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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 8/11/2026 has been entered.
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) 1-2, 5-15 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.
Claims 1 and 10 have been amended to recite the limitation “wherein the head of the bone fastener further includes a pair of planar surfaces extending perpendicularly outwardly from a bottom of the corresponding flat surfaces”, 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; since the specification does explicitly disclose that the pair of planar surfaces extend perpendicularly outward. While the drawings appear to show this feature, since they are not to scale, it cannot be determined if the planar surfaces extend exactly perpendicularly outward. For the purpose of compact prosecution, the limitation will be examined below under the assumption that the planar surfaces extend generally or substantially perpendicular from a bottom of the corresponding flat surfaces.
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, 5-6, 8, 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hammill, SR. et al. (U.S. Pub. No. 2011/0009911 A1, hereinafter “Hammill”) in view of Barry (U.S. Pub. No. 2011/0178559 A1, hereinafter “Barry”) and in view of Campbell et al. (U.S. Pub. No. 2017/0049482 A1, hereinafter “Campbell”).
Hammill discloses, regarding claim 1, an orthopedic fixation assembly (see Figs. 21G-21H) comprising:
a tulip head (30) having two arms (34, 36) defining a rod slot (e.g. U-shaped channel that receives rod 10) therebetween, a bore extending therethrough (see annotated Fig. 21G below), and a recess in an inner surface (see annotated Fig. 21G below);
a saddle (42) receivable in the bore of the tulip head (see annotated Fig. 21G below), the saddle having an upper surface defining a rod seat (53) aligned with the rod slot (see Fig. 21G);
a retaining clip (40), wherein the retaining clip is located at a bottom of the tulip head with excess clearance to allow the retaining clip to travel along the central axis of the tulip head (see annotated Figs. 21G-21H below); and
a bone fastener (12) having a head (20) receivable in the tulip head, through the retaining clip, and into the saddle (see Figs. 21A-21B).
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Regarding claim 9, wherein the retaining clip includes a split ring configured to fit in an internal groove in the tulip head and around a bottom of the screw head (see annotated Fig. 21G below).
Hammill in the embodiment shown in Figures 21A-21H, fails to explicitly disclose, regarding claim 1, wherein the retaining clip has a spherically tapered outer surface; and wherein the head of the bone fastener includes spherical surfaces in a direction of angulation and flat opposing surfaces parallel to the direction of angulation, and wherein the flat surfaces of the head engage with corresponding flat surfaces inside the saddle to restrict angulation of the bone fastener in a single direction; and regarding claim 1, wherein the head of the bone fastener further includes a pair of planar surfaces extending perpendicularly outwardly from a bottom of the corresponding flat surfaces; regarding claim 5, wherein the flat surfaces of the head and inside the saddle restrict rotation of the bone fastener about a central axis of the tulip; regarding claim 6, wherein orientation of the flat surfaces of the head and saddle parallel to the rod slot allow for coronal and axial corrections; regarding claim 8, wherein opposite sides of the saddle have flat surfaces configured to mate with corresponding flat surfaces inside the tulip head, thereby restricting the saddle from angling within the tulip head.
Hammill discloses in an alternative embodiment shown in Figures 26-31, wherein the bone fastener is wherein the head of the bone fastener includes spherical surfaces (see annotated Fig. 29 below) in a direction of angulation and flat opposing surfaces parallel to the direction of angulation (see annotated Fig. 27 below, see also para. [0117]), and wherein the flat surfaces of the head engage with corresponding flat surfaces (118) inside the saddle to restrict angulation of the bone fastener in a single direction (see para. [0117]); wherein the flat surfaces of the head and inside the saddle restrict rotation of the bone fastener about a central axis of the tulip (see Fig. 26, see para. [0117]); wherein orientation of the flat surfaces of the head and saddle parallel to the rod slot allow for coronal and axial corrections (see Figs. 26 and 31, see para. [0117]); wherein opposite sides of the saddle have flat surfaces configured to mate with corresponding flat surfaces inside the tulip head, thereby restricting the saddle from angling within the tulip head (see Fig. 26, see para. [0117]) in order to limit movement of the shaft relative to the tulip head to a single axis along one direction (see para. [0117]).
Barry discloses a bone screw assembly that limits pivoting to a single plane (see Fig. 26), wherein the head (340) of the bone fastener (304) includes flat surfaces (see annotated Fig. 26 below) with a pair of planar surfaces (342b) extending generally perpendicularly outwardly from a bottom of the corresponding flat surfaces (see annotated Fig. 26 below, see also para. [0130]) in order to provide a bearing surface to cooperate with different saddles (350, see Figs. 26, 28 and 30) to prevent the motion of the bone fastener in more than one plane (see para. [0130]), while enabling stops or limits for the motion of the bone fastener in the single plane (see para. [0134]).
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Campbell discloses a bone screw assembly that limits pivoting to a single plane (200, see Fig. 6, see also para. [0062]) with a retaining clip (230) and a saddle (240), wherein the saddle defines a rod seat (244) aligned with the rod slot (see Fig. 6) in order for the saddle to be sized and shaped to receive the rod (see para. [0060]), wherein the retaining clip has a spherically tapered outer surface (see para. [0061]) in order for the retaining clip to have a shape corresponding to the tulip head and the single plane rotation of the bone screw within the tulip head (see para. [0061]).
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the bone fastener and saddle in the embodiment shown in Figures 19-21H in Hammill to include spherical surfaces in a direction of angulation and flat opposing surfaces parallel to the direction of angulation, and wherein the flat surfaces of the head engage with corresponding flat surfaces inside the saddle in view of an alternative embodiment shown in Figures 26-31 in Hammill in order to limit movement of the shaft relative to the tulip head to a single axis along one direction. And to modify the bone fastener to have a pair of planar surfaces extending generally perpendicularly outwardly from a bottom of the corresponding flat surfaces in view of Barry in order to provide a bearing surface to cooperate with different saddles to prevent the motion of the bone fastener in more than one plane, while enabling stops or limits for the motion of the bone fastener in the single plane. And it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the retaining clip in Hammill to have a spherically tapered outer surface in view of Campbell in order for the saddle to be sized and shaped to receive the rod and in order for the retaining clip to have a shape corresponding to the tulip head and the single plane rotation of the bone screw within the tulip head.
Claim(s) 2 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hammill in view of Barry and in view of Campbell, as applied to claim 1 above, and in further view of Johnson et al. (U.S. Pub. No. 2007/0088357 A1, hereinafter “Johnson”).
Hammill in view of Barry and in view of Campbell disclose all of the features of the claimed invention, as previously set forth above, except regarding claim 2, wherein the tulip head pivots on the head of the bone fastener to allow for medial-lateral angulation; and regarding claim 7, wherein orientation of the flat surfaces of the head and saddle perpendicular to the rod slot allow for sagittal corrections.
Johnson discloses a bone anchor assembly (see Figs. 15-16), with a bone anchor (14) with flat surfaces (70) that are positioned so as to allow for medial-lateral angulation (θ, see Fig. 16), wherein the orientation of the flat surfaces allows for angulation perpendicular to the rod slot to allow for sagittal corrections (θ, see Fig. 16, see para. [0062]) in order to enable the bone anchor assembly to enable only pivoting movement along a single axis based on the surgeon desires and/or as dictated by a particular patient’s condition (see paras. [0063] and [0065]).
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the flat surfaces of the head of the bone fastener and saddle in Hammill in view of Barry and in view of Campbell to be positioned so as to allow for medial-lateral angulation, and allows for angulation perpendicular to the rod slot to allow for sagittal corrections in further view of Johnson in order to enable the bone anchor assembly to enable only pivoting movement along a single axis based on the surgeon desires and/or as dictated by a particular patient’s condition.
Claim(s) 10-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hammill, SR. et al. (U.S. Pub. No. 2011/0009911 A1, hereinafter “Hammill”) and in view of Barry (U.S. Pub. No. 2011/0178559 A1, hereinafter “Barry”).
Hammill discloses, regarding claim 10, an orthopedic fixation assembly (see Figs. 21G-21H) comprising:
a tulip head (30) having two arms (34, 36) defining a rod slot therebetween (e.g. U-shaped channel that receives rod 10), each of the arms defining an interior threaded portion along an inner surface (see annotated Fig. 21G below), the tulip head having a bore extending therethrough (see annotated Fig. 21G below);
a bone fastener (12) including a screw head (18) receivable in the tulip head and a shaft (14) configured for engaging bone (see Fig. 21A),
a saddle (42) having an upper surface defining a rod seat (53) aligned with the rod slot (see Fig. 21G) and a lower portion (56) configured for receiving the screw head (see Fig. 21G); and
a retaining clip (40) positioned in a groove in the tulip head and around a bottom of the screw head.
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Regarding claim 11, further comprising a spinal rod (70) receivable in the rod slot of the tulip head and the rod seat of the saddle (see Fig. 1).
Regarding claim 12, further comprising a locking cap (80) having an outer body defining an exterior thread (see annotated Fig. 1 below), wherein the locking cap is threadable between the two arms of the tulip head to secure the spinal rod therein (see Fig. 1).
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Regarding claim 13, wherein when the locking cap is threaded downwardly onto the spinal rod, the spinal rod pushes against the seat of the saddle, and the saddle secures the bone fastener (see para. [0110]).
Hammill in the embodiment shown in Figures 19-21H, fails to explicitly disclose, regarding claim 10, wherein the bone fastener is uni-planar; wherein the screw head has a plurality of flats engaged with corresponding flats in the lower portion of the saddle to restrict movement of the shaft relative to the tulip head to one direction; and wherein the head of the bone fastener further includes a pair of planar surfaces extending perpendicularly outwardly from a bottom of the corresponding flat surfaces.
Hammill discloses in an alternative embodiment shown in Figures 26-31, wherein the bone fastener is uni-planar (see para. [0117]); wherein the screw head has a plurality of flats (116) engaged with corresponding flats (118) in the lower portion of the saddle in order to limit movement of the shaft relative to the tulip head to a single axis along one direction (see para. [0117]).
Barry discloses a bone screw assembly that limits pivoting to a single plane (see Fig. 26), wherein the head (340) of the bone fastener (304) includes flat surfaces (see annotated Fig. 26 above) with a pair of planar surfaces (342b) extending generally perpendicularly outwardly from a bottom of the corresponding flat surfaces (see annotated Fig. 26 above, see also para. [0130]) in order to provide a bearing surface to cooperate with different saddles (350, see Figs. 26, 28 and 30) to prevent the motion of the bone fastener in more than one plane (see para. [0130]), while enabling stops or limits for the motion of the bone fastener in the single plane (see para. [0134]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to filed the bone fastener and saddle in the embodiment shown in Figures 19-21H in Hammill to be uni-planar with the screw head having a plurality of flats and the saddle having corresponding flats in view of an alternative embodiment shown in Figures 26-31 in Hammill in order to limit movement of the shaft relative to the tulip head to a single axis along one direction. And to modify the bone fastener to have a pair of planar surfaces extending generally perpendicularly outwardly from a bottom of the corresponding flat surfaces in view of Barry in order to provide a bearing surface to cooperate with different saddles to prevent the motion of the bone fastener in more than one plane, while enabling stops or limits for the motion of the bone fastener in the single plane.
Claim(s) 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hammill in view of Barry, as applied to claim 10-12 above, and in further view of Jackson (U.S. Pub. No. 2004/0167526 A1, hereinafter “Jackson”).
Hammill in view of Barry discloses all of the features of the claimed invention, as previously set forth above, except regarding claim 14, wherein the interior threaded portion of the tulip head includes downward projecting hooks and the exterior thread of the locking cap includes corresponding upward projecting hooks configured to intermesh; and regarding claim 15, wherein when threaded together, the downward and upward hooks form inward-facing surfaces, which point toward one another at each level of engagement.
Jackson discloses an orthopedic fixation assembly (9, see Fig. 9) with a tulip head (16) with arms (18) having interior threaded portions (22), wherein the interior threaded portion of the tulip head includes downward projecting hooks (see annotated Fig. 9 below) and the exterior thread of the locking cap (4) includes corresponding upward projecting hooks configured to intermesh (see annotated Fig. 9 below); and wherein when threaded together, the downward and upward hooks form inward-facing surfaces, which point toward one another at each level of engagement (see Fig. 9) in order to provide interlocking thread that when the closure is securely torqued provides resistance to translational and rotational movement of the rod relative to the bone screw; and provides an anti-splay fastener (see para. [0039]).
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It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the threaded portions in Hammill in view of Barry to include projecting hooks in further view of Jackson in order to in order to provide interlocking thread that when the closure is securely torqued provides resistance to translational and rotational movement of the rod relative to the bone screw; and provides an anti-splay fastener.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-2,5-15 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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If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Eduardo C. Robert, at (571) 272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.C.G/ Examiner, Art Unit 3773
/JAN CHRISTOPHER L MERENE/Primary Examiner, Art Unit 3773
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