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 .
Priority
Due to applicant’s amendments, Claims 1-9 have support going back to the original parent application 12/875,818 filed September 3, 2010 and thus these claims have an effective filing date of September 3, 2010.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-9 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.
Examiner notes that with applicant’s amendments, the previous claim objections and 112 rejections are moot.
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 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over Shepard US 4,863,476 in view of Winslow US 5,885,299.
Regarding Claim 1, Shepard discloses a method of inserting an expandable fusion device (#22, #23 and #31) into an intervertebral disc space (col 5 lines 20-30), the method comprising:
passing a superior endplate of an expandable fusion device into an intervertebral disc space (see Fig below, Col 5 lines 20-30);
passing an inferior endplate of the expandable fusion device into the intervertebral disc space such that the inferior endplate is inferior to the superior endplate (see Fig below, Col 5 lines 20-30); and
with a first tool releasably mounted to the superior endplate and a second tool still releasably mounted to the inferior endplate (see Fig below, releasably mounted via threaded connection #27, #28, Col 4 lines 22-30), passing a central ramp (#31, having a ramp #34) through the endoscopic tube guided by the first tool and the second tool and between the superior endplate and the inferior endplate (see Fig below, Col 4 lines 31-50, see also Fig 7, where grooves #35, #36 allow the central ramp to be guided along the first and second tools).
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Shepard discloses the claimed invention as discussed above where the superior endplate is threadably coupled with the first tool and the inferior endplate is threadably coupled to the second tool (see Fig above, Col 4 lines 22-30) but does not disclose passing the superior endplate releasably mounted to the first elongate tool through the endoscopic tube and into an intervertebral disc space; passing the inferior endplate releasably mounted to the second elongate tool through the endoscopic tube,
wherein the superior endplate includes a first opening that extends from an upper surface of the endplate to a lower surface of the endplate configured and dimensioned to receive bone graft or similar bone growth inducing material, and wherein the central ramp includes a central opening that aligns with the first opening of the superior endplate when the central ramp when the central ramp is positioned between the superior endplate and the inferior endplate.
Winslow discloses an implant (#100, Fig 3) threadably coupled to an elongate tool (#132, which has threads #144, Fig 8a, Col 4 lines 66 – Col 5 line 2), passing the implant releasably mounted to the elongate tool through an endoscopic tube (#300, Fig 11) and into an intervertebral disc space (Fig 11, Col 6 lines 66 – Col 7 line 8), the tool used to place the implant into the disc space where the endoscopic tube providing a guide into the disc space through which the implant and tool can pass through (Col 6 line 66- Col 7 line 8).
It would have been obvious to one having ordinary skill in the at a time before the effective filing date of the claimed invention to modify Shepard and have the first and second tools used to pass the super and inferior endplates through the endoscopic tube in view of Winslow above because the tools help place the endplates into the disc space where the endoscopic tube providing a guide into the disc space through which the endplates and tool can pass through. Examiner notes with the modification, the endoscopic tube of Shepard would be sufficiently sized to allow the passage of the superior and inferior endplates as well as the central ramp, where the first and second tools would be able to pass their respective endplate through the endoscopic tube and into the disc space.
Michelson discloses a superior endplate (superior endplate #100, Figs 8-11), an inferior endplate (inferior endplate #100, Fig 8-11), a central ramp (#86, #88), wherein the superior endplate includes a first opening (#100, Fig 10-11) that extends from an upper surface of the endplate to a lower surface of the endplate (Fig 10-11, extends completely through the endplate) configured and dimensioned to receive bone graft or similar bone growth inducing material (paragraph 100, able to be packed with material for bone ingrowth, as evidenced by Scarborough US 2001/0016775 where holes #320 are packed with bone growth material, Fig 19-21, paragraph 65), and wherein the central ramp includes a central opening (corresponding opening #100, Fig 10-11) that aligns with the first opening of the superior endplate when the central ramp when the central ramp is positioned between the superior endplate and the inferior endplate (Fig 10-11), the openings assist with bone ingrowth (paragraph 100). It is noted that the inferior endplate also has openings (#100, Fig 10-11) for the same purpose (paragraph 100).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the superior endplate to have a first opening, the central ramp to have a central opening and the inferior endplate to also have an opening in view of Michelson above because they assist with bone ingrowth. As discussed above and evidenced by Scarborough, the holes are able to be filled with bone growth material.
Regarding Claim 2, Shepard as modified discloses removing the first tool from the superior endplate and the second tool from the inferior endplate (Col 5 lines 40-42 in Shepard).
Regarding Claim 4, Shepard as modified discloses the inferior endplate a first opening (#100 in Michelson, Fig 10-11, see discussion in claim 1 above) that extends from an upper surface of the endplate to a lower surface of the endplate configured and dimensioned to receive bone graft or similar bone growth inducing material (as discussed with the modification in view of Michelson above).
Regarding Claim 6, Shepard as modified discloses the first side surface of the inferior endplate includes at least one ramped portion (see Fig below where an upper first side of the inferior endplate has a ramped portion) that engages the central ramp during movement of the expandable fusion device from a collapsed position to an expanded position (as seen in Fig 6, 8, Col 4 lines 30-50 in Shepard), and a first side surface of the superior endplate includes at least one ramped portion (see Fig below where an lower first side of the inferior endplate has a ramped portion) that engages the central ramp during movement of the expandable fusion device from the collapsed position to the expanded position (as seen in Fig 6, 8, Col 4 lines 30-50 in Shepard).
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Regarding Claim 7, Shepard as modified discloses the central ramp is configured to move in a first direction (see Fig above in claim 1, first direction is a rightward movement towards the endplate, Col 5 lines 20-30 in Shepard) and cause the inferior endplate and the superior endplate to move away from one another as the expandable fusion device shifts from a collapsed position (Fig 6 in Shepard) to an expanded position (Fig 8 in Shepard, Col 5 lines 20-30).
Regarding Claim 8, Shepard as modified discloses the central ramp comprises an upper end and a lower end, wherein the upper end engages the superior endplate and the lower end engaged the inferior endplate (as seen in Fig 6 in Shepard where the central ramp #34 had upper and lower ends that engage with the superior and inferior endplates, as seen in Fig 8-9, Col 4 lines 25-31).
Regarding Claim 9, Shepard as modified discloses the central ramp has a first ramped surface and a second ramped surface (see Fig below), the first ramped surface is configured for engaging a portion of the inferior endplate and the second ramped surface is configured for engaging a portion of the superior endplate (see Fig below and Fig 8 where the ramped surfaces engage respective portions of the inferior and superior endplate, Col 4 lines 30-40 in Shepard).
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Regarding Claim 3, Shepard as modified discloses the claimed invention as discussed above but does not disclose passing the superior endplate of the expandable fusion device through the endoscopic tube occurs prior to passing the inferior endplate of the expandable fusion device through the endoscopic tube.
However, it would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the steps of Shepard to pass the superior endplate through the endoscopic tube occurs prior to passing the inferior endplate of the expandable fusion device through the endoscopic tube since this provides one of only three finite possibilities (passing the superior endplate first, passing the inferior endplate first or passing both endplates simultaneously) to obtain predictable results of passing the superior and inferior endplates into the disc space. Examiner notes that it has been held that it would have been “obvious to try” try one of the possible three finite possibilities to obtain predictable results of placing a fusion device into the disc space, where applicant has not disclosed that the order of the placement of the endplates solves any stated problem or is anything more than one of finite possibilities a person ordinary skill in the art would find obvious for the purpose of implanting endplates of a fusion device. [see MPEP 2144.05 (B)].
Regarding Claim 5, Shepard as modified discloses the claimed invention as discussed above but does not disclose the central ramp comprises an opening having an open proximal end and a closed distal end, the opening extending partially through the central ramp.
However, Shepard as modified discloses the endplates each have a threaded opening (#27, #28, Fig 6 in Shepard) having an open proximal end (to receive tools #27, #39, Fig 6 in Shepard) and a closed distal end (as seen in Fig 6 in Shepard), the threaded opening extending partially through the endplates (Fig 6 in Shepard), the threaded openings used to couple to respective tools (#27, #39) to hold and insert the endplates (see Fig above, Col 4 lines 22-30 in Shepard and with the modification in view of Winslow, Col 6 line 66- Col 7 line 8 in Winslow).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the central ramp of Shepard as modified to include a threaded opening in view of Shepard and Winslow above so that the central ramp can receive its own tool to hold and insert the central ramp. Examiner notes that with the inclusion of the threaded opening to the central ramp, where looking at Fig 7 of Shepard, the threaded opening would be located in one of the left or right portions of the central ramp so as to not interfere with the grooves (#35, #36 in Shepard).
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 JAN CHRISTOPHER L MERENE whose telephone number is (571)270-5032. The examiner can normally be reached Mon-Fri 8:30 am - 6pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eduardo Robert can be reached 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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/JAN CHRISTOPHER L MERENE/Primary Examiner, Art Unit 3773
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