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 .
Status of Claims
Claims 19-37 are pending and examined below
Response to Arguments
The remarks of 02/17/2026 have been considered but are not persuasive.
Applicant argues that it would not be obvious to a person of ordinary skill in the art to apply Yohanan’s tapered inflow end to Chamber’s valve support 104. However, Paragraph 0078 discloses that the tapered shape of the top-most cells (i.e. the cells are bent inwardly over the blood flow channel) facilitates re-sheathing and/or positioning of the prosthetic valve. This serves as motivation for a person of ordinary skill in the art to modify Chambers in view of Yohanan.
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) 19-22, 28, and 34-37 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2019/0365538 (Chambers) in view of US 2013/0150956 (Yohanan)
Regarding claim 19, Chambers discloses a prosthetic heart valve device (Fig. 5, 100) adapted for expansion and implantation into a heart chamber of a patient (¶0028, “support stent of prosthetic heart valve”), the device comprising: a collapsible and expandable stent (abstract, “collapsible and expandable prosthetic heart valve stent”) having:
an outer section (Fig. 5, 102) defining an interior (see Fig. 5); and
a valve support (Fig. 5, 104) that: extends upward into the interior (see Fig. 5, wherein 104 extends into the interior); comprises an inflow end (Fig. 5, “inflow end”), an outflow end (Fig. 5, “outflow end”), and a cylindrical body extending between the inflow end and the outflow end (Fig. 5, wherein 104 has a cylindrical body); and defines a blood flow channel between the inflow and outflow ends (Fig. 5); and
a plurality of prosthetic valve leaflets (Fig. 6, 106) disposed within the blood flow channel and configured to allow flow from the inflow end to the outflow end and prevent flow from the outflow end to the inflow end (¶0017, wherein “act as a one-way valve” corresponds to allow flow from the inflow end to the outflow end and prevent flow from the outflow end to the inflow end);
Chambers disclose an inflow end (Fig. 5, “inflow end”) but doesn’t explicitly teach or disclose that the inflow end comprises a plurality of top-most stent cells that are bent inwardly over the blood flow channel.
Yohanan discloses a prosthetic heart valve (Fig. 13, 300) wherein the inflow end of the valve support comprises a plurality of top-most stent cells that are bent inwardly over the blood flow channel (Fig. 13, wherein top-most cells of 302 are bent radially inwardly over the blood flow channel)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the inflow end of the valve support of Chambers to have a plurality of top-most stent cells that are bent inwardly over the blood flow channel, as taught by Yohanan, in order to facilitate re-sheathing and/or positioning of the prosthetic valve.
Regarding claim 20, Chambers further discloses a transition section (Fig. 5, 108) including transition cells that turn the outer section of the collapsible and expandable stent inwardly (¶0031, wherein “generally look like a ball” corresponds to turning the outer section inwardly), the transition cells being disposed between the outer section of the collapsible and expandable stent and the valve support (see Fig. 5, wherein 108 is between outer section 102 and valve support 104)
Regarding claim 21, Chambers discloses wherein the valve support (Fig. 5, 104), the transition section and the outer section of the collapsible and expandable stent comprise a single unitary structure (¶0035, “single unitary structure”)
Regarding claim 22, Chambers doesn't explicitly teach or disclose wherein at least one of the plurality of top-most stent cells defines a recapture assist mechanism.
Yohanan discloses wherein at least one of the plurality of top-most stent cells defines a recapture assist mechanism (Fig. 34, 324)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the prosthetic heart valve of Chamber with at least one top-most stent cell defining a recapture assistance mechanism, as taught by Yohanan, in order to be able to position, reposition or retrieve the valve (¶0078).
Regarding claim 28, Chambers doesn't explicitly teach or disclose wherein at least one of the plurality of top- most stent cells includes a recapture assist mechanism disposed thereon.
Yohanan discloses wherein at least one of the plurality of top-most stent cells includes a recapture assist mechanism disposed thereon (Fig. 34, wherein 324 is disposed thereon at least one of the plurality of top-most stent cells
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify at least one of the plurality of top-most stent cells of Chambers with a recapture assist mechanism disposed thereon, as taught by Yohanan, in order to be able to position, reposition or retrieve the valve (¶0078).
Regarding claim 34, Chamber doesn't explicitly teach or disclose a plurality of top-most cells defined by four struts.
Yohanan discloses wherein each of the plurality of top-most stent cells are defined by four struts (see annotated Fig. 15 below)
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It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify Chambers with a plurality of top-most stent cells defined by four struts, as taught by Yohanan, in order to provide proper structural integrity to the prosthetic heart valve
Regarding claim 35, Chambers doesn't explicitly teach or disclose a skirt disposed along a portion of an outer surface of the outer section and extending along an outer surface of the transition section and an inner surface of the inner valve support
Yohanan discloses a skirt disposed along a portion of an outer surface of the outer section (¶0065, “outer skirt”) and extending along an outer surface of the transition section and an inner surface of the inner valve support (Fig. 1, wherein 16 is on the inner surface of 10)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the prosthetic heart valve device of Yohanan with a skirt disposed along a portion of an outer surface of the outer section and extending along an outer surface of the transition section and an inner surface of the inner valve support, as taught by Yohanan, in order to avoid perivalvular leaks (¶0065).
Regarding claim 36, Chambers further discloses wherein the inner valve support defines a central axis (see annotated Fig. 5); and the plurality of top-most stent cells define a conical arrangement (¶0031, “conical arrangement”) the conical arrangement having a diameter that increases, along the axis, away from the inflow end (¶0031, wherein “smooth diameter decrease may extend from the outflow end to the inflow end” corresponds to an increase away from the inflow end)
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Regarding claim 37, Chambers further discloses wherein a minimum diameter of the conical arrangement is less than a cylindrical body diameter (¶0031, wherein “Inner valve support 104 may be cylindrical, but in a preferred embodiment may also be at least partially conical, with a larger diameter at an outflow end O than the diameter across at least portions of an inflow end” corresponds to a minimum diameter of the conical arrangement is less than a cylindrical body diameter”)
Claim(s) 23, 25-27, 29, and 31-33 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2019/0365538 (Chambers) in view of US 2013/0150956 (Yohanan), as applied to claims above, and further in view of US 2013/0331933 (Alkhatib)
Regarding claim 23, Chambers doesn't explicitly teach or disclose a recapture assist mechanism is configured to engage a wire to assist in positioning the device in the heart chamber. Yohanan doesn't explicitly teach or disclose a recapture assist mechanism is configured to engage a wire to assist in positioning the device in the heart chamber
Alkhatib discloses recapture assist mechanism (Fig. 1, 30) which is configured to engage a wire (¶0043, “wire”) to assist in positioning the device in the heart chamber (¶0043, wherein 30 is configured for this intended use because it can be used “for the purposes of repositioning or removing the valve”)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the prosthetic heart valve of Chambers in view of Yohanan with a recapture assist mechanism configured to engage a wire, as taught by Alkhatib, in order to properly position the heart valve within the body (¶0073)
Regarding claim 25, Chambers doesn't explicitly teach or disclose a push and/or pull wire. Yohanan doesn't explicitly teach or disclose a push and/or pull wire.
Alkhatib discloses wherein the wire comprises a push and/or pull wire (¶0043, wherein “wire” corresponds a pull wire)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the prosthetic heart valve of Chambers in view of Alkhatib with a push and/or pull wire, as taught by Alkhatib, in order to properly position the heart valve within the body (¶0073)
Regarding claim 26, Chambers doesn't explicitly teach or disclose a recapture assist mechanism which comprises an open paddle. Yohanan doesn't explicitly teach or disclose a recapture assist mechanism which comprises an open paddle.
Alkhatib discloses wherein the recapture assist mechanism comprises an open paddle (Fig. 1, wherein 30 corresponds to an open paddle) configured to engage the wire (¶0043, wherein 30 is configured to engage the wire)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify Chambers in view of Yohanan with a recapture assist mechanism comprising an open paddle, as taught by Alkhatib, in order to reposition or remove the device (¶0043).
Regarding claim 27, Chambers doesn't explicitly teach or disclose a recapture assist mechanism which comprises a slot configured to engage the wire. Yohana doesn't explicitly teach or disclose a recapture assist mechanism comprises a slot configured to engage the wire.
Alkhatib discloses a recapture assist mechanism (Fig. 1, 30) which comprises a slot configured to engage the wire (Fig. 1, wherein 30 corresponds to a slot)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the recapture assist mechanism of Chambers in view of Yohanan with a slot configured to engage the wire, as taught by Alkhatib, in order to reposition or remove the device (¶0043)
Regarding claim 29, Chambers doesn't explicitly teach or disclose a recapture assist mechanism. Yohanan doesn't explicitly teach or disclose wherein the recapture assist mechanism is configured to engage a wire to assist in positioning the device in the heart chamber.
Alkhatib discloses recapture assist mechanism (Fig. 1, 30) which is configured to engage a wire (¶0043, “wire”) to assist in positioning the device in the heart chamber (¶0043, wherein 30 is configured for this intended use because it can be used “for the purposes of repositioning or removing the valve”)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the prosthetic heart valve of Chambers in view of Yohanan with a recapture assist mechanism configured to engage a wire, as taught by Alkhatib, in order to properly position the heart valve within the body (¶0073)
Regarding claim 31, Chamber doesn't explicitly teach or disclose a push and/or pull wire. Yohanan doesn't explicitly teach or disclose a push and/or pull wire.
Alkhatib discloses wherein the wire comprises a push and/or pull wire (¶0043, wherein “wire” corresponds a pull wire)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the prosthetic heart valve of Chambers in view of Alkhatib with a push and/or pull wire, as taught by Alkhatib, in order to properly position the heart valve within the body (¶0073)
Regarding claim 32, Chambers doesn't explicitly teach or disclose a recapture assist mechanism which comprises an open paddle. Yohanan doesn't explicitly teach or disclose a recapture assist mechanism which comprises an open paddle.
Alkhatib discloses wherein the recapture assist mechanism comprises an open paddle (Fig. 1, wherein 30 corresponds to an open paddle) configured to engage the wire (¶0043, wherein 30 is configured to engage the wire)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify Chambers in view of Yohanan with a recapture assist mechanism comprising an open paddle, as taught by Alkhatib, in order to reposition or remove the device (¶0043).
Regarding claim 33, Chambers doesn't explicitly teach or disclose a recapture assist mechanism which comprises a slot configured to engage the wire. Yohana doesn't explicitly teach or disclose a recapture assist mechanism comprises a slot configured to engage the wire.
Alkhatib discloses a recapture assist mechanism (Fig. 1, 30) comprises a slot configured to engage the wire (Fig. 1, wherein 30 corresponds to a slot)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the recapture assist mechanism of Chambers in view of Yohanan with a slot configured to engage the wire, as taught by Alkhatib, in order to reposition or remove the device (¶0043)
Claim(s) 24 and 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2019/0365538 (Chambers) in view of US 2013/0150956 (Yohanan) in view of US 20130331933 (Alkhatib), as applied to claims above and further in view of EA 033745 (Rolf)
Regarding claim 24, Chambers discloses a hole for engaging the wire (see Fig. 5) but doesn't explicitly teach or disclose a stent cap. Yohanan doesn't explicitly teach or disclose a stent cap. Alkhatib doesn't explicitly teach or disclose a stent cap.
Rolf discloses a stent comprising a stent cap (Fig. 5, 7) defining a hole for engaging the wire (wherein guide holes for accommodating the wire guide” corresponds to a hole for engaging the wire
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the prosthetic heart valve device of Chamber in view of Yohanan in view of Alkhatib with a stent cap, as taught by Rolf, to in order to reliably attach the wire
Regarding claim 30, Chambers discloses a hole for engaging the wire (see Fig. 5) but doesn't explicitly teach or disclose a stent cap. Yohanan doesn't explicitly teach or disclose a stent cap. Alkhatib doesn't explicitly teach or disclose a stent cap.
Rolf discloses a stent comprising a stent cap (Fig. 5, 7) defining a hole for engaging the wire (wherein guide holes for accommodating the wire guide” corresponds to a hole for engaging the wire
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the prosthetic heart valve device of Chamber in view of Yohanan in view of Alkhatib with a stent cap, as taught by Rolf, to in order to reliably attach the wire
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 extension fee 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 date of this final action.
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/MAXIMILIAN TOBIAS SPENCER/Examiner, Art Unit 3774
/YASHITA SHARMA/Primary Patent Examiner, Art Unit 3774