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 .
Status of Claims
This office action is responsive to the amendment filed on 07/17/2026. As directed by the amendment: claims 10, 11 and 16-20 are withdrawn. Thus, claims 1-9 and 12-15 are presently pending in this application.
Response to Arguments
Applicant's arguments with respect to claims 1-4, 9, and 12-15 rejected under 35 U.S.C. 103 as being unpatentable over Phan et al. (2012/0136426) “Phan” in view of Mas et al. (2009/0228040) “Mas” and claims 5-8 rejected under 35 U.S.C. 103 as being unpatentable over Phan et al. (2012/0136426) “Phan” in view of Mas et al. (2009/0228040) “Mas” further in view of Alt (2004/0186560) have been considered but are moot in view of the new ground(s) of rejection.
Rejection under 112 (a) of claim 8 has been withdrawn.
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.
Claims 1-4, 9, and 12-15 are rejected under 35 U.S.C. 103 as being unpatentable over Phan et al. (2012/0136426) “Phan” in view of Binmoeller et al. (2014/0236064) “Binmoeller” and further in view of Glines et al. (2007/0239182) “Glines”.
Regarding claims 1-2, 4 and 13-14, Phan discloses a delivery and deployment system 100 (Fig. 4) for creating a bypass across a proximal anatomical structure T2 and a distal anatomical structure T1 (Figs. 6A-6G; par. 0011) and to deploy an implantable medical device 121 at a movable target site (the system 100 is fully capable of performing this intended use), said delivery and deployment system 100 comprising: a delivery sheath 120 having a wall defining a lumen therethrough (lumen carrying stent 122; Fig. 6F); a tissue-penetrating end 114 (Fig. 5B and par. 0043) at a distal end of said delivery sheath (as shown in Fig. 5B); said tissue-penetrating end 114 has a distal end configured to penetrate through tissue T2/T1 (Fig. 6B); and an implantable medical device 122 deliverable within said delivery sheath 120 (Figs. 6E-6G and par. 0053), and expandable from a delivery configuration, dimensioned to fit within said delivery sheath (Figs. 6D-6G), to an expanded configuration larger than the delivery configuration (Figs. 6D-6G and par. 0053), and configured to extend across the proximal anatomical structure and the distal anatomical structure (Fig. 6G and par. 0053).
Phan is silent regarding the tissue- penetrating end being a cauterization end and/or configured to puncture or cut through anatomical tissue; a suction lumen extending and defined along said delivery sheath and said tissue-penetrating end and fluidly couplable to a suction source to apply suction along said tissue-penetrating end; wherein said suction lumen extending adjacent said distal end to a tissue-penetrating surface of the distal end of said tissue-penetrating end to draw tissue to said tissue-penetrating surface to facilitate penetration therethrough by said tissue-penetrating distal end and wherein said suction lumen is defined through the wall of said delivery sheath and through said tissue-penetrating end.
However, Binmoeller teaches a similar delivery and deployment system (abstract and Fig. 3B) comprising a delivery sheath 27 having a tissue- penetrating end 35 being a cauterization end and/or configured to puncture or cut through anatomical tissue (par. 0112 discloses cutting element 35 configured cauterize tissue). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the delivery sheath in Phan to include a tissue- penetrating end being a cauterization end and/or configured to puncture or cut through anatomical tissue, as taught and suggested by Binmoeller, for providing an electrically controlled cutting mechanism minimizing or preventing leakage from the opening cut (par. 0137).
Furthermore, Glines teaches a similar delivery and deployment system (par. 0009 discloses use with stent delivery catheters) comprising an aspiration lumen 64 (par. 0033; Fig. 5) extending and defined along a delivery sheath 62 and said tissue-penetrating end (ends of lumens 66 and 64; Fig. 5) and fluidly couplable to a suction source 28 to apply suction along said tissue-penetrating end (par. 0021); wherein said suction lumen extending adjacent said distal end to a tissue-penetrating surface of the distal end of said tissue-penetrating end to draw tissue to said tissue-penetrating surface to facilitate penetration therethrough by said tissue-penetrating distal end (par. 0022 discloses the suction of the vacuum pulls the tissue 38 to the lumen; combination of the suction lumen in Glines with the tissue-penetrating distal end of Phan would arrive at the intended use of being capable to facilitate penetration therethrough by said tissue-penetrating distal end) and wherein said suction lumen is defined through the wall of said delivery sheath and through said tissue-penetrating end (Fig. 5 discloses the aspiration lumen 64 is extends through the walls of sheath 62 and extends to the distal most end which when combined with Phan, is a tissue-penetrating end).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the delivery sheath in Phan in view of Binmoeller to include a suction lumen extending and defined along said delivery sheath and said tissue-penetrating end and fluidly couplable to a suction source to apply suction along said tissue-penetrating end; wherein said suction lumen extending adjacent said distal end to a tissue-penetrating surface of the distal end of said tissue-penetrating end to draw tissue to said tissue-penetrating surface to facilitate penetration therethrough by said tissue-penetrating distal end and wherein said suction lumen is defined through the wall of said delivery sheath and through said tissue-penetrating end, as taught and suggested by Glines, for providing an aspiration lumen with vacuum force to pull the tissue closer to the lumen(par. 0022).
Regarding claims 3 and 15, Phan discloses wherein said delivery sheath 120 is proximally retractable with respect to said tissue-penetrating end to deploy an implantable medical device delivered therein (par. 0053 discloses the sheath 120 is retracted to deploy the stent).
Regarding claim 9, Phan discloses wherein: said implantable medical device is a bypass stent 122 (Fig. 6G) has a distal end and a proximal end; the bypass stent distal end is expandable to form a distal retention member 122 when said bypass stent expands to the expanded configuration; and the bypass stent proximal end is expandable to form a proximal retention member 124 when said bypass stent expands to the expanded configuration (par. 0053 and Fig. 6G).
Regarding claim 12, Phan discloses further comprising an endoscope (E; Fig. 6A; par. 0044) with a working channel configured to deliver said delivery sheath 120 to the proximal anatomical structure (par. 0044).
Claims 5-8 are rejected under 35 U.S.C. 103 as being unpatentable over Phan et al. (2012/0136426) “Phan” in view of Binmoeller et al. (2014/0236064) “Binmoeller” further in view of Glines et al. (2007/0239182) “Glines” further in view of Alt (2004/0186560).
Phan in view of Binmoeller and Glines teaches the claimed invention of claim 1 and wherein: said implantable medical device is a bypass stent 122 and has a distal end and a proximal end; the bypass stent distal end is expandable to form a distal retention member 122 when said bypass stent expands to the expanded configuration (Fig. 6G); the bypass stent proximal end is expandable to form a proximal retention member 124 when said bypass stent expands to the expanded configuration (par. 0053 and Fig. 6G); except for said delivery and deployment system further comprising a target stent implantable within the distal anatomical structure and defining a target lumen therethrough, said target stent having a wall configured to be penetrated by said tissue-penetrating end to deliver an end of said bypass stent into the target lumen; wherein said bypass stent defines a bypass lumen therethrough and is configured to be deployed with respect to said target stent with the bypass lumen extending transverse to the target lumen; and the wall of said target stent is configured to retain said bypass stent distal retention member within the target lumen and wherein said target stent as deployed within the distal anatomical structure along a target site facilitates penetration of said tissue-penetrating end through a wall of the distal anatomical structure along the target site.
However, Alt teaches a similar system fully capable of performing the intended use of creating a bypass across a proximal and distal anatomical structure comprising a target stent 32 (Fig. 2B) implantable within a distal anatomical structure 30 and defining a target lumen therethrough (as shown in Fig. 2B), said target stent 32 having a wall configured to be penetrated by a tissue-penetrating end (catheter 45; Fig. 3B) to deliver an end of a bypass stent 37 into the target lumen (par. 0067 discloses the bypass stent 32 is navigated through the mesh sidewall of the target stent 32); wherein said bypass stent defines a bypass lumen therethrough and is configured to be deployed with respect to said target stent with the bypass lumen extending transverse to the target lumen (the bypass stent 32 is transversely inserted into the target stent 32; par. 0067). The combination of the bypass stent 122 of Phan including the distal and proximal retention members 122/124 with the wall of said target stent 32 in Alt is configured to retain said bypass stent distal retention member within the target lumen and wherein said target stent as deployed within the distal anatomical structure along a target site facilitates penetration of said tissue-penetrating end through a wall of the distal anatomical structure along the target site (the structure of the target stent 32 is fully capable of performing this intended use).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system in Phan in view of Binmoeller and Glines to include said delivery and deployment system further comprising a target stent implantable within the distal anatomical structure and defining a target lumen therethrough, said target stent having a wall configured to be penetrated by said tissue-penetrating end to deliver an end of said bypass stent into the target lumen; wherein said bypass stent defines a bypass lumen therethrough and is configured to be deployed with respect to said target stent with the bypass lumen extending transverse to the target lumen; and the wall of said target stent is configured to retain said bypass stent distal retention member within the target lumen and wherein said target stent as deployed within the distal anatomical structure along a target site facilitates penetration of said tissue-penetrating end through a wall of the distal anatomical structure along the target site, as taught and suggested by Alt, for maintaining the distal anatomical structure in an open state facilitating insertion of the bypass stent.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YASHITA SHARMA whose telephone number is (571)270-5417. The examiner can normally be reached on 8am-5pm M-Th; 8am-4pm Fri. If attempts to reach the examiner by telephone are unsuccessful, the examiner' s supervisor, Jerrah Edwards, can be reached at 408-918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/YASHITA SHARMA/
Primary Examiner, Art Unit 3774
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