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 Objections
Claim 14 is objected to because of the following informalities: For clarity/consistency purposes and to avoid any 112 issues, line 1 should be amended as follows “…the control structure….”. Appropriate correction is required.
Claim 15 is objected to because of the following informalities: For clarity/consistency purposes and to avoid any 112 issues, lines 1-2 should be amended as follows “…the control structure….”. Appropriate correction is required.
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 1-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Publication 2017/0042549 to Kaplan.
As to claim 1, 10, 11, Kaplan discloses a left atrial appendage closure (LAAC) device (paragraph 13) adapted for occluding a patient’s left atrial appendage (LAA), the LAAC device comprising a shape memory foam deformable device body occlusive element (204, paragraph 77-79, figure 2; 1600, figure 16, paragraph 97; or 15, figures 27a-g, 28a-d, 29a,b ), adapted to expand from a crimped configuration for delivery (paragraph 77-79, 65) to an expanded configuration after delivery (paragraph 45, 46, 97, 117) to expand and span the proximal mouth of the LAA (figure 2; figure 16; figure 38), the shape memory foam occlusive element including in its expanded configuration a distal face (figure 2; figure 16; figure 38), a proximal face (figure 2; figure 16; figure 38), and an intervening periphery (figure 2; figure 16; figure 38), and a reinforcing member / control structure (206, 214, and/or the adhesive, paragraph 50, 53; or 1602; or 101) disposed relative to the shape memory foam occlusive element, the reinforcing member adapted to limit deformation of the shape memory occlusive element after the shape memory foam occlusive element has expanded into the expanded configuration (paragraph 53; paragraph 65; paragraph 130-133). Multiple embodiments (at least highlighted by figure 2; figure 16; figure 27-38 with different internal locking system) can read on the claims of record. The foam of the plug of each embodiment will be interpreted to be a shape memory foam since it does compress then expand once deployed. Further it is made of the same material (paragraph 78, at least polyurethane, polyolefin, collagen…) that the application as originally filed supports as a material for the shape memory foam (in paragraph 82,83). The materials listed for the foam plug of Kaplan can allow the plug to read a shape memory foam occlusive element. For the embodiment of figure 2, the outer cover 206 can limit the deformation of the foam since it will prevent the foam from tearing, being removed, and moved/expanded in the proximal direction. The tubes 214 also serves to guide adhesive to the correct location, the adhesive will limit deformation after the device is in the expanded configuration since it will allow the device to adhere to the tissue. For the embodiment of figure 16, paragraph 65 can also read on the claim limitations where the stent 1602 will limit the deformation once the foam is expanded. For the embodiment of figures 27-38, the internal locking system 101 will limit deformation since it will lock and secure the device in place.
As to claim 2, 12, Kaplan discloses the reinforcing member / control structure extends around at least a portion of the periphery of the shape memory foam occlusive element (figure 2, paragraph 53; figure 27a). The adhesive will end up along the periphery.
As to claim 3, 13 Kaplan discloses the reinforcing member / control structure extends across at least a portion of the distal face / side of the shape memory foam occlusive element (figure 2; figure 16).
As to claim 4, 14, Kaplan discloses the reinforcing member extends across at least a portion of the proximal face / side of the shape memory foam occlusive element (figure 2; figure 27a).
As to claim 5, 15, Kaplan discloses at least a portion of the reinforcing member extends through the shape memory foam occlusive element (figure 2; figure 27a).
As to claim 6, Kaplan discloses the reinforcing member is adapted to expand with the shame memory foam occlusive element when the shape memory foam occlusive element expands after deployment (paragraph 77-79). At least the tubes 214 and/or the cover 206 will expand with the foam.
As to claim 7, Kaplan discloses a second foam different from a first foam forming the shape memory foam occlusive element (paragraph 98).
As to claim 8, Kaplan discloses the reinforcing member comprises a polymeric structure (paragraph 77).
As to claim 9, Kaplan discloses the reinforcing member comprises a metal structure (paragraph 97).
As to claim 16, Kaplan discloses a left atrial appendage closure (LAAC) device (paragraph 13) adapted for occluding a patient’s left atrial appendage (LAA), the LAAC device comprising a shape memory foam occlusive element (15, the foam plug as seen in figure 27g, which will be in figure 29a,b, as supported in paragraph 45, 46), and a reinforcing member (101) disposed relative to the shape memory foam occlusive element, the reinforcing member including a central point (111, figure 28a-d), and a plurality of struts (120) emanating outwardly from the central point. The foam will be interpreted to be shape memory foam since it does compress then expand once deployed. Further it is made of the same material (paragraph 78, at least polyurethane, polyolefin, collagen…) that the application as originally filed supports as a material for the shape memory foam (in paragraph 82,83). The materials listed for the foam plug of Kaplan can allow the plug to read a shape memory foam occlusive element.
As to claim 17, Kaplan discloses the reinforcing member is adapted to limit deformation of the shape memory foam occlusive element after the shape memory form occlusive element has expanded (paragraph 116-119). The internal locking system can limit the deformation as it locks the device in place.
As to claim 18, Kaplan discloses the reinforcing member further comprises an annular ring (145, paragraph 139) extending around and connected to at least some of the plurality of struts (figure 29b).
As to claim 19, Kaplan discloses the annular ring has a diameter that is equal to or less than an overall diameter of the shape memory foam occlusive element (figure 29b).
As to claim 20, Kaplan discloses the reinforcing member further comprises one or more foam integration structures emanating from at least some of the plurality of struts (figure 26). Each barb has barb like elements.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. U.S. Patent 6,174,322 to Schneidt, U.S. Patent 6,245,090 to Gilson, U.S. Patent 10,667,896 to Delaney (as cited as Patent Reference 160 in the IDS filed 06/12/2022), U.S. Patent Publication 2006/0052816 to Bates (as cited as Publication Reference 62 in the IDS filed 06/12/2022), U.S. Patent Publication 2012/0283585 to Werneth (as cited as Publication Reference 106 in the IDS filed 06/12/2022), U.S. Patent Publication 2012/0323270 to Lee, and U.S. Patent Publication 2016/0331382 to Center (as cited as Publication reference 48 in the IDS filed 06/12/2025) all disclose similar device capable of disclosing, rending obvious, or providing evidence on the claims of record.
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
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