DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application Nos. 61/463,037; 13/373,289; 61/456,649; 61/460,234; 12/924,802; 61/278,240; 61/336,911; 61/343,737 ; 61/395,564; 61/395,752; 61/396,390; 61/398,807; 61/400,504; 61/402,959; 61/403,696; 61/403,915; 12/802,849; 61/396,390; 61/270,754; 61/268,708 fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
The Application Nos. fail to disclose a pivotal bone anchor assembly comprising: a receiver including: interior interference surfaces formed integrally into the receiver below the discontinuous guide and advancement structure; and opposed interior recesses formed integrally into the receiver below the interior interference surfaces; and an insert including a pair of spaced-apart insert arms defining an insert channel alignable with the open channel of the receiver with outwardly-facing projections, and as per claims 1, 13, 19, and 21, 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, wherein upon a forced downward displacement of the insert within the central bore, the projections of the insert are configured to engage and be pushed at least partially past the opposed interior interference surfaces 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 surfaces and the projections on the insert in the second position. As such, claims 1-21 are not entitled to the benefit of the priority of the filing dates of the Application Nos.
Claim(s) 1-21 have been given the priority date of Application No. 61/460,267; December 29, 2010.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim(s) 1-21 is/are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 was amended on 1/22/2026 to include subject matter which was not described in the specification in such a way to reasonably convey to one skilled in the relevant art that at the time the inventor, at the time the application was filed, had possession of the claimed invention. In addition Claims 13, 19, and 21 were added as new claims on 1/22/2026 and include subject matter, which was not described in the specification in such a way to reasonably convey to one skilled in the relevant art that at the time the inventor, at the time the application was filed, had possession of the claimed invention.
Claim 1 includes limitations that the receiver includes: interior interference surfaces formed integrally into the receiver below the discontinuous guide and advancement structure; and opposed interior recesses formed integrally into the receiver below the interior interference surfaces; and the insert including a pair of spaced-apart insert arms with outwardly-facing projections, and 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, wherein upon a forced downward displacement of the insert within the central bore, the projections of the insert are configured to engage and be pushed at least partially past the opposed interior interference surfaces 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 surfaces and the projections on the insert in the second position. Claim 1 was amended to include the limitation that the “outwardly-facing projections located entirely below top surfaces of the insert arms”, which was not described in the specification in such a way to reasonably convey to one skilled in the relevant art that at the time the inventor, at the time the application was filed, had possession of the claimed invention. Based on the specification, see for example Figures 24 and 29, it appears that the top surfaces of the insert arms form the outwardly-facing projections that in an initial first position above the opposed interior recesses of the receiver and upon being forced downward displacement past the opposed interior interference surfaces 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.
Newly presented claims 13, 19, and 21, include limitations that the receiver including opposed interior interference surfaces formed integrally into the receiver below the discontinuous guide and advancement structure; and opposed interior recesses located adjacent to and below the opposed interior interference surfaces; and an insert including a pair of spaced-apart insert arms defining an insert channel alignable with the open channel of the receiver, a lower collet structure configured to engage the head of the bone attachment structure, and outwardly-facing projections, 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 recesses of the receiver, wherein upon a forced downward displacement of the insert within the central bore, the projections of the insert are configured to engage and be pushed past the opposed interior interference surfaces 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 surfaces in the receiver and the projections on the insert in the second position. New claims 13, 19, and 21 includes the limitation that the “outwardly-facing projections located entirely below top surfaces of the insert arms”, which was not described in the specification in such a way to reasonably convey to one skilled in the relevant art that at the time the inventor, at the time the application was filed, had possession of the claimed invention. Based on the specification, , see for example Figures 24 and 29, it appears that the top surfaces of the insert arms form the outwardly-facing projections that in an initial first position above the opposed interior recesses of the receiver and upon being forced downward displacement past the opposed interior interference surfaces 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.
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) 1-6, 12-21 is/are rejected under pre-AIA 35 U.S.C. 102(e) as being anticipated by Biedermann et al. (U.S. Pub. No. 2010/0234902 A1, hereinafter “Biedermann”).
Biedermann discloses, regarding claim 1, a pivotal bone anchor assembly (see Fig. 1) intended for securing a longitudinal connecting member (6) to a bone of a patient (via 1), the pivotal bone anchor assembly comprising: a receiver (5) including: a top (10), a bottom (11), and a vertical centerline axis (“M”) extending therebetween; a base portion having a bottom (see annotated Fig. 8 below) with a bottom opening (18); a pair of spaced-apart receiver arms (14a, 14b) extending upward from the base portion and terminating as free ends at the top thereof (e.g. ends at top 10); an open channel (13) between the receiver arms (see Fig. 1); a discontinuous guide and advancement structure (15) formed into interior surfaces of the receiver arms configured to mate with a closure top (7); an internal cavity (19) in the base portion communicating with the open channel (see Fig. 8); 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. 8); interior interference surfaces (170b) formed integrally into the receiver below the discontinuous guide and advancement structure (see Figs. 13g-h); and opposed interior recesses (170c) formed integrally into the receiver below the interior interference surfaces (see Fig. 13g); a bone attachment structure (1) including a head (3) configured for positioning into the internal cavity of the receiver (see Fig. 9), and a body (2) extending downward from the head configured for attachment to the bone (see Fig. 2); and an insert (8) including a pair of spaced-apart insert arms (see annotated Fig. 5 below) defining an insert channel (83) alignable with the open channel of the receiver (see Fig. 5) and outwardly-facing projections (180c) located entirely below top surfaces of the insert arms (see Fig. 13g), 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 Fig. 13g), wherein upon a forced downward displacement of the insert within the central bore, the projections of the insert are configured to engage and be pushed at least partially past the opposed interior interference surfaces 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 surfaces and the projections on the insert in the second position (see Fig. 13h).
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Regarding claim 2, wherein a lower surface (85)of the insert is configured to engage the head of the bone attachment structure (see Figs. 8-9).
Regarding claim 3, wherein the insert includes a lower collet structure (82) configured to capture the head of the bone attachment structure therein (see Fig. 9).
Regarding claim 4, wherein the outwardly-facing projections of the insert extend parallel with respect to the insert channel (see Fig. 13g).
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 Figs. 8-9).
Regarding claim 6, wherein after the insert is forced downwardly within the receiver, the receiver and the bone attachment structure are engaged in a non-floppy friction fit arrangement before securing the longitudinal connecting member (see para. [0052]).
Regarding claim 12, and further comprising the longitudinal connecting member (6), wherein the closure top includes a continuous guide and advancement structure (7) configured to threadably engage the discontinuous guide and advancement structure of the receiver to advance the closure top into the receiver channel upon rotation of the closure top relative to the receiver (see Figs. 1-2).
Biedermann discloses, regarding claim 13, a pivotal bone anchor assembly (see Fig. 1) intended for securing a longitudinal connecting member (6) to a bone of a patient (via 1), the pivotal bone anchor assembly comprising: a receiver (5) including: a top (10), a bottom (11), and a vertical centerline axis (“M”) extending therebetween; a base portion having a bottom (see annotated Fig. 8 above) with an opening (18); a pair of spaced- apart receiver arms (14a, 14b) extending upward above the base portion and terminating as free ends at the top thereof (e.g. ends at top 10); an open channel (13) between the receiver arms (see Fig. 1); a discontinuous guide and advancement structure (15) formed into interior surfaces of the receiver arms configured to mate with a closure top (7); an internal cavity (19) in the base portion communicating with the open channel (see Fig. 8); 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. 8); opposed interior interference surfaces (170b) formed integrally into the receiver below the discontinuous guide and advancement structure (see Figs. 13g-h); and
opposed interior recesses (170c) located adjacent to and below the opposed interior
interference surfaces (see Fig. 13g); a bone attachment structure (1) including a head (3) configured for positioning into the internal cavity of the receiver (see Fig. 9), and a body (2) extending downward from the head configured for attachment to the bone (see Fig. 2); and an insert (8) including a pair of spaced-apart insert arms (see annotated Fig. 5 above) defining an insert channel (83) alignable with the open channel of the receiver (see Fig. 5), a lower collet structure (82, see Fig. 5) configured to engage the head of the bone attachment structure (see Fig. 9), and outwardly-facing projections (180c) located entirely below top surfaces of the insert arms (see Figs. 13g-h), 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 recesses of the receiver (see Fig. 13g), wherein upon a forced downward displacement of the insert within the central bore, the projections of the insert are configured to engage and be pushed past the opposed interior interference surfaces 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 surfaces in the receiver and the projections on the insert in the second position (see Fig. 13h).
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 Figs. 8-9).
Regarding claim 15, wherein the lower collet structure of the insert is configured to capture the head of the bone attachment structure therein (see Fig. 9).
Regarding claim 16, wherein the outwardly-facing projections of the insert extend parallel with respect to the insert channel (see Fig. 13g).
Regarding claim 17, wherein the head of the bone attachment structure is pivotally retained in the internal cavity by a non-pivoting resiliently expandable structure engaged against a seating surface adjacent the opening in the base portion of the receiver (see para. [0052], see Fig. 13h).
Regarding claim 18, wherein the opposed interior recesses are integrally formed into the receiver arms (see Figs. 13g-h).
Biedermann discloses, regarding claim 19, a pivotal bone anchor assembly (see Fig. 1) intended for securing a longitudinal connecting member (6) to a bone of a patient (via 1), the pivotal bone anchor assembly comprising: a receiver (5) including: an upper portion (e.g. portion near 10), a base portion (e.g. portion near 11), and a vertical centerline axis (“M”) extending therebetween; the base portion having a bottom (see annotated Fig. 8 above) with a bottom opening (18); a pair of spaced-apart receiver arms (14a, 14b) extending upward along the upper portion and terminating as free ends at a top thereof (e.g. ends at top 10); an open channel (13) between the receiver arms (see Fig. 1); a discontinuous guide and advancement structure (15) formed into interior surfaces of the receiver arms configured to mate with a closure top (7); an internal cavity (19) in the base portion communicating with the open channel (see Fig. 8); 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. 8); an interior interference passage (170b) formed integrally into the receiver below the discontinuous guide and advancement structure (see Figs. 13g-h); and opposed interior recesses (170c) formed integrally into the receiver below the interior interference passage (see Fig. 13g); a bone attachment structure (1) including a head (3) configured for positioning into the internal cavity of the receiver (see Fig. 9), and a body (2) extending downward from the head configured for attachment to the bone (see Fig. 2); and an insert (8) including a pair of spaced-apart insert arms (see annotated Fig. 5 above) defining an insert channel (83) alignable with the open channel of the receiver (see Fig. 5) and outwardly-facing projections (180c) located entirely below top surfaces of the insert arms (see Figs. 13g-h), the insert configured for top loading between the receiver arms with the outwardly-facing projections in an initial first position above the opposed interior recesses of the receiver (see Fig. 13g), wherein upon a forced downward displacement of the insert within the central bore, the projections of the insert are configured to engage and be pushed at least partially past the opposed interior interference surfaces 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 surfaces and the projections on the insert in the second position (see Fig. 13h).
Regarding claim 20, wherein the insert comprises a size and shape having a length longer than a width thereof (see Fig. 8).
Biedermann discloses, regarding claim 21, a pivotal bone anchor assembly (see Fig. 1) intended for securing a longitudinal connecting member (6) to a bone of a patient (via 1) using a closure top (7); the pivotal bone anchor assembly comprising: a receiver (5) including: a top (10), a bottom (11), and a vertical centerline axis (“M”) extending therebetween; a base portion having a bottom (see annotated Fig. 8 above) with a bottom opening (18); a pair of spaced-apart receiver arms (14a, 14b) extending upward from the base portion and terminating as free ends at a top thereof (e.g. ends at top 10); an open channel (13) between the receiver arms (see Fig. 1); a discontinuous guide and advancement structure (15) formed into a central bore of the receiver adjacent to the top of the receiver arms configured to mate with the closure top (7); an internal cavity (19) in the base portion communicating with the open channel (see Fig. 8); 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 the central bore centered about the vertical centerline axis (see Fig. 8); interior surfaces (170b) with inwardly protruding opposed interior interference surfaces formed integrally thereon below the discontinuous guide and advancement structure (see Figs. 13g-h); and
opposed interior recesses (170c) formed integrally into the interior surfaces below the
opposed interference surfaces (see Fig. 13g); a bone attachment structure (1) including a head (3) configured for positioning into the internal cavity of the receiver (see Fig. 9), and a body (2) extending downward from the head configured for attachment to the bone (see Fig. 2); and an insert (8) including a pair of spaced-apart insert arms (see annotated Fig. 5 above) defining an insert channel (83) alignable with the open channel of the receiver (see Fig. 5) and outwardly-facing projections (180c) located entirely below top surfaces of the insert arms (see Figs. 13g-h), 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 Fig. 13g), wherein upon a forced downward displacement of the insert within the central bore, the projections of the insert are configured to engage and be pushed at least partially past the opposed interference surfaces 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 on the insert in the second position and at least one of the downwardly facing surfaces in the opposed interior recesses and the opposed interference surfaces in the receiver (see Fig. 13h).
Claim(s) 1-5, 7, 9-11, 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 (see Fig. 4) intended for securing a longitudinal connecting member (108) to a bone of a patient (via 106), the pivotal bone anchor assembly comprising: a receiver (104) including: a top (114), a bottom (118), and a vertical centerline axis (107) extending therebetween; a base portion having a bottom (see annotated Fig. 4 below) with a bottom opening (415); a pair of spaced-apart receiver arms (see annotated Fig. 4 below) extending upward from the base portion and terminating as free ends at the top thereof (see annotated Fig. 4 below); an open channel (101) between the receiver arms (see Fig. 2); a discontinuous guide and advancement structure formed into interior surfaces of the receiver arms (see annotated Fig. 7 below) configured to mate with a closure top (900); an internal cavity (see annotated Fig. 7 below) in the base portion communicating with the open channel (see Fig. 4); the bottom opening at the bottom in communication with the internal cavity (see Fig. 4), with the open channel, the internal cavity, and the bottom opening together defining a central bore centered about the vertical centerline axis (see Fig. 4); interior interference surfaces (see annotated Fig. 7 below) formed integrally into the receiver below the discontinuous guide and advancement structure (see annotated Fig. 7 below); and opposed interior recesses (715a,b) formed integrally into the receiver below the interior interference surfaces (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 extending downward from the head configured for attachment to the bone (see Fig. 4); and an insert (612) including a pair of spaced-apart insert arms (see annotated Fig. 7 below) defining an insert channel (e.g. channel in 612 that receives rod 108, see Fig. 7) alignable with the open channel of the receiver (Fig. 7) and outwardly-facing projections (613a,b) located entirely below top surfaces of the insert arms (see annotated Fig. 7 below), the insert configured for top loading within the central bore of the receiver (see para. [0038] “sleeve 612 is inserted preferably downward through housing 710”) with the outwardly-facing projections in an initial first position above the opposed interior recesses of the receiver (see para. [0038] e.g. during downward insertion and prior to being snapped into slots 715a,b), wherein upon a forced downward displacement of the insert within the central bore, the projections of the insert are configured to engage and be pushed at least partially past the opposed interior interference surfaces 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 surfaces and the projections on the insert in the second position (see Fig. 4, note that the opposed interior interference surfaces overlapping interference arrangement prevents the insert from moving back up above the interior recesses, see also para. [0038]).
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Regarding claim 2, wherein a lower surface (625, see Fig. 7B1) of the insert is configured to engage the head of the bone attachment structure (via 814, see Fig. 7).
Regarding claim 3, wherein the insert includes a lower collet structure (626) configured to capture the head of the bone attachment structure therein (via 814, see Fig. 7).
Regarding claim 4, wherein the outwardly-facing projections of the insert extend parallel with respect to the insert channel (see Fig. 7).
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] “Anchor member 106 may be inserted from bottom opening 415 of bore 116”).
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]).
Regarding claim 9, and further comprising a resilient retainer (814, see para. [0044] “resilient material”).
Regarding claim 10, wherein the retainer further comprises an open ring structure (see para. [0043] “C-ring”) configured for uploading into the internal cavity through the bottom opening in the base portion and to capture and hold the head of the
bone attachment structure within the internal cavity with the bone attachment structure
extending downward through the bottom opening (see para. [0046] “the collet can be compressed to allow the collet to be inserted through bottom opening 415”).
Regarding claim 11, wherein the open ring structure of the retainer includes a first end surface (e.g. top surface of 814) and a second end surface (e.g. bottom surface of 814) disposed in spaced relation to one another when the retainer is in a neutral non-compressed state (see Fig. 8).
Peterson discloses, regarding claim 13, a pivotal bone anchor assembly (see Fig. 4) intended for securing a longitudinal connecting member (108) to a bone of a patient (via 106), the pivotal bone anchor assembly comprising: a receiver (104) including: a top (114), a bottom (118), and a vertical centerline axis (107) extending therebetween; a base portion having a bottom (see annotated Fig. 4 above) with an opening (415); a pair of spaced- apart receiver arms (see annotated Fig. 4 above) extending upward above the base portion and terminating as free ends at the top thereof (see annotated Fig. 4 above); an open channel (101) between the receiver arms (see Fig. 2); a discontinuous guide and advancement structure formed into interior surfaces of the receiver arms (see annotated Fig. 7 above) configured to mate with a closure top (900); an internal cavity (see annotated Fig. 7 above) in the base portion communicating with the open channel (see Fig. 4); the opening at the bottom in communication with the internal cavity (see Fig. 4), 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. 4); opposed interior interference surfaces (see annotated Fig. 7 above) formed integrally into the receiver below the discontinuous guide and advancement structure (see annotated Fig. 7 above); and opposed interior recesses (715a,b) located adjacent to and below the opposed interior interference surfaces (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 extending downward from the head configured for attachment to the bone (see Fig. 4); and an insert (612) including a pair of spaced-apart insert arms (see annotated Fig. 7 above) defining an insert channel (e.g. channel in 612 that receives rod 108, see Fig. 7) alignable with the open channel of the receiver (Fig. 7), a lower collet structure (626) configured to engage the head of the bone attachment structure (via 814), and outwardly-facing projections (613a,b) located entirely below top surfaces of the insert arms (see annotated Fig. 7 above), the insert configured for top loading (see para. [0038] “sleeve 612 is inserted preferably downward through housing 710”) into an abutment position within the central bore of the receiver with the outwardly-facing projections positioned above the opposed interior recesses of the receiver (see para. [0038] e.g. during downward insertion and prior to being snapped into slots 715a,b), wherein upon a forced downward displacement of the insert within the central bore, the projections of the insert are configured to engage and be pushed past the opposed interior interference surfaces 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 surfaces in the receiver and the projections on the insert in the second position (see Fig. 4, note that the opposed interior interference surfaces overlapping interference arrangement prevents the insert from moving back up above the interior recesses, see also para. [0038]).
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] “Anchor member 106 may be inserted from bottom opening 415 of bore 116”).
Regarding claim 15, wherein the lower collet structure of the insert is configured to capture the head of the bone attachment structure therein (via 814).
Regarding claim 16, wherein the outwardly-facing projections of the insert extend parallel with respect to the insert channel (see Fig. 7).
Regarding claim 18, wherein the opposed interior recesses are integrally formed into the receiver arms (see Fig. 7).
Peterson discloses, regarding claim 19, a pivotal bone anchor assembly (see Fig. 4) intended for securing a longitudinal connecting member (108) to a bone of a patient (via 106), the pivotal bone anchor assembly comprising: a receiver (104) including: an upper portion (e.g. portion near 114), a base portion (e.g. portion near 118), and a vertical centerline axis (107) extending therebetween; the base portion having a bottom (see annotated Fig. 4 above) with a bottom opening (415); a pair of spaced-apart receiver arms (see annotated Fig. 4 above) extending upward along the upper portion and terminating as free ends at a top thereof (see annotated Fig. 4 above); an open channel (101) between the receiver arms (see Fig. 2); a discontinuous guide and advancement structure formed into interior surfaces of the receiver arms see annotated Fig. 7 above) configured to mate with a closure top (900); an internal cavity (see annotated Fig. 7 above) in the base portion communicating with the open channel (see Fig. 4); the bottom opening at the bottom in communication with the internal cavity (see Fig. 4), with the open channel, the internal cavity, and the opening together defining a central bore centered about the vertical centerline axis (see Fig. 4); an interior interference passage (see annotated Fig. 7 above, note interference surfaces) formed integrally into the receiver below the discontinuous guide and advancement structure (see annotated Fig. 7 above); and opposed interior recesses (715a,b) formed integrally into the receiver below the interior interference passage (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 extending downward from the head configured for attachment to the bone(see Fig. 4); and an insert (612) including a pair of spaced-apart insert arms (see annotated Fig. 7 above) defining an insert channel (e.g. channel in 612 that receives rod 108, see Fig. 7) alignable with the open channel of the receiver (Fig. 7) and outwardly-facing projections (613a,b) located entirely below top surfaces of the insert arms (see annotated Fig. 7 above), the insert configured for top loading (see para. [0038] “sleeve 612 is inserted preferably downward through housing 710”) between the receiver arms with the outwardly-facing projections in an initial first position above the opposed interior recesses of the receiver (see para. [0038] e.g. during downward insertion and prior to being snapped into slots 715a,b), wherein upon a forced downward displacement of the insert within the central bore, the projections of the insert are configured to engage and be pushed at least partially past the opposed interior interference surfaces 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 surfaces and the projections on the insert in the second position (see Fig. 4, note that the opposed interior interference surfaces overlapping interference arrangement prevents the insert from moving back up above the interior recesses, see also para. [0038]).
Regarding claim 20, wherein the insert comprises a size and shape having a length longer than a width thereof (see Fig. 7B1).
Peterson discloses, regarding claim 21, a pivotal bone anchor assembly (see Fig. 4) intended for securing a longitudinal connecting member (108) to a bone of a patient (via 106) using a closure top (102); the pivotal bone anchor assembly comprising: a receiver (104) including: a top (114), a bottom (118), and a vertical centerline axis (107) extending therebetween; a base portion having a bottom (see annotated Fig. 4 above) with a bottom opening (415); a pair of spaced-apart receiver arms (see annotated Fig. 4 above) extending upward from the base portion and terminating as free ends at a top thereof (see annotated Fig. 4 above); an open channel (101) between the receiver arms (see Fig. 2); a discontinuous guide and advancement structure formed into a central bore of the receiver adjacent to the top of the receiver arms (see annotated Fig. 7 above) configured to mate with the closure top (900 of 102); an internal cavity (see annotated Fig. 7 above) in the base portion communicating with the open channel (see Fig. 4); the bottom opening at the bottom in communication with the internal cavity (see Fig. 4), with the open channel, the internal cavity, and the bottom opening together
defining the central bore centered about the vertical centerline axis (see Fig. 4); interior surfaces with inwardly protruding opposed interior interference surfaces (see annotated Fig. 7 above) formed integrally thereon below the discontinuous guide and advancement structure (see annotated Fig. 7 above); and opposed interior recesses (715a,b) formed integrally into the interior surfaces below the opposed interference surfaces (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 extending downward from the head configured for attachment to the bone (see Fig. 4); and an insert (612) including a pair of spaced-apart insert arms (see annotated Fig. 7 above) defining an insert channel (e.g. channel in 612 that receives rod 108, see Fig. 7) alignable with the open channel of the receiver (Fig. 7) and outwardly-facing projections (613a,b) located entirely below top surfaces of the insert arms (see annotated Fig. 7 above), the insert configured for top loading (see para. [0038] “sleeve 612 is inserted preferably downward through housing 710”) 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. [0038] e.g. during downward insertion and prior to being snapped into slots 715a,b), wherein upon a forced downward displacement of the insert within the central bore, the projections of the insert are configured to engage and be pushed at least partially past the opposed interference surfaces 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 on the insert in the second position and at least one of the downwardly facing surfaces in the opposed interior recesses and
the opposed interference surfaces in the receiver (see Fig. 4, note that the opposed interior interference surfaces overlapping interference arrangement prevents the insert from moving back up above the interior recesses, see also para. [0038]).
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 Biedermann, as applied to claim 1 above, and in further view of Hammer et al. (U.S. Pub. No. 2006/0058788 A1, hereinafter “Hammer”).
Biedermann discloses all of the features of the claimed invention, as previously 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 (103D) 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 as made to modify the bone attachment structure in Biedermann 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.
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 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 (103D) 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 as 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892.
The following references disclose polyaxial bone anchor assemblies with interference structures:
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/M.C.G/ Examiner, Art Unit 3773 /EDUARDO C ROBERT/ Supervisory Patent Examiner, Art Unit 3773