DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
Claim(s) 1-5, 7, 13-16, 18-21 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Peterson et al. (U.S. Pub. No. 2008/0294202 A1, hereinafter “Peterson”).
Peterson discloses, regarding claim 1, a pivotal bone anchor assembly (100, see Fig. 1) intended for securing a longitudinal connecting member (108) to a bone of a patient, the pivotal bone anchor assembly comprising:
a receiver (104) including: a top (730), a bottom (718), and a vertical centerline axis extending therebetween (107); a base portion (see annotated Fig. 1 below) having a bottom (see annotated Fig. 1 below) with a bottom opening (415); a pair of spaced-apart receiver arms (see annotated Fig. 1 below) extending upward from-above the base portion with interior surfaces defining an open channel (101) configured to receive the longitudinal connecting member (see Fig. 1); a discontinuous guide and advancement structure (2738 a,b) formed into the interior surfaces configured to mate with a closure top (900, see Fig. 7, see para. [0054]); an internal cavity in the base portion communicating with the open channel (see annotated Fig. 7 below); the bottom opening at the bottom in communication with the internal cavity, with the open channel, the internal cavity, and the bottom opening together defining a central bore centered about the vertical centerline axis (see Fig. 7); inwardly-protruding interference structures (see Fig. 7) formed integrally into the receiver below the discontinuous guide and advancement structure (see annotated Fig. 7 below); and opposed interior recesses formed integrally into the receiver below the interior interference structures (see Fig. 7);
a bone attachment structure (106) including a head (717) configured for positioning into the internal cavity of the receiver (see Fig. 7), and a body (see annotated Fig. 1 below) extending downward from the head configured for attachment to the bone (see Fig. 1); and
an insert (612 and 814) including a pair of spaced-apart insert arms (615 a,b) defining an insert channel (610) alignable with the open channel of the receiver (see Fig. 7), outwardly-facing projections (613 a,b) spaced below top surfaces of the insert arms 622, see Fig. 7B1), and a discontinuous lower interior surface (824) with gaps (806) configured to directly engage the head of the bone attachment structure (see Fig. 7), the insert configured for top loading within the central bore of the receiver with the outwardly-facing projections in an initial first position above the opposed interior interference structures of the open channel of the receiver (see para. [0046] “inserted into the top opening”),
wherein upon a forced downward displacement of the insert within the central bore (see para. [0046] “pressed down until retention tabs 613a,b snap in retention slots 715a,b”), the projections of the insert are configured to engage and be pushed at least partially entirely past the opposed interior interference structures of the open channel of the receiver to a second position within the opposed interior recesses so as to inhibit the insert from moving back up within the receiver to the first position due to an overlapping interference arrangement between the opposed interior interference structures and the projections of the insert in the second position (see para. [0046]), and
wherein with the insert in the second position, the assembly is in an unlocked configuration (see para. [0049] “when the retention tabs 613, ab are received in the retaining slots 710a,b. With the sleeve interested, the anchor member preferably is still permitted to polyaxial angulate and rotate about longitudinal axis 107 of housing 710”).
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Regarding claim 2, wherein the head of the bone attachment structure further comprises a partial spherical outer surface extending above and below a hemisphere plane defined at a maximum width of the head (see annotated Fig. 36 below), and wherein the discontinuous lower interior surface of the insert is configured to extend below the hemisphere plane of the head of the bone attachment structure (see annotated Fig. 36 below).
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Regarding claim 3, wherein the insert includes a lower collet structure (626) configured to capture the head of the bone attachment structure therein (see para. [0044] via 814).
Regarding claim 4, wherein the outwardly-facing projections of the insert extend parallel with respect to the insert channel (see Fig. 7B2).
Regarding claim 5, wherein the head of the bone attachment structure is configured to be uploaded into the internal cavity through the bottom opening of the base portion (see para. [0046]).
Regarding claim 7, wherein positioning the outwardly-facing projections within the opposed interior recesses is configured to maintain alignment between the insert channel and the open channel of the receiver (see para. [0038] “cannot rotate”).
Peterson discloses, regarding 13, a pivotal bone anchor assembly (100, see Fig. 1) intended for securing a longitudinal connecting member (108) to a bone of a patient, the pivotal bone anchor assembly comprising: a receiver (104) including: a top (730), a bottom (718), and a vertical centerline axis (107) extending therebetween; a base portion (see annotated Fig. 1 above) having a bottom (see annotated Fig. 1 above) with an opening (415); a pair of spaced- apart receiver arms (see annotated Fig. 1 above) extending upward above the base portion with interior surfaces defining an open channel (101) configured to receive the longitudinal connecting member (see Fig. 1); a discontinuous guide and advancement structure (2738 a,b) formed into the interior surfaces configured to mate with a closure top (900, see Fig. 7, see para. [0054]); an internal cavity in the base portion communicating with the open channel (see annotated Fig. 7 above); the opening at the bottom in communication with the internal cavity, with the open channel, the internal cavity, and the opening at the bottom together defining a central bore centered about the vertical centerline axis (see Fig. 7); opposed inwardly-protruding interference structures formed integrally into the receiver below the discontinuous guide and advancement structure (see annotated Fig. 7 above); and opposed interior recesses located adjacent to and below the opposed interior interference structures (see annotated Fig. 7 above); a bone attachment structure (106) including a head (717) configured for positioning into the internal cavity of the receiver (see Fig. 7), and a body extending downward from the head configured for attachment to the bone (see annotated Fig. 1 above); and an insert (612 and 814) including a pair of spaced-apart insert arms (615 a,b) defining an insert channel (610) alignable with the open channel of the receiver (see Fig. 7), a lower collet structure (626) further having a discontinuous lower interior surface (824) with gaps (806) configured to directly engage the head of the bone attachment structure (see Fig. 7), outwardly-facing projections (613 a,b) spaced below top surfaces of the insert arms (622, see Fig. 7B1), the insert configured for top loading into an abutment position within the central bore of the receiver with the outwardly-facing projections positioned above the opposed interior interference structures of the open channel of the receiver (see para. [0046] “inserted into the top opening”), wherein upon a forced downward displacement of the insert within the central bore (see para. [0046] “pressed down until retention tabs 613a,b snap in retention slots 715a,b”), the projections of the insert are configured to engage and be pushed entirely past the opposed interior interference structures of the receiver to a second position within the opposed interior recesses so as to inhibit the insert from moving back up within the receiver to the abutment position due to an overlapping interference arrangement between the interior interference structures in the receiver and the projections of the insert in the second position (see para. [0046]).
Regarding claim 14, wherein the head of the bone attachment structure is configured to be uploaded into the internal cavity through the opening of the base portion (see para. [0046]).
Regarding claim 15, wherein the lower collet structure of the insert is configured to capture the head of the bone attachment structure therein (see para. [0044] via 814).
Regarding claim 16, wherein the outwardly-facing projections of the insert extend parallel with respect to the insert channel (see Fig. 7B2).
Regarding claim 18, wherein the opposed interior recesses are integrally formed into the receiver arms (see Fig. 7).
Peterson discloses, regarding 19, a pivotal bone anchor assembly (100, see Fig. 1) intended for securing a longitudinal connecting member (108) to a bone of a patient, the pivotal bone anchor assembly comprising: a receiver (104) including: an upper portion (see annotated Fig. 1 above), a base portion (see annotated Fig. 1 above), and a vertical centerline axis (107) extending therebetween; the base portion having a bottom (see annotated Fig. 1 above) with a bottom opening (415); a pair of spaced-apart receiver arms extending upward along the upper portion (see annotated Fig. 1 above) with interior surfaces defining an open channel (101) configured to receive the
longitudinal connecting member (see Fig. 7); a discontinuous guide and advancement structure (2738 a,b) formed into the interior surfaces configured to mate with a closure top (900); an internal cavity in the base portion communicating with the open channel (see annotated Fig. 7 above); the bottom opening at the bottom in communication with the internal cavity, with the open channel, the internal cavity, and the opening together defining a central bore centered about the vertical centerline axis (see Fig. 7); an interior interference passage formed integrally into the interior surfaces of the open channel (see annotated Fig. 7 above); and opposed interior recesses formed integrally into the receiver below the interior interference passage (see annotated Fig. 7 above); a bone attachment structure (106) including a head (717) configured for positioning into the internal cavity of the receiver (see Fig. 7), and a body extending downward from the head configured for attachment to the bone (see annotated Fig. 1 above); and an insert (612 and 814) including a pair of spaced-apart insert arms (615 a,b) defining an insert channel (101) alignable with the open channel of the receiver and outwardly-facing projections (613 a,b) spaced below top surfaces of the insert arms (see Fig. 7), and a discontinuous lower interior surface (824) configured to directly engage the head of the bone attachment structure (see Fig. 7), the insert configured for top loading between the receiver arms with the outwardly-facing projections in an initial first position above the opposed interior interference passage of the open channel of the receiver (see para. [0046]), wherein upon a forced downward displacement of the insert within the central bore (see para. [0046]), the projections of the insert are configured to engage and be pushed at least partially past the interior interference passage of the receiver to a second position within the opposed interior recesses so as to inhibit the insert from moving back up within the receiver to the first position due to an overlapping interference arrangement between the interior interference passage and the projections of the insert in the second position (see para. [0046]).
Regarding claim 20, wherein the insert comprises a size and shape having a length longer than a width thereof (see Fig. 7B3, since 628 is generally cylindrically shaped and portions 613a, b extend outwardly / elongate 628, it has a length between 613a,b longer than a width between the surfaces 628 along the channel 101).
Peterson discloses, regarding 21, a pivotal bone anchor assembly (100, see Fig. 1) intended for securing a longitudinal connecting member (108) to a bone of a patient using a closure top (900); the pivotal bone anchor assembly comprising: a receiver (104) including: a top (730), a bottom (718), and a vertical centerline axis extending therebetween (107); a base portion (see annotated Fig. 1 above) having a bottom (see annotated Fig. 1 above) with a bottom opening (415); a pair of spaced-apart receiver arms extending upward from the base portion (see annotated Fig. 1 above) with interior surfaces defining an open channel (101) configured to receive the longitudinal connecting member (see Fig. 1); a discontinuous guide and advancement structure (2738 a,b) formed into a central bore of the receiver and configured to mate with the closure top (900); an internal cavity in the base portion communicating with the open channel (see annotated Fig. 7 above); the bottom opening at the bottom in communication with the internal cavity, with the open channel, the internal cavity, and the bottom opening together defining the central bore centered about the vertical centerline axis (see Fig. 7); interior surfaces with inwardly protruding opposed interior interference structures formed integrally thereon (see annotated Fig. 7 above); and opposed interior recesses formed integrally into the interior surfaces below the opposed interference structures (see annotated Fig. 7 above); a bone attachment structure (106) including a head (717) configured for positioning into the internal cavity of the receiver (see Fig. 7), and a body extending downward from the head configured for attachment to the bone (see Fig. 1); and an insert (612 and 814) including a pair of spaced-apart insert arms (615a,b) defining an insert channel (101) alignable with the open channel of the receiver and outwardly-facing projections (613 a,b) spaced below top surfaces of the insert arms (622, see Fig. 7), and a discontinuous lower interior surface (824) configured to directly engage the head of the bone attachment structure (see Fig. 7), the insert configured for top loading within the central bore of the receiver with the outwardly-facing projections in an initial first position above the opposed interior recesses of the receiver (see para. [0046]), wherein upon a forced downward displacement of the insert within the central bore (see para. [0046]), the projections of the insert are configured to engage and be pushed at least partially past the opposed interior interference structures of the open channel of the receiver to a second position within the opposed interior recesses so as to inhibit the insert from moving back up within the receiver to the first position due to an overlapping interference arrangement between the projections of the insert in the second position and the opposed interference structures in the receiver (see para. [0046]).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 8 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Peterson, as applied to claim 1 above, and in further view of Hammer et al. (U.S. Pub. No. 2006/0058788 A1, hereinafter “Hammer”).
Peterson discloses all of the features of the claimed invention, as previously set forth above, except regarding claim 8, wherein the bone attachment structure is cannulated with a central bore extending an entire length of the bone attachment structure along the longitudinal axis.
Hammer discloses a bone anchor (103, see Fig. 2) that is cannulated (103 D) in order to enable a guide wire to be passed through the bone anchor to aid in guiding the bone anchor into position (see para. [0031]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the bone attachment structure in Peterson to be cannulated with a central bore extending a length of the bone attachment structure along the longitudinal axis in view of Hammer in order to enable a guide wire to be passed through the bone anchor to aid in guiding the bone anchor into position.
Allowable Subject Matter
Claim(s) 6, 9-12, 17 is/are 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.
Response to Arguments
Applicant's arguments filed with respect to the amendments to claims 1-5, 7, 9-11, 13-16 and 18-21 and the rejection under pre-AIA 35 U.S.C. 102(b) as being anticipated by Peterson et al. (U.S. Pub. No. 2008/0294202 A1) have been fully considered but they are not persuasive.
The Applicant asserts that Peterson fails to disclose the amendment “a discontinuous lower interior surface configured to directly engage the head of the bone attachment structure”. The Applicant asserts that in Peterson interior surface 824 of collet 814 frictionally engages and mates with the curved head 717 of the anchor instead of a discontinuous lower interior surface of the insert 612.
The Office respectfully disagrees, both 612 and 814 are inserted into the receiver and therefore can be considered an insert and since the collet (814) and the lower interior surface (824) of the collet (814) are discontinuous with the rest of the insert (612) and since the interior surface (824) directly engages the head of the bone attachment structure (717).
Applicant’s arguments, see pages 9-10, filed 8/19/2026, with respect to claims 1-21 as being rejected under 35 U.S.C. 112 (pre-AIA ) have been fully considered and are persuasive. The rejection of claims 1-21 as being rejected under 35 U.S.C. 112 (pre-AIA ) has been withdrawn.
Applicant’s arguments, see page 10, filed 8/19/2026, with respect to the amendments of claims 1-6 and 12-21 as being rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Biedermann (U.S. Pub. No. 2010/0234902 A1) have been fully considered and are persuasive. The rejection of claims 1-21 as being rejected under 35 U.S.C. 112 (pre-AIA ) has been withdrawn.
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.
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/M.C.G/
Examiner, Art Unit 3773
/EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773
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