DETAILED ACTION
This office action is responsive to the amendment filed January 22, 2026. By that amendment, claims 1, 2, 6, 8-10, and 17 were amended; claims 3-5, 7, 11, 12, 15 and 16 were canceled; and claims 21-31 were newly presented. Claims 1, 2, 6, 8-10, 13, 14, 17, and 21-31 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
Applicant’s arguments with respect to the rejections of claim(s) 1, 2, 6, 8-10 and 14 under 35 USC 102(a)(1) in view of Suzuki (US 2005/0265805 A1); and claims 13 and 17 under 35 USC 103 in view of Suzuki and Zastrozna (US 2018/0303529 A1) 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 January 22, 2026.
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, 6, 8-10, and 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stager et al. (US 7,963,732 B2).
Regarding claim 1, Stager teaches an anchor 301 at figs. 17 and 18 capable of being used in bone comprising a shank capable of being anchored in bone, the shank having a longitudinal axis and comprising:
a core 310;
a tip 312 at one end of the core 310 bone anchor 301; and
a thread 320 configured to engage bone, the thread forming a helix that extends around the core 310;
wherein a first recess 370 in a first turn 335 of the thread 320 forms a first cutting structure 372, and a second recess 354 in a second turn of the thread 320 forms a second cutting structure 350, with shapes of the first and second recesses being different from one another as seen in fig. 18, and wherein part of a surface 372 forming at least one of the first or second cutting structures faces at least partially towards either the tip or an end of the bone anchor opposite the tip; and
wherein each of the first and second cutting structures 372/350 is located closer axially to an end of the thread 320 that is closer to the tip 312 than to an opposite end of the thread 320, and wherein the first and second cutting structures 372/350 are spaced apart from one another by at least one full turn of the thread 320 that is devoid of any cutting structures.
Regarding claim 2, at least one of the first or second cutting structures 372/350 is formed by at least one substantially planar surface (surface of 350 facing 354).
Regarding claim 6, at least one of the first or second recesses 354 extends circumferentially around the shank of 301 for less than 1/2 of a full turn of the thread 320.
Regarding claim 8, one of the first or second cutting structures 372 is formed at a turn of the thread 335 that is closest to the tip 312.
Regarding claim 9, a first portion of the thread 320 is cylindrical (from the head up to the tip 312) and a second portion 312 of the thread 320 between the first portion and the tip is tapered, and wherein one of the first or second cutting structures 372 is close to a transition between the first and second portions. For purposes of reading on this claim, the “tip” will now be understood to be the portion, only, beyond where the thread ends as in fig. 18. Only a single alternative at each optional statement is required for the claim to be read upon.
Regarding claim 10, choosing various parts of the screw, the screw can be said to have a third portion of the core and/or the thread closest to the tip that is tapered, and a fourth portion of the core and/or the thread between the second and third portions that is cylindrical. (e.g. the screw can be ‘split’ longitudinally to identify these regions; as written, first and second can be read on by ‘threads’ and third and fourth can be read on by core structures; etc.).
Regarding claim 14, the shank of 301 is closed at the tip 312.
Claim(s) 21-27 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mobasser et al. (US 2014/0277193 A1).
Regarding claim 21, Mobasser teaches a bone anchor 10 comprising a shank as at fig. 1 capable of being anchored in bone, the shank having a longitudinal axis and comprising:
a core 12;
a tip 50 at one end of the bone anchor; and
a thread 32/22 capable of engaging bone, the thread forming a helix that extends around the core 12;
wherein the core 12 has a first narrowing portion 48 with an outer diameter that narrows gradually as the core extends axially towards the tip 50, a second narrowing portion 46 with an outer diameter that narrows gradually as the core extends axially towards the tip 50, and an intermediate portion 28 between the first and second narrowing portions 46/50 with an outer diameter that does not narrow as the core 12 extends axially towards the tip 50; and
wherein both the first and second narrowing portions 46/50 of the core 12 are located closer axially to the end of the bone anchor with the tip 50 than to the end of the bone anchor opposite the tip 18, and wherein the thread 32/22 extends over the first narrowing portion 48, the intermediate portion 28, and the second narrowing portion 46.
Regarding claim 22, the bone anchor 10 is monolithic as at fig.1.
Regarding claim 23, the tip 50 is formed as part of the second narrowing portion 46.
Regarding claim 24, the anchor 10 includes a cutting structure 44 formed in the thread 32/22.
Regarding claim 25, the cutting structure 44 is formed close to a transition between the second narrowing portion 46 and the intermediate portion 28.
Regarding claim 26, the core 12 further has a cylindrical portion 18 that extends from the first narrowing portion 48 towards the end 18 of the bone anchor opposite the tip 50, and wherein the cutting structure is formed close to a transition between the first narrowing portion 48 and the cylindrical portion 18. “Close to” is considered to be a relative term.
Regarding claim 27, the anchor includes a second cutting structure 38 that is formed at or close to a transition between the second narrowing portion 46 and the intermediate portion 28.
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) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stager in view of Zastrozna (US 2018/0303529 A1).
Regarding claim 13, Stager teaches the limitations of claim 1, as above, but does not teach the shank of 301 being cannulated and open at the tip to facilitate guiding of a wire or a sensor device through the shank and out of the tip.
Zastrozna teaches a screw having a self-cutting tip design with a cannula 12.
It would have been obvious to one with ordinary skill in the art at the time of the invention to form the Stager screw with a cannula as suggested by Zastrozna. One would have done so in order to permit the Stager screw to be able to interface with and be guided into a target location by a guiding structure (Zastrozna [0003]).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stager in view of Foreman (US 1,088,892).
Regarding claim 17, Stager teaches the limitations of claim 1, as above, but fails to teach at least part of the first and/or second recess 370/354 extending into the core.
Foreman teaches a tip design in a helically threaded screw as at fig. 3. The thread includes a recess 5 which extends into a core 1 of the screw.
It would have been obvious to one with ordinary skill in the art at the time of the invention modify the Stager screw’s recess 354 to extend into the core 310 of the screw 301. One would have done so as a matter of providing Stager’s screw with a design which is known to prevent accidental displacement of the screw (Foreman, col. 1, lines 10-14).
Claim(s) 28-31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Foreman (US 1,088,892) in view of French (US 2004/0253076 A1).
Regarding claims 28-31, Foreman teaches a bone anchor at fig. 1 comprising a shank 1 capable of being anchored in bone, the shank having a longitudinal axis and comprising:
a core of 1;
a tip (down in fig. 1, not shown, but inherently present) at one end of the bone anchor; and
a thread 2 capable of engaging bone, the thread 2 forming a helix that extends around the core of 1;
wherein a cutting structure 6 is formed by a recess 5 that extends from a first turn of the thread 2 into a portion of the core of 1 on which the first turn is formed; and
wherein the first turn of the thread 2 on which the cutting structure 6 is formed is spaced apart from a free end of the tip by at least one full turn of the thread 2 (choosing one of the structures 6 which is not at the tip).
Foreman’s screw fails tot each the cutting structure 6 being spaced apart from every other portion of the thread above or below the first turn. The cutting structures are formed at 360 degree intervals about the thread turns.
French teaches a device including a cutting structure 26 at every other thread turn as in fig. 1. As at [0032], the barbed sections can be formed every 720, 180, or 360 degrees, or other interval. French appears to be teaching that this is a matter of selection between functionally equivalent structures as at [0032].
It would have been obvious to one with ordinary skill in the art at the time of the invention to form the Foreman screw with a cutting structure formed on every second thread turn, or more (720 degree interval or greater). Such would have been selection between functionally equivalent designs.
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
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