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
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, 9-11, 15-18, 22, and 25-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hunter (U.S. Pub. No. 2005/0143817) in view of Albertorio, et. al. (U.S. Pub. No. 2010/0324608) hereinafter, "Albertorio," in view of Rousseau (U.S. Pat. No. 6800082), and further in view of Grant, et. al. (U.S. Pub. No. 2013/0274795) hereinafter, "Grant."
Regarding claim 1, Hunter teaches an implantable device (surgical patch, pp. [0802]) for sealing an aperture in a tissue of a body lumen, the implantable device comprising:
a sealable member ("multilayer device," pp. [0815]), comprising
a flexible substrate ("film layer," pp. [0815]) comprising an extruded layer ("extruded layer" is being treated as a product by process limitation; that is the structure of the device is being claimed by the method in which it is made. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113. Here, Hunter teaches the flexible substrate (film) may be made by casting, which is considered to have the structure implied by the step of extrusion); and
a mesh layer ("mesh," pp. [0815]) comprising an electrospun material (0818) on the flexible substrate (pp. [0815]), the mesh layer comprises a textured surface (the mesh is taught as having a "porosity" which is a texture, pp. [0808]);
wherein, when the implantable device is in a sealing position, the sealable member (multilayer device) is disposed against an internal surface of the tissue adjacent to the aperture such that the mesh layer (mesh) is in direct contact with collogen from the internal surface (it is noted that this recitation is functional language, and therefore the reference must only teach that it is capable of performing the recited function; Hunter broadly teaches its films are flexible and useful for application to the surface of tissue, cavity or an organ which can interpreted to mean either internal or external surfaces, pp. [0803], see also pp. [0834], teaching the films and meshes can be applied to "any bodily conduit or any tissue that may be prone to the development of fibrosis.") to promote localized platelet activation at the aperture (the "mesh may be composed of a prosthetic fabric having a 3-dimensional structure separating two surfaces in which one is open to post-surgical cell colonization," pp. [0821]).
However, Hunter does not explicitly disclose the extruded layer comprising a thickness in a range from about 60 µm and about 120 µm or the mesh layer comprising a thickness in a range from about 10 µm to about 50 µm. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the invention of Hunter to have the extruded layer comprising a thickness in a range from about 60 µm and about 120 µm and the mesh layer comprising a thickness in a range from about 10 µm to about 50 µm since it has been held that "where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device" Gardner V. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the invention of Hunter operates in the same manner as the claimed invention, and an invention having the claimed relative dimensions would not perform differently than the invention of Hunter. Further, applicant places no criticality on the dimensions claimed, indicating simply that "the extruded layer 104 preferably has a range between about 60 µm and about 120 µm in thickness. The range of thicknesses may be between 5 µm and 4000 µm," (Specification, pp. [0089]), and "the first thickness (of the mesh layer) is between about 5 µm and about 500 µm, or between about 5 µm and about 750 µm, or between about 5 µm and about 1000 µm, or between about 5 µm and about 1500 µm, or between about 5 µm and about 2000 µm, or between about 5 µm and about 2500 µm, or between about 5 µm and about 3000 µm, or between about 5 µm and about 4000 µm (Specification, pp. [0014]).
Further, Hunter teaches adding a fibrosis-inducing agent to promote tissue growth (pp. [0822]) but does not explicitly disclose the mesh layer comprises a platelet impregnated mesh layer.
Albertorio teaches a surgical mesh (101; Fig. 1) comprising a platelet impregnated mesh layer (pp. [0026]).
Albertorio is considered to be analogous to the claimed invention because it is in the same field of surgical meshes. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the mesh layer of Hunter to incorporate the teachings of Albertorio by replacing the fibrosis-inducing agent with a platelet impregnated mesh layer. Doing so would be a simple substitution of one known mechanism for promoting tissue growth for another to obtain predictable results of providing a surgical mesh capable of promoting tissue growth and healing to surrounding tissue with a reasonable expectation of success.
Additionally, one of ordinary skill in the art would understand the platelets impregnated into the mesh would be in direct contact with the internal surface just as the mesh is.
Further, Hunter does not explicitly disclose the mesh layer having a larger surface area than the flexible substrate.
Hunter does teach that there may be two layers of mesh joined together with a flexible substrate layer in between (pp. [0815]-[0816]).
Rousseau teaches a configuration between two joined mesh layers (12 and 14; Fig. 3) with a separate layer (16; Fig. 3) disposed between the mesh layers such that the mesh layer (12 and 14) have a larger surface area than the flexible substrate (13, see portions 24 of the mesh in Fig. 3 extending beyond the edges of layer 16 so that the mesh layers can be joined together, wherein the flexible substrate if opposite the mesh layer,
Rousseau is considered to be analogous to the claimed invention because it is in the same field of surgical meshes. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the mesh and flexible substrate configuration of Hunter to incorporate the teachings of Rousseau by increasing the surface area of the mesh relative to the flexible substrate so that the mesh layers can be joined together while containing the layer of flexible substrate between. Doing so would be a simple substitution of one known layered mesh and flexible substrate configuration for another to obtain predictable results of providing an implantable surgical mesh with a reasonable expectation of success.
Further, Hunter does not explicitly disclose an anchorable member comprising a central portion and lateral portions extending radially outwardly from the central portion.
Grant teaches a sealable member (60; Fig. 1A) used with an anchorable member ("foot core" 20a; Fig. 4A) comprising a central portion (40a; Fig. 4B) and lateral portions (25a; Fig. 4B) extending radially outwardly from the central portion (40a) to apply the sealable member (60) to an internal surface of tissue (see Fig. 1A).
Grant is considered to be analogous to the claimed invention because it is in the same field of internal sealable members. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hunter to incorporate the teachings of Grant by providing the sealable member with an anchorable member. Doing so would provide a means to deliver and support the sealable member for use intra-luminal use as taught by Grant (pp. [0204]).
However, Hunter does not explicitly teach the sealable member is structured to flexibly roll when in a delivery configuration such that a delivery cross-sectional area of the rolled sealable member has a diameter smaller than that of the aperture.
Grant teaches a sealable member (60; Fig. 1A) is structured to flexibly roll when in a delivery configuration (pp. [0210]) such that a delivery cross-sectional area of the rolled sealable member (60) has a diameter smaller than that of the aperture (the rolled sealable member would have to have a delivery cross-sectional area diameter small than that of the aperture to be delivered through it; pp. [0210]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hunter to incorporate the teachings of Grant by providing the sealable member with a rollable delivery configuration. Doing so would reduce the diameter of the incision necessary to insert the device and repair the aperture.
Further, Grant does not explicitly disclose, in the rolled configuration, the sealable member comprises a cross-sectional area smaller than a cross-sectional area of a 30 French aperture, and when in the sealing position, at least one dimension of the sealable member is larger than a diameter of a 6 French aperture.
Grant does teach that access sites the device is used to seal are approximately 10 to 30 French (pp. [0006]-[0007]). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the sealing member of Grant would necessarily have the rolled configuration be a cross-sectional area smaller than a 30 French aperture and the sealing position would have a dimension of the sealable member is larger than a diameter of a 6 French aperture as to seal the 10 to 30 French puncture holes Hunter teaches the device is used to seal.
Regarding claim 9, Hunter in view of Grant teaches the invention as discussed above in claim 1. Hunter further teaches both the mesh layer (mesh) and the flexible substrate (film) comprise at least one material selected from the group consisting of Poly-L-lactide, Poly-D- lactide, Poly-DL-lactide, Polydioxanone, Polyglycolide, E-Caprolactone, Polyethylene glycol, and a copolymer thereof (Poly-L-lactide, pp. [0817]).
Regarding claim 10, Hunter in view of Grant teaches the invention as discussed above in claim 1. Hunter further teaches at least one of the mesh layer (mesh) and the flexible substrate (film) is formed at least in part of a material having an inherent viscosity in a range from 0.5 to 7.0 dl/g (Poly-L-lactide, pp. [0817]; it is noted that Poly-L-lactide has a viscosity of ~2.0 dL/g).
Regarding claim 11, Hunter in view of Grant teaches the invention as discussed above in claim 1. However, Hunter does not explicitly teach the sealable member is structured to flexibly roll when in a delivery configuration such that a delivery cross-sectional area of the rolled sealable member has a diameter smaller than that of the aperture.
Grant teaches a sealable member (60; Fig. 1A) is structured to flexibly roll when in a delivery configuration (pp. [0210]) such that a delivery cross-sectional area of the rolled sealable member (60) has a diameter smaller than that of the aperture (the rolled sealable member would have to have a delivery cross-sectional area diameter small than that of the aperture to be delivered through it; pp. [0210]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hunter to incorporate the teachings of Grant by providing the sealable member with a rollable delivery configuration. Doing so would reduce the diameter of the incision necessary to insert the device and repair the aperture.
Regarding claim 15, Hunter in view of Grant teaches the invention as discussed above in claim 1. Hunter further teaches a maximum thickness of the flexible substrate (5mm, pp. [0803]) is at least 10 times greater than a minimum thickness of the flexible substrate (10 microns, pp. [0803]).
Regarding claim 17, Hunter in view of Grant teaches the invention as discussed above in claim 1. Hunter further teaches the mesh layer (mesh) comprises a product of activated platelets (the mesh can include a fibrosis-inducing agent which would promote activated platelets; pp. [0822]).
Regarding claim 18, Hunter in view of Grant teaches the invention as discussed above in claim 17. Hunter further teaches the mesh layer (mesh) comprises a copolymer (pp. [0818]),
wherein the mesh layer (mesh) is formed on, and covers, a top surface of the flexible substrate (film, pp. [0816]).
However, Hunter does not explicitly disclose a hole is formed through both the mesh layer and the flexible substrate after the mesh layer has been formed on the flexible substrate.
Grant teaches a hole (65; Fig. 6A) in its sealable member (60) so that the anchorable member (20a) can extend through the sealable member (see Figs. 4E-4F).
Likewise, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hunter to incorporate the teachings of Grant by providing a hole formed through both the mesh layer and the flexible substrate. Doing so would allow the sealable member of Grant to be used with the anchorable member taught by Grant.
Regarding claim 22, Hunter in view of Grant teaches the invention as discussed above in claim 1. Grant further teaches the anchorable member (20a) further comprises a column portion (42a; Fig. 4A) that is disposed in the aperture when the implantable device is in the sealing position (see e.g., Fig. 1A).
Regarding claim 25, Hunter in view of Grant teaches the invention as discussed above in claim 1. Hunter further teaches the mesh layer (mesh) comprises a plurality of fibers (pp. [0806]), and wherein each fiber of the plurality of fibers is impregnated with one or more therapeutic agents (pp. [0827]) comprising at least one of an antibiotic and an anti-proliferative (pp. [0844]) such that the one or more therapeutic agents are impregnated within the structure of the mesh layer (mesh, pp. [0827]).
Regarding claim 26, Hunter in view of Grant teaches the invention as discussed above in claim 1. Hunter further teaches the mesh layer (mesh) is disposed on the flexible substrate (film) between the flexible substrate and the internal surface (pp. [0816], it is noted, applying the sealable member of Hunter with the anchoring member of Grant would result in the mesh being disposed between the flexible substrate and internal surface as seen in Fig. 1A of Grant).
Regarding claim 27, Hunter in view of Grant teaches the invention as discussed above in claim 22.
However, Hunter does not explicitly disclose the column portion is disposed through both the mesh layer and the extruded layer in the sealing position.
Grant teaches the column portion (42a) is disposed through its sealable member (60) so that the anchorable member (20a) can support the sealable member (see Figs. 4E-4F) in the sealing position (pp. [0204]).
Likewise, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hunter to incorporate the teachings of Grant by providing the column portion disposed through both the mesh layer and the extruded layer to support the sealable member of Hunter in the sealing position.
Regarding claim 28, Grant further teaches at least one guard member (80c; Fig. 8B), wherein the at least one guard member (80c) is engageable with an engagement portion (e.g., 20c; Fig. 8B) of the anchorable member (20a), the engagement portion (20c) configured to enable engagement of the at least one guard member (80c) against an exterior surface of the tissue when the implantable device is in a sealing position (pp. [0219]), and wherein the at least one guard member (80c) comprises a slotted cage (it is noted, there is no structure discussed in the specification or shown in the drawings of the instant applications to clearly define what Applicant means by "slotted cage." Guard member 80c has bar like prongs separated by slots forming a cage structure; therefore, guard member 80c is considered a "slotted cage.").
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hunter to incorporate the teachings of Grant by adding at least one guard member to the anchor member. Doing so would prevent the implant from moving after installation as taught by Grant (pp. [0219]).
Claim(s) 1, 9-11, 13-18, 22, 25-28, and 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grant et. al. (U.S. Pub. No. 2013/0274795) hereinafter, "Grant," in view of Hunter et. al. (U.S. Pub. No. 2005/0143817), hereinafter, "Hunter," and further in view of in view of Rousseau (U.S. Pat. No. 6800082).
Regarding claim 1, Grant teaches an implantable device (5; Fig. 1A) for sealing an aperture in a tissue of a body lumen (pp. [0187]), the implantable device comprising:
a sealable member (60; Fig. 1A), comprising:
a flexible substrate ("flexible wing"; pp. [0189]) comprising an extruded layer ("extruded layer" is being treated as a product by process limitation; that is the structure of the device is being claimed by the method in which it is made. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113. Here, Grant teaches the flexible substrate (wing) may be manufactured as a thin sheet (pp. [0190]), which is considered to have the structure implied by the step of extrusion; and
an anchorable member ("foot core" 20a; Fig. 4A) comprising a central portion (40a; Fig. 4B) and lateral portions (25a; Fig. 4B) extending radially outwardly from the central portion (40a),
wherein, when the implantable device (5) is in a sealing position (see Fig. 1A), the sealable member (60) is disposed against an internal surface of the tissue adjacent to the aperture (see Fig. 1A),
wherein the device (5) has a rolled configuration (pp. [0210]).
However, Grant does not explicitly disclose a mesh layer comprising a electrospun material on the flexible substrate such that the mesh layer is in contact with the internal surface of the tissue adjacent to the aperture.
Hunter teaches a sealable member (multilayer device, pp. [0815]) with a mesh layer (mesh, pp. [0815]) comprising an electrospun material (0818) configured for platelet impregnation having a textured surface (the mesh is taught as having a "porosity" which is a texture, pp. [0808], further, a mesh having a porous texture would be configured to gather platelets) on a flexible substrate (pp. [0815]) for use with bodily conduits (pp.[0834]).
Hunter is considered to be analogous to the claimed invention because it is in the same field of internal sealable members. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sealable member of Grant to incorporate the teachings of Hunter by providing an electrospun mesh on top of the flexible substrate. Doing so would provide a drug-delivery vehicle for applying drugs to the aperture site, as recognized by Hunter (pp. [0801]).
Further, one having skill in the art would recognize that placing a mesh layer on top of the flexible substrate (60) of Grant would lead to the mesh layer in contact with the internal surface of the tissue adjacent to the aperture as seen in Fig. 1C.
Further, neither Grant nor Hunter explicitly disclose the extruded layer comprising a thickness in a range from about 40 µm to about 500 µm or the mesh layer comprising a thickness in a range from about 10 µm to about 50 µm. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the invention of Hunter to have the extruded layer comprising a thickness in a range from about 40 µm to about 500 µm and the mesh layer comprising a thickness in a range from about 10 µm to about 50 µm since it has been held that "where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device" Gardner V. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the invention of Grant operates in the same manner as the claimed invention, and an invention having the claimed relative dimensions would not perform differently than the invention of Grant. Further, applicant places no criticality on the dimensions claimed, indicating simply that "the extruded layer 104 preferably has a range between about 60 µm and about 120 µm in thickness. The range of thicknesses may be between 5 µm and 4000 µm," (Specification, pp. [0089]), and "the first thickness (of the mesh layer) is between about 5 µm and about 500 µm, or between about 5 µm and about 750 µm, or between about 5 µm and about 1000 µm, or between about 5 µm and about 1500 µm, or between about 5 µm and about 2000 µm, or between about 5 µm and about 2500 µm, or between about 5 µm and about 3000 µm, or between about 5 µm and about 4000 µm (Specification, pp. [0014]).
Further, Hunter does not explicitly disclose the mesh layer having a larger surface area than the flexible substrate.
Hunter does teach that there may be two layers of mesh joined together with a flexible substrate layer in between (pp. [0815]-[0816]).
Rousseau teaches a configuration between two joined mesh layers (12 and 14; Fig. 3) with a separate layer (16; Fig. 3) disposed between the mesh layers such that the mesh layer (12 and 14) have a larger surface area than the flexible substrate (13, see portions 24 of the mesh in Fig. 3 extending beyond the edges of layer 16 so that the mesh layers can be joined together such that the flexible substrate is opposite the mesh layer.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the mesh and flexible substrate configuration of Grant in view of Hunter to incorporate the teachings of Rousseau by increasing the surface area of the mesh relative to the flexible substrate so that the mesh layers can be joined together while containing the layer of flexible substrate between. Doing so would be a simple substitution of one known layered mesh and flexible substrate configuration for another to obtain predictable results of providing an implantable surgical mesh with a reasonable expectation of success.
Grant teaches a sealable member (60; Fig. 1A) is structured to flexibly roll when in a delivery configuration (pp. [0210]) such that a delivery cross-sectional area of the rolled sealable member (60) has a diameter smaller than that of the aperture (the rolled sealable member would have to have a delivery cross-sectional area diameter small than that of the aperture to be delivered through it; pp. [0210]).
Further, Grant does not explicitly disclose, in the rolled configuration, the sealable member comprises a cross-sectional area smaller than a cross-sectional area of a 30 French aperture, and when in the sealing position, at least one dimension of the sealable member is larger than a diameter of a 6 French aperture.
Grant does teach that access sites the device is used to seal are approximately 10 to 30 French (pp. [0006]-[0007]). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the sealing member of Grant would necessarily have the rolled configuration be a cross-sectional area smaller than a 30 French aperture and the sealing position would have a dimension of the sealable member is larger than a diameter of a 6 French aperture as to seal the 10 to 30 French puncture holes Hunter teaches the device is used to seal.
Regarding claim 9, Grant in view of Hunter further teaches both the mesh layer (mesh of Hunter) and the flexible substrate (60) are composed of the same material comprising at least one material selected from the group consisting of Poly-L-lactide, Poly-DL-lactide, Polydioxanone, Polydioxanone, Polyglycolide, E-Caprolactone, Polyethylene glycol, and a copolymer thereof (Hunter teaches the mesh can be Poly-L-lactide, pp. [0817]; Grant teaches the flexible substrate can be Poly-L-lactide, pp. [0190]).
Regarding claim 10, Grant in view of Hunten further teaches at least one of the mesh layer (mesh of Hunter) and the flexible substrate (60) is formed at least in part of a material having an inherent viscosity in a range from 0.5 to 7.0 dl/g (both the mesh of Hunter and flexible substrate of Grant can be Poly-L-lactide, (see citations in claim 9 above); it is noted that Poly-L-lactide has a viscosity of ~2.0 dL/g).
Regarding claim 11, Grant further teaches teach the sealable member (60) is structured to flexibly roll when in a delivery configuration (pp. [0210]) such that a delivery cross-sectional area of the rolled sealable member (60) has a diameter smaller than that of the aperture (the rolled sealable member would have to have a delivery cross-sectional area diameter small than that of the aperture to be delivered through it; pp. [0210]).
Regarding claim 13, Grant further teaches thicknesses of each of the mesh layer (mesh of Hunter) and the flexible substrate (60) are less than 50% of a diameter of the aperture (see Fig. 6B; It is noted drawings must be evaluated for what they reasonably disclose and suggest to one of ordinary skill in the art. MPEP 2125. One of ordinary skill in the art would easily be able to understand the aperture 65 of the sealable member 60 would be about the same size as the aperture in the tissue (see also Fig. 1A) and the aperture 65 is over 50% larger than the thickness of the flexible substrate and the mesh of Hunter (the mesh of Hunter is taught as being 25 microns, pp. [0809).
Regarding claim 14, Grant further teaches a thickness of the sealable member (60) is at least one (1) mm smaller than a diameter of the aperture (the aperture is taught as being 10 to 30 French (about 3mm-30mm); pp. [0006])
However, Grant does not explicitly teach wherein a minimum thickness of the mesh layer is smaller than a minimum thickness of the flexible substrate.
Hunter teaches a minimum thickness of the mesh layer (e.g., 25 µm; [pp. 0809]) is smaller than a minimum thickness of the flexible substrate (e.g., 50 µm; pp. [0803]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sealable member of Grant to incorporate the teachings of Hunter by making a minimum thickness of the mesh layer smaller than a minimum thickness of the flexible substrate. Doing so would be a simple substitution of one known flexible substrate thickness for another to obtain predictable results of providing a sealable member for sealing an aperture in the body with a reasonable expectation of success.
Regarding claim 15, Grant further teaches that the thickness of the flexible substrate can vary such that the substrate could be thicker in its central region than in its circumferential periphery (pp. [0212]) but is silent as to the ratio between the thicknesses.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the invention of Grant to have a maximum thickness of the flexible substrate be at least 10 times greater than a minimum thickness of the flexible substrate since it has been held that "where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device" Gardner V. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the invention of Grant operates in the same manner as the claimed invention, and an invention having the claimed relative dimensions would not perform differently than the invention of Grant. Further, applicant places no criticality on the dimensions claimed, indicating simply that "In such embodiments, the second thickness (of the flexible substrate) is between about 40 pm and about 3000 pm, or between about 40 pm and about 8000 pm, or between about 40 pm and 20,000 pm (and greater), respectively, e.g., depending also on the size of the non-vascular body lumen." (Applicant's Specification, pp. [0015]).
Regarding claim 16, Hunter further teaches the mesh layer (mesh) comprises a plurality of fibers (pp. [0806]),
wherein a first portion of the plurality of fibers comprises a random orientation (pp. [0806]),
wherein a second portion of the plurality of fibers comprises a random orientation (pp. [0806]), and
wherein at least one of the flexible substrate (60 of Grant) and the mesh layer (mesh) comprises biocompatible material (the mesh can be made from expanded PTFE (pp. [0819] which is a biocompatible material; see pp. [0558]).
However, Hunter does not explicitly disclose each fiber having a diameter in a range from 0.3 µm to 8 µm. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the invention of Hunter to have each fiber having a diameter in a range from 0.3 µm to 8 µm since it has been held that "where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device" Gardner V. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the invention of Hunter operates in the same manner as the claimed invention, and an invention having the claimed relative dimensions would not perform differently than the invention of Hunter. Further, applicant places no criticality on the dimensions claimed, indicating simply that the fibers "are substantially (e.g., greater than 50% of the fibers) in the range of about 0.3 µm to about 8 µm in diameter." (Specification, pp. [0095]). In some instances, the fibers can have a diameter as low as 0.1 µm (Specification, pp. [0112]).
Regarding claim 17, Hunter further teaches the mesh layer (mesh) comprises a product of activated platelets (the mesh can include a fibrosis-inducing agent which would promote activated platelets; pp. [0822]).
Regarding claim 18, Hunter further teaches the mesh layer (mesh) comprises a copolymer (pp. [0818]),
wherein the mesh layer (mesh) is formed on, and covers, a top surface of the flexible substrate (film, pp. [0816]), and
Grant teaches a hole (65; Fig. 6A) formed through its sealable member (60) so that the anchorable member (20a) can extend through the sealable member (see Figs. 4E-4F).
Regarding claim 22, Grant further teaches the anchorable member (20a) further comprises a column portion (42a; Fig. 4A) that is disposed in the aperture when the implantable device is in the sealing position (see e.g., Fig. 1A), and
wherein the flexible substrate (60) is bioabsorbable (pp. [0042]) and Hunter teaches the mesh layer (mesh) is also bioabsorbable (pp. [0816]), thereby forming a flexible bilayer bioabsorbable polymer film when combining the two.
Regarding claim 25, Hunter further teaches the mesh layer (mesh) comprises a plurality of fibers (pp. [0806]), and wherein each fiber of the plurality of fibers is impregnated with one or more therapeutic agents (pp. [0827]) comprising at least one of an antibiotic and an anti- proliferative (pp. [0844]) such that the one or more therapeutic agents are impregnated within the structure of the mesh layer (mesh, pp. [0827]).
Regarding claim 26, Hunter further teaches the mesh layer (mesh) is disposed on the flexible substrate (film) between the flexible substrate and the internal surface (pp. [0816]).
Regarding claim 27, Grant further teaches the column portion (42a) is disposed through its sealable member (60) so that the anchorable member (20a) can support the sealable member (see Figs. 4E-4F) in the sealing position (pp. [0204]).
Regarding claim 28, Grant further teaches at least one guard member (80c; Fig. 8B), wherein the at least one guard member (80c) is engageable with an engagement portion (e.g., 20c; Fig. 8B) of the anchorable member (20a), the engagement portion (20c) configured to enable engagement of the at least one guard member (80c) against an exterior surface of the tissue when the implantable device is in a sealing position (pp. [0219]), and wherein the at least one guard member (80c) comprises a slotted cage (it is noted, there is no structure discussed in the specification or shown in the drawings of the instant applications to clearly define what Applicant means by "slotted cage." Guard member 80c has bar like prongs separated by slots forming a cage structure; therefore, guard member 80c is considered a "slotted cage.").
Regarding claim 30, Grant further teaches the body lumen comprises a blood vessel (pp. [0182]), and wherein the internal surface of the tissue comprises an internal surface of the blood vessel (see Fig. 1A).
Claim(s) 4 and 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grant in view of Hunter, in view of Rousseau, and further in view of Arcand, et. al. (U.S. Pub. No. 2014/0088343) hereinafter, "Arcand."
Regarding claim 4, Grant further teaches the sealable member (60) comprises a bioabsorbable polymer film (pp. [0041]), wherein the bioabsorbable polymer film (60), when introduced into cells, is broken down by at degradation (pp. [0042]).
However, Grant does not explicitly disclose the degradation as enzymatic degradation. Arcand teaches a sealable member (12; Fig. 3) with a bioabsorbable polymer film (pp. [0048]) when introduced into cells, is broken down by enzymatic degradation (pp. [0048]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the degradation properties of the polymer film covered sealable member of Grant to incorporate the teachings of Arcand by providing a polymer film that degrades by enzymatic degradation. Doing so would be a simple substitution of one known degradation property of a polymer film for another to obtain predictable results of providing a surgical mesh with a degradable polymer film with a reasonable expectation of success.
Regarding claim 19, Hunter further teaches the mesh layer (mesh) comprises a plurality of fibers (pp. [0806]) each shaped and sized to promote platelet capture (it is noted that is functional language, and therefore the reference only needs to be capable of performing the recited function. The mesh has sufficient porosity to facilitate tissue ingrowth; pp. [0808]), and wherein, when in contact with collagen from an exposed wound, one or more captured platelets encourages localized platelet activation thereby forming a sutureless seal (the "mesh may be composed of a prosthetic fabric having a 3-dimensional structure separating two surfaces in which one is open to post-surgical cell colonization," pp. [0821], see also pp. [0834] describing several ways the seal can be adhered without sutures).
However, Grant in view of Hunter does not explicitly disclose the spacing between the fibers is at least 2 µm.
There is no evidence of record that establishes that changing the spacing between the fibers would result in a difference in function in the device of Grant. Further, a person having ordinary skill in the art, being faced with modifying the fibers of the mesh of Grant would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed spacing. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that "spacing between the fibers may be about or greater than 2-3 µm," but "other thicknesses and spacing among the fibers may be employed" (Specification pp. [0095}]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the spacing of the fibers of Grant to have a range of at least 2 µm as an obvious matter of design choice within the skill of the art.
Regarding claim 20, Hunter further teaches one or more activated platelets adhere to a collagen surface thereby creating fibrins (the "mesh may be a film composed of hetero- bifunctional anti-adhesion binding agents that act to covalently link substrate materials, such as collagen, to receptive tissue."; pp. [0821]).
However, Grant in view of Hunter does not explicitly disclose the spacing between the fibers is in a range from about 2 µm to about 3 µm.
There is no evidence of record that establishes that changing the spacing between the fibers would result in a difference in function in the device of Grant. Further, a person having ordinary skill in the art, being faced with modifying the fibers of the mesh of Grant would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed spacing. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that "spacing between the fibers may be about or greater than 2-3 µm," but "other thicknesses and spacing among the fibers may be employed" (Specification pp. [0095]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the spacing of the fibers of Grant to have a range from about 2 µm to about 3 µm as an obvious matter of design choice within the skill of the art.
Claim(s) 21 and 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grant in view of Hunter, in view of Rousseau, in view of Arcand, and further in view of Stanford, et. al. (U.S. Pub. No. 2002/0115942) hereinafter, "Stanford."
Regarding claim 21, Hunter further teaches the mesh layer (mesh) comprises a material with low thrombogenicity (expanded PTFE (pp. [0819]) which is known for having a low thrombogenicity),
and Grant teaches the sealable member (60) comprises a textured surface (pp. [0250]) to engage against the internal surface of the tissue adjacent the aperture.
However, Grant in view of Hunter does not explicitly teach the mesh layer comprises a non-thrombogenic surface.
Stanford teaches applying a non-thrombogenic coating to a surgical mesh (pp. [0051]).
Stanford is considered to be analogous to the claimed invention because it is in the same field of surgical meshes used within the body. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the mesh of Grant in view of Hunter to incorporate the teachings of Stanford by providing a non-thrombogenic coating on the surface of the mesh. Doing so would prevent clots from forming on the mesh surface, as recognized by Stanford (pp. [0051]).
Regarding claim 29, Grant further teaches at least one guard member (80; Fig. 7B), wherein the at least one guard member (80) is engageable with an engagement portion (46a; Fig. 4A (seen as 46 in Fig. 7A)) of the anchorable member (20a), the engagement portion (46a) configured to enable engagement of the at least one guard member (80) against an exterior surface of the tissue when the implantable device is in a sealing position (pp. [0214]), and wherein the at least one guard member (80) comprises an extraluminal pin (pp. [0214]).
It is noted above Granted discloses “wherein the at least one guard member (80c) comprises a slotted cage (it is noted, there is no structure discussed in the specification or shown in the drawings of the instant applications to clearly define what Applicant means by "slotted cage." Guard member 80c has bar like prongs separated by slots forming a cage structure; therefore, guard member 80c is considered a "slotted cage.").”
Response to Arguments
Applicant's arguments filed 8/10/26 have been fully considered but they are not persuasive.
On page 8 Applicant argues Grant fails to teach rolled to less than 30 French aperture and diameter deployed exceeds 6 French aperture. Grant teaches the access site is 10-30 French, thus to cover the access site, the diameter is greater than 6 French. If the access site is 10-30 French, the device is rolled to less than 30 French to fit in the access site. Furthermore, as pointed out none of the dimensions contain criticality and are obvious ranges see in re Gardner.
On page 9 Applicant argues electrospun – this is taught by “Hunter teaches a sealable member (multilayer device, pp. [0815]) with a mesh layer (mesh, pp. [0815]) comprising an electrospun material (0818) configured for platelet impregnation having a textured surface (the mesh is taught as having a "porosity" which is a texture, pp. [0808], further, a mesh having a porous texture would be configured to gather platelets) on a flexible substrate (pp. [0815]) for use with bodily conduits (pp.[0834]).” Applicant argues Rousseau however the electrospun is taught by Hunter. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
On page 9, Applicant argues the larger surface area limitation, however “Rousseau teaches a configuration between two joined mesh layers (12 and 14; Fig. 3) with a separate layer (16; Fig. 3) disposed between the mesh layers such that the mesh layer (12 and 14) have a larger surface area than the flexible substrate (13, see portions 24 of the mesh in Fig. 3 extending beyond the edges of layer 16 so that the mesh layers can be joined together, wherein the flexible substrate if opposite the mesh layer”. This section does in fact discuss surface area relative to other contrary to Applicant’s arguments on page 9.
On page 9, Applicant argues the modification using Rousseau however arguments that there is nothing to join are not persuasive. Applicant has not precluded the use of multiple layers in the claim construction. Joining layers together is well known in the art.
On page 10 Applicant argues “a mesh that is capable of receiving platelets is not a mesh that comprises platelet impregnated mesh layer” but admits that Albertorio teaches this – see [0024] “the mesh may be provided with … platelet rich plasma” – so Albertorio teaches a mesh with platelets in it – or platelet impregnated mesh layer. Arguments pertaining to functional limitations are not persuasive as . In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
On page 11 Applicant argues the references are not combinable. In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, 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). The Examiner disagrees that in all cases, treating a vascular graft with PRP would constitute teaching away/destroy reference – for example see WO 2025159557 1.13 “The surface of the vascular graft was treated with platelet-rich plasma (PRP)”. It is generally well known in the vascular arts that both inhibiting thrombosis and promoting thrombosis are often taught.
On Page 12 Applicant argues the product by process limitation of “extruded layer” – Applicant has provided no evidence that the products of references would be different from their own – which is required by MPEP 2113 – the burden shifts to Applicant to prove. See: MPEP 2113
II. ONCE A PRODUCT APPEARING TO BE SUBSTANTIALLY IDENTICAL IS FOUND AND A PRIOR ART REJECTION IS MADE, THE BURDEN SHIFTS TO THE APPLICANT TO SHOW AN NONOBVIOUS DIFFERENCE
“The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature” than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974). Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an nonobvious difference between the claimed product and the prior art product. In re Marosi, 710 F.2d 799, 803, 218 USPQ 289, 292-33 (Fed. Cir. 1983) (The claims were directed to a zeolite manufactured by mixing together various inorganic materials in solution and heating the resultant gel to form a crystalline metal silicate essentially free of alkali metal. The prior art described a process of making a zeolite which, after ion exchange to remove alkali metal, appeared to be “essentially free of alkali metal.” The court upheld the rejection because the applicant had not come forward with any evidence that the prior art was not “essentially free of alkali metal” and therefore a different and nonobvious product.).
See also Ex parte Gray, 10 USPQ2d 1922 (Bd. Pat. App. & Inter. 1989) (The prior art disclosed human nerve growth factor (b-NGF) isolated from human placental tissue. The claim was directed to b-NGF produced through genetic engineering techniques. The factor produced seemed to be substantially the same whether isolated from tissue or produced through genetic engineering. While the applicant questioned the purity of the prior art factor, no concrete evidence of an nonobvious difference was presented. The Board stated that the dispositive issue is whether the claimed factor exhibits any unexpected properties compared with the factor disclosed by the prior art. The Board further stated that the applicant should have made some comparison between the two factors to establish unexpected properties since the materials appeared to be identical or only slightly different.).
Applicant has provided no evidence; mere allegations of patentability.
On page 13 Applicant argues that Arcand is non-analogous art. In order to determine if art is non-analogous, “A reference is analogous art to the claimed invention if: (1) the reference is from the same field of endeavor as the claimed invention (even if it addresses a different problem); or (2) the reference is reasonably pertinent to the problem faced by the inventor (even if it is not in the same field of endeavor as the claimed invention). Note that "same field of endeavor" and "reasonably pertinent" are two separate tests for establishing analogous art; it is not necessary for a reference to fulfill both tests in order to qualify as analogous art. See Bigio, 381 F.3d at 1325, 72 USPQ2d at 1212.” See MPEP 2141.01(a). Applicant’s arguments that two implantable medical devices are not analogous art is not persuasive, and they are the same field of endeavor- implanted medical devices.
Regarding arguments on page 14, as pointed out by Applicant the slotted cage limitation is addressed in the rejection in paragraph 10 and one version of claim 28. The typo where pin was not changed to cage has been updated as this was previously rejected and made of record.
Regarding arguments regarding no 112 rejection of “slotted cage” – it is noted that broad is not indefinite. Examiner is merely putting on the record the term is being given the broadest reasonable interpretation and no 112 rejected is required. Applicant has provided no structure to define “slotted cage” nor a drawing (which would be new matter) thus the broadest reasonable interpretation is appropriate in this case.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY REGINA WEISBERG whose telephone number is (571)270-5500. The examiner can normally be reached M-F 8:15-4:15.
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/AMY R WEISBERG/Supervisory Patent Examiner, Art Unit 3612
