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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2, 2026 has been entered.
Status of the Claims
This Office Action is responsive to the amendment filed March 2, 2026. As directed by the amendment: Claim 1 has been amended. Claims 1-15 are presently pending in this application.
Examiner’s Note
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.
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.
Claim(s) 1-3, 6-13, and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Theofilos (US 2014/0214166) in view of Duffield et al. (US 2013/0060339), herein referred to as Duffield.
Regarding claim 1, Theofilos discloses an intervertebral implant (200) (figures 6A-7) for implantation in an intervertebral space between adjacent vertebrae (¶2), the implant (200) comprising a spacer (140+210) having a superior surface (e.g. considered as a top surface, see figures 6A-7 below), an inferior surface (e.g. considered as a bottom surface, see figures 6A-7 below), a proximal end (see figures 6A-7 below), and a distal end (see figures 6A-7 below), wherein the superior surface (e.g. considered as a top surface, see figures 6A-7 below) and the inferior surface (e.g. considered as a bottom surface, see figures 6A-7 below) each have a contact area (see figures 6A-7 below) configured to (i.e. capable of) engage adjacent vertebrae (¶2), the spacer (140+210) defining an opening (see figure 6A below) extending from the superior surface (e.g. considered as a top surface, see figure 6A below) to the inferior surface (e.g. considered as a bottom surface, see figure 6A below) of the spacer (140+210), and the spacer (140+210) defining a plurality of cutouts (see figures 6A-7 below) in the proximal end (see figures 6A-7 below), wherein a proximal end of the plurality of cutouts (see figures 6A-7 below) is completely open to one of the superior surface (e.g. considered as a top surface, see figures 6A-7 below) and the inferior surface (e.g. considered as a bottom surface, see figures 6A-7 below), and a plurality of inserts (elements 192), each insert (192) at least partially defining a fastener aperture (see figures 6A-7 below) sized and dimensioned for (i.e. capable of) receiving a fastener (170), wherein each insert (elements 192) is coupled to the spacer (140+210) such that at least a portion of each insert (192) is received in a cutout of the plurality of cutouts (see figures 6A-7 below) in the spacer (140+210), wherein the superior surface (e.g. considered as a top surface, see figures 6A-7 below) and the inferior surface (e.g. considered as a bottom surface, see figures 6A-7 below) have a roughened (234) or porous surface (see figures 6A-7 below).
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Yet, Theofilos lacks wherein the proximal end includes a cam-style blocking mechanism that prevents backout of the fastener received in one of the plurality of inserts.
However, Duffield teaches a proximal end (figures 10-12) includes a cam-style blocking mechanism (38) that prevents backout of a fastener (36 or 37) (¶32).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide Theofilos’s implant with wherein the proximal end includes a cam-style blocking mechanism as taught by Duffield, since such a modification would provide additional securement/anti-backout mechanism (¶32).
Regarding claim 2, the modified Theofilos’s implant has wherein the plurality of cutouts are two cutouts (see figures 6A-7 above) and the plurality of inserts (elements 192) are two inserts (see figures 6A-7 above).
Regarding claim 3, the modified Theofilos’s implant has wherein the spacer (140+210 of Theofilos) is formed of a first material (¶56 of Theofilos) and the insert (!92 of Theofilos) is formed of a second material (¶56, ¶66 of Theofilos) different from the first material (¶56 of Theofilos).
Regarding claim 6, the modified Theofilos’s implant has wherein at least one cutout of the plurality of cutouts (see figures 6A-7 of Theofilos above) is in fluid communication with the opening (see figure 6A of Theofilos above) and extends from the superior surface (e.g. considered as a top surface, see figures 6A-7 of Theofilos above) towards the inferior surface (e.g. considered as a bottom surface, see figures 6A-7 of Theofilos above) of the spacer (140+210 of Theofilos).
Regarding claim 7, the modified Theofilos’s implant has wherein at least one cutout of the plurality of cutouts (see figures 6A-7 of Theofilos above) is in fluid communication with the opening (see figure 6A of Theofilos above) and extends from the inferior surface (e.g. considered as a bottom surface, see figures 6A-7 of Theofilos above) towards the superior surface (e.g. considered as a top surface, see figures 6A-7 of Theofilos above) of the spacer (140+210 of Theofilos).
Regarding claim 8, the modified Theofilos’s implant has wherein at least one cutout of the plurality of cutouts (see figures 6A-7 of Theofilos above) extends from a proximal edge of the proximal end of the spacer to the opening (see figures 6A-7 of Theofilos above).
Regarding claim 9, the modified Theofilos’s implant has wherein each insert of the plurality of inserts (elements 192 of Theofilos) is configured to (i.e. capable of) secure to a corresponding cutout of the spacer with a press-fit or friction-fit engagement (¶66 of Theofilos).
Regarding claim 10, the modified Theofilos’s implant has wherein a depth of an insert of the plurality of inserts (elements 192 of Theofilos) is less than a depth of the proximal end of the spacer (see figures 6A-7 of Theofilos above) such that the insert (192 of Theofilos) does not extend completely through the cutout when secured in the cutout (see figures 6A-7 of Theofilos above).
Regarding claim 11, the modified Theofilos’s implant has wherein the plurality of cutouts (see figures 6A-7 of Theofilos above) are in fluid communication with the opening (see figure 6A of Theofilos above).
Regarding claim 12, the modified Theofilos’s implant has wherein the superior surface (e.g. considered as a top surface, see figures 6A-7 of Theofilos above) and the inferior surface (e.g. considered as a bottom surface, see figures 6A-7 of Theofilos above) contain projections (234 of Theofilos) to engage the adjacent vertebrae (¶69 of Theofilos).
Regarding claim 13, the modified Theofilos’s implant has wherein the cam-style blocking mechanism (38 of Duffield) is configured to (i.e. capable of) block a head of a fastener (170 of Theofilos) in a first position (figure 10 of Duffield) and unblock the head of the fastener (170 of Theofilos) in a second position (figure 11 of Duffield).
Regarding claim 15, the modified Theofilos’s implant has wherein the fastener comprises a bone screw (170 of Theofilos).
Claim(s) 4 and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Theofilos and Duffield as applied to claim 1 above, and further in view of Anderson et al. (US 2009/0326580), herein referred to as Anderson.
Regarding claim 4, the modified Theofilos’s implant discloses all the features/elements as claimed but lacks wherein each insert of the plurality of inserts comprises a ring comprising a plurality of slits, wherein each slit of the plurality of slits is longitudinally positioned around a periphery of the ring.
However, Anderson teaches an insert (26) (figure 8) comprises a ring (figure 8) comprising a plurality of slits (elements 54) (¶103 and figures 8-10), wherein each slit of the plurality of slits (elements 54) is longitudinally positioned around a periphery of the ring (figures 8-10).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the modified Theofilos’s implant having a plurality of inserts with a ring comprising a plurality of slits, wherein each slit of the plurality of slits is longitudinally positioned around a periphery of the ring as taught by Anderson, since such a modification is a mere substitution of one known locking element for another to yield predictable results.
Regarding claim 5, the modified Theofilos’s implant discloses all the features/elements as claimed but lacks wherein each insert of the plurality of inserts comprises a partial ring comprising a plurality of slits, wherein each slit of the plurality of slits is longitudinally positioned around a periphery of the partial ring.
However, Anderson teaches an insert (26) (figure 8) comprises a partial ring (figure 8) comprising a plurality of slits (elements 54) (¶103 and figures 8-10), wherein each slit of the plurality of slits (elements 54) is longitudinally positioned around a periphery of the partial ring (figures 8-10).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the modified Theofilos’s implant having a plurality of inserts with a partial ring comprising a plurality of slits, wherein each slit of the plurality of slits is longitudinally positioned around a periphery of the partial ring as taught by Anderson, since such a modification is a mere substitution of one known locking element for another to yield predictable results.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Theofilos and Duffield as applied to claim 1 above, and further in view of Kotlus (US 2013/0238096).
Regarding claim 14, the modified Theofilos’s implant discloses all the features/elements as claimed but lacks a detailed description on wherein the spacer is manufactured using a 3D printer.
However, Kotlus teaches an implant fabricated by a 3D printer (¶33), thus creating a custom implant for the patient (¶38).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the modified Theofilos’s implant to be fabricated by a 3D printer as taught by Kotlus, since such a modification would create a custom implant for the patient.
Response to Arguments
Applicant's arguments filed March 2, 2026 have been fully considered but they are not persuasive.
Applicant’s arguments on page 4, under 35 U.S.C. 103, of the Remarks are directed to amended claim 1 and the reference Duffield. Thus, the Examiner has relied upon the reference Theofilos to teach applicant’s amended features, see Office Action above.
Conclusion
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/SI MING KU/Primary Examiner, Art Unit 3775