DETAILED ACTION
This action is in response to Applicant’s amendment filed on June 25, 2026.
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)(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) 1-7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pak et al. (U.S. Patent No. 10,258,395).
Pak et al. discloses a bone fixation system, comprising: a bone anchor (50), comprising: a tapered head (52) having threads (56), and a threaded body (58) extending from the tapered head (Figure 9); and a plate (10), comprising: a counterbore (20) extending into a top surface of the plate (Figure 5A), thereby forming a void (Figure 6) and a planar landing (22), an inner wall of the planar landing forming a circular ring interrupted by a plurality of reliefs extending radially into the inner wall of the landing (See annotated Figure 2 below; the arrows indicate the interrupted circular ring),
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wherein no portion of the void (Figure 5A), counterbore or landing is threaded (Figure 5A) and, for all non-zero angles of up to 50 degrees between a long axis of the bone anchor and a long axis of the void, the threads of the tapered head of the bone anchor are configured to deform the landing immediately adjacent at least one of the plurality of reliefs when the bone anchor mates with the plate, thereby, locking the bone anchor within the aperture of the plate (Column 3, Lines 60-67 and Column 4, Lines 1-6).
Regarding claim 2, the planar landing is orthogonal to the long axis of the void (See annotated Figure 5A below) and the inner wall of the landing extends parallel to the long axis of the void (as seen in figure 5A, the inner wall of 22 is parallel to the long axis).
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Regarding claim 3, it can be construed from the figures and disclosure that the bone anchor is monolithic; and the plate is monolithic.
Regarding claim 4, The plate includes no resilient members (Column 3, Lines 60-63, the element 22 is disclosed as being constructed to deform or defect, thus is the case of being construed to deform, there are no resilient member).
Regarding claim 5, the inner wall of the landing, and each of the plurality of reliefs extending radially into the inner wall of the landing, together, define an inner perimeter of the landing (see figure below, the arrows show the landings with reliefs therebetween defining an inner perimeter).
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Regarding claim 6, the threads of the tapered head of the bone anchor are configured to cut into the landing without critically deforming the landing, without shearing off portions of the landing and without creating burrs on the landing (Column 3, Lines 66-67 and Column 4, Lines 1-2; the screw is disclosed as being made of a harder material, thus it is configured/capable of cutting into the landing without shearing off portions of the landing and without creating burrs on the landing).
Regarding claim 7, each of the plurality of reliefs extending radially into the inner wall of the landing a same distance (See figure 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 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pak et al. (U.S. Patent No. 10,258,395).
Pak et al. discloses the claim invention except for a thickness of the inner wall of the landing is between 40% and 60% less than an axial advance of the bone anchor when rotated through one complete turn of 360 degrees. It would have been obvious to one having ordinary skill in the art at to construct the thickness of the inner wall landing of Pak et al. that is between 40% and 60% less than an axial advance of the bone anchor when rotated through one complete turn of 360 degrees, 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.
Pak et al. discloses the claimed invention except for a diameter of the counterbore is between 10% and 35% larger than a diameter of the inner wall of the planar landing. It would have been obvious to one having ordinary skill in the art at to construct the diameter of the counterbore of Pak et al. between 10% and 35% larger than a diameter of the inner wall of the planar landing, 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) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pak et al. (U.S. Patent No. 10,258,395) in view of O’Driscoll et al. (U.S. Publication No. 2005/0131413).
Pak et al. discloses the claimed invention except for the tapered head and the threaded body having a uniform pitch. O’Driscoll et al. O’Driscoll et al. teaches a bone plate with an interference fit screw such that the screw had a tapered threaded head and a threaded body where the pitch is constant (paragraph 17). O’Driscoll teaches that the pitch can be variable or constant and thus it can be construed that pitch between the head and body is matter of design choice. It would have been obvious to one skilled in the art to construct the screw of Pak et al. having a constant pitch along the tapered head and body in view of O’Driscoll as such is shown to be a mere matter of design choice.
Response to Arguments
In response to Applicant’s argument that Pak does not disclose a bone fixation system where, for all non-zero angles of up to 50 degrees between a long axis of the bone anchor and a long axis of the void, the bone anchor mates with the plate to lock the bone anchor within the aperture of the plate, the Examiner respectfully disagrees. As claimed, “up to 50 degrees” means a range anywhere from 0-50 degrees. The claim only limits the ceiling for the range of movement. As such 15 degrees is less than 50 degrees so thus, Pak anticipates up to 50 degrees since it does not go outside of the range.
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 ANDREW YANG whose telephone number is (571)272-3472. The examiner can normally be reached 9:00 - 9:00 M-F.
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/ANDREW YANG/Primary Examiner, Art Unit 3775
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