DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on December 10, 2025 has been entered.
Response to Amendment
This office action is in response to the request for continued examination filed December 10, 2025. Claim(s) 1, 9, 22, and 28-29 are amended. Claim 30 is newly added. Claim(s) 2-3, 5-8, 12, and 23-24 are canceled. Claim(s) 1, 4, 9-11, 13-22, and 25-30 are pending and addressed below.
Response to Arguments
Applicant’s amendments to the claims have overcome each and every drawing and claim objection set forth in the Final Office Action dates September 11, 2025.
Applicant's arguments filed December 10, 2025 have been fully considered but they are not persuasive.
General Arguments with respect to Hunter (U.S. Pub. No. 2005/0143817) and Grant (U.S. Pub. No. 2013/0274795)
First applicant argues that hunter is improperly combined with Grant because Hunter is directed to methods and uses for anti-scaring agents, not for vascular closure. Examiner respectfully disagrees as Hunter teaches use of vascular grafts (pp. [0747]) as well as using films and meshes with any bodily conduit (e.g., a vessel lumen) or tissue that may be prone to development of fibrosis (pp. [0834]) which would include use with vasculature. Therefore, Hunter is relevant to vascular closure devices.
Second, Applicant argues that the scope of Hunter is so diverse and wide that there is no clear frame of reference for a person of ordinary skill in the art to use Hunter. However, the MPEP does not preclude a reference from being prior art because of its length. Further, Examiner primarily cites to specific paragraphs between [0800] and [0844] of Hunter which spans 7 pages. Therefore, this argument is unpersuasive.
Third applicant argues that Hunter does not suggests a multi-layer devices used in intravascular applications. However, as addressed with the first argument, Hunter teaches use of vascular grafts (pp. [0747]) as well as using multi-layered films and meshes with any bodily conduit (e.g., a vessel lumen) or tissue that may be prone to development of fibrosis (pp. [0834]) which would include use with vasculature. Therefore, this argument is unpersuasive.
Finally Applicant argues that there would not be motivation to combine Grant with Hunter because Grant does not require nor suggest the benefits of using an anti-scaring agent in any capacity. However, the motivation for combining references does not come from the base reference (i.e., Grant), but instead from the modifying reference (i.e., Hunter). One having skill in the art would be motivated to combine the references of the implant of Grant in view of Hunter because of the benefits taught by Hunter (e.g., reducing scaring at an implant site pp. [0801]). Therefore, this argument is unpersuasive.
Arguments with respect to newly amended claim 1
Applicant argues that the newly amended claim language of the sealable member having a cross-sectional area within a first dimensional range when in a rolled configuration and a second dimensional range when in a sealing configuration is not taught, suggested, or disclosed by the cited references. Examiner respectfully disagrees. While none of the references explicitly teach the claimed language, Grant teaches the sealing member has a rolled configuration and a sealing configuration and also teaches the device is used with an aperture having the claimed ranges (pp. [0006]-[0007] of Grant). It would have been obvious to one of ordinary skill in the art the sealing member of Grant would have the claimed dimensional ranges based on the disclosed size of aperture the sealing device is delivery through and used to seal (see rejection below).
Arguments with respect to claim 1 and the combination of Hunter in view of Albertorio (U.S. Pub. No. 2010/0324608)
Applicant argues that modifying Hunter in view of Albertorio to replace the fibrosis-inducing agent of Hunter with a platelet impregnated mesh layer as taught in Albertorio would not have been obvious as Hunter generally discusses fibrosis-inhibiting agents instead of fibrosis inducing agents. Applicants supports this claim by citing 491 instances of the term “fibrosis-inhibiting” in Hunter’s disclosure compared to 13 instances of “fibrosis-inducing.” Applicants further argues that Hunter generally teaches fibrosis-inhibiting agents in contact with the wound (see pp. [1050] and [0394]) and fibrosis-inducing agents on the opposite side of the device (see pp. [0047]). However, “[d]isclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments…. Furthermore, [t]he prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed….” (MPEP 2123). While Hunter does teach the benefit of using fibrosis-inhibiting agents in its disclosure, nowhere does it specifically teach away from using a fibrosis-inducing agent. In fact, Hunter teaches that fibrosis inducing agents can be used, and the meshes disclosed can be used in other surgical procedures than those discussed, as cited in the previous office action (pp. [0822]). Additionally, paragraph [1050] cited by Applicant discloses uses specifically with spinal implants while paragraphs [0800]-[0844] cited by Examiner disclose meshes and films broadly, and paragraph [0394] cited by Applicants discloses applying fibrosis-inhibiting agents directly to the surface of tissue through pastes and gels as opposed to delivery through a mesh or film. Therefore, these cited sections are not relevant to the cited sections in the office action, and the argument is unpersuasive.
Arguments with respect to claim 4 and Arcand (U.S. Pub. No. 2014/0088343)
Applicant argues the reference of Arcand is not analogous to the claimed invention because it is in the field of “film encapsulated pelvic implants system[s] and method[s]” while Applicant’s disclosure is in the field of vascular closure devices. As cited by Applicant, "[a] reference outside of the field of endeavor is reasonably pertinent if a person of ordinary skill would have consulted it and applied its teachings when faced with the problem that the inventor was trying to solve." MPEP 2141.01(a) citing Airbus S.A.S. V. Firepass Corp., 41 F.3d at 1380-82. While Arcand teaches meshes specifically for pelvic floor prolapse, Arcand also teaches broad benefits of biocompatible polymers that can be used for coatings and implants (pp. [0048]). Some of the benefits listed are providing a foundation for cells to adhere to, or grow on, in order to better incorporate the implant at the treatment site and to reduce the inflammatory response of the implant (pp. [0048]). A person of ordinary skill viewing Grant, which deals with deploying a sealing implant within vasculature, would certainly look to other implants used within the body that address securing implants within the body while also reducing any inflammation associated with implantation as taught by Arcand. Therefore, Arcand’s disclosure is pertinent to the implant of Grant.
Arguments with respect to claim 20
Applicant argues that the claimed range of spacing between the fibers in a range from about 2 µm to about 3 µm recited in claim 20 is not a matter of design choice. Applicant points to “improved performance of the ‘New Device’ compared to the ‘Current Device’” as shown in Tables 4 and 5 and Figures 10A, 10B, 11A, and 11B, wherein the improved performance is alleged to be due to the fiber spacing. However, the “Current Device” is not disclosed as having an inferior fiber spacing, which upon adjusting to the claimed range of about 2 µm to about 3 µm, would lead to the improved performance of the “New Device.” Instead, the “Current Device” is disclosed as having no mesh at all (“a non-mesh sealable member,” Specification pp. [0138]). It appears based on Tables 4 and 5 and Figures 10A, 10B, 11A, and 11B that providing a mesh to the sealable member improves total leakage verses a device with no mesh at all as opposed to the specific spacing of the fibers of the mesh providing the advantage. As presented in the previous rejection, there is no evidence of record that establishes that changing the spacing between the fibers of the mesh would result in a difference in function. Further, Applicant teaches “other thicknesses and spacing among the fibers may be employed” (Specification pp. [0095]) further indicating a lack of criticality of the claimed range. 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.
Applicant further argues that the rejection of claim 20 used improper hindsight because there was no identified teaching, suggestion, or motivation as to why a person of ordinary skill in the art would want to modify the fibers. However, Examiner’s rejection does not rely on some teaching, suggestion, or motivation in the prior art, but rather indicates, modifying the fibers of the mesh of modified Grant would be a simple matter of design choice, as taught by case law, as 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 modified Grant and Applicant has not disclosed any criticality of the claimed range or 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]). MPEP 2144.04(IV)(A) citing Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 9-11, 15-18, 22-23, 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]) 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.
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]).
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 23, Hunter in view of Grant teaches the invention as discussed above in claim 1. Hunter further teaches the flexible substrate (film) and the mesh layer (mesh) form a flexible bilayer bioabsorbable polymer film (pp. [0816]).
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 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]) 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 a 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.
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.
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 cross-sectional area 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 larger than a cross-sectional area of a 6 French aperture to allow the sealable member to be delivered through and 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 Hunter 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 (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]).
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]).
Conclusion
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/DANIEL ICET/ Examiner, Art Unit 3771
/ELIZABETH HOUSTON/ Supervisory Patent Examiner, Art Unit 3771