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
Claims 1 and 14 have been amended in the claims filed 03/02/2025. Claims 1-24 are pending for review.
Response to Arguments
Applicant’s arguments, see Remarks, filed 03/02/2026, with respect to the rejection of claims 1, 3, 8, and 11-12 as anticipated under 35 U.S.C. 102(a)(2) by U.S. Patent No. 5,743,900 (Hara) have been fully considered and are persuasive. Hara does not teach the amended claim limitation “wherein the heated element is configured to self-expand to surround at least a portion of the thrombus to apply heat to the thrombus”. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of Everson (US 2011/0130756).
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/02/2026 was filed after the mailing date of the Non-Final Office Action on 10/10/2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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, 3, 8, and 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Hara (US Patent No. 5,743,900) in view of Everson (US 2011/0130756).
Regarding claim 1, Hara teaches “A thermal device configured to apply heat to a thrombus (Fig. 1, 2),” “the thermal device comprising: an outer tube (mandril 18) comprising a distal portion (20)”, “a heated element (26) disposed at the distal portion of the outer tube (Fig. 2)”, “and one or more conduits (40a) configured to apply an electrical current to the heated element to raise a temperature of the heated element to apply heat to a thrombus (Fig. 2, Col. 1, lines 6-10; col. 2, lines 54-58; col.3 lines 8-35)”. Hara does not teach that “the heated element is configured to self-expand to surround at least a portion of the thrombus to apply heat to the thrombus”, however, Everson does in an analogous vasculature device. Everson teaches in p.[0003] that it is known to use self-expanding structures to treat a thrombus and encompass/surround a portion of the thrombus (Fig. 7), and moreover, that electrical energy can be used to heat a thrombus (p.[0010]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the system of Everson with Hara. As stated in Everson, the use of self-expanding structures can be used to dredge a vessel or remove a stone (p.[0003]) and produces predictable results.
Regarding claim 3, the limitations of claim 1 are taught as described above. Hara teaches “wherein the heated element comprises a loop” with coil electrode 26, which comprises multiple loops as described in col. 3, line 31, where a spring is considered to be a series of multiple loops under broadest reasonable interpretation and therefore teaches the limitation as described.
Regarding claim 8, the limitations of claim 1 are taught as described above. Hara teaches “further comprising a temperature sensor” in col. 3, lines 39-53, which describes a thermocouple temperature sensor which is considered to be a temperature sensor under broadest reasonable interpretation and therefore teaches the limitation as described.
Regarding claims 11-12, the limitations of claim 1 are taught as described above. Hara teaches “further comprising an expandable device configured to be expanded proximally of the thrombus” and “wherein the expandable device comprises a balloon” in Figure 3, which shows balloon 14 expanded proximally of the thrombus and therefore teaches the limitation as described.
Claims 2, 14-21, and 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over Hara (US Patent No. 5,743,900) in view of Everson (US 2011/0130756) and Kasprzyk (US Patent No. 5,114,423).
Regarding claims 2 and 23, the limitations of claim 1 are taught as described above. Hara/Everson does not teach an inner tube disposed within the outer tube that is configured to receive a guidewire, wherein the thermal device is configured to be advanced over the guide wire, but Kasprzyk does. In an analogous electrosurgical device, Kaspryk teaches this limitation in Fig. 1 with inner tube 14 and thermal device 12. It would have been obvious to one of ordinary skill in the art to use the system of Kaspryk in Hara, as it is well known in the art for percutaneous catheters to be positioned by advancement over a guidewire. To further exemplify this point, the Examiner cites Rashidi, US 2005/0187456, in particular Fig. 1, p.[0025]. The addition of an inner tube having a guidewire lumen would be an obvious and straightforward modification of Hara in view of Kasprzyk.
Regarding claim 23 specifically, the limitations of claim 23 are taught by the limitations of claims 1-2. MPEP 2112.02 I states that “Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986)”. The device of claims 1-2 inherently performs the method of claim 23, therefore the rejection of claims 1-2 teaches the rejection of claim 23 as outlined above.
Regarding claims 14 and 24, Hara teaches “an expandable assembly comprising an expandable device, the expandable device configured to be expanded proximally of a thrombus” in Fig. 3, which shows balloon 14 expanded proximally of a thrombus. Hara teaches a heated element 26, but does not teach “the thermal assembly configured to be advanced distally over a guide wire and out of the expandable assembly to apply heat to the thrombus with the heated element”, but Kasprzyk does. In an analogous electrosurgical device, Kaspryk teaches this limitation in Fig. 1 with inner tube 14 and thermal device 12. It would have been obvious to one of ordinary skill in the art to use the system of Kaspryk in Hara, as it is well known in the art for percutaneous catheters to be positioned by advancement over a guidewire. To further exemplify this point, the Examiner cites Rashidi, US 2005/0187456, in particular Fig. 1, p.[0025]. The addition of an inner tube having a guidewire lumen would be an obvious and straightforward modification of Hara in view of Kasprzyk. Hara/Kasprzyk does not teach that “the heated element is configured to self-expand to surround at least a portion of the thrombus to apply heat to the thrombus”, however, Everson does in an analogous vasculature device. Everson teaches in p.[0003] that it is known to use self-expanding structures to treat a thrombus and encompass/surround a portion of the thrombus (Fig. 7), and moreover, that electrical energy can be used to heat a thrombus (p.[0010]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the system of Everson with Hara. As stated in Everson, the use of self-expanding structures can be used to dredge a vessel or remove a stone (p.[0003]) and produces predictable results.
Regarding claim 24 specifically, the limitations of claim 23 are taught by the limitations of claim 14. MPEP 2112.02 I states that “Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986)”. The device of claim 14 inherently performs the method of claim 24, therefore the rejection of claim 14 teaches the rejection of claim 24 as outlined above.
Regarding claim 15, the limitations of claim 14 are taught as described above. Hara teaches “wherein the thermal assembly further comprises one or more conduits configured to apply an electrical current to the heated element to raise a temperature of the heated element” with one or more conduits (40a) configured to apply an electrical current to the heated element to raise a temperature of the heated element to apply heat to a thrombus (Fig. 2, Col. 1, lines 6-10; col. 2, lines 54-58; col.3 lines 8-35), therefore teaching the limitation as described.
Regarding claim 16, the limitations of claim 14 are taught as described above. Hara teaches “wherein the expandable device is a balloon” in Figure 3, with balloon 14 expanded proximally of a thrombus.
Regarding claim 17, the limitations of claim 14 are taught as described above. Hara teaches “wherein the heated element comprises a loop” with coil electrode 26, which comprises multiple loops as described in col. 3, line 31, where a spring is considered to be a series of multiple loops under broadest reasonable interpretation and therefore teaches the limitation as described.
Regarding claims 18-20, the limitations of claim 17 are taught as described above. Hara discloses a temperature sensor attached to the coil 26 to at least monitor that the catheter tip is being optimally heated (col. 3, lines 39-47). However, Hara does not describe that the temperature sensor is located in a hollow lumen (or tube) of the loop. However, the arrangement of the loop/tube/hollow lumen is a mere matter of design choice and does not provide any technical advantage, nonobvious result, or patentable material that is advantageous over the external coil sensor of Hara. Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the controller 40 of Hara to modulate applied current based on the sensed temperature, as suggested in col. 5, lines 41-51.
Regarding claim 21, the limitations of claim 14 are taught as described above. Hara teaches “further comprising a temperature sensor” in col. 3, lines 39-53, which describes a thermocouple temperature sensor and therefore teaches the limitation as described.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Hara (US Patent No. 5,743,900) in view of Everson (US 2011/0130756) and Rafiee (US Patent Publication 2022/0054186).
Regarding claim 4, the limitations of claim 3 are taught as described above. Hara/Everson does not teach that the loop comprises a nickel titanium alloy, but Rafiee does in an analogous electrosurgical device. Rafiee teaches a similar heated element, snare 1520, comprises NiTi alloy, the same material thereby implicit to the embodiment already discussed (Figs. 10A, 10C, p.[0038]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a nickel-titanium alloy, as taught in Rafiee, in Hara. Nickel-titanium alloys are well known in the art as suitable material for a heated element and produces predictable results.
Claims 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Hara (US Patent No. 5,743,900) in view of Everson (US 2011/0130756).
Regarding claims 5-7, the limitations of claim 1 are taught as described above. Hara discloses a temperature sensor attached to the coil 26 to at least monitor that the catheter tip is being optimally heated (col. 3, lines 39-47). However, Hara/Everson does not describe that the temperature sensor is located in a hollow lumen (or tube) of the loop. However, the arrangement of the loop/tube/hollow lumen is a mere matter of design choice and does not provide any technical advantage, nonobvious result, or patentable material that is advantageous over the external coil sensor of Hara. Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the controller 40 of Hara to modulate applied current based on the sensed temperature, as suggested in col. 5, lines 41-51.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Hara (US Patent No. 5,743,900) in view of Everson (US 2011/0130756) and Townley (US Patent Publication 2021/0315634).
Regarding claim 9, the limitations of claim 1 are taught as described above. Hara/Everson does not teach "further comprising an electrode to sense leaked current", however, Townley does in an analogous electrosurgical device. Townley teaches in p.[0170] that "Electrical stimuli (e.g., constant or pulsed currents at one or more frequencies) are applied to the tissue by one or more electrodes 136 at or near the treatment site, and the voltage and/or current differences at various different frequencies between various pairs of electrodes 136 of the end effector 114 may be measured to produce a spectral profile or map of the detected bioelectric potential, which can be used to identify different types of tissues (e.g., vessels, neural structures, and/or other types of tissue) in the region of interest. For example, current (i.e., direct or alternating current) can be applied to a pair of electrodes 136 adjacent to each other and the resultant voltages and/or currents between other pairs of adjacent electrodes 136 are measured." Note that Townley demonstrates that the electrode is capable of measuring "leaked current" in the form of current differences after applying a voltage/current via the electrodes. 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 electrode of Townley in Hara. As stated in Townley, the resultant current and voltage can be used to determine the type of tissue being contacted or ablated, and produces predictable results.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Hara (US Patent No. 5,743,900) in view of Everson (US 2011/0130756), Townley (US Patent Publication 2021/0315634) and Rafiee (US Patent Publication 2022/0054186).
Regarding claim 10, the limitations of claim 9 are taught as described above. Neither Townley nor Hara/Everson teaches an electrode as a marker for visualization, but Rafiee does in an analogous electrosurgical device. Rafiee shows in Fig. 14 a marker band of the guidewire (p.[0046, 0067, 0081]), but does not teach that the electrode is a marker for visualization. However, it is the Examiner's position that 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 marker band of the guidewire in conjunction with the electrode for identifying the position of the electrode, in an analogous fashion to identifying the position of the guidewire. It is known in the art that it is advantageous to have a visual marker on various components of the device to determine the position of the device during use and while in the human body, and such modifications produce predictable results.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Hara (US Patent No. 5,743,900) in view of Everson (US 2011/0130756).
Regarding claim 13, the limitations of claim 11 are taught as described above. Hara does not explicitly teach “wherein the expandable device comprises a lumen through which the outer tube is configured to be advanced”, however, Hara does teach this limitation implicitly. The outer tube 18 is able to be advanced through lumen 16 of the balloon catheter 12 (see Fig. 2, col. 3, lines 24-28, the thermal assembly mandrel 18 being Teflon coated for manipulability and is thus implicitly able to slide in catheter 12), 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 slide the outer tube via the lumen of the expandable device, as taught in Hara implicitly. It is known and readily understood in the art to use concentric, overlapping, or slidable components within a device to allow for manipulation of the device within the human body (advancing via pushing or pulling), and such configuration produces predictable results.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Hara (US Patent No. 5,743,900) in view of Everson (US 2011/0130756), Kasprzyk (US Patent No. 5,114,423), and Townley (US Patent Publication 2021/0315634).
Regarding claim 22, the limitations of claim 14 are taught as described above. Neither Hara/Everson nor Kasprzyk teach "further comprising an electrode to sense leaked current", however, Townley does in an analogous electrosurgical device. Townley teaches in p.[0170] that "Electrical stimuli (e.g., constant or pulsed currents at one or more frequencies) are applied to the tissue by one or more electrodes 136 at or near the treatment site, and the voltage and/or current differences at various different frequencies between various pairs of electrodes 136 of the end effector 114 may be measured to produce a spectral profile or map of the detected bioelectric potential, which can be used to identify different types of tissues (e.g., vessels, neural structures, and/or other types of tissue) in the region of interest. For example, current (i.e., direct or alternating current) can be applied to a pair of electrodes 136 adjacent to each other and the resultant voltages and/or currents between other pairs of adjacent electrodes 136 are measured." Note that Townley demonstrates that the electrode is capable of measuring "leaked current" in the form of current differences after applying a voltage/current via the electrodes. 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 electrode of Townley in Hara/Kasprzyk. As stated in Townley, the resultant current and voltage can be used to determine the type of tissue being contacted or ablated, and produces predictable results.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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