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 Objections
Claim 1 is objected to because of the following informalities:
Claim 1, “facilitated by the rounded face” should read “facilitated by a rounded face”.
Appropriate correction is required.
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 6, 13 and 22 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.
Claims 6 and 13 recite “a rounded face” of the resilient tab. It is unclear if this is the same as or different than the rounded face as recited in clams 1 and 10. For purposes of examination, it is assumed to be the same.
Claim 22 recites a first and second chamber where the second chamber is configured to receive the resilient tab. However, claim 22 also states “inserting a split retaining ring through the distal opening such that a conical outer surface of the split retainer ring rests against a conical surface of the second tapered chamber”. It is unclear how the second chamber can receiver both the ring and resilient tab.
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) 1, 6 – 9 and 17 - 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Biedermann et al. (US 2014/0025119 A1).
Regarding claim 1, Biedermann discloses a fastener assembly for a spinal fixation system (Abstract), comprising:
a bone shank comprising a head portion (Fig. 1, ref. 3) and a distal threaded portion (Fig. 1, ref. 2) configured to be implanted into bone;
a receiver (ref. 4) comprising:
an axial bore extending longitudinally through the receiver from a proximal opening of the receiver to a distal opening (Fig. 5, ref. 8); and
an interior surface surrounding a portion of the axial bore, the interior surface defining a tapered recess, the tapered recess increasing in depth toward a distal end of the tapered recess (Fig. 5, ref. 15);
a pressure insert (ref. 6) disposed at least partly within the axial bore (Fig. 11a), the pressure insert comprising:
a saddle configured to seat a fixation rod (Fig. 9, ref. 6);
a distally-facing concave surface configured to contact the head portion of the bone shank (Fig. 9, ref. 63); and
a resilient tab projecting proximally and outward from an exterior cylindrical surface of the pressure insert (Fig. 9, refs. 69a, b, 70a, b and 66a, b);
wherein the pressure insert is longitudinally displaceable in the axial bore from a first longitudinal position to a second longitudinal position, wherein longitudinal displacement of the pressure insert to the second longitudinal position is resisted by a spring force facilitated by the rounded face of the resilient tab engaging the tapered recess (the first position may be an initial entry position into the receiver and second position may be any position in which the tabs engage the angles inner surfaces of the receiver), and
wherein, when the pressure insert returns to the first longitudinal position, the spring force urges the pressure insert distally against the head portion of the bone shank to facilitate a friction-fit engagement between the head portion of the bone shank and the receiver (paragraph [0059]).
Regarding claim 6, Biedermann discloses the fastener assembly of claim 1, wherein the resilient tab comprises a rounded face contacting the tapered recess (Fig. 7, ref. 69a, b).
Regarding claim 7, Biedermann discloses the fastener assembly of claim 6, wherein the rounded face is configured to make point contact with the tapered recess (Figs. 11a, b).
Regarding claim 8, Biedermann discloses the fastener assembly of claim 1, further comprising a second resilient tab disposed in the tapered recess, wherein the tapered recess comprises a conical bore (as shown in Fig. 11a, the pressure insert has two tabs which engage a conical bore ref. 15).
Regarding claim 9, Biedermann discloses the fastener assembly of claim 1, wherein:
the tapered recess comprises a planar ramped surface configured to contact the resilient tab;
the interior surface surrounding the axial bore further defines a second tapered recess comprising a second planar ramped surface; and
wherein the pressure insert further comprises a second resilient tab disposed in the second tapered recess and configured to make sliding contact with the second planar ramped surface (Figs. 11a, b).
Regarding claim 17, Biedermann discloses a receiver body for a polyaxial bone screw assembly (Abstract), the receiver body comprising:
an axial bore extending longitudinally through the receiver body from a proximal opening of the receiver body to a distal opening (Fig. 5);
a first tapered chamber disposed adjacent to the distal opening and configured to receive a head portion of a bone shank therein (from ref. 12 to 11, the chamber increases in width until a largest diameter of the chamber is reached, Fig. 5),
wherein the first tapered chamber increases in width toward a top portion of the first tapered chamber (Fig. 5);
a second tapered chamber disposed proximal to the first tapered chamber (ref. 15), wherein the second tapered chamber increases in width toward a bottom portion of the second tapered chamber (Fig. 5); and
a channel defined in an upper portion of the receiver body and configured to receive a fixation rod therein (Fig. 2).
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Regarding claim 18, Biedermann discloses the receiver body of claim 17, wherein the first tapered chamber comprises a first conical bore (Fig. 5, ref. 12, see remarked Fig. 5 above).
Regarding claim 19, Biedermann discloses the receiver body of claim 18, wherein the second tapered chamber comprises a second conical bore (Fig. 5, ref. 15).
Regarding claim 20, Biedermann discloses the receiver body of claim 18, wherein the second tapered chamber comprises a first planar ramped surface, and wherein the receiver body comprises a third tapered chamber comprising a second planar ramped surface (Fig. 5 shows two chambers with ramped surfaces refs. 15a, b).
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) 2 – 5, 10 – 16 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Biedermann et al. (US 2014/0025119 A1) in view of Jackson (US 2012/0310290 A1).
Regarding claim 2, Biedermann discloses the fastener assembly of claim 1, wherein:
the receiver further comprises a chamber disposed adjacent to the distal opening and configured to receive the head portion of the bone shank therein (Fig. 5, ref. 11);
the fastener assembly further comprises a retainer ring (ref. 5) disposed in the chamber; and the friction-fit engagement is at least partially between the head portion of the bone shank and the split retainer ring (once all of the components are assembly there is a pressure/friction fit).
Biedermann is silent that the retainer ring is a split retainer ring.
Jackson teaches an analogous device (Abstract) comprising a split retainer ring (ref. 12, Fig. 1) for frictionally engaging a head of the bone screw (paragraph [0039]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the retainer ring and cooperating bore of the receiver, such that the retainer ring is a split retainer ring, as taught by Jackson, for the purpose of enabling a plurality of different positions of the bone shank relative to the receiver and to allow for either top or bottom loading into the receiver due to it’s compressibility (paragraph [0050]).
Regarding claim 3, Biedermann in view of Jackson discloses the fastener assembly of claim 2, wherein the head portion of the bone shank comprises a spherical surface (Biedermann, Fig. 1), wherein the split retainer ring comprises an interior concave surface configured to contact the spherical surface to thereby provide a pivotable relationship between the head portion of the bone shank and the interior concave surface of the split retainer ring (Jackson, Fig. 10).
Regarding claim 4, Biedermann in view of Jackson discloses the fastener assembly of claim 3, wherein: the receiver comprises an interior conical surface defining the chamber, the split retainer ring further comprises an outer conical surface, and when the pressure insert is in the second longitudinal position, the outer conical surface abuts the interior conical surface of the receiver (Jackson, Fig. 4).
Regarding claim 5, Biedermann in view of Jackson discloses the fastener assembly of claim 4, further comprising a compression screw configured to be threadably received into an upper opening of the receiver along a longitudinal axis of the receiver (Biedermann, Fig. 1, ref. 7), and wherein the compression screw is configured to compress the fixation rod against the pressure insert, which in turn locks the fastener assembly by simultaneously urging: the spherical surface of the head portion of the bone shank against the interior concave surface of the split retainer ring; and the outer conical surface of the split retainer ring against the interior conical surface of the receiver (Biedermann, paragraph [0064]).
Regarding claim 10, Biedermann discloses a receiver for a polyaxial bone screw assembly (Abstract), the receiver comprising:
a body (ref. 4), comprising:
an axial bore extending longitudinally through the receiver from a proximal opening of the receiver to a distal opening (Fig. 5);
a chamber disposed adjacent to the distal opening and configured to receive a head portion of a bone shank therein (Fig. 5, ref. 11); and
an interior surface surrounding a portion of the axial bore, the interior surface defining a tapered recess (ref. 15), the tapered recess increasing in depth toward a distal end of the tapered recess (Fig. 5);
a retainer ring disposed in the chamber (ref. 5); and
a pressure insert disposed at least partly within the axial bore (ref. 6), the pressure insert comprising:
a first surface configured to seat a fixation rod (ref. 65);
a distally-facing concave surface configured to contact the head portion of the bone shank (ref. 63); and
a resilient tab projecting proximally and outward from an exterior cylindrical surface of the pressure insert (ref. 66, 70), the resilient tab comprising a rounded face engaging the tapered recess (ref. 69a, b),
wherein the pressure insert is longitudinally displaceable in the axial bore from a first longitudinal position (initial assembly) to a second longitudinal position (fully seated within the receiver),
wherein longitudinal displacement of the pressure insert to the second longitudinal position causes the resilient tab engaging the tapered recess to deflect, thereby providing a spring resistance in a distal direction (paragraph [0059], Fig. 11b).
Biedermann is silent that the retainer ring is a split retainer ring.
Jackson teaches an analogous device (Abstract) comprising a split retainer ring (ref. 12, Fig. 1) for frictionally engaging a head of the bone screw (paragraph [0039]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the retainer ring and cooperating bore of the receiver, such that the retainer ring is a split retainer ring, as taught by Jackson, for the purpose of enabling a plurality of different positions of the bone shank relative to the receiver and to allow for either top or bottom loading into the receiver due to it’s compressibility (paragraph [0050]).
Regarding claim 11, Biedermann in view of Jackson discloses the receiver of claim 10, wherein the split retainer ring comprises an interior concave surface (Jackson, Fig. 3).
Regarding claim 12, Biedermann in view of Jackson discloses the receiver of claim 11, wherein the body further comprises a conical bore (Jackson, Fig. 3, ref. 84), wherein:
the split retainer ring further comprises an outer conical surface, and when the pressure insert is in the second longitudinal position, the outer conical surface abuts the conical bore (Jackson, Fig. 3).
Regarding claim 13, Biedermann in view of Jackson discloses the receiver of claim 10, wherein the resilient tab comprises a rounded face contacting the tapered recess (Biedermann, Fig. 7, ref. 69a, b).
Regarding claim 14, Biedermann in view of Jackson discloses the receiver of claim 13, wherein the rounded face is configured to make point contact with the tapered recess (Biedermann, Fig. 11b).
Regarding claim 15, Biedermann in view of Jackson discloses the receiver of claim 10, further comprising a second resilient tab disposed in the tapered recess, wherein the tapered recess comprises a conical bore (Biedermann, Fig. 11a).
Regarding claim 16, Biedermann in view of Jackson discloses the receiver of claim 10, wherein:
the tapered recess comprises a planar ramped surface configured to contact the resilient tab;
the interior surface surrounding the axial bore further defines a second tapered recess comprising a second planar ramped surface; and wherein the pressure insert further comprises a second resilient tab disposed in the second tapered recess and configured to make sliding contact with the second planar ramped surface (Biedermann, Fig. 11a).
Regarding claim 21, Biedermann discloses a method for assembling a polyaxial fastener assembly (Abstract), comprising:
inserting a head portion of a bone shank through a distal opening of a receiver assembly and into a chamber of the receiver assembly (paragraph [0058]), wherein the receiver assembly comprises:
a receiver body (ref. 4), comprising:
the distal opening (ref. 12);
a conical interior surface disposed about the chamber (the distal portion of the chamber at ref. 12 as shown in Fig. 5 is conical);
an axial bore extending longitudinally through the receiver body (Fig. 5); and
a tapered recess defined in a surface of the axial bore (Fig. 5, ref. 15);
a retainer ring (Fig. 1, ref. 5) disposed in the chamber; and
a pressure insert (ref. 6) disposed at least partially within the axial bore (Fig. 11a), the pressure insert comprising:
a resilient tab projecting proximally and outward from an exterior surface of the pressure insert (Fig. 7, ref. 66, 70), the resilient tab comprising a rounded face engaging the tapered recess (refs. 69a, b), wherein the inserting comprises pushing the head portion through the distal opening of the receiver body and through the retainer ring to:
to collapse about a neck of the bone shank to retain the head portion within the chamber in a pivotable relationship with the receiver body (Fig. 11a, where the neck is considered to be any portion below the maximum diameter of the head); and
cause the pressure insert to move to a first longitudinal position (initial insertion position); wherein the method further comprises:
releasing a distally-directed force on the receiver assembly to allow the pressure insert to return to a second longitudinal position, wherein, in the second longitudinal position, a spring force provided by the resilient tab urges the pressure insert distally against the head portion of the bone shank to facilitate a friction-fit engagement between the head portion of the bone shank and the split retainer ring (paragraph [0059], Fig. 11b).
Biedermann is silent that the retainer ring is a split retainer ring and is configured to elastically expand about the head portion.
Jackson teaches an analogous device (Abstract) comprising a split retainer ring (ref. 12, Fig. 1) capable of elastically expanding and contracting (due to split surfaces refs. 101, 100) for frictionally engaging a head of the bone screw (paragraph [0039]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the retainer ring and cooperating bore of the receiver, such that the retainer ring is a split retainer ring, as taught by Jackson, for the purpose of enabling a plurality of different positions of the bone shank relative to the receiver and to allow for either top or bottom loading into the receiver due to it’s compressibility (paragraph [0050]).
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Biedermann et al. (US 2014/0025119 A1) in view of Gabelberger et al. (US 2010/0268279 A1) and in view of Jackson (US 2012/0310290 A1).
Regarding claim 23, Biedermann discloses a fastener system for a spinal fixation system, comprising:
a bone shank comprising a head portion (ref. 3) and a distal threaded portion (ref. 2) configured to be implanted into bone;
a receiver (ref. 4) comprising:
an axial bore extending longitudinally through the receiver from a proximal opening of the receiver to a distal opening (Fig. 5);
an interior surface surrounding a portion of the axial bore, the interior surface defining a tapered recess (ref. 15), the tapered recess increasing in depth toward a distal end of the tapered recess (Fig. 5); and
a lower tapered chamber adjacent the distal opening (ref. 11);
a pressure insert (ref. 6) configured to be positioned in the axial bore (Fig. 11a), the pressure insert comprising:
a saddle configured to seat a fixation rod (Fig. 7, ref. 65);
a distally-facing concave surface (ref. 63, Fig. 8); and
a resilient tab projecting proximally and outward from an exterior cylindrical surface of the pressure insert (refs. 66, 70), wherein the resilient tab is sized and shaped to extend at least partially within the tapered recess of the receiver (Fig. 11a);
a retainer ring (ref. 5) comprising an outer tapered surface and configured to be positioned within the lower tapered chamber (Fig. 11a).
Biedermann is silent that the fastening system is a kit and that the retainer ring is a split retainer ring.
Gabelberger teaches a kit (paragraph [0163]) for a fastening system (Abstract). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Biedermann to be a kit for the purpose of specifically meeting the particular needs/anatomy of a patient (paragraph [0163]).
Jackson teaches an analogous device (Abstract) comprising a split retainer ring (ref. 12, Fig. 1) for frictionally engaging a head of the bone screw (paragraph [0039]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the retainer ring and cooperating bore of the receiver, such that the retainer ring is a split retainer ring, as taught by Jackson, for the purpose of enabling a plurality of different positions of the bone shank relative to the receiver and to allow for either top or bottom loading into the receiver due to it’s compressibility (paragraph [0050]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892.
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
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