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 .
Election/Restrictions
Applicant's election with traverse of invention I in the reply filed on 5/22/2026 is acknowledged. The traversal is on the ground(s) that “it would not be unduly burdensome” to examine all of the originally presented claims. This is not found persuasive because the divergent classification of the leak testing method as compared to cryoablation systems in general, alone, is enough to require separate and burdensome search strategie formulation and execution. Furthermore, as noted, the method does not require the specific structure of either of the non-elected system claims, and as such, is not linked to the non-elected inventions. A search for leak testing methods will ultimately focus on the steps of the method rather than the structure of other distinct devices. Therefore, the requirement is still deemed proper and is therefore made FINAL.
Claims 13-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 5/22/2026.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Claim Rejections - 35 USC § 102
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.
Claims 1 and 10-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ryba et al. (US 2006/0004349 A1).
Considering claim 1, Ryba discloses a method for detecting leaks in a shaft of a cryoablation system, the shaft comprising a supply tube 20, a return tube 26, and an expansion chamber 50 towards a distal end 18 of the shaft 12, the shaft 12 configured to allow a working fluid 32 to travel from a proximal end 16 to the distal end 18 of the shaft 12, expand in the expansion chamber 50, and travel back to the proximal end of the shaft between the supply tube and the return tube (Figures 1 and 2A-2B; [0018-19]), the method comprising:
- placing a vacuum pump 38 in fluid communication with the return tube 26 and supply tube 20 ([0019-20]);
- pulling a vacuum within the supply tube 20 and the return tube 26 ([0022-23]);
- after pulling the vacuum for a predetermined amount of time, measuring a vacuum pressure within the supply tube 20 and the return tube 26 ([0023-25]);
- if the vacuum pressure is at or below a threshold pressure value, determining that there are no leaks in the shaft ([0023-25]); and
- if the vacuum pressure is above the threshold pressure value, determining that there is a leak in the shaft ([0023-25]).
Considering claim 10, Ryba discloses that the method is performed before the cryoablation system is introduced into a patient ([0022]).
Considering claim 11, Ryba discloses that the method is performed after the cryoablation system is introduced into a patient, during or after steering the cryoablation system to a treatment site ([0022]).
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.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Ryba et al. (US 2006/0004349 A1) in view of Candries et al. (WO 2023/021090 A1).
Considering claim 2, Ryba discloses recording pressure levels with a controller ([0011])
and repairing or replacing the cryoablation catheter ([0012]), but fails to explicitly
disclose upon determining that there is a leak in the shaft, recording a leak indication.
However, Candries teaches a leak detection system that records measured pressure during a leak detection process ([017]), whereby the system identifies and quantifies leaks based on the recorded pressures ([018]). Furthermore, the system is programmed to record the “presence” of a leak based on recorded data ([044]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to record a leak indication, as taught by Candries, in the invention by Ryba. The motivation for doing so is to provide automated leak detection, as suggested by Candries ([017-19]).
Claims 3, 5-9 are rejected under 35 U.S.C. 103 as being unpatentable over Ryba et al. (US 2006/0004349 A1) in view of Guazzo et al. (US 2011/0174060 A1).
Considering claim 3, Ryba discloses that the threshold pressure is approximately 3 psi (155 Torr) ([0010]), and thus fails to disclose that the threshold pressure is approximately 0.05 Torr (6.67 Pa).
However, Guazzo teaches that the pressure threshold is between 0 and 100 mbar (Figure 6; [0038], whereby aborted tests occur if the pressure P1 does not reach 100 mbar (75 Torr), P2 does not reach 10 mbar (7.5 Torr) by T2, and a good or tiny leak container reaches approximately 0 millibar (~0 Torr)).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to determine a leak/no leak condition when a pressure threshold is at .05 Torr, as rendered obvious by Guazzo, in the invention by Ryba. The motivation for doing so is to detect leaks on the order of magnitude of 1.0 micron ([0039]).
Considering claim 5, Ryba discloses that upon pulling the vacuum within the supply tube 20 and the return tube 26, the vacuum pressure is measured at predetermined time intervals ([0022]), and thus fails to disclose monitoring the pressure continuously.
However, Guazzo teaches upon pulling the vacuum, continuously monitoring the vacuum pressure over time during the predetermined time ([0002], [0008]; [0011]; [0035-36]; [0043]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to continuously monitor the pressure in the invention by Ryba, as taught by Guazzo. The motivation for doing so is to provide real-time information that would allow monitoring of rate of change of pressure, as taught by Guazzo ([0035-36]).
Considering claim 6, Ryba fails to disclose upon measuring a continuous increase in the vacuum pressure towards ambient pressure, determining that the shaft is not closed at the distal end.
However, Guazzo teaches monitoring an increase in vacuum pressure towards ambient pressure resulting from a system leak ([0013-14]; [0020]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to monitor vacuum pressure increase as an indicator of a gross system leak in the invention by Ryba, as taught by Guazzo. Prior to allowing fluid flow back into the system, Ryba could implement a pressure decay test, as taught by Guazzo, for the purpose of monitoring gross system leaks. Despite Guazzo nor Ryba not expressly teaching that the continuous rise means that the distal end of the shaft is not closed, the exact situation of an open distal end is considered a gross open-to-atmosphere condition, which is what Guazzo suggests. Furthermore still, Ryba is already concerned with patient safety in that it is desired to maintain the cyro-fluid within the cryo-catheter, so the advantage of monitoring for differently sized leaks would align with and enhance the already stated purpose of leak detection in Ryba.
Considering claim 7, Ryba fails to disclose monitoring an initial rise in the vacuum pressure; after the initial rise in vacuum pressure, monitoring that the vacuum pressure has stabilized to a value that is above the threshold pressure value; and determining that there is a leak in the shaft.
However, Guazzo teaches:
- monitoring an initial rise in the vacuum pressure ([0038]; [0041]);
- after the initial rise in vacuum pressure, monitoring that the vacuum pressure has stabilized to a value that is above the threshold pressure value ([0038]; [0041]); and
- determining that there is a leak in the shaft ([0038]; [0041]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to monitor vacuum pressure increasing to a stabilized value above a threshold as an indicator of a leak in the invention by Ryba, as taught by Guazzo. Prior to allowing fluid flow back into the system, Ryba already monitors whether the pressure reaches a threshold value during vacuum pulling, but it would have been obvious to further monitor for a stabilized value above a threshold as a pressure decay test, as taught by Guazzo, for the purpose of monitoring smaller system leaks. Essentially, large leaks will prevent a threshold pressure from being reached, while smaller leaks will show in the pressure measurements over a period of time. Furthermore still, Ryba is already concerned with patient safety in that it is desired to maintain the cyro-fluid within the cryo-catheter, so the advantage of monitoring for differently sized leaks would align with and enhance the already stated purpose of leak detection in Ryba.
Considering claim 8, Ryba fails to disclose monitoring an initial rise in the vacuum pressure; after the initial rise in vacuum pressure, monitoring that the vacuum pressure has stabilized to a value that is at or below the threshold pressure value; and determining that there are no leaks in the shaft.
However, Guazzo teaches:
- monitoring an initial rise in the vacuum pressure ([0038]; [0041]);
- after the initial rise in vacuum pressure, monitoring that the vacuum pressure has stabilized to a value that is at or below the threshold pressure value ([0038]; [0041]); and
- determining that there is no leak in the shaft ([0038]; [0041]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to monitor vacuum pressure increasing to a stabilized value at or below a threshold as an indicator of no leak in the invention by Ryba, as taught by Guazzo. Prior to allowing fluid flow back into the system, Ryba already monitors whether the pressure reaches a threshold value during vacuum pulling, but it would have been obvious to further monitor for a stabilized value above at or below threshold as a pressure decay test, as taught by Guazzo, for the purpose of monitoring smaller system leaks. Essentially, large leaks will prevent a threshold pressure from being reached, while smaller leaks will show in the pressure measurements over a period of time. Furthermore still, Ryba is already concerned with patient safety in that it is desired to maintain the cyro-fluid within the cryo-catheter, so the advantage of monitoring for differently sized leaks would align with and enhance the already stated purpose of leak detection in Ryba.
Considering claim 9, Ryba discloses measuring and monitoring the rate of pressure change of the pressure
∆
p
∆
t
of the chamber as a cyro-fluid is being supplied, after a vacuum has been pulled in the supply and return lines, whereby an initial rise in the vacuum pressure is monitoring and if the rate of change is above a threshold rate, determining that the shaft is compromised ([0024]).
In so much that Ryba introduces a cryo-fluid while monitoring the rate of pressure change, which is not currently precluded in the claims, it is also known from Guazzo to monitor the rate of change of pressure during a vacuum decay test prior to introduction of cryo-fluid ([0035-36]).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Ryba et al. (US 2006/0004349 A1) in view of Euteneuer (US 4930341 A).
Considering claim 4, Ryba discloses that the predetermined amount of time is about 5 seconds, in one example ([0023]), and thus fails to disclose that the amount of time is between about 10 seconds and about 45 seconds.
However, Euteneuer teaches pulling a vacuum for approximately 20 seconds to verify the leaktightness of a catheter (Column 2, lines 15-17).
The invention by Euteneuer merely utilizes a known technique to extend the duration of vacuum draw, already taught by Ryba, and provides the advantageous modification of allowing slightly more time for a system to reliably reach a vacuum condition, if possible. Furthermore, the increase of time appears to be a result-effective variable, whereby increasing the draw time allows more volume to be evacuated and gets the volume closer to a desired pressure level. Therefore, increasing the evacuation time to the claimed level, in which Euteneuer teaches, appears to be routine optimization of the known result-effective variable that balances test speed, target-pressure achievement, and leak-detection accuracy. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing of the claimed invention to utilize a vacuum draw time of about 10 to 45 seconds in the invention by Ryba, as taught by Euteneuer.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Ryba et al. (US 2006/0004349 A1) in view of Potocky et al. (US 5108390).
Considering claim 12, Ryba fails to explicitly disclose that the method is performed after a first cryoablation procedure has been completed with the cryoablation system and before a second cryoablation procedure is to be performed with the cryoablation system.
However, Potocky renders obvious testing a cryoablation probe before each subsequent use (Column 4, lines 43-56, whereby the probe can be reusable or disposable and is tested prior to use).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing of the claimed invention to test reusable cryoablation catheters between subsequent uses as suggested by the combination of Ryba and Potocky, whereby before each use the same reusable catheter would be leak tested. The motivation for doing so is to ensure patient safety, as understood in the art.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Solomon et al. (US 2013/0025349 A1) discloses a leak detection system that evacuates a chamber with a vacuum pump for a period of 25 seconds.
Colligan et al. (US 5361626 A) discloses a leak testing system that evacuates a chamber with a vacuum pump for a period of 30 seconds.
Abboud et al. (US 7716966 B2) discloses a cryosurgical device connected to a console, whereby leak detectors are positioned on the device and the console records the presence of a leak.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan M Dunlap whose telephone number is (571)270-1335. The examiner can normally be reached Mon-Fri 10AM - 7PM.
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/JONATHAN M DUNLAP/Primary Examiner, Art Unit 2855 June 24, 2026
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