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 .
The Amendment filed 6/10/2026 has been entered. Claims 1, 4, 5, and 7-30 are currently pending in this application. Claims 7, 8, 10-16, 20-22, 26-28, and 30 are withdrawn.
Response to Arguments
Applicant's arguments filed 6/10/2026 have been fully considered but they are not persuasive.
With regard to applicant’s argument on pages 10-12 that it would not have been obvious to modify Vesley with the teachings of Ratz to arrive at the newly amended claimed invention, the examiner disagrees. As explained in the previous office action, Vesely clearly teaches an anti-migration element (barbs) extending out from the stent to improve migration resistance (paragraph 0117). Further, and regardless of the foreshortening portion, the anchors (anti-migration elements; 22) of Ratz include tips (unsupported apexes; 26) that are configured to expand radially outwardly in the distal direction at a first angle to resist migration of the stent in the distal direction (paragraphs 0043 and 0048; fig. 2A). The examiner therefore maintains that it would have been obvious to one of ordinary skill in the art to specify that the anti-migration element of Vesely are unsupported apexes within each cell that are formed as a result of the plurality of longitudinal struts only connecting and extending between selected valleys of adjacent circumferentially-extending struts, in order to resist migration in the distal direction as taught by Ratz. See rejection below for further explanation.
With regard to applicant’s argument on pages 12-13 that it would be impermissible to modify Vesely to include only the proximal anchors of Ratz because Ratz requires both proximal anchors and distal anchors of a foreshortening portion, the examiner disagrees. Vesley is the primary reference and clearly meets the limitations claimed, including barbs that extend from the outer surface to improve migration resistance, as explained in the previous office action. Modifying the device of Vesely to specify that the anti-migration barbs are anchors with tips/unsupported apexes, as shown by Ratz, would not render the device of Vesely inoperable since the anchors of Ratz would extend radially outwardly at an acute angle to engage tissue, thereby preventing migration, as intended by Vesely. See rejection below for further explanation.
With regard to applicant’s argument on page 13 that any combination of Vesely and Ratz could not include at least one longitudinal strut that extends along an entire length from a proximal end to a distal end, as recited by amended claim 1, the examiner disagrees. Again, applicant is reminded that Vesely is the primary reference and clearly meets the limitations claimed, including a longitudinal strut that extends along an entire length from a proximal end to a distal end (fig. 6F). Modifying the device of Vesely to specify that the anti-migration barbs are anchors with tips/unsupported apexes, as shown by Ratz, would not affect the longitudinal strut shown by Vesely. See rejection below for further explanation.
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) 1, 4, 9, 17-19, and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication No. 2021/0077257 A1 to Vesely et al. (Vesely) in view of US Patent Application Publication No. 2014/0277427 A1 to Ratz et al. (Ratz).
Regarding at least claim 1
Vesely teaches an apparatus and methods for repairing a cardiac valve that includes a prosthetic device coupled to an elongated support to suspend and maintain the prosthetic device within the cardiac valve (abstract).
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Vesely meets the limitations of a device for maintaining a prosthetic heart valve device having a support at a native heart valve of a patient's heart (abstract), the device comprising: a stent tube (360) having a lumen configured to receive the support therethrough (paragraph 0112 discloses a lumen of the stent tube); a stent (504) coupled to the stent tube and configured to transition between a collapsed, delivery state and an expanded, deployed state to anchor the support to a blood vessel coupled to the heart such that the prosthetic heart valve device coupled to the support is positioned at the native heart valve of the patient's heart (paragraph 0117 discloses transition of the stent between collapsed and expanded states as claimed), the stent having a proximal region (501), a distal region (503), and a tapered profile such that a cross-sectional area of the stent increases in a direction from the proximal region towards the distal region (paragraph 0117 discloses a tapered profile to improve anchoring as shown in fig. 6F, for example), the stent comprises a plurality of circumferentially-extending struts (506) having an alternating pattern of valleys facing in a proximal direction and apexes facing in the distal direction (fig. 6F shows valleys facing proximal end 501 and apexes facing distal end 503), and a plurality of longitudinal struts (508) configured to interconnect selected valleys of adjacent circumferentially-extending struts of the plurality of circumferentially-extending struts (fig. 6F shows that the longitudinal struts 508 interconnect valleys of adjacent circumferentially-extending struts 506), such that the apexes of the plurality of circumferentially-extending struts are unsupported by the plurality of longitudinal struts within each cell of the stent defined by a pair of the adjacent circumferentially-extending struts and a pair of adjacent longitudinal struts of the plurality of longitudinal struts (annotated fig. 6F below shows that the apexes are unsupported by the longitudinal struts within each cell as claimed), at least one longitudinal strut of the plurality of longitudinal struts extending along an entire length from a proximal end of the proximal region of the stent to a distal end of the distal region of the stent (fig. 6F shows at least one longitudinal strut 508 extending an entire length from a proximal end to a distal end as claimed).
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Vesely also teaches at least one antimigration element disposed on the stent and configured to resist migration of the stent in a distal direction when the stent is in the expanded, deployed state within the blood vessel (paragraph 0117 discloses a plurality of barbs extending from the stent outer surface to improve migration resistance and fully capable of resisting migration in a distal direction when the stent is expanded and deployed).
However, Vesely does not explicitly teach that the at least one antimigration element comprising at least one unsupported apex of the plurality of circumferentially-extending struts, such that, upon radial compression of the stent, the at least one unsupported apex is configured to expand radially outwardly in the distal direction at a first angle relative to an outer surface of the stent to interact with an inner wall of the blood vessel and resist migration of the stent in the distal direction.
Ratz teaches an expandable frame for deployment within a body cavity (abstract), such as a heart valve (paragraph 0034).
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More specifically, the frame (20) is defined by longitudinal struts (12) and undulating struts (circumferential struts; 14), as well as opposing anchors (22) (paragraph 0039). Distal anchors (24) are shown having first (36) and second (38) struts forming a chevron and connected to longitudinal struts (12) at a base of the anchor that are bent at the base so that the anchor (22) extends radially outwardly from the frame as it extends generally distally towards the tip (apex; 26) (paragraph 0043), for the purpose of engaging and/or grasping tissue, without necessarily piercing or puncturing through tissue (paragraph 0048).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the frame of Vesely, which includes at least one unsupported apex of the plurality of circumferentially-extending struts, as well as barbs extending from its outer surface to improve migration resistance, to specify that at least one of the barbs is an antimigration element comprising at least one unsupported apex of the plurality of circumferentially-extending struts, such that, upon radial compression of the stent, the at least one unsupported apex is configured to expand radially outwardly in the distal direction at a first angle relative to an outer surface of the stent to interact with an inner wall of the blood vessel and resist migration of the stent in the distal direction, in order to extend radially outwardly to engage and/or grasp tissue, as taught by Ratz, which would result in improvement of migration resistance as intended by Vesely.
Regarding at least claim 4
Vesely in view of Ratz teaches the device of claim 1. Vesely also teaches that, in at least one embodiment (6J), the longitudinal struts only connect and extend between selected valleys of adjacent circumferentially-extending struts, for the purpose of creating space (522) which may improve distribution of strain on the stent (504) (paragraph 0118).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify the stent, as shown in fig. 6F of Vesely, which includes a plurality of longitudinal struts connecting and extending between valleys of adjacent circumferentially-extending struts, such that the longitudinal struts only connect and extend between selected valleys of adjacent circumferentially-extending struts of the plurality of circumferentially-extending struts, as shown in fig. 6J, in order to create space which may improve distribution of strain on the stent, as taught by Vesely.
Regarding at least claim 9
Vesely in view of Ratz teaches the device of claim 1. Vesely also teaches wherein the at least one longitudinal strut of the plurality of longitudinal struts is configured to extend along an entire length from a valley of a distal-most circumferentially-extending strut of the plurality of circumferentially-extending struts to a valley of a proximal-most circumferentially-extending strut of the plurality of circumferentially-extending struts, adjacent the stent tube (fig. 6F shows at least one longitudinal strut 508 extending an entire length from a valley of a distal-most circumferentially-extending strut to a valley of a proximal-most circumferentially-extending strut as claimed).
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Regarding at least claim 17
Vesely in view of Ratz teaches the device of claim 1. Vesely also teaches wherein at least one circumferentially- extending strut of the plurality of circumferentially-extending struts (506) comprises a stiffness that increases in a direction towards a connection of the stent to the stent tube to thereby resist bending of the stent along the connection of the stent to the stent tube (stent spine 510 which connects the stent to the stent tube 360, as shown in fig. 6K, has a stiffness that is increased compared to longitudinal struts 508 for the purpose of supporting stent tube 360 as disclosed in paragraph 0112).
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Regarding at least claim 18
Vesely in view or Ratz teaches the device of claim 1. Vesely also teaches wherein the stent is configured to be implanted within a superior vena cava (paragraph 0015 discloses implantation within a blood vessel coupled to the heart such as the inferior vena cava or superior vena cava), and wherein the at least one antimigration element is disposed on the proximal region of the stent (the unsupported apexes located at the proximal end 501 are construed to be at least one antimigration element disposed on the proximal region of the stent) such that, when the stent is in the expanded, deployed state within the superior vena cava, the at least one antimigration element is positioned cranial to the patient's pulmonary artery and/or aorta (this limitation is a contingent limitation and requires only structure for performing the function should the condition occur – the at least one antimigration element of Vesely is capable of being positioned cranial to the patient’s pulmonary artery and/or aorta when it is in the expanded, deployed state within the superior vena cava).
Regarding at least claim 19
Vesely in view of Ratz teaches the device of claim 1. Vesely also teaches wherein the stent is configured to be implanted within a superior vena cava (paragraph 0015 discloses implantation within a blood vessel coupled to the heart such as the inferior vena cava or superior vena cava), and wherein the at least one antimigration element is selectively disposed at radial positions along the stent such that, when the stent is in the expanded, deployed state within the superior vena cava, the at least one antimigration element is positioned away from the patient's aorta (this limitation is a contingent limitation and requires only structure for performing the function should the condition occur – the at least one antimigration element of Vesely is capable of being positioned away from the patient’s aorta when it is in the expanded, deployed state within the superior vena cava).
Regarding at least claim 23
Vesely in view of Ratz teaches the device of claim 1. Vesely also teaches wherein the stent comprises an expandable wire frame having variable stiffness along a length of the stent (paragraph 0117 discloses that the stent is self-expandable and may have a variable stiffness along its length).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vesely in view of Ratz, as applied to claim 1 above, and further in view of US Patent No. 8,628,566 B2 to Eberhardt et al. (Eberhardt).
Vesely in view of Ratz teaches the device of claim 1, including an antimigration element comprising at least one unsupported apex of the plurality of circumferentially-extending struts, such that, upon radial compression of the stent, the at least one unsupported apex is configured to expand radially outwardly in the distal direction at a first angle relative to an outer surface of the stent to interact with an inner wall of the blood vessel and resist migration of the stent in the distal direction, in order to extend radially outwardly to engage and/or grasp tissue, as taught by Ratz, which would result in improvement of migration resistance as intended by Vesely.
However, Vesely in view of Ratz does not explicitly teach additional unsupported apexes, such that, upon radial compression of the stent, the additional unsupported apexes of the plurality of circumferentially-extending struts are configured to expand radially outwardly in the distal direction at a second angle relative to the outer surface of the stent to interact with the inner wall of the blood vessel and resist migration of the stent in the distal direction, wherein the first angle is greater than the second angle.
Eberhardt teaches a stent (10) that includes wire structures (32) that are flared at least slightly outward relative to the outer tubular shape of the stent (10), for the purpose of a visual docking feature to secure the stent against a wall of an opening in the heart to prevent migration of the stent (col. 7, lines 17-35). Eberhardt further teaches that the amount and angle at which the wire structures extend relative to the tubular outer shape of the stent can be selected for capturing native patient anatomical features (col. 7, lines 17-35).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the stent of Vesely in view of Ratz which includes at least one antimigration element with at least one unsupported apex of the plurality of circumferentially-extending struts that is configured to expand radially outwardly in the distal direction at a first angle relative to an outer surface of the stent, to further include additional unsupported apexes of the plurality of circumferentially-extending struts, such that, upon radial compression of the stent, the additional unsupported apexes of the plurality of circumferentially-extending struts are configured to expand radially outwardly in the distal direction at a second angle relative to the outer surface of the stent to interact with the inner wall of the blood vessel and resist migration of the stent in the distal direction, wherein the first angle is greater than the second angle, in order to provide unsupported apexes of the antimigration element that are capable of capturing native patient anatomical features that are dependent on the individual patient, as taught by Eberhardt.
Claim(s) 24-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vesely in view or Ratz, as applied to claim 23 above, in view of US Patent No. 6,241,762 B1 to Shanley (Shanley).
Regarding at least claim 24
Vesely in view of Ratz teaches the device of claim 23. Vesely also teaches the expandable wire frame. However, Vesely does not teach wherein the expandable wire frame comprises a decoupling section extending between and connecting a proximal-most circumferentially-extending strut of the distal region of the stent and a distal-most circumferentially-extending strut of the proximal region of the stent, the decoupling section configured to limit transmission of force from the distal region to the proximal region.
Shanley teaches an expandable tissue supporting device (80) that includes a plurality of struts (88) that extend circumferentially, as well as S-shaped bridging elements (decoupling section; 84), for the purpose of providing improved axial flexibility without sacrificing radial strength (col. 8, lines 51-63).
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The bridging elements extend between and connect a proximal-most circumferentially extending strut of the distal region of the stent and a distal-most circumferentially-extending strut of the proximal region of the stent (fig. 4a, col. 8, lines 51-63).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the expandable wire frame of Vesely to include a decoupling section extending between and connecting a proximal-most circumferentially-extending strut of the distal region of the stent and a distal-most circumferentially-extending strut of the proximal region of the stent, the decoupling section configured to limit transmission of force from the distal region to the proximal region, in order to provide improved axial flexibility without sacrificing radial strength, as taught by Shanley.
Regarding at least claim 25
Vesely in view of Ratz and Shanley teaches the device of claim 24. Shanley also teaches that the decoupling section comprises a plurality of wavy struts (84) extending between the proximal-most circumferentially-extending strut of the distal region of the stent and the distal-most circumferentially-extending strut of the proximal region of the stent (fig. 4A, col. 8, lines 51-63).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to specify that the decoupling section comprises a plurality of wavy struts extending between the proximal-most circumferentially-extending strut of the distal region of the stent and the distal-most circumferentially-extending strut of the proximal region of the stent, in order to provide improved axial flexibility without sacrificing radial strength, as taught by Shanley.
Regarding at least claim 26
Vesely in view of Ratz and Shanley teaches the device of claim 25. Shanley also teaches wherein the plurality of wavy struts (84) comprises an S-shape (fig. 4A, col. 8, lines 51-63).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to specify that the plurality of wavy struts comprises an S-shape, in order to provide improved axial flexibility without sacrificing radial strength, as taught by Shanley.
Claim(s) 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vesely in view of Ratz, as applied to claim 1 above, in view of US Patent Application Publication No. 2016/0166416 A1 to Yacoby et al. (Yacoby).
Vesely in view of Ratz teaches the device of claim 1. Vesley also teaches further comprising: a sheath configured to receive the stent in the collapsed, delivery state such that the stent tube is disposed oppositely from the slit, wherein, during deployment of the stent from the sheath (paragraph 0037). However, Vesely does not teach that the sheath comprises a slit extending proximally from a distal end of the sheath, the sheath configured to receive the stent in the collapsed, delivery state such that the stent tube is disposed oppositely from the slit, wherein during deployment of the stent from the sheath, the slit facilitates deployment of the portion of the stent opposite the stent tube towards a medial wall of the blood vessel to thereby push the stent tube away from the medial wall of the blood vessel and prevent in-folding of the stent during deployment from the sheath.
Yacoby teaches a delivery system that includes a self-expanding prosthesis and a sheath (abstract). Yacoby also teaches that the sheath includes a slit extending proximally from a distal end (25) in the wall that initiates rupturing of the sheath so that the self-expanding prosthesis may move from its compressed state to its expanded state (paragraphs 0011 and 0040).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the sheath of Vesely to include a slit extending proximally from a distal end of the sheath, the sheath configured to receive the stent in the collapsed, delivery state, in order to initiate rupturing of the sheath so that the self-expanding prosthesis may move from its compressed state to its expanded state, as taught by Yacoby. The sheath comprising a slit as taught by Vesely in view of Yacoby is fully capable of being oriented such that the stent tube is disposed oppositely from the slit, wherein during deployment of the stent from the sheath, the slit facilitates deployment of the portion of the stent opposite the stent tube towards a medial wall of the blood vessel to thereby push the stent tube away from the medial wall of the blood vessel, depending on the anatomical requirements of the individual patient, and would prevent in-folding of the stent during deployment from the sheath in the same way as applicant’s (see applicant’s specification at paragraph 0144).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA A HOBAN whose telephone number is (571)270-5785. The examiner can normally be reached Monday-Friday 8:00AM-5:00PM.
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/M.A.H/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
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