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 23 January 2026 have been entered. Claims 1-12 and 14-20 are pending.
Response to Arguments
Applicant's arguments filed 23 January 2026 have been fully considered but they are not persuasive. As disclosed in the rejection below, Cartledge teaches the amendments made to claims 1, 12, and 16.
Further, in response to applicant's argument that Vesely is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Vesley relates generally to the field of cardiovascular valve [0002] and Cartledge lies in the field of heart valves [0010].
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 1-5 and 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Maimon et al. (US 2018/0153689 A1), “Maimon” in view of Cartledge et al. (US 2014/0296962 A1), “Cartledge”.
Regarding claim 1, Maimon teaches a prosthetic heart valve (field) comprising: a frame (Fig. 18, frame 604 (Maimon’s delivery assembly 600 (Figs. 18-49) is constructed in a similar manner to the structure of the assembly depicted in the first embodiment of the prior art (Fig. 2) [0197])) comprising a plurality of struts (Fig. 2, struts 32) and having an inflow end (Fig. 2, inflow end portion 26), an outflow end (Fig. 2, outflow end portion 30), and a longitudinal axis extending from the inflow end to the outflow end (Fig. 18, delivery assembly 600 defines a longitudinal axis extending through the inflow and outflow end portions in a vertical manner), wherein the struts are pivotably coupled together (Fig. 2, struts 32 connect via fasteners 40) such that the frame can pivot between one or more radially compressed states and one or more radially expanded states (Figs. 2 and 7, frame 604 changes from radially expanded to radially compressed); a valve structure (Fig. 19A, valvular structure 606) disposed within the frame, wherein the valve structure comprises a plurality of leaflets (Fig. 19A, valve structure 606 is similar to valve structure 24 of Fig. 2 which comprises leaflet assembly 48) configured to allow blood flow through the valve structure (Fig. 2, valvular structure 24 is configured to regulate the flow of the blood through the valve [0125]) from the inflow end of the frame to the outflow end of the frame (Fig. 2, blood flows from inflow end 26 to outflow end 30) and to restrict blood flow through the valve structure from the outflow end of the frame to the inflow end of the frame (valve structure establishes seal to precent or minimize perivalvular leakage (i.e., capable of restricting blood flow) [0126]); and an actuator (Fig. 26A, expansion and locking mechanism 700) coupled to the frame (Fig. 26A, mechanism 700 attaches to frame 604) and configured to move the frame between the one or more radially compressed states and the one or more radially expanded states (Fig. 26A-B, expansion and locking mechanism 700 is in radially expanded and compressed states), but fails to teach further features of the actuator.
Cartledge teaches a controllable stent wherein the actuator (Fig. 30, jack assembly 3000 (shown clearer by Fig. 37, but unlabeled)) comprises a first portion (Fig. 30, disconnector drive block 3030), a second portion (Fig. 30, proximal drive block 3020), a first lumen (Fig. 30, retainer screw lumen 3022), a second lumen (Fig. 30, needle assembly lumen which comprises proximal needle lumen 3016 and distal needle lumen 3018 [0340]), a locking member (Fig. 30, retainer screw 760), and a locking element (Fig. 30, threaded portion of retainer screw lumen 3022), wherein each of the first lumen (Fig. 30, retainer screw lumen 3022) and the second lumen (Fig. 30, needle assembly lumen which comprises proximal needle lumen 3016 and distal needle lumen 3018 [0340]) extend axially through each of the first portion (Fig. 30, disconnector drive block 3030) and the second portion (Fig. 30, proximal drive block 3020) in a direction parallel to the longitudinal axis of the frame (Fig. 30, jack assembly 3000 defines longitudinal lumens [0340-0341]), wherein the first lumen (Fig. 30, retainer screw lumen 3022) and the second lumen (Fig. 30, needle assembly lumen which comprises proximal needle lumen 3016 and distal needle lumen 3018 [0340]) are circumferentially spaced apart from each other and are parallel to each other (Fig. 30, jack assembly 3000 defines longitudinal lumens which are spaced apart and parallel [0340-0341]) wherein the locking member (Fig. 30, retainer screw 760) is disposed in the first lumen (Fig. 30, threaded portion of retainer screw lumen 3022 is within retainer screw lumen 3022), is fixedly coupled to the first portion (Fig. 30, threaded portion of retainer screw lumen 3022 is within retainer screw lumen 3022), and is axially movable relative to a second portion (Figs. 32-33, threaded portion of retainer screw lumen 3022 unscrews from retainer 760 to separate from proximal drive block 3020), wherein the second lumen (Fig. 30, needle assembly lumen which comprises proximal needle lumen 3016 and distal needle lumen 3018 [0340]) is configured to receive an actuation shaft (Fig. 30, needle assembly lumen receives needle 3070 of needle subassembly 3090) of a delivery apparatus (Fig. 30, control of needle 3070 is carried out by needle disconnect wire 3098 of a delivery system [0371]), wherein the actuation shaft (Fig. 30, needle assembly lumen receives needle 3070 of needle subassembly 3090) comprises an outwardly threaded portion (Fig. 30, needle 3070 comprises needle base 3094 which comprises exterior threading [0345]) which can be releasably coupled to an inwardly threaded portion (Fig. 30, needle assembly lumen further comprises need disconnect nut 3096 which comprises interior threads and mates with needle base 3094 of needle 3070 [0346]) of the first portion (Figs. 32-33, needle assembly comprises needle disconnect nut 3096 which removes needle base 3094 for disconnection of the delivery system [0346]) and can move axially relative to the second portion (Figs. 32-33, needle disconnect wire 3098 cause needle disconnect nut 3096 to secure of remove needle base 3094 [0346]), and thereby can move the frame between the one or more radially compressed states and the one or more radially expanded states [0341], wherein the locking element is rotatable relative to both the first portion and the second portion (Figs. 32-33, retainer screw lumen 3022 facilitates connection and disconnection with proximal drive block 3020 and disconnector drive block 3030 [0342-0348]), and wherein the locking element is adjustably coupled to the locking member (Fig. 30, retainer screw 760 mates with retainer screw lumen 3022) and configured to restrict relative axial movement between the locking member and the second portion, and thereby lock the frame in the one or more radially compressed states or the one or more radially expanded states (Figs. 32-33, retainer screw 760 keeps drive blocks 3020 and 3030 connected to one another during placement [0348]). Cartledge discloses that the lumens and members within them allow for the expansion of the stent lattice to the desired diameter [0341]. 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 prosthetic heart valve taught by Maimon with the actuator and locking assembly taught by Cartledge in order to control the expansion of the stent during delivery and placement.
Regarding claim 2, Cartledge teaches wherein the first portion of the actuator (Fig. 30, disconnector drive block 3030) is a distal support member (Fig. 30, disconnector drive block 3030 is distally placed from other drive blocks), and wherein the second portion of the actuator (Fig. 30, proximal drive block 3020) is an intermediate support member (Fig. 30, proximal drive block 3020 is intermediate of other drive blocks).
Regarding claim 3, Maimon teaches wherein a locking nut (Fig. 26A, actuator nut 706), and wherein the locking nut is adjustably coupled to the locking member by a threaded connection (Fig. 26A, actuator nut 706 couples to locking screw 716 via threads), but fails to teach a locking element.
Cartledge teaches a controllable stent comprising a locking element (Fig. 30, threaded portion of retainer screw lumen 3022). Cartledge discloses that the lumens and members within them allow for the expansion of the stent lattice to the desired diameter [0341]. 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 locking nut taught by Maimon with the locking element taught by Cartledge in order to control the expansion of the stent during delivery and placement.
Regarding claim 4, Maimon fails to teach the limitations of claim 4. Cartledge teaches a controllable stent wherein the actuator further comprises a third portion (Fig. 30, distal drive block 3010), and wherein the third portion is a proximal support member (Fig. 30, distal drive block 3010 is proximal to proximal drive block 3020). 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 prosthetic valve taught by Maimon with the third portion taught by Cartledge in order to control the expansion of the stent during delivery and placement.
Regarding claim 5, Maimon teaches wherein the prosthetic heart valve (Fig. 19B, delivery assembly 600’) comprises exactly one actuator (Fig. 19B, linear actuator assembly 608).
Regarding claims 6 and 7, Maimon teaches the limitations of claim 1, and teaches an embodiment wherein the actuator is one of a plurality of actuators (Fig. 19A, delivery assembly 600 comprises multiple actuator assemblies 608 (actuator assemblies 608 can be replaced by expansion and locking mechanisms 700 [0218])) and wherein the actuators are spaced apart circumferentially relative to each other (Fig. 19A, actuator assemblies 608 are spaced around frame 604). This prosthetic heart valve can have any number of expansion and locking mechanisms [0218], including exactly three.
Regarding claim 10, Maimon teaches wherein the frame (Fig. 18, frame 604, frame 604 can be constructed in a manner similar to frame 22 and consists of struts similar to struts 32 depicted in Fig. 2 [0197]) comprises an apex formed by a pair of struts (Fig. 18, struts of frame 604 form apexes where overlapped) that is disposed adjacent to the actuator (Fig. 18, apexes are adjacent to actuator assemblies 608), and wherein the pair of struts comprises a first segment that extends radially outwardly relative to a main body of the frame and relative to the actuator (Fig. 18, struts extend radially outward relative to frame 604 and relative to the actuator assemblies 608) such that there is a radial gap between the first segment and the actuator (Fig. 19A, there is separation between struts 32 and actuator assemblies 608).
Regarding claim 11, Maimon teaches wherein the pair of struts (Fig. 18, struts similar to struts 32 of Fig. 2) comprises a second segment extending axially from the first segment toward the outflow end of the frame (Fig. 18, struts 32 extends axially outward toward the outflow end of the frame 30) and extending radially inwardly from the first segment so as to radially overlap with an outflow end of the actuator (Fig. 18, struts 32 curve (i.e., extend radially inward) and overlap at outflow end 30).
Regarding claim 12, Maimon teaches a prosthetic heart valve (field) comprising: a mechanically expandable frame (Fig. 18, frame 604) comprising a plurality of interconnected struts (Fig. 18 struts similar to struts 32 of Fig. 2), wherein the frame is movable from a radially compressed state to a radially expanded state and movable from the radially expanded state to the radially compressed state (Fig. 18, frame 604 moves from expanded to compressed state and vice versa); a valve structure (Fig. 19A, valvular structure 606) disposed radially within the frame (Fig. 19A, valvular structure 606 is within frame 604) and comprising a plurality of leaflets (Fig. 19A, valvular structure 606 comprises leaflets similar to valvular structure 24 [0197]); and an actuator coupled to the frame (Fig. 26A, expansion and locking mechanism 700 is coupled to frame 604), but fails to teach further elements of the actuator.
Cartledge teaches a controllable stent wherein the actuator (Fig. 30, jack assembly 3000) comprises an actuation lumen (Fig. 30, needle assembly lumen which comprises proximal needle lumen 3016 and distal needle lumen 3018 [0340]), a locking member (Fig. 30, retainer screw 760), and a locking element (Fig. 30, threaded portion of retainer screw lumen 3022), wherein the actuator (Fig. 30, jack assembly 3000) comprises a first support member (Fig. 30, disconnector drive block 3030), a second support member (Fig. 30, proximal drive block 3020), and a third support member (Fig. 30, distal drive block 3010), wherein the actuation lumen extends through the first support member (Fig. 24, disconnector drive block 730 comprises lumen extending through (and further through drive blocks 720, 710)), through the second support member, and through the third support member (Fig. 30, needle assembly lumen comprising needle subassembly 3090 extends adjacent disconnector drive block 3030 and through proximal drive block 3020 (needle disconnect nut 3096) and distal drive block 3010), wherein the actuation lumen is configured for receiving an axially movable actuation shaft (Fig. 30, needle assembly lumen receives needle 3070) that can move the frame between the radially compressed state and the radially expanded state [0344-0347], and wherein the locking element is rotatably coupled to the locking member (Fig. 30, retainer screw 760 mates with threaded portion of retainer screw lumen 3022) and is configured to lock the frame at a desired radially compressed state or a desired radially expanded state (Figs. 32-33, retainer screw 760 keeps drive blocks 3020 and 3030 connected to one another during placement [0348]). Cartledge discloses that the lumens and members within them allow for the expansion of the stent lattice to the desired diameter [0341]. 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 prosthetic heart valve taught by Maimon with the actuator and locking assembly taught by Cartledge in order to control the expansion of the stent during delivery and placement.
Regarding claim 14, Maimon fails to teach the limitations of claim 14. Cartledge teaches a controllable stent wherein the locking member (Fig. 30, retainer screw 760) extends from the first support member through the second support member and into the third support member (Fig. 30, retainer screw lumen 3022 which comprises threaded portion extends through all drive blocks). Cartledge discloses that the lumens and members within them allow for the expansion of the stent lattice to the desired diameter [0341]. 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 prosthetic heart valve taught by Maimon with the locking assembly taught by Cartledge in order to control the expansion of the stent during delivery and placement.
Regarding claim 15, Maimon fails to teach the limitations of claim 12. Cartledge teaches a controllable stent comprising and actuator (Fig. 30, jack assembly 3000) wherein the locking member comprises external threads (Fig. 30, retainer screw 760) and wherein the locking element comprises internal threads (Fig. 30, threaded portion of retainer screw lumen 3022). Cartledge discloses that the lumens and members within them allow for the expansion of the stent lattice to the desired diameter [0341]. 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 prosthetic heart valve taught by Maimon with the locking assembly taught by Cartledge in order to control the expansion of the stent during delivery and placement.
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Maimon et al. (US 2018/0153689 A1), “Maimon” in view of Cartledge et al. (US 2014/0296962 A1), “Cartledge”, and further in view of Cartledge et al. (US 2018/0104077 A1), “Cartledge A1”.
Regarding claims 8 and 9, Maimon in view of Cartledge does not disclose an actuator that comprises a window, or open slot, disposed between the first lumen and the second lumen, and wherein the window, or open slot, is configured to receive a commissure of the leaflets of the valve structure.
Cartledge A1 teaches a prosthetic heart valve (Fig. 73, replacement heart valve 7100), wherein the actuator (Fig. 73, jack assembly 3000) comprises a window (i.e., open slot, the only difference in claim 9) (Fig. 82, opening created by commissure plates 7150) disposed between the first lumen (Fig. 30, drive screw lumen 3014) and the second lumen (Fig. 82, commissure plates 7150), and wherein the window is configured to receive (Fig. 73, valve leaflets 7140 are held within the lumen of commissure plates 7150 which is between drive screw lumen 3014 and the commissure plates) a commissure of the leaflets (Fig. 73, valve leaflets 7140) of the valve structure. Cartledge A1 discloses that by using commissure plates, the valve leaflets are securely retained within the valve frame while at the same time avoids forming pointed edges that would cause wear and tear to the leaflets over the duration of the prosthesis’s lifetime [0325]. Therefore, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the device of Maimon in view of Cartledge to include this method of securement for the leaflets on the actuator as taught by Cartledge A1 to better secure the valve leaflets and avoid their wear to prolong the life of the implant and avoid the need for the prosthetic to be replaced.
Claim 16 and 19-20 is rejected under 35 U.S.C. 103 as being unpatentable over Maimon et al. (US 2018/0153689 A1), “Maimon” in view of Vesely (US 2011/0167603 A1), “Vesely”.
Regarding claim 16, Maimon teaches a prosthetic heart valve (field) comprising: a frame (Fig. 26A, frame 604) comprising a plurality of interconnected struts (Fig. 26A, struts similar to struts 32 of Fig. 2), wherein the frame is radially expandable and radially compressible (Fig. 26A, frame 604 is radially compressible and expandable) and has a first end portion (Fig. 2, inflow end portion 26) and a second end portion (Fig. 2, outflow end portion 30); a valve structure (Fig. 19A, valvular structure 606) disposed radially within the frame and comprising a plurality of leaflets (Fig. 19A, valvular structure 606); and an actuator (Fig.26A, expansion and locking mechanism 700) coupled to the frame and configured to control radial expansion and radial compression of the frame (Fig. 26A, expansion and locking mechanism 700 is connected to frame 604 and controls expansion and compression of the frame) and to selectively secure the frame at a desired radial configuration (Fig. 26A, expansion and locking mechanism 700 secures frame a desired radial configuration), wherein the actuator comprises an actuation plate (Fig. 26A, locking screw 716) and a locker housing (Fig. 26A, distal nut 704), wherein the actuation plate is coupled to the first end portion of the frame (Fig. 26A, locking screw 716 is coupled to inflow end of frame [0223]), wherein the locker housing is coupled to the second end portion of the frame (Fig. 26A, distal nut 704 is coupled to outflow end of frame [0220]), wherein the actuation plate extends from the first end portion of the frame and into the locker housing (Fig. 26A, locking screw 716 extends from inflow end of frame through distal nut 704), but fails to teach wherein the actuation plate comprises one or more tabs, wherein the locker housing comprises one or more slots, and their configuration when engaged and disengaged.
Vesely teaches a valve assembly having one or more tabs (Fig. 3, tabs 44), wherein the locker housing (Fig. 3, valve member 10) comprises on or more slots (Fig. 1, lower slots 34), wherein the one or more tabs (Fig. 3, tabs 44) are configured to selectively engage the one or more slots of the locker housing (Fig. 2, tabs 44 engage with lower slot 34), wherein when the one or more tabs (Fig. 2, three tabs 44 on valve member 10) are engaged with the one or more slots of the locker housing (Fig. 2, three lower slots 34 on valve member 10 to pair with tabs 44), relative movement is restricted (Fig. 2, tabs 44 are secured within lower slots 34 when valve member 10 and base member 40 are engaged), thereby securing the frame a desired radial configuration (Fig. 2, engagement of tabs 44 and lower slots 34 solidifies a radius for base member 40 and valve member 10), and wherein when the one or more tabs (Fig. 3, tabs 44) are disengaged from the one or more slots of the locker housing (Fig. 2, tabs 44 disengage from lower slots 34 [0056]), the actuation plate can move axially relative to the locker housing, thereby allowing radial expansion and radial compression of the frame (Fig. 2, frame 12 comprising lower slots 34 is elastic an dilated by outward deflection to disengage tabs 44 (i.e., frame is formed of a flexible material that changes radially when engaged and disengaged)).
Vesley discloses that the valve member is detachably coupled to the base member [0007] and further, that valve member is exchangeable [0004]. 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 teachings of Maimon with those of Vesley in order to provide securing elements on the prosthetic that can also be adjusted or replaced.
Regarding claim 19, Maimon teaches wherein the locker housing (Fig. 26B, support tube 712) has a circular cross-sectional profile taken in a plane perpendicular to a longitudinal axis of the locker housing (Fig. 26B, support tube 712 is a cylindrical shape and therefore has a circular cross-section when cut perpendicular to its length).
Regarding claim 20, Maimon teaches wherein the locker housing (Fig. 26B, support tube 712) has a U-shaped cross-sectional profile taken in a plane perpendicular to a longitudinal axis of the locker housing (Fig. 26B, support tube 712 is a cylindrical shape and therefore encompasses a U-shaped cross-section when cut perpendicular to its length).
Claims 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Maimon et al. (US 2018/0153689 A1), “Maimon”, in view of Vesely (US 2011/0167603 A1), “Vesely”, and further in view of Cohen et al. (CA 3060654 A1), “Cohen”.
Regarding claim 17, Maimon in view of Vesely fails to teach the limitations of claim 17, however Cohen teaches an actuation plate (Fig. 16D, outer member 418) that comprises jaws (Fig. 16D, locking member 472) that are movable between an open state and a closed state (Fig. 16D, position 480 and dashed line position labeled with latch portion 478), wherein the one or more tabs (Fig. 16D, latch portion 478) are disposed on the jaws (Fig. 16D, locking member 472), wherein in the open state (Fig. 16D, position 480), the one or more tabs disposed on the jaws are configured to engage the one or more slots of the locker housing (Fig. 16D, in position 480 locking member 472 is engaged with recesses 470), and wherein in the closed state (Fig. 16D, dashed line position labeled with latch portion 478), the one or more tabs (Fig. 16D, latch portion 478) disposed on the jaws (Fig. 16D, locking member 472) are configured to disengage the one or more slots of the locker housing (Fig. 16D, in dashed line position locking member 472 disengages from recesses 470).
Cohen teaches that when locking member is engaged with recesses the device is secured against axial movement thereby resisting radial contraction of the frame [00125]. 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 teachings of Maimon in view of Vesely with those of Cohen in order to adjust and secure the radial size of the frame of the prosthesis for best positioning and placement.
Regarding claim 18, fails to teach the limitations of claim 18, however Cohen teaches wherein the jaws (Fig. 16D, locking member 472) of the actuation plate (Fig. 16D, outer member 418) are biased to an open state (Fig. 16D, locking member 472 is biased radially inward toward inner member 416 [00125]).
Cohen teaches that when locking member is engaged with recesses the device is secured against axial movement thereby resisting radial contraction of the frame [00125]. 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 teachings of Maimon in view of Vesely with those of Cohen in order to adjust and secure the radial size of the frame of the prosthesis for best positioning and placement.
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 GABRIELLA GISELLE B RIOS whose telephone number is (703)756-5958. The examiner can normally be reached M-Th 7:30-6:00 EST.
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/G.G.R./ Examiner, Art Unit 3774
/THOMAS C BARRETT/ SPE, Art Unit 3799