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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 December 18th, 2025 has been entered.
Response to Amendment
The amendment filed December 18th, 2025 has been entered. Applicant’s amendments to the claims have overcome the claim objection previously set forth in the Final Office Action mailed October 16th, 2025.
Response to Arguments
Applicant’s arguments with respect to claim(s) 90 & 108 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 Objections
Claims 90 & 108 objected to because of the following informalities:
Claim 90, lines 14-15: “radial force” should read --a radial force--,
Claim 108, line 20: “radial force” should read --a radial force--.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 99-100 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 99, the claim recites “energy” in line 3 and it is unclear if this is the same energy as recited in claim 98, from which claim 99 depends or is a different energy. for examination purposes, these are the same energies and the limitation will be interpreted as “the energy”.
Claim 100 is also rejected by virtue of its dependency on claim 99.
Regarding claim 100, the claim recites “energy” in line 3 and it is unclear if this is the same energy as recited in claim 98, from which claim 100 depends or is a different energy. for examination purposes, these are the same energies and the limitation will be interpreted as “the energy”.
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.
Claims 90, 93-95, 102-103 & 105 are rejected under 35 U.S.C. 103 as being unpatentable over Govari et al. (U.S. Pub. No. 20180280080, cited in IDS), herein referred to as “Govari” and further in view of Rizq et al. (U.S. Pub. No. 20130304052), herein referred to as “Rizq”.
Regarding claim 90, Govari discloses a catheter system (Abstract: A medical apparatus), comprising:
a catheter shaft (tubular shaft 60) having a proximal end portion (proximal end of tubular shaft 60) and a distal end portion (distal end of tubular shaft 60), the catheter shaft defining a lumen (lumen not given a numerical call out but [0039]: balloon 36 comprises a main aperture 78 at proximal pole region 64 that connects the balloon to tubular shaft 60 (i.e., for inflation/deflation); wherein this describes tubular shaft 60 as being hollow for inflation/deflation of balloon 36 & see Fig. 3);
a balloon (balloon 36) including a proximal section (proximal side 70) and a distal section (distal side 72), wherein the proximal section of the balloon is coupled to the distal end portion of the catheter shaft ([0037]: Balloon 36 is affixed to a tubular shaft 60; see Fig. 3 where this section of the balloon is proximal side 70), the balloon defines a volume in fluid communication with the lumen ([0039]: balloon 36 comprises a main aperture 78 at proximal pole region 64 that connects the balloon to tubular shaft 60 (i.e., for inflation/deflation)), and the balloon is formed of a deformable material and is configured to be movable between a collapsed state and an expanded state ([0029]: Balloon 36 is typically formed from biocompatible material such as polyethylene terephthalate (PET), polyurethane, Nylon, or Pebax; [0040]: medical probe 22 has a diameter of 2.5 millimeters, and balloon 36 can have a diameter of up to eight millimeters when inflated. In a non-inflated state, balloon 36 can be retracted into the medical probe);
at least one ablation electrode (ablation electrodes 56) on an outer surface of the balloon extending between the proximal section and the distal section of the balloon ([0041]: ablation electrodes 56B are attached to balloon 36 and encompass both proximal side 70 and distal side 72; see Figs. 2 & 3 where electrode 56 extend between the proximal side 70 and distal side 72); and
a through structure (electrodes 44 & their corresponding wires ([0042])) extending into the volume of the balloon, through the distal section of the balloon, and terminating in a distal portion thereof located outside of the volume of the balloon, wherein the distal portion of the through structure is electrically insulated from the at least one ablation electrode ([0029]: Balloon 36 is typically formed from biocompatible material such as polyethylene terephthalate (PET), polyurethane, Nylon, or Pebax; [0034]: ablation electrodes 56 have non-polygonal shapes, and microelectrodes 44 are positioned in “islands” within the ablation electrodes. Electrodes 44 and 56 can be fabricated with the balloon and typically comprise gold overlaying the exterior wall of balloon 36; [0042]: For simplicity, connections of electrodes 56 and microelectrodes 44 to interface and module 58 are not shown. In some embodiments, the connections are made by wires (not shown) running from the inside of the balloon to the outer surface of the balloon; wherein this describes a structure where the electrodes 44 are electrically insulated from the ablation electrodes 56), and wherein the through structure is flexible and adapted to bend in response to radial force on the balloon ([0029]: Balloon 36 is typically formed from biocompatible material such as polyethylene terephthalate (PET), polyurethane, Nylon, or Pebax; [0041]: In a non-inflated state, balloon 36 can be retracted into the medical probe; wherein being able to be retracted into a medical probe, this is seen as the balloon and microelectrodes as being flexible and adapted to bend in response to radial force on the probe (the retraction into the probe)).
But Govari fails to explicitly disclose the through structure extending longitudinally from within the distal end portion of the catheter shaft into the volume of the balloon.
However, Rizq discloses the through structure (sensor 26 & lead 30) extending longitudinally from within the distal end portion of the catheter shaft into the volume of the balloon ([0040]: lead 30 may be a printed or applied lead that is disposed along, for example, the exterior of balloon 22 and/or shaft 34 … a flexible applied (and/or printed) lead, itself, may be used as sensor 26; see Fig. 2 where leads 30 are shown as within shaft distal end 34 but within the volume of balloon 22).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the through structure of Govari to be longitudinally extending and to be flexible, as taught by Rizq, for the purpose of the location enabling sensing desired parameters at the balloon, tissue, or both as well as at locations between the balloon and tissue (Rizq: [0039]).
Regarding claim 93, Govari discloses an introducer sheath (probe 22) defining a sheath lumen (lumen 62), wherein the introducer sheath is configured to constrain the balloon and the at least one ablation electrode in a collapsed configuration having a diameter less than an internal diameter of the introducer sheath when located axially within the sheath lumen ([0041]: In a non-inflated state, balloon 36 can be retracted into the medical probe. The inventors have found that using these dimensions, the balloon can form its non-elongated spherical shape when inflated, yet retract to fit within probe 22 when deflated)
Regarding claim 94, Govari discloses wherein in the expanded state, a body of the balloon has a spherical shape in absence of an externally applied force ([0040]: Furthermore, distal side 72 has a continuously smooth surface (i.e., there are no large apertures on the distal side) and balloon 36 has a non-elongated spherical shape when inflated see Fig. 2 where the neutral position is a spherical shape & no forces are being applied).
Regarding claim 95, Govari discloses wherein the at least one ablation electrode and the balloon are configured to be locally deformable at a contact region thereof in response to forces resulting from contact of the at least one ablation electrode and body at a target site ([0027]: varying the inflation pressure in the balloon impacts the compliance and size of the balloon, which therefore impacts the percentage of surface area of the electrode that is in contact with tissue in a body cavity; [0048]: In embodiments of the present invention, the inflation pressure in balloon 36 influences the compliancy of the balloon … In FIG. 5, the balloon is inflated using a low inflation pressure, thereby making the balloon smaller and presenting less electrodes towards the distal face of the balloon (i.e., less electrodes make contact with the tissue); wherein this describes a structure with higher compliancy and this is seen as being capable of being locally deformable).
Regarding claim 102, Govari discloses a guidewire, wherein the catheter shaft is configured to be delivered to a target side using the guidewire ([0029]: During a medical procedure, a medical professional 32 inserts medical probe 22 into a biocompatible sheath (not shown) that has been pre-positioned in a body cavity (e.g., a chamber of heart 28); wherein the biocompatible sheath is seen as a guidewire).
Regarding claim 103, Govari discloses wherein the catheter shaft is configured to be steerable ([0029]: a medical professional 32 inserts medical probe 22 into a biocompatible sheath (not shown) that has been pre-positioned in a body cavity (e.g., a chamber of heart 28) of the patient so that an inflatable balloon 36 (FIG. 2) affixed to distal end 26 of the medical probe enters the body cavity).
Regarding claim 105, Govari discloses wherein the at least one ablation electrode (ablation electrode 56) extends along the distal section of the balloon and is configured to abut heart tissue independent of an orientation of the distal section of the balloon to tissue ([0041]: ablation electrodes 56A and 56B. In embodiments of the present invention, ablation electrode 56A is attached to balloon 36 (i.e., as indicated by arrows 76) so that ablation electrode 56A extends over at least 50% of an area on distal side 72 that is within 30° of arc from distal pole 66. In some embodiments, ablation electrode 56A can extend over at least 75% of the area on distal side 72 that is within 30° of arc from distal pole 66. In additional embodiments, the shape of ablation electrode 56A is symmetrical around distal pole 66. In the example shown in FIG. 3, ablation electrodes 56B are attached to balloon 36 and encompass both proximal side 70 and distal side 72).
Claims 91-92 are rejected under 35 U.S.C. 103 as being unpatentable over Govari in view of Rizq as applied to claim 90 above, and further in view of Basu et al. (U.S. Pub. No. 20180161093, previously cited), herein referred to as “Basu”.
Regarding claim 91, while Govari utilizes microelectrodes 44 to sense positions, Govari fails to disclose a shaft electrode or sensor on the distal end portion of the catheter shaft.
However, Basu discloses a shaft electrode or sensor (electromagnetic position sensor 88) on the distal end portion of the catheter shaft ([0066]: An interior 87 of the housing 85 houses an electromagnetic position sensor 88; wherein housing 85 is part of the distal portion of expander 90 which is a portion of shaft 70 & see Fig. 10). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the catheter system of Govari in view of Rizq to include a shaft electrode or sensor, as taught by Basu, for the purpose of the shaft electrode or position sensor enabling the generation of electrical signals representative of the position of the distal end of the shaft (Basu: [0067]).
Regarding claim 92, Govari in view of Rizq and Basu discloses wherein the shaft electrode or sensor (Basu: electromagnetic position sensor 88) includes one or more coils configured to detect magnetic field signals to determine a position of the distal end portion of the catheter shaft ([0050]: processor 46 may use a magnetic tracking method, wherein magnetic transmitters 25x, 25y and 25z external to the patient 18 generate signals in coils positioned in the distal end of the probe 20; [0066]: An interior 87 of the housing 85 houses an electromagnetic position sensor 88).
Claim 96 is rejected under 35 U.S.C. 103 as being unpatentable over Govari in view of Rizq as applied to claim 90 above, and further in view of Byrd (U.S. Pub. No. 20200008869), herein referred to as “Byrd”.
Regarding claim 96, Govari discusses the wiring ([0042]) but fails to explicitly disclose a conductor extending from the catheter shaft, through an interior portion of the balloon and to the at least one ablation electrode, wherein the conductor is configured to be connected to a source of electrical energy to be delivered to the at least one ablation electrode.
However, Byrd discloses a conductor (electrical leads 845) extending from the catheter shaft, through an interior portion of the balloon and to the at least one ablation electrode, wherein the conductor is configured to be connected to a source of electrical energy to be delivered to the at least one ablation electrode ([0062]: the direct current is generated (by a signal generator) at a distal end of the catheter (outside the patient's body) and travels along two electrical leads 845.sub.A-B through the catheter shaft and the ablation balloon 801, and into contact with the conductive portion 838). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the catheter system of Govari in view of Rizq to include a conductor, as taught by Byrd, for the purpose of providing electrical coupling between a signal generator and an ablation electrode ([0062]).
Claim 97 is rejected under 35 U.S.C. 103 as being unpatentable over Govari in view of Rizq and Byrd as applied to claim 96 above, and further in view of Swanson et al. (U.S. Pat. No. 5797903, cited in IDS), herein referred to as “Swanson”.
Regarding claim 97, Govari in view of Rizq and Byrd fails to disclose an internal electrode within the balloon and spaced radially inwardly from the proximal section of the balloon and electrically isolated from the at least one ablation electrode.
However, Swanson discloses an internal electrode (interior electrode 30) within the balloon (body 22) and spaced radially inwardly from the proximal section of the balloon (see Fig. 14; Col. 19, lines 10-12: The structure 70 includes an expandable-collapsible body 22, as previously described, containing the interior electrode 30) and electrically isolated from the at least one ablation electrode (nonporous regions 72; Col. 20, lines 30-33: the signal wires serving the region 72 are electrically coupled to the generator 40 to convey radio frequency energy for transmission by one or more regions 72; Col. 7, lines 13-15: the transmitted energy can pass through tissue to an adjacent electrode in the heart chamber (forming a bipolar arrangement)). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the catheter system of Govari in view of Rizq and Byrd to include the internal electrode, as taught by Swanson for the purpose of the internal electrode enabling electric current to be carried by the ions within the pores of the balloon and the RF currents provided by the ions result in no net diffusion of ions, as would occur if a DC voltage were applied (Swanson: Col. 7, lines 1-5).
Claims 98-101 & 104 are rejected under 35 U.S.C. 103 as being unpatentable over Govari in view of Rizq as applied to claim 90 above, and further in view of Stewart et al. (U.S. Pat. No. 9387031, previously cited), herein referred to as “Stewart”.
Regarding claim 98, while Govari discloses an ablation generator (ablation module 58) coupled to the at least one ablation electrode ([0035]: Ablation module 58 is configured to monitor and control ablation parameters such as the level and the duration of ablation power (e.g., radio-frequency energy) conveyed to ablation electrodes 56), Govari fails to disclose an ablation generator coupled to the at least one ablation electrode and configured to provide a series of energy pulses to the at least one ablation electrode, wherein the at least one ablation electrode is configured to deliver energy to target tissue based on the series of energy pulses.
However, Stewart discloses an ablation generator (treatment energy source 58) coupled to the at least one ablation electrode (mesh 34) and configured to provide a series of energy pulses to the at least one ablation electrode (Col. 9, lines 26-29: treatment energy source 58 may provide electrical pulses to the medical device 12, such as the mesh 34 or electrically conductive portions thereof and/or the electrodes 37, to perform an electroporation procedure), wherein the at least one ablation electrode is configured to deliver energy to target tissue based on the series of energy pulses (Col. 12, lines 41-44: the medical device may be operated to deliver electroporating energy pulses through the conductive portions of the mesh 34 or arms 35 to achieve IEP of the targeted tissue). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the ablation generator of Govari in view of Rizq to be the ablation generator of Stewart for the purpose of the electroporation biphasic electrical pulses avoid the possible drawbacks of monophasic electrical pulses including: 1) atrial or ventricular fibrillation, 2) less effective in making lesions through fat, 3) propensity to make thermal lesions on the anode side of an electrode pair, and 4) prolonged muscle excitation (Stewart: Col. 10, lines 27-32).
Regarding claim 99, Govari in view of Rizq fails to disclose a return electrode coupled to the ablation generator and configured to be placed on an outer surface of a patient's body to complete a circuit for delivery of energy.
However, Stewart discloses a return electrode coupled to the ablation generator and configured to be placed on an outer surface of a patient's body to complete a circuit for delivery of energy (Col. 9, lines 16-21: monopolar or unipolar energy delivery to one or more of the electrodes or electrically-conductive portions on the medical device 12 within a patient's body and through a patient return or ground electrode (not shown) spaced apart from the electrodes of the medical device 12, such as on a patient's skin). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the catheter system of Govari in view of Rizq to include a return electrode, as taught by Stewart, for the purpose of forcing the provided electroporating, pulsed energy to travel deeper in the periphery of the frozen tissue and promote deeper tissue destruction and ablation (Stewart: Col. 13, lines 45-47).
Regarding claim 100, Govari in view of Rizq fails to disclose a catheter interface unit configured to provide an indication of impedance between the at least one ablation electrode and the return electrode during the delivery of energy.
However, Stewart discloses a catheter interface unit (control unit 14; Col. 01, lines 6-67: control unit 14 may include an impedance measurement module) configured to provide an indication of impedance between the at least one ablation electrode and the return electrode during the delivery of energy (Col. 11, lines 3-7: An excitation current may be applied between one or more of the junctions 38 on the medical device 12 and/or a patient return electrode, and the resulting impedance may be measured and recorded at multiple locations of the mesh 34; lines 13-18: The resulting measurements or recordings can thus be used to assess whether specific portions of the mesh 34 are in contact with a targeted tissue area, and the resulting treatment may be modified accordingly based on the assessed contact to direct therapeutic or treatment energies or methods towards the contacted sector or region of the device 12). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the catheter system of Govari in view of Rizq to include a catheter interface unit, as taught by Stewart for the purpose of assessing whether specific portions of the device are in contact with a targeted tissue area, and the resulting treatment may be modified accordingly based on the assessed contact to direct therapeutic or treatment energies or methods towards the contacted sector or region of the device (Stewart: Col. 11, lines 13-18).
Regarding claim 101, Govari in view of Rizq and Stewart discloses wherein the at least one ablation electrode is configured to deliver electroporation energy to target tissue based on the series of energy pulses (Stewart: Col. 12, lines 41-44: the medical device may be operated to deliver electroporating energy pulses through the conductive portions of the mesh 34 or arms 35 to achieve IEP of the targeted tissue).
Regarding claim 104, Govari in view of Rizq fails to disclose a control unit connected to one or more sensing electrodes, wherein the control unit is configured to:
receive measures of an electrical parameter sensed by the sensing electrodes, and based on the measures of the electrical parameter, determine at least one of:
a characteristic of contact between the outer surface of the balloon and tissue of a patient, and
a characteristic of an ablation of the tissue at the contact between the tissue and the outer surface of the balloon.
However, Stewart discloses a control unit (control unit 14) connected to one or more sensing electrodes (Col. 10, lines 66-67 & Col. 11, lines 1-3: control unit 14 may include an impedance measurement module or signal processing unit 60 to measure one or more impedance characteristics between the selected portions or regions of the mesh 34), wherein the control unit is configured to:
receive measures of an electrical parameter sensed by the sensing electrodes, and based on the measures of the electrical parameter (Col. 11, lines 3-7: An excitation current may be applied between one or more of the junctions 38 on the medical device 12 and/or a patient return electrode, and the resulting impedance may be measured and recorded at multiple locations of the mesh 34), determine at least one of:
a characteristic of contact between the outer surface of the balloon and tissue of a patient (Col. 11, lines 13-15: The resulting measurements or recordings can thus be used to assess whether specific portions of the mesh 34 are in contact with a targeted tissue area), and
a characteristic of an ablation of the tissue at the contact between the tissue and the outer surface of the balloon.
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the catheter system of Govari in view of Rizq to include the control unit of Stewart for the purpose of the control unit enabling resulting measurements or recordings can thus be used to assess whether specific portions of the mesh are in contact with a targeted tissue area, and the resulting treatment may be modified accordingly based on the assessed contact to direct therapeutic or treatment energies or methods towards the contacted sector or region of the device (Stewart: Col. 11, lines 13-18).
Claims 106-107 are rejected under 35 U.S.C. 103 as being unpatentable over Govari in view of Rizq as applied to claim 90 above, and further in view of Claude et al. (U.S. Pub. No. 20170143201, cited in IDS), herein referred to as “Claude”.
Regarding claim 106, Govari discloses wherein a body of the balloon comprises silicone, fluorosilicone, urethane, polyethylene, thermoplastic polyurethane, polyvinyl chloride, polyethylene terephthalate, nylon, polyurethane, and/or combinations thereof ([0029]: Balloon 36 is typically formed from biocompatible material such as polyethylene terephthalate (PET), polyurethane, Nylon, or Pebax) but fails to disclose wherein the body of the balloon has a wall thickness of 0.20 mm or less.
However, Claude discloses wherein a body of the balloon has a wall thickness of 0.20 mm or less ([0074]: flexible membrane 12 can be about 0.001″ to about 0.002″ in thickness; wherein this converts to 0.0254 mm to 0.0508 mm) and comprises silicone, fluorosilicone, urethane, polyethylene, thermoplastic polyurethane, polyvinyl chloride, polyethylene terephthalate, nylon, polyurethane, and/or combinations thereof ([0074]: membrane 12 has an expandable structure and can be constructed of materials such as those materials used in the construction of balloon catheters known in the art, including, but not limited to polyvinyl chloride (PVC), polyethylene (PE), cross-linked polyethylene, polyolefins, polyolefin copolymer (POC), polyethylene terephthalate (PET), nylon, polymer blends, polyester, polyimide, polyamides, polyurethane, silicone, polydimethylsiloxane (PDMS) and the like). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the body of the balloon of Govari in view of Rizq to the thickness of Claude for the purpose of that thickness providing sufficient burst strength and allowing for foldability (Claude: [0074]).
Regarding claim 107, Govari in view of Rizq fails to disclose wherein a body of the balloon further comprises a radiopaque additive.
However, Claude discloses wherein a body of the balloon further comprises a radiopaque additive ([0079]: The electrodes 14 can be a thin film of an electro-conductive or optical ink. The ink can be polymer-based for better adhesion to the membrane. The electrode material can be a biocompatible, low resistance metal such as silver, silver flake, gold, and platinum which are additionally radiopaque). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the body of the balloon of Govari in view of Rizq to comprise a radiopaque additive for the purpose of enhancing visualization under fluoroscopy (Claude: [0079]).
Claim 108 is rejected under 35 U.S.C. 103 as being unpatentable over Basu in view of Byrd.
Regarding claim 108, Basu discloses a catheter system (catheter 24; Abstract: An irrigated balloon catheter), comprising:
a catheter shaft (catheter body 17) having a proximal end portion (intermediate section 19) and a distal end portion (shaft 70), the catheter shaft defining a shaft lumen ([0054]: the shaft 70 has a central lumen 74);
a balloon (balloon 80) including a body having a proximal section (proximal half of balloon 80 including proximal end 80P) and a distal section (distal half of balloon 80 and including distal end 80D), wherein the proximal section of the body is coupled to the distal end portion of the catheter shaft ([0053]; the balloon 80 extends at the distal end of the catheter 24; see Fig. 3), the body of the balloon defines a volume in fluid communication with the lumen ([0054]: balloon 80 may be inflated and deflated by injection and expulsion of a fluid such as saline solution through the catheter shaft), and the balloon is formed of a deformable material ([0054]: the inflatable balloon 80 has an exterior wall or membrane 26 of a bio-compatible material, for example, formed from a plastic such as polyethylene terephthalate (PET), polyurethane or PEBAX®) and is configured to be movable between a collapsed state and an expanded state ([0054]: The balloon 80 is deployed, in a collapsed uninflated configuration, via the lumen 23 of the probe 20, and may be inflated after exiting from the distal end 22), wherein in the expanded state, the body of the balloon has a spherical shape in the absence of an externally applied force ([0062]: (3) a more neutral configuration N (solid lines) where the expander 90 is in between its distal and proximal positions; see Fig. 2A where the neutral position is a spherical shape & no forces are being applied);
at least one ablation electrode (contact electrodes 33) on an outer surface of the balloon (see contact electrodes 33 on the outside surface of balloon 80 in Fig. 3) extending between the proximal section and the distal section of the body of the balloon (see Fig. 3 where contact electrode 33 extends from the proximal and distal sections of the balloon), wherein a distal portion of the at least one ablation electrode extends along the distal section of the balloon and is configured to contact heart tissue and deform in response to an axial contact force on the balloon by the heart tissue (see Fig. 3; [0055]: The membrane 26 supports and carries a combined electrode and temperature sensing member which is constructed as a multi-layer flexible circuit electrode assembly 84; [0057]: For each leaf 30, an outer surface 36 of the substrate 34 supports and carries a contact electrode 33 adapted for tissue contact with the ostium; wherein this describes a structure capable of contacting heart tissue to deform and in response to an axial contact force on the balloon by the heart tissue), and a lateral portion of the at least one ablation electrode extends along a lateral portion of the balloon and is configured to contact heart tissue and deform in response to a side-contact force on the balloon by the heart tissue (see Fig. 3; [0055]: The membrane 26 supports and carries a combined electrode and temperature sensing member which is constructed as a multi-layer flexible circuit electrode assembly 84; [0057]: For each leaf 30, an outer surface 36 of the substrate 34 supports and carries a contact electrode 33 adapted for tissue contact with the ostium; wherein this describes a structure capable of contacting heart tissue and deform in response to a side-contact force on the balloon by the heart tissue); and
a tubular member (irrigation tubing 44) extending longitudinally from the shaft lumen and into the volume of the body ([0064]: Throughout the length of the catheter shaft, the proximal portion 90A of the expander 90 passes through a lumen 45 of an irrigation tubing 44 (see FIG. 2B and FIG. 9) which is longitudinally coextensive with the expander between the proximal end 80P of the balloon and into the control handle 16),
But Govari fails to disclose a tubular member extending longitudinally from the shaft lumen and into the volume of the body of the balloon and terminating in a distal portion located outside of the volume of the body of the balloon, wherein the tubular member is flexible and adapted to bend in response to radial force on the balloon.
However, Byrd discloses a tubular member (catheter shaft 231 in Fig. 2, catheter shafts 631, 731 in Figs. 6-7; [0024]: Referring now to the drawings wherein like reference numerals are used to identify similar components in the various views) extending longitudinally from the shaft lumen and into the volume of the body of the balloon and terminating in a distal portion located outside of the volume of the body of the balloon ([0037]: the ablation balloon catheter 231 may include mapping electrodes at proximal and distal ends of ablation balloon, 240 and 238, respectively; [0041]: being carried on ablation balloon catheter 231, mapping electrodes; [0057]: central lumen 641 of ablation balloon catheter 631; see Figs. 6-7 where the lumens 641, 741 extend longitudinally from the catheters 631, 731, respectively & through the lumens of the balloons 601, 701, respectively, and terminate outside of the balloons), wherein the tubular member is flexible and adapted to bend in response to radial force on the balloon ([0037]: As shown in FIG. 2, an ablation balloon catheter 231 may be introduced into the left atrium 212L by an introducer sheath 230. A guidewire 232 and catheter shaft 234 may guide the ablation balloon 236, once introduced into the left atrium 212L by the introducer sheath 230; [0044]: FIG. 3 shows an ablation balloon catheter 331 including an ablation balloon 336 advancing into an antrum of pulmonary vein 314 (by extending out of introducer sheath 330); [0048]: FIG. 4 shows ablation balloon catheter 431 with ablation balloon 436 in position near target pulmonary vein 414 prior to balloon deployment; wherein this delivery configuration transportation includes bending of shafts 234/334/434 and lumens 641/741 that are positioned within shafts 631/731).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the catheter system of Govari to include a tubular member, as taught by Byrd, for the purpose of the flexibility enabling movement within a patient’s body and the tubular member enabling use of a guidewire such that both are manipulated until the distal tip of the ablation balloon catheter is directed toward the target pulmonary vein, after which the ablation balloon is extended into the pulmonary vein (Byrd: [0031], [0039]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Abigail M Ziegler whose telephone number is (571)272-1991. The examiner can normally be reached M-F 8:30 a.m. - 5 p.m. EST.
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/ABIGAIL M ZIEGLER/Examiner, Art Unit 3794
/THOMAS A GIULIANI/Primary Examiner, Art Unit 3794