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 .
Response to Arguments
Applicant's arguments filed 09/16/2025 have been fully considered but they are not persuasive.
Regarding arguments on labeled page 7 of 14, it is argued that the method of forming a stent in McMahon (US Pub No.: 2015/00450908) will not be combinable with La Francesca and Costello. Examiner disagrees. Regarding the argument that McMahon does not teach a mandrel spaced radially inwardly, as a mesh scaffolding is formed on a mandrel, examiner argues that, as the mesh is on top of a mandrel, the mandrel is inward with respect to the scaffold. As a mesh scaffold is formed on a mandrel as per [0045], the mesh scaffold will have to be radially outward of the mandrel if said mesh is formed on the mandrel. In figure 3, part 50 will have to be the innermost portion while part 16, being the mesh scaffolding, will be the outward meshed portion. As such, the mandrel will satisfy the requirements of being radially inward of the scaffolding.
Regarding arguments pertaining to La Francesca starting on page on page 8 of 14, examiner states that electrospinnining is know in the art as being a method to deposit a fiber through a scaffold, as per previously cited paragraph [0103] of La Francesca. Additionally, paragraph [0081] of La Francesca further defines an electrospinning to form an outwardly oriented layer. With respect to a formation of a valve, the part of independent claim 1 that La Francesca was relied upon to teach did not involve a formation of a valve. La Francesca was only relied upon to teach a depositing of a material and not a formation of a valve. As per how electrospinning is performed, examiner states that the process of electrospinning allows for a depositing of a material through an aperture as electrospinning is known in the art to involve a spraying of a material. If an opening or aperture is present, said sprayed material will have to pass through the aperture as there will be nothing to prevent the passage of a material through an aperture. Examiner also notes that a limiting of a direct contact between layers is not required in claim 1, as argued in paragraph 1 on page 10 of 14 of the applicant’s arguments. However, as there is a spacing depicted between the mandrel and scaffold of McMahon and as an electrospinning is applied to the device of McMahon as taught in La Francesca, it is unclear how a spacing would disappear between the layers in the combination of McMahon and La Francesca.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, with respect to Costello, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Costello is relied upon to teach a stent valve positioning that is not present in McMahon with a design that allows food to pass in through the esophagus while blocking gastric fluids from entering the esophagus when coupled with a stent (as per [0005]-[0007] of McMahon). Regarding the formation of a valve, the limitation that Costello was brought in to teach was that a portion of the inner layer of material forms a valve. As per the wording of the claim, the valve was recited as being a portion of the inner layer where a specific or method structure for explicitly forming a valve was not present. As such, La Francesca and Costello were relied upon to teach the depositing of a material and a presence of a valve independently. Stating “depositing a material forms a valve” will require Costello to have a teaching regarding a formation of a valve, which will overcome Costello. Regarding arguments to claim 17, as per figure 1 of McMahon, examiner asserts that the ends of the structure in figure 1 will satisfy the definition of a flared end as the shape of the stents widens at both ends. From here, the inner portion was argued to be recessed with respect to the flared portions.
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, 3-11, 17-18, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over McMahon (US Pub No.: 2015/0045908) in view of La Francesca (US Pub No.: 2017/0151049) and Costello (US Pub No.: 2014/0031951).
Regarding claim 1, McMahon (US Pub No.: 2015/0045908) discloses a method of manufacturing an expandable stent (forming of a stent in the abstract, esophagus implanting in [0016]), the method comprising: positioning a mandrel within a lumen of a tubular scaffold (as per [0045], wherein a mandrel 50 is disclosed and the mesh scaffolding 16 is formed on said mandrel. As the scaffolding is formed on the mandrel, the mandrel is within the lumen of the mesh scaffold), the mandrel including first and second end regions, and a middle region extending therebetween (mandrel part 50 has a first end region 52, second end region 56, and a middle region 54, defined in paragraph [0045]), the mandrel further including a recessed portion defining a recessed surface extending radially inward from an outer surface of the middle region (being the part of region 54 that extends inward in figure 2. The edges of part 54 at parts 52 and 56 are outward with respect to the recessed portion of part 54), the tubular scaffold defined by a wall having an inner surface (being the scaffold in figure 1 where said scaffold has an inner surface), an outer surface, and a plurality of apertures extending from the inner surface to the outer surface through the wall (being the openings in the scaffold, shown in figures 1 and 1A), wherein the recessed surface is spaced apart radially inward from the inner surface of a portion of the tubular scaffold extending across the recessed portion (shown in figure 2, where the scaffold, including the inner surface of the scaffold, is spaced apart from the surface of the mandrel); and removing the mandrel (as the scaffolding is formed on a mandrel (scaffolding being part 16 in [0045]) where the scaffolding is used for an anti-reflux valve in the abstract, the mandrel has to be removed after the mesh is formed in order for the mesh to be implanted in the body, with medical uses for the mesh disclosed in [0002]).
However, McMahon does not teach a depositing a material through the plurality of apertures of the tubular scaffold such that the material contacts the recessed surface of the mandrel thereby forming an inner layer of material within the lumen of the tubular scaffold, wherein a portion of the inner layer of material forms a valve extending radially inward from the inner surface of the tubular scaffold, the valve having an outer surface spaced apart radially inward of and not in contact with the inner surface of the portion of the wall extending across the recessed portion.
Instead, La Francesca (US Pub No.: 20170151049) teaches depositing a material through the plurality of apertures of the tubular scaffold such that the material contacts the recessed surface of the mandrel thereby forming an inner layer of material within the lumen of the tubular scaffold (as per [0103], an electrospraying and/or electrospinning on to a mandrel is disclosed. If implemented in the device of figure 2 of McMahon, the electrospraying would deposit through the apertures of the tubular scaffold of McMahon). 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 spraying to deposit a material as presented in la Francesca for the purpose of creating an inner layer like part 22 of figure 1A of La Francesca (disclosed in [0079]). It is assumed that, as this is part of the scaffold (as per [0079]), it would provide additional stability to the interior mesh part 20 of La Francesca which is seen as being equivalent to the mesh formed with part 28 of McMahon.
From here, McMahon in view of La Francesca does not teach an instance wherein the portion of the inner layer of material that is spaced radially inward of and spaced away from the inner surface of the scaffold forms a valve extending radially inward from the inner surface of the scaffold.
Instead, Costello teaches wherein a portion of the inner layer of material forms a valve extending radially inward from the inner surface of the tubular scaffold (a valve is shown in figure 1. As the valve is disclosed as being implanted in a body lumen in the abstract, it stands to reason that the valve would be radially inward with respect to the inner surface of the scaffold to which the valve resides within), the valve having an outer surface spaced apart radially inward of and not in contact with the inner surface of the portion of the wall extending across the recessed portion (the valve in figure 1 has surfaces 12 and 44 that are spaced radially inward from the inner surface portion of the wall shown in figure 1). 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 valve of Costello into the combination of McMahon and La Francesca for the purpose of providing a means to control a flow through a bodily lumen, as disclosed in the abstract of Costello. The device of Costello is disclosed to have a benefit with respect to esophageal prosthesis and/or stents in [0005]-[0007] as the valve is disclosed to provide a method to allow food to pass in through the esophagus while blocking gastric fluids from entering the esophagus when coupled with a stent.
Regarding claim 3, McMahon in view of La Francesca and Costello teach the method of claim 1, wherein McMahon discloses that the tubular scaffold includes a plurality of filaments (in the abstract) extending from the first end region to the second end region and arranged to define the plurality of apertures (as the scaffolding is formed of filaments, the filaments will extend from a first end region to a second end region (being the top and bottom of part 32 in figure 1 or part 16 in figure 2) and form the apertures, being the openings in the scaffolding in figures 1-2).
Regarding claim 4, McMahon in view of La Francesca and Costello teach the method of claim 1, wherein Costello teaches that the material forms the valve in a middle region of the tubular scaffold with first and second end regions of the tubular scaffold extending axially away from opposite ends of the valve (the valve of Costello, shown in figure 1 is in the middle region of a scaffold in figure 1 and in figure 13, where part 612 is a tubular body and the valve being 622, extends axially away from the ends of the scaffold such that the first and second end regions of said scaffold are extending axially away with respect to the placement of the valve).
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 valve of Costello into the combination of McMahon and La Francesca for the purpose of providing a means to control a flow through a bodily lumen, as disclosed in the abstract of Costello. The device of Costello is disclosed to have a benefit with respect to esophageal prosthesis and/or stents in [0005]-[0007] as the valve is disclosed to provide a method to allow food to pass in through the esophagus while blocking gastric fluids from entering the esophagus when coupled with a stent.
Regarding claim 5, McMahon in view of La Francesca and Costello teach the method of claim 1, wherein the recessed portion extends circumferentially around a longitudinal axis of the mandrel (shown visually in figure 2, where the recessed portion of part 16 extends circumferentially about part 54). However, McMahon does not teach a depositing of the material that forms the valve extending circumferentially around the tubular scaffold.
Instead, La Francesca teaches a depositing of the material that forms the valve extending circumferentially around the tubular scaffold (as per [0103], an electrospraying and/or electrospinning on to a mandrel is disclosed to create a scaffold).
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 spraying to deposit a material as presented in la Francesca for the purpose of creating an inner layer like part 22 of figure 1A of La Francesca (disclosed in [0079]). As this is part of the scaffold (as per [0079]), it would provide additional stability to the interior mesh part 20 of La Francesca which is seen as being equivalent to the mesh formed with part 28 of McMahon.
Regarding claim 6, McMahon in view of La Francesca and Costello teaches the method of claim 5, wherein La Francesca teaches that the depositing further comprises depositing the inner layer of material on the inner surface of the tubular scaffold between a first circumferential location and a first end of the tubular scaffold and between a second circumferential location and a second end of the tubular scaffold (in [0100], a depositing of a material through a nozzle onto a target surface is present, where said surface is the inner surface of a tubular scaffold).
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 spraying to deposit a material as presented in la Francesca for the purpose of creating an inner layer like part 22 of figure 1A of La Francesca (disclosed in [0079]). It is assumed that, as this is part of the scaffold (as per [0079]), it would provide additional stability to the interior mesh part 20 of La Francesca which is seen as being equivalent to the mesh formed with part 28 of McMahon.
Regarding claim 7, McMahon in view of La Francesca and Costello teach the method of claim 6, with La Francesca further comprising depositing an outer layer of material along the outer surface of the tubular scaffold from the first end of the tubular scaffold to the second end of the tubular scaffold (in [0100], a depositing of a material through a nozzle onto a target surface is present, where said surface is the inner surface of a tubular scaffold. As a layering via the electrospinning is present in [0084] and [0087], layers in addition to the inner layer of claim 6 are provided for in La Francesca). 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 spraying to deposit a material as presented in la Francesca for the purpose of creating an inner layer like part 22 of figure 1A of La Francesca (disclosed in [0079]). It is assumed that, as this is part of the scaffold (as per [0079]), it would provide additional stability to the interior mesh part 20 of La Francesca which is seen as being equivalent to the mesh formed with part 28 of McMahon.
Regarding claim 8, McMahon in view of La Francesca and Costello teach the method of claim 7, wherein La Francesca teaches depositing the outer layer results in the inner layer being circumferentially attached to the outer layer at the first circumferential location and circumferentially attached to the outer layer at the second circumferential location thereby forming an annular chamber (in La Francesca paragraph [0133], a scaffold part 10 is formed via two or more layers, meaning that two layers are attached to each other to form part 10, shown in figure 1A. in Figure 1A, an attachment of multiple layers 18 and 20 (layers defined in [0097]) forms an annular, hollow chamber, pictured in figure 1A. It should be noted that, as the annular chamber is not claimed to be between the two layers, the chamber presented in La Francesca will read upon claim 8). 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 spraying to deposit a material as presented in la Francesca for the purpose of creating an inner layer like part 22 of figure 1A of La Francesca (disclosed in [0079]). It is assumed that, as this is part of the scaffold (as per [0079]), it would provide additional stability to the interior mesh part 20 of La Francesca which is seen as being equivalent to the mesh formed with part 28 of McMahon.
Regarding claim 9, McMahon in view of La Francesca and Costello teach the method of claim 8, wherein the annular chamber extends circumferentially around a central longitudinal axis of the tubular scaffold (shown in figure 1A of La Francesca). 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 spraying to deposit a material as presented in la Francesca for the purpose of creating an inner layer like part 22 of figure 1A of La Francesca (disclosed in [0079]). It is assumed that, as this is part of the scaffold (as per [0079]), it would provide additional stability to the interior mesh part 20 of La Francesca which is seen as being equivalent to the mesh formed with part 28 of McMahon.
Regarding claim 10, McMahon in view of La Francesca and Costello teach the method of claim 8, wherein forming the annular chamber results in the annular chamber being air-filled (as the chamber manufactured in figure 1A is hollow, said chamber is filled with air as no removal of air and means to keep air out are present). 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 spraying to deposit a material as presented in la Francesca for the purpose of creating an inner layer like part 22 of figure 1A of La Francesca (disclosed in [0079]). It is assumed that, as this is part of the scaffold (as per [0079]), it would provide additional stability to the interior mesh part 20 of La Francesca which is seen as being equivalent to the mesh formed with part 28 of McMahon.
Regarding claim 11, McMahon in view of La Francesca and Costello teach the method of claim 8, wherein forming the annular chamber includes filling the annular chamber with a substance selected from the group consisting of liquids, gels and polymers (as the chamber and the device of figure 1A is placed in a patient body, like a gastrointestinal region in [0014], the chamber can be filled with a liquid when in use in a patient body). 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 spraying to deposit a material as presented in la Francesca for the purpose of creating an inner layer like part 22 of figure 1A of La Francesca (disclosed in [0079]). It is assumed that, as this is part of the scaffold (as per [0079]), it would provide additional stability to the interior mesh part 20 of La Francesca which is seen as being equivalent to the mesh formed with part 28 of McMahon.
Regarding claim 17, McMahon discloses a method of manufacturing an expandable stent (forming of a stent in the abstract, esophagus implanting in [0016]), the method comprising: positioning a mandrel within a lumen of a tubular scaffold (as per [0045], wherein a mandrel 50 is disclosed and the mesh scaffolding 16 is formed on said mandrel. As the scaffolding is formed on the mandrel, the mandrel is within the lumen of the mesh scaffold), the mandrel including first and second flared end regions each having a first diameter (mandrel part 50 has a first end region 52, second end region 56, where both regions are flared as per figure 2), and a middle region extending therebetween with a second diameter smaller than the first diameter (and a middle region 54 with the ends of parts 52 and 56 that extend toward 54, defined in paragraph [0045]), the mandrel further including a recessed portion defining a recessed surface extending radially inward from an outer surface of the middle region (being the part of region 54 that extends inward in figure 2. The edges of part 54 at parts 52 and 56 are outward with respect to the recessed portion of part 54), the tubular scaffold defined by a wall having an inner surface (being the scaffold in figure 1 where said scaffold has an inner surface), an outer surface (being the outward most part of the scaffold in figure 1), and a plurality of apertures extending from the inner surface to the outer surface through the wall (being the openings in the scaffold, shown in figures 1 and 1A), wherein the recessed surface is spaced apart radially inward from the inner surface of a portion of the tubular scaffold extending across the recessed portion (shown in figure 2, where the scaffold, including the inner surface of the scaffold, is spaced apart from the surface of the mandrel), and removing the mandrel (as the scaffolding is formed on a mandrel (scaffolding being part 16 in [0045]) where the scaffolding is used for an anti-reflux valve in the abstract, the mandrel has to be removed after the mesh is formed in order for the mesh to be implanted in the body, with medical uses for the mesh disclosed in [0002]).
However, McMahon does not teach a depositing a material through the plurality of apertures of the tubular scaffold continuously from the first flared end region to the second flared end region such that the material contacts the outer surface of the middle region and the recessed surface of the mandrel thereby forming an inner layer of material within the lumen of the tubular scaffold, and depositing an outer layer of the material along an entirety of the tubular scaffold from the first flared end region to the second flared end region of the mandrel.
Instead, La Francesca (US Pub No.: 20170151049) teaches depositing a material through the plurality of apertures of the tubular scaffold such that the material contacts the recessed surface of the mandrel thereby forming an inner layer of material within the lumen of the tubular scaffold (as per [0103], an electrospraying and/or electrospinning on to a mandrel is disclosed. If implemented in the device of figure 2 of McMahon, the electrospraying would deposit through the apertures of the tubular scaffold of McMahon) and depositing an outer layer of the material along an entirety of the tubular scaffold from the first flared end region to the second flared end region of the mandrel (as per [0087], as it is disclosed that, in some embodiments, part 20 does not extend across the scaffold body 12, it is implied that embodiments are present where part 20 does extend across the scaffold part 12. From here, in [0089]-[0090], the scaffold is layered with a material that part 20 extends across. Said layering also will extend between the flared regions of McMahon). 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 spraying to deposit a material as presented in la Francesca for the purpose of creating an inner layer like part 22 of figure 1A of La Francesca (disclosed in [0079]). It is assumed that, as this is part of the scaffold (as per [0079]), it would provide additional stability to the interior mesh part 20 of La Francesca which is seen as being equivalent to the mesh formed with part 28 of McMahon.
From here, McMahon in view of La Francesca does not teach wherein a portion of the inner layer of material forms a valve extending radially inward from the inner surface of the tubular scaffold, the valve having an outer surface spaced apart radially inward of and not in contact with the inner surface of the portion of the wall extending across the recessed portion.
Instead, Costello teaches wherein a portion of the inner layer of material forms a valve extending radially inward from the inner surface of the tubular scaffold (a valve is shown in figure 1. As the valve is disclosed as being implanted in a body lumen in the abstract, it stands to reason that the valve would be radially inward with respect to the inner surface of the scaffold to which the valve resides within), the valve having an outer surface spaced apart radially inward of and not in contact with the inner surface of the portion of the wall extending across the recessed portion (the valve in figure 1 has surfaces 12 and 44 that are spaced radially inward from the inner surface portion of the wall shown in figure 1). 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 valve of Costello into the combination of McMahon and La Francesca for the purpose of providing a means to control a flow through a bodily lumen, as disclosed in the abstract of Costello. The device of Costello is disclosed to have a benefit with respect to esophageal prosthesis and/or stents in [0005]-[0007] as the valve is disclosed to provide a method to allow food to pass in through the esophagus while blocking gastric fluids from entering the esophagus when coupled with a stent.
Regarding claim 18, McMahon in view of La Francesca and Costello teach the method of claim 17, wherein McMahon teaches the recessed portion extends circumferentially around a longitudinal axis of the mandrel (shown visually in figure 2, where the recessed portion of part 16 extends circumferentially about part 54). However, McMahon does not teach a depositing of the material forms the valve extending circumferentially around the tubular scaffold.
Instead, La Francesca teaches a depositing of the material forms the valve extending circumferentially around the tubular scaffold (as per [0103], an electrospraying and/or electrospinning on to a mandrel is disclosed to create a scaffold). 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 spraying to deposit a material as presented in la Francesca for the purpose of creating an inner layer like part 22 of figure 1A of La Francesca (disclosed in [0079]). As this is part of the scaffold (as per [0079]), it would provide additional stability to the interior mesh part 20 of La Francesca which is seen as being equivalent to the mesh formed with part 28 of McMahon.
Regarding claim 20, McMahon discloses a method of manufacturing an expandable stent (forming of a stent in the abstract, esophagus implanting in [0016]), the method comprising: positioning a mandrel within a lumen of a tubular scaffold (as per [0045], wherein a mandrel 50 is disclosed and the mesh scaffolding 16 is formed on said mandrel. As the scaffolding is formed on the mandrel, the mandrel is within the lumen of the mesh scaffold), the mandrel including first and second end regions, and a middle region extending therebetween (mandrel part 50 has a first end region 52, second end region 56, with part 54 in the middle in figure 2), the mandrel further including a recessed portion defining a recessed surface extending circumferentially around a longitudinal axis of the mandrel and extending radially inward from an outer surface of the middle region (being the part of region 54 that extends inward in figure 2. The edges of part 54 at parts 52 and 56 are outward with respect to the recessed portion of part 54), the tubular scaffold defined by a wall having an inner surface (being the scaffold in figure 1 where said scaffold has an inner surface), an outer surface (being the outward most part of the scaffold in figure 1), and a plurality of apertures extending from the inner surface to the outer surface through the wall (being the openings in the scaffold, shown in figures 1 and 1A), wherein the recessed surface is spaced apart radially inward from the inner surface of a portion of the tubular scaffold extending across the recessed portion (shown in figure 2, where the scaffold, including the inner surface of the scaffold, is spaced apart from the surface of the mandrel); and removing the mandrel (as the scaffolding is formed on a mandrel (scaffolding being part 16 in [0045]) where the scaffolding is used for an anti-reflux valve in the abstract, the mandrel has to be removed after the mesh is formed in order for the mesh to be implanted in the body, with medical uses for the mesh disclosed in [0002]).
However, McMahon does not teach a depositing a material through the plurality of apertures of the tubular scaffold continuously from the first flared end region to the second flared end region such that the material contacts the outer surface of the middle region and the recessed surface of the mandrel thereby forming an inner layer of material within the lumen of the tubular scaffold, and depositing an outer layer of the material along an entirety of the tubular scaffold from the first flared end region to the second flared end region of the mandrel.
Instead, La Francesca (US Pub No.: 20170151049) teaches depositing a material through the plurality of apertures of the tubular scaffold such that the material contacts the recessed surface of the mandrel thereby forming an inner layer of material within the lumen of the tubular scaffold, (as per [0103], an electrospraying and/or electrospinning on to a mandrel is disclosed. If implemented in the device of figure 2 of McMahon, the electrospraying would deposit through the apertures of the tubular scaffold of McMahon) depositing an outer layer of material along the outer surface of the tubular scaffold from the first end region to the second end region of the mandrel (as per [0087], as it is disclosed that, in some embodiments, part 20 does not extend across the scaffold body 12, it is implied that embodiments are present where part 20 does extend across the scaffold part 12. From here, in [0089]-[0090], the scaffold is layered with a material that part 20 extends across. Said layering also will extend between the flared regions of McMahon), resulting in the inner layer being circumferentially attached to the outer layer at a first circumferential location and circumferentially attached to the outer layer at a second circumferential location thereby forming an annular chamber (in La Francesca paragraph [0133], a scaffold part 10 is formed via two or more layers, meaning that two layers are attached to each other to form part 10, shown in figure 1A. in Figure 1A, an attachment of multiple layers 18 and 20 (layers defined in [0097]) forms an annular, hollow chamber, pictured in figure 1A. It should be noted that, as the annular chamber is not claimed to be between the two layers, the chamber presented in La Francesca will read upon claim 8). 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 spraying to deposit a material as presented in la Francesca for the purpose of creating an inner layer like part 22 of figure 1A of La Francesca (disclosed in [0079]). It is assumed that, as this is part of the scaffold (as per [0079]), it would provide additional stability to the interior mesh part 20 of La Francesca which is seen as being equivalent to the mesh formed with part 28 of McMahon.
McMahon in view of La Francesca also does not teach wherein a portion of the inner layer of material forms a valve extending circumferentially and radially inward from the inner surface of the tubular scaffold, the valve having an outer surface spaced apart radially inward of and not in contact with the inner surface of the portion of the wall extending across the recessed portion.
Instead, Costello teaches wherein a portion of the inner layer of material forms a valve extending circumferentially and radially inward from the inner surface of the tubular scaffold (a valve is shown in figure 1. As the valve is disclosed as being implanted in a body lumen in the abstract, it stands to reason that the valve would be radially inward with respect to the inner surface of the scaffold to which the valve resides within), the valve having an outer surface spaced apart radially inward of and not in contact with the inner surface of the portion of the wall extending across the recessed portion (the valve in figure 1 has surfaces 12 and 44 that are spaced radially inward from the inner surface portion of the wall shown in figure 1). 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 valve of Costello into the combination of McMahon and La Francesca for the purpose of providing a means to control a flow through a bodily lumen, as disclosed in the abstract of Costello. The device of Costello is disclosed to have a benefit with respect to esophageal prosthesis and/or stents in [0005]-[0007] as the valve is disclosed to provide a method to allow food to pass in through the esophagus while blocking gastric fluids from entering the esophagus when coupled with a stent.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over McMahon (US Pub No.: 2015/0045908) in view of La Francesca (US Pub No.: 2017/0151049) and Costello (US Pub No.: 2014/0031951). In further view of Hall (US Pub No.: 2016/0250048).
Regarding claim 2, McMahon in view of La Francesca and Costello teach the method of claim 1, wherein McMahon discloses the tubular scaffold is a monolithic structure formed from a cylindrical tube cut to form the plurality of apertures (the scaffold in figure 2 is a monolithic structure with a plurality of apertures).
However, McMahon does not detail a cutting to form a scaffold. Instead, Hall (US Pub No.: 2016/0250048) discloses a cylindrical tube cut to form the plurality of apertures (cutting of a tube to form a scaffolding in [0084], where a scaffolding 200 is defined in [0084] and shown to have apertures in figure 5) 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 cutting presented in Hall into McMahon in order to provide a “rapid manufacturing technique” as per [0084] that is used to form a scaffold, where the cutting via a laser is known in the art to allow for creating multiple different designs for a stent to be used for various different purposes.
Claim(s) 12-14 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over McMahon (US Pub No.: 2015/0045908) in view of La Francesca (US Pub No.: 2017/0151049) and Costello (US Pub No.: 2014/0031951) in further view of Parker (US Pub No.: 2016/0331528).
Regarding claim 12, McMahon in view of La Francesca and Costello teach the method of claim 1. However, McMahon does not teach details with respect to the recessed portion of a mandrel.
Instead, Parker (US Pub No.: 2016/0331528) teaches wherein the recessed portion includes a first conical section tapering from the outer surface of the middle region toward a central longitudinal axis of the mandrel, and a second section extending from the outer surface toward the central longitudinal axis at an angle (the first and second section being the left and rightmost portions of the device in figure 13, where figure 13 is a part of a mandrel used to design leaflets as per [0047]), wherein depositing material forms the valve with a first conical section and a second section extending inward at the angle (material deposited on a mandrel in [0090], where depositing material on the mandrel of figure 13 creates two sections forming in at an angle to create a valve. Angled extension shown in figure 13). 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 shape of the mandrel of Parker into McMahon to allow for the formation of a valve (to which McMahon discloses a valve in the abstract but does not disclose a structure to form a valve on the mandrel) where the mandrel of parker allows for “customized valve scaffolds” in [0007] that can be created with growth factors and stem cells at lower cost than specialized valve implants (also in [0007]).
Regarding claim 13, McMahon in view of La Francesca, Costello, and Parker teach the method of claim 12, wherein Parker teaches the angle is an acute angle, wherein depositing material forms the valve with a first conical section and a second section extending inward at the acute angle (as per figure 13, and the axial length and diameter disclosed in [0159], the angle of the mandrel to which the valve is formed in Parker is an acute angle). 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 shape of the mandrel of Parker into McMahon to allow for the formation of a valve (to which McMahon discloses a valve in the abstract but does not disclose a structure to form a valve on the mandrel) where the mandrel of parker allows for “customized valve scaffolds” in [0007] that can be created with growth factors and stem cells at lower cost than specialized valve implants (also in [0007]).
Regarding claim 14, McMahon in view of La Francesca, Costello, and Parker teach the method of claim 12, wherein Parker teaches the angle is an obtuse angle (as per [0103], as the valve may have any desired length and thickness, the angle of the mandrel may be obtuse as the mandrel, in [0104] may have a conical shape. said conical shape defines an obtuse angle. Additionally, the mandrel about part 240 in figure 3B is depicted as being obtuse), wherein depositing material forms the valve with a first conical section and a second section extending inward at the obtuse angle (depositing of a material in [0068] with a valve formation via a mandrel in [0096]). 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 shape of the mandrel of Parker into McMahon to allow for the formation of a valve (to which McMahon discloses a valve in the abstract but does not disclose a structure to form a valve on the mandrel) where the mandrel of parker allows for “customized valve scaffolds” in [0007] that can be created with growth factors and stem cells at lower cost than specialized valve implants (also in [0007]).
Regarding claim 16, McMahon in view of La Francesca, Costello, and Parker teach the method of claim 12, wherein Parker teaches depositing material includes depositing a greater thickness of material on the second section of the recessed portion than on the first conical section (as Parker discloses that the valve may have any desired length and thickness in [0103], depositing of more material on a second section than a first section to create a thicker section is provided for in Parker). 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 shape of the mandrel of Parker into McMahon to allow for the formation of a valve (to which McMahon discloses a valve in the abstract but does not disclose a structure to form a valve on the mandrel) where the mandrel of parker allows for “customized valve scaffolds” in [0007] that can be created with growth factors and stem cells at lower cost than specialized valve implants (also in [0007]).
Claim(s) 15 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over McMahon (US Pub No.: 2015/0045908) in view of La Francesca (US Pub No.: 2017/0151049) and Costello (US Pub No.: 2014/0031951) in further view of Parker (US Pub No.: 2016/0331528) and Radhakrishnan (US Patent No.: 8,287,937).
Regarding claim 15, McMahon in view of La Francesca, Costello, and Parker teach the method of claim 12, wherein Parker teaches that the first conical section of the recessed portion is devoid of the surface texture (no surface texture is shown in figure 13 of Parker or disclosed in the specification with respect to this section of the mandrel). 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 shape of the mandrel of Parker into McMahon to allow for the formation of a valve (to which McMahon discloses a valve in the abstract but does not disclose a structure to form a valve on the mandrel) where the mandrel of parker allows for “customized valve scaffolds” in [0007] that can be created with growth factors and stem cells at lower cost than specialized valve implants (also in [0007]).
However, McMahon in view of Parker does not teach wherein the second section of the recessed portion includes a surface texture.
Instead, Radhakrishnan (US Patent No.: 8,287,937) does teach wherein does not teach wherein the second section of the recessed portion includes a surface texture (a mandrel with a surface texture present in column 6 lines 3-16). 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 texture of the mandrel of Radhakrishnan into McMahon and Parker as the texture of the mandrel will control a deposition rate (as per column 6 lines 3-16), where a deposition rate controls the coating on the mandrel, allowing for the coating of material to me “smoother and denser,” thereby adjusting properties of the formed stent body, as per column 5 lines 32-50.
Regarding claim 19, McMahon in view of La Francesca and Costello teach the method of claim 17. However, said combination does not teach wherein the recessed portion includes a first conical section tapering from the outer surface of the middle region toward a central longitudinal axis of the mandrel, and a second section extending from the outer surface toward the central longitudinal axis at an angle, wherein depositing material forms the valve with a first conical section and a second section extending inward at the angle, wherein the second section of the recessed portion includes a surface texture and the first conical section of the recessed portion is devoid of the surface texture.
Instead, Parker (US Pub No.: 2016/0331528) teaches wherein the recessed portion includes a first conical section tapering from the outer surface of the middle region toward a central longitudinal axis of the mandrel, and a second section extending from the outer surface toward the central longitudinal axis at an angle (the first and second section being the left and rightmost portions of the device in figure 13, where figure 13 is a part of a mandrel used to design leaflets as per [0047]), wherein depositing material forms the valve with a first conical section and a second section extending inward at the angle (material deposited on a mandrel in [0090], where depositing material on the mandrel of figure 13 creates two sections forming in at an angle to create a valve. Angled extension shown in figure 13), and the first conical section of the recessed portion is devoid of the surface texture (no surface texture is shown in figure 13 of Parker or disclosed in the specification with respect to this section of the mandrel).
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 shape of the mandrel of Parker into McMahon to allow for the formation of a valve (to which McMahon discloses a valve in the abstract but does not disclose a structure to form a valve on the mandrel) where the mandrel of parker allows for “customized valve scaffolds” in [0007] that can be created with growth factors and stem cells at lower cost than specialized valve implants (also in [0007]).
McMahon in view of Parker does not teach also does not teach wherein the second section of the recessed portion includes a surface texture
Instead, Radhakrishnan (US Patent No.: 8,287,937) does teach wherein does not teach wherein the second section of the recessed portion includes a surface texture (a mandrel with a surface texture present in column 6 lines 3-16). 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 texture of the mandrel of Radhakrishnan into McMahon and Parker as the texture of the mandrel will control a deposition rate (as per column 6 lines 3-16), where a deposition rate controls the coating on the mandrel, allowing for the coating of material to me “smoother and denser,” thereby adjusting properties of the formed stent body, as per column 5 lines 32-50.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Hingston (US Pub No.: 2017/0049590) considered for, in figure 11, the outer surface of the stent 12 has a center portion spaced radially inward with respect to the topmost and bottommost end of the stent.
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/AREN PATEL/Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774
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