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 .
Claim Status
Applicant’s amendments in the response filed on 08/15/2025 has been considered by the Examiner. Currently claims 6, 9, 32-33, and 35 are pending, claims 1-5, 7-8, 10-31, 34, and 36 are canceled, and claim 6 has been amended. A complete action on the merits of claims 6, 9, 32-33, and 35 follows below.
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.
Claim(s) 6, 9, 32-33, and 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Knight (3,306252) in view of Mizui (JP 2012/187371), Citterio (5,289,818), Barbut (2010/0211140), and in further view of Hermanson (5,730,118).
Regarding claim 6, Knight teaches an assembly for dispensing a [[vapocoolant]] towards an application site of a subject (Fig. 2 Col. 1 lines 10-12 The present invention relates to aerosol units for spraying medicament directly upon the skin), comprising a housing having a longitudinal axis (hood 13 ), the housing comprising appendage[s] (one appendage appears on one side , Fig. 2, finger grip 19), a nozzle (nozzle 43), and a neck extending longitudinally along the longitudinal axis with taper from the housing, the neck disposed a distance from the nozzle (outer section 14 of hood 13 , tapered portion includes spray opening 16 spaced axially outwardly of the nozzle 43, Col. 4 line 21) and configured to dispense the vapocoolant from a predetermined distance relative to the surface of the skin (Fig. 2 Col. 2 lines 43-44);
a container (aerosol vessel 11), the container comprising an outlet (opening at the distal portion) sealably engaged with a valve member (valve member 26 passes through the opening in slideable relation therewith. A disc shaped annular sealing diaphragm 28 is positioned in the top of the housing 25 around the valve member 26), the valve member comprises an actuator (Col. 3 lines 55-63 spring 32; valve member 26 merely is depressed against the pressure of the spring 32 until the inlet opening 35 moves below the sealing diaphragm), wherein the container consists of [[one or more vapocoolants or one or more vapocoolants in combination with a medicament]] (Fig. 2 Col. 1 lines 10-12 The present invention relates to aerosol units for spraying medicament directly upon the skin);
a stop member fixedly positioned in the housing and configured to receive at least a portion of the outlet of the container and to engage the actuator (Col 3 lines 33-35, housing 25, A disc shaped annular sealing diaphragm 28 is positioned in the top of the housing 25 around the valve member 26);
wherein the actuator is configured to actuate the valve member upon engagement with the stop member so as to allow release of an amount of the one or more [[vapocoolants or one or more vapocoolants in combination with a medicament]] from the nozzle and through the neck along the longitudinal axis so as to exit towards an application site of a subject’s skin (Col. 3 lines 55-63, To operate the unit, the valve member 26 merely is depressed against the pressure of the spring 32 until the inlet opening 35 moves below the sealing diaphragm. The space immediately below the sealing diaphragm 28 is exposed to the pressure chamber 12 so that fluid under pressure will enter the axial passage 34 in the valve member 26 through the inlet opening 35 as soon as the inlet opening is depressed below the diaphragm… Col. 1 lines 13-15 This invention is particularly concerned with providing such a spray unit which will allow a medicament to be applied to any part of the body) ;
wherein the neck extends distally away from the actuator and the container (outer section 14 of hood 13 , tapered portion includes spray opening 16 spaced axially outwardly of the nozzle 43, Col. 4 line 21).
While Knight provides for a medicament it is silent about specifically teaching vapocoolant in combination with a medicament.
However, Mizui teaches a device within the same field of invention (therapy device) comprising a device that can spray liquified gas…The refrigerant can also be used for emergency treatment by mixing and impregnating a medicine or the like having bactericidal action.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine coolant with medicine to provide for a bactericidal action as taught by Mizui during in emergency treatment.
While Knight teaches an appendage that extends in an opposite direction from the housing (19), it does not teach appendages that extend in opposite directions from the housing.
However, Citterio teaches a device within the same field of invention ([Abstract] spray dispenser device dispenses a dose of liquid medicament ) and includes two outwardly projecting opposing fins 60 to act as a grip for operating the device 10 (Col 4 lines 63-66).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include an additional appendage that would act as a grip as taught by Citterio and since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis C o . , 193 USPQ 8 MPEP 2144.04 (VI-B).
While Mizui provides for a the vapocoolant in combination with medicament it is silent about specifically teaching the amount of the one or more vapocoolants released for approximately 1 to 10 seconds reduces the subject’s skin temperature at least 5°F; but not below 40°F.
However, Barbut teaches a device within the same field of invention (cooling device), it teaches a perfluorocarbon spray delivered to a patient’s nasal cavity to reduce the cerebral temperature of the patient by at least 1 degree°C [0010]. Barbut provides the device can be used on other parts of the body [0002] and “The rate of cooling can be adjusted by varying the temperature of the inhalate, the concentration of the responsible compound or compound mixture, the rate of delivery, the particle size, and the percentage of each compound in the mixture [0059].”
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the application time, temperature of cooling, or the type of vapocoolant in order to achieve the desired cooling effect without damaging the tissue, since it has been held that the provision of adjustability, where needed, involves routine skill in the art . In re Stevens 1954.
Knight does not teach a cover assembly or cap aseptically engaged with the nozzle and configured to prevent contamination and/or maintain sterility prior to use. However, Hermanson teaches a device within the same field of invention (an applicator that sprays medicament to a body part) comprising a cap 40a.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide for a cap on the applicator of Knight to keep the passageways clean when not in use (Col. 3 lines 35-37).
Regarding claim 9, Knight in view of Mizui , Citterio, and Barbut teaches the limitations of claim 6. Knight teaches wherein the stop member comprising a surface having a recess dimensioned to receive at least a portion of the outlet and at least a portion of the valve member (diaphragm and depressed cap 23 receives valve 26 which includes an axial passage in fluid communication with opening 35 that provides for the fluid).
Regarding claim 32, Knight in view of Mizui , Citterio, Barbut, and Hermanson teaches the limitations of claim 6. Knight teaches further comprising a peripheral seal that engages the container so as to retain the container in the housing and to isolate the interior of the housing from the ambient environment (Col 3 lines 20-24 The cap 23 includes a flange 24 which snaps over the bead 22 on the container, and is permanently secured to the container 21 to provide a pressure-tight seal).
Regarding claim 33, Knight in view of Mizui, Citterio, Barbut, and Hermanson teaches the limitations of claim 6 and wherein each of the appendages have distally facing surfaces for receiving fingers of a human hand (Knight Fig.2, 19 ; Citterio fins 60).
Regarding claim 35, Knight in view of Mizui, Citterio, Barbut, and Hermanson teaches the limitations of claim 6. While Mizui provides for Freon which is a type of chlorocfluorocarbon, hydrochlorofluorocarbon and Barbut specifically provides for a perfluorocarbon [0010] it is silent about specifically teaching wherein the vapocoolant comprises a mixture of two or more of hydrochlorofluoroolefin, hydrochloric carbon hydrochloroolefin, perfluorocarbon, perfluroolefin, perchlorocarbon, and perchloroolefin.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have mixed any two of the known compounds to provide for the desired cooling and it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Response to Arguments
Applicant’s remarks in the response filed on 08/15/2025 has been considered by the Examiner.
Applicant recites on pages 1 and 2,“ None of the cited references, alone or in permissible combination disclose or reasonably suggest the amount of the one or more vapocoolants released for approximately 1 to 10 seconds reduces the subject’s skin temperature at least 5F; but not below 40 F”…. “The examples of Barbut all involve the introduction of the device to a nasal cavity or oral cavity and the reduction of temperature therein …Nowhere in Barbut is skin cooled.”
The Examiner respectfully disagrees. Since the claims are directed to an apparatus the combination is capable of applying vapocoolant and medicament to the skin. The primary reference by Knight specifically teaches the structure of the claimed device and spraying medicament on the skin. Mizui teaches combining a medicament and refrigerant for medical purposes and Barbut provides for reducing a temperature of a body part by at least 1 degree C [0010] and further provides “The rate of cooling can be adjusted by varying the temperature of the inhalate, the concentration of the responsible compound or compound mixture, the rate of delivery, the particle size, and the percentage of each compound in the mixture [0059].”
Applicant’s new amendments necessitates a new grounds of rejection over Knight (3,306252) in view of Mizui (JP 2012/187371), Citterio (5,289,818), Barbut (2010/0211140), and in further view of Hermanson (5,730,118).
Conclusion
An updated search revealed a pertinent reference by Hipskind (5,861,022) which teaches the application of vapocoolant sprays over the skin representing the muscles associated with the hiccup reflex, particularly regions of the lower thoracic and upper lumbar regions across the back, have been reported to block myofascial reflex and relieve hiccupping (Col. 2 lines 41-46)
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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/Y.E/ Examiner, Art Unit 3794
/KAITLYN E SMITH/ Primary Examiner, Art Unit 3794
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