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 .
Drawings
The drawings were received on August 3, 2026. These drawings have been entered.
Claim Objections
Claim 21 is objected to because of the following informalities: the limitation “wherein the second surface of the body part has the rounded edge” is redundant as claim 1 has been amended to recite “wherein the intervertebral insert has a rounded edge at the second surface” (line 1 of the last paragraph). Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 11-14 and 21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 11 has been amended to recite “a plurality of bone graft transfer holes.” Such a recitation constitutes new matter. The phrase “a plurality” can include more than two. However, there is no indication in the specification or drawings that there are more than two bone graft transfer holes 40. Accordingly, claim 11 contains new matter. Claims 12-14 and 21 depend from claim 11 and therefore also contain new matter.
Claims 11-14 and 21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 11 has been amended to recite “each of the plurality of bone graft transfer holes being configured to intersect and communicate with the plurality of bone graft filling holes to form interconnected bone-graft passages within the body part.” Such a recitation constitutes new matter. There is no indication in the specification or drawings that bone graft transfer holes 40 communicate with each other, and thus each bone graft transfer hole 40 only appears to communicate with two bone graft filling holes 30 as shown in the figures, not the plurality of bone graft filling holes as claimed. Accordingly, claim 11 contains new matter. Claims 12-14 and 21 depend from claim 11 and therefore also contain new matter.
Claim 12 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 12 has been amended to recite “wherein the rounded edge has a gradual slope without a discontinuity between the insertion part and the body part.” Such a recitation constitutes new matter. The specification fails to disclose that the rounded edge does not have a discontinuity. Furthermore, such is not readily apparent in the figures due to the limited views the rounded edge 60. Accordingly, claim 12 contains new matter.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 14 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Due to the amendments to claim 1, it is clear that (a) the first and second surfaces are the surfaces having bone graft filling holes 30, which are side surfaces of the insert, and (b) the third and fourth surfaces are the surfaces having bone graft transfer holes 40, which are top and bottom surfaces of the insert and configured to be in contact with the vertebral bodies when inserted into the intervertebral disc space. The specification refers to “height” as the distance between the top and bottom surfaces of the insert (see para. 0058), which is consistent with the commonly-accepted meaning of “height” and thus would refer to the distance between the third and fourth surfaces. However, “height direction” as used in claim 14 is inconsistent with such as it would need to refer to the distance between the first and second surfaces because fixing grooves 52 are spaced from coupling hole 51 between the first and second surfaces, not the third and fourth surfaces (see Figs. 1, 4, and 7). In order to overcome this rejection, the Examiner suggests amending claim 14 to recite “wherein one of the pair of fixing grooves is defined at a predetermined distance from the coupling hole along a first direction defined by a width of the body part, and the other of the pair of fixing grooves is defined at a predetermined distance from the coupling hole along a second direction of the body part, wherein the second direction is opposite the first direction.”
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, 12, 14, and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jones et al. (US 2009/0299479 A1).
Claim 11. Jones discloses an intervertebral insert comprising:
an insertion part (see Fig. 5 inset) configured to be initially inserted into a vertebral interbody and has a shape gradually narrower towards an insertion direction (see Figs. 2-5, which show narrowing at edge 18) to facilitate insertion (see paras. 0024 and 0027);
a body part (see Fig. 5 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 paras. 0024-0025), the body part further having a first surface (back edge 32) and a second surface (front edge 30) facing in opposite directions, and a third surface (top surface 22) and a fourth surface (bottom surface 24) each extending between the first surface and the second surface and facing in opposite directions;
a plurality of bone graft filling holes (openings 34; see para. 0025, which states that back edge 32 can also include openings 34) configured to be penetrated at the first surface and the second surface of the body part to be filled with bone graft material (see paras. 0025 and 0034);
a plurality of bone graft transfer holes (see Fig. 5 inset) configured to be penetrated at the third surface and the fourth surface of the intervertebral insert, and each of the plurality of bone graft transfer holes being configured to intersect and communicate with the plurality of bone graft filling holes to form interconnected bone-graft passages within the body part (see Fig. 2), filling the vertebral interbody with the bone graft material compactly (see paras. 0033-0034); and
a coupling part (see Fig. 5 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 Fig. 8),
wherein the intervertebral insert has a rounded edge (see Fig. 5 inset) at the second surface, the rounded edge extending continuously along the insertion part and the body part, the rounded edge at the second surface having a radius of curvature greater than a radius of curvature of an edge (see Fig. 5 inset) at the first surface (see Fig. 5), and the intervertebral insert is asymmetric between the first surface and the second surface when viewed in a direction facing the third surface (see Fig. 5) (Figs. 1-10; paras. 0020-0035).
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Claim 12. Jones discloses wherein the rounded edge extends from the insertion part to the body part (see Fig. 5), has a predetermined slope to facilitate rotation within the vertebral interbody (note that the arcuate shape of the rounded edge would facilitate rotation if so desired), and is a single continuous edge extending across an entirety of the insertion part and the body part (see Fig. 5), and wherein the rounded edge has a gradual slope without a discontinuity between the insertion part and the body part (see Fig. 5), and the rounded edge is configured to contact an inside of the vertebral interbody first when the intervertebral insert enters the vertebral interbody (note that the insert could be used such that the rounded edge contacts an inside of the vertebral interbody first) (Figs. 1-10; paras. 0020-0035).
Claim 14. Jones discloses wherein the coupling part includes:
a coupling hole (recess 44) defined at a center of a rear end surface (see Fig. 4 inset) of the intervertebral insert, the coupling hole having an internal thread (see para. 0031); and
a pair of fixing grooves (see Fig. 4 inset),
wherein one of the pair of fixing grooves (see Fig. 4 inset) is defined at a predetermined distance from the coupling hole along a first direction (see Fig. 4 inset) defined by a width of the body part, and the other of the pair of fixing grooves (see Fig. 4 inset) is defined at a predetermined distance from the coupling hole along a second direction (see Fig. 4 inset) of the body part, wherein the second direction is opposite the first direction,
wherein each of the pair of fixing grooves has a predetermined depth (see Figs. 2-4) (Figs. 1-10; paras. 0020-0035).
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Claim 21. Jones discloses wherein the second surface of the body part has the rounded edge whereas the first surface of the body part is substantially straight (see Fig. 5) (Figs. 1-10; paras. 0020-0035).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 11 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Peterson et al. (US 2011/0208309 A1) in view of Jones et al. (US 2009/0299479 A1).
Claim 11. Peterson discloses an intervertebral insert comprising:
an insertion part (distal end 22) configured to be initially inserted into a vertebral interbody and has a shape gradually narrower towards an insertion direction (see Figs. 1-2, which show narrowing at end 22) to facilitate insertion (see para. 0033);
a body part (portion between distal end 22 and proximal end 20) 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. 0036), the body part further having a first surface (side surface 16) and a second surface (side surface 18) facing in opposite directions, and a third surface (top surface 12) and a fourth surface (bottom surface 14) each extending between the first surface and the second surface and facing in opposite directions;
a plurality of bone graft filling holes (openings 30) configured to be penetrated at the first surface and the second surface of the body part to be filled with bone graft material (see para. 0040);
a plurality of bone graft transfer holes (apertures 26 and 28) configured to be penetrated at the third surface and the fourth surface of the intervertebral insert, and each of the plurality of bone graft transfer holes being configured to intersect and communicate with the plurality of bone graft filling holes to form interconnected bone-graft passages within the body part (see Fig. 1), filling the vertebral interbody with the bone graft material compactly (see paras. 0037-0038); and
a coupling part (proximal end 20) 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 Fig. 9),
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[AltContent: textbox (Rounded Edge)][AltContent: arrow][AltContent: arrow][AltContent: textbox (Edge)]wherein the intervertebral insert has a rounded edge (see Fig. 3 inset) at the second surface, the rounded edge extending continuously along the insertion part and the body part (see Fig. 3), the rounded edge at the second surface having a radius of curvature greater, wherein the intervertebral insert has an edge (see Fig. 3 inset) at the first surface, the edge having a radius of curvature (see Fig. 3) (Figs. 1-9; paras. 0031-0041).
Claim 13. Peterson discloses wherein the body part includes:
a plurality of protrusions (ridges 24) configured to protrude towards vertebral bones from the third surface and the fourth surface of the intervertebral insert, the plurality of protrusions being disposed at regular intervals continuously (see Figs. 1-4),
wherein each of the plurality of protrusions has a first incline (see Fig. 2 inset) at a front side of each of the plurality of protrusions and a second incline (see Fig. 2 inset) 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 the second incline is steeper than the first incline) 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 the first and second inclines functions as recited in the claim) (Figs. 1-9; paras. 0031-0041).
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Peterson fails to disclose wherein the rounded edge at the second surface has a radius of curvature greater than the radius of curvature of the edge at the first surface and wherein the intervertebral insert is asymmetric between the first surface and the second surface when viewed in a direction facing the third surface (claim 11).
Jones teaches an intervertebral insert comprising: an insertion part (see Fig. 5 inset on pg. 8 above); a body part (see Fig. 5 inset on pg. 8 above), the body part further having a first surface (back edge 32) and a second surface (front edge 30) facing in opposite directions, and a third surface (top surface 22) and a fourth surface (bottom surface 24) each extending between the first surface and the second surface and facing in opposite directions; a coupling part (see Fig. 5 inset on pg. 8 above); wherein the intervertebral insert has a rounded edge (see Fig. 5 inset on pg. 8 above) at the second surface, the rounded edge extending continuously along the insertion part and the body part, the rounded edge at the second surface having a radius of curvature greater than a radius of curvature of an edge (see Fig. 5 inset on pg. 8 above) at the first surface (see Fig. 5), and the intervertebral insert is asymmetric between the first surface and the second surface when viewed in a direction facing the third surface (see Fig. 5) (Figs. 1-10; paras. 0020-0035).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the intervertebral insert of Peterson by reducing the curvature of the edge at the first surface such that the rounded edge at the second surface has a radius of curvature greater than the radius of curvature of the edge at the first surface and the intervertebral insert is asymmetric between the first surface and the second surface when viewed in a direction facing the third surface (claim 11), as suggested by Jones, since Applicant has not disclosed that such a shape of the edge of the firs surface solves any stated problem or is anything more than one of numerous shapes or configurations a person of ordinary skill in the art would find obvious for the purpose of providing an edge of an intervertebral insert. In re Dailey and Eilers, 149 USPQ 47 (1966).
Response to Arguments
Applicant’s arguments with respect to claims 11-14 and 21 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.
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 JULIANNA N HARVEY whose telephone number is (571)270-3815. The examiner can normally be reached Mon.-Fri. 8:00am-5:00pm EST.
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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.
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/JULIANNA N HARVEY/Primary Examiner, Art Unit 3773
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