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 28 October 2025 have been entered. Claims 16-33 are pending.
Response to Arguments
Applicant’s arguments with respect to claims 16 and 22 have been considered but are moot because the new ground of rejection does not rely on any reference 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 16-35 are rejected under 35 U.S.C. 103 as being unpatentable over Gross et al. (US 2018/263777 A1), “Gross” in view of Lashinski et al. (US 2017/0135816 A1), “Lashinski” and further in view of Arai et al. (AU 2014237833 A1), “Arai”.
Regarding claim 16, Gross teaches an implant (Fig. 1, annuloplasty structure 100) comprising: a frame (Fig. 5A, ratchet body 202) having a proximal end (Fig. 5, dynamic end 220) and distal end (Fig. 5, fixed end 210); an anchor (Fig. 12, anchoring structure 1800); an anchor housing (Fig. 9, anchor mount 461) coupled to one of the proximal end or distal end of the frame (Fig. 5A, anchor mount 461 is coupled to fixed end 210); and an anchor sleeve (Fig. 11, channel 1200) disposed within a bore (Fig. 4, aperture 340) of the anchor housing (Fig. 9, anchor mount 461), the anchor sleeve (Fig. 11, channel 1200) having a lumen (Fig. 11, channel 1210) extending therethrough including at least one feature (Fig. 11, slits 1230, 1240) disposed on an internal wall of the lumen (Fig. 11, channel 1210) for translatably engaging the anchor (Fig. 12, anchoring structure 1800); wherein the anchor sleeve (Fig. 11, channel 1200): is axially translatable within the bore (Fig. 4, channel 1200 is free to rotate with respect to aperture 340 [0577]) of the anchor housing (Fig. 9, anchor mount 461) to adjust the distal extent of the anchor from the anchor housing (anchoring structure 1800 extends through channel 350 (and furthermore channel 1200) of anchor mount 461 to engage tissue [0630]); and is configured to limit translation of the anchor through the anchor housing (Fig. 5A and 5C, channel 1200 has features that limit distal motion beyond a certain depth [0620]), but fails to teach axial translation of the anchor with respect to the anchor sleeve such that a distal tip of the anchor extends distally from the anchor housing by an adjustable extent, and the anchor housing having an internal thread, and the anchor sleeve includes an external thread that is threadably engaged with the internal thread of the anchor housing.
Lashinski teaches a heart valve replacement implant including axial translation of the anchor (Fig. 3, anchor 20) with respect to the anchor sleeve (Fig. 3, abutment 24 is cylindrical (i.e., sleeve, tube shape) [0083]) such that a distal tip of the anchor extends distally from the anchor housing (Fig. 3, lower crowns 16) by an adjustable extent (Fig. 3, anchors 20 are rotationally advanced through lower crows 16 while abutments control extent of axial travel of anchors 20 [0087]). Lashinski discloses that the implant’s anchored state may be less than equal to, or greater than the tissue engaging state heights and diameters [0087]. 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 anchors taught by Gross with the adjustability taught by Lashinski in order to create a more adaptable implant. However, Gross in view of Lashinski fails to teach the anchor housing having an internal thread, and the anchor sleeve includes an external thread that is threadably engaged with the internal thread of the anchor housing.
Arai teaches an anchor assembly wherein the anchor housing having an internal thread (Fig. 7, elongated center housing 721 comprises a threaded drive hub receiving cavity 722 [0051]), and the anchor sleeve includes an external thread (Fig. 3, elongated outer drive hub 723 comprises threading) that is threadably engaged with the internal thread of the anchor housing (Fig. 7, elongated outer drive hub 723 is counter threaded with threaded drive hub receiving cavity 722 [0051]). Arai discloses that the threading allows the descendible anchor driver sufficient additional longitudinal travel to compensate for any additional clearance necessary during implantation [0051]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to modify the shape of the anchor housings and sleeve taught by Gross to reflect the threading taught by Arai in order to provide sufficient longitudinal reach of the device during the implantation process.
Regarding claim 17, Gross teaches wherein the anchor sleeve (Fig. 11, channel 1200) comprises a collar (Fig. 11, ring 1220) disposed on a proximal end of the anchor sleeve (Fig. 11, top-most portion of figure) to limit the translation of the anchor sleeve within the bore (Fig. 4, aperture 340) or the translation of the anchor within the anchor sleeve, or both (Fig.5A and 5C, channel 1200 comprises ring 1220 to limit distal motion beyond a certain depth [0620])
Regarding claim 18, Gross fails to teach the limitations of claim 18. Lashinski teaches a collar (Figs. 7A-D, collar 70) with a proximal surface (Fig. 7A, left side of collar 70) with at least one driver engagement feature disposed on the proximal surface (Fig. 7A, locking tab 74 extends to proximal surface of collar 70).
Lashinski discloses that the collar and tab can provide a security feature that keeps the collar engaged with the frame and anchors during implantation, and the tab is made of flexible material that allows for a smoother translation of the collar over the frame [0095]. Therefore, it would have been obvious to one of ordinary skill in the art to incorporate a collar with an engagement feature on its proximal surface to Gross’s implant in order to better secure the anchor and anchor housing to the frame of the device. With better security of the anchors and housing to the frame, it will be unlikely for the annuloplasty implant to fail or be positioned incorrectly in the heart, and therefore would lead to the implant functioning at its best.
Regarding claim 19, Gross teaches wherein the anchor (Fig. 12, anchoring structure 1800) further includes an anchor head (Fig. 12, head portion 1830) disposed at a proximal end, the head comprising a drive coupler (Fig. 12, raised surfaces 1832)
Regarding claim 20, Gross teaches wherein the anchor head (Fig. 12, head portion 1830) comprises a distal surface having a sleeve engagement feature disposed thereon (Fig. 19A, catheter 410) the sleeve engagement feature configured to cooperate with a driver engagement feature of a drive tube (Fig. 19A, steerable catheter 421) to translate the anchor sleeve (Fig. 11, channel 1200) within the bore (Fig. 4, aperture 340) of the anchor housing (Fig. 9, anchor mount 461).
Regarding claim 21, Gross teaches wherein the anchor housing (Fig. 21, multiple anchor mounts 461) is one of a plurality of anchor housings, the anchor sleeve (Fig. 11, multiple channels 1200 for each anchoring structure 1800) is one of a plurality of anchor sleeves, the anchor (Fig. 12, multiple anchoring structures 1800) is one of a plurality of anchors wherein the plurality of anchor housings are disposed about the frame (Fig. 21, anchor mounts 461 are placed around structure 100) and each anchor housing engages one of the plurality of anchor sleeves which supports one of the plurality of anchors (Fig. 21, anchor mounts 461 are connected to channels 1200 about structure 100) wherein each of the plurality of anchors are coupled to one drive tube (Fig. 11, tubes 2810) of a plurality of drive tubes for independent translation of the coupled anchor and an associated anchor sleeve (Fig. 22, tubes 2810 allow for individual implantation of anchoring structures 1800 [0758-0759])
Regarding claim 22, Gross teaches a system for annuloplasty (abstract) comprising: a delivery catheter (Fig. 11, multitube portion 2808) having a proximal handle (Fig. 21, handle 2802), a distal end (Fig. 11, distal portions of tubes 2810) and a plurality of drive tubes (Fig. 11, tubes 2810) extending therethrough; an implant (Fig. 1, annuloplasty structure 100), coupled to the plurality of drive tubes (Fig. 11, tubes 2810) of the delivery catheter (Fig. 11, multitube portion 2808), the implant (Fig. 1, annuloplasty structure 100) comprising: a frame (Fig. 5A, ratchet body 202) having a proximal end (Fig. 5, dynamic end 220) and a distal end (Fig. 5, fixed end 210); and a plurality of anchors (Fig. 12, anchoring structure 1800), each anchor coupled to a drive tube (Fig. 21, anchor mounts 461 (anchoring structure 1800 within) connect to tubes 2810) of the plurality of drive tubes for independent translation of the anchor (Fig. 21, anchoring structure 1800 is coupled to plurality of tubes 2810 to deliver annuloplasty structure 100 [0756]); and a plurality of anchor housings (Fig. 9, anchor mount 461) coupled to one of the proximal end (Fig. 5, dynamic end 220) or distal end (Fig. 5, fixed end 210) of the frame (Fig. 5A, ratchet body 202), each anchor housing (Fig. 9, anchor mount 461) including an anchor sleeve (Fig. 11, channel 1200) disposed within a bore (Fig. 4, aperture 340) of the anchor housing (Fig. 9, anchor mount 461), the anchor sleeve (Fig. 11, channel 1200) having a lumen (Fig. 11, channel 1210) extending therethrough including at least one feature (Fig. 11, slits 1230, 1420) disposed on an internal wall of the lumen for translatably engaging at least one anchor (Fig. 12, anchoring structure 1800); wherein at least one anchor sleeve (Fig. 11, channel 1200): is axially translatable within the bore (Fig. 4, channel 1200 is free to rotate with respect to aperture 340 [0577]) of at least one anchor housing (Fig. 9, anchor mount 461) to adjust the distal extent of the at least one anchor (Fig. 12, anchoring structure 1800) extending through the lumen (Fig. 11, channel 1210) of the at least one anchor sleeve (Fig. 11, channel 1200) and distally from the at least one anchor housing (anchoring structure 1800 is advanced through channel 1210 wherein the channel 1210 controls distal motion [0632]); and is configured to limit translation of at least one anchor through the at least one anchor housing (Fig. 5A and 5C, channel 1200 comprises ring 1220 to limit distal motion beyond a certain depth [0620]), but fails to teach axial translation of the at least one anchor with respect to the anchor sleeve such that a distal tip of the at least one anchor extends distally from the anchor housing by an adjustable distal extent.
Lashinski teaches a heart valve replacement implant including axial translation of the anchor (Fig. 3, anchor 20) with respect to the anchor sleeve (Fig. 3, abutment 24 is cylindrical (i.e., sleeve, tube shape) [0083]) such that a distal tip of the anchor extends distally from the anchor housing (Fig. 3, lower crowns 16) by an adjustable extent (Fig. 3, anchors 20 are rotationally advanced through lower crows 16 while abutments control extent of axial travel of anchors 20 [0087]). Lashinski discloses that the implant’s anchored state may be less than equal to, or greater than the tissue engaging state heights and diameters [0087]. 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 anchors taught by Gross with the adjustability taught by Lashinski in order to create a more adaptable implant. However, Gross in view of Lashinski fails to teach the anchor housing having an internal thread, and the anchor sleeve includes an external thread that is threadably engaged with the internal thread of the anchor housing.
Arai teaches an anchor assembly wherein the anchor housing having an internal thread (Fig. 7, elongated center housing 721 comprises a threaded drive hub receiving cavity 722 [0051]), and the anchor sleeve includes an external thread (Fig. 3, elongated outer drive hub 723 comprises threading) that is threadably engaged with the internal thread of the anchor housing (Fig. 7, elongated outer drive hub 723 is counter threaded with threaded drive hub receiving cavity 722 [0051]). Arai discloses that the threading allows the descendible anchor driver sufficient additional longitudinal travel to compensate for any additional clearance necessary during implantation [0051]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to modify the shape of the anchor housings and sleeve taught by Gross to reflect the threading taught by Arai in order to provide sufficient longitudinal reach of the device during the implantation process.
Regarding claim 23, Gross teaches wherein the anchor sleeve (Fig. 11, channel 1200) comprises a collar (Fig. 11, ring 1220) disposed on a proximal end of the anchor sleeve (Fig. 11, top-most portion of figure) to limit one or both of the translation of the anchor sleeve within the bore (Fig. 4, aperture 340) and the translation of the anchor within the anchor sleeve (Fig. 5A and 5C, channel 1200 comprises ring 1220 to limit distal motion beyond a certain depth [0620]).
Regarding claim 24, Gross fails to teach the limitations of claim 24. Lashinski teaches a collar (Figs. 7A-D, collar 70) with a proximal surface (Fig. 7A, left side of collar 70) with at least one driver engagement feature disposed on the proximal surface (Fig. 7A, locking tab 74 extends to proximal surface of collar 70).
Lashinski discloses that the collar and tab can provide a security feature that keeps the collar engaged with the frame and anchors during implantation, and the tab is made of flexible material that allows for a smoother translation of the collar over the frame [0095]. Therefore, it would have been obvious to one of ordinary skill in the art to incorporate a collar with an engagement feature on its proximal surface to Gross’s implant in order to better secure the anchor and anchor housing to the frame of the device. With better security of the anchors and housing to the frame, it will be unlikely for the annuloplasty implant to fail or be positioned incorrectly in the heart, and therefore would lead to the implant functioning at its best.
Regarding claim 25, Gross teaches wherein each anchor (Fig. 12, anchoring structure 1800) further includes an anchor head (Fig. 12, head portion 1830) disposed at a proximal end (Fig. 11, proximal end 1250), the anchor head comprising a drive coupler (Fig. 12, raised surfaces 1832).
Regarding claim 26, Gross teaches wherein at least one drive tube (Fig. 21, tubes 2810) comprises a distal driver (Fig. 22, wire coupling element 2830) configured to releasably couple to the anchor head (Fig. 12, head portion 1830) to drive the anchor through the lumen of the anchor sleeve (Fig. 22, wire coupling element 2830 connects tubes 2810 to head portion 1830 through lumen).
Regarding claim 27, Gross teaches wherein the distal driver (Fig. 22, wire coupling element 2830) includes a sleeve engagement feature (Fig. 21, distal end 2840 of tube 2810) extending radially from its distal end (Fig. 21, distal end 2840 extends radially outward from tube 2810) the sleeve engagement feature (Fig. 21, distal end 2840 of tube 2810) configured to cooperate with the driver engagement feature (Fig. 21, distal end 2840 works in tandem with wire coupling element 2830 to secure anchors) on the proximal surface of the collar (Fig. 11, ring 1220) to translate the anchor sleeve (Fig. 11, channel 1200) within the bore (Fig. 4, aperture 340) of the anchor housing (Fig. 9, anchor mount 461)
Regarding claim 28, Gross teaches wherein the anchor head (Figs. 5A and 12, head portion 1830) comprises a distal anchor head diameter that is larger in size than a lumen diameter (Fig. 12, head portion 1830 has a diameter that is larger than lumen 501 diameter [0628]) of the lumen of the anchor sleeve (Fig. 11, channel 1210) to preclude distal translation of the anchor head into the lumen of the anchor sleeve (Figs. 5A and 12, diameter difference inhibits continued distal motion [0628])
Regarding claim 29, Gross teaches wherein the collar (Fig. 11, ring 1220) extends radially from the lumen of the anchor sleeve (Fig. 11, channel 1210) and a collar diameter (Fig. 11, width of ring 1220) of the collar is larger than a bore diameter (Fig. 4, width of aperture 340) of the bore (Fig. 4, aperture 340) of the anchor housing (Fig. 9, anchor mount 461) to preclude distal translation of the collar into the bore (Fig. 11, ring 1220 impedes continued distal motion of channel 1200 beyond a certain depth (i.e., aperture 340) [0620])
Regarding claim 30, Gross teaches wherein the anchor sleeve (Fig. 11, channel 1210) comprises at least one external engagement feature (Fig. 11, channel 1210 comprises head portion 380 that interacts with anchor mount 341) disposed on an external surface of the anchor sleeve, the bore (Fig. 4, aperture 340) comprises at least one internal engagement feature (Fig. 4, anchor mount 341 within aperture 340) disposed on a wall of the bore and the at least one external engagement feature of the anchor sleeve (Fig. 11, channel 1210 comprises head portion 380 that interacts with anchor mount 341) cooperates with the at least one internal engagement feature of the bore (Fig. 4, anchor mount 341 within aperture 340) to translate the anchor sleeve (Fig. 11, channel 1210) within the bore (Fig. 4, aperture 340) of the anchor housing (Fig. 9, anchor mount 461)
Regarding claim 31, Gross teaches wherein the at least one feature disposed on an internal wall of the lumen of the anchor sleeve (Fig. 11, channel 1210 creates a lumen with slits 1230 and 1240) is configured to cooperate with at least one edge of an anchor (Fig. 12, anchoring structure 1800) to translate the anchor within the anchor sleeve (Figs. 11 and 12, anchoring structure 1800 goes within channel 1210 and abuts proximal end 1250 [0632])
Regarding claim 32, Gross teaches the system of claim 30 with a frame (Fig. 5A, ratchet body 202) and wherein at least one anchor housing (Fig. 9, anchor mount 461) and an actuator (Fig. 1, contracting wire (not shown) within the lumen structure 100 [0546]) to compress the frame (Fig. 1, pulling contracting wire (not shown) reduces perimeter of structure 100 [0546]), but fails to teach that the frame is expandable and comprises at least two struts joined at distal ends to form a distal apex, at least two struts joined at proximal ends to form a proximal apex, and wherein at least one anchor housing is disposed about the distal apex of the frame and an actuator is translatably disposed about the proximal apex of the frame.
Lashinski teaches an expandable frame (Fig. 1, implant 1 (i.e., frame 10) is capable of expanding out [0012]) with at least two struts (Fig. 1, struts 12) joined at distal ends which form a distal apex (Fig. 1, crown 16), and at least two struts joined at proximal ends to form a proximal apex (Fig. 1, crown 14), and wherein at least one anchor housing (Fig. 1, abutment 24) is disposed about the distal apex of the frame (Fig. 1, abutments 24 are placed on lower portion 4 apexes of frame 10) and an actuator (Fig. 4, collar 18) is translatably disposed about the proximal apex of the frame (Fig. 4, collar 18 is placed on crown 14 and slides up and down to lock frame 10 in a particular position).
Lashinski discloses that an expandable frame having struts and apexes at both proximal and distal ends allows for the implant to change shape at various phases of use, e.g., pre-delivery, during delivery, after engagement with tissue, after contracting the annulus, post-contraction, during the lifetime of use while implanted, and more [0067]. Lashinski further teaches that anchor housings on the distal apexes limit the axial advance of the anchors into patient tissue, and that having an actuator on the proximal apexes of the frame assists in the adjustment of the implant during the delivery process [0083].
Therefore, it would have been obvious to one of ordinary skill in the art to modify Gross’s implant frame to be expandable with frame apexes at both proximal and distal ends, and have an actuator on the proximal apex, in order to allow for easier adjustment of the implant before, during, and after delivery so that the implantation process is more efficient and the implant functions longer in the patient. The inclusion of anchor housings on the distal apexes would also be obvious to one of ordinary skill in the art because they allow for a more accurate implantation of the anchors into the cardiac tissue, causing less unnecessary damage to the tissue and less need for replacement of the implant.
Regarding claim 33, Gross teaches wherein each drive tube (Fig. 21, tubes 2810) of the plurality of drive tubes is independently controlled to customize translation of the anchor (Fig. 22, tubes 2810 allow for individual implantation of anchoring structures 1800 [0758-0759]), translation of the anchor sleeve (Fig. 11, channel 1210), or both.
Regarding claim 34, Gross teaches a method of annuloplasty (abstract) comprising: transluminally advancing a delivery catheter (Fig. 21, sheath (not shown) surrounds tubes 2810 and is sealed at ring 2820 [0756]) to a valve treatment site (Fig. 18A, annulus 40), the delivery catheter comprising a proximal handle (Fig. 21, handle 2802), a distal end (Fig. 21, distal end 2840) and a plurality of drive tubes (Fig. 11, tubes 2810) extending from the proximal handle to the distal end of the delivery catheter (Fig. 21, tubes 2810 extend from handle 2802 out of ring 2820); releasing an implant (Fig. 1, annuloplasty structure 100) from the distal end of the delivery catheter (Fig. 21, ring 2820 is the end of sheath (not shown) surrounding tubes 2810), the implant comprising: a frame (Fig. 5A, ratchet body 202) having a proximal end (Fig. 5, dynamic end 220) and a distal end (Fig. 5, fixed end 210); a plurality of anchor housings (Fig. 21, anchor mount 461) coupled to one of the proximal end (Fig. 5, dynamic end 220) or distal end (Fig. 5, fixed end 210) of the frame (Fig. 5A, ratchet body 202), each anchor housing (Fig. 9, anchor mount 461) including an anchor sleeve (Fig. 11, channel 1200) disposed within a bore (Fig. 4, aperture 340) of the anchor housing (Fig. 9, anchor mount 461), each anchor sleeve including a proximal collar (Fig. 11, ring 1220) having a drive tube engagement feature (Fig. 21, distal end 2840 works in tandem with wire coupling element 2830 to secure anchors); and a plurality of anchors (Fig. 12, anchoring structure 1800), each anchor comprising a proximal anchor head (Figs. 5A and 12, head portion 1830) coupled to a drive tube and a distal tip (Fig. 21, distal end 2840), each anchor disposed within one of the anchor sleeves (Fig. 11, channel 1210) of the plurality of anchor housings, wherein each anchor sleeve (Fig. 11, channel 1210) is axially translatable within the bore (Fig. 4, channel 1200 is free to rotate with respect to aperture 340 [0577]) of one of the plurality of anchor housings (Fig. 9, anchor mount 461), wherein each anchor sleeve (Fig. 11, channel 1210) has a lumen extending therethrough (Fig. 11, channel 1210) including at least one feature (Fig. 11, slits 1230, 1420) disposed on an internal wall of the lumen (Fig. 11, channel 1210) for translatable engaging an anchor (Fig. 12, anchoring structure 1800), and wherein each anchor sleeve is configured to limit translation of the anchor therein through the one of the plurality of anchor housings (Fig. 5A and 5C, channel 1200 comprises ring 1220 to limit distal motion beyond a certain depth [0620]); advancing each anchor through each anchor sleeve (Fig. 11, channel 1210) until translation of the proximal anchor head (Figs. 5A and 12, head portion 1830) is precluded by the proximal collar of the anchor sleeve (Fig. 11, ring 1220) and the drive tube engagement feature engages a sleeve engagement feature of the drive tube (Fig. 21, distal end 2840 works in tandem with wire coupling element 2830 to secure anchors); and independently advancing each anchor sleeve (Fig. 11, channel 1210) through the anchor housing (Fig. 9, anchor mount 461) by action of the drive tube engagement feature (Fig. 21, wire coupling element 2830) on the sleeve engagement feature (Fig. 21, distal end 2840 of tube 2810) to advance the distal tip of the anchor (Fig. 12, distal end 1820) past the anchor housing into tissue to a customized extent (Fig. 12, distal end 1820 extends beyond anchor mount 461 to be corkscrewed into the tissue of the annulus) until translation of the anchor sleeve (Fig. 11, channel 1210) is precluded (Fig. 12, helical element 1802 implants into tissue until channel 1210 restricts it from implanting further), but fails to teach axial translation of the anchor of the plurality of anchors with respect to the anchor sleeve such that a distal tip of the anchor of the plurality of anchors extends distally from the anchor housing by an adjustable distal extent.
Lashinski teaches a heart valve replacement implant including axial translation of the anchor (Fig. 3, anchor 20) with respect to the anchor sleeve (Fig. 3, abutment 24 is cylindrical (i.e., sleeve, tube shape) [0083]) such that a distal tip of the anchor extends distally from the anchor housing (Fig. 3, lower crowns 16) by an adjustable extent (Fig. 3, anchors 20 are rotationally advanced through lower crows 16 while abutments control extent of axial travel of anchors 20 [0087]). Lashinski discloses that the implant’s anchored state may be less than equal to, or greater than the tissue engaging state heights and diameters [0087]. 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 anchors taught by Gross with the adjustability taught by Lashinski in order to create a more adaptable implant.
Regarding claim 35, Gross teaches releasing the drive tube (Fig. 11, tubes 2810) from the anchor sleeve (Fig. 11, channel 1210) while maintaining a coupling with the anchor (Fig. 12, anchoring structure 1800) when translation of the anchor sleeve is precluded (Fig. 12, anchoring structure 1800 is connected to channel 1210 when movement of channel 1210 is limited); and continuing to drive the anchor to pull tissue into the anchor (Fig. 12, anchoring structure 1800 draws tissue proximally when implanted [0623])
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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