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) 1-10, 14-24, and 28-30 are rejected under 35 U.S.C. 103 as being unpatentable over Ullrich Jr. et al (US 20120312778 A1) “Ullrich”.
Regarding Claim 1, the main embodiment of Ullrich teaches a medical implant (implant 1, 101, 101a, 201, pars. [0051] and [0126], Figs. 1 and 12) comprising a textured tissue contact surface (top and /or bottom surfaces, Figs. 1-6B), said textured tissue contact surface comprising:
a roughened surface (topography 80, 180, 180a, 280, par. [0126], Fig. 12) on said tissue contact surface (pars. [0061, [0066, [0079], [0088]) that includes a three dimensional geometric structure (par. [0060]), but does not teach nanostructures with laterally spaced elongated waves each having a crest and trough.
However, another embodiment of Ullrich discloses a plurality of nanostructures on said three dimensional geometric structure (pars. [0084] and [0119]), said nanostructures comprising a plurality of elongated waves, each wave having a crest and a trough, said crests extending along rows of elongated waves that are laterally spaced from each other (pars. [0011] and [0119], describes the spaced and repeating pattern nano features having a peak to valley height, the peak being the crest and the valley being the trough, the average amplitude inferring that there are waves). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by the main embodiment of Ullrich to include nanostructures with laterally spaced elongated waves each having a crest and trough, as taught by another embodiment of Ullrich, in order to interact with the tissues and stimulate their natural remodeling and growth (par. [0090]).
Regarding Claim 2, the main embodiment of Ullrich further teaches the medical implant of claim 1, wherein the nanostructures comprise a plurality of individual polygonal structures (pars. [0047] and [0061]).
Regarding Claim 3, the main embodiment of Ullrich further teaches the medical implant of claim 2, wherein at least some of said plurality of individual polygonal structures comprise pyramidical-type shapes (par. [0061]).
Regarding Claim 4, the main embodiment of Ullrich does not teach a gyroid lattice structure. However, another embodiment of Ullrich discloses the medical implant of claim 1, wherein said three dimensional geometric structure includes a gyroid lattice structure (par. [0057]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by the main embodiment of Ullrich to include a gyroid lattice structure, as taught by another embodiment of Ullrich, in order to provide certain frictional characteristics, load dispersion, and to influence the biological responses (Abstract).
Regarding Claim 5, the main embodiment of Ullrich further teaches the medical implant of claim 1, wherein said three dimensional geometric structure includes a plurality of 3-D printed macroscale and microscale projections and recesses (pars. [0060] and [0068]).
Regarding Claim 6, the main embodiment of Ullrich further teaches the medical implant of claim 5, wherein said plurality of projections and recesses have a maximum peak to valley height difference, H.sub.max (Rmax between 40 and 500 microns, par. [0117]), and wherein said plurality of nanostructures have a maximum peak to valley height difference, h.sub.max (Rmax between 0.2 to 2 microns, par. [0119]), and wherein H.sub.max is greater than h.sub.max (pars. [0117] and [0119]).
Regarding Claim 7, the main embodiment of Ullrich further teaches the medical implant of claim 6, wherein the maximum peak to valley height difference, H.sub.max ranges up to 400 μm (par. [0117]).
Regarding Claim 8, the main embodiment of Ullrich further teaches the medical implant of claim 6, wherein the maximum peak to valley height difference, h.sub.max ranges up to 712 nm (par. [0119]).
Regarding Claim 9, the main embodiment of Ullrich further teaches the medical implant of claim 1, wherein the maximum spacing, S between peaks of said elongated waves is 2.2 μm (par. [0119]).
Regarding Claim 10, the main embodiment of Ullrich further teaches the medical implant of claim 1, wherein said implant is formed of titanium or a titanium alloy (par. [0165]).
Regarding Claim 14, the main embodiment of Ullrich further teaches the medical implant of claim 1, wherein said implant is a spinal interbody fusion device (pars. [0042] and [0166]).
Regarding Claim 15, the main embodiment of Ullrich does not teach a spinal interbody fusion device with top and bottom surfaces including a textured tissue contact surface. However, another embodiment of Ullrich discloses the medical implant of claim 14, wherein the spinal interbody fusion device comprises a cage (body 2, par. [0094], Figs. 11 and 12) having a hollow interior (aperture 60, par. [0094], Figs. 11 and 12), a top surface (top surface 10, par. [0094]. Fig. 12) and a bottom surface (bottom surface 20, par. [0094], Fig. 12), each of said top surface and said bottom surface including a respective textured tissue contact surface (pars. [0093] and [0094], both top and bottom surfaces may be included in the integration surface that has a roughened surface topography 80 and possibly integration plates 82), each said textured tissue contact surface extending on at least a portion of said respective top and bottom surfaces (par. [0093], Figs. 11A and 11B). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by the main embodiment of Ullrich to include a spinal interbody fusion device with top and bottom surfaces including a textured tissue contact surface, as taught by another embodiment of Ullrich, in order to provide certain frictional characteristics, load dispersion, and to influence the biological responses (Abstract).
Regarding Claim 16, the main embodiment of Ullrich does not teach top and bottom surfaces comprising fixation structures. However, another embodiment of Ullrich discloses the medical implant of claim 15, wherein said top surface and said bottom surface of said cage each comprise fixation structures, each said textured tissue contact surface being included on a respective fixation structure (par. [0095]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by the main embodiment of Ullrich to include top and bottom surfaces comprising fixation structures, as taught by another embodiment of Ullrich, in order to provide certain frictional characteristics, load dispersion, and to influence the biological responses (Abstract).
Regarding Claim 17, the main embodiment of Ullrich teaches a medical implant (implant 1, 101, 101a, 201, pars. [0051] and [0126], Figs. 1 and 12) comprising a textured tissue contact surface (top and /or bottom surfaces, Figs. 1-6B), said medical implant comprising titanium or titanium alloys (par. [0165]), said textured tissue contact surface being prepared by a process comprising the steps of:
initially forming a roughened surface (topography 80, 180, 180a, 280, par. [0126], Fig. 12) on said tissue contact surface (pars. [0061, [0066, [0079], [0088]) that includes a hierarchy of macrostructures and microstructures that are tactically rough (par. [0068]), but does not disclose laser ablating to form nanostructures without interrupting the macrostructures and microstructures.
However, another embodiment of Ullrich discloses laser ablating said roughened surface (par. [0050], Claim 12) with a femtosecond pulsed laser to form a plurality of nanostructures on said roughened surface without interrupting the hierarchy of macrostructures and microstructures (pars. [0050] and [0081]-[0084]), said nanostructures comprising a plurality of spaced elongated waves, each wave having a crest and a trough, said crests extending along rows of elongated waves that are laterally spaced from each other (pars. [0011] and [0119], describes the spaced and repeating pattern nano features having a peak to valley height, the peak being the crest and the valley being the trough, the average amplitude inferring that there are waves). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by the main embodiment of Ullrich to include laser ablating to form nanostructures without interrupting the macrostructures and microstructures, as taught by another embodiment of Ullrich, in order to adjust the surface of the implant to therefore provide certain frictional characteristics, load dispersion, and to influence the biological responses (Abstract, par. [0050]).
Regarding Claim 18, the main embodiment of Ullrich further teaches the medical implant of claim 17, wherein said roughened surface is formed by an additive manufacturing process (par. [0060]).
Regarding Claim 19, the main embodiment of Ullrich further teaches the medical implant of claim 18, wherein the additive manufacturing process comprises a 3-D printing process (par. [0060]).
Regarding Claim 20, the main embodiment of Ullrich further teaches the medical implant of claim 17, wherein said hierarchy of macrostructures and microstructures comprises a plurality of projections and recesses (pars. [0060] and [0068]), said plurality of spaced elongated waves extending at least on said projections (par. [0119]).
Regarding Claim 21, the main embodiment of Ullrich further teaches the medical implant of claim 20, wherein the nanostructures comprise a plurality of individual polygonal structures extending at least within said recesses (pars. [0047] and [0061]).
Regarding Claim 22, the main embodiment of Ullrich further teaches the medical implant of claim 21, wherein at least some of said plurality of individual polygonal structures comprise pyramidical-type shapes (par. [0061]).
Regarding Claim 23, the main embodiment of Ullrich does not teach the implant formed monolithically as a unitary structure. However, another embodiment of Ullrich discloses the medical implant of claim 17, wherein said implant is formed monolithically as a unitary structure by machining prior to the step of laser ablation by said femtosecond pulsed laser (pars. [0060] and [0061], additive processes are applied to the surface of the implant, implying that the implant is wholly formed as a unitary structure before ablations). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by the main embodiment of Ullrich to include implant formed monolithically as a unitary structure, as taught by another embodiment of Ullrich, in order to more easily provide additive processes to the surface of the implant (par. [0060]).
Regarding Claim 24, the main embodiment of Ullrich does not teach the implant formed monolithically as a unitary structure. However, another embodiment of Ullrich discloses the medical implant of claim 17, wherein said implant is formed monolithically as a unitary structure by an additive manufacturing process prior to the step of laser ablation by said femtosecond pulsed laser (pars. [0060] and [0061], additive processes are applied to the surface of the implant, implying that the implant is wholly formed as a unitary structure before ablations). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by the main embodiment of Ullrich to include implant formed monolithically as a unitary structure, as taught by another embodiment of Ullrich, in order to more easily provide additive processes to the surface of the implant (par. [0060]).
Regarding Claim 28, the main embodiment of Ullrich further teaches the medical implant of claim 17, wherein said implant is a spinal interbody fusion device (pars. [0042] and [0166]).
Regarding Claim 29, the main embodiment of Ullrich teaches a medical implant (implant 1, 101, 101a, 201, pars. [0051] and [0126], Figs. 1 and 12) comprising a textured tissue contact surface (top and /or bottom surfaces, Figs. 1-6B), said textured tissue contact surface comprising:
a roughened surface (topography 80, 180, 180a, 280, par. [0126], Fig. 12) on said tissue contact surface that includes a plurality of macroscale and microscale projections and recesses (par. [0068]), said plurality of projections and recesses having an average height, Havg (Ra, pars. [0104] and [0117]), but does not disclose nanostructures comprising spaced elongated waves and polygonal structures.
However, another embodiment of Ullrich discloses a plurality of nanostructures on said projections and within said recesses (par. [0119]), said nanostructures comprising a plurality of spaced elongated waves, each wave having a crest and a trough, wherein the nanostructures comprise a plurality of individual polygonal structures (pars. [0011] and [0119]), said plurality of polygonal structures having an average height, h.sub.avg (pars. [0061] and [0119]), and wherein H.sub.avg is greater than h.sub.avg (pars. [0117] and [0119], Ra for macro features between 8 and 200 microns and Ra for nano features between 1 and 20 microns). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by the main embodiment of Ullrich to include nanostructures comprising spaced elongated waves and polygonal structures, as taught by another embodiment of Ullrich, in order to provide certain frictional characteristics, load dispersion, and to influence the biological responses (Abstract).
Regarding Claim 30, the main embodiment of Ullrich does not teach the plurality of projections and recesses with a maximum height. However, another embodiment of Ullrich discloses the medical implant of claim 29, wherein said plurality of projections and recesses have a maximum height, H.sub.max (par. [0117], half of maximum peak-to-valley height Rmax), and wherein said plurality of polygonal structures have a maximum height, h.sub.max (par. [0119], half of maximum peak-to-valley height Rmax), and wherein H.sub.max is greater than h.sub.max (pars. [0117] and [0119]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by the main embodiment of Ullrich to include the plurality of projections and recesses with a maximum height, as taught by another embodiment of Ullrich, in order to provide certain frictional characteristics, load dispersion, and to influence the biological responses (Abstract).
Claim(s) 11-13 and 25-27 are rejected under 35 U.S.C. 103 as being unpatentable over Ullrich Jr. et al (US 20120312778 A1) “Ullrich” in view of Ogawa (US 20200113700 A1) “Ogawa”.
Regarding Claims 11 and 25, Ullrich does not teach a knee prosthesis. However, Ogawa, in the same field of art, discloses a medical implant with a hierarchical surface roughness (Abstract), wherein said implant is a knee prosthesis (par. [0048]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Ullrich to include a knee prosthesis, as taught by Ogawa, in order to extend the scope of the invention to to other parts of the body to treat various other medical conditions (par. [0048]).
Regarding Claims 12 and 26, Ullrich does not teach a hip prosthesis. However, Ogawa, in the same field of art, discloses a medical implant with a hierarchical surface roughness (Abstract), wherein said implant is a hip prosthesis par. [0048]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Ullrich to include a hip prosthesis, as taught by Ogawa, in order to extend the scope of the invention to other parts of the body to treat various other medical conditions (par. [0048]).
Regarding Claims 13 and 27, Ullrich does not teach a dental implant. However, Ogawa, in the same field of art, discloses a medical implant with a hierarchical surface roughness (Abstract), wherein said implant is a dental implant (par. [0048]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Ullrich to include a dental implant, as taught by Ogawa, in order to extend the scope of the invention to other parts of the body to treat various other medical conditions (par. [0048]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATALIE NICOLE THOMAS whose telephone number is (571)272-0004. The examiner can normally be reached Monday - Friday 8:30am-5pm.
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/NATALIE N THOMAS/ Examiner, Art Unit 3774
/JERRAH EDWARDS/ Supervisory Patent Examiner, Art Unit 3774
