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 .
EXAMINER’S COMMENT
There does not appear to be any overlapping subject matter requiring a Double Patenting over US Patents 12178715, 11484414, 10548743 and 9901459 at this time.
Claim Objections
Claims 1-10 are objected to because of the following informalities:
Claim 1 line 7 recites “non-expanded” instead of “non-expanded state”. This appears to be a typographical error. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 12-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 12-20 each recites the limitation "the method of claim 1" in respective line 1. There is insufficient antecedent basis for this limitation in these claims. For purposes of compact prosecution, these claims will be interpreted as being dependent upon claim 11.
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.
Claim(s) 1-5 and 8-10 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Michelson (US 20050060037).
With respect to claim 1, Michelson discloses an expandable intervertebral implant (100 or 600, see fig. 1 and 32 below for further detail), having a proximal end and a distal end (e.g., see fig. 1 and 32 below), configured to be inserted between adjacent vertebral bodies (e.g., see abstract), comprising: a shell (e.g., body of 100 or 600) extending from the proximal end to the distal end (see fig. 1 and 6 below), the shell including an upper endplate (e.g., 102) and a lower endplate (e.g., 106), the shell further including threads (e.g., 118) disposed on an outer surface of the shell (para. 142, also see fig. 1 below and note that comparable elements are annotated on fig. 32 below); a nut (e.g., any of fig. 1-1c below or 722) disposed on the proximal end configured to be engaged by an actuation member (e.g., tool- see para. 146, also see fig. 30 and note that a comparable tool is inserted into 712/714) to rotate the shell in a non-expanded and drive the threads into the adjacent vertebral bodies (e.g., see 11-12b, and fig. 35-36b); and a shaft (e.g., tool, see para. 146 or element 704, see fig. 32 below) disposed between the upper end plate and the lower end plate 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 para. 146-147, 197).
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As for claim 2, Michelson further discloses the expandable intervertebral implant of claim 1, wherein the threads are provided on the upper endplate and the lower endplate such that the threads are continuous in the collapsed state (see fig. 32 above, also see fig. 4 below).
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As for claim 3, Michelson further discloses the expandable intervertebral implant of claim 1, wherein the shell contains one or more bone graft windows (e.g., 110, 112, or elements 610- see fig. 1 and 32 above).
As for claim 4, Michelson further discloses the expandable intervertebral implant of claim 1, wherein a diameter of the shell in a non-expanded state is larger than a drill hole provided between the adjacent vertebral bodies (see fig. 11, 35).
As for claim 5, Michelson further discloses the expandable intervertebral implant of claim 1, wherein the shaft has one or more ramps (e.g., threads on 704 or surface at 726, see fig. 32 above, fig. 33) that engage upper endplate and the lower endplate.
As for claim 8, Michelson further discloses 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.
As for claim 9, Michelson further discloses the expandable intervertebral implant of claim 1, wherein the upper endplate expands toward a first vertebral body during expansion of the shell and the lower endplate expands toward a second vertebral body during expansion of the shell (e.g., see fig. 11, 35-36b).
As for claim 10, Michelson further discloses the expandable intervertebral implant of claim 1, wherein the upper endplate and the lower endplate contain graft windows to promote fusion of the adjacent vertebral endplates when bone graft material is provided inside the expandable intervertebral implant (see para. 149, fig. 1 and 32 above and note that this device is capable of performing this function).
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) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Michelson (US 20050060037), as applied to claim 1 above, in view of Michelson (US 20050060037).
As for claim 6, Michelson (embodiment of fig. 1) teaches surfaces of the nut that are modified in design but contact the endplates in a predetermined fashion (see fig. 1-1c) does not appear to teach wherein the nut includes one or more pins to retain the upper endplate and lower endplate.
Michelson (embodiment of fig. 16) teaches an alternate equivalent nut (222) wherein the nut includes one or more pins (268) to retain the upper endplate and lower endplate (at corresponding surfaces 266, see para. 173-174) in order to orient the nut in a predetermined location relative to the endplates (see para. 173-174).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Michelson (embodiment of fig. 1) wherein the nut includes one or more pins to retain the upper endplate and lower endplate, in view of Michelson (embodiment of fig. 16), as a matter of engineering design choice, to perform the same function of orienting the nut in a predetermined location relative to the endplates.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Michelson (US 20050060037), as applied to claim 1 above, in view of Michelson (US 20050060037).
As for claim 7, 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 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) 11-15 and 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Michelson (US 20050060037) in view of Ray (US 6042582).
With respect to claims 11-15 and 18-20, Michelson teaches a method of inserting an expandable intervertebral implant (e.g., 100 or 600, see fig. 1 and 32 above), having a proximal end and a distal end, between adjacent vertebral bodies (see fig. 1 and 32 above and also fig. 11 and 35-36b), drilling a hole in a disc space between the adjacent vertebral bodies (see para. 99); providing the expandable intervertebral implant including: a shell extending from the proximal end to the distal end (see fig. 1 and 32 above), the shell including an upper endplate and a lower endplate (see fig. 1 and 32 above), the shell further including threads disposed on an outer surface of the shell (see fig. 1 and 32 above), a nut disposed on the proximal end configured to be engaged by an actuation member to rotate the shell in a non-expanded and drive the threads into the adjacent vertebral bodies (see fig. 1 and 32 above), and a shaft (e.g., tool- see para. 146 or 704) disposed between the upper end plate and the lower end plate 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 abstract and fig. 1 and 32 above); rotating the shell to drive expandable intervertebral implant between the adjacent vertebral bodies (see para. 146, 197); and expanding the shell to the expanded state (see para. 146, 197); wherein the threads are provided on the upper endplate and the lower endplate such that the threads are continuous in the collapsed state (see fig. 4 and 32 above); wherein the shell contains one or more bone graft windows (see fig. 1 and 32 above); wherein a diameter of the shell in a non-expanded state is larger than the hole provided between the adjacent vertebral bodies (see fig. 11, 35); wherein the shaft has one or more ramps (e.g., threads on 704 or surface at 726, see fig. 32 above) that engage upper endplate and the lower endplate; 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. 1 and 32 and note that this device is capable of performing this function); wherein the upper endplate expands toward a first vertebral body during expansion of the shell and the lower endplate expands toward a second vertebral body during expansion of the shell (see fig. 12, 36a); wherein the upper endplate and the lower endplate contain graft windows to promote fusion of the adjacent vertebral endplates when bone graft material is provided inside the expandable intervertebral implant (see para. 149).
Michelson does not appear to explicitly teach 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.
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 Michelson 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.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Michelson (US 20050060037) and Ray (US 6042582), as applied to claim 11 above, in view of Michelson (US 20050060037).
As for claim 16, Michelson (embodiment of fig. 1), as modified by Ray, teaches surfaces of the nut that are modified in design but contact the endplates in a predetermined fashion (see fig. 1-1c) does not appear to teach wherein the nut includes one or more pins to retain the upper endplate and lower endplate.
Michelson (embodiment of fig. 16), as modified by Ray, teaches an alternate equivalent nut (222) wherein the nut includes one or more pins (268) to retain the upper endplate and lower endplate (at corresponding surfaces 266, see para. 173-174) in order to orient the nut in a predetermined location relative to the endplates (see para. 173-174).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Michelson (embodiment of fig. 1), as modified by Ray, wherein the nut includes one or more pins to retain the upper endplate and lower endplate, in view of Michelson (embodiment of fig. 16), as a matter of engineering design choice, to perform the same function of orienting the nut in a predetermined location relative to the endplates.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Michelson (US 20050060037) and Ray (US 6042582), as applied to claim 11 above, in view of Michelson (US 20050060037).
As for claim 17, Michelson (embodiment of fig. 1), as modified by 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, as modified by Ray, 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 Michelson (embodiment of fig. 1), as modified by 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: US 6451057; US 7407483; US 5489210, US 7431735.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Tara Carter whose telephone number is (571) 272-3402. The examiner can normally be reached on M-F 7am-3pm.
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If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Eduardo Robert, at (571) 272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TARA ROSE E CARTER/ Examiner, Art Unit 3773
/EDUARDO C ROBERT/ Supervisory Patent Examiner, Art Unit 3773