DETAILED ACTION
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 6/22/2026 has been entered.
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.
Claim(s) 11 is/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.
Claim 11 recites the limitation “wherein the seat also includes a pair of legs defining a pair of opposing axially oriented channels arranged for receipt of the rod for locking the seat via the locking element” in lines 1-3 which renders the claim indefinite, since it is unclear if the pair of legs and pair of opposing axially oriented channels are an additional pair of legs and opposing axially oriented channels or refer back to the pair of legs and opposing axially oriented channels in lines 21-22 of claim 1 from which it depends. For the purpose of compact prosecution, the claim will be examined below as referring back to the pair of legs and opposing axially oriented channels introduced in claim 1, e.g. “wherein the seat includes the pair of legs defining the pair of opposing axially oriented channels arranged for receipt of the rod for locking the seat via the locking element”.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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) 1, 4-9, 11-12, 14-15, 17, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Biedermann et al. (U.S. Pub. No. 2010/0234902 A1, hereinafter “Biedermann”) in view of Chao et al. (U.S. Pub. No. 2011/0196431 A1, hereinafter “Chao”) and in view of Jackson et al. (U.S. Pub. No. 2020/0155202 A1, hereinafter “Jackson”).
Biedermann discloses, regarding claim 1, a pedicle screw assembly (see Figs. 1-2) of a modular construction (see Figs. 1-2, note multiple components) comprising: a bone screw (1) having a threaded bone shaft (2) adapted for insertion in a vertebra (see Fig. 1, see para. [0040]); an inner collet (8) configured in an operative position (see Fig. 11) to clamp about a head (3) of the bone screw (see para. [0048]), said head being substantially ball-shaped (3), wherein the inner collet includes a plurality of claw elements (see annotated Fig. 5 below) together configured in the inoperative position of the inner collet to permit tilting of the inner collet about the tilt axis of the head of the bone screw (see para. [0047]); a seat (5) arranged to provide seating for retention of the inner collet (via 9a-9b, see Fig. 8, see para. [0045]), the seat designed to tilt in conjunction with the inner collet in the inoperative position about the tilt axis (e.g. axis about which the bone anchor pivots, see para. [0047]) of the head of said bone screw (via 9a-9b, see Fig. 8, see para. [0045]); a rod (6, see Fig. 1) for securement to the seat (via 8, see Fig. 14); an inner collet actuator (7, see Fig. 1) configured to engage the seat (via threads 15) to activate the inner collet for movement into the operative position for clamping about the head of the bone screw to lock the inner collet and the seat to the head of said bone screw (see Fig. 14, see paras. [0048] and [0053]); the seat including (a) a pair of legs (14a-b) defining a pair of opposing and axially oriented channels (13) arranged for receipt of the rod for locking to the seat via the inner collet actuator (via internal threads 15), and (b) a recess (12) within which the inner collet seats for retention in either the inoperative (see Figs. 8-10) or operative positions (see Figs. 11-14), the inner collet being movable via the inner collet actuator from i) the inoperative position where the head of the bone screw is received within the inner collet with radial separation of the inner collet into the recess of the seat (see Figs. 8-10, see also annotated Fig. 8 below), to ii) the operative position where the head of the bone screw is clamped within the inner collet (see Figs. 11-14).
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Regarding claim 5, wherein the seat includes an aperture (18) formed continuous with the recess and arranged for receipt of the head of the bone screw into the inner collet which is retained in the inoperative position for seating in the recess of the seat (see Figs. 8-9).
Regarding claim 6, wherein the recess of the seat includes an annular rebate (19) configured, with the inner collet in the inoperative position, to permit the radial separation of the claw elements of the inner collet into the annular rebate on receipt of the head of the bone screw into the inner collet (see Fig. 9, see para. [0047]).
Regarding claim 7, wherein the seat includes an annular flange (16-17) defining the aperture through which the head of the bone screw is received (see Fig. 8), said flange configured with the inner collet in the operative position to urge the claw elements of the inner collet for clamping about the head of the bone screw (see Fig. 12).
Regarding claim 8, further comprising a locking element (7, see Fig. 1) operatively coupled to the seat to lock the rod to the seat (via threads 15, see Figs. 1-2).
Regarding claim 9, wherein the inner collet actuator serves as the locking element wherein the inner collet actuator is in the form of a set screw (7) arranged to engage the seat for activation of the inner collet and to lock the rod to the seat (see para. [0048]).
Regarding claim 11, wherein the seat includes the pair of legs (14a-b) defining the pair of opposing and axially oriented channels (13) arranged for receipt of the rod (6) for locking to the seat via the locking element (7, see Fig. 2).
Regarding claim 12, wherein the inner collet also includes a pair of legs (see annotated Fig. 5 above), said legs of the inner collet defining a pair of opposing and axially oriented channels (83) substantially aligned with the channels of the seat and arranged for receipt of the rod (see Fig. 14).
Regarding claim 14, wherein the set screw (7) of the inner collet actuator threadably engages (via 15) the legs of the seat for contact with the inner collet to effect its movement in a sliding action (via 9a-b within 84, see Figs. 8-14, see paras. [0047]-[0048]) from the inoperative position (see Fig. 8) to the operative position (see Fig. 14) where the annular flange of the seat contacts the claw elements of the inner collet for clamping about the head of the bone screw with increasing pressure (see Fig. 14).
Regarding claim 17, wherein the set screw of the inner collet actuator during movement of the inner collet from its inoperative to operative positions also effects locking of the rod to the seat (see Fig. 14, see paras. [0053]-[0054]).
Regarding claim 19, wherein the modular construction of the uniaxial pedicle screw assembly enables the uniaxial pedicle screw assembly to be intraoperatively installed (see Fig. 8, note bottom loading enables intraoperative installation).
Biedermann further discloses that the head of the bone screw can have another shape whereby a monoaxial bone screw is provided allowing rotation of the bone screw with respect to the seat around a single axis (see para. [0061]). However fails to explicitly disclose regarding claim 1, wherein the inner collet is a uniaxial inner collet; wherein the inner collet includes a pair of radially extending arms aligned with one another and arranged for seating within the pair of opposing channels of the seat, the pair of radially extending arms extending in a direction of the rod received within the channels of the seat thereby orienting the rod at a fixed angular disposition relative to the tilt axis of the head of the bone screw, and wherein the pair of radially extending arms rest at a base of the respective channels of the seat within which they are seated; wherein the head of the bone screw has a truncated surface arranged to cooperate with a corresponding bearing surface of the uniaxial inner collet in an inoperative position to permit tilting of the uniaxial inner collet about a tilt axis of the head of the bone screw; said angular disposition determined by the angular position of the bearing surface of the uniaxial inner collet relative to the pair of radially extending arms; the uniaxial inner collet being selected from either (1) a first uniaxial inner collet wherein said pair of radial arms are directionally parallel with the selected bearing surface of the uniaxial inner collet; wherein the rod is oriented substantially perpendicular with the tilt axis of the head of the bone screw about which the selected uniaxial inner collet in the operative position is arranged to tilt, or (2) a second uniaxial inner collet wherein the pair of radial arms of the selected uniaxial inner collet are directionally perpendicular with the bearing surface of said selected inner collet wherein the rod is oriented substantially parallel with the tilt axis of the head of the bone screw, and wherein one of the claw elements includes a bearing surface defining the corresponding bearing surface of the uniaxial inner collet configured to cooperate with the truncated surface of the head of the bone screw to permit tilting of the uniaxial inner collet in the inoperative position about the fixed tilt axis of the head of said bone screw; regarding claim 4, wherein the bearing surface of the claw element is one of a pair of opposing bearing surfaces formed in respective of an opposing pair of the plurality of claw elements, the pair of opposing bearing surfaces arranged to cooperate with respective of a pair of the truncated surfaces in the head of the bone screw; regarding claim 12, wherein the pair of legs of the uniaxial inner collet are disposed either side of the pair of radially extending arms; and regarding claim 15, wherein the radially extending arms of the inner collet are arranged to rest at a base of the respective channels of the seat within which they are seated when in the operative position the inner collet is clamped about the head of the bone screw with sufficient locking pressure.
Chao discloses a uniaxial pedicle screw assembly (see Fig. 5), wherein the head of the bone screw has a truncated surface (163, 165, see Fig. 5) arranged to cooperate with a corresponding bearing surface (e.g. flat inner side surfaces of 192, 194) of the uniaxial inner collet in an inoperative position to permit tilting of the uniaxial inner collet about a tilt axis of the head of the bone screw (see para. [0051]); said angular disposition determined by the angular position of the bearing surface of the uniaxial inner collet relative to the pair of radially extending arms (see Figs. 5-7, see para. [0051]); the uniaxial inner collet being selected from either (1) a first uniaxial inner collet wherein said pair of radial arms are directionally parallel with the selected bearing surface of the uniaxial inner collet (see Figs. 5-7, see para. [0051]); wherein the rod is oriented substantially perpendicular with the tilt axis of the head of the bone screw about which the selected uniaxial inner collet in the operative position is arranged to tilt (see Figs. 5-7, see para. [0051]), or (2) a second uniaxial inner collet wherein the pair of radial arms of the selected uniaxial inner collet are directionally perpendicular with the bearing surface of said selected inner collet wherein the rod is oriented substantially parallel with the tilt axis of the head of the bone screw (see para. [0052], note preferred r-r axis, however other pivot directions considered); wherein one of the claw elements (192 and 194) includes a bearing surface (e.g. flat inner surfaces of 192 and 194) defining the corresponding bearing surface of the uniaxial inner collet configured to cooperate with the truncated surface of the head of the bone screw to permit tilting of the uniaxial inner collet in the inoperative position about the fixed tilt axis of the head of said bone screw (see Figs. 5-7, see para. [0051]); wherein the bearing surface of the claw element is one of a pair of opposing bearing surfaces formed in respective of an opposing pair of the plurality of claw elements (see Figs. 5-7, see para. [0051]), the pair of opposing bearing surfaces arranged to cooperate with respective of a pair of the truncated surfaces in the head of the bone screw (see Figs. 5-7, see para. [0051]) in order to allow for controlled angulation between the bone screw and the seat in one selected direction about an axis, while preventing pivoting along other directions (see ABSTRACT, see para. [0051]).
Jackson discloses a bone anchor assembly (see Fig. 1) with a seat (100) and an inner collet (150), wherein the inner collet includes a pair of radially extending arms (180, see Fig. 11) aligned with one another and arranged for seating within the pair of opposing channels of the seat (see Fig. 46), the pair of radially extending arms extending in a direction of the rod received within the channels of the seat thereby orienting the rod at a fixed angular disposition relative to the tilt axis of the head of the bone screw (see Fig. 46), and wherein the pair of radially extending arms rest at a base of the respective channels of the seat within which they are seated (see annotated Fig. 46 below); wherein the pair of legs (154) of the uniaxial inner collet are disposed either side of the pair of radially extending arms (see Fig. 20); and wherein the radially extending arms of the inner collet are arranged to rest at a base of the respective channels of the seat within which they are seated when in the operative position the inner collet is clamped about the head of the bone screw with sufficient locking pressure (see annotated Fig. 46 below, see para. [0150]) in order to assist in aligning the channels (see para. [0115]) and provide a single load path for the rod (see para. [0152]).
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It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the bone screw assembly in Biedermann to have a uniaxial pedicle screw head with a truncated surface and to have a uniaxial inner collet with a corresponding bearing surface in view of Chao in order to allow for controlled angulation between the bone screw and the seat in one selected direction about an axis, while preventing pivoting along other directions. And it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the inner collet to include a pair of radially extending arms and to modify the seat to include a base in view of Jackson in order to assist in aligning the channels and provide a single load path for the rod.
Claim(s) 10 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Biedermann in view of Chao and in view of Jackson, as applied to claims 1, 8 and 10, as applied above, and in further view of Spratt et al. (U.S. Pub. No. 2014/0094849 A1, hereinafter “Spratt”).
Biedermann in view of Chao and in view of Jackson discloses all of the features of the claimed invention, as previously presented above, except regarding claim 10, wherein the inner collet actuator is independent of the locking element wherein the inner collet actuator is in the form of an external set screw arranged to engage the seat for activation of the inner collet, and the locking element is in the form of an internal set screw arranged to engage the external set screw for locking of the rod to the seat; and regarding claim 18, wherein the external set screw includes a threaded aperture within which the internal set screw is received for independent locking of the rod to the seat.
Spratt discloses a pedicle screw assembly (10, see Fig. 1), with an inner collet (60) and an inner collet actuator (16), wherein the inner collet actuator (16) comprises an external set screw (70) with a threaded aperture (102) and an inner set screw (72) received within the threaded aperture (see Fig. 3) in order to enable fixation of the spinal rod relative to the seat separate of fixation of the bone screw relative to the seat (see claim 1, see para. [0039]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the inner collet actuator in Biedermann in view of Chao and in view of Jackson to comprise an external set screw with a threaded aperture and an internal set screw in further view of Spratt in order to enable fixation of the spinal rod relative to the seat separate of fixation of the bone screw relative to the seat.
Claim(s) 13 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Biedermann in view of Chao and in view of Jackson, as applied to claims 1, 8 and 10, as applied above, and in further view of Garamszegi (U.S. Pub. No. 2008/0045953 A1, hereinafter “Garamszegi”).
Biedermann in view of Chao and in view of Jackson disclose all of the features of the claimed invention, as previously set forth above. Biedermann further discloses a protrusion (9a-b) and openings (84) that enable releasable retention and sliding movement between the seat and the inner collet (see paras. [0047]-[0048]). Biedermann in view of Chao and in view of Jackson fails to explicitly disclose, regarding claim 13, wherein each of the legs of the inner collet include a protrusion designed for releasable retention within a corresponding opening in the legs of the seat to retain the inner collet within the seat in both the inoperative and operative positions; and regarding claim 16, wherein the protrusion of each of the legs of the inner collet is retained for sliding movement within the corresponding opening of the legs of the seat during movement of the inner collet between the inoperative and operative positions.
Garamszegi discloses an alternative to a pin retention of an inner collet in a seat (see Fig. 15e), an inner collet (320, see Fig. 20A) and a seat (310), wherein each of the legs of the inner collet include a protrusion (335) designed for releasable retention within a corresponding opening (340) in the legs of the seat to retain the inner collet within the seat in both the inoperative and operative positions (see Fig. 20, see para. [0086]); and wherein the protrusion of each of the legs of the inner collet is retained for sliding movement within the corresponding opening of the legs of the seat during movement of the inner collet between the inoperative and operative positions (see Fig. 20, see para. [0086]) in order to enable the inner collet to be releasably retained within the seat and be retained for sliding movement in both the inoperative and operative positions (see para. [0086]) by providing flexible engagement between the walls of the seat to enable assembly of the inner collet by downwardly pushing the inner collet into the seat until the protrusions pop into the openings (see para. [0083]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the pins of the seat and the openings of the inner collet in Biedermann in view of Chao and in view of Jackson to be replaced with a protrusion on each of the legs of the inner collet and wherein the protrusion of each of the legs of the inner collet is retained for sliding movement within the corresponding opening of the legs of the seat during movement of the inner collet between the inoperative and operative positions in further view of Garamszegi in order to enable the inner collet to be releasably retained within the seat and be retained for sliding movement in both the inoperative and operative positions by providing flexible engagement between the walls of the seat to enable assembly of the inner collet by downwardly pushing the inner collet into the seat until the protrusions pop into the openings.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Biedermann et al. (U.S. Pub. No. 2010/0234902 A1, hereinafter “Biedermann”) in view of Chao et al. (U.S. Pub. No. 2011/0196431 A1, hereinafter “Chao”) and in view of Jackson et al. (U.S. Pub. No. 2020/0155202 A1, hereinafter “Jackson”) and in view of May et al. (U.S. Pub. No. 2018/0021068 A1, hereinafter “May”).
Biedermann discloses, regarding claim 20, a pedicle screw assembly (see Figs. 1-2) of a modular construction (see Figs. 1-2, note multiple components) comprising: a bone screw (1) having a threaded bone shaft (2) adapted for insertion in a vertebra (see Fig. 1, see para. [0040]); an inner collet (8) configured in an operative position (see Fig. 11) to clamp about a head (3) of the bone screw (see para. [0048]), said head being substantially ball-shaped (3) arranged to cooperate with the inner collet in an inoperative position to permit tilting of the inner collet about a tilt axis of the head of the bone screw (see para. [0047]), said inner collet including a plurality of claw elements (see annotated Fig. 5 above) together configured in the inoperative position of the inner collet to permit tilting of the inner collet about the tilt axis of the head of the bone screw (see para. [0047]), one of the claw elements configured to cooperate with the head of the bone screw to permit tilting of the inner collet (see para. [0047]), a seat (5) arranged to provide seating for retention of the inner collet (via 9a-9b, see Fig. 8, see para. [0045]), the seat designed to tilt in conjunction with the inner collet in the inoperative position about the tilt axis of the head of said bone screw (e.g. axis about which the bone anchor pivots, see para. [0047]) of the head of said bone screw (via 9a-9b, see Fig. 8, see para. [0045]); a rod (6, see Fig. 1) for securement to the seat (via 8, see Fig. 14); an inner collet actuator (7, see Fig. 1) configured to engage the seat (via threads 15) to activate the inner collet for movement into the operative position for clamping about the head of the bone screw to lock the inner collet and the seat to the head of said bone screw (see Fig. 14, see paras. [0048] and [0053]); the seat including (a) a pair of legs (14a-b) defining a pair of opposing and axially oriented channels (13) arranged for receipt of the rod for locking to the seat via the inner collet actuator (via internal threads 15), and (b) a recess (12) within which the inner collet seats for retention in either the inoperative (see Figs. 8-10) or operative positions (see Figs. 11-14), the inner collet being movable via the inner collet actuator from i) the inoperative position where the head of the bone screw is received within the inner collet with radial separation the plurality of claw elements of the inner collet into the recess of the seat (see Figs. 8-10, see also annotated Fig. 8 below), to ii) the operative position where the head of the bone screw is clamped within the inner collet with the clamping of the plurality of the claw elements about the head of the bone screw (see Figs. 11-14).
Biedermann further discloses that the head of the bone screw can have another shape whereby a monoaxial bone screw is provided allowing rotation of the bone screw with respect to the seat around a single axis (see para. [0061]). However fails to explicitly disclose regarding claim 20, wherein the inner collet is a uniaxial inner collet, wherein the uniaxial inner collet is selected from a first uniaxial inner collet or a second uniaxial inner collet; wherein the inner collet including a pair of radially extending arms aligned with one another and arranged for seating within the pair of opposing channels of the seat thereby orienting the rod at a fixed angular disposition relative to the tilt axis of the head of the bone screw; said angular disposition determined by the angular position of the bearing surface of the inner collet relative to the pair of radially extending arms; and the seat being operable with (1) the first uniaxial inner collet wherein said pair of radial arms are directionally parallel with the selected bearing surface of the uniaxial inner collet; wherein the rod is oriented substantially perpendicular with the tilt axis of the head of the bone screw about which the selected uniaxial inner collet in the operative position is arranged to tilt, and (2) the second uniaxial inner collet wherein the pair of radial arms of the selected uniaxial inner collet are directionally perpendicular with the bearing surface of said selected inner collet wherein the rod is oriented substantially parallel with the tilt axis of the head of the bone screw; wherein the head of the bone screw includes a truncated surface arranged to cooperate with a corresponding bearing surface of the inner collet; and wherein one of the claw elements includes a bearing surface defining the corresponding bearing surface of the uniaxial inner collet configured to cooperate with the truncated surface of the head of the bone screw to permit tilting of the uniaxial inner collet in the inoperative position about the fixed tilt axis of the head of said bone screw.
Chao discloses a uniaxial pedicle screw assembly (see Fig. 5), wherein the head of the bone screw has a truncated surface (163, 165, see Fig. 5) arranged to cooperate with a corresponding bearing surface (e.g. flat inner side surfaces of 192, 194) of the uniaxial inner collet in an inoperative position to permit tilting of the uniaxial inner collet about a tilt axis of the head of the bone screw (see para. [0051]); said angular disposition determined by the angular position of the bearing surface of the uniaxial inner collet relative to the pair of radially extending arms (see Figs. 5-7, see para. [0051]); the uniaxial inner collet being selected from either (1) a first uniaxial inner collet wherein said pair of radial arms are directionally parallel with the selected bearing surface of the uniaxial inner collet (see Figs. 5-7, see para. [0051]); wherein the rod is oriented substantially perpendicular with the tilt axis of the head of the bone screw about which the selected uniaxial inner collet in the operative position is arranged to tilt (see Figs. 5-7, see para. [0051]), or (2) a second uniaxial inner collet wherein the pair of radial arms of the selected uniaxial inner collet are directionally perpendicular with the bearing surface of said selected inner collet wherein the rod is oriented substantially parallel with the tilt axis of the head of the bone screw (see para. [0052], note preferred r-r axis, however other pivot directions considered); wherein one of the claw elements (192 and 194) includes a bearing surface (e.g. flat inner surfaces of 192 and 194) defining the corresponding bearing surface of the uniaxial inner collet configured to cooperate with the truncated surface of the head of the bone screw to permit tilting of the uniaxial inner collet in the inoperative position about the fixed tilt axis of the head of said bone screw (see Figs. 5-7, see para. [0051]); wherein the bearing surface of the claw element is one of a pair of opposing bearing surfaces formed in respective of an opposing pair of the plurality of claw elements (see Figs. 5-7, see para. [0051]), the pair of opposing bearing surfaces arranged to cooperate with respective of a pair of the truncated surfaces in the head of the bone screw (see Figs. 5-7, see para. [0051]) in order to allow for controlled angulation between the bone screw and the seat in one selected direction about an axis, while preventing pivoting along other directions (see ABSTRACT, see para. [0051]).
Jackson discloses a bone anchor assembly (see Fig. 1) with a seat (100) and an inner collet (150), wherein the inner collet includes a pair of radially extending arms (180, see Fig. 11) aligned with one another and arranged for seating within the pair of opposing channels of the seat (see Fig. 46), the pair of radially extending arms extending in a direction of the rod received within the channels of the seat thereby orienting the rod at a fixed angular disposition relative to the tilt axis of the head of the bone screw (see Fig. 46), and wherein the pair of radially extending arms rest at a base of the respective channels of the seat within which they are seated (see annotated Fig. 46 above); wherein the pair of legs (154) of the uniaxial inner collet are disposed either side of the pair of radially extending arms (see Fig. 20); and wherein the radially extending arms of the inner collet are arranged to rest at a base of the respective channels of the seat within which they are seated when in the operative position the inner collet is clamped about the head of the bone screw with sufficient locking pressure (see annotated Fig. 46 above, see para. [0150]) in order to assist in aligning the channels (see para. [0115]) and provide a single load path for the rod (see para. [0152]).
May discloses a pedicle screw assembly (see Figs. 20-21), wherein the assembly is provided as a kit (see para. [0081]) with inner collets (334 and 434) selected from the kit (see para. [0081]), wherein the uniaxial inner collet is selected from a first uniaxial inner collet (see Fig. 20) or a second uniaxial inner collet (see Fig. 21); the first uniaxial inner collet the rod is oriented substantially perpendicular with the tilt axis of the head of the bone screw about which the selected uniaxial inner collet in the operative position is arranged to tilt (see Fig. 20, note tilt axis defined by orientation of elongated slot 494, which is perpendicular to the rod), and (2) the second uniaxial inner collet the rod is oriented substantially parallel with the tilt axis of the head of the bone screw (see Fig. 21, note tilt axis defined by orientation of elongated slot 496, which is parallel to the rod) in order to provide alternative inner collets to provide the bone fastener with different first and second selected movements (see paras. [0081] and [0083]) and prevent movement along other unselected movements (see paras. [0085]-[0086]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the bone screw assembly in Biedermann to have a uniaxial pedicle screw head with a truncated surface and to have a uniaxial inner collet with a corresponding bearing surface in view of Chao in order to allow for controlled angulation between the bone screw and the seat in one selected direction about an axis, while preventing pivoting along other directions. And it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the inner collet to include a pair of radially extending arms and to modify the seat to include a base in view of Jackson in order to assist in aligning the channels and provide a single load path for the rod. And it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the pedicle screw assembly in Biedermann to include a kit with a plurality of inner collets, wherein the inner collet is selected from a first uniaxial inner collet or a second uniaxial inner collet; the first uniaxial inner collet the rod is oriented substantially perpendicular with the tilt axis of the head of the bone screw about which the selected uniaxial inner collet in the operative position is arranged to tilt, and the second uniaxial inner collet the rod is oriented substantially parallel with the tilt axis of the head of the bone screw in view of May in order to provide alternative inner collets to provide the bone fastener with different first and second selected movements and prevent movement along other unselected movements.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 4-20 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michelle C. Green whose telephone number is (571)270-7051. The examiner can normally be reached on Monday-Friday between 9am-5pm.
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/M.C.G/ Examiner, Art Unit 3773
/JAN CHRISTOPHER L MERENE/Primary Examiner, Art Unit 3773
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