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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
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Claims 1-3 and 5-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 12,115,071. Although the claims at issue are not identical, they are not patentably distinct from each other because both the present claims and granted patent disclose an implant. The implant comprises an intramedullary body configured to be inserted into a medullary cavity of a bone, the intramedullary body comprising one or more outer contact faces. The implant includes a space truss coupled to at least one of the outer contact faces, wherein, during use, the space truss is positioned at least partially inside the medullary cavity and between the intramedullary body and the medullary cavity, wherein the space truss comprises two or more planar truss units having a plurality of struts joined at nodes, and wherein one or more dimensions of the struts are predetermined such that, when the space truss is in contact with the bone, at some of a strain on the intramedullary body is distributed through the space truss to the bone.
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.
Claims 1-3, 5-7, 50-53, and 55-63 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Pub. No. 2005/0015154 to Lindsey et al.
As to Claim 1, Lindsey discloses an implant (Fig. 3). The implant comprises an intramedullary body (Fig. 3, [0043]), insertable into a medullary cavity of a bone [0020], comprising one or more outer contact faces (upper and lower faces, Fig. 3), and a space truss coupled to the contact face (formed by frame of triangular fenestrations, [0043]), wherein, during use, the space truss is at least partially disposed inside the medullary cavity, between the intramedullary body of the implant and the medullary cavity [0020, 0043. 0046], wherein the space truss comprises two or more planar truss units having a plurality of struts joined at nodes (triangular frame, nodes at vertices, Fig. 3), and wherein a length of the struts are predetermined such that when the space truss is in contact with the bone at least a portion of strain on the intramedullary rod is distributed through the space truss to the bone (described in [0046])
As to Claim 2, Lindsey discloses an implant wherein the plurality of struts define openings configured to enable bone through growth through the openings (described in [0046]).
As to Claim 3, Lindsey discloses an implant wherein the intramedullary body is a rod (Fig. 3).
As to Claim 5, Lindsey discloses an implant wherein the planar truss units are planar triangular truss units having three substantially straight struts and three nodes in a triangular configuration (seen in Fig. 3).
As to Claim 6, Lindsey discloses an implant wherein each of the truss units lies in a plane that is not substantially parallel to a plane of an adjacent truss unit that shares at least one strut (triangular truss units not parallel to adjacent truss unit due to curvature of implant seen in Fig. 3).
As to Claim 7, Lindsey discloses an implant wherein the space truss comprises truss units forming a plurality of polyhedrons (space truss unit geometries described in [0046]).
As to Claim 50, Lindsey discloses an implant (Fig. 3).comprising a web structure comprising a plurality of struts joined at nodes (frame of triangular fenestrations, [0043], nodes at vertices, Fig. 3), wherein the web structure is configured to interface with human bone tissue [0042], and wherein the web structure comprises a space truss comprising two or more planar truss units (formed by triangular frame, joined by nodes at vertices, Fig. 3), wherein the web structure includes a first portion of struts and a second portion of struts (triangular fenestrations located at different areas of implant, Fig. 3) and wherein the first portion has a first density of struts that is different from a second density of struts in the second portion (described in [0045], e.g. “The structural and mechanical strength characteristics of the device need not be symmetrical; it could be polarized to match the loading expected”).
As to Claim 51, Lindsey discloses an implant wherein the first portion of struts is positioned along a different portion of the human bone tissue from the second portion of struts (different portions of anatomy described in [0045]).
As to Claim 52, Lindsey discloses an implant wherein the first portion (e.g. proximal portion of implant, Fig. 3) of struts is positioned at an interface with the human bone tissue, and wherein the second portion of struts is positioned distal from the interface (e.g. distal portion of implant, Fig. 3, [0043, 0045]).
As to Claim 53, Lindsey discloses an implant wherein the first density is higher than the second density (described in [0045], e.g. “The structural and mechanical strength characteristics of the device need not be symmetrical; it could be polarized to match the loading expected”).
As to Claim 55, Lindsey discloses an implant wherein the first density is predetermined to provide a specified change in length in the human bone tissue interfacing with the first portion (restore/preserve anatomy, [0044]).
As to Claim 56, Lindsey discloses an implant wherein the first portion has struts with a different diameter than struts in the second portion (irregular configurations, [0044, 0046]).
As to Claim 57, Lindsey discloses an implant wherein the first portion has struts with different lengths than struts in the second portion (irregular configurations, [0044, 0046]).
As to Claim 58, Lindsey discloses an implant wherein the first portion has struts with a different porosity than struts in the second portion (varying materials having different porosities, [0046]).
As to Claim 59, Lindsey discloses an implant wherein the first portion has struts made of a different material than struts in the second portion (varying materials, [0046]).
As to Claim 60, Lindsey discloses an implant wherein the first portion has struts oriented in different directions than struts in the second portion (due to curvature of implant seen in Fig. 4).
As to Claim 61, Lindsey discloses an implant wherein one or more of the planar truss units comprise one or more planar triangular truss units having three substantially straight struts and three nodes in a triangular configuration (triangular configuration of Fig. 3, [0043]).
As to Claim 62, Lindsey discloses an implant wherein one or more of the planar truss units are coupled to one another such that one or more planar truss units lie in a plane that is not substantially parallel to a plane of a planar truss unit that shares at least one strut with the one or more planar truss units (triangular truss units not parallel to adjacent truss unit due to curvature of implant seen in Fig. 3).
As to Claim 63, Lindsey discloses an implant wherein the space truss is coupled to at least one outer contact face of an intramedullary body configured to be inserted into a medullary cavity of a bone (described in [0052]).
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 54 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Pub. No. 2005/0015154 to Lindsey et al. in view of U.S. Patent No. 5,954,504 to Misch et al.
As to Claim 54, Lindsey discloses the claimed invention except for wherein the first density is predetermined to provide a specified microstrain in the human bone tissue interfacing with the first portion.
Misch discloses an implant (10) and method of implantation (Col. 7, Lines 45-48) wherein a diameter and length of the structure are predetermined such that when the web structure is in contact with the bone at least a portion of the struts create a microstrain in adhered osteoblasts (Col. 4, Lines 40-48) in order to induce strain in the surrounding bone to promote bone growth and osteointegration (Col. 4, Lines 40-48).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the implant of Lindsey with the microstrain modification of Misch in order to induce strain in the surrounding bone to promote bone growth and osteointegration.
Conclusion
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/CHRISTOPHER J BECCIA/Primary Examiner, Art Unit 3775