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
Claims 1-7 and 9-18 are currently pending. No new subject matter is added.
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 Malaknov et al. (US 20070190163 A1), hereinafter referred to as “Malaknov” 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.
Malaknov teaches microspheres being produced by contacting an aqueous solution of a protein or other macromolecule with an organic solvent and a counterion, and chilling the solution (see Abstract); wherein the macromolecules that can be used to form microspheres according to the methods provided herein include a variety of therapeutic agents, diagnostic agents, nutritional agents and other active agents including anti-infective agents and antiviral agents (see Paragraph [0114]); comprising a first and second components dissolved and/or dispersed in an aqueous medium (see Paragraph [0152]); and
aerosolizing the two components of a two-component aqueous therapeutic composition, either separately or following admixture of the two components wherein the compositions also can formulated for pulmonary or ophthalmic administration such as inhalation (see Paragraph [0039]), wherein a mean droplet size of the aerosol is less than 2 µm (for pulmonary administration to the throat, trachea and bronchi, the size can be from about or at 0.5 microns to about 2.0 microns, see Paragraph [0146]) and wherein the aerosol is capable of reaching an alveolus of the mammal (it is to be understood that pulmonary administration to the throat, trachea and bronchi with the stated micron size would reach the alveolus).
Hill and Malaknov are analogous art because both deal with an aerosolized wound irrigant used for bacterial and viral infections.
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 first and second components of Hill and further include wherein mean droplet size of the aerosol is less than 2 µm, as taught by Malaknov. Malaknov teaches the sizes of the microspheres obtained by the methods provided herein can be controlled by adjusting parameters including type and concentration of organic solvent, protein or macromolecule concentration, ionic strength, counterion type and concentration, rate and time of cooling, to provide microspheres in a wide range of sizes that can deliver therapeutic agents via a desired route including pulmonary subcutaneous, intramuscular, intravenous and other routes that render active components of inhalant medicines for human subjects. (see Paragraph [0097]).
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 Malaknov teaches all of the limitations as discussed above in claim 1 and Malaknov further teaches wherein a mean droplet size of the aerosol is between 0.5 µm and 2 µm (for pulmonary administration to the throat, trachea and bronchi, the microsphere size can be from about or at 0.5 microns to about 2.0 microns, see Paragraph [0146]).
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.
Malaknov teaches microspheres being produced by contacting an aqueous solution of a protein or other macromolecule with an organic solvent and a counterion, and chilling the solution (see Abstract); wherein the macromolecules that can be used to form microspheres according to the methods provided herein include a variety of therapeutic agents, diagnostic agents, nutritional agents and other active agents including anti-infective agents and antiviral agents (see Paragraph [0114]); comprising a first and second components dissolved and/or dispersed in an aqueous medium (see Paragraph [0152]); and
aerosolizing the two components of a two-component aqueous therapeutic composition, either separately or following admixture of the two components wherein the compositions also can formulated for pulmonary or ophthalmic administration such as inhalation (see Paragraph [0039]), wherein a mean droplet size of the aerosol is less than 2 µm (for pulmonary administration to the throat, trachea and bronchi, the size can be from about or at 0.5 microns to about 2.0 microns, see Paragraph [0146]).
Hill and Malaknov are analogous art because both deal with an aerosolized wound irrigant used for bacterial and viral infections.
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 first and second components of Hill and further include wherein mean droplet size of the aerosol is less than 2 µm, as taught by Malaknov. Malaknov teaches the sizes of the microspheres obtained by the methods provided herein can be controlled by adjusting parameters including type and concentration of organic solvent, protein or macromolecule concentration, ionic strength, counterion type and concentration, rate and time of cooling, to provide microspheres in a wide range of sizes that can deliver therapeutic agents via a desired route including pulmonary subcutaneous, intramuscular, intravenous and other routes that render active components of inhalant medicines for human subjects (see Paragraph [0097]).
Regarding Claim 12, Hill and Malaknov 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 Malaknov 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 Malaknov 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 Malaknov 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 Malaknov 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 Malaknov 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.
Malaknov teaches microspheres being produced by contacting an aqueous solution of a protein or other macromolecule with an organic solvent and a counterion, and chilling the solution (see Abstract); wherein the macromolecules that can be used to form microspheres according to the methods provided herein include a variety of therapeutic agents, diagnostic agents, nutritional agents and other active agents including anti-infective agents and antiviral agents (see Paragraph [0114]) to treat viruses (the microparticles provided herein can be used to treat viruses, see Paragraph [0466]); comprising a first and second components dissolved and/or dispersed in an aqueous medium (see Paragraph [0152]); and
aerosolizing the two components of a two-component aqueous therapeutic composition, either separately or following admixture of the two components wherein the compositions also can formulated for pulmonary or ophthalmic administration such as inhalation (see Paragraph [0039]) and the two component aqueous therapeutic composition to form an aerosol with a mean particle size between 0.5 and 2 um (for pulmonary administration to the throat, trachea and bronchi, the size can be from about or at 0.5 microns to about 2.0 microns, see Paragraph [0146]).
Hill and Malaknov are analogous art because both deal with an aerosolized wound irrigant used for bacterial and viral infections.
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 first and second components of Hill and further include wherein the mean particle size is between 0.5 and 2 um, as taught by Malaknov. Malaknov teaches the sizes of the microspheres obtained by the methods provided herein can be controlled by adjusting parameters including type and concentration of organic solvent, protein or macromolecule concentration, ionic strength, counterion type and concentration, rate and time of cooling, to provide microspheres in a wide range of sizes that can deliver therapeutic agents via a desired route including pulmonary subcutaneous, intramuscular, intravenous and other routes that render active components of inhalant medicines for human subjects (see Paragraph [0097]).
However, Hill and Malaknov 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).
Response to Arguments
Applicant's arguments filed 09/17/2025 have been fully considered but they are not persuasive.
Specifically, Applicant argues that Malaknov is directed to solid microspheres formed through precipitation and freeze-drying of proteins or other macromolecules and since Hill discloses fully aqueous composition, a person skilled in the art would not have looked to a disclosure regarding the size of solid particles in developing treatment involving a fully liquid composition with no phase separation and no distillation down to a solid or even semi-solid particle. Applicant further argues for this reason the references are not physically combinable.
In response to applicant's argument that Hills liquid system would not be able to modified by Malaknov’s solid-state microparticle teaching, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). In this case, Malaknov clearly suggest a method for treating a disease of the respiratory system by administering an inhalant therapeutic agent via a desired route of the pulmonary system and requiring a specific size through the alveolus. The combination of the claims are not directed towards changing the aqueous solution of Hill into a solid microsphere of Malaknov, but rather suggesting that the method of delivery of the aqueous solution can be sub 2 microns in order to reach the alveolus of a patient.
Specifically, Applicant argues that Malaknov’s microsphere particle size are improperly equated with aerosol droplet size in aqueous liquids. The applicant further states that they are distinct physical phenomena governed by entirely different principles and therefore cannot be combined.
The examiner respectfully disagrees that the prior art cannot be combined. As stated previously, the combination of Malaknov is directed towards the method of application of a therapeutic agent into the alveolus of a patient, regardless of the agent being a solid or liquid. Malaknov teaches that by controlling the size of the therapeutic agent, you can administer the agent into the desired route. Therefore, it would be reasonable to suggest that the therapeutic agent in Hill can be modified to control the size of the agent to be small enough to administer into the alveolus. Claim 1 remains rejected in view of Hill and Malaknov.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Nyce (US 20090258046 A1) teaches a method for treating a disease or disorder of the respiratory system of a mammal caused by the presence of a pathogen (see Abstract); the method comprising:
supplying a two component aqueous therapeutic composition (the compositions of the invention are prepared by uniformly and intimately admixing the active compound with a liquid or finely divided solid carrier, see Paragraph [0064]) comprising a first component (a first active agent selected from a non-glucocorticoid steroid or analogues, a ubiquinone, or salts thereof, see Abstract) and second component (a second active agent comprising a bronchodilator, see Abstract);
aerosolizing the two components of the two component aqueous therapeutic composition (see Paragraph [0070]); and
introducing the aerosol into the respiratory system of the mammal (administered into the respiratory system either by inhalation, respiration, nasal administration or intrapulmonary instillation (into the lungs) , see Paragraph [0070]), wherein the aerosol has a mean droplet size of less than 2 microns (particles being as small as 0.05 microns in size, see Paragraph [0070]), and wherein the aerosol is capable of reaching an alveolus of the mammal (the formulation may comprise respirable or inhalable liquid or solid particles of the active compound that, in accordance with the present invention, include respirable or inhalable particles of a size sufficiently small to pass through the mouth and larynx upon inhalation and continue into the bronchi and alveoli of the lungs, see Paragraph [0070]).
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 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/ (1/13/2026)Examiner, Art Unit 3781
/PHILIP R WIEST/Primary Examiner, Art Unit 3781