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 16, 18-19, 21-23, 25, 27-30, and 34-35 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Belliard et al. (US 20200337733 A1).
Regarding claim 16, Belliard teaches a receiver (consisting of 15, 32, and 20) configured to operably couple a spinal screw with a spinal rod (see Fig. 1), the receiver comprising:
a shell (14) defining an internal cavity, a proximal opening in communication with the internal cavity, a distal opening in communication with the internal cavity (see labelled diagram of Fig. 2 below), and
first and second lateral openings (see labelled diagram of Fig. 2 below) in communication with the internal cavity, the proximal opening configured to receive a screw distally therethrough with a head of the screw disposed within the internal cavity and a shank of the screw extending distally through the distal opening (see Para. [0070]), the first and second lateral openings configured to receive a rod extending through the internal cavity and laterally from opposing sides of the shell (see Para. [0069]), wherein the shell is formed from a first material (see Para. [0074]; note also that the shell is inherently made by a material); and
a bushing (32) lining the first lateral opening, the second lateral opening, and at least a portion of the internal cavity (see Fig. 2), wherein the bushing is formed from a second material different from the first material (see Para. [0073]), the bushing configured to inhibit contact between the shell and the screw, the shell and the rod, and the screw and the rod (see Para. [0076]).
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Regarding claim 18, Belliard teaches the receiver according to claim 16, wherein the bushing (32) includes a bushing body (38) that lines the at least a portion of the internal cavity, a first ring (34) that lines the first lateral opening, and a second ring (36) that lines the second lateral opening (see Para. [0076]).
Regarding claim 19, Belliard teaches the receiver according to claim 16, wherein the shell (14) includes a first inwardly angled ramp adjacent to the distal opening, and wherein the bushing includes a second inwardly angled ramp lining the first inwardly angled ramp (see labelled diagram of Fig. 2 below), the second inwardly angled ramp inhibiting contact between the screw and the shell without extending into the distal opening of the shell (see Para. [0086]).
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Regarding claim 21, Belliard teaches the receiver according to claim 16, wherein the bushing (32) is configured to permit sliding of the rod relative to the bushing and the shell (see Para. [0078]).
Regarding claim 22, Belliard teaches a spinal screw assembly (see Fig. 2) configured to operably couple a spinal screw with a spinal rod (see Fig. 1), the assembly comprising:
a screw (16) including a head (17) and a shank (18) extending from the head; and
a receiver (consisting of 15, 32, and 20), including:
a shell (14) defining an internal cavity having a screw head-receiving portion and a rod-receiving portion (see labelled diagram of Fig. 2 above),
a proximal opening in communication with the internal cavity (see labelled diagram of Fig. 2 above),
a distal opening in communication with the internal cavity, and first and second lateral openings in communication with the internal cavity (see labelled diagram of Fig. 2 above),
the proximal opening configured to receive the screw distally therethrough (see labelled diagram of Fig. 2 above) with the head of the screw disposed within the screw head-receiving portion of the internal cavity and the shank of the screw extending distally through the distal opening (see Para. [0069]),
the first and second lateral openings configured to receive a rod extending through the rod-receiving portion of the internal cavity (see Para. [0072]),
wherein the shell is formed from a first material (see Para. [0074]; note also that the shell is inherently made by a material); and
a bushing (32) lining at least a portion of the internal cavity (see Para. [0076]), the bushing formed from a second material different from the first material (see Para. [0073]), the bushing configured to inhibit contact between the shell (14) and the screw (16) and to maintain a gap between the screw and the rod within the internal cavity, thereby inhibiting contact between the screw and the rod within the internal cavity (see Para. [0076]).
Regarding claim 23, Belliard teaches the assembly according to claim 22, wherein the bushing (32) lines the first and second lateral openings and is configured to inhibit contact between the shell and the rod (see Para. [0076]).
Regarding claim 25, Belliard teaches the assembly according to claim 22, wherein the receiver (14) is configured to permit angulation of the screw relative to the receiver (see Para. [0087]).
Regarding claim 27, Belliard teaches the assembly according to claim 22, wherein the bushing (32) includes a bushing body (38) that lines the at least a portion of the internal cavity (see Para. [0076]), a first ring (34) that lines the first lateral opening, and a second ring (36) that lines the second lateral opening (see Para. [0076]).
Regarding claim 28, Belliard teaches the assembly according to claim 22, wherein the shell (14) includes a first inwardly angled ramp adjacent to the distal opening, and wherein the bushing includes a second inwardly angled ramp lining the first inwardly angled ramp (see labelled diagram of Fig. 2 below), the second inwardly angled ramp inhibiting contact between the screw and the shell without extending into the distal opening of the shell (see Para. [0086]).
Regarding claim 29, Belliard teaches a spinal stabilization system (see Fig. 1), comprising:
a rod (30);
a screw (16) including a head (17) and a shank (18) extending from the head; and
a receiver (consisting of 15, 32, and 20), including:
a shell (14) defining an internal cavity having a screw head-receiving portion and a rod-receiving portion (see labelled diagram of Fig. 2 above),
a proximal opening in communication with the internal cavity (see labelled diagram of Fig. 2 above),
a distal opening in communication with the internal cavity, and first and second lateral openings in communication with the internal cavity (see labelled diagram of Fig. 2 above),
the proximal opening configured to receive the screw distally therethrough (see labelled diagram of Fig. 2 above) with the head of the screw disposed within the screw head-receiving portion of the internal cavity and the shank of the screw extending distally through the distal opening (see Para. [0069]),
the first and second lateral openings configured to receive a rod extending through the rod-receiving portion of the internal cavity (see Para. [0072]),
a bushing (32) lining at least a portion of the interior surface of the shell (14) and the first and second lateral openings (see labelled diagram of Fig. 2 above), the bushing (32) configured to permit sliding of the rod relative to the bushing and the shell (see Para. [0078]), permit angulation of the screw relative to the bushing and the shell (see Para. [0069]), inhibit contact between the shell and the screw (see Para. [0086]), inhibit contact between the shell and the rod (see Para. [0078]), and maintain a gap between the screw and the rod within the internal cavity (see Para. [0086]).
Regarding claim 30, Belliard teaches the system according to claim 29, wherein the bushing (32) includes a bushing body (38) that lines the at least a portion of the internal cavity, a first ring (34) that lines the first lateral opening, and a second ring (36) that lines the second lateral opening (see Para. [0076]).
Regarding claim 34, Belliard teaches the system according to claim 29, wherein the bushing (32) fully surrounds the rod within each of the first and second lateral openings of the shell (see Fig. 1).
Regarding claim 35, Belliard teaches the system according to claim 29, wherein the bushing (32) includes an inwardly angled ramp configured to inhibit contact between the screw and the shell without extending into the distal opening of the shell (see labelled diagram of Fig. 2 above).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 17, 26, and 32-33 are rejected under 35 U.S.C. 103 as being unpatentable over Belliard as applied in the rejection of claims 16, 22, and 29 above, and further in view of Peterson et al. (US 20140249590 A1) (hereon referred to as Peterson).
Belliard teaches a receiver as outlined in the rejection of claims 16, 22, and 29 above, wherein the second material is a plastic (claims 17, 26, and 33), wherein the shell is formed from a first material (see Para. [0074]; note also that the shell is inherently made by a material), wherein the bushing is formed from a second material (see Para. [0073]) (claim 32), however fails to teach wherein the first material is a metal (claims 17, 26, and 33), and wherein the second material is relatively lower friction material than the first material (claim 32).
Peterson teaches a pedicle screw (100) comprising a shell (612), a bushing (814), and an anchor (106); wherein the bushing is configured to protect the shell from the anchor (see Para. [0044]). Peterson further teaches that the bushing may be of a softer material compared to the shell, which may be made of a metal material (see Para. [0045]).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first material of Belliard to be metal (claims 17, 26, and 33) as taught by Peterson, such that the second material is relatively lower friction material than the first material (claim 32), as this would allow the bushing to better absorb impact from the shell (see Para. [0045] of Peterson).
Allowable Subject Matter
Claims 20, 24, and 31 are 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.
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, the claimed combination of limitations recited in dependent claims 20, 24, and 31. In particular, none of the cited references teach or suggest “wherein the bushing includes an annular rib protruding radially inwardly into an interior of the bushing, the annular rib configured to releasably retain the head of the screw” as required by claims 20, 24, and 31.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20050033295 A1: This reference teaches a screw with an annular bushing.
US 20080154308 A1: This reference teaches a pedicle system with a rod held in place by two rings.
US 20100063551 A1: This reference teaches a screw with one or more hollow bushing members.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HOLLY J LANE whose telephone number is (703)756-4702. The examiner can normally be reached Monday-Friday 9:00am-5:00pm.
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/H.J.L./Examiner, Art Unit 3773 /EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773
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