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 .
Response to Arguments
Applicant's arguments filed August 31st, 2026 have been fully considered but they are not persuasive. Applicant argues it would not have been obvious to modify Biederman in view of Altarac include the internal threads, 60, of Altarac. Specifically, Applicant argues that the purpose of the internal threads of Altarac are to provide mating of an additional component like that of a screw would render Biedermann useless for its intended purpose as a surgical fastener. While the Examiner agrees that Altarac teaches the ability to use the threading to couple an additional component as outlined in column 4, lines 50-51 the mating component is not limited to a screw. By providing the screw of Biedermann with the internal threading you are providing an additional fixation/gripping surface for use of any additional component including the tool to insert the screw to the target location. As a result, Applicant’s arguments and remarks are not found persuasive to overcome the rejections of record.
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 1-19 are rejected under 35 U.S.C. 103 as being unpatentable over Biedermann et al. (US 2015/0289905) in view of Altarac et al. (US 6,685,412). Regarding claim 1, Biedermann et al. disclose a monolithic screw element for use in spinal, orthopaedic, or trauma surgery, the screw element having a screw axis (“S”, figure 1) and comprising a screw thread (3); and a drive portion (6) comprising a wall (Abstract, see figure below) that defines an axially extending recess (7) for engaging a tool (e.g. 20), the recess having a cross-sectional profile (figure 4) that extends from a first end (5) to a second end (7a) in a direction of the screw axis, wherein the cross-sectional profile has a first portion (see figure below) positioned closest radially to the screw axis and a plurality of drive grooves (8) that extend radially away from the first portion and that are spaced apart from each other in a circumferential direction around the screw axis (figure 3).
Biedermann et al. fail to expressly teach or disclose a portion of the wall comprises a protrusion that protrudes laterally away from the wall into the recess, and wherein the protrusion is spaced apart axially from the first and second ends of the recess.
Altarac et al. disclose a screw element (10, figures 1-3 column 3, lines 27-31, column 4, lines 1-6) wherein a portion of a wall of the screw (15) comprises a protrusion (60, figures 5-6) that protrudes laterally away from the wall into the recess (14’), and the protrusion is spaced apart axially from the first and second ends of the recess (figures 5-6). The projection(s) allow for the mating of a component to the screw (column 4, lines 50-51) in a manner to enhance fixation.
Accordingly, it would have been obvious to one of ordinary skill in the art at the time of filing to have constructed a portion of the wall of Biedermann et al. to include a protrusion that protrudes laterally away from the wall into the recess as taught by Altarac et al. as the projection(s) allow for the mating of a component to the screw in a manner to enhance fixation.
Regarding claim 2, Biedermann et al. in view of Altarac et al. disclose the protrusion comprises a geometrical shape (figures 5-6 of Altarac).
Regarding claim 3, Biedermann et al., in view of Altarac et al., disclosing the protrusion is formed by roughening a surface of the wall (the process of creating the threads yields a roughened surface, figures 5-6 of Altarac).
Regarding claim 4, Biedermann et al. disclose wherein the roughening is structured or organized (threads are organized in a vertical and rotational direction, see figures 5-6 of Altarac).
Regarding claim 5, Biedermann et al., in view of Altarac et al. disclose the protrusion is formed to be locally distinct on the wall (figures 5-6 of Altarac).
Regarding claim 6, Biedermann et al. in view of Altarac et al. disclose the protrusion comprises one or more bulges, pimples, and/or ribs (the thread segments form ribs/protrusions in Altarac).
Regarding claim 7, Biedermann et al., in view of Altarac et al. disclose the protrusion extends circumferentially around at least part of the recess (figures 5-6 of Altarac).
Regarding claim 8, Biedermann et al. disclose wherein the cross-sectional profile forms a star-like shape or a polygonal shape (figures 4-5).
Regarding claim 9, Biedermann et al. disclose the recess is a first recess (7), wherein the screw element defines a second recess (9) between the first recess and a free end (5) of the screw element, and wherein the second recess comprises guide grooves (10) that are wider than the drive grooves and that are located at circumferential positions corresponding to circumferential positions of the drive grooves (figures 1-5). Regarding claim 10, Biedermann et al. disclose the screw element comprises a bone screw (1, figure 1) comprising a shank (2) on which the screw thread (3) is formed on at least a portion thereof, and a head (4) having a free end (5) opposite the shank, and wherein the drive portion is formed at the free end of the head (figure 1). Regarding claim 11, Biedermann et al. disclose the screw element comprises a set screw (40, figure 12) configured to lock a polyaxially bone anchoring device or a bone plate (figures 12-13).
Regarding claim 12, Biedermann et al. in view of Altarac et al. disclose the protrusion is formed on a portion of the wall that defines the first portion of the cross-sectional profile (figures 5-6, Altarac).
Regarding claim 13, Biedermann et al. in view of Altarac et al. disclose the protrusion protrudes radially inwardly from the wall towards the screw axis (figures 5-6, Altarac).
Regarding claim 14, Biedermann et al. disclose a system comprising a monolithic screw element (1) for use in spinal, orthopaedic, or trauma surgery, the screw element having a screw axis (“S”, figure 1) and comprising a screw thread (3) and a drive portion (6) comprising a wall (Abstract, see figure below) that defines an axially extending recess (7) for engaging a tool (e.g. 20), the recess having a cross-sectional profile (figure 4) that extends from a first end (5) to a second end (7a) in a direction of the screw axis (figure 5), wherein the cross-sectional profile has a first portion (see figure below) positioned closest radially to the screw axis and a plurality of drive grooves (8) that extend radially away from the first portion and that are spaced apart from each other in a circumferential direction around the screw axis (figure 3); and a tool (20, figures 1-2) having a longitudinal axis (considered the central longitudinal axis of the tool) and comprising an engagement portion (30) for engaging the recess, wherein the engagement portion has a cross-sectional profile that corresponds substantially to the cross-sectional profile of the recess and that extends from a first end to a second end in a direction of a longitudinal axis (figures 9-10); wherein when the engagement portion of the tool is in the recess of the screw element with the region between the first and second ends of the engagement portion being positioned at a same axial height as a region between the first and second ends of the recess (figures 10, 11C).
Biedermann et al. fail to expressly teach or disclose a portion of the wall comprises a protrusion that protrudes laterally away from the wall into the recess
the engagement portion is configured to engage the protrusion, while at least part of the wall of the screw element positioned axially between the protrusion and the first end of the recess and at least part of the wall of the screw element positioned axially between the protrusion and the second end of the recess are both configured to be spaced apart from the engagement portion in a lateral direction.
Altarac et al. disclose a screw element (10, figures 1-3 column 3, lines 27-31, column 4, lines 1-6) wherein a portion of a wall of the screw (15) comprises a protrusion (60, figures 5-6) that protrudes laterally away from the wall into the recess (14’) the engagement portion of a tool is configured to engage the protrusion (column 4, lines 50-51), while at least part of the wall of the screw element positioned axially between the protrusion and the first end of the recess and at least part of the wall of the screw element positioned axially between the protrusion and the second end of the recess are both configured to be spaced apart from the engagement portion in a lateral direction (figures 1 and 4).
Accordingly, it would have been obvious to one of ordinary skill in the art at the time of filing to have constructed a portion of the wall of Biedermann et al. to include a protrusion that protrudes laterally away from the wall into the recess as taught by Altarac et al. as the projection(s) allow for the mating of a component to the screw in a manner to enhance fixation. The resultant device would perform the function of the engagement portion is configured to engage the protrusion, while at least part of the wall of the screw element positioned axially between the protrusion and the first end of the recess and at least part of the wall of the screw element positioned axially between the protrusion and the second end of the recess are both configured to be spaced apart from the engagement portion in a lateral direction as Biedermann et al. discloses the positioning of the tool relative to the screw head as the addition of the protrusion would enhance fixation and not impede the positioning and orientation of the tool relative to the recess.
Regarding claim 15, Biedermann et al. disclose the tool configured to engage the recess of the drive portion comprises a screwdriver (20, figure 6, see Abstract). Regarding claim 16, Biedermann et al. in view of Altarac et al. disclose
the protrusion is sized to reduce lateral movement of the engagement portion when the engagement portion is in the recess (column 4, lines 49-51, Altarac). Regarding claim 17, Biedermann et al. in view of Altarac et al. disclose the protrusion is configured to clamp the engagement portion by friction when the engagement portion is in the recess (column 4, lines 49-51, Altarac).
Regarding claim 18, Biedermann et al. disclose the recess forms a spiral-like shape, with an inner portion of the wall that is closer to the screw axis and an outer portion of the wall that is farther away from the screw axis together defining the recess, and wherein the protrusion is formed on the inner portion of the wall (figure 5). Regarding claim 19, Biedermann et al. in view of Altarac et al. disclose the protrusion is fixed relative to the wall (figures 5-6, Altarac).
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Conclusion
THIS ACTION IS MADE FINAL. 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 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
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