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
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 13 and 15 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Cummins et al. (US 10,285,745).
Regarding claim 13, Cummins et al. disclose a surgical method, comprising positioning a bone screw (10) at an angle relative to a body of a patient (column 3, lines 23-32), the bone screw having an elongate shank (12) that extends from a proximal end (14) to a distal end (16) having a plurality of threads (18’s) formed thereon that terminate at a distal tip of the distal end (figure 1), each of the plurality of threads having a cutting edge (22) formed on a distal facing surface of the distal end (24) such that a mid-portion of the distal facing surface is positioned more proximal than outer edges of the distal facing surface (figures 2-3, 6-7), the distal tip having at least two cutting edges (22’s) formed thereon that extend distal to the distal tip; inserting a bone screw into the body of the patient by placing a distal end of the bone screw against bone (column 3, lines 23-32); driving the bone screw into bone such that a concave distal surface of the at least two cutting edges cut away bone prior to the distal tip contacting bone (column 3, lines 23-32, figures 2-3, 6-7 via it being structured such that the tips are the first surfaces which contact the bone). Regarding claim 15, Cummins et al. discloses no portion of the distal end contacts bone until the at least two cutting edges engage bone (figures 2-3, 6-7 as the outermost/distalmost surfaces of the screw are the cutting edges therefore they will be the first which contact the bone).
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.
Claims 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Cummins et al. (US 10,285,745).
Regarding claim 16, Cummins et al. disclose the claimed invention except for the express teaching of the angle at which the bone screw is positioned relative to the body of the patient is an angle other than 90 degrees.
It would have been obvious to one of ordinary skill in the art at the time of filing to have positioned the bone screw at an angle other than 90 degrees as the screw is a polyaxial pedicle screw which allows for the elongate shank to be positioned at angles different from the tulip head which is traditionally at an angle of 90 degrees.
Regarding claim 17, Cummins et al. disclose the claimed invention except for the express teaching of adjusting the angle at which the bone screw is positioned relative to the body of the patient prior to insertion of the bone screw into the body of the patient.
It would have been obvious to one of ordinary skill in the art at the time of filing to have adjusted the angle at which the bone screw is positioned relative to the body of the patient prior to insertion in the instance(s) where alignment between the two surface is not correct to avoid insertion of the screw at angle that not optimized to the patient’s need.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Cummins et al. (US 10,285,745) in view of Hes et al. (US 2007/0282341).
Regarding claim 14, Cummins et al. disclose inserting various different orthopedic instrumentation through the hole to aid in the insertion of the orthopedic screw (column 4, lines 23-25). However, Cummins et al. fail teach that the inserting is a guidewire through the inner lumen (48) of the elongate shank.
Hes et al. disclose using a guidewire (¶25) through the inner lumen (¶25) of the elongate shank to facilitate placement of the bone screw in the body of the patient (¶25). Accordingly, it would have been obvious to one of ordinary skill in the art at the time of filing to have constructed the method of Cummins et al. to use a guidewire as the “various different orthopedic instrumentation” that can be inserted through the inner lumen of the elongate shank of Cummins et al. as taught by Hes et al. as it is a known piece of orthopedic instrumentation that facilitates placement of the bone screw in the body of the patient.
Claims 2-12 are rejected under 35 U.S.C. 103 as being unpatentable over Cummins et al. (US 10,285,745) in view of Melkent et al. (US 2011/0022173).
Regarding claim 2, Cummins et al. disclose a bone screw, comprising a proximal head (36, figure 4); an elongate shank (12, figure 1) that extends from a proximal end (14) to a distal end (16), the elongate shank having a plurality of threads formed thereon (18) that terminate at the distal end (figure 1), each of the plurality of threads having a cutting edge (22) formed on a distal facing surface of the distal end (figures 2-3, 6-7) such that a mid- portion of the distal facing surface is positioned more proximal than outer edges of the distal facing surface (figures 2-3, 6), with each thread of the plurality of threads having a proximal-facing surface (see figure below), a distal-facing surface (see figure below), and an outer-most radial surface (see figure below).
Cummins et al. fail to expressly teach or disclose that the outer-most radial surface extends at an angle to each of the proximal-facing surface and the distal-facing surface of each thread.
Melkent et al. discloses the use of a bone screw (20) having threads (21) with an outer-most radial surface (29, figure 12) that extends at an angle to each of the proximal-facing surface and the distal-facing surface of each thread (¶48) or may be tapered to allow for self-tapping (¶48). Accordingly, it would have been obvious to one of ordinary skill in the art at the time of filing to have constructed the outer-most radial surface of the screw of Cummins et al. to extend at an angle to each of the proximal-facing surface and the distal-facing surface of each thread as Melkent et al. show that a tapered or angled thread surface is an equivalent structure known in the art. Therefore, because these two thread forms were art-recognized equivalents at the time the invention was made, one of ordinary skill in the art would have found it obvious to substitute in the angled outer-most radial surface thread of Melkent et al. in for the tapered thread of Cummins et al. Regarding claim 3, Cummins et al. disclose the elongate shank further comprises a cannulation (48) formed therein that extends from the proximal end to the distal end (figure 4).
Regarding claim 4, Cummins et al. disclose the distal-facing surface of the distal end includes one or more sidewalls (24’s) that extend at an acute angle (see figure below) relative to a plane extending perpendicular to a central longitudinal axis that extends between the proximal end and the distal end of the elongate shank (see figure below).
Regarding claim 5, Cummins et al. disclose the acute angle is about (emphasis added) 10 degrees (see figure below).
Regarding claim 6, Cummins et al disclose the at least one cutting edge further comprises two or more cutting edges (22’s, figure 3). Regarding claim 7, Cummins et al. disclose the two or more cutting edges are positioned along an outer perimeter of the distal-facing surface of the distal end (figures 2-3, 6-7). Regarding claim 8, Cummins et al. disclose the two or more cutting edges are positioned on opposite sides of the outer perimeter (figures 2-3, 6-7).
Regarding claim 9, Cummins et al. disclose the at least one cutting edge is defined by an intersection between the distal-facing surface of each thread and the proximal surface of each thread of the plurality of threads (figures 2-3). Regarding claim 10, Cummins et al. disclose the at least one cutting edge extends radially outward between a central longitudinal axis (X, figure 6) that extends between the proximal end and the distal end of the elongate shank and an outer diameter of the bone screw (figures 2-3, 6-7).
Regarding claim 11, Cummins et al. disclose the proximal head further comprises a drive feature thereon (37, figure 4).
Regarding claim 12, Cummins et al. disclose the claimed invention except for the express teaching of the angle at which the proximal surface extends to the outer-most radial surface is smaller than the angle at which the distal-facing surface extends to the outer-most radial surface. It would have been an obvious matter of design choice to have the outer-most radial surface is smaller than the angle at which the distal-facing surface extends to the outer-most radial surface, since applicant has not disclosed that having the threads converge in an asymmetrical manner solves any stated problem or is for any particular purpose and it appears that the invention would perform equally well with the generally symmetrical threads of Cummins et al. Additionally, Applicant recites the thread surfaces being symmetrical is within the scope of the invention, see [0050] of the filed spec “In the illustrated embodiment, the threads are not symmetrical, such that the proximal surface 132 extends to the outer-most radial surface 136 at a steeper angle relative to a plane perpendicular to the longitudinal axis L1 as compared to the distal surface 134, as seen in FIGS. 1D and 1E. However, symmetrical threads can be used in various embodiments.”.
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Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW JAMES LAWSON whose telephone number is (571)270-7375. The examiner can normally be reached Mon - Fri 6:30-3:00. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anita Coupe can be reached at 571-270-3614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW J LAWSON/Primary Examiner, Art Unit 3619
