DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Rejections - 35 USC § 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.
Claims 5 and 26 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.
Claims 5 and 26 each recite “wherein the upper capture portion of the cannulated screw shank includes an integral drive structure formed therein”. However, claims 3 and 24 each recite an internal drive socket formed in the upper capture portion of the cannulated screw shank. Therefore, it is unclear whether claims 5 and 26 intend to further limit the internal drive socket or whether they introduce an additional drive structure. For examination purposes, the office considers claims 5 and 26 to further limit the internal drive socket of claims 3 and 24.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim 3-6, 8-13, 15, 16, 18, and 24-26 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Barker et al. (Pat. No. US 6,280,442 B1) in view of in view of Jackson (Pub. No. US 2005/0228379 A1) and further in view of Ensign et al. (Pub. No. US 2006/0241600 A1).
Regarding claims 3 and 4, Barker et al. discloses a method of assembling a polyaxial bone anchor into a bone of a patient in-vivo with a holding tool (col. 5, lines 14-20) and connecting to a rod (col. 8, lines 33-43), the polyaxial bone anchor comprising a screw shank 50, a receiver30, a retainer 90, a compression insert 70, and a closure top 120 (figure 7), the method comprising: obtaining the screw shank 50 comprising an upper capture portion 54 having a partial spherical outer surface extending outwardly and upwardly from a neck portion (figure 7), an anchor portion 52 opposite the upper capture portion 54 configured for implantation into the bone (figure 4A), and an internal drive socket 60 formed in the upper capture portion to a distal end of the anchor portion (figure 4B); obtaining the receiver 30 comprising a pair of arms 42, 43 extending upwards from a base 36 to define an open channel 45 configured to receive the rod, front and back faces of the receiver defined in part by parallel front planar surfaces and parallel back planar surfaces on the arms (illustrated in figures 3A-3D), and a tool engagement structure 46 formed into and extending horizontally at least partially across an outer side surface of each of the pair of arms 42, 43 (figures 3A and 3C), each of the tool engagement structures 46 being spaced from a top surface of the arm and having an outwardly-facing surface spaced apart from the front planar surfaces and the back planar surfaces on the arms (figures 3A-3C), the base 36 including an internal cavity 38 communicating with the open channel 45 to define an axial bore centered about a vertical centerline axis (figure 3C); implanting the anchor portion 52 of the screw shank into the bone of the patient (col. 8, lines 34-44); holding the tool engagement structures 46 of the receiver 30 with the holding tool (col. 5, lines 14-20); with the screw shank 50 in the bone of the patient, connecting the receiver 30, the compression insert 70, and the retainer 90 to the upper capture portion 54 of the screw shank 50 to assemble the polyaxial bone anchor (col. 8, lines 34-44), the retainer 90 being positioned within the internal cavity and having an inner surface configured to receive and pivotably support the upper capture portion 54 of the screw shank 50 within the internal cavity of the receiver 30 (figure 7), the compression insert 70 being positioned within the axial bore above the retainer 90 and having an upper surface 72 configured to engage the rod (figure 7); and securing the polyaxial bone anchor 50 to the rod R by engaging an outer cylindrical surface on the rod with the upper surface 72 of the compression insert 70 and by rotatably downwardly positioning the closure top 120 into the open channel 45 of the receiver 30 above the rod R (figure 7).
Regarding claim 5, the upper capture portion 54 of the screw shank includes an integral drive structure 60 formed therein (figure 7).
Regarding claims 6, the retainer 90 further comprises a resilient retainer having a through-and-through gap extending from a bottom surface to a top surface (figure 6A; col .7, lines 1-2).
Regarding claim 8, the retainer 90 is pivotal with respect to the receiver 30 (col. 6, lines 42-47- when the diameter of the retainer is less than the diameter of the groove, it can pivot within the groove by rotating back and forth about its central axis).
Regarding claim 9, the upper surface 72 of the compression insert 70 configured to engage the rod further comprises a planar surface (figures 5A-5C).
Regarding claim 10, the compression insert 70 includes a lower surface 78 configured to engage the partial spherical outer surface of the upper capture portion 54 of the screw shank 50 (figure 7).
Regarding claim 11, the axial bore of the receiver 30 extends upward from a lower opening of the base through to the top surfaces of the arms (figure 3C).
Regarding claim 12, a tool engaging aperture 46 extends into the outer side surface of each of the pair of arms (figure 3B).
Regarding claim 13, the receiver 30 includes a lower opening 35 configured to allow uploading of the upper capture portion 54 of the cannulated screw shank into the receiver (col 8, lines 34-44).
Regarding claim 15, the receiver 30 includes an internal helically wound splay-limiting thread form 44 configured to mate with a complementary thread form on the closure top 120 so as to lock the rod R in the receiver (figure 7).
Regarding claim 18, the compression insert 70 is configured to engage the retainer 90 (i.e. prior to assembly, the compression insert and retainer can be engaged).
Barker et al. discloses the claimed invention except wherein the screw shank is cannulated by a central bore extending an entire length of the cannulated screw shank; and wherein the receiver is connected to the cannulated screw shank while holding the receiver with the holding tool; wherein the method comprises holding the tool engagement structures of the receiver with the holding tool to assemble the cannulated polyaxial bone anchor; wherein the cannulated screw shank is implanted into the bone of the patient over an end of a guide structure (claim 4).
Jackson teaches wherein a holding tool is used during the assembly of the polyaxial bone anchor; wherein the method comprises holding the tool engagement structures of the receiver with the holding tool to assemble the cannulated polyaxial bone anchor (paragraph 0042 and 0056).
Ensign et al. teaches wherein a screw shank 110 is cannulated along its entire length, and wherein the cannulated screw shank is inserted into the bone of the patient over the end of a guide wire, for the purpose of providing precise placement of the pedicle screw (paragraph 0030).
It would have been obvious to a person having ordinary skill in the art at the time the invention was made to modify the method disclosed by Barker et al. such that a holding tool is used during the assembly of the polyaxial bone anchor; wherein the method comprises holding the tool engagement structures of the receiver with the holding tool to assemble the cannulated polyaxial bone anchor (paragraph 0042 and 0056), as taught by Jackson, in order to stabilize the subassembly during assembly with the screw shank and make assembly easier for the user.
It would have been further obvious to a person having ordinary skill in the art at the time the invention was made to modify the method disclosed by Barker et al. and Jackson to comprise inserting the screw shank into the bone of the patient over the end of a guide wire (claim 4), wherein the screw shank is cannulated over its entire length, as taught by Ensign et al., in order to provide precise placement of the pedicle screw.
Regarding claim 16, Barker et al. as modified by Jackson disclose the claimed invention except wherein the assembly is secured to the bone of the patient in a percutaneous or minimally invasive surgical manner.
However, Ensign teaches wherein the assembly 100 is percutaneously implanted (paragraph 0029).
It would have been obvious to a person having ordinary skill in the art at the time the invention was made to modify the method to include securing the assembly to the bone in a percutaneous manner, as taught by Ensign (paragraph 0029), for the purpose of minimizing damage to the patient’s tissue and allowing for a faster recovery.
Regarding claims 24 and 25, Barker et al. discloses a method of assembling a polyaxial bone anchor into a bone of a patient in-vivo with a holding tool (col. 5, lines 14-20) and connecting to a rod (col. 8, lines 33-43), the polyaxial bone anchor comprising a screw shank 50, a receiver 30, a resilient retainer 90, a compression insert 70, and a closure top 120 (figure 7), the method comprising: obtaining the screw shank 50 comprising an upper capture portion 54 having a partial spherical outer surface extending outwardly and upwardly from a neck portion (figure 7), an anchor portion 52 opposite the upper capture portion 54 configured for implantation into the bone (figure 4A), and an internal drive socket 60 formed in the upper capture portion to a distal end of the anchor portion (figure 4B); obtaining the receiver 30 comprising a pair of arms 42, 43 extending upwards from a base 36 to define an open channel 45 configured to receive the rod, front and back faces of the receiver defined in part by parallel front planar surfaces and parallel back planar surfaces on the arms (illustrated in figures 3A-3D), and a tool engagement structure 46 formed into and extending horizontally at least partially across an outer side surface of each of the pair of arms 42, 43 (figures 3A and 3C), each of the tool engagement structures 46 being spaced from a top surface of the arm and having an outwardly-facing surface spaced apart from the front planar surfaces and the back planar surfaces on the arms (figures 3A-3C), the base 36 including an internal cavity 38 communicating with the open channel 45 to define an axial bore centered about a vertical centerline axis (figure 3C); implanting the anchor portion 52 of the screw shank into the bone of the patient (col. 8, lines 34-44); holding the tool engagement structures 46 of the receiver 30 with the holding tool (col. 5, lines 14-20); with the screw shank 50 in the bone of the patient, connecting the receiver 30, the compression insert 70, and the resilient retainer 90 to the upper capture portion 54 of the screw shank 50 to assemble the polyaxial bone anchor (col. 8, lines 34-44), the resilient retainer 90 having a through and through gap 91 and an inner surface configured to receive and pivotably support the upper capture portion 54 of the screw shank 50 (figure 6A; col .7, lines 1-2) within the internal cavity of the receiver 30 (figure 7), the compression insert 70 being positioned within the axial bore above the resilient retainer 90 and having an upper surface 72 configured to engage the rod (figure 7); and securing the polyaxial bone anchor 50 to the rod R by engaging an outer cylindrical surface on the rod with the upper surface 72 of the compression insert 70 and by rotatably downwardly positioning the closure top 120 into the open channel 45 of the receiver 30 above the rod R (figure 7).
Regarding claim 26, the upper capture portion 54 of the screw shank includes an integral drive structure 60 formed therein (figure 7).
Barker et al. discloses the claimed invention except wherein the screw shank is cannulated by a central bore extending an entire length of the cannulated screw shank; wherein the method comprises holding the tool engagement structures of the receiver with the holding tool to assemble the cannulated polyaxial bone anchor; wherein the cannulated screw shank is implanted into the bone of the patient over an end of a guide structure (claim 4).
Jackson teaches wherein a holding tool is used during the assembly of the polyaxial bone anchor; wherein the method comprises holding the tool engagement structures of the receiver with the holding tool to assemble the cannulated polyaxial bone anchor (paragraph 0042 and 0056).
Ensign et al. teaches wherein a screw shank 110 is cannulated along its entire length, and wherein the cannulated screw shank is inserted into the bone of the patient over the end of a guide wire, for the purpose of providing precise placement of the pedicle screw (paragraph 0030).
It would have been obvious to a person having ordinary skill in the art at the time the invention was made to modify the method disclosed by Barker et al. such that a holding tool is used during the assembly of the polyaxial bone anchor; wherein the method comprises holding the tool engagement structures of the receiver with the holding tool to assemble the cannulated polyaxial bone anchor (paragraph 0042 and 0056), as taught by Jackson, in order to stabilize the subassembly during assembly with the screw shank and make assembly easier for the user.
It would have been further obvious to a person having ordinary skill in the art at the time the invention was made to modify the method disclosed by Barker et al. and Jackson to comprise inserting the screw shank into the bone of the patient over the end of a guide wire (claim 4), wherein the screw shank is cannulated over its entire length, as taught by Ensign et al., in order to provide precise placement of the pedicle screw.
Claim 7 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Barker et al. (Pat. No. US 6,280,442 B1) in view of in view of Jackson (Pub. No. US 2005/0228379 A1) in view of Ensign et al. (Pub. No. US 2006/0241600 A1) and further in view of Matthis et al. (Pub. No. US 2007/0055240 A1).
Regarding claim 7, Barker as modified by Jackson and Ensign discloses the claimed invention except wherein assembling the rod-engaging insert in the receiver comprises top-loading the retainer into the receiver.
However, Matthis et al.’240 teaches that assembling the rod engaging insert 3 in the receiver comprises top-loading the retainer into the receiver (figures 1 and 2).
It would have been obvious to a person having ordinary skill in the art at the time the invention was made to modify the method disclosed by Barker, Ensign, and Jackson such that assembling the rod-engaging insert in the receiver comprises top-loading the retainer into the receiver, as taught by Matthis, in order to prevent the retainer from falling out of the bottom opening during assembly with the screw shank.
Claim 23 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Barker et al. (Pat. No. US 6,280,442 B1) in view of Ensign et al. (Pub. No. US 2006/0241600 A1) in view of Sasing (Pub. No. US 2006/0149232 A1) and further in view of Jackson (Pub. No. US 2005/0228379 A1).
Regarding claim 23, Barker et al. discloses a method of assembling a polyaxial bone anchor into a bone of a patient in-vivo with a holding tool (col. 5, lines 14-20) and connecting to a rod (col. 8, lines 33-43), the polyaxial bone anchor comprising a screw shank 50, a receiver30, a retainer 90, a compression insert 70, and a closure top 120 (figure 7), the method comprising: obtaining the screw shank 50 comprising an upper capture portion 54 having a partial spherical outer surface extending outwardly and upwardly from a neck portion (figure 7), an anchor portion 52 opposite the upper capture portion 54 configured for implantation into the bone (figure 4A), and an internal drive socket 60 formed in the upper capture portion to a distal end of the anchor portion (figure 4B); obtaining the receiver 30 comprising a pair of arms 42, 43 extending upwards from a base 36 to define an open channel 45 configured to receive the rod, front and back faces of the receiver defined in part by parallel front planar surfaces and parallel back planar surfaces on the arms (illustrated in figures 3A-3D), and a tool engagement structure 46 formed into and extending horizontally at least partially across an outer side surface of each of the pair of arms 42, 43 (figures 3A and 3C), each of the tool engagement structures 46 being spaced from a top surface of the arm and having an outwardly-facing surface spaced apart from the front planar surfaces and the back planar surfaces on the arms (figures 3A-3C), the base 36 including an internal cavity 38 communicating with the open channel 45 to define an axial bore centered about a vertical centerline axis (figure 3C); implanting the anchor portion 52 of the screw shank into the bone of the patient (col. 8, lines 34-44); holding the tool engagement structures 46 of the receiver 30 with the holding tool (col. 5, lines 14-20); with the screw shank 50 in the bone of the patient, connecting the receiver 30, the compression insert 70, and the retainer 90 to the upper capture portion 54 of the screw shank 50 to assemble the polyaxial bone anchor (col. 8, lines 34-44), the retainer 90 being positioned within the internal cavity and having an inner surface configured to receive and pivotably support the upper capture portion 54 of the screw shank 50 within the internal cavity of the receiver 30 (figure 7), the compression insert 70 being positioned within the axial bore above the retainer 90 and having an upper surface 72 configured to engage the rod (figure 7); and securing the polyaxial bone anchor 50 to the rod R by engaging an outer cylindrical surface on the rod with the upper surface 72 of the compression insert 70 and by rotatably downwardly positioning the closure top 120 into the open channel 45 of the receiver 30 above the rod R (figure 7).
Barker et al. discloses the claimed invention except wherein the screw shank is cannulated by a central bore extending an entire length of the cannulated screw shank; wherein the retainer is connected to the upper capture portion of the screw shank after the screw shank is inserted into the bone of the patient; wherein the method comprises holding the tool engagement structures of the receiver with the holding tool to assemble the cannulated polyaxial bone anchor.
Ensign et al. teaches wherein a screw shank 110 is cannulated along its entire length, and wherein the cannulated screw shank is inserted into the bone of the patient over the end of a guide wire, for the purpose of providing precise placement of the pedicle screw (paragraph 0030).
Sasing teaches wherein a retainer 2 is a spherical retainer which is inserted into the receiver 4 prior to assembly of the receiver 4 with the screw shank (figures 7a-8b) for the purpose of providing a bottom loading polyaxial bone screw with increased angulation (paragraph 0009).
Jackson teaches wherein a holding tool is used during the assembly of the polyaxial bone anchor; wherein the method comprises holding the tool engagement structures of the receiver with the holding tool to assemble the cannulated polyaxial bone anchor (paragraph 0042 and 0056).
It would have been obvious to a person having ordinary skill in the art at the time the invention was made to modify the method disclosed by Barker et al. such that the screw shank is cannulated over its entire length, as taught by Ensign et al., in order to provide precise placement of the pedicle screw over a guide wire.
It would have been further obvious to a person having ordinary skill in the art at the time the invention was made to modify the method disclosed by Barker such that the retaining member is a spherical retaining member that is received in the receiver prior to insertion of the bone screw shank in the receiver, as taught by Sasing, in order to provide increased angulation of the bone screw (paragraph 0009)
It would have been further obvious to a person having ordinary skill in the art at the time the invention was made to modify the method disclosed by Barker such that a holding tool is used during the assembly of the polyaxial bone anchor; wherein the method comprises holding the tool engagement structures of the receiver with the holding tool to assemble the cannulated polyaxial bone anchor (paragraph 0042 and 0056), as taught by Jackson, in order to stabilize the subassembly during assembly with the screw shank and make assembly easier for the user.
Response to Arguments
Applicant’s arguments with respect to claim(s) 3-13, 15, 16, 18, 23-26 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 Lynnsy Summitt whose telephone number is (571)270-78567856. The examiner can normally be reached on Monday through Thursday from 8am until 5pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Eduardo 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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/LYNNSY M SUMMITT/Primary Examiner, Art Unit 3773