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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 7/1/26 has been entered.
Response to Arguments
Applicant’s arguments with respect to claim(s) 70-72, 74 and 76-82 have been considered but are moot because the new ground of rejection over Hamel et al. US 2020/0187954.
Hamel et al. discloses a tubular mesh 300 comprising the first and second mesh comprising petal-shaped regions (see annotated figure 7A below), the first and second petal-shaped regions have a first and second proximal portion, a first and second distal portion, and a first and second central portion between the first and second proximal portion and the first and second distal portion, respectively, wherein the proximal portions are narrower than the central portions. Examiner notes the central shaded portion may be considered any portion that is more narrow than any portion of the central region of the petal region, for example one interpretation as shown in annotated figure 7A below. A similar interpretation may be considered for the second petal-shaped regions on the opposite side.
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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.
Claim(s) 70, 71, 72, 74, 76, 78, 79, 80 82 and 90 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hamel et al. US 2020/0187954.
Regarding claims 70, 71, and 74, Hamel et al. discloses a system for treating an aneurysm, the system comprising: an occlusive device 300 (figure 3A, 7A) comprising:
a first mesh formed from a first tubular braid (see annotated figures 3A, 7A below), the first mesh including a first petal- shaped region (see annotated figures 3A, 7A below) formed from a first flattened section of the first tubular braid (paragraph 0014, mesh is a flattened tubular braid); wherein the first petal-shaped region has a first proximal portion, a first distal portion, and a first central portion between the first proximal portion and the first distal portion, wherein the first proximal portion is narrower than the first central portion (see annotated figure 4A below, Examiner notes any portion or sized portions may be considered for the first, second, and central portions, resulting in the proximal portion being more narrow than the central portion); and
a second mesh coupled to the first mesh (see annotated figures 3A, 7A below, coupled through undulations 301), the second mesh formed from a second tubular braid (paragraph 0014, mesh is a flattened tubular braid), the second mesh including a second petal-shaped region formed from a second flattened section of the second tubular braid (see annotated figures 3A, 7A below), wherein the second petal-shaped region has a second proximal portion, a second distal portion, and a second central portion between the second proximal portion and the second distal portion, wherein the second proximal portion is narrower than the second central portion (see annotated figure 4A below, Examiner notes any portion or sized portions may be considered for the first, second, and central portions, resulting in the proximal portion being more narrow than the central portion);
wherein, when the occlusive device is deployed within the aneurysm (figure 7A, aneurysm A), the first and second petal-shaped regions are configured to extend partially over a neck of the aneurysm (figure 7A) and define a passageway between the first and second proximal portions through the neck of the aneurysm (passageway within catheter 12, see annotated figure 7A below), and a coil 150 configured to be delivered through the passageway and into the aneurysm (figure 7A, 7B, paragraph 0432, 0433, embolic coil 150 or additional embolic members may be inserted), wherein the first mesh comprises a first tip connected to the first petal shaped region (see annotated figures 3A, 7A below), and the second mesh comprises a second tip connected to the second petal-shaped region (see annotated figures 3A, 7A below), wherein the first and second tubular braids are the same tubular braid (mesh 300, figure 3A).
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Regarding claim 72, Hamel et al. discloses wherein the first and second tips are rounded (figure 7A, tips are curved or rounded conforming to the aneurysm wall).
Regarding claim 76, Hamel et al. discloses wherein: the first proximal portion is configured to cover the neck N of the aneurysm (see annotated figure 7A below), and the first distal portion configured to engage a wall of the aneurysm (see annotated figure 7A below), and the second proximal portion is configured to cover the neck of the aneurysm (see annotated figure 7A below), and the second distal portion is configured to engage the wall of the aneurysm (see annotated figure 7A below).
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Regarding claims 78 and 79, Hamel et al. discloses wherein the first petal-shaped region has a preset curve oriented in a first direction (paragraph 0014, 0056, 0425, figure 7A, mesh may have a predetermined shape, mesh may be made of a shape memory material, mesh curved along the length) , and the second petal-shaped region has a preset curve oriented in a second direction (paragraph 0014, 0056, 0425, figure 7A, mesh may have a predetermined shape, mesh may be made of a shape memory material, mesh curved along the length), wherein the preset curves of the first and second petal-shaped regions are configured to bias at least a portion of the first and second petal-shaped regions against a wall of the aneurysm (figure 7A, shape memory or predetermined shape of mesh to conform to the sides of an aneurysm wall over the aneurysm neck).
Regarding claim 80, Hamel et al. discloses a detachment element configured to releasably couple the first and second meshes to a pusher member (paragraph 0432, device may be detached from the delivery member such as a pusher member via one or more detachment mechanisms).
Regarding claim 82, Hamel et al. discloses wherein the first and second meshes each have a low-profile state for intravascular delivery to the aneurysm, and an expanded state for deployment within the aneurysm (paragraph 0011).
Regarding claim 90, Hamel et al. discloses wherein the passageway is a first passageway, and wherein when the occlusive device is deployed within the aneurysm, the first and second petal shaped regions are configured to define a second passageway between the first and second proximal portions through the neck of the aneurysm, wherein the first passageway is on a first side of the occlusive device (figure 7A through 12) and the second passageway is on a second side of the occlusive device (Examiner notes depending on the size and/or shape of the aneurysm, if the aneurysm was large enough or having a non-uniform shape, any space may be formed next to the device and may be considered the second passageway, as there is no additional structure, but instead just space that may be available when placed within an aneurysm).
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) 77 and 81 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hamel et al. US 2020/0187954 in view of Aboytes et al. US 2013/0066357.
Regarding claims 77 and 81, Hamel et al. discloses a system essentially as claimed as discussed above, but fails to further comprise at least one third mesh coupled to the first and second meshes, the at least one third mesh formed from at least one third tubular braid, the at least one third mesh including a third petal-shaped region formed from a third flattened section of the at least one third tubular braid.
Aboytes et al. teaches an occlusive device for treating an aneurysm (paragraph 0002),
the occlusive device (for example, 200 or 900, or 1100) comprising the first and second meshes being coupled to each other at the first and second proximal end regions by a band (band 240, for example, figure 5A) to couple to the insertion device or provide radiopaque properties for visualization (paragraph 0084), and further comprising at least one third mesh coupled to the first and second meshes (paragraph 0093, any number of additional tubular meshes forming ribbon-like strands may be utilized), the at least one third mesh formed from at least one third tubular braid (paragraph 0093, any number of additional tubular meshes forming ribbon-like strands may be utilized), the at least one third mesh including a third petal-shaped region formed from a third flattened section of the at least one third tubular braid (paragraphs 0090, 0093, tubular mesh may form a flatted ribbon like structure within the aneurysm, implant may comprise any number of flattened ribbons to provide a specific density).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Hamel et al. with a band to couple the first and second proximal end regions to couple with a deployment catheter or to provide additional visualization, and a third mesh coupled to the first and second meshes, the at least one third mesh formed from at least one third tubular braid, the at least one third mesh including a third petal-shaped region formed from a third flattened section of the at least one third tubular braid, as taught by Aboytes et al. to provide visualization for delivery of the system and an additional flattened mesh within the aneurysm to provide the desired density.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA C LAUER whose telephone number is (571)270-5418. The examiner can normally be reached Monday-Thursday 7:00 AM-4:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTINA C LAUER/Examiner, Art Unit 3771
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