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
Claims 51, 54-56, and 58 are pending and examined below.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 51 and 58 is/are rejected under 35 U.S.C. 102(2) as being anticipated by WO 2017/109783 (Einav)
Regarding claim 51, Einav discloses a method for deploying a biliary stent in a lumen of a human body, using a guidewire arranged such that a distal end-section thereof is disposed within the body lumen and a proximal end-section thereof is outside the body (see Figs. 1 and 2), the method comprising:
a. providing a stent-deployment assembly (Fig. 2) comprising:
i. a biliary stent (Fig. 2, 52,54); and
ii. an elongated stent-conveyance tube (Fig. 2, 22) comprising a guidewire- retaining segment (Fig. 4, 122) that includes
(i) respective distal and proximal apertures defining a guidewire-path therethrough (Fig. 2, wherein distal and proximal ends of 22 defines a guidewire path), and
(ii) a lengthways laterally-breachable portion (Fig. 2, wherein the slit 27 corresponds to a lengthways laterally-breachable portion)
b. distally advancing the stent-deployment assembly along the guidewire into a body lumen of a human subject in a stent-advancement configuration (Page 17, Lines 4-6, wherein “apparatus 20 is advanced into a body of the subject along the guidewire 12)
(i) the guidewire passes through the respective apertures so as to interiorly traverse the guidewire-retaining segment (Page 16, Line 24 to Page 17, Line 5, wherein the guidewire 12 interiorly traverses guide tube 22), and
(ii) the stent is arranged to surround a stent-conveyance tube segment that is proximally displaced from the guidewire-retaining segment (see Figs. 2 and 4, wherein stents 52, 54 are surround 22 and are proximally displaced from 122); and
c. when the stent is disposed, in the stent-advancement configuration, at a target deployment location within the lumen, withdrawing the stent- conveyance tube a proximal-direction (Page 17, “guide tube 22 is pulled proximally”) so as to cause the guidewire to breach the laterally-breachable portion of the guidewire-retaining segment (Page 17, Line 27, wherein “guidewire 12 slides through slit 28 of guide tube 22” corresponds to cause the guidewire to breach the laterally-breachable portion of the guidewire-retaining segment) and decouple the guidewire from the tube without longitudinal displacement of the guidewire (Page 17, wherein “center within a lumen of the guide tube corresponds to decouple the guidewire from the tube without longitudinal displacement of the guidewire).
Regarding claim 58, Einav further discloses wherein the stent is deployed in the lumen (Page 18, Lines 9-11, wherein “allows for deployment of second stent 54” corresponds to the stent is deployed in the lumen) without manipulating the guidewire (Page 18, Lines 9-11, wherein “while maintaining guidewire 12 within lumen 4” corresponds to the without manipulating the guidewire)
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.
Claim(s) 54 and 55 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2017/109783 (Einav) in view of US 2005/0085891 (Goto)
Regarding claim 54, Einav doesn't explicitly teach or disclose a pushing tube or a proximally withdrawable locking mechanism.
Goto discloses a stent-deployment assembly (Fig. 1) additionally comprising:
(i) a pushing tube (Fig. 15C, pusher tube 60) and a proximally withdrawable locking mechanism (Fig. 1, 21) and
(ii) the proximally withdrawable locking mechanism engages the stent with the pushing tube (¶0050, wherein 21 engages with depression 17 of stent 14) and is effective to maintain a position of the stent relative to the tube when the assembly is advanced along the guidewire in the stent-advancement configuration (¶0051, wherein 14 fixes position of stent on the tube).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the stent deployment assembly of Einav with a pushing tube and a proximally withdrawable locking mechanism, as taught by Goto, in order to more easily manipulate the position of the stent.
Regarding claim 55, Einav discloses a method comprising a stent conveyance tube (see rejection of claim 51) but doesn't explicitly teach or disclose wherein proximally withdrawing the stent-conveyance tube disengages the proximally- withdrawable locking mechanism.
Goto discloses wherein proximally withdrawing the stent-conveyance tube (¶0051, wherein “when the guide catheter 11 is pulled off the stent 14” corresponds to proximally withdrawing the stent-conveyance tube) disengages the proximally- withdrawable locking mechanism (¶0051, wherein “the engagement member 21 moves out of the engagement depression” corresponds to disengaging the proximally withdrawable locking mechanism)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the method of Einav with a locking mechanism that disengages when proximally withdrawn, as taught by Goto, in order to complications when placing the stent.
Claim(s) 56 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2017/109783 (Einav) in view of US 2018/0344493 (Epstein)
Regarding claim 56, Einav discloses a stent conveyance tube (see rejection of claim 51 above) and a guidewire-retaining segment (Fig. 4, 122) but doesn't explicitly teach or disclose wherein a segment of the stent-conveyance tube proximally abutting the guidewire- retaining segment has a smaller diameter than does the guidewire-retaining segment.
Epstein discloses wherein a segment of the stent-conveyance tube proximally abutting (see annotated Fig. 1 below) the guidewire- retaining segment has a smaller diameter (see annotated Fig. 5 below wherein the diameter of the stent-conveyance tube is indicated with a dotted arrow) than does the guidewire-retaining segment (see annotated Fig. 5 below, wherein the diameter of the guide-wire retaining segment is indicated with a solid arrow)
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It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the diameter of the guidewire-retaining segment to be larger than segment distally abutting it, in order to navigate through regions of high resistance more easily.
Conclusion
Included below is relevant prior art that was considered but not relied upon for this office action:
US 2011/0087234 – discloses a method and apparatus for introducing multiple medical devices into a lumen
US 4,874,274 – discloses a medical tool introduction canula with a longitudinal slit in the proximal end
US 6,346, 093 – discloses a biliary catheter with a common distal lumen
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/MAXIMILIAN TOBIAS SPENCER/Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774