DETAILED ACTION
The following is a Non-Final Office Action on the merits.
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 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/11/2025 has been entered.
Response to Amendment
Acknowledgment is made to the amendment received 12/11/2025.
Applicant’s amendments are sufficient to overcome most of the claim objections set forth in the previous action.
Applicant’s amendments are sufficient to overcome 35 USC 112(b)/second paragraph rejections set forth in the previous action.
Claim Objections
Claim 9 is objected to because of the following informalities: amend “the value indicative of the impedance” to -the value indicative of the impedance of the tissue and the conductive fluid- in ll. 17. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: amend “the value indicative of the impedance” to -the value indicative of the impedance of the tissue and the conductive fluid- in ll. 3. Appropriate correction is required.
Claim 11 is objected to because of the following informalities: amend “the value indicative of the impedance” to -the value indicative of the impedance of the tissue and the conductive fluid- in ll. 2. Appropriate correction is required.
Claim 12 is objected to because of the following informalities: amend “the signal indicative of the impedance” to -the signal indicative of the impedance of the tissue and the conductive fluid- in ll. 2. Appropriate correction is required.
Claim 12 is objected to because of the following informalities: amend “the value indicative of the impedance” to -the value indicative of the impedance of the tissue and the conductive fluid- in ll. 2. Appropriate correction is required.
Claim 14 is objected to because of the following informalities: amend “the value indicative of the impedance” to -the value indicative of the impedance of the tissue and the conductive fluid- in ll. 3. Appropriate correction is required.
Claim 15 is objected to because of the following informalities: amend “the value indicative of the impedance” to -the value indicative of the impedance of the tissue and the conductive fluid- in ll. 3-4. Appropriate correction is required.
Claim 16 is objected to because of the following informalities: amend “the signal indicative of the impedance” to -the signal indicative of the impedance of the tissue and the conductive fluid- in ll. 17. Appropriate correction is required.
Claim 17 is objected to because of the following informalities: amend “the value indicative of the impedance” to -the value indicative of the impedance of the tissue and the conductive fluid- in ll. 3. Appropriate correction is required.
Claim 18 is objected to because of the following informalities: amend “the value indicative of the impedance” to -the value indicative of the impedance of the tissue and the conductive fluid- in ll. 2. Appropriate correction is required.
Claim 19 is objected to because of the following informalities: amend “the value indicative of the impedance” to -the value indicative of the impedance of the tissue and the conductive fluid- in ll. 2-3. Appropriate correction is required.
Claim 21 is objected to because of the following informalities: amend “the value indicative of the impedance” to -the value indicative of the impedance of the tissue and the conductive fluid- in ll. 3. Appropriate correction is required.
Claim 22 is objected to because of the following informalities: amend “the value indicative of the impedance” to -the value indicative of the impedance of the tissue and the conductive fluid- in ll. 3-4. Appropriate correction is required.
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.
Claim(s) 1-2, 4-5, 7-12, 14-17, 19 & 21-22 is/are rejected under 35 U.S.C. 103 as being obvious over Meads, Jr et al. (2016/0278854, previously cited) in view of Gutbrod et al. (2017/0273732, previously cited), Kotmel et al. (2008/0071257, previously cited) and Zhang et al. (2021/0282849, previously cited) and Hoey et al. (6,409,722, previously cited).
Concerning claims 1, 4-5 & 8, as illustrated in at least Figs. 8-11, Meads, Jr. et al. disclose a method of sealing blood vessels (method for vessel coagulation; [0052]), the method comprising:
applying, energy between two electrodes of a coagulation wand, the two electrodes abutting tissue of the blood vessels at a surgical site, and the energy at a coagulation energy (bipolar wires 114, 166 include distal end electrodes 140 that receive energy to coagulate tissue; [0042], [0052], [0061]);
supplying a flow of conductive fluid to the surgical site (cavity provided between an outer surface of suction tube 112 and an inner surface of lumen 150 may provide a delivery passage for saline or other fluid to be delivered to a surgical site; [0065]).
Meads, Jr. et al. fail to specifically disclose an electrosurgical controller applying radio frequency (RF), supplying the flow of the conductive fluid, measuring a value indicative of impedance of tissue and conductive fluid between the two electrodes, and in response to determining that the value indicative of impedance of tissue and conductive fluid is changing, commanding the flow of conductive fluid to decrease. However, Gutbrod et al. disclose a method of treating tissue comprising a controller (control component 128; [0067]) controlling application of RF energy to electrodes (control component 128 controls delivery of RF energy from RF generator 130 to electrodes; [0067-0068]), supplying a flow of conductive fluid (control component 128 controls irrigation system 136; [0072-0073]), measuring a value indicative of impedance of tissue and conductive fluid between the two electrodes (sensor 110 senses a fluid condition of irrigation fluid near tip assembly 104 and sends the signal to control component 128 which determines a fluid flow condition, which can be the fluid flow condition of irrigation fluid near the tip assembly, and increases or decreases output of irrigation system 136 based on the determined fluid flow condition, where amount of fluid at the site is indicative of impedance of the tissue and conductive fluid; [0050], [0055], [0073]), in response to determining that the value indicative of impedance of tissue and conductive fluid is changing, commanding the flow of conductive fluid to decrease (control component 128 may send instructions to the irrigation fluid output component 140 to provide a signal to the irrigation fluid source 136 to decrease its output if the catheter is in a region with a higher fluid flow than normal; [0074-0075]), increasing, by the electrosurgical controller, the flow of conductive fluid as the value indicative of impedance of the tissue and the conductive fluid changes (control component 128 may send instructions to the irrigation fluid output component 140 to provide a signal to the irrigation fluid source 136 to increase its output if the catheter is in a region with a fluid flow below a threshold fluid flow to avoid ineffective passive cooling, charring and steam popping; [0090]). Kotmel et al. further teach the importance of decreasing a fluid amount at the surgical site since impedance levels at the interface drop with increasing fluid amount as the excess fluid creates a path of conductivity through which the current traveling through the electrodes will flow ([0020]). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Meads, Jr. et al. to further comprise an electrosurgical controller applying radio frequency (RF), supplying the flow of the conductive fluid, measuring a value indicative of impedance of tissue and conductive fluid between the two electrodes, and in response to determining that the value indicative of impedance of tissue and conductive fluid is changing, commanding the flow of conductive fluid to decrease in order to provide the benefit of avoiding unintended ablation of a larger tissue area and damaging non-target tissue due to a conductivity path through excess fluid and to avoid ineffective passive cooling as taught by Gutbrod et al. ([0003]) and Kotmel et al. ([0020])
Gutbrod et al. teach the value indicative of impedance of tissue and conductive fluid to be a fluid flow condition of irrigation fluid near the tip assembly ([0055]), and thus decreasing the flow of conductive fluid when the value indicative of impedance of tissue and conductive fluid is increasing (fluid condition is high) due to a large amount of fluid presence and increasing the flow of conductive fluid to passively cool the electrode as the value indicative of the impedance decreases (fluid condition is low). Meads, Jr. et al. in view of Gutbrod et al. and Kotmel et al. fail to disclose decreasing the flow of conductive fluid as the value indicative of the impedance of the tissue and the conductive fluid decreases in response to determining that the value indicative of impedance of tissue and conductive fluid is decreasing and increasing the flow of conductive fluid in response to determining that the value indicative of impedance of tissue and conductive fluid is increasing. However, Zhang et al. disclose a method of treating tissue comprising a controller (58) that receives a measured value indicative of impedance of tissue and conductive fluid at the tissue site (value is impedance itself from sensor 60, and is thus also resistance), and adjusting fluid flow and amount at the surgical site to decrease the amount of fluid as the value indicative of the impedance of the tissue and the conductive fluid decreases at the surgical site by increasing/activating the suction. Zhang et al. further teach that impedance decreases corresponding to an increase in conductivity between electrodes (40, 42 or 46, 48) due to the presence of saline, blood or other body fluids, and that an event reflected by a significant drop in impedance, i.e., one below a predetermined level, will suggest excessive fluid or bleeding. Zhang et al. further teach that saline is delivered for flushing tissue from the treatment site. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Meads, Jr. et al. in view of Gutbrod et al. and Kotmel et al. such that the method further comprises decreasing the flow of conductive fluid as the value indicative of the impedance of the tissue and the conductive fluid decreases in response to determining that the value indicative of impedance of tissue and conductive fluid is decreasing and increasing the flow of conductive fluid in response to determining that the value indicative of impedance of tissue and conductive fluid is increasing in order to provide the benefit of flushing the tissue site with an appropriate amount of saline and removing excess fluid from the surgical site as taught by Zhang et al. ([0037], [0040-0041]) and since Zhang et al. and Gutbrod et al. both teach the adjusting the amount of fluid at the surgical site in response to measuring fluid, particularly excess fluid, at the surgical site, where the fluid sensor of Gutbrod et al. and the impedance sensor of Zhang et al. are equivalents in the art with respect to sensing fluid conditions at the surgical site.
Meads, Jr. et al. in view of Gutbrod et al., Kotmel et al. and Zhang et al. fail to disclose how the flow of conductive fluid is decreased, and specifically decreasing the flow of conductive fluid as the value indicative of the impedance of the tissue and the conductive fluid decreases comprising: decreasing directly proportional to the value indicative of impedance of the tissue and the conductive fluid; decreasing linearly proportional to the value indicative of impedance of the tissue and the conductive fluid; decreasing step-wise proportional to the value indicative of impedance of the tissue and the conductive fluid. However, Hoey et al. teach a method where a controller sends commands and fluid flow is adjusted in response to impedance measurements, the fluid flow adjustments being controlled in several ways, such as linearly adjusting the fluid flow in response to the measured impedance or providing a step wise change in the fluid flow in response to the measured impedance (Col. 20-21, ll. 27-15). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Meads, Jr. et al. in view of Gutbrod et al., Kotmel et al. and Zhang et al. such that decreasing the flow of conductive fluid further comprises at least one selected from a group comprising: decreasing directly proportional to the value indicative of impedance of the tissue and the conductive fluid; decreasing linearly proportional to the value indicative of impedance of the tissue and the conductive fluid; or decreasing step-wise proportional to the value indicative of impedance of the tissue and the conductive fluid in order to adjust fluid flow at a set rate of change or making adjustments such that fluid flow is maintained for specific predetermined periods of time as taught by Hoey et al. (Col. 20-21, ll. 27-15)
Concerning claim 2, Meads, Jr. et al. in view of Gutbrod et al. and Kotmel et al. and Zhang et al. fail to specifically teach ceasing the flow of conductive fluid when the value indicative of impedance of the tissue and the conductive fluid falls below a predetermined threshold. However, since Kotmel et al. teach that the presence of a current path in the fluid causes the liquid to heat and treat non-target tissue ([0020]), it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to modify the invention of Meads, Jr. et al. in view of Gutbrod et al. and Kotmel et al. and Zhang et al. such that the method further comprises ceasing the flow of conductive fluid when the value indicative of impedance of the tissue and the conductive fluid falls below a predetermined threshold in order to provide the benefit of stopping fluid flow such that more fluid is not in excess and thermally damaging non-target tissue in view of the teachings of Kotmel et al.
Concerning claim 7, Meads, Jr. et al. in view of Gutbrod et al. and Kotmel et al. and Zhang et al. fail to specifically disclose applying the RF energy further comprises decreasing the RF energy as the value indicative of impedance of the tissue and the conductive fluid decreases. However, Kotmel et al. teach that the presence of a current path in the fluid causes the liquid to heat and treat non-target tissue ([0020]). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Meads, Jr. et al. in view of Gutbrod et al. and Kotmel et al. and Zhang et al. such that applying the RF energy further comprises decreasing the RF energy as the value indicative of impedance of the tissue and the conductive fluid decreases in order to provide the benefit of stopping power such that the liquid is not heated to avoid thermally damaging non-target tissue in view of the teachings of Kotmel et al.
Concerning claims 9, 12, 14, as illustrated in at least Figs. 8-11, Meads, Jr. et al. disclose an electrosurgical system (Fig. 8) comprising:
a connector accessible on an external surface of a housing, the connector defines two electrical pins (wire plug 126 has two wires 114, 116 connecting to two pins; [0060]);
a voltage generator disposed within the housing, and electrically coupled to the two electrical pins of the connector (inherent power source to which plug 126 couples; [0052], [0060]);
a system configured to provide conductive fluid to a surgical site (cavity provided between an outer surface of suction tube 112 and an inner surface of lumen 150 may provide a delivery passage for saline or other fluid to be delivered to a surgical site; [0065]) and supply coagulation energy across the two electrical pins of the connector ((bipolar wires 114, 166 include distal end electrodes 140 that receive energy to coagulate tissue; [0042], [0052], [0061]).
Meads et al. fail to disclose the generator to be a RF generator, a measurement circuit disposed within the housing and electrically connected between the RF voltage generator and the two electrical pins of the connector, wherein the measurement circuit is configured to create a signal indicative of impedance; the system configured to provide conductive fluid to the surgical site to be a pump system configured to pump conductive fluid to a surgical site; and a controller disposed within the housing and communicatively coupled to the measurement circuit and the pump system, the controller configured to: command the RF voltage generator to supply RF energy across the two electrical pins of the connector; command the pump system to supply a flow of conductive fluid; read the signal indicative of impedance from the measurement circuit and create a value indicative of impedance; and in response to determining that the value indicative of impedance of the tissue and the conductive fluid is changing, command the pump system to decrease the flow of conductive fluid and command the pump system and to increase the flow of conductive fluid as the value indicative of impedance of the tissue and the conductive fluid changes. However, Gutbrod et al. disclose an electrosurgical controller system (system 100 comprises computing device 146; [0050], [0082]) comprising an RF generator (RF generator 130; [0067]), a measurement circuit disposed within the housing, wherein the measurement circuit is configured to create a signal indicative of impedance (sensor 110 senses a fluid condition of irrigation fluid near tip assembly 104 and sends the signal to control component 128 in computing device 146 which determines a fluid flow condition, which can be the fluid flow condition of irrigation fluid near the tip assembly, and increases or decreases output of irrigation system 136 based on the determined fluid flow condition; [0050], [0055], [0073], [0082]); the system configured to provide conductive fluid to the surgical site to be a pump system configured to pump conductive fluid to a surgical site (irrigation fluid source 138 may include a fluid reservoir and a pump to provide cooling fluid through the catheter; [0072]); and a controller disposed within the housing and communicatively coupled to the measurement circuit and the pump system (control component 128 in computing device 146 may be configured to control aspects of the functioning of one or more other components such as, for example, an RF generator 130, an irrigation system 136, and/or the like; [0067], [0082]), the controller configured to: command the RF voltage generator to supply RF energy across the two electrical connections (control component 128 in computing device 146 may be configured to control aspects of the functioning of one or more other components such as, for example, an RF generator 130, and/or the like; [0067], [0082); command the pump system to supply a flow of conductive fluid (control component 128 in computing device 146 may be configured to control aspects of the functioning of one or more other components such as irrigation system 136, and/or the like; [0067], [0082]); read the signal indicative of impedance from the measurement circuit and create a value indicative of impedance (sensor 110 senses a fluid condition of irrigation fluid near tip assembly 104 and sends the signal to control component 128 in computing device 146 which determines a fluid flow condition, which can be the fluid flow condition of irrigation fluid near the tip assembly, and increases or decreases output of irrigation system 136 based on the determined fluid flow condition; [0050], [0055], [0073], [0082); and in response to determining that the value indicative of impedance of the tissue and the conductive fluid is changing, command the pump system to decrease the flow of conductive fluid (control component 128 may send instructions to the irrigation fluid output component 140 to provide a signal to the irrigation fluid source 136 to decrease its output if the catheter is a region with a higher fluid flow than normal or; [0074-0075]) and increase the flow of conductive fluid as the value indicative of impedance of the tissue and the conductive fluid changes (control component 128 may send instructions to the irrigation fluid output component 140 to provide a signal to the irrigation fluid source 136 to increase its output if the catheter is in a region with a fluid flow below a threshold fluid flow to avoid ineffective passive cooling, charring and steam popping; [0090]). Kotmel et al. further teach the importance of decreasing a fluid amount at the surgical site since impedance levels at the interface drop with increasing fluid amount as the excess fluid creates a path of conductivity through which the current traveling through the electrodes will flow ([0020]). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Meads, Jr. et al. to further comprise a generator that is a RF generator, a measurement circuit disposed within the housing and electrically connected between the RF voltage generator and the two electrical pins of the connector, wherein the measurement circuit is configured to create a signal indicative of impedance; the system configured to provide conductive fluid to the surgical site to be a pump system configured to pump conductive fluid to a surgical site; and a controller disposed within the housing and communicatively coupled to the measurement circuit and the pump system, the controller configured to: command the RF voltage generator to supply RF energy across the two electrical pins of the connector; command the pump system to supply a flow of conductive fluid; read the signal indicative of impedance from the measurement circuit and create a value indicative of impedance; and in response to determining that the value indicative of impedance of the tissue and the conductive fluid is changing, command the pump system to decrease the flow of conductive fluid and command the pump system and to increase the flow of conductive fluid as the value indicative of impedance of the tissue and the conductive fluid changes in order to provide the benefit of avoiding unintended ablation of a larger tissue area and damaging non-target tissue due to a conductivity path through excess fluid and to avoid ineffective passive cooling as taught by Gutbrod et al. ([0003]) and Kotmel et al. ([0020])
Gutbrod et al. teach the value indicative of impedance of the tissue and the conductive fluid of tissue and conductive fluid to be a fluid flow condition of irrigation fluid near the tip assembly ([0055]), and thus decreasing the flow of conductive fluid when the value indicative of impedance of tissue and conductive fluid is increasing (fluid condition is high) due to a large amount of fluid presence and increasing the flow of conductive fluid to passively cool the electrode as the value indicative of the impedance decreases (fluid condition is low). Meads, Jr. et al. in view of Gutbrod et al. and Kotmel et al. fail to disclose the measurement circuit electrically connected between the RF voltage generator and the two electrical pins of the connector and commanding the pump system to decrease the flow of conductive fluid in response to determining that the value indicative of impedance of the tissue and the conductive fluid is decreasing and commanding the pump system to increase the flow of conductive fluid in response to determining that the value indicative of impedance of the tissue and the conductive fluid is increasing. However, Zhang et al. disclose an electrosurgical controller system for treating tissue comprising a controller (58) that comprises a measurement circuit electrically connected between a voltage generator and the two electrical connections, wherein the measurement circuit is configured to create a signal indicative of impedance (value is impedance itself from sensor 60, and is thus also resistance), and adjusting fluid flow and amount at the surgical site to decrease the amount of fluid at the surgical site by increasing/activating the suction. Zhang et al. further teach that impedance decreases correspond to an increase in conductivity between electrodes (40, 42 or 46, 48) due to the presence of saline, blood or other body fluids, and that an event reflected by a significant drop in impedance, i.e., one below a predetermined level, will suggest excessive fluid or bleeding. Zhang et al. further teach that saline is delivered for flushing tissue from the treatment site. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Meads, Jr. et al. in view of Gutbrod et al. and Kotmel et al. such that the electrosurgical system controller further comprises the measurement circuit electrically connected between the RF voltage generator and the two electrical pins of the connector and commanding the pump system to decrease the flow of conductive fluid in response to determining that the value indicative of impedance of the tissue and the conductive fluid is decreasing and commanding the pump system to increase the flow of conductive fluid in response to determining that the value indicative of impedance of the tissue and the conductive fluid is increasing in order to provide the benefit of removing excess fluid from the surgical site and flushing the tissue site with an appropriate amount of saline as taught by Zhang et al. ([0037], [0040-0041]) and since Zhang et al. and Gutbrod et al. both teach adjusting the amount of fluid at the surgical site in response to measuring fluid, particularly excess fluid, at the surgical site, where the fluid sensor of Gutbrod et al. and the impedance sensor of Zhang et al. are equivalents in the art with respect to sensing fluid conditions at the surgical site.
Meads, Jr. et al. in view of Gutbrod et al., Kotmel et al. and Zhang et al. fail to disclose how the flow of conductive fluid is decreased, and specifically decreasing the flow of conductive fluid as the value indicative of the impedance of the tissue and the conductive fluid decreases comprising: decreasing directly proportional to the value indicative of impedance of the tissue and the conductive fluid; decreasing linearly proportional to the value indicative of impedance of the tissue and the conductive fluid; decreasing step-wise proportional to the value indicative of impedance of the tissue and the conductive fluid. However, Hoey et al. teach a method where a controller sends commands and fluid flow is adjusted in response to impedance measurements, the fluid flow adjustments being controlled in several ways, such as linearly adjusting the fluid flow in response to the measured impedance or providing a step wise change in the fluid flow in response to the measured impedance (Col. 20-21, ll. 27-15). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Meads, Jr. et al. in view of Gutbrod et al., Kotmel et al. and Zhang et al. such that decreasing the flow of conductive fluid further comprises at least one selected from a group comprising: decreasing directly proportional to the value indicative of impedance of the tissue and the conductive fluid; decreasing linearly proportional to the value indicative of impedance of the tissue and the conductive fluid; or decreasing step-wise proportional to the value indicative of impedance of the tissue and the conductive fluid in order to adjust fluid flow at a set rate of change or making adjustments such that fluid flow is maintained for specific predetermined periods of time as taught by Hoey et al. (Col. 20-21, ll. 27-15)
Claim 10 is rejected upon the same rationale as applied to claim 2.
Concerning claim 11, Gutbrod et al. further disclose generating the alarm, by the electrosurgical controller, when the value indicative of impedance of the tissue and the conductive fluid remains below the predetermined threshold for a predetermined duration (duration is zero when value passes threshold) ([0079]).
Claim 15 is rejected upon the same rationale as applied to claim 7.
Concerning claims 16, 19, 21, as illustrated in at least Figs. 8-11, Meads, Jr. et al. disclose an electrosurgical coagulation system (Fig. 8) comprising:
a source of conductive fluid (inherent source of saline for delivery to surgical site; [0065]);
a coagulation wand defining first and second electrodes disposed at a distal end of the coagulation wand and a delivery lumen associated with a distal end of the coagulation wand (surgical device 100 comprises bipolar wires 114, 116 may each include a distal end 140 and inner surface of lumen 150 may provide a delivery passage for saline or other fluid to be delivered to a surgical site; [0061], [0065]);
an electrosurgical system comprising:
a voltage generator electrically coupled to the first and second electrodes of the coagulation wand (inherent power source to which plug 126 couples; [0052], [0060]);
a system configured to supply energy between the first and second electrodes of the coagulation wand, wherein the energy is a coagulation energy (bipolar wires 114, 166 include distal end electrodes 140 that receive energy to coagulate tissue; [0042], [0052], [0061]) and a system fluidly coupled to the source of conductive fluid and the delivery lumen to supply a flow of the conductive fluid (cavity provided between an outer surface of suction tube 112 and an inner surface of lumen 150 may provide a delivery passage for saline or other fluid to be delivered to a surgical site; [0065]).
Meads, Jr. et al. fail to disclose the generator to be a RF generator; an impedance sensitive circuit configured to create a signal indicative of impedance; the system configured to provide conductive fluid to the surgical site to be a pump system fluidly coupled to the source of conductive fluid and the delivery lumen; and a controller electrically coupled to the impedance sensitive circuit and the pump system, the controller configured to: command the RF voltage generator to supply RF energy between the electrodes; command the pump system to supply a flow of the conductive fluid; read the signal indicative of impedance from the impedance sensitive circuit and create a value indicative of impedance; and in response to determining that the value indicative of impedance of the tissue and the conductive fluid is changing, command the pump system to decrease the flow of conductive fluid to the delivery lumen and in response to determining that the value indicative of impedance of tissue and conductive fluid is changing, command the pump system to increase the flow of conductive fluid to the delivery lumen. However, Gutbrod et al. disclose an electrosurgical controller system (system 100 comprises computing device 146; [0050], [0082]) comprising an RF generator (RF generator 130; [0067]), an impedance sensitive circuit (sensor 110 senses a fluid condition of irrigation fluid near tip assembly 104 and sends the signal to control component 128 in computing device 146 which determines a fluid flow condition, which can be the fluid flow condition of irrigation fluid near the tip assembly, and increases or decreases output of irrigation system 136 based on the determined fluid flow condition, where fluid flow condition is sensitive and indicative of impedance; [0050], [0055], [0073], [0082]); the system configured to provide conductive fluid to the surgical site being a pump system fluidly coupled to the source of conductive fluid and the delivery lumen (irrigation fluid source 138 may include a fluid reservoir and a pump to provide cooling fluid through the catheter; [0072]) and a controller electrically coupled to the impedance sensitive circuit and the pump system (control component 128 in computing device 146 may be configured to control aspects of the functioning of one or more other components such as, for example, an RF generator 130, an irrigation system 136, and/or the like; [0067], [0082]), the controller configured to: command the RF voltage generator to supply RF energy between the electrodes (control component 128 in computing device 146 may be configured to control aspects of the functioning of one or more other components such as RF generator 130); command the pump system to supply a flow of the conductive fluid (control component 128 in computing device 146 may be configured to control aspects of the functioning of one or more other components such irrigation system 136 and/or the like; [0067], [0082]); read the signal indicative of impedance from the impedance sensitive circuit and create a value indicative of impedance (sensor 110 senses a fluid condition of irrigation fluid near tip assembly 104 and sends the signal to control component 128 in computing device 146 which determines a fluid flow condition, which can be the fluid flow condition of irrigation fluid near the tip assembly, and increases or decreases output of irrigation system 136 based on the determined fluid flow condition, where the fluid flow condition is indicative of impedance; [0050], [0055], [0073], [0082); and in response to determining that the value indicative of impedance of the tissue and the conductive fluid of tissue is changing, command the pump system to decrease the flow of conductive fluid to the delivery lumen (control component 128 may send instructions to the irrigation fluid output component 140 to provide a signal to the irrigation fluid source 136 to decrease its output if the catheter is a region with a higher fluid flow than normal or; [0074-0075]) and in response to determining that the value indicative of impedance of the tissue and the conductive fluid of tissue is changing, command the pump system to increase the flow of conductive fluid to the delivery lumen (control component 128 may send instructions to the irrigation fluid output component 140 to provide a signal to the irrigation fluid source 136 to increase its output if the catheter is in a region with a fluid flow below a threshold fluid flow to avoid ineffective passive cooling, charring and steam popping; [0090]). Kotmel et al. further teach the importance of decreasing a fluid amount at the surgical site since impedance levels at the interface drop with increasing fluid amount as the excess fluid creates a path of conductivity through which the current traveling through the electrodes will flow ([0020]). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Meads, Jr. et al. to the generator to be a RF generator; an impedance sensitive circuit configured to create a signal indicative of impedance; the system configured to provide conductive fluid to the surgical site to be a pump system fluidly coupled to the source of conductive fluid and the delivery lumen; and a controller electrically coupled to the impedance sensitive circuit and the pump system, the controller configured to: command the RF voltage generator to supply RF energy between the electrodes; command the pump system to supply a flow of the conductive fluid; read the signal indicative of impedance from the impedance sensitive circuit and create a value indicative of impedance; and in response to determining that the value indicative of impedance of the tissue and the conductive fluid is changing, command the pump system to decrease the flow of conductive fluid to the delivery lumen and in response to determining that the value indicative of impedance of tissue and conductive fluid is changing, command the pump system to increase the flow of conductive fluid to the delivery lumen in order to provide the benefit of unintended ablation of a larger tissue area as taught by Gutbrod et al. ([0003]) and in order to provide the benefit of decreasing the amount of the excess fluid to avoid damaging non-target tissue as taught by Kotmel et al. ([0020])
Gutbrod et al. teach the value indicative of impedance of tissue and conductive fluid to be a fluid flow condition of irrigation fluid near the tip assembly ([0055]), and thus decreasing the flow of conductive fluid when the value indicative of impedance of tissue and conductive fluid is increasing (fluid condition is high) due to a large amount of fluid presence and increasing the flow of conductive fluid to passively cool the electrode as the value indicative of the impedance decreases (fluid condition is low). Meads, Jr. et al. in view of Gutbrod et al. and Kotmel et al. fail to disclose a measurement circuit and electrically connected between the RF voltage generator and the two electrical pins of the connector, wherein the impedance sensitive circuit is configured to create a signal indicative of impedance and commanding the pump system to decrease the flow of conductive fluid in response to determining that the value indicative of impedance of the tissue and the conductive fluid is decreasing and commanding the pump system to increase the flow of conductive fluid in response to determining that the value indicative of impedance of the tissue and the conductive fluid is increasing. However, Zhang et al. disclose an electrosurgical controller system for treating tissue comprising a controller (58) that comprises an impedance sensitive/measurement circuit electrically connected between a voltage generator and the two electrical connections, wherein the measurement circuit is configured to create a signal indicative of impedance (value is impedance itself from sensor 60, and is thus also resistance), and adjusting fluid flow to decrease the amount of fluid at the surgical site by increasing/activating the suction. Zhang et al. further teach that impedance decreases corresponding to an increase in conductivity between electrodes (40, 42 or 46, 48) due to the presence of saline, blood or other body fluids, and that an event reflected by a significant drop in impedance, i.e., one below a predetermined level, will suggest excessive fluid or bleeding. Zhang et al. further teach that saline is delivered for flushing tissue from the treatment site. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Meads, Jr. et al. in view of Gutbrod et al. and Kotmel et al. such that the electrosurgical system controller further comprises an impedance sensitive/measuring circuit electrically connected between the RF voltage generator and the two electrical pins of the connector, wherein the measurement circuit is configured to create a signal indicative of impedance and commanding the pump system to decrease the flow of conductive fluid in response to determining that the value indicative of impedance of the tissue and the conductive fluid is decreasing and commanding the pump system to increase the flow of conductive fluid in response to determining that the value indicative of impedance of the tissue and the conductive fluid is increasing in order to provide the benefit of flushing the tissue site with an appropriate amount of saline and removing excess fluid from the surgical site as taught by Zhang et al. ([0037], [0040-0041]) and since Zhang et al. and Gutbrod et al. both teach the adjusting the amount of fluid at the surgical site in response to measuring fluid, particularly excess fluid, at the surgical site, where the fluid sensor of Gutbrod et al. and the impedance sensor of Zhang et al. are equivalents in the art with respect to sensing fluid conditions at the surgical site.
Meads, Jr. et al. in view of Gutbrod et al., Kotmel et al. and Zhang et al. fail to disclose how the flow of conductive fluid is decreased, and specifically decreasing the flow of conductive fluid as the value indicative of the impedance of the tissue and the conductive fluid decreases comprising: decreasing directly proportional to the value indicative of impedance of the tissue and the conductive fluid; decreasing linearly proportional to the value indicative of impedance of the tissue and the conductive fluid; decreasing step-wise proportional to the value indicative of impedance of the tissue and the conductive fluid. However, Hoey et al. teach a method where a controller sends commands and fluid flow is adjusted in response to impedance measurements, the fluid flow adjustments being controlled in several ways, such as linearly adjusting the fluid flow in response to the measured impedance or providing a step wise change in the fluid flow in response to the measured impedance (Col. 20-21, ll. 27-15). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Meads, Jr. et al. in view of Gutbrod et al., Kotmel et al. and Zhang et al. such that decreasing the flow of conductive fluid further comprises at least one selected from a group comprising: decreasing directly proportional to the value indicative of impedance of the tissue and the conductive fluid; decreasing linearly proportional to the value indicative of impedance of the tissue and the conductive fluid; or decreasing step-wise proportional to the value indicative of impedance of the tissue and the conductive fluid in order to adjust fluid flow at a set rate of change or making adjustments such that fluid flow is maintained for specific predetermined periods of time as taught by Hoey et al. (Col. 20-21, ll. 27-15)
Claim 17 is rejected upon the same rationale as provided for claim 2.
Claim 22 is rejected upon the same rationale as applied to claim 7.
Claim(s) 3 & 18 is/are rejected under 35 U.S.C. 103 as being obvious over Meads, Jr et al. (2016/0278854, previously cited) in view of Gutbrod et al. (2017/0273732, previously cited), Kotmel et al. (2008/0071257, previously cited) and Zhang et al. (2021/0282849, previously cited) and Hoey et al. (6,409,722, previously cited), as applied to claims 2 & 17, in further view of Sussman (6,315,755).
Concerning claims 3 & 18, Gutbrod et al. further disclose generating the alarm, by the electrosurgical controller, when the value indicative of impedance of the tissue and the conductive fluid remains below the predetermined threshold for a predetermined duration (duration is zero when value passes threshold) ([0079]). Meads, Jr. et al. in view of Gutbrod et al., Kotmel et al. and Zhang et al. fail to disclose the alarm indicating a clog in an aspiration tubing associated with the surgical site. However, Sussman teach a method where vacuum in a handpiece is monitored and excessive or rapid increases in vacuum level (indicating an occlusion or low aspiration flow) causes the power to the heating element to be reduced or eliminated which would cause excessive heated fluid at the surgical site (Col. 5-6, ll. 18-3). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Meads, Jr. et al. in view of Gutbrod et al., Kotmel et al. and Zhang et al. such that the alarm indicates a clog in an aspiration tubing associated with the surgical site in order to provide the benefit of preventing excess heated fluid at the tissue site as taught by Sussman.
Response to Arguments
Applicant's arguments filed 12/11/2025 have been fully considered but they are not persuasive.
In response to Applicant’s arguments that “’determining a flow condition’ is not analogous to measuring a value indicative of impedance of tissue and conductive fluid”, the Examiner respectfully disagrees. First, the claim uses the term “indicative” can be defined as: “serving to indicate” (www.ahdictionary.com). Under BRI, a flow condition at a tissue treatment site serves to indicate the impedance of the tissue the conductive fluid, since, as Kotmel and Zhang teach, increased fluid amounts, or excess fluid, creates a path of conductivity, whereby conductivity between electrodes increases, and thus impedance of the tissue and the fluid decreases.
In response to Applicant’s arguments that Zhang fails to teach adjusting fluid flow in response to the value indicative of the impedance of the tissue and conductive fluid, the Examiner notes that the rejection of record states that Zhang teaches adjusting the amount of fluid by either decreasing or increasing the amount of fluid, and thus fluid flow, at the treatment site in response to the value indicative of the impedance of the tissue and conductive fluid decreasing or increasing.
In response to Applicant’s arguments that Zhang fails to teach adjusting the fluid flow and amount at the treatment site as the value indicative of impedance decreases, the Examiner respectfully disagrees, as Zhang teaches that as the value decreases from above the predetermined level to below the predetermined level, the fluid adjusts.
In response to Applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In this case, Hoey relates to tissue treatment with two electrodes and fluid adjustments made in response to impedance measurements at the treatment site.
In response to Applicant's argument that that some of the references due not relate to a method of sealing blood vessels and thus are nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, those references relate to treating tissue by passing current through two electrodes while having a conductive fluid disposed at the treatment site, and thus are regarded as analogous art.
The Examiner notes: (1) the claim recites the term “a value indicative of impedance of tissue and conductive fluid” which is broadly interpreted as any parameter that relates to the actual impedance value, such as fluid at the treatment site; (2) the claim fails to recite when the fluid flow is decreased (e.g., immediately after the value starts to decrease, an entire duration when the value is decreasing) during the decreasing of the value indicative of impedance of tissue and conductive fluid. The Examiner notes that upon looking to the specification, there does not appear to be support for a specific timing associated with the decrease.
Conclusion
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/JAYMI E DELLA/Primary Examiner, Art Unit 3794
JAYMI E. DELLA
Primary Examiner
Art Unit 3794