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 .
Election/Restrictions
Applicant's election with traverse of Species A (Figs. 1 and 6-8b) in the reply filed on November 28, 2025 is acknowledged. The traversal is on the ground(s) that claim 1 is generic to all species. This is not found persuasive because Applicant has not addressed the finding of lack of unity between Species A, B, and C as set forth in the Restriction Requirement (see pg. 4).
The requirement is still deemed proper and is therefore made FINAL.
Claim 15, 17-20, and 22-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species as indicated by Applicant, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on November 28, 2025.
Claim 8 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species (species B, Figs. 2-5b; see para. 0048), there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on November 28, 2025.
Claims 27-30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species (species C, Figs. 9a-10; see para. 0056 regarding claim 27 and para. 0059 regarding claim 30), there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on November 28, 2025.
Claims 1-7, 9-14, 16, 21, 25, and 26 have been examined.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Objections
The claims are objected to because they include reference characters which are not enclosed within parentheses (see “R2” in claim 12; “R1” and “R2” in claim 13; and “S1” and “S2” in claim 21).
Reference characters corresponding to elements recited in the detailed description of the drawings and used in conjunction with the recitation of the same element or group of elements in the claims should be enclosed within parentheses so as to avoid confusion with other numbers or characters which may appear in the claims. See MPEP § 608.01(m).
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 1-7, 9-14, 16, 21, 25, and 26 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 1 recites the limitation "the head region of the bone anchor" in lines 10-11. There is insufficient antecedent basis for this limitation in the claim as claim 1 does not previously recite that the bone anchor includes a head region. Claims 2-7, 9-14, 16, 21, 25, and 26 are rejected because they depend from claim 1. For examination purposes, the Examiner is interpreting “the head region of the bone anchor” as “a head region of the bone anchor.”
Claim 4 is 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 4 recites the limitation "the central axis" in line 3. There is insufficient antecedent basis for this limitation in the claim as claim 1 does not recite a central axis. For examination purposes, the Examiner is interpreting claim 4 as depending from claim 3, which introduces a central axis.
Claim 5 is 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 5 recites the limitation "the ball head region of the bone anchor" in line 4. There is insufficient antecedent basis for this limitation in the claim as claim 1 does not recite that the head region is a ball head region. For examination purposes, the Examiner is interpreting claim 5 as reciting “the head region of the bone anchor.”
Claim 7 is 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 7 recites the limitation "the radially inwardly directed contact region" in liens 2-3. There is insufficient antecedent basis for this limitation in the claim as claim 1 does not recite a radially inwardly directed contact region. For examination purposes, the Examiner is interpreting claim 7 as depending from claim 6, which introduces a radially inwardly directed contact region.
Claim 9 is 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 9 recites the limitation "the contact point" in line 2. There is insufficient antecedent basis for this limitation in the claim as none of the preceding claims recite a contact point. For examination purposes, because claim 6 introduces a radially inwardly directed contact region, the Examiner is interpreting claim 9 as depending from claim 6 and as reciting “the radially inwardly directed contact region.”
Claim 9 is 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 9 recites the limitation "the temporary clamping in the proximal direction" in line 3. There is insufficient antecedent basis for this limitation in the claim as none of the preceding claims recite temporary clamping or clamping in any specific direction. For examination purposes, because claim 1 recites “the fixing element clamps the head region of the bone anchor,” the Examiner is interpreting claim 9 as reciting “the clamping.”
Claim 10 is 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 10 recites the limitation "the contact point" in line 2. There is insufficient antecedent basis for this limitation in the claim as none of the preceding claims recite a contact point (note that the Examiner is interpreting “the contact point” in claim 9 as reciting “the radially inwardly directed contact region”). For examination purposes, because claim 6 introduces a radially inwardly directed contact region, the Examiner is interpreting claim 10 as depending from claim 6 and as reciting “the radially inwardly directed contact region.”
Claim 10 is 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 10 recites the limitation "the temporary clamping in the proximal direction" in line 3. There is insufficient antecedent basis for this limitation in the claim as none of the preceding claims recite temporary clamping or clamping in any specific direction (note that the Examiner is interpreting “the temporary clamping in the proximal direction” in claim 9 as reciting “the clamping”). For examination purposes, because claim 1 recites “the fixing element clamps the head region of the bone anchor,” the Examiner is interpreting claim 10 as reciting “the clamping.”
Claim 12 is 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 12 recites the limitation "the contact region" in line 4. There is insufficient antecedent basis for this limitation in the claim as claim 1 does not recite a contact region. For examination purposes, because claim 6 introduces a radially inwardly directed contact region, the Examiner is interpreting claim 12 as depending from claim 6 and as reciting “the radially inwardly directed contact region.”
Claim 13 is 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 13 recites the limitation "the central axis" in line 4. There is insufficient antecedent basis for this limitation in the claim as claim 1 does not recite a central axis. For examination purposes, the Examiner is interpreting claim 13 as depending from claim 3, which introduces a central axis.
Claim 14 is 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 14 recites the limitation "at least one lateral wall" in line 3. There is insufficient antecedent basis for this limitation in the claim as claim 1 does not recite a lateral wall. For examination purposes, the Examiner is interpreting claim 14 as reciting “a wall.”
Claim 21 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 21 recites the limitation "the ball seat" in line 5. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, because claim 1 recites “a ball head receiving region,” the Examiner is interpreting claim 21 as reciting “the ball head receiving region.”
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.
Claims 1-5 and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sanders (US 2007/0270810 A1).
Claim 1. Sanders discloses an osteosynthesis device for treating the spine, comprising a fork head (body 10) which is U-shaped in a side view (see Fig. 3A, which shows a U-shape) and which has a through opening (see Fig. 3A inset) and the fork head has two fork legs (see Fig. 3A inset) with an inner-lying thread (thread in bore 40 – see para. 0015) in the proximal direction (see Fig. 3A inset), and a connecting rod (rod 32) can be received therein, and a ball head receiving region (region occupied by head 22 as shown in Fig. 3A) is provided in the fork head in the distal direction (see Fig. 3A inset) in the through opening, and a bone anchor (screw 18) is pivotably mounted therein, characterized in that a transverse opening (bore 40) is provided on the fork head, which transverse opening communicates with the through opening of the fork head via a wall cutout (see Fig. 3A inset), and a fixing element (setscrew 42 and wedge 48 in combination) is mounted in this transverse opening (wedge 48 is mounted in the transverse opening) so as to be mounted rotatably about a transverse opening axis (see Fig. 3A inset), and the fixing element clamps a head region (head 22) of the bone anchor in an angularly stable manner in the fork head with induction of a torsional moment about the transverse opening axis (Figs. 1-3A; paras. 0012-0018).
Claim 2. Sanders discloses wherein the head region of the bone anchor in the fork head becomes movable when the torsional moment at the fixing element is unloaded (when setscrew 42 is unscrewed, wedge 48 would not exert a force on head 22) (Figs. 1-3A; paras. 0012-0018).
Claim 3. Sanders discloses wherein the centre of the inner-lying thread (see Fig. 3A inset; note that “center” is being taken in the proximal-distal direction) and the centre of the ball head receiving region (see Fig. 3A inset; note that “center” is being taken in the proximal-distal direction) define a central axis (see Fig. 3A inset), and this central axis does not intersect with the transverse opening axis (see Fig. 3A) (Figs. 1-3A; paras. 0012-0018).
Claim 4. Sanders discloses wherein the transverse opening axis is arranged approximately orthogonally and at a distance from the central axis (see Fig. 3A inset; note that the transverse opening axis is offset in an orthogonal direction from the central axis) (Figs. 1-3A; paras. 0012-0018).
Claim 5. Sanders discloses wherein the fixing element protrudes at least in sections into the through opening of the fork head and abuts against the head region of the bone anchor (see Figs. 3 and 3A) (Figs. 1-3A; paras. 0012-0018).
Claim 13. Sanders discloses wherein the head region of the bone anchor is defined by a radius R1 (see Fig. 3A inset) and the fixing element is defined at its thickest point by a radius R2 (see Fig. 3A inset), and the shortest distance between the central axis and the transverse opening axis is smaller than the sum of the radii R1 and R2 (the shortest distance must necessarily be smaller than the sum in order for wedge 48 to abut head 22 as shown in Fig. 3A) (Figs. 1-3A; paras. 0012-0018).
Claims 1-3, 5, 11, and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jackson (US 2004/0204711 A1).
Claim 1. Jackson discloses an osteosynthesis device for treating the spine, comprising a fork head (head 11) which is U-shaped in a side view (see Fig. 2) and which has a through opening (comprised of channel 33 and chamber 45) and the fork head has two fork legs (arms 31 and 32) with an inner-lying thread (thread portions 39 and 40) in the proximal direction (see Fig. 2 inset), and a connecting rod (rod 5) can be received therein, and a ball head receiving region (chamber 45) is provided in the fork head in the distal direction (see Fig. 2 inset) in the through opening, and a bone anchor (shank 10) is pivotably mounted therein, characterized in that a transverse opening (bore 53) is provided on the fork head, which transverse opening communicates with the through opening of the fork head via a wall cutout (located at the intersection of bore 53 and chamber 45), and a fixing element (set screw 13) is mounted in this transverse opening so as to be mounted rotatably about a transverse opening axis (see Figs. 2 and 5 inset), and the fixing element clamps a head region (ball shaped structure 22) of the bone anchor in an angularly stable manner in the fork head with induction of a torsional moment about the transverse opening axis (Figs. 1-7; paras. 0023-0038).
Claim 2. Jackson discloses wherein the head region of the bone anchor in the fork head becomes movable when the torsional moment at the fixing element is unloaded (when set screw 13 is unscrewed, tip 59 would not exert a force on ball shaped structure 22) (Figs. 1-7; paras. 0023-0038).
Claim 3. Jackson discloses wherein the centre of the inner-lying thread and the centre of the ball head receiving region define a central axis (see Fig. 5 inset; extending into the page), and this central axis does not intersect with the transverse opening axis (see Fig. 5) (Figs. 1-7; paras. 0023-0038).
Claim 5. Jackson discloses wherein the fixing element protrudes at least in sections into the through opening of the fork head and abuts against the head region of the bone anchor (see Fig. 4 and para. 0037) (Figs. 1-7; paras. 0023-0038).
Claim 11. Jackson discloses wherein the fixing element is substantially pin-shaped (see Fig. 4) (Figs. 1-7; paras. 0023-0038).
Claim 21. Jackson discloses wherein the fixing element can assume a rotational position S1 (position when set screw 13 is fully screwed into bore 53) about the transverse opening axis, in which a compression force is transmitted on the bone anchor (via tip 59; see para. 0037), so that the bone anchor is held angularly stable in the ball head receiving region, and the fixing element can assume a second rotational position S2 (position when set screw 13 is not fully screwed into bore 53), in which the bone anchor is held movably in the ball seat (tip 59 would not be in contact with ball shaped structure 22) (Figs. 1-7; paras. 0023-0038).
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Claims 1 and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jirsak et al. (EP 2 638 874 A2).
Claim 1. Jirsak discloses an osteosynthesis device for treating the spine, comprising a fork head (head 1) which is U-shaped in a side view (see Fig. 2) and which has a through opening (comprised of slot 7 and opening 9) and the fork head has two fork legs (see Fig. 2 inset) with an inner-lying thread (see Fig. 2 inset) in the proximal direction (see Fig. 2 inset), and a connecting rod (rod 3) can be received therein, and a ball head receiving region (region that receives spherical end 5 as shown in Fig. 1) is provided in the fork head in the distal direction (see Fig. 2 inset) in the through opening, and a bone anchor (comprised of spherical end 5 and shaft 6) is pivotably mounted therein, characterized in that a transverse opening (occupied by thrust element 4 as shown in Fig. 1) is provided on the fork head, which transverse opening communicates with the through opening of the fork head via a wall cutout (see Fig. 2 inset), and a fixing element (thrust element 4) is mounted in this transverse opening so as to be mounted rotatably about a transverse opening axis (see Fig. 2 inset; thrust element 4 is rotatable via hinge 10), and the fixing element clamps a head region (spherical end 5) of the bone anchor in an angularly stable manner in the fork head with induction of a torsional moment about the transverse opening axis (Figs. 1-2; paras. 0015-0023).
Claim 14. Jirsak discloses wherein the fixing element extends beyond a wall (see Fig. 2 inset) of the fork head and a lever (see Fig. 2 inset) is attached thereto, and an actuation of the lever causes the fixing element to rotate (via insertion of rod 3 into slot 7 and against the lever, due to hinge 10) (Figs. 1-2; paras. 0015-0023).
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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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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.
Claims 6, 7, 9, 10, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Sanders (US 2007/0270810 A1) in view of Lin (US 2005/0096654 A1).
Claim 6. Sanders discloses wherein the fixing element has a contact region (see Fig. 3A inset) which abuts directly against the head region of the bone anchor (Figs. 1-3A; paras. 0012-0018).
Claim 9. Sanders discloses wherein the contact region for inducing the clamping lies above the equator (see Fig. 3A inset) of the bone anchor head region (Figs. 1-3A; paras. 0012-0018).
Claim 10. Sanders discloses wherein the contact region for inducing the clamping lies above the centre of the ball head receiving region (see Fig. 3A inset) in the fork head (Figs. 1-3A; paras. 0012-0018).
Claim 12. Sanders discloses wherein the fixing element describes a radius R2 (see Fig. 3A inset) at least at one point, and the radius R2 is greater than the radial distance between the contact region and the transverse opening axis (see Fig. 3A inset) (Figs. 1-3A; paras. 0012-0018).
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Sanders fails to disclose that the contact region is radially inwardly directed and concavely shaped at least in sections in a side view (claim 6), wherein the radially inwardly directed contact region of the fixing element approximates, in a side view, at least a portion of the outer surface of the bone anchor head region (claim 7).
Lin teaches a fixing element (plug 50) having a radially inwardly directed contact region (round recess 511) which abuts directly against a head region (ring 42) of a bone anchor (screw 41 and ring 42 in combination), wherein the contact region is concavely shaped (see para. 0023, which states that recess 511 corresponds to convex outer surface of ring 42) at least in sections in a side view, wherein the radially inwardly directed contact region of the fixing element approximates, in a side view, at least a portion of the outer surface of the bone anchor head region (see para. 0023, which states that recess 511 corresponds to convex outer surface of ring 42) (Fig. 1; para. 0023).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Sanders such that the contact region is radially inwardly directed and concavely shaped at least in sections in a side view (claim 6), wherein the radially inwardly directed contact region of the fixing element approximates, in a side view, at least a portion of the outer surface of the bone anchor head region (claim 7), as suggested by Lin, as doing so would allow for a greater area of contact between the bone anchor head region and the fixing element, thereby providing better fixation between the components.
Claims 1, 11, 16, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Biedermann et al. (US 2008/0147129 A1) in view of Jackson (US 2004/0204711 A1).
Claim 1. Biedermann discloses an osteosynthesis device for treating the spine, comprising a fork head (receiving part 1) which is U-shaped in a side view (see Fig. 3) and which has a through opening (bore 5) and the fork head has two fork legs (legs 9 and 10) with an inner-lying thread (thread 11) in the proximal direction (towards first end 2), and a connecting rod (rod 12) can be received therein, and a ball head receiving region (region of bore 5 occupied by head 15 as shown in Fig. 3) is provided in the fork head in the distal direction (towards second end 3) in the through opening, and a bone anchor (bone anchoring element 13) is pivotably mounted therein, characterized in that a transverse opening (through hole 34) is provided on the fork head, which transverse opening communicates with the through opening of the fork head via a wall cutout (see Fig. 8, which shows that through hole 34 intersects bore 5 at a cutout), and a fixing element (pin 33) is mounted in this transverse opening so as to be mounted about a transverse opening axis (axis extending along the longitudinal axis of through bore 34 as shown in Fig. 8, which would be perpendicular to axis 46), and the fixing element clamps a head region (head 15) of the bone anchor in an angularly stable manner in the fork head (head 15 can only rotate about axis 46 and thus is angularly stable in that rotation is limited to a single axis) (Figs. 1-8; paras. 0025-0042).
Claim 11. Biedermann discloses wherein the fixing element is substantially pin-shaped (see Fig. 1) (Figs. 1-8; paras. 0025-0042).
Claim 16. Biedermann discloses wherein a connecting rod (rod 12) can be inserted and can be fixed on the fork head by means of a locking element (fixation element 30), thereby achieving an angularly stable clamping between the bone anchor head region and the fork head (see para. 0042, which states that screw 30 locks the final position of head 15), and the angularly stable clamping with the aid of the locking element and the angularly stable clamping with the aid of the fixing element can be activated independently of one another (if so desired, (a) fixation element 30 can be actuated as stated in para. 0042 without the insertion of pins 33 in through holes 34 and (b) prior to inserting fixation element 30, pins 33 provide the clamping identified in claim 1) and can also be combined with one another (Figs. 1-8; paras. 0025-0042).
Claim 26. Biedermann discloses wherein the fork head provides a thrust piece (pressure element 20) and, when the bone anchor head region is clamped solely by the fixing element, the thrust piece is unloaded (prior to inserting fixation element 30, pressure element 20 is unloaded) (Figs. 1-8; paras. 0025-0042).
Biedermann fails to disclose that the fixing element is mounted rotatably about the transverse opening axis and the clamping occurs via induction of a torsional moment about the transverse opening axis (claim 1).
Jackson teaches a fixing element (set screw 13) mounted in a transverse opening (bore 53) of a fork head (head 11) so as to be mounted rotatably about a transverse opening axis (see Figs. 2 and 5 inset on pg. 13 above), wherein the fixing element clamps a head region (ball shaped structure 22) of a bone anchor (shank 10) in an angularly stable manner in the fork head with induction of a torsional moment about the transverse opening axis, wherein part of the fixing element and part of the transverse opening are threaded (threaded surface 58 of screw 13 engages complementary threads in bore 53 as shown in Fig. 4) (Figs. 1-7; paras. 0023-0038).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Biedermann such that part of the fixing element and part of the transverse opening are threaded, as suggested by Jackson, as such a configuration would ensure that the fixing element remains within the transverse opening post-operatively. In view of such a modification, in order to insert the fixing element into the transverse opening and into engagement with the head region of the bone anchor, the fixing element would necessarily be mounted rotatably about the transverse opening axis and the clamping would occur via induction of a torsional moment about the transverse opening axis (claim 1).
Claims 1 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Ark et al. (US 2020/0054366 A1) in view of Jackson (US 2004/0204711 A1).
Claim 1. Ark discloses an osteosynthesis device for treating the spine, comprising a fork head (housing 20) which is U-shaped in a side view (see Fig. 4) and which has a through opening (bore 24) and the fork head has two fork legs (sidewalls 20c and 20d) with an inner-lying thread (at threaded internal surface 20e) in the proximal direction (direction extending toward proximal opening 21a), and a connecting rod (rod R) can be received therein, and a ball head receiving region (seat 25a) is provided in the fork head in the distal direction (direction extending toward distal opening 21b) in the through opening, and a bone anchor (screw member 60) is pivotably mounted therein, characterized in that a transverse opening (hole 26) is provided on the fork head, which transverse opening communicates with the through opening of the fork head via a wall cutout (located at the intersection of hole 26 and bore 24 as shown in Figs. 4 and 4A), and a fixing element (spring 40 and pin 50 in combination) is mounted in this transverse opening so as to be mounted about a transverse opening axis (axis extending left-to-right in Fig. 4 and perpendicular to axis L), and the fixing element clamps a head region (head 62) of the bone anchor in an angularly stable manner in the fork head (see para. 0044) (Figs. 1-8; paras. 0037-0051).
Claim 25. Ark discloses wherein the fork head has a thrust piece (anvil 30), and the thrust piece has a through opening (opening 36), a distally directed contact region (surface in contact with head 62 as shown in Fig. 4) towards the bone anchor head region, a proximally directed stave bearing (saddle 34), and, in the region of the bone anchor head region, a lateral opening or partial cutout (slot 32b), in which the fixing element is arranged in a freely movable manner (see paras. 0045 and 0050) (Figs. 1-8; paras. 0037-0051).
Ark fails to disclose that the fixing element is mounted rotatably about the transverse opening axis and the clamping occurs via induction of a torsional moment about the transverse opening axis (claim 1).
However, Ark states that the fixing element is held in place via deforming the fork head adjacent the transverse opening (see para. 0050).
Jackson teaches a fixing element (set screw 13) mounted in a transverse opening (bore 53) of a fork head (head 11) so as to be mounted rotatably about a transverse opening axis (see Figs. 2 and 5 inset on pg. 13 above), wherein the fixing element clamps a head region (ball shaped structure 22) of a bone anchor (shank 10) in an angularly stable manner in the fork head with induction of a torsional moment about the transverse opening axis, wherein part of the fixing element and part of the transverse opening are threaded (threaded surface 58 of screw 13 engages complementary threads in bore 53 as shown in Fig. 4) (Figs. 1-7; paras. 0023-0038).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Ark such that part of the fixing element (such as, for example, head of pin 50) and part of the transverse opening are threaded, as suggested by Jackson, as such a configuration would ensure that the fixing element is held in place in the fork head and would simplify the surgical procedure by eliminating the need to deform the fork head. In view of such a modification, in order to insert the fixing element into the transverse opening and into engagement with the head region of the bone anchor, the fixing element would necessarily be mounted rotatably about the transverse opening axis and the clamping would occur via induction of a torsional moment about the transverse opening axis (claim 1).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Albert (US 2006/0235389 A1) discloses a fork head (tulip 200), a bone anchor (bone anchor 100) having a head region (head 102) received in a ball head receiving region (volume 230) of the fork head, and a fixing element (locking element 220) rotatably mounted in a transverse opening (threaded bore in base element 218) of the fork head to clamp the head region of the bone anchor in the fork head (Figs. 1-4). Lewis (US 2009/0082812 A1) discloses a fork head (bracket 104), a bone anchor (screw 102) having a head region (head 204) received in a ball head receiving region (occupied by head 204 as shown in Fig. 1A) of the fork head, and a fixing element (locking member 110) having a concave surface (bottom surface 122) mounted in a transverse opening (occupied by locking member 110as shown in Fig. 1A) of the fork head to clamp the head region of the bone anchor in the fork head (Figs. 1A-3). Carl’s (US 2013/0218207 A1) discloses a fork head (receiver 20), a bone anchor (anchor 30) having a head region (head 31) received in a ball head receiving region (reservoir 21) of the fork head, and a fixing element (dampener 40a) mounted in a transverse opening (opening 82) of the fork head to clamp the head region of the bone anchor in the fork head (Fig. 4). Sweeney (US 2018/0228517 A1) discloses a fork head (receiver member 200), a bone anchor (shank 102) having a head region (head 106) received in a ball head receiving region (cavity 240) of the fork head, and a fixing element (locking member 300) having a concave surface (concave portion 304) mounted in a transverse opening (recess 210) of the fork head to clamp the head region of the bone anchor in the fork head (Fig. 1A-D).
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/JULIANNA N HARVEY/Primary Examiner, Art Unit 3773