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 Amendments under 37 CFR 1.132 filed 07/13/2026 is sufficient to overcome the rejection of claims 1 and 14 based upon the rejection set forth in the non-final failing to teach all aspects of the amended claim.
Response to Arguments
Applicant’s arguments, see Remarks, filed 07/13/2026, with respect to the rejection(s) of independent claim(s) 1 and 14 under 35 USC 102(a)(1) and 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Choi (WO 2020013375 A1).
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.
Claim(s) 1, 5, 7-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harmouche (WO 2019161015 A1) in view of Choi (WO 2020013375 A1).
Regarding claim 1, Harmouche teaches a cryogen delivery system, comprising: a probe configured to deliver a cryogenic fluid to a treatment location ([0034] Figure 1 is a schematic view of one embodiment of a cryogenic balloon catheter system 10 (also sometimes referred to as a“catheter system”) for use with a patient 12, which can be a human being or an animal. Although the catheter system 10 is specifically described herein with respect to the cryogenic balloon catheter system); a cryogen inlet configured to interface with a first cryogenic fluid supply vessel of a plurality of cryogenic fluid supply vessels ([0035] a fluid source 16 (e.g., one or more fluid containers), a balloon catheter 18, a handle assembly 20) ([0037] The fluid container(s) 16 contains the cryogenic fluid 28, which is delivered to the balloon catheter 18 with or without input from the control system 14 during a cryoablation procedure) (Fig 2; a fluid injection line 225) to transfer cryogenic fluid from the first cryogenic fluid supply vessel to the probe ([0035] a fluid source 16 (e.g., one or more fluid containers), a balloon catheter 18, a handle assembly 20) ([0037] The fluid container(s) 16 contains the cryogenic fluid 28, which is delivered to the balloon catheter 18 with or without input from the control system 14 during a cryoablation procedure) (Fig 2; a fluid injection line 225); a support structure configured to position the first cryogenic fluid supply vessel relative to the cryogen inlet (Fig 1; control console 22 and a residual fluid measurement system 26); a sensor coupled to the support structure ([0036] the control system 14 can receive, monitor, assimilate and/or integrate any sensor output and/or any other data or information received from any structure within the catheter system 10 in order to control the operation of the balloon catheter 18) and configured to generate a signal indicative of a weight of a cryogenic fluid contained in the first cryogenic fluid supply vessel ([0050] the first fluid sensor 230 and/or the second fluid sensor 232 can be positioned adjacent to the fluid container 216 in order to monitor the weight of the cryogenic fluid 228 within the fluid container 216. For example, the first fluid sensor 230 and/or the second fluid sensor 232 can include a scale that monitors the weight of the fluid container 216, the cryogenic fluid 228 within the fluid container 216, or both) ([0050] As one non-exclusive example, sensor output can include the residual fluid quantity. In this example, the first fluid sensor 230 and/or the second fluid sensor 232 can sense and/or measure the residual fluid quantity based on a pressure of the cryogenic fluid 228 within the fluid container 216, a weight of the cryogenic fluid 228 therein, and/or a combination of the pressure and/or weight); based at least in part on a weight of a cryogenic fluid contained in the first cryogenic fluid supply vessel ([0050] As one non-exclusive example, sensor output can include the residual fluid quantity. In this example, the first fluid sensor 230 and/or the second fluid sensor 232 can sense and/or measure the residual fluid quantity based on a pressure of the cryogenic fluid 228 within the fluid container 216, a weight of the cryogenic fluid 228 therein, and/or a combination of the pressure and/or weight).
Harmouche fails to teach an automated fluid supply vessel switching system configured to automatically move the first cryogenic fluid supply vessel from the support structure and automatically place a second cryogenic fluid supply vessel of the plurality of cryogenic fluid supply vessels on the support structure.
However, Choi teaches an automated fluid supply vessel switching system ([Pg 4, Para 3] it automatically unloads empty gas cylinders used by transfers and then automatically loads new gas cylinders into the cabinet, which enables quick replacement of the gas cylinders) configured to automatically move the first cryogenic fluid supply vessel from the support structure ([Pg 6, Para 2] Clamping the gas cylinder 30 to the transfer 40 when loading the gas cylinder 30 located in the c) on the transfer 40, or when placing the gas cylinder 30 loaded on the transfer 40 in the cabinet 20, A gripper 42 having a gripper 42 as shown in FIG. 5 is used to clamp the gas cylinder 30 so that the gripper 42 rises, reverses, descends, and then releases the clamping to load the transfer 40 or clamps the gas cylinder 30) and automatically place a second cryogenic fluid supply vessel of the plurality of cryogenic fluid supply vessels on the support structure ([Pg 6, Para 4] the transfer 40 moves to the loading position 60a or the unloading position 61a to control the gas cylinder by the controller (not shown). Since waiting until the replacement signal is detected it will be able to continue to automatically replace the gas cylinder 30 in the cabinet (S700)). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Harmouche to include an automated fluid supply vessel switching system configured to automatically move the first cryogenic fluid supply vessel from the support structure and automatically place a second cryogenic fluid supply vessel of the plurality of cryogenic fluid supply vessels on the support structure. Doing so allows for a more efficient replacement mechanism. Further, it would have been obvious to use Harmouche’s weight based residual fluid determination as the replacement condition for the automated replacement system of Choi. Doing so allows for automatic vessel replacement based on the sensed weight of the fluid in the first vessel.
Regarding claim 5, Harmouche teaches the system of claim 1, wherein the cryogen delivery system further comprises a visual interface ([0042] In one embodiment, the GUI 24 can provide static visual data and/or information to the operator or user. In addition, or in the alternative, the GUI 24 can provide dynamic visual data and/or information to the operator or user, such as video data or any other data that changes over time, e.g., during an ablation procedure) configured to display information based on the signal indicative of the weight of the first cryogenic fluid contained in the cryogenic fluid supply vessel ([0060] The GUI 324 of the residual fluid measurement system 326 can provide the residual cryoablation information determined by the controller 334 to the operator or user. As non-exclusive examples, the GUI 324 can provide the residual cryoablation information to the operator or user visually by picture, data, numbers or percentages. In other non- exclusive embodiments, the GUI 324 can provide the operator or user with one or more of the following: a number of cryoablation procedures that may be performed based on the residual fluid quantity and/or an amount of time to perform cryoablation procedures based on the residual fluid quantity) ([0050] As one non-exclusive example, sensor output can include the residual fluid quantity. In this example, the first fluid sensor 230 and/or the second fluid sensor 232 can sense and/or measure the residual fluid quantity based on a pressure of the cryogenic fluid 228 within the fluid container 216, a weight of the cryogenic fluid 228 therein, and/or a combination of the pressure and/or weight).
Regarding claim 7, Harmouche teaches system of claim 5, wherein the visual interface is configured to display an amount of run time for operation of the cryogen delivery system based ([0048] The residual fluid quantity of the cryogenic fluid 228 remaining with the fluid container 216 can vary at any moment depending on the number of cryoablation procedures performed and/or the amount of time to perform the cryoablation procedures) ([0060] the GUI 324 can provide the operator or user with one or more of the following: a number of cryoablation procedures that may be performed based on the residual fluid quantity and/or an amount of time to perform cryoablation procedures based on the residual fluid quantity. However, any other suitable manner can be used by the GUI 324 to effectively provide and/or notify the operator or user of the residual cryoablation information) on the signal indicative of the weight of the cryogenic fluid contained in the first cryogenic fluid supply vessel ([0050] As one non-exclusive example, sensor output can include the residual fluid quantity. In this example, the first fluid sensor 230 and/or the second fluid sensor 232 can sense and/or measure the residual fluid quantity based on a pressure of the cryogenic fluid 228 within the fluid container 216, a weight of the cryogenic fluid 228 therein, and/or a combination of the pressure and/or weight).
Regarding claim 8, Harmouche teaches the system of claim 5, wherein the visual interface is configured to display a percentage representative of an amount of cryogenic fluid present in the first cryogenic fluid supply vessel ([0060] The GUI 324 of the residual fluid measurement system 326 can provide the residual cryoablation information determined by the controller 334 to the operator or user. As non-exclusive examples, the GUI 324 can provide the residual cryoablation information to the operator or user visually by picture, data, numbers or percentages. In other non- exclusive embodiments, the GUI 324 can provide the operator or user with one or more of the following: a number of cryoablation procedures that may be performed based on the residual fluid quantity and/or an amount of time to perform cryoablation procedures based on the residual fluid quantity), based on the signal indicative of the weight of the cryogenic fluid, as compared to an amount of cryogenic fluid present in a full cryogenic fluid supply vessel ([0050] As one non-exclusive example, sensor output can include the residual fluid quantity. In this example, the first fluid sensor 230 and/or the second fluid sensor 232 can sense and/or measure the residual fluid quantity based on a pressure of the cryogenic fluid 228 within the fluid container 216, a weight of the cryogenic fluid 228 therein, and/or a combination of the pressure and/or weight).
Regarding claim 9, Harmouche teaches the system of claim 1, wherein the cryogen delivery system is configured to perform cryoablation ([0034] Figure 1 is a schematic view of one embodiment of a cryogenic balloon catheter system 10).
Regarding claim 10, Harmouche teaches the system of claim 9, wherein the cryogen delivery system is configured perform a plurality of cooling cycles ([0043] residual cryoablation information can include a number of cryoablations that may be performed and/or an amount of time to perform cryoablations based on the residual fluid quantity. In other words, the residual fluid measurement system 26 can determine whether there is a sufficient residual fluid quantity within the fluid container 16 to perform a certain number of cryoablation procedures and/or a certain amount of time to perform cryoablation procedures) in which the probe delivers the cryogenic fluid to the treatment location ([0060] a number of cryoablation procedures that may be performed based on the residual fluid quantity and/or an amount of time to perform cryoablation procedures based on the residual fluid quantity).
Regarding claim 11, Harmouche teaches system of claim 10, wherein the cryogen delivery system is configured to compare an amount of cryogenic fluid present in the first cryogenic fluid supply vessel with an amount of cryogenic fluid available to perform a procedure ([0060] a number of cryoablation procedures that may be performed based on the residual fluid quantity and/or an amount of time to perform cryoablation procedures based on the residual fluid quantity).
Regarding claim 12, Harmouche teaches system of claim 11, wherein the cryogen delivery system is configured to indicate whether the amount of cryogenic fluid present in the first cryogenic fluid supply vessel is sufficient to complete a selected procedure ([0043] residual cryoablation information can include a number of cryoablations that may be performed and/or an amount of time to perform cryoablations based on the residual fluid quantity. In other words, the residual fluid measurement system 26 can determine whether there is a sufficient residual fluid quantity within the fluid container 16 to perform a certain number of cryoablation procedures and/or a certain amount of time to perform cryoablation procedures).
Claim(s) 6, 14, 16, 17-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harmouche (WO 2019161015 A1) in view of Choi (WO 2020013375 A1) in view of Harmouche (2) (WO 2018175103 A1).
Regarding claim 6, Harmouche teaches the system of claim 5, based on the signal indicative of the weight of the cryogenic fluid contained in the first cryogenic fluid supply vessel ([0060] In other non- exclusive embodiments, the GUI 324 can provide the operator or user with one or more of the following: a number of cryoablation procedures that may be performed based on the residual fluid quantity and/or an amount of time to perform cryoablation procedures based on the residual fluid quantity. However, any other suitable manner can be used by the GUI 324 to effectively provide and/or notify the operator or user of the residual cryoablation information) ([0050] As one non-exclusive example, sensor output can include the residual fluid quantity. In this example, the first fluid sensor 230 and/or the second fluid sensor 232 can sense and/or measure the residual fluid quantity based on a pressure of the cryogenic fluid 228 within the fluid container 216, a weight of the cryogenic fluid 228 therein, and/or a combination of the pressure and/or weight).
Harmouche fails to fully teach wherein the visual interface is configured to display a volume of the cryogenic fluid present in the first cryogenic fluid supply vessel.
However, Harmouche (2) teaches wherein the visual interface is configured to display a volume of the cryogenic fluid present in the first cryogenic fluid supply vessel ([0054] The container capacity includes the maximum amount, e.g., volume, of cryogenic fluid 228 that may be contained within the fluid container 216. In one embodiment, the container capacity may be expressed in terms of a weight of a maximum volume of cryogenic fluid 228 that may be contained within the fluid container 216). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Harmouche to include wherein the visual interface is configured to display a volume of the first cryogenic fluid present in the cryogenic fluid supply vessel. Doing so allows the user to know how much fluid volume is in the vessel for operation.
Regarding claim 14, Harmouche teaches a method for determining an amount of cryogenic fluid in a first cryogenic fluid supply vessel ([0050] As one non-exclusive example, sensor output can include the residual fluid quantity. In this example, the first fluid sensor 230 and/or the second fluid sensor 232 can sense and/or measure the residual fluid quantity based on a pressure of the cryogenic fluid 228 within the fluid container 216, a weight of the cryogenic fluid 228 therein, and/or a combination of the pressure and/or weight) of a plurality of cryogenic fluid supply vessels ([0035] a fluid source 16 (e.g., one or more fluid containers), a balloon catheter 18, a handle assembly 20) ([0037] The fluid container(s) 16 contains the cryogenic fluid 28, which is delivered to the balloon catheter 18 with or without input from the control system 14 during a cryoablation procedure) (Fig 2; a fluid injection line 225).
Harmouche fails to teach the method comprising: generating a signal from a sensor coupled to a support structure on which a first cryogenic fluid supply vessel is located, the signal being indicative of a total weight of the first cryogenic fluid supply vessel; and determining an amount of cryogenic fluid present in the first cryogenic fluid supply vessel based on the signal; and an automated fluid supply vessel switching system configured to automatically move the first cryogenic fluid supply vessel from the support structure and automatically place a second cryogenic fluid supply vessel of the plurality of cryogenic fluid supply vessels on the support structure.
However, Harmouche (2) teaches the method comprising: generating a signal from a sensor coupled to a support structure on which a first cryogenic fluid supply vessel is located ([0059] The container sensor 236 can transmit or send electronic and/or other signals, e.g., sensor output, to the controller 232. In other words, the container sensor 236 can generate sensor output), the signal being indicative of a total weight of the first cryogenic fluid supply vessel ([0059] the container sensor 236 can sense container dimension information, container weight information and/or the tare weight by recognition of identification information of the fluid container 216. In yet other embodiments, the container sensor 236 can transmit or send sensor output relating to container weight information to the controller 232); and determining an amount of cryogenic fluid present in the first cryogenic fluid supply vessel based on the signal ([0061] The controller 232 can process container dimension information and/or container weight information to determine the tare weight of the fluid container 216 via any suitable manner and/or method. The controller 232 can further process the tare weight, container dimension information and/or container weight information to determine the fluid quantity within the fluid container 216). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Harmouche to include generating a signal from a sensor coupled to a support structure on which a cryogenic fluid supply vessel is located, the signal being indicative of a total weight of the cryogenic fluid supply vessel; and determining an amount of cryogenic fluid present in the cryogenic fluid supply vessel based on the signal. Doing so allows for the amount of the fluid to be accurately calculated and monitored.
However, Choi teaches an automated fluid supply vessel switching system ([Pg 4, Para 3] it automatically unloads empty gas cylinders used by transfers and then automatically loads new gas cylinders into the cabinet, which enables quick replacement of the gas cylinders) configured to automatically move the first cryogenic fluid supply vessel from the support structure ([Pg 6, Para 2] Clamping the gas cylinder 30 to the transfer 40 when loading the gas cylinder 30 located in the c) on the transfer 40, or when placing the gas cylinder 30 loaded on the transfer 40 in the cabinet 20, A gripper 42 having a gripper 42 as shown in FIG. 5 is used to clamp the gas cylinder 30 so that the gripper 42 rises, reverses, descends, and then releases the clamping to load the transfer 40 or clamps the gas cylinder 30) and automatically place a second cryogenic fluid supply vessel of the plurality of cryogenic fluid supply vessels on the support structure ([Pg 6, Para 4] the transfer 40 moves to the loading position 60a or the unloading position 61a to control the gas cylinder by the controller (not shown). Since waiting until the replacement signal is detected it will be able to continue to automatically replace the gas cylinder 30 in the cabinet (S700)). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Harmouche to include an automated fluid supply vessel switching system configured to automatically move the first cryogenic fluid supply vessel from the support structure and automatically place a second cryogenic fluid supply vessel of the plurality of cryogenic fluid supply vessels on the support structure. Doing so allows for a more efficient replacement mechanism. Further, it would have been obvious to use Harmouche’s weight based residual fluid determination as the replacement condition for the automated replacement system of Choi. Doing so allows for automatic vessel replacement based on the sensed weight of the fluid in the first vessel.
Regarding claim 16, Harmouche teaches the method of claim 14, but fails to teach wherein determining an amount of a cryogenic fluid in the first cryogenic fluid supply vessel comprises subtracting an estimated weight of an empty cryogenic fluid supply vessel from the total weight of the first cryogenic fluid supply vessel.
However, Harmouche (2) teaches wherein determining an amount of a cryogenic fluid in the first cryogenic fluid supply vessel comprises subtracting an estimated weight of an empty cryogenic fluid supply vessel from the total weight of the first cryogenic fluid supply vessel ([0054] Figure 2, the fluid container 216 can include a tare weight and a container capacity. The tare weight includes the weight of the fluid container 216 when the fluid container 216 is empty, e.g., containing no or substantially no cryogenic fluid 228. In various embodiments, the tare weight of the fluid container 216 can be used to determine the fluid quantity, i.e., the amount of cryogenic fluid 228 remaining within the fluid container 216). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Harmouche to include wherein determining an amount of a cryogenic fluid in the cryogenic fluid supply vessel comprises subtracting an estimated weight of an empty cryogenic fluid supply vessel from the total weight of the cryogenic fluid supply vessel. Doing so allows for the accurate calculation of how much fluid is in the reservoir without adding in the weight of the vessel.
Regarding claim 17, Harmouche teaches the method of claim 14, further comprising providing an indication regarding the amount of cryogenic fluid present in the cryogenic fluid supply vessel ([0042] the GUI 24 can provide dynamic visual data and/or information to the operator or user, such as video data or any other data that changes over time, e.g., during an ablation procedure. Further, in various embodiments, the GUI 24 can include one or more colors, different sizes, varying brightness, etc., that may act as alerts to the operator or user. Additionally, or in the alternative, the GUI 24 can provide audio data or information to the operator or user) ([0060] the GUI 324 can provide the operator or user with one or more of the following: a number of cryoablation procedures that may be performed based on the residual fluid quantity and/or an amount of time to perform cryoablation procedures based on the residual fluid quantity. However, any other suitable manner can be used by the GUI 324 to effectively provide and/or notify the operator or user of the residual cryoablation information).
Regarding claim 18, Harmouche teaches the method of claim 17, wherein providing an indication regarding the amount of cryogenic fluid present in the cryogenic fluid supply vessel comprises one or more of a visible indication and an audible indication ([0042] the GUI 24 can provide dynamic visual data and/or information to the operator or user, such as video data or any other data that changes over time, e.g., during an ablation procedure. Further, in various embodiments, the GUI 24 can include one or more colors, different sizes, varying brightness, etc., that may act as alerts to the operator or user. Additionally, or in the alternative, the GUI 24 can provide audio data or information to the operator or user) ([0060] the GUI 324 can provide the operator or user with one or more of the following: a number of cryoablation procedures that may be performed based on the residual fluid quantity and/or an amount of time to perform cryoablation procedures based on the residual fluid quantity. However, any other suitable manner can be used by the GUI 324 to effectively provide and/or notify the operator or user of the residual cryoablation information).
Regarding claim 19, Harmouche teaches the method of claim 18, wherein providing an indication regarding the amount of cryogenic fluid present in the cryogenic fluid supply vessel includes displaying the indication on a display associated with a cryogen delivery system ([0042] the GUI 24 can provide dynamic visual data and/or information to the operator or user, such as video data or any other data that changes over time, e.g., during an ablation procedure. Further, in various embodiments, the GUI 24 can include one or more colors, different sizes, varying brightness, etc., that may act as alerts to the operator or user. Additionally, or in the alternative, the GUI 24 can provide audio data or information to the operator or user) ([0060] the GUI 324 can provide the operator or user with one or more of the following: a number of cryoablation procedures that may be performed based on the residual fluid quantity and/or an amount of time to perform cryoablation procedures based on the residual fluid quantity. However, any other suitable manner can be used by the GUI 324 to effectively provide and/or notify the operator or user of the residual cryoablation information).
Regarding claim 20, Harmouche teaches the method of claim 17, wherein providing the indication regarding the amount of cryogenic fluid present in the cryogenic fluid supply vessel ([0042] the GUI 24 can provide dynamic visual data and/or information to the operator or user, such as video data or any other data that changes over time, e.g., during an ablation procedure. Further, in various embodiments, the GUI 24 can include one or more colors, different sizes, varying brightness, etc., that may act as alerts to the operator or user. Additionally, or in the alternative, the GUI 24 can provide audio data or information to the operator or user) ([0060] the GUI 324 can provide the operator or user with one or more of the following: a number of cryoablation procedures that may be performed based on the residual fluid quantity and/or an amount of time to perform cryoablation procedures based on the residual fluid quantity. However, any other suitable manner can be used by the GUI 324 to effectively provide and/or notify the operator or user of the residual cryoablation information) comprises providing an indication of the amount of cryogenic fluid present in the cryogenic fluid supply vessel by weight ([0050] As one non-exclusive example, sensor output can include the residual fluid quantity. In this example, the first fluid sensor 230 and/or the second fluid sensor 232 can sense and/or measure the residual fluid quantity based on a pressure of the cryogenic fluid 228 within the fluid container 216, a weight of the cryogenic fluid 228 therein, and/or a combination of the pressure and/or weight).
Regarding claim 21, Harmouche teaches the method of claim 17, wherein providing the indication regarding the amount of cryogenic fluid present in the first cryogenic fluid supply vessel ([0042] the GUI 24 can provide dynamic visual data and/or information to the operator or user, such as video data or any other data that changes over time, e.g., during an ablation procedure. Further, in various embodiments, the GUI 24 can include one or more colors, different sizes, varying brightness, etc., that may act as alerts to the operator or user. Additionally, or in the alternative, the GUI 24 can provide audio data or information to the operator or user) ([0060] the GUI 324 can provide the operator or user with one or more of the following: a number of cryoablation procedures that may be performed based on the residual fluid quantity and/or an amount of time to perform cryoablation procedures based on the residual fluid quantity. However, any other suitable manner can be used by the GUI 324 to effectively provide and/or notify the operator or user of the residual cryoablation information).
Harmouche fails to teach comprises providing an indication of the amount of cryogenic fluid present in the first cryogenic fluid supply vessel by volume.
However, Harmouche (2) teaches comprises providing an indication of the amount of cryogenic fluid present in the first cryogenic fluid supply vessel by volume ([0054] The container capacity includes the maximum amount, e.g., volume, of cryogenic fluid 228 that may be contained within the fluid container 216. In one embodiment, the container capacity may be expressed in terms of a weight of a maximum volume of cryogenic fluid 228 that may be contained within the fluid container 216). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Harmouche to include comprises providing an indication of the amount of cryogenic fluid present in the cryogenic fluid supply vessel by volume. Doing so allows for the weight of the revisor and how much cryo fluid is left to be calculated and visualized as a volume on the GUI.
Regarding claim 22, Harmouche teaches method of claim 17, wherein providing the indication regarding the amount of cryogenic fluid present in the cryogenic fluid supply vessel ([0042] the GUI 24 can provide dynamic visual data and/or information to the operator or user, such as video data or any other data that changes over time, e.g., during an ablation procedure. Further, in various embodiments, the GUI 24 can include one or more colors, different sizes, varying brightness, etc., that may act as alerts to the operator or user. Additionally, or in the alternative, the GUI 24 can provide audio data or information to the operator or user) ([0060] the GUI 324 can provide the operator or user with one or more of the following: a number of cryoablation procedures that may be performed based on the residual fluid quantity and/or an amount of time to perform cryoablation procedures based on the residual fluid quantity. However, any other suitable manner can be used by the GUI 324 to effectively provide and/or notify the operator or user of the residual cryoablation information) comprises providing an indication that the amount of cryogenic fluid present is sufficient to complete a freezing cycle of a cryogen delivery system ([0043] residual cryoablation information can include a number of cryoablations that may be performed and/or an amount of time to perform cryoablations based on the residual fluid quantity. In other words, the residual fluid measurement system 26 can determine whether there is a sufficient residual fluid quantity within the fluid container 16 to perform a certain number of cryoablation procedures and/or a certain amount of time to perform cryoablation procedures), providing an indication that the amount of cryogenic fluid present is insufficient to complete a freezing cycle of the cryogen delivery system ([0043] residual cryoablation information can include a number of cryoablations that may be performed and/or an amount of time to perform cryoablations based on the residual fluid quantity. In other words, the residual fluid measurement system 26 can determine whether there is a sufficient residual fluid quantity within the fluid container 16 to perform a certain number of cryoablation procedures and/or a certain amount of time to perform cryoablation procedures); or providing an indication that the amount of cryogenic fluid present is sufficient to complete two freezing cycles of the cryogen delivery system ([0043] residual cryoablation information can include a number of cryoablations that may be performed and/or an amount of time to perform cryoablations based on the residual fluid quantity. In other words, the residual fluid measurement system 26 can determine whether there is a sufficient residual fluid quantity within the fluid container 16 to perform a certain number of cryoablation procedures and/or a certain amount of time to perform cryoablation procedures).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harmouche (WO 2019161015 A1) in view of Choi (WO 2020013375 A1) in view of Monger (WO 2013110154 A1).
Regarding claim 2, Harmouche teaches system of claim 1, but fails to fully teach wherein the sensor comprises a strain gauge sensor.
However, Monger teaches wherein the sensor comprises a strain gauge sensor ([Pg 5; Para 30] The load sensor 14 may be of any suitable type, for example one or more load cells or transducers in various configurations, which may include one or more strain gauges or other sensors of tension, compression, force, pressure, torque, and the like. An example load sensor may include multiple strain gauges arranged in different orientations that are deformed by mechanical forces on the load sensor, which then measures that deformation and produces at least one electrical signal. Based on these signals, the weight of the reservoir 12 and cryogens contained therein may be calculated). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Harmouche to include wherein the sensor comprises a strain gauge sensor. Doing so allows for the weight of the revisor and how much cryo fluid is left to be calculated based on the strain put on the support structure.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harmouche (WO 2019161015 A1) in view of Choi (WO 2020013375 A1) in view of Harmouche (2) (WO 2018175103 A1), further in view of Monger (WO 2013110154 A1).
Regarding claim 15, Harmouche teaches the method of claim 14, but fails to teach wherein generating a signal from a sensor coupled to the support structure comprises generating a signal from a strain gauge sensor coupled to the support structure.
However, Monger teaches wherein generating a signal from a sensor coupled to the support structure comprises generating a signal from a strain gauge sensor coupled to the support structure ([Pg 5; Para 30] The load sensor 14 may be of any suitable type, for example one or more load cells or transducers in various configurations, which may include one or more strain gauges or other sensors of tension, compression, force, pressure, torque, and the like. An example load sensor may include multiple strain gauges arranged in different orientations that are deformed by mechanical forces on the load sensor, which then measures that deformation and produces at least one electrical signal. Based on these signals, the weight of the reservoir 12 and cryogens contained therein may be calculated). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Harmouche to include wherein generating a signal from a sensor coupled to the support structure comprises generating a signal from a strain gauge sensor coupled to the support structure. Doing so allows for the weight of the revisor and how much cryo fluid is left to be calculated.
Claim(s) 3 and 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harmouche (WO 2019161015 A1) in view of Choi (WO 2020013375 A1) in view of DeLonzor (US 8092448 B2).
Regarding claim 3, Harmouche teaches the system of claim 1, wherein a plurality of cryogenic fluid supply vessels ([0035] a fluid source 16 (e.g., one or more fluid containers), a balloon catheter 18, a handle assembly 20) ([0037] The fluid container(s) 16 contains the cryogenic fluid 28, which is delivered to the balloon catheter 18 with or without input from the control system 14 during a cryoablation procedure) (Fig 2; a fluid injection line 225), but fails to teach wherein the support structure is a moveable support structure configured to move a respective one of the plurality of cryogenic fluid supply vessels from a first position to a second position the second position being a position in which a respective one of the plurality of cryogenic fluid supply vessels is interfaced with the cryogen inlet.
However, DeLonzor teaches wherein the support structure is a moveable support structure configured to move the cryogenic fluid supply vessel from a first position to a second position ([35] To assist the operator in installing dewars, a hydraulic lifter 51 is provided. The lifter functions to lift the dewar into position so that the dewar lip 52 is sealed in the dewar/cryoprobe interconnect 53 (which is fixed in the top of a cabinet which houses the dewar), the second position being a position in which the cryogenic fluid supply vessel is interfaced with the cryogen inlet (Fig 9; up/down). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Harmouche to include wherein the support structure is a moveable support structure configured to move a respective one of the plurality of cryogenic fluid supply vessel from a first position to a second position the second position being a position in which a respective one of the plurality of cryogenic fluid supply vessel is interfaced with the cryogen inlet. Doing so allows for the positioning on command for controlled connection between the two parts.
Regarding claim 4, Harmouche teaches the system of claim 3, but fails to teach wherein the moveable support structure comprises a pneumatic lift or an electromechanical lift.
However, DeLonzor teaches wherein the moveable support structure comprises a pneumatic lift or an electromechanical lift ([35] This lifter is powered by the pressurization pump in conjunction with the four-way valve 54 and the control system described above. The pneumatically operated check valve 54 is a configuration of valves that function to port pressurized air to the hydraulic lifter 51 to raise the lifter and the dewar into the position on command). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Harmouche to include wherein the moveable support structure comprises a pneumatic lift or an electromechanical lift. Doing so allows for the positioning on command for controlled connection between the two parts.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/ASHLEIGH LAUREN KERN/Examiner, Art Unit 3794
/ADAM Z MINCHELLA/Primary Examiner, Art Unit 3794
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