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 § 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 5-6, 8-10, 13, 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hanson et al. (U.S. Patent 6,641,582 B1, hereinafter “Hanson”).
Hanson discloses, regarding claim 1, a spinal joint access device (100, see Figs. 5-8) for accessing a spinal joint via a posterior access approach (see lines 7-22 of column 3, “for preparing an implant site for fusing cervical… intervertebral joints” and “performed using … posterior… approach”), the access device comprising an elongated tubular body (103, see Fig. 5) defining a longitudinal axis therethrough (see Fig. 5, see annotated Fig. 5 below), the body having a proximal portion (101) and a distal portion (102); and a chamfered or beveled end feature (120 and 121, see Fig. 5, note sloping or beveled surfaces 120c and 121c and 115a-b) positioned at the distal portion of the body and configured for insertion at the spinal joint (see Fig. 5, see lines 35-45 of column 6), wherein said end feature extends from the distal portion of the body in a same plane or in a parallel plane relative to the longitudinal axis of the body (see Fig. 5, see annotated Fig. 5 below, note that the end feature is coaxial with the longitudinal axis).
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Regarding claim 5, wherein the body has a rectangular shaped cross section (see Fig. 5).
Regarding claim 6, wherein the proximal portion has a first height (see annotated Fig. 5 below) and the distal portion has a second height and the first height is greater than the second height (see annotated Fig. 5 below).
Regarding claim 8, wherein the spinal joint is a cervical facet joint (see lines 7-22 of column 3, “for preparing an implant site for fusing cervical… intervertebral joints” and “performed using … posterior… approach”).
Regarding claim 9, wherein the device further comprises a stop (130a-b and 131a-b) adapted to abut an edge or posterior portion of the spinal joint (see Fig. 5, see lines 66-67 of column 6 and lines 1-4 of column 7).
Hanson discloses, regarding claim 10, a spinal fixation access and delivery system (100 and 104-106, see Figs. 5-8) for accessing the spinal joint via a posterior access approach (see lines 7-22 of column 3, “for preparing an implant site for fusing cervical… intervertebral joints” and “performed using … posterior… approach”), the system comprising: a spinal joint access device (100) comprising: an elongated tubular body (103) defining a longitudinal axis therethrough (see Fig. 5, see annotated Fig. 5 above), the body having a proximal portion (101) and a distal portion (102); and a chamfered or beveled end feature (120 and 121, , see Fig. 5, note sloping or beveled surfaces 120c and 121c and 115a-b) positioned at the distal portion of the body and configured for insertion at the spinal joint (see Fig. 5, see lines 35-45 of column 6), wherein said end feature extends from the distal portion of the body in a same plane or in a parallel plane relative to the longitudinal axis of the body (see Fig. 5, see annotated Fig. 5 above, note that the end feature is coaxial with the longitudinal axis).
Regarding claim 13, wherein the spinal joint is a cervical facet joint (see lines 7-22 of column 3, “for preparing an implant site for fusing cervical… intervertebral joints” and “performed using … posterior… approach”).
Regarding claim 15, wherein the stop feature comprises a raised or protruding feature (130a-b and 131a-b, protrudes / is raised from 120 and 121, see Fig. 5 and lines 66-67 of column 6 and lines 1-4 of column 7).
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.
Claim(s) 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hanson, as applied to claim 10 above, and in view of Cannestra (U.S. Pub. No. 2015/0230834 A1, hereinafter “Cannestra”).
Hanson discloses all of the features of the claimed invention, as previously set forth above. Hanson further discloses that the system includes mandrels (104 and 105, see lines 50-57 of column 7) and a bone chisel (106, see lines 24-34 of column 8). However fails to explicitly disclose, regarding claim 11, a further comprising a decortication tool; and regarding claim 12, wherein a portion of the decortication tool optionally includes a burr, a rasp or teeth.
Cannestra discloses a spinal access device (30-40, see Fig. 5) and a tool (10), wherein the top and bottom surfaces of the tool (26) may include rasping surfaces in order to decorticate the joint surface and promote arthrodesis (see para. [0046]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the bone chisel of the spinal access device in Hanson to include rasping / decorticating top and bottom surfaces in view of Cannestra in order to decorticate the joint surface and promote arthrodesis.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hanson, as applied to claim 1 above, and in view of McCormack et al. (U.S. Pub. No. 2009/0312763 A1, hereinafter “McCormack”).
Hanson discloses all of the features of the claimed invention, as previously set forth above, except regarding claim 14, wherein the end feature further comprises a top surface and a bottom surface and at least the bottom surface includes one or more teeth.
McCormack discloses a spinal joint access device (114, see Fig. 6A), the access device comprising an elongated tubular body (see Fig. 6A), the body having a proximal portion (e.g. end near 111) and a distal portion (e.g. end near 112); and a chamfered or beveled end feature (112) positioned at the distal portion of the body (see Fig. 2), wherein the end feature further comprises a top surface and a bottom surface (see annotated Fig. 2 below) and at least the bottom surface includes one or more teeth (see annotated Fig. 2 below) in order to assist with anchoring the access device within the joint (see para. [0195]).
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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 end feature in Hanson to include teeth in view of McCormack in order to assist with anchoring the access device within the joint.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 5-6, 8-15 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.
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 Michelle C. Green whose telephone number is (571)270-7051. The examiner can normally be reached on Monday-Friday between 9am-5pm.
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/M.C.G/ Examiner, Art Unit 3773 /EDUARDO C ROBERT/ Supervisory Patent Examiner, Art Unit 3773
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