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 .
Response to Amendment
According to the amendment filed October 2, 2025, claims 1 and 24 have been amended. Claims 1-2, 5-10, 14, 16, 28 and 30-31 remain pending in the present application.
Response to Arguments
Applicant's arguments filed October 2, 2025, have been fully considered but they are not persuasive.
On page 5 of Remarks, Applicant asserts that the spring and core of Goldfarb (US 2009/0292363 A1) are not “centrally located along a central vertical axis between the plates”. However, the claim currently recites that the spring and core are positioned at a central vertical axis relative to the first and second plates. Similarly, on page 6 of Remarks, Applicant states that the spring and core of Moumene (US 2006/0293752 A1) “are not aligned along a central vertical axis defined between the top and bottom plates”, ultimately arguing that the spring and core of the present invention (in contrast to the applied references) are each directly located/positioned so as to coincide with a central vertical axis defined between the two plates. 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 (i.e., that the spring and core are positioned at a central vertical axis and/or centrally located along a vertical axis) are not recited in the rejected claim(s). 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).
Examiner notes that “positioned at” takes into account the definition of the term “at” which is defined at least by Merriam-Webster, which describes the term as “used as a function word to indicate presence or occurrence in, on, or near” (emphasis added by Examiner; https://www.merriam-webster.com/dictionary/at). Therefore, it is clear that the claim does not require the spring and core to be directly positioned at a location coinciding with the vertical central axis between the plates, as noted in the rejections below. Additionally, Examiner notes that while the current interpretation (i.e., that “at” refers to being near something), further amendments to specify that both the core and the spring are directly located at a position coinciding with the central axis may result in a rejection under 35 U.S.C. 112(a) regarding new matter, as the specification in its entirety does not seem to provide support for a configuration in which the spring itself is directly, physically located on the central vertical axis.
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, 5-7, 28, 30 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Goldfarb (US 2009/0292363 A1) in view of Fehling (US 2003/0009223 A1).
Regarding claim 1, Goldfarb teaches a spinal implant (100; Figs. 1 and 4; para. 0041) comprising:
a first plate (102; Figs. 1, 4; para. 0024) having a first surface (defined by the inner surface, i.e. lower surface; Fig. 4);
a second plate (104; Figs. 1, 4; para. 0024) having a second surface(defined by the inner surface, i.e. upper surface; Fig. 4); and
a biasing element (defined by spring 106 and elastomeric sheath 414, collectively; Fig. 4; para. 0041) extending between the first plate and the second plate (as shown; Fig. 4), the biasing element comprising a spring (spring 106; Fig. 4) and a solid central core (sheath 414, centrally disposed between first/second plates 102/104; Fig. 4), wherein the spring and core are positioned at a central vertical axis relative to the first and second plates (as seen in at least Fig. 4, spring 106 and core/sheath 414 are located at/around a central vertical axis defined between the first and second plates),
the spring having a first end and a second end and 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 (as described in the Abstract, para. 0006-0008, 0026 and 0038, spring 106 includes upper/first and lower/second ends that directly engage and are affixed to the inner surfaces, i.e. first and second surfaces, of the respective first and second plates 102 and 104, respectively, at protrusions 408 on the inner surfaces; Figs. 1, 4), 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, centrally disposed core/sheath 414 is capable for limiting flexion/compression/rotation of first plate 102 relative to second plate 104; Figs. 1, 4).
Goldfarb also discloses wherein the solid central core covers the spring element (as recited in para. 0041, “elastomer sheath 414 can be used to cover the spring 106”; Fig. 4), and the solid central core appears to extend from the inner surface of the first plate to the inner surface of the second plate (see Fig. 1).
However Goldfarb does not explicitly disclose wherein the solid central core (i.e., elastomer sheath) is mechanically fixed to one of the first plate and the second plate.
Fehling, in analogous art, teaches a spinal implant (shown in Fig. 1) having first and second plates (10, 12; Fig. 1) and a biasing element (16, 24; Fig. 1) comprising a spring (16; Fig. 1) and a solid central core (“protective coating 24” defines a solid central core, and is described as a thin-walled cylindrical sleeve formed of a sufficiently soft and continuously elastic biocompatible synthetic material in para. 0025-0026; Fig. 1), wherein the solid central core is mechanically fixed to the first plate and the second plate (see Fig. 1 and para. 0025 reciting “the protective coating 24 is in the form of a thin-walled cylindrical sleeve, of which the exposed ends are wound up on the cranial disc 10 and the caudal disc 12, respectively, and which are sealed and mounted appropriately” so that the coating/core 24 is mechanically fixed and sealed to the first and second plates).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have formed Goldfarb’s spinal implant so that the elastomeric sheath defining the solid central core is mechanically fixed to the first and second plates, as taught by Fehling, because Fehling recognizes that attaching such a central core/sheath to the plates aids in preventing tissue from growing into the intervertebral disc prosthesis (see Fehling, para. 0025).
Regarding claim 5, Goldfarb and Fehling, in combination, teach the spinal implant of claim 1, further comprising: one or more attachment tabs (108; Fig. 1; para. 0025) coupled to at least one of the first and second plates (as shown, coupled to both of first and second plates 102, 104; Fig. 1).
Regarding claims 6-7, Goldfarb and Fehling, in combination, teach the spinal implant of claim 1, [claim 6] wherein the spring of the biasing element is a waveform spring or a coil spring, [claim 7] wherein the spring is a wave form spring (spring 106 of the biasing element is a waveform spring; Figs. 1-4; para. 0029-0033).
Regarding claim 28, Goldfarb teaches an arthroplasty implant comprising:
a first articulating subchondral engagement plate (102; Figs. 1, 4; para. 0024) having a first surface (defined by the inner surface, i.e. lower surface; Fig. 4);
a second articulating subchondral engagement plate (104; Figs. 1, 4; para. 0024) having a second surface(defined by the inner surface, i.e. upper surface; Fig. 4); and
a biasing element (defined by spring 106 and elastomeric sheath 414, collectively; Fig. 4; para. 0041) extending between the first plate and the second plate (as shown; Fig. 4), the biasing element comprising a spring (spring 106; Fig. 4) and a solid central core (sheath 414, centrally disposed between first/second plates 102/104; Fig. 4), wherein the spring and core are positioned at a central vertical axis relative to the first and second plates (as seen in at least Fig. 4, spring 106 and core/sheath 414 are located at/around a central vertical axis defined between the first and second plates), 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 (as described in the Abstract, para. 0006-0008, 0026 and 0038, spring 106 includes upper/first and lower/second end portions that directly engage and are affixed to the inner surfaces, i.e. first and second surfaces, of the respective first and second plates 102 and 104, respectively, at protrusions 408 on the inner surfaces; Figs. 1, 4), and the solid central core is configured to limit the flexion, compression and/or rotation of the first plate relative to the second plate (solid, centrally disposed core/sheath 414 is capable for limiting flexion/compression/rotation of first plate 102 relative to second plate 104; Figs. 1, 4), wherein the first and second articulating subchondral engagement plates are configured for a cervical facet joint (the first and second plates 102/104 are understood to be capable for use and insertion into a cervical facet joint; Figs. 1, 4).
Goldfarb also discloses wherein the solid central core covers the spring element (as recited in para. 0041, “elastomer sheath 414 can be used to cover the spring 106”; Fig. 4), and the solid central core appears to extend from the inner surface of the first plate to the inner surface of the second plate (see Fig. 1).
However Goldfarb does not explicitly disclose wherein the solid central core (i.e., elastomer sheath) is mechanically fixed to one of the first plate and the second plate.
Fehling, in analogous art, teaches a spinal implant (shown in Fig. 1) having first and second plates (10, 12; Fig. 1) and a biasing element (16, 24; Fig. 1) comprising a spring (16; Fig. 1) and a solid central core (“protective coating 24” defines a solid central core, and is described as a thin-walled cylindrical sleeve formed of a sufficiently soft and continuously elastic biocompatible synthetic material in para. 0025-0026; Fig. 1), wherein the solid central core is mechanically fixed to the first plate and the second plate (see Fig. 1 and para. 0025 reciting “the protective coating 24 is in the form of a thin-walled cylindrical sleeve, of which the exposed ends are wound up on the cranial disc 10 and the caudal disc 12, respectively, and which are sealed and mounted appropriately” so that the coating/core 24 is mechanically fixed and sealed to the first and second plates).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have formed Goldfarb’s spinal implant so that the elastomeric sheath defining the solid central core is fixed to the first and second plates, as taught by Fehling, because Fehling recognizes that attaching such a central core/sheath to the plates aids in preventing tissue from growing into the intervertebral disc prosthesis (see Fehling, para. 0025).
Regarding claims 30-31, Goldfarb and Fehling, in combination, teach the spinal implant of claim 28, and Goldfarb teaches [claim 30] wherein the spring of the biasing element is a waveform spring or a coil spring, [claim 31] wherein the spring is a wave form spring (spring 106 of the biasing element is a waveform spring; Figs. 1-4; para. 0029-0033).
Claims 1-2, 9-10, 14 and 16 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),
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).
Regarding claim 9, Moumene and Gauchet teach the spinal implant of claim 1, and Moumene discloses wherein the first plate and the second plate have a leading edge and a trailing edge, the leading edge is configured for insertion into a facet joint (see leading and trailing edges of first plate 32 and second plate 34 identified in Examiner’s Annotated Fig. 19 below, where the leading edge is considered capable for use and insertion into a facet joint).
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Examiner’s Annotated Fig. 19 of Moumene
Regarding claim 10, Moumene and Gauchet teach the spinal implant of claim 9, and Moumene discloses wherein the biasing element is positioned adjacent to the trailing edge (Examiner’s Annotated Fig. 19 above, where a U-shaped end 98 of the spring 38 of the biasing element is positioned adjacent to the trailing edge).
Regarding claim 16, Moumene and Gauchet teach the spinal implant of claim 9, and Moumene teaches wherein the facet joint is a cervical facet joint (where the leading edge of the implant, identified in Examiner’s Annotated Fig. 19 above, is considered capable for use and insertion into a facet joint, as stated above with respect to claim 9, it is also considered capable for use and insertion into a cervical facet joint).
Regarding claim 14, Moumene and Gauchet teach the spinal implant of claim 1, and Moumene teaches wherein: the solid central core comprises at least one of metal, plastic, hard rubber, or other suitable polymer (para. 0041 recites that the core 36 is comprised of a plastic).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Goldfarb (US 2009/0292363 A1) in view of Fehling (US 2003/0009223 A1), as applied to claim 1 above, and further in view of Ralph (US 2003/0040801 A1).
Regarding claim 8, Goldfarb teaches the spinal implant of claim 1.
Goldfarb also teaches various embodiments of a spinal implant including a protrusions extending from the first and second plates, i.e. upper and lower plates, to prevent lateral motion of the spring disposed therebetween, i.e. “to prevent a spring from shifting out from in between the endplates” (see para. 0039 and Figs. 5-6B).
However, Goldfarb does not explicitly disclose 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.
Ralph teaches a spinal implant having first and second plates and a biasing element therebetween (see Figs. 3A, 7; para. 0043), and discloses the spinal implant further comprising: a first hollow cylinder (108A identified in Fig. 3A; Fig. 7; para. 0034) coupled to the first plate (circumferential flange 108A is integrally coupled to first plate 100A; Figs. 3A, 7) and housing at least a portion of the biasing element (shown in Fig. 7 housing at least an upper portion of wave washer 130 of the biasing element); and a second hollow cylinder (108B identified in Fig. 3B; Fig. 7; para. 0034) coupled to the second plate (circumferential flange 108B is integrally coupled to second plate 100B; Figs. 3B, 7) and housing at least a portion of the biasing element (shown in Fig. 7 housing at least a lower portion of wave washer 130 of the biasing element).
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 Goldfarb’s first and second (upper and lower) plates to include hollow outwardly flanged cylinders extending inward therefrom as taught by Ralph, the hollow cylinders housing at least the upper and lower portions of Goldfarb’s wave spring disposed between the plates, because doing so would provide the desired lateral retention of the spring, as described above.
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 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