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 Group I, Species A, corresponding to claims 1-12 and Figures 1-13 in the reply filed on 10/2/26 is acknowledged.
Claims 13-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/2/26.
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) 1-4 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Porter US 2004/0044391.
Regarding claim 1, Porter discloses an occlusive implant system for occluding a left atrial appendage (Examiner notes this is functional language and the occlusive implant system would be configured for occluding an aneurysm or left atrial appendage), comprising:
an occlusive implant 100 comprising an expandable framework 118 configured to shift between a collapsed configuration (figure 8) and a deployed configuration (figure 10); and
an occlusive disk 30 configured to be fixedly attached to a proximal portion of the occlusive implant (for example, figures 10, 12; occlusive disk or securement 30 attached to occlusive member 20; Examiner notes a disk shape may be any thin, circular object – merriamwebster.com and therefore securement may be considered a disk as shown in figures 10, 12 once expanded from catheter);
wherein an occlusive portion of the occlusive disk is disposed entirely proximal of the expandable framework when the occlusive disk is fixedly attached to the proximal portion of the occlusive implant (figures 10, 12).
Regarding claim 2, Porter discloses wherein the occlusive portion of the occlusive disk comprises an expandable foam component configured to shift from a delivery configuration to an expanded configuration in vivo (figures 10, 12; paragraph 0050, securement member 30 may comprise a swellable material or compressed foam that expands to its expanded configuration upon release from the microcatheter 50).
Regarding claim 3, Porter discloses wherein expandable foam component comprises a shape memory foam (paragraph 0050).
Regarding claim 4, Porter discloses wherein the expandable foam component is configured to adapt and conform to surrounding anatomy when shifting from the delivery configuration to the expanded configuration (paragraph 0008, may be designed to expand at a target vascular defect and anchor within the defect, expandable foam may conform to anatomy when expanded adjacent to the anatomy).
Claim(s) 1, 7, 8, 11 and 12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ruiz US 2011/0082495.
Regarding claim 1, Ruiz discloses an occlusive implant system for occluding a left atrial appendage (paragraphs 0001, 0016), comprising:
an occlusive implant 120 comprising an expandable framework (paragraph 0067, struts 122) configured to shift between a collapsed configuration and a deployed configuration (paragraph 0065, 0067, self-expanding disk 120 with struts 122); and
an occlusive disk 130 configured to be fixedly attached to a proximal portion of the occlusive implant (paragraph 0068, ribs 125 mate with recesses 136 of base 131 on disk 130, figure 9);
wherein an occlusive portion of the occlusive disk is disposed entirely proximal of the expandable framework when the occlusive disk is fixedly attached to the proximal portion of the occlusive implant (for example, figures 10A-10C; when ribs 125 are attached within 131; disk 130 is proximal to implant 120).
Regarding claim 7, Ruiz discloses an occlusive implant system for occluding a left atrial appendage (paragraph 0016), comprising: a core wire 150 having a lumen extending therethrough (figure 10A); an occlusive implant (device comprising disks 120, 130, figure 9) releasably couplable to a distal end of the core wire (figure 10A), the occlusive implant 120 comprising an expandable framework (paragraph 0067, struts 122) configured to shift between a collapsed configuration and a deployed configuration (paragraph 0065, 0067, self-expanding disk 120 with struts 122); an occlusive disk 130 configured to be attached to a proximal portion of the occlusive implant (paragraph 0068, ribs 125 mate with recesses 136 of base 131 on disk 130); and an elongate strand 180 slidably disposed within the lumen of the core wire (figure 10A), wherein a distal end of the elongate strand is secured to the expandable framework (strand 180 secures the disk to inner member 150 to be manipulated and deployed); wherein the core wire is configured to advance the occlusive disk over the elongate strand and attach the occlusive disk to the proximal portion of the occlusive implant (paragraph 0076, pushing tube 160 is advanced in the distal direction to drive base 131 of occlusive disk 130 over ribs 125 thereby locking the disks together, figures 10A-10B).
Regarding claim 8, Ruiz discloses wherein the core wire is configured to advance the occlusive disk over the elongate strand to the occlusive implant and attach the occlusive disk to the proximal portion of the occlusive implant after shifting the expandable framework to the deployed configuration (disks 132 and 120 shown in the expanded configuration figure 10A; prior to advancing the pusher tube 160 to move the occlusive disk 130 over the strand and connect base of the occlusive disk recesses 130 with the ribs 125 to connect the occlusive disk to the occlusive implant).
Regarding claim 11, Ruiz discloses wherein an occlusive portion of the occlusive disk is disposed entirely proximal of the expandable framework when the occlusive disk is fixedly attached to the proximal portion of the occlusive implant (for example, figures 10A-10C; when ribs 125 are attached within 131; disk 130 is proximal to implant 120).
Regarding claim 12, Ruiz discloses wherein the occlusive disk is configured to be non-removably attached to the proximal portion of the occlusive implant (paragraph 0069, interlocking ribs 125 and/or other means, such as biocompatible adhesives, may be used to interlock the bases of the disk).
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) 2-5, 9 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ruiz US 2011/0082495 in view of Porter US 2004/0044391.
Regarding claim 2-4, Ruiz discloses wherein the occlusive portion of the occlusive disk comprises an expandable component configured to shift from a delivery configuration to an expanded configuration in vivo, but fails to disclose the expandable component being an expandable foam wherein the expandable foam component comprises a shape memory foam, wherein the expandable foam component is configured to adapt and conform to surrounding anatomy when shifting from the delivery configuration to the expanded configuration.
Porter discloses wherein the occlusive portion of the occlusive disk comprises an expandable foam component configured to shift from a delivery configuration to an expanded configuration in vivo (figures 10, 12; paragraph 0050, securement member 30 may comprise a swellable material or compressed foam that expands to its expanded configuration upon release from the microcatheter 50), wherein expandable foam component comprises a shape memory foam (paragraph 0050), wherein the expandable foam component is configured to adapt and conform to surrounding anatomy when shifting from the delivery configuration to the expanded configuration (paragraph 0008, may be designed to expand at a target vascular defect and anchor within the defect, expandable foam may conform to anatomy when expanded adjacent to the anatomy). Examiner further notes Porter discloses the device may be formed of a variety of materials including, but not limited to flexible polymeric materials and metallic materials including shape memory materials, superelastic materials, compressed foams, swellable materials, braided or woven materials and meshes formed from both polymeric materials and shape memory alloys (paragraph 0011).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Ruiz et al. with an expandable foam component, as taught by Porter and known in the art to provide a swellable or foam as a known material for expanding and sealing or securing an occlusive device at the location of the opening or defect.
Regarding claim 5, Ruiz et al. discloses wherein the occlusive disk 130 comprises a distal extension 134 (figure 9) configured to be fixedly attached to a proximal hub of the occlusive implant (base 121 with proximal portion 126, figure 9).
Regarding claims 9 and 10, Ruiz discloses the occlusive implant system essentially as claimed as discussed above wherein the expandable component is configured to be advanced over the elongate strand to the occlusive implant in the delivery configuration (figures 10A-10C advanced over strand 180 to connect disks 120 and 130), wherein the expandable component is configured to shift from the delivery configuration to the expanded configuration after attaching the occlusive disk to the occlusive implant (paragraph 0050; figures 9, 10, attached within the delivery catheter, foam expands once released from the catheter), but fails to disclose wherein the occlusive disk comprises an expandable foam component configured to shift from a delivery configuration to an expanded configuration in vivo, wherein the expandable foam component is configured to be advanced over the elongate strand to the occlusive implant in the delivery configuration.
Porter teaches an occlusive implant system an occlusive implant 100 comprising an expandable member 20 configured to shift between a collapsed configuration (figures 4, 8) and a deployed configuration (figures 7, 10); and an occlusive disk 30 configured to be fixedly attached to a proximal portion of the occlusive implant (for example, figures 10, 12; occlusive disk or securement 30 attached to occlusive member 20; Examiner notes a disk shape may be any thin, circular object – merriamwebster.com and therefore securement may be considered a disk as shown in figures 10, 12 once expanded from catheter); wherein the occlusive portion of the occlusive disk comprises an expandable foam component configured to shift from a delivery configuration to an expanded configuration in vivo (figures 10, 12; paragraph 0050, securement member 30 comprising a swellable material or compressed foam that expands to its expanded configuration upon release from the microcatheter 50), wherein the wherein the expandable foam component is configured to shift from the delivery configuration to the expanded configuration after attaching the occlusive disk to the occlusive implant (pusher wire 50 within tube 50 attached with junction 40, figure 11).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Ruiz et al. with an expandable foam component, as taught by Porter and known in the art to provide a swellable or foam as a known material for expanding and sealing or securing an occlusive device at the location of the opening or defect.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ruiz US 2011/0082495 in view of Porter US 2004/0044391 and further in view of Melanson et al. US 2020/0253614.
Regarding claim 6, Ruiz et al. in combination discloses the implant system essentially as claimed as discussed above, but fails to explicitly disclose wherein the expandable component comprises an axial passageway that is open in the delivery configuration and closed in the expanded configuration.
Melanson et al. discloses an occlusive implant system comprising an occlusive foam (foam plug 1040) having an axial passageway that is open during the delivery configuration (paragraph 0251, foam placed over guide-wire type device, the guide-wire type device positioned within an axial passageway), and closed in the expanded configuration (paragraph 0251, not desirable to have a residual central hole to allow leakage, the hole closes completely once the guidewire is removed).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Ruiz wherein the expandable component comprises an axial passageway that is open in the delivery configuration and closed in the expanded configuration, as taught by Melanson et al. to close the central delivery axial passageway to completely seal and prevent leakage.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Porter US 2004/0044391 in view of Melanson et al. US 2020/0253614.
Regarding claim 6, Porter discloses the implant system essentially as claimed as discussed above, but fails to explicitly disclose wherein the expandable component comprises an axial passageway that is open in the delivery configuration and closed in the expanded configuration.
Melanson et al. discloses an occlusive implant system comprising an occlusive foam (foam plug 1040) having an axial passageway that is open during the delivery configuration (paragraph 0251, foam placed over guide-wire type device, the guide-wire type device positioned within an axial passageway), and closed in the expanded configuration (paragraph 0251, not desirable to have a residual central hole to allow leakage, the hole closes completely once the guidewire is removed).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Porter wherein the expandable component comprises an axial passageway that is open in the delivery configuration and closed in the expanded configuration, as taught by Melanson et al. to close the central delivery axial passageway to completely seal and prevent leakage.
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
