (Upper Bone Contacting Surface)][AltContent: connector][AltContent: textbox (Upper Keel)][AltContent: arrow][AltContent: textbox (Upper Joint Body)][AltContent: textbox (Upper Joint Component)][AltContent: arrow]
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Concerning claim 2, wherein at least a portion of the second lower contact surface comprises a textured surface (see par. 0062).
Concerning claim 3, wherein at least a portion of the second lower contact surface comprises an osteoconductive material (see par. 0062).
Concerning claim 4, wherein at least a portion of the second lower contact surface comprises an osteoinductive material (see par. 0062).
However, Carls et al. does not explicitly disclose a metallic upper contact surface and a polyethylene upper articulation surface of the upper joint component, or a metallic lower articulation surface of the lower joint component. Carls et al. does disclose that the prosthetic system may be formed of any suitable biocompatible material including metals such as cobalt chrome (see par. 0061), and polymer materials such as UHMWPE. Carls et al. goes on to disclose that the various components comprising the prosthetic system may be formed of different materials thus permitting metal on polymer constructions.
Coppes et al. disclose an articulating insert (see Fig. 3) comprising a polymer (see par. 0101) which is attached to a metal endplate in the same field of endeavor for the purpose of “permitting a surgeon to have several different options for the materials of the articulating surface.”
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Carls’ system by incorporating an upper articulating insert made of UHMWPE, the concept of which is taught by Coppes et al., since it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art. Nerwin v. Erlichman, 168 USPQ 177, 179. Furthermore, Carls et al. discloses the concept of using different materials to form the various components comprising the prosthetic system permitting metal on polymer constructions. Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to form the articulating insert from UHMWPE since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claim 7, wherein the upper joint component further comprises a polyethylene anterior motion limiter, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to form the anterior motion limiter from polyethylene since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claim 8, wherein the lower joint component further comprises a metallic anterior retention surface, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to form the anterior retention surface from metal since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claim 9, wherein the upper joint component further comprises a polyethylene posterior motion limiter, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to form the posterior motion limiter from polyethylene since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claim 10, wherein the lower joint component further comprises a metallic posterior retention surface, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to form the posterior retention surface from metal since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Concerning claim 13, wherein the anterior motion limiter (see above) comprises a first generally horizontal anterior surface component and a first generally vertical anterior surface component.
Concerning claim 14, wherein the posterior motion limiter (see above) comprises a second generally horizontal posterior surface component and a second generally vertical posterior surface component.
Claim(s) 5-6, 11-12 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carls et al. (U.S. 2008/0300685 A1) in view of Coppes et al. (U.S. 2010/0280617 A1) as applied to claim 1 above, further in view of Davidson (US 5,358,529).
Carls et al. in view of Coppes et al. disclose the invention substantially as described above. However, Carls et al. in view of Coppes et al. do not explicitly disclose that the polyethylene upper articulation surface is positioned on a surface of a polyethylene insert, wherein at least a portion of the polyethylene insert is positioned within a recess formed in the upper joint component.
Davidson teaches the concept of layering polymers in orthopedic articulation surfaces.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to position the polyethylene upper articulation surface on a surface of a polyethylene insert that is positioned in a recess formed in the upper joint component, the concept of which is disclosed by Davidson, in order to enhance the implant by optimizing competing material properties. By layering the polymers, a highly crosslinked UHMWPE could be used on the articulation surface for superior wear resistance, and a convention UHMWPE could be used for the insert for superior fatigue strength, fracture toughness, and oxidative stability.
Regarding claim 6, the concept of overmolding contact surfaces is well known in the orthopedic art and beneficial as it eliminates the needs for mechanical fasteners due to the directed molecular or mechanical interlock between components. Those of ordinary skill in the art would find it obvious to utilize this technique to secure implant components.
Regarding claim 11, wherein the polyethylene insert further comprises a polyethylene posterior motion limiter and a polyethylene anterior motion limiter,
Regarding claim 12, wherein the lower joint component further comprises a metallic anterior retention surface and a metallic posterior retention surface, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to form anterior retention surface and posterior retention surface from metal, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Concerning claim 15, wherein the polyethylene upper articulation surface comprises a cross-linked ultra-high-molecular-weight polyethylene concave cup (see par. 0061), it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to form the upper articulation surface from cross-lined ultra-high-molecular-weight polyethylene since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELLEN HAMMOND whose telephone number is (571)270-3819. The examiner can normally be reached Monday-Friday 8 - 4 PM .
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Eduardo C. Robert, at 571 272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ELLEN C HAMMOND/Primary Examiner, Art Unit 3773