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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/26/2025 has been entered.
Response to Amendment
The amendment filed 11/26/2025 has been entered. Claim 2-7, 10-14, 17-25 are pending in the application. Applicant's amendments to the claims have overcome every objection and 112(b) rejection previously set forth in the Final Office Action mailed 08/26/2025.
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 (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.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 2-7, 10-14, 16, 17, 23 are rejected under 35 U.S.C. 103 as being unpatentable over Leibovici (US 2018/0369504) in view of Mosler (US 2022/0002072).
Regarding claim 17, Leibovici discloses an endothermic vapor applicator (200, Fig 21; Para 0004) attachable to a syringe (204, Fig 21) comprising: a canister (11, Fig 21) containing a liquefied endothermic gas, the canister fluidly connected through a manually operated valve (348 and 350, Fig 46) to a cold spray module (202, 210, 212, 214, Fig 21), the manually operated valve including a discharge tube (350, Fig 46) for discharging the liquified endothermic gas, the cold spray module including a body (210, Fig 21), the body including a core tube (270, Fig 31), a first end of the core tube being sized and shaped for removable attachment to the discharge tube of the manually operated valve (see threading 256, Fig 29) to provide fluid communication with the manually operated valve and the liquefied endothermic gas upon operation of the manually operated valve (Para 0127; the core tube is fluidly connected to the valve through the valve stem 350), a second end of the core tube including a discharge port (opening on the dispensing end 254, Figs 29-31) wherein the liquified endothermic gas is directed through the discharge port to impinge and pass across a rear surface of a nozzle (260, Fig 32) to be directed at in vivo tissue wherein the wet vapor cools the in vivo tissue to stop the propagation of painful nerve stimuli without causing frostbite (Para 0004, 0094).
Leibovici is silent regarding the manually operated valve including a dip tube extending into the liquified endothermic gas contained within the canister and the discharge port having a different cross sectional area than that of the core tube to control the flow of the liquefied endothermic gas through the core tube, the discharge port oriented on the second end of the core tube to cause the liquefied endothermic gas to exit the discharge port at an angle with respect to the longitudinal axis of the core tube so that a portion of the liquefied endothermic gas is directed at an angle with respect to the longitudinal centerline of the core tube, to impinge and pass across a rear breaker surface of a nozzle having at least one shearing corner, so that the expanded endothermic vapor, passed across the breaker surface exits a nozzle orifice as a wet vapor.
Mosler teaches an analogous endothermic vapor applicator (100b, Fig 2B) comprising a canister (120, Fig 2B) fluidly connected through a manually operated valve, the manually operated valve (136, Fig 3B) including a dip tube (tube forming opening 232, Fig 3B) extending into the liquified endothermic gas contained within the canister and a discharge tube (132, Fig 3C) for discharging the liquified endothermic gas (Para 0060); a body (101, Fig 3A) including a core tube (133, Fig 3B), a first end of the core tube being sized and shaped for removable attachment to the discharge tube (shoulder 137 of the first end removably receives the discharge tube; Para 0060) and a second end of the core tube including a discharge port (145, Fig 7B) having a different cross sectional area than that of the core tube to control the flow of the liquefied endothermic gas through the core tube, the discharge port oriented on the second end of the core tube to cause the liquefied endothermic gas to exit the discharge port at an angle with respect to the longitudinal axis of the core tube so that a portion of the liquefied endothermic gas is directed at an angle with respect to the longitudinal centerline of the core tube (Para 0067; See Fig 8B), to impinge and pass across a rear breaker surface (162, 163, Fig 11E) of a nozzle (107, Fig 11A) having at least one shearing corner (corners formed by platforms 162, Fig 11B), so that the expanded endothermic vapor, passed across the breaker surface exits a nozzle orifice as a wet vapor (Para 0068).
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 endothermic vapor applicator disclosed by Leibovici to include a dip tub, a discharge port having a different cross sectional area than the core tube, and a rear breaker surface on the nozzle as taught by Mosler in order to direct fluid from the container to the opening and causing the vapocoolant to form a vortex that aids in making a finer mist of vapocoolant (Para 0068).
Regarding claim 2, the modified invention of Leibovici and Mosler discloses the cold spray module (202, Fig 21 - Leibovici) includes a syringe barrel securing assembly (212, Fig 21 - Leibovici), the syringe barrel securing assembly including at least two members (286 and 288, Fig 33 - Leibovici) configured for securing said syringe barrel to the cold spray module (Par 0123 - Leibovici).
Regarding claim 3, the modified invention of Leibovici and Mosler discloses the at least two members (286 and 288, Fig 33 - Leibovici) configured for securing said syringe barrel in place includes two opposing spring-loaded clamping members (Para 0123; See springs 298 in Fig 36 - Leibovici).
Regarding claim 4, the modified invention of Leibovici and Mosler discloses the syringe barrel securing device (212, Fig 21 - Leibovici) includes a housing (292 and 294, Fig 36 - Leibovici) having a first upper portion (292, Fig 36 - Leibovici) and a second lower portion (294, Fig 36 - Leibovici).
Regarding claim 5, the modified invention of Leibovici and Mosler discloses the first upper portion (292, Fig 36 - Leibovici) comprises channels or slots (302, Fig 36 - Leibovici) sized and shaped to hold and allow said two opposing spring-loaded clamping members to slide therein (Para 0123 - Leibovici).
Regarding claim 6, the modified invention of Leibovici and Mosler discloses the canister (11, Fig 21 - Leibovici) is a metal canister having a valve assembly (17, Fig 22 - Leibovici) crimped and sealed within an open end of said canister to create a sealed pressure canister.
Regarding claim 7, the modified invention of Leibovici and Mosler discloses the valve (17, Fig 22 -Leibovici) is finger operable to release the liquefied endothermic gas (Para 0120 -Leibovici; pressing down on the trigger 214 opens the valve to release the liquefied endothermic gas).
Regarding claim 10, the modified invention of Leibovici and Mosler discloses the rear surface of the nozzle includes a plurality of shearing corners (See Annotated Fig 11E below).
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Regarding claim 11, the modified invention of Leibovici and Mosler discloses the at least one shearing corner is a sharp corner constructed from two adjoining planar surfaces, one of the planar surfaces aligned parallel with respect to the longitudinal centerline of the core tube, and one of the planar surfaces arranged perpendicular to the core tube (See Annotated Fig 11E above).
Regarding claim 12, the modified invention of Leibovici and Mosler discloses the at least one shearing corner is a pair of sharp corners constructed from three adjoining planar surfaces, constructing a U-shaped channel (163, Fig 11E -Crowell), two of the planar surfaces aligned parallel with respect to the longitudinal centerline of the core tube, and one of the planar surfaces arranged perpendicular to the core tube (See Annotated Fig 11E below).
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Regarding claim 13, the modified invention of Leibovici and Mosler discloses the rear surface of the nozzle includes four of the U-shaped channels (163, Fig 11E -Mosler).
Regarding claim 14, the modified invention of Leibovici and Mosler discloses the four U- shaped channels are arranged at right angles with respect to each other, breaking the rear surface into four quadrants (See Fig 11E - Mosler).
Regarding Claim 23, the modified invention of Leibovici and Mosler discloses a liquefied endothermic gas, however, is silent regarding the liquefied endothermic gas is 1,1,1,3,3 Pentaflouropropane CAS-No.: 460-73-1 at greater than 90% of the mixture combined with 1,1,1,2 Tetraflouroethane CAS-No.: 811-97-2 making up the remaining portion.
Mosler further teaches a liquefied endothermic gas is 1,1,1,3,3 Pentaflouropropane CAS-No.: 460-73-1 at greater than 90% of the mixture combined with 1,1,1,2 Tetraflouroethane CAS-No.: 811-97-2 making up the remaining portion (Para 0051).
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 liquefied endothermic gas to be a mixture of 1,1,1,3,3 Pentaflouropropane CAS-No.: 460-73-1 and 1,1,1,2 Tetraflouroethane CAS-No.: 811-97-2 as taught by Mosler in order to have vapocoolant with low toxicity, low flammability, and low combustibility (Para 0051).
Claims 18-22 are rejected under 35 U.S.C. 103 as being unpatentable over Leibovici (US 2018/0369504) in view of Mosler (US 2022/0002072) and further in view of Leibovici ‘334 (US 9,561, 334) and further in view of Briggs (US 4,981,679).
Regarding Claim 18, the modified invention of Leibovici and Mosler discloses all of the elements of the invention as discussed above, however, is silent regarding the endothermic gas includes up to ten percent of a miscible liquid as a mixture, the miscible liquid increasing the effective temperature of the endothermic gas as applied to the in vivo tissue.
Leibovici ‘334 teaches an analogous endothermic gas that includes a miscible liquid as a mixture, the miscible liquid increasing the effective temperature of the endothermic gas as applied to the in vivo tissue (Col 2, line 46-55).
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 endothermic gas to comprise a miscible liquid as taught by Leibovici ‘334 in order to sterilize an injection site immediately before inserting the needle (Col 3, lines 4-14).
The modified invention of Leibovici, Mosler, and Leibovici ‘334 discloses all of the elements of the invention as discussed above, however, is silent regarding up to ten percent of the miscible liquid is included in the mixture.
Briggs teaches an endothermic gas that includes a miscible liquid wherein up to ten percent of the miscible liquid is included in the mixture (Col 5, lines 45-62).
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 mixture to have up to ten percent of the miscible liquid as taught by Briggs in order to balance the cooling properties and antibacterial activity (Col 4, line 47- Col 5, line 62).
Regarding Claim 19, the modified invention of Leibovici, Mosler, Leibovici ‘334, and Briggs discloses the effective temperature is raised by slowing the evaporation speed of the endothermic gas (according to applicant’s arguments filed 11/26/2025, page 34, it is common knowledge that adding an antibacterial would raise the effective temperature by slowing the evaporation speed as antibacterials do not absorb as much energy as refrigerants. Thus, the modified invention of Leibovici, Mosler, Leibovici ‘334, and Briggs having an endothermic gas containing an antibacterial meets this limitation).
Regarding Claim 20, , the modified invention of Leibovici, Mosler, Leibovici ‘334, and Briggs discloses the miscible liquid is an antibacterial (Col 2, line 46-55 -Leibovici ‘334).
Regarding Claim 21, , the modified invention of Leibovici, Mosler, Leibovici ‘334, and Briggs discloses the antibacterial is chlorhexidine (Col 2, line 46-55 -Leibovici ‘334).
Regarding Claim 22, , the modified invention of Leibovici, Mosler, Leibovici ‘334, and Briggs discloses the antibacterial is chlorhexidine gluconate (Col 2, line 46-55 -Leibovici ‘334; Leibovici ‘334 gives Peridex TM as an example of a chlorhexidine that can be used. Peridex is chlorhexidine gluconate).
Claims 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Leibovici (US 2018/0369504) in view of Mosler (US 2022/0002072) and further in view of Ditto (US 2020/0039732).
Regarding Claim 24, the modified invention of Leibovici and Mosler discloses a liquefied endothermic gas, however, is silent regarding it being HFO-1234ze (E).
Ditto teaches an analogous liquefied endothermic gas for managing pain (Para 0002) wherein the liquefied endothermic gas is HFO-1234ze (Para 0038).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify liquefied endothermic gas to be made of HFO-1234ze and HFO-1233zd as taught by Ditto in order to have a vapocoolant that can be used to manage pain without presenting the unfavorable environmental risks and safety risks (Para 0004).
Regarding Claim 25, the modified invention of Leibovici and Mosler discloses a liquefied endothermic gas, however, is silent regarding it being HFO-1233zd(E).
Ditto teaches an analogous liquefied endothermic gas for managing pain (Para 0002) wherein the liquefied endothermic gas is HFO-1233zd(E) (Para 0038).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify liquefied endothermic gas to be made of HFO-1234ze and HFO-1233zd as taught by Ditto in order to have a vapocoolant that can be used to manage pain without presenting the unfavorable environmental risks and safety risks (Para 0004).
Response to Arguments
Applicant’s arguments filed 11/26/2025, on pages 32-34, regarding the instant specification failing to have support for claim 19 have been fully considered and are persuasive. While the specific language is not present in the specification, it appears that paragraph 0164, which states “other combinations of liquefied endothermic gasses and materials, such as antibacterials, may be combined with the endothermic gasses to reduce the possibility of frostbite”, hints at this feature. Examiner recommends that Applicant provides explanation and citations regarding how the specification supports newly added limitations to prevent such confusion in the future. Regardless, the limitations of claim 19 appear to be a latent property of the mixture claimed in claim 18 and per MPEP 2145 (II), recognizing additional advantages or latent properties present is not patentable.
Conclusion
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/ANTARIUS S DANIEL/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783