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 .
Response to Amendment
According to the amendment filed February 23, 2026, claims 1, 4-5 and 8 have been amended, claims 2-3, 8, 10-15 and 18-20 have been canceled, and new claims 21-36 have been added. Claims 1, 4-5, 8 and 21-36 are currently pending.
Response to Arguments
Applicant’s arguments with respect to claim(s) 34-36 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Objections
Claim 34 is objected to because of the following informalities:
In line 3 of claim 34, “the rod;” should be deleted, as the preamble recites “A bone anchoring device for anchoring a rod to a bone or vertebra”, the rod need not be recited as a component of the bone anchoring device.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 34-36 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 34 recites, in lines 12-13, “wherein the insert comprises a lower friction material than a material that forms the main body of the fixation member to increase slidability of the rod thereagainst”.
The specification in its entirety does not provide adequate support for this limitation. Examiner notes that, regarding the slidability of the rod against the fixation member and/or material(s) of the fixation member, the specification recites the following:
“The bone anchoring device can be employed as a bone anchoring device that can be fixed to the rod and as a bone anchoring device that is slidable with respect to the rod to permit a positional change of the bone anchoring device relative to the rod when implanted. Thus, the bone anchoring device can be used as a growing construct that allows the spine to grow while correcting a scoliotic deformity.” (para. 0009)
“Preferably, the surface of the rod 100 is smooth, at least to an extent such that the rod 100 can slide along a fixation member when the rod touches the fixation member while not being fixed. It shall be noted that the rod is not limited to a straight rod as depicted in the embodiments, but can be any elongate stabilization member that is configured to be displaceably, in particular slidably, receivable in the receiving part 5.” (para. 0053)
“The insert 85 is preferably made of a material that facilitates sliding of the rod along the lower surface 85a. More specifically, the insert 85 may be made of a polymer, particularly of a body-compatible polymer, such as PEEK.” (para. 0070)
“Moreover, the axial length of the first fixation member is such that there is a gap 800 between the upper surface of the rod 100 and the lower surface 85a of the first fixation member 8. The size of the gap 800 depends on the size of the rod. In some cases, the gap is so small so that the rod 100 is configured to slide along the lower surface 85a. In clinical use, if the gap 800 is large enough, the rod may even be able to move freely without contacting the first fixation member 8 or the pressure member 6. Alternatively, the axial length of the portion of first fixation member 8 that protrudes into the rod channel and/or the diameter of the rod may be such that the rod slides along the lower side of the first fixation member and on the first rod contacting surface 72 of the outer ring 7.” (para. 0071)
“The bone anchoring element, the receiving part, and the pressure member, as well as the rod and the fixation member, may be made of the same or of different materials, preferably of a bio-compatible material such as titanium or stainless steel, or of a bio-compatible alloy, such as NiTi alloys, for example Nitinol, or of a bio-compatible plastic material, for example, polyether ether ketone (PEEK).” (para. 0072)
Thus, while the specification describes the rod being slidable with respect to the bone anchoring device, the specification does not describe particular material selections for each of fixation member components that satisfy this limitation, where the insert comprises a “lower friction material” relative to that of the main body.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 34 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Stihl (US 2011/0040335 A1) in view of Carls (US 2009/0264933 A1).
Regarding claim 34, Stihl teaches a bone anchoring device (10, 12; Figs. 1-2; para. 0027) for anchoring a rod (45; Fig. 1) to a bone or vertebra (V; Fig. 2), the bone anchoring device comprising:
the rod (45);
a receiving part (20; Figs. 1-2; para. 0027) having a first end (at break-off region 150; Fig. 1), a second end (24; Fig. 1; para. 0031) below the first end, a central axis (20a; Figs. 1-2) extending between the first and second ends, two legs (28, 30; Figs. 1-2; para. 0027) defining a channel at (26; Fig. 1; para. 0027) the first end for receiving the rod (45, as shown; Figs. 1-2), and an accommodation space at the second end for accommodating a head of a bone anchoring element (accommodation space shown receiving bushing 36 and a head 14 of bone anchoring element 12; Figs. 1-2; para. 0031-0032); and
a fixation member (locking cap 40; Figs. 1-2; para. 0034) engageable with the legs of the receiving part (as shown in Fig. 2), the fixation member having a main body (44; Figs. 1-2) with a distal end (lower end of inner body part 44; Figs. 1-2), an unthreaded inner bore formed in the distal end (shown in Figs. 1-2, rotatably receiving an upper stem portion of saddle 46 as described in para. 0034), and an insert (46; Figs. 1-2) positionable in the inner bore and configured to extend axially out of the distal end of the fixation member to contact the rod in the channel (as shown in Fig. 2).
Stihl also contemplates the rod being a dynamic rod (see para. 0029) and generally states that components of the bone anchoring device “may be manufactured from any biocompatible material (see para. 0046).
However, Stihl does not disclose wherein the insert comprises a lower friction material than a material that forms the main body of the fixation member to increase slidability of the rod thereagainst.
Carls, in analogous art, is directed towards bone anchoring devices for use with a dynamic spinal rod system (see anchors 10, 80 in Figs. 2-4 in dynamic stabilization assembly 300 for anchoring rod 100 to vertebrae; para. 0022), where a first anchor allows for sliding movement of the rod (defined by anchor 10, with receiver 20 having a rod channel 50 that “is designed to help facilitate sliding motion between the receiver 20 and the rod 100” as recited in para. 0033; see Figs. 2-4 and 5A-B) and a second anchor that fixes the rod in a channel thereof (defined by anchor 80, which fixes rod and does not allow for movement thereof as described in para. 0022). To facilitate sliding of the rod within the first anchor, Cars discloses that the surfaces of the rod channel (50; Figs. 5A-B) “may include a suitable friction reducing material” by, for example, coating the surfaces with “a suitable low friction material (e.g., a ceramic or low friction polymer)” (recited in para. 0033).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used Stihl’s bone anchoring devices in a dynamic spinal rod system, so that at least one of the bone anchoring devices allows for sliding movement of the rod, as taught by Carls, by coating rod-contacting surfaces of the receiver member, including the rod-contacting insert of Stihl’s fixation member, with a low friction material as taught by Carls for facilitating sliding of the rod within the receiver, so that the insert increases slidability of the rod thereagainst, because Carls teaches that such providing sliding capability of the rod within at least one anchoring element of a dynamic stabilization system enables the system to tolerate some movement, thereby increasing a patient’s post-operative freedom of movement (see Carls, para. 0004, 0022).
Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have formed the main body of Stihl’s fixation member of a material having a higher friction material than the low friction material coated on the rod-contacting surface of Stihl’s insert as modified by Carls, described above, since it has been held to be within the general skill of a worker in the art to select a material on the basis of its suitability for the intended use as a matter of obvious design choice, and because where the main body of the fixation member does not contact the rod, forming the main body of such a material would not affect the desired functionality of the bone anchoring device and fixation member thereof, i.e. to facilitate sliding of the rod therein. In re Leshin, 125 USPQ 416.
Regarding claim 35, Stihl and Carls, in combination, disclose the bone anchoring device of claim 34, wherein the rod remains movable relative to the receiving part when the fixation member is fully advanced in the channel (where the rod-contacting surfaces of Stihl’s receiver and fixation member insert have been modified to include a low friction material to facilitate sliding of the rod relative to the receiver, in view of Carls, Stihl’s rod 45 is understood to remain movable relative to receiving part 20 when the fixation member 40 is fully advanced towards the rod in the channel; see Stihl, Fig. 2).
Claim 36 is rejected under 35 U.S.C. 103 as being unpatentable over Stihl (US 2011/0040335 A1) and Carls (US 2009/0264933 A1), as applied to claim 34 above, further in view of Peterson (US 2012/0253409 A1).
Regarding claim 36, Stihl and Carls, in combination, disclose the bone anchoring device of claim 34.
Stihl also discloses wherein the insert abuts against the main body of the fixation member (see insert 46 abutting against main body 44 of the fixation member 40; Figs. 1-2).
However, the combined teachings of Stihl and Carls do not disclose wherein the inner bore forms a proximal abutment in the main body, and wherein the insert is configured to abut against the abutment while extending out of the distal end of the fixation member.
Peterson, in analogous art, teaches a bone anchoring device (shown in Fig. 7) for anchoring a rod (108; Fig. 7) to a bone or vertebra (via anchor member 106; Fig. 7; abstract), the bone anchoring device comprising: a receiving part (104; Fig. 7; para. 0039) having two legs (733a,b in Fig. 7A) defining a channel for receiving the rod (as shown; Figs. 7, 7A), and an accommodation space at the second end for accommodating a head of a bone anchoring element (shown for receiving head 717; Fig. 7); and a fixation member (cap 102, including body 900, set screw 1000 and saddle 1100) engageable with the legs of the receiving part (as shown via body 900; Fig. 7), the fixation member having a main body (1000; Fig. 7) with a distal end (lower end; fig. 7), an unthreaded inner bore (1020; Fig. 19) formed in the distal end, and an insert (1100; Figs. 7, 11-13, 19-20) positionable in the inner bore and configured to extend axially out of the distal end of the fixation member to contact the rod in the channel (as shown; Figs. 7, 19-20).
Peterson also discloses wherein the inner bore forms a proximal abutment in the main body, and wherein the insert is configured to abut against the abutment while extending out of the distal end of the fixation member (inner bore 1020 of the main body, identified in Fig. 19, forms an angled abutment surface at a lower/distal opening thereof, described as “a tapered recess region” in para. 0053, which transition region 1135 of insert/saddle 1100 abuts while extending out of the lower/distal end of the fixation member, as shown in Figs. 7, 11-13 and 19-20).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the inner bore of Stihl’s main body to include a tapered recess region at a distal end thereof to define a proximal abutment, and to modify Stihl’s insert accordingly to have a transition region for abutting against the abutment of the main body, as claimed and as taught by Peterson, because where the fixation members of Stihl and Peterson are substantially similar structurally, and Peterson recognizes the claimed abutment structure as a suitable configuration for such an insert and main body of a fixation member, such a modification would have been an obvious smatter of design choice to form the insert and main body of whatever form or shape was desired. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
Allowable Subject Matter
Claims 1, 4-5, 8 and 21-33 are allowed.
The following is an examiner’s statement of reasons for allowance:
Claims 1, 4-5, 9 and 21-25 in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, the claimed combination of limitations recited in independent claim 1. In particular, none of the cited references teach or suggest “wherein when the head, the pressure member, and the ring-shaped member are assembled relative to the receiving part and when the ring-shaped member is at a first configuration, the ring-shaped member is configured to block the pressure member from being moved axially downward towards the second end of the receiving part; and wherein the ring-shaped member is adjustable from the first configuration to a second configuration where at least a part of the pressure member is movable axially downwardly past at least part of the ring-shaped member to increase the pressure exerted on the head” as required by claim 1.
Claims 26-33 in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, the claimed combination of limitations recited in independent claim 26. In particular, none of the cited references teach or suggest “wherein when the head, the pressure member, and the deformable member are assembled to the receiving part and when the deformable member is at a first configuration, the deformable member is configured to block the pressure member from being moved axially downwardly towards the second end of the receiving part; and wherein the deformable member is deformable from the first configuration to a second configuration where the pressure member is movable axially downwardly to increase the pressure exerted on the head, while the deformable member is configured to be spaced apart from the head, and while the pressure member and the deformable member are devoid of any axial abutments relative to one another” as required by claim 26.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNA VICTORIA LITTLE whose telephone number is (571)272-6630. The examiner can normally be reached M-F 9a-6p EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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/ANNA V. LITTLE/Examiner, Art Unit 3773 /EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773