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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/18/2026 has been entered.
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.
Claim 38 and 53 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 38 recites the limitation "the upper housing major surface" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 38 recites the limitation "the lower housing major surface" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 38 recites the limitation "the upper housing minor surfaces" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 38 recites the limitation "the lower housing minor surfaces" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 53 recites the limitation "the upper housing major surface" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 53 recites the limitation "the lower housing major surface" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 53 recites the limitation "the upper housing minor surfaces" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 53 recites the limitation "the lower housing minor surfaces" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 103
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) 31, 38, 49 and 53 is/are rejected under 35 U.S.C. 103 as being unpatentable over Biedermann (US 20070225708) in view of Leachmann (US 20100087861).
With respect to claim 31, Biedermann teaches an anchor device (see fig. 4, 6 below) for insertion into a bone (e.g., see fig. 4, 6 below), comprising a single post (2) suitable for implantation into a bone (see fig. 6 below), and a cord housing (3’, 22’) coupled to the post (see fig. 4, 6 below, para. 43 below), comprising a lower housing (3’) rigidly connected/monoaxial with the single post (see para. 43 below), the lower housing comprising at least a pair of cradles (41a, 41b), each of the cradles for receiving therein at least one cord (e.g., 50, 51) (see fig. 4, 6 below, para. 35); and an upper housing (22’), separate from the lower housing (see fig. 6 below, para. 43 below), comprising at least a pair of clamps (23a, 23b), each of the clamps for placement over the cords inserted into the cradles (see fig. 4, 6 below, para. 41, lines 4-8); wherein the joining of the upper housing to the lower housing forms a pair of cord channels (e.g., 23a+41a, 23b+41b, see fig. 4 below) by the cradles and the clamps, to encase in each cord channel the cord received by each of the cradles (see fig. 4, 6 below, para. 25-26, para. 41 lines 4-8); and means (6) for fastening the upper housing to the lower housing, causing the upper housing to press against and compress the cords within the cord channels to keep the cords clamped in held snugly in place (see fig. 4, 6 below, para. 26, para. 41 lines 4-8).
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While Biedermann teaches a monaxial screw embodiment (fig. 6) that is an alternate equivalent to a polyaxial screw (see para. 43 above), Biedermann does not appear to specifically teach a lower housing monolithic with the single post.
Leachmann, also drawn to anchor devices (see abstract), teaches that mono and polyaxial screws are well known in the art and that a rigidly connected anchor device (e.g., 12+20) may be formed as a monolithic structure (e.g., monoaxial screw) as a matter of engineering design choice (see para. 21 lines 18-24) in order to provide a known anchor device structure that will perform the function best suited to the procedure (see para. 21 lines 18-24).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the monoaxial anchor device of Biedermann such that a lower housing is monolithic with the single post, in view of Leachmann, as a matter of engineering design choice, in order to provide a known anchor device structure that will perform the function best suited to the procedure.
As for claim 38, Biedermann, as modified by Leachmann, further discloses the anchor device of claim 31 wherein the adjoining of a upper housing major surface (e.g., side surface) to a lower housing major surface (e.g., side surface) and upper housing minor surfaces (e.g., around clamps) to lower housing minor surfaces (e.g., around cradles) provides a limit to the compression of the cords (see fig. 4, 6 above and note that the joining of 22’ to 3’ is limited by the shape of these elements).
With respect to claim 49, Biedermann teaches spinal alignment apparatus (see fig. 4 above), comprising a pair of flexible cords (e.g., 50, 51, see para. 38), and a plurality of anchor devices (e.g., 1’’, 1’, 1) for securing the pair of cords to a plurality of vertebrae during a spinal alignment procedure (see fig. 4 above), each of the anchor devices comprising: a single post (2) suitable for implantation into a vertebra, and a cord housing (e.g., 3’, 22’) coupled to the post (see fig. 6 above), comprising a lower housing rigidly connected/monoaxial with the single post (see para. 43 above), the lower housing comprising a pair of cradles (41a, 41b, see fig. 6 above), each of the cradles for insertion of one of the cords therein (see fig. 4 above); and an upper housing (22’), separate from the lower housing (see fig. 6 above, para. 43 above), comprising a pair of clamps (23a, 23b), each of the clamps for placement over the cords inserted into the cradles (see fig. 4 above); wherein the joining of the upper housing to the lower housing forms a pair of cord channels by the cradles and the clamps (23a+41a, 23b+43b, see fig. 4 above), to encase in each cord channel the cord inserted into each of the cradles (see fig. 4 above); and means (6) for fastening the upper housing to the lower housing, causing the upper housing to press against and compress the cords within the cord channels to keep the cords clamped in and held snugly in place (see fig. 4, 6 above, para. 26, para. 41 lines 4-8).
While Biedermann teaches a monaxial screw embodiment (fig. 6) that is an alternate equivalent to a polyaxial screw (see para. 43 above), Biedermann does not appear to specifically teach a lower housing monolithic with the single post.
Leachmann, also drawn to anchor devices (see abstract), teaches that mono and polyaxial screws are well known in the art and that a rigidly connected anchor device (e.g., 12+20) may be formed as a monolithic structure (e.g., monoaxial screw) as a matter of engineering design choice (see para. 21 lines 18-24) in order to provide a known anchor device structure that will perform the function best suited to the procedure (see para. 21 lines 18-24).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the monoaxial anchor device of Biedermann such that a lower housing is monolithic with the single post, in view of Leachmann, as a matter of engineering design choice, in order to provide a known anchor device structure that will perform the function best suited to the procedure.
As for claim 53, Biedermann, as modified by Leachmann, further discloses the anchor device of claim 49 wherein the adjoining of a upper housing major surface (e.g., side surface) to a lower housing major surface (e.g., side surface) and upper housing minor surfaces (e.g., around clamps) to lower housing minor surfaces (e.g., around cradles) provides a limit to the compression of the cords (see fig. 4, 6 above and note that the joining of 22’ to 3’ is limited by the shape of these elements).
Reasons for Allowance
The claims 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 31. In particular, none of the cited references teach or suggest the anchor device including the lower housing further comprises a lower housing major surface located
between the cradles; and the upper housing further comprises an upper housing major surface located between the clamps; wherein the upper housing major surface substantially abuts the lower housing major surface when the upper housing is joined to the lower housing and provides a stop to prevent overtightening of the upper housing to the lower housing, as set forth in claims 32-36.
The claims 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 31. In particular, none of the cited references teach or suggest the anchor device including wherein the first end portion and the second end portion of each cradle each comprise an outwardly flared surface along an axis defined by the cord encased within and running along the cord channel; and each of the clamps comprise a first end portion where the cord enters the cord channel, a middle portion, and a second end portion where the cord exits the cord channel, wherein the first end portion and the second end portion of each clamp each comprise an outwardly flared surface along an axis defined by the cord encased within and running along the cord channel, as set forth in claims 39 and 40.
The claims 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 31. In particular, none of the cited references teach or suggest the anchor device including the means for fastening comprises a threaded fastener; the lower housing further comprises a receiving cylindrical portion comprising threads suitable for receiving the threaded fastener; and the upper housing further comprises an aperture for receiving therethrough the threaded fastener, as set forth in claims 44-46.
The claims 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 31. In particular, none of the cited references teach or suggest the anchor device including wherein each cradle provides a cross-sectional profile of greater than half of each cylinder and extends more than halfway around each cord, and each clamp provides a cross-sectional profile of less than half of each cylinder and extends less than halfway around each cord when placed over it; whereby each cord is press fit into each cradle with a small amount of force so the cord temporarily compresses to fit within the cradle and is held in place temporarily by the cradle until the upper housing is fastened to the lower housing, as set forth in claim 48.
The claims 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 49. In particular, none of the cited references teach or suggest the anchor device including the lower housing further comprises a lower housing major surface located
between the cradles; and the upper housing further comprises an upper housing major surface located between the clamps; wherein the upper housing major surface substantially abuts the lower housing major surface when the upper housing is joined to the lower housing and provides a stop to prevent overtightening of the upper housing to the lower housing, as set forth in claims 50-52.
The claims 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 49. In particular, none of the cited references teach or suggest the anchor device including wherein the first end portion and the second end portion of each cradle each comprise an outwardly flared surface along an axis defined by the cord encased within and running along the cord channel; and each of the clamps comprise a first end portion where the cord enters the cord channel, a middle portion, and a second end portion where the cord exits the cord channel, wherein the first end portion and the second end portion of each clamp each comprise an outwardly flared surface along an axis defined by the cord encased within and running along the cord channel, as set forth in claims 54 and 55.
The claims 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 49. In particular, none of the cited references teach or suggest the anchor device including wherein each cradle provides a cross-sectional profile of greater than half of each cylinder and extends more than halfway around each cord, and each clamp provides a cross-sectional profile of less than half of each cylinder and extends less than halfway around each cord when placed over it; whereby each cord is press fit into each cradle with a small amount of force so the cord temporarily compresses to fit within the cradle and is held in place temporarily by the cradle until the upper housing is fastened to the lower housing, as set forth in claim 56.
Allowable Subject Matter
Claims 32-36, 39, 40, 44-46, 48, 50-52, and 54-56 are 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.
Response to Arguments
Applicant’s arguments with respect to claim(s) s 31, 38, 49 and 53 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Tara Carter whose telephone number is (571) 272-3402. The examiner can normally be reached on M-F 7am-3pm.
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If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Eduardo Robert, at (571) 272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TARA ROSE E CARTER/Examiner, Art Unit 3773 /EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773