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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Status of the Claims
The current office action is made responsive to claims filed 12/29/2025.
Acknowledgement is made to the amendment of claims 1, 12, and 18.
Acknowledgement is made to the cancellation of claims 2, 14, and 16-17.
Any claims listed above as cancelled have sufficiently overcome any rejections set forth in any of the prior office actions.
Claims 1, 3-13, 15, and 18-22 are pending. A complete action on the merits appears below.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1 and 9-12 are rejected under 35 U.S.C. 103 as being unpatentable over Christian (US 20120165812 A1) in view of Cioanta (US 20040267340 A1) and Kelleher (US 6112123 A).
Regarding claim 1, Christian teaches a vapor ablation system ([0014]) comprising:
a controller ([0014]) having a user input configured to receive data indicative of a time of a treatment session;
a pump ([0042]) in data communication with the controller; and
a catheter ([0014]) in fluid communication with the pump and having an elongate shaft, a proximal end, and a distal end, the catheter comprising:
at least one lumen ([0014]); and
at least one electrode ([0014]) within the lumen,
wherein the controller is configured to control the pump to provide a fluid to the lumen of the catheter ([0090]), wherein the controller is configured to cause an electrical current to be delivered to at least one electrode in order to heat the fluid in the lumen and convert the fluid to a heated vapor ([0014]- [0016], [0018]- [0019]), [0103]), wherein the controller is configured to control a delivery of the fluid and a generation of the heated vapor by controlling a flow rate of the fluid and a level of power, voltage and/or current based solely on the data indicative of the treatment session ([0014]- [0016], [0018]- [0019]), [0103]), and wherein during the treatment session, a ratio of the flow rate of the fluid to the level of power, voltage and/or current is fixed based solely on the data indicative of the treatment session ([0090]).
However, Christian fails to teach the data which controls the delivery of the treatment as being data input into the controller which is indicative of the type of treatment session.
Cioanta teaches a thermal therapy treatment system having a catheter assembly for delivering a heated pressurized fluid to patient tissue so as to treat patient tissue (Abstract, [0007], [0010]).
Cioanta further teaches the system as accepting user input to select at least one of a plurality of different types of pre-programmed thermal therapy procedures ([0026]), wherein each of the procedures can have different treatment parameters ([0011]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the use of selecting the type of treatment session so as to control the delivery of the treatment to the patient, as is taught by Cioanta, into the system for delivering treatment to patient tissue, as is taught by Christian, so as to produce the predictable result of selecting a treatment procedure based on different physiologic treatment conditions, as is taught by Cioanta.
However, Christian as currently modified fails to specifically teach the control of the delivery of the fluid and the delivery of the electrical current to the electrode, which as is currently taught by Christian, generates a heated vapor, as being an open-loop manner, wherein the parameters of the fluid and the energy are not modified based on sensed data indicative of temperature, pressure, vapor quality, vapor moisture, or impedance.
Christian instead teaches the system as containing thermal sensors which are capable of controlling the energy output by the electrode (Abstract).
Kelleher teaches a device for performing an electrolyte assisted ablation using an electrode (Abstract). This device is taught as containing a sensor, such as a temperature sensor (Abstract).
Kelleher further teaches a variety of known manners of controlling an ablation having a delivery of fluid and energy via an electrode, such as closed-loop control by temperature, impedance or visual monitoring, or an open-loop control (Abstract), wherein the open-loop control procedure for performing an open-loop ablation may be accomplished by a look-up table or algorithm to determine the length of time needed to ablate tissue to a certain depth given a particular energy level or by using a look-up table or algorithm to determine the correct energy level and/or duration of therapy based on anatomical measurements of the area of tissue to be ablated (Col. 3, Lines 52-61).
Therefore, it would have been obvious to a person having ordinary skill before the effective filing date to have substituted the system which ablates tissue by the supply of a fluid and the supply of energy by an electrode which is controlled with thermal sensors as is taught by Christian with the system which ablates tissue by the supply of a fluid and the supply of energy by an electrode as being controlled in an open-loop control manner as is taught by Kelleher as both controlling the system by the use of sensors, also referred to as closed-loop control, and controlling the system without the use of sensors, also referred to as open-loop control, perform the same function of controlling a system which ablates tissue, as is taught by Kelleher, and it has been held that substituting parts of an invention which perform the same function involves only routine skill in the art. MPEP 2144.06(II).
Regarding claim 9, Christian as modified teaches the vapor ablation system of claim 1, wherein the controller is further configured to automatically apply a predefined on/off duty cycle for the time of a treatment session ([0014]- [0016], [0018]- [0019]), [0103]).
Regarding claim 10, Christian teaches the vapor ablation system of claim 1, wherein the fluid is saline ([0012], [0042]).
Regarding claim 11, Christian teaches the vapor ablation system of claim 1, wherein the controller is configured to deliver a power to the at least one electrode is in a range of 5 watts to 300 watts ([0092]).
Regarding claim 12, Christian teaches the vapor ablation system of claim 1, wherein the controller is configured to deliver a flow rate of fluid into the lumen in a range of 0.1-25 ml per minute ([0070]- [0071], [0082]).
Claims 3, 7, 18-20, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Christian (US 20120165812 A1) in view of Cioanta (US 20040267340 A1) and Kelleher (US 6112123 A), further in view of Wang (US 20100168736 A1).
Regarding claim 3, Christian teaches the vapor ablation system of claim 1.
However, Christian fails to teach the vapor ablation system further comprising a cap in fluid communication with the distal end of the catheter and configured to direct the heated vapor from the at least one lumen to a body tissue, wherein the cap is defined by a housing enclosing a volume and wherein an opening in the housing is positioned on a side of the cap that is parallel to a longitudinal axis of the catheter or that is angled relative to the longitudinal axis of the catheter by 5 degrees or greater.
Wang teaches an irrigated ablation catheter system having a catheter including a shaft and an electrode assembly affixed to a distal end of the shaft, the distal electrode assembly including a manifold and a distal irrigation passageway extending therethrough to an opening at a distal tip (Abstract, [0023]).
Wang further teaches the system comprising the distal electrode assembly (Fig. 4; distal electrode assembly 52) in fluid communication with the distal end of the catheter (Fig. 3A-4; shaft 22 of catheter 12) and configured to direct ablative agent from the at least one lumen to a body tissue ([0029], [0031]), wherein the cap is defined by a housing enclosing a volume ([0029]) and wherein an opening in the housing is positioned on a side of the cap and is parallel to a longitudinal axis of the catheter or that is angled relative to the longitudinal axis of the catheter by 5 degrees or greater ([0041]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to incorporate the teachings of the distal portion of the catheter having a cap comprising an opening for providing fluid to tissue, as is taught by Wang into the system of Christian to produce the predictable result of a catheter having a distal end for providing fluid to tissue.
Regarding claim 7, Wang further teaches the vapor ablation system of claim 3, wherein the side of the cap is angled relative to the longitudinal axis of the catheter in a range of 5 degrees to 45 degrees ([0041]).
Regarding claim 18, Christian teaches a vapor ablation system ([0014]) comprising:
a controller ([0014]) having a user interface configured to receive data indicative of a time of a treatment session;
a syringe pump in data communication with the controller ([0042]);
a catheter ([0014]) in fluid communication with the syringe pump and having an elongate shaft, proximal end, and a distal end, the catheter comprising:
at least one lumen ([0014]);
at least one electrode ([0014]) within the lumen,
wherein the controller ([0090]) is configured to control the pump to provide a fluid to the lumen of the catheter, wherein the controller is configured to cause an electrical current to be delivered to at least one electrode in order to heat the fluid in the lumen and convert the fluid to a heated vapor ([0014]- [0016], [0018]- [0019]), [0103]), wherein the controller is configured to control a delivery of the fluid and a generation of the heated vapor by controlling a flow rate of the fluid and a level of power, voltage and/or current of the electrical current based on the data indicative of the treatment session, wherein the controller is further configured to control the delivery of the fluid and the generation of the heated vapor without modifying the flow rate of the fluid or the level of voltage and/or current of the electrical current based on data from sensors positioned in or on the catheter ([0014]- [0016], [0018]- [0019]), [0103] as broadly as is currently claimed, the change of flow rate and power provided is changed when shifting between the first and second time periods based only on time for this shift and not on sensor measurements for the shift between periods), and wherein during the treatment session, a ratio of the flow rate of the fluid to the level of power, voltage and/or current is fixed based solely on the data indicative of the treatment session ([0014]- [0016], [0018]- [0019]), [0103]).
However, Christian fails to teach the data which controls the delivery of the treatment as being data input into the controller which is indicative of the type of treatment session.
Cioanta teaches a thermal therapy treatment system having a catheter assembly for delivering a heated pressurized fluid to patient tissue so as to treat patient tissue (Abstract, [0007], [0010]).
Cioanta further teaches the system as accepting user input to select at least one of a plurality of different types of pre-programmed thermal therapy procedures ([0026]), wherein each of the procedures can have different treatment parameters ([0011]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the use of selecting the type of treatment session so as to control the delivery of the treatment to the patient, as is taught by Cioanta, into the system for delivering treatment to patient tissue, as is taught by Christian, so as to produce the predictable result of selecting a treatment procedure based on different physiologic treatment conditions, as is taught by Cioanta.
Christian further fails to teach the system comprising: a cap in fluid communication with the distal end of the catheter and configured to direct ablative agent from the at least one lumen to a body tissue, wherein the cap is defined by a housing enclosing a volume and wherein an opening in the housing is positioned on a side of the cap that is parallel to a longitudinal axis of the catheter or that is angled relative to the longitudinal axis of the catheter by 5 degrees or greater.
Wang teaches an irrigated ablation catheter system having a catheter including a shaft and an electrode assembly affixed to a distal end of the shaft, the distal electrode assembly including a manifold and a distal irrigation passageway extending therethrough to an opening at a distal tip (Abstract, [0023]).
Wang further teaches the system comprising the distal electrode assembly (Fig. 4; distal electrode assembly 52) in fluid communication with the distal end of the catheter (Fig. 3A-4; shaft 22 of catheter 12) and configured to direct ablative agent from the at least one lumen to a body tissue ([0029], [0031]), wherein the cap is defined by a housing enclosing a volume ([0029]) and wherein an opening in the housing is positioned on a side of the cap and is parallel to a longitudinal axis of the catheter or that is angled relative to the longitudinal axis of the catheter by 5 degrees or greater ([0041]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to incorporate the teachings of the distal portion of the catheter having a cap comprising an opening for providing fluid to tissue, as is taught by Wang into the system of Christian to produce the predictable result of a catheter having a distal end for providing fluid to tissue.
However, Christian as currently modified fails to specifically teach the control of the delivery of the fluid and the delivery of the electrical current to the electrode, which as is currently taught by Christian, generates a heated vapor, as being an open-loop manner, wherein the parameters of the fluid and the energy are not modified based on sensed data indicative of temperature, pressure, vapor quality, vapor moisture, or impedance.
Christian instead teaches the system as containing thermal sensors which are capable of controlling the energy output by the electrode (Abstract).
Kelleher teaches a device for performing an electrolyte assisted ablation using an electrode (Abstract). This device is taught as containing a sensor, such as a temperature sensor (Abstract).
Kelleher further teaches a variety of known manners of controlling an ablation having a delivery of fluid and energy via an electrode, such as closed-loop control by temperature, impedance or visual monitoring, or an open-loop control (Abstract), wherein the open-loop control procedure for performing an open-loop ablation may be accomplished by a look-up table or algorithm to determine the length of time needed to ablate tissue to a certain depth given a particular energy level or by using a look-up table or algorithm to determine the correct energy level and/or duration of therapy based on anatomical measurements of the area of tissue to be ablated (Col. 3, Lines 52-61).
Therefore, it would have been obvious to a person having ordinary skill before the effective filing date to have substituted the system which ablates tissue by the supply of a fluid and the supply of energy by an electrode which is controlled with thermal sensors as is taught by Christian with the system which ablates tissue by the supply of a fluid and the supply of energy by an electrode as being controlled in an open-loop control manner as is taught by Kelleher as both controlling the system by the use of sensors, also referred to as closed-loop control, and controlling the system without the use of sensors, also referred to as open-loop control, perform the same function of controlling a system which ablates tissue, as is taught by Kelleher, and it has been held that substituting parts of an invention which perform the same function involves only routine skill in the art. MPEP 2144.06(II).
Regarding claim 19, Christian teaches the vapor ablation system of claim 18, wherein the controller is configured to use the data to determine a duration for which the at least one electrode receive electrical current to heat the fluid in the lumen and convert the fluid to the heated vapor ([0014]- [0016], [0018]- [0019]), [0103]).
Regarding claim 20, Christian teaches the vapor ablation system of claim 18, wherein the vapor ablation system is adapted to operate at a fixed rate of flow of fluid from the pump to the lumen of the catheter ([0014]- [0016], [0018]- [0019]), [0103]).
Regarding claim 22, Christian teaches the vapor ablation system of claim 18, wherein the controller is configured to maintain the impedance at a steady state by maintaining the rate of flow of the fluid and salinity at a steady state ([0012]).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Christian (US 20120165812 A1) in view of Cioanta (US 20040267340 A1) and Kelleher (US 6112123 A) further in view of Wang (US 20100168736 A1) and Olsen (US 6210402 B1).
Regarding claim 4, Wang teaches the vapor ablation system of claim 3, wherein the cap comprises rounded or curved exterior edges or surfaces ([0037]).
However, Wang fails to teach the cap being removably attachable to the distal end of the catheter.
Olsen teaches an electrosurgical probe comprising a shaft with a disposable tip which may be removably coupled to a proximal handle and an electrode support extending from the tip for supporting a plurality of electrode terminals (Col. 5, Lines 45-55; Col. 15, Lines 32-37).
Olsen further teaches this design as allowing a removable connection of the tip electrodes with the proximal handle portion so that the handle can be re-used with different tips (Col. 16, Lines 30-35).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date incorporate the teachings of making the distal electrode tip separable from the probe, as is taught by Olsen, into the system of Christian/ Wang to produce the benefit of reusing the proximal portion of the probe with different tips, as is taught by Olsen.
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Christian (US 20120165812 A1) in view of Cioanta (US 20040267340 A1) and Kelleher (US 6112123 A) further in view of Wang (US 20100168736 A1) and Anderson (US 20130274730 A1).
Regarding claim 5, Christian/Wang teaches the vapor ablation system of claim 3.
However, Christian/Wang fails to teach the vapor ablation system, wherein the sole opening has a footprint that is polygonal in shape
Anderson teaches an ablative catheter having an ablative port located adjacent to the distal end of the catheter, an ablative mechanism capable of ablating using a conductive fluid circulated to the ablative port through a lumen located within the catheter (Abstract).
Anderson further teaches the port having any size and shape which produces a desired rate of flow of conductive fluid (Fig. 6C; ablative port 210 is shown to be a rectangle; [0034]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to incorporate the teachings of the ablative port being rectangular, as is taught by Anderson, into the system of Christian/Wang to produce the predictable result of a catheter having an opening which produces a desired rate of flow, as is taught by Anderson.
Regarding claim 6, Anderson further teaches the vapor ablation system of claim 5, wherein the polygonal shape comprises one of a square, a rectangle, a pentagon, or a hexagon (Fig. 6C; ablative port 210).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Christian (US 20120165812 A1) in view of Cioanta (US 20040267340 A1) and Kelleher (US 6112123 A) further in view of Orszulak (US 20130267947 A1).
Regarding claim 8, Christian teaches the vapor ablation system of claim 1.
However, Christian fails to teach the vapor ablation system, wherein the controller is further configured to detect an actual start of said generation of the heated vapor, as independent and separate from an initiation of fluid flow to the at least one electrode, by monitoring a change in output power, output voltage, or output current.
Orszulak teaches a system for delivering electrosurgical energy to tissue for providing treatment (Abstract).
Orszulak further teaches the system as determining when the application of energy to treat tissue has been started based on the evaluation of a change in the level of applied current or a change in the level of applied voltage ([0047]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to incorporate the teachings as are taught by Orszulak into the system of Christian to produce the predictable result of determining the initiation of energy, as is taught by Orszulak.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Christian (US 20120165812 A1) in view of Cioanta (US 20040267340 A1) and Kelleher (US 6112123 A) further in view of Malis (US 20090240244 A1).
Regarding claim 13, Christian teaches the vapor ablation system of claim 1.
However, Christian fails to teach the vapor ablation system wherein the at least one electrode comprises a bipolar electrode.
Malis teaches an electrosurgical generator and system for treating tissue (Abstract).
Malis further teaches electrodes for treating tissue as being in either monopolar or bipolar electrode configurations as being well known in the art for the purpose of treating tissue ([0003], [0021]- [0023]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have substituted the monopolar electrode as is taught by Christian with a bipolar electrode as is taught by Malis as both electrode configurations perform the same function of treating patient tissue with electrosurgical energy and it has been held that substituting parts of an invention which perform the same function involves only routine skill in the art.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Christian (US 20120165812 A1) in view of Cioanta (US 20040267340 A1) and Kelleher (US 6112123 A) further in view of Taylor (US-6322558 B1).
Regarding claim 15, Christian teaches the vapor ablation system of claim 1.
However, Christian fails to teach the system wherein the catheter does not comprise sensors configured to sense vapor quality, temperature, moisture level, or pressure of the heated vapor.
Taylor teaches an RF energy ablation device (Abstract).
Taylor further teaches applying RF energy without the use of conventional sensors, as catheters without sensors are beneficial as being more flexible and achieving good continuous electrode-tissue contact (Col. 28, Lines 1-10).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to incorporate the teachings of utilizing a catheter without a sensor, as is taught by Taylor, into the system of Christian to produce the predictable result of a catheter which is more flexible and achieves better electrode-tissue contact compared to other known catheters.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Christian (US 20120165812 A1) in view of Cioanta (US 20040267340 A1) and Kelleher (US 6112123 A) further in view of Oyama (US 6464696 B1).
Regarding claim 21, Christian teaches the vapor ablation system of claim 18.
However, Christian fails to teach the system wherein the controller is configured to maintain a power delivered to the at least one electrode at a steady state by maintaining a voltage level and an impedance at a steady state.
Oyama teaches an electric surgical apparatus comprising an active electrode which performs medical treatment to an area to be treated by applying electric energy to the area (Abstract).
Oyama further teaches maintaining constant power control by controlling the voltage and impedance at constant/steady-state controlled ranges (Col. 17, Lines 1-30).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to incorporate the teachings of maintaining constant power control by controlling the voltage and impedance at similarly controlled ranges, as is taught by Oyama, into the system of Christian, to produce the predictable result of maintaining a power level at a steady-state as is taught by Oyama.
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because the amendments have necessitated new grounds of rejection.
Specifically, applicant’s arguments of the limitations that art not taught by the Christian/Cioanta reference are moot in view of the new rejections under Christian/Cioanta and Kelleher.
Conclusion
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/L.R.L./Examiner, Art Unit 3794