DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Election/Restrictions
Applicant's election with traverse of Species A, Figures 4A-4D, in the reply filed on 02/12/2026 is acknowledged. The traversal is on the ground(s) that the restriction requirement filed on 02/05/2026 failed to include the embodiments shown in Figs. 3A-3F. For this reason, the following regrouping of species was created to include the embodiments of Figs. 3A-3F.
Species A: Figures 3A-3F and 4A-4D the device using a balloon to achieve expansion of the prosthetic heart valve, wherein the device may include a temporary limiting band (510) or variable strut geometry to limit or control expansion (device with strut geometry to resist expansion) (paragraph 0049).
Species B: Figures 5A-5C, the device having outer cuffs (670a-b) in the form of a thread.
Elected Species A encompasses claims 1-17. Claims 18-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
The requirement is now deemed proper and is therefore made FINAL.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, a drawing of the first balloon positioned within the second balloon, the second balloon being positioned only at the distal portion of the balloon assembly, and in the deployment condition of the system, the second balloon is inflated to a diameter that is larger than the diameter of the center portion of the balloon assembly as recited in claim 4 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 1 is objected to because of the following informality: There appears to be a typographical error. Claim 1 reads “…and so that the outflow end of the prosthetic heart valve flares radially outwardly relative to the center portion of the prosthetic heart valve” in lines 12-13. These lines should instead read “…and so that the inflow end of the prosthetic heart valve flares radially outwardly relative to the center portion of the prosthetic heart valve”. Appropriate correction is required
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless – (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
1. Claims 1, 2, and 4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tamir (WO 2021252720 A1).
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), 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 distal portion of the balloon assembly has 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). The balloon assembly of Fig. 8 is capable of making the inflow end of an end portion of a prosthetic heart valve flares radially outward relative to the center portion of the prosthetic heart valve due to the balloon due to its apex/shoulder which inflates past the diameter of the center of the balloon assembly which may be aligned with the center portion of the prosthetic heart valve (see Fig. 3 illustrating the inflow end of a prosthetic heart valve disposed on the distal portion of a balloon assembly that expands to a diameter greater than the center of the balloon assembly so that the inflow end of an end portion of the prosthetic heart valve flares radially outward relative to the center portion of the prosthetic heart valve).
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Regarding claim 2, Tamir discloses that a balloon assembly includes a first balloon (16) and a second balloon (14).
Regarding claim 4, Tamir discloses the invention as claimed as discussed with respect to claim 2. Tamir further discloses that the first balloon (16) is positioned within the second balloon (14), the second balloon (14) being positioned only at the distal portion of the balloon assembly (see annotated figure 8 above), and in the deployment condition of the system, the second balloon (14) is inflated to a diameter that is larger than the diameter of the center portion of the balloon assembly (see annotated fig. 8 above).
2. Claims 1, 5, and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Baldwin et al. (US 20210186694 A1).
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), 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 that the distal portion of the balloon assembly has 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).
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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 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); 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).
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Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
3. Claims 2 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over et al. Baldwin et al. (US 20210186694 A1) as applied to claim 1 above, in view of Ridgley et al. (US 20140277351 A1).
Regarding claim 2, Baldwin discloses the invention as claimed as discussed with respect to claim 1. Baldwin fails to disclose that the balloon assembly includes a first balloon and a second balloon. Ridgley also discloses a delivery catheter 600 having a balloon assembly on a distal end portion of the delivery catheter (fig. 6 illustrates and ¶ 0030 discloses a balloon assembly disposed on the distal end portion 602 of the delivery catheter 600), the balloon assembly having a proximal portion, a distal portion, and a center portion between the proximal portion and the distal portion (see fig. 6 annotated below).
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Ridgley teaches the balloon assembly includes a first and second balloon (fig. 6 illustrates a first balloon 616 and a second balloon 614). 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 first and second balloon in order to deploy a stent using a multi-phase inflation balloon assembly (Ridgley ¶ 0007).
Regarding claim 3, Baldwin in view of Ridgley disclose the invention as claimed as discussed with respect to claim 2. Ridgley further discloses that the second balloon is positioned within the first balloon, the second balloon being positioned only at the distal portion of the balloon assembly (fig. 6 illustrates a second balloon 614 within a first balloon 616 the second balloon 614 positioned only at the distal end of the balloon assembly). Ridgley’s second balloon 614 in a deployment condition is capable of being inflated to a diameter that is larger than the diameter of the center portion of the balloon assembly due to the balloon assembly comprising a pressure sensitive valve that inhibits inflation of a balloon when a threshold pressure is exceeded (¶ 0033; i.e. the second balloon can be inflated to a diameter that is larger than the diameter of the center portion and once this threshold is exceeded the valve inhibits inflation of the first balloon).
4. Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Baldwin et al. (US 20210186694 A1) as applied to claim 5 above, and further in view of Yang et al. (US 20200078197 A1).
Regarding claim 6, Baldwin discloses the invention as claimed as discussed with respect to claim 5. Baldwin fails to disclose that the single balloon has a uniform compliance along a length of the single balloon, the single balloon being contoured so that when the single balloon is inflated, a distal portion of the single balloon has a diameter that is larger than a diameter of a center portion of the single balloon.
Yang also discloses a prosthetic heart valve system (¶ 0058), comprising: a balloon expandable prosthetic heart valve (140); and in an alternate embodiment Yang discloses a delivery catheter (112) having a balloon assembly on a distal end portion of the delivery catheter (fig. 4 illustrates and ¶ 0057 discloses a balloon assembly on the distal end 116 of a delivery catheter 112), the balloon assembly having a proximal portion, a distal portion, and a center portion between the proximal portion and the distal portion (see fig. 4 annotated below).
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Yang further teaches that the single balloon has a uniform compliance along a length of the single balloon (¶ 0031 discloses that a first membrane 22 i.e. the single balloon is made from a single compliant or non-compliant material and ¶ 0057 discloses that the balloon 110 may be constructed like previous embodiments from a first membrane), the single balloon being contoured (fig. 4 illustrates a single balloon being contoured) so that when the single balloon is inflated, a distal portion of the single balloon has a diameter that is larger than a diameter of a center portion of the single balloon (fig. 5C also illustrates that when the balloon is inflated the distal portion has a diameter that is larger than the center portion of the single balloon).
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 Yeung to include a single balloon with a uniform compliance and the single balloon being contoured so that when the single balloon is inflated, a distal portion of the single balloon has a diameter that is larger than a diameter of a center portion of the single balloon as taught by Yang in order to flare one or more ends of the prosthesis (Yang, Abstract; [0058]).
5. Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Baldwin et al. (US 20210186694 A1) as applied to claim 5 above, and further in view of Pedersen et al. (US 20050075662 A1).
Regarding claim 7, Baldwin discloses the invention as claimed as discussed with respect to claim 5. Baldwin discloses a single balloon but fails to disclose that the single balloon has a proximal portion having a first compliance, and a distal portion having a second compliance less than the first compliance, so that when the single balloon is inflated while a center portion of the single balloon is positioned within a native valve annulus of a patient, a distal portion of the single balloon has a diameter that is larger than a diameter of the center portion of the single balloon.
Pedersen also discloses a prosthetic heart valve system (¶ 0059 discloses a system for performing valvuloplasty procedures), comprising: a delivery catheter (100) having a balloon assembly on a distal end portion of the delivery catheter (fig. 1 illustrates a delivery catheter 100 with a balloon assembly 102/104 on a distal end portion). Pedersen teaches a single balloon (200) that has a proximal portion having a first compliance (figs. 5g-5i illustrate and ¶ 0087 discloses a balloon 200 with a compliant portion), and a distal portion having a second compliance less than the first compliance (figs. 5g-5i illustrates and ¶ 0087 discloses a balloon 200 with a non-compliant or partially compliant portion 202b), so that when the single balloon is inflated while a center portion of the single balloon is positioned within a native valve annulus of a patient, a distal portion of the single balloon has a diameter that is larger than a diameter of the center portion of the single balloon (figs. 5g-5i illustrate and ¶ 0084 discloses a single balloon 200 with a taper zone/narrower diameter 602 that is used to seat the balloon within the annulus of the valve and figs. 5g-5i illustrate a distal portion of the single balloon 200 with a diameter larger than the center portion).
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 of to include a single balloon has a proximal portion having a first compliance, and a distal portion having a second compliance less than the first compliance, so that when the single balloon is inflated while a center portion of the single balloon is positioned within a native valve annulus of a patient, a distal portion of the single balloon has a diameter that is larger than a diameter of the center portion of the single balloon in order to as taught by Pedersen in order to prevent excessive loads from being exerted by the balloon on the annulus during inflation (Pedersen ¶ 0084).
6. Claims 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Baldwin et al. (US 20210186694 A1) as applied to claim 1 above, and further in view of Nguyen et al. (US 20080140189 A1).
Regarding claim 8, Baldwin discloses the invention as claimed as discussed with respect to claim 1. Baldwin fails to disclose that in the delivery condition of the system, a band circumscribes the center portion of the prosthetic heart valve.
Nguyen also discloses a prosthetic heart valve system (abstract), comprising: a balloon expandable prosthetic heart valve (312, fig. 37), 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 (fig. 37 annotated below illustrates a prosthetic heart valve assembly 310 comprising a prosthetic heart valve 312 with an inflow end 316, a center portion, and an outflow portion 318 as); and a delivery catheter having a balloon assembly on a distal end portion of the delivery catheter (figs. 5-8 illustrate a delivery catheter 2 having a balloon assembly 13 on a distal end). Nguyen teaches an alternate embodiment wherein the deployment condition a band circumscribes the center portion of the prosthetic heart valve (fig. 58 illustrates and ¶ 0185 discloses that a prosthetic heart valve 310 with a band 691 circumscribing the center during expansion/deployment).
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 9, Baldwin in view of Nguyen disclose the invention as claimed as discussed with respect to claim 8. 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).
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).
7. Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Baldwin et al. (US 20210186694 A1) as applied to claim 11 above, in view of Tamir (WO 2021252720 A1)
Regarding claim 12, Baldwin discloses the invention as claimed as discussed with respect to claim 11. Baldwin discloses forcing an inflow end of a prosthetic heart valve to flare radially outwardly relative to the center portion of the heart valve (fig. 16 annotated above 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). Baldwin fails to discloses that inflating the balloon assembly includes inflating a first balloon of the balloon assembly to a first diameter, and inflating a second balloon of the balloon assembly to a second diameter greater than the first diameter, so that the second balloon forces the inflow end portion of the prosthetic heart valve to flare radially outwardly relative to the center portion of the prosthetic heart valve.
Tamir also discloses a method of implanting a prosthetic heart valve, 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; and inflating the balloon assembly to expand the prosthetic heart valve (¶ 0043 discloses and fig. 11 illustrates a method of implanting a prosthetic heart valve 12 to a native valve annulus while the valve is crimped on a balloon assembly 14/16 of a balloon catheter 26 and the balloon assembly is deflated. Fig. 13 illustrates inflating the balloon assembly to expand the prosthetic heart valve 12).
Tamir teaches inflating the balloon assembly includes inflating a first balloon (16) of the balloon assembly to a first diameter, and inflating a second balloon (14) of the balloon assembly to a second diameter greater than the first diameter (see fig. 8). Tamir additionally teaches an alternate embodiment in which the prosthetic heart valve is positioned on the balloon assembly such that the second balloon forces the inflow end portion of the prosthetic heart valve to flare radially outwardly relative to the center portion of the prosthetic heart valve (see fig. 3 annotated below).
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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 balloon assembly of Baldwin such that inflating the balloon assembly includes inflating a first balloon of the balloon assembly to a first diameter, and inflating a second balloon of the balloon assembly to a second diameter greater than the first diameter, so that the second balloon forces the inflow end portion of the prosthetic heart valve to flare radially outwardly relative to the center portion of the prosthetic heart valve, as taught by Tamir, in order to improve positioning of an expandable implant upon the expansion of one or more inflatable bodies (Tamir ¶ 0006).
8. Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Baldwin et al. (US 20210186694 A1) as applied to claim 11 above, and further in view of Yang et al. (US 20200078197 A1).
Regarding claim 13, Baldwin discloses the invention as claimed as discussed with respect to claim 11. Baldwin discloses a balloon assembly that includes a single balloon (313), but fails to disclose that the single balloon has a uniform compliance and that inflating the balloon assembly includes inflating the single balloon to a pre-defined shape in which a distal end of the single balloon has a diameter that is larger than a center portion of the single balloon.
Yang also discloses method of implanting a prosthetic heart valve (the abstract discloses and figs. 3d-3f illustrate methods for implanting a stent, prosthetic valve, or other tubular structures). Yang teaches single balloon has a uniform compliance (¶ 0031 discloses that a first membrane 22 i.e. the single balloon is made from a single compliant or non-compliant material and ¶ 0057 discloses that the balloon 110 may be constructed like previous embodiments from a first membrane) and that inflating the balloon assembly includes inflating the single balloon to a pre-defined shape in which a distal end of the single balloon has a diameter that is larger than a center portion of the single balloon (fig. 5 illustrates an inflated single balloon with a pre-defined shape in with a distal end of the single balloon has a diameter larger than the center portion).
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 single balloon having a uniform compliance, and inflating the balloon assembly includes inflating the single balloon to a pre-defined shape in which a distal end of the single balloon has a diameter that is larger than a center portion of the single balloon as taught by Yang in order to flare one or more ends of the prosthesis (Yang, Abstract).
9. Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Baldwin et al. (US 20210186694 A1) as applied to claim 11 above, and further in view of Pedersen et al. (US 20050075662 A1).
Regarding claim 14, Baldwin discloses the invention as claimed as discussed with respect to claim 11. Baldwin discloses a balloon assembly that includes a single balloon (figs. 14-16 illustrate a single balloon 303) and inflating the single balloon until the proximal portion presses the prosthetic heart valve into the native valve annulus (fig. 16 illustrates inflating a single balloon 313 until the proximal portion presses the prosthetic heart valve 100 into the native valve annulus). Baldwin fails to disclose that the single balloon has a proximal portion with a first compliance, and a distal portion with a second compliance less than the first compliance, and continuing to inflate the balloon assembly so that the distal portion of the single balloon has a diameter that is larger than a diameter of the center portion of the single balloon.
Pedersen also discloses a method comprising: inflating a balloon assembly so that a center portion contacts the native valve annulus (¶ 0084 discloses and fig. 5i illustrates inflating a balloon assembly 200 so that a center portion 602 seats the balloon within the native valve annulus). Pedersen teaches a single balloon (200) that has a proximal portion with a first compliance (figs. 5g-5i illustrate and ¶ 0087 discloses a balloon 200 with a compliant portion), and a distal portion with a second compliance less than the first compliance (figs. 5g-5i illustrates and ¶ 0087 discloses a balloon 200 with a non-compliant or partially compliant portion 202b) and continuing to inflate the balloon so that the distal portion of the single balloon has a diameter that is larger than the diameter of the center portion of the single balloon (figs. 5h-5i illustrates inflating a distal portion 202b of the single balloon 200 having a larger diameter that is larger than the diameter of the center portion).
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 method of implanting a prosthetic heart valve of Baldwin to include that the single balloon has a proximal portion with a first compliance, and a distal portion with a second compliance less than the first compliance, and continuing to inflate the balloon assembly so that the distal portion of the single balloon has a diameter that is larger than a diameter of the center portion of the single balloon as taught by Pedersen in order to prevent excessive loads from being exerted by the balloon on the annulus during inflation (Pedersen ¶ 0084).
10. Claims 15 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Baldwin et al. (US 20210186694 A1) as applied to claim 11 above, and in further view of Jackson (US 20200229956 A1).
Regarding claim 15, Baldwin discloses the invention as claimed as discussed with respect to claim 11. Baldwin fails to disclose that inflating the balloon assembly includes starting to inflate the balloon assembly while a band circumscribes the center portion of the prosthetic heart valve and a center portion of the balloon assembly, and continuing to inflate the balloon assembly so that a distal portion of the balloon assembly inflates to a diameter larger than a diameter of the center portion of the balloon assembly while the band still circumscribes the center portion of the prosthetic heart valve and the center portion of the balloon assembly.
Jackson also discloses a method of implanting a prosthesis (figs. 14a-c), the method comprising: delivering a prosthesis while the prosthesis is crimped on a balloon assembly of a balloon catheter and the balloon assembly is deflated (fig. 14a illustrates delivering a prosthesis 2320 while the prothesis is crimped on a balloon assembly 2330 of a balloon catheter 2300 and the balloon assembly is deflated); and inflating the balloon assembly to expand a prosthesis valve so that an inflow end portion of the prosthesis flares radially outwardly relative to the center portion of the prosthesis (fig. 14b annotated below illustrates inflating the balloon assembly to expand a prosthesis so that an inflow end portion flares radially relative to the center portion of the prosthesis).
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Jackson teaches that inflating the balloon assembly includes starting to inflate the balloon assembly while a band circumscribes the center portion of a prosthesis and a center portion of the balloon assembly (¶ 0119 discloses a delivery method of a flow modifying implant (any of the implants disclosed) i.e. a valve and fig. 8a illustrates an implant 1500 in which a band 1522/1524 circumscribes the center portion of the prothesis. ¶ 0091 discloses positioning a balloon catheter within the prosthesis and expanding/inflating the balloon.), and continuing to inflate the balloon assembly so that a distal portion of the balloon assembly inflates to a diameter larger than a diameter of the center portion of the balloon assembly (fig. 14b illustrates inflating a balloon so that a distal portion of the balloon assembly inflates to a diameter larger than the diameter at the center) while the band still circumscribes the center portion of the prosthesis and the center portion of the balloon assembly (¶ 0091 discloses that the band circumscribes the center of the implant until the balloon’s pressure exceeds the band’s threshold).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Baldwin to include inflating the balloon assembly by starting to inflate the balloon assembly while a band circumscribes the center portion of a prosthesis and a center portion of the balloon assembly, and continuing to inflate the balloon assembly so that a distal portion of the balloon assembly inflates to a diameter larger than a diameter of the center portion of the balloon assembly while the band still circumscribes the center portion of the prosthesis and the center portion of the balloon assembly as taught by Jackson in order to control expansion of a prosthesis (Jackson ¶ 0091-0092).
Regarding claim 16, Baldwin in view of Jackson disclose the invention as claimed as discussed with respect to claim 15. Jackson further discloses further inflating the balloon assembly until the band breaks and no longer circumscribes the center portion of the prosthetic heart valve and the center portion of the balloon assembly (¶ 0091 discloses expanding/inflating a balloon until the balloon’s pressure exceeds the bands threshold).
11. Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Baldwin et al. (US 20210186694 A1) as applied to claim 11 above, and in further view of Mesana (US 20200330225 A1).
Regarding claim 17, Baldwin discloses the invention as claimed as discussed with respect to claim 11. Baldwin fails to disclose that the prosthetic heart valve includes a frame formed of struts having a strut geometry, the strut geometry of the frame at the center portion of the prosthetic heart valve being different than the strut geometry of the frame at the inflow end of the prosthetic heart valve such that more force is required to expand the frame at the center portion of the prosthetic heart valve than is required to expand the frame at the inflow portion of the prosthetic heart valve.
Mesana discloses a method of implanting a prosthetic heart valve (¶ 0002), the method comprising: inflating a balloon assembly to expand the prosthesis (210) so that an inflow end portion of the flares radially outwardly relative to the center portion of the prothesis (fig. 25 illustrates inflating a balloon assembly 224/226 that flares the ends of a stent 210 radially outwardly relative to the center portion of the stent).
Mesana teaches the prosthetic heart valve includes a frame formed of struts having a strut geometry, the strut geometry of the frame at the center portion of the prosthetic heart valve being different than the strut geometry of the frame at the inflow end of the prosthetic heart valve (fig. 24 illustrates and ¶ 0082 discloses a prosthetic heart valve/stent that includes a frame 220 formed of struts having a strut geometry and that the strut geometry at the center portion of the prosthetic heart valve/stent 222 is different that the strut geometry at the inflow end. The reinforced area 222 may comprises thicker wires.) such that more force is required to expand the frame at the center portion of the prosthetic heart valve than is required to expand the frame at the inflow portion of the prosthetic heart valve (¶ 0082 discloses that the reinforced areas 222 will be stiffer and/or constrained compared to areas above and below i.e. inflow outflow portions).
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 method of implanting a prosthetic heart valve of Baldwin to include that the prosthetic heart valve includes a frame formed of struts having a strut geometry, the strut geometry of the frame at the center portion of the prosthetic heart valve being different than the strut geometry of the frame at the inflow end of the prosthetic heart valve such that more force is required to expand the frame at the center portion of the prosthetic heart valve than is required to expand the frame at the inflow portion of the prosthetic heart valve as taught by Mesana in order to allow the areas above and below the area with the different strut geometry to flare and help anchor the prosthetic valve/stent in place (Mesana ¶ 0082).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADRIANA BAUTISTA whose telephone number is (571)272-0927. The examiner can normally be reached Monday-Friday 7:30am-5:00pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at 571-272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/A.G.B./ Examiner, Art Unit 3774
/MELANIE R TYSON/ Supervisory Patent Examiner, Art Unit 3774
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