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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/27/2026 has been entered.
Response to Amendment
The amendment filed 02/27/2026 has been entered. Claims 2-6, 8-18, 20-22, 24-25, 27-39 are pending in the application. Applicant' s amendments to the claims have overcome every objection and 112(b) rejection previously set forth in the Final Office Action mailed 11/28/205.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 2-6, 8-9, 11-18, 20-22, 24-25, 27-30, 32-39 are rejected under 35 U.S.C. 103 as being unpatentable over Rajagopalan (US 2017/0014596) in view of Cioanta (US 2005/0192652).
Regarding claim 2, Rajagopalan discloses a system (System of Fig 1) for performing a medical procedure in the intestine of a patient, the system comprising: a catheter (100, Fig 1) for insertion into the intestine, the catheter comprising: a shaft (110, Fig 1) including a distal portion; and a functional assembly (130, Fig 1) on the distal portion of the shaft (See Fig 1), wherein the functional assembly is configured to receive a fluid comprising ablative fluid and neutralizing fluid (Para 0152, 0160); and a console (200, Fig 1) comprising: a connector (203, Fig 1) configured to operably attach the catheter to the console (Para 0159); and at least one pumping assembly (225, Fig 1) configured to deliver the fluid to the functional assembly from at least one reservoir (one of reservoirs 220, Fig 1) operably coupled to the console; wherein the system is configured to perform treatment of a first segment of the intestine via the console delivering the ablative fluid and the neutralizing fluid to the functional assembly while the functional assembly is positioned proximate the first segment of the intestine (Para 0102), wherein the console is configured to deliver the ablative fluid to the functional assembly when the functional assembly is positioned in the first segment of the intestine based on one or more ablative fluid delivery parameters, wherein the console is configured with an inline heater (229, Fig 1) and a heated-fluid holding volume (another one of reservoirs 220, Fig 1) (Para 0169, “one or more functional elements 229 comprise a heating element or a chilling element configured to heat or chill fluid within a reservoir 220” ), and wherein the one or more ablative fluid delivery parameters are determined based on at least a first set of one or more system parameters comprising a temperature of the ablative fluid of the console (Para 0008, 0162).
Rajagopalan is silent regarding prior to delivering the ablative fluid to the functional assembly, to cause the ablative fluid to perform a first pass through the inline heater in a recirculating arrangement that directs heated fluid to a heated-fluid holding volume of the console, and, subsequent thereto, to cause the ablative fluid to perform a second pass through the inline heater during a delivery arrangement that directs heated fluid toward the catheter.
Cioanta teaches a system (System shown in Fig 3A) for performing a medical procedure comprising a catheter (20, Fig 3A) having: a shaft (25, Fig 3A )including a distal portion; a functional assembly (23, Fig 3A) on the distal portion of the shaft; and an inline heater (14, Fig 3A) configured to heat the ablative fluid as the ablative fluid is pumped through the inline heater, wherein the console (12, Fig 3A) is further configured, prior to delivering the ablative fluid to the functional assembly, to cause the ablative fluid to perform a first pass through the inline heater in a recirculating arrangement, and, subsequent thereto, to cause the ablative fluid to perform a second pass through the inline heater during a delivery arrangement that directs heated fluid toward the catheter (Para 0058; since the system comprises a circulating loop of ablative fluid, the ablative fluid passes through the heater multiple times and is delivered to the functional assembly after each pass. Therefore, the ablative fluid passes through the inline heater at least two times and is delivered to the functional unit after the second pass as required by the claim)
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 of Rajagopalan to be configured such that the ablative fluid makes multiple passes through the heater as taught by Cioanta in order to promote thermal treatment penetration depth by closely controlling the pressure and temperature of the treatment balloon (Para 0010, 0018).
Examiner notes the modified invention would teaches that the first pass through the inline heater is in a recirculating arrangement that directs heated fluid to a heated-fluid holding volume of the console as Rajagopalan teaches a heated-fluid holding volume 220 that can be coupled to a return path as detailed in Para 0161. Thus, the modification in view of Cioanta to have the fluid recirculate through the inline heater and heated-fluid holding volume would read on all of the claim limitations.
Regarding claim 3, the modified invention of Rajagopalan and Cioanta discloses the console is configured to deliver the neutralizing fluid to the functional assembly after having delivered the ablative fluid to the functional assembly (Para 0160 - Rajagopalan; neutralizing fluid can be delivered before and after the ablative fluid is delivered).
Regarding claim 4, the modified invention of Rajagopalan and Cioanta discloses the console is further configured to deliver the neutralizing fluid to the functional assembly prior to delivering the ablative fluid to the functional assembly (Para 0160 - Rajagopalan; neutralizing fluid can be delivered before and after the ablative fluid is delivered).
Regarding claim 5, the modified invention of Rajagopalan and Cioanta discloses the console is configured to deliver the neutralizing fluid to the functional assembly prior to delivering the ablative fluid to the functional assembly (Para 0160 - Rajagopalan; neutralizing fluid can be delivered before and after the ablative fluid is delivered).
Regarding claim 6, the modified invention of Rajagopalan and Cioanta discloses the ablative fluid comprises fluid at a temperature above body temperature of the patient (Para 0160 - Rajagopalan; the ablative fluid can have a temp of above 44°C).
Regarding claim 8, the modified invention of Rajagopalan and Cioanta discloses the neutralizing fluid comprises fluid at a temperature below body temperature of the patient (Para 0160 - Rajagopalan; the neutralizing fluid can have a temp of below 37°C).
Regarding claim 9, the modified invention of Rajagopalan and Cioanta discloses the neutralizing fluid comprises fluid at a temperature of approximately a temperature of a room in which the console is positioned (Para 0289 - Rajagopalan; Room temperature is roughly 20-22°C and Rajagopalan says that the neutralizing or cooling fluid can be between 10-25°C).
Regarding claim 11, the modified invention of Rajagopalan and Cioanta discloses the one or more ablative fluid delivery parameters comprise a duration of delivery of the ablative fluid, and the console is configured to determine the duration as a function of the temperature of the ablative fluid and increase the duration in response to a decrease in the temperature of the ablative fluid (Para 0290 -Rajagopalan; “one or more of T.sub.A, T.sub.B, TP.sub.1, TP.sub.2 and/or TP.sub.3 can vary (e.g. be allowed to vary), such as when T.sub.A increases during an extraction of cooling fluid from catheter 100 (e.g. the recovered fluid warms the cooling fluid in the first reservoir 220.sub.A). These variations (e.g. as measured by one or more sensors of system 10) can result in an adjustment (e.g. an automatic adjustment) to another parameter (e.g. T.sub.A, T.sub.B, TP.sub.1, TP.sub.2 and/or TP.sub.3), such as an adjustment made by algorithm 251 (e.g. an algorithm comprising a lookup table including reservoir temperatures and corresponding treatment durations) based on a signal produced by one or more functional elements 109, 119, 139, 209, 229 and/or 309 described hereabove in reference to FIG. 1, that have been configured as a sensor”)
Regarding claim 12, the modified invention of Rajagopalan and Cioanta discloses the one or more ablative fluid delivery parameters comprises at least a flow rate at which the ablative fluid is provided to the functional assembly by the console (Para 0162 -Rajagopalan, “delivery rate of fluid into functional assembly 130”).
Regarding claim 13, the modified invention of Rajagopalan and Cioanta discloses the one or more ablative fluid delivery parameters comprises at least a duration for which the ablative fluid is positioned within the functional assembly during the treatment of the first segment of the intestine (Para 0162 -Rajagopalan, “duration of fluid contained within functional assembly 130”).
Regarding claim 14, the modified invention of Rajagopalan and Cioanta discloses the one or more ablative fluid delivery parameters comprises at least a duration for which the neutralizing fluid is positioned within the functional assembly during the treatment of the first segment of the intestine (Para 0162, “duration of fluid contained within functional assembly 130”).
Regarding claim 15, the modified invention of Rajagopalan and Cioanta discloses the one or more ablative fluid delivery parameters comprises at least a pressure of fluid delivered to the functional assembly by the console (Para 0162, “pressure of fluid delivered into functional assembly 130”).
Regarding claim 16, the modified invention of Rajagopalan and Cioanta discloses the console is configured to dynamically adjust at least one of the one or more ablative fluid delivery parameters during the treatment of the first segment of the intestine (Para 0289 -Rajagopalan, “the volume, temperature and/or duration of fluid delivered to functional assembly 130 is automatically and/or dynamically adjusted, such as an adjustment performed based on a signal provided by one or more sensors as described herein”).
Regarding claim 17, the modified invention of Rajagopalan and Cioanta discloses the console is configured to adjust the one or more ablative fluid delivery parameters in a closed loop arrangement (Para 0504-0507 -Rajagopalan; See Fig 34; the system can automatically check for completeness and repeat steps 3430 if it is detected by sensors that the procedure is not completed).
Regarding claim 18, the modified invention of Rajagopalan and Cioanta discloses the first set of one or more system parameters further comprises at least one parameter selected from the group consisting of: altitude of a room in which the console is positioned; patient temperature (Para 0138 -Rajagopalan; “patient parameter…temperature”); the temperature of the neutralizing fluid; the temperature of the ablative fluid (Para 0165 -Rajagopalan; “fluid from a reservoir 220 is delivered for a time period determined based on the temperature of fluid in that reservoir and/or based on the temperature of fluid in a separate reservoir 220, as described herebelow. For example, the amount of ablative fluid delivered by a reservoir 220 containing hot fluid can be adjusted based on the temperature of cooling fluid in a different reservoir 220”); and combinations thereof.
Regarding claim 20, the modified invention of Rajagopalan and Cioanta discloses the console is configured to deliver the neutralizing fluid to the functional assembly positioned in the first segment of the intestine based on one or more neutralizing fluid delivery parameters (Para 0008, 0162 -Rajagopalan; “temperature of a neutralizing fluid”), and wherein the one or more neutralizing fluid delivery parameters are determined based on the first set of one or more system parameters (Para 0138).
Regarding claim 21, the modified invention of Rajagopalan and Cioanta discloses the system is further configured to perform treatment of a second segment of the intestine via the console delivering the ablative fluid and the neutralizing fluid to the functional assembly while the functional assembly is positioned proximate the second segment of the intestine, and wherein the console is configured to deliver the ablative fluid to the functional assembly positioned proximate the second segment of the intestine based a second set of one or more ablative fluid delivery parameters (Para 0504-0507 -Rajagopalan)
Regarding claim 22, the modified invention of Rajagopalan and Cioanta discloses the second set of one or more system parameters comprise at least a duration of time since the treatment of the first segment of the intestine (Para 0538 -Rajagopalan).
Regarding claim 24, the modified invention of Rajagopalan and Cioanta discloses one or more sensors, wherein each sensor is configured to produce a signal, and wherein the system is configured to determine the first set of one or more system parameters based on the signal from each sensor (Para 0140 -Rajagopalan).
Regarding claim 25, the modified invention of Rajagopalan and Cioanta discloses one or more sensors comprises at least a temperature sensor (Para 0181 -Rajagopalan; “temperature sensor”).
Regarding claim 27 the modified invention of Rajagopalan and Cioanta discloses the temperature sensor is configured to produce a signal related to one or more temperatures selected from the group consisting of: temperature of fluid in the console; temperature of the shaft; temperature of fluid within the shaft; temperature of the functional assembly (Para 0162 -Rajagopalan; “temperature of functional assembly 130”); temperature of a fluid within the functional assembly of the catheter; temperature of the ablative fluid; temperature of the neutralizing fluid; temperature of tissue proximate the functional assembly; temperature of target tissue; temperature of non-target tissue; and combinations thereof.
Regarding claim 28, the modified invention of Rajagopalan and Cioanta discloses the temperature sensor comprises a first temperature sensor (119, Fig 1 -Rajagopalan) and a second temperature sensor (229b, Fig 1 -Rajagopalan) (Para 0181, 219 -Rajagopalan; the sensors 119 and 229b can both be temperature sensors to measure temperatures in different portions of the system).
Regarding claim 29, the modified invention of Rajagopalan and Cioanta discloses the first temperature sensor is configured to measure the temperature associated with a first parameter of the system and the second temperature sensor is configured to measure the temperature associated with a second parameter of the system (Para 0181, 219 -Rajagopalan; the sensors 119 and 229b can both be temperature sensors to measure temperatures in different portions of the system).
Regarding claim 30 the modified invention of Rajagopalan and Cioanta discloses the one or more sensors comprises at least a pressure sensor (Para 0182 -Rajagopalan).
Regarding claim 32, the modified invention of Rajagopalan and Cioanta discloses the medical procedure performed by the system is configured to treat insulin resistance, diabetes, and/or a metabolic condition of the patient (Para 0007, 0113 -Rajagopalan).
Regarding claim 33, the modified invention of Rajagopalan and Cioanta discloses the functional assembly is configured to radially expand and/or contract (Para 0134 -Rajagopalan).
Regarding claim 34, the modified invention of Rajagopalan and Cioanta discloses the functional assembly comprises a balloon (136, Fig 1 -Rajagopalan) that receives the ablative fluid and the neutralizing fluid (Para 0151, 0155 -Rajagopalan; “an ablative fluid (e.g. an ablative fluid to be maintained within balloon 136”).
Regarding claim 35, the modified invention of Rajagopalan and Cioanta discloses the functional assembly is configured to expand tissue of the first segment of the intestine prior to the delivery of the ablative fluid to the functional assembly (Para 0157; Para 0205 -Rajagopalan).
objective evidence present in the application indicating obviousness or nonobviousness.
Regarding Claim 36, the modified invention of Rajagopalan and Cioanta discloses the console includes a temperature sensor configured to measure the temperature of fluid prior to delivery to the catheter (Para 0162 -Rajagopalan; “temperature of an ablative fluid (e.g. temperature of an ablative fluid in reservoir 220, console 200, functional assembly 130 and/or catheter 100)”).
Regarding Claim 37, the modified invention of Rajagopalan and Cioanta discloses the inline heater is configured to heat the ablative fluid based on the measured temperature of the ablative fluid (Para 0067 -Cioanta).
Regarding Claim 38, the modified invention of Rajagopalan and Cioanta discloses the console is configured to adjust a temperature of the ablative fluid based on a measured temperature of the fluid (Para 0067 -Cioanta; Para 0162, 0289 - Rajagopalan).
Regarding Claim 39, Rajagopalan discloses a console (200, Fig 1) for performing a medical procedure in an intestine of a patient, the console comprising: a catheter interface (203, Fig 1) configured to operably couple to a catheter (100, Fig 1) insertable into the intestine (Para 0159), the catheter comprising a shaft (110, Fig 1) and a functional assembly (130, Fig 1) configured to receive a fluid comprising an ablative fluid and a neutralizing fluid (Para 0152, 0160); a fluid reservoir interface (212, Fig 1) configured to be operably coupled to at least one reservoir (one of reservoirs 220, Fig 1) containing the fluid (Para 0160); a pumping assembly (225, Fig 1) configured to pump the ablative fluid from the at least one reservoir (Para 0160); an inline heater (229, Fig 1) configured to heat the ablative fluid as the ablative fluid is pumped through the inline heater; a heated-fluid holding volume (another one of reservoirs 220, Fig 1) configured to receive heated ablative fluid after passage through the inline heater (Para 0169, “one or more functional elements 229 comprise a heating element or a chilling element configured to heat or chill fluid within a reservoir 220” ); and a controller (250, Fig 1) configured to control the pumping assembly and the inline heater (Para 0167, 0170),wherein the console is configured to determine one or more ablative fluid delivery parameters based on at least a first set of one or more system parameters comprising a temperature of the ablative fluid(Para 0008, 0162).
Rajagopalan is silent regarding the controller is configured, prior to delivering the ablative fluid to the catheter via the catheter interface, to cause the ablative fluid to perform a first pass through the inline heater in a recirculating arrangement that directs heated ablative fluid to the heated-fluid holding volume without delivering the heated ablative fluid to the catheter, and, subsequent thereto, to cause the ablative fluid to perform a second pass through the inline heater during a delivery arrangement that directs heated ablative fluid toward the catheter interface, and to deliver the heated ablative fluid to the catheter after the second pass.
Cioanta teaches a system (System shown in Fig 3A) for performing a medical procedure comprising a catheter (20, Fig 3A) having: a shaft (25, Fig 3A )including a distal portion; a functional assembly (23, Fig 3A) on the distal portion of the shaft; and an inline heater (14, Fig 3A) configured to heat the ablative fluid as the ablative fluid is pumped through the inline heater, wherein the controller (12, Fig 3A) is configured, prior to delivering the ablative fluid to the catheter via the catheter interface, to cause the ablative fluid to perform a first pass through the inline heater in a recirculating arrangement that directs heated ablative fluid to the heated-fluid holding volume (15, Fig 3A) without delivering the heated ablative fluid to the catheter, and, subsequent thereto, to cause the ablative fluid to perform a second pass through the inline heater during a delivery arrangement that directs heated ablative fluid toward the catheter interface, and to deliver the heated ablative fluid to the catheter after the second pass (Para 0058; since the system comprises a circulating loop of ablative fluid, the ablative fluid passes through the heater multiple times and is delivered to the functional assembly after each pass. Therefore, the ablative fluid passes through the inline heater at least two times and is delivered to the functional unit after the second pass as required by the claim. There is no language in the claim that prevents delivery of the ablative fluid to the catheter after delivery to the holding volume, but before the second pass).
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 of Rajagopalan to be configured such that the ablative fluid makes multiple passes through the heater as taught by Cioanta in order to promote thermal treatment penetration depth by closely controlling the pressure and temperature of the treatment balloon (Para 0010, 0018).
Examiner notes the modified invention would teaches that the first pass through the inline heater is in a recirculating arrangement that directs heated fluid to a heated-fluid holding volume of the console as Rajagopalan teaches a heated-fluid holding volume 220 that can be coupled to a return path as detailed in Para 0161. Thus, the modification in view of Cioanta to have the fluid recirculate through the inline heater and heated-fluid holding volume would read on all of the claim limitations.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Rajagopalan (US 2017/0014596) in view of Cioanta (US 2005/0192652) and further in view of Sharma (US 2015/0126990).
Regarding Claim 10, the modified invention of Rajagopalan and Cioanta discloses all of the elements of the invention, however, is silent regarding initiation of delivery of the ablative fluid is inhibited unless the console determines that (i) an amount of neutralizing fluid in a reservoir satisfies a threshold amount and (ii) a sensed temperature of the neutralizing fluid satisfies a temperature threshold indicative of neutralization capacity.
Sharma teaches an analogous thermal ablation system wherein initiation of delivery of the ablative fluid is inhibited unless the console determines that (i) an amount of neutralizing fluid in a reservoir satisfies a threshold amount and (ii) a sensed temperature of the neutralizing fluid satisfies a temperature threshold indicative of neutralization capacity (Para 0541; the system is shut down is water supply or fluid temperatures are abnormal and thus initiation of delivery of the ablative fluid is inhibited).
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 console to have a fault detection routine as taught by Sharma in order to ensure that the system is operating within a safe operating range (Para 0541).
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Rajagopalan (US 2017/0014596) in view of Cioanta (US 2005/0192652) and further in view of Griffiths (US 2007/0197963).
Regarding claim 31, the modified invention of Rajagopalan and Cioanta discloses at least one pumping assembly (225, Fig 1 -Rajagopalan), however, is silent regarding it comprises at least one syringe pump.
Griffiths teaches an analogous system comprising catheter (201, Fig 18), a functional assembly (B, Fig 18), and at least one pump assembly (240, Fig 15) configured to deliver the fluid to the functional assembly (Para 0058, 0088).
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 at least one pumping assembly disclosed by Rajagopalan to be a syringe pump as taught by Griffiths in order to have a pump that can easily achieve the desired pressures and flow rates for fluid injection and inflation procedures (Para 0058).
Response to Arguments
Applicant’s arguments filed 02/27/2026, on pages 10-13, regarding Rajagopalan and Cioanta failing tot each the amended claim limitations have been fully considered but are not persuasive. As detailed in the rejections of claims 2 and 39 above, the claim language does not prevent delivery of the ablative fluid to the catheter after delivery to the holding volume (i.e. reservoir 220 of Rajagopalan, but before the second pass of the fluid through the heater (i.e. recirculated fluid). Thus, the combination of Rajagopalan and Cioanta still reads on the claimed language. Examiner recognizes that Applicant is trying to capture the arrangement of the hot router 2140 describes in para 0488 of the instant specification. It is recommended that language be included to clarify that the fluid circulates through the hot router and back to the heater and reservoir before passing through the hot router to the catheter/functional assembly.
Conclusion
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/ANTARIUS S DANIEL/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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