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 .
Priority
This application claims priority from PCT/EP2020/065920, filed 06/09/2020.
Status of Claims
Claims 1-7 and 9-23 are pending.
Claims 22-23 have been withdrawn from consideration.
Election/Restrictions
Applicant elected Invention I (Apparatus) and Species 1 (Figures 4A) with traverse on 10/18/2024. The requirement was deemed proper and made FINAL.
Drawings
The objections to the drawings have been withdrawn in view of the applicant’s amendments and clarification of the record. Specifically, the term chevron shape is being given a very broad interpretation allowing for most irregular shapes as long as they have a taper between the narrowed upper end and the wider lower end. This interpretation is consistent with that shown in Figure 5B which the applicant cites as being chevron shaped.
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.
Claims(s) 1-6, 10-21, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Hansen US 2010/0274226 A1 in view of Gunderson et al (Gunderson) US 2004/0267348 A1 and Zadno-Azizi et al (Zadno) USPN 6,022,336.
1. Hansen discloses a catheter device (Figures 4 and 11) for transluminally delivering a self-expanding tubular implant (as explained above the stent is not part of the claimed invention, but Hansen discloses the use of a stent shown in Figure 3 and acknowledges they may be self-expanding in [0004]) to a site in a body, the device comprising:
an inner catheter (102/108 Figure 4) comprising an implant-receiving section of the inner catheter 102 with a wall (outer surface of 102),wherein the implant-receiving section of the inner catheter is arranged, in use, to be received within the lumen of the implant (the claims are directed solely at the catheter not the stent, so the stent limitations are given limited weight, the inner catheter of Hansen is described as a holding region for receiving the stent [0063]); and
a sheath 114 (Figure 11), coaxial with the inner catheter (Figure 11), wherein the sheath is arranged to sheath the implant until, in use, the sheath is withdrawn proximally (Figures 2, 3, and 11), relative to the implant and the inner catheter, to release the implant at the site,
wherein the implant-receiving section of the inner catheter includes a first plurality of implant retention elements 104 (Figure 4) of shape memory alloy [nitinol 0069], which, during withdrawal of the sheath protrude radially outwardly from the implant-receiving section of the inner catheter (Figure 4) to engage a radially inward facing surface of the implant to restrain the implant from being carried by the sheath proximally (the claims are directed solely at the catheter and do not positively claim a stent, so the stent limitations are given limited weight, the inner catheter of Hansen is fully capable of being inserted into any type of stent including ones which would overlap the extensions shown in Figures 4 and 11 allowing the extensions to engage the radially inward facing surface of a properly configured stent), relative to the implant-receiving section of the inner catheter, wherein the first plurality of implant retention elements are configured to assume a radially outwardly protruding configuration to engage the radially inward facing surface of the implant prior to the withdrawal of the sheath [0069], wherein at least one of the first plurality of implant retention elements is a flap 104 (fingers of Hansen are considered to read on the broadest reasonable interpretation of a flap because they are elongated and flex) arranged to extend distally from a root line (base where the fingers attach to the wall) in the implant-receiving section of the inner catheter, wherein the flap comprises a hinge portion (base where the fingers attach to the wall) about which the flap is arranged to deflect [0074], and an engaging portion (upper unattached end of fingers) arranged to engage the implant, and wherein the hinge portion extends along a root line and the engaging portion extends along a contact line (Figure 4) for contacting the implant.
However, Hansen does not disclose the implant-receiving section is made of a tube of shape-memory alloy or that the plurality of implant retention elements are formed from a portion of the wall of the implant-receiving section of the inner catheter such that the root line of the hinge portion is shorter than the contact line of the engaging portion in a circumferential direction.
Zadno teaches that is old and well known in the art of vascular catheters to form them from tubular stock of shape memory material because it is biocompatible readily available, flexible, and has some visibility under X-ray as to not interfere with other markers.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to form the entire inner catheter including the implant-receiving section from a tube of nitinol as taught by Zadno in order to provide a biocompatible catheter that is formed from a material that is readily available, flexible, and has some visibility under X-ray as to not interfere with other markers .
.
Gunderson teaches the use of a plurality of implant retention elements (see full explanation in previous office action) are formed from a portion of the wall of the implant-receiving section of the inner catheter (Figure 10 shows the flap is cut from the wall) and wherein the root line of the hinge portion is shorter than the contact line of the engaging portion in a circumferential direction (Figure 10) in the same field of endeavor for the purpose of providing projections that do not add any material to the catheter and can be folded completely flat for removal.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to replace the plurality of fingers of Hansen with a plurality of flaps cut from the wall as taught by Gunderson in order to remove unnecessary material and weight from the catheter and to allow for the projections to be folded completely flat for easier removal of the catheter device.
2. Hansen discloses the implant-receiving section of the inner catheter includes a second plurality of implant retention elements of shape memory alloy (Hansen discloses multiple groups that can be identified as first and second pluralities i.e. proximal and distal ends of the retention region shown in Figure 4 that are formed from nitinol [0069]), which are configured to utilize a shape memory effect to protrude radially outward from the implant-receiving section of the inner catheter to engage a radially inward facing surface of the implant to restrain the implant from being carried distally, relative to the implant-receiving section of the inner catheter [0069].
3. Hansen as modified to include the flap of Gunderson discloses that one of the second plurality of implant retention elements is a flap arranged to extend proximally from a root line in the implant-receiving section of the inner catheter (Figure 10 of Gunderson).
4. Hansen discloses pluralities of at least the first and second plurality of implant retention elements are arranged along a length of the implant-receiving section of the inner catheter, so that a force exerted on the implant by the at least first and second plurality of implant retention elements is distributed evenly along a length of an implant (Figure 4).
5. Hansen as modified to include the flap of Gunderson discloses the contact line is up to twice as long as the root line (the contact line is not limited by the claims so it is open to interpretation, accordingly the examiner is considering only the very tip of the flap in Figure 9 to be the contact line because it could be the only portion of the edge that is in contact with a stent, this portion is the same width as the root line but has a length longer, but not more than double the length because of the bent shape).
6. The prior art combination discloses the shape memory alloy is nitinol (Hansen [0069] Gunderson [0066] and Zadno 15:21-23).
10. Hansen discloses at least the first plurality of retention elements and the second plurality of retention elements are disposed in a same implant retention section (Each end of the same retention region of Figure 4).
11. Hansen discloses the first and second plurality of retention elements are arranged circumferentially around the implant-receiving section of the inner catheter in at least one row, wherein the first and second plurality of retention elements alternate along at least one row (Figure 9 shows how the fingers of the other embodiments extend circumferentially including both pluralities).
12. Hansen discloses the first plurality of retention elements is disposed at a location on the implant-receiving section of the inner catheter that is arranged to be received by a proximal region of the implant (left most fingers of Figure 4).
13. Hansen discloses the second plurality of retention elements are disposed at a location on the implant-receiving section of the inner catheter that is to be received by a distal region of the implant (right most fingers of Figure 4).
14. Hansen as modified to include the flap of Gunderson discloses the flap extends in an arc around the circumference of the implant-receiving section of the inner catheter (see rejection of claim 14 above).
15. Hansen as modified to include the flap of Gunderson discloses the first and/or second retention elements assume a configuration in which the first and/or second retention elements are deflected about the hinge portion (shown best in Figure 9 of Gunderson).
16. and 20. Hansen as modified to include the flap of Gunderson discloses the first and/or second plurality of retention elements are configured so that a force exerted on the implant by the first and/or second retention elements, respectively, within a range of deflection of the hinge is substantially the same over the range of deflection and the hinge portion is substantially in a plateau region of the stress-strain curve of the material of the at least first and second plurality of implant retention elements, when engaged with the implant, so that the at least first and second plurality of implant retention elements exert more or less the same force on the implant regardless of how much they protrude from the implant-receiving section of the inner catheter. (The hinges have uniform thickness, they from a straight line about the circumference, are made from the same material, and are cut from the wall in the same manner as the applicant’s flaps so they will inherently act with the same force exerting throughout the range of deflection).
17. Hansen as modified to include the flap of Gunderson discloses the flap is configured to be at least one of a barb, an arch, a chevron or a spike (see Gunderson rejection of claim 17 above).
18. Hansen as modified to include the flap of Gunderson discloses the first and/or second plurality of retention elements are unpolished (see Gunderson rejection of claim 18 above).
19. Hansen as modified to include the flap of Gunderson discloses the first plurality of implant retention elements are able to lie within the wall thickness (see Gunderson rejection of claim 19 above).
21. Hansen as modified to include the flap of Gunderson discloses the root line of the hinge portion is shorter than the contact line of the engaging portion in a circumferential direction, so that the force exerted on an ePTFE coating of the implant is distributed with respect to the coating(see Gunderson rejection of claim 21 above).
24. Hansen as modified discloses the hinge portion about which the flap deflects is heat set to be stress free when the engaging portion of the flap protrudes radially outward from the implant-receiving section of the inner catheter (as explained above the combination comprises an implant receiving section including the flaps with hinges that are made from the memory material nitinol, Nitinol within the medical area is well known to require the heat setting as the inherent method for preprogramming the material shape, memory metal implants are preset using heat setting methods such that after exposure to the body temperature the implant returns to the preset shape in a stress free condition, in this case Gunderson discloses the flaps are made from nitinol and hinge from the recessed flat shape to the preprogrammed angled shape, to achieve this, it inherently requires the hinge to be heat set in the same manner as the applicant’s invention, since there are no other changes in shape this portion has to be treated by heat setting).
Claim(s) 7 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gunderson, Hansen, and Zadno (Combination 1) as applied to claims 1-6, 10-21, and 24 above, and further in view of Lupton US 2003/0114911 A1.
Combination 1 discloses the invention substantially as claimed being described above. However, Combination 1 does not disclose the use of flexible sections along the implant-receiving section of the inner catheter.
Lupton teaches the use of catheter distal ends comprising flexible regions (10 Figures 3-6 corresponding to claim 7) formed from a plurality of staggered circumferentially extending slits forming a cardanic joint (Figures 4E-F forming a cardanic joint as much as the applicant’s own invention see 112 above, corresponding to claim 8) wherein the retention regions and flexible regions alternate along the length of the catheter (Figure 5 corresponding to claim 9) in the same field of endeavor for the purpose of allowing the catheter and stent to have the same shape/curve as the surrounding area and implant site throughout delivery and expansion of the stent.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to provide the multiple retention sections of Hansen with alternating flexible sections formed from a plurality of staggered circumferentially extending slits as taught by Lupton in order to allow the catheter and stent to have the same shape/curve as the surrounding area and implant site throughout delivery and expansion of the stent.
Response to Arguments
Applicant's arguments filed 06/06/2025 have been fully considered but they are not persuasive.
The applicant argues there is no reason to change the principle operation of Hansen’s stent retention mechanisms. This is not persuasive because the examiner has explained the motivation and benefits in exhaustive detail. The modification provides a clear improvement to Hansen. Hansen does not disclose the plurality of implant retention elements are formed from a portion of the wall of the inner catheter. The retention members of Hansen are attached and extend radially outward from the inner catheter. Even with their flexible nature they are not going to be as uniformly compressible or controllable as the a plurality of implant retention elements of Gunderson because they are cut out of a portion of the wall of the implant-receiving section of the inner catheter. By cutting them out of the wall they are locked in place and have consistent predictable ranges of motion. Both Gunderson and Hansen are in the same field of endeavor, stent delivery devices. The motivation/benefit of the modification is that Hansen will no longer need to have any material added to the exterior of the catheter because the wall is cut directly. This reduces the mass of the catheter, reduces the thickness of the implant receiving section, allows for the catheter to assume a completely flat configuration, and provides flaps with more predictable range of motion which reduces the chances of unwanted gripping or snagging during removal and encourages complete expansion of the implant.
The applicant further argues that the examiner has failed to provide a reasoned explanation for the motivation or a finding that there were design incentives or market forces which would have prompted adaption of the known device. This argument is misplaced because the examiner has provided an abundance of explanation. Again, the combination reduces the mass of the catheter, reduces the thickness of the implant receiving section, allows for the catheter to assume a completely flat configuration, and provides flaps with more predictable range of motion which reduces the chances of unwanted gripping or snagging during removal and encourages complete expansion of the implant.
The applicant further argues that Hansen’s fingers are necessary to perform the functions of providing resistance to longitudinal movement and resistance to twisting. This argument is not persuasive because as explained above the plurality of fingers are being replaced with a plurality of flaps cut from the tube. They will perform the same functions by attaching to openings and struts of the stent. Both components function with the same principal, but the combination now has flaps that recess and move in a more efficient and predictable manner.
The applicant further argues that the deflecting of the fingers nullifies the motivation of allowing the flaps to be folded completely flat. This is not persuasive because deflecting is not the same as folding to a fully recessed position. As explained above the combination allows for the flaps to be recessed leaving them free from catching or snatching. This also provides controlled movement because they can only move in the direction provided by the hinge, which provides more predictable and uniform movement.
In summary, the combination is replacing a flexible rudimentary stent retention finger with a recessed hinged flap. The benefits would be abundantly clear to any PHOSITA looking at the figures of the prior art.
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 CHRISTOPHER D PRONE whose telephone number is (571)272-6085. The examiner can normally be reached Monday-Friday 10 am - 6 pm (HST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie R Tyson can be reached on (571)272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Christopher D. Prone/Primary Examiner, Art Unit 3774