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
Applicant’s arguments with respect to claim(s) 1, 4-5, 7-14, 17-18 and 20 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 § 102
(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, 4-5, 7-14, 17 and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Elwood et al. US 20180263799 A1, herein referred to as Elwood.
Regarding claim 1, Elwood discloses a system (Fig 1, 100; [0047]) for delivering a stent (Figs 13-14, 200; [0052]) into a body lumen ([0047]), comprising: an inner tubular member (Fig 1, shaft that defines lumen 111) formed of PEEK ([0079]) and configured to advance through an access site in a wall of a body lumen ([0080] teaches endoscopically guiding the catheter system, including inner tubular member), the inner tubular member defining a guidewire lumen (111) and having a distal end (Fig 8, end closest to 178); a stent (200) configured to be disposed coaxially on the inner tubular member (Figs 13-17, [0052]); an outer sheath (Fig 2a, 132) disposed coaxially along at least a portion of the inner tubular member such that the stent is disposed between the inner tubular member and the outer sheath while the stent is in an undeployed configuration (Figs 13-14); a distal cutting element (Fig 9l, 170i) coupled with a distal end portion of the inner tubular member and having an electrode (171i) configured to create the access site in the wall of the body lumen [0059], the electrode having a distal edge; and a tubular sleeve (Fig 8, 116) formed of PTFE ([0078]) and disposed coaxially over the distal end portion of the inner tubular member (Fig 8) and configured to thermally insulate at least a portion of the inner tubular member ([0061]), wherein the distal end of the inner tubular member is disposed proximal to the distal edge of the electrode, wherein a distal end of the tubular sleeve is disposed at or distal to the distal edge of the electrode such that the tubular sleeve extends distally beyond the distal end of the inner tubular member (Fig 8), and wherein the tubular sleeve is configured to inhibit thermal deformation of the PEEK inner tubular member during electrosurgical cutting of tissue by the electrode ([0061]).
Regarding claim 4, Elwood discloses wherein a distal end of the tubular sleeve is disposed distal to a distal edge of the electrode (Fig 8).
Regarding claim 5, Elwood discloses wherein a distal end of the tubular sleeve is flush with a distal edge of the electrode (Fig 8).
Regarding claim 7, Elwood discloses wherein the tubular sleeve overlaps the distal end portion of the inner tubular member by about 6mm (Fig 8, overlaps most of the inner tubular member and is taught to adjust length via ratcheting mechanism [0099]).
Regarding claim 9, Elwood discloses further comprising an anchoring component (Figs 10a-b, 180 and 180’)disposed at the distal end portion of the inner tubular member and configured to retain a distal portion of the stent in place along the inner tubular member as the outer sheath is retracted proximally to deploy the stent ([0070] and [0080-0081]), wherein upon retraction of the outer sheath, the stent releases from the anchoring component [0070]and expands into a deployed configuration within the body lumen ([0080-0081]).
Regarding claim 10, further comprising a proximal marker (Fig 12, 113) disposed around the inner tubular member and positioned such that a proximal end of the stent abuts against the proximal marker while the stent is in the undeployed configuration ([0082]), wherein the proximal marker is configured to indicate a location of the proximal end of the stent ([0082]).
Regarding claim 11, Elwood discloses further comprising a middle member (Fig 13, 116a) disposed around the inner tubular member proximal to the proximal marker such that a proximal end of the proximal marker abuts a distal end of the middle member (Fig 13).
Regarding claim 12, Elwood discloses wherein the distal cutting element includes a cover (Fig 9l, 176i) having an extension extending distally from a distal end of the cover, and the electrode is looped around the extension (Fig 9l, 172i).
Regarding claim 13, Elwood discloses wherein the cover is formed of a material selected from the group consisting of ceramic, and PTFE ([0061]).
Regarding claim 14, Elwood discloses a system (Fig 1, 100; [0047]) for delivering a stent (Figs 13-14, 200; [0052]) into a body lumen [0047], comprising: an inner tubular member (Fig 1, shaft that defines lumen 111) formed of PEEK [0079] and configured to advance through an access site in a wall of a body lumen [0080] for delivering a stent into the body lumen [0080], the inner tubular member defining a guidewire lumen and having a distal end (Fig 8, 111; end closest to 178); an outer sheath (Fig 2a, 132) disposed coaxially along at least a portion of the inner tubular member (Fig 4); a distal cutting element (Fig 9l, 170i) coupled with a distal end portion of the inner tubular member and having an electrode (Fig 9l, 175i) configured to create the access site in the wall of the body lumen [0059], the electrode including a coiled electrode wire (Fig 9l, 172i) and having a distal edge (Fig 9l, end near tip); and a tubular sleeve (Fig 4, 116) formed of PTFE [0078] and disposed coaxially over the distal end portion of the inner tubular member (Fig 8) and configured to thermally insulate at least a portion of the inner tubular member [0061], wherein a distal end of the tubular sleeve is disposed distal to the distal edge of the electrode (Fig 8), wherein the distal end of the inner tubular member is disposed proximal to the distal edge of the electrode (Fig 5a), wherein the tubular sleeve extends distally beyond the distal end of the inner tubular member (Fig 8), wherein the tubular sleeve is configured to inhibit thermal deformation of the PEEK inner tubular member during electrosurgical cutting of tissue by the electrode ([0061), and wherein the distal cutting element includes a cover (Fig 9l, 176i) having a distal extension (171i) extending distally from a distal-most end of the cover (Fig 9l), the distal extension being stepped down relative to an outer surface of the cover (Fig 9l), and wherein the coiled electrode wire is looped around the distal extension (Fig 9l) and has an outermost radial surface that is radially inward of or flush with the outer surface of the cover (Fig 9l).
Regarding claim 17, Elwood discloses wherein the tubular sleeve overlaps the distal end portion of the inner tubular member by about 6mm (Fig 8, overlaps most of the inner tubular member and is taught to adjust length via ratcheting mechanism [0099]).
Regarding claim 20, Elwood discloses a system (Fig 1, 100; [0047]) for delivering a stent (Figs 13-14, 200; [0052]) into a body lumen [0047], comprising: an inner tubular member (Fig 1, shaft that defines lumen 111) formed of PEEK [0079] and defining a guidewire lumen (Fig 8, 111;), the inner tubular member having a distal end and (end closest to 178) being configured to advance through an access site in a wall of a body lumen for delivering a stent into the body lumen [0080]; an electrode (Fig 9l, 175i) coupled with a distal end portion of the inner tubular member and configured to create the access site in the wall of the body lumen (Fig 4), the electrode having a distal edge (Fig 9l, end near tip); and a tubular sleeve formed of PTFE, ceramic [0061], the tubular sleeve and disposed coaxially over the distal end portion of the inner tubular member (Fig 8) and configured to thermally insulate at least a portion of the inner tubular member [0061], wherein the distal end of the inner tubular member is disposed proximal to the distal edge of the electrode (Fig 9l), wherein a distal end of the tubular sleeve is disposed at or distal to the distal edge of the electrode such that the tubular sleeve extends distally beyond the distal end of the inner tubular member (Fig 9l), and wherein the tubular sleeve is configured to inhibit thermal deformation of the PEEK inner tubular member during electrosurgical cutting of tissue by the electrode (Fig 9l, [0061]).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Elwood in view of Brown et al. US Patent 9381041, herein referred to as Brown.
Regarding claim 8, Elwood does not disclose wherein the distal end of the inner tubular member is spaced proximally from a disposed about 2mm proximal to the distal edge of the electrode.
However, Brown teaches a distal end of the inner tubular member (see annotated Figures below) is about 2mm proximal to the distal edge of the electrode. (Brown Fig 2A; Col 20 6-34, anticipated dimension).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the inner tubular member spacing of Elwood to incorporate wherein the distal end of the inner tubular member is spaced proximally from a disposed about 2mm proximal to the distal edge of the electrode, as taught and suggested by Brown in order to allow anchoring of a stent therein (Brown Col 20 6-34).
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Regarding claim 18, Elwood does not disclose wherein the distal end of the inner tubular member is spaced proximally from a disposed about 2mm proximal to the distal edge of the electrode.
However, Brown teaches a distal end of the inner tubular member (see annotated Figures above) is about 2mm proximal to the distal edge of the electrode. (Brown Fig 2A; Col 20 6-34, anticipated dimension).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the inner tubular member spacing of Elwood to incorporate wherein the distal end of the inner tubular member is spaced proximally from a disposed about 2mm proximal to the distal edge of the electrode, as taught and suggested by Brown in order to allow anchoring of a stent therein (Brown Col 20 6-34)
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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A.F./Patent Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774
