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 .
Election/Restrictions
Applicant’s election without traverse of Species A (Figs. 1-9) in the reply filed on April 21, 2026 is acknowledged.
Claims 15-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on April 21, 2026.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "30" (see Fig. 9) and "40" (see Figs. 1, 2, 7, 8A, and 8B) have both been used to designate the bone graft transfer hole. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 12 is objected to because of the following informalities: the word “a” should be “an” in “a intervertebral insertion mechanism” (lines 2-3 of the last paragraph). Appropriate correction is required.
Claim 13 is objected to because of the following informalities: the word “the” should be deleted from “from the both” (line 2). Appropriate correction is required.
Claim 14 is objected to because of the following informalities: a comma should be inserted after “a pair of fixing grooves” (line 5). Appropriate correction is required.
Examiner’s Comment Regarding Claim Terms
The Examiner notes that Applicant appears to be using upper surface, lower surface, and sides (see claims 11 and 13) consistent with the orientation of the insert as shown in Fig. 7 (bone graft filling holes 30 are at upper and lower surfaces; bone graft transfer holes 40 are at both sides; protrusions 21 protrude from both sides), and thus height direction (see claim 14) is also consistent with the orientation of the insert as shown in Fig. 7 (fixing grooves 52 located above and below coupling hole 51). The Examiner notes that this is inconsistent with the use of upper surface, lower surface, and sides as commonly used in the art, wherein bone graft filling holes 30 would be at both sides, bone graft transfer holes 40 and protrusions would be at the upper and lower surfaces, and thus fixing grooves would be positioned in a width direction relative to coupling hole 51.
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.
Claims 11-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Soo et al. (US 2008/0288076 A1).
Claim 11. Soo discloses an intervertebral insert (spacer 100) comprising:
an insertion part (see Fig. 3 inset) configured to be initially inserted into a vertebral interbody and has a shape gradually narrower towards an insertion direction (see Fig. 3 inset) to facilitate insertion (see para. 0037, which states that the insertion part has a blunt nose profile to enhance its atraumatic character);
a body part (see Fig. 3 inset) extending from the insertion part in a direction opposite to the insertion direction, the body part having a height to support and maintain the vertebral interbody (see para. 0035, which refers to surfaces 112a and 112b as vertebral engaging surfaces);
a bone graft filling hole (apertures 170) configured to be penetrated at an upper surface (side surface 162a) and a lower surface (side surface 162b) of the body part to be filled with bone graft material (see para. 0053, which states that apertures 170 may be filled with osteoconductive or osteoinductive material);
a bone graft transfer hole (apertures 172) configured to be penetrated at both sides (top and bottom vertebral engaging surfaces 112a and 112b) of the intervertebral insert, and is configured to communicate with the bone graft filling hole to fill the vertebral interbody with the bone graft material compactly (see para. 0053, which states that apertures 172 may be filled with osteoconductive or osteoinductive material to promote fusion); and
a coupling part (see Fig. 3 inset) extending from the body part in the direction opposite to the insertion direction, the coupling part being configured to be coupled with an intervertebral insertion mechanism used in lumbar interbody fusion (see para. 0056, which states that threaded aperture 176 and depressions 178 engage with an insertion tool) (Figs. 1-12; paras. 0035-0056).
[AltContent: connector]
Claim 12. Soo discloses wherein the intervertebral insert forms a lower edge (see Fig. 3 inset above) extending from the insertion part to the body part, and the lower edge has a predetermined slope to facilitate rotation within the vertebral interbody (note that the arcuate shape of the lower edge would facilitate rotation if so desired) (Figs. 1-12; paras. 0035-0056).
Claim 13. Soo discloses wherein the body part includes:
a plurality of protrusions (protrusions 122) configured to protrude towards vertebral bones from both sides of the intervertebral insert, the plurality of protrusions being disposed at regular intervals continuously (see Fig. 2),
wherein each of the plurality of protrusions has a first incline (second face 128) at a front side of each of the plurality of protrusions and a second incline (first face 126) at a rear side of each of the plurality of protrusions, and
wherein the second incline is more inclined than the first incline (see Fig. 2, which shows that first face 126 has a steeper incline from base 114 to tip 134’ than that of second face 128) to facilitate an entry of the intervertebral insert and prevent a backward movement of the intervertebral insert (it is well-known in the art that such a configuration of first face 126 and second face 128 functions as recited in the claim) (Figs. 1-12; paras. 0035-0056).
Claim 14. Soo discloses wherein the coupling part includes:
a coupling hole (threaded aperture 176) defined at a center of a rear end surface (second end surface 108) of the intervertebral insert, the coupling hole having an internal thread (see para. 0056, which states that threaded aperture 176 is threaded; see also Fig. 1); and
a pair of fixing grooves (depressions 178),
wherein one of the pair of fixing grooves (one of depressions 178) is defined at a predetermined distance above the coupling hole along a height direction (see Fig. 1 inset) of the body part, and the other of the pair of fixing grooves (the other of depressions 178) is defined at a predetermined distance below the coupling hole along the height direction of the body part,
wherein each of the pair of fixing grooves has a predetermined depth (see Fig. 1 inset) (Figs. 1-12; paras. 0035-0056).
[AltContent: arrow]
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Flickinger (US 2014/0156008) discloses an insert (implant 10) comprising an insertion part, a body part, a bone graft filling hole, a bone graft transfer hole, and a coupling part as recited in claim 11 (see Figs. 1-15).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JULIANNA N HARVEY whose telephone number is (571)270-3815. The examiner can normally be reached Mon.-Fri. 8:00am-5:00pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JULIANNA N HARVEY/Primary Examiner, Art Unit 3773
Prosecution Insights