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.
Claims 1-4 and 6-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Pub. No. 2009/0043392 to Duggal et al.
As to Claim 1, Duggal discloses an artificial disc (10) for insertion between two adjacent vertebrae [0084]. The artificial disc comprises an upper plate (92) contacting an upper vertebra [0116, 0099], a lower plate (94) contacting a lower vertebra [0116, 0099], and an inserter (96) inserted between the upper plate (92) and the lower plate (94) to allow the upper plate to rotate by a set angle with respect to the lower plate ([0116], various angles seen in Figs. 2A-2C, described in [0103-0105]). The upper plate (92) and the lower plate (94) are characterized in that an upper wing portion and a lower wing portion are formed along a lateral axis while the inserter is inserted (seen in Fig. 9, below).
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As to Claim 2, Duggal discloses an artificial disc wherein the upper plate and the lower plate each have a thickness greater in an anterior direction than in a posterior direction (thickness including 116, seen in Figs. 13A-13B, varying according to degree and type of correction required).
As to Claim 3, Duggal discloses an artificial disc wherein an upper keel portion (106) and a lower keel portion (106) are respectively formed along a lateral axis on an upper plate outer surface of the upper plate and a lower plate outer surface of the lower plate (Fig. 10, [0119]).
As to Claim 4, Duggal discloses an artificial disc wherein a plurality of upper protrusions (100) and lower protrusions (100) are respectively formed on an upper plate outer surface of the upper plate and a lower plate outer surface of the lower plate (Figs. 10-12, [0117, 0118]).
As to Claim 6, Duggal discloses an artificial disc wherein the inserter (96) includes an upper dome portion (97) on an upper side thereof (Fig. 10) and a first axial rotation portion (inferior portion of 96, Fig. 12) on a lower side thereof, an upper groove (103) corresponding to the upper dome portion is formed in the upper plate for a sliding contact with the upper dome [0119], and a second axial rotation portion (104) is formed on the lower plate that contacts the first axial rotation portion [0119].
As to Claim 7, Duggal discloses an artificial disc wherein the upper dome portion (97) is formed in an elliptical hemispherical shape in which a lateral axis is on the lateral axis line and minor axis is on the anterior to posterior axis line (orientation seen in Figs. 11 and 12), and the upper plate performs lateral bending and an anterior to posterior flexion-extension motion with respect to the lower plate by moving the upper dome portion and upper groove (103) contacting each other [0116, 0119].
As to Claim 8, Duggal discloses an artificial disc wherein a maximum depth of the upper groove (103) is less than a maximum height of the upper dome portion (seen in Figs. 10-12).
As to Claim 9, Duggal discloses an artificial disc wherein an upper stopper (104) is formed around the upper groove (Figs. 10-12), and an angular momentum of the upper plate is limited by the upper stopper coming into contact with an inserter upper surface of the inserter body formed around the upper dome portion [0114].
As to Claim 10, Duggal discloses an artificial disc wherein an inserter lower surface (at 22b, Fig. 2A, [0100]) of the inserter body is flat [0100], and the inserter upper surface is formed so that a thickness thereof is gradually reduced from the upper dome portion to an end of the inserter body (along curved surfaces 24A towards end of body of 10, Fig. 2A).
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.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Pub. No. 2009/0043392 to Duggal et al. in view of U.S. Patent Pub. No. 2019/0274842 to Siccardi et al.
As to Claim 5, Duggal discloses the claimed invention except for wherein the plurality of upper protrusions and the lower protrusions each have a quadrangular pyramid shape with a quadrangular cross section including four line segments each perpendicular to the lateral axis and the anterior to posterior axis.
Siccardi discloses an artificial disc (1) including a plurality of upper protrusions(2a) and lower protrusions (3a) that each have a quadrangular pyramid shape with a quadrangular cross section including four line segments each perpendicular to the lateral axis and the anterior to posterior axis (seen in Figs. 1, 2, 4, [0031]) in order to increase the grip between the upper lower plates of the implant with the respective endplates of the upper and lower vertebrae [0030].
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the artificial disc for insertion between two adjacent vertebrae of Duggal with the pyramid projection modification of Siccardi in order to increase the grip between the upper lower plates of the implant with the respective endplates of the upper and lower vertebrae.
Claims 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Pub. No. 2009/0043392 to Duggal et al. in view of U.S. Patent Pub. No. 2022/0151799 to Keem.
As to Claims 11 and 12, Duggal discloses the claimed invention except for wherein the first axial rotation portion is a lower outer protrusion formed on the inserter lower surface, the second axial rotation portion is a lower outer groove formed on the lower plate, and the above lower outer groove is formed in an arc shape, and wherein a lower center protrusion is formed at a center of the inserter lower surface, and a lower center groove corresponding to the lower center protrusion is formed on the lower plate.
Keem discloses an artificial disc (500) including wherein a first axial rotation portion is a lower outer protrusion (221, 222) formed on an inserter (100) lower surface (Fig. 4), the second axial rotation portion is a lower outer groove (312) formed on the lower plate (300, Fig. 5), and the above lower outer groove is formed in an arc shape (arc formed by shape of body 310, 311 and 312, Fig. 5), and wherein a lower center protrusion (210) is formed at a center of the inserter lower surface (Fig. 4), and a lower center groove (311) corresponding to the lower center protrusion is formed on the lower plate (Fig. 5, [0093]) in order to allow the implant to be configured to closely mimic natural movements of the spine to the greatest extent, thereby preventing stress and fatigue with the surrounding tissues and improving a patient's joint mobility [0034].
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the artificial disc for insertion between two adjacent vertebrae of Duggal with the protrusion and groove modification of Keem in order to allow the implant to be configured to closely mimic natural movements of the spine to the greatest extent, thereby preventing stress and fatigue with the surrounding tissues and improving a patient's joint mobility.
Conclusion
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/CHRISTOPHER J BECCIA/ Primary Examiner, Art Unit 3775