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 .
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 (i.e., changing from AIA to pre-AIA ) 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.
Response to Amendment
Upon entry of the amendments filed 12/22/2025, claims 1-9, 18-24, and 32-35 are pending in the application. Claims 1, 18, and 32 have been amended, with no new claims added or cancelled.
Response to Arguments
Applicant’s arguments, see Remarks pages 8-13, filed 12/22/2025, with respect to the rejections of claims 1-6 and 32-35 as rejected under 35 U.S.C. 102 as anticipated by Hartley (US 2020/0253682) have been fully considered and are persuasive. Hartley does not teach “the assembly having an input and output axially spaced along the expandable member and fluidly coupled to ports disposed along the length of the expandable member”, and “a mechanism configured to circulate the fluid through the expandable member in a first axial direction, and, when the flow direction is switched, configured to recirculate the fluid in a second axial, opposite direction, the circulation and recirculation of the fluid being through the same ports, wherein the mechanism maintains substantially constant fluid pressure within the expandable member during circulation, recirculation, and switching of the flow direction.” Therefore, the rejection has been withdrawn. However, upon further consideration, a new grounds of rejection are made in view of Aklog (US 2016/0262823).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-6, 18, and 32-35 are rejected under 35 U.S.C. 103 as being unpatentable over Hartley (US Patent Publication 2020/0253682) in view of Aklog (US Patent Publication 2016/0262823).
Regarding claim 1, 18, and 32, Hartley teaches
“A system for treatment of tissue (Fig. 56, p.[0124]), the system comprising”
“An expandable member designed to be positioned at a site of interest against tissue to be treated and to accommodate fluid set at a temperature range to affect the tissue at the site of interest (101; Fig. 56; p.[0124-0126], where p.[0126] teaches the heat exchanger 101 is in the form of a balloon, which is an expandable member)”,
“An assembly for directing the fluid set at the temperature range into the expandable member (103, 127, collectively; Fig. 56; p.[0124])”,
“The assembly having an input… to introduce the fluid into the expandable member to circulate substantially along an entire length of the expandable member (116; Fig. 56; p.[0124]) (150; Fig. 56; p.[0124])”.
Hartley does not teach “an output axially spaced along the expandable member and fluidly coupled to ports disposed along the length of the expandable member,” but Aklog does in an analogous expandable balloon device. Aklog teaches an output axially spaced along the expandable member and fluidly coupled to ports along the expandable member in Figures 1 and 3B, but also in p.[0041-0042]. Further, Hartley does not teach “a mechanism configured to circulate the fluid through the expandable member in a first axial direction, and when the flow direction is switched, configured to recirculate the fluid in a second axial, opposite direction, the circulation and recirculation of the fluid being through the same ports, wherein the mechanism maintains substantially constant fluid pressure within the expandable member during circulation, recirculation, and switching of the flow direction”, but Aklog does in an analogous expandable balloon device. Aklog teaches this limitation in p.[0035, 0040, 0056-0057, 0059, and 0079]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the system of Aklog in Hartley. As stated in Aklog, the use of the output axially spaced allows for deflating the balloon, and the use of the mechanism allows for recycling the fluid to create reservoirs to maintain the desired therapeutic effect and creates predictable results.
Regarding claim 2, the limitations of claim 1 are taught as described above. Hartley teaches “wherein the assembly includes an input fluid pathway (127; Fig. 56; p.[0124], [0118]) and an output fluid pathway (lumen of 103; Fig. 56; p.[0124], p.[0118]) and wherein the input fluid pathway extends from the mechanism to the input (Fig. 56, p.[0124], p.[0118]; the tube 127 inherently extends from the mechanism to supply fluid to the heat exchanger 101) and the output fluid pathway extends from the mechanism to the output (Fig. 56; p.[0124], p.[0118]; the lumen of shaft 103 inherently extends to the mechanism to collect returned fluid).”
Regarding claims 3 and 33-34, the limitations of claim 2 and 32 are taught as described above. Hartley teaches “wherein the input fluid pathway is disposed concentrically with the output fluid pathway (Fig. 56, p.[0124])”, and therefore teaches the claimed invention as described. Note that while claim 3 and 33 do not mirror each other identically, these claims do share the same limitations (albeit described with different, synonymous terms) and therefore the rejection of claim 3 constitutes the rejection of claim 33 for this reason.
Regarding claims 4 and 35, the limitations of claim 3 and 32 are described as taught above. Hartley teaches “wherein the output fluid pathway is arranged between an inner surface of an elongated member and an outer surface of the input fluid pathway (Fig. 56; p.[0124]; the lumen 103 is shown to be positioned between the walls of shaft 103 and outer surface of the tube 127)” and therefore teaches the limitation as described.
Regarding claim 5, the limitations of claim 4 are taught as described above. Hartley teaches “wherein the input fluid pathway extends into the expandable member to deliver fluid into the expandable member (Fig. 56; p.[0124]; tube 127 is shown to extend through heat exchanger 101)” and “a proximal end of the expandable member is partially disposed within the output fluid pathway (Fig. 56; p.[0124]; the proximal end of the heat exchanger 101 is shown to be disposed within the lumen of shaft 103).”
Regarding claim 6, the limitations of claim 5 are taught as described above. Hartley teaches “wherein the proximal end of the expandable member is adhered to an inner surface of the elongated member (Fig. 56; p.[0124]; the heat exchanger 101 is taught to be attached to shaft 103 and is shown to be attached to the inner surface of shaft 103)”.
Claims 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Hartley (US Patent Publication 2020/0253682) in view of Aklog (US Patent Publication 2016/0262823) and Wallsten (US Patent Publication 2013/0184791).
Regarding claim 7, the limitations of claim 5 are taught as described above. Hartley does not teach "wherein a portion of the input fluid pathway that is disposed within the expandable member defines a plurality of inflow ports adjacent a distal end of the input fluid pathway", but Wallsten does in an analogous catheter device. Wallsten teaches this limitation in Fig. 3, (further described in p.[0038]) with the upper two holes 35 being considered to be positioned adjacent to the distal end of the tube 32, and therefore teaches the limitation of the claim described. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use inflow ports adjacent to the end of the input fluid pathway. As stated in Wallsten, the use of the ports adjacent to the distal end of the input fluid pathway allows for the pressured hot liquid to continue circulating through the balloon and heating compartment and produces predictable results (p.[0038]).
Regarding claim 8, the limitations of claim 7 are taught as described above. Hartley does not teach "wherein the plurality of inflow ports are arranged in a plurality of sets, each of the plurality of sets being axially spaced from others of the plurality of sets", but Wallsten does in an analogous catheter device. Wallsten teaches in Fig. 3 and p.[0038] a set of holes, 35, wherein each of the upper two holes 35 are considered to be a part of a separate set and further shown to be positioned axially from one another, and therefore teaches the limitation as described. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use inflow ports in a plurality of sets, each being spaced axially from one another, as taught in Wallsten in Hartley. As stated in Wallsten, the use of the ports adjacent to the distal end of the input fluid pathway allows for the pressured hot liquid to continue circulating through the balloon and heating compartment and produces predictable results (p.[0038]).
Regarding claim 9, the limitations of claim 8 are taught as described above. Hartley does not teach "wherein each of the plurality of sets is circumferentially misaligned with adjacent ones of the plurality of sets", but Wallsten does in an analogous catheter device. Wallsten teaches in Fig. 3 and p.[0038], with the upper two holes 35 are shown to be circumferentially misaligned and therefore teaches the limitation as described. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use inflow ports that are misaligned circumferentially, as taught in Wallsten in Hartley. As stated in Wallsten, the use of the ports adjacent to the distal end of the input fluid pathway allows for the pressured hot liquid to continue circulating through the balloon and heating compartment and produces predictable results (p.[0038]).
Claims 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Hartley (US Patent Publication 2020/0253682) in view of Aklog (US Patent Publication 2016/0262823), Wallsten (US Patent Publication 2013/0184791), and Levin (US Patent Publication 2014/0371736).
Regarding claim 19, the limitations of claim 18 are taught as described above. Hartley/Aklog/Wallsten does not teach the limitations described, but Levin does in an analogous catheter device. Levin teaches an elongate member (shaft 100; Fig. 12A-12C; p.[0159-0164]) and advancing the elongate member through a lumen of the endoscope (Fig. 12A-C; p.[0161]; device 100 is taught to be introduced through an endoscope, wherein the endoscope inherently comprises a lumen to receive the device 100). Levin further teaches that the expandable member can be rotated (Fig. 12A-12C; p.[0161]; p.[0127] teaches wherein the ballon 120, similar to the balloon 180 of Fig. 12A-C, can be rotated prior to or during tissue treatment, such that balloon 180 is reasonably considered to be rotated within and independent of the endoscope while maintaining a stationary view of the endoscope and maintaining the endoscope in a stationary position). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the system of Levin in Wallsten. Levin's system allows for an improvement in advancement and placement of the expandable member and produces predictable results.
Regarding claim 20, the limitations of claim 19 are taught as described above. Hartley/Aklog/Wallsten does not teach "the method further comprising expanding an outer expandable member, disposed about the expandable member to contact surrounding tissue at a pressure sufficient to anchor the elongate member in place within a lumen in a patient proximate to the tissue", however, Levin does in an analogous catheter device. Levin teaches outer expandable member 120 to contact tissue (p.[0121]) at a pressure sufficient to achieve the desired outcome. While Levin does not specifically teach that the expandable member can anchor into the lumen of the patient via pressure regulation, Levin does teach that the device can regulate the pressure applied to the tissue during treatment (p.[0034]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use pressure sufficient to anchor the elongate member, as taught in Levin, in Wallsten. It is known in the art to use pressure to either inflate or deflate a balloon to achieve desirable results and produces predictable results.
Claims 21-22 are rejected under 35 U.S.C. 103 being unpatentable over Hartley (US Patent Publication 2020/0253682) in view of Aklog (US Patent Publication 2016/0262823), Wallsten (US Patent Publication 2013/0184791) in view of Levin (US Patent Publication 2014/0371736) and Fogarty (US Patent No. 4,338,942).
Regarding claims 21-22, the limitations of claim 20 are taught as described above. Neither Wallsten/Aklog/Hartley nor Levin teaches the limitation "further rotating the expandable member independent of the outer expandable member to treat additional tissue about a circumference of the lumen", or “further including translating the expandable member relative to the outer expandable member to treat additional tissue along a length of a tract” however, Fogarty does in an analogous electrosurgical device. Fogarty teaches in Fig. 1-3 the use of expandable member 34 with inflatable bag 34 taught to be untwisted to allow the inflatable bag 34 to inflate (col. 2, lines 40-51), where additional tissue can be treated along the length of a tract (48, Fig. 1-3, col. 2, lines 16- col. 3, line 4). Note that the inner balloon element 34 is shown to be attached to the guidewire 38, which can be moved axially via screwing of stem 40, which in term shortens the inner balloon element 34 such that it is translated independently (Col. 2, lines 16-39). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the system of Fogarty, in Levin/Wallsten, to improve the placement of the device and treatment of tissue and produces predictable results.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Hartley (US Patent Publication 2020/0253682) in view of Aklog (US Patent Publication 2016/0262823), Wallsten (US Patent Publication 2013/0184791), Levin (US Patent Publication 2014/0371736) and Dobak (US Patent Publication 2008/0300585).
Regarding claim 23, the limitations of claim 20 are taught as described above. Neither Hartley nor Aklog nor Wallsten nor Levin teaches the limitation "wherein thermal energy from the fluid directed into and out of an interior of the expandable member treats the target tissue through the expandable member and the outer expandable member", however Dobak does in an analogous catheter device. Dobak teaches in Figure 1A and further in p.[0027-0036] and further in p.[0047] that the heat transfer fluid transfer thermal energy from the balloon 104 from the cooling fluid within the second interior volume 110 and into adjacent vascular tissue, therefore teaching the limitation as described. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the system of Dobak in Wallsten/Levin. As stated in Dobak, this allows for improved thermal treatment of tissue and produces predictable results.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable Hartley (US Patent Publication 2020/0253682) in view of Aklog (US Patent Publication 2016/0262823), Wallsten (US Patent Publication 2013/0184791), Levin (US Patent Publication 2014/0371736) and Wallsten ‘004 (US Patent Publication 2004/0148004).
Regarding claim 24, the limitations of claim 20 are taught as described above. Neither Hartley nor Aklog nor Wallsten nor Levin teaches the limitations, however, Wallsten '004 does. Wallsten '004 teaches a distal balloon 8 in Figures 1-3, and further in p.[0070-0080], where distal balloon 8 is shown to be placed distal to balloon 5, wherein balloon 5 and 8 are reasonably considered to be the expandable member. Note that p.[0070] teaches that balloon 8 is arranged to be positioned during treatment via expansion of the balloon to contact surrounding tissue at a pressure sufficient to anchor the expandable member in place, and therefore teaches the limitation as described. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to employ the distal balloon of Wallsten '004 in Hartley/Aklog/Wallsten/Levin in order to improve placement of the device within the vessel and produces predictable results.
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Abigail M Bock whose telephone number is (571)272-8856. The examiner can normally be reached M-F 7:30am - 5:00pm.
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/ABIGAIL BOCK/Examiner, Art Unit 3794
/LINDA C DVORAK/Primary Examiner, Art Unit 3794