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 § 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) 1-11, 13-22 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 I”).
Biedermann I discloses, regarding claim 1, a pivotal bone anchor assembly (see Figs. 1-14) intended for securing an elongate rod (6) to a bone of a patient (via 1) with tooling (see para. [0047] “tool (not shown)”, see also para. [0048] “manually by pushing down”), the pivotal bone anchor assembly comprising: a receiver (5) comprising a lower body (e.g. portion of 5 below U-shaped recess 13) defining a cavity (19) communicating with bottom surface (11) of the receiver through a bottom opening (18) and a pair of upright arms (14a, 14b) extending upwardly from the lower body with opposed inwardly facing surfaces defining an open first channel (13) configured to receive the elongate rod and having a closure-mating structure (15) formed therein (see Fig. 1), the open first channel communicating with the cavity to define a central bore (12), the central bore including upper and lower receiver abutment structures (e.g. upper and lower surfaces of pins 9a-b or upper and lower surfaces of snap ring, see para. [0062] “snap rings”) extending at least partially circumferentially around the central bore (see annotated Fig. 1 below, note that the diameter of the pins 9a-b extend circumferentially around a part of the central bore defined by the bores 20a-b, see also para. [0062] “snap rings”, note the snap rings would extend circumferentially around the central bore) and spaced between a shank head retaining region (17) adjacent to the bottom opening (see Fig. 9) and the closure-mating structure (15, see Fig. 9); a compression insert (8) configured for positioning in the central bore of the receiver (see Fig. 8), the compression insert comprising a central tool receiving opening (90, see Fig. 6, see para. [0044]), an upwardly- facing surface (e.g. surface of 81 that forms U-shaped recess 83) sized and shaped to receive the elongate rod (see Fig. 14), and exterior upper (84) and lower insert abutment structures (e.g. top and bottom surfaces of 84, note that 84 are positioned on the exterior surface facing outward toward the central bore) configured to have simultaneously overlapping arrangements with the upper and lower receiver abutment structures (see annotated Fig. 8 below, see also Fig. 11 and paras. [0047]-[0048], “pre-locking position”), respectively, when the compression insert is positioned in a first position in the central bore (see Fig. 11, see para. [0048], “pre-locking position”), so as to inhibit upward and downward movement of the compression insert within the central bore of the receiver (see Fig. 11, see para. [0048], “pre-locking position”) until acted on by the tooling (see para. [0047] “tool (not shown)”, see also para. [0048] “loosened only by exerting an additional force” or “manually by pushing down”); a shank (1) comprising a shank head (3) and a bone anchoring portion (2) opposite the shank head configured to attach to the bone (see Fig. 1), the shank head having a partial spherical shape (see Fig. 1) defining a hemisphere plane (e.g. top surface of 3, see Fig. 8) and an internal drive socket (4) having a multi- faceted inner surface (see annotated Fig. 8 below), the shank head configured for positioning within the cavity of the receiver with the shank extending downward through the bottom opening and being initially pivotable with respect to the receiver (see Figs. 8-10); and a closure top (7) configured for positioning entirely within the central bore of the receiver above the compression insert and in engagement with the closure-mating structure to apply a downward pressure toward the compression insert and the shank head of the shank until an angular orientation of the shank relative to the receiver is locked with the closure top (see Fig. 2), wherein after the shank head is captured within the shank head retaining region and prior to locking with the closure top (see Fig. 14), the compression insert is configured for forcible downward displacement within the receiver (see Fig. 14) by direct engagement with the tooling to push the insert into (see para. [0047] “tool (not shown)”, see also para. [0048] “manually by pushing down”) a second position (see Fig. 14, see para. [0053] “locking position”) where at least one of the upper and lower insert abutment structures is configured to abut or engage with at least one of upper and lower receiver abutment structures so as to inhibit the compression insert from moving back up within the central bore of the receiver into the first position (see Fig. 14, see para. [0053] “locking position”), and wherein after the forcible downward displacement of the compression insert within the central bore (see para. [0047] “tool (not shown)”, see also para. [0048] “manually by pushing down”), the shank is configured to remain pivotable with respect to the receiver until the angular orientation of the shank relative to the receiver is locked with the closure top (see para. [0048] “loosened only by exerting an additional force”, note that until the set screw is fully tightened the locking feature can be overcome to allow pivoting).
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Regarding claim 2, wherein the compression insert is engageable with shank head (via 82) positioned within the cavity of the receiver in the second position (see Fig. 14, note that shank head is engaged).
Regarding claim 3, wherein after the forcible downward displacement of the compression insert within the receiver, the pivotal bone anchor assembly is configured for unlocked but non-floppy pivotal angular positioning of the shank relative to the receiver (see para. [0048] “loosened only by exerting an additional force”, note that until the set screw is fully tightened the locking feature can be overcome to allow pivoting).
Regarding claim 4, wherein the compression insert is configured to be pulled back up within the receiver after removal of the closure top so as to release the locked angular orientation between the shank and the receiver (see para. [0048] “loosened only by exerting an additional force”, note that until the set screw can be unscrewed and the locking feature can be overcome to allow pivoting).
Regarding claim 5, and further comprising a retainer (82) intended for positioning in the cavity and engaging with a surface in the shank head retaining region of the receiver (see Fig. 9).
Regarding claim 6, wherein the shank head is uploaded into the receiver through the bottom opening and captured by the retainer (see Figs. 8-9).
Regarding claim 7, wherein the retainer is configured to have an overlapping engagement with the compression insert in the first and second position (see annotated Fig. 4 below).
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Regarding claim 8, wherein the retainer is configured to engage the shank head above and below the hemisphere plane (see Fig. 14) when the shank is positioned in the receiver and in a non-pivotal and longitudinally aligned arrangement with the respect to the receiver (see Fig. 14).
Regarding claim 9, wherein the upper insert abutment structure further comprises a top surface of the compression insert (see Fig. 8, note that the upper insert abutment structure is a top surface of 84).
Regarding claim 10, wherein the compression insert is positioned into the first position within the central bore of the receiver prior to the shank (see para. [0048] “loosened only by exerting an additional force”, note that the compression insert could be positioned into the first position prior to insertion of the shank and moved back into the insertion position by providing additional force).
Regarding claim 11, wherein the compression insert is top loaded into the first position within the central bore of the receiver (see Fig. 1, see also para. [0045]).
Biedermann I discloses, regarding claim 13, a pivotal bone anchor assembly (see Figs. 1-14) intended for securing an elongate rod (6) to a bone of a patient (via 1) with tooling (see para. [0047] “tool (not shown)”, see also para. [0048] “manually by pushing down”), the pivotal bone anchor assembly comprising: a receiver (5) comprising a lower body (e.g. portion of 5 below U-shaped recess 13) defining a cavity (19) communicating with bottom surface (11) of the receiver through a bottom opening (18) and a pair of upright arms (14a-b) extending upwardly from the lower body with opposed inwardly facing surfaces defining an open channel (13) configured to receive the elongate rod and having a closure-mating structure (15) formed therein, the open channel communicating with the cavity to define a central bore (12), the central bore including upper and lower receiver abutment structures extending at least partially circumferentially around the central bore below the closure-mating structure (e.g. upper and lower surfaces of pins 9a-b or upper and lower surfaces of snap ring, see para. [0062] “snap rings”); a compression insert (81) configured for positioning in the central bore of the receiver (see Fig. 8), the compression insert comprising a central tool receiving opening (90), a U-shaped seating surface (e.g. surface of 83) sized and shaped to receive the elongate rod (see Fig. 8), and exterior upper and lower insert abutment structures (e.g. top and bottom surfaces of 84, note that 84 are positioned on the exterior surface facing outward toward the central bore) configured to have simultaneously overlapping arrangements with the upper and lower receiver abutment structures (see annotated Fig. 8 above, see also Fig. 11 and paras. [0047]-[0048], “pre-locking position”), respectively, when the compression insert is positioned in a first position in the central bore (see annotated Fig. 8 above, see also Fig. 11 and paras. [0047]-[0048], “pre-locking position”), so as to inhibit upward and downward movement of the compression insert within the central bore of the receiver until acted on by the tooling (see Fig. 11, see para. [0048], “pre-locking position”); a shank (1) comprising a shank head (3) and a bone anchoring portion (2) opposite the shank head configured to attach to the bone (see Fig. 1), the shank head having a partial spherical shape (see Fig. 8) defining a hemisphere plane (e.g. top surface of 3, see Fig. 8) and an internal drive socket (4) having a multi- faceted inner surface (see annotated Fig. 8 above), the shank head configured for positioning within the cavity of the receiver with the shank extending downward through the bottom opening and being initially pivotable with respect to the receiver (see Figs. 8-10); and a closure top (7) configured for positioning entirely within the central bore of the receiver above the compression insert and in engagement with the closure-mating structure to apply a downward pressure toward the compression insert and the shank head of the shank until an angular orientation of the shank relative to the receiver is locked with the closure top (see Fig. 2, see paras. [0053]-[0054]), wherein after the shank head is captured within the cavity and prior to locking with the closure top (see Fig. 14), the compression insert is configured for forcible downward displacement within the receiver by direct engagement with the tooling to push the insert see para. [0047] “tool (not shown)”, see also para. [0048] “manually by pushing down”) into a second position (a second position (see Fig. 14, see para. [0053] “locking position”) where at least one of the upper and lower insert abutment structures is configured to abut or engage with at least one of upper and lower receiver abutment structures so as to inhibit the compression insert from moving back up within the central bore of the receiver into the first position (see Fig. 14, see para. [0053] “locking position”), and wherein after the forcible downward displacement of the compression insert within the central bore (see para. [0047] “tool (not shown)”, see also para. [0048] “manually by pushing down”), the shank is configured to remain pivotable with respect to the receiver until the angular orientation of the shank relative to the receiver is locked with the closure top (see para. [0048] “loosened only by exerting an additional force”, note that until the set screw is fully tightened the locking feature can be overcome to allow pivoting).
Regarding claim 14, wherein the compression insert is engageable with shank head (via 82) positioned within the cavity of the receiver in the second position (see Fig. 14, note that shank head is engaged).
Regarding claim 15, wherein after the forcible downward displacement of the compression insert within the receiver, the pivotal bone anchor assembly is configured for unlocked but non-floppy pivotal angular positioning of the shank relative to the receiver (see para. [0048] “loosened only by exerting an additional force”, note that until the set screw is fully tightened the locking feature can be overcome to allow pivoting).
Regarding claim 16, wherein the compression insert is configured to be pulled back up within the receiver after removal of the closure top so as to release the locked angular orientation between the shank and the receiver (see para. [0048] “loosened only by exerting an additional force”, note that until the set screw can be unscrewed and the locking feature can be overcome to allow pivoting).
Regarding claim 17, and further comprising a retainer (82) configured for positioning in the cavity of the receiver and engaging with a seating surface (17) adjacent the bottom opening (see Figs. 11 and 14).
Regarding claim 18, wherein the shank head is uploaded into the receiver through the bottom opening and captured by the retainer (see Figs. 8-9).
Regarding claim 19, wherein the retainer is configured to have an overlapping engagement with the compression insert in the first and second position (see Figs. 11-14, see also annotated Fig. 4 above).
Regarding claim 20, wherein the retainer is configured to engage the shank head above and below the hemisphere plane when the shank is positioned in the receiver and in a non-pivotal and longitudinally aligned arrangement with the respect to the receiver (see Fig. 14).
Regarding claim 21, wherein the compression insert is positioned into the receiver prior to the shank (see Fig. 8).
Regarding claim 22, wherein the compression insert is top loaded into the first position within the central bore of the receiver (see Fig. 1, see also para. [0045]).
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.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 12 and 23, is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Biedermann I, as applied to claims 1 and 13 above, and in view of Biedermann et al. (U.S. Patent 5,672,176, hereinafter “Biedermann II”).
Biedermann I discloses all of the features of the claimed invention, as previously set forth above, Biedermann I further discloses, regarding claims 12 and 23, wherein the upwardly-facing surface of the compression insert further comprises an open second channel (83) held in alignment (via 9a-b) with the open first channel (13, see Fig. 8); however fails to disclose, regarding claims 12 and 23 a plurality of inwardly crimped structures formed in the receiver after the compression insert is positioned within the central bore of the receiver.
Biedermann II discloses a bone anchor assembly (see Fig. 2) with a plurality of inwardly crimped structures (17) in order to enable the structures to be provided as a part of the receiver (5, see lines 4-7 of column 3).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the structures in Biedermann I to be crimped inwardly in view of Biedermann II in order to enable the structures to be provided as a part of the receiver.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892.
Peterson et al. (U.S. Pub. No. 2008/0294202 A1), Walsh et al. (U.S. Pub. No. 2010/0152787 A1), and Savage (U.S. Pub. No. 2013/0211465 A1, hereinafter “Savage”) disclose polyaxial bone anchor assemblies with compression inserts and retainer rings.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michelle C. Green whose telephone number is (571)270-7051. The examiner can normally be reached on Monday-Friday between 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Eduardo C. Robert, at (571) 272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.C.G/ Examiner, Art Unit 3773 /EDUARDO C ROBERT/ Supervisory Patent Examiner, Art Unit 3773