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 8 is objected to because of the following informalities: “A pedicle insulator” in line 2 should be lowercase. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: claim 9 states “thickness 1 based” it appears the “1” is a typo and should be removed. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 8-10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 8 recites the limitation "third geometries" in line 20. There is insufficient antecedent basis for this limitation in the claim. It appears line 19 should read “a third geometry” instead of “a second geometry” and line 19 should be changed and will be examined as line 19 reading “a second geometry.”
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.
Claim(s) 1-4 and 6-7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hays et al. (US Pub 2008/0015710).
With respect to claim 1, Hays discloses an implant for stabilizing a surgical fixture (see figures 24-26 below) comprising: a semi-cylindrical elongate body (fig 24, 400) formed about an axis of revolution (fig 25, L), wherein the elongate body further comprises a proximal end (fig 24, left); a distal end (fig 24, right) comprising a tapered tip surface (see fig 24 below); a channel surface (see fig 25B below) extending an entire distance between the proximal and distal ends; a ridged surface (fig 24, 410) opposite the channel surface extending between the proximal and distal ends comprising one or more ridges (410); a first longitudinal runner (see fig 24 and 25 below) and a second longitudinal runner (See fig 24 and 25 below) adjacent the channel surface and extending between the proximal and distal ends; a first teeth section (see fig 24 below) extending outwardly from the first longitudinal runner comprising one or more teeth (fig 24, 420); and a second teeth section (See fig 24 below) extending outwardly from the second longitudinal runner comprising one or more teeth, wherein the radial distance between the axis of revolution to the outermost point of the one or more teeth is greater than the radial distance between the axis of revolution and the apex of the one or more ridges (fig 25B the teeth are further out radially than the ridges). With respect to claim 2, Hays wherein the channel surface is configured to receive a surgical implant (fig 26, 700). With respect to claim 3, Hays wherein the implant is a pedicle screw (fig 26, 700). With respect to claim 4, Hays wherein the ridges have an elliptical profile (See fig 25B below). With respect to claim 6, Hays wherein the shape of the teeth is different from the shape of the ridges (teeth are trapezoidal shaped while the ridges are rectangularly shaped). With respect to claim 7, Hays wherein the longitudinal width of the teeth is less than the longitudinal width of the ridges (fig 24 there are 17 teeth to 16 ridges in the same length such that the width of the teeth is less than the ridges to account for the extra tooth).
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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.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hays et al. (US Pub 2008/0015710).
With respect to claim 5, Hays discloses the claimed invention except for wherein the tooth height of at least one of the teeth as measured from the runner is between about 0.5 mm and 5 mm. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention was made to have wherein the tooth height of at least one of the teeth as measured from the runner is between about 0.5 mm and 5 mm, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claim(s) 8-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hays et al. (US Pub 2008/0015710) in view of McCormack et al. (US patent 8,361,152).
With respect to claim 8, Hays discloses a system for stabilizing a surgical fixture (See figs 24-26 above) comprising: a pedicle insulator (fig 24, 400) comprising: an elongate body having a curved shape (cylindrical shape) about its longitude (fig 25, L), the elongate body further comprising: a proximal end (fig 24, left); a distal end (fig 24, right); a channel surface (see fig 25 above) extending between the proximal and distal ends having a first longitudinal edge and a second longitudinal edge (see fig 24 above); a first runner surface (See figs 24 and 25 above) adjacent to the first longitudinal edge and a second runner surface (see fig 24 and 25 above) adjacent to the second longitudinal edge; a ridged surface (fig 24, 410) opposite the channel surface and extending between the proximal and distal ends wherein the ridge section comprises one or more ridges (Fig 24, 410) having a first geometry (rectangular shape); a first teeth section (See fig 24 above) extending outwardly from the first runner surface wherein the first tooth section comprises one or more teeth having a second geometry (trapezoidal); and a second teeth section (See fig 24 above)extending outwardly from the second runner surface wherein the second tooth section comprises one or more teeth having a third geometry (trapezoidal); wherein the second and third geometries are different from the first geometry (trapezoidal verses rectangular).
With respect to claim 8, Hays discloses the claimed invention except for a pedicle insulator inserter comprising: a guide rod at a distal end; a first shaft section having an elliptical cross section; a second shaft section having a substantially circular cross section, wherein the second shaft section is connected to the first shaft section by a tapered section; and a handle.
McCormack discloses a pedicle insulator inserter (see fig 6A below) comprising: a guide rod (Fig 6A, 106) at a distal end; a first shaft section (fig 6A, 114) having an elliptical cross section (shown in fig 9); a second shaft section (See fig 6A below) having a substantially circular cross section (fig 6A), wherein the second shaft section is connected to the first shaft section by a tapered section (see fig 6A below); and a handle (fig 6A, 139) to hold the implant while delivering it (abstract). With respect to claim 9, McCormack discloses wherein the pedicle insulator inserter comprises a wall thickness based on one or more dimensions of the pedicle insulator (fig 12 the thickness is sized to fit the insulator inside of). With respect to claim 10, McCormack discloses wherein the pedicle insulator inserter comprises a filleted tip (See fig 6A below) at the distal end.
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It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Hays to include a pedicle insulator inserter comprising: a guide rod at a distal end; a first shaft section having an elliptical cross section; a second shaft section having a substantially circular cross section, wherein the second shaft section is connected to the first shaft section by a tapered section; and a handle in view of McCormack in order to hold the implant while delivering it.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20070162027 A1 discloses a pedicle insulator and inserter tool
US 20110106177 A1 discloses a pedicle insulator
US 20100174320 A1 discloses a pedicle insulator
US 20080161864 A1 discloses a pedicle insulator
US 20130006278 A1 discloses a pedicle insulator
US 20050216012 A1 discloses a pedicle insulator
US 20080133007 A1 discloses a pedicle insulator
US 7534265 B1 discloses a pedicle insulator
US 9888911 B2 discloses a pedicle insulator
US 10575885 B2 discloses a pedicle insulator
US 10588750 B2 discloses a pedicle insulator
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEVEN J COTRONEO whose telephone number is (571)270-7388. The examiner can normally be reached Monday-Friday 9am-5pm 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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/S.J.C/Examiner, Art Unit 3773 /EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773
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