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
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 1-5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yue (US 2016/0220278 A1).
Claim 1. Yue discloses a spinal stabilization assembly for surgical implantation, comprising:
a spinal stabilization rod (rod 830) including
a shaft (see Fig. 12B inset) including a first terminus (see Fig. 12B inset) and a second terminus (see Fig. 12B inset);
a head (ball 835) disposed at the first terminus, the head including a continuously curved contact surface (ball 835 is spherical) extending around an entire circumference of the head orthogonal to the shaft (see Figs. 12B and 18); and
an engagement recess (see Fig. 12B inset) disposed opposite across the head from the first terminus of the shaft in the continuously curved contact surface (Figs. 12B-18; paras. 0056-0058 and 0080-0081).
Claim 2. Yue discloses wherein the head includes a spheroidal conformation (ball 835 is spheroidal) truncated at a juncture between the head and the first terminus (Figs. 18 shows that ball 835 truncates where it is attached to the shaft) (Figs. 12B-18; paras. 0056-0058 and 0080-0081).
Claim 3. Yue discloses wherein the head includes a spherical conformation (ball 835 is spherical) truncated at a juncture between the head and the first terminus (Figs. 18 shows that ball 835 truncates where it is attached to the shaft) (Figs. 12B-18; paras. 0056-0058 and 0080-0081).
Claim 4. Yue discloses wherein the engagement recess is disposed to mate with a retention projection of an inserter tool (the engagement recess is capable of mating with a retention projection of an inserter tool if so desired), and wherein the head includes a surface (curved surface of ball 835) disposed to contact a locking projection of the inserter tool (the curved surface of ball 835 is capable of contacting a locking projection of an inserter tool if so desired) (Figs. 12B-18; paras. 0056-0058 and 0080-0081).
Claim 5. Yue discloses wherein the second terminus includes a tapered conformation (see Fig. 18, which shows that the shaft tapers inward at tip 831) (Figs. 12B-18; paras. 0056-0058 and 0080-0081).
[AltContent: textbox (Shaft)][AltContent: textbox (First Terminus)][AltContent: textbox (Second Terminus)][AltContent: textbox (Engagement Recess)]
Claim 8 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Altarac et al. (US 2007/0239159 A1).
Claim 8. Altarac discloses a spinal stabilization system for surgical implantation, comprising:
a fixation screw assembly having a seat (coupler 529) includes at least one concave curved surface (surface of coupler 529 in contact with ball end 541 as shown in Fig. 25);
a spinal stabilization rod (rod 540) including
a shaft (see Fig. 25 inset) including a first terminus (see Fig. 25 inset) and a second terminus (see Fig. 25 inset);
a head (ball end 541) disposed at the first terminus, the head including a continuously curved contact surface (see Fig. 25 inset) extending around an entire circumference of the head orthogonal to the shaft (see Fig. 25); and
an engagement recess (see Fig. 25 inset) disposed opposite across the head from the first terminus of the shaft in the continuously curved contact surface; and
a rod inserter tool (introducer assembly 1186 and guidewire – see para. 0204), including:
an elongate body (adjacent reference character 1186 as shown in Fig. 70);
a handle (collar 1188) at a first end of the elongate body; and
an engagement projection (guidewire – see para. 0204) at the second end of the elongate body;
wherein:
the engagement projection is shaped and disposed to mate with the engagement recess of the spinal stabilization rod (see para. 0204);
the rod inserter tool is adjustable from the handle to disengage from the engagement recess of the rod (see para. 0313); and
the at least one concave curved surface is complementary to the continuously curved contact surface of the head (see Fig. 25) to receive, retain, and permit rotational articulation of the head in the seat (see para. 0205) (Figs. 23-25 and 70; paras. 0204-0210 and 0313).
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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 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Yue (US 2016/0220278 A1) in view of Moore et al. (US 2010/0114179 A1).
Claim 6. Yue discloses at least one fixation screw assembly selected from a monoaxial screw assembly and pivoting screw assembly (see Figs. 12B and 18)
the monoaxial fixation screw assembly comprising
a monoaxial fixation screw having a shank that extends from a receiver body, the receiver body and shank being fixedly engageable with one another along a shared central axis, the shank having threads to engage bone and the receiver body having opposing sidewalls, forming a generally U-shaped aperture, threads on at least a portion of an interior side of the sidewall, and a seat for receiving the stabilization rod head, the seat including at least one spherical surface;
a pair of elongate opposing slats extending from the receiver body defining a central passaging having a first end that opens into the central passage, and a second end releasably engageable with the receiver body of the monoaxial fixation screw;
the pivoting screw assembly comprising
a fixation screw (shaft part 801), including:
a threaded shank (threaded shank 805), and a head (head 806) having a concave curved cradle (see Fig. 12B inset) that is shaped and disposed to receive and support a cylindrical stabilization rod, and a tapered surface (rounded lower surface 804) that is adjacent to the threaded shank, the tapered surface including a linear taper, a curved taper (see Fig. 12B), or a combination thereof;
a receiver body (tulip 811) adapted for engagement with the fixation screw having an aperture (slot 816) having a generally U-shaped conformation (see Figs. 14 and 18), and including
a base (see Fig. 12B inset) that includes a curved exterior surface (see Fig. 12B inset), an interior surface having a through slot (see Fig. 12B inset) for receiving the shank and a seat (surface in contact with rounded lower surface 804 as shown in Fig. 12B) with a curved surface for contacting the tapered surface of the fixation screw (see Fig. 12B); and
opposing sidewalls (see Fig. 12B inset) extending from the base, the opposing sidewalls including interior and exterior surfaces, and including on the interior surfaces opposing flats (see Fig. 14 inset; only one flat labeled in Fig. 14, but the opposite side of slot 816 also has a flat) adjacent to the base and a threaded portion (threaded part 815) proximal to the flats; and
wherein the base and the opposing sidewalls are shaped and disposed to receive the spinal stabilization rod in contact with the cradle of the screw head inserted in the through slot (see Fig. 12B), and wherein the curved exterior surface of the base and the curved surface of the seat of the base include an essentially common curvature (see Fig. 12B);
wherein the stabilization rod is sized for insertion through the central passage of the selected fixation screw assembly and through the generally U-shaped aperture for engagement of the stabilization rod head within the receiver body (see Figs. 13 and 14) (Figs. 12B-18; paras. 0056-0058 and 0080-0081). Note that claim 6 only requires at least one of a monoaxial screw assembly and a pivoting screw assembly and thus Yue need not disclose a monoaxial screw assembly.
Claim 7. Yue discloses a generally cylindrical compression component (locking cap 820) configured to engage a portion of the receiver body and be complimentarily received therein, the compression component configured to compress at least one of the head and the shaft of the stabilization rod into the receiver body to lock the position of the stabilization rod relative to the selected fixation screw assembly (see Fig. 16B) (Figs. 12B-18; paras. 0056-0058 and 0080-0081).
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Yue fails to disclose that the pivoting screw assembly includes a pair of elongate opposing slats extending from the receiver body defining a central passage, the pair of elongate opposing slats further defining an opening at a first end of the pair of elongate opposing slats that opens into the central passage, and the pair of elongate opposing slats having a second end releasably engageable with the receiver body (claim 6) and at least one handle grip adapted to be affixed to the pair of elongate opposing slats via insertion of the pair of elongate opposing slats into opposing engagement slots, the at least one handle grip including a central through hole (claim 7).
Moore teaches a fixation screw assembly comprising: a fixation screw (screw 410 and screw head 420) having a shank (screw 410) and a receiver body (screw head 420); a pair of elongate opposing slats (arms 432) extending from the receiver body defining a central passage (the passage between arms 432 as shown in Fig. 17), the pair of elongate opposing slats further defining an opening (opening between free ends of arms 432) at a first end (located at free ends of arms 432) that opens into the central passage, and the pair of elongate opposing slats having a second end (located at joined ends of arms 432, which are joined at defects 433) releasably engageable with the receiver body of the fixation screw (see para. 0090); and at least one handle grip (guide 520) adapted to be affixed to the pair of elongate opposing slats via insertion of the pair of elongate opposing slats into opposing engagement slots (passageways 522), the at least one handle grip including a central through hole (hole that receives screwdriver 500 as shown in Fig. 19a), wherein the slats and the handle grip allow for percutaneous insertion of the fixation screw while also providing a more rigid configuration to do so (see para. 0091) (Figs. 10-19c; paras. 0087-0091).
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 assembly of Yue such that the monoaxial fixation screw assembly includes a pair of elongate opposing slats extending from the receiver body defining a central passage, the pair of elongate opposing slats further defining an opening at a first end of the pair of elongate opposing slats that opens into the central passage, and the pair of elongate opposing slats having a second end releasably engageable with the receiver body of the monoaxial fixation screw (claim 6) and at least one handle grip adapted to be affixed to the pair of elongate opposing slats via insertion of the pair of elongate opposing slats into opposing engagement slots, the at least one handle grip including a central through hole (claim 7), as suggested by Moore, as such allows for percutaneous insertion of the fixation screw while also providing a more rigid configuration to do so.
Allowable Subject Matter
Claim 9 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.
Response to Arguments
Applicant’s arguments with respect to Spitler and Markworth 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