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) 1-4, 6, 12, and 13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sun et al. (KR 20130034288 A; hereinafter “Sun”).
Sun discloses the following regarding claim 1: an augment implant to which different types of porous structures are applied, the augment implant comprising: a body part (Figs. 1-7) of a porous structure which has pores which induce bone ingrowth (pg. 3 of the provided translation), wherein the body part comprises a plurality of porous parts (e.g., 11, 12) having porosities different from each other (pg. 3).
Sun discloses the following regarding claim 2: the augment implant of claim 1, wherein the body part comprises a first porous part (e.g., 12) constituting an outer side of the body part (e.g., Fig. 3), and a second porous part (e.g., 11) constituting an inner side of the body part (e.g., Fig. 3).
Sun discloses the following regarding claim 3: the augment implant of claim 2, wherein a porosity of the first porous part is smaller than a porosity of the second porous part (pg. 3).
Sun discloses the following regarding claim 4: the augment implant of claim 3, wherein a size of a pore of the first porous part is smaller than a size of a pore of the second porous part (pg. 3).
Sun discloses the following regarding claim 6: the augment implant of claim 2, wherein a porous structure of the second porous part is formed to have a regular shape (e.g., Figs. 1-4).
Sun discloses the following regarding claim 12: the augment implant of claim 1, wherein the body part comprises an edge (upper edge boundaries of Fig. 3) which is a boundary between a surface and a surface (among surfaces 11, 12, 14), and the augment implant further comprises an edge frame part (upper portion of element 14) of a nonporous structure formed along the edge (Fig. 3; pg. 4).
Sun discloses the following regarding claim 13: the augment implant of claim 1,wherein the augment implant is integrally manufactured by 3D printing (Fig. 3; pgs. 3-4). Regarding method limitations in article claims, it has been held that the method of forming a device is not germane to the issue of patentability of the device itself. Method language has been considered in so far as it further defines the structure of the claimed apparatus. As presently worded, the scope of the subject matter fails to structurally distinguish the claims over the prior art.
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) 5 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sun in view of Brown et al. (Pub. No.: US 2006/0241776 A1; hereinafter “Brown”).
Regarding claim 5, Sun discloses the limitations of the claimed invention, as described above. However, it does not explicitly recite that the porous structure of the first, outer porous part is formed to have an irregular shape. Brown teaches that it is well known in the art that the porous structures of augment implants can be provided with a variety of configurations, including irregular shapes (Figs. 1D-2B; paras. 0038-0039, 0043), as would be needed to properly fit a patient’s specific implantation site. It would have been obvious to one having ordinary skill in the art to modify the shape of the porous structure of the first, outer porous part of Sun to be irregular, as taught by Brown, in order to properly fit a patient’s specific implantation site. Such a modification would be made with a reasonable expectation of success.
Regarding claim 7, Sun discloses the limitations of the claimed invention, as described above. However, it does not explicitly recite the augment implant further comprising a wall frame part of a nonporous structure formed along a boundary surface between the first porous part and the second porous part. Brown teaches that it is well known in the art that a wall frame part (e.g., 614) of a nonporous structure is formed along a boundary surface between the first, outer porous part and the second, inner porous part (Fig. 19; para. 0078), for the purpose of providing additional structural support to the implant. It would have been obvious to one having ordinary skill in the art to modify the implant of Sun to comprise a wall frame part, as taught by Brown, in order to provide additional structural support to the implant. Such a modification would be made with a reasonable expectation of success.
Claim(s) 8-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sun in view of Grady, Jr. et al. (Pub. No.: US 2005/0261688 A1; hereinafter “Grady”).
Sun discloses the limitations of the claimed invention, as described above. However, it does not explicitly recite that the body comprises a through hole, a hole frame part, and a powder hole. Grady teaches that it is well known in the art that an implant comprises a through hole (90) formed through a second, inner surface of the body part from a first, outer surface thereof (Figs. 1A-4B), and a hole frame part (interior surfaces of element 90) of a nonporous structure formed along an inner surface of the through hole (Figs. 1A-4B). The hole frame part of Grady comprises a powder hole (e.g., 70, 84) that is fully capable of holding powder and is formed through a second surface (surface of hole frame part positioned farthest away from the central lumen of the through hole) the of the hole frame part from a first surface thereof (surface of hole frame part positioned closet to the central lumen of the through hole) (Figs. 1A-4B). The powder hole is formed at a position at which the powder hole communicates with the second, inner porous part of the body part (Figs. 1A, 2A, 3A, 4A). The through hole comprises a first tapered hole which has a truncated cone-shaped space by having a diameter decreasing gradually toward a second side from a first side (Figs. 1A-4B), and a second tapered hole which faces the first tapered hole and has a truncated cone-shaped space by having a diameter decreasing gradually toward the first side from the second side so that multidirectional fixing of a fixing means is possible (Figs. 1A-4B; paras. 0046-0048). This configuration allows the implant device to be more securely anchored at its implantation site. It would have been obvious to one having ordinary skill in the art to modify the implant of Sun to comprise the through hole, hole frame part, and powder hole taught by Grady, in order to more securely anchor the implant at its implantation site. Such a modification would be made with a reasonable expectation of success.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ann Hu whose telephone number is (571) 272-6652. The examiner can normally be reached on Monday-Friday (9:00 am-5:30 pm EST).
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/ANN HU/Primary Examiner, Art Unit 3774