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 .
Response to Arguments
Applicant's arguments filed November 3rd, 2025 have been fully considered but they are not persuasive. Applicant’s argument and amendment to further define that the plate comprises a single port disposed on a periphery of the plate configured to individually receive an instrument for plate insertion. Is not found persuasive to overcome the prior art of record. Faulhaber teaches a plate (174) which has a single port (either the left or right 134 shown in figure 3) which is disposed on a periphery of the plate (the peripheral surface/face which drive screw 132 passes through) and it is to individually receive an instrument for plate insertion (¶52 “corresponding engagement of spacer insertion device (e.g. 202 on FIGS. 12 and 13)”. The Examiner notes that the claim uses the term comprising when setting forth the components of the spinal fixation system so the claim is open ended and can allow for more than one port. As a result, Applicant’s amendments, arguments and remarks are not found persuasive to overcome the prior art of rejection.
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.
Claims 1, 4-8 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Faulhaber (US 2017/0172756) in view of Melkent et al. (US 2012/0041559).
Regarding claim 1, Faulhaber discloses a spinal fixation system for fusion of adjacent vertebral bodies comprising a bone plate (174 or alternatively 104) having a longitudinal axis extending from a top of the plate (“top” considered toward the top of the page) to a bottom of the plate (“bottom” considered toward the bottom of the page), the bone plate further including a screw hole (186), one or more anchor holes (220’s), a blocking screw (224) for each of the anchor holes, a single port (134, figure 3, ¶58 or alternatively 214) disposed on a periphery of the plate (174) configured to individually receive an instrument for plate insertion (¶52); a spacer (see figure below) configured to attach to the bone plate via a coupling screw (132) threaded into the screw hole; and a bone fixation device (222) configured to be inserted into each of the anchor holes to fixate the bone plate to one or more of the adjacent vertebral bodies (figure 18), and the bone plate is asymmetrical with respect to both the longitudinal axis (see figure below) and a vertical axis (see figure below) extending perpendicular to the longitudinal axis and through a center of the bone plate.
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Faulhaber fails to expressly teach or disclose the bone plate having first and second prongs disposed on either side of the screw hole that are separate components disposed in an inserter pocket of the bone plate and each of the first prong and second prong extend in a direction perpendicular to the longitudinal axis.
Melkent et al. disclose a spinal fixation system (figures 21-22, 35) having a spacer (10) configured to attach to a bone plate (414” or alternatively 714) having a longitudinal axis extending from a top of the bone plate (434”/see figure below) to a bottom (436”/see figure below) of the bone plate, the bone plate further including a screw hole (see figure below), one or more anchor holes (442, 444/see figure below) and a first prong (454, ¶64/752) and a second prong (456, ¶60/754), wherein the first prong and the second prong are disposed on either side of the screw hole (figures 21/35), wherein the first prong and the second prong are separate components disposed in an inserter pocket of the bone plate (formed via 472” and 448”/748) and each of the first prong and second prong extend in a direction perpendicular to the longitudinal axis (figures 21/35) as the prongs provide additional fixation surfaces/elements for coupling the bone plate to the spacer (¶60, ¶65).
Accordingly, it would have been obvious to one of ordinary skill in the art at the time of filing to have constructed the spinal fixation system of Faulhaber to include first and second prongs located on either side of the screw hole that extend in a direction perpendicular to the longitudinal axis of the plate and are disposed in an inserter pocket as taught by Melkent et al. as the prongs provide additional fixation surfaces/elements for coupling the bone plate to the spacer.
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Regarding claim 4, Faulhaber discloses an underside of the bone plate contains one or more prongs (184’s) that are received in a portion of the spacer.
Regarding claim 5, Faulhaber discloses the port is threaded (214, ¶57).
Regarding claim 6, Faulhaber discloses the port is configured to receive a threaded end (212, figure 13)of an inserter instrument (¶57).
Regarding claim 7, Faulhaber discloses each blocking screw (224) is configured to rotate from a first position to a second position to lock one bone fixation device to the bone plate (¶58).
Regarding claim 8, Faulhaber discloses each bone fixation device is a bone screw (222, figure 18).
Regarding claim 10, Faulhaber discloses inserter (202, figures 12-13) configured to attach to the bone plate via the port (¶57).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Faulhaber (US 2017/0172756) in view of Melkent et al. (US 2012/0041559) in further view of Campbell et al. (US 2014/0277175).
Regarding claim 2, Faulhaber in view of Melkent disclose the claimed invention except for an underside of the bone plate contains a toothy ridge configured to engage one of the adjacent vertebral bodies. Campbell et al. disclose a bone plate (4, figures 4-8) having an underside (figure 6) that contains a toothy ridge (5, figure 6) configured to engage adjacent bone structure (¶101-102) which provides a distributed monocortical fixation of the bone which assists to resists rotation of the bone(s) (¶102). Accordingly, it would have been obvious to one of ordinary skill in the art at the time of filing to have constructed the underside of the bone plate of Faulhaber to contain a toothy ridge as taught by Campbell et al. as it provides a distributed monocortical fixation of the bone which assists to resists rotation of the bone(s).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Faulhaber (US 2017/0172756) in view of Melkent et al. (US 2012/0041559) in further view of Geisler et al. (US 2014/0107785).
Regarding claim 3, Faulhaber in view of Melkent disclose the claimed invention except for the underside of the bone plate contains a cutout configured to receive a portion of the spacer. Geisler et al. disclose a bone plate (120) having an underside (figure 5) containing a cutout (424, 426, figures 5, 12, 14) to receive a portion of a spacer (110, figure 5, ¶68, ¶78) as they act as a bone plate alignment feature (¶68).
Accordingly, it would have been obvious to one of ordinary skill in the art at the time of filing to have constructed the underside of the bone plate of Faulhaber to contain a cutout configured to receive a portion of a spacer as taught by Geisler et al. as the cutout(s) act as a bone plate alignment feature thereby improving the location and orientation of the plate relative to the spacer.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Faulhaber (US 2017/0172756) in view of Melkent et al. (US 2012/0041559) in further view of Gahman (US 2019/0125419). Regarding claim 9, Faulhaber in view of Melkent disclose the claimed invention except for each of the bone fixation devices being a shim and rather teaches the bone fixation device is a screw. Gahman shows that a shim is an equivalent structure known in the art. Therefore, because these two fasteners were art-recognized equivalents at the time the invention was made, one of ordinary skill in the art would have found it obvious to substitute the shim of Gahman in for the screw of Faulhaber.
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 MATTHEW JAMES LAWSON whose telephone number is (571)270-7375. The examiner can normally be reached Mon - Fri 6:30-3:00.
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/MATTHEW J LAWSON/Primary Examiner, Art Unit 3619
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