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 .
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.
Claim(s) 1-6, 10-11, 15-16 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sabaria (US Pub No.: 2009/0133817) in view of Ryan (US Pub No.: 2021/0154372).
Regarding claim 1 , Sabaria (US Pub No.: 2009/0133817) discloses a device with a stent structure (polymer stent in the abstract) which is intended for insertion into blood vessels of the human or animal body (Disease treatment in [0002]-[0003]), wherein the stent structure assumes an expanded state in which it is in contact with the inner wall of the blood vessel (contact with a lumen wall in [0036], expansion of a stent in a lumen wall in [0054]) and has a diameter-reduced state in which it is movable through the blood vessel within a microcatheter (stent on a catheter when inserted in [0054]. As the stent expands in [0054], the stent is in a diameter-reduced state on the stent before expansion occurs), wherein the stent structure, preferably at its proximal end, is connected to an insertion aid (being the guidewire that aids the advancement of a catheter in [0056]. As a catheter is advanced via the guide wire, a guidewire will be placed at a proximal end to advance said catheter), and wherein the device is deployable for the treatment of a vasospasm (in [0003]) wherein :the stent structure [[(2)]] is designed so as to be detachable from the insertion aid (as the stent is placed in the body in [0054], a detachment from an insertion aid and catheter is required), wherein at least portions of the stent structure are provided with a coating and said coating comprises a functional layer (coatings in [0040], drugs for coating in [0032]).
However, Sabaria does not teach that said functional layer comprising at least one sugar alcohol and/or being formed by an oligo- or polymerization of monosaccharides functionalized with polymerizable groups.
Instead, Ryan (US Pub No.: 2021/0154372) teaches that said functional layer (being the coating in [0022] that comprises a therapeutic agent and a surfactant) comprising at least one sugar alcohol (sugar alcohols as a surfactant in [0041]) and/or being formed by an oligo- or polymerization of monosaccharides functionalized with polymerizable groups (being glucose disclosed in [0211]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the coating with a surfactant as presented in Ryan into Sabaria as surfactant coatings are known in the art as being used to minimize an inflammatory response for an implanted device, with the surfactants of Ryan disclosed as preventing a loss of a coated drug on a stent as per [0134].
Regarding claim 2, Sabaria in view of Ryan teach a device according to Claim 1, wherein Sabaria discloses that the stent structure is composed of interconnected struts (strut pattern in [0036]-[0037] or wires forming a mesh structure (forming of a knitted mesh in [0037]. The structure in figures 1-2 of Sabaria also shows a mesh structure).
Regarding claim 3, Sabaria in view of Ryan teach a device according to Claim 1, wherein Sabaria discloses the stent structure is self- expanding and autonomously changes to the expanded state after release from the microcatheter (self-expanding stent in [0037], delivery via catheter in [0054] and [0056], where it stands to reason that the catheter is removed after delivery of the stent).
Regarding claim 10, Sabaria in view of Ryan teach a device according to Claim 1, wherein Sabaria discloses the monosaccharide of the functional layer is functionalized in a form not bonded to the device via at least one reactive multiple bond (as Sabaria teaches polytrimethylenecarbonate in [0031], Sabaria teaches a monosaccharide where the functionalized in a form not bonded to the device via at least one reactive multiple bond).
Regarding claim 11, Sabaria in view of Ryan teach a device according to Claim 10, wherein Sabaria discloses the reactive double bond is a constituent of a (meth)acrylic group (polytrimethylenecarbonate in [0031] of Sabaria).
Regarding claim 15, Sabaria in view of Ryan teach a method for the treatment of a vasospasm (in [0003] of Sabaria), wherein Sabaria discloses that the stent structure of a device according to Claim 1 is brought to the position of the vasospasm with the aid of the insertion aid and expanded, and a detachment of the stent structure is carried out (as the stent is placed in the body in [0054] for a treatment, a detachment from an insertion aid and catheter is required).
Regarding claim 16, Sabaria in view of Ryan teach a device according to claim 1, wherein Sabaria discloses the stent structure at its proximal end is connected to the insertion aid (being the guidewire that aids the advancement of a catheter in [0056]. As a catheter is advanced via the guide wire, a guidewire will be placed at a proximal end to advance said catheter).
Regarding claim 18, Sabaria in view of Ryan teach a device according to Claim 10, wherein the reactive multiple bond is a double bond (polytrimethylenecarbonate in [0031] of Sabaria has a double bond).
Claim(s) 4-9, 12 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sabaria (US Pub No.: 2009/0133817) in view of Ryan (US Pub No.: 2021/0154372) in further view of Liebig (US Pub No.: 2019/0110912).
Regarding claim 4, Sabaria in view of Ryan teach a device according to Claim 2. However, Sabaria in view of Ryan does not teach wherein the struts or wires in the event of an essentially rectangular cross section have a height and width of between 30 and 300 µm and in the event of a circular cross section have a diameter ranging between 30 and 300 µm.
Liebig (US Pub No.: 2019/0110912) teaches wherein the struts or wires in the event of an essentially rectangular cross section have a height and width of between 30 and 300 µm and in the event of a circular cross section have a diameter ranging between 30 and 300 µm (height and width details with a rectangular cross section in [0025]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the physical properties of Liebig into the device of Sabaria for the purpose of providing openings in the stent large enough to allow a blood flow through said openings (in [0025] of Liebig) while allowing the stent to provide a sufficient radial outward force (in [0025]) that holds the stent in place.
Regarding claim 5, Sabaria in view of Ryan teach a device according to claim 2. Sabaria in view of Ryan does not teach wherein no struts or wires are arranged at the proximal or distal end or both at the proximal and distal end in the center of the stent structure.
Instead, Liebig teaches wherein no struts or wires are arranged at the proximal or distal end or both at the proximal and distal end in the center of the stent structure (shown in figure 1a of Liebig where the rightmost end of the device has no struts). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the physical properties of Liebig into the device of Sabaria for the purpose of providing openings in the stent large enough to allow a blood flow through said openings (in [0025] of Liebig) unimpeded by struts or wires.
Regarding claim 6, Sabaria in view of Ryan teach a device according to Claim 1, wherein Sabaria teach a diameter of the stent structure of 2.00 mm (diameter of 0.5mm to 8mm in [0042] of Sabaria).
However, Sabaria in view of Ryan does not teach the force exerted radially outward by the expanded stent structure ranges between 2 and 30 N/m, preferably between 5 and 10 N/m
Instead, Liebig teaches wherein the force exerted radially outward by the expanded stent structure ranges between 2 and 30 N/m, preferably between 5 and 10 N/m (range of 2-16 N/M in [0029] of Liebig), based on a diameter of the stent structure of 2.00 mm (diameter of a stent from 0.1-6mm in [0022] of Liebig). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the physical properties of Liebig into the device of Sabaria for the purpose of providing an outward force not disclosed in Sabaria that causes the stent to radially expand (in [0029]), where said force is used in a treatment as per [0023].
Regarding claim 7, Sabaria in view of Ryan teach a device according to Claim 1, wherein the stent structure has a proximal, a middle and a distal portion (it stands to reason that the stent of Sabaria has a proximal, middle, and distal portion as per the structure of a stent known in the art).
However, Sabaria in view of Ryan does not teach wherein the proximal portion comprises the proximal end at which the stent structure is connected to the insertion aid, and wherein the expanded stent structure outside the proximal end exerts a substantially constant radial force along its entire length.
Instead, Liebig teaches wherein the proximal portion comprises the proximal end at which the stent structure is connected to the insertion aid (the stent of Liebig is connected at it’s proximal end to a delivery wire in [0007], wherein the delivery wire is an insertion aid), and wherein the expanded stent structure outside the proximal end exerts a substantially constant radial force along its entire length (constant radial force in [0033]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the physical properties of Liebig into the device of Sabaria for the purpose of providing a cross section for a stent that applies outward force not disclosed in Sabaria that causes the stent to radially expand (in [0029]), where said force is used in a treatment as per [0023].
Regarding claim 8, Sabaria in view of Ryan and Liebig teach a device according to Claim 7. However, Sabaria in view of Ryan does not teach wherein the struts or wires have a larger crosssection in the proximal and distal section than in the middle section (in figure 1b of Liebig, the cross section of the stent closer to proximal end part 3 is larger than the middle section closer to part 2).
Instead, Liebig teaches wherein the struts or wires have a larger crosssection in the proximal and distal section than in the middle section (in figure 1b of Liebig, the cross section of the stent closer to proximal end part 3 is larger than the middle section closer to part 2). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the physical properties of Liebig into the device of Sabaria for the purpose of providing a cross section for a stent that applies outward force not disclosed in Sabaria that causes the stent to radially expand (in [0029]), where said force is used in a treatment as per [0023].
Regarding claim 9, Sabaria in view of Ryan and Liebig teach a device according to Claim 7. However, Sabaria in view of Ryan does not teach wherein the density of the struts or wires is higher in the proximal and distal section than in the middle section (in [0035] of Liebig).
Instead, Liebig teaches wherein the density of the struts or wires is higher in the proximal and distal section than in the middle section (in [0035] of Liebig). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the physical properties of Liebig into the device of Sabaria for the purpose of providing a cross section for a stent that applies outward force not disclosed in Sabaria that causes the stent to radially expand (in [0029]), where said force is used in a treatment as per [0023].
Regarding claim 12, Sabaria in view of Ryan teach a device according to Claim 1. However, Sabaria in view of Ryan does not teach wherein the stent structure is provided with a gold coating under the functional layer.
Instead, Liebig teaches wherein the stent structure is provided with a gold coating under the functional layer (gold coating in [0038]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the physical properties of Liebig into the device of Sabaria for the purpose of providing a radiopaque material throughout the entirety of a stent structure to help visualize the deice in the body, as per [0038].
Regarding claim 17, Sabaria in view of Ryan and Liebig teach a device according to Claim 6. However, Sabaria in view of Ryan does not teach wherein the force exerted radially outward by the expanded stent structure ranges between 5 and 10 N/m, based on a diameter of the stent structure of 2.00 mm.
Instead, Liebig teaches wherein the force exerted radially outward by the expanded stent structure ranges between 5 and 10 N/m (range of 2-16 N/M in [0029] of Liebig), based on a diameter of the stent structure of 2.00 mm (diameter of a stent from 0.1-6mm in [0022] of Liebig). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the physical properties of Liebig into the device of Sabaria for the purpose of providing an outward force not disclosed in Sabaria that causes the stent to radially expand (in [0029]), where said force is used in a treatment as per [0023].
Claim(s) 13-14 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sabaria (US Pub No.: 2009/0133817) in view of Ryan (US Pub No.: 2021/0154372) in further view of Hodgkinson (US Pub No.: 2013/0060348).
Regarding claim 13, Sabaria in view of Ryan teach a device according to Claim 1. However, Sabaria in view of Ryan does not teach wherein the coating comprises a carrier layer located on the stent structure with an adhesion promoter, and the functional layer is bonded to the carrier layer.
Instead, Hodgkinson (US Pub No.: 2013/0060348) teaches wherein the coating comprises a carrier layer located on the stent structure with an adhesion promoter (being disclosed as an adhesion promoting layer in the abstract and [0008]. Use for surgical implant also in the abstract), and the functional layer is bonded to the carrier layer (being the hydrogel layer in [0029]. It stands to reason that the functional layer of Sabaria can also be bonded to the adhesion layer of Hodgkinson as the hydrogel layer encompasses a medical drug in [0031], making it equivalent to the functional layers of Sabaria). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a silane based adhesion layer for the purpose of providing an adhesion promoting layer (in the abstract) that enable an attachment of the device in the body while preventing scarring (as per the definition of adhesion, facilitation of attachment of implants in [0003]).
Regarding claim 14, Sabaria in view of Ryan teach a device according to Claim 13, wherein the adhesion promoter is a silicon compound, in particular a silane compound, or a polyolefin.
Instead, Hodgkinson (US Pub No.: 2013/0060348) teaches wherein the adhesion promoter is a silicon compound, in particular a silane compound, or a polyolefin (silane based adhesion promoting layer for an implant in the abstract and [0008]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a silane based adhesion layer for the purpose of providing an adhesion promoting layer (in the abstract) that enable an attachment of the device in the body while preventing scarring (as per the definition of adhesion, facilitation of attachment of implants in [0003]).
Regarding claim 19, Sabaria in view of Ryan and Hodgkinson teach a device according to Claim 14. However, Sabaria in view of Ryan does not teach wherein the silicon compound is a silane compound.
Instead, Hodgkinson teaches wherein the silicon compound is a silane compound (silane based adhesion promoting layer for an implant in the abstract and [0008]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a silane based adhesion layer for the purpose of providing an adhesion promoting layer (in the abstract) that enable an attachment of the device in the body while preventing scarring (as per the definition of adhesion, facilitation of attachment of implants in [0003]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. (Mertens US Pub No.: 2022/0176084) disclosed for a medical stent in the abstract with a coating layer in [0030]. Fulkerson (US Patent No.: 9,220,522) teaches a stent with self-expanding details in column 2 lines 32-44.
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/AREN PATEL/Examiner, Art Unit 3774
/YASHITA SHARMA/Primary Patent Examiner, Art Unit 3774