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 .
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-14, 16, 20-27, 29, 30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2020/225698 to Rolando.
As to claim 1, Rolando discloses a recrossable closure device for treating a patient (paragraph 23, 58), the closure device comprising: an anchor structure (2, paragraph 58, figure 2,3) configured to extend through an opening in an anatomical structure (figure 1, 3, paragraph 60) separating a first body region (101) and a second body region (102) of the patient, wherein the anchor structure is configured to anchor the device to the anatomical structure (paragraph 60, figure 3), and has an aperture (lumen 4, that the central support structure 3 delimits, paragraph 58, figure 2,33) spanning at least a portion thereof; and a membrane (8, paragraph 62) coupled to the anchor structure and covering the aperture, wherein, when the device is implanted in the opening, the membrane is configured to fluidly separate the first body region and the second body region (paragraph 62, 64, 70 figure 3 the membrane closed the majority of the lumen which can fluidly separate the first and second body region), wherein, after implantation, the device is configured to enable a recrossing of a surgical tool between the first body region and the second body region via puncturing of the membrane to provide access therebetween (paragraph 63), and wherein the device is further configured to limit tearing of patient tissue during the recrossing (paragraph 64, 90-93, via 21; 30, paragraph 112-119, 308; or 40, paragraph 132-134 ). The occluding ribs 21, threads 40, and/or the stiffening structure 30 can help to limit tearing of the patient tissue during recrossing. The application of the present invention states “that structural members helps to prevent tearing … by acting as reinforcement or stress distribution points”. Therefore, elements that reinforce the membrane or help to distribute forces/stress can help prevent tearing. The stiffening structure 30 can reinforce the membrane 8. Alternatively the occluding ribs 21 can distribute the stress based on the elastic nature of the diaphragm. The ribs 21 will guide the device through the opening and thereby reduce stress. Alternatively, the elastic thread 4 which makes up the membrane 8 can act as a structural member which can provide reinforcement as the tool crosses the membrane. Of note: the different embodiments of the diaphragm 8 of Rolando will be able to read on the membrane, as well as tearing limiting.
As to claim 2, Rolando discloses the anchor structure has a neck portion (3) configured to extend through the opening in the anatomical structure (figure 3), and wherein the neck portion is transitionable between a low-profile delivery configuration and a deployed configuration (paragraph 60).
As to claim 3, Rolando discloses the neck portion is configured to change a shape of the opening when positioned within the opening and transitioned between the low-profile delivery configuration and the deployed configuration (paragraph 60, 305, the device is expandable and can widen the hole in the anatomical structure).
As to claim 4, Rolando discloses the neck portion is configured to increase a dimension of the opening when positioned within the opening and transitioned between the low-profile delivery configuration and the deployed configuration (paragraph 60, 305).
As to claim 5, Rolando discloses a closure device for treating a patient (paragraph 23, 58), the closure device comprising: an anchor structure (2, figure 2, 3, paragraph 58-60) configured to extend through an opening in an anatomical structure (figure 1, 3, paragraph 60) separating a first body region (101) and a second body region (102), wherein the anchor structure is configured to anchor the device to the anatomical structure (paragraph 60), and has an aperture (lumen 4, that the central support structure 3 delimits, paragraph 58, figure 2,33) spanning at least a portion thereof; a membrane (8) coupled to the anchor structure and covering the aperture (figure 3, paragraph 62, 70), wherein, when the device is implanted in the opening, the membrane is configured to fluidly separate the first body region and the second body region (paragraph 70); and one or more structural members (21, paragraph 64-69; 30, paragraph 112-119, 308;) extending at least partially across the aperture, wherein the one or more structural members are embedded within or otherwise coupled to the membrane (paragraph 64-69, 94; or 112-119; 132-134, the occluding bridges or the stiffening structure are a part of the diaphragm), and wherein the one or more structural members are at least partially deformable (paragraph 90, 119, 138, 311 the membrane/occluding bridges and stiffening member (bridges) are all made of an elastic material, which can therefore be deformable). Of note: the different embodiments of the diaphragm 8 with different types of occluding members 21 and supporting structure 40 can read on the “membrane” and “structural members” with respect to dependent claims as argued below.
As to claim 6, Rolando discloses the anchor structure has a neck portion (3) configured to extend through the opening in the anatomical structure (figure 3), and wherein the neck portion is transitionable between a low-profile delivery configuration and a deployed configuration (paragraph 60).
As to claim 7, Rolando discloses the neck portion is configured to change a shape of the opening when positioned within the opening and transitioned between the low-profile delivery configuration and the deployed configuration (paragraph 60, 305 the device is expandable and can widen the hole in the anatomical structure).
As to claim 8, Rolando discloses the neck portion is configured to increase a dimension of the opening when positioned within the opening and transitioned between the low-profile delivery configuration and the deployed configuration (paragraph 60, 305).
As to claim 9, Rolando discloses the one or more structural members are configured to deform relative to a preferred orientation (preferred orientation is interpreted to be the at rest configuration where no tool is crossing the membrane) when contacted by a percutaneous tool to facilitate crossing of the percutaneous tool through the closure device (figure 6, paragraph 91). The diaphragm is elastic, as well as the stiffening members 40 and/or the occluding bridges 21. As seen in figure 6, the device is configured to deform to allow the tool to cross therethrough.
As to claim 10, Rolando discloses the one or more structural members are parallel to a plane defined by the membrane (figure 2, 6, 7a-e, 25), and wherein the one or more structural members are configured to remain within the plane defined by the membrane when deformed. The occluding bridges and stiffening remain within the membrane, and therefore will remind within the plane of the membrane when the membrane is deformed.
As to claim 11, Rolando discloses, when in the preferred orientation, the one or more structural members are parallel to a plane defined by the membrane (figure 7a-e,8a,b, paragraph 103), and wherein the one or more structural members are configured to deflect in a direction normal to the plane defined by the membrane when deformed (figure 9, 10, 15, paragraph 103, 109, 110, 113, 119). The ribs that are interlaced can extend in the normal direction to the plane as the tool crosses the membrane. Alternatively, the stiffening members can also extend in the normal direction as the tools crosses the membrane based on the stiffening members are oriented on the membrane.
As to claim 12, Rolando discloses the one or more structural members are elastic or superelastic such that the one or more structural members are configured to automatically return toward the preferred orientation following removal of the percutaneous tool (paragraph 90-93, 119, 131-141, 195-197, 219, 221, 226-236, 257, 268). The elastic nature of the ribs and/or support member will allow “the structural members” to automatically return to the preferred orientation.
As to claim 13, Rolando discloses the one or more structural members are coupled to the anchor structure (figure 2, 3, 25, paragraph 167, 179, 242). The diaphragm 8 is coupled to the support structure 2. Therefore the occluding bridges (structural members) can be coupled to the support structure (anchor structure).
As to claim 14, Rolando discloses the one or more structural members form a grid-like shape over the aperture (figure 9, 32). The overlapping occluding bridges can read on a grid-like structure.
As to claim 16, Rolando discloses the one or more structural members are configured to reduce tearing of the membrane and/or reduce tearing of patient tissue overgrown over the membrane (paragraph 64, 90-93, via 21; 30, paragraph 112-119, 308; or 40, paragraph 132-134 ). The occluding ribs 21, threads 40, and/or the stiffening structure 30 can help to limit tearing of the patient tissue during recrossing. The application of the present invention states “that structural members helps to prevent tearing … by acting as reinforcement or stress distribution points”. Therefore, elements that reinforce the membrane or help to distribute forces/stress can help prevent tearing. The stiffening structure 30 can reinforce the membrane 8. Alternatively the occluding ribs 21 can distribute the stress based on the elastic nature of the diaphragm. The ribs 21 will guide the device through the opening and thereby reduce stress.
As to claim 20, Rolando discloses a closure device for treating a patient (paragraph 23, 58), the closure device comprising: an anchor structure (2, figure 2, 3, paragraph 58-60) configured to extend through an opening in an anatomical structure (figure 1, 3, paragraph 60) separating a first body region (101) and a second body region (102), wherein the anchor structure is configured to anchor the device to the anatomical structure (paragraph 60, figure 3), and has an aperture (lumen 4 that the central support structure 3 delimits, paragraph 58, figure 2,3) spanning at least a portion thereof; a membrane (8) carried by the anchor structure and covering the aperture, wherein, when the device is implanted in the opening, the membrane is configured to fluidly separate the first body region and the second body region (paragraph 71), and wherein the membrane includes— one or more first regions (regions contacting the occluding bridges 21, threads 40, stiffening structures 30 paragraph 112-119, and/or “reinforcing material” of figure 25, paragraph 308) having a first set of mechanical properties, and one or more second regions (the regions with the cuts 27) having a second set of mechanical properties different than the first set of mechanical properties (the occluding bridges, threads, stiffening structures, and/or reinforcing material will have a different stronger, sturdy, mechanical property than the regions with the slots that will allow a tool to pass), wherein, after implantation, the device is configured to enable a recrossing of a surgical tool between the first body region and the second body region via puncturing of an individual second region of the one or more second regions of the membrane (paragraph 63), and wherein the one or more first regions of the membrane are configured to contain tearing of the membrane to the individual second region (paragraph 64, 90-93, via 21; 30, paragraph 112-119, 308; or 40, paragraph 132-134 ). The occluding ribs 21, threads 40, and/or the stiffening structure 30 can help to limit tearing of the patient tissue during recrossing. The application of the present invention states “that structural members helps to prevent tearing … by acting as reinforcement or stress distribution points”. Therefore, elements that reinforce the membrane or help to distribute forces/stress can help prevent tearing. The stiffening structure 30 can reinforce the membrane 8. Alternatively the occluding ribs 21 can distribute the stress based on the elastic nature of the diaphragm. The ribs 21 will guide the device through the opening and thereby reduce stress. Alternatively, the elastic thread 4 which makes up the membrane 8 can act as a structural member which can provide reinforcement as the tool crosses the membrane. Of note: the different embodiments of the diaphragm 8 of Rolando will be able to read on the membrane, as well as tearing limiting.
As to claim 21, Rolando discloses the one or more first regions are configured to dilate without tearing to accommodate the surgical tool during recrossing (paragraph 70, 91-93, 119, 131-137, 141, 219, 221, 226-229, 257, 313). The first regions will have the bridges/ribs/wires that are able elastically move to accommodate the tool, which can allow the device to dilate without tearing.
As to claim 22, Rolando discloses the one or more first regions are biased toward a pre-dilated configuration (paragraph 70). The diaphragm can move, when not urged, to the occlusion position which can be the pre-dilated configuration.
As to claim 23, Rolando discloses wherein the one or more first regions and the one or more second regions are formed by a contiguous piece of material (paragraph 94, 95, figure 2, 3).
As to claim 24, Rolando discloses the membrane includes a porous structure (figure 5, the cuts 27 allow for the membrane to be a porous structure) forming the one or more first regions and a laminate portion (the second diaphragm 8 can read on the laminate structure) covering the porous structure, and wherein material forming the porous structure corresponds to the one or more first regions and openings in the porous structure correspond to the one or more second regions (paragraph 33, figure 5).
As to claim 25, Rolando discloses the one or more first regions have a first thickness and the one or more second regions have a second thickness (figure 8b, 25), and wherein the first thickness is greater than the second thickness (figure 8b, 25). The region with the bridges/support member will have a greater thickness than a region that comprise the slots 27.
As to claim 26, Rolando discloses the device is configured such that, after a recrossing of the surgical tool, a residual hole in the membrane has a length that is smaller than a diameter of the surgical tool (paragraph 70). The membrane will return to the occlusion position after the tool is crossed, which will allow a length to be smaller than a diameter of the tool.
As to claim 27, Rolando discloses a method of closing an opening in an anatomical structure, the method comprising: implanting a closure device (1) within the opening such that an expandable neck portion (3, paragraph 60, 71, 305) of the closure device passes through the opening; and expanding the expandable neck portion of the closure device to a deployed configuration, wherein expanding the neck portion of the closure device to the deployed configuration (1) reshapes the opening (paragraph 305) and (2) increases at least one dimension associated with the opening (paragraph 305), wherein the closure device includes a membrane (8) that at least partially seals the opening when the closure device is in the deployed configuration (paragraph 70).
As to claim 29, Rolando discloses the at least one dimension is a surface area of the opening (paragraph 305, the widening will increase the surface area).
As to claim 30, Rolando discloses the at least one dimension is a diameter of the opening (paragraph 305, the widening will increase the diameter).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 15 is rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over WO 2020/225698 to Rolando in view of U.S. Patent Publication 2011/0306916 to Nitzan.
As to claim 15, Rolando discloses the one or more structural members extend radially inward from the anchor structure toward a central portion of the aperture, and wherein each of the one or more structural members includes a free end unconnected to the anchor structure (figure 25, paragraph 216, 308). Rolando seems to disclose a stiffening structure that has a rib extending along a diameter and the device of figure 25 has a reinforcing material. The specific structure is not highlighted in the figure but can be interpreted to be the members as shown in the annotated figure below. The member seems to have a free end that is not attached to the anchor structure 2.
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If it would not be interpreted that Rolando would be able to read on the structural members extending radially inward and having a free end, Nitzan teaches a similar device (device for positioning in a septal defect, abstract) having structural members extend radially inward from the anchor structure toward a central portion of the aperture, and wherein each of the one or more structural members includes a free end unconnected to the anchor structure (figure 6a, paragraph 121-122) for the purpose of supporting a membrane. The arms of Nitzan are used to support a valve/membrane which opens and closes as desired, similar to the diaphragm of Rolando. The arms of Nitzan are used to support the valve/membrane. Having the structural members of Rolando extend radially inward and have a free end, similar to that of Nitzen, can be an alternative orientation of the shaping mechanism which can support the membrane and yield the predicable result of allowing the diaphragm to stay closed, but can flex open when the tools is passed therethrough. It would have been obvious to one of ordinary skill in the art before the effective filing date to have the one or more structural members of Rolando extend radially inward from the anchor structure toward a central portion of the aperture, and wherein each of the one or more structural members includes a free end unconnected to the anchor structure in order for using an alternative orientation of members for supporting a membrane.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over WO 2020/225698 to Rolando in view of U.S. Patent Publication 2008/0147111 to Johnson.
As to claim 17, Rolando discloses the device but is silent about the one or more structural members include a honeycomb structure having a plurality of openings extending therethrough. Rolando does disclose the diaphragm can be made of a braiding of elastic wires (figure 11-13, 33, paragraph 131-134, 141, 253), where the wires can read on the structural members. The wires can be braided and/or be a part of multiple diaphragm layers.
Johnson teaches a similar device (membrane device, abstract), having a membrane like element made of a wires that form cells of any shape including a hexagonal shape (figure 54a-c, 55a-d, 59a-g, 60a-e, paragraph 145-149) for the purpose of forming a variety of different shape and sized cells for a filter-like structure. The teaching of the cell shape of Johnson can be applied to the wires that form the diaphragm of Rolando which would then result in a honeycomb structure. Using a honeycomb structure in the device of Rolando would yield the predictable result of have a membrane that can prevent unwanted elements from passing through. It would have been obvious to one of ordinary skill in the art before the effective filing date to have the structural members of Rolando include a honeycomb structure having a plurality of openings extending therethrough in order for trying different sized and shaped cells formed by the wires as desired to filter out unwanted material from passing through.
Claim 18 is rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over WO 2020/225698 to Rolando in view of U.S. Patent Publication 2016/0331382 to Center.
As to claim 18, Rolando discloses the membrane has a textured surface (figure 5, 9). The membrane of Rolando can have two diaphragms 8 that will be coupled together at least based on the anchoring structure. One diaphragm can have the occluding bridges 21 which will read on the mechanism for limiting tearing. The other diaphragm will have the slits 27 which can provide the textured surface of the membrane.
If it would not be known that Rolando would be able to read on the textured membrane, Center teaches a similar device (occlusion device) having a membrane with a textured surface (paragraph 102) for the purpose of providing beneficial mechanism properties and tissue response interactions to the membrane. It would have been obvious to one of ordinary skill in the art before the effective filing date to have the membrane of Rolando have a textured surface in order for obtaining beneficial mechanism properties and tissue response interactions.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over WO 2020/225698 to Rolando.
As to claim 19, Rolando discloses the device above but is silent about the membrane has a durometer of between about 75A and 90A. Rolando discloses the membrane is made of an elastic material that is capable of deformation (paragraph 90, 91, 301) as well as having the device be characterized for a specific design adapted to optimize the functionality of the device. Rolando discloses the membrane/diaphragm is configured to occlude the lumen but movable when desired (paragraph 70, 71. As seen in paragraph 27 of the application, membrane have structural properties to mimic tissue proximate the opening and provide similar resistance to puncture. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of Rolando by making the durometer of the membrane be between 75A and 90A as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim 28 is rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over WO 2020/225698 to Rolando in view of U.S. Patent Publication 2017/0224323 to Rowe.
As to claim 28, Rolando discloses implanting the closure device includes advancing the closure device from a catheter, and wherein expanding the expandable neck portion includes automatically expanding the neck portion upon deployment of the closure device from the catheter (paragraph 60, 70, 149, 309, 310). Rolando discloses the device is elastic and will expand once it is delivered and that it can be used with a delivery catheter. Therefore, the expandable neck of the device will automatically expand upon deployment from a catheter.
If it would not be known that the Rolando would be able to read on a method step of advancing the closure device from a catheter, and automatically expanding the neck portion upon deployment from the catheter, Rowe teaches a similar device and method (septal closure, abstract) comprising advancing a closure device (20) from a catheter (102), and automatically expanding a neck portion (30) upon deployment from the catheter (figure 5-10, paragraph 35, 50-52) in order for deploy the device at the desired site. It would have been obvious to one of ordinary skill in the art before the effective filing date to have the method of Rolando include advancing the closure device from a catheter, and automatically expanding the neck portion upon deployment from the catheter in order for being able to deploy the device at the desired site.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDER J ORKIN whose telephone number is (571)270-7412. The examiner can normally be reached Monday - Friday 9am - 5pm.
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/ALEXANDER J ORKIN/Primary Examiner, Art Unit 3771