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 .
Response to Amendment
The Amendment filed 05/08/2026 has been entered. Claims 1-16 and 18-20 remain pending in the application. Claim 17 has been cancelled. Claims 1-10 remain withdrawn from consideration. Applicant’s amendments to the Claims have overcome each and every objection and 112(b) rejections previously set forth in the Non-Final Office Action mailed 03/11/2026.
Response to Arguments
Applicant’s arguments, see pgs. 5-7, filed 05/08/2026, with respect to the rejection of claims 11-16 and 18-20 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the previous rejections have been withdrawn and new grounds of rejection have been set forth below as necessitated by applicant’s amendment received 05/08/2026.
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 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Thomas et al. (US 20160235530 A1), in view of Escalona et al. (US 20170325951 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 having 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, wherein at least one anchor is substantially circular and configured and arranged to pass through an open cell of the stent when the stent is expanded, and to be trapped by a collapsed closed cell when the stent is at least partially collapsed, the at least one anchor having a fixed shape and/or size during a secured condition where it is coupled to the prosthetic heart valve and a release condition where it is being decoupled from the prosthetic heart valve.
Escalona also discloses a prosthetic heart valve system (¶ 0067), comprising: a prosthetic heart valve (16); and a delivery device (10) having an inner shaft (14). Escalona teaches a delivery device (10) having a garter system (302) including at least one anchor (318) configured to mate with a cell of the stent (¶ 0092), and at least one coupler (302) connected to the at least one anchor (see fig. 6), wherein at least one anchor is substantially circular and configured and arranged to pass through an open cell of the stent when the stent is expanded, and to be trapped by a collapsed closed cell when the stent is at least partially collapsed, the at least one anchor having a fixed shape and/or size during a secured condition where it is coupled to the prosthetic heart valve and a release condition where it is being decoupled from the prosthetic heart valve (Fig. 6 illustrates an anchor 318 that is substantially circular. ¶ 0094 discloses that the distal end 318 is rounded in order to engage the arm 302 to the braided anchor member 70, i.e. cells of a stent. ¶ 0096 discloses that the arms 302 remain engaged in the anchor member 70 to facilitate re-sheathing, i.e. the anchor/distal end 318 is trapped by the collapsed cell of the braided anchor/stent 70. Escalona does not mention change in shape of the anchor/distal end 318 and discloses in ¶ 0094 that the distal end has a fixed enlarged shaped to engage the anchor/stent 70).
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 that the delivery device having 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, wherein at least one anchor is substantially circular and configured and arranged to pass through an open cell of the stent when the stent is expanded, and to be trapped by a collapsed closed cell when the stent is at least partially collapsed, the at least one anchor having a fixed shape and/or size during a secured condition where it is coupled to the prosthetic heart valve and a release condition where it is being decoupled from the prosthetic heart valve, as taught by Escalona, in order to re-sheath an anchor/stent-like structure allowing for the re-positioning of the anchor/stent-like structure (¶ 0096).
Regarding claim 12, Thomas in view of Escalona discloses the invention as claimed as discussed with respect to claim 11. Escalona further discloses that the at least one coupler (302) joins the at least one anchor to the delivery device (¶ 0092 discloses that the coupler 302 may be used with sheathing mechanism 200 and in figs. 4 the sheathing system 200 is coupled to the delivery device).
Regarding claim 13, Thomas in view of Escalona discloses the invention as claimed as discussed with respect to claim 11. Escalona further discloses that the at least one coupler joins the at least one anchor to the inner shaft of the delivery device (as previously discussed ¶ 0092 discloses that the coupler 302 may be used with sheathing mechanism 200 and ¶ 0094 discloses that each coupler/arm 302 joins the anchor/distal end 318 to an inner shaft/inner catheter 14 of the delivery device).
Regarding claim 14, Thomas in view of Escalona discloses the invention as claimed as discussed with respect to claim 11. Escalona further discloses that the at least one anchor includes a plurality of anchors (¶ 0082 discloses that a sheathing aid may comprise less or more than three arms, i.e. may have a plurality of anchor/distal ends 318; see fig. 9) the anchors considered removably coupleable to an inflow end of the stent as they are able to engage any opening/cell along an anchor/stent as shown in figs. 3-4 (see ¶ 0096 which discloses that the delivery system may be withdrawn or removed).
Regarding claim 15, Thomas in view of Escalona discloses the invention as claimed as discussed with respect to claim 11. Escalona further discloses that the at least one anchor includes a plurality of anchors (¶ 0082 discloses that a sheathing aid may comprise less or more than three arms, i.e. may have a plurality of anchor/distal ends 318; see fig. 9) removably coupleable to an outflow end of the stent (see figs. 3-4; also see ¶ 0096 which discloses that the delivery system may be withdrawn or removed).
Regarding claim 16, Thomas in view of Escalona discloses the invention as claimed as discussed with respect to claim 11. Escalona further discloses that the at least one anchor includes a plurality of anchors considered removably coupleable to both an inflow end and an outflow end of the stent (see claims 14 and 15 above).
Regarding claim 18, Thomas in view of Escalona discloses the invention as claimed as discussed with respect to claim 11. Escalona further discloses that the at least one coupler is capable of being coupled to the inner shaft of the delivery device adjacent an inflow end of the stent and extend to an outflow end of the stent as Escalona discloses that the arm 314 and coupler 302 are placed within the lumen of the anchor/stent 70 along its inner surface and the distal end/anchor 318 engages the anchor/stent 70 woven structure. Furthermore, 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 length of the shaft/catheter or the length of the couplers to reach a further distance down the lumen of the anchor/stent 70 (e.g. Argento et al., WO 2021183610 A1, teaches an anchor and coupler/arm extending from one end of a stent to another).
Regarding claim 19, Thomas in view of Escalona discloses the invention as claimed as discussed with respect to claim 11. Escalona further discloses that the at least one coupler is capable of being coupled to the inner shaft of the delivery device adjacent an outflow end of the stent and extends to an inflow end of the stent as Escalona discloses that the arm 314 and coupler 302 are placed within the lumen of the anchor/stent 70 along its inner surface and the distal end/anchor 318 engages the anchor/stent 70 woven structure. Furthermore, 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 length of the shaft/catheter or the length of the couplers to reach a further distance down the lumen of the anchor/stent 70 (e.g. Argento et al., WO 2021183610 A1, teaches an anchor and coupler/arm extending from one end of a stent to another).
Regarding claim 20, Thomas in view of Escalona discloses the invention as claimed as discussed with respect to claim 11. Escalona further discloses that the at least one coupler comprises multiple couplers circumferentially arranged about the stent (see fig. 9).
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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/A.G.B./Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774
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