DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim 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(s) 14, 17, 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by van der Pol (U.S. Publication No. 2016/0361096).
Van der Pol disclose a method for installing a polyaxial spinal fixation system comprising: inserting a bone fixation screw (10) using an insertion tool (43); installing a collet (30) into a collet cavity of a lower section of a polyaxial head (20) (Figures 4a-4g); rotating the collet within the collet cavity (Figure 4c-4d) to position one or more tabs (37) within a collet retention groove (24a) but below an upper ledge (24b) to limit rotation of the collet within the polyaxial head (paragraph 76); selectively translating the collet within the collet cavity between the upper ledge (24b) and a lip (24c); attaching the collet to the bone fixation screw (Figure 8) by contacting a lower portion of the collet having multiple flanges (32a) with the head of the bone fixation screw such that the multiple flanges splay outwardly to accept the head within the lower portion wherein a first portion of each flange at least partially contacts a lower hemisphere of the head and a second portion of each flange at least partial contacts an upper hemisphere of the head to frictionally hold the head of the bone fixation screw within the collet (Paragraph 83, Figure 8, 9a-9d); inserting a rod (100) into a U-shaped channel of the polyaxial head (paragraph 73); installing a set screw (50) to engage with an internal threading within an upper portion of the polyaxial head (paragraph 38, 78); and tightening the set screw to direct the rod to interact with the collet to securely fix an angular orientation of the bone fixation screw with respect to the polyaxial head (paragraph 38).
Regarding claim 15, the collet and polyaxial head are preassembled (Figure 5, paragraph 78) and attached in unison to the head of the bone fixation screw (Figure 5, insertion direction E indicates the screw is inserted into the preassembled assembly).
Regarding claim 17, one or more slits (33) separate the multiple flanges to enable at least a portion of the collet to expand as the head of the bone fixation screw passes through the collet.
Regarding claim 19, tightening the set screw creates a wedging action applying downward force to the collet via the rod and compresses the multiple flanges around the head of the bone fixation screw (paragraph 38).
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) 1-3, 5-7, 9, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Biester et al. (U.S. Publication No. 2018/0014858) in view of Gladieux (U.S. Patent No. 10507043).
Biester et al. discloses a polyaxial spinal fixation system comprising: a polyaxial head (200) having an upper section (200p) and a lower section (200d), the upper section having two upstanding members (202, 204) comprising internal threading therein (paragraph 116); the lower section having a collet cavity (222) having a first section, a second section, and a third section (Figure 2J, three sections further shown below); wherein the first section includes a collet retention groove (240) and an upper ledge (242) at a top portion of the collet retention groove; the second section (226) has a partially spherical concave surface (234); and the third section (228) has a conical shape (238) terminating in a lip (236); a bone fixation screw (400) having a head (402) and a threaded shank (404); a rod (256) configured for insertion into the two upstanding members; a set screw (102) having threads thereon (Paragraph 116) configured to mate with the internal threading of the polyaxial head; and a collet (300) configured for insertion into the collet cavity (Figure 1H), and wherein the collet further comprises an upper portion and a lower portion (Figure 3A, more details following), the upper portion including one or more tabs (308) extending outwardly from an outer cylindrical surface (Figure 3A), and the lower portion including multiple flanges (316) separated by multiple slits (Figure 3A-3D), each flange of the multiple flanges having an external surface having a partially spherical convex surface and a conical surface (See figure below), and an internal surface having at least one partially spherical concave surface (paragraph 130, “the inner surfaces of the fingers 316 form sections of a common sphere), a cylindrical surface (See Figure below), and a conical surface (320).
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Biester et al. fails to disclose that the collet further comprises a split-ring cylindrical body having a hinge thereon. Gladieux teaches a polyaxial spinal fixation system having a polyaxial head (400) having an upper section with two upstanding members (Figure 1) and a lower portion having a collet cavity (420). A collet 200 is configured for insertion into the collet cavity and having a split-ring cylindrical body (Figure 2) with a hinge (260) thereon. The collet limits the axial compression force transferred from the locking element to the screw head by deforming outwards at the at least one flexible hinge until contact is made with the concave interior of the moveable head (paragraph 3). It would have been obvious to one skilled in the art to construct the collet Biester et al. with a split ring configuration and at least one hinge in view of Gladieux so that the collet limits the axial compression force transferred from the locking element to the screw head by deforming outwards at the at least one flexible hinge until contact is made with the concave interior of the moveable head.
The following claims are obvious over Biester et al. in view of Gladieux, however reference is only made to Biester et al. unless otherwise stated.
Regarding claim 2, the two upstanding members of the upper section define a U-shaped channel (Figure 1D).
Regarding claim 3, the rod is secured within the U-shaped channel by the set screw (102).
Regarding claim 5, Gladieux shows that the split-ring cylindrical body further comprises a first side and a second side, wherein the first side and the second side are joined at the hinge (Figure 2).
Regarding claim 6, viewing both Biester and Gladieux, it can be construed that., the slits (Figure 3A of Biester) are arranged parallel to a vertical axis of the split-ring cylindrical body and disposed circumferentially about the split-ring cylindrical body (Figure 2 of Gladieux).
Regarding claim 7, wherein one or more of the slits extends beyond the lower portion and into the upper portion of the collet (As seen in figure 3A of Biester the upper portion is the cylindrical portion and the lower portion is the generally spherical portion. The slits1 extend partially into the upper portion termination in a circular end).
Regarding claim 9, further comprising a collet assembly groove (210) comprising a collet assembly groove diameter that is greater than a tab diameter (Figure 2J).
Regarding claim 20, Biester et al. discloses a polyaxial spinal fixation system comprising: a polyaxial head (200) having an upper section (200p) and a lower section (200d), the upper section having two upstanding members (202, 204) comprising internal threading therein (paragraph 116); the lower section having a collet cavity (222) having a first section, a second section, and a third section (Figure 2J, three sections further shown below); wherein the first section includes a collet retention groove (240), a collet retention assembly (210) and an upper ledge (242) at a top portion of the collet retention groove; the second section (226) has a partially spherical concave surface (234); and the third section (228) has a conical shape (238) terminating in a lip (236); a bone fixation screw (400) having a head (402) and a threaded shank (404); a rod (256) configured for insertion into the two upstanding members; a set screw (102) having threads thereon (Paragraph 116) configured to mate with the internal threading of the polyaxial head; and a collet (300) configured for insertion into the collet cavity (Figure 1H), and wherein the collet further comprises an upper portion and a lower portion (Figure 3A, more details following), the upper portion including one or more tabs (308) extending outwardly from an outer cylindrical surface (Figure 3A), and the lower portion including multiple flanges (316) separated by multiple slits (Figure 3A-3D), each flange of the multiple flanges having an external surface having a partially spherical convex surface and a conical surface (See figure below), and an internal surface having at least one partially spherical concave surface (paragraph 130, “the inner surfaces of the fingers 316 form sections of a common sphere), a cylindrical surface (See Figure below), and a conical surface (320).
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Biester et al. fails to disclose that the collet further comprises a split-ring cylindrical body having a hinge thereon. Gladieux teaches a polyaxial spinal fixation system having a polyaxial head (400) having an upper section with two upstanding members (Figure 1) and a lower portion having a collet cavity (420). A collet 200 is configured for insertion into the collet cavity and having a split-ring cylindrical body (Figure 2) with a hinge (260) thereon. The collet limits the axial compression force transferred from the locking element to the screw head by deforming outwards at the at least one flexible hinge until contact is made with the concave interior of the moveable head (paragraph 3). It would have been obvious to one skilled in the art to construct the collet Biester et al. with a split ring configuration and at least one hinge in view of Gladieux so that the collet limits the axial compression force transferred from the locking element to the screw head by deforming outwards at the at least one flexible hinge until contact is made with the concave interior of the moveable head.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Biester et al. (U.S. Publication No. 2018/0014858) in view of Gladieux (U.S. Patent No. 10507043) and further in view of Schumacher (U.S. Publication No. 2006/0293664).
Biester et al. and Gladieux disclose the claimed invention except for the threading of the upstanding members is chamfered or tapered. Schumacher teaches a polyaxial spinal fixation system having a polyaxial head (16) with two upstanding arms (Figure 3) with internal threading (Figure 4) that is chamfered to facilitate the insertion of the clamping screw (Paragraph 12, 13). It would have been obvious to construct the threading of the upstanding members of Biester et al. as modified by Gladieux is chamfered or tapered further in view of Schumacher to facilitate insertion of the clamping screw.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over van der Pol (U.S. Publication No. 2016/0361096).
Van der Pol discloses the claimed invention except for a hinge provides a circumferential connection between a first side and a second side of a body of the collet to enable the first side and the second side to contract or expand about the hinge.
Gladieux teaches a polyaxial spinal fixation system having a polyaxial head (400) having an upper section with two upstanding members (Figure 1) and a lower portion having a collet cavity (420). A collet 200 is configured for insertion into the collet cavity and having a split-ring cylindrical body (Figure 2) with a hinge (260) thereon. The collet limits the axial compression force transferred from the locking element to the screw head by deforming outwards at the at least one flexible hinge until contact is made with the concave interior of the moveable head (paragraph 3). It would have been obvious to one skilled in the art to construct the collet van der Pol with a split ring configuration and at least one hinge in view of Gladieux so that the collet limits the axial compression force transferred from the locking element to the screw head by deforming outwards at the at least one flexible hinge until contact is made with the concave interior of the moveable head.
Allowable Subject Matter
Claims 8, 10-13, 16 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.
The following is a statement of reasons for the indication of allowable subject matter: The prior art alone or in combination fails to disclose a polyaxial spinal fixation system as in claim 1 and further including at least one flange of the collet defining a partially spherical concave surface having a first radius and a second radius such that the second radius is smaller. Furthermore, the details of the collet retention groove and its positioning are not disclosed.
The prior art alone or in combination also fails to disclose the method of claim 14 and further limited so that the method includes installing the collet from a top and pushed down to compress each flange pass a relief cut to retain the collet in the polyaxial head.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW YANG whose telephone number is (571)272-3472. The examiner can normally be reached 9:00 - 9:00 M-F.
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/ANDREW YANG/Primary Examiner, Art Unit 3775