DETAILED ACTION
Response to Amendment
This action is in response to the amendment after non-final filed 19 November 2025. Claims 1-20 are pending.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 1, 7-9, and 13 is/are 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 Besselink (US Publication no. 2006/00515136).
In regard to claim 1, Besselink disclose an implantable medical device (para 116, the device is a filter which may be implanted for long term use), comprising:
an expandable frame (see figure 7A) defining a profile of the implantable medical device, the expandable frame moveable between a collapsed configuration for delivery and an expanded configuration for deployment (para 108, describes expanded and collapsed states), the expandable frame comprising:
a plurality of frame members 26 and 48 each having a proximal end and a distal end (considering end 22 being the proximal end of the strut and end 46 being the distal end of the strut, thus struts 26 are proximal, and struts 48 are distal); and
a securement member 24 adapted to secure the plurality of frame members 26 and 48 at a location between the proximal end 22 and the distal end 46 of each frame member 26 and 48, the securement member 24 adapted to allow the expandable frame to move between the collapsed configuration and the expanded configuration (para 108); and
a covering 28 extending over the proximal end (between securement member 24 and proximal end 22) of at least some of the plurality of frame members 26 and 48;
wherein each frame member 26 and 48 extends linearly from the securement member to the proximal end in the collapsed configuration, and each frame member extends linearly from the securement member to the distal end in the collapsed configuration (para 107, and as shown in figure 12).
It is recognized that the Besselink is directed to a vascular filter, not a left atrial appendance closure device. However, Besselink is describe with such structure that substantially reads on the claimed structural limitations that support a conclusion that the present invention is substantially similar to and is anticipated by Besselink since the only differentiation is in the intended use. Additionally, the application of the expandable strut technique of Besselink to serve the intended purpose is considered to have been obvious to one of ordinary skill in the art as the application of a known technique to a known device to yield predictable expandable forces to a closure device.
In regard to claim 7, Besselink teaches that the expandable frame 44 is biased into the expanded configuration (para 107, all the parts of 44, except for membrane 28, may be made in one piece of a memory metal that has been processed to bias the filter toward its radially expanded configuration).
In regard to claim 8, Besselink teaches that the expandable frame 44 is biased into the expanded configuration by at least some of the frame members having a remembered shape (para 107, all the parts of 44, except for membrane 28, may be made in one piece of a memory metal that has been processed to bias the filter toward its radially expanded configuration).
In regard to claim 9, Besselink teaches that the expandable frame 44 further comprises a biasing member that is adapted to bias the expandable frame into the expanded configuration (para 107, all the parts of 44, except for membrane 28, may be made in one piece of a memory metal that has been processed to bias the filter toward its radially expanded configuration, thus a strut 26 made be considered to be a biasing member).
In regard to claim 13, Besselink disclose an expandable frame (e.g., figure 7A or embodiment for figure 5) moveable between a collapsed configuration for delivery and an expanded configuration for deployment, the expandable frame comprising:
a plurality of frame members 26 each having a proximal end and a distal end, wherein each frame member is substantially straight from the proximal end to the distal end in the collapsed configuration and in the expanded configuration;
a securement member 24 adapted to secure the plurality of frame members 26, the securement member adapted to allow the expandable frame to move between the collapsed configuration and the expanded configuration (para 107; and
a biasing member that is adapted to move the expandable frame into the expanded configuration when not otherwise constrained (para 107, all parts of the assembly 44 may be made from shape memory metal to bias assembly in the radially expanded configuration, thus a strut 26 made be considered to be a biasing member); and
a covering extending 28 over the proximal end of at least some of the plurality of frame members.
It is recognized that the Besselink is directed to a vascular filter, not a left atrial appendance closure device. However, Besselink is describe with such structure that substantially reads on the claimed structural limitations that support a conclusion that the present invention is substantially similar to and is anticipated by Besselink since the only differentiation is in the intended use. Additionally, the application of the expandable strut technique of Besselink to serve the intended purpose is considered to have been obvious to one of ordinary skill in the art as the application of a known technique to a known device to yield predictable expandable forces to a closure device.
Claim(s) 2-6 and 16-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Besselink (US Publication no. 2006/00515136), in view of Campbell et al. (US Publication no. 2012/0172927 – previously cited).
In regard to claim 2, Besselink suggests the invention as claimed, however does not teach at least some of the plurality of frame members are adapted to bend relative to the securement member when moving between the collapsed configuration and the expanded configuration. Campbell et al. show that at least some of the plurality of frame members 102 are adapted to bend relative to the securement member 110 when moving between the collapsed configuration and the expanded configuration (figure 1 shows the expandable state of members 102 and 106 around hub 110, and figures 7 and 8 show that members 106 and 102 in a collapsed state around hub 110). Campbell et al. teaches that this feature was known in the art at the time of the invention, there modification of Besselink is considered to have been obvious to one of ordinary skill in the art as the application of known elements to known devices to yield predictable results.
In regard to claim 3, Besselink suggests the invention as claimed, however does not teach at least some of the plurality of frame members are adapted to pivot relative to the securement member when moving between the collapsed configuration and the expanded configuration. Campbell et al. show that at least some of the plurality of frame members are adapted to pivot relative to the securement member when moving between the collapsed configuration and the expanded configuration (figure 1 shows the expandable state of members 102 and 106 around hub 110, and figures 7 and 8 show that members 106 and 102 in a collapsed state around hub 110, wherein the moving to expandable configuration of figure 1 from the collapsed configuration of figures 7 and 8 is considered to show that members 102 and 106 pivot around hub 110). Campbell et al. teaches that this feature was known in the art at the time of the invention, there modification of Besselink is considered to have been obvious to one of ordinary skill in the art as the application of known elements to known devices to yield predictable results.
In regard to claim 4, Besselink suggests the invention as claimed, however does not teach wherein the plurality of frame members comprise: a plurality of sealing frame members over which the covering extends; and a plurality of anchoring frame members that are adapted to anchor the implantable medical device in place. Campbell et al. show the plurality of frame members 102 comprise: a plurality of sealing frame members 112 over which the covering 109 extends; and a plurality of anchoring frame members 106 that are adapted to anchor the implantable medical device in place (para 53, anchors 106 secure the device 104 to the left atrial appendage wall, para 91; para 60, frames 102 are used to effectively seal or occlude the left atrial appendage wherein the petal shape 112 increases the conformability to provide more effective sealing). Campbell et al. teaches that this feature was known in the art at the time of the invention, there modification of Besselink is considered to have been obvious to one of ordinary skill in the art as the application of known elements to known devices to yield predictable results.
In regard to claim 5, Besselink suggests the invention as claimed, however does not teach the plurality of sealing frame members pivot in a first direction when moving from the collapsed configuration to the expanded configuration and the plurality of anchoring frame members pivot in a second direction opposite the first direction when moving from the collapsed configuration to the expanded configuration. Campbell et al. show the plurality of sealing frame members 102 pivot in a first direction when moving from the collapsed configuration to the expanded configuration and the plurality of anchoring frame members 106 pivot in a second direction opposite the first direction when moving from the collapsed configuration to the expanded configuration (figure 1 shows the expandable state of members 102 and 106 around hub 110, and figures 7 and 8 show that members 106 and 102 in a collapsed state around hub 110, wherein the moving to expandable configuration of figure 1 from the collapsed configuration of figures 7 and 8 causes members 102 and 106 to move towards one another which is considered to be movement in opposite directions). Campbell et al. teaches that this feature was known in the art at the time of the invention, there modification of Besselink is considered to have been obvious to one of ordinary skill in the art as the application of known elements to known devices to yield predictable results.
In regard to claim 6, Besselink suggests the invention as claimed, however does not teach the plurality of anchoring frame members comprise anchor hooks extending from a distal end of at least some of the plurality of anchoring frame members. Campbell et al. show the plurality of anchoring frame members comprise anchor hooks extending from a distal end of at least some of the plurality of anchoring frame members (para 61, anchors 106 are considered to be hook shaped, and are configured to hook the device to the left atrial appendage). Campbell et al. teaches that this feature was known in the art at the time of the invention, there modification of Besselink is considered to have been obvious to one of ordinary skill in the art as the application of known elements to known devices to yield predictable results.
In regard to claim 16, Besselink suggests the invention as claimed, however does not teach the at least some of the plurality of frame members are adapted to pivot relative to the securement member in response to a biasing force applied by the biasing member. Campbell et al. show that at least some of the plurality of frame members are adapted to pivot relative to the securement member when moving between the collapsed configuration and the expanded configuration (figure 1 shows the expandable state of members 102 and 106 around hub 110, and figures 7 and 8 show that members 106 and 102 in a collapsed state around hub 110, wherein the moving to expandable configuration of figure 1 from the collapsed configuration of figures 7 and 8 is considered to show that members 102 and 106 pivot around hub 110). Campbell et al. teaches that this feature was known in the art at the time of the invention, there modification of Besselink is considered to have been obvious to one of ordinary skill in the art as the application of known elements to known devices to yield predictable results.
In regard to claim 17, Besselink suggests the invention as claimed, however does not teach the plurality of frame members comprise: a plurality of sealing frame members over which the covering extends; and a plurality of anchoring frame members that are adapted to anchor the implantable medical device in place. Campbell et al. show the plurality of frame members 102 comprise: a plurality of sealing frame members 112 over which the covering 109 extends; and a plurality of anchoring frame members 106 that are adapted to anchor the implantable medical device in place (para 53, anchors 106 secure the device 104 to the left atrial appendage wall, para 91; para 60, frames 102 are used to effectively seal or occlude the left atrial appendage wherein the petal shape 112 increases the conformability to provide more effective sealing). Campbell et al. teaches that this feature was known in the art at the time of the invention, there modification of Besselink is considered to have been obvious to one of ordinary skill in the art as the application of known elements to known devices to yield predictable results.
In regard to claim 18, Besselink suggests the invention as claimed, however does not teach the plurality of sealing frame members are adapted to pivot in a first direction and the plurality of anchoring frame members are adapted to pivot in a second direction opposite the first direction when moving from the collapsed configuration to the expanded configuration. Campbell et al. show the plurality of sealing frame members 102 pivot in a first direction when moving from the collapsed configuration to the expanded configuration and the plurality of anchoring frame members 106 pivot in a second direction opposite the first direction when moving from the collapsed configuration to the expanded configuration (figure 1 shows the expandable state of members 102 and 106 around hub 110, and figures 7 and 8 show that members 106 and 102 in a collapsed state around hub 110, wherein the moving to expandable configuration of figure 1 from the collapsed configuration of figures 7 and 8 causes members 102 and 106 to move towards one another which is considered to be movement in opposite directions). Campbell et al. teaches that this feature was known in the art at the time of the invention, there modification of Besselink is considered to have been obvious to one of ordinary skill in the art as the application of known elements to known devices to yield predictable results.
Claim(s) 10 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Besselink (US Publication no. 2006/00515136) in view of Campbell et al. (US Publication no. 2012/0172927), further in view of Kaplan et al. (US Publication no. 2020/0305889).
In regard to claims 10 and 14, Campbell et al. substantially describe the invention as claimed, however do not teach that the biasing member is a spring or a screw and tether arrangement. The biasing member of Campbell et al. includes a shape memory wire 101 such as nitinol. These wires of Campbell et al. are sufficient to bias the expandable frame 104 into a natural self-expanding state. Kaplan et al. describes a device and method for occluding the left atrial appendage with an expandable device. Kaplan et al. teach that the occlusion device is biased in the expanded state, wherein the biasing force may come from nitinol wires or spring bias materials (para 130). Thus Kaplan et al. demonstrate that these features are alternative equivalents suitable for substitution to provide a biasing force to the frame. Therefore, it is considered to have been obvious to one of ordinary skill in the art at the time of filing to modify the shape memory metal with either a spring arrangement since the modification include the selection from among alternative equivalents to yield predictable results of biasing members in a particular position as a matter of design choice.
Allowable Subject Matter
Claims 19 and 20 are allowed.
Claims 11 and 15 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is an examiner’s statement of reasons for allowance: claim 19, the prior art does not teach wherein in the expanded configuration, the proximal end of each frame member is disposed radially outward of the securement member and the distal end of each frame member is disposed radially inward of the securement member.
The following is a statement of reasons for the indication of allowable subject matter: a tether and screw is not taught by the prior art as a biasing member in a left atrial appendage closure device.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN T GEDEON whose telephone number is (571)272-3447. The examiner can normally be reached M-F 8:00 am to 5:30 PM ET.
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/BRIAN T GEDEON/Primary Examiner, Art Unit 3796 27 February 2026