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 .
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.
Claim(s) 1, 5, 6 and 10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Betz et al. (US Pub 2007/0276501).
With respect to claim 1, Betz discloses a cervical artificial disc (paragraph 8 can be used for cervical spine discs) comprising: a cranial plate (fig 10, 72) configured to be coupled to an upper unit cervical vertebra; a caudal plate (fig 10, 73) configured to be coupled to a lower unit cervical vertebra; and an artificial disc member (Fig 10, 74) configured to be coupled between the cranial plate and the caudal plate to support a longitudinal load, wherein the cranial plate, the caudal plate, and the artificial disc member are formed based on an available space (paragraph 107) in which the cervical artificial disc represented by a plurality of landmarks (paragraph 91-97) is implanted. With respect to claim 5, Betz discloses wherein the cranial plate is configured to be manufactured to have a size capable of covering the body of the upper unit cervical vertebra, thereby preventing the cranial plate from being recessed in the unit cervical vertebra to which the cranial plate is attached, or preventing bleeding caused by the cranial plate not covering a part of the body of the unit cervical vertebra (paragraph 21, the implant endplates are contoured to the surfaces of the endplates).
With respect to claim 6, Betz discloses a method for constructing a cervical artificial disc, the method comprising: configuring a cranial plate (fig 10, 72 and paragraph 21, contoured to the surfaces) for coupling to an upper unit cervical vertebrae; configuring a caudal plate (fig 10, 73 and paragraph 21) for coupling to a lower unit cervical vertebrae; and configuring an artificial disc member (fig 10, 74) coupled between the cranial plate and the caudal plate to support a longitudinal load, wherein the cranial plate, the caudal plate, and the artificial disc member are formed based on the available space(paragraph 107) in which a cervical artificial disc represented by a plurality of landmarks (paragraphs 91-97 discloses making the 3D model from points on images) is implanted. With respect to claim 10, Betz discloses wherein, in configuring the cranial plate, the cranial plate is configured to be manufactured to have a size capable of covering the body of the upper unit cervical vertebra, thereby preventing the cranial plate from being recessed in the unit cervical vertebra to which the cranial plate is attached, or preventing bleeding caused by the cranial plate not covering a part of the body of the unit cervical vertebra (paragraph 21, the implant endplates are contoured to the surfaces of the endplates).
Claim Rejections - 35 USC § 103
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 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) 2-4 and 7-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Betz et al (US Pub 2007/0276501) in view of Heggeness et al. (US Patent 5,514,180).
With respect to claims 2 and 7, Betz discloses using landmarks and making a model to configure an artificial disc but does not specifically disclose the landmarks being a cranial anterior center, a cranial anterior right, and a cranial anterior left, each landmark in a front outer region of the upper unit cervical vertebrae; a cranial apex in a center of the upper unit cervical vertebrae; a cranial posterior center, a cranial posterior right, and a cranial posterior left, each landmark in a rear outer region of the upper unit cervical vertebrae; a caudal anterior center, a caudal anterior near right, a caudal anterior far right, a caudal anterior near left, and a caudal anterior far left, each landmark respectfully of an anterior outer region of a lower unit caudal vertebrae; and a caudal posterior center, caudal posterior near right, caudal posterior far right, caudal posterior near left, and caudal posterior far left, at each landmark in respectfully of a posterior outer periphery of the lower unit cervical vertebrae.
Heggeness discloses using landmarks (fig 30, 210) including a cranial anterior center (See fig 30 below), a cranial anterior right (see fig 30 below), and a cranial anterior left (see fig 30 below), each landmark of a front outer region of the upper unit cervical vertebrae (fig 12); a cranial apex (see fig 30 below) in a center of the upper unit cervical vertebrae (fig 12); a cranial posterior center (see fig 30 below), a cranial posterior right (see fig 30 below), and a cranial posterior left (see fig 30 below), each landmark in a rear outer region of the upper unit cervical vertebrae (fig 12); a caudal anterior center (See fig 30 below), a caudal anterior near right (see fig 30 below), a caudal anterior far right (See fig 30 below), a caudal anterior near left (See fig 30 below), and a caudal anterior far left (see fig 30 below), each landmark in respectfully of an anterior outer region of a lower unit caudal vertebrae (fig 16); and a caudal posterior center (see fig 30 below), caudal posterior near right (See fig 30 below), caudal posterior far right (See fig 30 below), caudal posterior near left (See fig 30 below), and caudal posterior far left (see fig 30 below), at each landmark in respectfully of a posterior outer periphery of the lower unit cervical vertebrae (fig 16) to quantitatively determine the bone morphology (col. 12, ll. 23-25). With respect to claims 3 and 8, Heggeness discloses wherein the available space is a space defined by the plurality of landmarks (fig 12 and 16), and models an A-space between two unit cervical vertebrae to which the cervical artificial disc is implanted, and comprises: a cranial edge line (see fig 12 below), which is a line connecting the cranial anterior center, cranial anterior right, cranial anterior left, cranial posterior center, cranial posterior right, and cranial posterior left; a cranial center line (see fig 12 and 11A below), which is a line connecting the cranial anterior center, cranial apex, and cranial posterior center, and is a center line that runs across between left and right sides of the cranial plate; an apex height (fig 11A, D2), which is a distance between the cranial center line and the cranial apex; a caudal edge line (See fig 16 below), which is a line connecting the caudal anterior near right, caudal anterior center, caudal anterior near left, caudal posterior near right, caudal posterior center, and caudal posterior near left; a caudal center line (fig 16 below), which is a line connecting the caudal anterior center and caudal posterior center, and a center line (see fig 16 below) that runs across between left and right sides of the caudal plate; a caudal wing line (See fig 16 below), which is a line connecting the caudal anterior near right and caudal anterior far right, the caudal anterior near left and caudal anterior far left, the caudal posterior near right and caudal posterior far right, and the caudal posterior near left and caudal posterior far left; a caudal wing angle (fig 16 shows angles between lines), which is an inner angle of a center vertex of a triangle with caudal wing line as a hypotenuse; and a caudal wing plate, which is a quadrilateral (fig 16 shows quadrilaterals formed between shapes) formed by connecting the caudal anterior near right, caudal anterior far right, caudal posterior far right, and caudal posterior near right, and the caudal anterior near left, caudal anterior far left, caudal posterior far left, and caudal posterior near left with lines.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device and method of Betz to include wherein the landmarks being a cranial anterior center, a cranial anterior right, and a cranial anterior left, each landmark in of a front outer region of the upper unit cervical vertebrae; a cranial apex in a center of the upper unit cervical vertebrae; a cranial posterior center, a cranial posterior right, and a cranial posterior left, each landmark in a rear outer region of the upper unit cervical vertebrae; a caudal anterior center, a caudal anterior near right, a caudal anterior far right, a caudal anterior near left, and a caudal anterior far left, each landmark in respectfully of an anterior outer region of a lower unit caudal vertebrae; and a caudal posterior center, caudal posterior near right, caudal posterior far right, caudal posterior near left, and caudal posterior far left, at each landmark in respectfully of a posterior outer periphery of the lower unit cervical vertebrae in view of Heggeness in order to quantitatively determine the bone morphology. With respect to claims 4 and 9, Betz in view of Heggeness discloses wherein the caudal wing angle is used for positioning the caudal plate at the center of the left and right sides of the cervical plate when implanting the caudal plate in the unit cervical vertebrae; and wherein the caudal wing plate is used for preventing the cervical artificial disc from being rotated through friction with the unit cervical vertebra when implanting the caudal plate in the unit cervical vertebrae (Betz discloses using a 3D model to conform the implant to the disc space (paragraph 21).
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Response to Arguments
Applicant’s arguments, see remarks, filed 7/10/2025, with respect to the U.S.C. 112 rejection of claims 2-4 and 7-9 have been fully considered and are persuasive. The U.S.C. 112 rejection of claims 2-4 and 7-9 has been withdrawn.
Applicant's arguments filed 7/10/2025 have been fully considered but they are not persuasive. The applicant argues that Betz does not disclose a caudal plate a cranial plate and an artificial disc member coupled between because Betz teaches a unitary structure and that Betz does not disclose plates. The examiner respectfully disagrees. 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., a non-unitary body) 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). The claim only requires that parts are coupled together not that they are separable too. Betz also discloses that the implant has primary surfaces 72 and 73 that are formed of mesh material layer with rigid keels to form the plate members and that these surfaces correspond to vertebral end plates in a natural disc (paragraph 135). The implant is shown with artificial disc material between the plate members in figure 10 such that Betz discloses two mesh endplates with a disc material coupled there between meeting the claimed limitations.
The applicant does not individually argue the 103 rejection.
The rejections are deemed proper.
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 STEVEN J COTRONEO whose telephone number is (571)270-7388. The examiner can normally be reached Monday-Friday 9am-5pm EST.
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/S.J.C/Examiner, Art Unit 3773 /EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773