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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March 23, 2026, has been entered.
Response to Amendment
According to the amendment filed March 23, 2026, claims 1 and 28 have been amended. Claims 1-2, 5-10, 14, 16, 28, 30 and 31 are currently pending in this application.
Response to Arguments
Applicant’s arguments, see page 5 of Remarks, last three paragraphs, filed March 23, 2026, with respect to the rejection(s) of claim(s) 1, 5-7, 28, 30 and 31 under 35 U.S.C. 103 as being unpatentable over Goldfarb (US 2009/0292363 A1) and Fehling (US 2003/0009223 A1), in view of the present amendments to independent claims 1 and 28, have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Gauchet (US 6,582,468 B1), which anticipates or renders obvious claims 1, 5, 9-10, 14, 16 and 28, as described in the rejections below.
Applicant's arguments filed March 23, 2026, regarding the rejection of claims 1-2, 10, 14 and 16 under 35 U.S.C. 103 as being unpatentable over Moumene (US 2006/0293752 A1) and Gauchet, have been fully considered but they are not persuasive. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies are not recited in the rejected claim(s). Specifically, on page 6 of Remarks, first paragraph, Applicant states that Moumene’s spring 38 “does not encompass or surround the core [36]”. However, the independent claims have been amended to recite “and wherein the core is positioned within the spring” (emphasis added). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Thus, Examiner maintains that the combined teachings of Moumene and Gauchet render obvious the presently amended independent claims.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1, 9-10, 14, 16 and 28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gauchet (US 6,582,468 B1).
Regarding claim 1, Gauchet teaches a spinal implant (2; Fig. 6; col. 2, ll. 59-61; col. 5, ll. 11-15) comprising:
a first plate (upper plate 4; Fig. 6) having a first surface (defined by inner face 20; Fig. 6);
a second plate (lower plate 4; Fig. 6) having a second surface (defined by inner face thereof; Fig. 6); and
a biasing element (defined by intermediate cushion part 10, including bellows 22 and solid body 12, collectively; Fig. 6; col. 3, ll. 3-45) extending between the first plate and the second plate (as shown; Fig. 6), the biasing element comprising a spring (bellows 22 form a compression spring, as recited in col. 3, ll. 30-33; Fig. 6) and a solid central core (12; Fig. 6), wherein the spring and core are positioned at a central vertical axis relative to the first and second plates (see Fig. 6) and wherein the core is positioned within the spring (solid core 12 positioned within bellows/spring 22; Fig. 6),
the spring having a first end and a second end wherein the spring is directly, fixedly coupled to the first surface of the first plate at the first end and the second surface of the second plate at the second end (bellows/spring 22 has first upper end attached to first/inner surface of upper plate 4 and a second lower end attached to second/inner surface of lower plate 4; Fig. 6; col. 3, ll. 36-45), and
wherein the solid central core is mechanically fixed to one of the first plate and the second plate and configured to limit the flexion, compression and/or rotation of the first plate relative to the second plate (compressible solid core 12, in the embodiment of Fig. 6, has a lower end that is “invariable and fixed” to lower plate 4, as recited in …, and is configured to limit flexion, compression and/or rotation of first upper plate 4 relative to second lower plate 4).
Regarding claim 9, Gauchet teaches the spinal implant of claim 1, wherein the first plate and the second plate have a leading edge and a trailing edge, the leading edge configured for insertion into a facet joint (first and second edges of plates 4, i.e. right and left edges, respectively, define a leading edge and a trailing edge, respectively, where the leading edge is considered capable for insertion into a facet joint; Fig. 6).
Regarding claim 10, Gauchet teaches the spinal implant of claim 9, wherein the biasing element is positioned adjacent to the trailing edge (at least bellows/spring 22 of the biasing element is positioned adjacent the trailing edge of the implant described above; Fig. 6).
Regarding claim 16, Gauchet teaches the spinal implant of claim 9, wherein the facet joint is a cervical facet joint (as noted above, where the leading edge is considered capable for insertion into a facet joint, the leading edge is also considered capable for insertion into a cervical facet joint; Fig. 6).
Regarding claim 14, Gauchet teaches the spinal implant of claim 1, wherein: the solid central core (12; Fig. 6) comprises at least one of metal, plastic, hard rubber, or other suitable polymer (“made of viscoelastic material, for example silicone” as recited in col. 3, ll. 4-6).
Regarding claim 28, Gauchet teaches an arthroplasty implant comprising:
a first articulating subchondral engagement plate (upper plate 4; Fig. 6) having a first surface (defined by inner face 20; Fig. 6);
a second articulating subchondral engagement plate (lower plate 4; Fig. 6) having a second surface (defined by inner surface thereof; Fig. 6); and
a biasing element (defined by intermediate cushion part 10, including bellows 22 and solid body 12, collectively; Fig. 6) extending between the first plate and the second plate (as shown; Fig. 6), the biasing element comprising a spring (bellows 22 form a compression spring, as recited in … ; Fig. 6) and a solid central core (12; Fig. 6), wherein the spring and core are positioned at a central vertical axis relative to the first and second plates (see Fig. 6) and the core is positioned within the spring (solid core 12 positioned within bellows/spring 22; Fig. 6),
the spring having a first portion and a second portion, and directly, fixedly coupled to the first surface of the first engagement plate at or near the first portion and the second surface of the second engagement plate at or near the second portion (bellows/spring 22 has first upper end portion directly attached to first/inner surface of upper plate 4 and a second lower end portion directly attached to second/inner surface of lower plate 4; Fig. 6; …), and the solid central core is mechanically fixed to one of the first plate and the second plate and is configured to limit the flexion, compression and/or rotation of the first plate relative to the second plate (compressible solid core 12, in the embodiment of Fig. 6, has a lower end that is “invariable and fixed” to lower plate 4, as recited in …, and is configured to limit flexion, compression and/or rotation of first upper plate 4 relative to second lower plate 4),
wherein the first and second articulating subchondral engagement plates are configured for a cervical facet joint (plates 4 of the implant described above are considered capable for use at a cervical facet joint; Fig. 6).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1 and 2 are rejected under 35 U.S.C. 103 as being unpatentable over Moumene (US 2006/0293752 A1) in view of Gauchet (US 6,582,468 B1).
Regarding claim 1, Moumene teaches a spinal implant (implant 30 shown in Figs. 19-20C; para. 0056) comprising:
a first plate (32; Fig. 19) having a first surface (defined by the inner surface, i.e. lower surface; Fig. 19);
a second plate (34; Fig. 19) having a second surface (defined by the inner surface, i.e. upper surface); and
a biasing element (defined by springs 38 and core 36, where each spring 38 includes an upper mount 74 and a lower mount 76; Figs. 19-20C; para. 0041-0042, 0056) extending between the first plate and the second plate (as shown; Figs. 19-20C), the biasing element comprising a spring (spring 38, including upper mount 74 and lower mount 76; Figs. 19-20C) and a solid central core (36; Figs. 19-20C), wherein the spring and core are positioned at a central vertical axis relative to the first and second plates (as shown in Figs. 19-20C, the springs 38 and core 36 are positioned at/near a central vertical axis) and wherein the core is positioned within the spring (as shown, core 36 located within the spring collectively defined by springs 38, i.e. the core is positioned at an interior location of the collective spring; Figs. 19-20C),
the spring having a first end and a second end (spring 38, including mounts 74, 76 as described above, has a first end at the upper end of upper mount 74 and a second end at the lower end of mount 76, as identified Examiner’s Annotated Fig. 20C below) and wherein the spring is directly, fixedly coupled to the first surface of the first plate (via upper mount 74 of the spring 38, as shown; see Figs. 19-20C and Examiner’s Annotated Fig. 20C below; para. 0052) at the first end and the second surface of the second plate at the second end (via lower mount 76, as shown; see Figs. 19-20C and Examiner’s Annotated Fig. 20C below; para. 0052), and
wherein the solid central core is configured to limit the flexion, compression and/or rotation of the first plate relative to the second plate (solid central core 36 is understood to limit flexion, compression and/or rotation of first plate 32 relative to second plate 34, as depicted in the analogous embodiment in Figs. 2-5 with the springs removed for clarity; see Figs. 19-20C, para. 0014-0017, 0045).
In the embodiment described above, Moumene’s solid central core is shaped and configured to articulate with respect to the respective inner surfaces of the first and second plates (see Figs. 2-5; para. 0043-0044), which is to say that Moumene does not disclose wherein the solid central core is mechanically fixed to one of the first plate and the second plate.
Gauchet, in analogous art, teaches an intervertebral disk prosthesis comprising first and second plates and a biasing element positioned between the first and second plates, the biasing element comprising a spring and a solid central core (see embodiments in Fig. 1-2 and in Fig. 6, showing an intervertebral disc prosthesis 2 with plates 4 and an intermediate biasing element part 10 positioned therebetween, the biasing element part including spring/bellows 22 and solid central core 12; col. 2, l. 40 – col. 3, l. 35).
Gauchet discloses, in one embodiment similar to the configuration of Moumene described above, wherein the solid central core is shaped and configured to articulate with respect to the inner surfaces of the plates, to limit flexion, compression and/or rotation of the plates with respect to one another (see embodiment of disc 2 in Figs. 1-2, described in col. 3, ll. 2-23.
In a suitable alternate embodiment, Gauchet discloses wherein the solid central core is fixed to one of a first plate and a second plate (see Fig. 6, where the upper face of the solid central core 12 is shaped to articulate with respect to the upper plate and the “other end, which is the lower end in FIG. 6, has a plane circular shape whose area of contact with the associated plate is invariable and fixed with respect thereto” as recited in col. 5, ll. 11-15). Where the solid central core directly contacts and is fixed to the second plate (as shown in Fig. 6), the core is understood to be mechanically fixed to the second plate.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Moumene’s implant so that the solid central core is fixed to one of the first plate and the second plate, e.g. by modifying the lower plate to have a flat surface to which the solid central core is fixed as taught by Gauchet, because Gauchet recognizes that either configuration is suitable for an intervertebral disk prosthesis (see Figs. 1-2 and 6) and providing an arrangement where a solid central core that is fixed to one of the upper and lower plates at one end and has an articulating relationship at the opposite end with the other one of the upper and lower plates “offers selfcentering of the two faces while permitting sideways relative displacement of the body with respect to the plate in any direction perpendicular to a longitudinal direction of the spine (see Gauchet, Fig. 6 and column 4, line 61 – column 5, line 6).
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Examiner’s Annotated Fig. 20C of Moumene
Regarding claim 2, Moumene and Gauchet teach the spinal implant of claim 1, and Moumene discloses the implant further comprising: a first plurality of teeth coupled to a third surface opposite the first surface of the first plate; and a second plurality of teeth coupled to a fourth surface opposite the second surface of the second plate (first and second pluralities of teeth 46/56, identified in at least Fig. 1 and described in para. 0038, are shown coupled to outer surfaces, i.e. third and fourth surfaces, of the first plate 32 and the second plate 34, respectively, of the implant shown in Figs. 19-20C).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Gauchet (US 6,582,468 B1).
Regarding claim 5, Gauchet teaches the spinal implant of claim 1.
In the first embodiment described above (see Gauchet, Fig. 6), Gauchet does not explicitly disclose the implant further comprising one or more attachment tabs coupled to at least one of the first and second plates.
However, in a similar second embodiment, Gauchet discloses a spinal implant (in Figs. 1-2) having first and second plates (4; Figs. 1-2), a biasing element disposed between the plates and comprising a spring and a core (bellows/spring 22 and solid core 12; Figs. 1-2), and the implant further comprising one or more attachment tabs (25; Figs. 1-2; col. 3, ll. 55-67) coupled to the first and second plates (as shown; Figs. 1-2).
It would have been obvious to one or ordinary skill in the art before the effective filing date of the claimed invention to have modified Gauchet’s first embodiment to include the attachment tabs of the second embodiment, the tabs attached to the upper plate and/or the lower plate, because Gauchet recognizes that providing such tabs for receiving bone screws allows for anchoring of the spinal implant adjacent the implantation site (see Gauchet, col. 3, ll. 55-67).
Allowable Subject Matter
Claims 6-8 and 30-31 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.
Claims 6 and 30 in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, the claimed combination of limitations recited in these claims. In particular, none of the cited references teach or suggest an implant having the claimed biasing element structure comprising a spring and a core, configured in the claimed manner, and “wherein the spring of the biasing element is a waveform spring or a coil spring” as required by dependent claims 6 and 30. Note that claims 7 and 31 would be allowable due to dependency on claims 6 and 30, respectively.
Claim 8 in the instant application has not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, the claimed combination of limitations recited in claim 8. In particular, none of the cited references teach or suggest the implant “further comprising: a first hollow cylinder coupled to the first plate and housing at least a portion of the biasing element; and a second hollow cylinder coupled to the second plate and housing at least a portion of the biasing element” as required by claim 8.
The most relevant prior art of record includes Moumene (US 2006/0293752 A1) and Gauchet (US 6,582,468 B1).
Regarding the limitations of claims 6 and 30 noted above, the spring of Moumene’s implant (in Figs. 19-20C) comprises a pair of torsion springs positioned on lateral sides of the implant and mounted to inner surfaces of upper and lower plates (see torsion springs 38; Figs. 19-20C; para. 0053, 0056). Gauchet’s spring is formed as bellows having corrugations and a certain axial rigidity so as to form a compression spring, where the bellows are bonded to the plates in a leaktight manner to define a sealed variable-volume enclosure extending around the body (see Gauchet, col. 3, ll. 24-45). It would not have been obvious to one of ordinary skill in the art to have modified either of Moumene’s or Gauchet’s springs to be a waveform spring or a coil spring as claimed, because such a modification may interfere with the articulation capabilities and/or the leaktight features of the enclosure, in the case of Gauchet.
Regarding the limitations of claim 8, modifying Moumene’s implant to comprise hollow cylinders housing portions of the biasing element may structurally interfere with the springs located on lateral sides of the implant, and modifying Gauchet’s implant to comprise such cylinders may prevent proper expansion or compression of the bellows defining the spring, so that one of ordinary skill in the art would not be motivated to alter either implant in such a manner.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNA VICTORIA LITTLE whose telephone number is (571)272-6630. The examiner can normally be reached M-F 9a-6p EST.
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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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/ANNA V. LITTLE/Examiner, Art Unit 3773 /EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773
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