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 .
Status of Claims
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 May 21, 2026 has been entered.
Status of Claims
Claims 1-7 and 9-18 are currently pending. Claim 1 and 18 are currently amended. No new subject matter is added.
Response to Arguments
Applicant’s arguments, see pg. 1-3, filed 05/21/2026, with respect to the rejection(s) of claims 1-7 and 9-18 under 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Berry et al. (WO 2007095041 A2).
Specifically, applicant argues that the solid particles in Malaknov’s system would have no reasonable expectation of success to combine with the liquid droplet system of Hill. The applicant further states that Malaknov teaches particle size wherein Hill discloses liquid droplet size. The examiner agrees with applicant the system of Malaknov and Hill are different. Therefore, Berry et al. (WO 2007095041 A2) teaches various delivery device, i.e. metered pump sprays, which is manually operated that when actuated pumps a measured amount of a medicament contained therein through an orifice in the provision of an aerosol of droplets having a respirable size of appropriate average diameter and size distribution to reach the site of action to which the medicament is to be administered upon inhalation of the aerosol (see Col. 18 second paragraph). Furthermore, the first and second components of Hill are not being modified by Berry, but rather the method of aerosolizing the therapeutic aqueous components. The specific components in Hill are not required to be compatible with the components in Berry.
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.
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 1-7 and 9-17 are rejected under 35 U.S.C. 103 as being unpatentable over Hill (US 20200390808 A1) in view of Berry et al. (WO 2007095041 A2), hereinafter referred to as “Berry” and as evidence by (CDC “About Pneumonia", published on October 7th , 2024 on https://www.cdc.gov/pneumonia/about/index.html).
Regarding Claim 1, Hill teaches a method for treating a disease or disorder of the respiratory system of a mammal caused by the presence of a pathogen (an aerosolized wound irrigant may be used for certain pulmonary applications, such as for pneumonia and other respiratory infections, like bronchitis; the aerosolizer for distributing the charged wound irrigant may be, but is not limited to, a nebulizer, atomizer, mister, or other aerosol dispensing device, see Paragraph [0030]) (it is understood that pneumonia is caused by a pathogen, see CDC article "About Pneumonia"), the method comprising:
(a) supplying a two component aqueous therapeutic composition (mixing the first fluid with the second fluid, see Paragraph [0005]) comprising a first component containing at least one transition metal in elemental, ionic, compound, or complexed form (the first fluid including an ion rich compound having free available ions, see Paragraph [0005]; the first fluid may include a source of zinc ions, copper ions, silver ions, or a mixture thereof, see Paragraph [0006]) dissolved and/or dispersed in an aqueous medium (the ion rich compound being in a first fluid, Paragraph [0009]) (it to be understood that the ion rich compound is dissolved/dispersed into an aqueous medium), and a second component containing an aqueous solution of an oxidation-reduction potential raising component (the second fluid including an oxidation-reduction potential increasing compound, see Paragraph [0005]), the oxidation-reduction potential raising component aiding the concentration of transition metal ions of the transition metal of the first component (an ionically charged fluid with an oxidation-reduction higher than the wound site oxidation-reduction potential, the ionically charged fluids increase antimicrobial activity of the wound upon application, it is understood then that the oxidation-reduction potential raising component aids the metal ions by having the redox potential higher than the wound site, see Paragraph [0009]), wherein the aqueous therapeutic composition is configured to treat bacterial and viral pathogens (the charged wound irrigant may further include an antibiotic agent and antiviral agent, see Paragraph [0027]);
(b) aerosolizing the two components of the two-component aqueous therapeutic composition, either separately or following admixture of the two components (the charged wound irrigant may be applied by first combining two solutions retained in separate compartments in a charging portion to form the charged compound, and then distributed via an aerosol irrigator, see Paragraph [0029]),
(c) introducing an aerosol formed in step (b) into the respiratory system of said mammal (applying a mixture may include delivering the ion rich fluids and oxidation-reduction potential increasing fluid to a charging portion to form the mixture, and releasing the mixture onto the potential infection site, see Paragraph [0008]) (an aerosolized wound irrigant may be used for certain pulmonary applications, see Paragraph [0030]).
However, Hill does not explicitly disclose wherein a mean droplet size of the aerosol is less than 2 microns, and wherein the aerosol is capable of reaching an alveolus of the mammal.
Berry teaches a method for treating a respiratory disease medicament suitable for administration as a inhalant including an aqueous carrier (see Abstract) using metered pump spray dispensers comprise a pump which is manually operated that when actuated pumps a measured amount of a medicament contained therein through an orifice in the provision of an aerosol of droplets having a respirable size of appropriate average diameter and size distribution to reach the site of action to which the medicament is to be administered upon inhalation of the aerosol (see pg. 12 last paragraph), and wherein a mean droplet size of the aerosol is less than 2 microns (for administration via oral inhalation, the mass median aerodynamic particle size should be from about 1 micron to about 5 microns, see Col. 12 last line of first paragraph), and wherein the aerosol is capable of reaching an alveolus of the mammal (a respirable size of appropriate average diameter and size distribution to reach the site of action to which the medicament is to be administered, see pg. 12 last paragraph).
Hill and Berry are analogous art because both teach a delivery method utilized to administer medicament.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the method of aerosolizing the two component aqueous therapeutic aerosol of Hill and further including wherein the method includes aerosolizing a medicament with a mean droplet size of less than 2 microns, as taught by Berry. Berry teaches it is beneficial for the delivery device to administer the medicament, for example, by a nebulizer, a metered pump spray, and a pressurized metered dose inhaler, to provide particle-containing droplets having an appropriate size range for deposition onto the desired area of the respiratory system (see Col. 18 second paragraph).
Regarding Claim 2, Hill further teaches wherein the transition metal present in the first component is selected from the group consisting of zinc, silver, copper, cobalt, nickel, and mixtures thereof (the first fluid may include a source of zinc ions, copper ions, silver ions, or a mixture thereof, see Paragraph [0006]).
Regarding Claim 3, Hill further teaches wherein the transition metal is present in aqueous solution having a pH of less than 7 (the solutions are stored separately at either neutral, acidic or basic pH, see Paragraph [0028]).
Regarding Claim 4, Hill further teaches wherein the oxidation-reduction potential raising component is selected from the group consisting of hydrogen peroxide, chlorite, or a mixture thereof (the second fluid includes a source of chlorite ions, see Paragraph [0006]).
Regarding Claim 5, Hill further teaches wherein the oxidation-reduction potential raising component comprises a soluble chlorite (the second fluid includes a source of chlorite ions, see Paragraph [0006]) (it is to be understood the chlorite is soluble as it is in solution).
Regarding Claim 6, Hill further teaches wherein the first component and the second component are separately stored (keeping a first fluid separate from a second fluid in a container, see Paragraph [0005]), combined immediately prior to aerosolization)(applying a mixture may include delivering the ion rich fluid and oxidation-reduction potential increasing fluids to a charging portion to form the mixture, and releasing the mixture onto the potential infection site, see Paragraph [0008]), and aerosolized (an aerosolized wound irrigant may be used for certain pulmonary applications, see Paragraph [0030]).
Regarding Claim 7 Hill further teaches wherein a further active substance is present in one of the two components, or in a separate component, the active substance being selected from the group consisting of antimicrobials, vitamins, antivirals, and desensitizing agents (the first fluids and/or the second fluids may further include an antibiotic compound, an antiseptic compound, or both, see Paragraph [0006]).
Regarding Claim 9, Hill and Berry teaches all of the limitations as discussed above in claim 1 and Berry further teaches wherein a mean droplet size of the aerosol is between 0.5 µm and 2 µm (for administration via oral inhalation, the mass median aerodynamic particle size should be from about 1 micron to about 5 microns, see Col. 12 last line of first paragraph; particle size can be 1 micron).
Regarding Claim 10, Hill further teaches wherein at least one of the first component and second component further comprises ascorbic acid (the vitamin C may be any form of vitamin C such as, but not limited to, ascorbic acid.. The vitamin C component may be included in either or both solutions prior to charging, see Paragraph [0039]).
Regarding Claim 11, Hill teaches all of the limitations in claim 1 and Hill further teaches an aerosol suitable for treating a disease or disorder of a mammalian respiratory system (aerosol for treating pneumonia, as described in claim 1),
the droplets comprising a two component aqueous therapeutic composition as described in claim 1 (it is understood the method as described in claim 1 will result in aerosol droplets), each component of the aqueous therapeutic composition being contained in the same droplets and/or in separate droplets of the aerosol (applying a mixture may include delivering the ion rich fluids and oxidation-reduction potential increasing fluid to a charging portion to form the mixture, and releasing the mixture onto the potential infection site, see Paragraph [0008]) (an aerosolized wound irrigant may be used for certain pulmonary applications, see Paragraph [0030]) (it is understood that as the components are mixed beforehand that they are contained in the same droplets after aerosolizing).the aerosol
However, Hill does not explicitly disclose wherein the aerosol containing droplets have a mean droplet size less than 2 µm.
Berry teaches a method for treating a respiratory disease medicament suitable for administration as a inhalant including an aqueous carrier (see Abstract) using metered pump spray dispensers comprise a pump which is manually operated that when actuated pumps a measured amount of a medicament contained therein through an orifice in the provision of an aerosol of droplets having a respirable size of appropriate average diameter and size distribution to reach the site of action to which the medicament is to be administered upon inhalation of the aerosol (see pg. 12 last paragraph), and wherein a mean droplet size of the aerosol is less than 2 microns (for administration via oral inhalation, the mass median aerodynamic particle size should be from about 1 micron to about 5 microns, see Col. 12 last line of first paragraph).
Hill and Berry are analogous art because both teach a delivery method utilized to administer medicament.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the method of aerosolizing the two component aqueous therapeutic aerosol of Hill and further including wherein the method includes aerosolizing a medicament with a mean droplet size of less than 2 microns, as taught by Berry. Berry teaches it is beneficial for the delivery device to administer the medicament, for example, by a nebulizer, a metered pump spray, and a pressurized metered dose inhaler, to provide particle-containing droplets having an appropriate size range for deposition onto the desired area of the respiratory system (see Col. 18 second paragraph).
Regarding Claim 12, Hill and Berry teaches all of the limitations as discussed above in claim 10 and Hill further teaches one or more antibacterial, antiviral, vitamin, or desensitizing agent components, supplied as a separate component or in one or both of said first and second components (the first fluids and/or second fluid may further include an antibiotic compound, antiseptic compound, or both, see Paragraph [0006]) (it is to be understood that the aerosol will contain this as well).
Regarding Claim 13, Hill and Berry teaches all of the limitations as discussed above in claim 10 and Hill further teaches wherein the transition metal is zinc (the first fluids may include a source of zinc ions, see Paragraph [0006]).
Regarding Claim 14, Hill and Berry teaches all of the limitations as discussed above in claim 12 and Hill further teaches wherein zinc is present in the form of Zn2+ ions (the first fluids includes zinc chloride (ZnCl2); it is understood that ZnCl2 includes Zn2+ ions, see Paragraph [0038]).
Regarding Claim 15, Hill and Berry teaches all of the limitations as discussed above in claim 10 and Hill further teaches wherein the oxidation-reduction potential raising component comprises chlorite ions (the second fluid includes a source of chlorite ions, see Paragraph [0006]).
Regarding Claim 16, Hill and Berry teaches all of the limitations as discussed above in claim 14 and Hill further teaches wherein the second component is maintained at a neutral or basic pH (the solutions are stored separately at either neutral, acidic, or basic pH, see Paragraph [0028]).
Regarding Claim 17, Hill and Berry teaches all of the limitations as discussed above in claim 10 and Hill further teaches the droplets further comprising ascorbic acid (the vitamin C may be any form of vitamin C such as, but not limited to, ascorbic acid.. the vitamin C component may be included in either or both solutions prior to charging, see Paragraph [0039]) (it is to be understood that the droplets will also contain ascorbic acid).
Regarding Claim 18, Hill teaches a method for treating a disease or disorder of the respiratory system of a mammal caused by the presence of a virus (an aerosolized wound irrigant may be used for certain pulmonary applications, such as for pneumonia and other respiratory infections, like bronchitis; the aerosolizer for distributing the charged wound irrigant may be, but is not limited to, a nebulizer, atomizer, mister, or other aerosol dispensing device, see Paragraph [0030]) (it is understood that pneumonia is caused by a pathogen, see CDC article "Causes of Pneumonia"), the method comprising:
(a) determining an effective concentration of a first component containing at least one transition metal in elemental, ionic, compound, or complexed form, dissolved and/or dispersed in an aqueous medium (the first fluid including an ion rich compound having free available ions, see Paragraph [0005]; the first fluid may include a source of zinc ions, copper ions, silver ions, or a mixture thereof, see Paragraph [0006]; the ion rich compound being in a first fluid, Paragraph [0009]; it to be understood that the ion rich compound is dissolved/dispersed into an aqueous medium), and of a second component containing an aqueous solution of an oxidation-reduction potential raising component (the second fluid including an oxidation-reduction potential increasing compound, see Paragraph [0005]), the oxidation-reduction potential raising component aiding the concentration of transition metal ions of the transition metal of the first component (an ionically charged fluid with an oxidation-reduction higher than the wound site oxidation-reduction potential, the ionically charged fluids increase antimicrobial activity of the wound upon application, it is understood then that the oxidation-reduction potential raising component aids the metal ions by having the redox potential higher than the wound site, see Paragraph [0009]);
(b) supplying a two component aqueous therapeutic composition comprising the first and the second component (mixing the first fluid with the second fluid, see Paragraph [0005]);
(c) aerosolizing the two components of the two component aqueous therapeutic composition, either separately or following admixture of the two components (the charged wound irrigant may be applied by first combining two solutions retained in separate compartments in a charging portion to form the charged compound, and then distributed via an aerosol irrigator, see Paragraph [0029]); and
(d) introducing the aerosol formed in step (c) into the respiratory system of the mammal (applying a mixture may include delivering the ion rich fluids and oxidation-reduction potential increasing fluid to a charging portion to form the mixture, and releasing the mixture onto the potential infection site, see Paragraph [0008]) (an aerosolized wound irrigant may be used for certain pulmonary applications, see Paragraph [0030]), the aerosol being capable of reducing an infectivity of the virus (the charged wound irrigant increases the redox potential at the wound site, thus reducing bacterial proliferation and preventing/curing/fighting infections, see Paragraph [0075])
However, Hill does not explicitly disclose treating a disease or disorder of the respiratory system of a mammal caused by the presence of a virus and a two component aqueous therapeutic composition to form an aerosol with a mean particle size between 0.5 and 2 um.
Berry teaches a method for treating a viral respiratory disease medicament suitable for administration as a inhalant including an aqueous carrier (see Abstract; pg. 1 paragraph 2) using metered pump spray dispensers comprise a pump which is manually operated that when actuated pumps a measured amount of a medicament contained therein through an orifice in the provision of an aerosol of droplets having a respirable size of appropriate average diameter and size distribution to reach the site of action to which the medicament is to be administered upon inhalation of the aerosol (see pg. 12 last paragraph), and a two component aqueous therapeutic composition (see pg. 11 paragraph 3) to form an aerosol with a mean particle size between 0.5 and 2 um (for administration via oral inhalation, the mass median aerodynamic particle size should be from about 1 micron to about 5 microns, see Col. 12 last line of first paragraph; mean particle size can be 1 micron).
Hill and Berry are analogous art because both teach a delivery method utilized to administer medicament.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the method of aerosolizing the two component aqueous therapeutic aerosol of Hill and further including wherein the method includes aerosolizing a medicament with a mean droplet size between 0.5 and 2 um, as taught by Berry. Berry teaches it is beneficial for the delivery device to administer the medicament, for example, by a nebulizer, a metered pump spray, and a pressurized metered dose inhaler, to provide particle-containing droplets having an appropriate size range for deposition onto the desired area of the respiratory system (see Col. 18 second paragraph).
However, Hill and Berry do not explicitly disclose the aerosol being capable of reducing an infectivity of the virus by greater than 50% within one hour after introducing the aerosol.
Hill discloses that the aerosol is capable of reducing an infectivity of the virus after introducing the aerosol. As described in Paragraph [0038] and [0039], the aerosol mixture comprise the specific mixture composition of zinc chloride, ascorbic acid, and sodium chlorite, as such the aerosol composition is disclosed to be a result effective variable in that changing the composition of the mixture changes the ability to reduce an infectivity of the virus which affects the application time and results. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success to formulate the claimed range, as it involves adjusting composition ranges disclosed to require adjustment. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of Hill by making the aerosol being capable of reducing an infectivity of the virus by greater than 50% within one hour after introducing the aerosol as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIC RASSAVONG whose telephone number is (408)918-7549. The examiner can normally be reached Monday - Friday 9:00am-5:30pm PT.
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/ERIC RASSAVONG/ (6/12/2026)Examiner, Art Unit 3781
/ANDREW J MENSH/Primary Examiner, Art Unit 3781
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