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 1-22 & 30-31 are pending and examined below.
Response to Arguments
Applicant's arguments filed 06/04/2025 have been fully considered but they are not persuasive.
Applicant argues that the amendments to the independent claim overcome the rejections of record (pages 12-17) and that the dependent claims rise and fall with the same arguments (pages 12-17). Applicant's arguments are moot due to the additional references applied to the newly added limitations, as detailed in the rejection below.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-9, 11, 22, & 30-31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beshchasna et al. (Surface evaluation of titanium oxynitride coatings used for developing layered cardiovascular stents, Beshchasna et al., Materials Science & Engineering C (2019) 405-416, 2019) in view of Park et al. (US 20210154373 A1), hereinafter, Park and further in view of Cao et al. (US 20190003016 A1) hereinafter, Cao.
Regarding claim 1, Beshchasna teaches
a medical device (stents, Fig. 1, pg. 406) includes a body that is formed of a base material (stainless steel, pg. 406) and an enhancement coating (TiOxNy
coatings, pg. 406) that is directly coated on at least a portion of an outer surface of said base material (stents coated with TiOxNy, pg. 406);
a thickness of said enhancement coating (100 nm, pg. 409) is less than a thickness of said base material (150-170 nm, pg. 406);
said medical device is at least partially formed from a metal alloy selected from the group consisting of a) stainless steel (stainless steel, pg. 406), b) cobalt-chromium alloy, c) titanium-aluminum-vanadium alloy, d) aluminum alloy, e) nickel alloy, f) titanium alloy, g) tungsten alloy, h) molybdenum alloy, i) copper alloy, j) beryllium-copper alloy, k) titanium-nickel alloy, l) refractory metal alloy, or m) metal alloy that includes at least 5 atomic weight percent (awt.%) rhenium;
said metal alloy includes no more than 5 wt.% magnesium (the metal alloys presented in Beshchasna (pg. 406) does not include magnesium, therefore the metal alloy includes no more than 5 wt. % magnesium);
said enhancement coating is formed of
a) a coating material that is titanium oxynitride (titanium oxynitride, abstract) and/or zirconium oxynitride which is coated on at least a portion of said outer surface of base material that is formed of said metal alloy (abstract), or
b) a metallic adhesion layer and a coating material, and wherein said coating material is titanium oxynitride and/or zirconium oxynitride, and wherein said metallic adhesion layer is a layer of metal that is coated on at least a portion of an outer surface of said base material and said coating material is coated on at least a portion of an outer surface of said metallic adhesion layer, and wherein said metallic adhesion layer is titanium, titanium alloy, zirconium or zirconium alloy (stent coated with titanium oxynitride, abstract, Beshchasna). This limitation is viewed as nonlimiting due to the “and/or” statement.
Beshchasna does not specify said enhancement coating is formulated to promote generation of nitric oxide on an outer surface. However, Park teaches a cardiovascular device having a surface modified heparin-phenol derivative and copper nanoparticles as a NO (nitric oxide)-generating catalyst on the surface of a material (abstract, Park) wherein
said enhancement coating (coating of the HT/Cu (heparin-tyramine derivative/copper), ¶0044, Park) is formulated to promote generation of nitric oxide (generates NO, ¶0160, Park) on an outer surface of said enhancement coating when said medical device is implanted in a patient (heparin and copper particles were immobilized on each material surface, ¶0154 & ¶0160, Park).
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 Beshchasna by incorporating the enhancement coating as taught by Park in order to promote the proliferation of endothelial cells while significantly inhibiting the adhesion and activation of platelets and smooth muscle cells, thus, may be advantageously applied to cardiovascular devices for inhibiting thrombosis and restenosis (¶0160, Park).
Beshchasna does not specify said metal alloy includes no more than 5 wt.% magnesium. However, Cao teaches an alloy material and an implantable medical device using the alloy material (abstract, Cao) wherein
said metal alloy includes no more than 5 wt.% magnesium (less than 3%, ¶0008, Cao).
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 Beshchasna and Park by incorporating no more than 5 wt.% magnesium as taught by Cao in order to prevent degradation in the mechanical properties of the alloy material (¶0023, Cao).
Regarding claim 2, Beshchasna teaches
wherein said coating material is titanium oxynitride (TiOxNy coatings, pg. 406) or zirconium oxynitride.
Regarding claim 3, Beshchasna teaches
wherein said coating material has a thickness of 10 nanometers to 10 microns (100 nm, pg. 409).
Regarding claim 4, Beshchasna teaches
wherein said coating material has an oxygen to nitrogen atomic ratio of 1:10 to 10:1 (O:N ratio 1:10, Table 2, pgs. 409-420).
Regarding claim 5, Beshchasna teaches
wherein said coating material is at least partially coated on said metallic adhesion layer (stent coated with titanium oxynitride, abstract, Beshchasna).
Regarding claim 6, Beshchasna teaches
wherein said metallic adhesion layer is titanium metal (pg. 406), or zirconium metal.
Regarding claim 7, Beshchasna teaches
wherein said enhancement coating includes no more than 0.1 wt.% nickel, no more than 0.1 wt.% chromium, and/or no more than 0.1 wt.% cobalt (the coating taught by Beshchasna is a of titanium oxynitride coatings (pg. 406) therefore the coating would include no more than 0.1% nickel, no more than 0.1 wt.% chromium, and/or no more than 0.1 wt.% cobalt).
Regarding claim 8, Beshchasna teaches
wherein said base material includes no more than 0.1 wt.% nickel, no more than 0.1 wt.% chromium, and/or no more than 0.1 wt.% cobalt (Beshchasna teaches the stent is stainless steel therefore the frame would include no more than 0.1% nickel, no more than 0.1 wt.% chromium, and/or no more than 0.1 wt.% cobalt, pg. 406, Beshchasna).
Regarding claim 9, Beshchasna teaches
wherein said base material is formed of said refractory metal alloy (tantalum, pg. 406) or said metal alloy that includes at least 15 atomic weight percent (awt.%) rhenium.
Regarding claim 11, Beshchasna teaches
wherein said body includes an expandable frame (stents were expanded, pg. 406); said expandable frame includes a shape-memory material; said shape-memory material includes nickel-titanium alloy (nickel‑titanium alloy, pg. 406).
Regarding claim 22, Beshchasna teaches
wherein said medical device is
an orthopedic device selected form the group consisting of expandable devices for use in the repair of bone fractures; spinal implant; spinal discs; frame and other structure for use with a spinal implant; bone implant; artificial disk; artificial spinal disk; spinal interbody; expandable spinal interbody; interbody fusion device; expandable interbody fusion device; prosthetic implant or device to repair, replace and/or support a bone; knee replacement; hip replacement; shoulder replacement; ankle replacement; nail; rod; screw; post; cage; expandable cage; expandable orthopedic insert; bone plate; cervical plate; spinal plate; bone plate nail; spinal rod; bone screw; post; spinal cage; pedicle screw; cap; hinge; joint system; screw extension; tulip extension; tether; graft; anchor; spacer; shaft; disk; ball; tension band; and/or locking connector;
a vascular device selected from the group consisting of a PFO (patent foramen ovale) device; a vascular stent (stents, Fig. 1, pg. 406), a stent for use in aortic, iliac, subclavian, carotid, femoral artery, tibial, and/or intracranial arteries; aneurysm exclusion devices; devices for aneurysm for use in aorta, iliac, and/or intracranial arteries; vascular valve; heart valve; TAVR valve; aortic valve replacement; mitral valve replacement; tricuspid valve replacement; pulmonary valve replacement; anchoring devices for vascular valves; anchoring devices for heart valves, TAVR valves, aortic valves, mitral valves, tricuspid valves, and/or pulmonary valves; vascular valve frames; occluders; occluders for patent foramen ovale, ventricular septal defect, and/or left atrial appendage; vascular guide wire; vascular implant; vascular graft; sheath, expandable sheath; catheter; needle; stent catheter; electrophysiology catheter; hypotube; pacemaker;
an orthodontic device selected from the group consisting of dental implant; dental crown; and/or dental braces; and/or
other types of medical devices selected from the group consisting of staples; needles, cutting devices; wire used in medical procedures; sutures; surgical staples.
Regarding claim 30, Beshchasna teaches
a medical device (stents, Fig. 1, pg. 406) that is formed of a base material (stainless steel, pg. 406) and an enhancement coating (TiOxNy coatings, pg. 406);
said medical device is at least partially formed from a metal alloy selected from the group consisting of a) stainless steel (stainless steel, pg. 406), b) cobalt-chromium alloy, c) titanium-aluminum- vanadium alloy, d) aluminum alloy, e) nickel alloy, f) titanium alloy, g) tungsten alloy, h) molybdenum alloy, i) copper alloy, j) beryllium-copper alloy, k) titanium-nickel alloy, l) refractory metal alloy, or m) metal alloy that includes at least 5 atomic weight percent (awt.%) rhenium;
said metal alloy includes no more than 5 wt.% magnesium (the metal alloys presented in Beshchasna (pg. 406) does not include magnesium, therefore the metal alloy includes no more than 5 wt. % magnesium);
said enhancement coating is coated on at least a portion of an outer surface of said base material that is formed of said metal alloy (stents coated with TiOxNy, pg. 406);
a thickness of said enhancement coating (100 nm, pg. 409) is less than a thickness of said base material (150-170 nm, pg. 406);
said enhancement coating is formed of
a) a coating material that is titanium oxynitride (titanium oxynitride, abstract) which is coated on at least a portion of said outer surface of base material that is formed of said metal alloy (abstract), or
b) a metallic adhesion layer and a coating material, and wherein said coating material is titanium oxynitride, and wherein said metallic adhesion layer is a layer of metal that is coated on at least a portion of an outer surface of said base material and said coating material is coated on at least a portion of an outer surface of said metallic adhesion layer and wherein said metallic adhesion layer is titanium, or titanium alloy (stent coated with titanium oxynitride, abstract, Beshchasna) this limitation is viewed as nonlimiting due to the “and/or” statement;
medical device is
an orthopedic device selected form the group consisting of expandable devices for use in the repair of bone fractures; spinal implant; spinal discs; frame and other structure for use with a spinal implant; bone implant; artificial disk; artificial spinal disk; spinal interbody; expandable spinal interbody; interbody fusion device; expandable interbody fusion device; prosthetic implant or device to repair, replace and/or support a bone; knee replacement; hip replacement; shoulder replacement; ankle replacement; nail; rod; screw; post; cage; expandable cage; expandable orthopedic insert; bone plate; cervical plate; spinal plate; bone plate nail; spinal rod; bone screw; post; spinal cage; pedicle screw; cap; hinge; joint system; screw extension; tulip extension; tether; graft; anchor; spacer; shaft; disk; ball; tension band; and/or locking connector; II)
a vascular device (stents, Fig. 1, pg. 406) selected from the group consisting of a vascular guide wire; catheter; needle; hypotube; and/or pacemaker;
an orthodontic device selected from the group consisting of dental implant; dental crown; and/or dental braces; and/or IV) other types of medical devices selected from the group consisting of staples; needles, cutting devices; wire used in medical procedures; sutures; surgical staples.
Beshchasna does not specify said enhancement coating is formulated to promote generation of nitric oxide on an outer surface. However, Park teaches
said enhancement coating (coating of the HT/Cu (heparin-tyramine derivative/copper), ¶0044, Park) is formulated to promote generation of nitric oxide (generates NO, ¶0160, Park) on an outer surface of said enhancement coating when said medical device is implanted in a patient (heparin and copper particles were immobilized on each material surface, ¶0154 & ¶0160, Park).
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 Beshchasna by incorporating the enhancement coating as taught by Park in order to promote the proliferation of endothelial cells while significantly inhibiting the adhesion and activation of platelets and smooth muscle cells, thus, may be advantageously applied to cardiovascular devices for inhibiting thrombosis and restenosis (¶0160, Park).
Beshchasna does not specify said metal alloy includes no more than 5 wt.% magnesium. However, Cao teaches an alloy material and an implantable medical device using the alloy material (abstract, Cao) wherein
said metal alloy includes no more than 5 wt.% magnesium (less than 3%, ¶0008, Cao).
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 Beshchasna and Park by incorporating no more than 5 wt.% magnesium as taught by Cao in order to prevent degradation in the mechanical properties of the alloy material (¶0023, Cao).
Regarding claim 31, Beshchasna teaches
wherein said enhancement coating is
a) a coating of titanium oxynitride (TiOxNy coatings, pg. 406) or
b) a coating of titanium oxynitride that is coated on at least a portion of said outer surface of said metallic adhesion layer, and wherein said metallic adhesion layer is formed of titanium or titanium alloy (stent coated with titanium oxynitride, abstract);
said coating of said titanium oxynitride forms an outermost layer of said medical device; said coating of said titanium oxynitride has an oxygen to nitrogen atomic ratio of 1:10 to 10:1 (O:N ratio 1:10, Table 2, pgs. 409-420).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beshchasna in view of Park and further in view of Buckman et al. (US 20130216421 A1) hereinafter, Buckman.
Regarding claim 10, Beshchasna does not teach wherein said base material is formed of at least 0.1 wt.% rhenium. However, Buckman teaches a medical device that is at least partially formed of a metal alloy which improves the physical properties of the medical device (abstract, Buckman)
wherein said base material is formed of at least 0.1 wt.% rhenium (rhenium content of the metal alloy is at least about 40 weight percent, ¶0018, Buckman) and one or more metal selected from molybdenum, chromium, cobalt, nickel, titanium, tantalum, niobium, zirconium, and/or tungsten (molybdenum, chromium, cobalt, nickel, titanium, tantalum, niobium, zirconium, and/or tungsten, ¶0016, Buckman). 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 Beshchasna and Park by incorporating at least 0.1 wt.% rhenium as taught by Buckman in order to achieve a medical device having the desired high ductility at about room temperature (¶0023, Buckman).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beshchasna in view of Park and further in view of Quintana-Ponce et al. (US 20210251766 A1), hereinafter, Quintana.
Regarding claim 12, Beshchasna does not teach the medical device is a a) a spinal implant, b) a frame and other structure for use with a spinal implant, c) a bone implant etc. However, Quintana teaches an implant having a substrate and a coating disposed on the surface of the substrate (abstract, Quintana)
wherein said medical device is a) a spinal implant, b) a frame and other structure for use with a spinal implant, c) a bone implant (knee prosthesis 10, Fig. 1, Quintana), d) an artificial disk, e) an artificial spinal disk, f) a spinal interbody, g) an expandable spinal interbody, h) an interbody fusion device, i) an expandable interbody fusion device, j) a prosthetic implant or device to repair, replace and/or support a bone and/or cartilage, k) a bone plate nail, 1) a spinal rod, m) a bone screw, n) a post, o) a spinal cage, p) a bone plate, q) a pedicle screw, r) a cap, s) a hinge, t) a joint system, u) an anchor, v) a spacer, w) a shaft, x) an anchor, y) a disk, z) a ball, aa) a tension band, or ab) a locking connector or other structural assembly that is used in a body to support a structure, mount a structure, and/or repair a structure in a body.
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 Beshchasna and Park by incorporating a bone implant as taught by Quintana in order to enhance wear resistance, resists delamination, tunable stiffness, ductile, corrosion resistance, and oxidation resistance (¶0144, Quintana).
Claim(s) 13-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beshchasna in view of Park and further in view of Hoang et al. (US 20150157455 A1) hereinafter, Hoang.
Regarding claim 13, Beshchasna teaches
an expandable metallic frame (expandable stent, pg. 406, Beshchasna); and
at least one component of said prosthetic heart valve is at least partially coated with said enhancement coating (TiOxNy coatings, pg. 406, Beshchasna).
Beshchasna does not teach wherein said medical device is a prosthetic heart valve. However, Hoang teaches prosthetic heart valves (abstract, Hoang)
wherein said medical device is a prosthetic heart valve (10, Fig. 1, Hoang) that includes a plurality of components;
two of said components include an expandable metallic frame (12, Fig. 1, Hoang) and at least one leaflet (14, Fig. 1, Hoang);
said expandable metallic frame is directly or indirectly attached to said at least one leaflet (Fig. 1, Hoang);
said at least one leaflet is configured to at least partially control blood flow through said expandable metallic frame when said prosthetic heart valve is positioned in a heart (Figs. 5A-B).
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 Beshchasna and Park by incorporating the components as taught by Hoang in order to provide an additional barrier against paravalvular leakage following implantation of the stent in a subject (¶0117, Hoang).
Regarding claim 14, Beshchasna does not teach one or more of an inner skirt, an outer skirt, and/or sutures. However, Hoang teaches
wherein said plurality of components further include one or more of an inner skirt (upper skirt 443, Fig. 35, Hoang),
an outer skirt (sealing skirt 449, Fig. 35, Hoang), and/or
sutures (sutures 455, Fig. 35, Hoang).
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 Beshchasna and Park by incorporating the components as taught by Hoang in order to provide an additional barrier against paravalvular leakage following implantation of the stent in a subject (¶0117, Hoang).
Regarding claim 15, Beshchasna teaches
wherein said plurality of components include said frame (expandable stent, pg. 406, Beshchasna).
Beshchasna does not teach at least one leaflet, said inner skirt, and said outer skirt. However, Hoang teaches
said at least one leaflet (14, Fig. 1, Hoang), said inner skirt (upper skirt 443, Fig. 35, Hoang), and said outer skirt (sealing skirt 449, Fig. 35, Hoang).
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 Beshchasna and Park by incorporating the components as taught by Hoang in order to provide an additional barrier against paravalvular leakage following implantation of the stent in a subject (¶0117, Hoang).
Regarding claim 16, Beshchasna teaches
wherein said enhancement coating is only coated on or over at least a portion of said expandable metallic frame (stents coated with TiOxNy, pg. 406).
Claim(s) 17-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beshchasna in view of Park and Hoang and further in view of Rittgers et al. (US 20060111773 A1) hereinafter, Rittgers.
Regarding claim 17, Beshchasna teaches
wherein said enhancement coating is coated on or over at least a portion of an outer surface of said expandable metallic frame (stents coated with TiOxNy, pg. 406, Beshchasna).
Beshchasna does not teach said enhancement coating is coated on an outer surface of said at least one leaflet. However, Rittgers teaches a prosthetic venous valve includes a frame and leaflets (abstract, Rittgers) wherein
wherein said enhancement coating is coated on or over at least a portion of an outer surface of said at least one leaflet (¶0081, Rittgers).
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 Beshchasna, Park, and Hoang by incorporating the enhancement coating on the leaflet as taught by Rittgers in order to provide a coating of an anti-thrombotic agent to suppress blood clotting, an anti-proliferative agent to suppress excessive tissue ingrowth, or another drug (¶0081, Rittgers).
Regarding claim 18, Beshchasna teaches
wherein said enhancement coating is coated on or over at least a portion of an outer surface of said expandable metallic frame (stents coated with TiOxNy, pg. 406, Beshchasna).
Beshchasna does not teach said enhancement coating is coated on an outer surface of said at least one leaflet. an outer surface of said inner skirt and an outer surface of said outer skirt. However, Hoang teaches
said at least one leaflet (14, Fig. 1, Hoang), said inner skirt (upper skirt 443, Fig. 35, Hoang), and said outer skirt (sealing skirt 449, Fig. 35, Hoang).
Beshchasna in view of Park and Hoang does not teach an enhancement coating on these surfaces, However, Rittgers teaches
said enhancement coating is coated on or over at least a portion of an outer surface of said at least one leaflet, an outer surface of said inner skirt and an outer surface of said outer skirt (matrix of the frame and/or leaflets member, ¶0081, Rittgers).
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 Beshchasna, Park, and Hoang by incorporating the enhancement coating on the matrix of the frame and/or leaflets member as taught by Rittgers in order to provide a coating of an anti-thrombotic agent to suppress blood clotting, an anti-proliferative agent to suppress excessive tissue ingrowth, or another drug (¶0081, Rittgers).
Regarding claim 19, Beshchasna teaches
wherein said expandable metallic frame (stents were expanded, pg. 406) is formed of a plastically deformable metal alloy; said plastically deformable metal alloy includes a) stainless steel (pg. 406), b) cobalt-chromium alloy, c) titanium-aluminum-vanadium alloy, d) aluminum alloy, e) nickel alloy, f) titanium alloy, g) tungsten alloy, h) molybdenum alloy, i) copper alloy, j) beryllium-copper alloy, k) refractory metal alloy, or m) titanium-nickel alloy, n) metal alloy that includes at least 15 atomic weight percent (awt.%) rhenium.
Regarding claim 20, Beshchasna teaches
wherein said metallic frame is formed of said refractory metal alloy (tantalum, pg. 406) or said metal alloy that includes at least 15 atomic weight percent (awt.%) rhenium.
Regarding claim 21, Beshchasna teaches
wherein said medical frame includes an expandable frame (stents were expanded, pg. 406); said expandable frame includes a shape-memory material; said shape-memory material includes nickel-titanium alloy (nickel‑titanium alloy, pg. 406).
Conclusion
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/K.X.W./Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774