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 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.
Claim(s) 1, 3, 5, 6 and 8-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kambin (US 5665122) in view of Michelson (US 20050060037).
With respect to claim 1, Kambin teaches an expandable intervertebral implant (10) (see fig. 4, 9 below), having a proximal end (couples with inserter tool 35) and a distal end (closest to 22/23) (see fig. 4, 9 below), configured to be inserted between adjacent vertebral bodies (see fig. 4 below), comprising: a shell (e.g., body 15) extending from the proximal end to the distal end, the shell including an upper endplate (16) and a lower endplate (17), the shell further including threads disposed on an outer surface of the shell (see col. 3 lines 30-37), the threads in a non-expanded state defining a threading adapted for inserting the shell between the adjacent vertebral bodies by rotation of the shell (see col. 3 lines 30-37); a nut (27) disposed on the proximal end configured to be engaged by an actuation member (35, 39) to rotate the shell in the non-expanded state and drive the threads into the adjacent vertebral bodies (see col. 4 lines 1-10); and a shaft (26) disposed between the upper endplate and the lower endplate and configured to be rotated in a first direction (e.g., 40) by the nut to move the shell from the non-expanded state to an expanded state by moving the upper endplate away from the lower endplate such that both the distal end and the proximal end of the upper plate move away from respective ends of the lower plate (see fig. 9 below and also col. 9 lines 30-45).
Kambin does not appear to explicitly teach the threads in a non-expanded state defining a continuous threading.
Michelson, also drawn to expandable intervertebral implants, teaches an exterior of the implant with the threads (118) in a non-expanded state defining a continuous threading (see fig. 4 and 32, para. 142) in order to provide a known exterior surface design that will result in locking engagement with the adjacent vertebral bodies (see para. 142).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Kambin with the threads in a non-expanded state defining a continuous threading, in view of Michelson, as a matter of engineering design choice, in order to provide a known exterior surface design that will result in an expected locking engagement with the adjacent vertebral bodies.
As for claim 3, Kambin, as modified by Michelson, further teaches the expandable intervertebral implant of claim 1, wherein the shell contains one or more bone graft windows (41, 42, 43).
As for claim 5, Kambin, as modified by Michelson, further teaches the expandable intervertebral implant of claim 1, wherein the shaft has one or more ramps (e.g., note that 26 is triangular shaped) that engage upper endplate and the lower endplate (see fig. 9 above).
As for claim 6, Kambin, as modified by Michelson, further teaches the expandable intervertebral implant of claim 1, wherein the nut includes one or more pins (e.g., 30) to retain the upper endplate and lower endplate (see fig. 8).
As for claim 8, Kambin, as modified by Michelson, further teaches the expandable intervertebral implant of claim 1, wherein the threaded shaft is configured to be rotated in a second direction by the nut to move the shell from the expanded position to the non-expanded position (see fig. 9 above and note that this device is capable of performing thus function if one so desires).
As for claim 9, Kambin, as modified by Michelson, further teaches the expandable intervertebral implant of claim 1, wherein the upper endplate expands toward a first vertebral body (e.g., upper vertebral body) during expansion of the shell and the lower endplate expands toward a second vertebral body (e.g., lower vertebral body) during expansion of the shell (see fig. 4 above).
As for claim 10, Kambin, as modified by Michelson, further teaches the expandable intervertebral implant of claim 1, wherein the upper endplate and the lower endplate contain graft windows (e.g., 41, 42, 43) to promote fusion of the adjacent vertebral endplates when bone graft material is provided inside the expandable intervertebral implant (see fig. 9 above).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kambin (US 5665122) and Michelson (US 20050060037), as applied to claim 1 above, in view of Varela (US 20110172774).
As for claim 4, Kambin as modified by Michelson does not appear to teach wherein a diameter of the shell in a non-expanded state is larger than a drill hole provided between the adjacent vertebral bodies.
Varela, also drawn to expandable intervertebral implants, teaches, use of a guide wire to create a drill hole between adjacent vertebral bodies (see para. 38) and a cannulated implant, nut and shaft (see fig. 7 and para. 38) in order to accommodate passage of the implant over a guide wire (i.e., smaller in diameter relative to the non-expanded implant) to aid in placement of the implant (see para. 38).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Kambin, as modified by Michelson, wherein a diameter of the shell in a non-expanded state is larger than a drill hole provided between the adjacent vertebral bodies.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kambin (US 5665122) and Michelson (US 20050060037), as applied to claim 1 above, in further view of Michelson (US 20050060037).
As for claim 7, Kambin, as modified by Michelson (embodiment of fig. 1), does not appear wherein the distal end is tapered and configured to be a leading end when inserting the shell between the adjacent vertebral bodies.
However, Michelson teaches other embodiments (fig. 54 or 58) with comparable elements wherein the distal end is tapered and configured to be a leading end when inserting the shell between the adjacent vertebral bodies (see para. 207-208) in order to provide a known tapered shape that better facilitates insertion into the spine (see para. 208).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Kambin, as modified by Michelson (embodiment of fig. 1), wherein the distal end is tapered and configured to be a leading end when inserting the shell between the adjacent vertebral bodies, in view of Michelson (embodiment of fig. 54 or 58), as a matter of engineering design choice, in order to provide a known tapered shape that better facilitates insertion into the spine.
Claim(s) 11-16 and 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kambin (US 5665122) in view Michelson (US 20050060037) in view of Ray (US 6042582).
With respect to claim 11, Kambin does not teach a method of inserting an expandable intervertebral implant (10), having a proximal end (e.g., at 31) and a distal end (e.g., at 22, 23) (see fig. 4 and 9 above), between adjacent vertebral bodies (see fig. 4 above), providing the expandable intervertebral implant including: a shell (15) extending from the proximal end to the distal end (see fig. 4 and 9 above), the shell including an upper endplate (16) and a lower endplate (17), the shell further including threads disposed on an outer surface of the shell (see col. 3 lines 30-37), the threads in a non-expanded state defining a threading (see col. 3 lines 30-37), a nut (27) disposed on the proximal end configured to be engaged by an actuation member (e.g., 35, 39) to rotate the shell in the non-expanded state and drive the threads into the adjacent vertebral bodies (see col. 4 lines 1-10), and a shaft (26) disposed between the upper endplate and the lower endplate and configured to be rotated in a first direction by the nut to move the shell from the non-expanded state to an expanded state by moving the upper endplate away from the lower endplate (see col. 4 lines 1-10); rotating the shell in the first direction to drive the expandable intervertebral implant between the adjacent vertebral bodies (see fig. 9 above and col. 4 lines 1-10); and expanding the shell to the expanded state such that both the distal end and the proximal end of the upper plate move away from respective ends of the lower plate (see fig. 9 above and col. 4 lines 1-10).
Kambin does not teach the method comprising: inserting a drill into an endoscopic tube; drilling a hole in a disc space between the adjacent vertebral bodies, a diameter of the hole being larger than a height of the disc space; explicitly teach the threads in a non-expanded state defining a continuous threading; and delivering the expandable intervertebral implant in the non-expanded state to the hole via the endoscopic tube.
Michelson, also drawn to expandable intervertebral implants, teaches an exterior of the implant with the threads (118) in a non-expanded state defining a continuous threading (see fig. 4 and 32, para. 142) in order to provide a known exterior surface design that will result in locking engagement with the adjacent vertebral bodies (see para. 142).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Kambin with the threads in a non-expanded state defining a continuous threading, in view of Michelson, as a matter of engineering design choice, in order to provide a known exterior surface design that will result in an expected locking engagement with the adjacent vertebral bodies.
Ray, also drawn to methods of inserting intervertebral implants, teaches inserting a drill (200) into an endoscopic tube (e.g., 100); a diameter of the hole being larger than a height of the disc space (see fig. 7); delivering the intervertebral implant in a non-expanded state to the hole via the endoscopic tube (see fig. 8) in order to provide known tools that facilitate stable and minimally invasive insertion of an implant into the spine (see col. 7 lines 14-31).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Kambin with the method comprising: inserting a drill into an endoscopic tube; a diameter of the hole being larger than a height of the disc space; delivering the expandable intervertebral implant in the non-expanded state to the hole via the endoscopic tube, in view of Ray, in order to provide known tools that facilitate stable and minimally invasive insertion of an implant into the spine.
As for claim 13, Kambin, as modified by Michelson and Ray, further teaches the method of claim 11, wherein the shell contains one or more bone graft windows (41, 42, 43).
As for claim 14, Kambin, as modified by Michelson and Ray, further teaches the method of claim 11, wherein a diameter of the shell in a non-expanded state is larger than the hole provided between the adjacent vertebral bodies (see Ray fig. 7).
As for claim 15, Kambin, as modified by Michelson and Ray, further teaches the method of claim 11, wherein the shaft has one or more ramps (note that 26 is triangular shaped) that engage upper endplate and the lower endplate.
As for claim 16, Kambin, as modified by Michelson and Ray, further teaches the method of claim 11, wherein the nut includes one or more pins (31) to retain the upper endplate and lower endplate.
As for claim 18, Kambin, as modified by Michelson and Ray, further teaches the method of claim 11, wherein the threaded shaft is configured to be rotated in a second direction by the nut to move the shell from the expanded position to the non-expanded position (see fig. 9 and note that this device is able to perform this function if one so desires).
As for claim 19, Kambin, as modified by Michelson and Ray, further teaches the method of claim 11, wherein the upper endplate expands toward a first vertebral body (e.g., upper vertebral body) during expansion of the shell and the lower endplate expands toward a second vertebral body (e.g., lower vertebral body) during expansion of the shell (see fig. 4 above).
As for claim 20, Kambin, as modified by Michelson and Ray, further teaches the method of claim 11, wherein the upper endplate and the lower endplate contain graft windows (41, 42, 43) to promote fusion of the adjacent vertebral endplates when bone graft material is provided inside the expandable intervertebral implant.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kambin (US 5665122), Michelson (US 20050060037) and Ray (US 6042582), as applied to claim 11 above, in view of Michelson (US 20050060037).
As for claim 7, Kambin, as modified by Michelson (embodiment of fig. 1) and Ray, does not appear wherein the distal end is tapered and configured to be a leading end when inserting the shell between the adjacent vertebral bodies.
However, Michelson teaches other embodiments (fig. 54 or 58) with comparable elements wherein the distal end is tapered and configured to be a leading end when inserting the shell between the adjacent vertebral bodies (see para. 207-208) in order to provide a known tapered shape that better facilitates insertion into the spine (see para. 208).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Kambin, as modified by Michelson (embodiment of fig. 1) and Ray, wherein the distal end is tapered and configured to be a leading end when inserting the shell between the adjacent vertebral bodies, in view of Michelson (embodiment of fig. 54 or 58), as a matter of engineering design choice, in order to provide a known tapered shape that better facilitates insertion into the spine.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 3-11 and 13-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument, as Kambin is introduced to teach the limitations presented in the amendment entered on 4/26/2026.
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.
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/TARA ROSE E CARTER/Examiner, Art Unit 3773 /EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773
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