DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. 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 (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.
Claim Objections
2. Claims 2-18 are objected to because of the following informalities.
Claims 2-18 contain minor typographical errors.
Claims 2-18 recite “The system” which should be changed to “The cryoablation system”.
Claim 12, line 1: The Examiner suggests changing “comprising seal” to “comprising a seal”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
3. Claims 11, 16, and 19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Although claims 11 and 19 recite “cryogenic temperatures below -140”, claims 11 and 19 do not recite any metric unit (e.g., Celsius, Kelvin, or Fahrenheit) for the temperature below -140. Thus, claims 11 and 19 are indefinite, as the claims do not define the exact metric unit for the temperature below -140.
Although claims 16 and 19 recite “wherein the shape of the stem and housing define a Thermal Bridge Number ranging from 10 to 32”, claims 16 and 19 do not recite any metric unit for the thermal bridge number. Thus, claims 16 and 19 are indefinite, as the claims do not define the exact metric unit for the thermal bridge number.
Claim Rejections - 35 USC § 102
4. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
5. Claim 1 is rejected under 35 U.S.C. 102 (a) (1) and (a) (2) as being anticipated by Lalonde et al. (US 2008/0077124 A1).
Regarding claim 1, Lalonde teaches a cryoablation system operable with a cryoablation catheter ([abstract, 0013]), the system comprising:
a freeze circuit for cooling and driving fluid through the catheter, the freeze circuit comprising a catheter inlet line for transporting fluid from a first high pressure-generating tank assembly, through a first heat exchanger, through the catheter, and to a first fluid reservoir (the high-pressure refrigerant tank 231 provides transports fluid through the heat exchanger 245 and further into inlet line 251 of the catheter [0030-0032, FIG. 3]. Furthermore, the return line 262 of the catheter is configured to exhaust or return the fluid into a compressor inlet line 241 [0035]. Specifically, the compressor inlet line 241 provides the fluid to a refrigerant bottle or reservoir [0036]. Meanwhile, the refrigerant bottle or reservoir provides the fluid through the compressor output line 242b to refill the high-pressure refrigerant tank 231 [0036]), and a refill circuit to replenish the first high pressure-generating tank assembly with fluid from the first reservoir (as stated previously above, the compressor inlet line 241 provides the fluid to a refrigerant bottle or reservoir [0036]. Furthermore, the refrigerant bottle or reservoir provides the fluid through the compressor output line 242b to refill the high-pressure refrigerant tank 231 [0036]), the refill circuit comprising a refill line to fluidly connect the first fluid reservoir with the first high pressure-generating tank assembly (as stated previously above, the compressor inlet line 241 provides the fluid to a refrigerant bottle or reservoir [0036]. Furthermore, the refrigerant bottle or reservoir provides the fluid through the compressor output line 242b to refill the high-pressure refrigerant tank 231 [0036]).
Claim Rejections - 35 USC § 103
6. 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.
7. Claims 2-4 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Lalonde et al. in view of Baust et al. (US 2012/0059364 A1).
Regarding claim 2, Lalonde teaches the cryoablation system of claim 1. Lalonde does not explicitly teach wherein spent gas from the catheter is recondensed to liquid in the first fluid reservoir; and
the fluid in the first reservoir is maintained at a low pressure between 0 and 25 psi.
The prior art by Baust is analogous to Lalonde, as they both teach cryoablation systems comprising a catheter ([abstract, 0155]).
Baust teaches wherein spent gas from the catheter is recondensed to liquid in the first fluid reservoir (the gas is recondensed to a liquid (e.g., liquid nitrogen) when resupplied into the dewar or reservoir [0087, 0118]); and
the fluid in the first reservoir is maintained a low pressure of about 0 psi (the pressure of the liquid nitrogen may be near or at ambient pressure (e.g., 0 psi) while contained within the dewar [0118, 0125, 0151]).
Baust does not explicitly teach wherein fluid is maintained at a low pressure between 0 and 25 psi. The Examiner respectfully submits that person having ordinary skill in the art would have found it obvious to modify the fluid in the first reservoir to be maintained at a low pressure between 0 and 25 psi. The advantage of such modification will maintain the fluid (e.g., liquid nitrogen) at or near ambient pressure which allows the fluid to reach lower temperatures within the fluid reservoir (e.g., dewar) (see paragraphs [0118, 0125, 0151] by Baust). The Examiner further submits that the skilled artisan could arrive at the claimed pressure range via routine experimentation (MPEP 2144.05).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify the Lalonde’s catheter to exhaust gas that is recondensed into liquid in the first fluid reservoir at a low pressure between 0 and 25 psi, as suggested by Baust. The advantage of such modification will maintain the fluid (e.g., liquid nitrogen) at or near ambient pressure which allows the fluid to reach lower temperatures within the fluid reservoir (e.g., dewar) (see paragraphs [0118, 0125, 0151] by Baust).
Regarding claim 3, Lalonde in view of Baust suggests the cryoablation system of claim 2. Baust teaches wherein the first high pressure-generating tank assembly is operable to raise the fluid to at least 1000 psi (figure 17 illustrates the pressurization tank assembly 530 comprising a pressurization system 503 that is configured to raise the pressure of the fluid to 1000 psi or greater [0092, 0096, FIG. 17]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify the first high pressure-generating tank assembly suggested by Lalonde in view of Baust to raise the pressure of the fluid to at least 1000 psi, as further taught by Baust. The advantage of such modification will allow the fluid (e.g., liquid nitrogen) to be converted into a critical state (e.g., super critical nitrogen) (see paragraphs [0092, 0096, 0100] by Baust).
Regarding claim 4, Lalonde in view of Baust suggests the cryoablation system of claim 3. Baust teaches the wherein the first high pressure-generating tank assembly comprises:
a vessel (figure 17 illustrates the pressurization tank assembly 530 comprising a pressurization system 503 [0092, 0095, FIG. 17]. Specifically, the pressurization system 503 comprises a first vessel 505 [0092, 0095, FIG. 17]);
a heater arranged within the vessel (the heater 512 is arranged internal to the first vessel 505 [0092, 0095, FIG. 17]); and
a tank body enclosing the vessel (figure 17 illustrates the pressurization tank assembly 530 comprising a reservoir or tank body 501 enclosing the first vessel 505 [0092, FIG. 17]), and defining a space between the body and the vessel (figure 17 illustrates a space being defined between the tank body 501 (e.g., reservoir) and the first vessel 505 [FIG. 17]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify the first high pressure-generating tank assembly suggested by Lalonde in view of Baust to comprise a heater arranged within a vessel and a tank body enclosing the vessel, as further taught by Baust. The advantage of such modification will allow for adjusting the fluid pressure, such that the fluid (e.g., liquid nitrogen) is converted into a critical state (e.g., super critical nitrogen) (see paragraphs [0092, 0095-0096, 0100] by Baust).
Regarding claim 7, Lalonde in view of Baust suggests the cryoablation system of claim 4. Baust teaches wherein the first high pressure-generating tank assembly further comprises a pump to evacuate said space (figure 17 illustrates the pressurization tank assembly 530 comprising a reservoir or tank body 501 enclosing the first vessel 505 [0092, FIG. 17]. Furthermore, figure 17 illustrates a space being defined between the tank body 501 (e.g., reservoir) and the first vessel 505 [FIG. 17]. Specifically, a pump is configured to draw or evacuate the fluid (e.g. liquid nitrogen) from the interior space defined by the tank body 501 (e.g., reservoir) and transfer the fluid into the first vessel 505 [0102]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify the first high pressure-generating tank assembly suggested by Lalonde in view of Baust to comprise a pump that is configured to evacuate the fluid from said space, as further taught by Baust. The advantage of such modification will allow the pump to draw or evacuate the fluid (e.g. liquid nitrogen) from the interior space defined by the tank body (e.g., reservoir) and transfer the fluid into the vessel (see paragraph [0102] by Baust).
8. Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Lalonde et al. in view of Baust et al. further in view of Niedbala et al. (US 2020/0360070 A1).
Regarding claim 5, Lalonde in view of Baust suggests the cryoablation system of claim 4, Lalonde and Baust do not explicitly teach wherein a first end of the vessel is sealed from the space by an O-ring.
The prior art by Niedbala is analogous to Lalonde, as they both teach a cryogenic device comprising a flow path ([abstract, 0050-0051]).
Niedbala teaches wherein a first end of the vessel is sealed from the space by an O-ring (the vessel or interior of the tank 870 is sealed by a thread and O-ring combination [0051])
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify a first end of the vessel suggested by Lalonde in view of Baust to be sealed from the space by an O-ring, as taught by Niedbala. The advantage of such modification will provide a seal along the fluid path within the vessel of the tank (see paragraph [0051] by Niedbala).
9. Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Lalonde et al. in view of Baust et al. further in view of Dam-Huisman (US 2021/0196338 A1).
Regarding claim 6, Lalonde in view of Baust suggests the cryoablation system of claim 4. Lalonde and Baust do not explicitly teach wherein a first end of the tank body is sealed from fluid in the first reservoir by spring seal or indium type of O-ring.
The prior art by Dam-Huisman is analogous to Lalonde, as they both teach a device that can be used for cryotherapy applications ([0016]).
Dam-Huisman teaches wherein a first end of the tank body is sealed from fluid in the first reservoir by spring seal (the tubular tank body 2 is sealed from the container 3 (e.g., reservoir) by an actuation mechanism 10 consisting of a spring biased seal or valve element 12 [0029-0030, FIG. 3]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify the tank body suggested by Lalonde in view of Baust to be sealed from the first reservoir by a spring seal, as taught by Dam-Huisman. This modification is beneficial, as the spring biased seal or valve will prevent the egress of cryogenic fluid from the container or reservoir (see paragraphs [0029-0030] by Dam-Huisman).
10. Claims 8-9 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Lalonde et al. in view of Baust et al. further in view of Clarke (US Patent No. 5,946,920).
Regarding claim 8, Lalonde in view of Baust suggests the cryoablation system of claim 4. Lalonde and Baust do not explicitly teach a pressure overflow circuit, the pressure overflow circuit comprising a pressure relief valve operable to open if the pressure within the vessel exceeds a threshold pressure, and to circulate fluid from the vessel along pressure relief flow path through a second heat exchanger, through the vessel, and to the first reservoir, thereby cooling the fluid in the vessel.
The prior art by Clarke is analogous to Lalonde, as they both teach cryogenic devices ([abstract]).
Clarke teaches a pressure overflow circuit, the pressure overflow circuit comprising a pressure relief valve operable to open if the pressure within the vessel exceeds a threshold pressure, and to circulate fluid from the vessel along pressure relief flow path through a second heat exchanger, through the vessel, and to the first reservoir, thereby cooling the fluid in the vessel (the pressure control valve (e.g., pressure relief valve) is configured to open if the pressure within the vessel 42 exceeds a threshold to circulate the fluid through a heat exchange conduit 46, through the vessel 42, and into the reservoir to thereby cool the fluid in the vessel 42 [abstract, column 5 lines 65-67, column 6 lines 1-16, column 6 lines 33-41, column 8 lines 60-64, column 9 lines 21-32]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify the cryoablation system suggested by Lalonde in view of Baust to a comprise a pressure relief valve that opens to circulate fluid from the vessel through a second heat exchanger through the and to the first reservoir, as taught by Clarke. The advantage of such modification will allow for keeping the vessel sufficiently cool such that any exhaust gas can be condensed back to the liquid phase (see the [abstract, column 5 lines 65-67, column 6 lines 1-16, column 6 lines 33-41, column 9 lines 21-32] by Clarke).
Regarding claim 9, Lalonde in view of Baust and Clark suggests the cryoablation system of claim 8. Clark teaches wherein the flow path through the vessel comprises a spiral-shaped (or coil) heat transfer element that communicates with the heater ([column 5 lines 35-55]).
Clark does not explicitly teach wherein the spiral-shaped (or coil) heat transfer element surrounds the heater.
The Examiner respectfully submits, as Clark teaches the use of a spiral-shaped (or coil) heat transfer element that communicates with the heater ([column 5 lines 35-55]), configuring the spiral-shaped (or coil) heat transfer element to surround the heater would be a matter of rearranging the known elements without producing a new and unexpected result, with such matters having been held by the Courts as being obvious to the skilled artisan (MPEP 2144.04).
Therefore, it would have been obvious to a person having ordinary skill in the art to modify the flow path of the vessel suggested by Lalonde in view of Baust and Clark to comprise a spiral-shaped (or coil) heat transfer element that surrounds the heater, as further suggested by Clarke. The advantage of such modification will allow increasing the pressure of the fluid that is drawn from the vessel (see [column 5 lines 35-55] by Clarke).
Regarding claim 17, Lalonde teaches a computer programmed and operable to control the valves based on measured catheter pressure (the treatment system 100 comprises a console having a display screen 120a and a microprocessor that is programmable [abstract, 0019, 0032]. Specifically, the microprocessor is programmed to control the valves (e.g., bypass valve or solenoid operated valve) based on the pressure buildup in the catheter [abstract, 0036]. The Examiner respectfully submits that the entire system may be controlled by a microprocessor [abstract, 0036]).
11. Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Lalonde et al.
Regarding claim 10, Lalonde teaches the cryoablation system of claim 1, wherein the first high pressure generating tank assembly fluidly being fluidly connected to the catheter and the first reservoir (the high-pressure refrigerant tank 231 provides transports fluid through the heat exchanger 245 and further into inlet line 251 of the catheter [0030-0032, FIG. 3]. Furthermore, the return line 262 of the catheter is configured to exhaust or return the fluid into a compressor inlet line 241 [0035]. Specifically, the compressor inlet line 241 provides the fluid to a refrigerant bottle or reservoir [0036]. Meanwhile, the refrigerant bottle or reservoir provides the fluid through the compressor output line 242b to refill the high-pressure refrigerant tank 231 [0036])
Lalonde does not explicitly teach a second high-pressure generating tank assembly fluidly connected to the catheter and the first reservoir.
The Examiner respectfully submits, as Lalonde teaches a first high-pressure generator tank fluidly connected to the catheter and the first reservoir (see the explanation above), configuring a second high-pressure generator tank fluidly connected to the catheter and the first reservoir would be a matter of duplicating the known elements without producing a new and unexpected result, with such matters having been held by the Courts as being obvious to the skilled artisan (MPEP 2144.04).
12. Claims 11 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Lalonde et al. in view of Dam-Huisman and DeLonzor et al. (US 2009/0163902 A1).
Regarding claim 11, Lalonde teaches the cryoablation system of claim 1. Lalonde does not explicitly teach wherein the freeze circuit comprises a cold valve comprising:
an inlet;
an outlet;
a seal surface;
a seat adapted to interface with the seal surface;
a stem coupled to the seat for moving the seat relative to the seal surface; and
a housing defining a chamber for the stem to be moved; and
an actuator to move the stem, wherein the valve is adapted to withstand cryogenic temperatures below -140 based on the shape, material and arrangement of the sealing surface, seat, stem and housing.
The prior art by Dam-Huisman is analogous to Lalonde, as they both teach a device that can be used for cryotherapy applications ([0016]).
Dam-Huisman teaches wherein the freeze circuit comprises a cold valve (the valve 12 [0030]) comprising:
an inlet (the inlet side of the valve 12 is configured to control the flow of the fluid from the container 3 [0030, FIG. 3]. For example, inlet side of the valve 12 cannot receive fluid from the container 3 while the valve 12 is in a closed position [0030-0032, FIG. 3]);
an outlet (the outlet side of the valve 12 may be attached directly to the capillary 5 [0030-0032]. Specifically, the outlet side of the valve 12 provides the fluid through the capillary 5 [0030-0032, FIG. 3]);
a seal surface (sealing configuration includes a valve seal [0030]);
a seat adapted to interface with the seal surface (the valve 12 may be a spring-based ball valve [0030]. Specifically, the seat is considered to be the “ball” which can be biased by a spring (e.g., stem) in a distal direction towards a valve seal against which the ball seals [0030]);
a stem coupled to the seat for moving the seat relative to the seal surface (the seat is considered to be the “ball” which can be biased by a spring (e.g., stem) in a distal direction towards a valve seal against which the ball seals [0030]); and
a housing defining a chamber for the stem to be moved (the spring (e.g., stem) of the valve 12 is moved or biased along the chamber or interior of the housing [0030-0032]); and
an actuator to move the stem (the actuation mechanism 10 is configured to move the spring (e.g., stem) of the valve 12 [0030]).
The prior art by DeLonzor is analogous to Lalonde, as they both teach a cryogenic device ([abstract]).
DeLonzor teaches wherein the valve is adapted to withstand cryogenic temperatures below -140 based on the shape, material and arrangement of the sealing surface, seat, stem and housing (DeLonzor teaches the valve having sealing surface, seat, spring (e.g., stem), and a housing or body which allows the spring (e.g., stem) to move [0020-0021]. Specifically, DeLonzor teaches the structure of the valve being configured to withstand temperatures of -320.44 degrees Fahrenheit [0021]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify the Lalonde’s freeze circuit to comprise a cold valve having an inlet, an outlet, a seal surface, a seat, a stem, a housing, and an actuator, as taught by Dam-Huisman. The advantage of such modification will allow for simple on and off operation to allow cryogenic fluid to flow (see paragraphs [0030-0032] by Dam-Huisman). Furthermore, it would have been obvious to modify the structure of cold valve suggested by Lalonde in view of Dam-Huisman to withstand temperatures below -140 degrees, as taught by DeLonzor. The advantage of such modification will allow the cold valve to be maintain its operation and/or functionally while low cryogenic fluid temperatures are applied (see paragraphs [0020-0021] by DeLonzor).
Regarding claim 16, Lalonde in view of Dam-Huisman and DeLonzor suggests the cryoablation system of claim 11. Lalonde, Dam-Huisman, and DeLonzor do not explicitly teach wherein the shape of the stem and housing define a Thermal Bridge Number ranging from 10 to 32.
However, the Examiner respectfully submits that a person having ordinary skill in the art would have found it obvious to configure the stem and housing to define a Thermal Bridge Number ranging from 10 to 32. The advantage of such will improve the overall thermal capacitance for maintaining low cryogenic fluid temperatures (see paragraphs [0020, 0030] by Dam-Huisman). The Examiner further submits that the skilled artisan may arrive at the claimed Thermal Bridge Number via routine experimentation (MPEP 2144.05).
13. Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Lalonde et al. in view of Dam-Huisman and DeLonzor et al., further in view of Melsky et al. (US 2018/0193613 A1).
Regarding claim 12, Lalonde in view of Dam-Huisman and DeLonzor suggests the cryoablation system of claim 11. Lalonde, Dam-Huisman, and DeLonzor do not explicitly teach a seal between the stem and the housing, and wherein the seal comprises an O-ring.
The prior art by Melsky is analogous to Lalonde, as they both teach a catheter that is configured to circulate fluid during a medical procedure ([0007, 0047]).
Melsky teaches a seal between the stem and the housing, and wherein the seal comprises an O-ring (the rocker valve assembly 208 comprises a plunger 246 (e.g., stem) and an outer housing 209 [0062, 0069, FIGS. 4-5, FIG. 12]. Furthermore, figures 5, 12, and 15 illustrates the valve assembly 208 comprising an O-ring 250 that is provided between the plunger 246 (e.g., stem) and the outer housing 209 [0062, 0069, FIG. 5, FIG. 12, FIG. 15]. Specifically, the O-ring 250 abuts the distal portion of the plunger 246 (e.g., stem) which is located within the outer housing 209 [0062, 0069, FIGS. 5, FIG. 12, FIG. 15]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively was effectively filed to modify the cryoablation system suggested by Lalonde in view of Dam-Huisman and DeLonzor to comprise an O-ring between the stem and the housing, as taught by Melsky. The advantage of such modification will help prevent leakage of fluid outside of the valve assembly (see paragraphs [0062, 0069] by Melsky).
14. Claims 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Lalonde et al. in view of Dam-Huisman and DeLonzor et al., further in view of Cao (WO 2022/199057 A1, with citations to the corresponding US Publication No. 2024/0142000 A1).
Regarding claim 13, Lalonde in view of Dam-Huisman and DeLonzor suggests the cryoablation system of claim 11. Lalonde, Dam-Husiman, and DeLonzor do not explicitly teach wherein the seat is machined PCTFE.
The prior art by Cao is analogous to Lalonde, as they both teach a system that is configured to control the flow of a pressurized cryogenic fluid from a tank ([0002]).
Cao teaches wherein the seat is machined PCTFE ([0058]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify the seat suggested by Lalonde in view of Dam-Huisman and DeLonzor to be machined from a PCTFE material, as taught by Cao. The advantage of such modification will improve seat’s resistance to cryogenic temperatures (see paragraph [0058] by Cao).
Regarding claim 14, Lalonde in view of Dam-Huisman and DeLonzor suggests the cryoablation system of claim 11. Lalonde, Dam-Huisman, and DeLonzor do not explicitly teach wherein the sealing surface is a high polished metal.
However, Cao teaches wherein the sealing surface is a high polished metal (the sealing portion 226 of the valve 100 may be composed of austenitic stainless steel [0065-0066]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify the sealing surface suggested by Lalonde in view of Dam-Huisman and DeLonzor to be composed of a high polished metal, as taught by Cao. The advantage of such modification will allow the sealing surface to be composed of austenitic stainless steel which is capable of withstanding extreme cryogenic operating temperatures (see paragraphs [0065-0066] by Cao).
15. Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Lalonde et al. in view of Dam-Huisman and DeLonzor et al., further in view of Fourkas et al. (US 2013/0190745 A1).
Regarding claim 15, Lalonde in view of Dam-Huisman and DeLonzor suggests the cryoablation system of claim 11. Lalonde, Dam-Huisman, and DeLonzor do not explicitly teach wherein the actuator is a stepper motor.
The prior art by Fourkas is analogous to Lalonde, as they both teach a cryogenic system ([abstract, 0009]).
Fourkas teaches wherein the actuator is a stepper motor (the valve comprises an actuator (e.g., stepper motor) [0015, 0093]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify the actuator suggested by Lalonde in view of Dam-Huisman and DeLonzor to be a stepper motor, as taught by Fourkas. This modification is beneficial, as the stepper motor enables the use of the system with main power or self-contained battery power (see paragraphs [0015, 0093] by Fourkas).
16. Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Lalonde et al. in view of Baust et al. and Clarke, further in view of Ma et al. (US 2023/0233243 A1).
Regarding claim 18, Lalonde in view of Baust and Clarke suggests the cryoablation system of claim 1. Lalonde teaches a computer that is programmable (the treatment system 100 comprises a console having a display screen 120a and a microprocessor that is programmable [abstract, 0019, 0032]).
Lalonde, Baust, and Clarke do not explicitly teach the computer being programmed and operable to control the heater based on measured catheter pressure or flowrate.
The prior art by Ma is analogous to Lalonde, as they both teach the use of a cryoablation catheter ([abstract]).
Ma teaches the computer being programmed and operable to control the heater based on measured catheter pressure (the electronic controller (e.g., computer) is configured to regulate the heater 46 based on the detected pressure of the refrigerant that is delivered through the medical device (e.g., cryoablation catheter 16) via the refrigerant-delivery line [abstract, 0025, 0083]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify the computer suggested by Lalonde in view of Baust and Clarke to control the heater based on measured catheter pressure, as taught by Ma. The advantage of such modification will allow for regulating the heater to increase the pressure of the refrigerant to a level that is sufficient for an efficient delivery of refrigerant through the catheter (see the [abstract] and paragraphs [0025, 0083] by Ma).
17. Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Dam-Huisman in view of DeLonzor et al.
Regarding claim 19, Dam-Huisman teaches a cold valve (the valve 12 is configured to regulate the flow of the cryogenic fluid [0030]) comprising:
an inlet (the inlet side of the valve 12 is configured to control the flow of the fluid from the container 3 [0030, FIG. 3]. For example, inlet side of the valve 12 cannot receive fluid from the container 3 while the valve 12 is in a closed position [0030-0032, FIG. 3]);
an outlet (the outlet side of the valve 12 may be attached directly to the capillary 5 [0030-0032]. Specifically, the outlet side of the valve 12 provides the fluid through the capillary 5 [0030-0032, FIG. 3]);
a seal surface (sealing configuration includes a valve seal [0030]);
a seat adapted to interface with the seal surface (the valve 12 may be a spring-based ball valve [0030]. Specifically, the seat is considered to be the “ball” which can be biased by a spring (e.g., stem) in a distal direction towards a valve seal against which the ball seals [0030]);
a stem coupled to the seat for moving the seat relative to the seal surface (the seat is considered to be the “ball” which can be biased by a spring (e.g., stem) in a distal direction towards a valve seal against which the ball seals [0030]); and
a housing defining a chamber for the stem to be moved (the spring (e.g., stem) of the valve 12 is moved or biased along the chamber or interior of the housing [0030-0032]); and
an actuator to move the stem (the actuation mechanism 10 is configured to move the spring (e.g., stem) of the valve 12 [0030]).
Dam-Huisman does not explicitly teach wherein the shape of the stem and housing define a Thermal Bridge Number ranging from 10 to 32.
However, the Examiner respectfully submits that a person having ordinary skill in the art would have found it obvious to configure the stem and housing to define a Thermal Bridge Number ranging from 10 to 32. The advantage of such will improve the overall thermal capacitance for maintaining low cryogenic fluid temperatures (see paragraphs [0020, 0030] by Dam-Huisman). The Examiner further submits that the skilled artisan may arrive at the claimed Thermal Bridge Number via routine experimentation (MPEP 2144.05).
Dam-Huisman does not explicitly teach wherein the valve is adapted to withstand cryogenic temperatures below -140 based on the shape, material and arrangement of the sealing surface, seat, stem and housing.
The prior art by DeLonzor is analogous to Dam-Huisman, as they both teach a cryogenic device ([abstract]).
DeLonzor teaches wherein the valve is adapted to withstand cryogenic temperatures below -140 based on the shape, material and arrangement of the sealing surface, seat, stem and housing (DeLonzor teaches the valve having sealing surface, seat, spring (e.g., stem), and a housing or body which allows the spring (e.g., stem) to move [0020-0021]. Specifically, DeLonzor teaches the structure of the valve being configured to withstand temperatures of -320.44 degrees Fahrenheit [0021]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify the structure of Dam-Huisman’s cold valve to withstand temperatures below -140 degrees, as taught by DeLonzor. The advantage of such modification will allow the cold valve to be maintain its operation and/or functionally while low cryogenic fluid temperatures are applied (see paragraphs [0020-0021] by DeLonzor).
18. Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Lalonde et al. in view of Lalonde et al. (US 2002/0111612 A1, referred to herein as “Lalonde-612”)
Regarding claim 20, Lalonde teaches a method for performing cryoablation on a tissue (the ablation catheter is configured to provide cryoablation to the tissue [abstract, 0003, 0013]) comprising:
providing a high-pressure tank of fluid in a condensed liquid phase; circulating the fluid in the condensed liquid phase from the high-pressure tank, through an ablation apparatus, and into a main reservoir (the high-pressure refrigerant tank 231 provides transports fluid or liquid through the heat exchanger 245 and further into inlet line 251 of the catheter (e.g., ablation apparatus) [abstract, 0030-0032, 0036, FIG. 3]. Furthermore, the return line 262 of the catheter is configured to exhaust or return the fluid into a compressor inlet line 241 [0035]. Specifically, the compressor inlet line 241 provides the fluid to a refrigerant bottle or reservoir [0036]. Meanwhile, the refrigerant bottle or reservoir provides the fluid through the compressor output line 242b to refill the high-pressure refrigerant tank 231 [0036]).
Lalonde does not explicitly teach wherein an amount of the fluid returned to the main reservoir expands to a gas phase; recondensing the returned fluid in the gas phase to the liquid phase in the main reservoir; and
refilling the high-pressure tank of fluid with the recondensed fluid in the liquid phase.
The prior art by Lalonde-612 is analogous to Lalonde, as they both teach cryoablation systems ([abstract]).
Lalonde-612 teaches wherein an amount of the fluid returned to the main reservoir expands to a gas phase; recondensing the returned fluid in the gas phase to the liquid phase in the main reservoir (the control section (e.g., reservoir) of the conditioner 40 receives the phase changed coolant (e.g., gas phase coolant) from the return lumen section 60 of the catheter [0025-0026, FIG. 2]. Specifically, the control section (e.g., reservoir) of the conditioner 40 liquefies the coolant (e.g., gas phase to liquid phase) [0026]. Furthermore, figure 2 illustrates the control section of the conditioner 40 returning the liquified coolant through the supply 30 and into the tank [0026, FIG. 2]); and
refilling the high-pressure tank of fluid with the recondensed fluid in the liquid phase (as stated previously above, the control section (e.g., reservoir) of the conditioner 40 receives the phase changed coolant (e.g., gas phase coolant) from the return lumen section 60 of the catheter [0025-0026, FIG. 2]. Specifically, the control section (e.g., reservoir) of the conditioner 40 liquefies the coolant (e.g., gas phase to liquid phase) [0026]. Furthermore, figure 2 illustrates the control section of the conditioner 40 returning the liquified coolant through the supply 30 and into the tank [0026, FIG. 2]).
Therefore, it would have been obvious to a person having ordinary skill in the art to modify the Lalonde’s main reservoir to condense the fluid from a gas phase to liquid phase and provide the condensed fluid to the high-pressure tank, as further taught by Lalonde-612. The advantage of such modification will improve the circulation of the fluid through the tank and cryoablation catheter (see paragraph [0026, 0028-0029] by Lalonde-612).
Conclusion
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/JOSHUA BRENDON SOLOMON/Examiner, Art Unit 3792
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