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 Objections
Claim(s) 9-17 is/are objected to because of the following informalities:
Claim 9 recites “implant body” in line 3 instead of “an implant body” in order to be grammatically correct. For the purpose of compact prosecution, the claim is being interpreted below under this assumption.
Appropriate correction is required.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-7, 9-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Weiman (U.S. Pub. No. 2014/0249632 A1, hereinafter “Weiman”).
Weiman discloses, regarding claim 1, a method for stabilizing adjacent vertebral bodies (see paras. [0051]-[0052]) comprising the steps of: providing an intervertebral implant (100D, see Figs. 23-38) for implantation in an intervertebral space between vertebrae (see Fig. 22), the implant comprising: an implant body (126D) having an upper plate (see annotated Fig. 23 below) and a lower plate (see annotated Fig. 23 below), and extending from an upper surface to a lower surface (see annotated Fig. 23 below), the implant body having a front end (see annotated Fig. 23 below), a rear end (see annotated Fig. 23 below) and a pair of spaced apart first and second side walls (see annotated Fig. 23 below) extending between the front and rear ends such that an interior chamber is defined by the upper and lower plates and the sidewalls (see annotated Fig. 23 below), wherein the rear end includes an elongated opening (see annotated Fig. 23 below) defining a pivoting recess (see annotated Fig. 23 below), an upper track formed on an interior surface of the upper plate (see annotated Fig. 23 below) and a lower track formed on an interior surface of the lower plate (see annotated Fig. 23 below); a pivoting member (160D, 106D, 108D, 280) including an enlarged head (280 and 160D) and an elongated shaft (106D and 108D) terminating at a distal end (106D, see Fig. 25), wherein the distal end is positioned within the pivoting recess and the enlarged head is positioned between the upper and lower tracks (see Fig. 24); and a blocking member (134 and 136) extending from the upper plate to the lower plate of the implant body and securing the pivoting member within the upper and lower tracks (via 202D, see Fig. 25, see also paras. [0073]-[0074]), wherein the pivoting member is configured to slide along the tracks and articulate from an initial position to a final position (see Figs. 25 and 27), wherein an upper portion (e.g. upper 296, see Fig. 23) of the enlarged head is received within the upper track and a lower portion (e.g. lower 396, see Fig. 23) of the enlarged head is received within the lower track (see Fig. 23), positioning the intervertebral implant between adjacent vertebral bodies (see paras. [0051]-[0052]).
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Regarding claim 2, wherein the pivoting recess acts as a pivot point for the pivoting member (see Figs. 25 and 27).
Regarding claim 3, wherein the at least one track extends along an arc having a constant radius from the pivot point (see Fig. 24).
Regarding claim 4, wherein a gap in the tracks allows for the pivoting member to be inserted into the elongated opening (see annotated Fig. 23 above).
Regarding claim 5, wherein the upper and lower tracks extend to one of the side walls for receiving the enlarged head of the pivoting member (see annotated Fig. 23 above) and terminate before the other of the side walls to prevent the enlarged head from exiting the implant body (see annotated Fig. 23 above).
Regarding claim 6, wherein the pivoting member includes an instrument receiving recess extending into the shaft, thereby forming a blind hole (see annotated Fig. 23 above).
Regarding claim 7, wherein the instrument receiving recess extending into the shaft is internally threaded (see annotated Fig. 23 above).
Weiman discloses, regarding claim 9, a method for stabilizing adjacent vertebrae bodies (see paras. [0051]-[0052]), the method comprising the steps of: providing an intervertebral implant (100D, see Figs. 22-38) having: implant body (102D, 104D, 126D) extending from an upper surface to a lower surface (see annotated Fig. 23 above), the implant body having a front end (see annotated Fig. 23 above), a rear end (see annotated Fig. 23 above) and a pair of spaced apart first and second side walls (see annotated Fig. 23 above) extending between the front and rear ends such that an interior chamber is defined by the upper and lower plates and the sidewalls (see annotated Fig. 23 above), wherein the rear end includes an elongated opening (see annotated Fig. 23 above) defining an upper track (e.g. upper 298, see Fig. 23) on an interior surface of the upper plate (see annotated Fig. 23 above), a lower track (e.g. lower 298, see Fig. 23) on an interior surface of the lower plate (see annotated Fig. 23 above), and a dimple (202D); a pivoting member including an enlarged head (280 and 160D) and an elongated shaft (106D and 108D) terminating at a distal end (106, see Fig. 23), wherein the distal end is positioned within the dimple (see Fig. 25) and the enlarged head is positioned within the upper and lower tracks (see Fig. 24); and a blocking member (134 and 136) extending from the upper surface to the lower surface of the implant body and securing the pivoting member within the upper and lower tracks (see Fig. 25, see para. [0073]), wherein the pivoting member is configured to slide along the upper and lower tracks and articulate from an initial position to a final position (see Figs. 25 and 27), wherein an upper portion (e.g. upper 296, see Fig. 23) of the enlarged head is received within the upper track and a lower portion (e.g. lower 396, see Fig. 23) of the enlarged head is received within the lower track (see Fig. 23), positioning the intervertebral implant between adjacent vertebral bodies (see paras. [0051]-[0052]).
Regarding claim 10, wherein the dimple acts as a pivot point for the pivoting member (see Figs. 24-27).
Regarding claim 11, wherein the upper and lower tracks each extend along an arc having a constant radius from the pivot point (see Figs. 24-27).
Regarding claim 12, wherein a gap in each of the upper and lower tracks allows for the pivoting member to be inserted into the elongated opening (see annotated Fig. 23 above).
Regarding claim 13, wherein the upper and lower tracks extend to one of the side walls for receiving the enlarged head of the pivoting member (see annotated Fig. 23 above) and terminate before the other of the side walls to prevent the enlarged head from exiting the implant body (see annotated Fig. 23 above).
Regarding claim 14, wherein the pivoting member includes an instrument receiving recess extending into the shaft, thereby forming a blind hole (see annotated Fig. 23 above).
Regarding claim 15, wherein the instrument receiving recess extending into the shaft is internally threaded (see annotated Fig. 23 above).
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(s) 8 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Weiman, as applied to claim(s) 1 and 10 above, and in view of Savage et al. (U.S. Pub. No. 2008/0161927 A1, hereinafter “Savage”).
Weiman discloses all of the features of the claimed invention, as previously set forth above, except regarding claim 8, wherein the implant includes a solid support structure and an integral porous structure; and regarding claim 16, wherein the implant includes a solid support structure and an integral porous structure.
Savage discloses an intervertebral implant (200, see Fig. 17) with a solid layer (220) and a porous layer (222, 224) which are bonded together (see para. [0094]) to from an intervertebral component (see Fig. 17) in order to promote bone growth and subsequent fusion (see paras. [0089] and [0095]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the upper and lower endplates of the implant in Weiman to include a solid support structure and an integral porous layer in view of Savage in order to promote bone growth and subsequent fusion.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Weiman, as applied to claim(s) 10 above, and in view of Hansell et al. (U.S. Pub. No. 2017/0360574 A1, hereinafter “Hansell”).
Weiman discloses all of the features of the claimed invention, as previously set forth above, except regarding claim 17, wherein the implant body includes three radiographic markers, and the implant is in the final position when the three radiographic markers are aligned along a common axis.
Hansell discloses an intervertebral spacer (10, see Fig. 1) with a rotatable insert (14) that enables the insert to be rotated between a first position and a second position during insertion (see ABSTRACT), wherein the implant includes three-radio-opaque markers (51, see Fig. 3) that are aligned in the second position (see claim 10) in order to visually indicate using fluoroscopy that the implant is in the second position (see claim 10, see para. [0040]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the implant in Weiman to include three radiographic markers that are aligned in the final position in view of Hansell in order to enable visual indication using fluoroscopy that the implant is in the final position.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michelle C. Green whose telephone number is (571)270-7051. The examiner can normally be reached on Monday-Friday between 9am-5pm.
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/M.C.G/ Examiner, Art Unit 3773
/EDUARDO C ROBERT/ Supervisory Patent Examiner, Art Unit 3773
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