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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on April 24th, 2026 has been entered.
Response to Amendment
Claims filed on April 24th, 2026 have been entered. Claims 11, 16- 17, and 42- 58 are pending in the application. Claims 16 and 57 are withdrawn for being drawn to an unelected species.
The affidavit under 37 CFR 1.132 filed April 24th, 2026 is insufficient to overcome the rejection of claims 11 and 17 under 35 U.S.C. 103 over Wang et al. (WO 2018/121322 (English Machine Translation)) in view of Rafiee et al. (US 9,364,324) and in view of Hopkins et al. (US 2013/0338788) as set forth in the last Office action because: the arguments fail to set forth any evidence based facts. More specifically:
With respect to points 7- 15, Examiner acknowledges the statements set forth regarding what Wang, Rafiee, and Hopkins disclose. Examiner acknowledges the statement regarding that applicant would consider the inflow end being disposed adjacent to the distal tip of the delivery system according to their opinion and the statement regarding the windsock effect and the statement that applicant considers that the mechanism of Wang mitigates the windsock effect. Examiner also acknowledges the statement regarding the opinion that applicant considers Rafiee being entered into the body through an antegrade approach and therefore the opinion of applicant is that the outflow end disposed adjacent to the distal tip of the delivery system.
With respect to point 16, Examiner acknowledges the argument that disposing the positioning end of the positioning device onto a coil is not desirable and the reasons given. However, this statement is an opinion and fails to provide evidence. Furthermore, within the combination, the modification in regards to Wang, Rafiee and Hopkins involves modifying both the retaining mechanism of the delivery system and the attachment members of Wang. Therefore, within the combination the interplay with the positioning device and the coil is not relevant as it has been replaced with the attachment members which are taught to interact with the coil by Hopkins.
With respect to point 17, Examiner acknowledges the argument that the interplay between the positioning device and the coil as a release mechanism would be fraught with unintended movement of the positioning end. However, this statement is an opinion and fails to provide substantial evidence regarding this opinion. Examiner notes that there is no statement negating the inclusion of the fixed cap in regards to the addition of the coil for the combination. Furthermore, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Therefore, the statements within the affidavit are found to be not persuasive.
Claim Objections
Claims 49-56 and 58 are objected to because of the following informalities:
Claim 49, Line 20 states “release of the plurality”, it is suggested to change this to “release the plurality”.
Claims 50- 56 and 58 are objected to for being dependent on or from claim 49.
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.
Claim(s) 11, 17, 42- 43, and 48 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) and in view of Hebert et al. (US 2009/0306761).
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 an inflow capture device mounted on a distal end thereof, the inflow capture device configured for engagement through openings in the plurality of first attachment members on the device, wherein the inflow capture device includes a coil, the coil including at least a first complete winding configured about a longitudinal axis of the outer shaft and the coil being mounted on the outer shaft to be rotatable therewith, wherein the outer shaft is rotatable relative to the intermediate shaft and to the retractable sheath in order to release the plurality of first attachment members 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);
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); and
Wherein the outer shaft is rotatable relative to the inner shaft and to the retractable sheath in order to release the plurality of attachment members (Column 6, Line 66- Column 7, Line 16).
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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 and to have the outer coil be rotated to release the plurality of attachment members from the coil 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) and Wang teaches that the outer shaft is movable (Paragraph 0042).
Additionally, Hebert (Hebert et al.) teaches a similar delivery system (100)(Figs. 4B and 4C) for a prosthetic device (130)(abstract and Paragraphs 0067- 0068), wherein the inflow end (proximal end 133) and the outflow end (distal end 134) of the device are captured by coils (119, 120)(Paragraphs 0067 and 0068). Therefore, Hebert shows that it is known in the art to have coils capture both ends of a prosthetic device for the purpose of “inhibiting longitudinal movement of the prosthesis while permitting a sliding relationship between the catheter and elongate guide” (Paragraph 0069).
Regarding wherein the outer shaft is rotatable to the intermediate shaft and to the retractable sheath in order to release the plurality of first attachment members, as Rafiee teaches that the outer shaft rotates relative to the inner shaft and the outer sheath to release the plurality of attachments (Column 6, Line 66- Column 7, Line 16) and Wang teaches that the outer shaft is able to move relative to the retractable sheath and the intermediate shaft (Paragraph 0042), then within the combination the outer shaft would be capable of rotation relative to the intermediate shaft and the retractable sheath to release the plurality of first attachment members.
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 of the inflow capture device.
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 42, 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.
Regarding wherein the device is a prosthetic heart valve this recitation is merely an intended use. Applicant’s attention is drawn to MPEP 2111.02 which states that intended use statements must be evaluated to determine whether the intended use results in a structure difference between the claimed invention and the prior art. Only if such structure difference exists, does the recitation serve to limit the claim. If the prior art structure is capable of performing the intended use, then it meets the claim. It is the examiner’s position that the intended use recited in the present claim does not result in a structural difference between the presently claimed invention and the prior art and further that the prior art structure is capable of performing the intended use. In this case, as Wang teaches that the delivery system is for delivering devices into vasculature (Paragraphs 0002 and 0017), so it would be capable of performing the intended use presently claimed as required in the above cited portion of the MPEP.
Regarding claim 43, 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 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 does not teach wherein the device is a prosthetic heart valve, wherein the inflow end of the prosthetic heart valve device has a plurality of endmost inflow crowns and the outflow end of the prosthetic heart valve device has a plurality of endmost outflow crowns and wherein the plurality of first attachment members are suture loops attached to at least a portion of the endmost outflow crowns, and wherein the plurality of second attachment members are suture loops attached to at least a portion of the endmost inflow crowns.
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) wherein the inflow end of the prosthetic device has a plurality of endmost inflow crowns (see annotated Fig. 2 of Rafiee 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) 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 (Column 10, Lines 54- 58), 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); 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); and wherein the device is a prosthetic heart valve (Column 7, Lines 23- 26).
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It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device as taught by the combination to be a prosthetic heart valve as taught by Rafiee, for the purpose of delivering a heart valve through the vasculature as taught by Rafiee in abstract and Page 7, Lines 23- 29 and since Wang teaches that the delivery system is for delivering supports within vasculature (Paragraphs 0002 and 0017).
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.
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 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).
Regarding claim 48, 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 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.
Claim(s) 44- 47 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), in view of Hopkins et al. (US 2013/0338788) and in view of Hebert et al. (US 2009/0306761), as applied to claim 11 above, and in view of Acosta De Acevedo (US 2011/0251664).
Regarding claims 44 and 46, 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 further teaches wherein the coil of the outflow capture device includes the first complete winding and a second complete winding (see annotated Fig. 1 of Hopkins below) and wherein the coil of the inflow capture device includes the first complete winding and a second complete winding (see annotated Fig. 1 of Rafiee below)(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 when the prosthetic heart valve is in a radially compressed configuration, each attachment member of the plurality of second attachment members is attached to the coil of the outflow capture device in a non-consecutive manner or wherein when the prosthetic heart valve is in a radially compressed configuration, each attachment member of the plurality of first attachment members is attached to the coil of the inflow capture device 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 well as to have this same configuration with the attachment members at the outflow end with the coil of the outflow end 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 claims 45 and 47, Wang, Rafiee, Hopkins, and Acosta de Acevedo 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 for each loop of the first attachment members and each loop of the second attachment members to be alternatively captured on the coil of the inflow capture device and the coil of the outflow capture device in view of Rafiee, Hopkins and Acosta De Acevedo. As such, the teachings of the prior art are considered to encompass wherein the plurality of first attachment members include at least a first set of first attachment members and a second set of first attachment members (see annotated Acosta De Acevedo Fig. 7 below), and wherein each attachment member of the first set of first attachment members is disposed adjacent to at least one attachment member of the second set of first attachment members, and wherein when the prosthetic heart valve is in the radially compressed configuration, the first complete winding of the coil of the respective inflow capture device or outflow capture device engages the first set (every other loop captured the first time around) and the second complete winding of the coil of the respective inflow capture device or outflow capture device engages the second set (the remaining loops captured the second time around), wherein the two sets alternate. Thus, the claimed limitations are considered obvious over the teachings of the prior art.
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Claim(s) 49 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 Hebert et al. (US 2009/0306761).
Regarding claim 49, 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:
An inner shaft (inner core tube 205) having a distal tip (tip 207)(Paragraph 0042);
A first shaft (outer core tube 203) slidingly disposed over the inner shaft (Paragraph 0042) 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 first attachment members on the prosthetic heart device, wherein the first shaft is rotatable relative to the inner shaft and to the second shaft in order to release the plurality of second attachment members, or wherein the second shaft is rotatable relative to the retractable sheath and the first shaft in order to release the plurality of first attachment members, or wherein the release of the plurality of second attachment members is configured to be controlled separately from the release of the plurality of first attachment members by different components of the delivery system.
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 an inflow capture device comprising 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); and wherein the outer shaft is rotatable relative to the inner shaft and to the retractable sheath in order to release the plurality of attachment members (Column 6, Line 66- Column 7, Line 16).
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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 and to have the outer coil be rotated to release the plurality of attachment members from the coil 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) and Wang teaches that the outer shaft is movable (Paragraph 0042).
Additionally, Hebert (Hebert et al.) teaches a similar delivery system (100)(Figs. 4B and 4C) for a prosthetic device (130)(abstract and Paragraphs 0067- 0068), wherein the inflow end (proximal end 133) and the outflow end (distal end 134) of the device are captured by coils (119, 120)(Paragraphs 0067 and 0068). Therefore, Hebert shows that it is known in the art to have coils capture both ends of a prosthetic device for the purpose of “inhibiting longitudinal movement of the prosthesis while permitting a sliding relationship between the catheter and elongate guide” (Paragraph 0069).
Regarding wherein the second shaft is rotatable to the first shaft and to the retractable sheath in order to release the plurality of first attachment members, as Rafiee teaches that the outer shaft rotates relative to the inner shaft and the outer sheath to release the plurality of attachments (Column 6, Line 66- Column 7, Line 16) and Wang teaches that the outer shaft is able to move relative to the retractable sheath and the intermediate shaft (Paragraph 0042), then within the combination the outer shaft would be capable of rotation relative to the intermediate shaft and the retractable sheath to release the plurality of first attachment members.
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.
Regarding wherein the device is a prosthetic heart valve this recitation is merely an intended use. Applicant’s attention is drawn to MPEP 2111.02 which states that intended use statements must be evaluated to determine whether the intended use results in a structure difference between the claimed invention and the prior art. Only if such structure difference exists, does the recitation serve to limit the claim. If the prior art structure is capable of performing the intended use, then it meets the claim. It is the examiner’s position that the intended use recited in the present claim does not result in a structural difference between the presently claimed invention and the prior art and further that the prior art structure is capable of performing the intended use. In this case, as Wang teaches that the delivery system is for delivering devices into vasculature (Paragraphs 0002 and 0017), so it would be capable of performing the intended use presently claimed as required in the above cited portion of the MPEP.
Claim(s) 50- 52 and 58 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 Hebert et al. (US 2009/0306761), as applied to claim 49 above, in further view of Hopkins et al. (US 2013/0338788).
Regarding claim 50, 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.
The combination teaches wherein the inflow capture device is a coil (Rafiee 122)(Fig. 1 of Rafiee) on a distal end thereof (Rafiee, Column 7, Lines 3- 4), the coil configured for engagement through openings in the plurality of attachment members on the device (Rafiee, Column 10, Lines 54- 58), wherein the coil includes at least a first complete winding configured about a longitudinal axis of the second shaft (see annotated Fig. 1 of Rafiee below) and the coil of the second shaft being mounted on the second shaft to be rotatable therewith (Rafiee, Column 6, Line 66- Column 7, Line 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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The combination does 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 51, 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 the coil of the inflow capture device 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 52, 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 does not teach wherein the device is a prosthetic heart valve, wherein the inflow end of the prosthetic heart valve device has a plurality of endmost inflow crowns and the outflow end of the prosthetic heart valve device has a plurality of endmost outflow crowns and wherein the plurality of first attachment members are suture loops attached to at least a portion of the endmost outflow crowns, and wherein the plurality of second attachment members are suture loops attached to at least a portion of the endmost inflow crowns.
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) wherein the inflow end of the prosthetic device has a plurality of endmost inflow crowns (see annotated Fig. 2 of Rafiee 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) 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 (Column 10, Lines 54- 58), 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); 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); and wherein the device is a prosthetic heart valve (Column 7, Lines 23- 26).
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It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device as taught by the combination to be a prosthetic heart valve as taught by Rafiee, for the purpose of delivering a heart valve through the vasculature as taught by Rafiee in abstract and Page 7, Lines 23- 29 and since Wang teaches that the delivery system is for delivering supports within vasculature (Paragraphs 0002 and 0017).
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.
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 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).
Regarding claim 58, 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 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).
Claim(s) 53-56 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 Hebert et al. (US 2009/0306761), as applied to claim 49 above, in further view of Hopkins et al. (US 2013/0338788) and Acosta De Acevedo (US 2011/0251664).
Regarding claim 53 and 55, 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.
The combination further teaches wherein the coil of the inflow capture device includes the first complete winding and a second complete winding (see annotated Fig. 1 of Rafiee below)(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 coil of the outflow capture device includes the first complete winding and a second complete winding or wherein when the prosthetic heart valve is in a radially compressed configuration, each attachment member of the plurality of second attachment members is attached to the coil of the outflow capture device in a non-consecutive manner or wherein when the prosthetic heart valve is in a radially compressed configuration, each attachment member of the plurality of first attachment members is attached to the coil of the inflow capture device 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), 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).
The combination does not teach wherein when the prosthetic heart valve is in a radially compressed configuration, each attachment member of the plurality of second attachment members is attached to the coil of the outflow capture device in a non-consecutive manner or wherein when the prosthetic heart valve is in a radially compressed configuration, each attachment member of the plurality of first attachment members is attached to the coil of the inflow capture device 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 well as to have this same configuration with the attachment members at the outflow end with the coil of the outflow end 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 claims 54 and 56, Wang, Rafiee, Hopkins, and Acosta de Acevedo 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 for each loop of the first attachment members and each loop of the second attachment members to be alternatively captured on the coil of the inflow capture device and the coil of the outflow capture device in view of Rafiee, Hopkins and Acosta De Acevedo. As such, the teachings of the prior art are considered to encompass wherein the plurality of first attachment members include at least a first set of first attachment members and a second set of first attachment members (see annotated Acosta De Acevedo Fig. 7 below), and wherein each attachment member of the first set of first attachment members is disposed adjacent to at least one attachment member of the second set of first attachment members, and wherein when the prosthetic heart valve is in the radially compressed configuration, the first complete winding of the coil of the respective inflow capture device or outflow capture device engages the first set (every other loop captured the first time around) and the second complete winding of the coil of the respective inflow capture device or outflow capture device engages the second set (the remaining loops captured the second time around), wherein the two sets alternate. Thus, the claimed limitations are considered obvious over the teachings of the prior art.
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Response to Arguments
Applicant’s arguments filed on April 24th, 2026 have been fully considered but are not persuasive.
Applicant’s arguments, see Pages 8- 10, regarding that the push rod is not slidably disposed over the outer core tube of Wang, have been fully considered but are not persuasive. Although examiner acknowledges that the Office cannot assume dimensions in regards to figures, the differences between Figure 3 and Figure 5 of Wang are not from a mere difference in dimensions. When regarding Figure 3 and Figure 5, one of ordinary skill in the art would recognize that movement has occurred as the outer core tube is further extended within Fig. 5 in comparison to a less extended position shown within Fig. 3. Therefore, a sliding disposition can be assumed. It is also noted that the limitation of the outer shaft slidingly disposed over the intermediate shaft does not exclude a before use situation, where the shafts are put together, thus enabling a sliding relationship.
Applicant’s arguments, see Pages 10- 14, regarding that the coil of Hopkins is not an equivalent structure to the anchor of Wang, have been fully considered but are not persuasive. Applicant’s arguments that it would not have been obvious to one of ordinary skill in the art to modify the anchor member of Wang to be a coil as it would change the principle of operation of Wang and destroy an advantageous property of the anchor member construction of Wang have also been fully considered but are not persuasive. Wang does not state that the manner in which the stent is secured is critical and nowhere does Wang point out that it is the sole way to attached a stent to the delivery system. Furthermore, although Wang may only contemplate the anchor member, “[a] reference does not teach away… if it merely expresses a general preference for an alternative invention but does not ‘criticize, discredit, or otherwise discourage’ investigation into the invention claimed.” DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc. 567 F.3d 1314, 1327 (Fed. Cir. 2009)(quoting In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004)). Applicant fails to explain adequately how Wang criticizes, discredits, or discourages the use of a coil instead of the anchoring member. 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). In regards to applicant’s arguments that the combination would destroy an advantageous property of the anchor member construction of Wang, this argument is not persuasive because “[t]he fact that the motivating benefit comes at the expense of another benefit, however, should not nullify its use as a basis to modify the disclosure of one reference with the teachings of another. Instead, the benefits, both lost and gained, should be weighed against one another” Winner Int’l Royalty Corp v. Wang, 202 F.3d 1340, 1349 n.8 (Fed. Cir. 2000); see also Medichem, S.A. v. Rolabo, S. L., 437 F.3d 1157, 1165 (Fed. Cir. 2006) (“[A] given course of action often has simultaneous advantages and disadvantages, and this does not necessarily obviate motivation to combine” (citation omitted). Furthermore, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Applicant’s arguments, see Pages 14- 16, regarding that one of ordinary skill in the art would not have been motivated at the time of the invention to modify Wang in view of Rafiee, have been fully considered but are not persuasive. In response to applicant's argument that the intended use of Wang is of consequence, this is not persuasive, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Therefore, the structure of Wang is what is considered when combining Wang with Rafiee and Hopkins, not the intended use. As the structure of Wang has the limitations as set forth within the claim limitations (see the rejection of claim 11 above), it is capable of accomplishing the function and capable of having the inflow end be considered the outflow end. Furthermore, as discussed above, another prior art reference Hebert (Hebert et al.) teaches a similar delivery system (100)(Figs. 4B and 4C) for a prosthetic device (130)(abstract and Paragraphs 0067- 0068), wherein the inflow end (proximal end 133) and the outflow end (distal end 134) of the device are captured by coils (119, 120)(Paragraphs 0067 and 0068). Therefore, Hebert shows that it is known in the art to have coils capture both ends of a prosthetic device for the purpose of “inhibiting longitudinal movement of the prosthesis while permitting a sliding relationship between the catheter and elongate guide” (Paragraph 0069).
Conclusion
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/L.R.R./Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771
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