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 .
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 27 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mishra et al. (Pub. No. US 2014/0188175 A1).
Regarding claim 27, Mishra et al. discloses a pivotable medical implant assembly intended for securing an elongate rod to a bone of a patient with tooling (figures 1 and 30), the pivotal medical implant assembly comprising: a shank 4 comprising a longitudinal axis, a head 16 at a proximal end, and a body 18 extending distally from the head with an anchor portion 20 configured for anchoring to the bone (figure 1); a receiver 10 comprising a base defining a lower portion of a central bore centered about a vertical centerline axis and communicating with a bottom of the base through a bottom opening (figure 6), and a pair of upright arms 80 extending upwardly from the base with opposing interior arm surfaces defining an open channel 62 extending between front and back faces of the receiver and configured to receive the elongate rod (figure 6), the central bore extending upward from the bottom opening through the open channel to tops of the upright arms 80 and including a closure mating structure 70 adjacent the tops of the upright arms 80 configured to mate with a closure top (figure 30), and upper downwardly-facing abutment surfaces and lower downwardly-facing abutment surfaces (illustrated in figures 6 and 7) integrally formed in the opposing interior arm surfaces of the upright arms below the closure mating structure 70, the lower portion of the central bore configured to receive the head of the shank upon its uploading through the bottom opening with the shank being pivotal with respect to the receiver (figures 12-14); and an insert 6 positionable into the central bore of the receiver 10 (figure 6), the insert 6 having an upwardly- facing saddle surface 56 (figure 3) configured to engage the elongate rod, a downwardly- facing lower surface 42 configured to engage and transfer a downward force to the head of the shank (figure 14), a central opening 50 (figure 2) defined by an inner cylindrical surface centered on a central axis (figure 2), outer side surfaces, and upwardly-facing abutment surfaces (illustrated in figure 3), the insert 6 being of solid construction and devoid of slots or gaps between in the inner cylindrical surface and the outer side surfaces (figure 2), wherein the insert 6 is positioned into a first position in the central bore with the upwardly- facing abutment surfaces being disposed between the upper and lower downwardly-facing abutment surfaces so as to inhibit vertical axial movement of the insert within the central bore and to hold the insert in a stabilized first position prior to and during the uploading of the head of the shank into the lower portion of the central bore through the bottom opening (figure 6).
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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 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.
Claim(s) 1, 2, 3, 4, 6, 7, 8, 10, 11, 23, 25, 26, and 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mishra et al. (Pub. No. US 2014/0188173 A1) in view of Biedermann et al. (Pub. No. US 2010/0234902 A1).
Regarding claims 1, 6, 7, 8, 10, 11, 25, and 26, Mishra et al. disclose a pivotable medical implant assembly (figure 1) intended for securing an elongate rod 14 to a bone of a patient with tooling, the pivotal medical implant assembly comprising: a shank 4 comprising a longitudinal axis, a head 16 at a proximal end, and a body 18 extending distally from the head 16 with an anchor portion 20 configured for anchoring to the bone (figure 1); a receiver 10 comprising a base defining a lower portion of a central bore centered about a vertical centerline axis and communicating with a bottom of the base through a bottom opening (figure 6), and a pair of upright arms 80 extending upwardly from the base with interior arm surfaces defining an open channel 62 extending between front and back faces of the receiver and configured to receive the elongate rod (figure 6), the central bore extending upward from the bottom opening through the open channel 62 to tops of the upright arms 80 and including a closure mating structure 70 adjacent the tops of the upright arms configured to mate with a closure top (figure 30) and at least one non-resilient inwardly-protruding abutment structure 78 with an upwardly-facing surface preformed into the central bore below the closure mating structure 70, the at least one inwardly-protruding abutment structure 78 extending continuously and circumferentially around the central bore between vertical planar surfaces formed into the interior arm surfaces adjacent the front and back faces of the receiver (figure 1), the lower portion of the central bore configured to receive the head 16 of the shank upon its uploading through the bottom opening with the shank being pivotal with respect to the receiver (figures 12-14); and an insert 6 positionable into the central bore of the receiver (figures 1 and 6), the insert 6 having a downwardly-facing lower surface 7 configured to engage and transfer a downward force to the head of the shank (figure 30), a central opening defined by an inner cylindrical surface centered on a central axis (illustrated in figure 3), a top surface 56, and outer side surfaces having at least one horizontally extending at least partially circumferential abutment groove 54 formed therein (figures 1-7), the insert 6 being of solid construction and devoid of slots or gaps between the inner cylindrical surface and the outer side surfaces (figures 1-7), wherein the at least one inwardly-protruding abutment structure 78 is positionable within the at least one abutment groove 54 of the insert 6 prior to the uploading of the head of the shank through the bottom opening of the receiver (figure 6), with the upwardly-facing surface of the at least one inwardly-protruding abutment structure 78 being configured to inhibit at least downward axial movement of the insert within the central bore by engagement with the at least one abutment groove 54 (figure 6; paragraph 0056) and to hold the insert in a stabilized first position prior to and during the uploading of the head of the shank into the lower portion of the central bore through the bottom opening (paragraph 0056; figures 12 and 13). The insert 6 is configured for forced downward axial displacement within the central bore to a second position via direct engagement from the tooling so as to move the downwardly-facing lower surface 7 of the insert 6 into a shank engageable configuration with the head of the shank and to move the at least one abutment groove 54 of the insert under the at least one inwardly-protruding abutment structure 78 (figure 14), and wherein after the forced downward axial displacement of the insert 6 to the second position, an overlapping arrangement between the at least one inwardly-protruding abutment structure 78 and the insert 6 is configured to restrict the insert 6 from returning to the first position within the central bore of the receiver (figures 7 and 14). The insert 6 includes an upwardly-facing surface 56 (figure 5) configured to engage the elongate rod. The pivotable medical implant assembly of wherein the insert 6 is uploadable through the bottom opening into the central bore of the receiver into the stabilized first position (paragraph 0056; figure 1). The receiver further includes vertically-aligned guide surfaces formed into the central bore below the closure mating structure and configured to slidably engage with vertically-aligned outer surfaces of the insert to maintain an alignment of the insert 6 relative to the receiver during the uploading of the insert 6 into the central bore (paragraph 0051). The insert 6 further comprises a cylindrical base portion 52 defining the central opening 50 and a pair of insert arms 57 extending upwardly from the cylindrical base portion 52 to define an upwardly-facing saddle surface 56 therebetween (figure 1). The assembly further comprises the elongate rod 14, wherein the closure top 12 is configured for positioning entirely within the central bore of the receiver 10 above the elongate rod 14 and in engagement with the closure mating structure 72 to apply a downward pressure to the elongate rod 14, so as to secure the elongate rod 14 to the bone of the patient (figure 30). The at least one abutment groove 54 of the insert further comprises a single pair of opposite horizontally extending at least partially circumferential abutment grooves 54 (figure 3). A tool 144 positioned within the central bore between the pair of upright arms is configured to facilitate an uploading of the insert 6 into the central bore through the bottom opening of the receiver 10 (figure 29- the tool can be used to facilitate uploading of the insert if one so desires).
Regarding claims 3, 4, and 23, in an alternate interpretation, the insert is considered to be element 8, as shown in figures 17 and 18, wherein the pivotable medical implant assembly further comprises a resilient retainer 7 (figure 17), wherein the resilient retainer 7 is configured to capture the head 16 of the shank within the lower portion of the central bore upon the uploading of the head of the shank through the bottom opening (figure 18). The lower portion of the central bore includes an expansion chamber region (figure 17) and the resilient retainer 7 is configured to expand within the expansion chamber region to capture the head of the shank upon the uploading of the head of the shank through the bottom opening (figures 12-14). The resilient retainer 7 is constrained in the expansion chamber region prior to the head of the shank being uploaded into the receiver through the bottom opening (figure 12).
Mishra et al. discloses the claimed invention except wherein the inwardly protruding abutment structure is non-resilient. Mishra et al. is silent regarding which element of the groove/projection arrangement is resilient in order to allow the groove to pass over the projection.
Biedermann et al. teaches wherein the arms 91a, 91b of the insert are resilient in order to allow the arms of the insert 8’ to pass over the non-resilient inwardly protruding abutment structure 93 with the appropriate amount of force (figure 22).
It would have been obvious to a person having ordinary skill in the art at the time the invention was effectively filed for the inwardly protruding abutment structure to be non-resilient while the arms of the insert are resilient, as taught by Biedermann et al., in order to achieve the predictable result of allowing the groove to pass over the inwardly protruding abutment structure.
Regarding claim 2, Mishra et al. as modified by Biederman et al. discloses the claimed invention except wherein the shank remains pivotal relative to the receiver and to the insert prior to locking the pivotal medical implant assembly with the closure top.
However, Biedermann et al. teaches wherein a shank remains pivotal after downward displacement of the insert 180 below the abutment structure 93, for the purpose of providing a pre-locking condition in which the shank is frictionally engaged with the insert, but can be adjusted with the appropriate amount of force (paragraph 0052).
It would have been obvious to a person having ordinary skill in the art at the time the invention was effectively filed to modify the implant assembly disclosed by Mishra et al. and Biedermann et al., such that the shank remains pivotal relative to the receiver and to the insert prior to locking the pivotal medical implant assembly with the closure top, as taught by Biedermann et al., for the purpose of providing a pre-locking condition in which the shank is frictionally engaged with the insert, but can be adjusted with the appropriate amount of force (paragraph 0052).
Regarding claim 28, Mishra et al. discloses the insert 6 is configured for forced downward axial displacement within the central bore to a second position via direct engagement from the tooling so as to move the upwardly-facing abutment surfaces of the insert 6 under the lower downwardly-facing abutment surfaces (figure 7), and wherein after the forced downward axial displacement of the insert 6 to the second position, the lower downwardly-facing abutment surfaces are overlappingly engageable with the upwardly-facing abutment surface on the insert 6 so as to restrict the insert from returning to the first position within the central bore of the receiver (figure 7), but fails to disclose wherein the shank remains pivotal relative to the receiver and to the insert prior to locking the pivotal medical implant assembly with the closure top.
However, Biedermann et al. teaches wherein a shank remains pivotal after downward displacement of the insert 180 below the abutment structure 93, for the purpose of providing a pre-locking condition in which the shank is frictionally engaged with the insert, but can be adjusted with the appropriate amount of force (paragraph 0052).
It would have been obvious to a person having ordinary skill in the art at the time the invention was effectively filed to modify the implant assembly disclosed by Mishra et al. and Biedermann et al., such that the shank remains pivotal relative to the receiver and to the insert prior to locking the pivotal medical implant assembly with the closure top, as taught by Biedermann et al., for the purpose of providing a pre-locking condition in which the shank is frictionally engaged with the insert, but can be adjusted with the appropriate amount of force (paragraph 0052).
Response to Arguments
Applicant’s arguments with respect to the claims 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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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
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