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 Objections
Claim(s) 8-14 is/are objected to because of the following informalities:
Line 13 is missing a comma following “tulip head” in order to have proper punctuation.
Line 17 is missing a semi-colon following “split ring” in order to have proper punctuation.
Appropriate correction is required.
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) 15-17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Doubler et al. (U.S. Patent 10,258,385 B1, hereinafter “Doubler”).
Doubler discloses, regarding claim 15, a method of installing an orthopedic fixation device (see Fig. 26), the method comprising: providing an implant (see Fig. 26) including a tulip head (28) having two arms (see annotated Fig. 26 below) defining a rod slot therebetween (e.g. u-shaped slot that receives rod 70, see also annotated Fig. 26 below), and a saddle (82), a bearing washer (40a), a breakable shear clip (40b), and a support clip (40) housed in the tulip head (see Fig. 26); and inserting a bone fastener (12) having a head (18) into a bottom of the tulip head (see Fig. 17) such that (a) the head pushes the shear clip upward until the shear clip tops out on the bearing washer (see Fig. 17, note that the shear clip 40b moves upward from ring groove 40b), (b) when enough upward pressure is placed on the shear clip, the shear clip fractures, allowing the shear clip to radially expand and accept the head (see lines 25-47 of column 12), and (c) as the head continues to travel upwardly into contact with the saddle (see Fig. 21), the shear clip collapses around the head, thereby securing of the bone fastener (see Figs. 22-23, note inward forces from 40a collapse shear clip 40b).
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Regarding claim 16, wherein the bone fastener is inserted into the tulip head intra-operatively (see lines 4-10 of column 14, note bone anchor is fixed to bone then tulip is inserted onto it, e.g. intra-operatively).
Regarding claim 17, further comprising positioning a rod (70) between the two
arms and into the rod slot of the tulip head (see Fig. 1).
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) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Doubler, as applied to claim 15 above, and in view of Hammill, SR. et al. (U.S. Pub. No. 2010/0125302 A1, hereinafter “Hammill”).
Doubler discloses all of the features of the claimed invention, as previously set forth above. Doubler further discloses, regarding claim 18, further comprising threading a locking cap (80) downwardly between the two arms of the tulip head (see Fig. 26), wherein the rod presses against the saddle (see lines 20-40 of column 16, see also Fig. 26), and the saddle presses against the head of the bone fastener (see lines 20-40 of column 16, see also Fig. 26), thereby securing the rod and bone fastener (see lines 20-40 of column 16, see also Fig. 26). Doubler fails to disclose, regarding claim 18, wherein the rod presses against a rod seat of the saddle.
Hammill discloses an orthopedic fixation assembly (see Fig. 4), with a saddle (42), wherein the upper surface of the saddle defines a rod seat (53), wherein the rod (70) is pressed against the rod seat (see para. [0101]) in order to provide additional surface area for contact with the connecting rod and enhance gripping between the rod and the connector assembly (see para. [0100]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the method in Doubler to include pressing the rod against the rod seat of the saddle in view of Hammill in order to provide additional surface area for contact with the connection rod and enhance gripping between the rod and the connector assembly.
Allowable Subject Matter
Claim(s) 1-14 is /are allowed.
The following is a statement of reasons for the indication of allowable subject matter: The claims in the instant application have not been rejected using prior art because no references, or reasonable combination thereof could be found which disclose, or suggest:
A method of installing an orthopedic fixation assembly, comprising:
providing an orthopedic fixation assembly having: a saddle receivable in the bore of the tulip head; a bearing washer positionable below the saddle; a shear clip positionable over the bearing washer; and a support clip configured to retain the shear clip in the tulip head, wherein the shear clip is breakable at a fracture site upon application of a force; and as per claim 1, wherein the bearing washer is configured to center the shear clip within the tulip head to limit translation.
Doubler et al. (U.S. Patent 10,258,385 B1, hereinafter “Doubler”) discloses an orthopedic fixation device (see Fig. 26), including a saddle (82), a bearing washer (40a), a breakable shear clip (40b), and a support clip (40) housed in the tulip head (see Fig. 26); however fails to disclose, regarding claim 1, wherein the bearing washer is configured to center the shear clip within the tulip head to limit translation.
A method of installing an orthopedic fixation assembly, comprising: providing an orthopedic fixation assembly comprising: a tulip head; a breakable shear clip positioned in the bore of the tulip head, wherein the breakable shear clip has an initial solid form, and when the bone fastener is loaded into the tulip head, the shear clip breaks forming a split ring that expands radially outward to accept the screw head, and then the shear clip collapses around the screw head, thereby securing the bone fastener to the tulip head wherein a bearing washer housed in an internal groove in the tulip head; and as per claim 8, wherein the bearing washer including a split ring with a radial neck protruding outward from the split ring and a plurality of slits defined through the top of the neck downward into the split ring.
Doubler et al. (U.S. Patent 10,258,385 B1, hereinafter “Doubler”) discloses an orthopedic fixation device (see Fig. 26), including a saddle (82), a bearing washer (40a), a breakable shear clip (40b), and a support clip (40) housed in the tulip head (see Fig. 26); however fails to disclose, regarding claim 8, wherein the bearing washer including a split ring with a radial neck protruding outward from the split ring and a plurality of slits defined through the top of the neck downward into the split ring.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892.
The following references disclose bone anchor assemblies with retaining rings, however fail to disclose, a bearing washer positionable below the saddle; a shear clip positionable over the bearing washer; and a support clip configured to retain the shear clip in the tulip head, wherein the shear clip is breakable at a fracture site upon application of a force; and as per claim 1, wherein the bearing washer is configured to center the shear clip within the tulip head to limit translation; and a breakable shear clip positioned in the bore of the tulip head, wherein the breakable shear clip has an initial solid form, and when the bone fastener is loaded into the tulip head, the shear clip breaks forming a split ring that expands radially outward to accept the screw head, and then the shear clip collapses around the screw head, thereby securing the bone fastener to the tulip head wherein a bearing washer housed in an internal groove in the tulip head; and as per claim 8, wherein the bearing washer including a split ring with a radial neck protruding outward from the split ring and a plurality of slits defined through the top of the neck downward into the split ring.
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/M.C.G/ Examiner, Art Unit 3773 /EDUARDO C ROBERT/ Supervisory Patent Examiner, Art Unit 3773