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 § 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) 1 - 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tanaka et al. (US 2016/0331553 A1) in view of Stoffman et al. (US 2014/0207240 A1).
Regarding claim 1, Tanaka discloses a system for delivering a facet screw toa vertebra (Abstract), the system comprising:
a facet device (ref. 200, Fig. 6A) comprising a head (proximal portion) with at least one guide tube engagement feature (see remarked Fig. 6A below) and an elongated shaft (distal portion); and
a guide tube (paragraph [0062], ref. 300, Fig. 7A) comprising a proximal end (end comprising ref. 306), a distal end configured to receive the facet screw (Fig. 7B), and a lumen (ref. 304) comprising a bend (ref. 356) disposed nearer the distal end than the proximal end (paragraph [0013]), wherein the bend in the guide tube is configured to change a trajectory of a screw device advancing through the lumen from a first trajectory along a longitudinal axis of the guide tube to a second trajectory that is angled relative to the longitudinal axis (paragraph [0013]), and wherein the second trajectory is configured to direct the screw device out of the distal end of the guide tube and into the facet device and the vertebra at an angle offset from a longitudinal axis of the facet screw (paragraph [0013)).
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Tanaka is silent that the facet device is a screw, wherein a diameter of the elongated shaft is substantially consistent along a portion of its length and wherein the guide tube engagement feature is a recessed engagement feature.
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 engagement feature to be a recessed opening to receive a prong or protrusion from an engagement tool (300) to better create a low profile proximal surface and since it has been held that a mere reversal of the essential working parts of a device involves only routine skill in the art. In re Einstein, 8 USPQ 167.
Stoffman teaches a spinal fusion device (Fig. 3, ref. 10, paragraph [0031]) wherein the device is a screw (paragraph [0033] discloses a helical threading ref. 50 and Fig. 3 shows a screw-like body, in addition paragraph [0033] discloses a non-tapered cone which would have a consistent diameter along its length) and is configured to receive a screw device (refs. 90, 100). 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 fusion device of Tanaka for the screw of Stoffman, for the purpose of better securing the device between the fusion structures via threading, e.g., vertebrae (paragraph [0033]).
Regarding claim 2, Tanaka in view of Stoffman discloses the system of claim 1, wherein the angle defines a trans-facet direction to fixate a facet joint without joint distraction (note that this is treated as an intended use limitation in which the angle, as shown in Fig. 8D of Tanaka the angle is fully capable of being used in a trans-facet direction as this is dependent upon the angle of use of the system).
Regarding claim 3, Tanaka in view of Stoffman discloses the system of claim 1, further comprising the screw device (Tanaka, refs. 102, 110), wherein the screw device comprises a locking screw (ref. 102) configured to screw into the facet screw and the vertebra (Tanaka, Fig. 8B).
Regarding claim 4, Tanaka in view of Stoffman discloses the system of claim 3, wherein the screw device comprises a shaft, and wherein the locking screw is detachably coupled to the shaft at a breakable junction (Tanaka, Fig. 11A).
Regarding claim 5, Tanaka in view of Stoffman discloses the system of claim 4, wherein the shaft comprises a flexible region that flexes as it advances through the bend (Tanaka, paragraph [0055], ref. 126).
Regarding claim 6, Tanaka in view of Stoffman discloses the system of claim 4, wherein the bend concentrates a bending force in the shaft at the breakable junction to cause the breakable junction to break when the locking screw is screwed into the facet screw and the vertebra a predetermined amount (Tanaka, paragraph [0008, 9, 11-13]).
Regarding claim 7, Tanaka in view of Stoffman discloses the system of claim 1, wherein the facet screw comprises a channel extending at a second angle offset from the longitudinal axis of the facet screw (Tanaka, paragraph [0060], ref. 220, Figs. 5A-D).
Regarding claim 8, Tanaka in view of Stoffman discloses the system of claim 7, wherein the angle and the second angle cause a locking screw to detach from the screw device (Tanaka, paragraph [0064]).
Regarding claim 9, Tanaka discloses a system (Abstract) comprising:
a facet joint implant (ref. 200, Fig. 6A) comprising at least one guide tube engagement feature (see remarked Fig. 6A above) and an elongated shaft (ref. 202), the implant further having a longitudinal axis configured to extend along a facet joint (paragraphs [0005, 8]); and
an implant delivery device (paragraph [0062], ref. 300, Fig. 7A) comprising an inner guide tube (ref. 302) to receive a screw device (ref. 110) advancing therethrough to deliver a locking screw (ref. 102) to a vertebra (paragraph [0005]),
wherein the inner guide tube comprises a bend configured to change a trajectory of the screw device from a first trajectory to a second trajectory that is angled relative to the first trajectory (paragraph [0005]), and
wherein the second trajectory is configured to direct the locking screw into the facet joint implant and the vertebra at an angle offset from the longitudinal axis of the facet joint implant (Fig. 8D).
Tanaka is silent that a diameter of the elongated shaft is substantially consistent along a portion of its length (note that the facet device of Tanaka is a fusion device paragraph [0004]) and wherein the guide tube engagement feature is a recessed engagement feature.
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 engagement feature to be a recessed opening to receive a prong or protrusion from an engagement tool (300) to better create a low profile proximal surface and since it has been held that a mere reversal of the essential working parts of a device involves only routine skill in the art. In re Einstein, 8 USPQ 167.
Stoffman teaches a spinal fusion implant (Fig. 3, ref. 10, paragraph [0031]) wherein the implant comprises an elongated shaft having a diameter that is substantially consistent along a portion of its length (paragraph [0033] discloses a non-tapered cone which would have a consistent diameter along its length) and is configured to receive a screw device (refs. 90, 100). 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 fusion device of Tanaka for the implant of Stoffman, for the purpose of better securing the device between the fusion structures via threading, e.g., vertebrae (paragraph [0033]).
Regarding claim 10, Tanaka in view of Stoffman discloses the system of claim 9, wherein the angle extends transverse to a direction of the facet joint (Tanaka, Fig. 8D).
Regarding claim 11, Tanaka in view of Stoffman discloses the system of claim 9, wherein the implant delivery device comprises a shaft (Tanaka, ref. 302) and a handle (ref. 306), the shaft comprising a lumen (ref. 304) extending therethrough, the inner guide tube extending within the lumen (Fig. 8D).
Regarding claim 12, Tanaka in view of Stoffman discloses the system of claim 11, wherein the inner guide tube comprises:
a proximal portion that extends along a first axis; and
a distal portion that extends along a second axis,
wherein the proximal portion and the distal portion are joined at the bend (see remarked Fig. 8C of Tanaka).
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Regarding claim 13, Tanaka in view of Stoffman discloses the system of claim 12, wherein the bend is disposed nearer the distal end than the proximal end (Tanaka, Fig. 8C).
Regarding claim 14, Tanaka in view of Stoffman discloses the system of claim 9, wherein the first trajectory extends along a longitudinal axis of the inner guide tube (the first trajectory extends along the first axis as shown in Fig. 8C above).
Regarding claim 15, Tanaka in view of Stoffman discloses the system of claim 9, wherein the facet joint implant is a facet screw (Stoffman discloses a threaded implant, thus a screw).
Regarding claim 16, Tanaka discloses a system for delivering a facet screw to a vertebra (Abstract), the system comprising:
a facet device (ref. 200) having a longitudinal axis configured to extend along a facet joint (Fig. 8D), the facet device further comprising at least one guide tube engagement feature (see remarked Fig. 6A above) and an elongated shaft (Fig. 5A-D);
a screw device (ref. 102); and
a guide tube (ref. 300) comprising a lumen (ref. 304) to receive the screw device (Fig. 8A),
wherein the lumen comprises a bend configured to change a trajectory of the screw device from a first trajectory to a second trajectory that is angled relative to the first trajectory (Fig. 8C),
wherein the second trajectory is configured to direct the screw device out of the guide tube and into the facet device and the vertebra at an angle offset from the longitudinal axis of the facet device (Fig. 9B).
Tanaka is silent that the facet device is a screw, wherein a diameter of the elongated shaft is substantially consistent along a portion of its length. Note that the facet device of Tanaka is a fusion device (paragraph [0004]) and wherein the guide tube engagement feature is a recessed engagement feature.
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 engagement feature to be a recessed opening to receive a prong or protrusion from an engagement tool (300) to better create a low profile proximal surface and since it has been held that a mere reversal of the essential working parts of a device involves only routine skill in the art. In re Einstein, 8 USPQ 167.
Stoffman teaches a spinal fusion device (Fig. 3, ref. 10, paragraph [0031]) wherein the device is a screw (paragraph [0033] discloses a helical threading ref. 50 and Fig. 3 shows a screw-like body, in addition paragraph [0033] discloses a non-tapered cone which would have a consistent diameter along its length) and is configured to receive a screw device (refs. 90, 100). 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 fusion device of Tanaka for the screw of Stoffman, for the purpose of better securing the device between the fusion structures via threading, e.g., vertebrae (paragraph [0033]).
Regarding claim 17, Tanaka in view of Stoffman discloses the system of claim 16, wherein the bend is disposed proximate to a distal end of the guide tube to direct the screw device out of the distal end at the angle (Tanaka, Fig. 9A).
Regarding claim 18, Tanaka in view of Stoffman discloses the system of claim 16, wherein the first trajectory extends along a longitudinal axis of the guide tube (see remarked Fig. 8C above of Tanaka).
Regarding claim 19, Tanaka in view of Stoffman discloses the system of claim 16, wherein the angle extends transverse to a direction of the facet joint (Tanaka, Fig. 9B).
Regarding claim 20, Tanaka in view of Stoffman discloses the system of claim 16, wherein the screw device comprises a shaft (ref. 126) and a locking screw (ref. 120) detachably coupled to the shaft at a breakable junction (Tanaka, Fig. 1A).
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 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