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 . Claims 1-11, 18-28, & 35-36 are pending and examined below.
Claim Objections
Claim 35 objected to because of the following informalities:
Claim 35 recites “rhemium” in line 2. It appears to be a typographical error. For the purpose of examination, the examiner is regarding it as “rhenium.” Appropriate correction is required.
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) 1-4 & 7-8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Aharonov et al. (US 20050191408 A1) hereinafter, Aharonov.
Regarding claim 1, Aharonov teaches
a medical device (10, Fig. 1) that includes a body portion (body of 10, Fig. 1);
said body portion is partially or fully coated with a titanium containing coating (titanium nitride, ¶0010);
said titanium containing coating includes titanium metal, titanium nitride (titanium nitride, ¶0010), and/or titanium oxide.
Regarding claim 2, Aharonov teaches
wherein said titanium containing coating is used to
a) improved an ability to identify said medical device, b) improve lubricity of said medical device, c) improve biocompatibility of said medical device, d) alter antimicrobial behavior of said medical device, e) create a smooth surface on said medical device, f) improve corrosion resistance of said medical device, g) improve wear resistance of said medical device (reduced risk of such delamination over time, ¶0026), h) color code said medical device, i) improved an ability to identify said medical device, j) form improved anti-galling surfaces on said medical device, k) inhibit or prevent microbial growth and/or contamination of an outer surface of one or more portions of said medical device, 1) improve a success rate of said medical device after implantation of said medical device, m) reduce adverse tissue reactions after implantation of said medical device, n) reduce metal ion release after implantation of said medical device, o) reduce corrosion of said medical device after implantation of said medical device, p) reduce allergic reaction after implantation of said medical device, q) improve hydrophilicity of said medical device, r) lower ion release from said medical device into tissue, and/or s) reduce toxicity of said medical device after implantation of said medical device.
Regarding claim 3, Aharonov teaches
wherein said medical device is an orthopedic device, PFO (patent foramen ovale) device, stent, prosthetic heart valve, spinal implant, bone plate nail, rod, screw, post, cage, plate, pedicle screw, bone implant, artificial disk, artificial spinal disk, or prosthetic implant (orthopedic implant devices, ¶0029).
Regarding claim 4, Aharonov teaches
wherein said medical device is at least partially formed of a metal alloy (cobalt chromium, ¶0025 & 0037) that includes less than 1 wt.% titanium (device is made of cobalt chromium therefore it includes less than 1 wt. % titanium).
Regarding claim 7, Aharonov teaches
wherein said titanium containing coating is applied by one or more of chemical vapor deposition (vapor deposited coating, ¶0008), plating, metal spraying, cladding, flame spray coating, powder deposition, dip coating, flow coating, dip-spin coating, roll coating (direct and reverse), sonication, brushing, plasma deposition, and/or MEMS technology.
Regarding claim 8, Aharonov teaches
wherein said thickness of said titanium containing coating is 0.01-2000 µm (3-15 micrometers, ¶0011).
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) 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aharonov in view of Furst et al. (US 20140099279 A1) hereinafter, Furst.
Regarding claim 5, Aharonov teaches
wherein said metal alloy includes stainless steel, CoCr alloy (cobalt chromium, ¶0025 & 0037, Aharonov), Al alloy, Ni alloy, W alloy, Mo alloy, Cu alloy, Beryllium Copper alloy, or refractory metal alloy; and less than 1 wt.% titanium (device is made of cobalt chromium therefore it includes less than 1 wt. % titanium).
Aharonov does not teach the metal alloy includes at least 10 atw.% rhenium. However, Furst teaches a medical device that is at least partially formed of a novel metal alloy, which novel metal alloy improves the physical properties of the medical device (abstract, Furst) wherein
metal alloy includes at least 10 atw.% rhenium (at least about 40 weight percent rhenium ¶0016, Furst). It has been held that in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (MPEP 2144.05(I)).
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 teachings of Aharonov by incorporating the teachings above as taught by Furst in order to create a medical device having the desired high ductility at about room temperature (¶0021, Furst).
Regarding claim 6, Aharonov does not teach wherein said metal alloy includes rhenium and one or more alloying metals. However, Furst teaches
wherein said metal alloy includes rhenium and one or more alloying metals selected from the group consisting of aluminum, bismuth, chromium, cobalt, copper, hafnium, iridium, iron, magnesium, manganese, molybdenum, nickel, niobium, osmium, platinum, rhodium, ruthenium, silicon, silver, tantalum, technetium, tin, tungsten, vanadium, yttrium, and zirconium (molybdenum and rhenium, ¶0016, Furst);
said metal alloy has a) an increase of at least 10% in ductility as compared to said metal alloy that is absent rhenium (desired high ductility, ¶0016-0017, Furst), and/or b) an increase of at least 10% in tensile strength as compared to said metal alloy that is absent rhenium (desired ultimate tensile strength, ¶0016-0017, Furst).
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 teachings of Aharonov by incorporating the teachings above as taught by Furst in order to create a medical device having the desired high ductility at about room temperature and the desired ultimate tensile strength and yield strength (¶0021, Furst).
Claim(s) 9-10, 18, 21, 23, 25, & 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aharonov in view of Rathenow et al. (US 20050079200 A1) hereinafter, Rathenow.
Regarding claim 9, Aharonov teaches
wherein titanium containing coating includes titanium metal and/or titanium nitride (titanium nitride, ¶0010, Aharonov).
Aharonov does not teach said coating of titanium metal and/or titanium nitride includes a surface coating of titanium oxide. However, Rathenow teaches implantable medical devices with biocompatible coatings (abstract, Rathenow) wherein
said coating of titanium metal and/or titanium nitride includes a surface coating of titanium oxide (titanium oxides, ¶0053, Rathenow).
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 teachings of Aharonov by incorporating the teachings above as taught by Rathenow in order to modify and adjust e.g. biological, mechanical and thermal properties of the films and of the resulting carbon coatings (¶0054, Rathenow).
Regarding claim 10, Aharonov teaches
wherein said surface coating has a thickness of 0.01-2000 µm (0.5-25 micrometers, ¶0011, Aharonov).
Regarding claim 18, Aharonov teaches
a medical device (10, Fig. 1, Aharonov) that includes a body portion (body of 10, Fig. 1, Aharonov);
at least a portion of said body portion is formed of a metal alloy (cobalt chromium, ¶0025 & 0037, Aharonov);
at least a portion of said metal alloy (cobalt chromium, ¶0025 & 0037, Aharonov) is coated with a metal containing material (titanium carbonitride, ¶0025, Aharonov);
a composition of said metal containing material (titanium carbonitride, ¶0025, Aharonov) is different from a composition of said metal alloy (cobalt chromium, ¶0025 & 0037, Aharonov);
said metal containing material is titanium or a titanium containing material (titanium carbonitride, ¶0025, Aharonov);
at least a portion of said metal containing material (titanium carbonitride, ¶0025, Aharonov) is coated with a coating material (aluminum oxide, ¶0026, Aharonov);
a composition of said coating material (aluminum oxide, ¶0026, Aharonov) is different from said composition of said metal containing material (titanium carbonitride, ¶0025, Aharonov);
a thickness of said metal containing material is 0.01-2000 µm (3-15 micrometers, ¶0011, Aharonov);
a thickness of said coating material is 0.01-2000 µm (0.5-25 micrometers, ¶0011, Aharonov).
Aharonov does not teach said coating material is formed of a compound that includes at least two materials selected from the group consisting of titanium, nitrogen and oxygen. However, Rathenow teaches
said coating material is formed of a compound that includes at least two materials selected from the group consisting of titanium, nitrogen and oxygen (titanium oxides, ¶0053, Rathenow).
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 teachings of Aharonov by incorporating the teachings above as taught by Rathenow in order to modify and adjust e.g. biological, mechanical and thermal properties of the films and of the resulting carbon coatings (¶0054, Rathenow).
Regarding claim 21, Aharonov teaches
wherein said medical device is a stent, a frame for a heart valve, a spinal implant, a bone plate, a rod for spinal surgery, a bone screw, a pedicle screw, a bone implant, an artificial disk, an artificial spinal disk, or a prosthetic implant (orthopedic implant devices, ¶0029, Aharonov).
Regarding claim 23, Aharonov teaches
wherein said metal containing material is titanium or titanium nitride (titanium nitride, ¶0010, Aharonov).
Regarding claim 25, Aharonov does not teach wherein said coating material is an oxide containing coating. However, Rathenow teaches
wherein said coating material is an oxide containing coating (titanium oxides, ¶0053, Rathenow).
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 teachings of Aharonov by incorporating the teachings above as taught by Rathenow in order to modify and adjust e.g. biological, mechanical and thermal properties of the films and of the resulting carbon coatings (¶0054, Rathenow).
Regarding claim 27, Aharonov does not teach said coating material includes titanium dioxide and/or titanium monoxide. However, Rathenow teaches
wherein said coating material includes titanium dioxide and/or titanium monoxide (titanium oxides, ¶0053, Rathenow).
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 teachings of Aharonov by incorporating the teachings above as taught by Rathenow in order to modify and adjust e.g. biological, mechanical and thermal properties of the films and of the resulting carbon coatings (¶0054, Rathenow).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aharonov in view of Thorwarth (US 20180353635 A1).
Regarding claim 11, Aharonov does not teach wherein said a surface color of said medical device that is caused by said titanium containing coating is silver, bronze, purple, blue, light blue, gold, rose, pink, magenta, teal or green. However, Thorwarth teaches a surface coating for a medical instrument (abstract & ¶0003, Thorwarth)
wherein said a surface color of said medical device that is caused by said titanium containing coating is silver, bronze, purple, blue, light blue, gold, rose, pink, magenta, teal or green (blue color, ¶0051, Thorwarth).
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 teachings of Aharonov, by incorporating the teachings above as taught by Thorwarth in order to create a color change that is clearly perceptible to the human eye (¶0032, Thorwarth).
Claim(s) 19-20, 22, 24, 26, & 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aharonov in view of Rathenow and further in view of Furst.
Regarding claim 19, Aharonov teaches
wherein said metal alloy metal alloy is stainless steel, CoCr alloy (cobalt chromium, ¶0025 & 0037, Aharonov), Al alloy, Ni alloy, W alloy, Mo alloy, Cu alloy, beryllium-copper alloy, or refractory metal alloy; and less than 1 wt.% titanium (device is made of cobalt chromium therefore it includes less than 1 wt. % titanium).
Aharonov does not teach the metal alloy includes at least 10 atw.% rhenium. However, Furst teaches
said metal alloy includes at least 10 atw.% rhenium (at least about 40 weight percent rhenium ¶0016, Furst). It has been held that in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (MPEP 2144.05(I)).
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 teachings of Aharonov and Rathenow by incorporating the teachings above as taught by Furst in order to create a medical device having the desired high ductility at about room temperature (¶0021, Furst).
Regarding claim 20, Aharonov does not teach said metal alloy metal alloy is a refractory metal alloy. However, Furst teaches
wherein said metal alloy metal alloy is a refractory metal alloy (molybdenum and rhenium, ¶0016, Furst);
said refractory metal alloy includes up to 30 wt.% molybdenum (at least about 40 weight percent molybdenum, ¶0017, Furst), at least 10 atw.% rhenium (at least about 40 weight percent rhenium ¶0016, Furst) and less than 1 wt.% titanium (molybdenum and rhenium and the at least one additional metal in the novel metal alloy is at least about 99 weight percent, therefore titanium is less than 1 wt%, ¶0017, Furst). It has been held that in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (MPEP 2144.05(I)).
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 teachings of Aharonov and Rathenow by incorporating the teachings above as taught by Furst in order to create a medical device having the desired high ductility at about room temperature and the desired ultimate tensile strength and yield strength (¶0021, Furst).
Regarding claim 22, Aharonov teaches
wherein said medical device is a stent, a frame for a heart valve, a spinal implant, a bone plate, a rod for spinal surgery, a bone screw, a pedicle screw, a bone implant, an artificial disk, an artificial spinal disk, or a prosthetic implant (orthopedic implant devices, ¶0029, Aharonov).
Regarding claim 24, Aharonov teaches
wherein said metal containing material is titanium or titanium nitride (titanium nitride, ¶0010, Aharonov).
Regarding claim 26, Aharonov does not teach wherein said coating material is an oxide containing coating. However, Rathenow teaches
wherein said coating material is an oxide containing coating (titanium oxides, ¶0053, Rathenow).
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 teachings of Aharonov by incorporating the teachings above as taught by Rathenow in order to modify and adjust e.g. biological, mechanical and thermal properties of the films and of the resulting carbon coatings (¶0054, Rathenow).
Regarding claim 28, Aharonov does not teach said coating material includes titanium dioxide and/or titanium monoxide. However, Rathenow teaches
wherein said coating material includes titanium dioxide and/or titanium monoxide (titanium oxides, ¶0053, Rathenow).
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 teachings of Aharonov by incorporating the teachings above as taught by Rathenow in order to modify and adjust e.g. biological, mechanical and thermal properties of the films and of the resulting carbon coatings (¶0054, Rathenow).
Claim(s) 35-36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aharonov in view of Rathenow and Furst, and further in view of Zhang et al. (US 20060184251 A1) hereinafter, Zhang.
Regarding claim 35, Aharonov teaches
a medical device (10, Fig. 1, Aharonov) that includes a body portion (body of 10, Fig. 1, Aharonov);
at least a portion of said body portion is formed of a metal alloy (cobalt chromium, ¶0025 & 0037, Aharonov);
at least a portion of said metal alloy (cobalt chromium, ¶0025 & 0037, Aharonov) is coated with a metal containing material (titanium nitride, ¶0010, Aharonov);
a composition of said metal containing material (titanium nitride, ¶0010, Aharonov) is different from a composition of said metal alloy (cobalt chromium, ¶0025 & 0037, Aharonov);
said metal containing material is titanium or a titanium containing material (titanium carbonitride, ¶0025, Aharonov);
at least a portion of said metal containing material (titanium carbonitride, ¶0025, Aharonov) is coated with a coating material (aluminum oxide, ¶0026, Aharonov);
a composition of said coating material (aluminum oxide, ¶0026, Aharonov) is different from said composition of said metal containing material (titanium carbonitride, ¶0025, Aharonov);
a thickness of said metal containing material is 0.01-2000 µm (3-15 micrometers, ¶0011, Aharonov);
a thickness of said coating material is 0.01-2000 µm (0.5-25 micrometers, ¶0011, Aharonov, Aharonov);
said medical device is a stent, a frame for a heart valve, a spinal implant, a bone plate, a rod for spinal surgery, a bone screw, a pedicle screw, a bone implant, an artificial disk, an artificial spinal disk, or a prosthetic implant (orthopedic implant devices, ¶0029, Aharonov).
Aharonov does not teach said coating material is formed of a compound that includes at least two materials selected from the group consisting of titanium, nitrogen and oxygen. However, Rathenow teaches
said coating material is formed of a compound that includes at least two materials selected from the group consisting of titanium, nitrogen and oxygen (titanium oxides, ¶0053, Rathenow).
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 teachings of Aharonov by incorporating the teachings above as taught by Rathenow in order to modify and adjust e.g. biological, mechanical and thermal properties of the films and of the resulting carbon coatings (¶0054, Rathenow).
Aharonov does not teach the metal alloy includes at least 5 atw.% rhenium. However, Furst teaches
said metal alloy includes at least 5 atw.% rhenium (at least about 40 weight percent rhenium ¶0016, Furst). It has been held that in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (MPEP 2144.05(I)).
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 teachings of Aharonov and Rathenow by incorporating the teachings above as taught by Furst in order to create a medical device having the desired high ductility at about room temperature (¶0021, Furst).
Aharonov does not teach said coating material is formed by use of an anodizing process in an aqueous electrolyte solution. However, Zhang teaches coatings deposited onto surfaces of medical devices (¶0003, Zhang) wherein
said coating material is formed on said top surface of said metal containing material by use of an anodizing process (electric anodizing, ¶0038, Zhang) in an aqueous electrolyte solution (nitric acid, ¶0038, Zhang).
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 teachings of Aharonov, Rathenow, and Furst by incorporating the teachings above as taught by Zhang in order to create an oxidized layer to serve as a corrosion barrier to prevent the metallic structural member from undergoing corrosion and releasing metallic ions into the bloodstream (¶0038, Zhang).
Regarding claim 36, Aharonov teaches
wherein said metal containing material is titanium, titanium nitride, titanium dioxide and/or titanium monoxide (titanium nitride, ¶0010, Aharonov).
Conclusion
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/K.X.W./Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774
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