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 § 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.
Claim(s) 1,5, 7-12, 17-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Froehlich (US Pub 2010/0331898) in view of Ratron et al. (US Pub 2016/0220275).
With respect to claim 1, Froehlich discloses an implant (see figures 3 and 4B below) for stabilizing relative motion between bones or sections of bone, the implant comprising: a trunk (see fig 3 below) comprising a distal end (bottom) and a proximal end (top) defining a longitudinal axis (see fig 3 below) of the implant, wherein the trunk defines a bore (Fig 3, 24); a distal anchor (see fig 3 below) comprising a neck (fig 3,30) extending distally from the distal end of the trunk, and an expandable member (fig 3, 18) coupled to the neck and configured to receive an injectable material (fig 4B) through the bore to expand and harden in engagement with a first bone or section of bone.
With respect to claim 8, Froehlich discloses further comprising at least one rib (fig 3, 30) coupled to and extending radially outwardly from the neck.
With respect to claim 9, Froehlich discloses wherein the expandable member further comprises fenestrations (paragraph 19, made of a woven material such that the space between the weave forms fenestrations).
With respect to claim 10, Froehlich discloses wherein the trunk further defines an orifice (fig 3, 34) between the proximal and distal ends of the trunk and in fluid communication with the bore.
With respect to claim 11, Froehlich discloses wherein the trunk comprises an outer surface and further defines a recess (fig 3, 34) extending inwardly from the outer surface, wherein the recess is sized to receive tissue growth-promoting material.
With respect to claim 1, Froehlich discloses the claimed invention except for a proximal anchor extending proximally from the proximal end of the trunk to define a cavity, wherein the proximal anchor further defines apertures arranged circumferentially about the longitudinal axis to form deformable features configured to buckle into engagement with a second bone or section of bone, wherein the apertures are positioned proximal to the proximal end of the trunk.
Ratron discloses an implant (See fig 4 below) with a distal anchor(fig 4, 2) and a proximal anchor (see fig 4 below) extending proximally from the proximal end of the trunk to define a cavity (fig 4, 13), wherein the proximal anchor further defines apertures (fig 4, 15) arranged circumferentially about the longitudinal axis to form deformable features (fig 4, 16) configured to buckle (buckles out into the bone) into engagement with a second bone or section of bone, wherein the apertures are positioned proximal to the proximal end of the trunk (fig 4) to prevent the screw from loosening over time (paragraph 5).
With respect to claim 5, Ratron discloses wherein the proximal anchor comprises a cap (fig 5, 100 pedical screw head), wherein the cap comprises a base, and annular teeth (threads inside the head of 100 for a set screw) disposed at a proximal end of the base and configured to engage complementary teeth of an insertion tool.
With respect to claim 7, Ratron discloses wherein the deformable features of the proximal anchor are integrally formed with the trunk (fig 4 the deformable members are integral).
With respect to claim 12, Ratron discloses wherein the distal anchor, and the proximal anchor are configured to be deployed independently and sequentially (Fig 5 the proximal anchor is deployed first by 100).
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It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Froehlich to include a proximal anchor extending proximally from the proximal end of the trunk to define a cavity, wherein the proximal anchor further defines apertures arranged circumferentially about the longitudinal axis to form deformable features configured to buckle into engagement with a second bone or section of bone, wherein the apertures are positioned proximal to the proximal end of the trunk in view of Ratron in order to prevent the screw from loosening over time.
With respect to claim 17, Froehlich discloses an implant (See figures 3 and 4B below) for stabilizing relative motion between bones or sections of bone, the implant comprising: a trunk (See fig 3 below) comprising a distal end (bottom) and a proximal end (top) defining a longitudinal axis (see fig 3 below) of the implant, wherein the trunk defines a bore (fig 3, 24) extending between the proximal and distal ends; a distal anchor (see fig 3 below) comprising a neck (see fig 3 below) extending distally from the distal end of the trunk, and an expandable member (Fig 3, 18) coupled to the neck; a proximal end define a cavity (see fig 3 below), and comprises a stem (fig 4B, 58) disposed within the cavity, wherein the bore is coaxial with the longitudinal axis of the implant and extends through the stem, the trunk, and the neck so as to provide for injectable material being injectable through the implant (fig 4B, shows the fluid connection from 52 to 92) to expand the expandable member to harden in engagement with a first bone or section of bone.
With respect to claim 18, Froehlich discloses wherein the stem further defines a counterbore (See fig 4B below) proximal to the bore and configured to receive a delivery cannula for injecting the injectable material into the bore.
With respect to claim 19, Froehlich discloses wherein the expandable member further comprises fenestrations (paragraph 19, made of a woven material such that the space between the weave forms fenestrations).
With respect to claim 20, Froehlich discloses wherein the trunk further defines an orifice (Fig 3, 34) between the proximal and distal ends of the trunk and in fluid communication with the bore.
With respect to claim 17, Froehlich discloses the claimed invention except for a proximal anchor configured to buckle into engagement with a second bone or section of bone, wherein the proximal anchor extends proximally from the proximal end of the trunk.
Ratron discloses an implant (See fig 4 above) with a distal anchor(fig 4, 2) and a proximal anchor (see fig 4 below) configured to buckle (buckles out into the bone) into engagement with a second bone or section of bone, wherein the proximal anchor extends from the proximal end of the trunk (fig 4) to prevent the screw form loosening over time (paragraph 5).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Froehlich to include a proximal anchor configured to buckle into engagement with a second bone or section of bone, wherein the proximal anchor extends proximally from the proximal end of the trunk in view of Ratron in order to prevent the screw form loosening over time.
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Claim(s) 2-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Froehlich in view of Ratron as applied to claim 1 above, and further in view of Schwappach (US Pub 2013/0144348).
With respect to claim 2, Froehlich in view of Ratron discloses further comprising a stem (fig 4B, 58) extending proximally from the proximal end of the trunk and disposed within the cavity (see fig 4B above),
With respect to claim 3, Froehlich, in view of Ratron wherein the bore extends through the stem and the neck (fluid communication from 52 to 92 in fig 4B).
With respect to claim 4, Froehlich in view of Ratron wherein the stem defines a counterbore (see fig 4B above) proximal to the bore and configured to receive a delivery cannula for injecting the injectable material into the bore.
With respect to claim 2, Froehlich in view of Ratron discloses the claimed invention except for wherein the stem comprises driven features configured to be engaged by drive features of an insertion tool.
Schwappach discloses a stem (fig 3, 170) comprises driven features (fig 1, 66) configured to be engaged by drive features of an insertion tool to reinforce the screw (paragraph 73).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Froehlich in view of Ratron to include the stem comprises driven features configured to be engaged by drive features of an insertion tool in view of Schwappach in order to reinforce the screw.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Froehlich in view of Ratron as applied to claim 1 above, and further in view of Drew et al. (US Pub 2005/0065526).
With respect to claim 6, Froehlich in view of Ratron discloses the apertures can have different shapes (paragraph 175) but does not disclose the apertures are oval in shape with a major axis arranged parallel to the longitudinal axis of the implant.
Drew et al. discloses deformation apertures that are oval (fig 3, 24) in shape with a major axis arranged parallel to the longitudinal axis of the implant (fig 3) to cause axial compression to secure the implant (paragraph 6).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Froehlich in view of Ratron to include the apertures are oval in shape with a major axis arranged parallel to the longitudinal axis of the implant in view of Drew in order to allow for axial compression to secure the implant.
Claim(s) 13-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Froehlich (US Pub 2010/0331898) in view of Ratron et al. (US Pub 2016/0220275) and in view of Schwappach (US Pub 2013/0144348).
Froehlich discloses an implant (see figs 3 and 4B above) for stabilizing relative motion between bones or sections of bone, the implant comprising: a trunk (see fig 3 above) comprising a distal end (bottom) and a proximal end (top) defining a longitudinal axis (fig 3)of the implant, wherein the trunk defines a bore (fig 3, 24); a distal anchor (fig 3, 18) comprising an expandable member configured to receive an injectable material through the bore to expand and harden in engagement with a first bone or section of bone; the proximal end of the trunk to define a cavity (see fig 3 below), wherein the proximal end comprises a stem (fig 4, 58) disposed within the cavity.
Froehlich discloses the claimed invention except for a proximal anchor configured to buckle into engagement with a second bone or section of bone, wherein the proximal anchor extends proximally from and a cap comprising engagement features configured to be engaged by engagement features of the insertion tool and Froehlich does not disclose the stem having driven features configured to be engaged by drive features of an insertion tool.
Ratron discloses an implant with a distal anchor (fig 4, 2) and a proximal anchor (fig 4, 3) configured to buckle into engagement with a second bone or section of bone, wherein the proximal anchor extends proximally from and a cap (fig 5, 100) comprising engagement features (threads inside the pedicle screw cap 100) configured to be engaged by engagement features of the insertion tool prevent the screw form loosening over time (paragraph 5).
With respect to claim 15, Ratron discloses wherein the engagement features are annular teeth (threads in 100).
With respect to claim 16, Ratron discloses wherein the cap and the trunk are formed of unitary construction (fig 5 formed together to form one body).
Schwappach discloses a stem (fig 3, 170) comprises driven features (fig 1, 66) configured to be engaged by drive features of an insertion tool to reinforce the screw (paragraph 73).
With respect to claim 14, Schwappach discloses wherein the driven features are threads (fig 1, 66).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Froehlich to include a proximal anchor configured to buckle into engagement with a second bone or section of bone, wherein the proximal anchor extends proximally from and a cap comprising engagement features configured to be engaged by engagement features of the insertion tool in view of Ratron in order to prevent the screw form loosening over time (paragraph 5) and it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Froehlich in view of Ratron to include the stem comprises driven features configured to be engaged by drive features of an insertion tool in view of Schwappach in order to reinforce the screw.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20120029578 A1 discloses an implant with an expandable anchor
US 20130053902 A1 discloses an implant with anchors and orifices
US 20130096634 A1 discloses an implant with an expandable anchor
US 20060155297 A1 discloses an implant with an expandable anchor
US 20130267836 A1 discloses an implant with proximal and distal anchors
US 20150313720 A1 discloses an implant with an expandable anchor
US 20040225292 A1 discloses an implant with an injectable material
US 20100016905 A1 discloses an implant with an expandable anchor
US 20130218215 A1 discloses an implant with proximal and distal anchors
US 7491236 B2 discloses an implant with proximal and distal anchors
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEVEN J COTRONEO whose telephone number is (571)270-7388. The examiner can normally be reached Monday-Friday 9am-5pm EST.
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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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/S.J.C/Examiner, Art Unit 3773 /EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773
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