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 .
Priority
This application is a National Stage entry of PCT/CN2022/085545, filed 04/07/2022, and claims foreign priority to CN202110376269.X, filed 04/08/2021.
Information Disclosure Statement
The IDS filed on 6/12/2025 and 10/5/2023 has been considered. See the attached PTO 1449 form.
Election/Restrictions
Applicant's election with traverse of the first coating being a stack layer formed by the elemental metal layer and the metal-ceramic layer, and the elemental metal layer being located between the substrate and the metal-ceramic layer, the second coating being a carbon layer and being provided on the metal-ceramic layer in the reply filed on 1/21/2026 is acknowledged. Applicant made the election with traverse, however, Applicant did not provide any substantial arguments and/or supposed errors in the restriction requirement.
The requirement is still deemed proper and is therefore made FINAL.
Claims 5 and 13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim.
Claim Status
Receipt of Remarks filed on 1/21/2026 is acknowledged. Claims 1-18 are currently pending. Claims 5 and 13 have been withdrawn. Accordingly, claims 1-4, 6-12, 14-18 are currently under examination.
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 1-18 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.
Claim 1 recites “the substrate contains a metal element X with a content of ≥ 5 wt%”. This recitation makes it unclear whether “a content of ≥ 5 wt%” refers to the concentration of metal element X in the substrate or whether a content of ≥ 5 wt% is referring to some other content in the substrate and not the metal element X. For the purpose of examination, the examiner interprets “a content of ≥ 5 wt%” refers to the concentration of metal element X in the substrate.
Claim 1 also recites “the first coating comprises at least one of an elemental metal layer of the metal element X, an alloy layer of the metal element X, and a metal-ceramic layer of the metal element X”. The recitation “at least one of” suggests the coating can have either one or more than one of the layers recited. However, the conjunction “and” before the metal-ceramic layer in the phrase above suggests the coating comprises all three layers recited. Thus, the recitation above in the claim makes it unclear whether all the recited layers are required or at least one is required. For the purpose of examination, the examiner interprets that at least one layer is required. The examiner suggests amending the above claimed recitation to replace “and” with “and/or” which would encompass one or more than one layer.
In claim 14, the recitation “within 100 mV” renders the claim indefinite because it unclear whether “within 100 mV” means that the self corrosion potential difference is about 100 mV or it is less than 100 mV. The metes and bounds of the claim are unclear because it is not clear what exactly within means (e.g., does it mean about 100 mV or less than 100 mV). The specification also does not clearly define what “within” exactly means in this recitation of claim 14.
Claim 15 recites “wherein thicknesses of the elemental metal layer, the alloy layer, and the metal-ceramic layer range from 10 nm to 500 nm”. It is unclear whether the thickness recited in this limitation is the thickness of each of these layers or whether the recited thickness is the thickness of all three layers combined.
Claims 2-4, 6-12, 16-18 are included in the rejection as they depend on a rejected base claim and do not clarify the issues discussed above.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2, 4, 6-11 and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Li et al. (CN104195508A; 2016-10-26)(cited in IDS; see attached English Translation) as evidenced by Bsstainless (https://www.bsstainless.com/chromium-the-strength-behind-stainless-steel; 12 August 2020).
Li throughout the reference teaches a method for preparing Cr/CrN/Cu-TiN film on the surface of stainless steel surgical instrument.
Regarding claims 1, 2, 4, 6, 7, 8, 10, 11, Li teaches Cr/CrN/Cu-TiN film is prepared on stainless steel instruments surface. Stainless steel reads on the substrate and the Cr/CrN/Cu-TiN film reads on the coating on the substrate. As evidenced by Bsstainless, chromium (Cr) is an essential component of all stainless steels, making up a minimum of 10.5% of the alloys content. (see entire document). This reads on the substrate contains a metal element X (i.e. Cr) and the concentration of metal element X in the substrate. Li teaches first depositing Cr layer on the substrate, followed by depositing CrN layer (i.e., on the Cr layer and away from the substrate). Cr layer on the substrate reads on the elemental metal layer and CrN layer (chromium nitride) reads on the metal ceramic layer. This coating of Li does not require nickel and cobalt.
Regarding claim 9, Li teaches stainless steel as the substrate, which is the same substrate recited in the instant claims and the examples of the instant specification. The specification disclose the substrate such as stainless steel comprising chromium provide plastic deformation. Thus, the stainless steel taught by Li would necessarily be capable of plastic deformation.
Regarding claim 16, as discussed supra, Li teaches chromium as the metal element X, which reads on claim 16 wherein the metal element X is not titanium.
(see e.g. abstract; claims; entire document of Li et al.).
Claims 1, 2, 4, 6, 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lammer (EP1674117A1; 2006-06-28) (cited in IDS).
Lammer throughout the reference teaches mechanical piece having a structure comprising a substrate and at least one surface coating layer of nanometric thickness.
Regarding claims 1, 2, 4, 6, 15, Lammer discloses mechanical piece constituted by a medical body implant, for instance a heart valve having ceramic coating. Specifically, Lammer in example 3 discloses a titanium valve plate ( which reads on substrate containing metal element X with a content of >5% since it constitutes 100% titatnium), which is deposited with a nanometric layer of essentially pure titanium (elemental metal layer), to which follows a nanometric layer of titanium nitride (metal ceramic layer). The coating layers have a thickness of 10 to 40 nm. (see e.g. abstract; claims; example 3).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 2, 4, 6-11, and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Rodriguez (WO2015153986A1; 2015-10-08) (cited in IDS) as evidenced by Bsstainless (https://www.bsstainless.com/chromium-the-strength-behind-stainless-steel; 12 August 2020).
Rodriguez throughout the reference teaches heart bioprosthetic device having a metal frame wireform or stent having an outer external surface.
Regarding claims 1, 2, 4, 6, 7, 8, 10, 11, Rodriguez teaches a metal frame of an implantable device. A bond layer disposed over the metal frame (substrate) and coating layer deposited over the bond layer. The metal frame comprising at least one of stainless steel, cobalt-chromium, titanium alloy, nitinol, a metal alloy, a shape-memory metal, or a super-elastic metal. As evidenced by Bsstainless, chromium (Cr) is an essential component of all stainless steels, making up a minimum of 10.5% of the alloys content. (see entire document). This reads on the substrate contains a metal element X (i.e. Cr) and the concentration of metal element X in the substrate. The bond layer comprising at least one elemental metal and coating layer deposited over the bond layer, the coating layer comprising at least one of a metal oxide, a metal nitride, or a metal carbide. The at least one elemental metal is selected from the group consisting of aluminum, titanium, zirconium, hafnium, vanadium, niobium, tantalum, chromium, molybdenum, tungsten, ruthenium, cobalt, rhenium, iridium, palladium, platinum, copper, silver, and gold. The at least one of the metal oxide, the metal nitride, or the metal carbide of the coating layer comprises at least one metal selected from the group consisting of aluminum, titanium, zirconium, hafnium, vanadium, niobium, tantalum, chromium, molybdenum, tungsten, ruthenium, cobalt, rhenium, iridium, palladium, and platinum. Rodriguez does not require nickel and cobalt.
Regarding claim 9, Rodriguez teaches stainless steel as a suitable substrate, which is the same substrate recited in the instant claims and the examples of the instant specification. The specification disclose the substrate such as stainless steel comprising chromium provide plastic deformation. Thus, the stainless steel taught by Li would necessarily be capable of plastic deformation.
Regarding claim 15, Rodriguez teaches the coating layer comprises vacuum depositing a coating layer with a thickness of about 10 micron or less, which overlaps the claimed thickness.
Regarding claim 16, Rodriguez does not require the metal element to be titanium.
(see e.g. abstract; claims; examples; entire document).
The teachings of Rodriguez have been set forth above.
As discussed supra, Rodriguez teaches the substrate can be stainless steel (comprising chromium as metal element X), the bond layer comprising at least one elemental metal wherein chromium is taught as a suitable elemental metal for the bond layer. The coating layer is deposited over the bond layer, the coating layer comprises at least one of a metal oxide, a metal nitride, or a metal carbide wherein chromium is taught as a suitable metal (e.g. chromium carbide which is metal ceramic layer). While Rodriguez does not explicitly exemplify wherein a substrate contains a metal element X (e.g. chromium), an elemental metal layer of the metal element X (e.g. chromium as the elemental metal), and a metal ceramic layer of the metal element X (e.g. chromium carbide), however, Rodriguez teaches wherein stainless steel comprising chromium can be used as the substrate, chromium as the elemental metal layer and chromium carbide as the metal ceramic layer. Therefore, all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention. Note: MPEP 2141 KSR International CO. v. Teleflex Inc. 82 USPQ 2d 1385 (Supreme Court 2007). It would have been obvious to one of ordinary skill in the art to substitute the alternative metal frame (substrate), bonding layer (elemental metal layer) and the coating layer (ceramic metal layer) as a person with ordinary skill has good reason to pursue known options within his or her technical grasp. see MPEP 2141 KSR International CO. v. Teleflex Inc. 82 USPQ 2d 1385 (Supreme Court 2007).
From the combined teaching of the cited reference, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Claims 3 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Rodriguez (WO2015153986A1; 2015-10-08) (cited in IDS) as evidenced by Bsstainless (https://www.bsstainless.com/chromium-the-strength-behind-stainless-steel; 12 August 2020) as applied to claims 1, 2, 4, 6-11, and 15-16 above and further in view of Osorio (US20160122865A1).
The teachings of Rodriguez have been set forth above.
Rodriguez does not teach wherein the elemental metal layer is a passivated metal coating and wherein the medical device further comprises a second coating provided on the metal-ceramic layer, the second coating being a carbon layer. However, Osorio cures these deficiencies.
Osorio teaches multilayered metal coatings for the treatment of biomedical substrates such as stainless steel. Osorio discloses coatings which include layers of titanium and titanium nitride. Osorio also teaches that many metals in pure state cause biocompatibility problems, for example: Ni (carcinogenic), 316L (release of Fe), Co, Cu, and V (highly toxic) [17, 18], hence, needing surface treatments, or passivation, to regulate the problem of anti-biocompatibility. Further, Osorio teaches one of the surface treatments used most frequently are the nanometric layers of DLC (diamond like carbon or amorphous carbon). In DLC structures, bonds are normally sp2 and sp3 type, in different concentrations with hardness in the order of 30 GPa, transparent and with high wear resistance, making it a high-performance material, besides being biocompatible, by being chemically inert. Another carbon-based coating is the amorphous carbon nitride (a-CN), used for cutting and machining tools and because of its biological inertness as biomaterial, besides having excellent anti-wear properties and low friction coefficient. (see e.g. abstract; claims; para 0008; 0014; entire document).
It would have been prima facie obvious to one or ordinary skill in the art to have combined the teaching of Rodriguez and Osorio and passivate the metal coating and/or further provide a coating of carbon as suggested by Osorio. Both Rodriguez and Osorio teaches multilayered metal coatings for the treatment of biomedical substrates such as stainless steel. Osorio also teaches that many metals in pure state cause biocompatibility problems needing surface treatments, or passivation, to regulate the problem of anti-biocompatibility. Further, Osorio teaches one of the surface treatments used most frequently are the nanometric layers of DLC (diamond like carbon or amorphous carbon) which is transparent and with high wear resistance, making it a high-performance material, besides being biocompatible, by being chemically inert. Another carbon-based coating is the amorphous carbon nitride (a-CN), used for cutting and machining tools and because of its biological inertness as biomaterial, besides having excellent anti-wear properties and low friction coefficient. Therefore, it would have been obvious to passivate the metal coating and/or further provide a coating of carbon on the surface (e.g. metal ceramic) of the medical device of Rodriguez.
From the combined teaching of the cited reference, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Rodriguez (WO2015153986A1; 2015-10-08) (cited in IDS) as evidenced by Bsstainless (https://www.bsstainless.com/chromium-the-strength-behind-stainless-steel; 12 August 2020) as applied to claims 1, 2, 4, 6-11, and 15-16 above and further in view of Xyleminc (Corrosion of metal; https://web.archive.org/web/20141028053043/https://xapps.xyleminc.com/Crest.Grindex/help/grindex/contents/Metals.htm).
The teachings of Rodriguez have been set forth above.
Rodriguez does not teach wherein a difference of self-corrosion potential between any two adjacent layers of layer structures with different materials of the medical device is within 100 mV. However, Xyleminc cures this deficiency.
Xyleminc throughout the reference discusses corrosion of metals. Xyleminc teaches that when two different metals are connected and in contact, the corrosion rate depends on the magnitude of potential difference. (see e.g. page 7; entire document).
It would have been prima facie obvious to one or ordinary skill in the art to have combined the teaching of Rodriguez and Xyleminc and ensure the difference of self corrosion potential between two adjacent layers is within 100 mV. Xyleminc teaches that when two different metals are connected and in contact, the corrosion rate depends on the magnitude of potential difference and it would have been obvious to determine an optimal potential difference which would not lead to corrosion of the metals. Further, Rodriguez renders obvious the same metal layers recited in the instant claims and therefore, they would necessarily result in a potential difference (e.g. within 100 mV) which is recited in the instant claims. Although the prior art does not disclose all the characteristics and properties of the composition disclosed in the present claims, based on the substantially identical process using identical components, the Examiner has a reasonable basis to believe that the properties claimed in the present invention are inherent in the composition disclosed by the prior art. Because the PTO has no means to conduct analytical experiments, the burden of proof is shifted to the Applicant to prove that the properties are not inherent. ““[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art' s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).” MPEP § 2112, I.
From the combined teaching of the cited reference, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Claim 17-18 is rejected under 35 U.S.C. 103 as being unpatentable over Rodriguez (WO2015153986A1; 2015-10-08) (cited in IDS) as evidenced by Bsstainless (https://www.bsstainless.com/chromium-the-strength-behind-stainless-steel; 12 August 2020) as applied to claims 1, 2, 4, 6-11, and 15-16 above and further in view of Meer (Cardiovasc Intervent Radiol (2017) 40:1237-1245) and Lansky (Lancet 2018: 392: 1117-26).
The teachings of Rodriguez have been set forth above.
Rodriguez does not teach wherein the medical device further comprises a medicine active layer on the surface of the first coating and wherein the first coating is formed with a medicine-carrying recess, and the medicine active layer is located within the medicine carrying recess. However, Meer and Lansky cure this deficiency.
Meet teaches grooved stainless steel stents for primary endothelial cell carrier. Smooth and grooved stents were compared. The grooved stent provides a potential percutaneous means to deliver sufficient numbers of viable and functional cells to a vessel segment during vascular intervention. The grooves were found to offer a favorable surface for EC attachment and protection during stent deployment in an in vitro setting. The stent with the grooved wire could accommodate three times more cells than the similarly sized smooth stent.
Lansky teaches drug-eluting stent with a fully biodegradable sirolimus-containing polymer coating localized to recessed abluminal grooves on the stent surface. The stent is a thin-strut cobalt chromium stent platform that elutes sirolimus (or rapamycin) from a biodegradable polymer applied to recessed abluminal grooves designed to minimize polymer burden and reduce vessel wall drug concentrations.
It would have been prima facie obvious to one or ordinary skill in the art to have combined the teaching of Rodriguez, Meet and Lansky and further include a medicine active layer on the surface of the coating and wherein the coating is formed with a medicine-carrying recess, and the medicine active layer is located within the medicine carrying recess. Rodriguez teaches stainless steel stents but is silent on the stents further comprising a drug/medicine/active component. Meet teaches grooved stainless steel stents for primary endothelial cell carrier. Smooth and grooved stents were compared. The grooved stent provided a potential percutaneous means to deliver sufficient numbers of viable and functional cells to a vessel segment during vascular intervention. The grooves were found to offer a favorable surface for EC attachment and protection during stent deployment in an in vitro setting. The stent with the grooved wire could accommodate three times more cells than the similarly sized smooth stent. Lansky teaches drug-eluting stent with a fully biodegradable sirolimus-containing polymer coating localized to recessed abluminal grooves on the stent surface. The stent elutes drug from a biodegradable polymer applied to recessed abluminal grooves designed to minimize polymer burden and reduce vessel wall drug concentrations. Thus, in view of the teachings of Meet and Lansky, it would have been obvious to add a groove (medicine carrying recess) and the active/drug component into the groove on the coating of the stent disclosed by Rodriguez.
From the combined teaching of the cited reference, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-4, 6-12, 14-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/006,340 (US20230270921A1) in view of Rodriguez (WO2015153986A1; 2015-10-08), Meer (Cardiovasc Intervent Radiol (2017) 40:1237-1245), Lansky (Lancet 2018: 392: 1117-26), Xyleminc (Corrosion of metal; https://web.archive.org/web/20141028053043/https://xapps.xyleminc.com/Crest.Grindex/help/grindex/contents/Metals.htm) and Osorio (US20160122865A1).
‘340 recites a medical device comprising a metal substrate(such as stent), cladding layer which is nickel free and cobalt free. The cladding layer is selected from at least one of a metal element or a metal alloy, wherein the metal element is Ir, Pt, Ru, Ta, W or Au, and the metal alloy comprises at least one of PtIr, PtPd, or PtRh (claimed metal element layer). The thickness of the cladding layer is less than 25 nm. The medical device further comprises at least one reinforcing layer deposited between the metal substrate and the cladding layer by metal bonding. A total thickness of the reinforcing layer is less than or equal to 500 nm. A material of the reinforcing layer is selected from at least one of a metal element, a metal alloy, a metal oxide, or a metal nitride (claimed ceramic metal layer). The metal element is Ir, Pt, Ru, Ta, W or Au; the metal alloy comprises at least one of PtIr, PtPd, or PtRh; the metal oxide comprises at least one of HfO2, TiO2, Ta205, ZnO, ZrO2, MgO, SrTiOx, La203, or CeO2; and the metal nitride comprises at least one of TiN or TaNx.
‘340 does not teach the elemental metal layer is located between the substrate and the metal-ceramic layer, however, Rodriguez teaches a stent metal wherein the metal layer can be located between the metal stent substrate and the metal ceramic layer. There are only two options of stacking the metal element and ceramic layer on the substrate, and in view of the teachings of Rodriguez, one skilled in the art would have easily envisioned utilizing the claimed order of stacking as taught by Rodriguez as there are only two options.
Regarding the metal being passivated, the specific substrate and substrate being capable of plastic deformation, the carbon layer, potential difference and the medicine layer, the teachings of references discuss above also render obvious these limitations in medical device such as a stent.
From the combined teaching of the cited reference, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
This is a provisional nonstatutory double patenting rejection.
Conclusion
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/ALI S SAEED/Examiner, Art Unit 1616