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 .
Status of Claims
Claims 1-14 are pending and examined below.
Claim Objections
Regarding claim 3, the claim reads “wherein the poly-L-lactide layer is a micro-arc oxidized”. Examiner believes this should read ““wherein the poly-L-lactide layer is micro-arc oxidized”
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 2 rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Regarding claim 2, the claim recites “wherein the Zotarolimus and Rosuvastatin are dispersed in the poly-L-lactide layer”. Claim 2 depends from claim 1 which already requires Zotarolimus and Rosuvastatin integrated into the poly-L-lactide layer. “Integrated into” and “dispersed in” have the same interpretation therefore claim 2 fails to further limit claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
(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.
Claim(s) 1-3, 5, 7-10, 12-14 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US 2020/0139017 (Meyer-Kobbe)
Regarding claim 1, Meyer-Kobbe discloses a drug-eluting stent for insertion in a blood vessel (Fig. 4, ¶0005), comprising:
a) a tubular mesh structure (Fig. 4, ¶0098, wherein a mesh cut from a solid tube corresponds to a tubular mesh structure) composed of a magnesium alloy (¶0186, “magnesium alloys”)
b) a poly-L-lactide disposed over the tubular mesh structure (¶0193, “organic coating of PLLA”); and
c) Zotarolimus (¶0182, “zotarolimus”) and Rosuvastatin (¶0182 “rosuvastatin”) or pharmaceutically derivatives thereof integrated into the poly-L-lactide layer (¶0193, wherein “present therein” corresponds to integrated into) to provide controlled and sustained drug release (¶0180, wherein “drug release system” corresponds to controlled and sustained drug release),
wherein the drug-eluting stent is configured to be deployed in the blood vessel to provide drug delivery to a target site (¶0002, wherein the stent is configured for this intended use because it configured to be implanted in a vessel and comprises a drug release system)
Regarding claim 2, Meyer-Kobbe further discloses wherein the Zotarolimus and Rosuvastatin (¶0182, “Zotarolimus” and “rosuvastatin”) are dispersed in the poly-L-lactide layer (¶0193, wherein “present therein” corresponds to “dispersed into”)
Regarding claim 3, as best understood, the claimed phrase “is micro-arc oxidized” is being treated as a product by process limitation; that is, that the product (poly-L-lactide layer) is formed by the process (micro-arc oxidation). As set forth in MPEP 2113, product-by-process claims are NOT limited to the manipulations of the recited steps, only to the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 U.S.C. 103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. See MPEP 2113.
Thus, even though Meyer-Kobbe is silent as to the process used to create the poly-L-lactide layers, it appears that the product would be the same or similar as that claimed; especially since both applicant’s product and the prior art product can both be made of poly-L-lactide
Regarding claim 5, Meyer-Kobbe further discloses wherein the tubular mesh structure is a metallic (¶0002, “metallic”), expandable (¶0009, “expanded”), porous scaffold (see Fig. 4, wherein the stent has pores)
Regarding claim 7, Meyer-Kobbe further discloses wherein the magnesium alloy includes magnesium (¶0160, “magnesium”), yttrium (¶0160, “yttrium”), and rare earth elements (¶0160, wherein “neodymium, zirconium, and gadolinium” correspond to rare earth elements)
Regarding claim 8, Meyer-Kobbe further discloses wherein the rare earth elements include neodymium, zirconium, and gadolinium (¶0160, “neodymium, zirconium, and gadolinium”)
Regarding claim 9, Meyer-Kobbe further discloses wherein the magnesium alloy includes magnesium in an amount from about 93 to 94 weight percent magnesium (¶0161, wherein 92.0% to 93.0% corresponds to about 93 to 94%) and yttrium in an amount of about 4 to 5 weight percent of the total weight of the magnesium alloy (¶0161, wherein “3.9% - 4.3% yttrium” overlaps the claimed range of 4% to 5%).
Regarding claim 10, Meyer-Kobbe further discloses wherein the magnesium alloy includes the rare earth elements in an amount from about 2 to 3 weight percent of the total weight of the magnesium alloy (¶0160, see proof below wherein the prior art range, 2.6% to 3% overlaps the claimed range, 2% - 3%)
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Regarding claim 12, Meyer-Kobbe further wherein the magnesium alloy further includes manganese (¶0058, “manganese”) to assist in dispersing the Zotarolimus and Rosuvastatin (¶0082, wherein the manganese is configured for this intended use because it is bio-degradable)
Regarding claim 13, Meyer-Kobbe discloses wherein the tubular mesh structure has a diameter from about 2.25 mm to 4.0 mm (¶0333, wherein “diameter of 3.0mm” falls within the claimed range) and a length from about 8 mm to 40 mm (¶0333, wherein “length of 14mm” falls within the claimed range)
Regarding claim 14, Meyer-Kobbe further discloses wherein the loading of the Zotarolimus and Rosuvastatin (¶0182, “zotarolimus” and “rosuvastatin”) on the stent are each independently from about 50 µg/mm2 to 200 µg/mm2 (¶0182, end of page 18, wherein the concentration per active agent is preferably in the range of 0.001 – 500 mg per cm^2 which overlaps the claimed range as shown below)
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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(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0139017 (Meyer-Kobbe) in view of US 2018/0272043 (Taylor)
Regarding claim 4, Meyer-Kobbe discloses a tubular mesh structure (see rejection of claim 1) with struts (¶0098. “struts”) but doesn't explicitly teach or disclose struts having a thickness from about 50 micrometers to 150 micrometers.
Taylor discloses a stent with a strut thickness from about 50 micrometers to 150 micrometers (¶0170, wherein “average strut thickness is at most 140 microns” overlaps the claimed range of about 50 micrometers to 150 micrometers”
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the strut thickness of Meyer-Kobbe to be about 50 micrometers to 150 micrometers, as taught by Taylor, to over to provide proper mechanical properties to provide patency to the blood vessel.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0139017 (Meyer-Kobbe) in view of US 2010/0076544 (Hoffmann)
Regarding claim 6, Meyer-Kobbe discloses a metallic, expandable, porous scaffold (see rejection of claim 5) but doesn't explicitly teach or disclose that it includes chromium.
Hoffman discloses wherein the metallic, expandable, porous scaffold includes chromium (¶0081, wherein the stent may further contain chromium)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the metallic, expandable, porous scaffold of Meyer-Kobbe with chromium, as taught by Meyer-Kobbe, in order to improve the mechanical properties and flexibility of the stent.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0139017 (Meyer-Kobbe) in view of US 2009/0081313 (Aghion)
Regarding claim 11, Meyer-Kobbe disclose wherein the magnesium alloy includes magnesium, yttrium, and rare earth elements (see rejection of claim 7) but doesn't explicitly teach or disclose wherein the magnesium alloy further includes calcium to increase plasticity and strength.
Aghion discloses an implantable medical device (¶0001-0002) to increase plasticity and strength (¶0201, wherein the alloy comprises calcium)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the magnesium alloy of Meyer-Kobe to include calcium, as taught by Weber, in order to improve strength and flexibility (¶0015)
Conclusion
Included below is relevant prior art that was considered but not relied upon for this office action:
US 2015/0050325 – discloses a drug eluting stent with a magnesium alloy frame and a PLLA carrier
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/MAXIMILIAN TOBIAS SPENCER/Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774