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 § 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.
Claims 22, 25, 27, 49, 52 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.
Each claim recites “a longitudinal axis” claims 21 and 47 which the claims depend on already claim the longitudinal axis making the claims unclear if there are two longitudinal axes. The claims should be amended to read “the longitudinal axis.”
Claim Rejections - 35 USC § 102
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 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) 21-23 and 25-37 and 47-63 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Asher et al. (US Patent 5,217,461).
With respect to claim 21, Asher discloses an implantable fixation rod (see figures 3-5 below) comprising: first (fig 3, 26) and second rod regions (fig 3, 28), wherein the first rod region comprise a first diameter (fig 4) and a first externally exposed surface and the second rod region comprises a second diameter (fig 5) and a second externally exposed surface, wherein the first diameter is different from the second diameter (fig 4 and 5); and a transition region (fig 3, 32) positioned between the first and second rod regions and monolithically formed (fig 3) with the first and second rod regions, wherein the transition region comprises an externally-exposed surface that is continuous wherein an interface between the first externally-exposed surface and the externally-exposed surface of the transition region comprises an arcuate surface (fig 3 shows the edges between the portions are curved and col. 3, ll. 18-23, the junction can have a concave radius) between the first and second diameters at a constant rate around an entirety of a perimeter of the transition region (32 is tapered), and wherein the transition region provides a continually variable stiffness (tapered) along a longitudinal axis (fig 3, 34) of the first and second rod regions.
With respect to claim 22, Asher discloses wherein the first and second rod regions are linearly aligned (fig 3) along the longitudinal axis.
With respect to claim 23, Asher discloses wherein the transition region forms a frustoconical shape (see fig 3 below) between the first and second rod regions.
With respect to claim 25, Asher discloses wherein the first and second rod regions and the transition region collectively extend up to 600 mm (col. 3, ll. 40-44, up to 24 inches or 609mm) in an axial direction along a longitudinal axis.
With respect to claim 26, Asher discloses further comprising: a third rod region comprising a third diameter, wherein the third diameter is different from the second diameter; and a second transition region positioned between the second rod region and the third rod region, wherein the second transition region comprises an externally-exposed surface that is continuous wherein an interface between the second externally-exposed surface and the externally-exposed surface of the second transition region comprises an arcuate surface between the second and first diameters at a constant rate around an entirety of a perimeter of the second transition region (col. 4, ll. 40-49 discloses that there can be 3 sections of different diameters with a transition between them).
With respect to claim 27, Asher discloses wherein the second transition region provides a continually variable stiffness (the transition region 32 is tapered) along a longitudinal axis of the second and third rod regions.
With respect to claim 28, Asher discloses wherein first rod region is configured to be secured with a first pedicle screw and retaining cap and wherein the transition region is configured to be secured with a second pedicle screw and retaining cap (a screw and cap can be placed on the rod in various locations).
With respect to claim 29, Asher discloses wherein a plurality of commonly sized pedicle assemblies (fig 1, 20 are shown at any length) are configured to be attached at any location along the length of the fixation rod.
With respect to claim 30, Asher discloses wherein the transition region is free of stress concentrations (fig 3 shows a taper that leaves no sharp changes).
With respect to claim 31, Asher discloses wherein the transition region is free of sharp edges (fig 3).
With respect to claim 32, Asher discloses wherein the first rod region comprises a circular cross-sectional shape (fig 4).
With respect to claim 33, Asher discloses wherein the first rod region comprises an elliptical cross-sectional shape (fig 4 a circle is an ellipse with one focal point).
With respect to claim 34, Asher discloses, wherein the second rod region comprises a circular cross-sectional shape (fig 5).
With respect to claim 35, Asher discloses wherein the second rod region comprises an elliptical cross-sectional shape (fig 4 a circle is an ellipse with one focal point).
With respect to claim 36, Asher discloses, wherein the transition region comprises an elliptical cross-sectional shape (fig 3 a circle is an ellipse with one focal point).
With respect to claim 37, Asher discloses wherein the transition region comprises a shape with a predetermined rigidity to mitigate effects of fatigue (taper).
With respect to claim 47, Asher discloses a system (see figs 3-5 below) comprising an implantable fixation rod (fig 3) and a pedicle assembly (fig 1, 20), the system comprising: first (fig 3, 26) and second rod regions (fig 3, 28), wherein the first and second rod regions each comprise different continuous cross-sectional diameters (fig 4 and 5) tailored to provide the first and second rod regions with different rigidities configured to provide structural support to specific regions of a spinal column where the fixation rod is to be installed (fig 1); at least one smooth and gradual transition region (fig 3, 32) positioned between the first and second rod regions and integrally formed as part of a common monolithic structure with the first and second rod regions (Fig 3), wherein the transition region is tapered gradually between the different continuous cross-sectional diameters of the first and second rod regions around an entirety of a perimeter of elongated fixation rod (fig 3), wherein the at least one smooth and gradual transition region provides the fixation rod with continually variable stiffness (fig 3, taper) along a longitudinal axis (fig 3, 34); wherein first rod region is configured to be secured with a first pedicle screw and retaining cap (Fig 1, 20); and wherein the transition region is configured to be secured with a second pedicle screw and retaining cap (fig 1, 20 could be placed over the transition portion as it is shown used in both the larger and smaller diameters).
With respect to claim 48, Asher discloses wherein the transition region comprises an externally- exposed surface that is continuous wherein an interface between a first externally-exposed surface of the first rod region and the externally-exposed surface of the transition region comprises an arcuate (See fig 3 below and col. 3, ll. 18-23) surface between the first and second rod regions.
With respect to claim 49, Asher discloses wherein the first and second rod regions are linearly aligned along a longitudinal axis (fig 3).
With respect to claim 50, Asher discloses wherein the transition region forms a frustoconical shape (fig 3, 32) between the first and second rod regions.
With respect to claim 51, Asher discloses further comprising: a third rod region comprising a third diameter, wherein the third diameter is different from the continuous cross-sectional diameter of the second rod region; and a second transition region positioned between the second rod region and the third rod region, wherein the second transition region comprises an externally-exposed surface that is continuous wherein an interface between the second externally-exposed surface and the externally-exposed surface of the second transition region comprises an arcuate surface between the continuous cross-sectional diameters of the first and second rod regions at a constant rate around an entirety of a perimeter of the second transition region (col. 4, ll. 40-49 discloses that there can be 3 sections of different diameters with a transition between them).
With respect to claim 52, Asher discloses wherein the second transition region provides a continually variable stiffness along a longitudinal axis of the second and third rod regions (tapered 32).
With respect to claim 53, Asher discloses wherein the transition region is free of stress concentrations (Fig 3, 32 is shown tapered with no sharp changes).
With respect to claim 54, Asher discloses wherein the transition region is free of sharp edges.
With respect to claim 55, Asher discloses an implantable fixation rod (see figs 3-5 below) comprising: first (Fig 3, 26) and second rod regions (fig 3, 28), wherein the first rod region comprises a first diameter (fig 4) and the second rod region comprises a second diameter (fig 5), wherein the first diameter is different from the second diameter (Fig 4 and 5); and a transition region (fig 3, 32) positioned between the first and second rod regions and monolithically formed (fig 3) with the first and second rod regions, wherein the transition region is tapered (fig 3, 32shows a taper) gradually between the first and second diameters at a constant rate around an entirety of a perimeter of elongated fixation rod, wherein the transition region provides a continually variable stiffness along a longitudinal axis of the first and second rod regions (consistent taper is shown); wherein first rod region is configured to be secured with a first pedicle screw and retaining cap (fig 1, 20); and wherein the transition region is configured to be secured with a second pedicle screw and retaining cap (fig 1, 20 could be attached at the transition as they are shown being used for both the larger and smaller diameter portions of the rod).
With respect to claim 56, Asher discloses further comprising: a third rod region comprising a third diameter, wherein the third diameter is different from the second diameter; and a second transition region positioned between the second rod region and the third rod region, wherein the second transition region comprises an externally-exposed surface that is continuous wherein an interface between the second externally-exposed surface and the externally-exposed surface of the second transition region comprises an arcuate surface (fig 3 and col. 3, ll. 18-22) between the second and first diameters at a constant rate around an entirety of a perimeter of the second transition region (col. 4, ll. 40-49 discloses that there can be 3 sections of different diameters with a transition between them).
With respect to claim 57, Asher discloses wherein the second transition region provides a continually variable stiffness along a longitudinal axis of the second and third rod regions (tapered 32).
With respect to claim 58, Asher discloses wherein the transition region is free of stress concentrations (Fig 3, 32 is shown tapered with no sharp changes).
With respect to claim 59, Asher discloses, wherein the transition region comprises a shape with a predetermined rigidity to mitigate effects of fatigue (fig 3, 32, tapered).
With respect to claim 60, Asher discloses wherein the transition region forms a gradual transition (fig 3, 32 taper) between the first rod region and the second rod region.
With respect to claim 61, Asher discloses wherein the transition region elongates a portion of the implantable fixation rod over which the diameter of the first rod region changes to the diameter of the second rod region (fig 3, 32, taper as opposed to an instant step down).
With respect to claim 62, Asher discloses, wherein an interface between a surface of the first rod region and a surface of the transition region comprises an arcuate surface (see fig 3 below).
63. (New) The implantable fixation rod of claim 55, wherein an interface between a surface of the second rod region and a surface of the transition region comprises an arcuate surface (see fig 3 below).
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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) 24 and 38-46 is/are rejected under 35 U.S.C. 103 as being unpatentable over Asher et al. (US Patent 5,217,461) in view of Lee et al. (US Pub 2018/0168694).
With respect to claim 24, Asher et al discloses the transition region can take on a variety of forms but does not specifically disclose a transition region that is at least 5mm in length.
Lee discloses a transition region that is at least 5mm in length (paragraph 97) to provide a rod that allows for the proper placing of anchors and to account for the rod diameter (paragraph 97 and 101).
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 Asher to have a transition region that is at least 5mm in length in view of Lee in order to provide a rod that allows for the proper placing of anchors and to account for the rod diameter.
With respect to claim 38, Asher et al discloses the transition region can take on a variety of forms but does not specifically disclose a transition region that is between 5mm and 50mm in length.
Lee discloses a transition region that is between 5mm and 50mm in length (paragraph 97 5mm -20mm) to provide a rod that allows for the proper placing of anchors and to account for the rod diameter (paragraph 97 and 101).
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 Asher to have a transition region that is between 5mm and 50mm in length in view of Lee in order to provide a rod that allows for the proper placing of anchors and to account for the rod diameter.
With respect to claim 39, Asher et al discloses the transition region can take on a variety of forms but does not specifically disclose a transition region that is at least 10mm in length.
Lee discloses a transition region that is at least 10mm in length (paragraph 97) to provide a rod that allows for the proper placing of anchors and to account for the rod diameter (paragraph 97 and 101).
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 Asher to have a transition region that is at least 10mm in length in view of Lee in order to provide a rod that allows for the proper placing of anchors and to account for the rod diameter.
With respect to claim 40, Asher et al discloses the transition region can take on a variety of forms but does not specifically disclose a transition region that is at least 15mm in length.
Lee discloses a transition region that is at least 15mm in length (paragraph 97) to provide a rod that allows for the proper placing of anchors and to account for the rod diameter (paragraph 97 and 101).
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 Asher to have a transition region that is at least 15mm in length in view of Lee in order to provide a rod that allows for the proper placing of anchors and to account for the rod diameter.
With respect to claim 41, Asher et al discloses the transition region can take on a variety of forms but does not specifically disclose a transition region that is at least 20mm in length.
Lee discloses a transition region that is at least 20mm in length (paragraph 97) to provide a rod that allows for the proper placing of anchors and to account for the rod diameter (paragraph 97 and 101).
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 Asher to have a transition region that is at least 20mm in length in view of Lee in order to provide a rod that allows for the proper placing of anchors and to account for the rod diameter.
With respect to claim 42, Asher discloses the claimed invention except for the transition region being at least 25mm in length. Lee discloses that the length of a transition region can vary based on rod diameter. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention was made to have wherein the transition region being at least 25 mm in length, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
With respect to claim 43, Asher discloses the claimed invention except for the transition region being at least 30 mm in length. Lee discloses that the length of a transition region can vary based on rod diameter. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention was made to have wherein the transition region being at least 30 mm in length, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. Inre Aller, 105 USPQ 233.
With respect to claim 44, Asher discloses the claimed invention except for the transition region being at least 35mm in length. Lee discloses that the length of a transition region can vary based on rod diameter. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention was made to have wherein the transition region being at least 35 mm in length, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. Inre Aller, 105 USPQ 233.
With respect to claim 45, Asher discloses the claimed invention except for the transition region being at least 40mm in length. Lee discloses that the length of a transition region can vary based on rod diameter. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention was made to have wherein the transition region being at least 40 mm in length, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. Inre Aller, 105 USPQ 233.
With respect to claim 46, Asher discloses the claimed invention except for the transition region being at least 50mm in length. Lee discloses that the length of a transition region can vary based on rod diameter. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention was made to have wherein the transition region being at least 50 mm in length, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. Inre Aller, 105 USPQ 233.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20120290013 A1 discloses rods that gradually taper between diameters
US 20100114165 A1 discloses rods that gradually taper between diameters
US 20130158606 A1 discloses rods that gradually taper between sizes
US 20150282842 A1 discloses rods with different rod portions
US 5593408 A discloses rods that gradually taper between diameters
US 8641735 B2 discloses rods that gradually taper between diameters
US 8657856 B2 discloses rods that gradually taper between diameters
US 12251133 B2 discloses a parent application that could lead to a double patenting rejection is the claims are amended to match the claims of the parent.
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/S.J.C/Examiner, Art Unit 3773 /EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773
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