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 .
Election/Restrictions
Applicant’s election without traverse of Species H, Figures 12A, 12B in the reply filed on 3/5/26 is acknowledged.
Claim Objections
Claim 11 is objected to because of the following informalities: claims 9-10 discloses “with disk coating” and should be changed to “with disk” to be consistent with the claim language of the disk in line 7. The “coating” limitation has been deleted. Appropriate correction is required.
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) 11-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goyal US 2019/0216467 in view of Richter et al. US 2019/0209178.
Regarding claims 11, 21 and 24, Goyal discloses a cerebral aneurysm device comprising: a half spherical shaped frame 60a (figure 6I, first portion 60a may be a sphere, ellipsoid, or half sphere/ellipsoid, paragraph 0017) sized to fit within a cerebral aneurysm (figure 6I, brain aneurysm 10, paragraph 0002) with an open end and a closed end (closed end at hub 60c, open end within aneurysm); a hub or band 60C coupled to the closed end to keep the closed end from opening (figure 6I, paragraph 0069, connection point 60c by weaving or spot welding the portions together, or by using another suitable attachment mechanism holding the segments together); a flared-out base coupled to the hub or band extending outward extending from the closed end (figure 6A, paragraph 0056, wire mesh forming a thin disk 60B or alternatively paragraph 0061, figure 6J, segment arm radial segments 67 coupled to hub or band 60c at closed end or end with connection point 60c); a disk coupled to the flared-out base (paragraph 0056, a wire mesh coated with a non-thrombogenic material or a bio-absorbable material, the coating layer will be in the shape of the wire mesh, or a disk shape; the second portion comprises at least one layer, therefore, a minimum of one layer, but second layer or more would also be realized, a second layer may be considered the disk portion coupled to the flared-out base; alternatively, paragraph 0061, figure 6J, disc 65a coupled to base arms 67 and hub connection 60c), wherein the half spherical shaped frame is positioned within a cerebral aneurysm with the half spherical frame against the wall of the aneurysm (figure 6A) closed end positioned in a neck of the cerebral aneurysm (figure 6A, 6I) and the flared-out base with disk extend from the other side of the neck to seal the neck and prevent blood from entering the cerebral aneurysm (figure 6A; paragraph 0056), but fails to explicitly disclose a covering coupled to an outer surface of the half spherical shaped frame, wherein the covering is designed to be a barrier that is reinforced by the half spherical shape against the wall of the aneurysm.
Richter et al. discloses an aneurysm closure device 100 (figure 3B) comprising a half-spherical shaped fame 120 (paragraph 0084) and further comprising a covering coupled to an outer surface of the half-spherical frame (mesh 130) to cover substantially all of the aneurysm neck and cover the void spaces defined by the frame (paragraph 0084) and cause slow and non-linear blood flow to cause clotting in the aneurysm sac to eventually exclude blood flow and prevent expansion or rupture of the aneurysm (paragraph 0075), the covering is designed to be a barrier that is reinforced by the half spherical shape against the wall of the aneurysm (mesh is supported by arms 120 to cover the aneurysm neck opening by deploying within the aneurysm walls, shaped to conform to the aneurysm sac shape, and provide a barrier for tissue ingrowth and to exclude blood flow into the aneurysm, paragraph 0020, 0064, 0071, 0075).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Goyal, with a covering coupled to an outer surface of the half-spherical shaped frame, as taught by Richter et al. to provide a barrier within the aneurysm, supported by the half spherical shape, to provide slow and non-linear blood flow and cause clotting in the aneurysm sac to eventually exclude blood flow and prevent expansion or rupture of the aneurysm.
Regarding claims 12, 13, 17, 22, 23 and 30, Goyal discloses the half spherical shaped frame and flared-out base are made of an expandable material (paragraphs 0015, 0016, frame and base or first and second portions are collapsible and expandable), the portions being made of shape memory material (paragraph 0057), wherein the half spherical shaped frame with covering and the flared-out base with disk may be collapsed or compressed into a delivery configuration sized to fit within a lumen of a delivery catheter and delivered to the cerebral aneurysm, exiting the lumen and expanding into an expanded configuration (paragraph 0016, device is collapsible within the microcatheter and expandable and detachable from a microcatheter), blocking the flow of blood into an aneurysm (figure 6A, paragraph 0056, when in position, the device prevents of slows the flow of blood into the aneurysm), further comprising an expandable stent coupled with the hub or band (figure 6M, stent 100 coupled through base 60b for support, paragraph 0048, 0066, 0067), but fails to explicitly disclose the material being a self-expanding material.
Richter et al. teaches an aneurysm closure device comprising a shape memory material being self-expandable (paragraph 0012).
Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to provide a self-expandable material, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claims 14, 26 and 27, Goyal discloses an aneurysm device essentially as claimed, but fails to explicitly disclose wherein the half spherical shape includes arms extending upward from the closed end, the arms are petal and/or finger strut shaped arm.
Richter et al. teaches an aneurysm closure device comprising a half-spherical frame 120 including arms extending upward from the closed end (figure 3B, arms 120 extending upward from closed end at attachment hub 110), the arms are petal and/or finger strut shaped arm (paragraph 0015, may be straight, wavy, spiral, ellipse, petal, or triangle shaped, for example), or any convenient shape for supporting the mesh (paragraph 0071), and conforming to the shape of the aneurysm sac (paragraph 0071), the arms supporting the mesh covering (paragraph 0064, 0071) and being constructed of a self-expandable shape memory for forming the deployed device shape (paragraph 0069.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Goyal with a frame comprising arms, the arms are petal and/or finger strut shaped arm, as taught by Richter et al., as known in the art to provide a frame shape with arms suitable to support the mesh covering and shape the device for placement within an aneurysm.
Regarding claims 15 and 28, Goyal discloses an aneurysm closure device essentially as claimed, but fails to disclose wherein the covering and/or disk are made from a polyurethane, ePTFE and/or other collagen film.
Richter et al. teaches an aneurysm closure device comprising the covering and/or disk are made from a polyurethane, ePTFE and/or other collagen film (paragraph 0075, covering may be made of ePTFE or polyurethane).
Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to provide the covering and/or disk are made from a polyurethane, ePTFE and/or other collagen film, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claims 16 and 29, Goyal discloses an aneurysm closure device essentially as claimed, but fails to disclose wherein the covering and/or disk are a platform as a drug carrier.
Richter et al. teaches an aneurysm closure device wherein the covering and/or disk are a platform as a drug carrier (paragraph 0014, may contain a thrombogenic agent).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Goyal with a covering and/or disk are a platform as a drug carrier, as taught by Richter et al., as known in the art to provide additional agents to a target location for healing or treatment.
Regarding claim 18, Goyal discloses a cerebral aneurysm device comprising: an expanding half spherical shaped frame 60a (figure 6I, first portion 60a may be a sphere, ellipsoid, or half sphere/ellipsoid, paragraph 0017, expandable and compressible, paragraphs 0016-0017) sized to fit within a cerebral aneurysm (figure 6I, brain aneurysm 10, paragraph 0002) with an open end and a closed end (closed end at hub 60c, open end within aneurysm); a hub or band 60C coupled to the closed end of the half spherical shaped frame (figure 6I); an expanding flared-out base with a disk extending outward from the hub or band (figure 6A, paragraph 0056, wire mesh forming a thin disk 60B or alternatively paragraph 0061, figure 6J, segment arm radial segments 67 coupled to hub or band 60c, a disk coupled to the flared-out base, paragraph 0056, a wire mesh coated with a non-thrombogenic material or a bio-absorbable material, the coating layer will be in the shape of the wire mesh, or a disk shape; the second portion comprises at least one layer, therefore, a minimum of one layer, but second layer or more would also be realized, a second layer may be considered the disk portion coupled to the flared-out base; alternatively, paragraph 0061, figure 6J, disc 65a coupled to base arms 67 and hub connection 60c, expandable and compressible, paragraphs 0016-0017), wherein the expanding half spherical shaped frame and the flared-out base with disk may be collapsed or compressed into a delivery configuration sized to fit within a lumen of a delivery catheter and delivered to the cerebral aneurysm, exiting the lumen and expanding into an expanded configuration (paragraph 0016, device is collapsible within the microcatheter and expandable and detachable from a microcatheter), blocking the flow of blood into an aneurysm (figure 6A, paragraph 0056, when in position, the device prevents of slows the flow of blood into the aneurysm), but fails to explicitly disclose a covering coupled to an outer surface of the half spherical shaped frame, or a self-expanding half spherical shaped frame or flared-out base with a disk.
Richter et al. teaches an aneurysm closure device comprising a shape memory material being self-expandable (paragraph 0012). It would have been obvious to one having ordinary skill in the art at the time the invention was made to provide a self-expandable material, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Richter et al. discloses an aneurysm closure device 100 (figure 3B) comprising a half-spherical shaped fame 120 (paragraph 0084) and further comprising a covering coupled to an outer surface of the half-spherical frame (mesh 130) to cover substantially all of the aneurysm neck and cover the void spaces defined by the frame (paragraph 0084) and cause slow and non-linear blood flow to cause clotting in the aneurysm sac to eventually exclude blood flow and prevent expansion or rupture of the aneurysm (paragraph 0075).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Goyal, with a covering coupled to an outer surface of the half-spherical shaped frame, as taught by Richter et al. to provide slow and non-linear blood flow and cause clotting in the aneurysm sac to eventually exclude blood flow and prevent expansion or rupture of the aneurysm.
Regarding claim 19, Goyal discloses an aneurysm closure device essentially as claimed, but fails to disclose wherein the covering and/or disk are made from a polyurethane, ePTFE and/or other collagen film.
Richter et al. teaches an aneurysm closure device comprising the covering and/or disk are made from a polyurethane, ePTFE and/or other collagen film (paragraph 0075, covering may be made of ePTFE or polyurethane).
Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to provide the covering and/or disk are made from a polyurethane, ePTFE and/or other collagen film, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claim 20, Goyal discloses an aneurysm closure device essentially as claimed, but fails to disclose wherein the covering and/or disk are a platform as a drug carrier.
Richter et al. teaches an aneurysm closure device wherein the covering and/or disk are a platform as a drug carrier (paragraph 0014, may contain a thrombogenic agent).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Goyal with a covering and/or disk are a platform as a drug carrier, as taught by Richter et al., as known in the art to provide additional agents to a target location for healing or treatment.
Regarding claim 25, Goyal discloses wherein the disk is designed to be a barrier that is reinforced by the (paragraph 0056, a wire mesh coated with a non-thrombogenic material or a bio-absorbable material, the coating layer will be in the shape of the wire mesh, or a disk shape, the mesh providing the support or reinforcement for the coating or barrier material).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kealey et al. US 2018/0296224 teaches an aneurysm closure device comprising a generally half-spherical shaped frame (umbrella structure 602, figure 6B) comprising a frame with struts 606 and a covering coupled to an outer surface of the half spherical shaped frame (thin film mesh 100, paragraph 0061) to facilitate regrowth or tissue ingrowth and blood clotting reaction within the aneurysm (paragraph 0065).
Werneth et al. US 2012/0283585 teaches a closure device comprising a generally half-spherical shaped frame 78 comprising a cover 72 and a disk anchor 71 (figure 6) for closing a left atrial appendage.
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/CHRISTINA C LAUER/Examiner, Art Unit 3771
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