DETAILED ACTION
This office action is responsive to the amendment filed November 17, 2025. By that amendment, claims 1-4, 7-9, 11-13, and 15-18 were amended; claims 14, and 19-24 were canceled; and claim 25 was newly presented. Claims 1-13, 15-18, 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 .
Response to Arguments
The outstanding objections to claims 3, 7 and 19 were overcome by the amendments of November 17, 2025.
The outstanding rejections of claims 2-4, 7-9, 11-20, 23 and 24 under 35 USC 112(b) were mainly overcome by the amendments of November 17, 2025. Those not overcome are maintained, herein, and new issues identified at this time are also rejected under this section.
Applicant’s arguments with respect to the rejection under 35 USC 102(a)(1) in view of Kirschman (US 2012/0197311 A1) of claim(s) 1-10, 19 and 21; the rejections under 35 USC 103 in view of Kirschman and Reimels (US 2014/0094860 A1) of claims 11-13 and 20; and in view of Kirschman and Biester (US 2019/0150989 A1) of claims 14-18, 23, and 24; and in view of Kirschman and Tempco (US 2019/0343564 A1) of claim 22; have been considered but are moot because the new ground of rejection does not rely on any combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The rejections were overcome by the amendments of November 17, 2025.
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 1-13, 15-18 and 25 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.
Regarding claims 1 and 25, the term “the neck” lacks antecedent basis in the claims. Examiner understands this to have been meant to refer to “a neck area” for examination purposes.
Regarding claim 3, the term “the cannulation diameter” lacks antecedent basis in the claims. Examiner understands this to have been meant to refer to “a cannulation diameter” for examination purposes.
Claim 8 refers to “a distal formation” and “a proximal formation”. In context, it appears that these limitations are referring to one of the proximal laterally extending openings and one of the distal laterally extending openings. Examiner requests clarification of this in the claim, and suggests referring to “a distal one of the laterally extending openings” and “a proximal one of the laterally extending openings” as a clarifying amendment.
Further, and alternatively, if applicant wishes to keep the “formation” language, then it is respectfully noted that “the proximal formation” lacks antecedent basis in the claim and would need to be amended to ‘a proximal formation’.
Claim 10 also recites ‘a neck area’. It is unclear if this is an additional neck area, or the same of claim 1. Examiner understands this to be an inadvertent re-recitation of “the neck area” of claim 1, and suggests removal of the limitation from the claim.
Regarding claim 11, the claim fails to provide antecedent basis for “the tool attachment point”. Examiner suggests the claim was intended to depend from claim 10 and further examines with this understanding. Correction is required.
Regarding claims 16-18, the claims refers to “cutting edges” in multiple. It is assumed that this claims were intended to depend from claim 15, as this is the first instance in which a second cutting edge is required. Claim 1, from which claims 16-18 depend recites only a single cutting edge. The claims are examined as though they depend from claim 15. Correction is required.
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, 15-18 and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kirschman (US 2012/0197311 A1) in view of Whipple et al. (US 9,055,986 B1).
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 152 with an external thread 134/132 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]). 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 distal threaded area 134 merges into the proximal threaded area 132 in a transition zone, and the proximal threaded area 132 forms at least one additional thread which forms at least one cutting edge within the transition zone, said cutting edge is oriented substantially in radial direction.
Whipple teaches a bone screw as at fig. 1. The screw includes a shaft 20 with an external thread 40/60 having a proximal thread 60 and a distal thread 40, a tip 11 and a neck 70. The distal thread 40 exists in a region 1 and merges with proximal thread 60 in a region 3 through a transition zone 2. The proximal thread 60 includes an additional thread (note presence of double start threads 60A/B notated in fig. 2) and a cutting edge at 61 formed in the transition zone 2. The cutting edge is formed as a groove, causing the thread to have a radial transition where the thread meets the groove 61. The cutting edge on the thread is formed to be planar and oriented in the radial direction.
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 Whipple 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 a larger cut second section to permit mating of the second threads into the bone without damaging the threads formed by the first section. (Whipple, col. 2, lines 5-15)
Regarding claim 2, wherein the polygon has at least one panel element (sidewall) 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 the cannulation diameter at an outlet of the openings (e.g. the distance between the flat walls of the hexagon is smaller than a diameter measured from corner to corner of the hexagon).
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 (this is true in 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 at which 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 and have different opening cross-sectional areas per formation as seen clearly at fig. 20B. (The claim includes the statement “and in case of…” which is understood to be an optional limitation. Only one of the options needs to be evaluated and shown in the prior art for the claim to be met).
Regarding claim 8, as best understood, the opening cross-sectional area of a distal formation (a distal opening of the openings 154) is larger than the opening cross- sectional area of a proximal formation (approximal opening of the openings 154) – see fig. 20B.
Regarding claim 9, the lateral openings 154 are positioned in a base of the thread 134/132 as seen in fig. 20B.
Regarding claim 10, the screw element at figs. 20A/B additionally comprises a head 150/164, the neck area between 150 and 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 15-18 (16-18 best understood to depend from 15), the distal tip area 11 includes a cutting edge at 41. The cutting edges at 41/61 are planar. Alternatively the valley or peak of the thread at this beginning point can be considered to be the cutting edge, which points are concave and convex, respectively.
Claims 11-13 are rejected under 35 USC 103 as being unpatentable over Kirschman in view of Whipple and Reimels (US 2014/0094860 A1).
Regarding claims 11-13, as best understood to depend from claim 10, the combination of Kirschman and Whipple suggests the limitations of claim 10, above.
However, the combination does not suggest the tool attachment point is restricted in the distal direction by a wall and said wall is inclined radially inward in increasing distal direction and a cone angle formed by the wall is less than 120 degrees.
Reimels teaches a screw head design in a cannulated screw, being spherical as seen 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 as seen clearly at fig. 2). The cone angle is clearly less than 120 degrees and is substantially a 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
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 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