FINAL 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
Receipt is acknowledged of the claim amendments filed on 20 January 2026.
Claims 1-4, 6-11 and 13 have been amended.
Claim 12 is cancelled.
Claims 14-20 remains withdrawn from consideration.
Claim 21 has been added.
Claims 1-11, 13 and 21 are presented for examination herein to the extent that the virus is SARS-CoV-2, e.g., applicant's elected species.
Information Disclosure Statement
The information disclosure statement (IDS) filed 03/14/2026 and 04/13/2026 have been considered by the Examiner. A signed and initialed copy of the IDS is included with the instant Office Action.
Rejections Withdrawn
The rejection of claims 1-13 under U.S.C. 112(a), due to scope of enablement, is withdrawn in view of the claim amendments filed on 20 January 2026.
The rejection of claims 1-13 under U.S.C. 112(a), as failing to comply with the written description requirement, is withdrawn in view of the claim amendments filed on 20 January 2026.
Rejection Modified as Necessitated by the Claim Amendments
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over HSUEH (US 2019/0091436 A1, publication date of 28 March 2019) in view of NTYONGA-PONO (“COVID-19 infection and oxidative stress: an underexplored approach for prevention and treatment?”, Pan Africa Medical Journal, 35(2):12, 2 pages, published 29 April 2020) and CISNEROS (US 2011/0059189 A1, publication of 10 March 2011) as evidenced by the instant specification.
Hsueh (US 2019/0091436 A1, publication date of 28 March 2019) is primarily directed towards systems and methods for therapeutic gas (e.g., hydrogen gas) delivery for personal medical consumption (abstract).
Regarding claims 1 and 5, Hsueh discloses that ionized water including water infused or treated with hydrogen gas, exhibit anti-oxidant properties, which help reduce free radicals in the body and offer other health benefits. Hsueh discloses that beneficial effects including anti-oxidant properties and beneficial effects on immune system (paragraph [0003]). Hsueh discloses that beneficial effects of hydrogen gas including infused in drinking water includes immune-boosting (paragraphs [0013-0014]). Hsueh discloses that it is generally believed that treated water (e.g., hydrogen gas-enriched water) must develop an ORP of at least -250 millivolts (e.g., negatively charged) to produce health benefits (paragraph [0029]).
Hsueh does not specifically teach administration of a composition comprising hydrogen gas (e.g., negatively charged reducing gas) infused in water to an individual in need of treating or preventing a viral infection, specifically SARS-CoV-2 (e.g., applicant's elected species) or a symptom thereof. Hsueh does not specifically teach that the water includes an alkaline cationic silicate. The deficiencies are made up for by the teachings of Ntyonga-Pono and Cisneros.
Ntyonga-Pono is primarily directed towards use of anti-oxidants for prevention and treatment of COVID-19 (e.g., SARS-CoV-2) (see entire publication).
Regarding claims 1 and 12, Ntyonga-Pono teaches that viral infections lead to an increase in production of free radicals and depletion of antioxidants (second page, first column, first paragraph). Ntyonga-Pono teaches that “cytokine storm” in COVID-19 leads to production of ROS (reactive oxygen species) (second page, first column, first paragraph). Ntyonga-Pono teaches that elders and people suffering of diabetes, hypertension and cardiovascular diseases have already a state of oxidative stress, and a viral infection will increase the oxidative stress, giving one possible explanation of the severity of COVID-19 in these categories of patients (second page, first column, third paragraph). Ntyonga-Pono teaches suggestion for prevention and treatment of COVID-19 infection in frail people is to reduce the level of oxidative stress by providing them with substances that increase their antioxidant system with antioxidant compounds including glutathione which is an antioxidant and that also has an immunomodulating effect (second page, first column, last paragraph).
Cisneros is primarily directed towards a modified sodium silicate composition and methods of including treating viral infections using the modified sodium silicate composition (abstract).
Regarding claim 1, Cisneros teaches a silicon-based alkaline composition (e.g., modified sodium silicate/alkaline cationic silicate (paragraph [0010])) for including inhibiting oxidative stress (paragraph [0002]). As evidenced by the instant specification, alkaline cationic silicate includes an alkaline sodium silicate complex (SSC) that is described in Cisneros (e.g., modified sodium silicate/alkaline cationic silicate) (paragraph [0051] of the instant specification). Cisneros teaches that the composition can be used to treat including viral infection in a subject in need thereof, by providing one or more anti-viral effects including increasing nitric oxide dependent anti-viral effects; inhibiting enzymes involved in viral assembly; causing changes in viral carbohydrate composition; and inhibiting viral enzymes responsible for transcribing RNA to DNA (paragraph [0014]). Cisneros teaches that the composition is an aqueous solution (paragraph [0057]). Cisneros teaches administering to a patient to treat a viral infection or preventing a viral infection an effective amount of the silicon-based alkaline composition (e.g., an alkaline cationic silicate) (paragraphs [0072-0073]). Cisneros teaches that treatment with the modified sodium silicate (e.g., an alkaline cationic silicate) resulted in increased antioxidant response (paragraph [0136]).
Regarding claim 5, Cisneros teaches dosages comprise 0.01 to 100 mg/kg body weight for periods of time necessary to achieve the desired result (paragraph [0081]). Cisneros teaches that administration of the same compound of the invention may be repeated and the administrations may be separated by including at least 1 day (paragraph [0111]). Cisneros teaches that the silicon-based alkaline composition may be administered one or more times (paragraph [0112]). Cisneros teaches that the specific density of silicon-based alkaline (e.g., alkaline cationic silicate) is in the range of 1.24 to 1.26 (paragraph [0065]). A dosage of 5mg/kg (inside the range of Cisneros) silicon-based alkaline (e.g., alkaline cationic silicate) is calculated to be about 0.28 ml (Calculation: Volume (ml) = Mass (mg) / (Density in g/ml*1000); 350mg (e.g., for 70 kg person, 5mg*70= 350mg) / (1.24 * 1000) ~ 0.28 ml). Cisneros teaches modified sodium silicate (e.g., alkaline cationic silicate) diluted in DDI water including 1:100 for composition to reduce free radicals (paragraph [0184]). A composition with about 0.28 ml of modified sodium silicate (e.g., alkaline cationic silicate) would have a total volume of about 28.28 ml (e.g., 1:100 = .28 (modified sodium silicate (e.g., alkaline cationic silicate)) : 28 (water)). Therefore, the amount of the composition administered which includes about 28.28 ml overlaps the range of “10-100 mL” recited in claim 5. Thus, the claim is rendered prima facie obvious. See 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). See also MPEP 2144.05. Cisneros does not specifically teach that three or four times daily for at least a week. However, it is obvious for one of ordinary skill in the art to determine the optimum administrations and period of time necessary to achieve a desired result of including desired antiviral and antioxidant effect, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
It would have been prima facie obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to treat or prevent COVID-19 (e.g., SARS-CoV-2) by administering to an individual in need thereof an aqueous solution comprising water, alkaline cationic silicate silicate (e.g., an alkaline cationic silicate) and infused hydrogen gas (e.g., reducing gas); wherein the aqueous solution has an ORP of at least -250 millivolts (e.g., negatively charged reducing gas). The person of ordinary skill in the art would have been motivated to make those modifications because: 1) an hydrogen enriched water with an ORP of at least -250 millivolts (e.g., negatively charged reducing gas) provides benefits of including providing antioxidant properties and immune-boosting which are effects that Ntyonga-Pono suggests are beneficial for use in prevention and treatment of COVID-19 (e.g., SARS-CoV-2); and 2) alkaline cationic silicate silicate (e.g., e.g., alkaline cationic silicate) is another antioxidant that can be added for the same purpose of providing antioxidant effects and that will additionally provide anti-viral prevention and treatment properties as taught by Cisneros. The person of ordinary skill in the art would have reasonably expected success because Hsueh discloses that ionized water including water infused or treated with hydrogen gas, exhibit anti-oxidant properties, which help reduce free radicals in the body and offer other health benefits. Hsueh discloses that beneficial effects including anti-oxidant properties and beneficial effects on immune system (paragraph [0003]). Hsueh discloses that beneficial effects of hydrogen gas including infused in drinking water includes immune-boosting (paragraphs [0013-0014]). Hsueh discloses that it is generally believed that treated water (e.g., hydrogen gas-enriched water) must develop an ORP of at least -250 millivolts (e.g., negatively charged) to produce health benefits (paragraph [0029]). Ntyonga-Pono teaches that viral infections lead to an increase in production of free radicals and depletion of antioxidants (second page, first column, first paragraph). Ntyonga-Pono teaches that “cytokine storm” in COVID-19 leads to production of ROS (reactive oxygen species) (second page, first column, first paragraph). Ntyonga-Pono teaches that elders and people suffering of diabetes, hypertension and cardiovascular diseases have already a state of oxidative stress, and a viral infection will increase the oxidative stress, giving one possible explanation of the severity of COVID-19 in these categories of patients (second page, first column, third paragraph). Ntyonga-Pono teaches suggestion for prevention and treatment of COVID-19 infection in frail people is to reduce the level of oxidative stress by providing them with substances that increase their antioxidant system with antioxidant compounds including glutathione which is an antioxidant and that also has an immunomodulating effect (second page, first column, last paragraph). Cisneros teaches a silicon-based alkaline composition (e.g., modified sodium silicate/alkaline cationic silicate (paragraph [0010])) for including inhibiting oxidative stress (paragraph [0002]). As evidenced by the instant specification, alkaline cationic silicate includes an alkaline sodium silicate complex (SSC) that is described in Cisneros (e.g., modified sodium silicate/alkaline cationic silicate) (paragraph [0051] of the instant specification). Cisneros teaches that the composition can be used to treat including viral infection in a subject in need thereof, by providing one or more anti-viral effects including increasing nitric oxide dependent anti-viral effects; inhibiting enzymes involved in viral assembly; causing changes in viral carbohydrate composition; and inhibiting viral enzymes responsible for transcribing RNA to DNA (paragraph [0014]). Cisneros teaches that the composition is an aqueous solution (paragraph [0057]).
Claims 2-4 are rejected under 35 U.S.C. 103 as being unpatentable over Hsueh in view of Ntyonga-Pono and Cisneros as evidenced by the instant specification as applied to claims 1 and 5 above, and further in view of KATAYAMA (US 2012/0256329 A1, publication date of 11 October 2012).
Regarding claims 2-4, the method of claim 1 is described above in section 8.
Regarding claim 2, Hsueh discloses that water injected (e.g., infusing) with hydrogen gas produces water with an ORP level of at least -250 (negatively charged) millivolts (e.g., reducing gas reacts with the aqueous solution to produce a reducing liquid having the oxidation reduction potential (ORP) value of about -100 mV or more negative) (paragraph [0029]).
Hsueh, Ntyonga-Pono and Cisneros as evidenced by the instant specification does not specifically teach that the infusing involves mixing under turbulent conditions. Hsueh, Ntyonga-Pono and Cisneros as evidenced by the instant specification does not specifically teach that mixing occurs at a flow rate of 100-500 liters (e.g., claim 3) or 25-75 liters (e.g., claim 4) of reducing gas per hour under turbulent conditions, for at least five minutes. The deficiency is made up for by the teachings of Katayama.
Katayama is primarily directed towards a processing apparatus which is capable of performing uniform dispersion, dissolution, solubilization, emulsification of gas into liquid (abstract).
Regarding claims 2-4, Katayama teaches a process for including gas dissolution in liquid that includes pressurization, compression, stirring, mixing, centrifugation, and cavitation (e.g., mixing under turbulent conditions) in one process and provides a stably uniformized fluid (paragraphs [0039-0040]). Katayama teaches hydrogen gas at a flow rate of 1.5 L/min (e.g., 90 L/hour) and the process ending after 10 minutes (paragraph [0144]). Katayama teaches that cavitation effect worked by entrainment of gas to cause finer emulsification (paragraph [0156]). Katayama teaches infusing hydrogen gas in a rate of 1 L per minute (e.g., 60 L/hour) for 10 minutes (paragraph [0162]).
It would have been prima facie obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to treat or prevent COVID-19 (e.g., SARS-CoV-2) by administering to an individual in need thereof an aqueous solution comprising water, modified sodium silicate (e.g., alkaline cationic silicate) and infused hydrogen gas (e.g., reducing gas); wherein the aqueous solution has an ORP of at least -250 (negatively charged) millivolts; wherein the hydrogen gas is infused at a flow rate of including 1 L per minute (e.g., 60 L/hour) or 1.5 L/min (e.g., 90 L/hour) for 10 minutes in a process that includes cavitation (e.g., turbulent mixing) to provide a uniform and stable composition. The person of ordinary skill in the art would have been motivated to make those modifications to produce a uniform and stable composition by using the process taught by Katayama that includes cavitation (e.g., turbulent mixing) with infusing hydrogen gas at a flow rate of including 1 L per minute (e.g., 60 L/hour) or 1.5 L/min (e.g., 90 L/hour) for 10 minutes. The person of ordinary skill in the art would have reasonably expected success because Katayama teaches a process for including gas dissolution in liquid that includes pressurization, compression, stirring, mixing, centrifugation, and cavitation (e.g., mixing under turbulent conditions) in one process and provides a stably uniformized fluid (paragraphs [0039-0040]). Katayama teaches hydrogen gas at a flow rate of 1.5 L/min (e.g., 90 L/hour) and the process ending after 10 minutes (paragraph [0144]). Katayama teaches that cavitation effect worked by entrainment of gas to cause finer emulsification (paragraph [0156]). Katayama teaches infusing hydrogen gas in a rate of 1 L per minute (e.g., 60 L/hour) for 10 minutes (paragraph [0162]).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Hsueh in view of Ntyonga-Pono and Cisneros as evidenced by the instant specification as applied to claims 1and 5 above, and further in view of KATAYAMA (US 2012/0256329 A1, publication date of 11 October 2012) and DORFMAN (“AN ANTIVIRAL ANTISEPTIC GARGLE & NASAL SPRAY MAY HELP HEALTHY PEOPLE AVOID CORONAVIRUS INFECTION”, electronic publication obtained from URL: https://dental-edu.com/blog/cv/, obtained on 30 August 2025, publication date of 1 April 2020).
Regarding claim 6, the method of claim 1 is described above in section 8.
Regarding claim 6, Cisneros teaches dosages comprise 0.01 to 100 mg/kg body weight for periods of time necessary to achieve the desired result (paragraph [0081]). Cisneros teaches that administration of the same compound of the invention may be repeated and the administrations may be separated by including at least 1 day (paragraph [0111]). Cisneros teaches that the silicon-based alkaline composition may be administered one or more times (paragraph [0112]). Cisneros teaches that the specific density of silicon-based alkaline (e.g., modified sodium silicate/alkaline cationic silicate) is in the range of 1.24 to 1.26 (paragraph [0065]). A dosage of 10mg/kg (inside the range of Cisneros) silicon-based alkaline (e.g., modified sodium silicate/alkaline cationic silicate) is calculated to be about 0.56 ml (Calculation: Volume (ml) = Mass (mg) / (Density in g/ml*1000); 700mg (e.g., for 70 kg person, 10mg*70= 700mg) / (1.24 * 1000) ~ 0.56 ml). Cisneros teaches modified sodium silicate (e.g., alkaline cationic silicate) diluted in DDI water including 1:100 for composition to reduce free radicals (paragraph [0184]). A composition with about 0.56 ml of modified sodium silicate (e.g., alkaline cationic silicate) would have a total volume of about 56.56 ml (e.g., 1:100 = .56 (modified sodium silicate (e.g., alkaline cationic silicate)) : 56 (water)). Therefore, the amount of the composition administered which includes about 56.56 ml and the amount of (modified sodium silicate (e.g., alkaline cationic silicate) of including 0.56 ml overlaps the range of “10-100 mL” and “0.1 to 5 mL”, respectively, recited in claim 5. Thus, the claim is rendered prima facie obvious. See also MPEP 2144.05 (quoted supra).
Hsueh, Ntyonga-Pono and Cisneros as evidenced by the instant specification does not specifically teach that the composition is administered by rinsing or gargling and that the composition is prepared with mixing reducing gas at a flow rate of 25-75 liters per hour under turbulent conditions for at least five minutes. The deficiencies are made up for by the teachings of Katayama and Rennie.
Katayama is primarily directed towards a processing apparatus which is capable of performing uniform dispersion, dissolution, solubilization, emulsification of gas into liquid (abstract).
Regarding claim 6, Katayama teaches a process for including gas dissolution in liquid that includes pressurization, compression, stirring, mixing, centrifugation, and cavitation (e.g., mixing under turbulent conditions) in one process and provides a stably uniformized fluid (paragraphs [0039-0040]). Katayama teaches that cavitation effect worked by entrainment of gas to cause finer emulsification (paragraph [0156]). Katayama teaches infusing hydrogen gas in a rate of 1 L per minute (e.g., 60 L/hour) for 10 minutes (paragraph [0162]).
Dorfman is primarily directed towards use of antiviral gargle and nasal spray to help healthy people avoid coronavirus infection (see entire copy of the publication).
Regarding claim 6, Dorfman teaches that antiviral gargle may help healthy people avoid coronavirus infection (page 1/14 of the copy). Dorfman teaches the preventive concept of including antiviral gargling is to make the oral mucous membranes of a healthy person less hospitable to the initial viral inoculation (page 4/14 of the copy).
It would have been prima facie obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to prevent COVID-19 (e.g., SARS-CoV-2) by administering by gargling to an individual in need thereof an aqueous solution comprising water, modified sodium silicate (e.g., alkaline cationic silicate) and infused hydrogen gas (e.g., reducing gas); wherein the aqueous solution has an ORP of at least -250 (negatively charged) millivolts; wherein the hydrogen gas is infused at a flow rate of including 1 L per minute (e.g., 60 L/hour) or 1.5 L/min (e.g., 90 L/hour) for 10 minutes in a process that includes cavitation (e.g., turbulent mixing) to provide a uniform and stable composition; wherein the composition comprises including 10 mg/kg of modified sodium silicate (e.g., alkaline cationic silicate) and a 1:100 dilution of modified sodium silicate to water (e.g., about 56.56 ml). The person of ordinary skill in the art would have been motivated to make those modifications to: 1) produce a uniform and stable composition by using the process taught by Katayama that includes cavitation (e.g., turbulent mixing) with infusing hydrogen gas at a flow rate of including 1 L per minute (e.g., 60 L/hour) or 1.5 L/min (e.g., 90 L/hour) for 10 minutes; and 2) provide prevention by administration by gargling to make the oral mucous membranes of a healthy person less hospitable to the initial viral inoculation. The person of ordinary skill in the art would have reasonably expected success because Katayama teaches a process for including gas dissolution in liquid that includes pressurization, compression, stirring, mixing, centrifugation, and cavitation (e.g., mixing under turbulent conditions) in one process and provides a stably uniformized fluid (paragraphs [0039-0040]). Katayama teaches hydrogen gas at a flow rate of 1.5 L/min (e.g., 90 L/hour) and the process ending after 10 minutes (paragraph [0144]). Katayama teaches that cavitation effect worked by entrainment of gas to cause finer emulsification (paragraph [0156]). Katayama teaches infusing hydrogen gas in a rate of 1 L per minute (e.g., 60 L/hour) for 10 minutes (paragraph [0162]). Dorfman teaches that antiviral gargle may help healthy people avoid coronavirus infection (page 1/14 of the copy). Dorfman teaches the preventive concept of including antiviral gargling is to make the oral mucous membranes of a healthy person less hospitable to the initial viral inoculation (page 4/14 of the copy).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Hsueh in view of Ntyonga-Pono and Cisneros as evidenced by the instant specification as applied to claims 1 and 5 above, and further in view of KATAYAMA (US 2012/0256329 A1, publication date of 11 October 2012) and RENNIE (US 2004/0234457 A1, publication date of 25 November 2004).
Regarding claim 7, the method of claim 1 is described above in section 8.
Regarding claim 7, Cisneros teaches dosages comprise 0.01 to 100 mg/kg body weight for periods of time necessary to achieve the desired result (paragraph [0081]). Cisneros teaches that administration of the same compound of the invention may be repeated and the administrations may be separated by including at least 1 day (paragraph [0111]). Cisneros teaches that the silicon-based alkaline composition may be administered one or more times (paragraph [0112]). Cisneros teaches that the specific density of silicon-based alkaline (e.g., modified sodium silicate/alkaline cationic silicate) is in the range of 1.24 to 1.26 (paragraph [0065]). A dosage of .1mg/kg (inside the range of Cisneros) silicon-based alkaline (e.g., modified sodium silicate/alkaline cationic silicate) is calculated to be about 0.56 ml (Calculation: Volume (ml) = Mass (mg) / (Density in g/ml*1000); .7mg (e.g., for 70 kg person, .01mg*70= .7mg) / (1.24 * 1000) ~ 0.0029 ml). Cisneros teaches modified sodium silicate (e.g., alkaline cationic silicate) diluted in DDI water including 1:100 for composition to reduce free radicals (paragraph [0184]). A composition with about 0.29 ml of modified sodium silicate (e.g., alkaline cationic silicate) would have a total volume of about .2929 ml (e.g., 1:100 = .0029 (modified sodium silicate (e.g., alkaline cationic silicate)) : .29 (water)). Therefore, the amount of the composition administered which includes about .29 ml overlaps the range of “0.025 mL to 0.50 mL”, recited in claim 7. Thus, the claim is rendered prima facie obvious. See also MPEP 2144.05 (quoted supra).
Hsueh, Ntyonga-Pono and Cisneros as evidenced by the instant specification does not specifically teach that the composition is formulated for nasal administration, wherein the composition is administered per nostril, wherein the composition is administered via an atomizer mist delivery device configured to deliver a dose ranging from about 0.05 ml/t to about 1.0 ml/t, where “t” is the number of sprays applied per dose.
Katayama is primarily directed towards a processing apparatus which is capable of performing uniform dispersion, dissolution, solubilization, emulsification of gas into liquid (abstract).
Regarding claim 7, Katayama teaches a process for including gas dissolution in liquid that includes pressurization, compression, stirring, mixing, centrifugation, and cavitation (e.g., mixing under turbulent conditions) in one process and provides a stably uniformized fluid (paragraphs [0039-0040]). Katayama teaches that cavitation effect worked by entrainment of gas to cause finer emulsification (paragraph [0156]). Katayama teaches infusing hydrogen gas in a rate of 1 L per minute (e.g., 60 L/hour) for 10 minutes (paragraph [0162]).
Rennie is primarily directed towards methods of preventing and treating a Severe Acute Respiratory Syndrome (SARS) by the administration of respiratory tract compositions, wherein the respiratory tract includes the nasal cavity, to effectively prevent and treat respiratory tract viral infections (abstract).
Regarding claim 7, Rennie teaches administration intranasally to areas of the respiratory tract including the nasal respiratory tract which have been found to effectively contact mucosal tissues and fluids thus create an environment that is hostile to SARS-associated viruses. Rennie teaches that the nasal respiratory tract compositions can be administered in the form of including atomizers (paragraph [0012]). Rennie teaches that the composition are sprayed into each nostril at a volume of about 1 microliter to about 500 microliters (paragraph [0070]).
It would have been prima facie obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to treat or prevent COVID-19 (e.g., SARS-CoV-2) by administering by nasal using an atomizer to an individual in need thereof an aqueous solution comprising water, modified sodium silicate (e.g., alkaline cationic silicate) and infused hydrogen gas (e.g., reducing gas); wherein the aqueous solution has an ORP of at least -250 (negatively charged) millivolts; wherein the hydrogen gas is infused at a flow rate of including 1 L per minute (e.g., 60 L/hour) or 1.5 L/min (e.g., 90 L/hour) for 10 minutes in a process that includes cavitation (e.g., turbulent mixing) to provide a uniform and stable composition; and wherein the composition comprises including 0.01 mg/kg of modified sodium silicate (e.g., alkaline cationic silicate) and a 1:100 dilution of modified sodium silicate to water (e.g., about .29 ml); wherein a spray to each nostril provides a volume of about 1 microliter to about 500 microliters; and wherein the administration is for period of time necessary and repeated for at least 1 day. The person of ordinary skill in the art would have been motivated to make those modifications to: 1) produce a uniform and stable composition by using the process taught by Katayama that includes cavitation (e.g., turbulent mixing) with infusing hydrogen gas at a flow rate of including 1 L per minute (e.g., 60 L/hour) or 1.5 L/min (e.g., 90 L/hour) for 10 minutes; and 2) effectively contact mucosal tissues and fluids to create an environment that is hostile to viruses including SARS-CoV-2 by formulating the composition for nasal administration and administering the composition by nasal. The person of ordinary skill in the art would have reasonably expected success because Katayama teaches a process for including gas dissolution in liquid that includes pressurization, compression, stirring, mixing, centrifugation, and cavitation (e.g., mixing under turbulent conditions) in one process and provides a stably uniformized fluid (paragraphs [0039-0040]). Katayama teaches hydrogen gas at a flow rate of 1.5 L/min (e.g., 90 L/hour) and the process ending after 10 minutes (paragraph [0144]). Katayama teaches that cavitation effect worked by entrainment of gas to cause finer emulsification (paragraph [0156]). Katayama teaches infusing hydrogen gas in a rate of 1 L per minute (e.g., 60 L/hour) for 10 minutes (paragraph [0162]). Rennie teaches administration intranasally to areas of the respiratory tract including the nasal respiratory tract which have been found to effectively contact mucosal tissues and fluids thus create an environment that is hostile to SARS-associated viruses. Rennie teaches that the nasal respiratory tract compositions can be administered in the form of including atomizers (paragraph [0012]). Rennie teaches that the composition are sprayed into each nostril at a volume of about 1 microliter to about 500 microliters (paragraph [0070]).
Claims 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Hsueh in view of Ntyonga-Pono and Cisneros as evidenced by the instant specification as applied to claims 1 and 5 above, and further in view of KATAYAMA (US 2012/0256329 A1, publication date of 11 October 2012) and BAGLEY (US 2006/0273280 A1, publication date of 07 December 2006).
Regarding claims 8-10, the method of claim 1 is described above in section 8.
Regarding claim 8, Cisneros teaches dosages comprise 0.01 to 100 mg/kg body weight for periods of time necessary to achieve the desired result (paragraph [0081]). Cisneros teaches formulations for including oral including liquid formulations (paragraph [0084]). Cisneros teaches that administration of the same compound of the invention may be repeated and the administrations may be separated by including at least 1 day (paragraph [0111]). Cisneros teaches that the silicon-based alkaline composition may be administered one or more times (paragraph [0112]). Cisneros teaches that the specific density of silicon-based alkaline (e.g., modified sodium silicate/alkaline cationic silicate) is in the range of 1.24 to 1.26 (paragraph [0065]). A dosage of 0.01 to 100 mg/kg silicon-based alkaline (e.g., modified sodium silicate/alkaline cationic silicate) is calculated to be about 0.0029 ml (Calculation: Volume (ml) = Mass (mg) / (Density in g/ml*1000); .7mg (e.g., for 70 kg person, 0.01mg*70= .7mg) / (1.24 * 1000) ~ 0.00056 ml) to ml (Calculation: Volume (ml) = Mass (mg) / (Density in g/ml*1000); 700,000mg (e.g., for 70 kg person, 100mg*70= 700,000mg) / (1.24 * 1000) ~ 564 ml). Cisneros teaches modified sodium silicate (e.g., alkaline cationic silicate) diluted in DDI water including 1:100 for composition to reduce free radicals (paragraph [0184]). A composition with about 0.0029 ml to 564 ml of modified sodium silicate (e.g., alkaline cationic silicate) would have a total volume of about .29 ml (e.g., 1:100 = .0029 (modified sodium silicate (e.g., alkaline cationic silicate)) : .29 (water)) to 56,964 ml (e.g., 1:100 = 564 (modified sodium silicate (e.g., alkaline cationic silicate)) : 56,400 (water)). Therefore, the amount of the composition administered is about .29 ml to about 56,964 ml and the amount of (modified sodium silicate (e.g., alkaline cationic silicate) of about .29 ml to about 56,964 ml overlaps the range of “10-100 mL”, recited in claim 8. Thus, the claim is rendered prima facie obvious. See also MPEP 2144.05 (quoted supra).
Regarding claims 9-10, Ntyonga-Pono teaches suggestion for prevention (e.g., individual has not tested positive for COVID-19 infection) and treatment of COVID-19 infection (e.g., individual has tested positive for COVID-19 infection) in frail people is to reduce the level of oxidative stress by providing them with substances that increase their antioxidant system with antioxidant compounds including glutathione which is an antioxidant and that also has an immunomodulating effect (second page, first column, last paragraph). Cisneros teaches administering to a patient to treat a viral infection (e.g., individual has tested positive for COVID-19 infection) or preventing a viral infection (e.g., individual has not tested positive for COVID-19 infection) an effective amount of the silicon-based alkaline composition (e.g., modified sodium silicate/alkaline cationic silicate) (paragraphs [0072-0073]).
Hsueh, Ntyonga-Pono and Cisneros as evidenced by the instant specification does not specifically teach that the composition is formulated as a concentrated syrup prepared by mixing the aqueous solution, metasilicate and reducing gas at a flow rate of 25-75 liters of reducing gas per hour under turbulent conditions, for at least five minutes. The deficiencies are made up for by the teachings of Katayama and Bagley.
Katayama is primarily directed towards a processing apparatus which is capable of performing uniform dispersion, dissolution, solubilization, emulsification of gas into liquid (abstract).
Regarding claim 8, Katayama teaches a process for including gas dissolution in liquid that includes pressurization, compression, stirring, mixing, centrifugation, and cavitation (e.g., mixing under turbulent conditions) in one process and provides a stably uniformized fluid (paragraphs [0039-0040]). Katayama teaches that cavitation effect worked by entrainment of gas to cause finer emulsification (paragraph [0156]). Katayama teaches infusing hydrogen gas in a rate of 1 L per minute (e.g., 60 L/hour) for 10 minutes (paragraph [0162]).
Bagley is primarily directed towards composition having a negative oxidation reducing potential (ORP).
Regarding claims 8-10, Bagley teaches water having a negative oxidation reduction potential (ORP) (paragraph [0024]). Bagley teaches that for oral administration the composition can be in the form of including syrups (paragraph [0105]).
It would have been prima facie obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to treat (e.g., individual has tested positive for COVID-19 infection) or prevent (e.g., individual has not tested positive for COVID-19 infection) COVID-19 (e.g., SARS-CoV-2) by administering to an individual in need thereof a composition in the form of a syrup that comprises an aqueous solution comprising water, modified sodium silicate (e.g., alkaline cationic silicate) and infused hydrogen gas (e.g., reducing gas); wherein the aqueous solution has an ORP of at least -250 (negatively charged) millivolts; wherein the hydrogen gas is infused at a flow rate of including 1 L per minute (e.g., 60 L/hour) or 1.5 L/min (e.g., 90 L/hour) for 10 minutes in a process that includes cavitation (e.g., turbulent mixing) to provide a uniform and stable composition; wherein the composition comprises from 0.01 mg/kg to 100 mg/kg of modified sodium silicate (e.g., alkaline cationic silicate) and a 1:100 dilution of modified sodium silicate to water (e.g., about .29 ml to 56,956 ml total); and wherein the administration is for period of time necessary and repeated for at least 1 day. The person of ordinary skill in the art would have been motivated to make those modifications to: 1) produce a uniform and stable composition by using the process taught by Katayama that includes cavitation (e.g., turbulent mixing) with infusing hydrogen gas at a flow rate of including 1 L per minute (e.g., 60 L/hour) or 1.5 L/min (e.g., 90 L/hour) for 10 minutes; and 2) to administer the composition orally in a desired oral formulation including syrup formulation. The person of ordinary skill in the art would have reasonably expected success because Katayama teaches a process for including gas dissolution in liquid that includes pressurization, compression, stirring, mixing, centrifugation, and cavitation (e.g., mixing under turbulent conditions) in one process and provides a stably uniformized fluid (paragraphs [0039-0040]). Katayama teaches hydrogen gas at a flow rate of 1.5 L/min (e.g., 90 L/hour) and the process ending after 10 minutes (paragraph [0144]). Katayama teaches that cavitation effect worked by entrainment of gas to cause finer emulsification (paragraph [0156]). Katayama teaches infusing hydrogen gas in a rate of 1 L per minute (e.g., 60 L/hour) for 10 minutes (paragraph [0162]). Bagley teaches water having a negative oxidation reduction potential (ORP) (paragraph [0024]). Bagley teaches that for oral administration the composition can be in the form of including syrups (paragraph [0105]).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Hsueh in view of Ntyonga-Pono and Cisneros as evidenced by the instant specification as applied to claims 1 and 5 above, further in view of Katayama and Bagley as applied to claims 8-10, and further in view of MIAO (JP 2017079606 A, publication date of 18 May 2017).
Regarding claim 11, the method of claim 1 is described in section 8 and the method of claim 8 is described above in section 12.
Regarding claim 11, Hsueh discloses that it is generally believed that treated water (e.g., hydrogen gas-enriched water) must develop an ORP of at least -250 (negatively charged) millivolts to produce health benefits and discloses including -500 millivolts (paragraph [0029]). Hsueh discloses oxidation reduction potential comprising between -250 and -600 millivolts (claim 8 of Hsueh).
Regarding claim 11, Bagley teaches mixing with a sweetener for flavor (paragraph [0075]).
Hsueh, Ntyonga-Pono, Cisneros, Katayama and Bagley as evidenced by the instant specification does not specifically teach that the flavorant is selected from honey and ginger root extract. The deficiency is made up for by the teachings of Miao.
Miao is primarily directed towards an antioxidative functional beverage with including dissolved hydrogen gas and a minus oxidation-reduction potential (Abstract of English translation).
Regarding claim 11, Miao teaches an antioxidant beverage with a redox potential between about -10 mV and -600 mV (third page, third paragraph of the English translation). Miao teaches that the beverage includes sweetener including honey (third page, fifth paragraph of the English translation).
It would have been prima facie obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to treat (e.g., individual has tested positive for COVID-19 infection) or prevent (e.g., individual has not tested positive for COVID-19 infection) COVID-19 (e.g., SARS-CoV-2) by administering to an individual in need thereof a composition in the form of a syrup that comprises an aqueous solution comprising water, modified sodium silicate (e.g., alkaline cationic silicate), infused hydrogen gas (e.g., reducing gas) and a honey; wherein the aqueous solution has an ORP of -250 (negatively charged) millivolts to -600 (negatively charged) millivolts; wherein the hydrogen gas is infused at a flow rate of including 1 L per minute (e.g., 60 L/hour) or 1.5 L/min (e.g., 90 L/hour) for 10 minutes in a process that includes cavitation (e.g., turbulent mixing) to provide a uniform and stable composition; wherein the composition comprises from 0.01 mg/kg to 100 mg/kg of modified sodium silicate (e.g., alkaline cationic silicate) and a 1:100 dilution of modified sodium silicate to water (e.g., about .29 ml to 56,956 ml total); and wherein the administration is for period of time necessary and repeated for at least 1 day. The person of ordinary skill in the art would have been motivated to make those modifications to sweeten the composition by adding a sweetener including honey which is a suitable sweetener for an antioxidative composition with a negative ORP, as taught by Miao. The person of ordinary skill in the art would have reasonably expected success because Miao teaches an antioxidant beverage with a redox potential between about -10 mV and -600 mV (third page, third paragraph of the English translation). Miao teaches that the beverage includes sweetener including honey (third page, fifth paragraph of the English translation).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Hsueh in view of Ntyonga-Pono and Cisneros as evidenced by the instant specification as applied to claims 1 and 5 above, further in view of SIBER (US 2004/0235047 A1, publication date of 25 November 2004).
Regarding claim 13, the method of claim 1 is described above in section 8.
Regarding claim 13, Cisneros teaches administration in combination with other anti-viral agents (paragraph [0112]).
Hsueh, Ntyonga-Pono and Cisneros as evidenced by the instant specification does not specifically teach that the composition is administered in combination with hydroxychloroquine and/or azithromycin. The deficiency is made up for by the teachings of Siber.
Siber is primarily directed towards composition and methods for treating Severe Acute Respiratory Syndrome (SARS) (abstract).
Regarding claim 13, Siber teaches compositions and methods for treating Severe Acute Respiratory Syndrome (SARS) (paragraph [0012]). Siber teaches that medicaments to treat the diseases may be administered concurrently with composition comprising including hydroxychloroquine sulfate (paragraph [0052]). Siber teaches that the composition additionally comprise anti-opportunistic infection agents including azithromycin (paragraph [0126]).
It would have been prima facie obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to treat or prevent COVID-19 (e.g., SARS-CoV-2) by administering to an individual in need thereof an aqueous solution comprising water, modified sodium silicate (e.g., alkaline cationic silicate) and infused hydrogen gas (e.g., reducing gas); wherein the aqueous solution has an ORP of at least -250 (negatively charged) millivolts; and wherein the composition is administered in combination with including hydroxychloroquine or azithromycin. The person of ordinary skill in the art would have been motivated to make those modifications because other actives suitable for administration in combination with compositions for treating Severe Acute Respiratory Syndrome (SARS) includes hydroxychloroquine or azithromycin, which one of ordinary skill in the art would expect to be suitable to administer in combination in order to treat COVID-19 (e.g., SARS-CoV-2). The person of ordinary skill in the art would have reasonably expected success because Cisneros teaches administration in combination with other anti-viral agents or anti-viral therapies (paragraph [0112]). Siber teaches compositions and methods for treating Severe Acute Respiratory Syndrome (SARS) (paragraph [0012]). Siber teaches that medicaments to treat the diseases may be administered concurrently with composition comprising including hydroxychloroquine sulfate (paragraph [0052]). Siber teaches that the composition additionally comprise anti-opportunistic infection agents including azithromycin (paragraph [0126]).
Thus, the claimed invention as a whole is clearly prima facie obvious over the teachings of the prior art.
Response to Arguments
Applicant’s first argument on page 8 is that those of ordinary skill in the art would not have been motivated to combine Hsueh, Ntyonga-Pono, or Cisneros as of the instant application’s priority date. Applicant argues that Hsueh is silent with respect to viruses let alone SARS-CoV-2, therefore, those of ordinary skill in the art would not have been motivated to combine Hsueh with the virus-centered disclosures of Ntyonga-Pono or Cisneros. Applicant argues that Hsueh merely recites “anti-oxidant” and “immune-boosting” in paragraph [0014] as distinct and separate items in a list speculating about the “health benefits and effects [that] are believed to be possible from the human consumption of hydrogen gas, and/or drinking water infused with hydrogen gas.” Applicant argues that Hsueh offers those of ordinary skill in the art speculations and not data or otherwise. Applicant argues on page 9 that Ntyonga-Pono’s consideration of SARS-CoV-2 is mere conjecture. Applicant argues that Ntyonga-Pono expressly states that an oxidate storm had not been demonstrated, and Ntyonga-Pono states that this “hypothesis” remains untested. Applicant argues that Ntyonga-Pono also expressly indicates that its statements regarding SARS-CoV-2 and oxidative stress are speculative. Applicant argues that Ntyonga-Pono’s “proposal” merely identifies untested candidate antioxidants and none of the untested candidate antioxidants implicate any reducing gas or any alkaline cationic silicate. Applicant argues on page 10 that Cisneros exclusively concerns the effects of the modified sodium silicate disclosed therein. Applicant argues that Cisneros, therefore, would not have motivated those of ordinary skill in the art to look beyond the disclosed modified sodium silicate with respect to inhibiting oxidative stress. Applicant argues that Cisneros’s broader disclosure regarding oxidative stress does not include or implicate any reducing gas. Applicant argues that Cisneros would at least not have motivated those of ordinary skill in the art to consider a disclosure like Hsueh’s that has nothing to do with the modified sodium silicate disclosed in Cisneros.
Applicant's arguments filed on 20 January 2026 have been fully considered but they are not persuasive. In response, Hsueh discloses that ionized water including water infused or treated with hydrogen gas, exhibit anti-oxidant properties, which help reduce free radicals in the body (paragraph [0003]). Hsueh discloses that benefits including anti-oxidant are believed to be possible from the human consumption of hydrogen gas and/or drinking water infused with hydrogen gas (paragraph [0014]). Ntyonga-Pono teaches that it is known that oxidative stress is triggered by a wide variety of viral infections including respiratory viruses and most of the RNA viruses probably also corona viruses belonging to this family. Ntyonga-Pono teaches corona viruses that are encapsulated RNA viruses include COVID-19. Ntyonga-Pono teaches that, generally, viral infections lead to an increase in production of free radicals and a depletion of antioxidants (page 2, first column, first paragraph). Ntyonga-Pono teaches that “cytokine storm” in COVID-19 leads to production of ROS (reactive oxygen species) (second page, first column, first paragraph). Ntyonga-Pono teaches that elders and people suffering of diabetes, hypertension and cardiovascular diseases have already a state of oxidative stress, and a viral infection will increase the oxidative stress, giving one possible explanation of the severity of COVID-19 in these categories of patients (second page, first column, third paragraph). Ntyonga-Pono teaches suggestion for prevention and treatment of COVID-19 infection in frail people is to reduce the level of oxidative stress by providing them with substances that increase their antioxidant system with antioxidant compounds including glutathione which is an antioxidant (second page, first column, last paragraph). Ntyonga-Pono suggest to use also antioxidant agents in treatment of Covid-10 (page 2, second column, last paragraph). Cisneros teaches a silicon-based alkaline composition (e.g., modified sodium silicate (paragraph [0010])) for including inhibiting oxidative stress (paragraph [0002]). As evidenced by the instant specification, a metasilicate includes an alkaline sodium silicate complex (e.g., modified sodium silicate/silicon-based alkaline composition) (paragraph [0051] of the instant specification). Cisneros teaches that the composition can be used to treat including viral infection in a subject in need thereof, by providing one or more anti-viral effects including increasing nitric oxide dependent anti-viral effects; inhibiting enzymes involved in viral assembly; causing changes in viral carbohydrate composition; and inhibiting viral enzymes responsible for transcribing RNA to DNA (paragraph [0014]). Therefore, Hsueh provides a reasonable expectation for one of ordinary skill in the art that hydrogen gas infused in drinking water provides anti-oxidant properties, Ntyonga-Pono provides a reasonable expectation for one of ordinary skill in the art to include administration of antioxidants in treating Covid-19 infection since it is known that most viral infections and even RNA viruses which Covid-19 falls under, and Cisneros provides a reasonable expectation for one of ordinary skill in the art that silicon-based alkaline composition (e.g., silicon-based alkaline composition) can administered as an antioxidant with added effect of anti-viral effect. In light of the disclosure of Hsueh and the teachings of Ntyonga-Pono and Cisneros, described above, it would have been prima facie obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to treat or prevent COVID-19 (e.g., SARS-CoV-2) by administering to an individual in need thereof an aqueous solution comprising water, modified sodium silicate (e.g., a metasilicate) and infused hydrogen gas (e.g., reducing gas); wherein the aqueous solution has an ORP of at least -250 (negative) millivolts. The person of ordinary skill in the art would have been motivated to make those modifications because: 1) hydrogen gas infused in water with an ORP of at least -250 (negative) millivolts provides benefits of including providing antioxidant properties and immune-boosting which are effects that Ntyonga-Pono suggests are beneficial for use in prevention and treatment of COVID-19 (e.g., SARS-CoV-2); and 2) modified sodium silicate (e.g., alkaline cationic silicate) is another antioxidant that can be added for the same purpose of providing antioxidant effects and that will additionally provide anti-viral prevention and treatment properties as taught by Cisneros.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413,208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Further, 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).
Applicant is reminded that obviousness does not require absolute predictability, however, at least some degree of predictability is required. Evidence showing there was no reasonable expectation of success may support a conclusion of nonobviousness. In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976). See MPEP 2143.02(II).
Applicant argues on page 11 that Ntyonga-Pono purports that nitric oxide is among one of the reactive species that antioxidants must combat and Cisneros purports that nitric oxide is one way to exert antiviral effects and further purports that the disclosed modified sodium silicate increases nitric-oxide-dependent anti-viral effects. Applicant argues that those of ordinary skill in the art would not have been motivated to combine Cisneros and Ntyonga-Pono because they teach away from each other.
In response, Ntyonga-Pono teaches that nitric oxide will react with superoxide ion (e.g., free radicals/reactive oxygen species (ROS)) to give powerful oxidizing peroxynitrite radical (page 2, first column, first paragraph). Cisneros teaches that modified sodium silicate (e.g., alkaline cationic silicate) is able to reduce free radical induced oxidation (paragraph [0183]). Cisneros teaches that modified sodium silicate inhibits viral infection by inhibiting enzymes in viral assembly, changing the sugar composition in various and inhibiting enzymes responsible for transcribing RNA (paragraph [0200]). Thus, Cisneros does not teach away from Ntyonga-Pono because Cisneros teaches that modified sodium silicate (e.g., alkaline cationic silicate) reduces free radical including ROS (e.g., superoxide which would reduce reaction with nitric oxide to give peroxynitrite radical) and that the antiviral effect of modified sodium silicate (e.g., alkaline cationic silicate) includes inhibiting enzymes in viral assembly, changing the sugar composition in various and inhibiting enzymes responsible for transcribing RNA.
Applicant argues on page 11 that those of ordinary skill in the art would not have had a reasonable expectation of success at arriving at the instantly claimed method at least because Ntyonga-Pono would have failed to provide any reasonable expectation of success that any compound would treat or prevent a SARS-CoV-2 infection or a symptom thereof; Cisneros would have failed to provide a reasonable expectation of success that the purported antiviral effects of the modified sodium silicate composition disclosed therein would be observed with respect to a SARS-CoV-2 infection or a symptom thereof; and Hsueh would not have even provided a reasonable expectation of success that any of the purported outcomes of consuming hydrogen gas could have been achieved. Applicant argues on page 12 that Ntyonga-Pono’s statements regarding SARS-CoV-2 are almost entirely conjecture. Applicant argues that Ntyonga-Pono is clear that the field had yet to demonstrate whether SARS-CoV-2 produced oxidative stress. Applicant argues that Ntyonga-Pono also characterizes its position regarding oxidative stress and the severity of SARS-CoV-2 in people suffering of diabetes, hypertension and cardiovascular diseases is further conjecture as merely “one possible explanation”, therefore, those of ordinary skill in the art did not even have a reasonable expectation that oxidative stress was any explanation of SARS-CoV-2 severity let alone a substantive one. Applicant argues that Ntyonga-Pono admits there is no evidence that increasing antioxidant systems will have any effect on SARS-CoV-2 in any patient population let alone “frail people”, there is no evidence that oxidative stress in any way contributes to the severity of SARS-CoV-2 let alone meaningfully, and the field has yet to even determine whether SARS-CoV-2 in fact triggers any oxidative stress let alone meaningful levels. Applicant argues that those of ordinary skill in the art would in no way have had a reasonable expectation of success with respect to any of the substances identified by Ntyonga-Pono and that Ntyonga-Pono does not include or implicate any reducing gas or alkaline cationic silicate with the proposed untested candidates.
In response, Ntyonga-Pono teaches that it is known that oxidative stress is triggered by a wide variety of viral infections including respiratory viruses and most of the RNA viruses probably also corona viruses belonging to this family. Ntyonga-Pono teaches corona viruses that are encapsulated RNA viruses include COVID-19. Ntyonga-Pono teaches that, generally, viral infections lead to an increase in production of free radicals and a depletion of antioxidants (page 2, first column, first paragraph). Ntyonga-Pono teaches that “cytokine storm” in COVID-19 leads to production of ROS (reactive oxygen species) (second page, first column, first paragraph). Ntyonga-Pono teaches that elders and people suffering of diabetes, hypertension and cardiovascular diseases have already a state of oxidative stress, and a viral infection will increase the oxidative stress, giving one possible explanation of the severity of COVID-19 in these categories of patients (second page, first column, third paragraph). Ntyonga-Pono teaches suggestion for prevention and treatment of COVID-19 infection in frail people is to reduce the level of oxidative stress by providing them with substances that increase their antioxidant system with antioxidant compounds including glutathione which is an antioxidant (second page, first column, last paragraph). Ntyonga-Pono suggest to use also antioxidant agents in treatment of Covid-10 (page 2, second column, last paragraph). Therefore, from the teachings of Ntyonga-Pono, one of ordinary skill in the art would have had reasonable expectation of success that antioxidants administration can be included for treatment of Covid-10 because Ntyonga-Pono teaches that it is known that oxidative stress is triggered by a wide variety of viral infections including respiratory viruses and most of the RNA viruses which is a family COVID-19 belongs to and Ntyonga-Pono suggest to use also antioxidant agents in treatment of Covid-10.
Applicant argues on page 13 that Hsueh is silent regarding viruses and treating or preventing viral infections or symptoms thereof. Applicant argues that paragraphs [0013-0014] of Hsueh merely recite outcomes that ingestion or consumption of hydrogen gas are “believed to provide” or “are believed to be possible”. Applicant argues that Hsueh does not provide any disclosure, data or otherwise, that demonstrates these purported effects in fact occur or are reasonably expected to occur. Applicant argues that one of ordinary skill in the art would not have had a reasonable expectation that any of the effects listed in paragraphs [0013-0014] of Hsueh could have been achieved or combined that effect with Ntyonga-Pono or Cisneros.
In response, Hsueh discloses that ionized water including water infused or treated with hydrogen gas, exhibit anti-oxidant properties, which help reduce free radicals in the body (paragraph [0003]). Hsueh discloses that benefits including anti-oxidant are believed to be possible from the human consumption of hydrogen gas and/or drinking water infused with hydrogen gas (paragraph [0014]). Therefore, there is a reasonable expectation that water infused with hydrogen gas exhibit anti-oxidant properties.
Applicant is reminded that obviousness does not require absolute predictability, however, at least some degree of predictability is required. Evidence showing there was no reasonable expectation of success may support a conclusion of nonobviousness. In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976). See MPEP 2143.02(II).
Applicant argues on page 14 that Cisneros’s antiviral working examples employ a viral component that are HIV components and that retrovirus like HIV are distinguishable from other virus with respect to antiviral considerations. Applicant argues that Ntyonga-Pono distinguishes SARS-CoV-2 as a new variant “discovered in January 2020”, therefore, those of ordinary skill in the art would not have had a reasonable expectation that the modified sodium silicate composition disclosed in Cisneros would treat or prevent SARS-CoV-2 infections or symptoms thereof.
In response, Ntyonga-Pono teaches that it is known that oxidative stress is triggered by a wide variety of viral infections including respiratory viruses and most of the RNA viruses probably also corona viruses belonging to this family. Ntyonga-Pono teaches corona viruses that are encapsulated RNA viruses include COVID-19. Ntyonga-Pono teaches that, generally, viral infections lead to an increase in production of free radicals and a depletion of antioxidants (page 2, first column, first paragraph). Cisneros teaches that oxidative stress results from an abnormal level of reactive oxygen species (ROS), which can occur as a result of including viral infection (paragraph [0008]). Cisneros teaches that modified sodium silicate is effective in vitro against including viral infection (paragraph [0010]) and teaches administration of modified sodium silicate for treating viral infection in a subject (paragraph [0014]). Thus, in light of the teachings of Ntyonga-Pono and Cisneros, one of ordinary skill in the art would have had a reasonable expectation that modified sodium silicate taught by Cisnerso can be administered to treat or prevent SARS-CoV-2.
Thus, for the reasons of record and for the reasons presented above claims 1-11 and 13 are rejected under 35 U.S.C. 103(a).
Conclusion and Correspondence
No claims are allowed.
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 extension fee 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 date of this final action.
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/JOHN P NGUYEN/
Examiner, Art Unit 1619
/ANNA R FALKOWITZ/Primary Examiner., Art Unit 1600
