DETAILED ACTION
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 8/14/2025 has been entered.
Response to Arguments
Applicant's arguments filed 8/14/2025 have been fully considered but they are moot in view of the new grounds of rejection.
Information Disclosure Statement
The information disclosure statement filed 8/14/2025 fails to comply with 37 CFR 1.98(a)(3)(i) because it does not include a concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of each reference listed that is not in the English language. It has been placed in the application file, but the information referred to therein has not been considered.
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 18-27 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 18, line 10 recites “an outermost layer of the drug coating” but line 4 recites “the drug coating is a single layer”. It is unclear how there could be “an outermost layer” of a single layer.
Claim 18 recites the limitation "the drug coating layer" in line 12. There is insufficient antecedent basis for this limitation in the claim.
Claim 24 recites the limitation "the portion of the drug coating on the inner wall" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
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.
Claims 18, 19, 22, and 24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kaplan et al. US 2007/0281117 (hereafter referred to as Kaplan).
Regarding claim 18, Kaplan discloses a drug eluting device, comprising a substrate 402 and a drug coating 406 arranged on the substrate (fig.4), the substrate having an outer wall 410, side walls 412, and an inner wall 414, wherein the drug coating is a single layer that contains active drug 408 and a drug carrier (par.59 discloses polymer matrix 406 comprises drug 408 dispersed therein), the active drug is dispersed in the drug carrier (fig.4; par.59), the drug coating covers the outer wall, the side walls, and the inner wall of the substrate (fig.4), both of the content of the active drug on the outer wall and the content of the active drug on the side walls are greater than the content of the active drug on the inner wall and the content of the active drug on the inner wall is greater than 0 (fig.4 shows more drug coating, and therefore more drug content, on the outer and side walls than the inner wall), and wherein an outermost layer/the single layer of the drug coating completely and continuously covers the outer wall, the side walls, and the inner wall of the substrate, preventing separation of the drug coating layer from the substrate (fig.4 shows the drug coating completely and continuously covering all walls).
Regarding claim 19, see par.22 and claim 30 for the polymeric matrix being sufficiently porous.
Regarding claim 22, see par.51 for degradable polyester and degradable polyanhydride.
Regarding claim 24, see par.59 and fig.4 for the portion of the coating on the outer wall and side walls being thicker than the portion of the coating on the inner wall.
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.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Kaplan. Kaplan discloses the drug eluting device of claim 18 as discussed above. Kaplan further discloses the drug coating has a thickness in a range of about 0.2 microns to about 5 microns (par.10) but does not disclose the specific claimed range of 2-20 microns. However, MPEP 2144.05I states 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”. Also, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art (In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), MPEP 2144.05 II A). Therefore, because Kaplan discloses an overlapping thickness range and a range teaching the general conditions of the claimed range, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the thickness range of Kaplan to be in a range of 2 microns to 20 microns.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Kaplan as applied to claim 19 above, and further in view of Flanagan et al. US 2012/0316633 (hereafter referred to as Flanagan). Kaplan discloses the drug eluting device according to claim 19, but Kaplan does not disclose that the pore structure has a porosity in a range of 5% to 60%.
Flanagan teaches a drug eluting stent, in the same field of endeavor, wherein a coating, which can be between 5-90% biodegradable polymer (par.55), has a pore structure and the pore structure has a porosity in a range of 5-60% (par.36 discloses about 10%, 20%, 30%, 40%, 50%, or 60%) for the purpose of allowing the coating to compress and stretch without allowing stresses to build up on the coating, which would otherwise cause formation of macrocracks, thereby maintaining the integrity of the porous coating (par.35).
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 drug coating of Kaplan, including the drug coating on the inner wall, to have a pore structure with a porosity in a range of 5-60% as taught by Flanagan in order to allow the coating to compress and stretch to prevent macrocracks in the coating which results in maintaining the integrity and adherence of the coating.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Kaplan as applied to claim 18 above, and further in view of Kim et al. US 2014/0024992 (hereafter referred to as Kim). Kaplan discloses the drug eluting device according to claim 18, but Kaplan does not disclose a drug content of 0.5 µg/mm2 to 6 µg/mm2.
Kim teaches a drug eluting stent, in the same field of endeavor, wherein the drug content is 0.1-3 µg/mm2 (par.28).
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 drug content in the coating of the stent of Kaplan, if necessary, to be in a range of 0.5-6 µg/mm2 since Kim teaches a range that overlaps with the claimed range is suitable for vessel treatment. 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 21445.05I). Further, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art (In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), MPEP 2144.05 II A).
Claims 25-27 are rejected under 35 U.S.C. 103 as being unpatentable over Kaplan as applied to claim 18 above, and further in view of Qi et al. WO 2017/117923A1 (hereafter referred to as Qi; the WIPO version was published 7/13/2017 and therefore qualifies as prior art under 35 U.S.C. 102(a)(1); the examiner references the US version 11,020,514 below as a translation of the WIPO publication). Kaplan discloses the drug eluting device of claim 18 as discussed above. Kaplan discloses the substrate can be metal, metal alloy, or a bioerodible material (par.36), but Kaplan does not disclose that the substrate comprises pure iron or iron alloy and a zinc-containing protective layer arranged on the substrate, the zinc-containing protective layer covers at least the inner wall of the substrate, and the zinc-containing protective layer is covered by the drug coating, wherein the coverage of the zinc-containing protective layer on the substrate is in a range of 20%-100%.
Qi teaches a drug eluting stent, in the same field of endeavor, wherein the stent comprises an iron substrate 11, a zinc-containing protective layer 12, the zinc-containing protective layer is arranged on the substrate, the zinc-containing protective layer covers at least the inner wall of the substrate (fig.1), and the zinc-containing protective layer is covered by a drug coating 13, wherein the coverage of the zinc-containing protective layer on the substrate is in a range of 20%-100% (col.3, lines 44-45 teaches the zinc-containing protector “completely covers the entire surface of an iron-based alloy substrate”) for the purpose of controllably slowing down corrosion of the iron-based alloy substrate thereby ensuring the device has structural integrity and a sufficient mechanical property in the early stage (col.4, lines 11-27).
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 stent of Kaplan by selecting iron for the substrate and a zinc-containing protective layer that completely covers the iron substrate and is located between the iron substrate and polymer drug coating as taught by Qi in order to allow for controlled degradation of the stent while ensuring the device has sufficient structural integrity. It would have been further obvious to select the materials taught by Qi since it has been held that selection of a known material based on its suitability for an intended use is an obvious extension of prior art teaching (In re Leshin 227 F.2d 197, 125 USPQ 416 (CCPA 1960) MPEP 2144.07).
Conclusion
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/MEGAN Y WOLF/Primary Examiner, Art Unit 3774