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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/23/2026has been entered.
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.
Claim 1, 4,9- 10 and 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Govari et al. (US 2022/0192738) in view of Herrera et al. (US 2018/0140807) in further view of Gallardo et al. (US 2013/0030426).
Regarding claim 1 and 20, Govari discloses a medical device configured to deliver energy to tissue, comprising: an elongated shaft (fig.2A) having a proximal portion and a distal portion; an expandable element (inflatable balloon 18) coupled to the distal portion of the elongated shaft (fig.2A), the expandable element having an outer surface (outer surface of inflatable balloon 18) and an inner surface (inner surface of inflatable balloon 18) opposite the outer surface (fig.2A); a plurality of electrodes (part of the plurality of electrodes 32: conductive plating 44, see also [0041]) disposed on the outer surface of the expandable element and configured to apply energy to tissue (fig.2A, see also [0040]); and the expandable element comprising channel (fig.2B; first fluid delivery tube 50) having a plurality of irrigation ports (apertures 40 that surrounds the conductive plating 44) that surround a perimeter of each electrode of the plurality of electrodes (fig.2A-B), the channel being configured to irrigate at least one of the plurality of electrodes [0042] and wherein the plurality of irrigation ports are concentrated on a side of the perimeter of each electrode of the plurality of electrodes to increase the flow of the irrigant to the side with a higher concentration of the plurality of irrigation ports (fig.2A). The examiner would like to note that the first delivery tube 50 and the apertures 40 are fluidly connected by a fluid by between the aperture 52 and apertures 40 (fig.2B, see also [0042]. However, Govari does not specifically teach an expandable element comprising one or more irrigation channels having a plurality of irrigation ports and one or more wherein the one or more irrigation channels are configured to selectively deliver an irrigant to flow to the electrodes of the plurality of electrodes which have been selectively energized during the delivery of energy to tissue.
Herrera teaches medical apparatus comprising balloons 62 and 64 are inflated, and the outer balloon comprises electrodes 70 that typically comprise one or more thin metal layers formed over the outer balloon (fig.2). The Outer balloon 64 comprises irrigation spray ports 72 that are configured to convey irrigation fluid from within the outer balloon to tissue [0036]. Inflation module 78 inflates inner balloon 62 by conveying an inflation fluid 100 to the inner balloon, splines 82 constrain the inflation of the inner balloon in order to create lobes 88 that form channels 102 that direct an irrigation fluid 104 from irrigation conduit 66 to irrigation spray ports 72. Herrera clearly teaches an expandable comprising one or more irrigation channels (fig.6; channels 102) having a plurality of irrigation ports (spray ports 72), the one or more irrigation channels being configured to irrigate at least one of the plurality of electrodes [0046].
Gallardo teaches a catheter adapted for ablation has multiple dedicated irrigation tubings to supply fluid to their respective electrode or set of electrodes. The tubings provide parallel flow pathways through the catheter where irrigation fluid is delivered to irrigated tip and/or electrodes. Such separate and dedicated fluid pathways allow fluid to be delivered to the corresponding electrode or set of electrodes at different flow rates. Gallardo further teaches the RF generator 11 is configured to communicate with the irrigation pump 27 via the pump head controller control irrigation flow delivery in accordance with the selective energization of the electrodes for optimizing fluid flow to the catheter. That is, while RF energy is being delivered through one electrode or set of electrodes, the RF generator triggers the corresponding pump head(s) to deliver fluid at the desired flow rate(s) to that one electrode or set of electrodes [0036]. Therefore, it would have been obvious to one of ordinary skill in the art at the time the application was effectively filed to modify the device of Govari with expandable element comprising one or more irrigation channels having a plurality of irrigation ports and one or more wherein the one or more irrigation channels as taught by Herrera for the purpose of optimizing flow of irrigation fluid 104 to irrigation spray ports and with a system that is configured to selectively deliver an irrigant to flow to the electrodes of the plurality of electrodes which have been selectively energized during the delivery of energy to tissue as taught by Gallardo for the purpose of minimizing fluid load on the patient while flushing the electrode irrigation apertures.
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Regarding claim 4, Govari /Herrera/Gallardo teaches the device of Claim 1, wherein the irrigant is cooler than an ambient temperature of blood ([0028] of Govari).
Regarding claim 9, Govari /Gallardo does not teach wherein the irrigant is a contrast media that is visible using medical imaging under ultrasound or fluoroscopy to confirm irrigation.
Herrera teaches an apparatus, including a flexible insertion tube having a distal end for insertion into a body cavity (abstract). The system includes injecting a contrast agent into the inner balloon so as to inflate the inner balloon, visualizing the distal end of the medical probe in the body cavity by imaging the contrast agent in the inner balloon, thereby enabling the distal end to be maneuvered to a target location, and conveying, via the one or more spray ports in the outer balloon, irrigation fluid to tissue at the target location [0010]. Therefore, it would have been obvious to one of ordinary skill in the art at the time the application was effectively filed to modify the device of Govari /Gallardo with the irrigant that is a contrast media that is visible using medical imaging as taught by Herrera for the purpose of visibility.
Regarding claim 10, Govari /Herrera/Gallardo teaches the device of Claim 1, wherein the one or more channels are configured to selectively irrigate at least one of the plurality of electrodes based upon a desired flow rate, a particular timing, or an electrode temperature ([0036] of Gallardo).
Regarding claim 21, Govari /Herrera/Gallardo teaches wherein the one or more irrigation channels are connected to the plurality of irrigation ports that surround the perimeter of each electrode of the plurality of electrodes (fig.6, see also [0048] of Herrera). Channels 102 and spray ports 72 are fluidly connected [0048].
Claim 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Govari et al. (US 2022/0192738) in view of Herrera et al. (US 2018/0140807) in further view of Gallardo et al. (US 2013/0030426) in further view of STEWART (US 2019/0254735).
Regarding claim 5-6, Govari /Herrera/Gallardo does not explicitly disclose wherein the irrigant has a lower conductivity than blood and wherein the irrigant has a higher conductivity than blood. STEWART teaches a devices, systems, and methods for more efficiently ablating tissue with pulsed field ablation energy while minimizing collateral injury to non-target tissue (abstract). The system includes the one or more irrigation channels being configured to selectively irrigate the plurality of electrodes [0061]. The irrigant has a lower conductivity than blood [0060] and wherein the irrigant has a higher conductivity than blood [0051]. Therefore, it would have been obvious to one of ordinary skill in the art at the time the application was effectively filed to modify the device of Govari /Gallardo with a system that is configured to selectively irrigate the plurality of electrodes and have the irrigant with a lower conductivity than blood and wherein the irrigant with a higher conductivity than blood as taught by STEWART for the purpose selectively providing the desired fluid conductivity to the treatment area.
Claim 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Govari et al. (US 2022/0192738) in view of Herrera et al. (US 2018/0140807) in further view of Gallardo et al. (US 2013/0030426) in further view of Mayse et al. (US 2013/0310822)
Regarding claim 7-8 Govari /Herrera/Gallardo does not teach wherein the perimeter of each of the plurality of electrodes has a higher thermal conductivity compared to a remainder of the each one of the plurality of electrodes to reduce edge effects and heating and wherein the perimeter of each of the plurality of electrodes has a lower electrical conductivity compared to a remainder of the each one of the plurality of electrodes to reduce edge effects and heating.
Mayse teaches a system that includes Electrically shielding the edges of the electrode 620b with the layer 630a prevents unwanted heating in surface portions of the airway wall 100, while the thermal conductivity of the layer 630a allows the thermodynamic cooling to reach tissue immediately adjacent the electrode 620b [0291]. Therefore, it would have been obvious to one of ordinary skill in the art at the time the application was effectively filed to modify the device of Govari /Herrera/Gallardo with Electrically shielding the edges of the electrode that provides a higher thermal conductivity compared to a remainder of the of electrodes to reduce edge effects as taught by Mayse for the purpose of patient safety.
Claim 11-14, 16-17, 19 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Govari et al. (US 2022/0192738) in view of Herrera et al. (US 2018/0140807) in further view of Gallardo et al. (US 2013/0030426) in further view of STEWART (US 2019/0254735).
Regarding claim 11, Govari discloses a medical system configured to deliver pulsed electric field (PEF) energy to tissue [0028], comprising: a medical device, including: an elongated shaft (shaft 42 having a proximal portion (proximal portion of shaft 44) and a distal portion (distal portion of shaft 42); a balloon (an expandable balloon catheter 40) with an outer surface and an inner surface opposite the outer surface (inner and outer surface of inflatable balloon 18), the balloon being coupled to the distal portion of the elongated shaft (fig.2A); a plurality of electrodes (part of the plurality of electrodes 32: conductive plating 44, see also [0041]) disposed on the outer surface of the balloon (fig.2A) and configured to apply PEF energy to the tissue [0028], each electrode having a perimeter; and the balloon including one or more irrigation channels (first fluid-delivery tube 50) having a plurality of irrigation ports (apertures 40 that surrounds the conductive plating 44) that surround a perimeter of each electrode of the plurality of electrodes (fig.2A-B), and a fluid source in communication with the one or more irrigation channels [0042].
The examiner would like to note that the first delivery tube 50 and the apertures 40 are fluidly connected by a fluid by between the aperture 52 and apertures 40 (fig.2B, see also [0042]. However, Govari does not specifically teach an expandable element comprising one or more irrigation channels having a plurality of irrigation ports and the one or more irrigation channels being configured to selectively irrigate electrodes of the plurality of electrodes which have been selectively energized, wherein the one or more irrigation channels are configured to selectively deliver a fluid to flow to the electrodes of the plurality of electrodes which have been selectively energized during the delivery of PEF energy to tissue; and a controller in communication with the fluid source and the medical device, the controller being configured to deliver PEF energy to the plurality of electrodes and to modulate a delivery of the fluid from the fluid source to the one or more irrigation channels based upon at least one preset parameter derived from prior deliveries of PEF energy to the tissue.
Herrera teaches medical apparatus comprising balloons 62 and 64 are inflated, and the outer balloon comprises electrodes 70 that typically comprise one or more thin metal layers formed over the outer balloon (fig.2). The Outer balloon 64 comprises irrigation spray ports 72 that are configured to convey irrigation fluid from within the outer balloon to tissue [0036]. Inflation module 78 inflates inner balloon 62 by conveying an inflation fluid 100 to the inner balloon, splines 82 constrain the inflation of the inner balloon in order to create lobes 88 that form channels 102 that direct an irrigation fluid 104 from irrigation conduit 66 to irrigation spray ports 72. Herrera clearly teaches an expandable comprising one or more irrigation channels (fig.6; channels 102) having a plurality of irrigation ports (spray ports 72), the one or more irrigation channels being configured to irrigate at least one of the plurality of electrodes [0046].
Gallardo teaches a catheter adapted for ablation has multiple dedicated irrigation tubings to supply fluid to their respective electrode or set of electrodes. The tubings provide parallel flow pathways through the catheter where irrigation fluid is delivered to irrigated tip and/or electrodes. Such separate and dedicated fluid pathways allow fluid to be delivered to the corresponding electrode or set of electrodes at different flow rates. Gallardo further teaches the RF generator 11 is configured to communicate with the irrigation pump 27 via the pump head controller control irrigation flow delivery in accordance with the selective energization of the electrodes for optimizing fluid flow to the catheter. That is, while RF energy is being delivered through one electrode or set of electrodes, the RF generator triggers the corresponding pump head(s) to deliver fluid at the desired flow rate(s) to that one electrode or set of electrodes [0036]. Therefore, it would have been obvious to one of ordinary skill in the art at the time the application was effectively filed to modify the device of Govari with expandable element comprising one or more irrigation channels having a plurality of irrigation ports and one or more wherein the one or more irrigation channels as taught by Herrera for the purpose of optimizing flow of irrigation fluid 104 to irrigation spray ports and a system that is configured to selectively deliver an irrigant to flow to the electrodes of the plurality of electrodes which have been selectively energized during the delivery of energy to tissue as taught by Gallardo for the purpose of minimizing fluid load on the patient while flushing the electrode irrigation apertures. The modify system of Govari /Gallardo remain silent regarding the controller being configured to deliver PEF energy to the plurality of electrodes and to modulate a delivery of a fluid from the fluid source to the one or more irrigation channels based upon at least one preset parameter derived from prior deliveries of PEF energy to the tissue.
STEWART teaches a devices, systems, and methods for more efficiently ablating tissue with pulsed field ablation energy while minimizing collateral injury to non-target tissue (abstract). The system includes the controller being configured to deliver PEF energy to the plurality of electrodes and to modulate a delivery of a fluid from the fluid source to the one or more irrigation channels based upon at least one preset parameter derived from prior deliveries of PEF energy to the tissue [0057]. Therefore, it would have been obvious to one of ordinary skill in the art at the time the application was effectively filed to further modify the device of Govari/ Herrera /Gallardo with controller being configured to deliver PEF energy to the plurality of electrodes and to modulate a delivery based on preset parameters as taught by STEWART for the purpose of achieving the desired treatment while preventing surrounding tissue damage.
Regarding claim 12, Govari /Herrera /Gallardo/STEWART teaches the system of Claim 11, wherein the at least one preset parameters are derived from prior deliveries of PEF energy to the tissue including at least one from the group consisting of: temperature rise, impedance change, quantity of fluid delivered, pressure of the irrigation channel, measured flow rate, change in delivered current over a period of PEF delivery, and total energy expenditure of energy source for PEF energy delivery ([0051] of STEWART).
Regarding claim 13, Govari /Herrera /Gallardo/STEWART teaches the system of Claim 11, wherein the controller is further configured to modulate an amount of fluid delivered to the one or more irrigation channels based at least in part on preselected PEF ablation parameters ([0057] of STEWART).
Regarding claim 14, Govari /Herrera /Gallardo/STEWART teaches the system of Claim 13, wherein the preselected PEF parameters include at least one from the group consisting of applied voltage, pulse width, cycle lengths, number of applied pulses per application, number of applications, and selection of which ones of the plurality of electrodes are engaged in PEF delivery ([0057] of STEWART).
Regarding claim 16, Govari /Herrera /Gallardo/STEWART teaches the system of Claim 11, wherein the fluid source includes at least two type of fluids ([0051]: “both a hypotonic fluid and a hypertonic fluid may be used” of STEWART).
Regarding claim 17, Govari /Herrera /Gallardo/STEWART teaches the system of Claim 11, wherein the fluid in the fluid source has a net negative charge ([0051] of STEWART).
Regarding claim 19, Govari /Herrera /Gallardo/STEWART teaches the system of Claim 11, wherein the fluid in the fluid source is configured to increase a vulnerability of the tissue to PEF energy ([0051] of STEWART).
Regarding claim 22, Govari /Herrera /Gallardo/STEWART teaches he system of Claim 11, wherein the one or more irrigation channels are connected to the plurality of irrigation ports that surround the perimeter of each of the plurality of electrodes (fig.6, see also [0048] of Herrera). Channels 102 and spray ports 72 are fluidly connected [0048].
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Govari et al. (US 2022/0192738) in view of Herrera et al. (US 2018/0140807) in further view of Gallardo et al. (US 2013/0030426) in further view of STEWART (US 2019/0254735) in further view of Curley (US 2012/0265276).
Regarding claim 15, Govari /Herrera /Gallardo/STEWART is silent regarding wherein the controller is further configured to modify a temperature of the fluid in the fluid source.
Curley teaches a system for shaping an ablation treatment volume formed in fluid enhanced ablation therapy (abstract). Curley further teaches the control system can modify parameters such as saline temperature, saline flow, and duration of treatment to adjust the temperature of the profile [0062]. Therefore, it would have been obvious to one of ordinary skill in the art at the time the application was effectively filed to modify the device of Govari /Herrera /Gallardo/STEWART with controller is further configured to modify a temperature of the fluid in the fluid source as taught by Curley for the purpose having the desired treatment safely.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Govari et al. (US 2022/0192738) in view of Herrera et al. (US 2018/0140807) in further in view of Gallardo et al. (US 2013/0030426) in further view of STEWART (US 2019/0254735) in further view of Schuler et al. (US 2021/0177509).
Regarding claim 18, Govari /Herrera /Gallardo/STEWART does not teach the plurality of electrodes includes an anti- thrombogenic coating.
Schuler teaches a system that is configured to treating tissue during a medical procedure. The system includes filaments and splines that include electrodes. Anti-thrombotic coatings may be applied to the filaments and splines of the mapping device. When applied, care must be taken to prevent interference with the integrated electrodes. This may be achieved by masking the electrodes during application of the coating or by applying the coating prior to ablative formation of the electrode zones on the wires [0417]. Therefore, it would have been obvious to one of ordinary skill in the art at the time the application was effectively filed to modify the device of Govari /Herrera /Gallardo/STEWART with an electrode that includes an anti- thrombogenic coating as taught by Schuler for the purpose of mitigate risk of thrombosis.
Response to Arguments
Applicant’s arguments with respect to the one or more channels have been considered but are moot because the new ground of rejection includes Herrera reference to teach that specific feature as shown above.
In response to applicant's argument that it is improper to combine Gallardo with Govari the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). The examiner is only relying on Gallardo to teach the selective fluid delivery based on energized electrode. The examiner acknowledges these two references are structurally different. However, the system of selective fluid delivery based on the energized electrode maybe combined with the system of Govari. The proposed combination would have been withing the level or ordinary skill and would not render the device inoperable as it merry involves apply a known technique to a known device.
The examiner suggests the Applicant to include the actual structure (as shown in fig.2 of the instant application) of plurality of channels being extended from the proximal end of the device to the electrode and being directly connected to the electrode.
Conclusion
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/TIGIST S DEMIE/Primary Examiner, Art Unit 3794
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