DETAILED ACTION
This office action is responsive to the amendment filed May 15, 2026. By that amendment, claims 1-20 were amended. Claims 1-20 are pending.
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 .
Response to Arguments
The outstanding rejection of claims 8 and 17 under 35 USC 112(b) were overcome by the amendment of May 15, 2026.
Applicant’s arguments with respect to the rejections of claim(s) 1-9, 11, 15-18 and 20 under 35 USC 102(a)(1) in view of Padovani et al. (US 2015/0328005 A1); claims 10 and 19 under 35 USC 103 in view of Padovani and Melkent (US 2008/0161919 A1); and claims 12-14 under 35 USC 103 in view of Padovani; 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. The newly presented rejections are necessitated by the amendments to the claims of May 15, 2026.
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, 7-11, and 13-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Melkent (US 2008/0161919 A1).
Regarding claim 1, Melkent teaches An interbody implant configured to permit intra-implant movement at locations about relief cuts 30 while minimizing movement at a bone-implant interface, comprising:
an implant body 20 formed to permit a desired range of intra-implant movement between an upper surface thereof (up in fig. 1) and a lower surface thereof (down in fig. 1), the implant body comprising:
a first flexure (material about 30) configured to enable the implant body to provide a medial-lateral rolling motion when implanted in a patient's spine (lateral motion [0032]), wherein the first flexure is disposed at at least one of a first lateral portion and a second lateral portion of the implant body (the material about 30 can be seen to extend through the lateral side, out of the page in fig. 1);
a second flexure 30 configured to enable the implant body to provide an anterior-posterior rolling motion when implanted in the patient's spine (the material about 30 is located at anterior and posterior locations to provide the claimed motion [0032], e.g. flexion and extension), wherein the second flexure is disposed at at least one of an anterior portion and a posterior portion of the implant body; and
a receptacle 30 configured to receive an insert 40 configured to modify a kinematic profile of the implant body by selectively altering deformation of at least one of the first flexure and the second flexure [0032], wherein the receptacle is substantially coplanar with the implant body;
an upper fixation element (teeth at 22, see fig. 3) adapted to secure an upper portion of the implant body to a superior bone; and
a lower fixation element (teeth at 23, see fig. 3) adapted to secure a lower portion of the implant body to an inferior bone.
Regarding claim 2, at least a portion of the implant body 20 is integrally coupled together with at least one of the first flexure and the second flexure (about slots 30) as a single piece.
Regarding claim 3, the implant body 20 is integrally together about portions 30 with the first flexure and the second flexure together as a single piece.
Regarding claims 4 and 5, at least one of the first flexure and the second flexure comprises a leaf spring – the configuration of the device in fig. 1 is considered to be in the form of a plurality of leaf springs with slits in between. The leaf springs are considered to have first ends coupled to the implant body 20 and free ends at the distal extent of the springs.
Regarding claim 7, at least one of the first flexure and the second flexure is disposed between the receptacle 30 and at least one of the upper fixation element at 22 and the lower fixation element, and wherein each of the upper fixation element at 22 and the lower fixation element at 23 comprises an element selected from at least one of a screw and a blade – teeth at 22 are considered to be in the form of blades.
Regarding claim 8, the upper surface of the implant body 22 and the lower surface of the implant body 23 each comprise at least one of a roughened surface and a porous surface to facilitate at least one of bone on-growth and bone in-growth. See fig. 3.
Regarding claim 9, the first flexure above the first slot 30 in fig. 1 is disposed closer to the upper portion of the implant body 20 than to the lower portion of the implant body.
Regarding claim 10, the second flexure (the bottom slit 30 in fig. 1) is disposed closer to the lower portion of the implant body than to the upper portion of the implant body.
Regarding claim 11, Melkent teaches an interbody implant as at fig. 1 configured to permit intra-implant movement while minimizing movement at a bone-implant interface, comprising:
an implant body 20 formed to permit a desired range of intra-implant movement between a superior surface thereof and an inferior surface thereof [0032], the implant body comprising:
a first flexure (above top slit 30 in fig. 1) extending in a generally medial-lateral direction with respect to the implant body, thereby allowing the implant body to provide a medial-lateral rolling motion when implanted in a patient's spine (per [0032], the slits can permit flexion in both directions; the slit extends fully across the implant, see fig. 3);
a first insert 40 configured to be inserted into the implant body laterally to modify the medial-lateral rolling motion when the first insert is inserted ([0032]-[0040] describes insertion of inserts 40 of different configurations and combinations to result in different levels of flexibility in flexion, extension, and lateral bending);
a second flexure 30 extending in a generally anterior-posterior direction with respect to the implant body, thereby allowing the implant body to provide an anterior-posterior rolling motion when implanted in the patient's spine (see figs. 1 and 3); and
a second insert configured to be inserted at least one of anteriorly or posteriorly into the implant body, the second insert being configured to modify the anterior-posterior rolling motion when the second insert is inserted [0032]-[0040]; also see fig. 5;
a superior fixation element at 22 adapted to secure a superior portion of the implant body to a superior bone; and
an inferior fixation element at 23 adapted to secure an inferior portion of the implant body to an inferior bone.
Regarding claim 13, at least one of the first flexure and the second flexure comprises a substantially quadrilateral shape – various embodiments of different shapes are shown, such as the generally kidney bean configuration of fig. 3 and 4, and rectangular implant of fig. 5. Fig. 5 is considered quadrilateral.
Regarding claim 14, at least one of the first insert and the second insert comprises a substantially quadrilateral shape – see e.g. figs. 5 and 8 (shim 40 shown to be rectangular in fig. 8, and will also be for purposes of interacting with slots 30 in fig. 5).
Regarding claim 15, at least one of the first flexure about 30 and the second flexure about 30 comprises an elongated resilient member having a length and a thickness, the thickness being less than the length, wherein the elongated resilient member is configured to elastically deform under physiological loading. [0031]
Regarding claim 16, comprising a third flexure and a fourth flexure (at least four flexures seen in fig. 1), wherein each of the first flexure, the second flexure, the third flexure, and the fourth flexure is disposed at a position selected from at least one of an anterior portion of the implant body, a posterior portion of the implant body, a first lateral portion of the implant body, and a second lateral portion of the implant body.
Regarding claim 17, the first flexure above the top slit 30 is fully disposed closer to one of the superior surface 22 than is the second flexure below the bottom slit 30.
Regarding claim 18, the first flexure is disposed between the first insert 40 and one of the superior surface 22 and the inferior surface, and the second flexure is disposed between the second insert 40 and another of the superior surface and the inferior surface 23.
Regarding claim 19, the first insert 40 and the second insert 40 are each configured to be inserted between the first flexure and the second flexure as in fig. 1.
Regarding claim 20, at least one of the first insert 40 and the second insert 40 is configured to extend across a majority of a width of the implant body and across a majority of a length of the implant body – see fig. 3.
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 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Melkent.
Regarding claim 6, Melkent teaches the limitations of claim 1, as above. Further, Melkent teaches the upper fixation element can now be referred to as element 87 as seen at fig. 5. The at least one of the upper fixation 87 element is disposed proximate to (understood to be ‘near’) at least one of the first flexure. The upper fixation element at 87 comprises a first bone screw passing through an upper aperture 86 of the implant body (there is no structure to the ‘bone screw’; and no reason 87 could not be driven into bone).
Melkent does not demonstrate a lower fixation element being a second bone screw passing through a lower aperture of the implant body.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to form the Melkent body with a second aperture 86 and screw 87, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. One would have done so to permit retention of elements 40 in another of the sets of slots 30 in fig. 5.
Regarding claim 12, Melkent teaches the limitations of claim 11, as above.
Melkent does not teach the implant body 20 being formed from a plurality of pieces assembled together using an assembly method comprising at least one of a sliding assembly method and a press-fit assembly method.
It would have been obvious to one with ordinary skill in the art at the time of the invention to form the Melkent device of separable pieces since it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art. Press-fit assembly is old and well known in the art and is one of a small number of known methods of assembly of components together. One would have done so to permit selection of portions of different sizes to cause the Melkent device to be of a configuration which matches a particular patient anatomy.
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 David Bates whose telephone number is (571)270-7034. The examiner can normally be reached Monday through Friday, 10AM-6PM
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/DAVID W BATES/Primary Examiner, Art Unit 3799
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