DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Objections
Claims 7 and 17 are objected to because of the following informalities:
Regarding each of claims 7 and 17, “the first pair of upright arms” should be “the pair of upright arms”.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
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.
Claims 1, 6-12, and 17 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Patent Application Publication No. 2003/0125741 (Biedermann) in view of U.S. Patent Application Publication No. 2005/0277928 (Boschert).
Regarding claim 1, Biedermann discloses a pivotal bone anchor assembly (see Figs. 1 and 2 and Abstract) for securing a rod (100) to a bone of a patient with tooling (50/40) and a closure (60), the pivotal bone anchor assembly comprising: a first member (3) comprising a central bore (4) formed around a vertical centerline axis (see marked-up Fig. 1 below), a lower portion (6) with a bottom opening (4), and an upper portion (7) with a pair of upright arms (9/10) defining an open channel (8) configured to receive the rod (100), the pair of upright arms including upper tool engagement structures (12) accessible from an exterior of the first member (see Figs. 1 and 2) and configured for engagement and holding by the tooling (portion 50 of the tooling engages threading 12, see Fig. 2 and paragraph [0014]); a shank (1/2) comprising a head portion (2) having a partial spherical shape (see paragraph [0008] and Figs. 1 and 2) and an anchor portion (1) opposite the head portion configured for fixation to the bone (see paragraphs [0008] and [0016]), the head portion configured for positioning in the lower portion of the first member and for being pivotal with respect to the first member when the pivotal bone anchor assembly is in a non-locked configuration (see Figs. 1 and 2 and paragraphs [0008] and [0016]; head is polyaxial prior to fixing); and a second member (20) cooperating with the first member (see Figs. 1 and 2), the second member comprising a center aperture (26/27/30) alignable with the vertical centerline axis (see marked-up Fig. 1 below), lower tool engagement structures (28/29) accessible from an exterior of the second member (see Figs. 1 and 2), and an upwardly-facing surface (bottom of recess 27) engageable with the rod (see Fig. 2), the second member being downwardly displaceable relative to the first member along the vertical centerline axis from a first position to a second position by direct engagement of the lower tool engagement structures by the tooling (see paragraph [0016] and Figs. 1 and 2), so as to move second slidably mateable interference surfaces (outer surfaces of 23) on the second member into non-threaded frictional biased engagement with first slidably mateable interference surfaces (inner surfaces of 6) on the first member (see marked-up Fig. 2 below), wherein the downward displacement of the second member relative to the first member is configured to apply a frictional force on the head portion of the shank positioned in the central bore of the first member and thereby hold an angular position of the shank relative to the first member in a locked configuration prior to securing the rod in the open channel with the closure (see paragraph [0016]).
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Further regarding claim 1, Biedermann fails to disclose the head portion configured for uploading into the lower portion of the first member through the bottom opening. However, Boschert discloses a pivotal bone anchor assembly (10) in which a head portion (23) of a screw shank (20) is configured for uploading into a lower portion (31) of a receiver member (30) through a bottom opening of the receiver member (see paragraphs [0041] and [0043] and Fig. 3).
Regarding claim 6, Boschert discloses further comprising a retaining structure (50) separate from the shank and positionable within a lower portion of the first member to keep the head portion of the shank within the first member during pivotal movement between the shank and the first member in the non-locked configuration prior to being locked (see Fig. 3 and paragraph [0055]).
Regarding claim 10, Boschert discloses wherein the head portion of the shank is uploadable into the lower portion of the first member through the bottom opening after a second member (40) is placed in the first position with respect to the first member (see paragraph [0049]).
Further regarding claims 1, 6, and 10, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the assembly of Biedermann to have the head portion be configured for uploading into the lower portion of the first member through the bottom opening as suggested by Boschert as such a configuration allows for polyaxial pivoting and fixing of a screw shank relative to a rod positioned in the receiving part (see Boschert, paragraphs [0043] and [0056]), and thus, it is a matter of design choice to a user whether the head portion is configured for top-loading or bottom-loading into the assembly.
Regarding claim 7, Biedermann discloses wherein the upper tool engagement structure further comprises at least one horizontally-elongated downwardly-facing tool-engaging curvate surface (teeth of thread 12, see marked-up Fig. 1 below) formed on each of the upright arms of the first member and on diametrically opposite sides of the open channel (8), each tool-engaging curvate surface being spaced an equal distance below planar top surfaces on the first pair of upright arms and extending to at least one surface defining a front side outer face or a back side outer face of the first member (see marked-up Fig. 1 below).
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Regarding claim 8, Biedermann discloses wherein the displacement of the second member between the first or second positions by the tooling includes a linear non-rotating movement along the vertical centerline axis of the first member (see paragraphs [0010] and [0016]; linear, non-rotating sliding of the second member along the vertical centerline axis).
Regarding claim 9, Biedermann discloses wherein the second member is positioned substantially within the central bore formed in the first member (see Fig. 2).
Regarding claim 11, Biedermann discloses a method of assembling a pivotal bone anchor assembly (see Figs. 1 and 2 and Abstract) configured to secure a rod (100) to a bone of a patient with tooling (50/40) and a closure (60), the method comprising: positioning a second member (20) into cooperation with a first member (3) (see Figs. 1 and 2 and paragraph [0016]), the first member comprising a central bore (4) formed around a vertical centerline axis (see marked-up Fig. 1 above), a lower portion (6) with a bottom opening (4), and an upper portion (7) with a pair of upright arms (9/10) defining an open channel (8) configured to receive the rod (100), the pair of upright arms including upper tool engagement structures (12) accessible from an exterior of the first member (see Figs. 1 and 2) and configured for engagement and holding by the tooling (portion 50 of the tooling engages threading 12, see Fig. 2 and paragraph [0014]), and the second member comprising a center aperture (26/27/30) alignable with the vertical centerline axis (see marked-up Fig. 1 above), lower tool engagement structures (28/29) accessible from an exterior of the second member (see Figs. 1 and 2), and an upwardly-facing surface (bottom of recess 27) engageable with the rod (see Fig. 2), the second member being downwardly displaceable relative to the first member along the vertical centerline axis from a first position to a second position by direct engagement of the lower tool engagement structures by the tooling (see paragraph [0016] and Figs. 1 and 2), so as to move second slidably mateable interference surfaces (outer surfaces of 23) on the second member into non-threaded frictional biased engagement with first slidably mateable interference surfaces (inner surfaces of 6) on the first member (see marked-up Fig. 2 above); and positioning a head portion (2) of a shank (1/2) into the lower portion of the first member (see Figs. 1 and 2 and paragraphs [0008] and [0016]), the shank comprising the head portion (2) having a partial spherical shape (see paragraph [0008] and Figs. 1 and 2) and an anchor portion (1) opposite the head portion configured for fixation to the bone (see paragraphs [0008] and [0016]), the shank being pivotal with respect to the first member when the pivotal bone anchor assembly is in a non-locked configuration (see Figs. 1 and 2 and paragraphs [0008] and [0016]; head is polyaxial prior to fixing), wherein the downward displacement of the second member relative to the first member is configured to apply a frictional force on the head portion of the shank positioned in the central bore of the first member and thereby hold an angular position of the shank relative to the first member in a locked configuration prior to securing the rod in the open channel with the closure (see paragraph [0016]).
Biedermann fails to disclose uploading the head portion into the lower portion of the first member through the bottom opening. However, Boschert discloses a method of assembling a pivotal bone anchor assembly (10) in which a head portion (23) of a screw shank (20) is uploaded into a lower portion (31) of a receiver first member (30) through a bottom opening of the receiver member (see paragraphs [0041] and [0043] and Fig. 3). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the method of Biedermann to have the head portion be uploaded into the lower portion of the first member through the bottom opening as suggested by Boschert as such a configuration allows for polyaxial pivoting and fixing of a screw shank relative to a rod positioned in the receiving part (see Boschert, paragraphs [0043] and [0056]), and thus, it is a matter of design choice to a user whether the head portion is top-loaded or bottom-loaded into the assembly.
Regarding claim 12, Biedermann discloses further comprising downwardly displacing the second member to the second position with the tooling to establish the locked configuration between the shank and the first member (see paragraph [0016]).
Regarding claim 17, Biedermann discloses wherein the upper tool engagement structure further comprises at least one horizontally-elongated downwardly-facing tool-engaging curvate surface (teeth of thread 12, see marked-up Fig. 1 below claim 7) formed on each of the upright arms of the first member and on diametrically opposite sides of the open channel (8), each tool-engaging curvate surface being spaced an equal distance below planar top surfaces on the first pair of upright arms and extending to at least one surface defining a front side outer face or a back side outer face of the first member (see marked-up Fig. 1 below claim 7).
Claims 2, 3, 15, and 16 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Biedermann in view of Boschert, and further in view of U.S. Patent Application Publication No. 2008/0215100 (Matthis).
Regarding claims 2 and 15, Biedermann discloses wherein the lower tool engagement structures (28/29) further comprises lateral horizontal projecting structures having outer most surfaces extending entirely peripheral of the central bore of the first member (see marked-up Fig. 1 below; structures 28/29 are lateral horizontal structures projecting from the second pair of upright arms; see Fig. 2, structures 28/29 are entirely peripheral of central bore 4). It’s unclear if the structures are arcuate. However, Matti discloses a pivotal bone anchor assembly (see Fig. 1) comprising a first member (4) and a second member (14), wherein the second member comprises lower tool engagement structures (17/18) that are arcuate (see Fig. 1). It would have been prima facie obvious as a matter of design choice for a person of ordinary skill in the art to make the lower tool engagement structures of Biedermann arcuate as Matthis suggests lower tool engagement structures that are arcuate may perform substantially the same function as the lower tool engagement structures of Biedermann (see Matthis, paragraph [0034]; pressure on the structures results in downward movement and locking of a head (3) of a screw shank (1)), and thus, an arcuate shape is one of numerous shapes or configurations a person ordinary skill in the art would find obvious for the purpose of providing a lower tool engagement structure. See In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). Additionally, there is no evidence in the record that an arcuate shape is critical to the functioning of the structures.
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Regarding claims 3 and 16, Biedermann discloses wherein the second member further comprises a second pair of upright arms (see marked-up Fig. 1 above), and wherein the lower tool engagement structures further comprise lateral horizontal projecting structures extending outward from upper portions of the second pair of upright arms (see marked-up Fig. 1 above; structures 28/29 are lateral horizontal projecting structures extending outward from upper portions of the second pair of upright arms). See the analysis of claims 2 and 15 above regarding the lower tool engagement structures being arcuate.
Allowable Subject Matter
Claims 4, 5, 13, and 14 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.
The following is a statement of reasons for the indication of allowable subject matter: Dependent claims 4 and 13 (and claims 13 and 14 which are dependent thereon) have not been rejected because no reference, or reasonable combination of references, can be found which disclose or suggest the second member further configured for upward displacement from the second position to the first position by the tooling to re-establish the non-locked configuration (claim 4); or the method further comprising upwardly displacing the second member to the first position to re-establish the non-locked configuration between the shank and the first member. The Biedermann reference (U.S. Patent Application Publication No. 2003/0125741) discloses a similar assembly and method, but does not disclose the second member (20) configured for upward displacement from the second position to the first position by the tooling to re-establish the non-locked configuration, or a method in which the second member is upwardly displaced to the first position to re-establish the non-locked configuration.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
The Butler, Barker, Biedermann (U.S. 2009/0163956), and Biedermann (U.S. 2011/0213424) references discloses pedicle screw assemblies in which the screw may be bottom loaded into the receiver.
The Biedermann (US 5,672,176) and Jeon references disclose alternate pedicle screw assemblies.
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/NICHOLAS J PLIONIS/Primary Examiner, Art Unit 3773