DETAILED ACTION
Claims 1-8 and 10-21 are currently pending and under examination.
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 .
Examiner’s Note
Applicant's amendments and arguments filed 11/17/2025 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. In the Applicant’s response, filed 11/17/2025, it is noted that claim 1 has been amended and claims 11-21 are newly added. No new matter or claims have been added.
Modified Rejection:
The following rejection is modified based on Applicant’s claim amendments and newly added claims.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1-7, 10, 16-18 and 20-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over CN106806938 (Qi) in view of US 2018/0264178 (previously applied), US 2016/0263287 (previously applied) and US 2003/0125800 (previously applied).
US 2019/0022284 is used as an English language translation of CN106806938. Citation in the instant rejection will be cited as Qi and will refer to places in the ‘284 publication.
Regarding claims 1, 16 and 20, the limitation of an absorbable iron based instrument comprising anion based matrix, a zinc containing protective layer, a corrosion promoting layer and a drug-controlled release layer, wherein the iron based matrix is provided with an outer wall, an inner wall and a side wall; the zinc containing protective layer covers at least the outer wall and the inner wall of the iron-based matrix; the corrosion promoting layer fully covers the zinc containing protective layer, the corrosion promoting layer and the drug controlled release layer each contain degradable polymer, the thickness ratio of a portion of the zinc containing protection layer that is located the inner wall to a portion of the corrosion promoting layer that is located at the inner wall is greater than the thickness promoting layer on the outer wall is met by the Qi publication teaching an absorbable iron-based alloy medical device implant comprising an iron based alloy substrate, a degradable polymer provided on the surface of an or based alloy, a zinc containing protective membrane provided on the surface of the iron based alloy substrate (abstract, Figure 1). The degradable polymer layer is any one including poly(lactic acid-glycolic acid) [0026]. The degradable polymer coating layer may further include an active drug and may release therapeutic drugs during degradation. The device is taught to be a vascular stent [0027]. Zinc layer is taught to be 4um, the spraying of polylactic acid is 200,000 and 12 um [0037] or 6um [0039]. Wherein the polymer layer contains polylactic acid and sirolimus is taught to have a MW of 200,000 and a thickness of 5um [0041].
Regarding the limitation of wherein the zinc containing protective layer covers the outer wall the inner wall and the side all of the iron-based matrix; the corrosion promoting layer covers the entire surface of the zinc containing protective layer and the drug controlled release layer covers at least a portion of the corrosion promoting layer that is located on the outer wall is met by Qi teaching embodiments wherein the zinc coating layer has a thickness of 3um [0041] wherein the zinc containing surface coats the entire surface of the ion based alloy [0008]. Qi teaches the polylactic acid coating layer has a thickness of 8 microns [0038] wherein the entire surface of the device is coated [0028]. Qi teaching a coating layer of polylactic acid and sirolimus is coating layer having a thickness of 5 microns [0041].
Regarding claim 5 and 18, the limitation wherein the thickness portion of the zinc containing protective layer on the inner and outer wall is 0.5 to 2.0 microns is met by the Qi teaching embodiments wherein the zinc coating layer has a thickness of 3um [0041] wherein the zinc containing surface coats the entire surface of the iron-based alloy [0008].
Regarding claims 6 and 21, the limitation of wherein the portion of the corrosion-promoting layer that is located at the outer wall has a thickness range from 4 to 15 microns, and the portion of the corrosion promoting layer that is located at the inner wall has a thickness range from 3 to 10 microns is met by the Qi teaches the polylactic acid coating layer has a thickness of 8 microns [0038] wherein the entire surface of the device is coated [0028].
Regarding claim 7 and 18, the limitation of wherein the thickness of the drug controlled-release layer is less than or equal to 5 microns is met by Qi teaching a coating layer of polylactic acid and sirolimus is coating layer having a thickness of 5 microns [0041].
Regarding claims 10 and 20, the limitation wherein there is at least one corrosion-promoting layer; and when there is plurality of promoting corrosion promoting layer, the degradable polymers in the different corrosion promoting layer have different molecular weights is met by Qi teaching a single corrosion promoting layer. Qi the polylactic acid coating layer has a thickness of 8 microns [0038] wherein the entire surface of the device is coated [0028].
Qi does not specifically teach a combination of corrosion promoting layer and a drug-controlled release layer wherein the drug controlled-release layer only covers the corrosion promoting layer along the outer wall and the side wall (claim 1).
Qi does not specifically teach the weight average molecular weight of the degradable polymer in the corrosion promoting layer is greater than the weight average molecular weight of the degradable polymer in the drug-controlled release layer (claim 1) wherein the corrosion-promoting layer is at least twice as large as the weight -average molecular weight of the degradable polymer in the drug-controlled release layer (claim 2), specifically 100-100 kDa and 8-50 kDa (claim 3, 17).
Qi does not specifically teach the thickness ratio of a portion of the zinc containing protective layer that is located at the inner wall to a portion of the corrosion promoting layer that is located at the inner wall is greater than the thickness ratio of a portion of the zinc containing protective layer that is located at the outer wall to a portion of the corrosion promoting layer that is located at the outer wall (claim 1), wherein the thickness ratio of the portion of the zinc-containing protective layer that is located at the inner wall to the portion of the corrosion-promoting layer that is located at the inner wall is 0.05-0.7, and the thickness ratio of the portion of the zinc-containing protective layer that is located at the outer wall to the portion of the corrosion promoting layer that is located at the outer wall is 0.03-0.5 (claim 4 and 16).
The ’178 publication teaches an iron-based alloy implantable medical device incus an iron-based alloy matrix, a degradable polymer coating disposed on the surface of the iron-based ally matrix and a corrosion inhibition layer disposed on the surface (abstract). The degradable polymer may cover all surface of the iron-based alloy substrate and may cover at least part of the surface of the iron-based alloy substrate [0008]. The degradable polymer includes poly(lactic acid-glycolic acid) polymer [0010]. An active drug is mixed into the degradable polymer, or not active drug is mixed. The active drug may be for inhibiting vascular proliferation such as taxol, sirolimus [0011]. The absorbable iron-based alloy implanted medical device may further include a drug-loading layer which is disposed on the outermost layer of the medical device and includes a degradable polymer and an active drug [0015]. Figure 2 teaches the outer most layer of the iron absorbable medical implant is a drug loading layer which completely covers the surface of the corrosion inhibition layer 12, which covers a degradable polymer coating 16 on the surface of an iron base alloy ([0021]-[0022]).
The ‘287 publication teaches bioresorbable iron-based alloy stent (title) and a degradable polyester in contact with the surface of the substrate, in which the degradable polyester has a weight average molecular weight of between 20,000 and 1,000,000 (abstract). The degradable polyester comprises PLA, PGA and PLGA [0004]. The pure iron stent strut with a thickness of between 240 micron and 260 microns. The coating comprises two layers, i.e., a PLLA coating with a thickness of between 20 micron and 25 microns as a bottom layer in contact with the stent strut and mixed coating of PLGA and heparin according to a ratio of 1 to 1 as a top layer coated on the bottom layer, wherein the PLLA coating as a weight average molecular weight of 100,000 and the PLGA has a weight average of 30,000.
The ’800 publication teaches an intravascular stent for inhibiting restenosis. The stent has a drug releasing coating containing polylactide polymer on the substrate (abstract). The stent body with a drug containing polymer coating is taught. A polymer or polymer-drug solution onto the filaments of a stent body, to achieve one of a variety of stent-coating features, including uniform coating thickness on one or more sides of the stent body filaments, greater coating thickness on the outer (or inner) surfaces of the stent body than the other side, inner and outer coatings containing different drugs and/or coating thickness gradients are discrete coating patches on the stent body [0028]. The device is taught to have different drug components on the outer and inner sides of the filament such as the outer filament surface could contains anti-restenosis compound and the inner coating a secondary agent [0078]. Coating on the outer surface of each stent is taught [0159].
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use a combination of corrosion preventing polymeric layer and a drug containing layer as the Qi teaches the iron absorbable implant may be coated with a polymer and a drug polymer layer on the iron implantable device and the ‘178 publication specifically teaches the use of a both a polymeric layer and a drug containing layer on an iron based device wherein a drug coating layer is an outermost layer. It would have been obvious to one of ordinary skill in the art to use a combination of a polymeric layer and a drug containing polymeric layer on the device of Qi as Qi teaches embodiments containing a polymeric layer and a drug containing polymer layer and the ‘178 publication specifically teaches the combination of a polymeric layer and a drug containing layer on the iron-based implant. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as Qi and the ‘178 publication are both directed to iron based implants which are coated with polylactide polymers and drug containing polymeric layers. “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use the drug coating on the outer and side wall only as the ‘800 publication teaches antirestenoic agents such as everolimus to be applied to the outer layer only, wherein coating on one or more sides is taught. Thus it would be obvious to one of ordinary skill in the art before the filing date of the claimed invention that the polymer/drug containing layer may be applied to the outer surface and one or more sides to obtain the desired drug release as methods of coating outer and sides is known and taught as desired to obtain the drug release desired by the ‘800 publication and Qi is directed to limus drugs.
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use the bottom and top molecular weights taught by the ‘287 publication for the polymer layer and drug/polymer layer taught by the combination of Qi and the ‘178 publication because the combination of references teaches two layers of polylactide coatings and the ‘287 publication teaches specific known molecular weights of a top drug containing layer and a bottom layer containing specific polylactide polymers and the ‘178 publication teaches a polylactide layer bottom layer and a top layer of polylactide drug containing layer. It would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to optimize the molecular weights of the top and bottom polymeric coating layers as the ‘178 publication teaches degradation of the polymer can be adjusted by adjusting parameters such as thickness and molecular weight, thus leading to optimizable parameter [0024]. As MPEP 2144.05 recites “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine optimization”.
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use a thicker outer layer of the coatings than the inner layer of the coating layers taught by the combination of Qi and the ‘178 publication because the ‘800 publication teaches that it was known to provide thicker coatings on the outer layer than the inner layer of a stent. One of ordinary skill in the art before the filing date of claimed invention would have a reasonable expectation of success as the ‘800 publication teaches that it was known to use thicker coatings on the outer layer than the inner layer of stents for polymeric and drug containing coatings and Qi is directed to a polymeric and drug coated stent. It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to optimize the thickness of the top and bottom polymeric coating layers as the ‘178 publication teaches degradation of the polymer can be adjusted by adjusting parameters such as thickness and molecular weight, thus leading to optimizable parameter [0024]. As MPEP 2144.05 recites “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine optimization”.
Claim(s) 8, 11-15 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over CN106806938 (Qi), US 2018/0264178, US 2016/0263287 and US 2003/0125800 as applied to claims 1-7, 10, 16-18 and 20-21 above, and further in view of CN 104587535 (previously applied).
As mentioned in the above 103(a) rejection, all of the limitations of claims 1-7, 10, 16-18 and 20-21 are taught by the combination of Qi, the ‘178 publication, the ‘287 publication and the ‘800 publication.
Regarding claims 11-12 and 15, the limitation of an absorbable iron based instrument comprising anion based matrix, a zinc containing protective layer, a corrosion promoting layer and a drug-controlled release layer, wherein the iron based matrix is provided with an outer wall, an inner wall and a side wall; the zinc containing protective layer covers at least he outer wall and the inner wall of the iron-based matrix; the corrosion promoting layer fully covers the zinc containing protective layer, the corrosion promoting layer and the drug controlled release layer each contain degradable polymer, the thickness ratio of a portion of the zinc containing protection layer that is located the inner wall to a portion of the corrosion promoting layer that is located at the inner wall is greater than the thickness promoting layer on the outer wall is met by the Qi publication teaching an absorbable iron-based alloy medical device implant comprising an iron based alloy substrate, a degradable polymer provided on the surface of an or based alloy, a zinc containing protective membrane provided on the surface of the iron based alloy substrate (abstract, Figure 1). The degradable polymer layer is any one including poly(lactic acid-glycolic acid) [0026]. The degradable polymer coating layer may further include an active drug and may release therapeutic drugs during degradation. The device is taught to be a vascular stent [0027]. Zinc layer is taught to be 4um, the spraying of polylactic acid is 200,000 and 12 um [0037] or 6um [0039]. Wherein the polymer layer contains polylactic acid and sirolimus is taught to have a MW of 200,000 and a thickness of 5um [0041]. Regarding the limitation of wherein the zinc containing protective layer covers the outer wall the inner wall and the side all of the iron-based matrix; the corrosion promoting layer covers the entire surface of the zinc containing protective layer and the drug controlled release layer covers at least a portion of the corrosion promoting layer that is located on the outer wall is met by Qi teaching embodiments wherein the zinc coating layer has a thickness of 3um [0041] wherein the zinc containing surface coats the entire surface of the ion based alloy [0008]. Qi teaches the polylactic acid coating layer has a thickness of 8 microns [0038] wherein the entire surface of the device is coated [0028]. Qi teaching a coating layer of polylactic acid and sirolimus is coating layer having a thickness of 5 microns [0041]. The ‘178 publication teaches Figure 2 teaches the outer most layer of the iron absorbable medical implant is a drug loading layer which completely covers the surface of the corrosion inhibition layer 12, which covers a degradable polymer coating 16 on the surface of an iron base alloy ([0021]-[0022]). The ‘287 publication teaches bioresorbable iron-based alloy stent (title) and a degradable polyester in contact with the surface of the substrate, in which the degradable polyester has a weight average molecular weight of between 20,000 and 1,000,000 (abstract). The degradable polyester comprises PLA, PGA and PLGA [0004]. The pure iron stent strut with a thickness of between 240 micron and 260 microns. The coating comprises two layers, i.e., a PLLA coating with a thickness of between 20 micron and 25 microns as a bottom layer in contact with the stent strut and mixed coating of PLGA and heparin according to a ratio of 1 to 1 as a top layer coated on the bottom layer, wherein the PLLA coating as a weight average molecular weight of 100,000 and the PLGA has a weight average of 30,000. The ’800 publication teaches an intravascular stent for inhibiting restenosis. The stent has a drug releasing coating containing polylactide polymer on the substrate (abstract). The stent body with a drug containing polymer coating is taught. A polymer or polymer-drug solution onto the filaments of a stent body, to achieve one of a variety of stent-coating features, including uniform coating thickness on one or more sides of the stent body filaments, greater coating thickness on the outer (or inner) surfaces of the stent body than the other side, inner and outer coatings containing different drugs and/or coating thickness gradients are discrete coating patches on the stent body [0028].
Regarding claim 13, the limitation wherein the thickness portion of the zinc containing protective layer on the inner and outer wall is 0.5 to 2.0 microns is met by the Qi teaching embodiments wherein the zinc coating layer has a thickness of 3um [0041] wherein the zinc containing surface coats the entire surface of the iron based alloy [0008].
Regarding claim 14, the limitation of wherein the portion of the corrosion-promoting layer that is located at the outer wall has a thickness range from 4 to 15 microns, and the portion of the corrosion promoting layer that is located at the inner wall has a thickness range from 3 to 10 microns is met by the Qi teaches the polylactic acid coating layer has a thickness of 8 microns [0038] wherein the entire surface of the device is coated [0028]. The limitation of wherein the thickness of the drug controlled-release layer is less than or equal to 5 microns is met by Qi teaching a coating layer of polylactic acid and sirolimus is coating layer having a thickness of 5 microns [0041].
The combination of references does not specifically teach the grain sizes of the pure zinc and the zinc alloy are both submicron (claims 8, 11 and 19).
The ‘535 publication teaches drug eluting stent comprising biodegradable polymer coated drug-loaded magnesium alloy eluting stent [0002]. The magnesium alloy stent is taught as zinc coating on the surface of the magnesium alloy bare stent [0008]. The zinc coating has a thickness of 0.05-30 um and is mainly composed of nano zinc [0018]. Spaying nano zinc and/or zinc oxide particles on the bare metal stent are taught [0019].
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use nano sized zinc on the stent taught by Qi because the ‘535 publication teaches nanosized zinc being used to form a coating on a stent surface. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as the coating taught by Qi is taught to include zinc oxide and the ‘535 publication teaches the interchangeability of zinc and zinc oxide particles as a stent coating. One of ordinary skill in the art before the filing date of the claimed invention would have an expectation of success in using the nano sized zinc coating taught by the ‘535 publication on the surface of the stent of Qi because Qi teaches zinc spray coating on a stent and the ‘535 publication is directed to a zinc coating applied to a stent by spraying.
Response to Arguments:
Applicant’s arguments have been fully considered and are not deemed to be persuasive.
Applicant argues claim 1 has been amended to the zinc containing protective layer to be on all walls and the drug controlled-release layer only covers the corrosion promoting layer lang the outer and side walls. Qi the drug containing layer covers all walls. The distinction is more important because of the criticality factors, different technical objectives.
In response, Applicant is referred to the modified rejection above. The ’800 publication teaches an intravascular stent for inhibiting restenosis. The stent has a drug releasing coating containing polylactide polymer on the substrate (abstract). The stent body with a drug containing polymer coating is taught. A polymer or polymer-drug solution onto the filaments of a stent body, to achieve one of a variety of stent-coating features, including uniform coating thickness on one or more sides of the stent body filaments, greater coating thickness on the outer (or inner) surfaces of the stent body than the other side, inner and outer coatings containing different drugs and/or coating thickness gradients are discrete coating patches on the stent body [0028]. The device is taught to have different drug components on the outer and inner sides of the filament such as the outer filament surface could contains anti-restenosis compound and the inner coating a secondary agent [0078]. Coating on the outer surface of each stent is taught [0159]. It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use the drug coating on the outer and side wall only as the ‘800 publication teaches antirestenoic agents such as everolimus to be applied to the outer layer only, wherein coating on one or more sides is taught. Thus it would be obvious to one of ordinary skill in the art before the filing date of the claimed invention that the polymer/drug containing layer may be applied to the outer surface and one or more sides to obtain the desired drug release as methods of coating outer and sides is known and taught as desired to obtain the drug release desired by the ‘800 publication and Qi is directed to limus drugs.
Applicant argues newly added claims 11-16 are directed to submicron grain sized pure zinc. Nanozinc and submicron grain-sized pure zinc or zinc alloy are completely different types and different ranges of grain sizes. Submicron is a unit of length, whereas nanozinc is a material with a grain size below 100 nanometers. In contrast submicron level refers to the range of 100 nm -1000 nm, meaning the grain size in the claimed invention clearly different form tat of nanomaterials.
In response, the instant specification does not provide a definition for submicron, therefore submicron is interpreted as below micron level. Thus the teaching of nanozinc would meet the instant claim limitation for submicron zinc. The ‘535 publication teaches the zinc coating has a thickness of 0.05-30 um and is mainly composed of nano zinc [0018]. Spaying nano zinc and/or zinc oxide particles on the bare metal stent are taught [0019].
Applicant argues nanozinc is significantly better than that of non-nanozinc materials, meaning the corrosion resistance of the nanozinc or zinc allow with submicron grain size. Thus the corrosion resistance of nanozinc is significantly better than that of non-nano material, meaning a person of ordinary skill in the rat would expect that the corrosion resistance of the nanozinc mention in the ‘535 publication would be singingly better than that of submicron grain claimed. The instant specification states only when degradation rate of the corrosion promoting layer matched the corrosion rate of the zinc containing protective layer, the zinc containing protective layer can be protected in early stage thus avoiding fast corrosion. Thus the present invention requires controlling the corrosion rate of zinc to avoid fast corrosion of zinc protective layer. The present invention counter intuitively selects traditional zinc material with submicron grain size to avoid excessive corrosion and reduces zinc ion concentration by matching the carrion rate of the zinc containing layer. Thus the ‘535 publication teaches away from the desired objective of the present invention and achieves unexpected results.
In response, the instant claims are directed to submicron grain size, wherein the instant specification does not define submicron. The broadest reasonable interpretation therefore is grain size that are below a micron size reading on nanomaterials, as discussed above. It is believed Applicant is arguing unexpected results regarding submicron particle size vs nano particle size, which is not commensurate in scope with the instant claims, wherein submicron is not defined. Further Applicant has presented not factual data, wherein factual data is required.
Applicant argues neither Qi nor the ‘178 disclose specific feature of differentiating the thickness of the inner and outer layers of the substrate in the manner claimed. Qi does not recognize the relationship between these thickness ratios as an effective variable nor provide any motivation to pursue optimum ranges for this variable. Similarly, the ‘178 publication does not provide any teaching that would lead POSITA to adjust the thickness ration of layers on the inner and outer walls in the way Applicant has claimed. Applicant argues without necessary motivation to pursue optimal or workable ranges for this thickness variable there is no reasonable expectation of success in formulating the claimed thickness ratio. Applicant argues Qi teaches the amount of zinc-containing protective layer can be determined based on the type and properties of the polymer but does not separately address the coating on the inner and outer walls.
In response, the ’800 publication teaches an intravascular stent for inhibiting restenosis. The stent has a drug releasing coating containing polylactide polymer on the substrate (abstract). The stent body with a drug containing polymer coating is taught. A polymer or polymer-drug solution onto the filaments of a stent body, to achieve one of a variety of stent-coating features, including uniform coating thickness on one or more sides of the stent body filaments, greater coating thickness on the outer (or inner) surfaces of the stent body than the other side, inner and outer coatings containing different drugs and/or coating thickness gradients are discrete coating patches on the stent body [0028]. It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use a thicker outer layer of the coatings than the inner layer of the coating layers taught by the combination of Qi and the ‘178 publication because the ‘800 publication teaches that it was known to provide thicker coatings on the outer layer than the inner layer of a stent. One of ordinary skill in the art before the filing date of claimed invention would have a reasonable expectation of success as the ‘800 publication teaches that it was known to use thicker coatings on the outer layer than the inner layer of stents for polymeric and drug containing coatings and Qi is directed to a polymeric and drug coated stent. It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to optimize the thickness of the top and bottom polymeric coating layers as the ‘178 publication teaches degradation of the polymer can be adjusted by adjusting parameters such as thickness and molecular weight, thus leading to optimizable parameter [0024]. As MPEP 2144.05 recites “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine optimization”.
Applicant argues the specific thickness ratio configuration of the zinc containing protective layer and the corrosion promoting layer on the inner and outer walls is critical to achieving unexpected results. Applicant pointes to Examples 1-13 and comparative examples. The claimed invention successively achieves endothelization, controlled zinc release, long term corrosion resistance and absence of thrombosis. These results show criticality.
In response, the burden is on Applicant to establish that the results are in fact unexpected, unobvious an of statistical and practical significance. MPEP 716.02(b). Applicant has pointed to Examples in the instant specification without providing a nexus between the instant claims and the unexpected results, the resulting drug release and mass loss differing as a result of coating thickness is not considered unexpected as the ‘178 publication teaches degradation of the polymer can be adjusted by adjusting parameters such as thickness and molecular weight, thus leading to optimizable parameter [0024], the ‘800 publication teaches that it was known to use thicker coatings on the outer layer than the inner layer of stents for polymeric and drug containing coatings and Qi is directed to a polymeric and drug coated stent. Thus changes in drug release and mass loss using differing amounts of coating layers on the device is not considered unexpected and Applicant has not demonstrated criticality of the claimed range. Additionally, the examples presented in the instant specification are not commensurate in scope with the instant claims as the independent claims 1 and 11 do not contain limitations directed to the thickness of the layer or ratios between the layers. Instant claim 16 contains ranges to the thickness ratio of the zinc containing protective layer that is on the inner wall to the portion or corrosion promoting layer that is located on the inner wall and the thickness ratio of the portion of the zinc containing protect layer that is on the outer wall to the portion of the corrosion promoting layer that is located on the outer wall, wherein the ranges are broad and not tied to a specific coating thickness.
Conclusion
No claims are allowed.
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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/LYNDSEY M BECKHARDT/Examiner, Art Unit 1613
/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613