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 § 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 10-11 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.
Claims 10 recites “wherein the shank includes a plurality of lobes,” which appears to contradict the limitation of claim 1 “the at least one helical thread having…a minor diameter which is the diameter of an imaginary cylinder that just touches the root of the at least one helical thread”. Examiner has withdrawn these claims from examination.
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.
Claim(s) 1-8, 12, 14, 16-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lightcap et al. (US 2013/0172902), hereinafter “Lightcap”.
Regarding claim 1, Lightcap discloses a system (200) for securing a bone screw to a bone in a surgical procedure comprising: an effector (210) coupled to a machining element and a drive device of a surgical robot (FIG. 2), the effector capable to form a pilot hole (FIG. 4) including a plurality of lobes into the bone; and a surgical screw (110) configured to be driven into the pilot hole, wherein the surgical screw comprises a cylindrical shank section (FIG. 1), the shank section having at least one helical thread (at 110a, FIG. 1) for engaging bone material, the at least one helical thread having the major thread diameter that is the diameter of an imaginary coaxial cylinder that just touches the crest of the at least one helical thread and a minor diameter which is the diameter of an imaginary cylinder that just touches the root of the at least one helical thread (FIG. 1), wherein each lobe of the plurality of lobes projects radially outward from a center of the pilot hole and the pilot hole includes curvilinear concave vertices formed between each lobe of the plurality of lobes providing purchase areas for the surgical screw, wherein the plurality of lobes are sized and shaped to provide an open space between a major thread diameter of a surgical screw and a most radially outward portion of a respective end of each lobe (this statement is being interpreted as an intended use statement - the lobes are not positively recited; there is no reason that the effector disclosed in the prior art is not capable of forming a pilot hole including a plurality of lobes that project outward and are sized and shaped to provide an open space).
Regarding claim 2, Lightcap discloses the system of claim 1, wherein the open space between the major thread diameter and the most radially outward portion of a respective end of each lobe is sufficient for the insertion of a bone inducing growth material (this statement is being interpreted as an intended use statement in accordance with above).
Regarding claim 3, Lightcap discloses the system of claim 1, wherein the open space between the major thread diameter and the most radially outward portion of a respective end of each lobe is sufficient for the insertion of a plurality of bone fragments (this statement is being interpreted as an intended use statement in accordance with above).
Regarding claim 4, Lightcap discloses the system of claim 1, wherein the open space between the major thread diameter and the most radially outward portion of a respective end of each of the plurality of lobes is at least one eighth of an inch (this statement is being interpreted as an intended use statement in accordance with above).
Regarding claim 5, Lightcap discloses the system of claim 1, wherein each of the plurality of lobes are spaced at substantially equal angles with respect to each other (this statement is being interpreted as an intended use statement in accordance with above).
Regarding claim 6, Lightcap discloses the system of claim 1, wherein the pilot hole includes at least three lobes (this statement is being interpreted as an intended use statement in accordance with above).
Regarding claim 7, Lightcap discloses the system of claim 1, wherein the pilot hole includes at least four lobes (this statement is being interpreted as an intended use statement in accordance with above).
Regarding claim 8, Lightcap discloses the system of claim 1, wherein the shank portion is tapered at a distal end thereof (FIG. 1).
Regarding claim 12, Lightcap discloses the system of claim 1, wherein the surgical screw is a pedicle screw (FIG. 1).
Regarding claim 14, Lightcap discloses the system of claim 1, wherein the surgical screw is a mono-axial pedicle screw (FIG. 1).
Regarding claim 16, Lightcap discloses a system (200) for securing a bone screw comprising: an effector (210) capable to form a pilot hole (FIG. 4) including a plurality of lobes into the bone; and a surgical screw (110) capable to be driven into the pilot hole, wherein the surgical screw comprises a cylindrical shank section (at 110a, FIG. 1), the shank section having at least one helical thread (at 110a, FIG. 1) for engaging bone material, the at least one helical thread having the major thread diameter that is the diameter of an imaginary coaxial cylinder that just touches the crest of the at least one helical thread and a minor diameter which is the diameter of an imaginary cylinder that just touches the root of the at least one helical thread (FIG. 1), wherein the plurality of lobes can be sized and shaped to provide an open space between a major thread diameter of a surgical screw and a most radially outward portion of a respective end of each lobe (this statement is being interpreted as an intended use statement - the lobes are not positively recited; there is no reason that the effector disclosed in the prior art is not capable of forming a pilot hole including a plurality of lobes that are sized and shaped to provide an open space).
Regarding claim 17, Lightcap discloses the system of claim 16, wherein the open space between the major thread diameter and the most radially outward portion of a respective end of each lobe is sufficient for the insertion of a bone inducing growth material (this statement is being interpreted as an intended use statement in accordance with above).
Regarding claim 18, Lightcap discloses the system of claim 16, wherein the open space between the major thread diameter and the most radially outward portion of a respective end of each lobe is sufficient for the insertion of a plurality of bone fragments (this statement is being interpreted as an intended use statement in accordance with above).
Regarding claim 19, Lightcap discloses the system of claim 16, wherein the open space between the major thread diameter and the most radially outward portion of a respective end of each of the plurality of lobes is at least one eighth of an inch (this statement is being interpreted as an intended use statement in accordance with above).
Regarding claim 20, Lightcap discloses the system of claim 16, wherein each of the plurality of lobes are spaced at substantially equal angles with respect to each other (this statement is being interpreted as an intended use statement in accordance with above).
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.
Claim(s) 9, 13, 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lightcap.
Lightcap discloses the system of claim 1, except wherein the surgical screw is self-tapping, polyaxial, and the helical thread includes two different thread pitches along the length of the helical thread. These are all well known in the art as common variations of pedicle screws. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention, to form the screw of Lightcap to be self-tapping, polyaxial, and having two different thread pitches along its length, to produce predictable results.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLIVIA C CHANG whose telephone number is (571) 270-5017. The examiner can normally be reached Monday-Friday, 7:30AM-5:00PM.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, KEVIN TRUONG, at (571) 272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571 -273-8300.
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/OLIVIA C CHANG/Primary Examiner, Art Unit 3775
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