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 1-2, 12-13, and 15-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Burton (US 5282863 A).
Regarding claim 1, Burton teaches a spinal fixation system (see Fig. 10) comprising:
a. a bone anchor (23) including a head (24), the head including a channel (see labelled diagram of Fig. 10 below) disposed therein and a channel axis (see labelled diagram of Fig. 10 below), and the channel (see labelled diagram of Fig. 10 below) including an interior side surface (24b) and a lower surface (24c);
b. a spinal rod (26) having a textured surface (26b) configured to frictionally engage the lower surface (24c, see ), wherein the textured surface of the spinal rod (26b) is configured to form an interference fit (see Col. 7, ll. 40-43) with a corresponding textured surface of the lower surface (see Col. 7, ll. 36-50)
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Regarding claim 2, Burton teaches the system according to claim 1, wherein the textured surface (26b) of the spinal rod (26) is forms an interference fit with the textured surface (24c) of the lower surface (24c) when under compression, thereby increasing axial grip strength and rotational grip strength of the system (see Col. 7, ll. 36-50).
Regarding claim 11, Burton teaches the system according to claim 1, wherein the bone anchor comprises a pedicle screw (see Col. 3, ll. 27-32).
Regarding claim 12, Burton teaches the system according to claim 1, further comprising two or more bone anchors (see Figs. 1-2).
Regarding claim 13, Burton teaches the system according to claim 1, further comprising two or more of the spinal rod (see Figs. 1-2).
Regarding claim 15, Burton teaches a kit for a spinal fixation (see Fig. 10), the kit comprising:
a. a bone anchor (23) including a head (24), the head including a channel and a channel axis (see labelled diagram of Fig. 10 above), the channel including an interior side surface (24b) and a lower surface (24c);
b. a spinal rod (26) having a textured surface (26b) configured to frictionally engage the lower surface (see Col. 7, ll. 40-43), wherein the textured surface of the spinal rod is configured to form an interference fit with a corresponding textured surface of the lower surface when under compression (see Col. 7, ll. 36-50).
Regarding claim 16, Burton teaches the kit according to claim 15, further comprising a second bone anchor (see Figs. 1-2).
Regarding claim 17, Burton teaches the kit according to claim 15 further comprising a second spinal rod (see Figs. 1-2).
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.
Claims 4-5 and 14, and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Burton as applied to claim 1 above and further in view of Berrevoets et al. (US 20130172936 A1) (hereon referred to as Berrevoets).
Burton teaches a spinal fixation system as outlined in the rejection of claim 1 above, wherein the head (24) further comprises a first arm (24a) and a second arm (24b) that define the channel (see labelled diagram of Fig. 10 above), at least one of the first arm and second arm (24a, 24b) include the interior side surface (claim 5), and a method of using a spinal fixation system according to claim 1 (see Col. 3, ll. 24-43), the method comprising:
a. providing the head of the pedicle screw (see Col. 3, ll. 31-33);
b. providing the spinal rod (see Col. 3, ll. 35-37 and Fig. 1);
d. seating the spinal rod into the channel of the head (see Col. 7, ll. 25-27); and
e. securing the spinal rod into the head of the pedicle screw such that the textured surface of the spinal rod (see Col. 7, ll. 36-50) engages the lower surface of the channel (see Fig. 10), however fails to teach wherein the textured surface of the spinal rod is disposed on at least one of a medial face or a lateral face of the spinal rod and is constructed to engage the interior side surface, thereby increasing resistance to rod translation and rotation within the channel (claim 4), wherein the interior side surface of the at least one of the first arm and second arm includes a textured surface constructed to engage the textured surface of the spinal rod (claim 5), inserting a rod sleeve into the channel of the head; and wherein the textured surface of the spinal rod engages a surface of rod sleeve (claim 14), further comprising a rod sleeve (claim 18), further comprising a set screw (claim 19).
Berrevoets teaches a spinal fixation system (see Fig. 3), wherein the textured surface (59) of the spinal rod (55) is disposed on at least one of a medial face or a lateral face of the spinal rod and is constructed to engage the interior side surface (note that the entire surface of the rod is coated with the textured surface), thereby increasing resistance to rod translation and rotation within the channel (see Para. [0044]) (claim 4), wherein the interior side surface (see Para. [0045]) of the at least one of the first arm and second arm (81) includes a textured surface (see Para. [0045]) constructed to engage the textured surface of the spinal rod (claim 5), inserting a rod sleeve (80) into the channel (73) of the head (70); and wherein the textured surface (59) of the spinal rod (55) engages a surface of rod sleeve (see Para. [0045]) (claim 14), further comprising a rod sleeve (80) (claim 18), further comprising a set screw (75) (claim 19).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the spinal fixation system and method of Burton to have a textured surface on all faces of the rod and cooperating surfaces of the interior side surface of the first and second arm (claims 4 and 5), as this would improve grip of the rod to the head (see Paras. [0044]-[0045]), and further to modify the head to further consist of a rod sleeve configuration (claims 14 and 18), as this would secure the rod in place relative to the head (see Para. [0045]), and finally to include a set screw (claim 19), as this would enable locking of the rod in place (see Para. [0040]).
Claims 1, 6-10, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Jackson (US 8353932 B2) in view of Berrevoets et al. (US 20130172936 A1) (hereon referred to as Berrevoets).
Jackson teaches a spinal fixation system (see Fig. 11) comprising:
a. a bone anchor (4) including a head (10), the head including a channel (114) disposed therein and a channel axis (see labelled diagram of Fig. 6 below), and the channel (114) including an interior side surface (118) and a lower surface (116);
b. a spinal rod (140) is configured to form an interference fit with the interior side surface (see Col. 5, ll. 39-62) (claim 1), wherein the spinal rod has a rectangular cross section (see Col. 4, ll. 1-3) (claim 9), and a method of using a spinal fixation system (see Col. 11, ll. 30-44), the method comprising:
a. inserting a pedicle screw (1) in a vertebral bone to a predetermined distance, the pedicle screw (1) including a head (50) and a channel (56; see Col. 11, ll. 34-44);
b. placing a rod sleeve (12) into the channel, the rod sleeve including a top surface (116),
c. placing a spinal rod (140) in close proximity to the head (50) of the inserted pedicle screw (1), and
d. seating the spinal rod (140) into the channel (see Col. 11, ll. 45-50) (claim 20).
However fails to teach a textured surface configured to frictionally engage at least one of the interior side surface or the lower surface and a corresponding textured surface of at least one of the interior side surface, lower surface, rod sleeve, or set screw (claim 1), further comprising a set screw including a bottom surface, wherein the textured surface of the spinal rod is constructed to engage the bottom surface of the set screw (claim 6), wherein the bottom surface of the set screw includes a textured surface constructed to engage the textured surface of the spinal rod (claim 7), wherein the textured surface of the spinal rod is disposed on a top surface of the spinal rod (claim 8), wherein the textured surface of the spinal rod is disposed along the majority of a lower surface of the spinal rod (claim 10), wherein at least a portion of the top surface is a textured surface; the spinal rod including a textured surface disposed on a bottom surface of the spinal rod, the textured surfaces of the rod sleeve and spinal rod configured to engage each other; securing the spinal rod into the head such that the textured surfaces of the rod sleeve and spinal rod engage each other; and e. securing the spinal rod into the head such that the textured surface of the spinal rod forms an interferenece fit with the corresponding textured surface of the rod sleeve, thereby increasing axial grip strength and rotational grip strength (claim 20).
Berrevoets teaches a spinal fixation system (see Fig. 3), wherein a textured surface (59) is configured to frictionally engage at least one of the interior side surface or the lower surface and a corresponding textured surface of at least one of the interior side surface (79; note that the entire surface of the rod is coated with the textured surface) (claim 1), further comprising a set screw (75) including a bottom surface (see Fig. 3), wherein the textured surface (59) of the spinal rod (55) is constructed to engage the bottom surface of the set screw (claim 6), wherein the bottom surface of the set screw includes a textured surface constructed to engage the textured surface of the spinal rod (see Para. [0040]) (claim 7), wherein the textured surface (59) of the spinal rod (55) is disposed on a top surface of the spinal rod (note that the texture is on all sides of the rod, see Para. [0044]) (claim 8), wherein the textured surface (59) of the spinal rod (55) is disposed along the majority of a lower surface of the spinal rod (note that the texture is on all sides of the rod, see Para. [0044]) (claim 10), wherein at least a portion of the top surface (81) is a textured surface (see Para. [0045]); the spinal rod (55) including a textured surface disposed on a bottom surface of the spinal rod (note that the texture is on all sides of the rod, see Para. [0044]), the textured surfaces of the rod sleeve (80) and spinal rod (55) configured to engage each other (see Para. [0045]); securing the spinal rod (55) into the head (70) such that the textured surfaces (81) of the rod sleeve (80) and spinal rod (55) engage each other (see Para. [0045]); and e. securing the spinal rod (55) into the head (70) such that the textured surface (59) of the spinal rod (55) forms an interferenece fit with the corresponding textured surface (81) of the rod sleeve (80), thereby increasing axial grip strength and rotational grip strength (see Para. [0045]) (claim 20).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the spinal fixation system of Jackson to have textured surfaces at taught by Berrovets, such that corresponding engagement between components would result in increased grip strength, as this would reduce unwanted sliding between components (see Para. [0044]).
Allowable Subject Matter
Claim 3 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.
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 claim 3. In particular, none of the cited references teach or suggest “the lower surface comprises an implant grade metal surface that is softer than the textured surface of the spinal rod such that the difference in the hardness between the textured surface of the spinal rod and the lower surface enables the lower surface to be deformed by the textured surface of the spinal rod” as required by claim 3.
Response to Arguments
Applicant’s arguments with respect to claims 1-20 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 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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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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/H.J.L./Examiner, Art Unit 3773 /EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773
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