DETAILED ACTION
1. This office action is in response to the communicated dated 16 October 2025 concerning application number 18/331,729 effectively filed on 08 June 2023.
Notice of Pre-AIA or AIA Status
2. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Status of Claims
3. Claims 1, 3-6, 8-11, and 14-20 are pending, of which claims 1, 6, and 11 have been amended; claims 2, 7, and 12-13 have been cancelled; and claims 1, 3-6, 8-11, and 14-20 are under consideration for patentability.
Response to Arguments
4. Applicant’s arguments dated 16 October 2025, referred to herein as “the Arguments”, have been fully considered, but they are not persuasive.
The Examiner has addressed the amended limitations within the updated text below.
Applicant argues that the prior art of record does not explicitly suggest the percent concentrations of coolant within claims 1, 6, and 11. Specifically, Applicant acknowledges that Singh teaches the concentration of HFO-1234yf to range from about 5% to about 95%. However, Applicant states that Singh does not explicitly teach the percent concentrations for HFC-134a, HFC-125, or HFC-32. Thus, Applicant concludes that a person having ordinary skill in the art would not find it obvious to arrive at the claimed percent concentrations via routine experimentation. The Examiner respectfully disagrees, as Singh teaches the compounds of the composition to have a varying percent concentration (w/w) ([0029, 0032-0033, 0035]). Although Singh provides percent concentrations (e.g., about 5% to about 95%) for HFO-1234yf, Singh states that other compounds may be included in addition to HFO-1234yf ([0029, 0032-0033, 0035]). These additional compounds include HFC-32, HFC-125, and HFC-134a ([0029, 0032-0033, 0035]). Furthermore, the percent concentration of the additional compounds (e.g., HFC-32, HFC-125, and HFC 134a) need to be adjusted to form the complete composition ([0029, 0032-0033, 0035]). In this case, a person having ordinary skill in the art would have found it obvious to arrive at the claimed percent concentration for each of the compounds via routine experimentation (MPEP 2144.05). The adjustment of the percent concentration for each of the compounds may provide an advantage in sprayable composition applications (e.g., tissue cooling), sterilization applications, propellant applications, or foam and blowing agent applications ([0043, 0078]). Therefore, the Examiner respectfully maintains that Singh suggests the claimed percent concentration.
Claim Rejections - 35 USC § 103
5. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
6. Claims 1, 11, 14-15, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Singh et al. (US 2010/0127209 A1).
Regarding claim 1, Singh teaches a cryosurgery coolant delivery system ([0078-0080]), comprising:
a canister body defining an inner chamber (the pressurized container which contains the refrigerant composition [0078]);
a canister head portion coupled to the canister body (the pressurized container comprises a nozzle [0078]) and including a trigger actuator (the Examiner respectfully submits that a nozzle would inherently include a trigger to eject the refrigerant composition from nozzle [0078]), an outlet (the refrigerant composition is ejected through an outlet of the nozzle [0078]), and an outlet channel in fluid communication with the outlet and the inner chamber of the canister body (the Examiner respectfully submits that an outlet channel or pathway is inherently required to deliver the refrigerant composition from the inner chamber of pressurized container to the outlet of the nozzle [0078]); and
a coolant contained in the inner chamber (the refrigerant composition [0078]), the coolant including a mixture of 1,1,1,2-tetrafluoroethane (HFC-134a) ([0029, 0035, 0056, 0078]), 2,3,3,3-tetrafluoropropene (HFO-1234yf) ([0029, 0035, 0078]), pentafluoroethane (HFC-125) ([0029, 0033, 0035, 0078]), and difluoromethane (HFC-32) ([0029, 0032-0033, 0035, 0078]).
Singh does not explicitly teach wherein a percent concentration (w/w) of the coolant is about 25.7% 1,1,1,2-tetrafluoroethane (HFC-134a), about 25.3% 2,3,3,3-tetrafluoropropene (HFO-1234yf), about 24.7% pentafluoroethane (HFC-125), and about 24.3% difluoromethane (HFC-32).
However, the Examiner respectfully submits that a person having ordinary skill in the art would have found it obvious to use a percent concentration of the coolant that is about 25.7% 1,1,1,2-tetrafluoroethane (HFC-134a), about 25.3% 2,3,3,3-tetrafluoropropene (HFO-1234yf), about 24.7% pentafluoroethane (HFC-125), and about 24.3% difluoromethane (HFC-32). The advantage of such modification may further reduce the temperature of the body being treated (see paragraphs [0029, 0032-0033, 0035, 0078] by Singh). The Examiner further submits that the skilled artisan could arrive at the claimed percent concentration via routine experimentation (MPEP 2144.05).
Regarding claim 11, Singh teaches a method of administering a coolant for cryosurgical applications ([0078-0081]), comprising:
identifying a location of a patient’s skin surface to be treated (the nozzle is configured to spray the refrigerant composition at a desired region of the patient’s body [0078-0081]. Specifically, the refrigerant composition may be used for a dermatology procedure (e.g., skin treatment) [0080]);
actuating a trigger of a cryosurgery coolant delivery system (the pressurized container comprises a nozzle [0078]. The Examiner respectfully submits that a nozzle would inherently include a trigger to eject the refrigerant composition from nozzle [0078]), whereby an outlet of a head portion of the cryosurgery coolant delivery system sprays a coolant (the refrigerant composition is ejected through an outlet of the nozzle [0078]); and
applying the coolant to the skin surface (the nozzle is configured to spray the refrigerant composition at a desired region of the patient’s body [0078-0081]);
wherein the coolant includes a mixture of 1,1,1,2-tetrafluoroethane (HFC-134a) ([0029, 0035, 0056, 0078]), 2,3,3,3-tetrafluoropropene (HFO-1234yf) ([0029, 0035, 0078]), pentafluoroethane (HFC-125) ([0029, 0033, 0035, 0078]), and difluoromethane (HFC-32) ([0029, 0032-0033, 0035, 0078]).
Singh does not explicitly teach wherein a percent concentration (w/w) of the coolant is about 25.7% 1,1,1,2-tetrafluoroethane (HFC-134a), about 25.3% 2,3,3,3-tetrafluoropropene (HFO-1234yf), about 24.7% pentafluoroethane (HFC-125), and about 24.3% difluoromethane (HFC-32).
However, the Examiner respectfully submits that a person having ordinary skill in the art would have found it obvious to use a percent concentration of the coolant that is about 25.7% 1,1,1,2-tetrafluoroethane (HFC-134a), about 25.3% 2,3,3,3-tetrafluoropropene (HFO-1234yf), about 24.7% pentafluoroethane (HFC-125), and about 24.3% difluoromethane (HFC-32). The advantage of such modification may further reduce the temperature of the body being treated (see paragraphs [0029, 0032-0033, 0035, 0078] by Singh). The Examiner further submits that the skilled artisan could arrive at the claimed percent concentration via routine experimentation (MPEP 2144.05).
Regarding claim 14, Singh teaches allowing the coolant to evaporate from the skin surface ([0078, 0080]).
Regarding claim 15, Singh teaches selecting an applicator based on the location of the skin surface to be treated (the nozzle may be selected within certain embodiments to spray the refrigerant composition at a desired location of the tissue (e.g., skin) [0078, 0080]. The Examiner respectfully submits that the nozzle is not required to apply the refrigerant composition to the tissue [0078]).
Regarding claim 19, Singh teaches wherein the coolant is applied to the skin surface until blood supply to the skin surface ceases (the nozzle is configured spray a refrigerant composition that freezes the biological tissue (e.g., skin) to very low temperatures for therapeutic purposes (e.g., cryosurgery or pain alleviation) [0078-0079]. The Examiner respectfully submits that freezing the biological tissue (e.g., skin) to very low temperatures would inherently result in the reduction or suspension of blood flow to the biological tissue [0079]).
Regarding claim 20, Singh teaches wherein the coolant is applied to the skin surface directly from the outlet (the refrigerant composition is applied to the tissue (e.g., skin) directly from the outlet of nozzle ([0078, 0080-0081]).
7. Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Singh et al. in view of Klever et al. (US 2020/0146739 A1).
Regarding claim 3, Singh teaches the cryosurgery coolant delivery device of claim 1, further comprising a discharge valve ([0078]).
Singh does not explicitly teach a valve stem extending from the outlet channel;
a valve gasket extending from the valve stem;
a spring coupled to the valve gasket; and
a dip tube provided between the outlet and the inner chamber, wherein the outlet, the outlet channel, the valve stem, and the dip tube provide a flow path for the coolant between the inner chamber and the outlet.
The prior art by Klever is analogous to Singh, as they both teach a cryogenic treatment device comprising a nozzle ([abstract, 0043, 0047]).
Klever teaches a valve stem extending from the outlet channel (figure 1A illustrates the moveable valve portion or stem 19 extending proximally from the outlet 23 [0101, FIG. 1A]);
a valve gasket extending from the valve stem (figure 1A illustrates the gasket 60 extending from the moveable valve portion or stem 19 [0101-0102, FIG. 1A]);
a spring coupled to the valve gasket (the spring 64 [0102]); and
a dip tube provided between the outlet and the inner chamber (figures 1A and 1C illustrates the venturi tube 24 extending between the outlet 23 and the chamber 10 [0099-0100, FIG. 1A, FIG. 1C]. Specifically, the chamber 10 has an contains a liquid phase 11 and a gas phase 12 [0098-0100, FIG. 1A]), wherein the outlet, the outlet channel, the valve stem, and the dip tube provide a flow path for the coolant between the inner chamber and the outlet (the fluid is provided from the chamber 10 through the venturi tube 24 and towards the moveable valve portion or stem 19 [0100-0101, FIG. 1A, FIG. 1C]. Specifically, the moveable valve portion or stem 19 may be set an open position to allow the fluid to travel to the outlet 23 [0101, FIG. 1A, FIG. 1C]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify Singh’s cryosurgery coolant delivery device to include a valve stem having a valve gasket and a spring, as taught by Klever. This modification is beneficial, as the spring will compress the valve gasket to provide a fluid seal within the device. Specifically, this will prevent the fluid from escaping or leaking out of the outlet when the device is not being used (see paragraphs [0101-0102] by Klever). Furthermore, it would have been obvious to a person having ordinary skill in the art to modify the Singh’s cryosurgery coolant delivery device to include a dip tube that is provided between the outlet and inner chamber, as taught by Klever. The advantage of such modification will provide a venturi effect which results in a cryogenic liquid-in-gas dispersion that is expelled through the orifice of the nozzle (see paragraphs [0039-0040, 0100-0101] by Klever).
8. Claims 4-5 and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Singh et al. in view of Young et al. (US 2020/0188939 A1).
Regarding claim 4, Singh teaches the cryosurgery coolant delivery system of claim 1. Singh does not explicitly teach an extender tube configured to detachably couple to the outlet, wherein the extender tube, the outlet, and the outlet channel provide a flow path for the coolant between the interior chamber and the extender tube.
The prior art by Young is analogous to Singh, as they both teach a cryosurgical device comprising a container or canister that is coupled to a nozzle ([0036-0037, 0044]).
Young teaches an extender tube configured to detachably couple to the outlet (the extender or exit tube 205 may be connected to the outlet of the outlet tube 203 [0037, FIG. 2]), wherein the extender tube, the outlet, and the outlet channel provide a flow path for the coolant between the interior chamber and the extender tube (the outlet tube or channel 203 may be coupled to the interior chamber or container which contains the fluid [0037, FIG. 2]. Specifically, this allows the fluid to travel from the container through the outlet of the outlet tube 203 [0037]. Furthermore, the fluid may travel from the outlet of the outlet tube 203 through the exit tube 205 [0037]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify the Singh’s cryosurgery coolant delivery system to comprise an extender tube, as taught by Young. The advantage of such modification will allow for controlling the heat flux in the flow path keeping the pressurized fluid in a desired rheological state (see paragraphs [0037, 0042-0043] by Young).
Regarding claim 5, Young teaches an applicator configured for targeted delivery to a surface for cooling, wherein the applicator is selected from the group consisting of a foam-tipped applicator ([0046]).
Regarding claim 17, Singh teaches the method of claim 11. Singh does not explicitly teach wherein the coolant is sprayed on a foam tip of an applicator thereby freezing the foam tip applicator, and applying the coolant to the skin surface includes contacting the skin surface with the foam tip of the applicator.
The prior art by Young is analogous to Singh, as they both teach a cryosurgical device comprising a container or canister that is coupled to a nozzle ([0036-0037, 0044]).
Young teaches wherein the coolant is sprayed on a foam tip of an applicator thereby freezing the foam tip applicator, and applying the coolant to the skin surface includes contacting the skin surface with the foam tip of the applicator ([0046]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify Singh’s cryosurgery coolant delivery system to comprise a foam tip applicator, as taught by Young. This modification is beneficial, as the foam tip applicator can reach and hold the lowest temperature for a sufficiently long period of time (see paragraph [0046] by Young).
Regarding claim 18, Young teaches wherein spraying the coolant includes saturating a foam-tipped applicator with the coolant ([0046]).
9. Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Singh et al. in view of Martin et al. (US 2020/0109000 A1).
Regarding claim 6, Singh teaches a cryosurgery coolant delivery system ([0078-0080]), comprising:
a canister body defining an inner chamber (the pressurized container which contains the refrigerant composition [0078]);
a canister head portion coupled to the canister body (the pressurized container comprises a nozzle [0078]) and including a trigger actuator (the Examiner respectfully submits that a nozzle would inherently include a trigger to eject the refrigerant composition from nozzle [0078]), an outlet (the refrigerant composition is ejected through an outlet of the nozzle [0078]), and an outlet channel in fluid communication with the outlet and the inner chamber of the canister body (the Examiner respectfully submits that an outlet channel or pathway is inherently required to deliver the refrigerant composition from the inner chamber of pressurized container to the outlet of the nozzle [0078]); and
a coolant contained in the inner chamber (the refrigerant composition [0078]), the coolant including a mixture of difluoromethane (HFC-32) ([0029, 0032-0033, 0035, 0078]), pentafluoroethane (HFC-125) ([0029, 0033, 0035, 0078]), 1,1,1,2-tetrafluoroethane (HFC-134a) ([0029, 0035, 0056, 0078]), 2,3,3,3-tetrafluoroprop-1-ene (HFO-1234yf) ([0029, 0035, 0078]).
Singh does not explicitly teach wherein the mixture includes trans-1,3,3,3-Tetrafluoroprop-1-ene.
The prior art by Martin is analogous to Singh, as they both teach the use of a pressurized container that includes a cryogen (the pressurized container comprises a propellant 40 which may consist of trans-1,3,3,3-Tetrafluoroprop-1-ene and/or other chemical components [0055, 0065]. Specifically, trans-1,3,3,3-Tetrafluoroprop-1-ene is known to be a cryogen [0055, 0065]).
Martin teaches wherein the mixture includes trans-1,3,3,3-Tetrafluoroprop-1-ene (the pressurized container comprises a propellant 40 which may consist of trans-1,3,3,3-Tetrafluoroprop-1-ene and other chemical components to create the desired physical properties of the aerosol dispenser or spray [0055, 0065]).
Singh and Martin do not explicitly teach wherein a percent concentration (w/w) of the coolant is about 26.00% difluoromethane, about 26.00% pentafluoroethane, about 21.00% 1,1,1,2-Tetrafluoroethane, about 20.00% 2,3,3,3-tetrafluoroprop-1-ene, and about 7.00% trans-1,3,3,3-Tetrafluoroprop-1-ene. However, a person having ordinary skill in the art would have found it obvious to use a percent concentration of the coolant that is about 26.00% difluoromethane, about 26.00% pentafluoroethane, about 21.00% 1,1,1,2-Tetrafluoroethane, about 20.00% 2,3,3,3-tetrafluoroprop-1-ene, and about 7.00% trans-1,3,3,3-Tetrafluoroprop-1-ene. The advantage of such modification may further reduce the temperature of the body being treated (see paragraphs [0029, 0032-0033, 0035, 0078] by Singh). The Examiner respectfully submits that the skilled artisan could arrive at the claimed percent concentration via routine experimentation (MPEP 2144.05).
The Examiner further submits that it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify Singh’s mixture to include trans-1,3,3,3-Tetrafluoroprop-1-ene, as taught by Martin. The advantage of such modification may provide a treatment for the patient’s skin (see paragraphs [0055, 0065] by Martin).
10. Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Singh et al. in view of Martin et al., further in view of Klever et al.
Regarding claim 8, Singh in view of Martin suggests the cryosurgery coolant delivery system of claim 6. Singh teaches the use of a discharge valve ([0078]).
Singh and Martin do not explicitly teach a valve stem extending from the outlet channel;
a valve gasket extending from the valve stem;
a spring coupled to the valve gasket; and a dip tube provided between the outlet and the inner chamber, wherein the outlet, the outlet channel, the valve stem, and the dip tube provide a flow path for the coolant between the inner chamber and the outlet.
The prior art by Klever is analogous to Singh, as they both teach a cryogenic treatment device comprising a nozzle ([abstract, 0043, 0047]).
Klever teaches a valve stem extending from the outlet channel (figure 1A illustrates the moveable valve portion or stem 19 extending proximally from the outlet 23 [0101, FIG. 1A]);
a valve gasket extending from the valve stem (figure 1A illustrates the gasket 60 extending from the moveable valve portion or stem 19 [0101-0102, FIG. 1A]);
a spring coupled to the valve gasket (the spring 64 [0102]); and
a dip tube provided between the outlet and the inner chamber (figures 1A and 1C illustrates the venturi tube 24 extending between the outlet 23 and the chamber 10 [0099-0100, FIG. 1A, FIG. 1C]. Specifically, the chamber 10 has an contains a liquid phase 11 and a gas phase 12 [0098-0100, FIG. 1A]) wherein the outlet, the outlet channel, the valve stem, and the dip tube provide a flow path for the coolant between the inner chamber and the outlet (the fluid is provided from the chamber 10 through the venturi tube 24 and towards the moveable valve portion or stem 19 [0100-0101, FIG. 1A, FIG. 1C]. Specifically, the moveable valve portion or stem 19 may be set an open position to allow the fluid to travel to the outlet 23 [0101, FIG. 1A, FIG. 1C]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to the cryosurgery coolant delivery device suggested by Singh in view of Martin to include a valve stem having a valve gasket and a spring, as taught by Klever. This modification is beneficial, as the spring will compress the valve gasket to provide a fluid seal within the device. Specifically, this will prevent the fluid from escaping or leaking out of the outlet when the device is not being used (see paragraphs [0101-0102] by Klever). Furthermore, it would have been obvious to a person having ordinary skill in the art to modify the cryosurgery coolant delivery device suggested by Singh in view of Martin to include a dip tube that is provided between the outlet and inner chamber, as taught by Klever. The advantage of such modification will provide a venturi effect which results in a cryogenic liquid-in-gas dispersion that is expelled through the orifice of the nozzle (see paragraphs [0039-0040, 0100-0101] by Klever).
11. Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Singh et al. in view of Martin et al., further in view of Young et al.
Regarding claim 9, Singh in view of Martin suggests the cryosurgery coolant delivery system of claim 6. Singh and Martin do not explicitly teach an extender tube configured to detachably couple to the outlet, wherein the extender tube, the outlet, and the outlet channel provide a flow path for the coolant between the interior chamber and the extender tube.
The prior art by Young is analogous to Singh, as they both teach a cryosurgical device comprising a container or canister that is coupled to a nozzle ([0036-0037, 0044]).
Young teaches an extender tube configured to detachably couple to the outlet (the extender or exit tube 205 may be connected to the outlet of the outlet tube 203 [0037, FIG. 2]), wherein the extender tube, the outlet, and the outlet channel provide a flow path for the coolant between the interior chamber and the extender tube (the outlet tube or channel 203 may be coupled to the interior chamber or container which contains the fluid [0037, FIG. 2]. Specifically, this allows the fluid to travel from the container through the outlet of the outlet tube 203 [0037]. Furthermore, the fluid may travel from the outlet of the outlet tube 203 through the exit tube 205 [0037]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify the cryosurgery coolant delivery system suggested by Singh in view of Martin to comprise an extender tube, as taught by Young. The advantage of such modification will allow for controlling the heat flux in the flow path keeping the pressurized fluid in a desired rheological state (see paragraphs [0037, 0042-0043] by Young).
Regarding claim 10, Young teaches an applicator configured for targeted delivery to a surface for cooling, wherein the applicator is selected from the group consisting of a foam-tipped applicator ([0046]).
12. Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Singh et al. in view of Seney (US Patent No. 4,646,735).
Regarding claim 16, Singh suggests the method of claim 11. Singh does not explicitly teach contacting the skin surface with an isolation funnel, wherein applying the coolant to the skin surface includes spraying the coolant on the skin surface via the isolation funnel.
The prior art by Seney is analogous to Singh, as they both teach a device that is configured to deliver a cooling fluid to a tissue ([abstract]).
Seney teaches contacting the skin surface with an isolation funnel, wherein applying the coolant to the skin surface includes spraying the coolant on the skin surface via the isolation funnel ([column 3 lines 13-27]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify Singh’s cryosurgery coolant delivery system to include an isolation funnel that delivers the coolant to the skin surface, as taught by Seney. This modification is beneficial, as the funnel is capable of being maintained in a position for treating sores that require an extended continuous treatment (see [column 3 lines 13-27] by Seney).
Statement on Communication via Internet
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Conclusion
14. THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
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/J.B.S./Examiner, Art Unit 3792
/ANKIT D TEJANI/Primary Examiner, Art Unit 3796