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.
Status of Action/Claims
Receipt of Remarks filed on 5/29/2026 is acknowledged. Claims 1, 3-6, 8, 10-13, 17-18 are currently pending. Claims 5 and 13 have been withdrawn. Accordingly, claims 1, 3-4, 6, 8, 10-12, 17-18 are currently under examination.
Rejection(s) not reiterated from the previous Office Action are hereby withdrawn. The following rejections are either reiterated or newly applied. They constitute the complete set of rejections presently being applied to the instant application.
Terminal Disclaimer
The terminal disclaimer filed on 5/29/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of any patent granted on Application Number 18006340 has been reviewed and is accepted. The terminal disclaimer has been recorded.
New/Maintained Claim Objection(s) / Rejection(s)
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, 4, 6, 8, 10-11 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) in view of Xyleminc (Corrosion of metal; https://web.archive.org/web/20141028053043/https://xapps.xyleminc.com/Crest.Grindex/help/grindex/contents/Metals.htm).
Rodriguez throughout the reference teaches heart bioprosthetic device having a metal frame wireform or stent having an outer external surface.
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.
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.
Rodriguez teaches vacuum depositing a coating layer and bond layer wherein the combined bond and coating layer, together, may have a thickness of 1 micrometer or less, which overlaps the claimed total thickness of the first coating.
(see e.g. abstract; claims; examples; para 0067, 0070; entire document).
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 less than or equal to 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 less than or equal to 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.
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) in view of Xyleminc (Corrosion of metal; https://web.archive.org/web/20141028053043/https://xapps.xyleminc.com/Crest.Grindex/help/grindex/contents/Metals.htm) as applied to claims 1, 4, 6, 8, 10-11 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 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) in view of Xyleminc (Corrosion of metal; https://web.archive.org/web/20141028053043/https://xapps.xyleminc.com/Crest.Grindex/help/grindex/contents/Metals.htm) as applied to claims 1, 4, 6, 8, 10-11 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.
Response to Arguments
Applicant argued Rodriguez describes the coating as having a thickness of 10 micron, 5 micron, 1 micron or less, and that Rodriguez does not teach a coating having a total thickness that ranges from 100 nm to 300 nm as recited in amended claim 1.
In response, as discussed supra and acknowledged by applicant, Rodriguez teaches vacuum depositing a coating layer and bond layer wherein the combined bond and coating layer, together, may have a thickness of 1 micrometer or less, which overlaps the claimed total thickness of the first coating. Specifically, less than 1 micrometer (e.g. less than 1000 nm) encompasses 100 nm to 300 nm.
Applicant argued that Rodriguez does not teach a difference of self-corrosion potential between any two adjacent layers of layer structures with different material of the medical device is less than or equal to 100 mV as recited in amended claim 1.
In response, as discussed supra, 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.
Applicant further argued that claim 1 recites the thickness of the coating to range from 100 nm to 300 nm, and that the solution provided by claim 1, on the nanometer scale, is more compact than what is disclosed in the cited references, thus reducing or effectively avoiding dissolution or precipitation of sensitized and carcinogenic nickel and cobalt elements and thereby resulting in improved biocompatibility and safety as a medical implant device.
In response, firstly as mentioned previously, less than 1 micrometer (e.g. less than 1000 nm) taught by Rodriguez encompasses 100 nm to 300 nm and thus, Rodriguez does teach the thickness can be in nanometer scale. Further, applicant have not provided any evidence of the criticality or unexpected effect achieved with the claimed thickness of 100 nm to 300 nm. Applicant have not provided any data/results which show that the claimed thickness provides unexpected effect which would not occur over the broader range taught in the prior art. Changes in size, shape, or sequence of adding ingredients generally have limited impact on patentability unless they produce unexpected results or solve a specific problem. See: MPEP 2144.04.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/ALI S SAEED/Examiner, Art Unit 1616
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