DETAILED ACTION
This office action is responsive to the amendment of October 28, 2025. By that amendment, claims 1-4, 6, 7, 10, 13-16, 18, and 19 were amended; claim 8 was cancelled; and claim 21 was newly presented. Claims 1-7 and 9-21 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 rejection under 35 USC 112(b) was overcome by the amendments to the claims of October 28, 2025.
Applicant’s arguments with respect to the rejection under 35 USC 103 in view of Zink et al. (US 2021/0393394 A1) and Krause et al. (US 2020/0289183 A1) of claim(s) 1-20 have been considered but are moot because the new ground of rejection does not rely on any reference 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 October 28, 2025.
Claim Objections
Claim 6 is objected to because of the following informalities: at line 15, the word ‘therethrough’ should be replaced with the word ‘through’. Appropriate correction is required.
Claim 18 is objected to because of the following informalities: at line 14, the word ‘therethrough’ should be replaced with the word ‘through’. Appropriate correction is required.
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 18-20 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 claim 18, it is unclear if the claim is intended to positively recite engagement between the contact member and the (inferred) screw, or if this was intended as a positive recitation, thereby making the screw a positively recited limitation in the claim. Examiner believes this was intended to be an inferential recitation and examines the claim as such. Clarification is required. Examiner suggests amendment to use of “configured to” language at line 18 would obviate this rejection and clarify the limitation.
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, 2, 4-7, 12, 13, and 16-21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kulper et al. (US 10,966,842 B2).
Regarding claim 1, Kulper teaches a device 10 as at fig. 2A-2 capable of engaging a screw tip for a cannulated bone screw with a screw cannula (analogous to 15), comprising:
an elongated body 14/17 comprising a first end at 13, a second end opposite the first end near 17, and a screw tip contact member (distal portion of 17) disposed proximate the second end;
wherein the elongated body 14/17 is formed of a resilient material (col. 6, lines 30-40; col. 4, lines 62-65);
wherein the elongated body 14/17 has a first longitudinal axis (left to right in fig. 2A-2);
wherein the elongated body 14/17 further comprises a canted portion (at a proximal portion of 17) proximate the screw tip contact member, the canted portion extending along a second longitudinal axis that is canted relative to the first longitudinal axis, the first longitudinal axis being non-parallel with the second longitudinal axis (a proximal portion of 17, where it meets 14, is at a canted axis relative to the first axis).
Regarding claim 2, the screw tip contact member of 17 is capable of engaging a tip of the bone cannulated screw outside of the screw cannula (when choosing an appropriately sized and shaped screw).
Regarding claims 4 and 5, the elongated body 14/17 comprises a memory metal (Nitinol, col. 4, lines 60-65).
Regarding claim 6, Kulper teaches an assembly 10 as at fig. 2A-2 capable of use in engaging a cannulated bone screw with a screw tip and a screw head opposite the screw tip, comprising:
a screw tip engagement device 14/17 comprising an elongated body 14 having a first end (left in fig. 2A-2), a second end opposite the first end (at a junction between 14 and 17), and a screw tip contact member (the remainder of 17) disposed proximate the second end, the elongated body comprises a canted portion proximate the screw tip contact member (at the portion of 14/17 which is bent, but not yet the contact member at 17); and
a proximal screw engagement element 11 having a third end near 12 and a fourth end at 19 opposite the third end (left and right in fig. 2A-2), and a first hollow channel extending from the third end to the fourth end (through which 14 is seen passing);
wherein the fourth end 19 of the proximal screw engagement element 11 is capable of engaging a portion of the screw head of the cannulated bone screw (analogous to 19 engaging 15; depending on size of the hole, 19 can abut against an interior of 15 or a front face of 15);
wherein the screw tip contact member of 17 of the screw tip engagement device 14/17 is capable of engaging a portion of the screw tip (analogous to a distal end of 15) of the cannulated bone screw outside of a cannula of the cannulated bone screw as seen at fig. 2A-2;
wherein the screw tip engagement device 14/17 is movable to pass through the first hollow channel of 11 such that the first end of the screw tip engagement device extends outside the third end of the first hollow channel, and such that the second end of the screw tip engagement device travels past and extends outside the fourth end of the first hollow channel (by movement of 13 on the indicated direction arrow as seen comparing figs. 2A-1 and 2A-2); and
a gripping element 13 holding the screw tip engagement device 14/17 proximate the first end of the screw tip engagement device at the left end of 14.
Regarding claim 7, the proximal screw engagement element 11 further comprises a first handle 12 that is rotatable relative to the screw tip engagement device 14/17 (there is no reason that 12 cannot be rotated relative to the axis of 14/17.
Regarding claim 12, the screw tip engagement device 14/17 and the proximal screw engagement element 11 have exterior surfaces that are composed of biologically compatible material (several of the listed materials are known to be biocompatible (col. 4, lines 60-65).
Regarding claim 13, the screw tip engagement device 14/17 includes a deformably resilient wire that is capable of deforming the screw tip contact member of 17 into a compressed state while traveling through the first hollow channel of the proximal screw engagement element 11 (as seen in fig. 2A-1) and to return to an uncompressed state when the screw tip contact member engages the portion of the screw tip of the cannulated bone screw (as seen in fig. 2A-2).
Regarding claim 16, the screw tip engagement device 14/17 is adapted to pass through the cannula of the cannulated bone screw (analogous to passing through 15; depending on selection of an appropriately sized and shaped screw; the screw in this claim is only inferentially recited).
Regarding claim 17, the screw tip contact member of 17 comprises a bend and a point.
Regarding claim 21, the elongated body 14 of the screw tip engagement device 14/17 extending from the first end to the second end has a first longitudinal axis; and wherein the canted portion (along a portion of 17) extends along a second longitudinal axis that is canted relative to the first longitudinal axis when the deformably resilient wire is in a decompressed state as in fig. 2A-2, the first longitudinal axis being non-parallel with the second longitudinal axis.
Regarding claim 18, Kulper teaches a kit 10 as at fig. 2A-2 capable of use in removing a cannulated bone screw (analogous to 15), comprising:
a screw tip engagement device 14/17 including an elongated body 14 with a first end (left), a second end opposite the first end near 17, and a screw tip contact member (tip of 17) disposed proximate the second end;
a proximal screw engagement element 11 having a third end near 12, a fourth end 19 opposite the third end, and a first hollow channel extending from the third end to the fourth end; and
a screw tip engagement device grasping element 13 configured to hold the screw tip engagement device 14/17 in a position relative to the proximal screw engagement element 11,
wherein the fourth end of the proximal screw engagement element is configured to engage a portion of a screw head of the cannulated bone screw (analogous to 15; capable of engaging either interior of 15, or front face of 15, depending on size/shape of inferred 15 which the device is used with);
wherein the screw tip engagement device 14/17 is movable to pass through the first hollow channel of 11 such that the first end of the screw tip engagement device extends outside the third end of the first hollow channel as at fig. 2A-1, and such that the second end of the screw tip engagement device travels past and extends outside the fourth end of the first hollow channel as at fig. 2A-2; and
wherein the screw tip contact member of 17 is capable of engaging a screw tip of the cannulated bone screw outside of the cannula of the cannulated bone screw (analogous to engagement with a forward end of 15).
Regarding claim 19, the proximal screw engagement element 11 further comprises a first handle 12 that is rotatable relative to the screw tip engagement device (e.g. about the longitudinal axis thereof).
Regarding claim 20, the screw tip engagement device grasping element 13 further comprises a second handle (the enlarged button portion of 13 is formed as a handle).
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) 3 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kulper.
Regarding claims 3 and 14, Kulper has taught the limitations of claims 1 and 13, as above. Further, Kulper teaches forming the elongated body 14/17 of stainless steel or other materials. (col. 4, lines 60-65)
The particular alloy of the stainless steel is not taught.
It is noted that the instant application provides no reason or advantage for selection of this particular alloy of spring steel.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to form the Kulper elongate body of the claimed alloy, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice.
Claim(s) 9-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kulper in view of Krause et al. (US 2020/0289183 A1).
Regarding claims 9-11, Kulper teaches the limitations of claim 6 as above, but fails to teach the particular arrangement of the claimed gripping element.
Krause teaches a gripping element 100 for driving a flexible portion 140 and providing connection between the handle and a fastener (figs. 1, 10-13B). further comprises a second hollow channel extending through 100 at 130, wherein a portion analogous to the screw tip engagement device 140 proximate the first end extends into the second hollow channel 130. A distal end of 140 is considered to be in the form of a screw driver (e.g. for driving a fastener as at fig. 11B).
For purposes of rejecting making this combination to reject these claims, the flexible portion 140 of Krause is being treated as analogous to the screw tip engagement device 14/17 of Kulper.
It would have been obvious to one with ordinary skill in the art at the time of the invention to provide the Kulper device with a variety of different designs of actuation mechanisms. In this case, the actuator 13 would be replaced by the Krause design 140/130. Such would have been a modification from one type of known actuation design for moving two components longitudinally relative to one another for a functionally equivalent alternative design. One would have made the modification to provide a user with improved gripping on a T-handle as compared to the button design of Kulper.
Allowable Subject Matter
Claim 15 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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