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
This Office Action is responsive to the amendment filed on 20 April 2026. As directed by the amendment: claims 1, 11, 14, and 24 have been amended, claims 4-9, 12, 13, and 15-23 are cancelled, and claims 27, 29, 31, 32, and 36 are withdrawn. Claims 1-3, 10, 11, 14, and 24-36 currently stand pending in the application.
The amendments to the claims are sufficient to overcome the previous claim objections, which are correspondingly withdrawn.
Response to Arguments
Applicant’s arguments with respect to the rejections under 35 U.S.C. 102(a)(1)/(2) 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.
Claim Interpretation
As to claim 24, in the limitation “a movable lid configured to rotate relative to the body about an axis, wherein the axis extends along the longest dimension of the spinal implant device”, the phrase “extends along” is being interpreted as the axis extends beside or in a direction of the longest dimension. The drawings do not provide support for the axis being coaxial with the longest dimension, since as shown for example in FIG. 14, the rotational axis of the lid is on a tapered portion of the proximal end, i.e. not coaxial with the longest dimension of the device, but along or beside it.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 10, 11, and 14 are rejected under 35 U.S.C. 102(a)(1)/(2) as anticipated by U.S. Patent No. US 10,363,142 to McClintock et al. (hereinafter, “McClintock”).
As to claim 1, McClintock discloses a spinal implant device, FIGS. 19-27C, comprising: a shell comprising: a distal end (300b) and a proximal end (300a), a lower wall (330) forming a lower surface of the shell (col. 16 / lines 21-30), FIGS. 20-22B; a movable lid (310) forming an upper surface of the shell, FIGS. 20-22B, wherein the movable lid is configured to rotate (col. 20 / lines 4-25), FIGS. 25B-25C, and translate (col. 20 / line 26-52), FIGS. 26B-26C; and an insert (318) configured to couple with the shell by lowering the insert toward the lower wall (the insert is coupled to the shell by lowering the insert toward the shell which includes the lower wall) (col. 16 / line 56 – col. 17 / line 5), FIGS. 22A-22B.
As to claim 2, McClintock discloses the spinal implant device of claim 1, wherein the movable lid is configured to rotate up to 180 degrees (the lid is fully capable of rotating up to 180 degrees, where the lid is rotated a lesser angle and therefore not more than 180 degrees, i.e. up to 180 degrees, and is fully capable of rotating a greater angle up to 180 degrees as part of the whole device which can be rotated as a whole up to 180 degrees in the hand of the practitioner, for example).
As to claim 3, McClintock discloses the spinal implant device of claim 1, wherein the movable lid is configured to translate between 0 mm and 6 mm (from height h5 in FIG. 23B, which is 2.5 mm, col. 19 / lines 27-35, to height h9 in FIG. 26B, which is 5.5 mm, col. 20 / lines 26-40, resulting in a translation of 3 mm).
As to claim 10, McClintock discloses the spinal implant device of claim 1, wherein the insert comprises a retention feature (flange that is received in 316c) and the movable lid comprises a complementary retention feature (316c) (col. 16 / line 64 – col. 17 / line 2).
As to claim 11, McClintock discloses the spinal implant device of claim 1, wherein the insert comprises a first insert opening (opening in the flange extending from 318c, shown for example at 338d, FIG. 22B) and the lower wall comprises a first opening (336c), wherein the first insert opening and the first opening are aligned along a trajectory for insertion of a first fastener (interpreted as language of intended use; the openings are aligned and fully capable of being aligned along a trajectory for the insertion of a first fastener).
As to claim 14, McClintock discloses the spinal implant device of claim 1, wherein the insert comprises a first insert opening (opening in the flange extending from 318c, shown for example at 338d, FIG. 22B) and the movable lid comprises a first opening (316c), wherein the first insert opening and the first opening are aligned along a trajectory for insertion of a first fastener (interpreted as language of intended use; the openings are aligned and fully capable of being aligned along a trajectory for the insertion of a first fastener).
Claims 24-26, 28, 30, and 33-35 are rejected under 35 U.S.C. 102(a)(1)/(2) as anticipated by U.S. Patent Application Publication No. US 2013/0103154 to Trieu et al. (hereinafter, “Trieu”).
As to claim 24, Trieu discloses a spinal implant device comprising: a body (17) (par. [0024]), FIG. 2A; a movable lid (11) configured to rotate relative to the body about an axis (axis of pin 23), wherein the axis extends along the longest dimension of the spinal implant device, FIG. 2A; an endplate (31) (par. [0030]), FIG. 3A, wherein the body, the movable lid, and the endplate form a cavity (24) configured to be packed with material (interpreted as language of intended use; par. [0032]).
As to claim 25, Trieu discloses the spinal implant device of claim 24, further comprising a pin (23) (par. [0029]), wherein the movable lid is configured to rotate relative to the pin, FIGS. 2A and 3A.
As to claim 26, Trieu discloses the spinal implant device of claim 25, wherein the pin comprises titanium (as a component of the implant device, par. [0023]).
As to claim 28, Trieu discloses the spinal implant device of claim 24, wherein the movable lid is printed as a separate piece (the movable lid is a separate piece). The claimed phrase “printed” is being treated as a product by process limitation. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113. The movable lid disclosed by Trieu is a separate piece appearing to be substantially the same as the printed separate piece of the instant application.
As to claim 30, Trieu discloses the spinal implant device of claim 24, wherein the endplate is printed as a separate piece (the endplate is a separate piece). The claimed phrase “printed” is being treated as a product by process limitation. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113. The endplate disclosed by Trieu is a separate piece appearing to be substantially the same as the printed separate piece of the instant application.
As to claim 33, Trieu discloses the spinal implant device of claim 24, wherein the movable lid comprises titanium (as a component of the implant device, par. [0023]).
As to claim 34, Trieu discloses the spinal implant device of claim 24, wherein the body comprises PEEK (as a component of the implant device, par. [0023]).
As to claim 35, Trieu discloses the spinal implant device of claim 24, wherein the endplate comprises titanium (as a component of the implant device, par. [0023]).
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 TRACY L KAMIKAWA whose telephone number is (571)270-7276. The examiner can normally be reached M-F 10:00-6:30 PM.
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/TRACY L KAMIKAWA/Examiner, Art Unit 3775
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