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 without traverse of claims 11-20 in the reply filed on 02/11/2026 is acknowledged. Claims 1-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Claim Objections
Claim 17 is objected to because of the following informalities: typographical error. “each of the at least one anchor” should be --the at least one anchor--. Appropriate correction is required.
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.
Claims 11-16 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Thomas et al. (US 20160235530 A1), in view of Von Oepen et al. (US 10874512 B2).
Regarding claim 11, Thomas discloses a prosthetic heart valve system (¶ 0002 discloses devices, systems, and methods for transcatheter delivery of prosthetic heart valves), comprising: a prosthetic heart valve (100) including a stent (102), a cuff (136) and a plurality of leaflets (138), the cuff and the plurality of leaflets forming a valve assembly (fig. 2 illustrates and ¶ 0028 discloses a heart valve assembly 104); and a delivery device (10, 300) having an inner shaft (26) and an expandable balloon (330) transitionable between a deflated state and an inflated state (¶ 0038 discloses a balloon 330 that expands from a first diameter in the collapsed condition/deflated to a second diameter in the fully expanded condition/inflated). Thomas fails to disclose that the delivery device has a garter system including at least one anchor capable of mating with a cell of the stent, and at least one coupler connected to the at least one anchor.
Von Oepen also discloses a prosthetic heart valve system (abstract), comprising; a prosthetic heart valve (30 – prosthetic heart valve assembly) including a stent (fig. 4). Von Oepen teaches a garter system (fig. 5 illustrates a garter system) including at least one anchor (see fig. 6 annotated below) that is capable of mating with a cell of the stent (fig. 6 annotated below illustrates anchors mating/joined/linked onto a cell), and at least one coupler (36) connected to the at least one anchor (see fig. 6 annotated below).
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 Thomas to include a garter system including at least one anchor that is capable of mating with a cell of the stent, and the at least one coupler connected to the at least one anchor as taught by Von Oepen in order to securely connect the valve to the delivery device during delivery, positioning, and deployment (col. 7 lines 11-15).
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Regarding claim 12, Thomas in view of Von Oepen discloses at least one coupler (36) joins the at least one anchor (see fig. 6 annotated above) to the delivery device (see fig. 6).
Regarding claim 13, Thomas in view of Von Oepen discloses the at least one coupler joins the at least one anchor to the inner shaft of the delivery device (see fig. 14 annotated below).
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Regarding claim 14, Thomas in view of Von Oepen discloses that the at least one anchor includes a plurality of anchors removably coupleable to an inflow end of the stent (fig. 6 above illustrates a plurality of anchors removably coupleable to an inflow/atrial end 12 of the stent and col. 7 lines 16-20 discloses that the anchors/attachment members may facilitate a release of couplers from the valve i.e. removeable coupleable).
Regarding claim 15, Thomas in view of Von Oepen discloses that the at least one anchor includes a plurality of anchors removably coupleable to an outflow end of the stent (fig. 6 illustrates a plurality of anchors removably coupleable to an outflow/ventricular end 14 of the stent col. 7 lines 16-20 discloses that the anchors/attachment members may facilitate a release of couplers from the valve i.e. removably coupleable).
Regarding claim 16, Thomas in view of Von Oepen discloses that the at least one anchor includes a plurality of anchors removably coupleable to both an inflow end and an outflow end of the stent (fig. 6 illustrates anchors removable coupleable to both and inflow/atrial end 12 and an outflow/ventricular end 14 col. 7 lines 16-20 discloses that the anchors/attachment members may facilitate a release of couplers from the valve i.e. removably coupleable).
Regarding claim 20, Thomas in view of Von Oepen discloses that at least one coupler comprises multiple couplers circumferentially arranged about the stent (fig. 6 illustrates multiple couplers 36 circumferentially arranged about the stent).
Claims 11 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Thomas et al. (US 20160235530 A1), in view of Bloom et al. (US 20090192585 A1).
Regarding claim 11, Thomas discloses a prosthetic heart valve system (¶ 0002 discloses devices, systems, and methods for transcatheter delivery of prosthetic heart valves), comprising: a prosthetic heart valve (100) including a stent (102), a cuff (136) and a plurality of leaflets (138), the cuff and the plurality of leaflets forming a valve assembly (fig. 2 illustrates and ¶ 0028 discloses a heart valve assembly 104); and a delivery device (10, 300) having an inner shaft (26) and an expandable balloon (330) transitionable between a deflated state and an inflated state (¶ 0038 discloses a balloon 330 that expands from a first diameter in the collapsed condition/deflated to a second diameter in the fully expanded condition/inflated). Thomas fails to disclose that the delivery device has a garter system including at least one anchor capable of mating with a cell of the stent, and at least one coupler connected to the at least one anchor.
Bloom also discloses a stent (102), and a delivery device (fig. 17 illustrates and ¶ 0044 discloses a delivery device/system 100) having an inner shaft (102). Bloom teaches a delivery device that has a garter system including at least one anchor (figs. 17-18 annotated below illustrate a delivery device 100 with a garter system including at least one anchor 112) capable of mating with a cell of the stent (fig. 18 illustrates and ¶ 0068 discloses distal ends/anchors 112 that are able to attach/mate to the cell of a stent), and at least one coupler connected to the at least one anchor (fig. 18 illustrates at least one coupler 108 connected to at least one anchor 112).
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 delivery device of Thomas to include a garter system including at least one anchor capable of mating with a cell of the stent, and at least one coupler connected to the at least one anchor in order to reposition and/or retract the valve and ensure optimal placement (Bloom ¶ 0007).
Regarding claim 17, Thomas in view of Bloom further teaches that the at least one anchor is substantially circular (fig. 18 illustrates attachment members/anchors 112 that are substantially circular). The anchors (112) are considered capable of passing through an open cell of the stent when the stent is expanded given they may be sized to pass through the cell of an expanded stent (see fig. 18 annotated below), and to be trapped by a collapsed closed cell when the stent is at least partially collapsed given that the circular anchor may comprise a width larger than the width of the cell, opening, or aperture of a stent when in a collapsed configuration i.e. the anchor would be trapped due reduced width of the cell, opening, or aperture.
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Claims 11 and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Thomas et al. (US 20160235530 A1), in view of Argento et al. (WO 2021183610 A1).
Regarding claim 11, Thomas discloses a prosthetic heart valve system (¶ 0002 discloses devices, systems, and methods for transcatheter delivery of prosthetic heart valves), comprising: a prosthetic heart valve (100) including a stent (102), a cuff (136) and a plurality of leaflets (138), the cuff and the plurality of leaflets forming a valve assembly (fig. 2 illustrates and ¶ 0028 discloses a heart valve assembly 104); and a delivery device (10, 300) having an inner shaft (26) and an expandable balloon (330) transitionable between a deflated state and an inflated state (¶ 0038 discloses a balloon 330 that expands from a first diameter in the collapsed condition/deflated to a second diameter in the fully expanded condition/inflated). Thomas fails to disclose that the delivery device has a garter system including at least one anchor capable of mating with a cell of the stent, and at least one coupler connected to the at least one anchor.
Argento also discloses a prosthetic heart valve (10) including a stent (12); and a delivery device (30) having an inner shaft (52) and an expandable balloon transitionable between a deflated state and an inflated state (¶ 0085 discloses that the stent 12 may be expanded by an inflatable balloon). Argento teaches the delivery device has a garter system (fig. 4b) including at least one anchor (fig. 4b illustrates an anchor 15 with and anchor tip 22) and at least one coupler connected to the at least one anchor (fig. 4b illustrates a coupler 244 connected to the at least one anchor). The anchor (15) is considered capable of mating with the cell of a stent given that the retaining element of an anchor can be in various locations (inside, outside, or within a frame/stent i.e. the cell of a stent) and take various forms (tube, eyelet, grommet, aperture, etc.) (Argento ¶ 0061).
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 delivery device of Thomas to include a garter system including at least one anchor capable of mating with a cell of the stent, and at least one coupler connected to the at least one anchor in order to anchor/fix a frame structure to a native valve (Argento ¶ 0005).
Regarding claim 18, Thomas in view of Argento discloses that the at least one coupler is coupled to the inner shaft of the delivery device (fig. 1d illustrates at least one coupler 244 coupled to the inner shaft 52 of the delivery device 50) adjacent an inflow end of the stent (inflow end at left atrium 25) and extends to an outflow end of the stent (fig. 4b illustrates a coupler 244 adjacent to an inflow end at the left atrium 25 that extends to an outflow end of a stent end 12 at the left ventricle 26).
Regarding claim 19, Thomas in view of Argento discloses a delivery device adjacent to an outflow end of a stent (fig. 4 of Thomas illustrates a delivery device 10, 300 adjacent to an outflow region/aortic valve and ¶ 0039 discloses a transaortic delivery approach), the at least one coupler is coupled to the inner shaft of the delivery device (fig. 1d of Argento illustrates at least one coupler 244 coupled to the inner shaft 52 of the delivery device 50) and extends from one end of a stent to another (fig. 4a).
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.
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/A.G.B./Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774