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 .
Notice of Supplemental Action
Vacate the previous Final Rejection issued December 4th, 2025 and issue this Final Rejection. The period for reply has been reset to reflect the supplemental final rejection issued here.
Response to Amendment
Claims filed on August 21st, 2025 have been entered. Claims 11, 16- 17, 21, 24, and 27- 41 have been entered. Claim 16 remains withdrawn for being drawn to an unelected species. The amendments to claim 11 and claim 21 overcome the previous objections.
Claim Objections
Claims 21, 24, 27- 30, 32- 34, and 39- 41 are objected to because of the following informalities:
Claim 21, Line 23 states “the outer surface”, it is suggested to change this to “the tapered outer surface”.
Claims 24, 27-30, 39- 41 are objected for being dependent on or from objected claim 21.
Claim 32, Lines 5-6 state “to coil of”, it is suggested to change this to “to the coil of”.
Claim 32, Lines 4 and 6 state “the at least a first complete winding”, it is suggested to change this to “the at least first complete winding”.
Claim 33, Line 3 states “includes including”, it is suggested to change this to “includes”.
Claim 34, Line 1 states “the outer surface”, it is suggested to change this to “the tapered outer surface”.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The rejection of claims 11, 14, 21, 24 and 27 under 35 U.S.C. 103 over Wang et al. (WO 2018121344) in view of Rafiee et al. (US 9,364,324) has been withdrawn in light of applicant’s amendments, specifically Wang does not teach wherein the outflow capture device includes a coil, the coil including at least a first complete winding configured about a longitudinal axis of the intermediate shaft and the coil being mounted on the intermediate shaft to be rotatable therewith.
Claim(s) 11, 17, 21, 24, 27- 28, 31, 32, 34- 35, 37, and 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (WO 2018/121344 (English Machine Translation)) in view of Rafiee et al. (US 9,364,324) and in view of Hopkins et al. (US 2013/0338788).
Regarding claim 11, Wang (Wang et al.) teaches a delivery system (200)(Figs. 3-6) for delivery of a device (lumen stent/support 100)(Paragraph 0038) to a body lumen (abstract, Paragraph 0044), the device comprising an inflow end and an outflow end, a central lumen therethrough (see annotated Fig. 1 below), a plurality of attachment members (barb 123, corrugated ring 122)(Paragraph 0039) located at or near the outflow end (see annotated Fig. 1 below), the delivery system comprising:
An inner shaft (inner core tube 205) having a distal tip (tip 207)(Paragraph 0042);
An intermediate shaft (outer core tube 203) slidingly disposed over the inner shaft (Paragraph 0042), wherein the intermediate shaft includes an outflow capture device (anchoring member 204) mounted on a distal end thereof (see Fig. 3)(Paragraph 0043), the outflow capture device configured for engagement through openings in the plurality of attachment members on the device (Paragraph 0044);
An outer shaft (pushrod 202) slidingly disposed over the intermediate shaft (see annotated Figs. 3 and 5 below, as shown within these figures, the outer shaft 202 has moved from a distal position to a proximal position relative to the intermediate shaft 203, therefore the outer shaft is slidingly disposed over the intermediate shaft.); and
A retractable sheath (outer tube 201) slidingly disposed over the outer shaft to hold the device in a radially compressed configuration for delivery to the body lumen (Paragraphs 0042, 0044 and 0045).
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Regarding wherein the intermediate shaft is rotatable relative to the inner shaft and to the outer shaft in order to release the plurality of second attachment members, as Wang teaches in Paragraph 0046 that the intermediate shaft (203) can be moved proximally by a mechanism on the handle, and that the intermediate shaft is able to moved relative to the inner shaft and the outer shaft (Paragraph 0042; see annotated Figs. 3 and 5 above , it would be obvious that the intermediate shaft is able to rotate relative to the inner shaft and the outer shaft. Furthermore, as the proximal movement of the intermediate shaft is taught to release the plurality of attachments (Paragraph 0046), when the intermediate shaft is rotated and moved proximally, the plurality of second attachment members are released.
Wang does not teach a plurality of attachment members located at or near the inflow end or wherein the outer shaft includes a coil on a distal end thereof, the coil configured for engagement through openings in the plurality of attachment members located at or near the inflow end on the device, wherein the coil includes at least a first complete winding configured about a longitudinal axis of the outer shaft or wherein the outflow capture device includes a coil, the coil including at least a first complete winding configured about a longitudinal axis of the intermediate shaft and the coil being mounted on the intermediate shaft to be rotatable therewith.
Rafiee (Rafiee et al.) teaches a delivery system (100)(Fig. 1) for delivery of a device (500)(Fig. 2) to a body lumen (abstract), the device comprising an inflow end and an outflow end (see annotated Fig. 2 below), a central lumen (Column 7, Lines 48- 50) therethrough, a plurality of attachment members located at the inflow end (Column 8, Lines 59- 66), the delivery system comprising:
An inner shaft (inner catheter 114)(Fig. 1) having a distal tip (118)(Fig. 1),
An outer shaft (holding catheter 120)(Fig. 1) slidingly disposed over the inner shaft (Column 6, Line 62 - Column 7, Line 2), wherein the outer shaft includes a coil (122)(Fig. 1) on a distal end thereof (Column 7, Lines 3- 4), the coil configured for engagement through openings in the plurality of attachment members on the device (Column 10, Lines 54- 58), wherein the coil includes at least a first complete winding (see annotated Fig. 1 below) configured about a longitudinal axis of the outer shaft (see annotated Fig. 1 below); and
A retractable sheath (outer sheath 126)(Fig. 1)(Since 126 is taught to be retractable (Column 10, Lines 48- 52), it is herein considered a retractable sheath.) slidingly disposed over the outer shaft (Column 10, Lines 48- 52) to hold the device in a radially compressed configuration for delivery to a body lumen (see Fig. 7 and 8)(Column 10, Lines 39- 43).
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It would have been obvious to one of ordinary skill in the art to modify the prosthetic device and the outer shaft as taught by Wang to have a plurality of attachment members located at or near the inflow end of the prosthetic device and a coil disposed on the outer shaft, with the coil engaging the openings of the plurality of attachment members as taught by Rafiee, since Rafiee teaches that the coil and the attachment members allow for the device to “be easily re-compressed and moved to the correct location” (Column 2, Lines 61- 67).
The combination does not teach wherein the outflow capture device includes a coil, the coil including at least a first complete winding configured about a longitudinal axis of the intermediate shaft and the coil being mounted on the intermediate shaft to be rotatable therewith.
Hopkins (Hopkins et al.) teaches a delivery system (abstract)(Fig. 25) for delivery of a device to a body lumen (abstract, Paragraph 0008), the delivery system comprising:
An inner shaft (130) having a distal tip (atraumatic tip 335), wherein the inner shaft includes a coil (140) proximal to the distal tip (see annotated Fig. 25 below), the coil configured for engagement through openings in the plurality of attachment members on the device (Paragraph 0008), wherein the coil includes at least a first complete winding configured about a longitudinal axis of the inner shaft, and a deflector (enclosing member 390) having a tapered outer surface is mounted on the inner shaft adjacent to a proximal end of the coil (see annotated Fig. 25 below)(Paragraph 0114).
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Therefore, it would have been obvious to one of ordinary skill in the art to modify the outflow capture device of the combination to be as a coil as taught by Hopkins for the purpose of releasing a device during an operation (Wang, Paragraph 0044; Hopkins, Paragraph 0008). Furthermore, it would have been obvious to one of ordinary skill in the art to substitute the outflow capture device of Wang for the outflow capture device of Hopkins because both outflow capture device are disclosed as equivalent structures for capturing and releasing a device during an operation (Wang, Paragraph 0044; Hopkins, Paragraph 0008) and substitution of one for the other would have resulted in the predictable result of providing a different way of capturing and releasing a device during a procedure. KSR, 550 U.S. 398, 82 USPQ2d 1385 (2007).
Regarding claim 17, Wang, Rafiee, and Hopkins make obvious the delivery system, including a coil on a distal end of the outer shaft and a plurality of attachment members located at or near the inflow end.
The combination does not teach wherein a deflector having a tapered outer surface is mounted on the intermediate shaft adjacent to a proximal end of the coil.
Hopkins (Hopkins et al.) teaches a delivery system (abstract)(Fig. 25) for delivery of a device to a body lumen (abstract, Paragraph 0008), the delivery system comprising:
An inner shaft (130) having a distal tip (atraumatic tip 335), wherein the inner shaft includes a coil (140) proximal to the distal tip (see annotated Fig. 25 below), the coil configured for engagement through openings in the plurality of attachment members on the device (Paragraph 0008), wherein the coil includes at least a first complete winding configured about a longitudinal axis of the inner shaft (see annotated Fig. 25 below), and a deflector (enclosing member 390) having a tapered outer surface (395)(see annotated Fig. 25 below) is mounted on the inner shaft, a distal end of the deflector abutting against and being coupled to a proximal end of the outflow capture device, the outer surface of the deflector tapering in a distal to proximal direction from the proximal end of the outflow capture device to an outer surface of the inner shaft (see annotated Fig. 25 below)(Paragraph 0114).
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It would have been obvious to one of ordinary skill in the art to modify the system of the combination to have a deflector as taught by Hopkins, since Hopkins teaches that the deflector reduces the “drawbacks arising from direct interference between the distal end 142 of the coiled member 140 and the protective cage 370’” (Paragraph 0114).
Regarding claim 21, Wang (Wang et al.) teaches a delivery system (200)(Figs. 3-6) for delivery of a prosthetic device (lumen stent/support 100)(Paragraph 0038) to a body lumen (abstract, Paragraph 0044), the prosthetic device comprising an inflow end and an outflow end, a central lumen therethrough (see annotated Fig. 1 below), a plurality of attachment members (barb 123, corrugated ring 122)(Paragraph 0039) located at or near the outflow end (see annotated Fig. 1 below), the system comprising:
A first shaft (outer core tube 203) including an outflow capture device (anchoring member 204) mounted on a distal end thereof (see Fig. 3)(Paragraph 0043), the outflow capture device configured for engagement through openings in the plurality of attachment members on the prosthetic device (Paragraph 0044););
A second shaft (pushrod 202) slidingly disposed over the first shaft (see annotated Figs. 3 and 5 below, as shown within these figures, the outer shaft 202 has moved from a distal position to a proximal position relative to the intermediate shaft 203, therefore the outer shaft is slidingly disposed over the intermediate shaft.); and
A retractable sheath (outer tube 201) slidingly disposed over the second shaft to hold the prosthetic device in a radially compressed configuration for delivery to the body lumen (Paragraphs 0042, 0044 and 0045), wherein the first shaft is moveable relative to the second shaft in order to controllably release the plurality of attachment members located at or near the outflow end (Paragraph 0046), and wherein the second shaft is moveable relative to the retractable sheath and the first shaft (Paragraph 0042, see annotated Figs. 3 and 5 below).
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Wang does not teach a plurality of attachment members located at or near the inflow end, wherein the second shaft includes an inflow capture device mounted on a distal end thereof, the inflow capture device configured for engagement through openings in the plurality of attachment members located at or near the inflow end on the prosthetic device, or wherein the second shaft is moveable relative to the retractable sheath and the first shaft in order to selectively control the release of the plurality of attachment members located at or near the outflow end, such that the release of the plurality of attachment members located at or near inflow end is configured to be controlled separately from the release of the plurality of attachment members located at or near the outflow end by different components of the delivery system or wherein a deflector having a tapered outer surface is mounted on the first shaft, a distal end of the deflector abutting against and being coupled to a proximal end of the outflow capture device, the outer surface of the deflector tapering in a distal to proximal direction from the proximal end of the outflow capture device to an outer surface of the intermediate shaft.
Rafiee (Rafiee et al.) teaches a delivery system (100)(Fig. 1) for delivery of a device (500)(Fig. 2) to a body lumen (abstract), the device comprising an inflow end (see annotated Fig. 2 below) and an outflow end (see annotated Fig. 2 below), a central lumen (Column 7, Lines 48- 50) therethrough, a plurality of attachment members located at the inflow end (Column 8, Lines 59- 66), the delivery system comprising:
An inner shaft (inner catheter 114)(Fig. 1) having a distal tip (118)(Fig. 1),
An outer shaft (holding catheter 120)(Fig. 1) slidingly disposed over the inner shaft (Column 6, Line 62 - Column 7, Line 2), wherein the outer shaft includes a coil (122)(Fig. 1) on a distal end thereof (Column 7, Lines 3- 4), the coil configured for engagement through openings in the plurality of attachment members on the device (Column 10, Lines 54- 58), wherein the coil includes at least a first complete winding configured about a longitudinal axis of the outer shaft (see annotated Fig. 1 below); and
A retractable sheath (outer sheath 126)(Fig. 1)(Since 126 is taught to be retractable (Column 10, Lines 48- 52), it is herein considered a retractable sheath.) slidingly disposed over the outer shaft (Column 10, Lines 48- 52) to hold the device in a radially compressed configuration for delivery to a body lumen (see Fig. 7 and 8)(Column 10, Lines 39- 43).
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It would have been obvious to one of ordinary skill in the art to modify the prosthetic device and the outer shaft as taught by Wang to have a plurality of attachment members located at or near the inflow end of the prosthetic device and a coil disposed on the outer shaft, with the coil engaging the openings of the plurality of attachment members as taught by Rafiee, since Rafiee teaches that the coil and the attachment members allow for the device to “be easily re-compressed and moved to the correct location” (Column 2, Lines 61- 67).
Regarding wherein the second shaft is moveable relative to the retractable sheath and the first shaft in order to selectively control the release of the plurality of attachment members located at or near the outflow end, such that the release of the plurality of attachment members located at or near inflow end is configured to be controlled separately from the release of the plurality of attachment members located at or near the outflow end by different components of the delivery system, as Wang teaches that the shafts are moveable separately from each other (Paragraphs 0042, 0045 and 0046)(see annotated Figs. 3 and 5 above), when releasing the plurality of attachment members of the combination, it would be obvious that they can be controlled separately by different components of the delivery system.
The combination does not teach wherein a deflector having a tapered outer surface is mounted on the first shaft, a distal end of the deflector abutting against and being coupled to a proximal end of the outflow capture device, the outer surface of the deflector tapering in a distal to proximal direction from the proximal end of the outflow capture device to an outer surface of the intermediate shaft.
Hopkins (Hopkins et al.) teaches a delivery system (abstract)(Fig. 25) for delivery of a device to a body lumen (abstract, Paragraph 0008), the delivery system comprising:
An inner shaft (130) having a distal tip (atraumatic tip 335), wherein the inner shaft includes a coil (140) proximal to the distal tip (see annotated Fig. 25 below), the coil configured for engagement through openings in the plurality of attachment members on the device (Paragraph 0008), wherein the coil includes at least a first complete winding configured about a longitudinal axis of the inner shaft (see annotated Fig. 25 below), and a deflector (enclosing member 390) having a tapered outer surface (395)(see annotated Fig. 25 below) is mounted on the inner shaft, a distal end of the deflector abutting against and being coupled to a proximal end of the outflow capture device, the outer surface of the deflector tapering in a distal to proximal direction from the proximal end of the outflow capture device to an outer surface of the inner shaft (see annotated Fig. 25 below)(Paragraph 0114).
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It would have been obvious to one of ordinary skill in the art to modify the system of the combination to have a deflector as taught by Hopkins, since Hopkins teaches that the deflector reduces the “drawbacks arising from direct interference between the distal end 142 of the coiled member 140 and the protective cage 370’” (Paragraph 0114).
Regarding claim 24, Wang, Rafiee, and Hopkins make obvious the delivery system, including a coil on a distal end of the outer shaft and a plurality of attachment members located at or near the inflow end.
Wang further teaches the system further comprising a third shaft (inner core tube 205) including a distal tip (tip 207) attached thereto (Paragraph 0042), wherein the first shaft (outer core tube 203) is slidingly disposed over the third shaft (Paragraph 0042 teaches that the third shaft is slidable in the axial direction relative to the first shaft (outer core tube 203), therefore the first shaft is also slidable relative to the third shaft.).
Regarding claim 27, Wang, Rafiee, and Hopkins make obvious the delivery system, including a coil on a distal end of the outer shaft and a plurality of attachment members located at or near the inflow end.
Wang further teaches wherein the first shaft (outer tube 203) is rotatable relative to the third shaft (inner core tube 205) and to the second shaft (pushrod 202) in order to release the plurality of attachment members located at or near the outflow end (As Wang teaches in Paragraph 0046 that the first shaft can be moved proximally by a mechanism on the handle, and that the first shaft is able to moved relative to the third shaft and the second shaft (Paragraph 0042; see annotated Figs. 3 and 5 below), it would be obvious that the first shaft is able to rotate relative to the third shaft and the second shaft. Furthermore, as the proximal movement of the first shaft is taught to release the plurality of attachments (Paragraph 0046), when the first shaft is rotated and moved proximally, the plurality of attachments are released.).
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Regarding claim 28, Wang, Rafiee, and Hopkins make obvious the delivery system, including a coil on a distal end of the outer shaft and a plurality of attachment members located at or near the inflow end.
The combination of Wang and Rafiee further teaches wherein the inflow capture device is a coil (Rafiee, 122)(Rafiee, Fig. 1) that includes at least a first complete winding configured about a longitudinal axis of the second shaft (Rafiee, see annotated Fig. 1 below) and the coil of the second shaft being mounted on the second shaft to be rotatable therewith (Rafiee, Column 7, Lines 3- 16)(As discussed above, it would have been obvious to one of ordinary skill in the art to modify the prosthetic device and the outer shaft as taught by Wang to have a plurality of attachment members located at or near the inflow end of the prosthetic device and a coil disposed on the outer shaft, with the coil engaging the openings of the plurality of attachment members as taught by Rafiee, since Rafiee teaches that the coil and the attachment members allow for the device to “be easily re-compressed and moved to the correct location” (Column 2, Lines 61- 67)).
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Wang and Rafiee do not teach wherein the outflow capture device is a coil that includes at least a first complete winding configured about a longitudinal axis of the first shaft and the coil of the first shaft being mounted on the first shaft to be rotatable therewith.
Hopkins (Hopkins et al.) a delivery system (20)(abstract)(Figs. 1- 5) for delivery of a device (50)(Paragraph 0051), the device having a plurality of attachment members (suture loops 65)(Paragraph 00060) to a body lumen (abstract, Paragraph 0008), the delivery system comprising:
An inner shaft (30) having a distal tip (atraumatic tip 35), wherein the inner shaft includes a coil (40) proximal to the distal tip (see annotated Fig. 1 below) and mounted on the first shaft to be rotatable therewith (Paragraphs 0047 and 0060), the coil configured for engagement through openings in the plurality of attachment members on the device (Paragraphs 0049 and 0060), wherein the coil includes at least a first complete winding configured about a longitudinal axis of the inner shaft (see annotated Fig. 1 below);
An outer shaft disposed over the inner shaft (In Paragraph 0045, Hopkins teaches that “one or more outer cannulas or sheaths are disposed over the cannula”. Therefore, it would be obvious that Hopkins teaches an outer shaft disposed over the inner shaft.); and
A sheath (In Paragraph 0045, Hopkins teaches that “one or more outer cannulas or sheaths are disposed over the cannula”. Therefore, it would be obvious that Hopkins teaches a sheath.).
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Therefore, it would have been obvious to one of ordinary skill in the art to modify the outflow capture device of the combination to be as a coil as taught by Hopkins for the purpose of releasing a device during an operation (Wang, Paragraph 0044; Hopkins, Paragraph 0008). Furthermore, it would have been obvious to one of ordinary skill in the art to substitute the outflow capture device of Wang for the outflow capture device of Hopkins because both outflow capture device are disclosed as equivalent structures for capturing and releasing a device during an operation (Wang, Paragraph 0044; Hopkins, Paragraph 0008) and substitution of one for the other would have resulted in the predictable result of providing a different way of capturing and releasing a device during a procedure. KSR, 550 U.S. 398, 82 USPQ2d 1385 (2007).
Regarding claim 31, Wang, Rafiee, and Hopkins make obvious the delivery system, including a deflector, a coil on a distal end of the outer shaft and a plurality of attachment members located at or near the inflow end.
As discussed above, it would have been obvious to one of ordinary skill in the art to modify the outflow capture device of the combination to be as a coil as taught by Hopkins for the purpose of releasing a device during an operation (Wang, Paragraph 0044; Hopkins, Paragraph 0008). Furthermore, it would have been obvious to one of ordinary skill in the art to substitute the outflow capture device of Wang for the outflow capture device of Hopkins because both outflow capture device are disclosed as equivalent structures for capturing and releasing a device during an operation (Wang, Paragraph 0044; Hopkins, Paragraph 0008) and substitution of one for the other would have resulted in the predictable result of providing a different way of capturing and releasing a device during a procedure. KSR, 550 U.S. 398, 82 USPQ2d 1385 (2007).
The combination further teaches wherein the coil of the outflow capture device has an overall tapered profile with a distal end thereof having a larger diameter than a proximal end thereof (Hopkins, see annotated Fig. 21 below)(Paragraphs 0096 and 0114).
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Regarding claim 32, Wang, Rafiee, and Hopkins make obvious the delivery system, including a coil on a distal end of the outer shaft and a plurality of attachment members located at or near the inflow end.
As discussed above, it would have been obvious to one of ordinary skill in the art to modify the prosthetic device and the outer shaft as taught by Wang to have a plurality of attachment members located at or near the inflow end of the prosthetic device and a coil disposed on the outer shaft, with the coil engaging the openings of the plurality of attachment members as taught by Rafiee, since Rafiee teaches that the coil and the attachment members allow for the device to “be easily re-compressed and moved to the correct location” (Column 2, Lines 61- 67).
The combination further teaches wherein the coil at the distal end of the outer shaft has a winding direction such that the plurality of first attachment members coupled to the coil at the distal end of the outer shaft move in a distal direction along the at least first complete winding to release the inflow end of the prosthetic valve device (Rafiee, see annotated Fig. 1 below).
[AltContent: arrow][AltContent: textbox (Coil wound in such a way that the attachment members would move distally)]
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The combination does not teach wherein the coil at the distal end of the outer shaft and the coil of the outflow capture device have opposite winding directions such that the plurality of first attachment members coupled to the coil at the distal end of the outer shaft move in a distal direction along the at least a first complete winding to release the inflow end of the prosthetic valve device while the plurality of second attachment members coupled to the coil of the outflow capture device move in a proximal direction along the at least a first complete winding to release the outflow end of the prosthetic valve device.
Hopkins teaches in a different embodiment, a delivery system (20)(abstract)(Figs. 1- 5) for delivery of a device (50)(Paragraph 0051) to a body lumen (abstract, Paragraph 0008), the device comprising the device having an inflow end (proximal end 62), an outflow end (distal end 64), and plurality of attachment members located at or near the inflow end (suture loops 65)(Paragraph 00060), the delivery system comprising: an inner shaft (30) having a distal tip (atraumatic tip 35), wherein the inner shaft includes a coil (40) proximal to the distal tip (see annotated Fig. 1 below) and mounted on the first shaft to be rotatable therewith (Paragraphs 0047 and 0060), the coil configured for engagement through openings in the plurality of attachment members on the device (Paragraphs 0049 and 0060), wherein the coil has an at least first complete winding and is wound in a way such that the attachments members move in a proximal direction along the at least first complete winding to release the outflow end of the prosthetic valve device (see annotated Fig. 1 below); an outer shaft disposed over the inner shaft (In Paragraph 0045, Hopkins teaches that “one or more outer cannulas or sheaths are disposed over the cannula”. Therefore, it would be obvious that Hopkins teaches an outer shaft disposed over the inner shaft.); and a sheath (In Paragraph 0045, Hopkins teaches that “one or more outer cannulas or sheaths are disposed over the cannula”. Therefore, it would be obvious that Hopkins teaches a sheath.).
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It would have been obvious to try to one of ordinary skill in the art before the effective filing date to modify the coil of the outflow device to be wound in such a way that the plurality of second attachment members coupled to the coil of the outflow capture device move in a proximal direction along the at least first complete winding to release the outflow end of the prosthetic valve as taught by Hopkins. Hopkins discloses that the coil can be wound in such a way that the plurality of second attachment members move in a distal direction and wound in such a way that the plurality of second attachment members move in a proximal direction (Hopkins, Figs. 1- 2, Paragraphs 0047 and 0048, and Figs. 25- 26). Thus, having the coil of the outflow device be wound such that the plurality of the second attachment members move in a proximal direction to release the outflow end would have been obvious because “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp”. If this leads to the anticipated success, it is likely that product was not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103."KSR, 550 U.S. at 421, 82 USPQ2d at 1397. See MPEP 2143.
Regarding claim 34, Wang, Rafiee, and Hopkins make obvious the delivery system, including a deflector, a coil on a distal end of the outer shaft and a plurality of attachment members located at or near the inflow end.
As discussed above, it would have been obvious to one of ordinary skill in the art to modify the system of the combination to have a deflector as taught by Hopkins, since Hopkins teaches that the deflector reduces the “drawbacks arising from direct interference between the distal end 142 of the coiled member 140 and the protective cage 370’” (Paragraph 0114).
The combination further teaches wherein the outer surface of the deflector tapers in a distal to proximal direction from the proximal end of the coil of the outflow capture device to an outer surface of the intermediate shaft (see annotated Fig. 25 of Hopkins below).
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Regarding claim 35, Wang, Rafiee, and Hopkins make obvious the delivery system, including a deflector, a coil on a distal end of the outer shaft and a plurality of attachment members located at or near the inflow end.
As discussed above, it would have been obvious to one of ordinary skill in the art to modify the system of the combination to have a deflector as taught by Hopkins, since Hopkins teaches that the deflector reduces the “drawbacks arising from direct interference between the distal end 142 of the coiled member 140 and the protective cage 370’” (Paragraph 0114).
The combination further teaches wherein a distal end of the deflector abuts against and is coupled to a proximal end of the coil of the outflow capture device (see annotated Fig. 25 of Hopkins below).
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Regarding claims 37 and 40, Wang, Rafiee, and Hopkins make obvious the delivery system, including a deflector, a coil on a distal end of the outer shaft and a plurality of attachment members located at or near the inflow end.
As discussed above, it would have been obvious to one of ordinary skill in the art to modify the system of the combination to have a deflector as taught by Hopkins, since Hopkins teaches that the deflector reduces the “drawbacks arising from direct interference between the distal end 142 of the coiled member 140 and the protective cage 370’” (Paragraph 0114).
The combination further teaches wherein the deflector is non-movably mounted to an outer surface of the intermediate shaft (Paragraph 0114, Hopkins teaches that the enclosing member is secured to the outer surface of the inner shaft (cannula 130)).
Claim(s) 29- 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (WO 2018/121344 (English Machine Translation)) in view of Rafiee et al. (US 9,364,324) and in view of Hopkins et al. (US 2013/0338788), as applied to claims 11 and 21 above, in further view of Hopkins et al. (US 2013/0338788) and in view of Acosta De Acevedo (US 2011/0251664).
Regarding claim 29, Wang and Rafiee make obvious the delivery system, including a coil on a distal end of the outer shaft and a plurality of attachment members located at or near the inflow end.
Wang further teaches the system further comprising the prosthetic device (lumen stent 100)(Paragraph 0038), wherein the outflow end of the prosthetic device has a plurality of endmost outflow crowns (see annotated Fig. 1 below).
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The combination further teaches wherein the inflow end of the prosthetic device has a plurality of endmost inflow crowns (see annotated Fig. 2 of Rafiee below), and wherein the plurality of attachment members located at or near the inflow end are suture loops attached to at least a portion of the endmost crowns (Rafiee, Column 10, Lines 54- 58), wherein the inflow capture device is a coil (Rafiee, 122)(Rafiee, Fig. 1) including a first complete winding and a second complete winding (see annotated Fig. 1 of Rafiee below), and wherein when the prosthetic device is in the radially compressed configuration, each attachment member of the plurality of attachment members located at or near the inflow end is attached to the coil (Column 9, Lines 58- 67)(As discussed above, it would have been obvious to one of ordinary skill in the art to modify the prosthetic device and the outer shaft as taught by Wang to have a plurality of attachment members located at or near the inflow end of the prosthetic device and a coil disposed on the outer shaft, with the coil engaging the openings of the plurality of attachment members as taught by Rafiee, since Rafiee teaches that the coil and the attachment members allow for the device to “be easily re-compressed and moved to the correct location” (Column 2, Lines 61- 67).).
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The combination does not teach wherein the plurality of attachment members located at or near the outflow end are suture loops attached to at least a portion of the endmost crowns or wherein the plurality of attachment members located at or near the inflow end are attached to the first and second complete windings of the coil in a non-consecutive manner.
Hopkins (Hopkins et al.) a delivery system (20)(abstract)(Figs. 1- 5) for delivery of a device (50)(Paragraph 0051) to a body lumen (abstract, Paragraph 0008), the device comprising the device having an inflow end (proximal end 62), an outflow end (distal end 64), and plurality of attachment members located at or near the inflow end (suture loops 65)(Paragraph 00060), the delivery system comprising:
An inner shaft (30) having a distal tip (atraumatic tip 35), wherein the inner shaft includes a coil (40) proximal to the distal tip (see annotated Fig. 1 below) and mounted on the first shaft to be rotatable therewith (Paragraphs 0047 and 0060), the coil configured for engagement through openings in the plurality of attachment members on the device (Paragraphs 0049 and 0060), wherein the coil includes at least a first complete winding configured about a longitudinal axis of the inner shaft (see annotated Fig. 1 below);
An outer shaft disposed over the inner shaft (In Paragraph 0045, Hopkins teaches that “one or more outer cannulas or sheaths are disposed over the cannula”. Therefore, it would be obvious that Hopkins teaches an outer shaft disposed over the inner shaft.); and
A sheath (In Paragraph 0045, Hopkins teaches that “one or more outer cannulas or sheaths are disposed over the cannula”. Therefore, it would be obvious that Hopkins teaches a sheath.).
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Therefore, it would have been obvious to one of ordinary skill in the art to modify the outflow capture device and the plurality of attachment members located at or near the inflow end of the combination to be as a coil and suture loops as taught by Hopkins for the purpose of releasing a device during an operation (Wang, Paragraph 0044; Hopkins, Paragraph 0008). Furthermore, it would have been obvious to one of ordinary skill in the art to substitute the outflow capture device and the plurality of attachment members located at or near the inflow end of Wang for the outflow capture device and the plurality of attachment members located at or near the inflow end of Hopkins because both outflow capture devices and plurality of attachment members are disclosed as equivalent structures for capturing and releasing a device during an operation (Wang, Paragraph 0044; Hopkins, Paragraph 0008) and substitution of one for the other would have resulted in the predictable result of providing a different way of capturing and releasing a device during a procedure. KSR, 550 U.S. 398, 82 USPQ2d 1385 (2007).
The combination does not teach wherein the plurality of attachment members located at or near the inflow end are attached to the first and second complete windings of the coil in a non-consecutive manner.
Acosta De Acevedo teaches a delivery system (100)(Fig. 1) for delivery of a device (200)(Fig. 5) to a body lumen (abstract), the device comprising: an inflow end (207)(Fig. 5) and an outflow end (205)(Fig. 5), a plurality of attachment members (214)(Fig. 5) located at or near the inflow end (see annotated Fig. 5 below), the delivery system comprising:
An inner shaft (114)(Fig. 6) having a distal tip (118)(Fig. 3),
An outer shaft (120)(Fig. 7) slidingly disposed over the inner shaft (Paragraph 0038), wherein the outer shaft includes a coil (123)(Fig. 7) on a distal end thereof (Paragraph 0038), the coil configured for engagement through openings in the plurality of attachment members on the device (Paragraph 0043), wherein the coil includes at least a first complete winding (see annotated Fig. 7 below) configured about a longitudinal axis of the outer shaft (see annotated Fig. 7 below); and
A retractable sheath (126)(Fig. 3) slidingly disposed over the outer shaft (see annotated Fig. 3 below) to hold the device in a radially compressed configuration for delivery to a body lumen (Paragraph 0037).
Acosta De Acevedo further teaches wherein the coil of the inner shaft includes at least the first complete winding (see annotated Fig. 7 below) configured about a longitudinal axis of the outer shaft (see annotated Fig. 7 below) and a second complete winding (see annotated Fig. 7 below) configured about the longitudinal axis of the outer shaft (see annotated Fig. 7 below), and wherein when the device is in the radially compressed configuration (Paragraph 0044), the first attachment members are attached to the first and second complete windings of the coil in a non-consecutive manner (In Paragraph 0044, Acosta De Acevedo teaches that “the loops 214 can be captured consecutively around the circumference or by capturing alternate loops (peaks) around the circumference”. It would be obvious to one of ordinary skill in the art that the attachment members are attached to the first and second complete windings of the coil in a non-consecutive manner.).
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It would be obvious to one of ordinary skill in the art before the effective filing date to modify the device of the combination to have the attachment members at the inflow end and their configuration with the coil as taught by Acosta De Acevedo, since Acosta De Acevedo teaches that “the configuration of Fig. 8 with the loops 214 gathered in coil 123, permits the user to control the position of the first short leg 204 of bifurcated stent graft section 200 from the proximal end of the delivery system 100, such as by second valve 110” (Paragraph 0044).
Regarding claim 30, Wang, Rafiee, Hopkins, and Acosta De Acevedo make obvious the delivery system, including a coil on a distal end of the outer shaft, a coil as the outflow capture device, and a plurality of attachment members located at or near the inflow end.
The combination further teaches wherein the outflow capture device is the coil (Hopkins, 40)(As discussed above, it would have been obvious to one of ordinary skill in the art to modify the outflow capture device and the plurality of attachment members located at or near the inflow end of the combination to be as a coil and suture loops as taught by Hopkins for the purpose of releasing a device during an operation (Wang, Paragraph 0044; Hopkins, Paragraph 0008). Furthermore, it would have been obvious to one of ordinary skill in the art to substitute the outflow capture device and the plurality of attachment members located at or near the inflow end of Wang for the outflow capture device and the plurality of attachment members located at or near the inflow end of Hopkins because both outflow capture devices and plurality of attachment members are disclosed as equivalent structures for capturing and releasing a device during an operation (Wang, Paragraph 0044; Hopkins, Paragraph 0008) and substitution of one for the other would have resulted in the predictable result of providing a different way of capturing and releasing a device during a procedure. KSR, 550 U.S. 398, 82 USPQ2d 1385 (2007).
The combination does not teach wherein the plurality of second attachment members include at least a first set of second attachment members and a second set of second attachment members, and wherein each attachment member of the first set of the second attachment members is disposed adjacent to at least one attachment member of the second set of second attachment members, and wherein when the prosthetic device is in the radially compressed configuration, the first complete winding of the coil engages through openings in the first set of second attachment members and the second complete winding of the coil engages through openings in the second set of second attachment members.
Acosta De Acevedo teaches wherein the plurality of attachment members include at least a first set of attachment members (see annotated Fig. 7A below) and a second set of attachments members (see annotated Fig. 7A below), and wherein each attachment member of the first set of attachment members is disposed adjacent to at least one attachment member of the second set of attachment members (see annotated Fig. 7B below), and wherein when the device is in the radially compressed configuration, the first complete winding of the coil engages through openings in the first set of the attachment members (In Paragraph 0044, Acosta De Acevedo teaches that the “loops can be captured consecutively around the circumference or by capturing alternate loops (peaks) around the circumference” and that “the wire capture path can be consistent, i.e., threading the wire end inside- out on each loop or can be outside- in or alternate between inside-out and outside-in”. It would be obvious to one of ordinary skill in the art that through alternating the loops that are captured, Acosta De Acevedo teaches a first set of first attachment members that would be engaged through the first complete winding of the coil.) and the second complete winding of the coil engages through opening in the second set of attachment members (As discussed above, Acosta De Acevedo teaches in Paragraph 0044 that the coil can engage the loops alternatively. It would be obvious to one of ordinary skill in the art that the coil can therefore engage each loop alternatively as well, since the coil would be able to engage the first set of loops with the first complete winding and the coil would be able to engage the second set of loops with the second complete winding due to how the coil is threaded about the loops of the stent.).
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It would be obvious to one of ordinary skill in the art before the effective filing date to modify the device, specifically the first attachment members and the coil on the outer shaft, as disclosed by Wang, Rafiee, Hopkins and Acosta De Acevedo to have the first set of attachment members and the second set of attachment members and their configuration as taught by Acosta De Acevedo. This would be obvious since Acosta De Acevedo teaches that this configuration allows for the user to control the position of the stent (Paragraph 0044).
Claim(s) 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (WO 2018/121344 (English Machine Translation)) in view of Rafiee et al. (US 9,364,324) and in view of Hopkins et al. (US 2013/0338788), as applied to claims 11 and 21 above, in further view of Monroe et al. (US 6,322,586).
Regarding claim 33, Wang, Rafiee, and Hopkins make obvious the delivery system, including a deflector, a coil on a distal end of the outer shaft and a plurality of attachment members located at or near the inflow end.
The combination does not teach wherein the outflow capture device further includes a hub attached to a distal end of the coil, the hub including a plurality of threads on an inner surface thereof and the distal end of the intermediate shaft includes mating threads on an outer surface thereof such that the hub and the intermediate shaft have a threaded relationship, wherein the hub is configured to abut against a proximal end of a distal tip of the delivery system such that there is a smooth transition therebetween.
Hopkins teaches in another embodiment, a delivery system (20)(abstract)(Figs. 1- 5) for delivery of a device (50)(Paragraph 0051) to a body lumen (abstract, Paragraph 0008), the device comprising the device having an inflow end (proximal end 62), an outflow end (distal end 64), and plurality of attachment members located at or near the inflow end (suture loops 65)(Paragraph 00060), the delivery system comprising: an inner shaft (30) having a distal tip (atraumatic tip 35), wherein the inner shaft includes a coil (40) proximal to the distal tip (see annotated Fig. 1 below) and mounted on the first shaft to be rotatable therewith (Paragraphs 0047 and 0060), the coil configured for engagement through openings in the plurality of attachment members on the device (Paragraphs 0049 and 0060), wherein the coil has a hub attached to its distal end (see annotated Fig. 1 below); an outer shaft disposed over the inner shaft (In Paragraph 0045, Hopkins teaches that “one or more outer cannulas or sheaths are disposed over the cannula”. Therefore, it would be obvious that Hopkins teaches an outer shaft disposed over the inner shaft.); and a sheath (In Paragraph 0045, Hopkins teaches that “one or more outer cannulas or sheaths are disposed over the cannula”. Therefore, it would be obvious that Hopkins teaches a sheath.).
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It would have been obvious to try to one of ordinary skill in the art before the effective filing date to modify the coil of the outflow device to face proximally as taught by Hopkins. Hopkins discloses that the coil can face the proximal or distal direction (Hopkins, Figs. 1- 2, Paragraphs 0047 and 0048, and Figs. 25- 26). Thus, having the coil of the outflow device face proximally would have been obvious because “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp”. If this leads to the anticipated success, it is likely that product was not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103."KSR, 550 U.S. at 421, 82 USPQ2d at 1397. See MPEP 2143.
The combination does not teach the hub including a plurality of threads on an inner surface thereof and the distal end of the intermediate shaft includes mating threads on an outer surface thereof such that the hub and the intermediate shaft have a threaded relationship, wherein the hub is configured to abut against a proximal end of a distal tip of the delivery system such that there is a smooth transition therebetween.
Monroe (Monroe et al.) teaches a catheter assembly (160)(Figs. 14 and 15) for the delivery of a device (abstract), the catheter assembly comprising a distal tip (168) with internal threads (170) and a shaft (inner tube 162) with mating threads (166) on an outer surface (Column 7, Lines 63- 65), wherein the distal tip and the shaft have a threaded relationship (Column 7, Line 61- Column 8, Line 29).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system to modify the hub attached to the outflow capture device to have a threaded connection with the intermediate shaft as taught by Monroe et al., since it is making separable what was known to be formed from an integral part, which is an obvious engineering choice (see MPEP 2144.04 V).
Claim(s) 36 and 39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (WO 2018/121344 (English Machine Translation)) in view of Rafiee et al. (US 9,364,324) and in view of Hopkins et al. (US 2013/0338788), as applied to claims 17 and 21 above, in further view of Corbett (US 2011/0257739).
Regarding claims 36 and 39, Wang, Rafiee, and Hopkins make obvious the delivery system, including a deflector, a coil on a distal end of the outer shaft and a plurality of attachment members located at or near the inflow end.
The combination does not teach wherein the deflector is formed from rubber or silicone.
Hopkins teaches in a different embodiment a delivery system (abstract)(Figs. 21- 22) for delivery of a device to a body lumen (abstract, Paragraph 0008), the delivery system comprising: an inner shaft (130) having a distal tip (atraumatic tip 335), wherein the inner shaft includes a coil (140), the coil configured for engagement through openings in the plurality of attachment members on the device (Paragraph 0008) and a deflector (protective cage 370) formed from a polymer (Paragraph 0107).
It would have been obvious to one of ordinary skill in the art to modify the material of the deflector of the combination to be formed of a polymer as taught by Hopkins, since Hopkins teaches that the material is biocompatible within the body and is a known material for a deflector (Paragraph 0107).
Corbett teaches that silicone is a known biocompatible polymer (Paragraph 0081).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the material of the deflector of the combination to be silicone, as Hopkins teaches that the deflector can be made of any suitable polymer that is biocompatible (Paragraph 0107).
Allowable Subject Matter
Claims 38 and 41 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 a statement of reasons for the indication of allowable subject matter:
The closest prior art of record is Wang et al. (WO 2018/121344 (English Machine Translation)), Rafiee et al. (US 9,364,324) and Hopkins et al. (US 2013/0338788).
Wang (Wang et al.) teaches a delivery system (200)(Figs. 3-6) for a device (lumen stent/support 100)(Paragraphs 0038 and 0044), the device comprising a plurality of attachment members (barb 123, corrugated ring 122)(Paragraph 0039), the delivery system comprising:
an inner shaft (inner core tube 205)(Paragraph 0042), an intermediate shaft (outer core tube 203) (Paragraph 0042), wherein the intermediate shaft includes an outflow capture device (anchoring member 204)(Paragraphs 0043 and 0044), an outer shaft (pushrod 202) and a retractable sheath (outer tube 201)(Paragraphs 0042, 0044 and 0045).
Rafiee (Rafiee et al.) teaches a delivery system (100)(Fig. 1) for delivery of a device (500)(Fig. 2) the device comprising a plurality of attachment members located at the inflow end (Column 8, Lines 59- 66), the delivery system comprising: an inner shaft (inner catheter 114)(Fig. 1) having a distal tip (118)(Fig. 1), an outer shaft (holding catheter 120)(Fig. 1)(Column 6, Line 62 - Column 7, Line 2), wherein the outer shaft includes a coil (122)(Fig. 1) on a distal end thereof (Column 7, Lines 3- 4; Column 10, Lines 54- 58), and a retractable sheath (outer sheath 126)(Fig. 1)(Since 126 is taught to be retractable (Column 10, Lines 48- 52), it is herein considered a retractable sheath.) slidingly disposed over the outer shaft (Column 10, Lines 48- 52) to hold the device in a radially compressed configuration for delivery to a body lumen (see Fig. 7 and 8)(Column 10, Lines 39- 43).
Hopkins (Hopkins et al.) teaches a delivery system (abstract)(Fig. 25) for delivery of a device to a body lumen (abstract, Paragraph 0008), the delivery system comprising: an inner shaft (130) having a distal tip (atraumatic tip 335), wherein the inner shaft includes a coil (140), the coil configured for engagement through openings in the plurality of attachment members on the device (Paragraph 0008) and a deflector (enclosing member 390) having a tapered outer surface (395)(Paragraph 0114).
However, the prior art does not teach or suggest (claims 38 and 41) wherein the deflector is slidably mounted on the outer surface of the intermediate shaft. Furthermore, there is no motivation to modify the mechanism of Wang et al. (WO 2018/121344 (English Machine Translation)), Rafiee et al. (US 9,364,324) and Hopkins et al. (US 2013/0338788) to have the missing limitations.
Response to Arguments
Regarding applicant’s arguments filed August 21st, 2025 regarding the rejection of claims 11, 14, 21, 24 and 27 under 35 U.S.C. 103 over Wang et al. (WO 2018121344) in view of Rafiee et al. (US 9,364,324) has been fully considered but are moot since, as discussed above, the previous prior art rejection was withdrawn in view of applicant’s amendments. However, it is noted that the previous prior art references are still relied upon.
Applicant’s arguments, see Pages 7- 10, regarding the combination of Wang and Hopkins not being obvious to one of ordinary skill in the art since the modification would change the principle of operation of Wang has been fully considered but is not convincing. The principle of operation of Wang, specifically for the anchor component, is to hold the stent during delivery (Wang, Paragraphs 0043 and 0044), and the principle of operation of the coil of Hopkins is to hold the stent during delivery (Hopkins, Paragraph 0008). Therefore, modifying the device to have a coil and the plurality of attachments as taught by Hopkins would not destroy the principle of operation of Wang and they are equivalent structures.
Applicant’s arguments, see Pages 10- 11, regarding the combination of Wang and Hopkins and that the combination of the references is not obvious due to both references teaching the controlled release of an inflow end of a prosthetic device has been fully considered but is not convincing. As discussed above, Wang teaches an outflow capture device (anchoring member 204) that engages an end of a luminal stent (Paragraph 0044). As the inflow end and the outflow end are considered relative since the device can be inserted into the vessel in a way where the inflow end taught by Wang can be considered the outflow end, and vice versa, then Wang teaches a structure capable of engaging the outflow end of a prosthetic device.
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.
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/L.R.R./Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771