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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/05/2026 has been entered.
Response to Amendment
Claims 1-9, 18-19, 21-24, and 32-35 are pending in the present application. Claims 1-2, 5-7, 18-19, 21-24, 32-33, and 35 have been amended. Claim 20 has been cancelled.
Response to Arguments
Applicant’s arguments with respect to claims 1, 18, and 32 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 § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-9, 18-19, 21-24, and 32-35 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 1 and 32, the claim recites “a first expandable member desired to be positioned … against tissue to be treated” and then further recites “an outer expandable member disposed around the first expandable member and configured to expand against surrounding tissue …” therein. The specification lacks written description support for the first expandable member to be configured to be against tissue when it is within the outer expandable member as claimed.
Regarding claims 2-9 and 33-35, the rejections of claims 1 and 32 are taught as described above. Claims 2-9 and 33-35 are rejected due to inheriting the deficiencies on claim 1 and 32. Appropriate correction is required.
Regarding claim 18, the claim recites “… the outer expandable member configured to expand against surrounding tissue to anchor the inner expandable member at the site of interest and then further recites “… to retain the inner expandable member in at least one longitudinal position against the target tissue”. The specification lacks written description support for the first expandable member to be configured to be against tissue when it is within the outer expandable member as claimed.
Regarding claims 19 and 21-24, the rejection of claim 18 is taught as described above. Claims 19 and 21-24 are rejected due to inheriting the deficiencies of claim 18. Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation is: “a fluid control mechanism” in claims 1-2, and 32. See the three-prong analysis below.
The claim limitation uses a term that is a substitute for “means” (a fluid control mechanism) that has no structural meaning for performing a claimed function.
The term (a fluid control mechanism) is modified by functional language (configured to).
The term (a fluid control mechanism) is not modified by sufficient structure, material, or acts for performing the claimed function.
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2, 18-19, 21-22, and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Aklog (US Patent Publication 2016/0262823) herein after “Aklog”, Levin (US 2014/0371736) herein after “Levin”, further in view of Fogarty (US Patent No. 4,338,942) herein after “Fogarty”.
Regarding claim 1, 18, and 32, Aklog provides “for a system for treatment of tissue (p.[0003]), the system comprising:
a first 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 (inner balloon 1800),
a fluid delivery assembly configured to direct the fluid set at the temperature range into the first expandable member (infusion device 10, p.[0009,0035]),
the input configured to introduce the fluid into the first expandable member to circulate substantially along an entire length of the first expandable member and the output spatially situated from the input to permit fluid flow to be removed from within the first expandable member (p.[0035]),
a fluid control mechanism configured to circulate the fluid through the first 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 fluid control mechanism maintains substantially constant fluid pressure within the first expandable member during circulation, recirculation, and switching of the flow direction member (p.[0035, 0040, 0056-0057, 0059, and 0079]);
an outer expandable member disposed around the first expandable member and configured to expand against surrounding tissue to anchor the first expandable member at the site of interest (outer balloon 1801), and
a positioning mechanism including a handle configured to position the first expandable member within a lumen of an endoscope (a proximal portion of the device of Aklog that would necessarily be required to provide manipulation of the device, such as handle 703 in p.[0049]) such that rotation of the first expandable member is independent of rotation of the endoscope.”
Aklog, while providing for a majority of the structural and functional features, fails to provide that the fluid delivery assembly having an input and an output axially spaced along the first expandable member and fluidly coupled to ports disposed along the length of the first expandable member, and further fails to provide that the positioning mechanism/handle provides that and such that rotation of the first expandable member is independent of rotation the outer expandable member, during treatment of tissue while the outer member is expanded against the surrounding tissue.
Levin teaches “the fluid delivery assembly having an input and an output axially spaced along the first expandable member and fluidly coupled to the ports disposed along the length of the first expandable member (Fig. 2, p.[0128-0129])”. It is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have utilized an alternative structural connection of the fluid delivery assembly to have an input and output axially spaced along the first expandable member and coupled to the ports disposed along the length of the first expandable member to provide for even fluid distribution through an inflatable balloon and produces predictable results of even cooling of the treated tissue.
With respect to the positioning mechanism/handle provides that and such that rotation of the first expandable member is independent of rotation the outer expandable member, during treatment of tissue while the outer member is expanded against the surrounding tissue, this limitation is provided by Fogarty, an analogous catheter device. Fogarty provides for an exemplary positioning mechanism (20) in the form of a handle configured to position the first expandable member within a lumen of an endoscope such that rotation of the first expandable member is independent of rotation of the endoscope (20 functions to rotate the entirety of the device including the inner balloon 34 relative to a lumen within an endoscope). Fogarty further provides that rotation of the first expandable member is independent of rotation the outer expandable member during treatment of tissue while the outer member is expanded against the surrounding tissue (see figures 2/3 where the inner balloon 34 is capable being rotated independently and relative to 48).
Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have utilized an alternative structural connection at the proximal end of the device of Aklog/Levin to include the positioning mechanism and handle of Fogarty to 1) provide for an exemplary, known manner of providing overall control of the device, 2) provide for an exemplary manner of providing the requisite fluid connections between a source of fluid and the shaft of the device, and 3) to provide for an exemplary manner of deploying and subsequently deflating the inner, first expandable member of the device (See cols. 2 and 3 of Fogarty).
Regarding claim 2, the limitations of claim 1 are taught as described above. Aklog does not teach the claimed limitation, but Levin does in an analogous catheter device. Levin teaches the limitation “wherein the assembly includes an input fluid pathway (cold fluid delivery, hot fluid delivery) and an output fluid pathway (fluid extraction), and wherein the input fluid pathway extends from the fluid control mechanism to the input and the output fluid pathway extends from the fluid control mechanism to the output (Fig. 2, p.[0045], p.[0137])”. 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 assembly of Levin in Aklog. As stated in Levin (p.[0137]) “The simultaneous delivery and withdrawal of fluid maximizes the differential pressure across balloon 120 and enables high flow rate of fluids through balloon 120” and produces predictable results of maximizing fluid transfer through the balloon for temperature regulation.
Regarding claim 19, the limitations of claim 18 are taught as described above. Aklog/Fogarty 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 Aklog/Fogarty. Levin's system allows for an improvement in advancement and placement of the expandable member and produces predictable results.
Regarding claims 21-22, the limitations of claim 18 are taught as described above. Neither Aklog nor Levin teaches the limitation "further rotating the inner expandable member independent of the outer expandable member to treat additional tissue about a circumference of the lumen", or “further including translating the inner 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 Aklog/Levin to improve the placement of the device and treatment of tissue and produces predictable results.
Claims 3-6 and 33-35 are rejected under 35 U.S.C. 103 as unpatentable over Aklog in view of Levin and Fogarty, further in view of Hartley (US Patent Publication 2020/0253682).
Regarding claims 3 and 33-34, the limitations of claim 2 are taught as described above. Neither Aklog nor Levin nor Fogarty explicitly teach “wherein the input fluid pathway is disposed concentrically with the output fluid pathway” but Hartley does in an analogous catheter device. Hartley teaches this limitation in Fig. 56 and p.[0124]. 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 Hartley in Aklog/Levin/Fogarty to provide an exemplary, known manner of recirculating fluid and for providing an exemplary manner of providing heat exchange of fluid throughout the system and produce predictable results of circulating fluid through the system.
Note that while claims 3, 33, and 34 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 claims 33-34 for this reason.
Regarding claims 4 and 35, the limitations of claim 3 and 32 are described as taught above. Neither Aklog nor Levin nor Fogarty explicitly teach “wherein the output fluid pathway is arranged between an inner surface of an elongated member and an outer surface of the input fluid pathway”, but Hartley does in an analogous catheter device. 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. 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 Hartley in Aklog/Levin/Fogarty to provide an exemplary, known manner of recirculating fluid and for providing an exemplary manner of providing heat exchange of fluid throughout the system and produce predictable results of circulating fluid through the system.
Regarding claim 5, the limitations of claim 4 are taught as described above. Neither Aklog nor Levin nor Fogarty explicitly teach “wherein the input fluid pathway extends into the first expandable member to deliver fluid into the first expandable member, and a proximal end of the first expandable member is partially disposed within the output fluid pathway” but Hartley does in an analogous catheter device. Hartley teaches “wherein the input fluid pathway extends into the first expandable member to deliver fluid into the first expandable member (Fig. 56; p.[0124]; tube 127 is shown to extend through heat exchanger 101)” and “a proximal end of the first 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).” 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 Hartley in Aklog/Levin/Fogarty to provide an exemplary, known manner of recirculating fluid and for providing an exemplary manner of providing heat exchange of fluid throughout the system and produce predictable results of circulating fluid through the system.
Regarding claim 6, the limitations of claim 5 are taught as described above. Neither Aklog nor Levin nor Fogarty explicitly teach “wherein the proximal end of the first expandable member is adhered to an inner surface of the elongated member”, but Hartley does. 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)”. 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 Hartley in Aklog/Levin/Fogarty to provide an exemplary, known manner of recirculating fluid and for providing an exemplary manner of providing heat exchange of fluid throughout the system, and produce predictable results of circulating fluid through the system.
Claims 7-9, 19, and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Aklog, Levin, Fogarty, and Hartley, further in view of Wallsten (US Patent Publication 2013/0184791), herein after “Wallsten”.
Regarding claim 7, the limitations of claim 5 are taught as described above. Aklog/Levin/Fogarty/Hartley does not teach "wherein a portion of the input fluid pathway that is disposed within the first 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 in Aklog/Levin/Fogarty/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 of circulating fluid (p.[0038]).
Regarding claim 8, the limitations of claim 7 are taught as described above. Aklog/Levin/Fogarty/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 Aklog/Levin/Fogarty/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 of circulating fluid (p.[0038]).
Regarding claim 9, the limitations of claim 8 are taught as described above. Aklog/Levin/Fogarty/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 of circulating fluid (p.[0038]).
Claim 23 is rejected under 35 U.S.C 103 as being unpatentable over Aklog, Levin, and Fogarty, in view of Dobak (US Patent Publication 2008/0300585), herein after “Dobak”.
Regarding claim 23, the limitations of claim 18 are taught as described above. Neither Aklog, Levin, or Fogarty explicitly 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 Aklog/Levin/Fogarty. As stated in Dobak, this allows for improved thermal treatment of tissue and produces predictable results of improving heat transfer.
Claim 24 is rejected under 35 U.S.C 103 as being unpatentable over Aklog, Levin, and Fogarty, in view of Wallsten ‘004 (US Patent Publication 2004/0148004), herein after “Wallsten ‘004”.
Regarding claim 24, the limitations of claim 18 are taught as described above. Neither Aklog/Levin/Fogarty explicitly teaches “wherein the method further includes: expanding the distal balloon to contact surrounding tissue at a pressure sufficient to anchor the expandable member in place within the body, or expanding the distal balloon to dimensions greater than a diameter of a passageway within a body such that, when positioned beyond the passageway and expanded, such that the distal balloon is prevented from being pulled back through the passageway” but Wallsten ‘004 does in an analogous catheter device. 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 Aklog/Levin/Fogarty in order to improve placement of the device within the vessel and produces predictable results of more reliable placement of the device within the vessel.
Conclusion
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
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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