DETAILED ACTION
Claim Objections
Claim 44 is objected to because of the following informalities. In line 12, “interior” should be - - inferior - - to correct a minor typographical error. Appropriate correction is required.
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) 44, 48-52 and 62 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kim (US 20070179493).
Kim discloses an intervertebral disc replacement device including: a superior plate 102; an inferior plate 104; and a spacer 108 therebetween, wherein each plate includes an outer or fixation surface and an inner or articulating surface and the spacer includes a superior articulating surface and an inferior articulating surface, wherein the articulating surface of the superior plate is configured to articulate against the superior articulating surface of the spacer, and the articulating surface of the inferior plate is configured to articulate against the inferior articulating surface of the spacer, wherein the articulating surface of the superior plate and the superior articulating surface of the spacer have an interface including a flat surface and the articulating surface of the inferior plate and the inferior articulating surface of the spacer have an interface including a flat surface; and the superior plate 102 has a magnet 112 embedded therein and the inferior plate 104 has a magnet 114 embedded therein (Fig. 13 and para [0068]).
Regarding claim 48, Kim discloses spacer 108 to have two magnets 116a and 116b (Fig. 13 and para [0068]).
Regarding claims 49-52, Kim discloses “The polarity of the magnets 112, 114, 116a and 116b can be selected such that the magnetic forces induced between magnets 116a and 112 and between magnets 116b and 114 can both be repelling forces, one repelling force and one attraction force, or both attraction forces. If both are repelling forces, this configuration provides a maximum level of distraction and shock absorption against axial compression forces. If one is attraction and the other is repulsion, this configuration provides an intermediate level of distraction while magnetically holding the spacer 106 against either the first or second piece 102 or 104, respectively. If both provide attraction forces, the interchangeable spacer 106 is magnetically attached and held to each of the first and second pieces 102 and 104 to provide maximum holding strength between the spacer 106 and each of the first and second pieces 102 and 104 (para [0068]).”
Regarding claim 62, Kim discloses the implant device to be configured to replace all of an intervertebral disc (paras [0006] and [0011]). The claimed method step is performed when the implant device is implanted into intervertebral space after removal of a degenerated or diseased disc.
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.
Claims 58, 61 and 63 are rejected under 35 U.S.C. 103 as being unpatentable over Kim (US 20070179493) in view of Choksey et al. (GB 2410189 A).
Regarding claim 58, Kim discloses the surfaces of the superior and inferior plates contacting bone to include a rough surface (surface with texture) and can include protrusions (para [0043]). Kim discloses all elements of the claimed invention except for a surface feature in the form of a keel.
Choksey et al. disclose keels 51 on the vertebrae engaging surfaces of plates of an intervertebral disc prosthesis in order to provide greater surface area in contact with bone to provide enhanced rotational and translational stability (Figs. 6b-6c and page 15).
It would have been obvious to one of ordinary skill in the art to have provided surface features in the form of keels on the bone-contacting surfaces of the plates of the Kim device, as taught by Choksey et al., for the predictable result of providing enhanced rotational and translational stability.
Regarding claim 61, Kim discloses all elements of the claimed invention except for a fixation extension.
Choksey et al. disclose a fixation extension in the form of flanges 50 configured to adhere to the anterior or outer surfaces of the vertebral bodies lying adjacent to the disc prosthesis wherein the flanges are attached to the anterior surfaces by means of screws (Fig. 2a-c and 3a-c and supporting text).
It would have been obvious to one of ordinary skill in the art to have provided a fixation extension or flange on the Kim device, as taught by Choksey et al., for the predictable result of securing the intervertebral prosthesis to prevent sliding of the superior and inferior plates.
Regarding claim 63, Kim discloses replacement of a damaged or diseased intervertebral disc but does not specifically disclose reducing pain caused by degenerative disc disease.
It is well known, as evidenced by Choksey et al., to perform spinal surgery to replace a damaged or diseased disc to alleviate pain (page 2).
It would have been obvious to one of ordinary skill in the art to have utilized the Kim prosthetic disc to replace a damaged disc for the predictable result of reducing pain caused by degenerative disc disease.
Claim 59 is rejected under 35 U.S.C. 103 as being unpatentable over Kim (20070179493) in view of Whipple (US 9408714)
Regarding claim 59, Kim discloses the spacer to be made of a biocompatible material but does not describe the material of construction of spacer 16.
Regarding claim 59, Whipple discloses the intermediate bearing layer or spacer 16 of a three-part prosthesis to be made of a compressible cushion polymer (spacer comprises a polymer (col. 2, lines 47-50)).
It would have been obvious to one of ordinary skill in the art to have constructed the spacer of Kim of a polymer for the predictable result of providing cushioning under dynamic loading conditions.
Claim 60 is rejected under 35 U.S.C. 103 as being unpatentable over Kim (US 20070179493) in view of Hyde (US 6387096).
Kim discloses the magnets to be made entirely of magnetic alloy material or composition (para [0044]-[0046]).
Hyde discloses constructing permanent magnets of rare earth alloys such as cobalt-samarium or sintered neodymium-iron-boron (col. 10, lines 56-67 and col. 11, lines 1-30).
It is well known to construct permanent magnets of sintered neodymium-iron-boron or cobalt-samarium alloys, one of ordinary skill in the art would have found it obvious to choose either of these materials with a reasonable expectation of success since these are well identified materials for construction of permanent magnets.
Response to Arguments
Applicant's arguments have been considered by the Examiner. New grounds of rejection have been made in this action.
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 Anu Ramana whose telephone number is (571)272-4718. The examiner can normally be reached 8:00 am-5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong can be reached at (571)272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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March 25, 2026
/Anu Ramana/Primary Examiner, Art Unit 3775
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