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.
Election/Restrictions
2. Applicant’s election without traverse of Group I (claims 1-15) in the reply filed on 14 April 2026 is acknowledged. Therefore, the Examiner respectfully submits that Group II (claims 16-18) has been withdrawn from consideration.
Information Disclosure Statement
3. The Information Disclosure Statements submitted on 20 February 2025 and 11 May 2026 have been considered by the Examiner.
Claim Rejections - 35 USC § 112
4. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 4 is 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.
Claim 4 recites the limitation "the bubble barrier" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
5. 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.
6. Claims 1-2 are rejected under 35 U.S.C. 102 (a) (1) and (a) (2) as being anticipated by Baust et al. (US 2015/0282858 A1, referred to herein as “Baust-858”).
Regarding claim 1, Baust-858 teaches a cryoablation apparatus (the cryoablation catheter system 100 [0028, 0032, 0056, 0058]) comprising:
a Dewar defining an interior volume configured to retain a volume of cryogen (the cryoablation catheter system 100 comprises a console 102 having a dewar or fluid reservoir 106 which contains the fluid (e.g., nitrogen) [0034, 0042, FIG. 2]);
a supply tube extending into the interior volume of the Dewar (figure 2 illustrates the supply line 124 extending into the fluid reservoir 106 [0035, FIG. 2]);
a heating assembly positioned in the interior volume proximate the supply tube (the fluid reservoir 116 may include a heating and cooling elements which may be controlled to facilitate heating and/or cooling of the fluid within the reservoir [0034, FIG. 2]. Furthermore, figure 2 illustrates the supply line 124 extending into the fluid reservoir 106 which contains the heating element [0034-0035, FIG. 2]); and
a pump assembly positioned in the interior volume and operably coupled to the supply tube (the pump 130 is integrated within the fluid reservoir 106 to control the flow rate of the fluid (e.g., nitrogen) that is delivered through the supply line 124 [0035, 0042]).
Regarding claim 2, Baust-858 teaches wherein a distal end of the supply tube is positioned proximate a base of the Dewar (figure 2 illustrates the supply line 124 extending into the fluid reservoir 106, such that distal of the supply line 124 is positioned proximate to the base of the fluid reservoir 106 [FIG. 2]) and the pump is positioned proximate the distal end of the supply tube (the pump 130 is integrated within the fluid reservoir 106 to control the flow rate of the fluid (e.g., nitrogen) that is delivered through the distal end of the supply line 124 [0035, 0042, FIG. 2]).
Claim Rejections - 35 USC § 103
7. 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.
8. Claims 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Baust-858 in view of Curley (US 2012/0265199 A1).
Regarding claim 3, Baust-858 teaches the cryoablation apparatus of claim 1, wherein the heating assembly comprises a heater ([0034]).
However, Baust-858 does not explicitly teach wherein the heating assembly comprises:
a bubble barrier comprising at least one wall defining a heating boundary; and the heater positioned inside the bubble barrier.
The prior art by Curley is analogous to Baust-858, as the both teach an ablation catheter system comprising a heater and a lumen for fluid delivery ([0008, 0040, 0080])
Curley teaches wherein the heating assembly comprises a bubble barrier comprising at least one wall defining a heating boundary; and the heater positioned inside the bubble barrier (the fluid reservoir 112 may provide the fluid to a bubble barrier or degassing apparatus 119 [0051, 0061, 0066]. Furthermore, the bubble barrier or degassing apparatus 119 comprises a chamber which contains a heating element to degas the fluid [0061, 0066]. The Examiner respectfully submits that degassing is a process that is known to consist of removing gas bubbles from a fluid [0050-0051, 0061, 0066]. Specifically, the use of degassed fluids can increase the effectiveness, reproducibility, and overall reliability of fluid enhanced ablation systems [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 Baust-858’s heating assembly to comprise a bubble barrier, as taught by Curley. The advantage of such modification will allow for degassing the fluid to increase the effectiveness, reproducibility, and overall reliability of the ablation system (see paragraphs [0050-0051, 0061, 0066] by Curley).
Regarding claim 4, Baust-858 teaches the cryoablation apparatus of claim 2. Baust-858 does not explicitly teach wherein the distal end of the supply is positioned at a top of the bubble barrier.
However, Curley teaches wherein the distal end of the supply is positioned at the top of the bubble barrier (the fluid reservoir 112 may provide the fluid to the degassing apparatus 119 (e.g., bubble barrier) and then the fluid can flow through the supply conduit 114 [0050-0051, 0061, 0066]. Furthermore, figure 1 illustrates the distal end of fluid supply conduit 114 being connected at the top of the bubble barrier or degassing apparatus 119 [0061, FIG. 1]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively field to modify Baust-858’s distal end of the supply to be positioned at the top of the bubble barrier, as taught by Curley. The advantage of such modification will allow the bubble barrier (e.g., degassing apparatus) to provide a degassed fluid through the supply conduit which will improve the effectiveness and reliability of the ablation system (see paragraphs [0050-0051, 0061, 0066] by Curley).
9. Claim 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Baust-858 in view of Curley, further in view of Stopek et al. (US 2023/0218930 A1).
Regarding claim 5, Baust-858 in view of Curley suggests the cryoablation apparatus of claim 3. Baust-858 teaches the cryoablation apparatus further comprising at least one pressure sensor ([0041]).
Baust-858 and Curley do not explicitly teach the at least one pressure sensor positioned inside the bubble barrier.
The prior art by Stopek is analogous to Baust-858, as they both teach catheters that are used for ablation or cryoablation procedures ([0078, 0128]).
Stopek teaches the at least one pressure sensor positioned inside the bubble barrier (the system may include bubble barrier or degassing apparatus which includes various sensors (e.g., pressure sensors or temperature sensors) [0207]. As stated previously in claim 3 above, degassing is a process that is known to consist of removing gas bubbles from a fluid).
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 bubble barrier suggested by Baust-858 in view of Curley to include a pressure sensor, as taught by Stopek. The advantage of such modification will ensure that the fluid within the bubble barrier (e.g., degassing apparatus) is at the correct pressure for the ablation procedure (see paragraphs [0078, 0128, 0207] by Stopek).
Regarding claim 6, Baust-858 teaches a pressure control operably coupled to the heating assembly, and the pump assembly, the pressure control configured to activate and deactivate the heater to maintain the cryogen supplied to the supply tube at a pressure within a first predetermined operating range (the sensors 166 (e.g., pressure sensors) may be positioned at various positions within the console 102 and catheter 116 to monitor the fluid pressure [0055]. For example, the sensors 166 may be positioned within the reservoir 106 of the console 102, which contains the heating elements and the pump 130 [0034-0035, 0055]. Furthermore, the control system 148 may monitor the fluid pressure signals received from sensors 166 to further control the heating and/or cooling elements to regulate the temperature of the fluid [0034, 0055]. Additionally, the control system 148 may monitor the fluid pressure signals received from the sensors 166 to further control pump 130 to regulate the flow rate of the fluid [0035, 0055]. Based on the explanation above, the fluid flow rate and fluid temperature are regulated to maintain a desired fluid pressure range [0055]).
10. Claims 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Baust-858 in view of Curley and Stopek et al., further in view of Harmouche (US 2020/0060746 A1).
Regarding claim 7, Baust-858 in view of Curley and Stopek suggests the cryoablation apparatus of claim 6. Baust-858, Curley, and Stopek do not explicitly teach wherein the pressure control is further configured to operate the pump assembly to pressurize the cryogen at an outlet of a pump to a pressure within a second predetermined operating range.
The prior art by Harmouche is analogous to Baust-858, as they both teach a catheter that is configured to provide cryoablation ([abstract]).
Harmouche teaches wherein the pressure control is further configured to operate the pump assembly to pressurize the cryogen at an outlet of a pump to a pressure within a second predetermined operating range (the fluid source (e.g., pump) is coupled to a fluid supply line of a cryogenic ablation catheter [0034, 0040, claims 1-2]. Specifically, the fluid control system 28 is configured to control the fluid pressure (e.g., at least 500 psig) of the fluid source (e.g., pump) [0034, 0040-0041, 0052, 0071]. Furthermore, the fluid control system 28 is configured to control the fluid pressure (e.g., 30 psig to 100 psig) at the fluid supply line which supplies the fluid to the balloon [0034, 0040-0041, 0076]).
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 pressure control suggested by Baust-858 in view of Curley and Stopek operate the pump assembly to pressurize the cryogen at an outlet of a pump to a pressure within a second predetermined operating range, as taught by Harmouche. The advantage of such modification will help maintain allow the fluid source (e.g., pump) to maintain the fluid within a liquid state (see paragraphs [0034, 0040-0041, 0052, 0071] by Harmouche).
Regarding claim 8, Baust-858 in view of Curley, Stopek, and Harmouche suggests the cryoablation apparatus of claim 7. Harmouche teaches wherein the first predetermined operating range is a low pressure range and the second predetermined operating range is a high pressure range (the fluid source (e.g., pump) is coupled to a fluid supply line of a cryogenic ablation catheter [0034, 0040, claims 1-2]. Specifically, the fluid control system 28 is configured to control the fluid pressure (e.g., at least 500 psig) of the fluid source (e.g., pump) [0034, 0040-0041, 0052, 0071]. Furthermore, the fluid control system 28 is configured to control the fluid pressure (e.g., 30 psig to 100 psig) at the fluid supply line which supplies the fluid to the balloon [0034, 0040-0041, 0076]. The Examiner respectfully submits that the fluid pressure of the fluid source (e.g., at least 500 psig) is higher than the fluid pressure of the fluid supply line (e.g., 30 psig to 100 psig) [0034, 0040-0041, 0076]).
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 pressure control suggested by Baust-858 in view of Curley, Stopek, and Harmouche to adjust the first predetermined operating range to be a low pressure range and the second operating range to be high pressure range, as taught by Harmouche. The advantage of such modification will allow for transitioning the liquid from a liquid state to a gas state (see paragraphs [0034, 0040-0041, 0052, 0076] by Harmouche).
Regarding claim 9, Baust-858 teaches wherein the cryogen is Nitrogen ([0042]).
11. Claims 10-13 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Baust-858 in view of Pietryga (US 2020/0339324 A1).
Regarding claim 10, Baust-858 teaches the cryoablation apparatus of claim 1. Baust-858 does not explicitly teach a capacitance-based cryogen liquid level sensor positioned in the Dewar configured to provide a cryogen liquid level of the cryogen in the Dewar.
The prior art by Pietryga is analogous to Baust-858, as they both teach a cryotherapy system comprising a dewar or container for storing a cryogenic fluid ([0010, 0017])
Pietryga teaches a capacitance-based cryogen liquid level sensor positioned in the Dewar configured to provide a cryogen liquid level of the cryogen in the Dewar (the capacitive sensor 3 comprises a rod or cylindrical capacitor that is disposed within the container 5 (e.g., dewar) to measure the liquid nitrogen level [0010, 0017, FIG. 1, FIG. 4]).
Therefore, it would have been obvious to a person having ordinary skilli n the art at the time the application was effectively filed to modify Baust-858’s cryoablation apparatus to include a capacitance-based liquid level sensor positioned in the dewar, as taught by Pietryga. This modification is beneficial, as it will allow the operator to observe the liquid nitrogen level in real time to determine if it safe to refill the container (e.g., dewar) during the cryotherapy procedure (see paragraphs [0010, 0017] by Pietryga).
Regarding claim 11, Baust-858 in view of Pietryga suggests the cryoablation apparatus of claim 10. Pietryga teaches wherein the capacitance-based cryogen liquid sensor comprises a cryogen rod extending in the internal volume of the Dewar (the capacitive sensor 3 comprises a rod or cylindrical capacitor that is disposed within the container 5 (e.g., dewar) to measure the liquid nitrogen level [0010, 0017, FIG. 1, FIG. 4]).
Therefore, it would have been obvious to a person having ordinary skill n the art at the time the application was effectively filed to modify the capacitance-based liquid level sensor suggested by Baust-858 in view of Pietryga to comprise a cryogen rod extending in the internal volume of the dewar, as further taught by Pietryga. This modification is beneficial, as the rod or cylindrical capacitor of the capacitive sensor extends through the entirety of the container (e.g., dewar) to determine changes in liquid nitrogen level on a 10-step scale in real time during the cryotherapy procedure (see paragraphs [0010, 0017] by Pietryga).
Regarding claim 12, Baust-858 in view of Pietryga suggests the cryoablation apparatus of claim 12. Pietryga teaches wherein the cryogen rod comprises a first capacitor surface (the capacitive sensor 3 comprises a rod or cylindrical capacitor having a first capacitor surface or outer core 8 [0017, FIGS. 4-5]) and a second capacitor surface (the capacitive sensor 3 comprises a rod or cylindrical capacitor having a second capacitive surface or inner tube 7 [0017, FIGS. 4-5]), the first capacitor surface positioned concentrically around the second capacitor surface and defining an annular cavity therebetween (the capacitive sensor 3 comprises a rod or cylindrical capacitor having an outer core 8 (e.g., first capacitive surface) that concentrically surrounds the inner tube 7 (e.g., second capacitive surface) [0017, FIGS. 4-5]. Specifically, the inner tube 7 extends through the outer core 8 [0017, FIG. 5]. Furthermore, an annular space consisting of spacers 9 is defined between the inner tube 7 and the outer core 8 [0017, FIG. 5]).
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 cryogen rod suggested by Baust-858 in view of Pietryga to consist of a first capacitor surface and a second capacitor surface defining an annular cavity therebetween, as further taught by Pietryga. This modification is beneficial, as each of the capacitor surfaces (e.g., inner tube 7 and the outer core 8) of the rod or cylindrical capacitor may be connected to electrical conduits which provides sufficient power for the capacitor surfaces to detect liquid nitrogen levels (see paragraph [0017] by Pietryga).
Regarding claim 13, Baust-858 in view of Pietryga suggests the cryoablation apparatus of claim 12. Pietryga teaches a control circuit coupled to the capacitance-based cryogen liquid level sensor (the capacitive liquid level sensor 3 is coupled to an electronic box 4 which comprises a circuit board equipped with a microcontroller [0017]), the control circuit configured to continuously charge and discharge the capacitance-based cryogen liquid level sensor during a cryoablation cycle to continuously determine a cryogen liquid level in the Dewar (capacitive liquid level sensor 3 is electrically coupled to the circuit board of the electronic box 4 which is powered by a battery [0017]. Furthermore, the battery is configured to charge the capacitive liquid level sensor 3 to allow the detection of the liquid level inside the container 5 during the cryotherapy or cryoablation procedure [0017]. The Examiner respectfully submits that batteries will inherently discharge while being used [0017]).
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 capacitance-based cryogen liquid level sensor suggested by Baust-858 in view of Pietryga to be coupled to a control circuit that charges and discharges the capacitance-based cryogen level sensor, as further taught by Pietryga. This modification is beneficial, as the battery of the electronic box (e.g., circuitry) allows the capacitance-based cryogen level sensor to measure the liquid level inside the container without the external power supply (see paragraph [0017] by Pietryga).
Regarding claim 15, Baust-858 in view of Pietryga suggests the cryoablation apparatus of claim 10. Pietryga teaches wherein the capacitance-based liquid level sensor is configured to provide the cryogen liquid level for any level of cryogen along a length of the capacitance-based liquid level sensor (the capacitive sensor 3 comprises a rod or cylindrical capacitor that extends through the entirety of the container 5 (e.g., dewar) to measure the liquid nitrogen level [0010, 0017, FIG. 1, FIG. 4]).
Therefore, it would have been obvious to a person having ordinary skilli n the art at the time the application was effectively filed to modify the capacitance-based liquid level sensor suggested by Baust-858 in view of Pietryga to comprise a to provide the cryogen liquid level for any level of cryogen along a length of the capacitance-based liquid level sensor, as further taught by Pietryga. This modification is beneficial, as the rod or cylindrical capacitor of the capacitive sensor extends through the entirety of the container (e.g., dewar) to determine changes in liquid nitrogen level in real time during the cryotherapy procedure (see paragraphs [0010, 0017] by Pietryga).
12. Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Baust-858 in view of Pietryga, further in view of Baust et al. (US 2015/0300569 A1, referred to herein as “Baust-569”).
Regarding claim 14, Baust-858 in view of Pietryga suggests the cryoablation apparatus of claim 10. Baust-858 and Pietryga do not explicitly teach wherein the capacitance-based liquid level sensor is positioned on the supply tube.
The prior art by Baust-569 is analogous to Baust-858, as they both teach a cryogenic system comprising a supply line ([abstract]).
Baust-569 teaches wherein the capacitance-based liquid level sensor is positioned on the supply tube (the fluid level sensor may be arranged to monitor fluid level within the reservoir or the pressurized cryogen supply tube [claim 10, claims 14-15]).
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 capacitance-based liquid level sensor suggested by Baust-858 in view of Pietryga to be disposed on the supply tube, as taught by Baust-569. The advantage of such modification will allow for monitoring the fluid level within the supply tube (see [claim 10, claims 14-15] by Baust-569).
Statement on Communication via Internet
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Conclusion
14. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA BRENDON SOLOMON whose telephone number is (571)270-7208. The examiner can normally be reached on 7:30am -4:30pm.
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/JOSHUA BRENDON SOLOMON/Examiner, Art Unit 3792
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