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 .
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.
Claim(s) 1-11, and 14-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Brown et al. US Patent 9381041, herein referred to as Brown.
Regarding claim 1, Brown discloses system for delivering a stent into a body lumen (Abstract), comprising: an inner tubular member (annotated Fig. 2A. l below) configured to advance through an access site in a wall of a body lumen (Fig 5C, Col 7, lines 43-48); a stent (Fig 5C, stent 34) configured to be disposed coaxially on the inner tubular member (see annotated Fig. 2A. l below); an outer sheath (Fig 5C, retract sheath 27) 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 (annotated Fig. 2A.l below); a distal cutting element (Fig 2A & 3A, cutting element 35; According to the Oxford dictionary, electrocautery is defined as "cautery using a needle or other instrument that is electrically heated". Brown teaches in Column 6, Lines 12- 20 that the cutting element is "Configured to cut, heat, and/or cauterize tissue" and has electrical energy supplied to it. Brown teaches in Column 6, Lines 33- 35 that Fig. 3A shows distal tip 32, which is taught to be a part of the device 10 (Column 5, Line 61 and Figure 2A). Therefore Fig. 3A and Fig. 5C show the same embodiment) coupled with a distal end portion of the inner tubular member (Column 3, Lines 42- 48; Brown teaches that "the catheter has a guidewire lumen", in Fig. 2A the inner tubular member is shown to have the lumen disposed within it. Lumen is taught to be part of the inner tubular member, Brown therefore teaches in Column 6, Lines 6- 8 that the cutting element is coupled with the distal end of the inner tubular member) and having an electrode (annotated Fig. 3C below. Column 6, Lines 21- 32) configured to create the access site in the wall of the body lumen (Column 6, Lines 12- 15); and a tubular sleeve (Fig 5C, body 14, collapsed state over distend end and portions) disposed coaxially over a distal end portion of the inner tubular member (Figs 1, and 5A-E) and configured to thermally insulate at least a portion of the inner tubular member (Col 10, lines 55-67; teaches thermally insulating materials).
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Regarding claim 2, Brown discloses wherein the tubular sleeve is formed of PTFE (Col 20, 35-46).
Regarding claim 3, Brown discloses wherein the tubular sleeve is formed of silicone, ceramic, or a ceramic-impregnated material (Col. 20, 47-65).
Regarding claim 4, discloses wherein a distal end of the tubular sleeve is disposed distal to a distal edge of the electrode (annotated Fig. 3C above, col 6, lines 21- 32).
Regarding claim 5, Brown disclose wherein a distal end of the tubular sleeve is flush with a distal edge of the electrode (annotated Fig. 3C above).
Regarding claim 6, Brown discloses wherein a distal end of the tubular sleeve is disposed proximal to a distal edge of the electrode (in collapse configuration, electrode would be near distal edge of sleeve).
Regarding claim 7, Brown discloses wherein the tubular sleeve overlaps the distal end portion of the inner tubular member by about 6mm (Col 20 6-34, anticipated dimension).
Regarding claim 8, Brown discloses wherein a distal end of the inner tubular member is spaced proximally from a distal end of the electrode (Fig 2A).
Regarding claim 9, Brown discloses further comprising an anchoring component (Fig 2A, stent lock 30) disposed at the distal end portion of the inner tubular member (see annotated Fig. 2A.2 below which shows the distal portion of the device -Column 5 Lines 62-63) 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 (Column 6, Lines 3- 5; the stent lock as taught by Brown is considered a bump on the inner tubular member for retraining the stent), wherein upon retraction of the outer sheath, the stent releases from the anchoring component and expands into a deployed configuration within the body lumen (Col 2, lines 58- Col 3, lines 6).
Regarding claim 10, Brown discloses further comprising a proximal marker (Col 8, 21-61) 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 (Col 8, 21-61), wherein the proximal marker is configured to indicate a location of the proximal end of the stent (Col 8, 21-61).
Regarding Claim 11, Brown discloses further comprising a middle member (Fig 5C, catheter body 26) disposed around the inner tubular member (Col 7, 66- Col 8, lines 1-17) proximal to the proximal marker such that a proximal end of the proximal marker abuts a distal end of the middle member (Col 8, 21-61; configured as described).
Regarding claim 14, Brown discloses A system for delivering a stent into a body lumen (Abstract), comprising: an inner tubular member (annotated Fig. 2A. l below) configured to advance through an access site in a wall of a body lumen for delivering a stent into the body lumen (Fig 5C, Col 7, lines 43-48); an outer sheath (Fig 5C, retract sheath 27) disposed coaxially along at least a portion of the inner tubular member see annotated Fig. 2A. l below); a distal cutting element Fig 2A & 3A, cutting element 35; According to the Oxford dictionary, electrocautery is defined as "cautery using a needle or other instrument that is electrically heated". Brown teaches in Column 6, Lines 12- 20 that the cutting element is "Configured to cut, heat, and/or cauterize tissue" and has electrical energy supplied to it. Brown teaches in Column 6, Lines 33- 35 that Fig. 3A shows distal tip 32, which is taught to be a part of the device 10 (Column 5, Line 61 and Figure 2A). Therefore Fig. 3A and Fig. 5C show the same embodiment) coupled with a distal end portion of the inner tubular member (Column 3, Lines 42- 48; Brown teaches that "the catheter has a guidewire lumen", in Fig. 2A the inner tubular member is shown to have the lumen disposed within it. Lumen is taught to be part of the inner tubular member, Brown therefore teaches in Column 6, Lines 6- 8 that the cutting element is coupled with the distal end of the inner tubular member) and having an electrode configured to create the access site in the wall of the body lumen (Column 6, Lines 12- 15); and a tubular sleeve (Column 6, Lines 12- 15 disposed coaxially over the distal end portion of the inner tubular member (Fig 1, and 5A-E) and configured to thermally insulate at least a portion of the inner tubular member (Col 10, lines 55-67; teaches thermally insulating materials), wherein a distal end of the tubular sleeve is disposed distal to a distal edge of the electrode (Fig 1, 5A-E).
Regarding claim 15, Brown discloses wherein the tubular sleeve is formed of PTFE (Col 20, 35-46).
Regarding claim 16, Brown discloses wherein the tubular sleeve is formed of silicone, ceramic, or a ceramic-impregnated material (Col. 20, 47-65).
Regarding claim 17, Brown discloses wherein the tubular sleeve overlaps the distal end portion of the inner tubular member by about 6mm (Col 20 6-34, anticipated dimension).
Regarding claim 18, Brown discloses wherein a distal end of the inner tubular member is spaced proximally from a distal end of the electrode (Fig 2A).
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) 12,13 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brown.
Regarding claim 12, Brown discloses the invention substantially as claimed and as discussed above with respect to claim 1 wherein the distal cutting element (Fig 2A & 3A, cutting element 35. But does not disclose a cover having an extension extending distally from a distal end of the cover, and the electrode is looped around the extension. But in another embodiment Brown discloses a similar stent delivery system. Brown also teaches includes a (Fig 6B, insulating section 61a cover having an extension (Fig 6B, projection 65) extending distally from a distal end of the cover), and the electrode is looped around the extension (Fig 6B, Col 12, lines 21-39).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective date of the claimed invention to modify Brown to incorporate a distal end of the cover, and the electrode is looped around the extension, as taught and suggested by Brown In order to limit thermal damage to surrounding tissue (Col 5, lines 45, 55).
Regarding claim 13, the combination of Brown’s embodiments discloses the invention substantially as claimed and as discussed above with respect to claim 12 teaches wherein the cover is formed of a material selected from the group consisting of silicone, ceramic, and PTFE (Col 12, lines 21-39, Col. 20, 47-65; Brown teaches “co-molding” with described materials).
Regarding claim 19, the combination of Brown’s embodiments discloses the invention substantially as claimed and as discussed above with respect to claim 12 teaches wherein the distal cutting element (Fig 2A & 3A, cutting element 35) includes a cover (Fig 6B, insulating section 61a) having an extension (Fig 6B, projection 65) extending distally from a distal end of the cover, and the electrode is looped around the extension.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brown and in view of Corwin et al. 20170304097 A1, herein referred to as Corwin.
Regarding claim 20, Brown discloses the invention substantially as claimed and as discussed above with respect to claim 1. Brown discloses A system for delivering a stent into a body lumen (Abstract), comprising: an inner tubular member (annotated Fig. 2A. l below) […] and configured to advance through an access site in a wall of a body lumen for delivering a stent into the body lumen (Fig 5C, Col 7, lines 43-48; an electrode (annotated Fig. 3C below. Column 6, Lines 21- 32) coupled with a distal end portion of the inner tubular member (Figs 1, 5A-E1) and configured to create the access site in the wall of the body lumen (Column 6, Lines 12- 15); and a tubular sleeve () formed of PTFE, silicone, ceramic, or a ceramic-impregnated material, the tubular sleeve disposed coaxially over the distal end portion of the inner tubular member (Fig 5C, body 14, collapsed state over distend end and portions) and configured to thermally insulate at least a portion of the inner tubular member (Col 10, lines 55-67; teaches thermally insulating materials). Does not disclose: an inner tubular member formed of PEEK
However, Corwin discloses a similar stent delivery system. Corwin teaches an inner tubular member (Fig 1A, inner shaft component 112) formed of PEEK [0025].
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention an inner tubular member formed of PEEK
to modify Brown to incorporate as taught and suggested by Corwin in order to provide rigidity [0025].
Conclusion
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A.F./Patent Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799