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 .
Election/Restrictions
Applicant’s election without traverse of Species A (Figs. 4-6) in the reply filed on 12/8/2025 is acknowledged.
Claims 4-8 and 10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Species B-E, there being no allowable generic or linking claim.
Claims 11-20 have been canceled in the response to the Restriction Requirement. Claims 21-30 are new and are directed to the elected species.
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.
Claims 1, 27-30 are rejected under 35 U.S.C. 103 as being unpatentable over Rudakov et al. (US 2007/0255388).
Re Claim 1, Rudakov discloses a stent (stent 202, see Fig. 12), comprising:
an elongated tubular body having a scaffolding forming a plurality of cells; and
a coating (membrane 203) disposed over an outer surface of the elongated tubular body, the coating comprising:
a first layer (first layer 206, [0146]); and
a macro-porous layer (second layer 207, [0150] “the second layer … with pore sizes ranging from about 70-100 µm” and in [0159] discloses “in a microporous membrane … pores 25, may range in size from about 10 to 100 µm”) disposed over the micro-porous layer (Fig. 12).
Rudakov does not expressly disclose that the first layer is “micro-porous” but discloses that the first layer may have pores in a range that is smaller than that of the second layer (see [0149]). In a different part of the disclosure, Rudakov discloses that the coating/membrane surrounding the stent may be made microporous, or 1-10µm ([0159]). It would have been obvious to one skilled in the art at the time of filing to modify the first layer to be microporous, i.e., having pores in the 1-10 µm range, as this can optimize porosity based on the deployed stent’s uses (see e.g., [0160]-[0161]).
Re Claim 27, Rudakov discloses claim 1 and further discloses wherein the first micro-porous layer has interconnected pores in a range of about 0.05 micrometers to about 2 micrometers ([0159]).
Re Claim 28, Rudakov discloses claim 27 and further discloses wherein the macro-porous layer has a thickness in a range of at least 1 micron to at least one millimeter ([0150] “second layer has a thickness of about 25-50 µm”).
Re Claim 29, Rudakov discloses claim 1 and further disclosing wherein the first micro-porous layer has a thickness in a range of about 10 micrometers to about 80 micrometers ([0149] “first layer has a thickness of about 50-125 µm”).
Re Claim 30, Rudakov discloses claim 29 and further discloses that wherein the first micro-porous layer has interconnected pores in a range of about 0.05 micrometers to about 2 micrometers ([0149]), and the macro-porous layer has a thickness in a range of at least 1 micron to at least one millimeter ([0150]).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Rudakov in view of Chen (CN 110946675).
Re Claim 2, Rudakov discloses claim 1 but does not disclose wherein the macro-porous layer includes a columnar structure. Chen discloses a stent used for treating an aneurysm, thus in the same field as Rudakov, wherein the stent is covered in fluff that are filaments extending radially outwardly from an outer surface of the stent (see Figs. 1 & 4). It would have been obvious to one skilled in the art at the time of filing to modify Rudakov by changing the microporous layer to a layer of fluff because this improves the fit between the stent and the aneurysm to prevent leakage (Chen discloses “The purpose of the invention is to provide a controllable floss bracket, increases the fitness between the bracket and tumour neck, preventing the occurrence of leakage.”)
Allowable Subject Matter
Claims 3, 9, & 21-26 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Re Claim 3, everything in Rudakov suggests that the membranes are film-like structures and therefore would not be possible to be columnar or have loops.
Claims 9 & 21-26 are allowable at least for being dependent on Claim 3.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Three NPL references disclose known coatings for stents.
Anneaux et al. (US 2011/0030885) discloses a stent covered in a fibrous matrix of ePTFE.
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/SUSAN S SU/ Primary Examiner, Art Unit 3781
10 January 2026