DETAILED ACTION
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on February 10, 2026 has been entered.
Currently, claims 1-9, 11-17 and 19-22 are pending with claim 22 newly added, claims 10 and 18 cancelled, and claims 1, 11, 19 and 21 amended. The following is a complete response to the February 10, 2026 communication.
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 .
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 22 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Regarding claim 22, the claim recites that the method includes the step of “determining an amount or degree of ice formation at an ablation site based on the inner surface temperature or the outer surface temperature of the expandable element”.
The Examiner have reviewed the instant disclosure with respect to the above highlighted limitation but has failed to find an enabling disclosure for such subject matter. First, the Examiner recognizes that the nature of the art involves ablation of tissue of the body with a medical device having an expandable element and with fluid provided within the expandable element. Accordingly, the Examiner is of the position that the level of predictability in the art in rather routine given that such subject matter is routinely known and utilized in the art.
Turning to the instant disclosure, Applicant has only provided a substantial reiteration of the at-issue claim language in paragraph [0038] of the filed Specification in the form of “[t]he measurement of the temperature of the expandable element 40 may be used, in part, to determine the amount or degree of ice formation at the ablation site”. This is the only disclosure or evidence of a working example related to the at-issue claim language. The disclosure in [0038] even differs from the at-issue claim language given that the disclosure in [0038] sets forth that the temperature is only used in part to determine the amount of degree of ice formation, and not solely by itself as is presented contemplated in the language of claim 22.
There is no disclosure or working example of any manner of control system, or processor, or computer or program or algorithm for accomplishing the claimed “determining” step based on the inner surface temperature or the outer surface temperature of the expandable element. Accordingly, the Examiner is of the position that the development of a program or algorithm or other such arrangement to provide for the claimed determining step would require undue experimentation given the lack of direction in the instant disclosure including any manner in which the detected inner/outer surface temperature is correlated to the amount or degree of ice formation. Appropriate correction is required.
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.
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.
Claims 1-6, 11-15, 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Moriarty et al. (US Pat. Pub. 2015/0250524 A1) further in view of Newell et al. (US Pat. Pub. 2015/0126985 A1), Abboud et al. (US Pat. Pub. 2005/0228367 A1) and Abboud et al. (US Pat. Pub. 2008/0221508 A1) hereinafter “Abboud ‘508”.
Regarding claim 1, Moriarty provides for a method of predicting an adverse event during an ablation procedure, the method comprising providing a medical device having an expandable element (see figure 1A with the device 102 having the element 122 as in [0020]), positioning the medical device proximate to an area of target tissue (See at least [0029] providing for the placement of the device at the treatment location), the medical device including a fluid exhaust lumen and a fluid supply lumen each being in fluid communication with the expandable element (140 being the supply, 146 being the exhaust), delivering fluid to expandable element and exhausting fluid from the expandable element (via the flow of fluid through 140 to 122 and out through 146 as in [0030]-[0035]), measuring a pressure within a vacuum return path (see [0030] with the measuring of pressure within 146 via sensor 188), and measuring a period of time it takes for the pressure within the vacuum return path to reach a target pressure (See the measuring of time against thresholds as in at least [0037] and [0041]).
Moriarty, while contemplating a pressure sensor and pressure sensing, fails to specifically contemplate that such is via a pressure monitoring tube at least partially disposed within the expandable element and configured to monitor an internal pressure of the expandable element. Newell discloses a similar device as that of Moriarty and specifically contemplates the use of a pressure monitoring tube to provide pressure information from within the expandable element to a pressure sensor (56) and configured to monitor an internal pressure of the expandable element (see at least [0030]). Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art to have utilized a pressure monitoring tube as in Newell that is at least partially disposed within the expandable element of Moriarty to provide for a manner in which pressure within the expandable element is monitored. Newell readily provides that such is one of a known number of modalities in which to sense pressure within a cryosurgical balloon that would function with a reasonable expectation of success to provide for the pressure sensing within the expandable element as required for in Moriarty.
While Moriarty provides that the expandable element is a balloon, Moriarty fails to provide that such is a dual walled balloon including an inner balloon and an outer balloon and wherein the method further includes monitoring a pressure within an interstitial space defined between the inner balloon and the outer balloon via a pressure sensor coupled to an outer surface of the inner balloon or an inner surface of the outer balloon. Newell fails to cure this deficiency in Moriarty.
Abboud discloses a similar medical device as that of Moriarty that includes an expandable element at the distal end (device 12 with element 18 at the end; see further figure 5 providing for the expandable element at 50). Abboud further discloses the concern with detecting adverse events during a treatment via the inclusion of a dual walled balloon including an inner balloon and an outer balloon (50 with 58 and 62) and wherein the method further includes monitoring a parameter within an interstitial space defined between the inner balloon and the outer balloon via a sensor coupled to an outer surface of the inner balloon or an inner surface of the outer balloon (see figure 5 with the sensor at 68 indirectly coupled to one of 58 or 62 and located within the space at 64). While Abboud provides that 68 functions as a detector for changing conditions (see [0030]), Abboud fails to specifically recite that such is a pressure sensor to monitor pressure within the space between the inner and outer balloons.
Abboud ‘508 provides for a similar arrangement as that in Abboud and specifically discusses that a leak detector for use with a interstitial space may include a pressure sensor (30 detecting pressure changes within 26 as in [0023]).
Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have first utilized a dual-walled balloon arrangement and the leak detector contained therein as in Abboud to the device of Moriarty. Such would provide for an additional modality of adverse event detection such as the sensing of leaks, bursts or ruptures of the inner balloon during use of the system. The dual-wall arrangement further would prevent the ingress of coolant within the patient in the event that the inner balloon leaked or burst.
The Examiner is further of the position that it would have been obvious to utilize a pressure sensor as the leak detector of Abboud in view of the direction in Abboud ‘508. Specifically, Abboud ‘508 provides for the use of a pressure sensor as an exemplary manner of detecting conditions in the interstitial space between two balloons so as to provide a manner of adverse event detection and control. The Examiner, therefore, finds that it would have been obvious to utilize the pressure detector of Abboud ‘508 as the detector 68 in figure 5 of Abboud to provide a known alternative of event detection in the art that would function equally and with a reasonable expectation of success as the contemplated detector in Abboud.
Regarding claim 2, Moriarty provides that the medical device is in communication with a console (combined structure of 104/106/108)), the console including: processing circuitry (108), a fluid supply reservoir in fluid communication with the fluid supply lumen (154), and a fluid exhaust chamber in fluid communication with the fluid exhaust lumen (exhaust capturing device connected to 160 as in [0024]).
Regarding claim 3, Moriarty provides for triggering a fault to stop the delivery of fluid if the pressure within the vacuum return path does not reach the target pressure within a predetermined time period (at step 230 based on a failed testing situation).
Regarding claim 4, Moriarty provides that the vacuum return path is disposed within the console, the pressure of the vacuum return path is measured by a pressure sensor disposed within the console along the vacuum return path. (see figure 1A with 146 passing through the structure of 104/106 with 188 within 106).
Regarding claim 5, Moriarty provides for generating an alert when the fault to stop the delivery of fluid is triggered, the alert being at least one of an audible alert, a visual alert, and a tactile alert indicative of a presence of an adverse event (see [0036] providing for an error indicator displayed to the physician).
Regarding claim 6, Moriarty provides that the adverse event is a condition causing the restriction of fluid through the vacuum return path (see [0037] providing for a blockage in exhaust as a possible error).
Regarding claim 11, Moriarty provides for a medical system, comprising: a console having processing circuitry combined structure of 104/106/108),
a medical device in communication with the console, the medical device including: an expandable element (the device 102 having the element 122 as in [0020]), a fluid supply lumen and a fluid exhaust lumen in fluid communication with the expandable element and the console (140 being the supply, 146 being the exhaust), the fluid exhaust lumen being in communication with a vacuum return path disposed within the console (via the exhaust lumen being coupled to exhaust capturing device connected to 160 as in [0024]), and a pressure sensor disposed within the console along the vacuum return path and configured to measure a pressure within the vacuum return path (see [0030] with the measuring of pressure within 146 via sensor 188).
Moriarty, while contemplating a pressure sensor and pressure sensing, fails to specifically contemplate that such is via a pressure monitoring tube at least partially disposed within the expandable element and configured to monitor an internal pressure of the expandable element. Newell discloses a similar device as that of Moriarty and specifically contemplates the use of a pressure monitoring tube to provide pressure information from within the expandable element to a pressure sensor (56) and configured to monitor an internal pressure of the expandable element (see at least [0030]). Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art to have utilized a pressure monitoring tube as in Newell that is at least partially disposed within the expandable element of Moriarty to provide for a manner in which pressure within the expandable element is monitored. Newell readily provides that such is one of a known number of modalities in which to sense pressure within a cryosurgical balloon that would function with a reasonable expectation of success to provide for the pressure sensing within the expandable element as required for in Moriarty.
While Moriarty provides that the expandable element is a balloon, Moriarty fails to provide that such is a dual walled balloon including an inner balloon and an outer balloon and wherein the method further includes monitoring a pressure within an interstitial space defined between the inner balloon and the outer balloon via a pressure sensor coupled to an outer surface of the inner balloon or an inner surface of the outer balloon. Newell fails to cure this deficiency in Moriarty.
Abboud discloses a similar medical device as that of Moriarty that includes an expandable element at the distal end (device 12 with element 18 at the end; see further figure 5 providing for the expandable element at 50). Abboud further discloses the concern with detecting adverse events during a treatment via the inclusion of a dual walled balloon including an inner balloon and an outer balloon (50 with 58 and 62) and wherein the method further includes monitoring a parameter within an interstitial space defined between the inner balloon and the outer balloon via a sensor coupled to an outer surface of the inner balloon or an inner surface of the outer balloon (see figure 5 with the sensor at 68 indirectly coupled to one of 58 or 62 and located within the space at 64). While Abboud provides that 68 functions as a detector for changing conditions (see [0030]), Abboud fails to specifically recite that such is a pressure sensor to monitor pressure within the space between the inner and outer balloons.
Abboud ‘508 provides for a similar arrangement as that in Abboud and specifically discusses that a leak detector for use with a interstitial space may include a pressure sensor (30 detecting pressure changes within 26 as in [0023]).
Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have first utilized a dual-walled balloon arrangement and the leak detector contained therein as in Abboud to the device of Moriarty. Such would provide for an additional modality of adverse event detection such as the sensing of leaks, bursts or ruptures of the inner balloon during use of the system. The dual-wall arrangement further would prevent the ingress of coolant within the patient in the event that the inner balloon leaked or burst.
The Examiner is further of the position that it would have been obvious to utilize a pressure sensor as the leak detector of Abboud in view of the direction in Abboud ‘508. Specifically, Abboud ‘508 provides for the use of a pressure sensor as an exemplary manner of detecting conditions in the interstitial space between two balloons so as to provide a manner of adverse event detection and control. The Examiner, therefore, finds that it would have been obvious to utilize the pressure detector of Abboud ‘508 as the detector 68 in figure 5 of Abboud to provide a known alternative of event detection in the art that would function equally and with a reasonable expectation of success as the contemplated detector in Abboud.
Regarding claim 12, Moriarty provides for a fluid supply reservoir (154) and a fluid exhaust chamber each disposed within the console and in fluid communication with the medical device (exhaust capturing device connected to 160 as in [0024]).
Regarding clam 13, Moriarty provides that the processing circuitry is configured to measure a period of time it takes for the pressure within the fluid exhaust lumen to reach a target pressure (see the measuring of time against thresholds as in at least [0037] and [0041]).
Regarding claim 14, Moriarty provides that the console is further configured to: initiate a delivery of fluid from the fluid supply reservoir to the expandable element (via the flow of fluid through 140 to 122 and out through 146 as in [0030]-[0035]), and trigger the stoppage of the delivery of fluid to the expandable element if the measured pressure within the vacuum return path does not reach the target pressure within a predetermined time period (at step 230 based on a failed testing situation).
Regarding claim 15, Moriarty provides that the console is configured to generate and transmit an alert when the fault is triggered, the alert being at least one of an audible alert, a visual alert, and a tactile alert indicative of a presence of an adverse event (see [0036] providing for an error indicator displayed to the physician).
Regarding claim 19, Moriarty provides for a method of predicting an adverse event during an ablation procedure, the method comprising: providing a medical device having an expandable element (see figure 1A with the device 102 having the element 122 as in [0020]), the medical device being in communication with a console (combined structure of 104/106/108) having:
processing circuitry (108),
a fluid supply reservoir (154),
a fluid exhaust chamber (exhaust capturing device connected to 160 as in [0024]),
and a vacuum return path (path through 104/106/108 between 146 and 160),
positioning the medical device proximate to an area of target tissue (see at least [0029] providing for the placement of the device at the treatment location), the medical device including a fluid exhaust lumen and a fluid supply lumen each being in fluid communication with the expandable element and the console (140 being the supply, 146 being the exhaust),
delivering fluid from the fluid supply reservoir to expandable element and exhausting fluid from the expandable element to the fluid exhaust chamber (via the flow of fluid through 140 to 122 and out through 146 as in [0030]-[0035]), and
at least one of: (a) measuring a pressure of the vacuum return path, the pressure being measured by a pressure sensor disposed within the console along the vacuum return path (see [0030] with the measuring of pressure within 146 via sensor 188), and
(b) measuring a period of time it takes for the pressure within the vacuum return path to reach a target pressure (see the measuring of time against thresholds as in at least [0037] and [0041]),
and triggering the stoppage of the delivery of fluid to the expandable element if the pressure of the vacuum return path does not reach the target pressure within a predetermined time period (at step 230 based on a failed testing situation).
Moriarty, while contemplating a pressure sensor and pressure sensing, fails to specifically contemplate that such is via a pressure monitoring tube at least partially disposed within the expandable element and configured to monitor an internal pressure of the expandable element. Newell discloses a similar device as that of Moriarty and specifically contemplates the use of a pressure monitoring tube to provide pressure information from within the expandable element to a pressure sensor (56) and configured to monitor an internal pressure of the expandable element (see at least [0030]). Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art to have utilized a pressure monitoring tube as in Newell that is at least partially disposed within the expandable element of Moriarty to provide for a manner in which pressure within the expandable element is monitored. Newell readily provides that such is one of a known number of modalities in which to sense pressure within a cryosurgical balloon that would function with a reasonable expectation of success to provide for the pressure sensing within the expandable element as required for in Moriarty.
While Moriarty provides that the expandable element is a balloon, Moriarty fails to provide that such is a dual walled balloon including an inner balloon and an outer balloon and wherein the method further includes monitoring a pressure within an interstitial space defined between the inner balloon and the outer balloon via a pressure sensor coupled to an outer surface of the inner balloon or an inner surface of the outer balloon. Newell fails to cure this deficiency in Moriarty.
Abboud discloses a similar medical device as that of Moriarty that includes an expandable element at the distal end (device 12 with element 18 at the end; see further figure 5 providing for the expandable element at 50). Abboud further discloses the concern with detecting adverse events during a treatment via the inclusion of a dual walled balloon including an inner balloon and an outer balloon (50 with 58 and 62) and wherein the method further includes monitoring a parameter within an interstitial space defined between the inner balloon and the outer balloon via a sensor coupled to an outer surface of the inner balloon or an inner surface of the outer balloon (see figure 5 with the sensor at 68 indirectly coupled to one of 58 or 62 and located within the space at 64). While Abboud provides that 68 functions as a detector for changing conditions (see [0030]), Abboud fails to specifically recite that such is a pressure sensor to monitor pressure within the space between the inner and outer balloons.
Abboud ‘508 provides for a similar arrangement as that in Abboud and specifically discusses that a leak detector for use with a interstitial space may include a pressure sensor (30 detecting pressure changes within 26 as in [0023]).
Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have first utilized a dual-walled balloon arrangement and the leak detector contained therein as in Abboud to the device of Moriarty. Such would provide for an additional modality of adverse event detection such as the sensing of leaks, bursts or ruptures of the inner balloon during use of the system. The dual-wall arrangement further would prevent the ingress of coolant within the patient in the event that the inner balloon leaked or burst.
The Examiner is further of the position that it would have been obvious to utilize a pressure sensor as the leak detector of Abboud in view of the direction in Abboud ‘508. Specifically, Abboud ‘508 provides for the use of a pressure sensor as an exemplary manner of detecting conditions in the interstitial space between two balloons so as to provide a manner of adverse event detection and control. The Examiner, therefore, finds that it would have been obvious to utilize the pressure detector of Abboud ‘508 as the detector 68 in figure 5 of Abboud to provide a known alternative of event detection in the art that would function equally and with a reasonable expectation of success as the contemplated detector in Abboud.
Regarding claim 20, Moriarty provides for generating an alert when the fault is triggered, the alert being at least one of an audible alert, a visual alert, and a tactile alert indicative of a presence of an adverse event (see [0036] providing for an error indicator displayed to the physician).
Claims 7-9, 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Moriarty et al. (US Pat. Pub. 2015/0250524 A1) in view of Newell et al. (US Pat. Pub. 2015/0126985 A1), Abboud et al. (US Pat. Pub. 2005/0228367 A1) and Abboud et al. (US Pat. Pub. 2008/0221508 A1) as applied to claims 6 and 15 respectively above, and further in view of Baust et al. (US Pat. No. 5,437,673).
Regarding claims 7-9, while Moriarty contemplates the use of pressure sensing, Moriarty fails to contemplate measuring, with a flow sensor, a mass flow rate of fluid traveling from the expandable element to the fluid exhaust chamber via the vacuum return path per claim 7, fails to disclose comparing the measured mass flow rate of fluid to a mass flow rate threshold per claim 8, and fails to provide for the determining set forth in claim 9.
Baust discloses an exemplary manner of measuring a mass flow rate travelling through a fluid flow path in a cooling system utilizing a flow sensor (45). Baust provides for comparing the measured flow rate to a threshold (see col. 8; 17-60) and for determining, based on the comparison of the measured mass flow rate of fluid to the mass flow rate threshold, whether the adverse event is present (see col. 8; 45-60 providing for the detection of too low a flow with respect to a preset minimum) and generating the alert when the fault to stop the delivery of fluid is triggered (via the activation of the alarm 50).
Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have utilized a flow sensor and associated methodology as in Baust in combination with the methodology of Moriarty to provide for an additional level of monitoring the operation of the cryosurgical system to ensure proper operation and to further check for operational issues of the system (blockage, rupture and/or other mechanical failure). The Examiner is further of the position that the combined methodology would then result in the combined system to stop fluid delivery if an adverse event is detected based on the flow rate given that Moriarty already provides for such via the step at 230 in Moriarty.
Regarding claims 16 and 17, while Moriarty contemplates the use of pressure sensing, Moriarty fails to contemplate the flow sensor and associate limitations per claim 16, or the functionality of the processing circuitry with respect to the flow sensor and mass flow rate as in claim 17.
Baust discloses an exemplary manner of measuring a mass flow rate travelling through a fluid flow path in a cooling system utilizing a flow sensor (45). Baust provides for comparing the measured flow rate to a threshold (see col. 8; 17-60) and for determining, based on the comparison of the measured mass flow rate of fluid to the mass flow rate threshold, whether the adverse event is present (see col. 8; 45-60 providing for the detection of too low a flow with respect to a preset minimum) and generating the alert when the fault to stop the delivery of fluid is triggered (via the activation of the alarm 50).
Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have utilized a flow sensor and associated methodology as in Baust in combination with the methodology of Moriarty to provide for an additional level of monitoring the operation of the cryosurgical system to ensure proper operation and to further check for operational issues of the system (blockage, rupture and/or other mechanical failure). The Examiner is further of the position that the combined methodology would then result in the combined system to stop fluid delivery if an adverse event is detected based on the flow rate given that Moriarty already provides for such via the step at 230 in Moriarty.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Moriarty et al. (US Pat. Pub. 2015/0250524 A1) in view of Newell et al. (US Pat. Pub. 2015/0126985 A1), Abboud et al. (US Pat. Pub. 2005/0228367 A1) and Abboud et al. (US Pat. Pub. 2008/0221508 A1) as applied to claim 1 above and further in view of Wittenberger (US Pat. Pub. 2012/0029495 A1).
Regarding claim 22, while Moriarty contemplates temperature sensing via a temperature sensor 152 (see figure 1B) located within the expandable member, Moriarty fails to specifically provides that the method further includes determining an amount or degree of ice formation at an ablation site based on the inner surface temperature or the outer surface temperature of the expandable element.
Wittenberger contemplates the step of determining the temperature of an expandable member by a temperature sensor located on the surface of inner or outer surface of the expandable member (see [0048]). Therefore, it is the Examiner’s position that it would have been further obvious to one of ordinary skill in the art to provide one or more additional temperature sensors as in Wittenberger to the device of Moriarty to provide for the temperature sensing required in claim 21. Wittenberger specifically provides that such temperature sensing provides for the determination of sufficient thawing of tissue surrounding the balloon such that the device can be safely removed from the body after treatment (see [0048] in Wittenberger). The Examiner is of the position that such a determination would provide for an indicated of the degree or amount of ice formation at an ablation site based on the inner/outer surface temperature given that a thawing would indicate that a reduced or non-existent amount of ice would be present so as to allow the device to be removed from the body.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Moriarty et al. (US Pat. Pub. 2015/0250524 A1) in view of Newell et al. (US Pat. Pub. 2015/0126985 A1), Abboud et al. (US Pat. Pub. 2005/0228367 A1) and Abboud et al. (US Pat. Pub. 2008/0221508 A1) as applied to claim 1 above and further in view of Bencini et al. (US Pat. Pub. 2009/0299355 A1) and Wittenberger (US Pat. Pub. 2012/0029495 A1).
Regarding claim 21, while Moriarty contemplates temperature sensing via a temperature sensor 152 (see figure 1B) located within the expandable member, Moriarty fails to specifically provides for a plurality of electrodes coupled to the inner surface and/or the outer surface of either the inner balloon or the outer balloon, wherein the method further includes measuring an inner surface temperature or an outer surface temperature of the expandable element.
Bencini discloses a similar expandable treatment device as that in Moriarty and where the expandable member includes a plurality of electrodes coupled to one of the inner and/or outer surface of the balloon (see figure 1 with electrodes 112 on the balloon 103). Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have utilized a plurality of electrodes on, for example, the outer balloon of Moriarty in view of the teaching of Bencini. Such would provide, as discussed by Bencini in at least [0029], to provide for the ability to characterize tissue at a treatment site such as via mapping (see [0032]).
Bencini fails to cure the deficiency with respect to the step of measuring an inner surface temperature or an outer surface temperature of the expandable element. Wittenberger contemplates the step of determining the temperature of an expandable member by a temperature sensor located on the surface of inner or outer surface of the expandable member (see [0048]). Therefore, it is the Examiner’s position that it would have been further obvious to one of ordinary skill in the art to provide one or more additional temperature sensors as in Wittenberger to the device of Moriarty to provide fort he temperature sensing step as set forth in claim 21. Wittenberger specifically provides that such temperature sensing provides for the determination of sufficient thawing of tissue surrounding the balloon such that the device can be safely removed from the body after treatment (see [0048] in Wittenberger).
Response to Arguments
Applicant's arguments filed February 10, 2026 have been fully considered but they are not persuasive.
Applicant argues with respect to the rejection of claim 1 on pages 8-10 of the Remarks. Therein, Applicant contends that the amendments set forth therein which are based on now-cancelled claim 21 define over the prior art combination of Moriarty, Newell, Abboud and Abboud ‘508.
Applicant continues on page 9 that the cited Abboud and Abboud ‘508 references fail to provide for the requirement in claim 1 of “a pressure sensor coupled to an outer surface of the inner balloon or an inner surface of the outer balloon”. Applicant alleges that the Examiner’s interpretation that “the sensor at 68 is indirectly coupled to one of 58 or 62 and located within the space at 64” is not consistent with the broadest reasonable interpretation of the claim in light of the Specification. Applicant supports this position in stating that “Applicant does not claim that the pressure sensor is ‘indirectly coupled to’ one of the balloons” and highlights the instant claim language of the pressure sensor being ‘coupled to an outer surface of the inner balloon or an inner surface of the outer balloon’”. Applicant’s position on page 9 is that, while the Examiner’s interpretation of indirectly coupled to can be a valid interpretation of the language of coupled to, the proper interpretation of the terminology of coupled to in light of the Specification can be taken in view of [0038]. Applicant concludes on page 10 that the phrases set forth in [0038] of “coupled to the inner surface” and “coupled to the outer surface” should be interpreted to require the pressure sensor to be “disposed directly on the surface” and should not be interpreted to require the pressure sensor to be indirectly coupled to one of the inner/outer surface.
This is not persuasive.
As a preliminary matter, the Examiner notes that it is well established that while the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The Examiner further notes that both MPEP 2111 (as cited by Applicant in the Remarks) as well as MPEP 2173.01 readily address the manner in which the broadest reasonable interpretation of the claims is applied. In particular, the direction in each section is that the broadest reasonable interpretation of the language of the claims must be consistent with the specification as it would be interpreted by one of ordinary skill in the art.
Turning to the at-issue claim language, claim 1 current requires “a pressure sensor coupled to an outer surface of the inner balloon or an inner surface of the outer balloon”. The instant disclosure, most relevantly, describes this limitation in [0036] in stating that “the expandable element 40 includes at least one pressure sensor coupled to the outer surface of the inner balloon 42 or the inner surface of the outer balloon 44”. The Examiner finds it essential to note, however, that Applicant specifically notes that this embodiment is NOT SHOWN. Said differently, while substantially similar language appears in the Specification as in the at-issue recitation in claim 1, there is no depiction of any manner of structure of the pressure sensor in [0036] that would depict or otherwise imply that the terminology of “coupled to” necessarily requires the pressure sensor to be directly coupled to one of the inner/outer surfaces as alleged by Applicant in the remarks.
Turning to the disclosure in paragraph [0038] that Applicant has argued for with respect to in the Remarks, the Examiner notes that this disclosure makes no mention of any manner of pressure sensor. Rather, such is directed towards “a plurality of electrodes coupled to the inner surface and/or the outer surface of either the inner or outer balloons 42, 44”. The Examiner recognizes that the balance of [0038] discusses the electrodes to be distributed on an outer surface of the balloon or a particular portion of the balloon. The Examiner takes issue, however, with Applicant’s attempt to define the terminology of “coupled to” when utilized for the pressure sensor based on another materially different structure in the disclosure. There is nothing in the figures that show the placement of the electrodes with respect to any of the surfaces of the balloons 42/44. Rather, these features, much like the pressure sensor above, are NOT SHOWN in the figures. Further, the Examiner does not understand how the disclosure in [0038] positively limits the terminology to require an interpretation of “directly coupled to” when there is not description of the structure or methodology for distributing the electrodes on any of the balloons 42/44. There is not just one manner of placing electrodes on expandable members in the art so as to support Applicant’s undisclosed and undescribed distribution of the electrodes on the balloons 42/44 to required such to be “directly coupled to” any one of the balloons 42/44.
Further, the Examiner finds that Applicant has selectively cited to the coupling recitation in paragraph [0038] while ignoring another recitation that fails to support their desired interpretation of “coupled to”. In particular, paragraph [0034] sets forth the that “[c]oupled to the fluid supply reservoir 14 may be one or more valves and/or regulators (shown in FIG. 2) configured to control the flow of fluid from the fluid supply reservoir 14.” Figure 2 has been reproduced below for Applicant’s reference and with a select number of valves/regulators highlighted via arrows that would “control the flow of fluid from the fluid supply reservoir 14”.
PNG
media_image1.png
654
910
media_image1.png
Greyscale
The Examiner finds that this disclosure and depiction should be equally reviewed much like Applicant’s attempt to utilize the disclosure in [0038] to control the interpretation of “couple to” in the claims. The Examiner is of the position that the depiction in figure 2 displays at least one valve that would be “indirectly coupled to” the reservoir 14 in the form of PV1 given that the ‘High Pressure Regulator’ is disposed intermediate between 14 and PV1.
As such, the Examiner cannot find that the argument that the Examiner’s interpretation of the claim terminology of “coupled to” is overly broad and inconsistent with the instant disclosure when Applicant’s own disclosure provides varying usage of the terminology with regard to the coupling being either “direct” or “indirect”. Accordingly, the Examiner finds that the interpretation of the terminology of “coupled to” in the rejection of claim 1 above is indeed consistent with the broadest reasonably interpretation in light of the instant disclosure and as appreciated by one of ordinary skill in the art. Further, the Examiner maintains that each rejection proffered above remain tenable for at least this reasoning.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RONALD HUPCZEY, JR whose telephone number is (571)270-5534. The examiner can normally be reached Monday - Friday; 8 am - 4 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached at (571) 272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Ronald Hupczey, Jr./ Primary Examiner, Art Unit 3794