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
Applicant’s amendments, filed 06/03/2026, has been entered, claims 1-23 remain pending.
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.
Claim(s) 1, 3-10, 12-16, 22, 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Munro et al. (US20220257642), hereafter Munro, in view of Morane et al. (US4093124), further in view of Martin (WO2021040813), hereafter Martin.
Regarding Claim 1, Munro discloses a method for nasal delivery of nitric oxide (Abstract), comprising: providing a body (par. 0293, “…the evolved gas dispensed by means of suitable containers or reservoirs for holding the components before use and means for mixing the components, dispensing the reaction mixture and/or the evolved gas, and generally controlling the said mixing and dispensing.”; the disclosed container is a body).
Munro discloses that the body can be any suitable container (par. 0293), but does not specifically disclose wherein the body defines a volume and has a throat defining an exit opening of the volume, and wherein the body is compressible; providing a cap, wherein the cap is configured to removably engage with the body at the throat in a manner that seals the exit opening of the volume; providing a nozzle, wherein the nozzle is configured to removably engage engages the body at the throat in a manner that can direct the contents of the volume from the exit opening of the volume out through a nozzle exit.
However, Morane teaches a nasal aerosol delivery method (Abstract, col. 4 line 48-52, “In particular, the atomizer according to the invention may be used to dispense nasal sprays of pharmaceutical liquids”), comprising: providing a body (Fig. 1 and 4, container 2a), wherein the body defines a volume (See Fig. 1 and 4, the container defines a volume storing a solution) and has a throat (Fig. 4, neck 3a) defining an exit opening of the volume (See Fig. 4, neck 3a defines an exit opening of the volume), and wherein the body is compressible (Abstract, “When the container is compressed liquid flows into the atomization chamber through the tube…”); providing a cap, wherein the cap is configured to removably engage with the body at the throat in a manner that seals the volume (Fig. 5, cap 4a, col. 7 line 2-9, “The cap 4a which covers the dispensing head… to insure close sealing”; Fig. 4 and 5 shows the cap is threaded and is removably engaged at the throat 3a); providing a nozzle (Fig. 4, dispensing head 5a), wherein the nozzle is configured to removably engage the body at the throat (Fig. 4 shows the nozzle is removably engaged at the throat, col. 6 line 24-28 discloses filling the volume with liquid product, the nozzle is inherently removable since the nozzle must be removed to fill the volume of the body) in a manner that can direct the contents of the volume from the exit opening of the volume out through a nozzle exit (Fig. 4, ejection orifice 14a, col. 4 line 48-56, the nozzle dispense the content of the volume and eject at the nozzle exit). Therefore, it would have been obvious for one of ordinary skilled in the art to modify the known method of Munro, with the method of Morane, for simplicity and low costs, as taught by Morane (Morane, Col. 1 line 8-21).
The modified Munro is silent on providing at least one filter that can be positioned between the nozzle exit and the volume, wherein the filter is selected from the group consisting of a gas filter, a membrane filter, a vapor filter, a droplet filter, a barrier filter, and an antioxidant filter.
However, Martin teaches a method of generating nitric oxide (Abstract), wherein the container comprises of a membrane filter (par. 0111) and a droplet filter (par. 0195, “NO permeable membrane that prevents aerosol droplets from leaving”) positioned in a container (par. 0111, container 32, Fig. 21; par. 0111, “a filter on a surface of the container 32”). Therefore, it would have been obvious for one of ordinary skilled in the art to further modify the known method of Munro, with the membrane filter and droplet filter of Martin, and position it between the nozzle exit and the volume, to reduce toxicity from undesired particles and to delivery pure nitric oxide as taught by Martin (Martin, par. 0111, 0195).
The modified Munro further discloses providing a reactants packet (Munro, par. 0071, “the nitrite salt and the proton source are in dry powdered admixture or are present as encapsulated particles”), wherein the reactants packet comprises an acidic powder (Munro, par. 0179, “the proton source component or portions of it may be provided for use in the disclosure in dry form, optionally in particulate form such as a powder”) and a nitrite powder (Munro, par. 0096, “the nitrite component, optionally encapsulated or microencapsulated, can be present as a dry powder or crystals”); adding purified water to the volume (Munro, par. 0100, “and for the reaction to be initiated by the simple addition of water”); adding the powders of the reactants packet to the volume (Munro, par. 0071, “the nitrite salt and the proton source are in dry powdered admixture or are present as encapsulated particles which require water (e.g from mucosal membranes contacted by the combination) before the NOx generating reaction will start”); capping the exit opening of the volume at the throat with the cap to seal the contents of the volume (Munro, par. 0313, “the composition may be stored in a hermetically sealed container… after combining the nitrite component and the proton source component”; Munro teaches sealing the content of the volume, the cap of Morane is for sealing the volume, Morane col. 7 line 2-9); mixing the contents of the volume and initiating the production of nitric oxide within the volume (Munro, par. 0185); removing the cap from the throat (Morane Fig. 4 and 5, the cap must be removed prior to dispensing); positioning the nozzle and the at least one filter over the throat of the body such that the contents of the volume must pass through the exit opening of the volume and the at least one filter before going through the nozzle exit (Fig. A, Martin par. 0111, 0195, the prior art teaches filtering the nitric oxide, the claimed limitation is merely the intended use of the prior arts); positioning the nozzle exit near a user's nasal cavity (Morane, col. 4 line 51-53, “In this case the upper part of the central passage is shaped to penetrate the nasal passages where the mists are to be used”); and compressing the body to deliver nitric oxide to the user's nasal cavity (Morane col. 9 line 48-51, “compresses the flexible walls of the container so as to cause the liquid to pass through the tube 116, the spray chamber 118, and be ejected through the orifice 113”).
Regarding Claim 3, the modified Munro discloses the method of claim 1, but is silent on wherein the reactants packet further comprises a sodium bicarbonate powder.
However, Martin further teaches a nitric oxide generating formula (par. 0078), comprising of an inert material which includes a sodium bicarbonate powder (par. 0078, “the NO generating formulation (including the NO donor/adduct) further includes an inert material selected from the group consisting of sodium chloride, sodium bicarbonate”; par. 0082). Therefore, it would have been obvious for one of ordinary skilled in the art to further modify the known method of Munro, with the formula of Martin, to include a sodium bicarbonate powder, as an inert material for anticaking as taught by Martin (Martin, par. 0078).
Regarding Claim 4, the modified Munro discloses the method of claim 1, wherein the nitrite powder comprises one or more of powdered potassium nitrite and powdered sodium nitrite (Munro, par. 0113, “when the nitrite salt is sodium nitrite…when the nitrite salt is potassium nitrite”).
Regarding Claim 5, the modified Munro discloses the method of claim 1, further comprising, allowing the volume to vent, after removing the cap, for at least 60 seconds so the headspace of the volume is evacuated as the nitric oxide is produced (Munro par. 0019, “the administration of the reaction mixture to the subject could be done after a period of time after the initiation of the NOx generating reaction, for example about 10 minutes, 30 minutes or one hour or longer after the initiation of the NOx generating reaction”; the prior art discloses initiating the reaction for more than 60 seconds before administering, during this time, nitric oxide gas will generate and inherently evacuate the headspace).
Regarding Claim 6, the modified Munro discloses the method of claim 1, wherein at least two filters are positioned between the nozzle exit and the volume and the two filters are selected from the group consisting of a gas filter, a membrane filter, a vapor filter, a droplet filter, a barrier filter, and an antioxidant filter (See rejection for Claim 1, Martin par. 0111, 0195, a membrane filter and a droplet filter are disclosed).
Regarding Claim 7, the modified Munro discloses the method of claim 6, wherein the two filters are the droplet filter and the membrane filter (See rejection for Claim 1, Martin par. 0111, 0195).
Regarding Claim 8, the modified Munro discloses the method of claim 1, wherein the nitric oxide is produced at a rate greater than 3.0 nanomols/sec (See Munro par. 560-0566, Fig. 1 shows the nitric oxide is over 5000 nanomoles at 500 seconds, therefore the rate is within the claimed range).
Regarding Claim 9, the modified Munro discloses the method of claim 3, wherein the nitric oxide is produced at a rate greater than 5.0 nanomols/sec (See Munro par. 560-0566, Fig. 1 shows the nitric oxide is over 5000 nanomoles at 500 seconds, therefore the rate is within the claimed range).
Regarding Claim 10, Munro discloses a method for nasal delivery of nitric oxide (Abstract), comprising: providing a body (par. 0293, “…the evolved gas dispensed by means of suitable containers or reservoirs for holding the components before use and means for mixing the components, dispensing the reaction mixture and/or the evolved gas, and generally controlling the said mixing and dispensing.”; the disclosed container is a body).
Munro discloses that the body can be any suitable container (par. 0293), but does not specifically disclose wherein the body defines a volume, has a throat defining an exit opening of the volume, and wherein the body is compressible; providing a cap, wherein the cap is configured to removably engage with the body at the throat in a manner that seals the exit opening of the volume; providing a nozzle, wherein the nozzle is configured to removably engage engages the body at the throat in a manner that can direct the contents of the volume from the exit opening of the volume out through a nozzle exit.
However, Morane teaches a nasal aerosol delivery method (Abstract, col. 4 line 48-52, “In particular, the atomizer according to the invention may be used to dispense nasal sprays of pharmaceutical liquids”), comprising: providing a body (Fig. 1 and 4, container 2a), wherein the body defines a volume (See Fig. 1 and 4, the container defines a volume storing a solution), has a throat (Fig. 4, neck 3a) defining an exit opening of the volume (See Fig. 4, neck 3a defines an exit opening of the volume), and wherein the body is compressible (Abstract, “When the container is compressed liquid flows into the atomization chamber through the tube…”); providing a cap, wherein the cap is configured to removably engage with the body at the throat in a manner that seals the volume (Fig. 5, cap 4a, col. 7 line 2-9, “The cap 4a which covers the dispensing head… to insure close sealing”; Fig. 4 and 5 shows the cap is threaded and is removably engaged at the throat 3a); providing a nozzle (Fig. 4, dispensing head 5a), wherein the nozzle is configured to removably engage the body at the throat (Fig. 4 shows the nozzle is removably engaged at the throat, col. 6 line 24-28 discloses filling the volume with liquid product, the nozzle is inherently removable since the nozzle must be removed to fill the volume of the body) in a manner that can direct the contents of the volume from the exit opening of the volume out through a nozzle exit (Fig. 4, ejection orifice 14a, col. 4 line 48-56, the nozzle dispense the content of the volume and eject at the nozzle exit). Therefore, it would have been obvious for one of ordinary skilled in the art to modify the known method of Munro, with the method of Morane, for simplicity and low costs, as taught by Morane (Morane, Col. 1 line 8-21).
The modified Munro is silent on providing at least one filter that can be positioned between the nozzle exit and the volume, wherein the filter is selected from the group consisting of a gas filter, a membrane filter, a vapor filter, a droplet filter, a barrier filter, and an antioxidant filter.
However, Martin teaches a method of generating nitric oxide (Abstract), wherein the container comprises of a membrane filter (par. 0111) and a droplet filter (par. 0195, “NO permeable membrane that prevents aerosol droplets from leaving”) positioned in a container (par. 0111, container 32, Fig. 21; par. 0111, “a filter on a surface of the container 32”). Therefore, it would have been obvious for one of ordinary skilled in the art to further modify the known method of Munro, with the membrane filter and droplet filter of Martin, and position it between the nozzle exit and the volume, to reduce toxicity from undesired particles and to delivery pure nitric oxide as taught by Martin (Martin, par. 0111, 0195).
The modified Munro further discloses providing a reactants packet (Munro, par. 0071, “the nitrite salt and the proton source are in dry powdered admixture or are present as encapsulated particles”), wherein the reactants packet comprises an acidic powder (Munro, par. 0179, “the proton source component or portions of it may be provided for use in the disclosure in dry form, optionally in particulate form such as a powder”) and a nitrite powder (Munro, par. 0096, “the nitrite component, optionally encapsulated or microencapsulated, can be present as a dry powder or crystals”); adding purified water to the volume (Munro, par. 0100, “and for the reaction to be initiated by the simple addition of water”); adding the powders of the reactants packet to the volume (Munro, par. 0071, “the nitrite salt and the proton source are in dry powdered admixture or are present as encapsulated particles which require water (e.g from mucosal membranes contacted by the combination) before the NOx generating reaction will start”); capping the exit opening of the volume at the throat with the cap to seal the contents of the volume (Munro, par. 0313, “the composition may be stored in a hermetically sealed container… after combining the nitrite component and the proton source component”; Munro teaches sealing the content of the volume, the cap of Morane is for sealing the volume, Morane col. 7 line 2-9); mixing the contents of the volume and initiating the production of nitric oxide within the volume (Munro, par. 0185); removing the cap from the throat (Morane Fig. 4 and 5, the cap must be removed prior to dispensing); allowing the volume to vent, after removing the cap, for at least 60 seconds so a headspace of the volume is evacuated as the nitric oxide is produced (Munro par. 0019, “the administration of the reaction mixture to the subject could be done after a period of time after the initiation of the NOx generating reaction, for example about 10 minutes, 30 minutes or one hour or longer after the initiation of the NOx generating reaction”; the prior art discloses initiating the reaction for more than 60 seconds before administering, during this time, nitric oxide gas will generate and inherently evacuate the headspace); positioning the nozzle and the at least one filter over the throat of the body such that the contents of the volume must pass through the at least one filter before going through the nozzle exit (Martin par. 0111, 0195, the prior art teaches filtering the nitric oxide, the claimed limitation is merely the intended use of the prior arts); positioning the nozzle and the at least one filter over the throat of the body such that the contents of the volume must pass through the exit opening of the volume and the at least one filter before going through the nozzle exit (Fig. A, Martin par. 0111, 0195, the prior art teaches filtering the nitric oxide, the claimed limitation is merely the intended use of the prior arts); positioning the nozzle exit near a user's nasal cavity (Morane, col. 4 line 51-53, “In this case the upper part of the central passage is shaped to penetrate the nasal passages where the mists are to be used”); and compressing the body to deliver nitric oxide to the user's nasal cavity (Morane col. 9 line 48-51, “compresses the flexible walls of the container so as to cause the liquid to pass through the tube 116, the spray chamber 118, and be ejected through the orifice 113”).
Regarding Claim 12, the modified Munro discloses the method of claim 11, but is silent on wherein the reactants packet further comprises a sodium bicarbonate powder.
However, Martin further teaches a nitric oxide generating formula (par. 0078), comprising of an inert material which includes a sodium bicarbonate powder (par. 0078, “the NO generating formulation (including the NO donor/adduct) further includes an inert material selected from the group consisting of sodium chloride, sodium bicarbonate”; par. 0082). Therefore, it would have been obvious for one of ordinary skilled in the art to further modify the known method of Munro, with the formula of Martin, to include a sodium bicarbonate powder, as an inert material for anticaking as taught by Martin (Martin, par. 0078).
Regarding Claim 13, the modified Munro discloses the method of claim 12, wherein at least two filters are positioned between the nozzle exit and the volume and the two filters are selected from the group consisting of a gas filter, a membrane filter, a vapor filter, a droplet filter, a barrier filter, and an antioxidant filter (See rejection for Claim 1, Martin par. 0111, 0195, a membrane filter and a droplet filter are disclosed).
Regarding Claim 14, the modified Munro discloses the method of claim 13, wherein the two filters are the droplet filter and the membrane filter (See rejection for Claim 1, Martin par. 0111, 0195).
Regarding Claim 15, the modified Munro discloses the method of claim 14, wherein the nitric oxide is produced at a rate greater than 3.0 nanomols/sec (See Munro par. 560-0566, Fig. 1 shows the nitric oxide is over 5000 nanomoles at 500 seconds, therefore the rate is within the claimed range).
Regarding Claim 16, the modified Munro discloses The method of Claim 15, wherein the reactants packet is dissolvable in the purified water (Munro, par. 0071, 0096, 0179).
Regarding Claim 22, the modified Munro discloses the method of claim 17, wherein the cap is configured to removably engage the body and cover the nozzle (Morane, Fig. 4 and 5).
Regarding Claim 23, the modified Munro discloses the method of claim 17, wherein the cap is configured to removably engage the body and cover the nozzle (Morane, Fig. 4 and 5).
Claim(s) 2, 11, 17-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Munro in view of Morane in view of Martin, further in view of Park et al. (US20140199266), hereafter Park.
Regarding Claim 2, the modified Munro discloses the method of claim 1, wherein water is added to the volume (Munro, par. 0286-0287), but is silent on wherein the body further comprises a fill line to show how much purified water is added to the volume.
However, Park teaches a method for nasal delivery (Abstract), comprising of providing a body (Fig. 1, bottle 106), wherein the body further comprises a fill line to show how much purified water is added to the volume (par. 0037, “…then water or another liquid may be utilized to fill the rinse bottle 106 to or approximate the fill line 124”). Therefore, it would have been obvious for one of ordinary skilled in the art to further modify the known method of Munro, with the method of Park, and provide a fill line to for adding precise amount of water to the body as taught by Park (Park, par. 0037).
Regarding Claim 11, the modified Munro discloses the method of claim 10, wherein water is added to the volume (Munro, par. 0286-0287), but is silent on wherein the body further comprises a fill line to show how much purified water is added to the volume.
However, Park teaches a method for nasal delivery (Abstract), comprising of providing a body (Fig. 1, bottle 106), wherein the body further comprises a fill line to show how much purified water is added to the volume (par. 0037, “…then water or another liquid may be utilized to fill the rinse bottle 106 to or approximate the fill line 124”). Therefore, it would have been obvious for one of ordinary skilled in the art to further modify the known method of Munro, with the method of Park, and provide a fill line to for adding precise amount of water to the body as taught by Park (Park, par. 0037).
Regarding Claim 17, Munro discloses a method for nasal delivery of nitric oxide (Abstract), comprising: providing a body (par. 0293, “…the evolved gas dispensed by means of suitable containers or reservoirs for holding the components before use and means for mixing the components, dispensing the reaction mixture and/or the evolved gas, and generally controlling the said mixing and dispensing.”; the disclosed container is a body).
Munro discloses that the body can be any suitable container (par. 0293), but does not specifically disclose wherein the body defines a volume, has a throat defining an exit opening of the volume, and wherein the body is compressible; providing a cap, wherein the cap is configured to removably engage with the body at the throat in a manner that seals the exit opening of the volume; providing a nozzle, wherein the nozzle is configured to removably engage engages the body at the throat in a manner that can direct the contents of the volume from the exit opening of the volume out through a nozzle exit.
However, Morane teaches a nasal aerosol delivery method (Abstract, col. 4 line 48-52, “In particular, the atomizer according to the invention may be used to dispense nasal sprays of pharmaceutical liquids”), comprising: providing a body (Fig. 1 and 4, container 2a), wherein the body defines a volume (See Fig. 1 and 4, the container defines a volume storing a solution), has a throat (Fig. 4, neck 3a) defining an exit opening of the volume (See Fig. 4, neck 3a defines an exit opening of the volume), and wherein the body is compressible (Abstract, “When the container is compressed liquid flows into the atomization chamber through the tube…”); providing a cap, wherein the cap is configured to removably engage with the body at the throat in a manner that seals the volume (Fig. 5, cap 4a, col. 7 line 2-9, “The cap 4a which covers the dispensing head… to insure close sealing”; Fig. 4 and 5 shows the cap is threaded and is removably engaged at the throat 3a); providing a nozzle (Fig. 4, dispensing head 5a), wherein the nozzle is configured to removably engage the body at the throat (Fig. 4 shows the nozzle is removably engaged at the throat, col. 6 line 24-28 discloses filling the volume with liquid product, the nozzle is inherently removable since the nozzle must be removed to fill the volume of the body) in a manner that can direct the contents of the volume from the exit opening of the volume out through a nozzle exit (Fig. 4, ejection orifice 14a, col. 4 line 48-56, the nozzle dispense the content of the volume and eject at the nozzle exit). Therefore, it would have been obvious for one of ordinary skilled in the art to modify the known method of Munro, with the method of Morane, for simplicity and low costs, as taught by Morane (Morane, Col. 1 line 8-21).
The modified Munro is still silent on the body has a fill line.
However, Park teaches a method for nasal delivery (Abstract), comprising of providing a body (Fig. 1, bottle 106), wherein the body has a fill line (par. 0037, “…then water or another liquid may be utilized to fill the rinse bottle 106 to or approximate the fill line 124”). Therefore, it would have been obvious for one of ordinary skilled in the art to further modify the known method of Munro, with the method of Park, and provide a fill line to for adding precise amount of water to the body as taught by Park (Park, par. 0037).
The modified Munro is silent on the nozzle comprises two filters, a droplet filter nearer the volume and a membrane filter nearer the nozzle exit.
However, Martin teaches a method of generating nitric oxide (Abstract), wherein the container comprises of a droplet filter nearer the volume (par. 0195, “NO permeable membrane that prevents aerosol droplets from leaving”) and a membrane filter nearer the nozzle exit (par. 0111) (par. 0111, container 32, volume and nozzle exit shown in Fig. 21; par. 0111, “a filter on a surface of the container 32”). Therefore, it would have been obvious for one of ordinary skilled in the art to further modify the known method of Munro, with the membrane filter and droplet filter of Martin, and position it between the nozzle exit and the volume, to reduce toxicity from undesired particles and to delivery pure nitric oxide as taught by Martin (Martin, par. 0111, 0195).
The modified Munro further discloses providing a reactants packet (Munro, par. 0071, “the nitrite salt and the proton source are in dry powdered admixture or are present as encapsulated particles”), wherein the reactants packet comprises an acidic powder (Munro, par. 0179, “the proton source component or portions of it may be provided for use in the disclosure in dry form, optionally in particulate form such as a powder”) and a nitrite powder (Munro, par. 0096, “the nitrite component, optionally encapsulated or microencapsulated, can be present as a dry powder or crystals”); adding purified water in the volume to the fill line (Munro, par. 0100, “and for the reaction to be initiated by the simple addition of water”; Park, Fig. 1); adding the powders of the reactants packet to the volume (Munro, par. 0071, “the nitrite salt and the proton source are in dry powdered admixture or are present as encapsulated particles which require water (e.g from mucosal membranes contacted by the combination) before the NOx generating reaction will start”); capping the exit opening of the volume at the throat with the cap to seal the contents of the volume (Munro, par. 0313, “the composition may be stored in a hermetically sealed container… after combining the nitrite component and the proton source component”; Munro teaches sealing the content of the volume, the cap of Morane is for sealing the volume, Morane col. 7 line 2-9); mixing the contents of the volume and initiating the production of nitric oxide within the volume (Munro, par. 0185); removing the cap from the throat (Morane Fig. 4 and 5, the cap must be removed prior to dispensing); allowing the volume to vent, after removing the cap, for at least 60 seconds so a headspace of the volume is evacuated as the nitric oxide is produced (Munro par. 0019, “the administration of the reaction mixture to the subject could be done after a period of time after the initiation of the NOx generating reaction, for example about 10 minutes, 30 minutes or one hour or longer after the initiation of the NOx generating reaction”; the prior art discloses initiating the reaction for more than 60 seconds before administering, during this time, nitric oxide gas will generate and inherently evacuate the headspace); positioning the nozzle and the at least one filter over the throat of the body such that the contents of the volume must pass through the at least one filter before going through the nozzle exit (Martin par. 0111, 0195, the prior art teaches filtering the nitric oxide, the claimed limitation is merely the intended use of the prior arts); positioning the nozzle and the at least one filter over the throat of the body such that the contents of the volume must pass through the exit opening of the volume and the at least one filter before going through the nozzle exit (Fig. A, Martin par. 0111, 0195, the prior art teaches filtering the nitric oxide, the claimed limitation is merely the intended use of the prior arts); positioning the nozzle exit near a user's nasal cavity (Morane, col. 4 line 51-53, “In this case the upper part of the central passage is shaped to penetrate the nasal passages where the mists are to be used”); and compressing the body to deliver nitric oxide to the user's nasal cavity (Morane col. 9 line 48-51, “compresses the flexible walls of the container so as to cause the liquid to pass through the tube 116, the spray chamber 118, and be ejected through the orifice 113”).
Regarding Claim 18, the modified Munro discloses the method of claim 17, wherein the reactants packet is dissolvable in the purified water (Munro, par. 0071, 0096, 0179) and the mixing is done at least long enough to dissolve the reactants packet (Munro par. 0019)
Regarding Claim 19, the modified Munro discloses the method of claim 17, wherein the nitric oxide is produced at a rate greater than 3.0 nanomols/sec (See Munro par. 560-0566, Fig. 1 shows the nitric oxide is over 5000 nanomoles at 500 seconds, therefore the rate is within the claimed range).
Regarding Claim 20, the modified Munro discloses the method of Claim 17, wherein between 0 nanomoles and 20000 nanomoles of nitric oxide is generated (Munro, Fig. 1 shows nanomoles of nitric oxide generated over time), but does not explicitly disclose between about 300 nanomoles and about 500 nanomoles of nitric oxide is generated.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the amount of nitric oxide generated of the modified Munro from between 0 to 20000 nanomoles to 300 to 500 nanomoles, as applicant appears to have placed no criticality on the claimed range (See par. 0010 of applicant’s specification) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding Claim 21, the modified Munro discloses the method of claim 17, wherein the cap is configured to removably engage the body and cover the nozzle (Morane, Fig. 4 and 5).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
THIS ACTION IS MADE FINAL. 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 KRIS HANYU GONG whose telephone number is (703)756-5898. The examiner can normally be reached M-F 8:30-4:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brandy Lee can be reached at 571-270-7410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KRIS HANYU GONG/Examiner, Art Unit 3785
/VICTORIA MURPHY/Primary Patent Examiner, Art Unit 3785
