DETAILED ACTION
A complete action on the merits of claims 1-20 follows below.
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 .
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 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.
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.
Claims 1-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bagley (US Pub. No. 2015/0119881).
Regarding Claim 1, Bagley teaches a system for tissue treatment (abstract and Fig. 1A), the system comprising:
an elongate member 115; an expandable member 120 coupled to the elongate member ([0006] and [0088]), wherein the expandable member 120 is radially expandable relative to the elongate member (Figs. 3A-9 and 19A-24); and a flexible substrate 180 including an electrode array 160 disposed thereon (electrodes 502-504 and/or 702-718), the flexible substrate 180 having a header portion and a footer portion (top and bottom borders for example section marked 810 in Fig. 8 and 912 in Fig. 9 as the header portion and the opposite bottom surface as the footer portion, [0087] and [0092]), and
a first peripheral side portion (either the side portion marked as 181 in Fig. 9 and similar side portions in other embodiments or alternatively the side marked 912 in Fig. 9 is here interpreted to be a first peripheral side portion) and a second peripheral side portion (the opposite side portions such as the side marked as 914 or alternatively the side where the line 180 is drawn from in Fig. 9 and similar side portions in other embodiments is here interpreted to be a second peripheral side portion) each spanning between the header portion and the footer portion (Figs. 3A-9 and 19A-24), the flexible substrate including a first arm segment 140 or 1904 or 2002 extending outwardly from the header portion (Figs. 3A-9 and 19A-24) and a second arm segment 170 or 1902 extending outwardly from the footer portion (Figs. 3A-9 and 19A-24), wherein the flexible substrate 180 surrounds at least a portion of the expandable member 120 when in a stowed position with one of the first arm segment or the second arm segment of the flexible substrate coupled to the expandable member to retain the flexible substrate against the expandable member in the stowed position (“furled/collapsed mode” in Fig. 4, 19A, 20A, 23A), and wherein the flexible substrate is expandable from the stowed position to a deployed position in response to radial expansion of the expandable member (“unfurled/expanded mode” in Fig. 5, 19B, 20B, 23B).
Regarding Claim 2, Bagley teaches wherein the one of the first arm segment or the second arm segment is coupled to the expandable member when the flexible substrate is in the deployed position (either of 1904, 1902, 2002 or the distal portion 140 remain coupled to the expansion member 120 when the flexible substrate is in the deployed position).
Regarding Claim 3, Bagley teaches further comprising one or more electrical wires 170 coupled to the electrode array 160 and configured to power the electrode array, wherein the one or more electrical wires retain the flexible substrate in position along a proximal portion of the elongate member ([0089], [0113]-[0118] and Figs. 3A-9 and 20A-B).
Regarding Claim 4, Bagley teaches wherein the elongate member 115 includes a distal portion 140 and a proximal portion (proximal portion of the catheter extending from the expansion member 120 to the handle), and wherein the expandable member 120 is coupled to the elongate member between the distal portion and the proximal portion (Figs. 3A-9 and 19A-24).
Regarding Claim 5, Bagley teaches wherein the one of the first arm segment or the second arm segment of the flexible substrate (1904 or 2002) is coupled to the expandable member 120 adjacent the distal portion 140 of the elongate member 115 to retain the flexible substrate against the expandable member (Figs. 19A-20B).
Regarding Claim 6, Bagley teaches wherein the other of the first arm segment or the second arm segment of the flexible substrate is coupled to one or more electrical wires 170 configured to power the electrode array 160, the one or more electrical wires retaining the flexible substrate against the expandable member adjacent the proximal portion of the elongate member (Figs. 3A-9, 16B, 20A, 23A-24 show the wire 170 or wires 170a-170d coupled to the expansion member and electrodes and extending proximally to the handle and the power generator thereby even though the wire/wires are not shown in Figs. 19A-20B Examiner takes the position that they pass through the conical structure and therefore interpreted to be coupled together which the one or more electrical wires assist in retaining the flexible substrate against the expandable member adjacent the proximal portion of the elongate member).
Regarding Claim 7, Bagley teaches the flexible substrate 180 further including a leading edge (the most distal edge) defined along one of the header portion or the footer portion (header portion) of the flexible substrate 180 corresponding with the one of the first arm segment or the second arm segment (section 140) coupling the flexible substrate to the expandable member 120 when the flexible substrate is in the stowed position (Fig. 20A), the system further including a first cushion 2002 adjacent the leading edge of the flexible substrate to protect against tissue trauma during system delivery (“bumper overhang structure 2002 may be bonded to a portion of the distal lateral edges 2004 of the ablation structure 160. The bumper overhang structure 2002 may be made of a highly flexible material such that the structure does not significantly impede the unfurling of the ablation structure 160 in response to the expansion of the expansion member 120” [0140]).
Regarding Claim 8, Bagley teaches the flexible substrate 180 further including a trailing edge (the most proximal edge) defined along the other of the header portion or the footer portion (the footer portion) of the flexible substrate 180, the system further including a second cushion 2305 adjacent the trailing edge of the flexible substrate to protect against tissue trauma during system removal (Fig. 23A-B and [0143]).
Regarding Claim 9, Bagley teaches the flexible substrate further including a leading edge defined along one of the header portion or the footer portion of the flexible substrate corresponding with the one of the first arm segment or the second arm segment coupling the flexible substrate to the expandable member when the flexible substrate is in the stowed position, wherein the expandable member is partially expanded to form a first cushion 2002 adjacent the leading edge of the flexible substrate to protect against tissue trauma during system delivery (Figs. 20A-B and [0140]).
Regarding Claim 10, Bagley teaches the flexible substrate further including a trailing edge defined along the other of the header portion or the footer portion of the flexible substrate, wherein the expandable member is partially expanded to form a second cushion 2305 adjacent the trailing edge of the flexible substrate to protect against tissue trauma during system removal (Figs. 23A-B and [0143]).
Regarding Claim 11, Bagley teaches wherein the first arm segment and the second arm 1902/1904 segment are aligned relative to one another along a first axis extending across the flexible substrate from the header portion to the footer portion (Figs. 19A-B and 21-22).
Regarding Claim 12, Bagley teaches wherein the first arm segment and the second arm segment 1902/1904 are aligned relative to one another along one of the first peripheral side portion or the second peripheral side portion of the flexible substrate (with the side portions being interpreted to be sections numbered 181 and 914 in Fig. 9, conical structures 1902 and 1904 are aligned relative to those side portions, see Figs. 19A-B and 21-22).
Regarding Claim 13, Bagley teaches wherein the first arm segment is substantially orthogonal to the header portion and the second arm segment is substantially orthogonal to the footer portion (all of 140 or 1904 or 2002 or 170 or 1902 extend perpendicular to the header or footer, see for example section 810 in Fig. 8 that is interpreted to be the header portion and the opposite section at the bottom that is interpreted to be the footer portion).
Regarding Claim 14, Bagley teaches wherein the other of the first arm segment or the second arm segment is free of the electrode array (any one of 140 or 1904 or 2002 or 1902 are free of the electrode array).
Regarding Claim 15, Bagley teaches further comprising one or more apertures formed on the flexible substrate, wherein the one or more apertures are disposed between portions of the electrode array (although a plurality of holes are shown in Fig. 17 (1704) and Fig. 18 (1814, 1816, 1818) it is noted that the specification fails to disclose what these elements/holes are; however, it is noted that they are disclosed in its Patent (U.S. Patent No. 9,918,789) see for example Col. 23, ll. 33-Col. 24, ll. 36).
Regarding Claim 16, Bagley teaches the flexible substrate 160 further including a top surface and an opposite bottom surface, wherein the first peripheral side portion (for the purpose of this claim the side marked 810 in Fig. 8 or 912 in Fig. 9 is interpreted to be the first peripheral side portion) of the flexible substrate includes a first edge surface spanning from the top surface to the bottom surface (with a top surface being the outer surface of 180 configured to engage tissue and a bottom surface being the inner surface of 180 facing the expansion member 120, the thickness of section 180 at the edge of 810 in Fig. 8 or 912 in Fig. 9 or edge 1908 in Figs. 19A-B is here interpreted to be a first edge surface that spans from the top surface to the bottom surface) and wherein the second peripheral side portion (the end section where the line 180 is drawn from in Figs. 8-9) of the flexible substrate 160 includes a second edge surface (the thickness of the bottom section where the line 180 is drawn from in Figs. 8-9 or 1906 in Figs. 19A-B is interpreted to be a second edge) spanning from the top surface to the bottom surface (Figs. 6-9 and 19A-B, also note that similar edges exist in other embodiment, but reference is made to Figs. 8-9 for including numeral characteristics and showing the ablation support structure 160 in an opened configuration displaying both the inner surface and outer surface as well as the edges at both ends thereof), the system further comprising a protective coating layer (protection elements 1902, 1904) covering at least one of the first edge surface or the second edge surface of the flexible substrate (“Conical protection elements 1902, 1904 may be positioned along the catheter 115 at the lateral edges 1906, 1908 of the ablation structure 160” [0139], please note that ablation structure 160 is provided on the ablation support 180 as best seen in Figs.6-18).
Regarding Claim 17, Bagley teaches wherein the electrode array is disposed on the top surface of the flexible substrate 180, and wherein the protective coating layer covers at least a portion of the electrode array 160 (“Conical protection elements 1902, 1904 may be positioned along the catheter 115 at the lateral edges 1906, 1908 of the ablation structure 160” [0139]).
Regarding Claim 18, Bagley teaches the flexible substrate 180 further including a top surface and an opposite bottom surface (with a top surface being the outer surface and the opposite bottom surface being the inner surface), the system further comprising a protective coating layer 1902/1904 covering at least a portion of the top surface of the flexible substrate (Figs. 19A-B).
Regarding Claim 19, Bagley teaches wherein the electrode array 160 includes a plurality of spaced apart traces (602-608 in Fig. 6, 1402-1408 in Fig. 14 and 1802-1806 in Fig. 18) with a first trace being closest to a proximal end of the flexible substrate and a second trace being closest to a distal end of the flexible substrate, and wherein the flexible substrate includes a buffer region (for the purpose of this claim distal section 140 is the first arm segment and “bumper overhang structure 2002” disclosed in [0140] and shown in Figs. 19A-B is interpreted to be a buffer region) without an electrode trace, the buffer region being between at least one of: a) a distance between the first trace and the proximal end of the flexible substrate; or b) a distance between the second trace and the distal end of the flexible substrate (as seen in Figs. 19A-B it is between a distance between the second trace and the distal end of the flexible substrate).
Regarding Claim 20, Bagley teaches wherein the buffer region 2002 is between both a) the distance between the first trace and the proximal end of the flexible substrate; and b) the distance between the second trace and the distal end of the flexible substrate (although Figs. 20A-B only show the distal bumper and Figs. 23A-B only show the proximal bumper Bagley teaches “one or more protection elements include one or more bumpers coupled with one or more edges of the ablation structure. The one or more bumpers may overhang the edge of the ablation structure inwards towards the catheter” [0029] and “One or more protection elements are positioned at the distal portion, proximal portion or both of the ablation structure 160. These protection elements may, for example include conical shaped structures, bumper shaped structures, a raised bump 2305 coupled with the catheter 115, or a portion 2405 of the expansion member 120 that is bunched up, each positioned such that they prevent distension of the ablation structure 160 and/or prevent the leading edge of the ablation structure from scraping the lumen wall during insertion” in [0151]; therefore, Examiner takes the position that both the distal end and the proximal end can include bumpers that are positioned at the most distal end and most proximal end of the ablation structure thereby positioned between the first trace ad the distal end and likewise between the second trace and the proximal end).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KHADIJEH A VAHDAT whose telephone number is (571)270-7631. The examiner can normally be reached M-F 9-6 EST.
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/KHADIJEH A VAHDAT/Primary Examiner, Art Unit 3794
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