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 .
Response to Arguments
Applicant’s arguments, filed December 24, 2025, with respect to the rejection(s) of claim(s) 1-13 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made. Please direct attention to rejection below, specifically reference Shoshtaev regarding the amended limitations of wherein the expandable interbody spacer is expandable both horizontally and vertically, and the vertebral attachment plate is configured to be attached after in interbody spacer has been expanded both horizontally and vertically.
Allowable Subject Matter
Claims 14-22 are allowed.
The following is a statement of reasons for the indication of allowable subject matter: The prior art fails to teach the method steps including, but not limited to, a plurality of individual links, each link directly connecting one of the end bodies with one of the first and second support members; wherein each of the first upper body and the first lower body includes a first recess in communication with a second recess, wherein a ramp connects the first recess and the second recess; providing an application of axial force along the first axis, wherein the axial force moves the first support member away from the second support member along a first direction and moves the first upper body away from the first lower body along a second direction, wherein the first direction is perpendicular to the first axis, and wherein the second direction is perpendicular to the first axis and to the first direction; drawing the first end body toward the second end body along the first axis to expand the spacer; rotating each of the individual links laterally outward relative to the end body to which it is connected, to expand the first support member away from the second support member along the first direction; urging at least one of the individual links from the first recess along the ramp into the second recess to expand the upper body away from the lower body along the second direction.
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 1 and 3-12 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Pub. No. 2017/0172756 to Faulhaber et al. in view of U.S. Patent Pub. No. 2018/0193164 to Shoshtaev in view of U.S. Patent No. 7,172,627 to Fiere et al.
As to Claim 1, Faulhaber discloses a spinal system (100, Figs. 14-15) for implantation between vertebral bodies of a spine [0039, 0058]. The spinal system comprises an expandable interbody spacer (102), a locking plate assembly (104) including one or more bone screws (222) each including a bone threaded portion and a bone head (best seen in Fig. 18), and a vertebral attachment plate (174) configured to attach to a portion of the interbody spacer (104, via 178, [0052]) and to be seated against a side of a vertebral body of a vertebra [0052, 0058], wherein the vertebral attachment plate includes one or more through-holes (220) configured to receive one or more bone screws (222, [0058]), and a securement screw (132) configured to couple the locking plate assembly (104, [0054-0055) to the interbody spacer (102), wherein the securement screw includes a threaded portion (seen in Fig. 16) configured to engage the interbody spacer [0054-0055], and a screw head (113).
As to Claim 3, Faulhaber discloses a spinal system wherein the vertebral attachment plate (174) is configured to receive each of the one or more bone screws (222) angled in a different direction (angles seen in Fig. 18).
As to Claim 4, Faulhaber discloses a spinal system wherein at least one of the through-holes has a tapered configuration (angle described in [0064]).
As to Claim 5, Faulhaber discloses a spinal system wherein the screw head (113) of the locking screw (132) includes a tool-receiving feature including a socket (of 113, Fig. 16, [0054-0055]).
As to Claim 6, Faulhaber discloses a spinal system wherein the screw head (113) of the locking screw (132) is configured to be received by socket of a driver configured to rotate the locking screw [0054-0055].
As to Claim 9, Faulhaber discloses a spinal system wherein the vertebral attachment plate (174) includes one or more positioners (pins 146 within 184) configured to hold the interbody spacer and to prevent motion of the vertebral attachment plate with respect to the interbody spacer [0052].
As to Claim 10, Faulhaber discloses a spinal system wherein the one or more positioners is detachably coupled to the plate (guide pins 146, [0052]).
As to Claim 11, Faulhaber discloses a method for implanting an intervertebral spacer (102) and a locking plate assembly (104) between first and second vertebral bodies of a subject’s spine [0039-0040]. The method comprising inserting an expandable interbody spacer (102) between the first and second vertebral bodies (insertion described in [0043]), coupling one or more bone screws (222) to the first vertebral body and/or the second vertebral body to couple a vertebral attachment plate (174) against a side of the first vertebral body and/or the second vertebral body [0058-0059], and coupling the vertebral attachment plate (174) to the interbody spacer (102) using a securement screw (132)after expanding the interbody spacer [0054-0055].
As to Claims 1 and 3-12, Faulhaber discloses the claimed invention except for a locking screw configured to couple the locking plate assembly to the interbody spacer, wherein the locking screw includes a locking threaded portion configured to engage the interbody spacer, and a screw head, wherein the screw head of the locking screw is configured to prevent movement between the vertebral attachment plate and the locking screw when the locking screw is coupled to the locking plate assembly, wherein the locking screw is configured to allow micromotions between (a) the locking plate assembly and (b) the spine and/or the one or more bone screws, the method further comprising inserting a locking screw through the vertebral attachment plate and the interbody spacer, wherein the locking screw comprises a locking threaded portion and a male junction.
Shoshtaev discloses a spinal system (1000, Figs. 10D1-10D3) including wherein an expandable interbody spacer (100) is expandable both horizontally and vertically (expansion both horizontally and vertically seen in position from Fig. 10D1 to Fig. 10D2), and a vertebral attachment plate (including 143, [0289] is configured to be attached after in interbody spacer has been expanded both horizontally and vertically (seen in Figs. 10DA2 and 10D3, [0289]) in order to increase contact area between the implant and adjacent endplates, to ensure additional stability after expansion [0289].
Fiere discloses a spinal system (spacer 4, locking plate 17) and method including a locking screw (22) configured to couple the locking plate assembly (1) to the interbody spacer (4, Col. 3, Lines 44-65), wherein the locking screw (22) includes a locking threaded portion (seen in Fig. 1) configured to engage the interbody spacer (within 23), and a screw head (221, Fig. 1, Col. 3, Lines 44-65). The screw head (221 ) of the locking screw (22) is configured to prevent movement between the vertebral attachment plate (17) and the locking screw when the locking screw is coupled to the locking plate assembly (Col. 3, Lines 44-65). The locking screw (22) is configured to allow micromotions between (a) the locking plate assembly (1) and (b) the spine and/or the one or more bone screws (due to spacing means 30, Col. 3, Lines 66-67 – Col. 4, Lines 1-18). The method further comprises inserting a locking screw (22) through the vertebral attachment plate (17) and the interbody spacer (4, Col. 3, Lines 44-65), wherein the locking screw (22) comprises a locking threaded portion (seen in Fig. 1) and a male junction (of 22) in order to provide a mechanism for fixing the locking plate in position relative to the spacer (Col. 3, Lines 44-51).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the spinal system of Faulhaber with the expansion modification of Shoshtaev in order to increase contact area between the implant and adjacent endplates, to ensure additional stability after expansion, and with the locking screw modification of Fiere in order to provide a mechanism for fixing the locking plate in position relative to the spacer.
Claims 2 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Pub. No. 2017/0172756 to Faulhaber et al. in view of U.S. Patent Pub. No. 2018/0193164 to Shoshtaev in view of U.S. Patent No. 7,172,627 to Fiere et al. in view of U.S. Patent No. 9,149,368 to Jensen.
As to Claims 2 and 13, Faulhaber, Shoshtaev, and Fiere disclose the claimed invention except for wherein the locking plate assembly further comprises a lockout screw including a lockout threaded portion and a female junction configured to receive a male junction of the locking screw, wherein the lockout screw is configured to lock the interbody spacer in an expanded configuration, and wherein attaching the locking plate assembly further comprises inserting the male junction of the locking screw through a female junction of a lockout screw.
Jensen discloses a spinal system (Fig. 7) and method (100) wherein the locking plate assembly (74) further comprises a lockout screw (72) including a lockout threaded portion (Fig. 7) and a female junction (28) configured to receive a male junction of the locking screw (Col. 3, Lines 50-58), wherein the lockout screw is configured to lock the interbody spacer in an expanded configuration (Col. 3, Lines 50-58). The lockout screw (72) is configured to lock the interbody spacer (10) in an expanded configuration (Col. 3, Lines 50-58), and wherein attaching the locking plate assembly (74) further comprises inserting the male junction of the locking screw (Col. 3, Lines 50-58) through a female junction (28) of a lockout screw (Col. 3, Lines 50-58) in order to restrict rotation of the locking screw when the lockout screw engages the locking plate (Col. 3, Lines 50-58).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the spinal system of Faulhaber, Shoshtaev, and Fiere with the lockout screw modification of Jensen in order to restrict rotation of the locking screw when the lockout screw engages the locking plate.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER J BECCIA whose telephone number is (571)270-7391. The examiner can normally be reached Mon - Fri 8:30-5:00.
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/CHRISTOPHER J BECCIA/Primary Examiner, Art Unit 3775