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 Status
Applicant’s Remarks and Amendments filed 2 June 2026 have been entered. Claims 1-9 are canceled. Claims 21-22 are new. Claims 10-22 are pending.
Response to Arguments
Applicant’s arguments, see pg. 5 of remarks, filed 2 June 2026, with respect to claims 11 and 16-20 have been fully considered and are persuasive. The 112(b) rejection of claims 11 and 16-20 has been withdrawn.
Applicant’s arguments with respect to claims 10-20 have been considered but are moot because the new ground of rejection does not rely on any combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 103
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.
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.
Claims 10-12 and 15-22 are rejected under 35 U.S.C. 103 as being unpatentable over Burkart et al. (US 2022/0183831 A1), “Burkhart” in view of Vidlund et al. (US 2018/0271653 A1), “Vidlund”.
Regarding claim 10, Burkart teaches a prosthetic heart valve (Fig. 2A, prosthetic valve 1000), comprising: an inner frame (Fig. 2A, leaflet frame subcomponent 1200) having a longitudinal axis (Fig. 2A, longitudinal axis X); a plurality of prosthetic leaflets coupled to the inner frame (Fig. 2A, leaflet frame subcomponent 1200 comprising leaflets 1230), the plurality of prosthetic leaflets configured to allow blood to flow through the inner frame in an antegrade direction along the longitudinal axis (flexible leaflets coupled to the leaflet frame are operable to open to allow flow in antegrade direction [0036]) and to block or resist blood from flowing through the inner frame in a retrograde direction along the longitudinal axis (flexible leaflets coupled to leaflet frame are operable to close to restrict flow in a retrograde direction [0036]); an outer frame connected to the inner frame (Fig. 2A, anchor frame subcomponent 1100); a sealing feature (Fig. 11A, connecting sheath 1300) including a first portion coupled to the inner frame at a first coupling point (Fig. 11A, portion of connecting sheath 1300 connected to leaflet frame subcomponent 1200 at inflow end 1202), a second portion coupled to the outer frame at a second coupling point (Fig. 11A, portion of connecting sheath 1300 connected to anchor frame subcomponent 1100 at outflow end 1104), wherein the embolic retention feature has a permeability that is greater than at least one of the first portion or the second portion (Fig. 11A, inflow annular groove cover is blood-permeable in extended configuration [0122] whereas connecting sheath 1300 is less permeable to blood [0181, 0184-0185]), but fails to teach an embolic retention feature coupled to the outer frame at a third coupling point and coupled to at least one of the first portion of the sealing feature or the second portion of the sealing feature.
Vidlund teaches a prosthetic heart valve comprising an embolic retention feature coupled to the outer frame at a third coupling point (Fig. 9B, second portion 586 connected to outer frame 520 at coupling joint 589 [0068]) and coupled to at least one of the first portion of the sealing feature or the second portion of the sealing feature (Fig. 9B, second portion 586 connected to first portion 584 at coupling joint 588 [0068]). Vidlund discloses that the pocket closure can be formed of any suitable material that is sufficiently porous to allow blood to enter the pocket which enhances clotting and ingrowth of tissue into the surfaces of the valve [0067-0069]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the sealing feature and permeability taught by Burkart with the embolic retention feature taught by Vidlund in order to increase tissue ingrowth surrounding the valve.
Regarding claim 11, Burkart teaches wherein the first portion (Fig. 11A, portion of connecting sheath 1300 connected to leaflet frame subcomponent 1200 at inflow end 1202), the second portion (Fig. 11A, portion of connecting sheath 1300 connected to anchor frame subcomponent 1100 at outflow end 1104), the inner frame (Fig. 2A, leaflet frame subcomponent 1200), and the outer frame (Fig. 2A, anchor frame subcomponent 1100) define a partially bounded first pocket that is open and faces a ventricular side of the prosthetic valve (Fig. 11A, connecting sheath lumen 1340), and the second portion (Fig. 11A, portion of connecting sheath 1300 connected to anchor frame subcomponent 1100 at outflow end 1104), embolic retention feature (Fig. 11A, inflow annular groove cover 1400 connected to anchor frame subcomponent 1100 nearest inflow end 1102), and outer frame (Fig. 2A, anchor frame subcomponent 1100) define a bounded pocket configured to retain a blood clot therein (Fig. 11A, embolus may form in inflow annular groove 1704 [0210]).
Regarding claim 12, Burkart teaches wherein the embolic retention feature has a permeability that is greater than both of the first portion and the second portion (Fig. 11A, inflow annular groove cover is blood-permeable in extended configuration [0122] whereas connecting sheath 1300 is less permeable to blood [0181, 0184-0185]).
Regarding claim 15, Burkart teaches wherein the third coupling point is positioned radially outward relative to the second coupling point (Figs. 11A, inflow end 1102 is further radially distanced from axis X than outflow end 1104).
Regarding claim 16, Burkart teaches a prosthetic heart valve (Fig. 2A, prosthetic valve 1000), comprising: an inner frame (Fig. 2A, leaflet frame subcomponent 1200) having a longitudinal axis (Fig. 2A, longitudinal axis X); a plurality of prosthetic leaflets coupled to the inner frame (Fig. 2A, leaflet frame subcomponent 1200 comprising leaflets 1230), the plurality of prosthetic leaflets configured to allow blood to flow through the inner frame in an antegrade direction along the longitudinal axis (flexible leaflets coupled to the leaflet frame are operable to open to allow flow in antegrade direction [0036]) and to block or resist blood from flowing through the inner frame in a retrograde direction along the longitudinal axis (flexible leaflets coupled to leaflet frame are operable to close to restrict flow in a retrograde direction [0036]); an outer frame (Fig. 2A, anchor frame subcomponent 1100); a sealing feature (Fig. 11A, connecting sheath 1300) coupled to the inner frame at a first coupling point (Fig. 11A, portion of connecting sheath 1300 connected to leaflet frame subcomponent 1200 at inflow end 1202) and extending radially outward and coupling to the outer frame at a second coupling point (Fig. 11A, portion of connecting sheath 1300 extends diagonally to connect to anchor frame subcomponent 1100 at outflow end 1104), but fails to teach an embolic retention feature coupled to the outer frame at a third coupling point that is distinct from the second coupling point such that a partially bounded pocket that is open on an outflow side between the inner frame and the outer frame is defined and a bounded pocket is defined, wherein the bounded pocket is configured to retain a blood clot therein.
Vidlund teaches a prosthetic heart valve comprising an embolic retention feature coupled to the outer frame at a third coupling point that is distinct from the second coupling point (Fig. 9B, second portion 586 connected to outer frame 520 at coupling joint 589 [0068]) such that a partially bounded pocket that is open on an outflow side between the inner frame and the outer frame is defined (Fig. 9B, region above first and second portions 584, 586) and a bounded pocket is defined (Fig. 9B, pocket 585), wherein the bounded pocket is configured to retain a blood clot therein (Fig. 9B, pocket 585 is an atrial pocket in which blood can clot forming thrombus [0067]). Vidlund discloses that the pocket closure can be formed of any suitable material that is sufficiently porous to allow blood to enter the pocket which enhances clotting and ingrowth of tissue into the surfaces of the valve [0067-0069]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the sealing feature taught by Burkart with the embolic retention feature taught by Vidlund in order to increase tissue ingrowth surrounding the valve.
Regarding claim 17, Burkart teaches wherein the sealing feature (Fig. 11A, connecting sheath 1300) comprises a first portion (Fig. 11A, portion of connecting sheath 1300 connected to leaflet frame subcomponent 1200 at inflow end 1202) and a second portion (Fig. 11A, portion of connecting sheath 1300 connected to anchor frame subcomponent 1100 at outflow end 1104).
Regarding claim 18, Burkart teaches wherein a combination of the first portion (Fig. 11A, portion of connecting sheath 1300 connected to leaflet frame subcomponent 1200 at inflow end 1202) and the embolic retention feature (Fig. 11A, inflow annular groove cover 1400 connected to anchor frame subcomponent 1100 nearest inflow end 1102) spans an entire annular span (Fig. 11A, inflow annular groove cover 1400 extends from inflow end 1202 to inflow end 1102) between the first coupling point (Fig. 11A, inflow end 1202) and the third coupling point (Fig. 11A, inflow end 1102).
Regarding claim 19, Burkart teaches: wherein the embolic retention feature has a greater permeability than both of the first portion and the second portion (Fig. 11A, inflow annular groove cover is blood-permeable in extended configuration [0122] whereas connecting sheath 1300 is less permeable to blood [0181, 0184-0185]).
Regarding claim 20, Burkart teaches wherein the partially bounded pocket (Fig. 11A, connecting sheath lumen 1340) is defined in part by the first portion (Fig. 11A, portion of connecting sheath 1300 connected to leaflet frame subcomponent 1200 at inflow end 1202 forms upper region of connecting sheath lumen 1340) and the second portion (Fig. 11A, portion of connecting sheath 1300 connected to anchor frame subcomponent 1100 at outflow end 1104 forms lower region of connecting sheath lumen 1340) such that the partially bounded pocket is radially inward relative to the bounded pocket (Fig. 11A, connecting sheath lumen 1340 is nearer axis X than inflow annular groove 1704).
Regarding claim 21, Burkart fails to teach the limitations of claim 21. Vidlund teaches a prosthetic heart valve wherein the embolic retention feature is integrally formed with at least one of the first portion of the sealing feature or the second portion of the sealing feature (Fig. 9B, first portion 584 (i.e., sealing feature) and second portion 586 may be formed as one continuous segment or portion of material [0068]). Vidlund discloses that the pocket closure can be formed of any suitable material that is sufficiently porous to allow blood to enter the pocket which enhances clotting and ingrowth of tissue into the surfaces of the valve [0067-0069]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the sealing feature taught by Burkart with the embolic retention feature taught by Vidlund in order to increase tissue ingrowth surrounding the valve.
Regarding claim 22, Burkart fails to teach the limitations of claim 22. Vidlund teaches a prosthetic heart valve wherein the embolic retention feature and the sealing feature are a single woven fabric (Fig. 9B, first portion 584 (i.e., sealing feature) and second portion 586 may be formed as one continuous segment or portion of material such as a woven or knit polyester fabric [0068-0069]). Vidlund discloses that the pocket closure can be formed of any suitable material that is sufficiently porous to allow blood to enter the pocket which enhances clotting and ingrowth of tissue into the surfaces of the valve [0067-0069]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the sealing feature taught by Burkart with the embolic retention feature taught by Vidlund in order to increase tissue ingrowth surrounding the valve.
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Burkart et al. (US 2022/0183831 A1), “Burkhart” in view of White et al. (US 2019/0175338 A1), “White”.
Regarding claim 13, Burkart teaches an inner frame (Fig. 2A, leaflet frame subcomponent 1200) having a longitudinal axis (Fig. 2A, longitudinal axis X); a plurality of prosthetic leaflets coupled to the inner frame (Fig. 2A, leaflet frame subcomponent 1200 comprising leaflets 1230), the plurality of prosthetic leaflets configured to allow blood to flow through the inner frame in an antegrade direction along the longitudinal axis (flexible leaflets coupled to the leaflet frame are operable to open to allow flow in antegrade direction [0036]) and to block or resist blood from flowing through the inner frame in a retrograde direction along the longitudinal axis (flexible leaflets coupled to leaflet frame are operable to close to restrict flow in a retrograde direction [0036]); an outer frame connected to the inner frame (Fig. 2A, anchor frame subcomponent 1100); a sealing feature (Fig. 11A, connecting sheath 1300) including a first portion coupled to the inner frame at a first coupling point (Fig. 11A, portion of connecting sheath 1300 connected to leaflet frame subcomponent 1200 at inflow end 1202), a second portion coupled to the outer frame at a second coupling point (Fig. 11A, portion of connecting sheath 1300 connected to anchor frame subcomponent 1100 at outflow end 1104); and an embolic retention feature coupled to the outer frame at a third coupling point (Fig. 11A, inflow annular groove cover 1400 connected to anchor frame subcomponent 1100 nearest inflow end 1102) wherein the embolic retention feature has a permeability that is greater than at least one of the first portion or the second portion (Fig. 11A, inflow annular groove cover is blood-permeable in extended configuration [0122] whereas connecting sheath 1300 is less permeable to blood [0181, 0184-0185]), but fails to teach wherein the inner frame comprises a first coupling arm extending radially outward of the longitudinal axis and the outer frame comprises a second coupling arm extending radially inward toward the longitudinal axis such that the first coupling arm and the second coupling arm meet and are coupled together at an anchoring point.
White teaches a prosthetic valve wherein the inner frame comprises a first coupling arm extending radially outward of the longitudinal axis (Fig. 8, first connecting members 70 are attached to and project outwardly from inner frame 40 [0054]) and the outer frame comprises a second coupling arm extending radially inward toward the longitudinal axis (Fig. 8, second connecting members 72 are attached to and project inwardly from outer frame 42 [0054]) such that the first coupling arm and the second coupling arm meet and are coupled together at an anchoring point (Fig. 8, first connecting members 70 and second connecting members 72 form apex 76 [0054]). White discloses that that connection assembly including the connecting members allow for rotation of the inner frame relative to the outer frame [0054]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the inner and outer frame taught by Burkart with the coupling arms taught by White in order to provide a more adaptable implant which can adjust to internal movements.
Regarding claim 14, Burkart teaches wherein the second coupling point (Fig. 11A, outflow end 1104) is on a ventricular side [0098] and the third coupling point (Fig. 11A, inflow end 1102) is on an atrial side [0098] but fails to teach an anchoring point.
White teaches a prosthetic valve comprising an anchoring point (Fig. 8, first connecting members 70 and second connecting members 72 form apex 76 [0054]). White discloses that that connection assembly including the connecting members allow for rotation of the inner frame relative to the outer frame [0054]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the inner and outer frame taught by Burkart with the coupling arms taught by White in order to provide a more adaptable implant which can adjust to internal movements.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/G.G.R./ Examiner, Art Unit 3774
/JERRAH EDWARDS/ Supervisory Patent Examiner, Art Unit 3774
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