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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March 27, 2026 has been entered.
Response to Arguments
Applicant’s arguments, filed March 27, 2026, with respect to the rejection(s) of claim(s) 1-20 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 Therefore, the rejection has been withdrawn.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 Baynham regarding the amended limitations of wherein one or more of the first knuckle portion, the second knuckle portion, and the third knuckle portion, or the fourth knuckle portion and the fifth knuckle portion comprises a bone engagement surface.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Pub. No. 2018/0303621 to Brotman et al. in view of U.S. Patent Pub. No. 2014/0277500 to Logan in view of U.S. Patent No. 8,303,663 to Jimenez et al. in view of U.S. Patent Pub. No. 2018/0014947 to Baynham et al.
As to Claim 1, Brotman discloses an expandable implant device (100, Fig. 1). The device comprises a first endplate (112) having a first side and a second side (See annotated Fig. 1, below), the first endplate (112) moveably coupled to a second endplate (114) at the first side (at 162, Fig. 4, [0050]), and an expansion mechanism disposed on the first endplate (112) at a second side (seen in Fig. 8, [0050], and Figs. 1-4), wherein actuation of the expansion mechanism causes the first endplate to pivot at the first side relative to the second endplate to expand the expandable implant device (Figs. 1-2, [0050]). A hinge (162) is formed on the first side by mating one or more first knuckle portions on the first endplate (112) with one or more second knuckle portions on the second (114) endplate (see annotated Fig. 5, below).
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As to Claim 2, Brotman discloses an expandable implant device wherein the expansion mechanism is configured to vary a distance between the first endplate (112) and the second endplate (114, [0050], seen in Figs. 3-4).
As to Claim 3, Brotman discloses an expandable implant device wherein the first endplate (112) comprises a leading end (near ref. 112, Fig. 2), a trailing end (near ref. 116, Fig. 2), a first side (near 162, Fig. 4), and a second side (near 117, Fig. 4), and the second endplate (114) comprises a leading end (136), a trailing end (140), a first side (near 162, Fig. 4) and a second side (near 158, Fig. 4), and wherein the first side of the first endplate is movably coupled to the first side of the second endplate (at 162, [0050]).
As to Claim 4, Brotman discloses an expandable implant device wherein the expansion mechanism includes a drive screw (120) rotatably coupled to the second endplate [0049], and at least one threaded nut (118) configured to receive at least a portion of the drive screw [0049-0050].
As to Claim 5, Brotman discloses an expandable implant device wherein the at least one threaded nut (118) is configured to translate along a length of the drive screw upon a rotation of the drive screw [0049-0050].
As to Claim 6, Brotman discloses an expandable implant device wherein the at least one threaded nut (118) is coupled to at least one linkage (116), and wherein the linkage has a first end pivotably coupled to the threaded nut and a second end in contact with an interior surface of the first endplate (seen in Figs. 2-3, [0050]).
As to Claim 7, Brotman discloses an expandable implant device wherein the at least one threaded nut (118) is configured to, upon a rotation of the drive screw (120) pivot the at least one linkage (116), and cause an angle of the linkage relative to the drive screw to change, thereby changing a distance between the first endplate and the second endplate (seen in Figs. 1-6, [0049-0050]).
As to Claim 8, Brotman discloses an expandable implant device further comprising a locking mechanism configured to inhibit undesired or unintentional rotation of the drive screw while the expandable implant device is in use (locking mechanism described in [0060-0061]).
As to Claim 11, Brotman discloses an expandable implant device wherein the locking mechanism further comprises a spring (392) with a spring end, wherein the spring end of the leaf spring is configured to engage the spline [0061].
As to Claim 12, Brotman discloses an expandable implant device wherein the engaging of the spring end of the leaf spring with the spline inhibits undesired or unintentional rotation of the drive screw while the expandable implant device is in use, and prevents collapse of the expandable implant device in an expanded position (engagement of spring 392 described in [0061]).
As to Claim 13, Brotman discloses an expandable implant device wherein at least one of the first endplate or the second endplate further comprises a planar extension (213) extending generally perpendicularly relative to a bone contact surface of the respective endplate (Fig. 11, [0053]).
As to Claim 14, Brotman discloses an expandable implant device wherein the planar extension (213) is configured to enclose an inner volume of the expandable implant device (Fig. 9), and wherein the inner volume is configured to contain a bone graft [0051-0052] or a bone graft substitute material within the expandable implant device [0053, 0055].
As to Claim 15, Brotman discloses an expandable implant device further comprising a fusion aperture (126) extending through the first endplate or the second endplate, from the bone contact surface of the respective endplate to the inner volume (Fig. 1, [0047]).
As to Claim 16, Brotman discloses an expandable implant device further comprising a first fusion aperture (126) extending through the first endplate, from the bone contact surface of the first endplate to the inner volume (Fig. 1, [0047]), and a second fusion aperture (126) extending through the second endplate, from the bone contact surface of the second endplate to the inner volume [0048].
As to Claim 17, Brotman discloses an expandable implant device wherein the first fusion aperture (126) and the second fusion aperture (126) are disposed such that the expansion mechanism does not interfere with or invade the inner volume between the first fusion aperture and the second fusion aperture [0047-0051].
As to Claim 18, Brotman discloses an expandable implant device wherein the first endplate or the second endplate includes an aperture (142) configured to receive at least a portion of a bone fixation device (144) therethrough [0048].
As to Claim 19, Brotman discloses an expandable implant device further comprising a threaded aperture (166) on a side of the expandable implant device, the threaded aperture being configured to receive a combiner (146) to secure a plate (144) to the expandable implant device [0048].
As to Claim 20, Brotman discloses an expandable implant device wherein the plate includes a fixation plate (144), and the fixation plate is configured to receive at least a portion of a bone fixation device therethrough [0051-0052].
As to Claims 1-20, Brotman discloses the claimed invention except for wherein the expansion mechanism includes a drive screw extending across the first endplate and including a first threaded shank and a second threaded shank, a first threaded nut configured to engage at least a portion of the first threaded shank and a second threaded nut configured to engage at least a portion of the second threaded shank, wherein the drive screw includes first and second drive heads at respective ends of the drive screw for receiving an implant inserter to allow the drive screw to be rotated from either end, wherein the first endplate has a first knuckle portion, a second knuckle portion, and a third knuckle portion, wherein the second endplate has a fourth knuckle portion configured to be disposed between the first knuckle portion and the second knuckle portion, and wherein the second endplate has a fifth knuckle portion configured to be disposed between the second knuckle portion and the third knuckle portion forming a hinge on the first side, wherein one or more of the first knuckle portion, the second knuckle portion, and the third knuckle portion, or the fourth knuckle portion and the fifth knuckle portion comprises a bone engagement surface, wherein the first threaded shank is configured to receive a spline at an end thereof, the second threaded shank is configured to receive a spline at an end thereof, wherein the spline is configured to couple the first threaded shank and the second threaded shank, wherein the first threaded shank has a right-handed thread pattern and the second threaded shank has a left-handed thread pattern.
Logan discloses an expandable implant device (100, Figs. 1-3B) wherein an expansion mechanism includes a drive screw (108, [0040]) extending across the first endplate (near 118 to near 109, Fig. 3A), and including a first threaded shank (107A) and a second threaded shank (107B, Fig. 2. 0040), a first threaded nut (106A) configured to engage at least a portion of the first threaded shank and a second threaded nut (106B) configured to engage at least a portion of the second threaded shank [0038-0039] in order to provide means for providing uniform stability along the length of the device as the device is expanded to a desired position [0039].
Jimenez discloses an expandable implant (100, Figs. 1A-1D) including a drive screw (140) that includes first (143) and second (144) drive heads at respective ends of the drive screw (Fig. 1C, Col. 6, Lines 26-28, Col. 8, Lines 64-66) for receiving an implant inserter to allow the drive screw to be rotated from either end (Col. 6, Lines 26-28, Col. 8, Lines 64-66). The drive screw (140) comprises a first threaded shank (141) configured to receive a spline at an end thereof (Fig. 1C), a second threaded shank (142) configured to receive a spline at an end thereof (Fig. 1C), and a spline configured to couple the first threaded shank and the second threaded shank (Fig. 1C). The first threaded shank (141) has a right- handed thread pattern and the second threaded shank (142) has a left-handed thread pattern (Col. 6, Lines 41-67 – Col. 7, Lines 1-14) in order to allow for uniform expansion of the implant along the length of the body of the endplates via a delivery tool at either end of the device (Col. 6, Lines 41-67 – Col. 7, Lines 1-14, Col. 6, Lines 26-28, Col. 8, Lines 64-66).
Baynham discloses an expandable implant wherein a first endplate (12) has a first knuckle portion (24), a second knuckle portion (25), and a third knuckle portion (26, Figs. 1-2), wherein a second endplate (14) has a fourth knuckle portion (18) configured to be disposed between the first knuckle portion (24) and the second knuckle portion (26), and wherein the second endplate (14) has a fifth knuckle portion (30) configured to be disposed between the second knuckle portion (25) and the third knuckle portion (26) forming a hinge (assembly 95) on the first side (Figs. 1-2, [0037]). One or more of the first knuckle portion, the second knuckle portion, and the third knuckle portion, or the fourth knuckle portion and the fifth knuckle portion comprises a bone engagement surface (including teeth 33, [0044) in order to provide stability to the hinge assembly on a side of the implant [0037] and for the device to be inserted with a lower resistance while providing for stability between adjacent vertebrae [0044].
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It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the expandable implant of Brotman with the drive screw modification of Logan in order to provide means for providing uniform stability along the length of the device as the device is expanded to a desired position, with the drive head and drive screw splines modification of Jimenez in order to allow for uniform expansion of the implant along the length of the body of the endplates via a delivery tool at either end of the device, and with the knuckle and bone engagement surface modification of Baynham in order to provide stability to the hinge assembly on a side of the implant and for the device to be inserted with a lower resistance while providing for stability between adjacent vertebrae.
Conclusion
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/CHRISTOPHER J BECCIA/Primary Examiner, Art Unit 3775
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