Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3 – 6 and 16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 3 recites “an upper-most engagement surface”. It is unclear if this is the same as the “upper-most engagement surface” of the insert of claim 1. For purposes of examination, they are assumed to be different.
Claim 16 is amended to cancel the limitation “a closure”, but then proceeds to reference the closure in further limitations. It is unclear if the closure is meant to be part of the claimed invention or is functionally recited. For purposes of examination the closure is assumed to be part of the claimed invention.
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 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 –
(a) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
Claim(s) 1 – 3, 5 – 6, 8 – 10 and 13 - 16 is/are rejected under pre-AIA 35 U.S.C. 102(a) as being anticipated by Hammill, SR. et al. (US 2011/0040336 A1).
Regarding claim 1, Hammill discloses a pivotal bone anchor assembly intended for securing a longitudinal connecting member to a bone of a patient (Abstract), the pivotal bone anchor assembly comprising:
a receiver (ref. 30) comprising a base portion (ref. 33) defining a lower portion of a central bore centered about a vertical centerline axis (Fig. 6 shows the lower portion having a bore to receive a head of a bone screw which is aligned along a central vertical axis) and communicating with a bottom surface of the base portion through a bottom opening (ref. 50), and an upper portion defining a channel configured to receive the longitudinal connecting member (best shown in Figs. 7A – 7E), the central bore extending upward from the bottom opening through the channel to a top of the upper portion (Fig. 6) and including a support surface adjacent the bottom opening (the support surface is considered to be the semi-spherical surface which accepts the head of the bone screw), a guide and advancement structure adjacent the top of the upper portion configured to mate with a closure (paragraph [0076], ref. 54), and an integral preformed non-threaded downward-facing abutment surface below the guide and advancement structure (see remarked Fig. 6 below);
a shank (ref. 12) comprising a head portion (ref. 18) and an anchor portion opposite the head portion configured for attachment to the bone (ref. 16), the head portion being positionable within the lower portion of the central bore and pivotably supported therein by the support surface with the shank extending downwardly through the bottom opening (Fig. 6); and
a single-piece insert (Fig. 6, ref. 42) at least partially positionable within the channel of the receiver and configured to engage the longitudinal connecting member (Figs. 6, 13), the insert comprising at least one upper-most engagement surface (see remarked Fig. 6 below), a center opening (Fig. 8B, ref. 61), and a downward-facing lower surface (Fig. 8B, ref. 56), the at least one upper-most engagement surface located radially outward from the center opening (Fig. 8A), and configured for biased engagement with the downward-facing abutment surface of the central bore (paragraph [0080], where the insert is biased through coil spring ref. 102),
wherein the insert is configured to sustain a pressure in a direction opposite from the downward-facing abutment surface toward the head portion of the shank so as to establish a pre-lock non-floppy friction fit engagement between the shank and the receiver (paragraph [0080-87], the insert is configured to sustain a pressure in the axial direction through the coil springs, which would establish a pre-lock on the head of the shank).
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Regarding claim 2, Hammill discloses the pivotal bone anchor assembly of claim 1, wherein the insert further comprises a pair of upright insert arms (Fig. 8A, ref. 52) defining an open insert channel therebetween configured to receive the longitudinal connecting member when the insert and the longitudinal connecting member are positioned together in the receiver (Fig. 13).
Regarding claim 3, Hammill discloses the pivotal bone anchor assembly of claim 2, wherein each of the pair of upright insert arms includes an upper-most engagement surface extending above top surfaces of the upright insert arms (see remarked Fig. 8D below which shows an upper-most surface and top surfaces, note that any of the surfaces on an upper half or portion of the insert may be considered to be “top surfaces”).
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Regarding claim 5, Hammill discloses the pivotal bone anchor assembly of claim 3, wherein the insert is configured for positioning into the central bore of the receiver in a first position and then for rotation about the vertical centerline axis toward a second position with the upper-most engagement surfaces being rotated into engagement with the downward-facing abutment surface of the central bore (the insert is fully capable of being inserted and rotated until the engagement surface contact the abutment, see Fig. 13).
Regarding claim 6, Hammill discloses the pivotal bone anchor assembly of claim 5, wherein the central bore further comprises:
at least one inner pocket formed into the central bore of the receiver between the at least one downward-facing abutment surface and the support surface (see remarked Fig. 13 below which shows the inner pocket shaded in on the right side); and
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at least one protuberant interference structure projecting radially outward from a side of the insert, wherein the at least one inner pocket is configured to receive the at least one protuberant interference structure upon positioning of the insert into the receiver so as to inhibit further movement of the insert with respect to the receiver in at least one direction (as shown in remarked Fig. 13, the insert has symmetric protuberants which fit into the symmetric pockets of the receiving and inhibit upward movement of the insert).
Regarding claim 8, Hammill discloses the pivotal bone anchor assembly of claim 1, wherein the insert is downloadable into the central bore through the upper portion of the receiver (the insert is fully capable of being downloadable into the central bore of the lower part of the receiver from the upper portion prior the parts of the receiver being connected).
Regarding claim 9, Hammill discloses the pivotal bone anchor assembly of claim 1, wherein the downward- facing lower surface of the insert is configured to engage the head portion of the shank. (Fig. 13)
Regarding claim 10, Hammill discloses the pivotal bone anchor assembly of claim 9, wherein the head portion of the shank further comprises a spherical upper surface, and wherein the downward-facing lower surface of the insert further comprises a spherical inner surface configured to directly engage the spherical upper surface of the head portion of the shank (Fig. 13).
Regarding claim 13, Hammill discloses the pivotal bone anchor assembly of claim 1, wherein the support surface adjacent the bottom opening of the central bore further comprises a spherical surface configured to slidably engage with a lower spherical surface of the head portion of the shank to provide for pivotal motion between the shank and the receiver prior to locking the pivotal bone anchor assembly with the closure (Fig. 13).
Regarding claim 14, Hammill discloses the pivotal bone anchor assembly of assembly of wherein the upper portion of the receiver further comprises a pair of upright arms integrally formed with and extending upward from the base portion to define the channel as an upwardly-open channel (Figs. 7C, 13, ref. 32), and wherein the downward-facing abutment surface of the central bore further comprises a discontinuous abutment surface formed into inner surfaces of the pair of upright arms (the U-shapped channel breaks the circumferential surface of the abutment, thus making it a discontinuous surface).
Regarding claim 15, Hammill discloses the pivotal bone anchor assembly of claim 14, wherein the guide and advancement structure further comprises a discontinuous helically wound guide and advancement structure formed into upper inner surfaces of the pair of upright arms (Fig. 13).
Regarding claim 16, Hammill discloses the pivotal bone anchor assembly of claim 1 and further comprising the longitudinal connecting member (Fig. 13, ref. 70), wherein the closure is configured for positioning entirely within the upwardly-open channel of the receiver above the longitudinal connecting member (Fig. 3) and in engagement with the guide and advance structure to apply a downward pressure to a top of the longitudinal connecting member, so as to secure the longitudinal connecting member to the bone of the patient (Fig. 3).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 11 and 12 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Hammill, SR. et al. (US 2011/0040336 A1) in view of Hawkes et al. (US 2006/0173456 A1).
Regarding claim 11, Hammill discloses the pivotal bone anchor assembly of claim 1, but is silent regarding a retainer configured for positioning within the lower portion of the central bore, the retainer having a lower outer surface configured to engage the support surface of the central bore and an inner surface configured to capture and hold the head portion of the shank within the base portion of the receiver.
Hawkes teaches an analogous pivotal bone anchoring assembly comprising a spherical head of a bone anchor (Fig. 2, ref. 16), a receiver (Fig. 4C, ref. 18) and a retainer (Fig. 4C, ref. 22) configured for positioning within a lower portion of the receiver (Fig. 8A), the retainer having a lower outer surface configured to engage an support surface of the receiver (this is considered to be the outer surface) and an inner surface configured to capture and hold the head portion within the receiver (Fig. 4C shows an inner surface ref. 465) for positionlly fixing the receiver relative to the anchor (paragraph [0044]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the assembly of Hammill to include the retainer, as taught by Hawkes for the purpose of better holding the relative position of the anchor and receiver.
Regarding claim 12, Hammill in view of Hawkes discloses the pivotal bone anchor assembly of claim 11, wherein the retainer is positionable within the lower portion of the central bore prior to the head portion of the shank (during assembly, the ring is fully capable of being positioned in the lower portion prior to the anchor).
Allowable Subject Matter
Claim 4 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claim 7 is 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: Claims 4 and 7 in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found to disclose, or suggest a pivotal bone screw assembly comprising: an insert with upright arms including horizontal slots and wherein the bone screw if uploaded into the receiver.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 which lists prior art used in the current rejection and other similar pivotal bone anchor assemblies.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TESSA M MATTHEWS whose telephone number is (571)272-8817. The examiner can normally be reached M - F 8am - 1pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eduardo Robert can be reached 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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/TESSA M MATTHEWS/Examiner, Art Unit 3773