DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim(s) 1-4, 7-10, 12-19 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-4, 7-10 of U.S. Patent No. 12,016,594 B2 in view of Biedermann et al. (U.S. Pub. No. 2010/0234902 A1, hereinafter “Biedermann”).
The table below shows the application claims and the patent claims side by side for direct comparison, with the differences between the claims are highlighted below by bolding all the limitations that differ, italicizing additional limitations, and underlining limitations that will be addressed below.
Application Claims:
Patent Claims:
1. A pivotal bone anchor assembly intended for securing an elongate rod to a bone of a patient with tooling, the pivotal bone anchor assembly comprising: a bone anchor having a longitudinal axis, a capture portion with a partial spherical shape defining a hemisphere plane at a maximum width perpendicular to the longitudinal axis, and an anchor portion opposite the capture portion configured for attachment to the bone; a receiver having a vertical centerline axis, a base with a bottom opening centered about the vertical centerline axis, and an upper portion defining a channel configured to receive the elongate rod, the channel communicating with the bottom opening through a central bore having a lower portion configured to receive the capture portion of the bone anchor with the bone anchor being pivotal with respect to the receiver in a non-locked configuration, the upper portion including opposed inward-facing surfaces having a guide and advancement structure configured to receive a closure; and a compression insert configured to be at least partially disposed within the central bore and having an upper surface configured for engagement with the elongate rod and a lower interior surface configured for engagement with the capture portion of the bone anchor, the compression insert having a central opening and upward-facing surfaces on tool engagement structures positioned radially outward from the central opening, wherein after the capture portion of the bone anchor is received within the central bore of the receiver, the upward facing surfaces on the tool engagement structures of the compression insert are configured for direct engagement by the tooling to receive a downwardly-directed force that drives the compression insert downwardly against the capture portion to frictionally hold the bone anchor in a non-movable configuration with respect to the receiver for the duration of the downwardly-directed force, and wherein prior to the elongate rod being secured within the channel in a locked configuration with the closure, a releasing of the downwardly-directed force by the tooling is configured to remobilize the bone anchor to again be pivotal with respect to the receiver.
1. A pivotal bone anchor assembly configured for temporary positional locking with tooling and for securing an elongate rod to a bone of a patient via a closure, the pivotal bone anchor assembly comprising: a bone anchor having a longitudinal axis, a capture portion with a partial spherical shape defining a hemisphere plane at a maximum width perpendicular to the longitudinal axis, and an anchor portion opposite the capture portion configured for attachment to the bone; a receiver having a vertical centerline axis, a base with a bottom opening centered about the vertical centerline axis, and an upper portion defining a channel configured to receive the elongate rod, the channel communicating with the bottom opening through a central bore having a lower portion configured to receive the capture portion of the bone anchor with the bone anchor being pivotal with respect to the receiver in a non-locked configuration, the pair of upright arms including opposed inward-facing surfaces having a closure-mating structure formed therein and outward-facing surfaces opposite the inward-facing surfaces; and a compression insert configured to be at least partially disposed within the central bore and having an upper surface configured for engagement with the elongate rod and a lower interior surface configured for engagement with the capture portion of the bone anchor, the compression insert having a central opening and upward-facing surfaces on tool engagement structures positioned radially outward from the central opening, wherein after the capture portion of the bone anchor is received within the central bore of the receiver, and prior to or with the elongate rod being positioned within the channel of the receiver in the non-locked configuration, the upward-facing surfaces on the tool engagement structures of the compression insert are configured for direct engagement by the tooling to receive a continuously-applied downwardly-directed force for driving the compression insert downwardly against the capture portion, so as to temporarily lock a position of the bone anchor with respect to the receiver prior to the elongate rod being secured within the channel in a locked configuration, and wherein the lower interior surface of the compression insert does not extend below the hemisphere plane of the capture portion of the bone anchor when the longitudinal axis of the bone anchor is collinear with the vertical centerline axis of the receiver.
2. The pivotal bone anchor assembly of claim 1, wherein the guide and advancement structure of the receiver is configured to not be engaged or overlapped by the tooling as the tooling applies the downwardly-directed force to the upward-facing surfaces on the tool engagement structures of the compression insert.
2. The pivotal bone anchor assembly of claim 1, wherein the closure-mating structure of the receiver is configured to not be engaged or overlapped by the tooling as the tooling applies the downwardly-directed force to the upward-facing surfaces on the tool engagement structures of the compression insert.
3. The pivotal bone anchor assembly of claim 1, wherein the upper portion of the receiver further includes longitudinal guide surfaces configured for receiving and guiding movable engagement extensions of the tooling toward the upward-facing surfaces on the tool engagement structures of the insert.
3. The pivotal bone anchor assembly of claim 1, wherein each upright arm of the receiver further includes guide engagement surfaces configured for receiving and guiding a distal end portion of the tooling toward the upward-facing surfaces on the tool engagement structures of the insert.
4. The pivotal bone anchor assembly of claim 1, wherein the compression insert is configured to be at least partially disposed into the central bore of the receiver in a first position and then rotated into a second position in which the upward-facing surfaces become engageable by the tooling.
4. The pivotal bone anchor assembly of claim 1, wherein the compression insert is configured to be at least partially disposed into the central bore of the receiver in a first position and then rotated into a second position in which the upward-facing surfaces become engageable by the tooling.
7. The pivotal bone anchor assembly of claim 1, wherein the lower interior surface of the compression insert engageable with the capture portion of the bone anchor further comprises a concave bottom surface.
7. The pivotal bone anchor assembly of claim 1, wherein the lower interior surface of the compression insert engageable with the capture portion of the bone anchor further comprises a concave bottom surface.
8. The pivotal bone anchor assembly of claim 1 and further comprising a retainer configured to be positioned within the central bore of the receiver prior to the capture portion of the bone anchor and to capture the capture portion upon an uploading of the capture portion through the bottom opening.
8. The pivotal bone anchor assembly of claim 1 and further comprising a retainer configured to be positioned within the central bore of the receiver prior to the capture portion of the bone anchor and to capture the capture portion upon an uploading of the capture portion through the bottom opening.
9. The pivotal bone anchor assembly of claim 8, wherein the retainer is pivotal with respect to the receiver after the capture of the capture portion of the bone anchor therein.
9. The pivotal bone anchor assembly of claim 8, wherein the retainer is pivotal with respect to the receiver after the capture of the capture portion of the bone anchor therein.
10. The pivotal bone anchor assembly of claim 8, wherein the retainer is pivotal with respect to the bone anchor after the capture of the capture portion of the bone anchor therein.
10. The pivotal bone anchor assembly of claim 8, wherein the retainer is pivotal with respect to the bone anchor after the capture of the capture portion of the bone anchor therein.
12. A pivotal bone anchor assembly intended for securing an elongate rod to a bone of a patient with tooling, the pivotal bone anchor assembly comprising: a bone anchor having a longitudinal axis, a capture portion with a partial spherical shape defining a hemisphere plane at a maximum width perpendicular to the longitudinal axis, and an anchor portion opposite the capture portion configured for attachment to the bone; a receiver having a vertical centerline axis, a base with a bottom opening centered about the vertical centerline axis, and a pair of upright arms extending upward from the base to define a channel configured to receive the elongate rod, the channel communicating with the bottom opening through a central bore having a lower portion configured to receive the capture portion of the bone anchor with the bone anchor being pivotal with respect to the receiver in a non-locked configuration, the upright arms including opposed inward-facing surfaces having a guide and advancement structure formed therein and configured to receive a closure; and a compression insert configured to be at least partially disposed within the central bore and having an upper surface configured for engagement with the elongate rod and a lower surface configured for engagement with the capture portion of the bone anchor, the compression insert having a central opening and at least one upward-facing surface on a tool engagement structure positioned radially outward from the central opening, wherein after the capture portion of the bone anchor is received within the central bore of the receiver, the at least one upward-facing surface on the tool engagement structure of the compression insert is configured for direct engagement by the tooling to receive a downwardly-directed force that drives the compression insert downwardly against the capture portion to frictionally hold the bone anchor in a non-movable configuration with respect to the receiver for the duration of the downwardly-directed force, and wherein prior to the elongate rod being secured within the channel in a locked configuration with the closure, a releasing of the downwardly-directed force by the tooling is configured to remobilize the bone anchor to again be pivotal with respect to the receiver.
1. A pivotal bone anchor assembly configured for temporary positional locking with tooling and for securing an elongate rod to a bone of a patient via a closure, the pivotal bone anchor assembly comprising: a bone anchor having a longitudinal axis, a capture portion with a partial spherical shape defining a hemisphere plane at a maximum width perpendicular to the longitudinal axis, and an anchor portion opposite the capture portion configured for attachment to the bone; a receiver having a vertical centerline axis, a base with a bottom opening centered about the vertical centerline axis, and an upper portion defining a channel configured to receive the elongate rod, the channel communicating with the bottom opening through a central bore having a lower portion configured to receive the capture portion of the bone anchor with the bone anchor being pivotal with respect to the receiver in a non-locked configuration, the pair of upright arms including opposed inward-facing surfaces having a closure-mating structure formed therein and outward-facing surfaces opposite the inward-facing surfaces; and a compression insert configured to be at least partially disposed within the central bore and having an upper surface configured for engagement with the elongate rod and a lower interior surface configured for engagement with the capture portion of the bone anchor, the compression insert having a central opening and upward-facing surfaces on tool engagement structures positioned radially outward from the central opening, wherein after the capture portion of the bone anchor is received within the central bore of the receiver, and prior to or with the elongate rod being positioned within the channel of the receiver in the non-locked configuration, the upward-facing surfaces on the tool engagement structures of the compression insert are configured for direct engagement by the tooling to receive a continuously-applied downwardly-directed force for driving the compression insert downwardly against the capture portion, so as to temporarily lock a position of the bone anchor with respect to the receiver prior to the elongate rod being secured within the channel in a locked configuration, and wherein the lower interior surface of the compression insert does not extend below the hemisphere plane of the capture portion of the bone anchor when the longitudinal axis of the bone anchor is collinear with the vertical centerline axis of the receiver.
13. The pivotal bone anchor assembly of claim 12, wherein the guide and advancement structure of the receiver is configured to not be engaged or overlapped by the tooling as the tooling applies the downwardly-directed force to the upward-facing surfaces on the tool engagement structures of the compression insert.
2. The pivotal bone anchor assembly of claim 1, wherein the closure-mating structure of the receiver is configured to not be engaged or overlapped by the tooling as the tooling applies the downwardly-directed force to the upward-facing surfaces on the tool engagement structures of the compression insert.
14. The pivotal bone anchor assembly of claim 12, wherein each upright arm of the receiver further includes longitudinal guide surfaces configured for receiving and guiding movable engagement extensions of the tooling toward the upward-facing surfaces on the tool engagement structures of the insert.
3. The pivotal bone anchor assembly of claim 1, wherein each upright arm of the receiver further includes guide engagement surfaces configured for receiving and guiding a distal end portion of the tooling toward the upward-facing surfaces on the tool engagement structures of the insert.
15. The pivotal bone anchor assembly of claim 12, wherein the compression insert is configured to be at least partially disposed into the central bore of the receiver in a first position and then rotated into a second position in which the upward-facing surfaces become engageable by the tooling.
4. The pivotal bone anchor assembly of claim 1, wherein the compression insert is configured to be at least partially disposed into the central bore of the receiver in a first position and then rotated into a second position in which the upward-facing surfaces become engageable by the tooling.
16. The pivotal bone anchor assembly of claim 12, wherein the lower surface of the compression insert engageable with the capture portion of the bone anchor further comprises a concave bottom surface.
7. The pivotal bone anchor assembly of claim 1, wherein the lower interior surface of the compression insert engageable with the capture portion of the bone anchor further comprises a concave bottom surface.
17. The pivotal bone anchor assembly of claim 12 and further comprising a retainer configured to be positioned within the central bore of the receiver prior to the capture portion of the bone anchor and to capture the capture portion upon an uploading of the capture portion through the bottom opening.
8. The pivotal bone anchor assembly of claim 1 and further comprising a retainer configured to be positioned within the central bore of the receiver prior to the capture portion of the bone anchor and to capture the capture portion upon an uploading of the capture portion through the bottom opening.
18. The pivotal bone anchor assembly of claim 17, wherein the retainer is pivotal with respect to the receiver after the capture of the capture portion of the bone anchor therein.
9. The pivotal bone anchor assembly of claim 8, wherein the retainer is pivotal with respect to the receiver after the capture of the capture portion of the bone anchor therein.
19. The pivotal bone anchor assembly of claim 17, wherein the retainer is pivotal with respect to the bone anchor after the capture of the capture portion of the bone anchor therein.
10. The pivotal bone anchor assembly of claim 8, wherein the retainer is pivotal with respect to the bone anchor after the capture of the capture portion of the bone anchor therein.
As is apparent from the table above, Patent claim 1 explicitly discloses all of the features of application claim 1, except “the upper portion including opposed inward-facing surfaces having a guide and advancement structure configured to receive a closure”, “downwardly-directed force that drives the compression insert downwardly against the capture portion to frictionally hold the bone anchor in a non-movable configuration with respect to the receiver for the duration of the downwardly-directed force, and wherein prior to the elongate rod being secured within the channel in a locked configuration with the closure, a releasing of the downwardly-directed force by the tooling is configured to remobilize the bone anchor to again be pivotal with respect to the receiver”; and regarding claim 12, “a pair of upright arms extending upward from the base”, “the upright arms including opposed inward-facing surfaces having a guide and advancement structure formed therein and configured to receive a closure”, and “a downwardly-directed force that drives the compression insert downwardly against the capture portion to frictionally hold the bone anchor in a non-movable configuration with respect to the receiver for the duration of the downwardly-directed force, and wherein prior to the elongate rod being secured within the channel in a locked configuration with the closure, a releasing of the downwardly-directed force by the tooling is configured to remobilize the bone anchor to again be pivotal with respect to the receiver”.
Biedermann discloses a polyaxial pedicle screw assembly (see Fig. 1) with a compression insert (8) that includes tool engagement structures (see annotated Fig. 6 below) configured for direct engagement by the tooling (see paras. [0047]-[0048]), wherein the upper portion including a pair of upright arms extending upward from the base (see annotated Fig. 8 below) with opposed inward-facing surfaces (see annotated Fig. 8 below) having a guide and advancement structure (15) configured to receive a closure (7); wherein a downwardly-directed force that drives the compression insert downwardly against the capture portion to frictionally hold the bone anchor in a non-movable configuration with respect to the receiver for the duration of the downwardly-directed force (see paras. [0047]-[0048] “the pressure element 8 is pressed down slightly”, note the pressure element is capable of being continuously pressed downward by direct engagement by a tool received in receiver 5 to keep it in a pre-locking position), and wherein prior to the elongate rod being secured within the channel in a locked configuration with the closure, a releasing of the downwardly-directed force by the tooling is configured to remobilize the bone anchor to again be pivotal with respect to the receiver (see paras. [0047]-[0048] and [0052], note releasing downwardly directed force with an exertion of force to overcome the pre-locking condition enables remobilization of the screw); in order to enable the surgeon to provide provisional locking and unlocking of the receiver relative orientation of the shank before insertion of the rod and closure (see paras. [0047]-[0048]).
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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 downwardly-directed force that drives the compression insert downwardly against the capture portion in Patent claim 1 to frictionally hold the bone anchor in a non-movable configuration with respect to the receiver for the duration of the downwardly-directed force, releasing of the downwardly-directed force by the tooling is configured to remobilize the bone anchor to again be pivotal with respect to the receiver in view of Biedermann in order to enable the surgeon to lock and unlock relative orientation of the shank before insertion of the rod and closure.
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, 7, 12, 16 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 an elongate rod (6) to a bone of a patient with tooling the pivotal bone anchor assembly (see paras. [0048]-[0049]) comprising: a bone anchor (1) having a longitudinal axis (M, see Fig. 1), a capture portion (3) with a partial spherical shape (see Fig. 1) defining a hemisphere plane at a maximum width perpendicular to the longitudinal axis (see Fig. 1), and an anchor portion (2) opposite the capture portion configured for attachment to the bone (via threads, see Fig. 1); a receiver (5) having a vertical centerline axis (M, see Fig. 1), a base (see annotated Fig. 8 below) with a bottom opening (18) centered about the vertical centerline axis (see annotated Fig. 4 below), and an upper portion (see annotated Fig. 8 below) defining a channel (13) configured to receive the elongate rod (see Fig. 1), the channel communicating with the bottom opening through a central bore having a lower portion (19) configured to receive the capture portion of the bone anchor (see Fig. 1) with the bone anchor being pivotal with respect to the receiver in a non-locked configuration (see paras. [0048]-[0049]), the upper portion including opposed inward-facing surfaces (see annotated Fig. 8 below) having a guide and advancement structure (15) configured to receive a closure (7) and a compression insert (8) configured to be at least partially disposed within the central bore (see Fig. 8) and having an upper surface (83) configured for engagement with the elongate rod (see Fig. 6) and a lower interior surface (85) configured for engagement with the capture portion of the bone anchor (see Fig. 6), the compression insert having a central opening (90) and upward-facing surfaces (see annotated Fig. 6 below) on tool engagement structures positioned radially outward from the central opening (see annotated Fig. 6 below), wherein after the capture portion of the bone anchor is received within the central bore of the receiver, the upward facing surfaces on the tool engagement structures of the compression insert are configured for direct engagement by the tooling to receive a downwardly-directed force that drives the compression insert downwardly against the capture portion to frictionally hold the bone anchor in a non-movable configuration with respect to the receiver for the duration of the downwardly-directed force (see paras. [0047]-[0048] “the pressure element 8 is pressed down slightly”, note the pressure element is capable of being continuously pressed downward by direct engagement by a tool received in receiver 5 to keep it in a pre-locking position), and wherein prior to the elongate rod being secured within the channel in a locked configuration with the closure, a releasing of the downwardly-directed force by the tooling is configured to remobilize the bone anchor to again be pivotal with respect to the receiver (see paras. [0047]-[0048] and [0052], note releasing downwardly directed force with an exertion of force to overcome the pre-locking condition enables remobilization of the screw).
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Regarding claim 7, wherein the lower interior surface of the compression insert engageable with the capture portion of the bone anchor further comprises a concave bottom surface (85, see Fig. 6).
Biedermann discloses, regarding claim 12, a pivotal bone anchor assembly (see Fig. 1) intended for securing an elongate rod (6) to a bone of a patient with tooling (see paras. [0048]-[0049]), the pivotal bone anchor assembly comprising: a bone anchor (1) having a longitudinal axis (M, see Fig. 1), a capture portion (3) with a partial spherical shape defining a hemisphere plane at a maximum width perpendicular to the longitudinal axis (see Fig. 1), and an anchor portion (2) opposite the capture portion configured for attachment to the bone (via threads, see Fig. 1); a receiver (5) having a vertical centerline axis (M, see Fig. 1), a base (see annotated Fig. 8 above) with a bottom opening (18) centered about the vertical centerline axis (see Fig. 8), and a pair of upright arms extending upward from the base to define a channel (13) configured to receive the elongate rod (see Fig. 1), the channel communicating with the bottom opening through a central bore having a lower portion (19) configured to receive the capture portion of the bone anchor (see Fig. 8) with the bone anchor being pivotal with respect to the receiver in a non-locked configuration (see paras. [0047]-[0048]), the upright arms including opposed inward-facing surfaces (see annotated Fig. 8 above) having a guide and advancement structure (15) formed therein and configured to receive a closure (7); and a compression insert (8) configured to be at least partially disposed within the central bore and having an upper surface (83) configured for engagement with the elongate rod (see Fig. 6) and a lower surface (85) configured for engagement with the capture portion of the bone anchor (see Fig. 6), the compression insert having a central opening (90) and at least one upward-facing surface on a tool engagement structure (see annotated Fig. 6 above) positioned radially outward from the central opening (see Figs. 6), wherein after the capture portion of the bone anchor is received within the central bore of the receiver (see paras. [0047]-[0048] “the pressure element 8 is pressed down slightly”, note the pressure element is capable of being continuously pressed downward by direct engagement by a tool received in receiver 5 to keep it in a pre-locking position), the at least one upward-facing surface on the tool engagement structure of the compression insert is configured for direct engagement by the tooling to receive a downwardly-directed force that drives the compression insert downwardly against the capture portion to frictionally hold the bone anchor in a non-movable configuration with respect to the receiver for the duration of the downwardly-directed force (see paras. [0047]-[0048]), and wherein prior to the elongate rod being secured within the channel in a locked configuration with the closure, a releasing of the downwardly-directed force by the tooling is configured to remobilize the bone anchor to again be pivotal with respect to the receiver (see paras. [0047]-[0048] and [0052], note releasing downwardly directed force with an exertion of force to overcome the pre-locking condition enables remobilization of the screw).
Regarding claim 16, wherein the lower surface of the compression insert engageable with the capture portion of the bone anchor further comprises a concave bottom surface (85, see Fig. 6).
Allowable Subject Matter
Claim(s) 11 and 20 is/are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim(s) 2-4, 8-10, 13-15, 17-19 would be allowable if a terminal disclaimer is filed to overcome the rejection(s) under Nonstatutory Double Patenting, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The claims in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest:
A pivotable bone anchor assembly comprising a bone anchor, a receiver, and a compression insert, the compression insert having an upper surface configured for engagement with the elongate rod and the lower interior surface configured for engagement with the capture portion of the bone anchor, the compression insert having a central opening and upward-facing surfaces on tool engagement structures positioned radially outward from the central opening, wherein after the capture portion of the bone anchor is received within the central bore of the receiver, the upward facing surfaces on the tool engagement structures of the compression insert are configured for direct engagement by the tooling to receive a downwardly-directed force that drives the compression insert downwardly against the capture portion to frictionally hold the bone anchor in a non-movable configuration with respect to the receiver for the duration of the downwardly-directed force, and wherein prior to the elongate rod being secured within the channel in a locked configuration with the closure, a releasing of the downwardly-directed force by the tooling is configured to remobilize the bone anchor to again be pivotal with respect to the receiver as the tooling applies the downwardly-directed force; and as per claim 2, wherein the guide and advancement structure of the receiver is configured to not be engaged or overlapped by the tooling; and as per claim 3, wherein the upper portion of the receiver further includes longitudinal guide surfaces configured for receiving and guiding movable engagement extensions of the tooling; and as per claim 4, wherein the compression insert is configured to be inserted in a first position and then rotated into a second position in which the upward-facing surfaces become engageable by the tooling; and as per claim 8, further comprising a retainer configured to be positioned within the central bore of the receiver prior to the capture portion of the bone anchor; and as per claim 11, wherein the receiver further comprises outer tool receiving recesses formed therein, wherein the upward-facing surface on the tool engagement structures of the compression insert are configured for direct engagement by movable engagement extension of the tooling simultaneous with holding portions of the tooling being received within the outer tool receiving recesses.
A pivotable bone anchor assembly comprising a bone anchor, a receiver, and a compression insert, the compression insert having an upper surface configured for engagement with the elongate rod and the lower surface configured for engagement with the capture portion of the bone anchor, the compression insert having upward-facing surfaces on tool engagement structures positioned radially outward from the central opening, wherein after the capture portion of the bone anchor is received within the central bore of the receiver, the upward facing surfaces on the tool engagement structures of the compression insert are configured for direct engagement by the tooling to receive a downwardly-directed force that drives the compression insert downwardly against the capture portion to frictionally hold the bone anchor in a non-movable configuration with respect to the receiver for the duration of the downwardly-directed force, and wherein prior to the elongate rod being secured within the channel in a locked configuration with the closure, a releasing of the downwardly-directed force by the tooling is configured to remobilize the bone anchor to again be pivotal with respect to the receiver as the tooling applies the downwardly-directed force; and as per claim 13, wherein the guide and advancement structure of the receiver is configured to not be engaged or overlapped by the tooling; and as per claim 14, wherein each upright arm of the receiver further includes longitudinal guide surfaces configured for receiving and guiding movable engagement extensions of the tooling; and as per claim 15, wherein the compression insert is configured to be inserted in a first position and then rotated into a second position in which the upward-facing surfaces become engageable by the tooling; and as per claim 17, further comprising a retainer configured to be positioned within the central bore of the receiver prior to the capture portion of the bone anchor; and as per claim 20, wherein the receiver further comprises outer tool receiving recesses formed therein, wherein the upward-facing surface on the tool engagement structures of the compression insert are configured for direct engagement by movable engagement extension of the tooling simultaneous with holding portions of the tooling being received within the outer tool receiving recesses.
Response to Arguments
Applicant's arguments filed 2/13/2026 have been fully considered but they are not persuasive.
The Applicant asserts that Biedermann fails to teach "to frictionally hold the bone anchor in a non- movable configuration with respect to the receiver for the duration of the downwardly- directed force," as recited in claim 1. The Applicant asserts that the pre-locking position in Biedermann is not equivalent to the non-movable configuration, since Biedermann discloses "frictionally clamping of the head" in a pre-locking position in which the head is pivotable upon exertion of a force (assumed as the claimed downwardly-directed force). Specifically, Biedermann discloses, in [0052], as follows: As shown in FIG. 13 g, when the pressure element 180 moves downwards, its lowermost edge 180 d engages in the groove 170 C. In this position, there is a frictional clamping of the head 3, which still allows the head 3 to be pivoted upon exertion of a force which is greater than the force needed to pivot the head 3 when the head 3 is introduced in the insertion position.
The Office respectfully disagrees. The claim only requires that the upward-facing surfaces be configured for direct engagement by the tooling, and that the upward-facing surfaces are configured to receive a downwardly-directed force that is capable to frictionally hold the bone anchor in a non-movable configuration for the duration of the downwardly-directed force. Biedermann discloses in paragraph [0048] that the pressure element 8 (e.g. the compression insert) is pressed down manually by pushing down on it into the pre-locking position (e.g. non-movable configuration). Biedermann discloses in paragraph [0048] that downward force on the pressure element 8 (e.g. the compression insert) compresses the tapered portion 88 into the tapered portion of the receiving part body 5 (e.g. receiver) and to pre-lock screw head 3 (e.g. capture portion) and that the angular position of the bone anchoring element 1 is maintained under conditions arising during surgery. And Biedermann discloses in paragraph [0052] that in the pre-locking position (e.g. non-movable position) that there is frictional clamping of the head 3 (e.g. capture portion). While Biedermann discloses in para. [0048] that exerting an additional force can “loosen” the hold and in para. [0052] that the head can be pivoted upon exertion of a force that is greater; this does not teach away from Biedermann disclosing previously in para. [0048] that in the pre-locking position the angular position of the bone anchoring element 1 is maintained under conditions arising during surgery e.g. non-movable for the duration of the downwardly-directed force. Since the upper surfaces of the pressure element in Biedermann are capable of being engaged by a tool to receive a downward force, since the downward force is capable of creating a frictional clamping on the head of the bone screw to hold it in an angular position for the duration of a downwardly directed force so long as an additional force is not applied that is greater than the downwardly directed force, Biedermann is considered to disclose this functional limitation of the claim.
The Applicant asserts that Biedermann fails to teach "the at least one upward-facing surface on the tool engagement structure of the compression insert is configured for direct engagement by the tooling a releasing of the downwardly-directed force by the tooling is configured to remobilize the bone anchor to again be pivotal with respect to the receiver," as recited in claim 1. The Applicant asserts that Biedermann the insertion position is limited against upward movement, and that the pressure element can be held in the insertion position by means of a tool (not shown)." However, Biedermann does not disclose the same tool for holding the head in a locking position. Instead, Biedermann discloses putting the head in a locking position without any tool e.g. that the locking position is achieved by further tightening the inner screw 7, thereby further pressing down the rod 6. No tool is explicitly disclosed here to lock the screw head. The Applicant further asserts that Biedermann does not disclose "a releasing of the downwardly-directed force by the tooling is configured to remobilize the bone anchor to again be pivotal with respect to the receiver," as recited in claim 1. Instead, Biedermann is silent on disclosing remobilizing the bone anchor from the locking position (assumed as the claimed non- movable configuration) to the insertion position (assumed as the claimed "pivotal configuration").
The Office respectfully disagrees. The claim only requires that prior to the elongate rod being secured in a locked configuration with the closure that a releasing for the downwardly-directed force by the tooling be configured to remobilize the bone anchor to be pivotable again. Biedermann discloses that pressure element 8 (e.g. compression insert) is configured to be moved downward from the insertion position, to the pre-locking position (e.g. non-movable configuration), and to the locking position (e.g. locked configuration); that the pressure element 8 may be moved by manually pushing down (see para. [0048]); and that the pins 9a-9b maintain the pressure element 8 within the receiving part body 5 (e.g. receiver) throughout the movement, only preventing the pressure element 8 from exiting the top or bottom of the receiving part body 5 e.g. going above the insertion position or below the locking position. Biederman further discloses in para. [0048] that exerting an additional force can “loosen” the hold and in para. [0052] that the head can be pivoted upon exertion of a force that is greater. Since the pins 9a-9b do not prevent the pressure element 8 (e.g. compression insert) from moving from the pre-locking position to the insertion position, since the upward facing surfaces are capable of being engaged by a tooling to receive both downward-directed force as well as for that downward force to be released or lessened; and since with the exertion of a greater force than the downwardly directed force / released downwardly directed force is capable of moving the pressure element 8 into the insertion position / enabling pivotable movement of the bone anchoring element 1 (e.g. bone anchor) / remobilize to be pivotable again, Biedermann is considered to disclose this functional limitation of the claim.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/M.C.G/ Examiner, Art Unit 3773 /EDUARDO C ROBERT/ Supervisory Patent Examiner, Art Unit 3773