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 .
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.
Claim Objections
Claim 20 is objected to because of the following informalities: lines 8-9 reads “…securement arms adapted to releasably secure the alignment tool relative to the loader.” The lines should instead read “…securement arms adapted to releasably secure the alignment tool relative to a loader” for clarity. 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-4 and 6-19 are rejected under 35 U.S.C. 103 as being unpatentable over Dwork et al. (US 20180280174 A1) in view of High et al. (US 20190021856 A1), Robinson (US 20130116772 A1), and Alon et al. (US 10820994 B2).
Regarding claim 1, Dwork discloses an alignment tool (102) for loading a stent (¶ 0010 discloses loading of a stent into a delivery catheter) having a plurality of alignment loops (¶ 0068 discloses and fig. 11 illustrates a valve prosthesis/stent 300 with a plurality of alignment loops/tethers 216) onto a delivery catheter (¶ 0049 discloses that a delivery tool 102 is used for loading a valve prosthesis into a delivery catheter 200) having a corresponding plurality of alignment pins adapted to be received within a corresponding alignment loop (fig. 11 illustrates alignment loops 216 on a delivery catheter 200 having corresponding plurality of alignment pins/posts/protrusions 212), the alignment tool (102) comprising: a body (see fig. 1 annotated below); a plurality of alignment arms extending from the body (fig. 2a illustrates a plurality of alignment arms extending from the body), each of the plurality of alignment arms including a first end (144) and an opposing second end including a handle portion (142, ¶ 0055 discloses that the first end comprises and actuator surface that is configured for user manipulation to pivot corresponding pivotable elements 136), the plurality of alignment arms movable between a closed configuration defining a minimum distance between the first end of each of the plurality of alignment arms (fig. 1 illustrates the alignment arms 136 in a closed configuration defining a minimum distance between the first end 144 of each of the plurality of alignment arms) and an open configuration defining a maximum distance between the first end of each of the plurality of alignment arms (fig. 2b illustrates the alignment arms 136 in an open configuration defining a maximum distance between the first end of each of the plurality of alignment arms); wherein the plurality of alignment arms are biased into the closed configuration (¶ 0053 discloses that the plurality of alignment arms 136 are biased by a biasing element 162 into a first/closed configuration). Dwork fails to disclose that the stent is disposed within a loader having a loader housing.
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High also discloses a tool for loading a stent (the abstract and ¶ 0028 discloses a tool/assembly 200 for loading a stent) having a plurality of alignment loops (fig. 4, 118). High teaches a stent disposed within a loader having a loader housing (fig. 12 annotated a heart valve with a stent 100 disposed within a loader 200 having a loader housing 202).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Dwork to include a stent disposed within a loader having a loader housing as taught by High in order to load a collapsible prosthetic heart valve/stent 100 into a delivery device (High ¶ 0055).
Dwork in view of High fails to disclose a plurality of securement arms extending from the body, each of the plurality of securement arms adapted to secure the alignment tool relative to the loader.
Robinson discloses a device in a similar technical field and class as the present invention. Robinson discloses systems and methods of sheathing a stent prior to an insertion procedure (see Abstract). Robinson teaches a plurality of securement arms extending from a body (fig. 3 illustrates a plurality of securement arms 216 extending from a body/base portion 214). The plurality of securement arms of Robinson are capable of securing the alignment tool of Dwork to the loader of High due to the arms’ (216) flanged ends and ability to couple to or receive a plate-like member as disclosed in ¶ 0138 and as shown in figure 5c.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Dwork in view of High to include a plurality of securement arms extending from the body, each of the plurality of securement arms adapted to releasably secure the alignment tool relative to the loader as taught by Robinson in order to align and secure a housing or funnel (Robinson ¶ 0139).
Dwork in view of High and Robinson fails to disclose that the plurality of alignment arms includes a first end having an alignment slot.
Alon also discloses a tool for loading a stent having a plurality of alignment loops onto a delivery catheter (fig. 10 and fig. 13 illustrate a tool 114 for loading a stent 10 having a plurality of loops 32 into a catheter 106). Alon teaches a plurality of arms which includes an end having an alignment slot (fig. 13 illustrates a slot 150 that aligns with the loop 32 of a valve stent 10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Dwork in view of High and Robinson to include a plurality of arms which includes an end having an alignment slot as taught by Alon in order to mount a valve into a delivery sheath (Alon - abstract).
Regarding claim 2, Dwork in view of High, Robinson, and Alon disclose the invention as claimed as discussed with respect to claim 1. Dwork further discloses that a biasing member that biases the plurality of alignment arms into the closed configuration (¶ 0053 discloses that the plurality of alignment arms 136 are biased by a biasing member 162 into a first/closed configuration).
Regarding claim 3, Dwork in view of High, Robinson, and Alon discloses the invention as claimed as discussed with respect to claim 2. Dwork further discloses that the biasing member comprises a garter spring extending around each of the plurality of alignment arms (¶ 0058 discloses that the biasing member 162 may comprise a coil, spring, or other similar biasing elements around extending around each of the plurality of alignment arms as seen in fig. 1).
Regarding claim 4, Dwork in view of High, Robinson, and Alon discloses the invention as claimed as discussed with respect to claim 2. Dwork further discloses an alternate embodiment that the biasing member comprises an elastomeric member extending around each of the plurality of alignment arms (¶ 0058 discloses that the biasing element 162 is an elastic band and that its elastic structure allows the biasing element to stretch/expand when manipulated and return to a collapsed state when not manipulated i.e. elastomeric).
Regarding claim 6, Dwork in view of High, Robinson, and Alon discloses the invention as claimed as discussed with respect to claim 2. High further discloses that the loader housing includes a face plate (fig. 6g illustrates a loader housing 200 that includes a face-plate 260) the face plate is capable of permitting the alignment tool to be secured relative to the loader within a range of relative rotational positions due to its having reduced diameter portions at various locations along its circumferential edge (see fig. 6g). Robinson discloses a plurality of securement arms capable of engaging with a face-plate when securing the alignment tool to the loader due to the arms’ (216) flanged ends and ability to couple to or receive a plate-like member as disclosed in ¶ 0138 and as shown in figure 5c.
Regarding claim 7, Dwork in view of High, Robinson, and Alon disclose the invention as claimed as discussed with respect to claim 1. Robinson discloses that the plurality of securement arms are monolithically formed as part of the body (¶ 0135 discloses a part 206 that includes a body/base portion 214 and a flared portion 212 and ¶ 0138 discloses that the flared portions are divided into elongate securement projections/arms 216. Fig. 3 illustrates that the body/base portion 214 and the plurality securement arms 216 form a monolithic structure or part 206).
Regarding claim 8, Dwork in view of High, Robinson, and Alon discloses the invention as claimed as discussed with respect to claim 1. Dwork further discloses that the plurality of alignment arms are pivotably secured relative to the body (fig. 1 illustrates a plurality of alignment arms 136 pivotably secured by a biasing member 162).
Regarding claim 9, Dwork discloses an alignment tool (102) for loading a replacement cardiac valve (¶ 0060-0062 disclose devices and methods for delivery of a heart valve prosthesis)
having a plurality of alignment loops (¶ 0068 discloses and fig. 11 illustrates a valve prosthesis 300 with a plurality of alignment loops/tethers 216) onto a delivery catheter (¶ 0049 discloses that a delivery tool 102 is used for loading a valve prosthesis on a deliver catheter 200) having a corresponding plurality of alignment pins adapted to be received within a corresponding alignment loop (fig. 11 illustrates alignment loops 216 on a delivery catheter 200 having corresponding plurality of alignment pins/posts/protrusions), the alignment tool (102) comprising: a body (see fig. 1 annotated above); a plurality of alignment arms extending from the body (fig. 2a illustrates a plurality of alignment arms extending from the body 104), each of the plurality of alignment arms including a first end (144) and an opposing second end including a handle portion (142, ¶ 0055 discloses that the first end comprises and actuator surface that is configured for user manipulation to pivot corresponding pivotable elements 136), the plurality of alignment arms movable between a closed configuration defining a minimum distance between the first end of each of the plurality of alignment arms (fig. 1 illustrates the alignment arms 136 in a closed configuration defining a minimum distance between the first end 144 of each of the plurality of alignment arms) and an open configuration defining a maximum distance between the first end of each of the plurality of alignment arms (fig. 2b illustrates the alignment arms 136 in an open configuration defining a maximum distance between the first end of each of the plurality of alignment arms); and a biasing member adapted to bias the plurality of alignment arms into the closed configuration (¶ 0053 discloses that the plurality of alignment arms 136 are biased by a biasing member 162 into a first/closed configuration). Dwork fails to disclose that the replacement cardiac valve is disposed within a loader having a loader housing.
High also discloses a tool for loading a cardiac valve (the abstract and ¶ 0028 discloses a tool/assembly 200 for loading a cardiac valve) having a plurality of alignment loops (fig. 4, 118). High teaches a replacement cardiac valve disposed within a loader having a loader housing (fig. 12 annotated a heart valve 100 disposed within a loader 200 having a loader housing 202). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Dwork to include a replacement cardiac valve disposed within a loader having a loader housing as taught by High in order to load a collapsible prosthetic heart valve 100 into a delivery device (High ¶ 0055).
Dwork in view of High fails to disclose a plurality of securement arms extending from the body, each of the plurality of securement arms adapted to secure the alignment tool relative to the loader.
Robinson discloses a device in a similar technical field and class as the present invention. Robinson discloses systems and methods of sheathing a stent prior to an insertion procedure (see Abstract). Robinson teaches a plurality of securement arms extending from a body (fig. 3 illustrates a plurality of securement arms 216 extending from a body/base portion 214). The plurality of securement arms of Robinson are capable of securing the alignment tool of Dwork to the loader of High due to the arms’ (216) flanged ends and ability to couple to or receive a plate-like member as disclosed in ¶ 0138 and as shown in figure 5c.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Dwork in view of High to include a plurality of securement arms extending from the body, each of the plurality of securement arms adapted to releasably secure the alignment tool relative to the loader as taught by Robinson in order to align and secure a housing or funnel (Robinson ¶ 0139).
Dwork in view of High and Robinson fails to disclose that the plurality of alignment arms includes a first end having an alignment slot.
Alon also discloses a tool for loading a replacement cardiac valve having a plurality of alignment loops onto a delivery catheter (fig. 13 illustrates a slot 150 that aligns with the loop 32 of a valve 10). Alon teaches a plurality of arms which includes an end having an alignment slot (fig. 13 illustrates a slot 150 that aligns with the loop 32 of a valve stent 10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Dwork in view of High and Robinson to include a plurality of arms which includes an end having an alignment slot as taught by Alon in order to mount a valve into a delivery sheath (Alon - abstract).
Regarding claim 10, Dwork in view of High, Robinson, and Alon disclose the invention as claimed as discussed with respect to claim 9. Robinson discloses a body comprising one or more securement arms (fig. 3 illustrates a plurality of securement arms 216 extending from a body/base portion 214) capable of releasably securing an alignment tool relative to a loader due to the arms’ ability to couple to or receive a plate-like member as disclosed in ¶ 0138 and as shown in figure 5c.
Regarding claim 11, Dwork in view of High, Robison, and Alon disclose the invention as claimed as discussed with respect to claim 9. Dwork further discloses that the body (104) includes an annular structure (fig. 1 illustrates and ¶ 0058 discloses an annular structure such as a biasing member 162 that is disposed around pivotable elements 136). The annular structure or biasing member 162 is capable of releasably securing the alignment tool relative to a loader due to its ability to move between and closed and open configuration and apply an inward radial force when in a closed configuration e.g. for trapping or securing elements.
Regarding claim 12, Dwork in view of High, Robinson, and Alon disclose the invention as claimed as discussed with respect to claim 9. Dwork discloses that the biasing member comprises an annular spring (fig. illustrates an annular biasing member 162 and ¶ 0058 discloses that the biasing member 162 may comprise a coil, spring, or other similar biasing elements).
Regarding claim 13, Dwork in view of High, Robinson, and Alon disclose the invention as claimed as discussed with respect to claim 9. Dwork further discloses that the biasing member comprises an O-ring (fig. 1 illustrates and ¶ 0058 discloses a biasing member 162 that encircles/circumferentially surrounds pivotable arms 136 i.e. an O-ring).
Regarding claim 14, Dwork in view of High, Robinson, and Alon disclose the invention as claimed as discussed with respect to claim 9. Dwork further discloses that the plurality of alignment arms are capable of moving from the closed configuration to the open configuration in response to an inward force applied to the second ends of each of the plurality of alignment arms (¶ 0059 discloses that the alignment arms 136 move from a first/closed configuration to a second/open configuration when a user applies an inward force to the second end 142 which comprises an actuator surface 146).
Regarding claim 15, Dwork in view of High, Robinson, and Alon disclose the invention as claimed as discussed with respect to claim 9. Dwork further discloses in ¶ 0059 that the second ends of each of the plurality of alignment arms are capable of being squeezed together in order to move from the closed configuration to the open configuration. This is due to the ability of the alignment arms 136 to move from a first/closed configuration to a second/open configuration when a user applies an inward force to the second end 142 which comprises an actuator surface 146. Inward forces can be a result of e.g. squeezing, pinching, or pressing the second/actuator ends.
Regarding claim 16, Dwork in view of High, Robinson, and Alon disclose the invention as claimed as discussed with respect to claim 9. Dwork further discloses that the plurality of alignment arms are capable of pivoting between the closed configuration and the open configuration (¶ 0059 discloses pivotable alignment arms 136 that move or pivot from a first/closed configuration to a second/open configuration).
Regarding claim 17, Dwork in view of High, Robinson, and Alon disclose the invention as claimed as discussed with respect to claim 9. Robinson discloses a plurality of securement arms extending from the body (fig. 3 illustrates a plurality of securement arms 216 extending from a body 214), each of the plurality of securement arms capable of releasably securing the alignment tool relative to the loader due to the arms’ (216) flanged ends and ability to couple to or receive a plate-like member as disclosed in ¶ 0138 and as shown in figure 5c.
Regarding claim 18, Dwork in view of High, Robinson, and Alon disclose the invention as claimed as discussed with respect to claim 17. Robinson discloses that the body and the plurality of securement arms are molded together (¶ 0135 discloses a part 206 that includes a body/base portion 214 and a flared portion 212 and ¶ 0138 discloses that the flared portions are divided into elongate securement projections/arms 216. Fig. 3 illustrates that the body/base portion 214 and the plurality securement arms 216 of the part 206 are molded into a monolithic structure).
Regarding claim 19, Dwork in view of High, Robinson, and Alon disclose the invention as claimed as discussed with respect to claim 17. High further discloses that loader housing includes a face plate (fig. 6g illustrates a loader housing 200 that includes a face-plate 260) the face plate is capable of permitting the alignment tool to be secured relative to the loader within a range of relative rotational positions due to its having reduced diameter portions at various locations along its circumferential edge (see fig. 6g). Robinson further discloses a plurality of securement arms capable of engaging with a face-plate of the loader when securing the alignment tool to the loader due to the arms’ (216) flanged ends and ability to couple to or receive a plate-like member as disclosed in ¶ 0138 and as shown in figure 5c.
Claims 5 are rejected under 35 U.S.C. 103 as being unpatentable over Dwork et al. (US 20180280174 A1), High et al. (US 20190021856 A1), Robinson (US 20130116772 A1), and Alon et al. (US 10820994 B2) as applied to claim 2 above, and in further view of Tamir et al. (US 20210030533 A1).
Regarding claim 5, Dwork in view of High, Robinson, and Alon discloses the invention as claimed as discussed with respect to claim 2. Dwork in view of High, Robinson, and Alon fails to disclose that the biasing member comprises a separate biasing member secured relative to each of the plurality of alignment arms. Tamir also discloses a tool for loading a stent (abstract, 12) and a plurality of arms (446), wherein the plurality of alignment arms are biased (¶ 0234). Tamir teaches biasing members that comprises a separate biasing member secured relative to each of the plurality of alignment arms (¶ 0234 discloses fig. 16b annotated below illustrates separate biasing members/coils 458 secured relative to a plurality of arms 446).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Dwork in view of High, Robinson, and Alon to include that the biasing member comprises a separate biasing member secured relative to each of the plurality of alignment arms as taught by Tamir in order to aid the arms in engaging with or securing a frame (Tamir ¶ 0234).
Claims 20 is rejected under 35 U.S.C. 103 as being unpatentable over Dwork et al. (US 20180280174 A1) in view of Robinson et al. (US 20130116772 A1) and Alon et al. (US 10820994 B2).
Regarding claim 20, Dwork discloses a method of loading a stent onto a stent holder using an alignment tool (fig. 8a illustrates and ¶ 0063-0064 discloses a method of loading a stent 300 onto a holder 210), the method comprising: inserting the stent having a plurality of terminal end loops into the stent holder having a plurality of pins on which the terminal end loops are to be placed (fig. 8a illustrates inserting a stent 300 with a plurality of terminal end loops 216 into a stent holder 210 having a plurality of pins/posts/protrusions 212 and ¶ 0060 discloses that the loops/tethers 216 have a corresponding of the pins/posts/protrusions 212); securing the alignment tool to the stent holder (fig. 11 illustrated securing the alignment tool 102 to the stent holder 210), the alignment tool having: a body (see fig. 1 annotated above); a plurality of alignment arms extending from the body (fig. 2a illustrates a plurality of alignment arms 136extending from the body), each of the plurality of alignment arms including a first end (144) and an opposing second end including a handle portion (142, ¶ 0055 discloses that the first end comprises and actuator surface that is configured for user manipulation to pivot corresponding pivotable elements 136), the plurality of alignment arms movable between a closed configuration defining a minimum distance between the first end of each of the plurality of alignment arms (fig. 1 illustrates the alignment arms 136 in a closed configuration defining a minimum distance between the first end 144 of each of the plurality of alignment arms) and an open configuration defining a maximum distance between the first end of each of the plurality of alignment arms (fig. 2b illustrates the alignment arms 136 in an open configuration defining a maximum distance between the first end of each of the plurality of alignment arms); and a biasing member that biases the plurality of alignment arms into the closed configuration (¶ 0053 discloses that the plurality of alignment arms 136 are biased by a biasing element 162 into a first/closed configuration); advancing the stent and moving one stent loop over each pin (figs. 9-11 illustrate and ¶ 0068 discloses loading a stent onto a holder 210 and moving/placing a loop 216 over each pin/post/protrusion 212); compressing the stent onto the stent holder (fig. 9 illustrates compressing a stent 300 onto a stent holder 210); and removing the alignment tool from the stent holder and the stent (fig. 13a-13d illustrate removing an alignment tool 102 from a stent holder 210 and stent 300).
Dwork fails to disclose a plurality of securement arms extending from the body, each of the plurality of securement arms adapted to releasably secure the alignment tool relative to a loader.
Robinson discloses a device in a similar technical field and class as the present invention. Robinson discloses systems and methods of sheathing a stent prior to an insertion (see Abstract). Robinson teaches that a plurality of securement arms extend from the body (fig. 3 illustrates a plurality of securement arms 216 extending from a body/base portion 214), each of the plurality of securement arms adapted to releasably secure the alignment tool relative to a loader (fig. 5c illustrates the plurality of securement arms adapted to releasably secure a tool relative to a loader 208 and ¶ 0139 discloses that the loader 208 is used to load a stent or valve).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Dwork to include a plurality of securement arms adapted to be releasably secured to a loader as taught by Robinson in order to align and secure a housing or funnel (Robinson ¶ 0139).
Dwork in view of Robinson fails to disclose that the plurality of alignment arms includes a first end having an alignment slot.
Alon also discloses a method of loading a stent (figs. 17-18 illustrate a method of loading a stent 10 into a delivery catheter 106). Alon teaches a plurality of arms which includes an end having an alignment slot (fig. 13 illustrates a slot 150 that aligns with the loop 32 of a valve stent 10). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Dwork in view of Robinson to include a plurality of arms which includes an end having an alignment slot as taught by Alon in order to mount a valve into a delivery sheath (Alon - abstract).
Conclusion
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/A.G.B./Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774
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