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 .
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1, 22-24, 27-29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tamir (WO 2021252720 A1) in view of Nguyen (2008/0140189A1).
Regarding claim 1, Tamir discloses a prosthetic heart valve system (fig. 8), comprising:
a balloon expandable prosthetic heart valve (12), the prosthetic heart valve having an inflow end portion, an outflow end portion, and a center portion between the inflow end portion and the outflow end portion (see fig. 8 annotated below);
and a delivery catheter having a balloon assembly on a distal end portion of the delivery catheter (fig. 8 illustrates a delivery catheter 26 having a balloon assembly on a distal end), the balloon assembly having a proximal portion, a distal portion, and a center portion between the proximal portion and the distal portion (see fig. 8 annotated below) the balloon assembly having a substantially cylindrical configuration in an inflated condition (element 16 meets substantially cylindrical in the inflated condition; see for example fig 5 where 16 is substantially cylindrical),
wherein, in a delivery condition of the system, the prosthetic heart valve is crimped over the balloon while the balloon assembly is deflated (figs. 11-12 illustrates a prosthetic heart valve 12 crimpled over the balloon assembly 14/16 while the balloon is deflated),
and wherein in a deployment condition of the system, the balloon assembly is inflated so that the proximal portion and the distal portion of the balloon assembly both have a diameter that is larger than a diameter of the center portion of the balloon assembly (fig. 13 illustrates that in the deployment condition of the system the balloon assembly has a diameter that is larger than a diameter of the center portion as can be seen in better detail in fig. 8 annotated below).
However, Tamir does not teach a band circumscribes the center portion of the heart valve or that the inflow end portion and the outflow end portion of the prosthetic heart valve both flare radially outwardly relative to the center portion of the prosthetic heart valve.
Nguyen teaches a band 691 circumscribes the center portion of the prosthetic heart valve 310 (fig 58); and
that the inflow end portion and the outflow end portion of the prosthetic heart valve both flare radially outwardly relative to the center portion of the prosthetic heart valve (see flared ends 318, 316).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the band and flared end shape of the valve of Nguen in the valve of Tamir because the band resistance expansion of the central support band [0185; 0188] and the flared ends assist in anchoring the valve [0172].
In regard to claim 22, Tamir meets the claim limitations as discussed in the rejection of claim 1, but does not teach the band as claimed.
Nguyen further teaches the band 691 has a continuous ring shape (see fig 58) with a perforation partially interrupting the continuity of the ring shape. (sutures 692 create perforations in the ring shape, see fig 58)
In regard to claim 23, Tamir meets the claim limitations as discussed in the rejection of claim 22, but does not teach the band as claimed.
Nguyen further teaches the band 691 includes one line of perforations extending across the band in a direction parallel to a longitudinal axis of the prosthetic heart valve. (see fig 58, at least some of the perforations are in a line parallel to the longitudinal axis of valve 310 as shown in figure 58)
In regard to claim 24, Tamir meets the claim limitations as discussed in the rejection of claim 22, but does not teach the band as claimed.
Nguyen further teaches the band 691 includes a plurality (defined as two or more) of lines of perforations (holes from sutures 692) extending across the band 691 in a direction parallel to a longitudinal axis of the prosthetic heart valve 310 (see fig 58, at least some of the suture holes are in longitudinal lines).
In regard to claim 27, Tamir meets the claim limitations as discussed in the rejection of claim 1, but does not teach the band as claimed.
Nguyen further teaches at least a portion of the band 691 is fixed to the prosthetic heart valve 310 (see sutures 692 in figure 58) such that the band 691 remains attached to the prosthetic heart valve after breaking. This is a statement of intended use, patentable only based on the resulting structure. Since band is sutured to the heart valve (fig 58), should the band break, the remainder of the band will remain attached. It is suggested to further clarify the claim language.
In regard to claim 28, Tamir meets the claim limitations as discussed in the rejection of claim 27, but does not teach the band as claimed.
Nguyen further teaches at least the portion of the band 691 is sutured (via 692) to the prosthetic heart valve 310 (see fig 58).
In regard to claim 29, Tamir meets the claim limitations as discussed in the rejection of claim 1, but does not teach the band as claimed.
Nguyen further teaches in the deployment condition of the system (interpreted as best understood to mean in the deployed or expanded state), a plurality of bands circumscribe the prosthetic heart valve 210 (as shown in figure 58 a band circumscribes the heart valve). As shown in figure 57 a plurality of radial restraints instead of one restraint can be used to change the shape of the heart valve (see figure 57) Accordingly, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the cuff of Tamir in view of Nguyen to have multiple radial restraints as shown in the embodiment of figure 57 and apply this to the embodiment of figure 58 of Nguyen in order to modify the valve shape for the individual application.
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tamir (WO 2021252720 A1) in view of Nguyen (2008/0140189A1) and further in view of Nakayama (2005/0107868A1).
In regard to claim 25, Tamir meets the claim limitations as discussed in the rejection of claim 1, but does not teach the band as claimed.
While the combination of Tamir in view of Nguyen teaches the band as discussed in the rejection of claim 1, the combination does not teach the band material is an a thermoplastic resin.
Nakayama teaches the band is formed of a thermoplastic resin. (cuff is thermoplastic resin; abstract)
It would have been obvious to one of ordinary skill in the art of biomedical materials at the time the invention was filed to make the band of Tamir in view of Nguyen thermoplastic resin as taught by Nakayama because this material allows a porous three dimensional network to be created for easy vascularization (abstract).
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tamir (WO 2021252720 A1) in view of Nguyen (2008/0140189A1) and further in view of Hariton (2018/0263769A1).
In regard to claim 26, Tamir meets the claim limitations as discussed in the rejection of claim 1, but does not teach the band.
While the combination of Tamir in view of Nguyen teaches the band as discussed in the rejection of claim 1, the combination does not teach the band material is an elastomer.
Hariton teaches the band 204 is formed of an elastomer. [0071:elastomeric materials; claim 1: elastomer; claim 2: silicone].
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the elastomer material of Hariton in the band of Tamir in view of Nguyen because the material can expand and stretch when the valve is expanded or crimped [0012] and the material prevents tools from directly contacting the valve [0071] and allows a seal.
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Claim(s) 1, 5, 9-11, 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Baldwin (2021/0186694A1) in view of Nguyen (2008/0140189A1) and further in view of Yang (2018/0214289A1).
Regarding claim 1, Baldwin discloses a prosthetic heart valve system (¶ 0001), comprising: a balloon expandable prosthetic heart valve (fig. 9 illustrates a balloon expandable heart valve 100), the prosthetic heart valve having an inflow end portion (108), an outflow end portion (110), and a center portion between the inflow end portion and the outflow end portion (see fig. 1 annotated below);
and a delivery catheter (303) having a balloon assembly (313) on a distal end portion of the delivery catheter (fig. 9 illustrates a delivery catheter 303 having a balloon assembly 313 on the distal end of the delivery catheter), the balloon assembly having a proximal portion, a distal portion, and a center portion between the proximal portion and the distal portion (see fig. 10 annotated below), the balloon assembly having a substantially cylindrical configuration in an inflated condition (see fig 13, 11);
wherein, in a delivery condition of the system, the prosthetic heart valve is crimped over the balloon while the balloon assembly is deflated (fig. 14 illustrates a PHV 100 crimped over the balloon 313 which the balloon assembly is deflated),
and wherein in a deployment condition of the system, the balloon assembly is inflated so distal portion of the balloon assembly both have a diameter that is larger than a diameter of the center portion of the balloon assembly (fig. 16 illustrates that in the deployment condition the balloon assembly 313 is inflated and the distal portion has a diameter larger than the diameter of the center portion)
and so that the inflow end portion of the prosthetic heart valve flares radially outwardly relative to the center portion of the prosthetic heart valve (fig. 16 illustrates a deployment condition as claimed in which the inflow end portion of the prosthetic heart valve flares radially outwardly relative to the center portion of the prosthetic heart valve).
However, Baldwin does not teach a band circumscribes the center portion of the prosthetic heart valve or that in a deployment condition the balloon assembly has a diameter at the proximal and distal portions that is larger than a diameter of the center of the balloon assembly or that the outflow end portion or the heart valve flares radially outward.
Nguyen teaches a band 691 circumscribes the center portion of the prosthetic heart valve 310 (fig 58); and
that the inflow end portion and the outflow end portion of the prosthetic heart valve both flare radially outwardly relative to the center portion of the prosthetic heart valve (see flared ends 318, 316).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the band and flared ends of the valve of Nguen in the valve of Baldwin because the band resistance expansion of the central support band [0185; 0188] and the flared ends assist in anchoring the valve [0172].
Yang teaches the balloon assembly has a diameter at the proximal and distal portions that is larger than a diameter of the center of the balloon assembly. (see figures 4, 5C, 5B)
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to flare the balloon of Baldwin as taught by Yang because this allows the ends of the prosthesis to be flared (abstract) and to ensure the stent is expanded fully against the walls for improved treatment and lower risk of damage [0006].
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Regarding claim 5, Baldwin discloses the invention as claimed as discussed with respect to claim 1. Baldwin further discloses that the balloon assembly includes only a single balloon (figs. 9-11 illustrate a balloon assembly with only a single balloon 313).
Regarding claim 9, Baldwin in view of Nguyen disclose the invention as claimed as discussed with respect to claim 1. Nguyen further discloses that the band (691) is capable of limiting the expansion of the balloon assembly to maintain the diameter of the center portion of the balloon assembly due to the bands ability to resist expansion of the center portion of the prosthetic heart valve (¶ 0185, fig. 58). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the prosthetic heart valve system of Baldwin to include a band circumscribes the center portion of the prosthetic heart valve in the delivery condition of the system as taught by Nguyen in order to resist expansion of the central portion of the prosthetic heart valve (Nguyen ¶ 0185).
Regarding claim 10, Baldwin in view of Nguyen disclose the invention as claimed as discussed with respect to claim 9. Nguyen further discloses wherein the system has a final implanted condition in which the band circumscribes the center portion of the prosthetic heart valve (¶ 0185 discloses and fig. 58 illustrates a band 691 circumscribing the center portion of a prosthetic heart valve 310 and ¶ 0188 discloses that the band 691 limits/resists diameter changes of a valve once a preset diameter is reached), the band (691) is capable of stretching upon transition from the deployment condition to the final implanted condition due to the band being made of ePTFE or other flexible polymers allowing it to stretch until reaching a preset diameter (¶ 0185 and ¶ 0188).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the prosthetic heart valve system of Baldwin to include a band circumscribes the center portion of the prosthetic heart valve in the delivery condition of the system as taught by Nguyen in order to resist expansion of the central portion of the prosthetic heart valve (Nguyen ¶ 0185).
Regarding claim 11, Baldwin discloses a method of implanting a prosthetic heart valve (¶ 0001), the method comprising:
delivering a prosthetic heart valve to a native valve annulus while the prosthetic heart valve is crimped on a balloon assembly of a balloon catheter and the balloon assembly is deflated (fig. 15 illustrates delivering a prosthetic heart valve 100 while the PHV is crimped on a balloon assembly 303 of a balloon catheter 313); the balloon assembly having a substantially cylindrical configuration in an inflated condition (see fig 12A-13; elliptical is substantially cylindrical);
and inflating the balloon assembly to expand the prosthetic heart valve so that a center portion of the prosthetic heart valve contacts the native valve annulus and so that an inflow end portion of the prosthetic heart valve flares radially outwardly relative to the center portion of the prosthetic heart valve (fig. 16 annotated below illustrates and ¶ 0077 discloses that a balloon assembly is inflated and expands the PHV 100 and the center of the PHV contacts the valve annulus and that an inflow end portion of the prosthetic heart valve flares radially outwardly relative to the center portion of the PHV 100).
However, Baldwin does not teach a band or that the balloon has proximal and distal portions with a diameter larger than the center portion of the balloon assembly or that the inflow and outflow ends of the heart valve are flared.
Nguyen teaches a band 691 circumscribes the center portion of the prosthetic heart valve 310 (fig 58); and
that the inflow end portion and the outflow end portion of the prosthetic heart valve both flare radially outwardly relative to the center portion of the prosthetic heart valve (see flared ends 318, 316).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the band and flared ends of the valve of Nguen in the valve of Baldwin because the band resistance expansion of the central support band [0185; 0188] and the flared ends assist in anchoring the valve [0172].
Yang teaches the balloon assembly has a diameter at the proximal and distal portions that is larger than a diameter of the center of the balloon assembly (see figures 4, 5C, 5B).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to expand the proximal and distal ends of the balloon of Baldwin as taught by Yang because this allows the ends of the prosthesis to be flared (abstract) and to ensure the stent is expanded fully against the walls for improved treatment and lower risk of damage [0006]. The balloon of Baldwin can remain elliptical while the ends are still expanded as taught by Yang.
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In regard to claim 30, Baldwin meets the claim limitations as discussed in the rejection of claim 11, but does not teach the inflow and outflow shapes or balloon shape as claimed.
As discussed in the rejection of claim 11, Yang teaches the balloon shape assists in when inflating the balloon assembly causes the inflow end portion and the outflow end portion of the prosthetic heart valve to contour along the surfaces of the native valve annulus. [0006]
Response to Arguments
In regard to the objection of claim 1, the amendments have overcome the objections.
In regard to the 102(a)(1) rejection of claims 1, 2 and 4 as anticipated by Tamir (WO2021/252720A1), the applicant’s arguments have been fully considered but are directed towards newly amended claim limitations which have been addressed above.
In regard to the 102(a)(1) rejection of claims 1, 5 and 11 as anticipated by Baldwin (2021/0186694A1), the applicant’s arguments have been fully considered but are directed towards newly amended claim limitations which have been addressed above.
Claims 2-3, 6, and 7, 12-17 have been cancelled rendering any arguments moot.
In regard to the 103(a) rejection of claims 8-10 as unpatentable over Baldwin in view of Nguyen (2008/0140189), the applicant’s arguments have been fully considered are directed towards newly amended claim limitations which have been addressed above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTIE BAHENA whose telephone number is (571)270-3206. The examiner can normally be reached M-F 9-3.
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/CHRISTIE BAHENA/Primary Examiner, Art Unit 3774
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