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 Objections
Claims 5, 10, 17 are objected to because of the following informalities:
Claims 5, 10, 17 recites “the headspace of the volume”, should read “a headspace of the volume” for proper antecedent basis.
Appropriate correction is required.
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) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stenzler et al. (US20150157657), hereafter Stenzler, in view of Martin (WO2021040813), hereafter Martin, further in view of Munro et al. (US20220257642).
Regarding Claim 1, Stenzler discloses a method for nasal delivery of nitric oxide (Abstract), comprising: providing a body (Fig. 8, reservoir 12), wherein the body defines a volume (Fig. 8, reservoir 12 defines a volume) and has a throat (Fig. 7, 8, par. 0067, the body is a reservoir connected to a barrel 11, a throat is defined between the reservoir and the barrel) and is compressible (par. 0067, “liquid reservoir 12 may be a collapsible container”); providing a cap, wherein the cap engages with the body in a manner that seals the volume (Fig. 7, 8, par. 0067, the body connects to the housing barrel 11 through a port, the port is a cap that seals the volume); providing a nozzle, wherein the nozzle engages the body at the throat in a manner that can direct the contents of the volume out through a nozzle exit (Fig. 7, spray nozzle 14, par. 0070);
Stenzler 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 Stenzler, 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 Stenzler further discloses the container is filled with nitric oxide releasing solution (Stenzler par. 0067), but is still silent on providing a reactants packet, wherein the reactants packet comprises an acidic powder and a nitrite powder; adding purified water to the volume; adding the powders of the reactants packet to the volume; capping the volume with the cap to seal the contents of the volume; mixing the contents of the volume and initiating the production of nitric oxide;
However, Munro teaches a method for producing nitric oxide (Abstract), comprising of providing a reactants packet (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 (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 (par. 0096, “the nitrite component, optionally encapsulated or microencapsulated, can be present as a dry powder or crystals”); adding purified water to the volume (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 (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 volume with the cap to seal the contents of the volume (par. 0313, “the composition may be stored in a hermetically sealed container… after combining the nitrite component and the proton source component”); mixing the contents of the volume and initiating the production of nitric oxide (par. 0185). Therefore, it would have been obvious for one of ordinary skilled in the art to further modify the known method of Stenzler, with the method of generating nitric oxide of Munro, for separate storage of the reactants and simple procedure of initiating the reaction as taught by Munro (Munro, par. 0100).
The modified Stenzler further teaches removing the cap (Stenzler, Fig. 7-8, prior to delivery, the body is open to fluidly communicate with the nozzle, therefore removing the sealing of the cap); 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 exit near a user's nasal cavity (Stenzler, par. 0057, “The nitric oxide releasing solution may be administered to the respiratory tract of the subject via the nasal cavity or oral cavity of the subject”); and compressing the body to deliver nitric oxide to the user's nasal cavity (par. 0067, “liquid reservoir 12 collapses as the solution is delivered or administered via spray mechanism 16”).
Regarding Claim 2, the modified Stenzler discloses the method of claim 1, wherein the body further comprises a fill line to show how much purified water is added to the volume (Stenzler Fig. 7D shows fill line on the body, using fill lines to show how much water is added is merely the intended use of the fill line).
Regarding Claim 3, the modified Stenzler 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 Stenzler, 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 Stenzler 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 Stenzler 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 Stenzler 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 Stenzler 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 Stenzler 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 Stenzler 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, Stenzler discloses a method for nasal delivery of nitric oxide (Abstract), comprising: providing a body (Fig. 8, reservoir 12), wherein the body defines a volume (Fig. 8, reservoir 12 defines a volume) and has a throat (Fig. 7, 8, par. 0067, the body is a reservoir connected to a barrel 11, a throat is defined between the reservoir and the barrel) and is compressible (par. 0067, “liquid reservoir 12 may be a collapsible container”); providing a cap, wherein the cap engages with the body in a manner that seals the volume (Fig. 7, 8, par. 0067, the body connects to the housing barrel 11 through a port, the port is a cap that seals the volume); providing a nozzle, wherein the nozzle engages the body at the throat in a manner that can direct the contents of the volume out through a nozzle exit (Fig. 7, spray nozzle 14, par. 0070);
Stenzler 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 Stenzler, 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 Stenzler further discloses the container is filled with nitric oxide releasing solution (Stenzler par. 0067), but is still silent on providing a reactants packet, wherein the reactants packet comprises an acidic powder and a nitrite powder; adding purified water to the volume; adding the powders of the reactants packet to the volume; capping the volume with the cap to seal the contents of the volume; mixing the contents of the volume and initiating the production of nitric oxide;
However, Munro teaches a method for producing nitric oxide (Abstract), comprising of providing a reactants packet (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 (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 (par. 0096, “the nitrite component, optionally encapsulated or microencapsulated, can be present as a dry powder or crystals”); adding purified water to the volume (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 (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 volume with the cap to seal the contents of the volume (par. 0313, “the composition may be stored in a hermetically sealed container… after combining the nitrite component and the proton source component”); mixing the contents of the volume and initiating the production of nitric oxide (par. 0185). Therefore, it would have been obvious for one of ordinary skilled in the art to further modify the known method of Stenzler, with the method of generating nitric oxide of Munro, for separate storage of the reactants and simple procedure of initiating the reaction as taught by Munro (Munro, par. 0100).
The modified Stenzler further teaches removing the cap (Stenzler, Fig. 7-8, prior to delivery, the body is open to fluidly communicate with the nozzle, therefore removing the sealing of the cap); 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); 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 exit near a user's nasal cavity (Stenzler, par. 0057, “The nitric oxide releasing solution may be administered to the respiratory tract of the subject via the nasal cavity or oral cavity of the subject”); and compressing the body to deliver nitric oxide to the user's nasal cavity (Stenzler, par. 0067, “liquid reservoir 12 collapses as the solution is delivered or administered via spray mechanism 16”).
Regarding Claim 11, the modified Stenzler discloses the method of claim 10, wherein the body further comprises a fill line to show how much purified water is added to the volume (Stenzler Fig. 7D shows fill line on the body, using fill lines to show how much water is added is merely the intended use of the fill line).
Regarding Claim 12, the modified Stenzler 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 Stenzler, 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 Stenzler 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 Stenzler 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 Stenzler 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 Stenzler discloses The method of Claim 15, wherein the reactants packet is dissolvable in the purified water (Munro, par. 0071, 0096, 0179).
Regarding Claim 17, the modified Stenzler discloses a method for nasal delivery of nitric oxide (Abstract), comprising: providing a body (Fig. 8, reservoir 12), wherein the body defines a volume (Fig. 8, reservoir 12 defines a volume), has a throat (Fig. 7, 8, par. 0067, the body is a reservoir connected to a barrel 11, a throat is defined between the reservoir and the barrel), has a fill line (Fig. 7D) and is compressible (par. 0067, “liquid reservoir 12 may be a collapsible container”); providing a cap, wherein the cap engages with the body in a manner that seals the volume (Fig. 7, 8, par. 0067, the body connects to the housing barrel 11 through a port, the port is a cap that seals the volume); providing a nozzle, wherein the nozzle engages the body at the throat in a manner that can direct the contents of the volume out through a nozzle exit (Fig. 7, spray nozzle 14, par. 0070)
Stenzler 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 Stenzler, 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 Stenzler further discloses the container is filled with nitric oxide releasing solution (Stenzler par. 0067), but is still silent on providing a reactants packet, wherein the reactants packet comprises an acidic powder and a nitrite powder; adding purified water to the volume; adding the powders of the reactants packet to the volume; capping the volume with the cap to seal the contents of the volume; mixing the contents of the volume and initiating the production of nitric oxide;
However, Munro teaches a method for producing nitric oxide (Abstract), comprising of providing a reactants packet (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 (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 (par. 0096, “the nitrite component, optionally encapsulated or microencapsulated, can be present as a dry powder or crystals”); adding purified water in the volume (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 (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 volume with the cap to seal the contents of the volume (par. 0313, “the composition may be stored in a hermetically sealed container… after combining the nitrite component and the proton source component”); mixing the contents of the volume and initiating the production of nitric oxide (par. 0185). Therefore, it would have been obvious for one of ordinary skilled in the art to further modify the known method of Stenzler, with the method of generating nitric oxide of Munro, for separate storage of the reactants and simple procedure of initiating the reaction as taught by Munro (Munro, par. 0100).
The modified Stenzler further discloses adding purified water in the volume to the fill line (a fill line is already disclosed in Stenzler Fig. 7B, after the modification, the fill line would be used as intended to indicate the water volume), removing the cap (Stenzler, Fig. 7-8, prior to delivery, the body is open to fluidly communicate with the nozzle, therefore removing the sealing of the cap); 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); 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 exit near a user's nasal cavity (Stenzler, par. 0057, “The nitric oxide releasing solution may be administered to the respiratory tract of the subject via the nasal cavity or oral cavity of the subject”); and compressing the body to deliver nitric oxide to the user's nasal cavity (Stenzler, par. 0067, “liquid reservoir 12 collapses as the solution is delivered or administered via spray mechanism 16”).
Regarding Claim 18, the modified Stenzler 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 Stenzler 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 Stenzler 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 Stenzler 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).
Conclusion
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/KRIS HANYU GONG/Examiner, Art Unit 3785
/VICTORIA MURPHY/Primary Patent Examiner, Art Unit 3785