DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
This Office action is in response to the applicant’s communication filed on 8/10/2026. Each argument and/or amendment directed towards a maintained rejection is addressed below. Rejections/objections not repeated herein have been withdrawn.
Applicant’s arguments, see page 6, with respect to Applicant’s claim amendments made in view of the previous claim objections have been fully considered and are persuasive. The previous claim objections have been withdrawn.
Applicant’s arguments, see pages 6-7, with respect to the deficiencies of Rabito and/or Dale in view of the present amendments to the respective independent claims have been fully considered and are persuasive. Therefore, the previous prior art rejections have been withdrawn. However, upon further consideration, new ground(s) of rejection are made under Rabito in view of Dale and further in view of Liu et al. (US 2012/0239142), as set forth below.
Claim Rejections - 35 USC § 103
Claim(s) 1-4, 6-9 and 11-20 are rejected under 35 U.S.C. 103 as being unpatentable over Rabito et al. (US 2015/0238315) in view of Dale et al. (WO 2015/073394) and Liu et al. (US 2012/0239142).
Rabito discloses (see Figs. 9-24) a prosthesis delivery system (100) comprising the following claim limitations:
(claims 1, 12 and 16) A system for replacing a deficient native heart valve (see Abstract; [0003]), comprising: an expandable implant (30, Figs. 15B, 20B and 24); and a delivery catheter, comprising: an elongate tubular shaft (114, Figs. 9-10) having an enlarged distal end portion (116, Figs. 9-10 and 14B) sized to radially constrain the expandable implant (30) in a compressed configuration (see Figs. 9-10; [0080]; implant retention expressly disclosed); an inner shaft (124, Figs. 11-13) including a distal end portion (128, Figs. 11-13) adapted for releasable attachment to a proximal end (31) of the expandable implant (30) (as shown in Figs. 11-19B; tether retention assembly 128 is expressly releasably attached to proximal end 31 of the implant 30); and a handle (110, Fig. 9) at a proximal end of the delivery catheter (as expressly shown in Fig. 9), wherein the handle (110) comprises a second rotational actuator (1024, Fig. 31) operably connected to the elongate tubular shaft (114), wherein rotational activation of the second rotational actuator (1024) causes retraction of the elongate tubular shaft (114) ([0134]; [0146]; [0149]; rotational actuation to retract sheath and deploy heart valve prosthesis expressly disclosed);
(claims 7, 15 and 18) wherein the expandable implant (30) is a replacement heart valve (as shown in Fig. 20B; [0003]; [0065]);
(claim 8) wherein the second rotation actuator (12024) comprises a knob (as shown in Figs. 9 and 36A; [0134]; retraction knob expressly disclosed);
(claims 9 and 20) further comprising an introducer sheath (112, Fig. 9); and
(claims 11 and 13) wherein the elongate tubular shaft (114) is slidably disposed over the steerable shaft to allow the elongate tubular shaft to move proximally and distally with respect to the steerable shaft ([0078]; the plurality of shafts of the system are expressly sized and shaped to be slidable relative to each other).
Rabito, as applied above, further teaches (see the embodiment of Fig. 32) the internal assembly further incorporating a steerable catheter (1034, Fig. 32) located within the tubular shaft (1022; Fig. 32) to bend the inner shaft (1032, Fig. 32) and tubular shaft (1020) in order to beneficially provide a component that steers, bends and maneuvers the system through the vasculature thereby eliminating the need for a guidewire component (see Figs. 32 and 38; [0112]; [0140]). Rabito further expressly teaches that its outer sheath may comprise a slotted hypotube ([0032]; [0036]).
Rabito therefore discloses and/or teaches a prosthesis delivery system comprising all the limitations of the claim except for the steerable shaft having a spine pattern including a distal bending section comprising a plurality of distal slots forming a first pair of longitudinal spines and a proximal bending section comprising plurality of proximal slots forming a second pair of longitudinal spines, the first pair of longitudinal spines being circumferentially offset (i.e. such as 90 degrees offset) from the second pair of longitudinal spines; two or more pull wires operably connected to the steerable shaft for application of a proximal force on the steerable shaft and for causing the distal section to bend before the proximal section during application of a proximal force on the one or more pull wires, the handle having a first rotational knob actuator operably connected to a proximal end of one or more pull wires to provide proximal force on the two or more pull wires, wherein the first rotational knob actuator is configured to bend the steerable shaft in multiple planes/directions. Rabito further fails to disclose the elongate tubular shaft comprising a slot pattern having one or more longitudinal slots and one or more circumferential slots, wherein individual longitudinal slots intersect with individual circumferential slots.
However, Dale teaches (see Figs. 1-5 and 10) a similar surgical introduction system (10, Fig. 1) comprising a steerable shaft (19, Fig. 3A) having a spine pattern including a distal bending section (42, Fig. 3A) comprising a plurality of distal slots forming a first pair of longitudinal spines (i.e. spines shown in region 42 of Fig. 3A) and a proximal bending section (44, Fig. 3A) comprising plurality of proximal slots forming a second pair of longitudinal spines (i.e. spines shown in region 44 of Fig. 3A), the first pair of longitudinal spines being circumferentially offset (i.e. such as 90 degrees offset) from the second pair of longitudinal spines (i.e. 90 degree offset between adjacent spine sections expressly shown in Fig. 3A); two or more pull wires (46a-46d, Fig. 3A) operably connected to the steerable shaft (19) for application of a proximal force on the steerable shaft and for causing the distal section to bend before the proximal section during application of a proximal force on the one or more pull wires (as shown in Figs. 1 and 3A; proximal force on pull wire 46d attached to the distal pull ring 66 will bend region 42 before region 44), the handle (18, Fig. 1) having a first rotational knob actuator (20,22,24; Fig. 1) configured to (i.e. capable of) apply a proximal force on the one or more pull wires (46a-46d), thereby bending the steerable shaft (19) (see Figs. 1 and 10; [0028]; [0043]), wherein the first rotational knob actuator (20,22,24) is configured to (i.e. capable of) bend the steerable shaft (19) in multiple planes/directions (as shown in Fig. 3A; [0031]; [0038]; at least regions 42,44 bend in different planes) in order to beneficially provide a steerable surgical system capable of selectively articulating in multiple planes within any particular anatomic structure as desired while further resisting ovaling of the shafts cross-sectional shape as well as resisting directional bias (see Abstract; [0007]; [0027]; [0031]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system of Rabito as set forth above in order to beneficially provide a steerable surgical system capable of selectively articulating in multiple planes within any particular anatomic structure as desired while further resisting ovaling of the shafts cross-sectional shape as well as resisting directional bias, as taught by Dale. Rabito in view of Dale fails to disclose or teach the elongate tubular shaft comprising a slot pattern having one or more longitudinal slots and one or more circumferential slots, wherein individual longitudinal slots intersect with individual circumferential slots.
However, Liu teaches (see Figs. 10 and 28A-28B) a similar heart valve delivery system comprising an elongate tubular shaft (104, Fig. 10) comprising a slot pattern having one or more longitudinal slots and one or more circumferential slots (as shown in annotated Fig. 28B below; [0104]), wherein individual longitudinal slots intersect with individual circumferential slots (as shown in annotated Fig. 28B below) in order to beneficially increase shaft flexibility thereby allowing the delivery apparatus to be highly steerable, especially when used in combination with an internal torque shaft ([0103]-[0105]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system of Rabito in view of Dale to have an elongate tubular shaft comprising a slot pattern having one or more longitudinal slots and one or more circumferential slots, wherein individual longitudinal slots intersect with individual circumferential slots in order to beneficially increase shaft flexibility thereby allowing the delivery apparatus to be highly steerable, especially when used in combination with an internal torque shaft, as taught by Liu.
PNG
media_image1.png
329
316
media_image1.png
Greyscale
Allowable Subject Matter
Claims 5 and 10 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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 Robert Lynch whose telephone number is (571)270-3952. The examiner can normally be reached on Monday-Friday (9:00AM-6:00PM, with alternate Fridays off).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Elizabeth Houston, at (571) 272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ROBERT A LYNCH/Primary Examiner, Art Unit 3771
