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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 08/25/2026 has been entered.
Response to Amendment
The amendment filed 08/25/2026 has been entered. Claims 1-4, 6-7, 11-22 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 03/25/2026.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-2, 11-21 are rejected under 35 U.S.C. 103 as being unpatentable over Leibovici (US 2018/0369504) in view of Ditto (US 2020/0039732) and further in view of Mosler (US 2022/0002072).
Regarding Claim 1, Leibovici discloses an endothermic vapor applicator (200, Fig 21; Para 0004) comprising: a canister assembly (11, Fig 21) containing a liquefied endothermic gas (Para 0091), the canister assembly fluidly connected to the cold spray module (202, 210, 212, 214, Fig 21) to discharge from the cold spray module (Para 0122, lines 1-4), the canister assembly including an antimicrobial liquid mixed with the endothermic gas within the canister, wherein the liquefied endothermic gas causes the antimicrobial liquid to be entrained within the liquefied endothermic gas as it is expelled from the canister (Para 0100), the liquefied endothermic gas being constructed and arranged to have a suitable temperature to cause numbness when directed at human skin without causing frostbite, the antibacterial liquid disinfecting the numbed area (Para 0109); wherein the cold spray module and the canister assembly form a unitary structure (the claim language is broader than Para 0049 of the instant specification which requires the discharge actuator 116 (which is a part of the cold spray module) to be welded to the cannister assembly. The current claim language only requires the two elements to form one unit. When the canister assembly 11 and cold spray module 202, 210, 212, 214 are coupled, they form a single endothermic vapor applicator unit 200 as detailed in Para 0118.).
Leibovici is silent regarding the liquefied endothermic gas comprising HFO-1233zd and the liquefied endothermic gas is broken up into droplets prior to discharge.
Ditto teaches an analogous liquefied endothermic gas wherein the liquefied endothermic gas is a combination of HFO- 1234ze and HFO-1233zd (Para 0002, 0005).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the HFC-134a disclosed by Leibovici with the HFO-1234ze and HFO-1233zd as taught by Ditto in order to manage pain and swelling without presenting the unfavorable environmental risks and safety risks associated with previous vapocoolant compositions (Para 0003-0004).
The modified invention of Leibovici and Ditto disclose all of the elements of the invention as discussed above, however, is silent regarding the liquefied endothermic gas is broken up into droplets prior to discharge.
Mosler teaches an analogous endothermic vapor applicator (100b, Fig 2B) comprising a canister assembly (120, Fig 2B) containing a liquefied endothermic gas, the canister assembly fluidly connected to a cold spray module (101, 105, Fig 2B) so that the liquified endothermic gas is broken up into droplets prior to discharge from the cold spray module (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 rear breaker surface and have the core tube have an angled opening 145 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, Ditto, and Mosler discloses the liquefied endothermic gas (29) is mixture of the HFO-1233zd and HFO-1234ze (E) (Para 0002, 0005 -Ditto)
Regarding Claim 11, the modified invention of Leibovici, Ditto, and Mosler discloses the canister assembly (11, Fig 21 -Leibovici) is connected to the cold spray module (10), the cold spray module (202, 210, 212, 214, Fig 21 -Leibovici) includes a core tube (270, Fig 31 -Leibovici as modified by Mosler to have the angled opening 145) a distal end of the core tube including a discharge port (distal opening of the discharge port 270, Fig 31) for controlling the flow of the liquefied endothermic liquid and directing the liquefied endothermic liquid to impinge against a breakup surface (162, 163, Fig 11B -Mosler) for breaking the liquid stream into an endothermic vapor before the endothermic vapor is directed through a breakup nozzle (Para 0068 -Mosler), the breakup nozzle is constructed and arranged to cause the endothermic vapor to be directed as a stream (Para 0068 -Mosler).
Regarding Claim 12, the modified invention of Leibovici, Ditto, 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 the canister to create a sealed pressure canister, the valve assembly including a discharge tube (58, Fig 22 -Leibovici) extending outwardly therefrom for connection to the cold spray module (Para 0101 -Leibovici).
Regarding Claim 13, the modified invention of Leibovici, Ditto, and Mosler discloses the valve assembly (17, Fig 22 -Leibovici) is finger operable to release the liquefied endothermic gas (Para 0101 -Leibovici).
Regarding Claim 14, the modified invention of Leibovici, Ditto, and Mosler discloses the breakup surface (162, 163, Fig 11B -Mosler) is a rear surface of the breakup nozzle, the liquefied endothermic gas directed at the breakup surface to impinge the breakup surface adjacent a nozzle orifice (107, Fig 11A -Mosler), wherein the liquefied endothermic gas breaks up and expands to exit the nozzle orifice with velocity (Para 0068 -Mosler).
Regarding Claim 15, the modified invention of Leibovici, Ditto, and Mosler discloses the breakup surface of the breakup nozzle includes at least one shearing corner (See Annotated Fig 11E below).
Regarding Claim 16, the modified invention of Leibovici, Ditto, and Mosler discloses the breakup surface of the breakup nozzle includes a plurality of shearing corners (See Annotated Fig 11E below).
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Regarding Claim 17, the modified invention of Leibovici, Ditto, and Mosler discloses the at least one shearing corner is a sharp corner constructed from two adjoining planar surfaces, one of the two adjoining planar surfaces aligned parallel with respect to the longitudinal centerline of the core tube, and one of two adjoining the planar surfaces (136) arranged perpendicular to the core tube (See Annotated Fig 11E above).
Regarding Claim 18, the modified invention of Leibovici, Ditto, 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 -Mosler), two of the three adjoining planar surfaces aligned parallel with respect to the longitudinal centerline of the core tube, and one of the three adjoining planar surfaces arranged perpendicular to the core tube
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(See Annotated Fig 11E below).
Regarding Claim 19, the modified invention of Leibovici, Ditto, and Mosler discloses the core tube (270, Fig 31 -Leibovici as modified by Mosler to have the angled opening 145) is constructed and arranged to direct the liquefied endothermic gas at the breakup surface of the breakup nozzle at an acute angle with respect to the longitudinal centerline of the core tube (Para 0067-0068; See Fig 8B wherein the opening 145 is at an acute angle relative to the centerline).
Regarding Claim 20, the modified invention of Leibovici, Ditto, and Mosler discloses a discharge actuator (214, Fig 21 -Leibovici) is constructed and arranged to operate by depressing a dispenser tube in the valve assembly, which allows the liquefied endothermic gas to flow through the valve assembly and through the discharge tube (Para 0068 -Mosler; Para 0124 -Leibovici).
Regarding Claim 21, the modified invention of Leibovici, Ditto, and Mosler discloses a siphon valve (spring valve within valve assembly 17 -Leibovici) is opened when the valve assembly is operated, the siphon valve causes the liquified endothermic gas to be expelled at the same or similar rates as the antimicrobial liquid through the siphon valve, the antimicrobial liquid having a higher density than the liquefied endothermic gas, causing it to be drawn through the dispenser tube while a preponderance of the liquefied endothermic gas is passed through the siphon valve, causing both materials to be expelled through the discharge tube (Para 0113 -Leibovici).
Claims 3-4, 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Leibovici (US 2018/0369504) in view of Ditto (US 2020/0039732) and further in view of Mosler (US 2022/0002072) and further in view of Leibovici ‘334 (US 9,561,334) as evidenced by 3M (“Peridex™ (CHLORHEXIDINE GLUCONATE 0.12%) ORAL RINSE”).
Regarding Claim 3, the modified invention of Leibovici, Ditto, and Mosler discloses an antibacterial liquid (Para 0100 -Leibovici), however, is silent that the antibacterial liquid is alcohol.
Leibovici ‘334 teaches an analogous endothermic gas including an antimicrobial liquid mixed with the endothermic gas within the canister, wherein the antibacterial liquid is alcohol (Col 2, lines 46-65) (As evidenced by 3M, Peridex is an oral rinse containing 0.12% chlorhexidine gluconate (1, 11-hexamethylene bis [5-(p-chlorophenyl) biguanide] di-D-gluconate) in a base containing water, 11.6% alcohol, glycerin, PEG-40 sorbitan diisostearate, flavor, sodium saccharin, and FD&C Blue No. 1.)..
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 antibacterial liquid to be alcohol as taught by Leibovici ‘334 in order to have a commonly used and understood antibacterial mixed with the endothermic gas to provide sterilization of the patient’s mouth and gums (Col 2, lines 46-65).
Regarding Claim 4, the modified invention of Leibovici, Crowell, Ditto, and Leibovici ‘334 discloses the antibacterial liquid further includes chlorhexidine gluconate (Col 2, lines 46-65 - Leibovici ‘334)(As evidenced by 3M, Peridex is an oral rinse containing 0.12% chlorhexidine gluconate (1, 11-hexamethylene bis [5-(p-chlorophenyl) biguanide] di-D-gluconate) in a base containing water, 11.6% alcohol, glycerin, PEG-40 sorbitan diisostearate, flavor, sodium saccharin, and FD&C Blue No. 1.).
Regarding Claim 6, the modified invention of Leibovici, Crowell, and Ditto discloses an antibacterial liquid (Para 0100 -Leibovici), however, is silent that the antibacterial liquid is alcohol.
Leibovici ‘334 teaches an analogous endothermic gas including an antimicrobial liquid mixed with the endothermic gas within the canister, wherein the antibacterial liquid is alcohol (Col 2, lines 46-65) (As evidenced by 3M, Peridex is an oral rinse containing 0.12% chlorhexidine gluconate (1, 11-hexamethylene bis [5-(p-chlorophenyl) biguanide] di-D-gluconate) in a base containing water, 11.6% alcohol, glycerin, PEG-40 sorbitan diisostearate, flavor, sodium saccharin, and FD&C Blue No. 1.)..
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 antibacterial liquid to be alcohol as taught by Leibovici ‘334 in order to have a commonly used and understood antibacterial mixed with the endothermic gas to provide sterilization of the patient’s mouth and gums (Col 2, lines 46-65).
Regarding Claim 7, the modified invention of Leibovici, Crowell, Ditto, and Leibovici ‘334 discloses the antibacterial liquid further includes chlorhexidine gluconate (Col 2, lines 46-65 - Leibovici ‘334)(As evidenced by 3M, Peridex is an oral rinse containing 0.12% chlorhexidine gluconate (1, 11-hexamethylene bis [5-(p-chlorophenyl) biguanide] di-D-gluconate) in a base containing water, 11.6% alcohol, glycerin, PEG-40 sorbitan diisostearate, flavor, sodium saccharin, and FD&C Blue No. 1.).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Leibovici (US 2018/0369504) in view of Mosler (US 2022/0002072).
Regarding Claim 22, Leibovici discloses an endothermic vapor applicator (200, Fig 21; Para 0004) comprising: an actuator assembly comprising: a discharge actuator (214, Fig 21), a cold spray module (202, 210, 212, Fig 21), wherein the cold spray module forms a unitary structure with the discharge actuator (See Figs 21 and 22 wherein the discharge actuator 214 forms a single unit 200 for applying the endothermic vapor (Para 0118)), a core tube (270, Fig 31) positioned within the cold spray module, wherein the core tube is inserted into an internal bore of the cold spray module (See Fig 31); a canister (11, Fig 21) comprising a liquefied endothermic gas (Para 0091), wherein the canister is fluidly connected to the cold spray module such that the liquefied endothermic gas is discharge from the cold spray module (Para 0122, lines 1-4); a dispenser tube (58, Fig 22) fluidly connected to the actuator assembly and extending into the canister; and wherein the liquefied endothermic gas is dispensed from the canister by depressing the discharge actuator to allow the liquefied endothermic gas to flow through the cold spray module (Para 0096).
Leibovici is silent regarding the liquefied endothermic gas is broken up into droplets prior to discharge from the cold spray module.
Mosler teaches an analogous endothermic vapor applicator (100b, Fig 2B) comprising a canister assembly (120, Fig 2B) containing a liquefied endothermic gas, the canister assembly fluidly connected to a cold spray module (101, 105, Fig 2B) so that the liquified endothermic gas is broken up into droplets prior to discharge from the cold spray module (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 rear breaker surface and have the core tube have an angled opening 145 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).
Response to Arguments
Applicant’s arguments filed 08/25/2026, on pages 7-10, regarding Leibovici, Ditto, and Mosler failing to teach the cold spray module and the canister assembly form a unitary structure have been fully considered but is not persuasive. Applicant argues that the canister of Leibovici and Mosler teach that the canisters are designed to be removed and are separate and distinct structures. Firstly, the instant specification in paragraph 0049, states that the discharge actuator (which is part of the cold spray module) and the canister are welded together. The cold spray module as seen in Figs 4 and 5 of the instant applications is a distinct and separate structure from the canister. These distinct and separate structures are simply welded together at some point in manufacture as detailed in Para 0049. This seems to contradict Applicant’s arguments that seem to be suggesting that the two elements are monolithic. The claim language, however, is broader. It only requires that the two elements form a unitary structure or form a unit. There is no requirement that the canister and cold spray module are not removable from one another or must be welded together. Therefore, as detailed in the rejection above, the prior art of record still read on the amended claims.
Conclusion
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/ANTARIUS S DANIEL/Examiner, Art Unit 3783
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
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