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
Acknowledgment is made to the amendment received 9/12/2025.
Response to Arguments
Applicant’s arguments with respect to claims 1 and 29 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. Previously, claims 1 and 29 were rejected under 35 U.S.C. 103 as being unpatentable over Burger in view of McHale. Now, based on applicant’s arguments and amendments to the claim language, claims 1 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Burger in view of Bek and McHale.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
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 1-3, 6, 13, 29-30 and 42 are rejected under 35 U.S.C. 103 as being unpatentable over Burger et al., US 20090248001, herein referred to as "Burger", in view of Bek et al., US 20050187546, herein referred to as "Bek", further in view of McHale et al., US 20200022745, herein referred to as "McHale".
Regarding claim 1, Burger discloses a cryogenic device (Figures 1A-3: system 10) for applying a cooling therapy to a target tissue of a patient (Abstract: “The cooling may remodel one or more target tissues so as to effect a desired change in composition of the target tissue and/or a change in its behavior, often to interfere with transmission of pain signals along sensory nerves.”), the cryogenic device comprising: a housing (Figures 1A-B: housing 16) comprising a cryogen pathway (Figure 1B and [0034]: “Probe 26 is thermally coupled to a cooling fluid path extending from cooling fluid source 18”) configured to conduct a cryogen from a pressurized cryogen cartridge (Figures 1B and 2: cooling fluid source 18) toward a needle probe (Figures 1A-3: cooling probe 26) comprising one or more needles (Figures 1A-1B and [0034]: “The exemplary probe 26 comprises a 30 g needle having a sharpened distal end that is axially sealed.”), wherein the cryogen is configured to deliver cryotherapy to a target tissue via the one or more needles ([0041]: “the cooling fluid injected into lumen 38 of needle 26 will typically comprises liquid, though some gas may also be injected. At least some of the liquid vaporizes within needle 26, and the enthalpy of vaporization cools the tissue engaged by the needle”); a supply valve coupled to the cryogen pathway coupled to the needle probe (Figure 3: supply valve 32); an auxiliary pathway (Figure 3: channel through pressure relief valve 46) coupled to the cryogen pathway (Figure 3: pressure relief valve 46 has a channel connected to the cryogen pathway and [0042]: “During initiation of a cooling cycle, a large volume along the cooling fluid pathway between the exit from the supply tube and exit from the pressure relief valve 46 may cause excessive transients.”) and exposed to a relatively low- pressure environment (Figure 3: pressure relief valve 46 is exposed to external the device, which is a relatively low pressure environment); a movable sealing element (Figure 3: valve body 48 of pressure relief valve 46) configured to seal the auxiliary pathway when the movable sealing element is biased in a closed position by a biasing force ([0041]: “A relatively simple mechanical pressure relief valve 46 may be used to control the pressure within the lumen of the needle, with the exemplary valve comprising a valve body 48 (here in the form of a ball bearing) urged against a valve seat 50 by a biasing spring 52.”), and further configured to open the auxiliary pathway so as to vent an amount of the cryogen to the relatively low-pressure environment when the movable sealing element is in an open position ([0041] and [0042]: “During initiation of a cooling cycle, a large volume along the cooling fluid pathway between the exit from the supply tube and exit from the pressure relief valve 46 may cause excessive transients.”) by a force of the pressure in the cryogen pathway opposing the biasing force ([0042]: “To limit such transients, the pressure relief valve 46 may be integrated into a housing 54 supporting needle 26, with the valve spring 52 being located outside the valve seat (and hence the pressure-control exit from pressure relief valve 46). ” and [0041]), wherein the cryogen flows through the supply valve to the needle probe when the movable sealing element is biased in the closed position (Figure 3: cryogen flows though supply valve to needle 26 when biasing spring 52 is biased in the closed position and [0039]: “The cooling fluid from valve 32 flows through a lumen 34 of a cooling fluid supply tube 36. Supply tube 36 is, at least in part, disposed within a lumen 38 of needle 26”); and a biasing element (Figure 3: biasing spring 52) configured to apply the biasing force to the movable sealing element toward the cryogen pathway ([0041]), wherein the biasing element is a spring element (Figure 3: biasing spring 52). Burger does not explicitly disclose a cryogenic device comprising a user-actuatable element coupled to the movable sealing element, wherein the user-actuatable element is configured to be actuated by a user to move the movable sealing element, an automatic pressure relief mechanism, wherein the movable sealing element is separately configured to be moved by the automatic pressure relief mechanism in response to the pressure within the cryogen pathway exceeding a maximum pressure value; wherein the supply valve is disposed along the cryogen pathway between an opening to the auxiliary pathway and the needle probe.
However, Bek teaches a cryogenic device (Figure 17) comprising a user-actuatable element ([0076]: “(e.g., in response to a foot switch operated by the physician)”) coupled to the movable sealing element (Figure 17: relief valve 76 and [0076]), wherein the user-actuatable element is configured to be actuated by a user to move the movable sealing element ([0076]), an automatic pressure relief mechanism (Figure 17: controller 52), wherein the movable sealing element is separately configured to be moved by the automatic pressure relief mechanism in response to the pressure within the cryogen pathway exceeding a maximum pressure value ([0075]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the cryogenic device of Burger so that it includes a user-actuatable element coupled to the movable sealing element, wherein the user-actuatable element is configured to be actuated by a user to move the movable sealing element, and an automatic pressure relief mechanism, wherein the movable sealing element is separately configured to be moved by the automatic pressure relief mechanism in response to the pressure within the cryogen pathway exceeding a maximum pressure value as taught by Bek to provide a desired flow of fluid to the tissue region (Bek [0010]).
Further, McHale teaches a cryogenic device (Figure 1) wherein the supply valve (Figure 1: inlet valve 202) is disposed along the cryogen pathway between an opening to the auxiliary pathway (Figure 1: auxiliary pathway is from inlet valve 202 through exhaust valve 204 to exhaust hose 306) and the needle probe (Figure 1: inlet valve 202 is between exhaust valve 204 and cryosurgical probe 102).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the cryogenic device of Burger so that the supply valve is disposed along the cryogen pathway between an opening to the auxiliary pathway and the needle probe as taught by McHale to control the back pressure during operation of the device (McHale [0031]).
Regarding claim 2, Burger in view of Bek and McHale discloses the cryogenic device of claim 1, and Burger further discloses a cryogenic device (Figure 3) wherein the biasing force causes the movable sealing element to be urged against an opening of the auxiliary pathway ([0041]: “A relatively simple mechanical pressure relief valve 46 may be used to control the pressure within the lumen of the needle, with the exemplary valve comprising a valve body 48 (here in the form of a ball bearing) urged against a valve seat 50 by a biasing spring 52.”), wherein the movable sealing element is configured to be moved to the open position when the biasing force is overcome by a pressure in the cryogen pathway exceeding a maximum pressure value (Figure 3: biasing spring 52, springs compress in response to pressure).
Regarding claim 3, Burger in view of Bek and McHale discloses the cryogenic device of claim 2, and Burger further discloses a device (Figure 3) wherein the biasing element is an elastic element coupled to the movable sealing element (Figures 3: biasing spring is coupled to valve body 38 and [0041]).
Regarding claim 6, Burger in view of Bek and McHale disclose the cryogenic device of claim 1, and Burger further discloses a cryogenic device (Figures 1A-3: system 10) wherein the relatively low-pressure environment is an ambient-air environment (Claim 22: “a pressure control valve disposed between the lumen and an ambient environment.”) in which the housing (Figures 1A-B: housing 16) is disposed.
Regarding claim 13, Burger in view of Bek and McHale disclose the cryogenic device of claim 1, and Burger further discloses a cryogenic device (Figures 1A-3: system 10), wherein the movable sealing element comprises a cylindrical portion, a spherical portion, or a semi-spherical portion that is configured to fit within the auxiliary pathway (Figure 3: valve body 48).
Regarding claim 29, Burger discloses a method for relieving pressure in a cryogenic device (Figures 1A-3: system 10) the method comprising: actuating an element (Figures 1A-1B: input 24 and [0033]: “Some embodiments may, at least in part, be manually activated, such as through the use of a manual supply valve and/or the like, so that processors, electrical power supplies, and the like may be absent.”) of the cryogenic device having a cryogen pathway (Figure 1B and [0034]: “Probe 26 is thermally coupled to a cooling fluid path extending from cooling fluid source 18”) configured to deliver cryogen from a first cryogen cartridge (Figures 1B and 2: cooling fluid source 18) to a needle probe (Figures 1A-3: cooling probe 26), wherein the element (Figures 1A-1B: input 24 and [0033]: “Some embodiments may, at least in part, be manually activated, such as through the use of a manual supply valve and/or the like, so that processors, electrical power supplies, and the like may be absent.”) is coupled to a movable sealing element (Figure 3: valve body 48 of pressure relief valve 46) adapted for sealing an auxiliary pathway (Figure 3: channel 66) when the movable sealing element is biased in a closed position (Figure 3: channel to pressure relief valve 46) by a biasing force ([0041]), wherein the auxiliary pathway is exposed to a relatively low-pressure environment ([0041] and [0042]: “During initiation of a cooling cycle, a large volume along the cooling fluid pathway between the exit from the supply tube and exit from the pressure relief valve 46 may cause excessive transients.”) wherein the biasing force is applied by a biasing element (Figure 3: biasing spring 52) to the movable sealing element toward the cryogen pathway ([0041]); causing the movable sealing element to be automatically moved by an automatic pressure relief mechanism when the pressure within the cryogen pathway exceeds a maximum pressure value ([0042]), wherein the biasing element is configured to exert an elastic force urging the movable sealing element against the auxiliary pathway when the pressure within the cryogen pathway is below the maximum pressure value (Figure 3: biasing spring 52 and [0041]), and wherein the movable sealing element is configured to be moved to the open position when the elastic force is overcome by the pressure in the cryogen pathway exceeding a maximum pressure value ([0042]); and in response to the automatic pressure relief mechanism, moving the movable sealing element from the closed position to an open position ([0041]), wherein the movable sealing element is configured to open the auxiliary pathway so as to vent an amount of the cryogen to the relatively low-pressure environment when the movable sealing element is in the open position ([0041]: “A relatively simple mechanical pressure relief valve 46 may be used to control the pressure within the lumen of the needle, with the exemplary valve comprising a valve body 48 (here in the form of a ball bearing) urged against a valve seat 50 by a biasing spring 52.”) by a force of the pressure in the cryogen pathway opposing the biasing force ([0042]: “To limit such transients, the pressure relief valve 46 may be integrated into a housing 54 supporting needle 26, with the valve spring 52 being located outside the valve seat (and hence the pressure-control exit from pressure relief valve 46). ” and [0041]), wherein the cryogen flows through a supply valve (Figure 2: supply valve 32) to the needle probe when the movable sealing element is biased in the closed position (Figure 3: cryogen flows though supply valve to needle 26 when biasing spring 52 is biased in the closed position and [0039]: “The cooling fluid from valve 32 flows through a lumen 34 of a cooling fluid supply tube 36. Supply tube 36 is, at least in part, disposed within a lumen 38 of needle 26”).Burger does not explicitly disclose a method wherein the element is a user-actuatable element, wherein in response to actuation of the user-actuatable element or, separately, in response to the automatic pressure relief mechanism, the method comprises moving the movable sealing element from the closed position to an open position, or wherein the supply valve is disposed along the cryogen pathway between an opening to the auxiliary pathway and the needle probe.
However, Bek teaches a method (Figure 17) wherein the element is a user-actuatable element ([0076]: “(e.g., in response to a foot switch operated by the physician)”), wherein in response to actuation of the user-actuatable element ([0076]) or, separately, in response to the automatic pressure relief mechanism ([0075]), the method comprises moving the movable sealing element (Figure 17: relief valve 76) from the closed position to an open position ([0075]-[0076]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method of Burger so that it includes a user-actuatable element wherein in response to actuation of the user-actuatable element or, separately, in response to the automatic pressure relief mechanism, the method comprises moving the movable sealing element from the closed position to an open position as taught by Bek to provide a desired flow of fluid to the tissue region (Bek [0010]).
Further, McHale teaches a method (Figure 1) wherein the supply valve (Figure 1: inlet valve 202) is disposed along the cryogen pathway between an opening to the auxiliary pathway (Figure 1: auxiliary pathway is from inlet valve 202 through exhaust valve 204 to exhaust hose 306) and the needle probe (Figure 1: inlet valve 202 is between exhaust valve 204 and cryosurgical probe 102).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method of Burger so that the supply valve is disposed along the cryogen pathway between an opening to the auxiliary pathway and the needle probe as taught by McHale to control the back pressure during operation of the device (McHale [0031]).
Regarding claim 30, Burger in view of Bek and McHale discloses the method of claim 29, and Burger further discloses a method (Figure 3) further comprising: causing the movable sealing element (Figure 3: valve body 48 of pressure relief valve 46) to be automatically moved when the pressure within the cryogen pathway exceeds a maximum pressure value (Figure 3: biasing spring 52, springs compress in response to pressure), wherein the biasing element is configured to exert an elastic force urging the movable sealing element against the auxiliary pathway when the pressure within the cryogen pathway is below the maximum pressure value (Col. 10, line 43 – Col. 11, line 40), and wherein the movable sealing element is configured to be moved to the open position when the elastic force is overcome by the pressure in the cryogen pathway exceeding a maximum pressure value ([0041]: “A relatively simple mechanical pressure relief valve 46 may be used to control the pressure within the lumen of the needle, with the exemplary valve comprising a valve body 48 (here in the form of a ball bearing) urged against a valve seat 50 by a biasing spring 52.”).
Regarding claim 42, Burger in view of Bek and McHale disclose the method of claim 29, and Burger further discloses a method (Figure 3) wherein the pressure in the cryogen pathway actuates the movable sealing element disposed at the opening of the auxiliary pathway by the force of the pressure in the cryogen pathway opposing the biasing force (Figure 3: biasing spring 52, springs compress in response to pressure). McHale further teaches a method wherein the cryogen passes an opening of the auxiliary pathway (Figure 1: pathway that includes pressure sensor 112) prior to passing a valve in the cryogen pathway (Figure 1: pathway that includes pressure sensor 112 is prior to inlet valve 202).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method of Burger so that the cryogen passes an opening of the auxiliary pathway prior to passing a valve in the cryogen pathway as taught by McHale to control the back pressure during operation of the device (McHale [0031]).
Claims 5 and 31-35 are rejected under 35 U.S.C. 103 as being unpatentable over Burger in view of Bek and McHale, further in view of Niedbala et al., US 20200360070, herein referred to as “Niedbala”.
Regarding claim 5, Burger in view of Bek and McHale discloses the cryogenic device of claim 1 but does not explicitly disclose a cryogenic device wherein the user-actuatable element is coupled to a bracket element that is coupled to the movable sealing element, the user-actuatable element configured to be actuated by a user to move the bracket element along a first direction or a second direction, wherein moving the bracket element along the first direction causes the movable sealing element to move to the open position and moving the bracket element along the second direction causes the movable sealing element to move to the closed position.
However, Niedbala teaches a cryogenic device (Figure 8A) wherein the user-actuatable element (Figure 8A: lever 865) is coupled to a bracket element ([0052]: “the lever 865 receives the adapter 864 and pushes on the post, which depresses the pin valve 875 in the cryogen tank 870”; wherein the post corresponds to the bracket element) that is coupled to the movable sealing element (Figure 8B: pin valve 875), the user-actuatable element configured to be actuated by a user to move the bracket element along a first direction or a second direction ([0052]: “the pressure from the cryogen tank pushes the post to a closed (sealed) position in the adapter 864 that prevents cryogen gas and/or cryogen liquid from flowing out of the adapter. When the user installs the combination of the cryogen tank 870 and adapter 864 into the flow path assembly 260, the lever 865 receives the adapter 864 and pushes on the post”), wherein moving the bracket element along the first direction causes the movable sealing element to move to the open position ([0053]: “To open the cryogen tank 870 to allow the flow of cryogenic material 872 through the flow path assembly 260, an operator engages lever 865, which in turn pushes a post in the pin valve assembly that opens the cryogen tank pin valve.”) and moving the bracket element along the second direction causes the movable sealing element to move to the closed position ([0052]: “the pressure from the cryogen tank pushes the post to a closed (sealed) position in the adapter 864 that prevents cryogen gas and/or cryogen liquid from flowing out of the adapter.”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the device disclosed by Burger so that it includes the bracket element disclosed by Niedbala so that the pressure from the cryogen tank prevents the cryogen liquid or gas from flowing out of the valve unless a user actuates an element (Niedbala [0052]).
Regarding claim 31, Burger in view of Bek and McHale discloses the method of claim 29 but does not explicitly disclose a method wherein the user-actuatable element is coupled to the movable sealing element via a bracket element.
However, Niedbala teaches a method (Figure 8A) wherein the user-actuatable element (Figure 8A: lever 865) is coupled to the movable sealing element (Figure 8B: pin valve 875) via a bracket element ([0052]: “the lever 865 receives the adapter 864 and pushes on the post, which depresses the pin valve 875 in the cryogen tank 870”; wherein the post corresponds to the bracket element).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed by Burger so that it includes the bracket element disclosed by Niedbala so that the pressure from the cryogen tank prevents the cryogen liquid or gas from flowing out of the valve unless a user actuates an element (Niedbala [0052]).
Regarding claim 32, Burger in view of Bek, McHale, and Niedbala discloses the method of claim 31, and Niedbala further discloses a method wherein actuating the user-actuatable element (Figure 8A: lever 865) moves the bracket element ([0052]: “the lever 865 receives the adapter 864 and pushes on the post, which depresses the pin valve 875 in the cryogen tank 870”; wherein the post corresponds to the bracket element) along a first direction ([0052]: “the pressure from the cryogen tank pushes the post to a closed (sealed) position in the adapter 864 that prevents cryogen gas and/or cryogen liquid from flowing out of the adapter. When the user installs the combination of the cryogen tank 870 and adapter 864 into the flow path assembly 260, the lever 865 receives the adapter 864 and pushes on the post”), wherein moving the bracket element along the first direction causes the movable sealing element to move to the open position ([0053]: “To open the cryogen tank 870 to allow the flow of cryogenic material 872 through the flow path assembly 260, an operator engages lever 865, which in turn pushes a post in the pin valve assembly that opens the cryogen tank pin valve.”), and wherein the bracket element is movable along a second direction to cause the movable sealing element to move to the closed position ([0052]: “the pressure from the cryogen tank pushes the post to a closed (sealed) position in the adapter 864 that prevents cryogen gas and/or cryogen liquid from flowing out of the adapter.”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed by Burger so that it includes the bracket element disclosed by Niedbala so that the pressure from the cryogen tank prevents the cryogen liquid or gas from flowing out of the valve unless a user actuates an element (Niedbala [0052]).
Regarding claim 33, Burger in view of Bek, McHale, and Niedbala discloses the method of claim 32, and Niedbala further discloses a method wherein the first direction is in opposition to the second direction ([0053]: “To open the cryogen tank 870 to allow the flow of cryogenic material 872 through the flow path assembly 260, an operator engages lever 865, which in turn pushes a post in the pin valve assembly that opens the cryogen tank pin valve.”; wherein pushing and a lack of pushing are in opposition to each other directionally), and wherein the first direction and the second direction are along an axis of the cryogenic device (Figure 8C: adapter 864 is along an axis of the cryogenic device), the first direction extending distally (Figure 8C: when the post of adapter 864 is pushed into the pin valve assembly, it is pushed distally) and the second direction extending proximally with respect to the cryogenic device (Figure 8C: when the post of adapter 864 is no longer pushed into the pin valve assembly, it returns to its initial position which is proximal with respect to the cryogenic device).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed by Burger so that it includes the bracket element that moves in two directions as disclosed by Niedbala so that the pressure from the cryogen tank prevents the cryogen liquid or gas from flowing out of the valve unless a user actuates an element (Niedbala [0052]).
Regarding claim 34, Burger in view of Bek, McHale, and Niedbala discloses the method of claim 33, and Niedbala further discloses a method wherein the user-actuatable element (Figure 8A: lever 865) is a slidable element, and wherein actuation of the user-actuatable element comprises sliding the user- actuatable element along the first direction (Figures 8A: lever 865 can slide upwards and downwards; upwards is along the first direction).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed by Burger so that actuation of the user-actuatable element comprises sliding the user-actuatable element along the first direction as disclosed by Niedbala so that the pressure from the cryogen tank prevents the cryogen liquid or gas from flowing out of the valve unless a user actuates an element (Niedbala [0052]).
Regarding claim 35, Burger in view of Bek, McHale, and Niedbala discloses the method of claim 34, and Niedbala further discloses a method wherein the user-actuatable element (Figure 8A: lever 865) is biased toward the second direction, the user-actuatable element being configured to automatically slide in the second direction when an external force is not being applied to the user-actuatable element ([0082]: “the user lifts up the lever 865 to activate the adapter 864 to enable the flow of cryogenic material.”; thus without a user lifting up, the lever is biased towards the second direction, which is downwards).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed by Burger so that the user-actuatable element is configured to automatically slide in the second direction when an external force is not being applied to it as disclosed by Niedbala so that the pressure from the cryogen tank prevents the cryogen liquid or gas from flowing out of the valve unless a user actuates an element (Niedbala [0052]).
Claims 7-9 and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Burger in view of Bek and McHale, further in view of Kaveckis et al., US 20140276792, herein referred to as “Kaveckis”.
Regarding claim 7, Burger in view of Bek and McHale discloses the cryogenic device of claim 1 but does not explicitly disclose a cryogenic device further comprising a locking mechanism, wherein the locking mechanism is configured to lock the cryogen cartridge within a cartridge holder of the housing until the movable sealing element is in the open position.
However, Kaveckis teaches a cryogenic device (Figure 8) comprising a locking mechanism (Figures 8 and 11A-B: cam system 237), wherein the locking mechanism is configured to lock ([0107]: “When the cam system 237 is in the disengaged state D, the cam system 237 is positioned to allow the front plate 234 to slideably receive the cartridge 228. Once the cartridge 228 fully engaged into the front plate 234, the cam system 237 may be actuated to the engaged state E by rotating the cam lever 338 and cam shaft 340 in a downward rotational direction depicted by arrow C in order to secure the cartridge 228 in the front plate 234 and to bias cartridge 228 to the thermal plate 38 of the cooling device 236 (FIG. 12B). Thus, when moved to the engaged state E, the cam lobes 342 simultaneously bias against respective piston rods 354 of the actuation devices 346, which tends to force the actuation devices 346 downwardly in a direction depicted by arrow F, which tends to force the actuation member 344 against the cartridge 228 approximately in a direction depicted by arrow G, which is further discussed below (FIG. 12B).”) the cryogen cartridge (Figures 11A-B: cartridge 228) within a cartridge holder (Figures 11A-B: receiving surface 245) of the housing (Figures 11A-B: front plate 234) until the movable sealing element is in the open position ([0107]: “the cam system 237 may be actuated to the engaged state E by rotating the cam lever 338 and cam shaft 340 in a downward rotational direction depicted by arrow C in order to secure the cartridge 228 in the front plate 234 and to bias cartridge 228 to the thermal plate 38 of the cooling device 236 (FIG. 12B).”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the device disclosed by Burger so that it includes the locking mechanism for the cartridge as taught by Kaveckis to improve surface-to-surface contact in the device which aids in the effective and efficient cooling of fluid (Kaveckis [0107]).
Regarding claim 8, Burger in view of Bek, McHale, and Kaveckis disclose the cryogenic device of claim 7, and Kaveckis further discloses a cryogenic device (Figure 8) wherein the locking mechanism (Figures 8 and 11A-B: cam system 237) is configured to lock the cryogen cartridge (Figures 11A-B: cartridge 228) within the cartridge holder (Figures 11A-B: receiving surface 245) until the user-actuatable element is actuated to move the movable sealing element along a first direction ([0107]), such that the cryogen cartridge is unable to be removed until the movable sealing element is moved along the first direction ([0107]: “Conversely, when the cam system 237 is moved from the engaged state E to the disengaged state D for removal of the cartridge 228, by virtue of actuating the cam lever 338 in a direction depicted by arrow B, the cam shaft 340 and cam lobes 342 rotate in a similar direction, which tends to remove the force applied to the actuation devices 346, which tends to remove the force applied by the actuation member 344 so that the cartridge 228 may be removed (FIG. 11A).”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the device disclosed by Burger so that it includes the locking mechanism for the cartridge as taught by Kaveckis to improve surface-to-surface contact in the device which aids in the effective and efficient cooling of fluid (Kaveckis [0107]).
Regarding claim 9, Burger in view of Bek, McHale, and Kaveckis disclose the cryogenic device of claim 7, and Kaveckis further discloses a cryogenic device (Figure 8) wherein the locking mechanism (Figures 8 and 11A-B: cam system 237) is coupled to a bracket element (Figure 12B: piston rod 354 and cam shaft 340 and cam lobes 342) coupled to the movable sealing element (Figure 12B: spring 356) and the user-actuatable element (Figure 12A: cam lever 338), the locking mechanism being configured to lock the cryogen cartridge within the cartridge holder until the user-actuatable element is actuated to move the bracket element along a first direction ([0107]), such that the cryogen cartridge is unable to be removed until the bracket element is moved along the first direction [0107]: “Conversely, when the cam system 237 is moved from the engaged state E to the disengaged state D for removal of the cartridge 228, by virtue of actuating the cam lever 338 in a direction depicted by arrow B, the cam shaft 340 and cam lobes 342 rotate in a similar direction, which tends to remove the force applied to the actuation devices 346, which tends to remove the force applied by the actuation member 344 so that the cartridge 228 may be removed (FIG. 11A).”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the device disclosed by Burger so that it includes the locking mechanism for the cartridge as taught by Kaveckis to improve surface-to-surface contact in the device which aids in the effective and efficient cooling of fluid (Kaveckis [0107]).
Regarding claim 40, Burger in view of Bek and McHale discloses the method of claim 29 but does not explicitly disclose a method further comprising causing a locking mechanism to lock or unlock the cryogen cartridge within a cartridge holder of the cryogenic device.
However, Kaveckis teaches a method (Figures 8 and 11A-B) comprising causing a locking mechanism (Figures 8 and 11A-B: cam system 237) to lock or unlock ([0107]: “When the cam system 237 is in the disengaged state D, the cam system 237 is positioned to allow the front plate 234 to slideably receive the cartridge 228. Once the cartridge 228 fully engaged into the front plate 234, the cam system 237 may be actuated to the engaged state E by rotating the cam lever 338 and cam shaft 340 in a downward rotational direction depicted by arrow C in order to secure the cartridge 228 in the front plate 234 and to bias cartridge 228 to the thermal plate 38 of the cooling device 236 (FIG. 12B). Thus, when moved to the engaged state E, the cam lobes 342 simultaneously bias against respective piston rods 354 of the actuation devices 346, which tends to force the actuation devices 346 downwardly in a direction depicted by arrow F, which tends to force the actuation member 344 against the cartridge 228 approximately in a direction depicted by arrow G, which is further discussed below (FIG. 12B).”) the cryogen cartridge (Figures 11A-B: cartridge 228) within a cartridge holder (Figures 11A-B: receiving surface 245) of the cryogenic device (Figure 8).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed by Burger so that it includes the locking mechanism for the cartridge as taught by Kaveckis to improve surface-to-surface contact in the device which aids in the effective and efficient cooling of fluid (Kaveckis [0107]).
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Burger in view of Bek, McHale, and Kaveckis, further in view of Scholten et al., US 20150157336, herein referred to as “Scholten”.
Regarding claim 10, Burger in view of Bek and McHale discloses the cryogenic device of claim 1. Kaveckis further discloses a cryogenic device (Figure 8) with a pressure sensor ([0068]: “Performance can be optimized based on feedback from sensors that detect fluid and tissue temperatures, tissue impedance, and fluid supply to the treatment device (e.g., a pressure sensor, a temperature sensor, a thermocouple, a contact sensor, or the like).”) wherein the locking mechanism (Figures 8 and 11A-B: cam system 237) is configured to lock the cryogen cartridge (Figures 11A-B: cartridge 228) within the cartridge holder (Figures 11A-B: receiving surface 245) until the user-actuatable element is actuated to move the movable sealing element along a first direction ([0107]). Burger in view of McHale and Kaveckis does not explicitly disclose a locking mechanism, wherein the locking mechanism is configured to lock the cryogen cartridge within a cartridge holder of the housing until a pressure level detected at the pressure sensor within the cryogen pathway is below a threshold pressure value.
However, Scholten teaches a device (Figure 1) wherein the locking mechanism is configured to lock an element until a pressure level detected at the pressure sensor within the cryogen pathway is below a threshold pressure value ([0047]: “Once the pressure provided by the pressurized gas reservoir has decreased below a predetermined value, the locking element is transferred from its active position to a non-active position and the pressurized gas reservoir is released for removal.
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the device disclosed by Burger so that it includes the locking mechanism for the cartridge as taught by Kaveckis to improve surface-to-surface contact in the device which aids in the effective and efficient cooling of fluid (Kaveckis [0107]).
Also, it would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the device disclosed by Burger in view of Kaveckis so that feedback from the pressure sensor can unlock the locking mechanism as taught by Scholten to prevent the device from being used when the cartridge is empty (Scholten [0067]-[0068]).
Regarding claim 11, Burger in view of Bek, McHale, Kaveckis, and Scholten discloses the cryogenic device of claim 10, and Scholten further discloses a device wherein the threshold pressure value is less than a maximum pressure value ([0067]: “When, as a result of operating the instrument, the pressure inside the gas cartridge 18 decreases to a predetermined pressure value, for example approximately 2 bar, the control piston 36 is by spring force moved in the bore 34 in a direction towards the closed end 33 of the bore 34.”; wherein 2 bar is less than a maximum pressure value). Burger discloses a cryogenic device (Figures 1A-3) wherein there is a maximum pressure value beyond which the automatic pressure relief mechanism is configured to cause the movable sealing element to move to the open position ([0045]: “O-rings 60 help to isolate the cooling fluid supply flow (which may be at pressures of up to about 900 psi) from the exhaust gas (which may be at a controlled pressure in a range between about 50 and 400 psi, depending on the desired temperature). Exemplary O-rings may comprise hydrogenated Buna-N O-rings, or the like.”).
Claims 12 and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Burger in view of Bek and McHale, further in view of Duong et al., US 20200100826, herein referred to as “Duong”.
Regarding claim 12, Burger in view of Bek and McHale discloses the cryogenic device of claim 1 but does not explicitly disclose a cryogenic device wherein the movable sealing element comprises a conical portion that is configured to fit within the auxiliary pathway.
However, Duong teaches a cryogenic device (Figure 1) wherein the movable sealing element (Figure 4: safety valve assembly 70) comprises a conical portion (Figure 4: conical surface 72) that is configured to fit within the auxiliary pathway (Figure 4: manifold assembly 66).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the device disclosed by Burger so that the movable sealing element comprises a conical portion as taught by Duong so that sealing does not result in “whipping” of the probe assembly (Duong [0050]).
Regarding claim 38, Burger in view of Bek and McHale discloses the method of claim 29 but does not explicitly disclose a method wherein the movable sealing element comprises a conical portion that is configured to fit within the auxiliary pathway.
However, Duong teaches a method (Figure 1) wherein the movable sealing element (Figure 4: safety valve assembly 70) comprises a conical portion (Figure 4: conical surface 72) that is configured to fit within the auxiliary pathway (Figure 4: manifold assembly 66).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed by Burger so that the movable sealing element comprises a conical portion as taught by Duong so that sealing does not result in “whipping” of the probe assembly (Duong [0050]).
Claim 37 is rejected under 35 U.S.C. 103 as being unpatentable over Burger in view of Bek, McHale, and Niedbala, further in view of Cluzeau et al., US 6141985, herein referred to as “Cluzeau”.
Regarding claim 37, Burger in view of Bek, McHale, and Niedbala discloses the method of claim 33, and Cluzeau further discloses a method wherein the button (Figure 1: switch 12) comprises a mechanical or virtual button (Figure 1: switch 12 is a mechanical button).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed by Burger so that the user-actuatable element is a button as taught by Cluzeau because this is a simple substitution of an input device with a button for the predictable result of causing something to occur when the button is pressed, which is well known in the art (MPEP Section 2143 I. (B)).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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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/N.W.R./Examiner, Art Unit 3794 /SEAN W COLLINS/Primary Examiner, Art Unit 3794