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 .
Response to Amendment
The amendment filed February 20th, 2026 has been entered. Claims 1, 21, & 28 are amended. Claims 3, 5, 11, 14-20, & 22-23 are canceled. Claims 31-32 are new. Claims 1-2, 4, 6-10, 12-13, 21, & 24-32 remain pending.
Response to Arguments
Applicant’s arguments with respect to claims 1-2, 4, 6-10, 12-13, 21, & 24-32 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument; as necessitate by amendment.
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.
Claims 1-2, 4, 6-7, 10, 12-13, 21, & 24-30 are rejected under 35 U.S.C. 103 as being unpatentable over Birdsall et al. (previously presented-US 20150148791 A1), hereinafter “Birdsall”, in view of Johansson et al. (US 20210157472 A1), hereinafter “Johansson”.
Regarding claim 1, Birdsall discloses a cryotherapy system, comprising: a base station comprising: a housing ([0133]; Figure 7A—element 1202) including a canister receptacle that is configured to receive a canister containing a cryogen ([0135]-[0137], & [0141]; Figure 7A—elements 1222 & 1224), wherein the housing defines an internal chamber ([0133]; Figure 7A—element 1202; the internal chamber being the internal chamber of housing 1202), a cryogen outlet on an exterior surface of the housing, wherein the cryogen outlet is configured to output the cryogen from the base station ([0133] & [0134]; Figure 7A—element 1206 & 1216), a cryogen flow assembly in the internal chamber of the housing, wherein the cryogen flow assembly is configured to supply the cryogen from the canister to the cryogen outlet ([0134], [0147], & [0148]; Figure 7A—element 1220; the cryogen flow assembly comprising the supply passage 1220 including the supply passage components such as the branch connection 1256, isolation valve 1262, and the supply valve 1264), and a controller configured to control a flow of the cryogen through the cryogen flow assembly from the canister to the cryogen outlet ([0111], [0149], & [0150]; Figure 7A—element 1272; the controller is configured to operate the supply control valve 118); a cryotherapy applicator ([0133]; Figure 7A—element 1204) comprising: a handle that is configured to be gripped by a user during a cryotherapy procedure, wherein the handle has a proximal end and a distal end ([0133]; Figure 7A—element 1204; the applicator 1204 can include a handle (not shown); the examiner is considering the proximal end to be the proximal end of the handle and the distal end to be the distal end of the handle), a shaft extending from the distal end of the handle ([0133]; Figure 7A—element 1210), and an end-effector coupled to the shaft ([0133]; Figure 7A—element 1212), wherein the end-effector is configured to use the cryogen to ablate a target tissue ([0119] & [0334]); and a cryogen conduit configured to couple the cryotherapy applicator to the base station and supply the cryogen from the base station to the cryotherapy applicator, wherein the cryogen conduit has (i) a first end extending from the proximal end of the handle of the cryotherapy applicator and (ii) a second end configured to couple to the cryogen outlet of the base station ([0133]; Figure 7A—element 1208 & 1214), wherein an entirety of the cryotherapy applicator is movable relative to an entirety of the base station while the cryogen conduit couples the cryotherapy applicator to the base station ([0133]; Figure 7A—elements 1202 & 1204; it is the examiners position that the entirely of the cryotherapy applicator 1204 would be movable relative to the entirety of the base station in order to reach the desired treatment location), and wherein the controller is configured to: determine a threshold amount of the cryogen required for a next cryotherapy procedure ([0152]; the supply sensors are configured to determine if the canister contains sufficient refrigerant for a treatment procedure by comparing the sensed parameters to a threshold value); perform a comparison of an amount of the cryogen in the canister with the determined threshold amount; and responsive to a determination that the amount of the cryogen in the canister is less than the determined threshold amount, disable the cryogen flow assembly such that the next cryotherapy procedure cannot be started ([0131], [0141], [0150] & [0152]; if the sensed parameter is less than the threshold amount, the controller is configured to override the initiation switch 1284).
Birdsall does not disclose the controller is configured to: identify a type of the cryotherapy applicator coupled to the base station and determine the threshold amount of the cryogen required for a next cryotherapy procedure based on the type of the cryotherapy applicator identified by the controller.
Johansson teaches a cryotherapy system comprising a controller, the controller is configured to: identify a type of the cryotherapy applicator coupled to the base station ([0032]-[0033]; the applicator is able to transmit and/or receive information to/from the handpiece portion (e.g., via its processor), such as a probe descriptor that may identify a corresponding probe type) and determine the threshold amount of the cryogen required for a next cryotherapy procedure based on the type of the cryotherapy applicator identified by the controller ([0033], [0035], [0036], [0043], [0045]; based on the probe descriptor information the processor may calculate a cryogen amount used during a cycle, a cryogen amount remaining in the cartridge, and a number of treatment cycles that can be performed with the remaining cryogen cartridge, for example the cryogen status indicator may appear empty or flash to indicate that the cartridge has been depleted or does not have sufficient cryogen for a treatment cycle).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the controller configured to determine a threshold amount of the cryogen required for a next cryotherapy procedure and responsive to a determination that the amount of the cryogen in the canister is less than the determined threshold amount, disable the cryogen flow assembly such that the next cryotherapy procedure cannot be started, as disclosed by Birdsall, to further include the controller is configured to: identify a type of the cryotherapy applicator coupled to the base station and determine the threshold amount of the cryogen required for a next cryotherapy procedure based on the type of the cryotherapy applicator identified by the controller, as taught by Johansson, as both references and the claimed invention are directed toward cryotherapy systems configured to be used with a plurality of cryotherapy applicators. As disclosed by Birdsall, the console can be compatible with a variety of suitable cryotherapeutic devices and more than one cryotherapeutic devices can be included in a kit each having different properties ([0225] & [0232]). As disclosed by Johansson, the cryotherapy system may be used with a variety of cryotherapy applicators, the cryotherapy applicators may transmit a probe descriptor to the controller to identify a corresponding probe type so that the controller can determine that the cryotherapy applicator is of a particular probe type of a plurality of probe types, the probe descriptor information may be used to derive treatment related information such as cryogen flow amount, cryogen amounts used during a cycle, and cryogen amounts remaining in the cartridge, the device can further indicate the number of treatment cycles that can be performed with the remaining cryogen, for example the system may determine when the cartridge does not have sufficient cryogen for the treatment cycle ([0032]-[0033], [0043], & [0045]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the controller configured to determine a threshold amount of the cryogen required for a next cryotherapy procedure and responsive to a determination that the amount of the cryogen in the canister is less than the determined threshold amount, disable the cryogen flow assembly such that the next cryotherapy procedure cannot be started, as disclosed by Birdsall, to further include the controller is configured to: identify a type of the cryotherapy applicator coupled to the base station and determine the threshold amount of the cryogen required for a next cryotherapy procedure based on the type of the cryotherapy applicator identified by the controller, as taught by Johansson, as such a modification would allow for the controller to determine if the cryogen canister contains enough cryogen to complete a treatment cycle based on the characteristics of a particular cryotherapy applicator coupled to the base station.
Regarding claim 2, Birdsall in view of Johansson disclose all of the limitations of claim 1, as described above.
Birdsall further discloses wherein the canister receptacle is further configured to receive a second canister, which has a size that is greater than a size of the canister, wherein the canister contains a first volume of the cryogen and the second canister contains a second volume of the cryogen, and wherein the second volume is greater than the first volume ([0131], [0140], [0141], [0160], [0260], & [0433]; Figure 7A—element 1224; the cartridge housing is configured to receive a replacement cartridge or canister, when the cartridge is depleted; the cartridge 1222 can be replaced with a canister that is received within the cartridge housing; the canister has a greater capacity than the cartridge).
Regarding claim 4, Birdsall in view of Johansson disclose all of the limitations of claim 1, as described above.
Birdsall further discloses one or more additional cryotherapy applicators, wherein each of the one or more additional cryotherapy applicators are configured to be coupled to the cryogen outlet of the base station ([0133], [0225], [0231], [0232], & [0433]; the console may be compatible with a variety of suitable cryotherapeutic devices; more than one cryotherapy applicators can be included in a kit; for example, a kit can include a plurality of cryotherapy applicators having different properties to accommodate the anatomies of different patients).
Regarding claim 6, Birdsall in view of Johansson disclose all of the limitations of claim 1, as described above.
Birdsall further discloses wherein the base station further comprises one or more sensors configured to sense at least one parameter selected from among: a pressure in the canister and a flow rate of the cryogen in the cryogen flow assembly ([0151] & [0152]; Figure 7A—elements 1290 & 1296).
Regarding claim 7, Birdsall in view of Johansson disclose all of the limitations of claim 6, as described above.
Birdsall further discloses wherein the base station comprises a heater that is configured to increase a temperature of the canister in the canister receptacle ([0151]; Figure 7A—element 1292), wherein the one or more sensors are configured to transmit to the controller a sensor signal indicative of the at least one parameter sensed by the one or more sensors, and wherein the controller is configured to, based on the sensor signal, cause the heater to increase the temperature of the canister of the canister receptacle ([0151]; Figure 7A—element 1290; the controller is configured to activate the heater 1292 if the sensor 1290 registers a temperature below a threshold value range).
Regarding claim 10, Birdsall in view of Johansson disclose all of the limitations of claim 1, as described above.
Birdsall further discloses wherein the cryotherapy applicator further comprises a user input device on the handle, wherein the user input device is configured to transmit to a control signal to the controller to cause the controller to control the flow of the cryogen ([0149], [0150], & [0163]; Figure 7A—element 1268; the handle can include all or a portion of the user interface 1268; the user interface 1268 includes an initiation switch 1284 and termination switch 1286 that can be used to initiate or terminate the refrigerant flow to the cryotherapy applicator).
Regarding claim 12, Birdsall in view of Johansson disclose all of the limitations of claim 1, as described above.
Birdsall further discloses wherein the handle of the cryotherapy applicator is elongated along a longitudinal axis such that the handle is configured to be held by the user using a pencil grip ([0109], [0112], [0126], & [0133]; Figure 1A & 5—element 124; the handle 124 is shown to be elongated along a longitudinal axis; it is the examiners position that a user would be capable of holding the handle using a pencil grip).
Regarding claim 13, Birdsall in view of Johansson disclose all of the limitations of claim 1, as described above.
Birdsall further discloses wherein the base station comprises a base-station input device that is configured to receive one or more inputs from the user ([0149]; Figure 7A—element 1268), and wherein the controller is configured to perform one or more actions responsive to the one or more inputs received via the base-station input device, and wherein the one or more actions comprises at least one action selected from a group consisting of: (i) starting a flow of the cryogen, (ii) stopping the flow of the cryogen, (iii) increasing a flow rate of the cryogen, and (iv) decreasing a flow rate of the cryogen ([0149], [0150]; the controller is configured to open and close the supply valve 1264 in response to signals from the initiation switch 1284 and termination switch 1286 of the input device 1268, respectively).
Regarding claim 21, Birdsall in view of Johansson disclose all of the limitations of claim 1, as described above.
Birdsall further discloses wherein the base station further comprises one or more sensors that are configured to sense the amount of cryogen that is in the canister ([0152], [0241], & [0433]; Figure 7A—elements 1202 & 1222; the base station 1202 can include supply sensors 1296 that indicate whether the canister 1222 is full and properly connected; the supply sensors can include weight sensors, flow meters, and/or pressure sensors).
Regarding claim 24, Birdsall in view of Johansson disclose all of the limitations of claim 21, as described above.
Birdsall further discloses wherein the one or more sensors are configured to a weight of the canister in the canister receptacle ([0152]; the supply sensors can include a weight sensor to determine a weight of the canister 1222).
Regarding claim 25, Birdsall in view of Johansson disclose all of the limitations of claim 21, as described above.
Birdsall further discloses wherein the one or more sensors are configured to sense a flow rate of the cryogen, and wherein the controller is configured to determine the amount of the cryogen in the canister based on the flow rate of the cryogen sensed by the one or more sensors over a period of time ([0152]; the supply sensors can detect a flow rate of the refrigerant which can be compared to a threshold value to determine if there is sufficient or insufficient refrigerant within the canister 1222).
Regarding claim 26, Birdsall in view of Johansson disclose all of the limitations of claim 21, as described above.
Birdsall further discloses wherein the base station further comprises an output device that is configured to output an indication of the amount of the cryogen in the canister sensed by the one or more sensors ([0152], [0288], & [0291]; Figure 53—elements 7200 & 7238; the base station can include a display that outputs the quantity of refrigerant remaining in the canister).
Regarding claim 27, Birdsall in view of Johansson disclose all of the limitations of claim 21, as described above.
Birdsall further discloses wherein the canister receptacle is configured to receive a plurality of types of canisters, wherein at least one type of the plurality of types of canisters has a different size than at least another type of the plurality of types of canisters ([0131], [0137], [0140], [0141], [0160], [0260], & [0433]; Figure 7A—element 1224; the cartridge housing is configured to receive a plurality of replacement cartridges or canisters, when the cartridge is depleted; the cartridge 1222 can be replaced with another cartridge or a canister that is received within the cartridge housing; the canister has a greater capacity than the cartridges).
Regarding claim 28, Birdsall in view of Johansson disclose all of the limitations of claim 27, as described above.
Birdsall further discloses wherein the one or more sensors is configured to determine a type of the canister received in the canister receptacle from among the plurality of types ([0131], [0137], [0140], [0141], [0152], [0160], [0260], & [0433]; the one or more sensors can include a weight sensor that is configured to weigh the cartridge or canister; as the canister has a higher capacity than the cartridge it is the examiners position sensor would be able to determine whether the cartridge or canister is being used).
Regarding claim 29, Birdsall in view of Johansson disclose all of the limitations of claim 1, as described above.
Birdsall further discloses wherein the base station is configured to be coupled to one or more additional cryotherapy applicators, wherein the one or more additional cryotherapy applicators are different from the cryotherapy applicator in at least one item of information selected from a group consisting of: a size, a shape, and a manufacturer ([0133], [0225], [0231], [0232], & [0433]; more than one cryotherapy applicators can be included in a kit; for example, a kit can include a plurality of cryotherapy applicators having different properties (e.g., shaft lengths, shaft diameters, balloon lengths, or balloon diameters) to accommodate the anatomies of different patients; the examiner notes the rest are in the alternative), and wherein the base station comprises one or more applicator sensors that are configured to determine the at least one item of information determined for the cryotherapy applicator that is coupled to the base station ([0154], [0240], [0287], [0298], [0299], & [0433]; Figure 56—element 7504; the base station 1202 can include suitable sensors configured to detect conditions of the cytotherapeutic device that can be reported to the user interface and controller; the reporting interface can include device characteristics and device serial numbers).
Regarding claim 30, Birdsall in view of Johansson disclose all of the limitations of claim 29, as described above.
Birdsall does not disclose wherein the controller is configured to set one or more parameters for operating the base station based on the at least one item of information, wherein the one or more parameters comprise at least one parameter selected from a group consisting of: a flow rate of the cryogen, a timer for supplying the cryogen, an amount of the cryogen to supply, and a temperature at which to maintain the canister using a heater of the base station.
Johansson further teaches a base station that is configured to be coupled to one or more additional cryotherapy applicators, wherein the base station comprises one or more applicator sensors that are configured to determine the at least one item of information determined for the cryotherapy applicator that is coupled to the base station ([0032]-[0033]); wherein the controller is configured to set one or more parameters for operating the base station based on the at least one item of information, wherein the one or more parameters comprise at least one parameter selected from a group consisting of: a flow rate of the cryogen, a timer for supplying the cryogen, an amount of the cryogen to supply, and a temperature at which to maintain the canister using a heater of the base station ([0032]-[0033]; the at least one item of information may be used to derive treatment information such as cryogen flow amount, cryogen amount used during a cycle; the examiner notes the rest are in the alternative).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the controller, as disclosed by Birdsall, to include wherein the controller is configured to set one or more parameters for operating the base station based on the at least one item of information, as further taught by Johansson, as both references and the claimed invention are directed toward cryotherapy systems configured to be used with a plurality of cryotherapy applicators. As disclosed by Birdsall, the console can be compatible with a variety of suitable cryotherapeutic devices and more than one cryotherapeutic devices can be included in a kit each having different properties ([0225] & [0232]). As disclosed by Johansson, the cryotherapy system may be used with a variety of cryotherapy applicators, the cryotherapy applicators may transmit a probe descriptor to the controller to identify a corresponding probe type so that the controller can determine that the cryotherapy applicator is of a particular probe type of a plurality of probe types, the probe descriptor information may be used to derive treatment related information such as cryogen flow amount, cryogen amounts used during a cycle ([0032]-[0033], [0043], & [0045]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the controller, as disclosed by Birdsall, to include wherein the controller is configured to set one or more parameters for operating the base station based on the at least one item of information, as further taught by Johansson, as such a modification would allow for the controller to control the cryotherapy applicator based on the characteristics of a particular cryotherapy applicator coupled to the base station.
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.
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Birdsall in view of Johansson and Saadat et al. (previously presented-US 20170231474 A1), hereinafter “Saadat”.
Regarding claims 8 & 9, Birdsall in view of Johansson disclose all of the limitations of claim 1, as described above.
Birdsall further discloses wherein the base station comprises a display device that is communicatively coupled to the controller ([0268]; Figures 51-56) (claim 8).
Birdsall does not disclose wherein the cryotherapy applicator comprises a mount configured to couple a camera to the cryotherapy applicator, wherein the camera comprises a connector configured to transmit image data that is representative of an image captured by the camera, wherein the base station comprises an optical input configured to couple the connector of the camera to the controller of the base station, and wherein the controller is configured to use the image data to cause the display device to display the image captured by the camera (claim 8); wherein the base station comprises a light source that is configured to generate light, and wherein the connector is configured to transmit the light to the camera to illuminate a field of view of the camera (claim 9).
Saadat teaches a cryotherapy system comprising a cryotherapy applicator ([0088]; Figures 12A-12D—element 1216 & 1218), comprising a base station ([0088]; Figure 12A—element 1202) wherein the cryotherapy applicator comprises a mount configured to couple a camera to the cryotherapy applicator ([0089]; Figure 12A—elements 1212 & 1214), wherein the camera comprises a connector configured to transmit image data that is representative of an image captured by the camera, wherein the base station comprises an optical input configured to couple the connector of the camera to the controller of the base station ([0026] & [0089]; Figure 12A—element 1208, 1212, & 1214; the examiner is considering the connector and optical input to be the connections between the imaging sensor and the base station 1202 for displaying the image information on the display 1208 (e.g. the optic fibers)), and wherein the controller is configured to use the image data to cause the display device to display the image captured by the camera ([0089]; Figure 12A—element 1208) (claim 8); wherein the base station comprises a light source that is configured to generate light, and wherein the connector is configured to transmit the light to the camera to illuminate a field of view of the camera ([0089]; Figures 12A & 12B—element 1202; the base station 1202 may include one or more LEDs or other light elements that are coupled to the optic fibers in imaging cannula 1212) (claim 9).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the cryotherapy system and display, as disclosed by Birdsall, to include the cryotherapy system including an imaging system including a camera, as taught by Saadat, as both references and the claimed invention are directed toward cryotherapy systems for ablating tissue. As disclosed by Birdsall, imaging guidance can be used to aid in manipulating and delivering the system ([0126] & [0128]). As disclosed by Saadat, including an integrated imaging system with a cryotherapy system limits the invasiveness of using the device, improves the visualization of the procedure by ensuring the imaging is able to obtain detailed visualization of the target region, and allows for a user to perform a therapeutic procedure with visualization of the procedure using a single hand which may decrease the time, cost, labor, and difficulty involved in a procedure ([0025] & [0105]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the cryotherapy system and display, as disclosed by Birdsall, to include the cryotherapy system including an imaging system including a camera, as taught by Saadat, as such a modification would provide for a cryotherapy system with an integrated imaging system that limit the invasiveness of using the device, improves the visualization of the procedure by ensuring the imaging is able to obtain detailed visualization of the target region, and allows for a user to perform a therapeutic procedure with visualization of the procedure using a single hand which may decrease the time, cost, labor, and difficulty involved in a procedure.
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Birdsall in view of Johansson and Brannan et al. (US 20180055538 A1), hereinafter “Brannan”.
Regarding claim 31, Birdsall in view of Johansson disclose all of the limitations of claim 1, as described above.
Birdsall does not disclose a cryogen collection reservoir removably coupled to the housing, wherein the cryogen conduit is further configured to return the cryogen from the cryotherapy applicator to the base station, and wherein the cryogen flow assembly is further configured to supply the cryogen returned from the cryotherapy applicator to the cryogen collection reservoir.
Brannan teaches a cryotherapeutic system ([0060]) comprising a cryogen collection reservoir removably coupled to the housing ([0063]; Figure 4—element 400), wherein the cryogen conduit is further configured to return the cryogen from the cryotherapy applicator to the base station ([0063]; Figures 4 & 5—element 204), and wherein the cryogen flow assembly is further configured to supply the cryogen returned from the cryotherapy applicator to the cryogen collection reservoir ([0063]; Figure 4—elements 218a & 400).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the cryogen return, as disclosed by Birdsall, to include a cryogen collection reservoir removably coupled to the housing, wherein the cryogen conduit is further configured to return the cryogen from the cryotherapy applicator to the base station, and wherein the cryogen flow assembly is further configured to supply the cryogen returned from the cryotherapy applicator to the cryogen collection reservoir, as taught by Brannan, as both references and the claimed invention are directed toward cryotherapeutic systems. As disclosed by Birdsall, the returned cryogen can be exhausted into the atmosphere near the base station ([0144] & [0146]). As disclosed by Brannan, the cryogen may be exhausted from the interior portion of the cryotherapy applicator to the atmosphere at the proximal end, or alternatively the cryotherapy system may be configured to releasably mate to an exhaust reservoir such that exhaust reservoir receives the returned cryogen from the cryotherapy applicator ([0063]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the cryogen return, as disclosed by Birdsall, to include a cryogen collection reservoir removably coupled to the housing, wherein the cryogen conduit is further configured to return the cryogen from the cryotherapy applicator to the base station, and wherein the cryogen flow assembly is further configured to supply the cryogen returned from the cryotherapy applicator to the cryogen collection reservoir, as taught by Brannan, as providing a cryogen collection reservoir that is configured to receive the returned cryogen is a known and suitable alternative to exhausting the returned cryogen into the atmosphere.
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Birdsall in view of Johansson and Nevo et al. (US 20090306639 A1), hereinafter “Nevo”.
Regarding claim 32, Birdsall in view of Johansson disclose all of the limitations of claim 1, as described above.
Birdsall further disclose wherein the cryotherapy applicator further comprises a data storage device ([0177]; Figure 8E—element 1357).
Birdsall does not disclose wherein the base station further comprises a reader device configured to: (i) write usage information to the data storage device indicating that the cryotherapy applicator has been used for a first cryotherapy procedure, and (ii) read the usage information from the data storage device prior to a second cryotherapy procedure, wherein the controller is configured to prevent the flow of the cryogen for the second cryotherapy procedure responsive to a determination that the usage information indicates the cryotherapy applicator was used for the first cryotherapy procedure.
Nevo teaches a cryotherapy applicator ([0119]; Figure 1—element 110) and a base station ([0119]; Figure 1—element 570), wherein the cryotherapy applicator further comprises a data storage device ([0123]; Figures 1 & 2—elements 200/210/220), wherein the base station further comprises a reader device ([0127]; Figure 1—element 400; controller 400 is configured to read information from memories 210 & 220 and write information to member 220) configured to: (i) write usage information to the data storage device indicating that the cryotherapy applicator has been used for a first cryotherapy procedure, and (ii) read the usage information from the data storage device prior to a second cryotherapy procedure, wherein the controller is configured to prevent the flow of the cryogen for the second cryotherapy procedure responsive to a determination that the usage information indicates the cryotherapy applicator was used for the first cryotherapy procedure ([0127], [0131], [0137]; the controller 400 may record and report individual and collective probe usage statistics so as to limit and regulate probe re-use; the controller 400 is configured to prevent supplying of cryogen to any cryoprobe if more than a predetermined amount of usage has been recorded thus preventing unsafe repeated use).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the cryotherapy applicator data storage device and base unit, as disclosed by Birdsall, to include wherein the base station further comprises a reader device configured to: (i) write usage information to the data storage device indicating that the cryotherapy applicator has been used for a first cryotherapy procedure, and (ii) read the usage information from the data storage device prior to a second cryotherapy procedure, wherein the controller is configured to prevent the flow of the cryogen for the second cryotherapy procedure responsive to a determination that the usage information indicates the cryotherapy applicator was used for the first cryotherapy procedure, as taught by Nevo, as both references and the claimed invention are directed toward cryotherapy systems compatible with a plurality of cryotherapeutic applicators. As disclosed by Birdsall, the console can be compatible with a variety of suitable cryotherapeutic devices and more than one cryotherapeutic devices can be included in a kit each having different properties ([0225] & [0232]). As disclosed by Nevo, the base unit controller is configured to read and write information to and from the memory of the cryotherapeutic devices this allows for the controller to record and report usage statistics of the cryotherapeutic devices and allows the controller to prevent the supply of cryogen to any cryotherapeutic device if more than a predetermined amount of usage has been recorded thereby providing a safety check to prevent excessive and unsafe repeated use of an individual cryotherapeutic device by limiting the amount of repeated use to a predetermined amount ([0127] & [0137]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the cryotherapy applicator data storage device and base unit, as disclosed by Birdsall, to include wherein the base station further comprises a reader device configured to: (i) write usage information to the data storage device indicating that the cryotherapy applicator has been used for a first cryotherapy procedure, and (ii) read the usage information from the data storage device prior to a second cryotherapy procedure, wherein the controller is configured to prevent the flow of the cryogen for the second cryotherapy procedure responsive to a determination that the usage information indicates the cryotherapy applicator was used for the first cryotherapy procedure, as taught by Nevo, as such a modification would provide a safety check to prevent excessive and unsafe repeated use of an individual cryotherapeutic device by limiting the amount of repeated use to a predetermined amount.
Conclusion
Accordingly, claims 1-2, 4, 6-10, 12-13, 21, & 24-32 are rejected.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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.
/M.D.T./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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