DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment filed 11/26/2025 has been entered. Claims 1-4, 6-7, 11-21 are pending in the application. Applicant’s amendments to the claims have not overcome every objection and 112(b) rejection previously set forth in the Non-final Office Action mailed 08/26/2025 (See rejection below).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 11, 14-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 11 recites “the canister assembly including the cold spray module”. It is unclear how the canister assembly can include a cold spray module when claim 1 requires the canister assembly to be fluidly connected to the cold spray module. As stated, claim 11 requires the cold spray module to be a part of the canister assembly while claim 1 requires them to be separate elements coupled together. For the sake of examination, the limitation will be interpreted as reciting “the canister assembly is connected to the cold spray module and ”.
Claims 14-20 are rejected as depending from rejected claims.
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).
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 planar surfaces aligned parallel with respect to the longitudinal centerline of the core tube, and one of 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 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
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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 endothermic gas to be expelled at the same or similar rates as the antimicrobial agent through the valve, the antimicrobial having a higher density than the endothermic gas, causing it to be drawn through the dispenser tube while the preponderance of the 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.).
Response to Arguments
Applicant’s arguments filed 11/26/2025, on pages 13-17, regarding it is not obvious for any antimicrobial to be mixed with any refrigerant have been fully considered but are moot in view of the current rejection that now relies on Ditto to teach the refrigerant claimed in the independent claim. Applicant states that alcohol is incompatible with 134a and227a. As detailed in the rejection, Leibovici teaches that an antimicrobial can be added to refrigerants (Para 0100) and Ditto further teaches that the refrigerant can be HFO-11233zd and HFO-1234ze for reasons relating to the environment. As stated by Applicant on page 16 of the arguments, it is known in the art that HFO-1233zd and HFO-1234ze are compatible with alcohol. Therefore, it would have been obvious to one of ordinary skill in the art to combine an antimicrobial such as alcohol with HFO-1233zd and HFO-1234ze for disinfecting the sprayed region as detailed by Leibovici.
Applicant’s arguments filed 11/26/2025, on pages 18-22, regarding Examiner fails to provide a single reference that discloses chlorhexidine gluconate in combination with a refrigerant have been fully considered but is not persuasive. Examiner points out that Leibovici ‘334 teaches that the bactericide such as chlorhexidine gluconate can be mixed with an endothermic gas (Col 2, lines 46-65). Leibovici also teaches mixing an antimicrobial refrigerant (Para 0100). Ditto further teaches that the refrigerant can be HFO-11233zd and HFO-1234ze for reasons relating to the environment. Therefore, one of ordinary skill in the art would have ample motivation to combine an antimicrobial such as chlorhexidine gluconate with a refrigerant given there is nothing explicitly stating an incompatibility of the materials.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANTARIUS S DANIEL whose telephone number is (571)272-8074. The examiner can normally be reached M-F 7:00am to 4:30pm EST.
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/ANTARIUS S DANIEL/Examiner, Art Unit 3783
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785