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 without traverse of Species D (#400, Figs 24-28) in the reply filed on March 10, 2026 is acknowledged.
Claims 1-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on Mach 10, 2026. Claim 1 recites “the contact of the first tube clip with the surface of the link member causes the first and second clip arms to move inward toward a threaded shaft axis” and “the contact of the second tube clip with the surface of the link member cause the first and second clip arms to move inward toward a threaded shaft axis” which was not disclosed in the elected Species D. These limitations were discussed in non-elected Species A (#100, Figs 1-15). See paragraph 47, Fig 11 in the application where shoulder #126 of the tube clip contacts the surface of the link member to cause the clip arms to move inward. As such Claims 1-10 are withdrawn.
Claim Rejections - 35 USC § 102
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 11 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mickiewicz US 2011/0077689.
Regarding Claim 11, Mickiewicz discloses a cluster derotation assembly (Fig 9-10, paragraph 70 where the embodiment of Fig 9-10 is used in similar fashion to the embodiment of Fig 7) comprising:
a. a first locking tube (see Fig below) having a distal end portion (see Fig below) configured to securely join to a bone anchor (#42a, see Fig below) and a proximal end portion having an outer surface (see Fig below);
b. a second locking tube (see Fig below) having a distal end portion (see Fig below) configured to securely join to a bone anchor (#42b) and a proximal end portion having an outer surface (see Fig below);
c. a link member (#312, paragraph 70 where #312 is similar to #12) having a surface and an open slot through the link member (see Fig below);
d. a first tube clip (#314, paragraph 70 where it is similar to clip #14a but uses a nut #333 instead of lever #32, see Fig below) having a shaft extending through the open slot (see Fig below), a first clip arm extending from an end of the shaft (see Fig below), and a second clip arm (see Fig below) extending from the end of the shaft,
wherein one or both of the first clip arm and the second clip arm have an inner surface that is complementary to the outer surface of the proximal end portion of the first locking tube (see Fig below, where it is curved match the locking tube), wherein the first and second clip arms are opposed to each other, and wherein the first and second clip arms are movable between a first position away from a shaft axis (#314c) and a second position toward a shaft axis (#314c) such that the inner surface of one or both of the first clip arm and the second clip arm engages the outer surface of the proximal end portion of the first locking tube (paragraph 70 where the clip arms are similar to the clip arms of clip #14a, see paragraph 61, see Fig below where the first position is when the arms do not receive the locking tube and the second position is when the clip arms are brought closer together to clamp onto the locking tube);
e. a second tube clip (see Fig below, paragraph 49, 70 where the second tube clip has the same configuration as the first tube clip, as such for clarity only one tube clip is annotated) having a shaft extending through the open slot (see Fig below), a first clip arm extending from an end of the shaft (see Fig below), and a second clip arm extending from the end of the shaft, wherein one or both of the first clip arm and the second clip arm have an inner surface that is complementary to the outer surface of the proximal end portion of the second locking tube (see Fig below, where it is curved match the locking tube), wherein the first and second clip arms are opposed to each other, and wherein the first and second clip arms are movable between a first position away from a shaft axis (#314c) and a second position toward a shaft axis (#314c) such that the inner surface of one or both of the first clip arm and the second clip arm engages the outer surface of the proximal end portion of the second locking tube (paragraph 70 where the clip arms are similar to the clip arms of clip #14a, see paragraph 61, see Fig below where the first position is when the arms do not receive the locking tube and the second position is when the clip arms are brought closer together to clamp onto the locking tube).
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Claim 18 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mickiewicz US 2011/0077689.
Regarding Claim 18, Mickiewicz discloses a method of using a cluster derotation assembly (Fig 7), the method comprising:
a. securing a first locking tube to a first bone anchor secured to in a vertebra (see Fig 7 below, paragraph 11, 62);
b. securing a second locking tube to a second bone anchor secured to in a vertebra (see Fig 7 below, paragraph 11, 62);
c. providing a link member (#12) having a first tube clip (Fig below) and a second tube clip (see Fig below, paragraph 49 where the second tube clip has the same configuration as the first tube clip, as such for clarity only one tube clip is annotated) secured thereto;
d. urging the first tube clip onto the first locking tube until the first locking tube is seated against inner surfaces of a first clip arm and a second clip arm of the first tube clip (see Figs below, Fig 7, paragraph 11, 61, 62 where the first tube clip is urged onto the first locking tube to couple to the locking tube);
e. directing one or both of the link member and the second tube clip into a position to engage the second locking tube (see Fig 7 below, paragraph 11, 62, where after attaching to the first locking tube, one or both of the link member and the second tube clip is directed to attach the second tube clip to the second locking tube);
f. urging the second tube clip onto a second locking tube until the second locking tube is seated against inner surfaces of a first clip arm and a second clip arm of the second tube clip (see Figs below, Fig 7, paragraph 11, 61, 62 where the second tube clip is urged to couple onto the second locking tube);
g. securing the first tube clip to a link member (Fig 7, paragraph 55);
h. securing the second tube clip to the link member (Fig 7, paragraph 55);
i. causing the first and second clip arms of the first tube clip to move from a first position to a second position causing the inner surfaces of the first clip arm and the second clip arm to engage an outer surface of the first locking tube and secure the first tube clip to the first locking tube (as seen in Fig 7, paragraph 61 where each clip has a slot or well #30w to aid in clamping and holding onto their respective locking tube);
j. causing the first and second clip arms of the second tube clip to move from a first position to a second position causing the inner surfaces of the first clip arm and the second clip arm to engage an outer surface of the second locking tube and secure the second tube clip to the second locking tube (as seen in Fig 7, paragraph 61); and
k. manipulating at least one of the vertebra using the cluster derotation assembly (abstract, paragraph 43, 64 where the locking tubes are manipulated to manipulate the vertebra).
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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.
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 12-13, 17 are rejected under 35 U.S.C. 103 as being unpatentable over Mickiewicz US 2011/0077689 in view of Leff US 2018/0070994.
Mickiewicz discloses the claimed invention as discussed above where the inner surfaces of the first and second clip arms of the first and second tube clips are complimentary to the cylindrical first and second locking tubes are cylindrical (Fig 7, see Fig in claim 11 above, as discussed above in claim 11) but does not disclose each of the inner surface of one or both of the first clip arm and the second clip arm of the first tube clip and the inner surface of one or both of the first clip arm and the second clip arm of the second tube clip comprises a plurality of axially-aligned ridges and the outer surface of the proximal end portion for each of the first locking tube and the second locking tube comprises a plurality of axially-aligned faces and a plurality of axially-aligned points.
Leff discloses a clamp (Fig 11) with first and second arms (#194, #198) that clamp onto a cylindrical rod (#380, Fig 12, paragraph 60), each of the inner surface of one or both of the first arm and the second arm comprises a plurality of axially-aligned ridges (#380a, #380b, Fig 10-11, paragraph 60) and the outer surface (#382) of the cylindrical rod comprises a plurality of axially-aligned faces and a plurality of axially-aligned points (see Fig 10-11 where the axially aligned faces receive the ridges and the axially aligned points are adjacent to the axially aligned faces), where this configuration reduces the risk of slippage (paragraph 60).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the inner surface of the first and second clip arms (of the first and/or second tube clips) and the proximal end portions of the first and/or second locking tubes of Mickiewicz to include a plurality of axially-aligned ridges and a plurality of axially-aligned faces and a plurality of axially-aligned points in view of Leff as discussed above in order to reduce slippage between the first and/or second tube clips with the first and/or second locking tubes, respectively.
Regarding Claim 13, Mickiewicz as modified discloses wherein the plurality of axially-aligned faces comprises 8 faces about a circumference of the locking tube (see Fig 10-11 in Leff where each arm has at least four axially aligned ridges and thus there would be at least 8 axially aligned faces).
Regarding Claim 17, Mickiewicz as modified discloses one of the first and second locking tubes is an offset locking tube (paragraph 71 and see also Fig 7 in Mickiewicz, where the first an second arms of the first and second tube clips can rotate about axis #314c such that first and second tubes can be placed in an orientation where they are not parallel to each other but offset from each other).
Claim 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Mickiewicz US 2011/0077689 and Leff US 2018/0070994, as applied to claim 12 above, and further view of Hart US 5,792,112 and Kolb US 2009/0228053.
Mickiewicz as modified discloses the claimed invention as discussed above but does not disclose wherein one or both of the first locking tube and the second locking tube comprises at least two diametrical rings.
Hart, pertinent to the problem of providing a section for applying a clip to a tube, discloses a tube (#12, Fig 3) comprising two diametrical rings (#43, #45, Fig 3) that defines a recess/section (#47) for application of a clip (#14, Fig 1-3, Col 5 lines 15-20).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the first and second locking tubes of Mickiewicz to include two diametrical rings in view of Hart because the rings define a recess/section for placement of the first and second tube clips.
Kolb discloses a locking tube (#16) with multiple diametrical rings defining a plurality of recesses/sections therebetween (see Fig below).
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It would have also been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the first and second locking tubes of Mickiewicz as modified by Hart to include more than two diametrical rings in view of Kolb because they provide additional recesses/sections for placement of the first and second tube clips (as taught by Hart).
Regarding Claim 15, Mickiewicz as modified discloses wherein the plurality of axially-aligned faces and the plurality of axially-aligned points are arranged in at least one section about a circumference of one or both of the first locking tube and the second locking tube, wherein the at least one section is axially bounded by two of the at least two diametrical rings (with the modification discussed above in claims 12, 14, the sections/recesses provide locations for the first and second tube clips to couple thereto, where these sections would include the plurality of axially-aligned faces and the plurality of axially-aligned points positioned about a circumference of the first and second locking tubes).
Regarding Claim 16, Mickiewicz as modified discloses a length of the at least one section can be the same as or substantially the same as a width of the respective tube clip (as discussed above in claim 14 and see Fig 1-3 in Hart where since the sections/recesses provide a location for the first and second tube clips, it would have a length that is the same or substantially same as a width of the respective tube clip).
Claims 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Mickiewicz US 2011/0077689 in view of Leff US 2018/0070994.
Mickiewicz discloses the claimed invention as discussed above where the inner surfaces of the first and second clip arms of the first and second tube clips are complimentary to the cylindrical first and second locking tubes are cylindrical (Fig 7, see Fig in claim 11 above, as discussed above in claim 11) but does not disclose wherein the inner surfaces of the first clip arm and the second clip arm of the first tube clip and the inner surfaces of the first clip arm and the second clip arm of the second tube clip comprise a plurality of axially-aligned ridges and the outer surface of each of the first locking tube and the second locking tube comprises a plurality of axially-aligned faces and a plurality of axially-aligned points.
Leff discloses a clamp (Fig 11) with first and second arms (#194, #198) that clamp onto a cylindrical rod (#380, Fig 12, paragraph 60), each of the inner surface of one or both of the first arm and the second arm comprises a plurality of axially-aligned ridges (#380a, #380b, Fig 10-11, paragraph 60) and the outer surface (#382) of the cylindrical rod comprises a plurality of axially-aligned faces and a plurality of axially-aligned points (see Fig 10-11 where the axially aligned faces receive the ridges and the axially aligned points are adjacent to the axially aligned faces), where this configuration reduces the risk of slippage (paragraph 60).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the inner surface of the first and second clip arms (of the first and/or second tube clips) and the proximal end portions of the first and/or second locking tubes of Mickiewicz to include a plurality of axially-aligned ridges and a plurality of axially-aligned faces and a plurality of axially-aligned points in view of Leff as discussed above in order to reduce slippage between the first and/or second tube clips with the first and/or second locking tubes, respectively.
Regarding Claim 20, Mickiewicz as modified discloses the claimed invention as discussed above where the first tube clip is rotatable (paragraph 56, rotatable about axis #14c) and that the derotation assembly is placed in an orientation/position to couple to the first and second locking tubes (paragraphs 11, 61-62) but does not specifically disclose rotating the first tube clip about the first locking tube to place the second tube clip into a position to engage the second locking tube.
However, it would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the method of Mickiewicz to rotate the first tube clip about the first locking tube to place the second tube clip into a position to engage the second locking tube since this provides one of a finite number of possible solutions (where the possible solutions are 1. no adjustment is needed and the second tube clip is already aligned to receive the second locking tube, 2. rotate the second tube clip, the second locking tube, the first tube clip, the first locking tube, and/or the link member to orient the second tube clip into a position to engage the second locking tube) to properly orient the second tube clip into a position to engage the second locking tube. [See MPEP 2145.05 (II)(B)] The examiner also notes that one of ordinary skill in the art recognizes that each patient’s anatomy would be unique and a certain amount of “play” with the one or more of the components of the derotation assembly (ie rotating one or more components of the derotation assembly) would obviously need to happen in order to properly align and couple the derotation assembly to the first and second locking tubes.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO 892 for art of cited interest, in particular other systems that uses clips coupled to tubes.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAN CHRISTOPHER L MERENE whose telephone number is (571)270-5032. The examiner can normally be reached Mon-Fri 8:30 am - 6pm 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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/JAN CHRISTOPHER L MERENE/Primary Examiner, Art Unit 3773