DETAILED ACTION
This office action is responsive to the amendment and request for continued examination filed June 15, 2026. By that amendment, claims 1, 3, 8, 10, 11, 16-18 and 25 were amended; and claim 15 was canceled. Claims 1-13, 16-18 and 25 are pending.
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on June 15, 2026, has been entered.
Response to Arguments
The outstanding rejections under 35 USC 112(b) were overcome by the amendments to the claims.
Applicant’s arguments with respect to the rejection of claim(s) 1-10, 15-18, and 25 under 35 USC 103 in view of Kirschman (US 2012/0197311 A1) in view of Whipple et al. (US 9,055,966 B1); and claims 11-13 under 35 USC 103 in view of Kirschman, Whipple and Reimels (US 2014/0094860 A1); have been considered but are moot because the new ground of rejection does not rely on any of the combinations of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The newly presented rejections are necessitated by the amendments to the claims of June 15, 2026.
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) 1-10, 16-18, and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kirschman (US 2012/0197311 A1) in view of Sauvage et al. (US 10,188,430 B2).
Regarding claims 1 and 25, Kirschman teaches a screw element as at figs. 20A/B for the fixation of bone components and bone fragments (abstract) comprising a shaft with an external thread 134/132 and a thread core (portions of 112 on which threads 132/134 are formed) and a longitudinal central axis SA extending along the shaft and thereby defining a distal and a proximal direction (down/up, respectively), and the screw element comprises a continuous cannulation as in fig. 20A, the cannulation comprises at least two laterally extending openings 154 communicating with the cannulation,
wherein the openings are configured as a polygon in a side view (figs. 20A-B, [0093]),
wherein the external thread 134/132 is divided into a proximal threaded area 132 adjacent to a neck area (between 150 and 132) and extending in distal direction, and a distal threaded area 134 adjacent thereto, and distal tip area 112b adjacent thereto.
Kirschman fails to teach the thread being 1) continuous proximal to a distal cutting area; 2) the distal threaded area merging into the proximal threaded area in a transition zone, 3) the proximal threaded area forming at least one additional thread which forms at least one cutting edge within the transition zone; 4) the cutting edge oriented substantially in radial direction, and 5) the cutting edge being formed only on the thread but not in the thread core.
Sauvage teaches a bone screw as at figs. 1-3, including a shaft with an external thread 6 and a thread core 4 and a longitudinal axis (up/down in fig. 3), the screw being cannulated at 13. The external thread 6 is divided into a proximal area 7 adjacent a neck area between 6 and head 2, a distal threaded area 10, and a distal tip area 11. Sauvage further teaches 1) the thread 6 in region 10 being continuous proximal to a distal cutting area 12; 2) the distal threaded area 10 merging into the proximal threaded area 7 at a transition zone 8/9; 3) the proximal threaded area 7 forming at least one additional thread 5 which forms at least one cutting edge (at the beginning of thread 5 where it extends from the core 4; alternatively, as claimed, a flat flank of the thread reads on this cutting edge and is planar) within the transition zone 8/9; 4) the cutting edge is oriented substantially in the radial direction (best seen in fig. 1); and 5) the cutting edge formed only on the thread but not on the thread core 4.
It would have been obvious to one with ordinary skill in the art at the time of the invention to modify the Kirschman threadform to be that of the Sauvage screw while maintaining the cannulations and openings of the Kirschman device. One would have done so in order to cause the Kirschman screw to create additional anchoring in different regions of bone hardness and strength (Sauvage, abstract).
Regarding claim 2, the polygon has at least one panel element (sidewall of the polygon) formed substantially parallel to the central axis SA – e.g. top and bottom sidewalls in the hexagonal polygon version.
Regarding claim 3, the distance between the panel elements extending parallel to the central axis is smaller than a cannulation diameter at an outlet of the openings (see arrangement of fig. 20B).
Regarding claim 4, the polygon has at least two panel elements which, in a side view, are each oriented at an angle of from 25 to 65 degrees with respect to an axis parallel to the central axis SA (e.g. the hexagonal variant).
Regarding claim 5, at least two panel elements (sidewalls of the hexagonal polygon) are symmetrically oriented with respect to the central axis SA.
Regarding claim 6, there is no reason the point where the panel elements of the hexagonal polygon meet cannot be said to be defining a curve which merges the two panel elements together.
Regarding claim 7, the lateral openings in peripheral direction are positioned in ring-like formation have different opening cross-sectional areas per formation as seen at fig. 20B. (The claim includes the statement “and in case of…” which is understood to be an optional limitation, and therefore was not evaluated as a required limitation).
Regarding claim 8, the opening cross-sectional area of a distal formation is larger than the opening cross-sectional area of a proximal one of the laterally extending openings – see fig. 20B.
Regarding claim 9, the lateral openings are positioned in a base of the thread 134/132 as seen in fig. 20B.
Regarding claim 10, the screw element additionally comprises a head 150/164, the neck area between 150/132, and a shaft area below 150 with bone thread 132/134 and a tool attachment point 140b is provided in the head 150/164.
Regarding claims 16-18, the cutting edge of the distal tip 12 is a concave surface as at fig. 1 (alternatively, the cutting edge can be said to be at the junction of the thread and portion 12, in which case one of the flanks of the thread can be referred to as the cutting surface, which surface can be said to be planar or convex).
Claim(s) 11-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kirschman in view of Sauvage and Reimels (US 2014/0094860 A1).
Regarding claim 11, the combination of Kirschman and Whipple suggests the limitations of claim 10, above.
However, the combination does not suggest the tool attachment portion being restricted in the distal direction by a wall and said wall being inclined radially inward in increasing distal direction and cone angle formed by the wall is less than 120 degrees.
Reimels teaches a screw head design in a cannulated screw being spherical as in cross section in fig. 2. The head includes a tool attachment point 123 which includes a distal wall inclined radially inward in increasing distal direction (in the same fashion as the instant application figures do e.g. fig. 2). The cone angle is clearly less than 120 degrees and is a substantially right angle as seen in the figures.
It would have been obvious to one with ordinary skill in the art at the time of the invention to form the combination screw with a head in the form of Reimels. One would have done so in order to modify the Kirschman screw for use with a differently configured screwdriver.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to David Bates whose telephone number is (571)270-7034. The examiner can normally be reached Monday through Friday, 10AM-6PM
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/DAVID W BATES/Primary Examiner, Art Unit 3799
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