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 .
Response to Amendment
The amendment filed 27 October 2025 has been entered. Claims 15-17 and 22-23 are currently amended. Claims 15-23 are pending in the application.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 15-23 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 15 and 22 both recite the limitation "the pressure". There is insufficient antecedent basis for this limitation in the claim.
It is unclear whether the following terms recited throughout the claims refer to the same entities, which renders the scope of the claims unclear:
"a temperature signal," "the signal," "the temperature," and "the temperature of the sent liquid"
"a preset threshold," "a preset pressure," and "a preset temperature"
"a preset time" (for releasing/sending liquid, recited twice in claim 15 and 22 such that it is unclear whether the second instance refers to the same time period) and “a preset time” (for suction of liquid)
Dependent claims 16 and 18-21 are necessarily rejected as depending upon rejected base claims.
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.
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.
Claims 15-23 are rejected under 35 U.S.C. 103 as being unpatentable over Fishel (US PGPub No. 2009/0069875) in view of Catanzaro et al. (US PGPub No. 2019/0380761), hereinafter Catanzaro, and Flaherty et al. (US PGPub No. 2014/0012155), hereinafter Flaherty, and further in view of Cosmescu (US Patent No. 5,836,909).
Regarding claims 15 and 22, Fishel teaches an in vivo temperature control system (Fig. 1: esophageal cooling system 10) and a method for its control, the system comprising a catheter insertable into a living body (Fig. 1: esophageal catheter 20);
a temperature probe containing a temperature sensor and that is insertable into the catheter (Fig. 2: suction lumen 38 extending through catheter 20 with temperature sensor 66 thereon);
a liquid storage section that stores a temperature-controlled liquid (Fig. 3: coolant tank 54; par. 0040: “the coolant lumen receives fluid regulated within the tank 54 by a heat-exchanger unit 64 which controls the temperature of the cooling fluid”);
a pump that supplies the liquid from the liquid storage section to the catheter (Fig. 3: coolant pump 58; par. 0039: “A coolant pump 58 is utilized for transferring the cooling fluid from the tank 54 through a flow control 60 as well as the coolant lumen 32”);
and a control section that controls driving of the pump based on a signal detected from the temperature probe (Fig. 3: controller 40; par. 0040: “the sensors 66 may be utilized to automatically control the flow, e.g. volumetric and start/stop, of cooling fluid using electromechanical flow control valves 60 and the like that are in electrical communication with the controller”), wherein the pump is driven such that the liquid in the liquid storage section is delivered through the catheter to outside of to the catheter (par. 0036: “The phoximal balloon 24 includes a coolant lumen 32 therethrough for transfer of a liquid coolant 34. The coolant lumen terminates in a nozzle 36. The nozzle is constructed and arranged to direct the liquid coolant against the inner surface of the esophageal lumen”)
and such that a liquid outside of the catheter is sucked through the catheter (par. 0039: “A vacuum pump 62 is also provided for transferring coolant fluid from the suction lumen 38 to the coolant tank 54. In this manner cooling fluid may be recycled through the system numerous times until the ablation procedure is completed”).
Fishel does not explicitly teach wherein the pump is a roller type tube pump, and the control section drives the pump such that a rotation speed during suction of the liquid is lower than a rotation speed during sending of the liquid. However, in a related cardiac ablation art, Catanzaro teaches a temperature control system utilizing a roller type tube pump (par. 0125: “the inlet tube for room temperature water is attached to a pump and the outlet tube is placed in a waste beaker. This pump system can be replaced with a peristaltic pump;” examiner notes that a peristaltic pump is a roller type pump) and wherein suction speed for recovering a liquid outside the catheter is lower than the speed of releasing the liquid (par. 0060: “fluid may be admitted into tube 110 and slidable sleeve 116 at a lower pressure than for device 100 for a similar spray velocity at active port 118A/120A”), which Catanzaro teaches is sufficient for fluid recovery, though less efficient (par. 0060: “While recovery of warming/cooling fluid may not be as efficient as for device 100, it may be sufficient depending on the total amount of fluid to be released, and the effect of the released fluid upon the esophagus or other components of the digestive system”).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the system and method of Fishel by substituting the peristaltic pump of Catanzaro for the pump of Fishel, since one of ordinary skill in the art could have performed such a substitution and the results were predictable, i.e., the system would pump fluids using the rotary motion of the peristaltic pump. It would further have been obvious to one of ordinary skill in the art to modify the system and method of Fishel by configuring the suction speed to be lower than the liquid-releasing speed, as taught by Catanzaro, since Catanzaro teaches that a lower suction speed is sufficient for recovery of the liquid.
Although Fishel teaches controlling the driving of the pump based on a signal detected from the temperature probe, Fishel is silent with respect to the specific control logic and does not explicitly teach wherein the control signal is based on a preset threshold wherein the control section controls the pump such that the liquid in the liquid storage section is released to outside of the catheter through the catheter when the signal reaches a preset threshold.
However, in a related temperature control art, Flaherty teaches a temperature control system and method wherein the control signal is based on a preset threshold, comparing the temperature signal to the threshold (par. 0049: “The feedback circuit may be configured to control a tissue and/or probe cooling assembly, such as to activate the cooling assembly when one or more temperature measurements are above a threshold. The feedback circuit may be configured to control a tissue and/or probe warming assembly, such as to activate a warming assembly when one or more temperature measurements are below a threshold”), which allows the system to cool or warm tissue that is being monitored by temperature sensors (par. 0109: “Fluids may be delivered from port 116 to cool or warm tissue being monitored by sensor assembly 120, such as fluids delivered manually or automatically by system 10 when one or more patient locations exceed one or more temperature thresholds”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the system and method of Fishel in view of Catanzaro by specifically incorporating a preset threshold into the control logic, as taught by Flaherty, in order to allow the system to cool or warm tissue that is being monitored by temperature sensors.
The combination does not explicitly teach wherein the control section is configured to stop release of the liquid when a preset time from the beginning of the release elapsed or when the temperature reaches a threshold, whichever occurs earlier; to control the pump such that the liquid outside of the catheter is sucked through the catheter when a time from stopping sending of the liquid has reached a preset time; and stopping suction to prevent flattening of esophagus when a preset time from the beginning of the suction elapsed or the pressure reaches a threshold, whichever is earlier. However, in an analogous art, Cosmescu teaches an automatic fluid control system for surgery wherein a control section is configured to deliver fluid into an organ for a preset time (col 7, line 25-29: “irrigation will be activated and remain on until the time period designated by adjusting potentiometer 48 has passed, the end of which time period will also be when the irrigation will stop”),
to begin suction after a predetermined delay when fluid delivery is stopped (col 7, lines 29-34: “the third time delay solid state relay 44 will be activated thereby activating the suction just as previously described with reference to the manual mode. As a result, in automatic mode 1, the irrigation will turn on when the electro surgical device or laser is deactivated and the suction will turn on when the irrigation stops”),
and stopping suction to prevent damage to an organ when a preset time from the beginning of the suction elapses, unless interrupted by another control signal signifying unsafe pressure (col 7, lines 34-37: “The suction will start at the time that the suction is triggered "ON" after irrigation is off and will be on for a period of time determined by adjustment by adjusting potentiometer 49;” col 3, lines 35-38: “a vacuum sensor connected to the suction tubing having means for disconnecting the suctioning means and irrigation means upon the detection of an unsafe vacuum pressure”).
Cosmescu teaches that the disclosed control features provide the ability to automatically employ fluid delivery and suction without requiring manual activation (col 2, lines 3-8: “an automatic fluid control system and method that will automatically employ suction and/or irrigation for a desired time period, where suction and/or irrigation are necessary, without requiring separate activation from the surgeon or operating room staff”);
and that stopping suction upon detection of unsafe pressure is a known safety feature for a system utilizing automatic fluid control during surgery (Abstract: “Several safety features for monitoring the fluid control system are also incorporated within the system such as fluid sensors for detecting the absence of irrigation fluid, pressure sensors and vacuum systems for monitoring fluid pressure, fluid sensors for monitoring fluid volume, and warning signals for detecting empty containers. All of the safety features are designed to automatically deactivate suction and/or irrigation means contained within the fluid control system upon detection of unsafe levels”).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the control section of the combined reference to include the automatic control features taught by Cosmescu and thereby arrive at the invention of claims 15 and 22, since Cosmescu teaches that they provide the ability to employ fluid delivery and suction without requiring manual activation, as well as enhancing safety during surgery.
Regarding claim 16, the combination teaches the system of claim 15 as described previously. Cosmescu further teaches further comprising a pressure sensor that detects an internal pressure of the catheter (Fig. 2-3: vacuum sensor 40), wherein the control section controls driving of the pump based on a signal detected by the pressure sensor such that the pump stops the sucking of the liquid when the signal detected by the pressure sensor has reached a preset pressure (col 3, lines 55-58: “a vacuum sensor connected to the suction tubing having means for disconnecting the suctioning means and irrigation means upon the detection of an unsafe vacuum pressure”).
Regarding claims 17 and 23, Fishel teaches an in vivo temperature control system (Fig. 1: esophageal cooling system 10) and a method for its control, the system comprising a catheter insertable into a living body (Fig. 1: esophageal catheter 20);
a temperature probe containing a temperature sensor and that is insertable into the catheter (Fig. 2: suction lumen 38 extending through catheter 20 with temperature sensor 66 thereon);
a liquid storage section that stores a temperature-controlled liquid (Fig. 3: coolant tank 54; par. 0040: “the coolant lumen receives fluid regulated within the tank 54 by a heat-exchanger unit 64 which controls the temperature of the cooling fluid”);
a pump that supplies the liquid from the liquid storage section to the catheter (Fig. 3: coolant pump 58; par. 0039: “A coolant pump 58 is utilized for transferring the cooling fluid from the tank 54 through a flow control 60 as well as the coolant lumen 32”);
and a control section that controls driving of the pump based on a signal detected from the temperature probe (Fig. 3: controller 40; par. 0040: “the sensors 66 may be utilized to automatically control the flow, e.g. volumetric and start/stop, of cooling fluid using electromechanical flow control valves 60 and the like that are in electrical communication with the controller”),
wherein the pump is driven such that the liquid in the liquid storage section is delivered through the catheter to outside of to the catheter (par. 0036: “The phoximal balloon 24 includes a coolant lumen 32 therethrough for transfer of a liquid coolant 34. The coolant lumen terminates in a nozzle 36. The nozzle is constructed and arranged to direct the liquid coolant against the inner surface of the esophageal lumen”) and such that the liquid outside of the catheter is sucked through the catheter (par. 0039: “A vacuum pump 62 is also provided for transferring coolant fluid from the suction lumen 38 to the coolant tank 54. In this manner cooling fluid may be recycled through the system numerous times until the ablation procedure is completed”).
Fishel does not explicitly teach wherein the pump is a roller type tube pump, and the control section drives the pump such that a rotation speed during suction of the liquid is lower than a rotation speed during sending of the liquid. However, Fishel in view of Catanzaro teaches these limitations for the same reasons laid out previously in the rejection of claims 15 and 22.
The combination does not explicitly teach further comprising a pressure sensor that detects an internal pressure of the catheter, wherein the control section controls driving of the pump based on a signal detected by the pressure sensor such that the pump stops the sucking of the liquid when the signal detected by the pressure sensor has reached a preset pressure; wherein the control section controls the pump such that release of the liquid is stopped when a preset time from the beginning of the release elapsed or when the temperature reaches a threshold, whichever occurs earlier; and the suction is stopped when a preset time from the beginning of the suction elapsed or the pressure reaches a threshold, whichever occurs earlier. However, Cosmescu teaches further comprising a pressure sensor that detects an internal pressure of the catheter (Fig. 2-3: vacuum sensor 40), wherein the control section controls driving of the pump based on a signal detected by the pressure sensor such that the pump stops the sucking of the liquid when the signal detected by the pressure sensor has reached a preset pressure (col 3, lines 55-58: “a vacuum sensor connected to the suction tubing having means for disconnecting the suctioning means and irrigation means upon the detection of an unsafe vacuum pressure”), and the combination in view of Cosmescu teaches these limitations for the same reasons laid out previously in the rejection of claims 15 and 22.
The combined reference does not explicitly teach wherein the control signal is based on a preset temperature threshold, comparing the temperature signal to the threshold, such that the liquid in the liquid storage section is released outside of the catheter through the catheter when the temperature signal reaches a threshold. However, the combination in view of Flaherty teaches this limitation for the same reasons laid out previously in the rejection of claims 15 and 22.
Regarding claims 18-19, the combination teaches the systems of claims 15 and 17 as described previously. Fishel does not explicitly teach further comprising a monitor that displays the signal detected from the temperature probe, as a digital number, bar graph, or trend graph, and means that allow an operator to know that the signal detected from the temperature probe exceeded the preset threshold, by way of changing display color of the digital number, bar graph, or trend graph on the monitor. However, Flaherty teaches a monitor that displays the signal detected from the temperature probe as a digital number, bar graph, or trend graph (Fig. 1: display 155; par. 0024: “The probe may include or otherwise be electronically attachable to a display unit used to display the temperature information” and par. 0025: “numeric temperature information may be included, such as information representing current temperature; an average of temperature over time; peak or maximum temperature over time; a representation of historic temperature information; and combinations of these”), including means that allow an operator to know that the signal detected from the temperature probe exceeded the preset threshold (par. 0097: “the various types and forms of recorded and calculated temperature information can be compared to one or more alarm thresholds such as to activate alarm transducer 157”) and the ability to change display color correlated with particular temperatures or temperature ranges (par. 0025: “The display may be configured to allow an operator to adjust a domain of values of the displayed temperature map, such as to correlate a display property such as color to a particular temperature or temperature range”), which allows the user to analyze temperature data (par. 0165: “As a result of this analysis and/or processing, a temperature map of multiple patient locations is displayed. The system comprises many features enabling the user, e.g. a clinician, to analyze temperature and other data”).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to provide the system of the combined reference with a monitor that displays the signal detected from the temperature probe as a digital number, including means that allow an operator to know that the signal detected from the temperature probe exceeded the preset threshold and the ability to change display color correlated with particular temperatures or temperature ranges, as taught by Flaherty, in order to allow the user to analyze temperature data, as taught by Flaherty. In light of Flaherty’s teaching, it would further have been obvious to change the display color of a digital number or graph when a temperature threshold is exceeded, since Flaherty already teaches evaluating temperature thresholds for alarm conditions and changing display colors correlated with particular temperatures (e.g., thresholds).
Regarding claims 20-21, the combination teaches the systems of claims 15 and 17 as described previously. Fishel further teaches wherein the system comprises a liquid-sending pump and a suction pump, as said pump (Fig. 3: coolant pump 58 and vacuum pump 62), and the control section drives the liquid-sending pump when the liquid is to be sent, and drives the suction pump when the liquid is to be sucked (par. 0039: “A coolant pump 58 is utilized for transferring the cooling fluid from the tank 54 through a flow control 60 as well as the coolant lumen 32 […] A vacuum pump 62 is also provided for transferring coolant fluid from the suction lumen 38 to the coolant tank 54” and par. 0040: “the controller 40 is constructed and arranged to control at least one parameter of the system which may include, but should not be limited to, cooling fluid flow, cooling fluid temperature, vacuum operation, vacuum pressure”), and wherein the control section controls the pump when a preset time or temperature is reached, and the pump is driven such that liquid is sucked through the catheter from the environment exterior to the catheter (par. 0040: “The controller may also receive fluid from liquid detecting sensors which can be used to regulate the vacuum applied and maintained in the system. In this manner, cooling fluid would only be evacuated after a predetermined accumulation thereof”).
Response to Arguments
Applicant’s arguments, filed 27 October 2025, with respect to the rejection(s) of claim(s) 15, 17, and 22 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, in light of the amendments to the claims, the previous rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Cosmescu. As described previously, Cosmescu teaches control logic for a surgical fluid system including preset times for fluid delivery and suction, as well as a safety feature utilizing a pressure sensor to stop suction when an unsafe pressure is detected.
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 DAVINA E LEE whose telephone number is (571)272-5765. The examiner can normally be reached Monday through Friday between 8:00 AM and 5:30 PM (ET).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, LINDA C DVORAK can be reached at 571-272-4764. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/D.E.L./Examiner, Art Unit 3794