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 Arguments
Applicant’s arguments with respect to claim(s) 1 - 20 have been considered but are moot because the new ground of rejection does not rely on any combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 112
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.
Claims 12 – 13 and 17 are 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.
Claim 12 recites “a compression force”. However, claim 12 is dependent upon claim 9 which recites “a distraction force”. It is unclear how the method can have both a distraction and a compression force.
Claim 17 positively recites the bone augment material. However, claim 17 is dependent from claim 16 which only functionally recites the bone augment material. It is unclear if the bone augment material is intended to be part of the claimed invention. For purposes of examination, claim 17 is assumed to positively recited the material and will be read as “The method of claim 16, further comprising the bone augment material which comprises at least one of….”.
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) 9, 10 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Errico et al. (US 2007/0123985 A1) over in view of McDevitt (US 2010/0036498 A1).
Regarding claim 9, Errico discloses a method of implanting an intervertebral implant within an intervertebral space between a superior vertebral body and an inferior vertebral body (Abstract), the method comprising:
preparing the intervertebral space to receive the intervertebral implant therein, comprising:
placing a first bone pin in the superior vertebral body (paragraph [0018]);
placing a second bone pin in the inferior vertebral body (paragraph [0018]); and
applying a distraction force between the first bone pin and the second bone pin to distract the superior vertebral body and the inferior vertebral body away from each other to access the intervertebral space (paragraph [0018]);
placing a distal end of an intervertebral implant adjacent the intervertebral space (paragraph [0021]).
Errico is silent that the implant has a shaft and associated implant steps of engaging a concave undercut surface of a helical thread disposed about the shaft with at least one of the superior vertebral body and the inferior vertebral body; and
rotating the intervertebral implant in a first rotational direction to insert the intervertebral implant within the intervertebral space;
wherein, when the intervertebral implant is implanted within the intervertebral space, the concave undercut surface is shaped to resist at least one force transmitted between the superior vertebral body and the inferior vertebral body to stabilize the intervertebral space.
McDevitt teaches an analogous method of implanting an intervertebral implant (Abstract) comprising the steps of;
placing a distal end of a shaft of the intervertebral implant adjacent the intervertebral space (paragraph [0054, 65], ref. 10, Fig. 1);
engaging a concave undercut surface of a helical thread disposed about the shaft with at least one of the superior vertebral body and the inferior vertebral body (paragraph [0057] discloses that threads ref. 35 of the implant have an undercut profile in leading and trailing surfaces ref. 50, 55, see Fig. 2); and
rotating the intervertebral implant in a first rotational direction to insert the intervertebral implant within the intervertebral space (paragraph [0065]);
wherein, when the intervertebral implant is implanted within the intervertebral space, the concave undercut surface is shaped to resist at least one force transmitted between the superior vertebral body and the inferior vertebral body to stabilize the intervertebral space (paragraph [0015] discloses that the undercut threading holds the adjacent vertebral bodies in position when subjected to forces, thus resisting the forces to hold the position). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to substitute the implant of Errico with the threaded rotatable implant as taught by McDevitt such that the method comprises the steps of rotating the intervertebral implant in a first rotational direction to insert the intervertebral implant within the intervertebral space;
wherein, when the intervertebral implant is implanted within the intervertebral space, the concave undercut surface is shaped to resist at least one force transmitted between the superior vertebral body and the inferior vertebral body to stabilize the intervertebral space for the purpose of provide better stabilization to the space (McDevitt, paragraph [0010]).
Regarding claim 10, Errico in view of McDevitt discloses the method of claim 9, wherein preparing the intervertebral space to receive the intervertebral implant therein further comprises:
removing at least a portion of an intervertebral disc intermediate the superior vertebral body and the inferior vertebral body to prepare the intervertebral space to receive the intervertebral implant therein (Errico, paragraph [0033] discloses a discectomy).
Regarding claim 14, Errico in view of McDevitt discloses the method of claim 9, wherein preparing the intervertebral space to receive the intervertebral implant therein further comprises:
forming at least one tapped bone thread in at least one of:
a superior vertebral endplate of the superior vertebral body; and
an inferior vertebral endplate of the inferior vertebral body (McDevitt, paragraph [0064] discloses forming, via tapping, dovetail thread seats ref. 90 into the vertebral bodies, see Fig. 5).
Claim(s) 15 - 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over McDevitt (US 2010/0036498 A1) in view of Frey et al. (US 2020/0397491 A1).
Regarding claim 15, McDevitt discloses a method of implanting an intervertebral implant within an intervertebral space between a superior vertebral body and an inferior vertebral body (Abstract, Fig. 3), the method comprising:
placing a distal end of a shaft of the intervertebral implant (paragraph [0054], ref. 10, Fig. 1) adjacent the intervertebral space (paragraph [0065]);
engaging a concave undercut surface of a helical thread disposed about the shaft with at least one of the superior vertebral body and the inferior vertebral body (paragraph [0057] discloses that threads ref. 35 of the implant have an undercut profile in leading and trailing surfaces ref. 50, 55, see Fig. 2); and
rotating the intervertebral implant in a first rotational direction to insert the intervertebral implant within the intervertebral space (paragraph [0065]);
wherein, when the intervertebral implant is implanted within the intervertebral space, the concave undercut surface is shaped to resist at least one force transmitted between the superior vertebral body and the inferior vertebral body to stabilize the intervertebral space (paragraph [0015] discloses that the undercut threading holds the adjacent vertebral bodies in position when subjected to forces, thus resisting the forces to hold the position).
McDevitt is silent that the intervertebral implant comprises a plurality of passages formed in the shaft of the intervertebral implant that are positioned adjacent to each other in between the helical thread, wherein the plurality of passages do not overlap the helical thread that is disposed about the shaft of the intervertebral implant.
Frey teaches a fixation device in the related field of orthopedic threaded implants (Abstract), the threaded implant (Fig. 1) comprises a plurality of passages formed in the shaft of the intervertebral implant that are positioned adjacent to each other in between the helical thread, wherein the plurality of passages do not overlap the helical thread that is disposed about the shaft of the intervertebral implant (Fig. 2 shows the plurality of passages formed in the shaft being adjacent to each other and do not overlap or interfere with the threading). 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 implant of McDevitt to include the plurality of passages formed in the shaft of the intervertebral implant that are positioned adjacent to each other in between the helical thread, wherein the plurality of passages do not overlap the helical thread that is disposed about the shaft of the intervertebral implant, as taught by Frey, for the purpose of aiding in osteo-integration (paragraph [0006]).
Regarding claim 16, McDevitt in view of Frey discloses the method of claim 15, wherein the plurality of passages are configured to receive a bone augment material therein (the passages are fully capable of receiving a bone augment material (Frey, paragraph [0009, 16]).
Regarding claim 17, McDevitt in view of Frey discloses the method of claim 16, wherein the bone augment material comprises at least one of:
a bone graft material (Frey, paragraph [0016]); and
a bone cement material.
Regarding claim 18, McDevitt in view of Frey discloses the method of claim 15, wherein the plurality of passages are configured to open on opposite sides of the shaft to permit bone growth transverse to a longitudinal axis of the shaft (Frey, Figs. 11 – 13).
Regarding claim 19, McDevitt in view of Frey discloses the method of claim 15, wherein the plurality of passages comprise a plurality of lattice-like structures configured to facilitate bone in-growth within the intervertebral implant (Frey, Fig. 4).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over McDevitt (US 2010/0036498 A1) in view of Frey et al. (US 2020/0397491 A1) and in view of Feng et al. (US 2022/0160410 A1).
Regarding claim 20, McDevitt in view of Frey discloses the method of claim 15, except wherein:
the concave undercut surface is positioned on a first side of the helical thread; and
the helical thread further comprises a convex undercut surface that is positioned on a second side of the helical thread, opposite the concave undercut surface on the first side of the helical thread.
Feng teaches an orthopedic threaded implant (Abstract) comprising a concave undercut surface of a helical thread (Fig. 1D, refs. 111d,113d) on a first side of the helical thread and a convex undercut surface (Fig. 1D, refs. 117d, 119d) that is positioned on a second side of the helical thread, opposite the concave undercut surface on the first side of the helical thread (Fig. 1D). 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 threading of McDevitt such that the concave undercut surface is positioned on a first side of the helical thread; and
the helical thread further comprises a convex undercut surface that is positioned on a second side of the helical thread, opposite the concave undercut surface on the first side of the helical thread, as taught by Feng, for the purpose of reduction in stress concentration (paragraph [0146]).
Allowable Subject Matter
Claims 1 – 8 are allowed.
Claim 11 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892.
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 TESSA M MATTHEWS whose telephone number is (571)272-8817. The examiner can normally be reached M - F 8am - 1pm.
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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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/TESSA M MATTHEWS/Examiner, Art Unit 3773
