DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
Claim(s) 1-4, 6, 9-10, 12-15, 17-20 is/are rejected under pre-AIA 35 U.S.C. 102(e) as being anticipated by Sherman et al. (U.S. Pub. No. 2006/0149238 A1, hereinafter “Sherman”).
Sherman discloses, regarding claim 1, a longitudinal connecting member assembly (500, see Figs. 43-47) having at least first and second bone anchors (80, 80’, 80”, see Fig. 48) spanning between at least a pair of vertebrae (see Fig. 48), the assembly comprising: a) a soft core portion (528) in continuous tension and having a steady state length (see paras. [0131] and [0143]), the core portion being in slideable relation with at least one of the first and second bone anchors (see paras. [0130]-[0131]).
Regarding claim 2, further comprising a stiff end structure (506) fixed to the soft core portion, the stiff end structure positioned entirely outside of the at least one of the first and second bone anchors (see Figs. 47-48).
Regarding claim 3, further comprising an elastic bumper (130, see para. [0139] “elastomers”) in slidable relation with the core portion (see para. [0130]), the elastic bumper positioned between the stiff end structure and one of the first and second bone anchors (see Fig. 48).
Regarding claim 4, wherein the stiff end structure is a first stiff end structure (506) and further comprising an opposing second stiff end structure (510) also positioned entirely outside of the at least first and second bone anchors (see Figs. 47-48), the soft core portion being in slideable relation with both the first and second bone anchors (see paras. [0130]-[0131]).
Regarding claim 6, wherein the stiff end structure has a through bore (518) for receiving the soft core portion and walls that are crimpable toward the soft core portion (505, see para. [0128] “collapsed by crimping”), fixing the core portion within the through bore (see para. [0128]).
Regarding claim 9, wherein the stiff end structure further comprises a rod (504).
Regarding claim 10, wherein the stiff end structure is fixable to a rod (504).
Regarding claim 12, further comprising a spacer (530) located between the first and second bone anchors (see Fig. 48), the spacer having a through bore that slidingly receives the core portion therethrough (see Fig. 47, see para. [0130]).
Regarding claim 13, wherein the spacer is compressible (see para. [0130]).
Regarding claim 14, wherein the spacer is elastic (see para. [0139] “elastomers”).
Regarding claim 15, wherein the spacer is substantially tubular and the spacer through bore runs along a central axis thereof (501, see Fig. 47).
Regarding claim 17, wherein at least one of the first and second bone anchors has a closure top (96), one of the bone anchor and the closure top having a stop (e.g. end of threads 95, see Fig. 26), the stop prohibiting the closure top from pressing on the soft core portion (see Figs. 26 and 48, note that threads stop for set screws to engage with rods 502 and 504 that spaces them from soft core portion 524, e.g. prohibits the closure top from pressing against the soft core portion).
Regarding claim 18, wherein the stop is a surface of the bone anchor partially defining a run-out feature of a guide and advancement structure for receiving the closure top (e.g. end of threads 95, see Figs. 26 and 48, note that threads stop for set screws to engage with rods 502 and 504 that spaces them from soft core portion 524, e.g. prohibits the closure top from pressing against the soft core portion).
Regarding claim 19, wherein at least one of the first and second bone anchors has an elongate threaded shank (82) and a head (88), the shank having a central axis (e.g. long axis of 80), the head having a central bore (e.g. bores that receive 502 and 504) running there through (see Fig. 48), the bore disposed: perpendicular to the shank central axis, the core portion being slidingly received in the bore (see para. [0130]), the head having an upper opening for receiving a set screw (96).
Regarding claim 20, wherein at least one of the first and second bone anchors is a polyaxial screw (see para. [0074] “multi-axial screws”), the screw having a shank (81), a receiver (88) for holding the soft core portion, and a closure top (96), the receiver being pivotable with respect to the shank (see para. [0074] “pivotably coupled”), the closure top capturing the soft core portion within the receiver (via engagement with 504 or 502), the closure top being spaced from the soft core portion when the closure top is locked onto the receiver (spaced from via 504 or 502).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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.
Claim(s) 5 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Sherman, as applied to claim 1 above.
Sherman discloses all of the features of the claimed invention in the embodiment shown in Figure 48, as set forth above, except regarding claim 5, wherein the elastic bumper is a first elastic bumper and further comprising a second elastic bumper, the second elastic bumper positioned between the second end structure and one of the first and second bone anchors.
Sherman discloses in an alternative embodiment shown in Figures 49-50 wherein the longitudinal connecting member includes first and second elastic bumpers (630, 640, see Figs. 49-50, see para. [0139] “elastomers”) positioned between first and second end structures (e.g. plates of 602, 604 and 606, see Figs. 49-50) in order to provide dynamic spinal stabilization at each vertebral level (see paras. [0136]-[0137]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the embodiment of Figure 48 in Sherman to include first and second elastic bumpers in order to provide dynamic spinal stabilization at each vertebral level.
Claim(s) 7 and 11 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Sherman, as applied to claims 1-2 and 10 above, and in view of Hestad et al. (U.S. Pub. No. 2009/0012562 A1, hereinafter “Hestad”).
Sherman discloses all of the features of the claimed invention, as previously set forth above. Sherman further discloses the use of pins to extend through a bore disposed in the end structures to intersect the tether to secure it to the end structures (see para. [0123]). However fails to explicitly disclose, regarding claim 7, wherein the stiff end structure has a through bore for receiving the soft core portion and a threaded bore disposed perpendicular to the through bore, the threaded bore matable with a set screw, the set screw pressing against the soft core portion and fixing the soft core portion against the stiff end structure within the through bore; regarding claim 11, wherein the stiff end structure has a first through bore for receiving the soft core portion and two threaded bores disposed perpendicular to the first through bore, each of the threaded bores matable with a set screw, one of the set screws pressing against the soft core portion and fixing the soft core portion against the stiff end structure within the first through bore, the other of the set screws pressing against the rod and fixing the rod against the stiff end structure within the first through bore.
Hestad discloses a dynamic stabilization device (12, see Fig. 10A) with stiff end structures (42) and a soft core portion (38), wherein the stiff end structures include threaded bores (56) and set screws (54) in order to provide a secure attachment between the soft core portion and the stiff end structures (see para. [0037]) that would provide an additional benefit of being removable and retightenable via the threaded connection (see Figs. 10-11, note that set screw 54 is shown to be easily removed from the bore when desired via hex driver engagement feature).
It would have been one having ordinary skill in the art at the time the invention was made to modify the stiff end structures in Sherman to include threaded bores and set screws in view of Hestad in order to provide a secure attachment between the soft core portion and the stiff end structures that would provide an additional benefit over the pin connection in Sherman of being removable and retightenable via the threaded connection to enable adjustment between the stiff end structures and the soft core portion.
Claim(s) 8 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Sherman, as applied to claims 1-2 above, and in view of Zylber et al. (U.S. Pub. No. 2008/0234744 A1, hereinafter “Zylber”).
Sherman discloses all of the features of the claimed invention, as previously set forth above, except regarding claim 8, wherein the stiff end structure is a plate having at least two holes and the soft core portion is a cord, the cord being looped through the holes, fixing the cord to the plate.
Zylber discloses a dyanamic spinal stabilization system (see Fig. 1) with a soft core portion (94) with a stiff end structure that is a plate (98, see annotated Fig. 5 below) having at least two holes (see annotated Fig. 5 below) where the soft core portion is a cord (94) looped through the holes (see annotated Fig. 5 below) in order to retain the cord relative to the stiff end structure and provide resistance to pullout (see para. [0033]).
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It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the stiff end structure / plate in Sherman to include at least two holes with the soft core portion / cord to be looped through in view of Zylber in order to retain the cord relative to the stiff end structure and provide resistance to pullout.
Claim(s) 16 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Sherman, as applied to claims 1 and 12 above, and in view of Justis et al. (U.S. Pub. No. 2007/0191841 A1, hereinafter “Justis”).
Sherman discloses all of the features of the claimed invention, as previously set forth above, except regarding claim 16, wherein the spacer has a width and a height, the height running from a top surface to a bottom surface, the height being greater than the width and the through bore being located closer to the top surface than to the bottom surface.
Justis discloses a spacer (10) having a height (h, see Fig. 3) greater than a width (b, see Fig. 3) and the through bore located closer to a top surface (32R, see Fig. 18) in order to provide direction-dependent flexural stiffness (see paras. [0015] and [0026]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the spacer in Sherman to have a width and a height, the height running from a top surface to a bottom surface, the height being greater than the width and the through bore being located closer to the top surface than to the bottom surface in view of Justis in order to provide direction-dependent flexural stiffness.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892.
The following references disclose soft core portions with slidable connections to the bone anchors:
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michelle C. Green whose telephone number is (571)270-7051. The examiner can normally be reached on Monday-Friday between 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Eduardo C. 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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/M.C.G/ Examiner, Art Unit 3773 /EDUARDO C ROBERT/ Supervisory Patent Examiner, Art Unit 3773