DETAILED ACTION
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 22 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2006/0149381 (Kim) in view of U.S. Patent Application Publication No. 2007/0050032 (Gittings).
Regarding claim 22, Kim discloses an interbody fusion implant (88), comprising: a metallic frame (90/92/94/96/98/100/102/104) including a superior endplate (90) and inferior endplate (92) defining a cavity (see Fig. 9) therebetween and being interconnected by at least one compressible strut (94/96/98/100/102/104).
Kim fails to disclose polymeric body formed within the cavity by an injection molding process, the polymeric body being bonded to an interior surface of the superior endplate, an interior surface of the inferior endplate, wherein the at least one compressible strut is completely surrounded by the polymeric body and directly contacts the polymeric body. However, Kim discloses concern regarding fibrous growth inside of the implant and containing loose debris (see paragraph [0118]). Additionally, Gittings discloses an intervertebral implant (100) including a polymeric body (150) formed within a cavity between upper and lower endplates (110/120) of the implant, the polymeric body capable of being formed by an injection molding process (see paragraphs [0087] and [0092]), wherein at least one strut (140) between the endplates is completely surrounded by the polymeric body and directly contacts the polymeric body (see Fig. 3 and paragraphs [0087] and [0092]; fibers 140 may be encapsulated or coated with polymeric body). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the implant of Kim to include a polymeric body that completely surrounds and contacts the at least one strut as suggested by Gittings in order to protect against fibrous in-growth in the body of the implant and improve the stiffness and wear of the strut to a degree desired by the user (see Gittings, paragraphs [0087] and [0092]).
Gittings appears to disclose the polymeric body bonded to interior surfaces of the superior and inferior endplates (see Fig. 3 and paragraphs [0087] and [0092]). Alternatively, it would be obvious to have the polymeric body bonded to interior surfaces of the superior and inferior endplates in order to avoid gaps that would prevent the polymeric body from acting as a barrier between the body of the disc and the outside of the disc (see Gittings, paragraph [0092]).
Allowable Subject Matter
Claims 1, 3-13, 21, and 25 are allowed.
Claims 23 and 24 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant's arguments filed January 14, 2016 have been fully considered but they are not persuasive.
Applicant argues on page 8 of the Remarks that the rejection of claim 22 overlooks the “interbody fusion” limitation, and that Kim discloses an intervertebral disc prosthesis that prevents fibrous growth through the inside of the intervertebral disc prosthesis, and thus does not disclose an interbody fusion implant. The examiner disagrees.
A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. As noted in the rejection of claim 22, the combination of Kim and Gittings suggests all of the structure of the claimed implant comprising a metallic frame, compressible strut, and polymeric body. Thus, the claimed invention is not patentably distinguished over the prior art.
Additionally, U.S. Patent Application Publication No. 2005/0251260 (Gerber), previously cited prior art, discloses an artificial intervertebral disc implant (10) that, similar to the implant of Kim, is intended to restore natural range of motion to an intervertebral disc (see Abstract and paragraphs [0010] and [0016]), wherein Gerber suggests that the implant can nevertheless be used as an interbody fusion implant when necessary (see paragraph [0172]). Thus, Gerber is evidence that intervertebral implants which are not initially intended for use as an interbody fusion implant may nevertheless be used as one when necessary.
Conclusion
THIS ACTION IS MADE FINAL. 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 NICHOLAS J PLIONIS whose telephone number is (571)270-3027. The examiner can normally be reached on Monday - Friday, 10:00 a.m. - 6:00 p.m. EST.
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/NICHOLAS J PLIONIS/Primary Examiner, Art Unit 3773
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