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 Amendment
The amendments filed on 02/04/2026 have been entered. Claims 1 and 3-16 remain pending in the application.
Response to Arguments
Applicant's arguments filed 02/04/2026 have been fully considered but they are not persuasive. Applicant argues on pages 5-6 that Reis fails to teach “blocking further withdrawal” as claimed. Applicant argues that blocking must be interpreted “to mean that movement in one direction is completely inhibited”, rather than resisted or made more difficult. It is the examiners position that this interpretation is overly narrow and inconsistent with the specification of the present invention. Applicants’ definition of blocking suggests that no further movement is permitted at any time. However, as set forth in the claims, further withdrawal of the pull tab is selectively permitted by a first release mechanism (claim 3). Therefore, it is believed that examiners interpretation of Reis is consistent with this disclosure. Upon certain conditions (i.e. insufficient force to overcome the frictional engagement), further withdrawal of the pull tab of Reis is completely inhibited. A blocked state does exist, as supported by the language of [0041] “the latch(es) 107 may then clip onto another slot 109a to again prevent proximal retraction” and “the sliding block 122 and the outer sheath 130 may be immobilized from proximal retraction by friction”. Therefore, applicants’ argument that Reis fails to teach “blocking of further withdrawal of the pull tab” is not found to be persuasive.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 3-12, and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Reis et al. (US 2018/0098869).
Regarding claim 1, Reis et al. discloses a system (100, FIG 1A-1E) for deploying an implant (“SG”, FIG 1B, [0040]), the system comprising: a handle (105), a catheter (117, [0040]) extending from the handle (FIG 1B), the catheter being arranged for holding an implant (SG) at an implant holding portion (135, [0040]) at a distal end of the catheter (FIG 1B), an implant retaining sheath (130, [0039-0042]), the implant retaining sheath being arranged so as to surround the implant holding portion so as to retain an implant that is arranged at the implant holding portion (FIG 1B, [0039-0040]), a pull tab (122 and at least 1 of 107, [0041]), the pull tab being connected to the implant retaining sheath (107 is connected to 130 at 122, [0041]) so that a proximal pull on the pull tab pulls back the implant retaining sheath so as to release an implant arranged at the implant holding portion ([0041-0042]), the pull tab further comprising an engagement feature (124) that is arranged on the pull tab (On 122 of the pull tab, [0041]) and that is moved proximally as the pull tab is moved proximally (0041]), the engagement feature being arranged to engage with a first interference feature (One of slots 109a towards the proximal end of track 109) arranged at a first fixed longitudinal position on the system for deploying the implant (Slots 109a are formed in the track 109 which remains at a fixed longitudinal position which 122 is retracted proximally therethrough, [0041]), wherein an engagement between the engagement feature and the first interference feature provides tactile feedback to a user of the system that the implant retaining sheath has been pulled back a pre-set distance (The user can feel the engagement of 124 within 109a because it requires greater pulling force to overcome the engagement and continue proximal retraction. Because the slots 109a are located at predefined intervals, this tactile feedback can be used to determine an amount of retraction of sheath 130), wherein the tactile feedback is blocking further withdrawal of the pull tab ([0041], the engagement of 124 within 109a prevents further withdrawal until a threshold tension is achieved. The user feels said resistance/blocking. [0041] further states that the engagement of 124 within 109a “prevent proximal retraction” which is interpreted as meeting the limitations of “blocking”. Further, the retractable latch(es) 124 may be biased outwardly to touchingly contact and frictionally interface with the sliding track 109, and the sliding block 122 and the outer sheath 130 may be immobilized from proximal retraction by friction), the system further comprising a pull tab withdrawal mechanism (110/112) the pull tab withdrawal mechanism being arranged pull the pull tab proximally so as to release an implant arranged at the implant holding portion ([0041]), the pull tab withdrawal mechanism comprising a thumbwheel (110, FIGs 1C) coupled to a spindle (Spool 112, FIG 1B and 1E), the spindle being arranged for winding up the pull tab so as to exert a proximal pull on the pull tab ([0041]).
PNG
media_image1.png
397
781
media_image1.png
Greyscale
Regarding claim 3, Reis et al. discloses a first release mechanism for selectively releasing the blocking of further withdrawal of the pull tab ([0041] discloses the handle may be provided with a further button to unlatch or otherwise disengage the latch(es). Although this function is described as allowing distal advancement of 122, it would also free the latches such that proximal retraction could occur too).
Regarding claim 4, Reis et al. discloses the engagement features comprises a protrusion (124 is an outwardly biased latch, which is interpreted as a protrusion) that is fixedly provided on the pull tab (via mechanical connection and constraint to 122) and wherein the first interference feature comprises an opening provided inside the handle (109a is a slot inside of the handle), with the opening being sized so that the protrusion engages with the opening to provide tactile feedback to the user ([0041] 124 becoming locked within 109a provides the tactile feedback).
Regarding claim 5, Reis et al. discloses a second interference feature (The slots 109a which receives pin 124 in the configuration shown in FIG 1B) that is arranged at a second fixed longitudinal position on the system for deploying the implant (FIG 1B shows the different locations of slots 109a), the engagement feature being arranged to engage with the second interference features (as described previously, [0041]) so as to provide tactile feedback to the user (The user can feel the engagement of 124 within 109a because it requires greater pulling force to overcome the engagement and continue proximal retraction).
Regarding claim 6, Reis et al. discloses a second release mechanism for selectively releasing the blocking of withdrawal of the pull tab by the engagement between the second interference feature and the engagement feature ([0041] discloses the handle may be provided with a further button to unlatch or otherwise disengage the latch(es). Although this function is described as allowing distal advancement of 122, it would also free the latches such that proximal retraction could occur too. Because claim 6 does not depend from claim 3, the same element is interpreted as both the first and second release mechanism).
Regarding claim 7, Reis et al. discloses the engagement between the second interference feature and the engagement feature corresponding to the implant retaining sheath fully covering the implant holding portion (In the state of FIG 1B, 124 is engage within a slot 109a. At the same time, 132a, the distal end of the implant retaining sheath, is fully cover implant holding portion 135).
Regarding claim 8, Reis et al. discloses the system further comprising an implant (“SG”, FIG 1B), optionally a stent graft implant ([0040]), arranged at the implant holding portion (FIG 1B, [0040, 0042])
Regarding claim 9, Reis et al. discloses the implant being a self-expanding implant ([0037, 0059]).
Regarding claim 10, Reis et al. discloses engagement between the engagement feature and the first interference feature corresponds to a partial deployment of the implant (At least some amount of proximal retraction of 130/122 is required in order for 124 to engage the first slot 109a, therefore corresponding to a partial deployment of the implant).
Regarding claim 11, Reis et al. discloses the first release mechanism is operable by a user operable button ([0041] describes the handle 105 may be provided with a further button to unlatch or otherwise disengage the latch(es)).
Regarding claim 12, Reis et al. discloses the tactile feedback is a blocking of withdrawal of the pull tab ([0041], the engagement of 124 within 109a blocks withdrawal of the pull tab).
Regarding claim 14, Reis et al. discloses the second release mechanism is operable by a user operable slider (A button on the handle is interpreted as a user operable slider. The button slides in a direction along the axis of which it is depressed or released).
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.
Claim(s) 15 is rejected under 35 U.S.C. 103 as being unpatentable over Reis et al. (US 2018/0098869) in view of Cully et al. (US 2019/0125517).
Regarding claim 15, Reis et al. discloses the claimed invention substantially as claimed, as set forth above for clam 8.
Reis is silent regarding the stent graft implant being a TIPS stent graft.
However, Cully teaches in the same filed of endeavor a stent graft implant (10, FIG 1) which is deployable to a form a transjugular intrahepatic portosystemic shunt ([0002, 0007, and 0029]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to select a stent graft configured to form a TIPS stent graft, as taught by Cully ([0029] discloses preferable sizing for a stent graft used for this particular procedure), for the purpose of configuring the device for treatment at a particular site, i.e. between the portal vein and the vena cava.
Claim(s) 16 is rejected under 35 U.S.C. 103 as being unpatentable over Reis et al. (US 2018/0098869) in view of Wuebbeling et al. (US 2010/0174290).
Regarding claim 16, Reis et al. discloses the claimed invention substantially as claimed, as set forth above for clam 1.
Reis is silent regarding the handle further comprising a flexible distal tip.
However, Wuebbeling teaches in the same filed of endeavor a handle (1, FIG 2) for retracting a sheath to deploy a stent ([0004, 0037, 0063]) wherein the handle comprises a flexible distal tip (18, FIG 1-2, [0068] discloses the tip “relieves localised compression and bending forces at the catheter proximal end where it is connected to the housing 10”, which is understood to mean that the tip is flexible to provide strain relief).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the handle of Reis to comprise a flexible distal tip, as taught by Wuebbeling, for the purpose of providing a structure at the distal end of the handle where the handle connects to the catheter sheath such that the user can apply controlled forces to the surgical catheter, and relieves localised compression and bending forces at the catheter shaft proximal end where it is connected to the housing of the handle.
Allowable Subject Matter
Claim 13 is 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 BROOKE N LABRANCHE whose telephone number is (571)272-9775. The examiner can normally be reached M-F 8-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 5712727134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BROOKE LABRANCHE/Primary Examiner, Art Unit 3771