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 .
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-3, 5-8, 11-13, 15-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by van der Pol (U.S. Pub. No. 2016/0361096 A1, hereinafter “van der Pol”).
van der Pol discloses, regarding claim 1, a method of pre-assembling an orthopedic fixation assembly (see Fig. 4a-e) comprising: providing a tulip head (20) having two arms (see annotated Fig. 2 below) defining a rod slot therebetween (see annotated Fig. 2 below), the tulip head having a bore (22) extending therethrough (see Fig. 2); providing a bone fastener (10, see Fig. 7) including a screw head (12) receivable in the tulip head (see para. [0078]) and a shaft (14) configured for engaging bone (see para. [0082]); placing the screw head in the bore (see para. [0071]); placing into the tulip head a saddle (31b) having an upper surface (e.g. upper surface of 30, see Fig. 3) defining a rod seat (39) in a first position with the rod seat offset relative to the rod slot (see Figs. 4a-b, see paras. [0074]-[0075]); rotating the placed saddle into a second position with the rod seat aligned with the rod slot (see Figs. 4c-d, see paras. [0076]-[0077]) in order to lock the saddle to the tulip head so as to allow a rod to be positioned through the rod slot and over the rod seat (see para. [0078]).
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Regarding claim 2, wherein rotating includes rotating the saddle by 90° about a central longitudinal axis (“L”) of the tulip head from the first position to the second position (see Figs. 4a-d, see paras. [0074]-[0077], see also para. [0071] and Figs. 1a-b, note that the channel of the tulip is rotated 90° from the arms of the tulip).
Regarding claim 3, wherein an outer surface (e.g. outer surface of 37) of the saddle and the groove are elliptically shaped (see Figs. 2-3, note outer surface of saddle is elongated via 37 and the inner surface tulip is elongated via 24 transverse to “L” to form an elliptical shape), thereby preventing the saddle from rotating out of alignment (see para. [0077] “rotationally fixed”).
Regarding claim 5, wherein the saddle includes a pair of wings (37) extending outwardly from opposite sides of the saddle (see Fig. 3), wherein rotating includes rotating the placed saddle such that the wings are received in an internal groove (24a, see Fig. 2) in the tulip head (see para. [0077]).
Regarding claim 6, wherein the bore of the tulip head defines an internal taper (see annotated Fig. 2 above), wherein the screw head is prevented from disengaging from the tulip head by the internal taper (via DImin and 32, see Fig. 8, see also paras. [0030]-[0031]).
Regarding claim 7, wherein the rotating includes rotating the placed saddle such that a clamp (31a) coupled to the saddle clamps the placed screw head to lock the screw head to the tulip head (see paras. [0078], see also para. [0082], “screw head 12 to be inseparably connected to receiving region 32 of saddle 30 when saddle 30 is in locked position 23b”).
Regarding claim 8, wherein placing the screw head in the bore includes placing the screw head such that a retainer ring (32) received in a groove (see annotated Fig. 2 above) of the bore applies pressure against the screw head to retain the screw head in the tulip head (see para. [0078]).
van der Pol discloses, regarding claim 11, a method of pre-assembling an orthopedic fixation assembly (see Fig. 4a-e) comprising: providing a tulip head (20) having a central longitudinal axis (“L”), a tulip base (see annotated Fig. 2 above) and two arms (see annotated Fig. 2 above) extending upwardly from the tulip base and defining a rod slot therebetween (see annotated Fig. 2 above), the tulip base having a bore (22) extending therethrough about the vertical longitudinal axis (see Fig. 2); providing a polyaxial bone fastener (10, see Fig. 7) including a spherical screw head (12) receivable in the tulip head (see para. [0078]) and a shaft (14) configured for engaging bone (see para. [0082]); placing the spherical screw head in the bore (see para. [0071]); placing downwardly into the tulip head a saddle (31b) having an upper surface (e.g. upper surface of 30, see Fig. 3) defining a rod seat (39) in a first position with the rod seat offset relative to the rod slot (see Figs. 4a-b, see paras. [0074]-[0075]); rotating the placed saddle into a second position about the central longitudinal axis with the rod seat aligned with the rod slot (see Figs. 4c-d, see paras. [0076]-[0077]) in order to lock the saddle to the tulip head so as to allow a rod to be positioned through the rod slot and over the rod seat (see para. [0078]).
Regarding claim 12, wherein rotating includes rotating the saddle by 90° about a central longitudinal axis (“L”) of the tulip head from the first position to the second position (see Figs. 4a-d, see paras. [0074]-[0077], see also para. [0071] and Figs. 1a-b, note that the channel of the tulip is rotated 90° from the arms of the tulip).
Regarding claim 13, wherein an outer surface (e.g. outer surface of 37) of the saddle and the groove are elliptically shaped (see Figs. 2-3, note outer surface of saddle is elongated via 37 and the inner surface tulip is elongated via 24 transverse to “L” to form an elliptical shape), thereby preventing the saddle from rotating out of alignment (see para. [0077] “rotationally fixed”).
Regarding claim 15, wherein the saddle includes a pair of wings (37) extending outwardly from opposite sides of the saddle (see Fig. 3), wherein rotating includes rotating the placed saddle such that the wings are received in an internal groove (24a, see Fig. 2) in the tulip head (see para. [0077]).
Regarding claim 16, wherein the bore of the tulip head defines an internal taper (see annotated Fig. 2 above), wherein the screw head is prevented from disengaging from the tulip head by the internal taper (via DImin and 32, see Fig. 8, see also paras. [0030]-[0031]).
Regarding claim 17, wherein the rotating includes rotating the placed saddle such that a clamp (32) coupled to the saddle clamps the placed screw head to lock the screw head to the tulip head (see paras. [0078], see also para. [0082], “screw head 12 to be inseparably connected to receiving region 32 of saddle 30 when saddle 30 is in locked position 23b”).
Regarding claim 18, wherein placing the screw head in the bore includes placing the screw head such that a retainer ring (32) received in a groove of the bore see annotated Fig. 2 above) applies pressure against the screw head to retain the screw head in the tulip head (see para. [0078]).
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.
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.
Claim(s) 4 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over van der Pol, as applied to claims 1 and 11 above, and in view of May (U.S. Pub. No. 2018/0193062 A1, hereinafter “May”).
van der Pol discloses all of the features of the claimed invention, as previously set forth above. van der Pol further discloses, regarding claims 4 and 14, wherein the saddle includes a through bore (see annotated Fig. 5 above). van der Pol fails to disclose, regarding claims 4 and 14, and a pair of engagement recesses in the upper surface of the saddle on opposite sides of the through bore, wherein rotating includes: engaging the engagement recesses with an assembly tool; and rotating the engaged assembly tool to facilitate rotation of the saddle.
May discloses an orthopedic fixation device / method (see Fig. 3) with a tulip head (14) and a saddle (44), wherein the saddle includes a pair of engagement recesses in the upper surface (76, see Fig. 3) on opposite side of the through bore (see Fig. 4), wherein rotating includes engaging the engagement recesses with an assembly tool (see para. [0037]), and rotating the engaged assembly tool facilitates rotation of the saddle (see para. [0037]) in order to enable a mating engagement with a surgical instrument such as a driver to facilitate rotation of the saddle (see para. [0037]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the saddle in van der Pol to include a pair of engagement recesses in the upper surface on opposite side of the through bore, wherein rotating includes engaging the engagement recesses with an assembly tool, and rotating the engaged assembly tool facilitates rotation of the saddle in view of May in order to enable a mating engagement with a surgical instrument such as a driver to facilitate rotation of the saddle.
Claim(s) 9-10 and 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over van der Pol, as applied to claims 1 and 11 above, and in view of Biedermann et al. (U.S. Pub. No. 2013/0338721 A1, hereinafter “Biedermann”).
van der Pol discloses all of the features of the claimed invention, as previously set forth above except, regarding claims 9 and 19, wherein the retainer ring is a clip; and regarding claims 10 and 20, wherein the retainer ring is a split ring.
Biedermann discloses an orthopedic fixation device / method (see Fig. 1) with a tulip head (5) and a saddle (61) and a retaining ring (66), wherein the retainer ring is a clip (71); and wherein the retainer ring is a split ring (71, see para. [0047]) in order to create a ring-shaped portion extending from the bottom of the head receiving portion (see para. [0046]) that enables the retaining ring to elastically expand and contract for receiving and locking around the head of the bone anchor (see paras. [0054]-[0055]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify retaining ring in van der Pol to be a clip / a split ring in view of Biedermann in order to create a ring-shaped portion extending from the bottom of the head receiving portion that enables the retaining ring to elastically expand and contract for receiving and locking around the head of the bone anchor.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michelle C. Green whose telephone number is (571)270-7051. The examiner can normally be reached on Monday-Friday between 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Eduardo C. Robert, 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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/M.C.G/ Examiner, Art Unit 3773 /EDUARDO C ROBERT/ Supervisory Patent Examiner, Art Unit 3773
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